Powerpoint Presentation

Using the following assigned scenario below and attachments, please complete the following:

Creating the PowerPoint Presentation:

Survey Readiness PowerPoint:
Must be 10-12 slides, excluding the introduction slide(s) and reference page slide(s).
Presenter Notes:
Every slide must have presenter notes except for the reference page(s).
Your presenter notes will be the information that you will be sharing with your team.
Your notes should be detailed and contain APA in-text citations.
References:
Minimum of five scholarly references, professional publications, and/or academic journals from the last five years.
Include any references from your assigned LTC facility or setting such as the website, company information, facility website, service-level website, etc.
Every reference must have a correlating in-text citation(s).

Save Time On Research and Writing

Hire a Pro to Write You a 100% Plagiarism-Free Paper.

Get My Paper
APA 7th Edition Style:
PowerPoint slides, cover page, and reference page.

The PowerPoint Must Contain the Following Content Aspects for Your Assigned Scenario:

Aspect A: Introduction Slide(s)

APA Cover Page – Include the title of the presentation, your name, your instructor’s name, course name, your assigned LTC facility or setting, your assigned regulation, and date submitted.
Provide bulleted points to identify each Content Aspect that will be presented in the presentation.

Aspect B: Regulatory Survey Readiness Analysis Slide(s)

Provide an analysis of the regulatory survey process that includes the importance of survey readiness; a mock survey overview; and an assessment of being survey ready, as a means for creating successful survey outcomes.

Aspect C: Stakeholders Evaluation and Leadership Selection Analyses Slide(s)

Include an evaluation of at least three stakeholders for the regulatory survey process.
You must include the internal stakeholders of the patients and/or residents.
The other stakeholders that you present, as part of your evaluation, may be internal or external.
Include at least two of the applicable items from this list in your evaluation of the stakeholders: (a.) survey awareness; (b.) survey process understanding; (c.) survey engagement; (d.) stakeholder contribution; (e.) stakeholder justification; and/or (f.) importance of the stakeholder.
Identify at least three specific leadership roles that will be involved in the mock survey process and provide an analysis of the assigned facility-level or service-level leaders involved in the mock survey.
You must include the Administrator, Executive Director, or a top leader of the LTC facility or service in your analysis.
The other two leadership roles may be any manager or director-level position at your assigned LTC facility or service for your analysis.

Aspect D: Regulation Assessment Slide(s)

State the regulation that you assigned from your scenario and provide an assessment of this regulation to your assigned LTC facility or setting.
You must include the regulatory standard, condition, rule, and/or tag in the assessment.
Include an evaluation of the mock survey process for the assigned regulation, applying this information to your assigned LTC facility or setting.

Apply your assigned specific regulation for one mock survey step, as this will act as an introduction for your LTC employees to understand the entire mock survey process. (Note – Remember you are only introducing the mock survey process to your staff, so this should be an overview of the potential regulatory mock survey steps.)

Aspect E: Conclusion Slide(s)

Highlight the key takeaways of your presentation and include an explanation to why the information presented in the PowerPoint is essential for the staff to know.
Include one call to action and share with your team any next steps for the upcoming mock survey.

Aspect F: APA Reference Page Slide(s)

Provide the list of all references presented in the PowerPoint, formatted in APA 7th Edition.

***********ASSIGNED SCENARIO BELOW*********************************

Option C: Maryland Skilled Nursing Facilities

SNF Option 3: Waldorf Center located in Waldorf, Maryland

SNF Regulation Option 2: Federal CMS SNF Regulation: Freedom from

Abuse, Neglect, and Exploitation 483.12 o Regulatory Reference: Reporting of Alleged Violations 483.12(b) o Regulatory Tag: F608

o Regulatory Information: Page 1 of the CMS SNF F Tags June 2021 PDF and Pages 141 to 150 of the CMS State Operations Manual Appendix PP for LTC Facilities.

Healthcare Administrationhealthcare management

Federal Regulatory Groups for Long Term Care
*Substandard Quality of Care = one or more deficiencies with s/s levels of F, H, I, J, K, or L in Red

** Tag to be cited by CMS

June 2023 Page 1

F540 Definitions 483.12 Freedom from Abuse, Neglect, and Exploitation 483.24 Quality of Life
483.10 Resident Rights F600 *Free from Abuse and Neglect F675 *Quality of Life

F550 *Resident Rights/Exercise of Rights F602 *Free from Misappropriation/Exploitation F676 *Activities of Daily Living (ADLs)/ Maintain Abilities
F551 Rights Exercised by Representative F603 *Free from Involuntary Seclusion F677 *ADL Care Provided for Dependent Residents
F552 Right to be Informed/Make Treatment Decisions F604 *Right to be Free from Physical Restraints F678 *Cardio‐Pulmonary Resuscitation (CPR)
F553 Right to Participate in Planning Care F605 *Right to be Free from Chemical Restraints F679 *Activities Meet Interest/Needs of Each Resident
F554 Resident Self‐Admin Meds‐Clinically Appropriate F606 *Not Employ/Engage Staff with Adverse Actions F680 *Qualifications of Activity Professional
F555 Right to Choose/Be Informed of Attending Physician F607 *Develop/Implement Abuse/Neglect, etc. Policies 483.25 Quality of Care
F557 Respect, Dignity/Right to have Personal Property F609 *Reporting of Alleged Violations F684 Quality of Care
F558 *Reasonable Accommodations of Needs/Preferences F610 *Investigate/Prevent/Correct Alleged Violation F685 *Treatment/Devices to Maintain Hearing/Vision
F559 *Choose/Be Notified of Room/Roommate Change F686 *Treatment/Svcs to Prevent/Heal Pressure Ulcers
F560 Right to Refuse Certain Transfers 483.15 Admission, Transfer, and Discharge F687 *Foot Care
F561 *Self Determination F620 Admissions Policy F688 *Increase/Prevent Decrease in ROM/Mobility
F562 Immediate Access to Resident F621 Equal Practices Regardless of Payment Source F689 *Free of Accident Hazards/Supervision/Devices
F563 Right to Receive/Deny Visitors F622 Transfer and Discharge Requirements F690 *Bowel/Bladder Incontinence, Catheter, UTI
F564 Inform of Visitation Rights/Equal Visitation Privileges F623 Notice Requirements Before Transfer/Discharge F691 *Colostomy, Urostomy, or Ileostomy Care
F565 *Resident/Family Group and Response F624 Preparation for Safe/Orderly Transfer/Discharge F692 *Nutrition/Hydration Status Maintenance
F566 Right to Perform Facility Services or Refuse F625 Notice of Bed Hold Policy Before/Upon Transfer F693 *Tube Feeding Management/Restore Eating Skills
F567 Protection/Management of Personal Funds F626 Permitting Residents to Return to Facility F694 *Parenteral/IV Fluids
F568 Accounting and Records of Personal Funds 483.20 Resident Assessments F695 *Respiratory/Tracheostomy care and Suctioning
F569 Notice and Conveyance of Personal Funds F635 Admission Physician Orders for Immediate Care F696 *Prostheses
F570 Surety Bond ‐ Security of Personal Funds F636 Comprehensive Assessments & Timing F697 *Pain Management
F571 Limitations on Charges to Personal Funds F637 Comprehensive Assmt After Significant Change F698 *Dialysis
F572 Notice of Rights and Rules F638 Quarterly Assessment At Least Every 3 Months F699 *Trauma Informed Care
F573 Right to Access/Purchase Copies of Records F639 Maintain 15 Months of Resident Assessments F700 *Bedrails
F574 Required Notices and Contact Information F640 Encoding/Transmitting Resident Assessment 483.30 Physician Services
F575 Required Postings F641 Accuracy of Assessments F710 Resident’s Care Supervised by a Physician
F576 Right to Forms of Communication with Privacy F642 Coordination/Certification of Assessment F711 Physician Visits‐ Review Care/Notes/Order
F577 Right to Survey Results/Advocate Agency Info F644 Coordination of PASARR and Assessments F712 Physician Visits‐Frequency/Timeliness/Alternate NPPs
F578 Request/Refuse/Discontinue Treatment;Formulate Adv Di F645 PASARR Screening for MD & ID F713 Physician for Emergency Care, Available 24 Hours
F579 Posting/Notice of Medicare/Medicaid on Admission F646 MD/ID Significant Change Notification F714 Physician Delegation of Tasks to NPP
F580 Notify of Changes (Injury/Decline/Room, Etc.) 483.21 Comprehensive Resident Centered Care Plan F715 Physician Delegation to Dietitian/Therapist
F582 Medicaid/Medicare Coverage/Liability Notice F655 Baseline Care Plan 483.35 Nursing Services
F583 Personal Privacy/Confidentiality of Records F656 Develop/Implement Comprehensive Care Plan F725 Sufficient Nursing Staff
F584 *Safe/Clean/Comfortable/Homelike Environment F657 Care Plan Timing and Revision F726 Competent Nursing Staff
F585 Grievances F658 Services Provided Meet Professional Standards F727 RN 8 Hrs/7 days/Wk, Full Time DON
F586 Resident Contact with External Entities F659 Qualified Persons F728 Facility Hiring and Use of Nurse

F660 Discharge Planning Process F729 Nurse Aide Registry Verification, Retraining
F661 Discharge Summary F730 Nurse Aide Perform Review – 12Hr/Year In‐ service
F731 Waiver‐Licensed Nurses 24Hr/Day and RN Coverage
F732 Posted Nurse Staffing Information

Federal Regulatory Groups for Long Term Care
*Substandard Quality of Care = one or more deficiencies with s/s levels of F, H, I, J, K, or L in Red

** Tag to be cited by CMS

June 2023 Page 2

483.40 Behavioral Health F811 Feeding Asst ‐Training/Supervision/Resident 483.90 Physical Environment
F740 Behavioral Health Services F812 Food Procurement, Store/Prepare/Serve ‐ Sanitary F906 Emergency Electrical Power System
F741 Sufficient/Competent Staff‐Behav Health Needs F813 Personal Food Policy F907 Space and Equipment
F742 *Treatment/Svc for Mental/Psychosocial Concerns F814 Dispose Garbage & Refuse Properly F908 Essential Equipment, Safe Operating Condition
F743 *No Pattern of Behavioral Difficulties Unless Unavoidable 483.65 Specialized Rehabilitative Services F909 Resident Bed
F744 *Treatment /Service for Dementia F825 Provide/Obtain Specialized Rehab Services F910 Resident Room
F745 *Provision of Medically Related Social Services F826 Rehab Services‐ Physician Order/Qualified Person F911 Bedroom Number of Residents
483.45 Pharmacy Services 483.70 Administration F912 Bedrooms Measure at Least 80 Square Ft/Resident
F755 Pharmacy Svcs/Procedures/Pharmacist/ Records F835 Administration F913 Bedrooms Have Direct Access to Exit Corridor
F756 Drug Regimen Review, Report Irregular, Act On F836 License/Comply w/Fed/State/Local Law/Prof Std F914 Bedrooms Assure Full Visual Privacy
F757 *Drug Regimen is Free From Unnecessary Drugs F837 Governing Body F915 Resident Room Window
F758 *Free from Unnec Psychotropic Meds/PRN Use F838 Facility Assessment F916 Resident Room Floor Above Grade
F759 *Free of Medication Error Rate sof 5% or More F839 Staff Qualifications F917 Resident Room Bed/Furniture/Closet
F760 *Residents Are Free of Significant Med Errors F840 Use of Outside Resources F918 Bedrooms Equipped/Near Lavatory/Toilet
F761 Label/Store Drugs & Biologicals F841 Responsibilities of Medical Director F919 Resident Call System
483.50 Laboratory, Radiology, and Other Diagnostic Services F842 Resident Records ‐ Identifiable Information F920 Requirements for Dining and Activity Rooms
F770 Laboratory Services F843 Transfer Agreement F921 Safe/Functional/Sanitary/ Comfortable Environment
F771 Blood Blank and Transfusion Services F844 Disclosure of Ownership Requirements F922 Procedures to Ensure Water Availability
F772 Lab Services Not Provided On‐Site F845 Facility closure‐Administrator F923 Ventilation
F773 Lab Svs Physician Order/Notify of Results F846 Facility closure F924 Corridors Have Firmly Secured Handrails
F774 Assist with Transport Arrangements to Lab Svcs F847 Enter into Binding Arbitration Agreements F925 Maintains Effective Pest Control Program
F775 Lab Reports in Record‐Lab Name/Address F848 Select Arbitrator/Venue, Retention of Agreements F926 Smoking Policies
F776 Radiology/Other Diagnostic Services F849 Hospice Services 483.95 Training Requirements
F777 Radiology/Diag. Svcs Ordered/Notify Results F850 *Qualifications of Social Worker >120 Beds F940 Training Requirements ‐ General
F778 Assist with Transport Arrangements to Radiology F851 Payroll Based Journal F941 Communication Training
F779 X‐Ray/Diagnostic Report in Record‐Sign/Dated 483.75 Quality Assurance and Performance Improvement F942 Resident’s Rights Training
483.55 Dental Services F865 QAPI Program/Plan, Disclosure/Good Faith Attempt F943 Abuse, Neglect, and Exploitation Training
F790 Routine/Emergency Dental Services in SNFs F867 QAPI/QAA Improvement Activities F944 QAPI Training
F791 Routine/Emergency Dental Services in NFs F868 QAA Committee F945 Infection Control Training
483.60 Food and Nutrition Services 483.80 Infection Control F946 Compliance and Ethics Training
F800 Provided Diet Meets Needs of Each Resident F880 Infection Prevention & Control F947 Required In‐Service Training for Nurse Aides
F801 Qualified Dietary Staff F881 Antibiotic Stewardship Program F948 Training for Feeding Assistants
F802 Sufficient Dietary Support Personnel F882 Infection Preventionist Qualifications/Role F949 Behavioral Health Training
F803 Menus Meet Res Needs/Prep in Advance/Followed F883 *Influenza and Pneumococcal Immunizations

F804 Nutritive Value/Appear, Palatable/Prefer Temp F884 **Reporting – National Health Safety Network

F805 Food in Form to Meet Individual Needs F885 Reporting – Residents, Representatives & Families

F806 Resident Allergies, Preferences and Substitutes F887 COVID‐19 Immunization

F807 Drinks Avail to Meet Needs/P references/ Hydration

F808 Therapeutic Diet Prescribed by Physician

F809 Frequency of Meals/Snacks at Bedtime 483.85 Compliance and Ethics Program

F810 Assistive Devices ‐ Eating Equipment/Utensils F895 Compliance and Ethics Program

State Operations Manual
Appendix J – Guidance to Surveyors: Intermediate Care

Facilities for Individuals with Intellectual Disabilities

Table of Contents
(Rev. 178, 04-13-18)

Transmittals for Appendix J

Part 1 – Survey Protocol for Intermediate Care Facilities for Individuals with Intellectual
Disabilities

I – Introduction
II – Survey Levels

A – Focused Fundamental Survey
B – Extended Survey
C – Full Survey

III – Entrance
IV – Task One – Sample Selection
V – Task Two – Review of Facility Systems to Prevent Abuse, Neglect and Mistreatment and To

Resolve Complaints

A – Task Two Phase One
1. Phase One Observations

2. Phase One Interviews

3. Phase One Record Reviews

B – Task Two Phase Two
VI – Task Three – Focused Observation
VII -Task Four – Required Interviews with Individuals and/or Family/Advocate
Direct Care Staff

A – Purpose
B – Interview Procedure
C – Content of In-depth Interviews

1 – General Impressions
2 – Specific Activities and Interactions
3 – Individuals in Sample
4 – Areas for Further Observation

D – Suggested Interview Questions
E – Interviews to Clarify Observations

F – Documentation

VIII – Task Five – Drug Pass Observation
A – Purpose
B – Interview Procedure
C – Content of In-depth Interviews
D – Suggested Interview Questions
E – Interviews to Clarify Observations
F – Documentation

IX – Task Six – Visit to Each Area of Facility Serving Certified Individuals
A – Purpose

B – Protocol

X – Task Seven – Record Review of Individuals in the
Sample

A – Introduction

B – The Individual Program Plan (IPP)
C – Program Monitoring and Change

D – Health and Safety Supports

XI – Exit Conference

Part II- Interpretive Guidelines-Responsibilities of Intermediate Care Facilities

for Individuals with Intellectual Disabilities
§440.150 Intermediate Care Facility Services, Other Than in Institutions for Mental Diseases
§483.410 Condition of Participation: Governing Body and Management
§483.410(a) Standard: Governing Body
§483.410(b) Standard: Compliance With Federal, State and Local Laws.
§483.410(c) Standard: Client Records
§483.410(d) Standard: Services Provided Under Agreements With Outside Sources
§483.410(e) Standard: Licensure
§483.420 Condition of Participation: Client Protections
§483.420(a) Standard: Protection of Clients’ Rights
§483.420(b) Standard: Client Finances
§483.420(c) Standard: Communication With Clients, Parents, and Guardians
§483.420(d) Standard: Staff Treatment of Clients
§483.430 Condition of Participation: Facility Staffing
§483.430(a) Standard: Qualified Intellectual Disabilities Professional
§483.430(b) Standard: Professional Program Services
§483.430(c) Standard: Facility Staffing
§483.430(d) Standard: Direct Care Residential Living Unit Staff
§483.430(e) Standard: Staff Training Program
§483.440 Condition of Participation: Active Treatment Services
§483.440(a) Standard: Active Treatment
§483.440(b) Standard: Admissions, Transfers, and Discharge
§483.440(c) Standard: Individual Program Plan
§483.440(d) Standard: Program Implementation
§483.440(e) Standard: Program Documentation
§483.440(f) Standard: Program Monitoring and Change
§483.450 Condition of Participation: Client Behavior and Facility Practices
§483.450(a) Standard: Facility Practices – Conduct Toward Clients
§483.450(b)Standard: Management of Inappropriate Client Behavior
§483.450(c) Standard: Time-Out Rooms
§483.450(d)Standard: Physical Restraints
§483.450(e) Standard: Drug Usage
§483.460 Condition of Participation: Health Care Services
§483.460(a) Standard: Physician Services
§483.460(b) Standard: Physician Participation in the Individual Program Plan
§483.460 (c) Standard: Nursing Services
§483.460(d) Standard: Nursing Staff
§483.460(e) Standard: Dental Services
§483.460(f) Standard: Comprehensive Dental Diagnostic Services
§483.460(g) Standard: Comprehensive Dental Treatment
§483.460(h) Standard: Documentation of Dental Services
§483.460(i) Standard: Pharmacy Services
§483.460(j) Standard: Drug Regimen Review
§483.460(k) Standard: Drug Administration
§483.460(l) Standard: Drug Storage and Recordkeeping
§483.460(m) Standard: Drug Labeling
§483.460(n) Standard: Laboratory Services

§483.470 Condition of Participation: Physical Environment
§483.470(a) Standard: Client Living Environment
§483.470(b)Standard: Client Bedrooms
§483.470(c) Standard: Storage Space in Bedrooms
§483.470(d) Standard: Client Bathrooms
§483.470(e) Standard: Heating and Ventilation
§483.470(f) Standard: Floors
§483.470(g) Standard: Space and Equipment
§483.470(h) Standard: Emergency Plan and Procedures
§483.470(i) Standard: Evacuation Drills
§483.470 (j) Standard: Fire Protection
§483.470(k) Standard: Paint
§483.470(l) Standard: Infection Control
§483.480 Condition of Participation: Dietetic Services
§483.480(a) Standard: Food and Nutrition Services
§483.480(b) Standard: Meal Services
§483.480(c) Standard: Menus
§483.480(d) Standard: Dining Areas and Service
§483.480(d) Standard: Dining Areas and Service

The facility must —

Part 1 – Survey Protocol for Intermediate Care Facilities for Individuals with
Intellectual Disabilities

I – Introduction
(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

The principal focus of the ICF/IID survey process is on the “outcome” of the facility’s provision of
active treatment as defined by 42 CFR 483.440(a). Direct your principal attention to what actually
happens to clients: whether the facility provides needed services and interventions; whether the
facility insures clients are free from abuse, mistreatment, or neglect; whether clients, families and
guardians participate in identifying and selecting services; whether the facility promotes greater
independence, choice, integration and productivity; how competently and effectively the staff interact
with clients; and whether all health needs are being met.

Use observation as the primary method of information gathering.
Conduct interviews and record reviews after completion of observations to confirm specific issues.
Verify that the facility develops interventions and supports that address the clients’ needs, and
provides required client protections and health services. Do not conduct in-depth reviews of
assessments, progress notes or historical data unless outcomes fail to occur for clients.

The provision of active treatment includes:

Comprehensive Functional Assessment (42 CFR 483.440(c)(3)).–Each individual client’s
interdisciplinary team must perform accurate, comprehensive functional assessments and
reassessments within 30 days after admission that identifies all of the client’s:

Specific developmental strengths, including client preferences;
Specific functional and adaptive social skills the client needs toacquire; Any presenting disabilities,
and when possible their causes; and
The need for services without regard to their availability.
(W196, W197, W200, W210, W211, W212, W213, W214, W215, W216, W217, W218, W219, W220,
W221, W222, W223, W224, W225, W259)

Individual Program Plan (IPP) (42 CFR 483.440(c)).–The interdisciplinary team must prepare an
IPP which:

� Includes opportunities for individual choice and self-management;

� Identifies the discrete, measurable, criteria-based objectives the client is to achieve;

� Identifies the specific individualized program of specialized and generic strategies,
supports, and techniques to be employed; and

� Must be directed toward the acquisition of the skills necessary for the client to function with
as much self-determination and independence as possible and the Prevention or egression
or loss of current optimal functional status.

(W196, W209, W227, W240, W242, W247, W159)

Program Implementation (42 CFR 483.440(d)).–Each client must receive a continuous active
treatment program consisting of needed interventions and services in sufficient intensity and
frequency to support the achievement of IPP objectives.

(W196, W249, W104, W120, W159, W164, W186, 189, W190, W194, W436, W474, W488)

Program Documentation (42 CFR 483.440(e)).–Accurate, systematic, behaviorally-stated data
about the client’s performance toward meeting the IPP objectives serves as the basis for necessary
change and revision to the program.

(W196, W252, W253, W254, W111)

Program Monitoring and Change (42 CFR 483.440(f)).–At least annually, the comprehensive
functional assessment of each client is reviewed by the interdisciplinary team for its relevancy and
updated, as needed. The IPP is revised, as appropriate.

(W196, W255, W256, W257, W262, W263, W258, W259, W260, W264, W104, W159, W448,
W449)

II – Survey Levels
(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

There are three levels of ICF/IID surveys. They are the focused fundamental survey, the extended
survey, and the full survey. Initial certifications and annual re-certification of ICF/IIDs also
requires a Life Safety Code survey (see instructions in Appendix I), which is separate from these
three health surveys). A full survey must be conducted for initial certification surveys and do not
require a focused fundamental survey. A focused fundamental survey should be conducted for
recertification surveys, unless, the State Survey Agency determines that a full survey is warranted
based on the survey agency’s identification of concerns related to the provider’s capacity to furnish
adequate services. A recertification survey can be expanded at any time to an extended survey or to a
full survey based on surveyor findings.

A. Focused Fundamental Survey

The focused fundamental survey may be utilized for all ICF/IID recertification surveys. In addition
to the entrance and exit, the focused fundamental survey follows the procedures outlined in tasks
one through three. Initial surveys will still require a full survey. The focused fundamental survey
process focuses the predominance of the survey time on the basic elements of the active treatment
process. This is accomplished through the concept of regulatory standards; an emphasis on
increased client observation time; and more effective use of interviews and client record reviews.
During the focused fundamental survey, the primary method of information gathering is observation.
Interviews and record reviews are conducted to confirm and/or provide additional information on
any concerns identified during observations. Beyond the IPP and the comprehensive functional
assessment (CFA), in-depth review of progress notes or historical data is not performed unless there
is suspected non-compliance of a key standard. As a result, this focused fundamental survey requires
less on- site survey time than the full survey while still providing sufficient information regarding the

delivery of services by the facility to enable the State Survey Agency (SA) and/or CMS Regional
Office (RO) to determine compliance or non- compliance with the Conditions of Participation
(CoPs).

The focused fundamental survey involves the identification of key standards within the ICF/IID
CoPs from which all other standards correspond When the facility is determined to be in
substantial compliance with the identified key standard, the standards corresponding from that
key standard are automatically determined as being met since the key standard could not be
compliant otherwise. However, if any key standard is found to be out of compliance, all
regulations corresponding to the key standard (s) must be reviewed to determine compliance or
non-compliance of each corresponding standard. The SA or CMS RO must, at this point, make a
decision as to whether it would be more appropriate to continue the focused fundamental survey
by simply adding review of the regulations under the non-compliant key standard(s) or to
convert the survey to an extended survey. The SA or CMS RO must convert the focused
fundamental survey to an extended survey if standard-level deficiencies are found during survey
and the survey team has determined or suspects that one or more CoPs examined during the
survey may be out of compliance.

The focused fundamental survey process is focused on the key standards. However, the
surveyors are not precluded from reviewing or citing any of the corresponding standards if
indicated during the review of the key standards.

The key standard list and the corresponding regulations associated with each key standard is
provided below in Table 1. The CoP is highlighted in bold and the key standard(s) under each
CoP is shaded in gray. The specified W tags under each shaded key standard are the
corresponding regulations associated with that key standard.

Table 1: Key standards and corresponding standards within the CoPs for the focused
fundamental survey:

CONDITION OF
PARTICIPATION

Key Standard(s)
Regulatory Reference
within the CoP

W-tag
associated with
the key standard
regulation

Corresponding
standard(s) under the key
standard (W-tag
reference)

42 CFR 483.410
Governing Body
and Management

*This Condition is
reviewed only during a
full survey.

CONDITION OF
PARTICIPATION

Key Standard(s)
Regulatory Reference
within the CoP

W-tag
associated with
the key standard
regulation

Corresponding
standard(s) under the key
standard (W-tag
reference)

(W102)

42 CFR 483.420
Client Protections
(W122)

42 CFR 483.420(a)(5)
Ensure that clients are not
subjected to physical,
verbal, sexual or
psychological abuse or
punishment

42 CFR 483.420(a)(7)
Provide each client with
the opportunity for
personal privacy

42 CFR 483.420(a)(12)
Ensure that clients have
the right to retain and use
appropriate personal
possessions and clothing

W127

W129

W137

W149, W150, W151,
W152, W153, W154,
W155, W156, W157

W130, W133, W134,
W135, W145, W146

W126, W138, W140,
W141, W142

*The corresponding
standards below are
reviewed when any key
standard (W127, W129 or
W137) under the CoP at
42 CFR 483.420 is out of
compliance and is
reviewed in conjunction
with the corresponding
standards under that key
standard.
W123, W124, W125,
W128, W131, W132,
W136, W139, W143,
W144, W147, W148

42 CFR 483.430
Facility Staffing
(W158)

42 CFR 483.430(a)
Each client’s active
treatment program must

W159 W160, W161, W162,
W163

CONDITION OF
PARTICIPATION

Key Standard(s)
Regulatory Reference
within the CoP

W-tag
associated with
the key standard
regulation

Corresponding
standard(s) under the key
standard (W-tag
reference)

be integrated, coordinated
and monitored by a
qualified intellectual
disability professional

42 CFR 483.430(d)(1)

W186

W164, W165, W166,

The facility must provide W167, W168, W169,
sufficient direct care staff W170, W171, W172,
to manage and supervise W173, W174, W175,
clients in accordance with W176, W177, W178,
their individual program W179, W180, W181,
plans W182, W183, W184,
W185, W186, W187,
W188, W189, W190,
W191, W192, W193,
W194

42 CFR 483.440 42 CFR 483.440(a)(4) W226 W200, W206, W207,
Active Treatment Within 30 days after W208, W209, W210,
Services admission, the W211, W212, W213,
(W195) interdisciplinary team W214, W215, W216,
must prepare for each W217, W218, W219,
client an individual W220, W221, W222,
program plan W223, W224, W225,
W227, W228, W229,
W230, W231, W232,
W233, W234, W235,
W236, W237, W238,

42 CFR 483.440(d)(1)
As soon as the
interdisciplinary team has
formulated a client’s
individual program plan,
each client must receive a
continuous active
treatment program
consisting of needed

W249

W239, W240

W196, W197, W198,

W199, W250, W251,
W252, W253, W254

CONDITION OF
PARTICIPATION

Key Standard(s)
Regulatory Reference
within the CoP

W-tag
associated with
the key standard
regulation

Corresponding
standard(s) under the key
standard (W-tag
reference)

interventions and services

W256, W257, W258,
W259, W260, W261,
W262, W263, W264,
W265

*The corresponding
standards below are
reviewed when any key
standard (W226, W249,
W255) under the CoP at
42 CFR 483.440 is out of
compliance and is
reviewed in conjunction
with the corresponding
standards under that key
standard.
W201, W202, W203,
W204,
W205, W241, W242,
W243, W244, W245,
W246, W247,

in sufficient number and
frequency to support the
achievement of the
objectives identified in the
individual program plan

42 CFR 483.440(f)(1)(i)

W255

(1) The individual
program plan must be
reviewed at least by a
qualified intellectual
disabilities professional
and revised as necessary,
including, but not limited
to situations in which the
client—
(i) Has successfully
completed an objective or
objectives identified in the
individual program plan

CONDITION OF
PARTICIPATION

Key Standard(s)
Regulatory Reference
within the CoP

W-tag
associated with
the key standard
regulation

Corresponding
standard(s) under the key
standard (W-tag
reference)

W248

42 CFR 483.450 42 CFR 483.450(a)(1)(i) W268 W267, W269, W270,
Client Behavior and The facility policies and W271, W272, W273
Facility Practices procedures must—
(W266) Promote the growth,
development and
independence of the client

42 CFR 483.450(b)(1)(iii)

W278

W274, W275, W276,

Facility procedures W277, W279, W280,
must— W281, W282, W283,
Insure prior to the use of W284
more restrictive
techniques, that the
client’s record documents
that programs
incorporating the use of
less intrusive or more
positive techniques have
been tried systematically
and demonstrated to be
ineffective

42 CFR 483.450(b)(2)

W285

W286, W287, W288,

Interventions to manage W289, W290, W291,
inappropriate client W292, W293, W294
behavior must be
employed with sufficient
safeguards and
supervision to ensure that
the safety, welfare and
civil and human rights of
clients are adequately
protected.

42 CFR 483.450(d)(1)(i)

W295

W296, W297, W298,

(1) The facility may W299, W300, W301,

CONDITION OF
PARTICIPATION

Key Standard(s)
Regulatory Reference
within the CoP

W-tag
associated with
the key standard
regulation

Corresponding
standard(s) under the key
standard (W-tag
reference)

employ physical restraint W302, W303, W304,
only— W305, W306, W307,
(i) As integral part of an W308, W309
individual program plan
that is intended to lead to
less restrictive means of
managing and eliminating
the behavior for which the
restraint is applied.

W310 W311, W312, W313,
42 CFR 483.450(e)(1) W314, W315, W316,
The facility must not use W317
drugs in doses that
interfere with the
individual client’s daily
living activities

42 CFR 483.460 42 CFR 483.460(a)(3) W322 W319, W320, W321,
Health Care The facility must provide W323, W324, W325,
Services or obtain preventive and W326, 327, W328, W329,
(W318) general care W330, W331, W332,
W333, W334, W335,
W336, W337, W338,
W339, W340, W341,
W342, W343, W344,
W345, W346, W347,

42 CFR 483.460(e)(1)
The facility must provide
or make arrangements for
comprehensive diagnostic
and treatment services for
each client from qualified
personnel, including,
licensed dentists and
dental hygienists either
through organized dental
services in-house or

W348

W393, W394

W349, W350, W351,

W352, W353, W354,
W355, W356, W357,
W358, W359, W360

CONDITION OF
PARTICIPATION

Key Standard(s)
Regulatory Reference
within the CoP

W-tag
associated with
the key standard
regulation

Corresponding
standard(s) under the key
standard (W-tag
reference)

through arrangement

42 CFR 483.460(j)(1)

W362

W361, W363, W364,

A pharmacist with input W365, W366, W367,
from the interdisciplinary W368, W369, W370,
team must review the drug W371, W372, W373,
regimen of each client at W374, W375, W376
least quarterly

42 CFR 483.460(l)(2)

W382

W377, W378, W379,

The facility must keep all W380, W381, W383,
drugs and biologicals W384, W385, W386,
locked except when being W387, W388, W389,
prepared for W390, W391, W392
administration

42 CFR 483.470 42 CFR 483.470(a)(1) W407 W408
Physical The facility must not
Environment house clients of grossly
(W406) different ages,
developmental levels, and
social needs in close
physical or social
proximity unless the
housing is planned to
promote the growth and
development of all those
housed together

42 CFR 483.470(b)(4)(i)

W417

W409, W410, W411,

(4) The facility must W412, W413, W414,
provide each client with— W415, W416, W418,
(i) A separate bed of W419, W420, W421,
proper size and height for W422, W423, W427,
the convenience of the W428
client

CONDITION OF
PARTICIPATION

Key Standard(s)
Regulatory Reference
within the CoP

W-tag
associated with
the key standard
regulation

Corresponding
standard(s) under the key
standard (W-tag
reference)

42 CFR 483.470(d)(1) W424 W425, W426

W429, W430, W431,
W432, W433, W434,
W436, W437

W454, W456, W457,
W458

*The corresponding
standards below are
reviewed when any key
standard (W407, W417,

The facility must—
Provide toilet and bathing
facilities appropriate in
number, size, and design
to meet the needs of the
clients

42 CFR 483.470(g)(1)

W435

The facility must—
Provide sufficient space
and equipment in dining,
living, health services,
recreation, and program
areas (including
adequately equipped and
sound treated areas for
hearing and other
evaluations if they are
conducted in the facility)
to enable staff to provide
clients with needed
services, as required by
this subpart and as
identified in each client’s
individual program plan

42 CFR 483.470(l)(1)

W455

There must be an active
program for the
prevention, control, and
investigation of infection
and communicable
diseases

CONDITION OF
PARTICIPATION

Key Standard(s)
Regulatory Reference
within the CoP

W-tag
associated with
the key standard
regulation

Corresponding
standard(s) under the key
standard (W-tag
reference)

W424, W435 or W455)
under the CoP at 42 CFR
483.470 is out of
compliance and is
reviewed in conjunction
with the corresponding
standards under that key
standard.
W438, W439, W440,
W441, W442, W443,
W444, W445, W446,
W447, W448, W449,
W450, W451, W452,
W453

42 CFR 483.480 42 CFR 483.480(a)(1) W460 W461, W462, W463,
Dietetic Services Each client must receive a W464, W465, W466,
(W459) nourishing, well balanced, W467, W468, W469,
diet including modified W470, W471
and specially prescribed

diets

(2) Food must be served–
42 CFR 483.480(b)(2)(i)
In appropriate quantity;

W472

W476, W477, W478,
W479, W480, W481,
W482, W483, W484,
W485, W486, W487,
42 CFR 483.480(b)(2)(ii) W473 W488, W489
At appropriate
temperature;

W474

42 CFR 483.480(b)(2)(iii)

In a form consistent with
the developmental level of
the client; and

W475

42 CFR 483.480(b)(2)(iv)

With appropriate utensils

B. Extended Survey

During a focused fundamental survey, if a key standard of a CoP is found to be out of compliance,
then the surveyor will review all corresponding standards under that key standard to determine
compliance with that condition (i.e., to determine condition-level compliance). If the review of the
key standard and corresponding standards could result in a condition-level non-compliance
finding, then the SA can decide to survey all the standards within that CoP. This review of all the
standards within an ICF/IID CoP is known as an extended survey.

However, if the review of the key standard and corresponding standards results in a CoP non-
compliance finding at 42 CFR 483.420, 42 CFR 483.450 or 42 CFR 483.460, then the team must
convert the extended survey to a full survey and follow the procedures for a full survey as indicated
below.

NOTE: Neither the focused fundamental nor the extended survey processes preclude the survey
agency from review of any standard, if evidence of non-compliant facility practice is suspected
during any survey.

C. Full Survey

A full survey is a review of all of the standards within all eight ICF/IID CoPs. In addition to
the entrance and exit, a full survey follows the procedures outlined in all seven tasks.

A full survey is conducted when any one or more of the following criteria are met:

• The survey team is conducting an initial survey;

• An immediate jeopardy is called;

• The survey team determines from the extended survey that Condition-level deficiencies
exist at one or more of the specific CoPs at 42 CFR 483.420, 42 CFR 483.450 or CFR
483.460; or

• At the discretion of the SA

III – Entrance
(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

In addition to standard entrance procedures, the surveyor will complete the Form CMS-3070G
“Intermediate Care Facilities for Individuals with Intellectual Disabilities Survey Report,” to
capture characteristics of the facility and the facility’s population. Furthermore, the surveyor will
establish the client sample selection by requesting a complete and accurate list of all the

clients that currently reside in the facility. After the core number of clients are selected (see Task 1
below), the surveyor will request a copy of each selected client’s Individual Program Plan (IPP).
Each IPP will be utilized during observations to determine:

1. If the client’s skills matches the IPP;

2. If the IPP is being followed;

3. If staff understand the IPP;

4. Staff and client interactions during the programs; and

5. Health concerns interfering with the IPP.

IV – Task One – Sample Selection
(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

The complete sample for the facility will include a core number of clients selected at the beginning
of the survey and additional clients are added during the process of the survey as needed based on
observations and/or interviews. Do not permit the facility staff to select the sample.

A full review (observation, record review and interview) will be conducted on all clients in the
core sample to include:

1. Comparison of the Comprehensive Functional Assessment to the Individualized Program

Plan (IPP);

2. Comparison of the IPP to actual activity observed;

3. Review of documentation of client participation and progress compared toobservations;

4. Timely and appropriate behavior program plan development and implementation as
indicated; and

5. Medical assessments conducted as indicated and indicated medical care or interventions.

The core sample of clients is selected from a list of the facility’s current client list without regard
to client developmental levels or locations in the facility. At minimum, the core sample should
include clients that meet any one or more of the following criteria:

 Admission within the last six (6) months;

 Participation in a day program;

 On a self-administration program; and/or

 Frequent hospitalizations or ER visits.

Table 2: Guidance to Calculate Core Sample Size:

Number of Clients Residing in the Facility Minimum Number in Core Sample

4 2
5-16 3
17-50 4
51-100 6
101-150 8
Over 150 10

During observations, additional clients should be added to the core sample if areas of concern
are identified. Examples may include, but are not limited to:

1. Clients with significant medical involvement which may be impacting
the implementation of their IPP;

2. Clients with significant behaviors with lack of or inappropriate staff intervention;

3. Clients that are idle for extended periods oftime;

4. Clients that appear to have strengths but are not encouraged to use those skills
or are performing activities below their skill levels; and

5. Clients who are not provided appropriate medical care.

Additional Sample Clients:

A client added to the core sample, during observations, does not require a full review of his/her
program record. There is no minimum or maximum number of additional clients that must be
added to the core sample. The program records for clients added to the core sample (additional
clients), should only be reviewed for the observed areas of concern. For instance, in the case of a
client observed to be doing work that appears to be for the benefit of the facility, the record
should be reviewed to determine whether the work is included in the client’s IPP; whether fair
compensation is provided; and whether the client’s needs are being addressed by the facility.
The client and the staff should be interviewed and the information compared to the program
records.

Another client may be added to the sample based solely on the fact that he/she is on a self –
administration program for medication. In this case, the surveyor would focus the record review
on:

� Whether the comprehensive assessment supported the indication for such a
program;

� What the current objectives of the program are and whether the client is
following those objectives; and

� What documentation is maintained of oversight of the objectives and whether the
objectives are revised as indicated.

Observations and interviews with the client and staff would focus on the medication
administration.

V – Task Two – Review of Facility Systems to Prevent Abuse, Neglect and
Mistreatment and to Resolve Complaints
(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

When determining whether or not facility systems are in place to prevent abuse, neglect, and
mistreatment and to resolve complaints, surveyors will use Task Two.

Task Two consists of two phases. In the absence of pre-existing characteristics as described
below, only Phase One should be completed. If there are pre-existing criteria or if in the course of
the survey concerns with client protections are identified, the surveyor should extend to the Phase
Two review. Any one or more of the following are pre-existing criteria that would initiate a Phase
Two review.

� Substantiated complaints or facility reported events in Client Protections since the
last recertification survey;

� A survey history of citations at W127, W153-W157; or

� Concerns identified by the SA that warrant a Phase Two review.

A. Task Two Phase One

The critical components of this Phase are client observations including staff-to-client and client-
to-client interactions, and staff/client/family interviews. These observations and interviews identify
the reporting records or investigation records that will be reviewed by the surveyor.
These records/reports are requested after the observations and interviews have been completed.

If the surveyor determines during Phase One that there is evidence of possible abuse, neglect and
mistreatment, then the surveyor should follow-up with associated interviews and record reviews.
The surveyor should contact his or her SA for a possible Immediate Jeopardy (IJ) call. If the CoP
for Client Protections at 42 CFR 483.420 is cited, then this concludes Task Two.
Additional review of Task Two is completed at the discretion of the SA or CMS RO.

If during Phase One, the surveyor does not observe any instances of possible abuse, neglect and
mistreatment, then Task Two may be ended.

1. Phase One Observations:

• Any signs of client injury (e.g., bruising, splints, bandages, scratches, limping or favoring a
limb, etc.);

• Client-to-client aggression;

• Inappropriate staff-to-client interactions (e.g., physical, verbal);

• Signs of fear in the presence of specific clients or staff;

• Signs of mistreatment or punishment by staff such as rudeness, rough handling,
restriction of rights, etc.; or

• Any clients currently in the hospital or experiencing recent hospitalizations or emergency
room visits

2. Phase One Interviews:

If Phase One observations identify any concerns with possible abuse, neglect and mistreatment, as
well as failure to resolve complaints, then specifically associated interviews must be conducted.

The client is interviewed first. Do not exclude clients who use alternate means of communication,
such as communication boards or gestures. Most clients are able to communicate in some manner.
Questions to the client may include, but are not be limited to:

a. Are the staff nice to you?

b. Do the staff yell, swear, or hit? Who?

c. Has anyone ever hurt you? Who? When?

d. Are you ever punished for anything? What was yourpunishment?

e. How did you get injured? (If the client has an obviousinjury)
Interview the family, legal guardian, advocates (if applicable) and close friends (if identified) of
each client for whom a concern was identified either during observations or client interviews.
Family members, legal guardians, advocates and close friends may be interviewed at the facility or
by telephone. Questions to the families, legal guardians, advocates and close friends may include,
but are not be limited to:

a. Have you noticed any bruises or injuries of an unknown source on (client’sname)?

b. If so, did you speak with thestaff?

c. What did they say?

d. How does the staff interact with (client’sname)?

e. Does (client name) complain of any mistreatment duringvisits?
Facility staff should be interviewed as indicated. This includes direct care staff from more than one
shift, the applicable Qualified Intellectual Disability Professional (QIDP) and medical personnel.
The goals of the interviews are to determine how often injuries/mistreatment are occurring, what
process the facility is using for reporting such instances, the timeliness of notifications, whether
clients are protected from harm during investigations and whether process changes are
implemented by the facility to prevent future injuries and/or mistreatment. The questions during
each interview should be tailored according to the observations made.

3. Phase One Record Reviews:

For any specific injury noted during observations (regardless of whether the client is in the sample
or not), the surveyor requests the documentation associated with the injury
(reporting/investigation/disposition). The goal of this documentation review is to verify the
information provided by the staff and to ensure the prompt reporting, investigation and protection
of clients with injuries and allegations of mistreatment.

If the observations, interviews or record reviews during Phase One confirm that the facility is
identifying injuries and mistreatment promptly, notifying the appropriate persons, doing
appropriate investigations, and doing appropriate interventions, then Task Two is concluded.
Deficiencies may be written at Phase One without proceeding to Phase Two.

B. Task Two Phase Two:

If the surveyor determines during Phase One that there is insufficient evidence to find that the
facility is in compliance with the Condition of Participation for client protections at 42 CFR
483.420, a more global review is indicated. Request the facility log of client incidents and reports
and select a sample of 5 percent of the incidents from the total client incidents occurring during
the last three (3) months (a minimum of 10 if available). Request the investigative reports for these
incidents. Look for any evidence that suggests that clients are being abused, neglected or
mistreated. Determine whether in each case the incident was reported promptly and investigated
thoroughly and that safeguards were put into place during the investigation and corrective
measures taken in order to prevent recurrences.

If the facility has a system in place to prevent abuse, neglect and mistreatment and to resolve
complaints and takes the appropriate corrective measures, then, Task Two is complete.
If the 5 percent sample review is not determinative as to the compliance with the CoP for client
protections, or the surveyor identifies any patterns of possible abuse, mistreatment or neglect, or
the incident report logs for the past three (3) months indicate an extremely high incident rate, the
surveyor should proceed to a full review of the total number of incidents and reports for the past
three (3) months to identify any deficient practice by the facility.

If the surveyor believes that issues exist that rise to the level of an Immediate Jeopardy, investigate
and procedures in Appendix Q should be followed.

VI – Task Three – Focused Observation
(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

The majority of the time on an ICF/IID focused fundamental survey is spent doing observation,
associated interviews and associated targeted record review. It is critical that observations of
sufficient duration occur across the entire survey (i.e. early morning, afternoon, and evening) and
occur across the client’s various environments (home, recreation and day program). A minimum of
two meals must be observed and two medication pass observations must be conducted.

Once the client core sample is selected and copies of the Individual Program Plan for each
selected client have been obtained, the observations should begin. Do not delay beginning

observations awaiting the IPPs. Begin general observations until the IPPs are provided by the
facility.

Initially note and record the first general impressions of each area where the clients are observed
(i.e., the milieu). Conduct these observations, without intruding (unless it is necessary to alert a
staff member to a possible risk to a client) for at least an hour in each initial location. Note things
on the general milieu such as:

a. Are all the clients in the area dressed appropriately but individually according to
what appears to be their preferences?

b. What activities are taking place? Note the time of day. Are these activities appropriate
for the time of day?

c. How many staff are present?

d. Does the environment appear calm andpurposeful?

e. What is the staff doing? How is the staff interacting with the clients? How are clients
interacting with each other?

f. Are clients being encouraged by the staff to participate in activities or are things done for
them?

g. What types of adaptive equipment or assistive devices areused?

h. Do the staff use teachable moments with the clients?

i. How are behavioral episodes addressed?

j. Do clients appear well nourished? Do they appear sleepy (not early in themorning)?

k. Do any clients have signs of injury? (Note for subsequent staff interview and Task 2
review.)

The results of these initial observations are critical to the focused fundamental survey process on
two levels. The surveyor(s) may observe specific issues which would indicate further investigation
or additional clients may need to be added to the core sample. The SA may determine that, based
upon the overall initial observation findings, the facility will require an extended or full survey
rather than a focused fundamental.

Focused Observation Areas:

1. Active Treatment-
Each IPP must be appropriate for the client based upon a comprehensive assessment and revised
with changes in client program needs. The IPP must correspond to what treatments, programs or
services the client is actually receiving. Programs should be appropriate for the client (i.e., is the
client able to accomplish/complete the program too easily; have they already accomplished the
components of the program; or does the client have program needs that have not been addressed
by the IPP (e.g., ADL, behavioral, socialization))? If there are discrepancies with the IPP

programs after observing the client in several environments, the surveyor should speak with the
client and/or appropriate staff (QIDP, direct care staff, psychology staff) for additional
information on the identified concerns. Interviews with staff are not done routinely. If during
observations the surveyor(s) determine that the current objectives of the IPP match the strengths
and needs of the client, the staff is familiar with the methodology of accomplishing these programs,
and they are being carried out as written in the IPP, there is no need to conduct formal staff
interviews. The surveyor should ask the staff (direct care staff carrying out the program(s)) for
records documenting program(s). Generally, the client should be making steady progress and this
should be reflected in the program data. However, if there is no progress made or if there has been
a regression, there should be evidence that the QIDP/ID team is aware of the issue and is
addressing it. In this case or in the case where actual programs do not match IPP programs or do
not seem appropriate for the client based upon the client’s identified skills, it will be necessary for
the surveyors to interview appropriate staff.

2. Staff
Generally, an inadequate number of staff will result in concerns with client programming and
client protection. During observations, note how the on duty staffing ratios either promote or
prevent a safe and productive active treatment environment. In some instances surveyors will see
the effects of inadequate staffing early (during the first impression observation). These effects may
include chaotic environment, client-to-client abuse, self-abuse by clients, clients sitting unengaged
for long periods of time with little or no staff presence, clients not given the opportunity to assist in
ADLs or participate in the rhythms of life due to the need to “get things done” (such as assisting
with mal preparation), or programs not being carried out due to inadequate on-duty staffing.

3. Qualified Intellectual Disabilities Professional (QIDP)
The increased time devoted to observations during the survey provides more of an opportunity to
also observe the QIDP in action. Observe interactions between the QIDP and the staff and the
QIDP and the clients. Is the QIDP familiar with client programs and client progress? How much
direct interaction is occurring among the QIDP, the staff and the clients? Is the QIDP intervening
when necessary and facilitating revisions to IPP as indicated? If the surveyor has unresolved
discrepancies, any concerns should be discussed with the QIDP.

4. Health Care Services
The surveyor should determine from observations whether or not the sampled clients are receiving
medical care as indicated. NOTE:

a. Do any of the clients have acute or chronic medical issues? How are these issues
being addressed by the medical staff at the facility?

b. Do the clients seem alert and energetic?

c. Are clients at a healthy weight?

d. Do the clients have good oral health? Have any dental problems been dealt
with promptly and appropriately?

e. Are the staff trained on first aid and reporting of medical issues?

If during observation there is concern about the health of a client, the nurse surveyor should talk
with the client and/or the nurse about the issues observed. In the event that there is not a nurse
surveyor, the non-clinical surveyor will need to consult with a clinician at the SA. Determine what
interaction is occurring between the client and the medical staff and whether the situation is
improving or deteriorating? Review the pertinent portions of the client record and discuss with the
medical staff as necessary.

If there are clients on a self-administration of medications program, the evaluation of the program
should be part of the active treatment observations.

5. Physical Environment
During observations, the surveyor should observe the facility for cleanliness, comfortable
temperature and any safety hazards (i.e. obstructed walkways, resilient, nonabrasive, and slip-
resistant floors).

Client Record Review:

Review of the client record during the focused fundamental survey is kept to a minimum. No
routine record review is done. All record reviews are focused on obtaining additional information
to clarify or completely document areas of question or concern identified during observation.

VII – Task Four – Required Interviews with Individuals and/or Family/Advocate
Direct Care Staff
(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

A – Purpose

Individuals living in the facility, their families/guardians and advocates, and direct care staff are
important sources of information about the receipt of active treatment on a daily basis.
Interviews are conducted for two purposes: to determine how the individual perceives the services
delivered by the facility, and to clarify information gathered during observations.

B – Interview Procedure

Start with the individual in the sample and the people most closely associated with the individual’s
daily program implementation. Use the following hierarchy of sources, to the maximum extent
possible, in the order shown:

� Individual;

� Families, legal guardian, or advocate;

� Direct care staff;

� Qualified intellectual disabilities professional (QIDP) and/or professional staff; and

� Managers, administrators, or department heads.

Determine from your observations and from the staff how the individual communicates with others.
Also determine from the staff the extent of involvement of family members, guardians or advocates
with the individuals in the sample. Based on this information, select the individuals from the sample
with whom you will conduct more in-depth interviews. Select those individuals who will be able to
communicate at least some basic information or those who have actively involved family members,
guardians or advocates. Do not exclude from interviews individuals who use alternate means of
communication, such as communication boards, sign language, and gestures. Most individuals are
able to communicate in some manner.

Attempt to obtain the required number of interviews first from individuals and then from family
members, guardians or advocates. In the absence of individuals who are able to communicate and
active significant others, interview the direct care staff person who works most closely with the
individual in order to obtain the required number of in-depth interviews.
The questions and communication method will vary from person to person. For individuals who use
a specialized communication method, attempt to begin the interview on a one to one basis. If you
find you are unable to communicate with the individual, ask someone familiar with the person to
assist you (e.g., a family member or a staff person.) For this individual, pay close attention to how
the staff communicates with him or her. If the person uses sign language or a communication board,
does staff understand and interact with the individual using the same method? If the person uses
gestures, does staff take time to determine his or her needs?
Family members, guardians or advocates may be interviewed at the facility, at a location convenient
to both the surveyor and the interviewee, or by telephone. All interviews should be conducted in
private locations and scheduled at mutually agreed upon times in order to minimize disruptions to
individual, family, or staff activities.

C – Content of In-depth Interviews
Determine what the facility does to provide individualized services and supports; and how
individuals and families participate in service planning and in making choices about matters
important to them.

� Are individuals treated with respect and dignity?

� Does the facility attempt to help the person set and attain individual goals?

� Are there consistent opportunities for making choices?

� When a choice is not an option, how is the individual assisted to understand?

� For example, if a planned activity is to go to a restaurant for dinner, who chooses
the restaurant?

� Is it staff or the individuals living in the facility?

� If one group of people does not want to go, how is this choice accommodated?

� Is the accommodation based on individual choice, staff convenience, or a
reasonable justification if a choice is not an option?

See section D for suggested interview questions. Unless designated that certain questions be directed
to a certain person, questions are relevant to whoever is being interviewed (individual, family
member, advocate or staff person.) Modify the wording of the questions based on the person being
interviewed (individual, family member, or staff) and on the communication skills of that individual.
For example, you may discover that the person responds better to questions that can be answered
“yes” or “no” than to open-ended questions. Be sensitive to signs that the
individual is tiring or becoming uncomfortable and either end the interview or continue it at a later
time if this occurs. It is not necessary to ask every question in the guide, but do try to ask at least one
question from each topic area.

D – Suggested Interview Questions
If you have not met the person before, begin the interview by explaining who you are and what your
role is. To put the person at ease you may want to begin with some general conversation, e.g., about
the weather or a special event coming up. At the end of the interview, if you think you may need to
discuss or confirm personal information with staff or family, ask the person if it is OK to share that
information.

Questions Related to Choice and Community Participation (W136, W147, W247):

� What sorts of things do you like to do for fun?

� Do you go out to activities or events in the community (like shopping, movies or
church)?

� How often do you do this?

� How do you get there?

� Who chooses where you go?

� Do you go to visit family members or take vacations?

� Is there something you would like to do more often?

Questions Related to Personal Finances and Possessions (W126, W137):

� Do you earn money on your job (at your day program)?

� What do you like to buy with your money?

� Do you have enough money to buy the things you want or need?

� Does someone help you with spending or saving your money?

� When you go to the store, do you pay for items or does a staff person pay for them?

� Do you have enough clothes and shoes?

� Do you always have enough deodorant and toothpaste, etc.?

� What do you do if you need to buy something?

Questions Related to Personal Relationships and Privacy (W129-W130, W133, W143 – W148):

� Do you have family or friends who visit you?

� Does your family write to you or telephone you?

� Does someone help you read their letters/ call them on the phone?

� If you feel like being alone or spending private time with a friend or family where do you
go?

� Does staff knock on your door before they come into the room?

For family member/advocate:

� How do you learn about things like the services your family member receives, an
illness or a change in medication?

� Are there any restrictions on when you visit your family member or where you can go
within the home?

Questions Related to Individual’s and Family’s Participation in the IPP Process (W209, W247):

� Do you go to (team) meetings with the staff where they talk about the services you get?

� Does your family/advocate come to these meetings?

� Were you asked if the date and time of the meeting were OK with you?

� What would you like to learn to do for yourself?

� Does the staff ask you what you want?

� Who chooses what you do?

� Does the staff listen to you and make changes based on what you want?

For staff:

� How do you communicate with this individual?

� What does (s) he like and dislike? How do you know that?

Questions Related to Service Delivery (W242, W249, W436):

� What help do you need from staff to dress, eat, bathe, etc?

� Do you get any special therapy (e.g., speech or physical therapy)?

� What new things are you learning to do?

� What chores do you help with around the house?

� Who helps you when you do not know how to do something?

� What special equipment do you use?

Questions Related to Individual’s Rights and Protections: W124-W125, W127, W153 – W157,
W127-W128, W263:

� Who do you tell if you do not like something, or something is wrong?

� Are there rules that everyone who lives here must follow?

� What sorts of things are you allowed to do or not do?

� How does the staff treat you?

� Are staff loud?

� Does staff yell, swear or hit?

� Do you ever do things you are not supposed to do? What happens then?

� Were you ever asked to give consent for any treatments or services?

� Were you told the benefits, risks and alternatives?

Questions Related to Health Status (W322, W356):

� How often do you see a doctor? A dentist?

� Do you have any health problems?

� Do you take any medicines? Do you know what they are for?

Wrap-up Questions:

� Is there anything you especially like about living here? Anything you especially dislike?

� Is there anything else you think I should know about what it is like to live here?

E – Interviews to Clarify Observations
In the absence of finding appropriate interaction between staff and individuals during observations,
it may be necessary to judge whether or not staff is knowledgeable about individual objectives and
techniques for implementation of programs. If possible, interview staff following the interval in
which the individual was observed with the particular staff member. (For example, if you have just
observed Individual A engaging in stereotypical behaviors, ask: “Can you tell me what, if anything,
you do when he rocks back and forth?”) Ask questions that elicit information about how staff learns
what to do with individuals across the spectrum of support and programming activities they are
expected to perform. Ask professional staff questions to see if they know how to implement
programs for an individual other than their professional discipline (e.g., how to carry through with a
behavior program in the midst of communications training).

Ascertain whether the staff is competent to carry out the individual’s choices and skill development
activity. Is there evidence that programs are in fact being carried out throughout the individual’s
waking hours? Are interventions revised based on changes in the individual’s progress toward
goals? If staff cannot demonstrate the skills necessary to implement the individual’s programs and
choices, if interventions are not being carried out consistently, or if revisions to interventions do not
occur, you have findings that active treatment is not being delivered.

F – Documentation

Record each interview you conduct with individuals, staff, consultants, off-site day program staff,
legal guardians, etc., in your personal notes or on the optional observation worksheet (Form CMS-
3070I). Include the following information in your notes for each interview:

� Date and time of interview;

� Job title and assignment at the ICF/IID;

� Relationship to the individual or reason for the interview; and

� Summary of the information obtained.

VIII – Task Five – Drug Pass Observation

(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

Observe the preparation and administration of medications to individuals. With this approach, there
is no doubt that the errors detected, if any, are errors in drug administration, not documentation.

http://www.cms.hhs.gov/forms/cms3070I

Follow the procedure in the interpretive guidelines at W369 for conducting the drug pass
observation. Notes on observations of the drug pass may be recorded on Form CMS- 677 (LTC
Medication Pass Worksheet) or in the surveyor’s personal notes. The purpose of the review is to
direct the facility’s attention to assuring an error free drug distribution system and away from the
paper processes that often do not represent actual errors in medication administration. For the
purposes of this task, a “small” facility is one that houses 16 or fewer residents.

IX – Task Six – Visit to Each Area of Facility Serving Certified Individuals
(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

A – Purpose

By the end of the survey, visit each area of the facility serving certified individuals in order to:

� Ensure that all areas of the facility (including those that are not represented by individuals
in the sample) are providing services in the manner required by the regulations.

� Assess generally the physical safety of the environment.

� Assess that individual rights are proactively asserted and protected.

B – Protocol

After individuals in the sample have been assigned to team members, review the facility’s map or
building layout. Assign members to visit each remaining residential and on-campus day program
site prior to completing the survey. Insure that each area of the facility that is utilized by individuals
has been visited. This visit may be done with or without facility staff accompanying you, as you
prefer, and subject to their availability. Record your observations in your notes.

Converse with individuals, family members/significant others (if present), and staff. Ask open-
ended questions in order to confirm observations, obtain additional information, or corroborate
information, e.g., accidents, odors, apparent inappropriate dress, adequacy and appropriateness of
training activities. Observe staff interactions with other staff members as well as with individuals for
insight into matters such as individual rights and staff responsibilities.

X – Task Seven – Record Review of Individuals in the Sample
(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

A – Introduction
Do not spend an excessive amount of time looking at fine details in the record review of the
selected sample. The purposes are to:

• Verify the applicable information obtained from your observations and
interviews;

• Review revisions that have been made to the objectives; and

• Verify that needed health and safety supports are in place.

http://www.cms.hhs.gov/forms/cms677

Do not review in detail the written training programs that are developed for each individual
unless you discover serious differences between the record and your observations and
interviews. Review those parts of the record most relevant to your purposes as described
below.

B – The Individual Program Plan (IPP)

Identify the developmental, behavioral, and health objectives the facility has committed itself
to accomplish during the current IPP period. Identify what, if any, behavioral strategies (e.g.,
behavior modification programs, use of psychotropics) are being used with individuals in your
sample. Determine what, if any, health or other problems might interfere with participation in
program services.

C – Program Monitoring and Change

Skim the most recent interdisciplinary team review notes to identify what revisions were made
to the IPP. Determine whether revisions were based on objective measures of the individual’s
progress, regression, or lack of progress toward his/her objectives.

D – Health and Safety Supports

Verify, either through the interdisciplinary team review notes or through the most recent
nursing notes, that the individual has received follow-up services for any health or dental
needs identified in the IPP and check the person’s current drug regimen. For individuals with
whom restrictive or intrusive techniques are used, verify that the necessary consents and
approvals have been obtained.

If this information is consistent with your observations and interviews, conclude the record
review. If discrepancies are found, conduct further observations or interviews as needed to
verify your findings.

XI – Exit Conference
(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

During the pre-exit conference, the survey team records on the Form CMS-3070H
(“Intermediate Care Facilities for Individuals with Intellectual Disabilities Deficiencies
Report”) those requirements that are determined to be deficient and the findings that
support that determination. Write the deficiency statement in terms specific enough to
allow a reasonably knowledgeable person to understand the aspect(s) of the
requirement(s) that is (are) not met. Indicate on the Form CMS-3070H the data prefix
tag, followed by a summary of the deficient facility practice(s). Briefly identify the
supporting findings for each deficiency (i.e., transfer to the Form CMS-3070H the
identifier numbers of all clients to whom the deficient practice applies.) It is not necessary
to write a full description of the findings on the Form CMS- 3070H since they will be
described in more detail on the completed Statement of Deficiencies (Form CMS-2567).
It is necessary to complete the Form CMS-3070H for each survey because the Form
CMS-3070H is the only document in which the survey team’s recommendations for
deficiencies are recorded (which may be changed later on the final Form CMS-2567 as a
result of supervisory review) and because not all client examples may be used on the
Form CMS-2567. During the exit conference, provide the facility administrator with all
regulations determined to not be met during the survey. Provide examples as necessary,
allow the facility to provide additional information if it chooses, inform the facility that
the findings are preliminary and final compliance determinations will be made by the
survey office.

http://www.cms.hhs.gov/forms/cms3070h

Part II- Interpretive Guidelines-Responsibilities of Intermediate
Care Facilities for Individuals with Intellectual Disabilities

§440.150 Intermediate Care Facility Services, Other Than
in Institutions for Mental Diseases

W101

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

W101 is reassigned to §483.410(e). Section 442.251, the standard which requires that facilities
meet the requirement for a State license, is redesignated to §483.410(e) and W101 is reassigned
as well to afford a sense of continuity.

W102

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410 Condition of participation: Governing body and management

(a) Standard: Governing body

W103

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(a) The facility must identify an individual or individuals to constitute the governing
body of the facility.

Guidance §483.410(a)

If concerns are noted regarding the governing body, written documentation verifies that the
facility has designated the individual or individuals to constitute the governing body and their
titles.

W104

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(a)(1) The governing body must exercise general policy, budget, and operating
direction over the facility.

Guidance §483.410(a)(1)

The governing body develops, monitors, and revises, as necessary, policies and operating
directions which ensure the necessary staffing, training resources, equipment and environment
to provide clients with active treatment and to provide for their health and safety.

Direction by the Governing Body includes areas such as health, safety, sanitation, maintenance
and repair, and utilization and management of staff.

Condition level operational deficiencies may be associated with a failure by the Governing Body
to exercise general direction of the facility.

W105

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(a)(2) The governing body must set the qualifications (in addition to those already set
by State law, if any) for the administrator of the facility.

Guidance §483.410(a)(2)

The policies of the facility must include the qualifications of the administrator, and the
qualifications are stated in the job description of the administrator.

W106

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(a)(3) The governing body must appoint the administrator of the facility.

Guidance §483.410(a)(3)

This appointment must be in writing.

(b) Standard: Compliance with Federal, State and local laws

§483.410(b) The facility must be in compliance with all applicable provisions of Federal, State
and local laws, regulations and codes pertaining to:

Guidance §483.410(b)

The facility has no final adverse action by a Federal, State, or local authority. Such adverse
actions include, but are not limited to fines, limitation on services that may be provided, or loss
of licensure.

The facility must be able to provide for review, current licenses and permits as well as applicable
reports of inspections by State or local health authorities.

If a situation is identified indicating the provider may not be in compliance with Federal, State,
or local law, refer that information to the authority having jurisdiction (AHJ) for follow-up
actions. See W107, W108, or W109.

W107

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(b) health,

Guidance §483.410(b)

Reference the specific law, regulation, or code not met.

W108

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(b) safety, and

Guidance §483.410(b)

Reference the specific law, regulation, or code not met.

W109

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(b) sanitation.

Guidance §483.410(b)

Reference the specific law, regulation, or code not met.

W110

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(c)(1) The facility must develop and maintain a record keeping system that includes a
separate record for each client and;

W111

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(c)(1) that documents the client’s health care, active treatment, social information,
and protection of the client’s rights.

Guidance §483.410(c)(1)

The structure and content of a client’s record must be an accurate, functional representation of
the actual experience of the client in the facility.

The record should contain an accurate account of all information relevant to the client’s health
care, active treatment, social information and protection of the client’s rights, such as
communications, correspondence, program plans (to include both in-house and outside service
programs), progress summaries, activity plans and activity participation, incidents, consent
forms and all medical information.

If the records are maintained electronically, the facility staff should be able to access various
parts of the record without difficulty. If they are unable to access components of the record
upon request, then this may indicate a lack of training by the facility.

W112

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(c)(2) The facility must keep confidential all information contained in the clients’
records, regardless of the form or storage method of the records.

Guidance §483.410(c)(2)

“Keep confidential” means safeguarding the content of information including video, audio,
and/or computer stored information from unauthorized disclosure without the specific
informed consent of the client, parent of a minor child, or legal guardian, and consistent with
the advocate’s right of access. Facility staff and consultants, hired to provide services to the
client, sign confidentiality agreements before having access to client records and should have
access to only that portion of information that is necessary to provide effective responsive
services to the client.

These agreements should be renewed according to the policies of the facility. The agreement
may stipulate that the agreements are in place until either the facility or member terminates the
agreement.

The facility has in place safeguards to ensure that access to all information regarding clients is
limited to those clients designated by Health Insurance Portability and Accountability Act
(HIPAA) requirements, the Developmental Disabilities Act, State law and facility policy.

The facility should prevent any instances of unauthorized access or dissemination. For example,
the staff is observed to leave the client record (hard copy or electronic version) in the living
room of the house when visitors or persons not authorized to access client records are present.
Client records must be secured when staff is not present.

The facility must develop and follow procedures for maintaining the confidentiality of client
information during transport to medical appointments or to other locations outside the facility.

Confidentiality applies to both central records and information kept at dispersed locations. If
there is information considered too confidential to place in the record used by all staff (e.g.,
identification of the family’s financial assets, sensitive medical data), it may be retained in a
companion record located in a secure location in the facility with a notation made in the primary
record as to the location of confidential information. The facility must ensure that any client
information provided to day services programs is maintained confidential.

The sharing of client specific information with members of the “specially constituted
committee” required by §483.440(f)(3), who are not affiliated with the agency, does not violate

a client’s right to have information about him or her kept confidential. The committee must
have relevant information to function properly.

Facility confidentiality safeguards include the development and implementation of written
policies to assure that members of the specially constituted team maintain confidentiality. Such
processes may include signed confidentiality agreements.

W113

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(c)(3) The facility must develop and implement policies and procedures governing the
release of any client information, including consents necessary from the client, or parents (if
the client is a minor) or legal guardian.

Guidance §483.410(c)(3)

The facility develops and follows written policies governing the release of client information.

Release of any personally identifiable information does not occur unless consent(s) is obtained
prior to the release.

These policies must address at a minimum who must give consent for the release of information
from records. The policy and procedures should account for other situations involving the
release of client information, such as:

who should be notified when records have been released;

procedures to be followed with subpoenas;

time frames for providing requested information; and

information regarding a client’s HIV status may not be released without specific consent
and may not be in the record if that consent has not been given.

W114

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(c)(4) Any individual who makes an entry in a client’s record must make it legibly,
date it, and sign it.

Guidance §483.410(c)(4)

Illegible writing in hard copy records can contribute to communication deficits among staff.
Illegible writing which cannot be easily interpreted by facility staff upon surveyor request may
constitute a safety issue.

Electronic signatures are acceptable in the electronic record system.

W115

§483.410(c)(5) The facility must provide a legend to explain any symbol or abbreviation used
in a client’s record.

W116

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(c)(6) The facility must provide each identified residential living unit with appropriate
aspects of each client’s record.

Guidance §483.410(c)(6)

“Appropriate” means those parts of each client’s record are most likely (or known) to be needed
by the residential staff to carry out the client’s active treatment program in the unit; to alert
staff to health risks and other aspects of medical treatment; to support the psychosocial needs
of the client; to contact family or emergency contacts, and to provide anything else necessary to
the staff’s ability to work on behalf of the client.

The staff of the residential living unit has, and can access, all information which is relevant to
implementing client program plans, appropriate care of, interaction with, and provision of
services for the client.

(d) Standard: Services provided under agreements with
outside sources

W117

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(d)(1) If a service required under this subpart is not provided directly, the facility
must have a written agreement with an outside program, resource, or service to furnish the
necessary service, including emergency and other health care.

Guidance §483.410(d)(1)

If a service is not provided directly, there must be a written agreement for such services.

Written agreements are required for emergency services such as dentists and pharmacies. For
those services that require a visit to a hospital, the Intermediate Care Facilities for Individuals
with Intellectual Disabilities (ICF/IID) typically utilizes services from an emergency department of
the hospital, thus no written contract is required.

Federal statute (P.L. 94-142) requires all school-aged children to receive a free and appropriate
school education. Therefore, a written agreement between ICF/IIDs and public schools is not
necessary.

W118

(d)(2)(i) Contain the responsibilities, functions, objectives, and other terms agreed to by both
parties; and

W119

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(d)(2)(ii) Provide that the facility is responsible for assuring that the outside services
meet the standards for quality of services contained in this subpart.

W120

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(d)(3) The facility must assure that outside services meet the needs of each client.

Guidance §483.410(d)(3)

Outside services are any services needed by the clients and not provided directly by the facility
(hospital visits, dental visits, day program services, etc.).

Programs and services must be coordinated between the facility and the outside service, and
foster consistency of implementation across settings of teaching strategies and behavior
management.

The facility monitors outside services on an ongoing basis to ensure that services provided are
consistent with the needs of each client as identified in the Individual Program Plan (IPP). For
example, if the facility is implementing a behavior management or a communication program
for the client, it is shared with the outside program and implemented by the outside program
(workshop, day program, etc.) and the outside program agrees to incorporate it into their day
program. At periodic intervals, the facility staff visit or communicate with the outside program
to verify consistency across the two settings.

With outside resources, it is the responsibility of the facility to assure that the services are
provided in a safe clean environment, by appropriately qualified professions, and any untoward
outcome of services are promptly addressed. If, in spite of attempts by the facility to assure
compliance, the outside program does not implement the program for the client, then the
facility remains responsible for the lack of active treatment.

W121

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(d)(4) If living quarters are not provided in a facility owned by the ICF/IID, the ICF/IID
remains directly responsible for the standards relating to physical environment that are
specified in §483.470(a) through (g), (j) and (k).

Guidance §483.410(d)(4)

Even though the facility’s premises may be rented from a landlord, the facility must ensure that
the requirements for physical environment are met, either through arrangement with the
landlord or through the facility’s own services.

(e) Standard: Licensure

§483.420(a) Standard: Protection of Clients’ Rights

The facility must ensure the rights of all clients. Therefore, the facility must

Guidelines §483.420(a)

“Ensure” means that the facility actively asserts the individual’s rights and does not wait for him
or her to claim a right. This obligation exists even when the individual is less than fully
competent and requires that the facility is actively engaged in activities which result in the pro-
active assertion of the individual’s rights, e.g., guardianship, advocacy, training programs, use of

specially constituted committee, etc.

§483.410(e) Standard: Licensure

W101

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.410(e) The facility must be licensed under applicable State and local
law.

Guidance §483.410(e)

The facility has a current, valid State license when required under State law.

W122

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420 Condition of participation: Client protections

(a) Standard: Protection of clients’ rights

§483.420(a) The facility must ensure the rights of all clients. Therefore the facility must

Guidance §483.420(a)

The facility must ensure the client’s rights and does not wait for him or her to claim a right. This
obligation exists even when the client is less than fully competent and requires that the facility is
actively engaged in activities which result in the protection of the client’s rights, advocacy for
individual clients who have no family or an inactive family, and training programs for clients and
staff on the understanding and protection of client rights.

W123

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(1) Inform each client, parent (if the client is a minor), or legal guardian, of the
client’s rights and the rules of the facility;

Guidance §483.420(a)(1)

The obligation to inform requires that the facility presents information on rights to the client, his
or her family or his or her legal guardian in a manner and form which they can understand. In
most instances, family means parent. However, in those instances where parents are deceased
or choose not to be active in the client’s life and there is another family member who does wish
to be active, but is not the legal guardian, this family member should be informed of the client’s
rights. Printed materials should be provided in understandable terms and provided in the
language necessary to ensure understanding. Specialized methods, as indicated, should be
provided for communication with clients, families or legal guardians with hearing or vision
impairment.

Pro-active assertion of client rights includes, but is not limited to:

• Signed evidence that the client, his or her family and/or his or her legal guardian have
been informed of the client’s rights, and

• Evidence that the communication of these rights were provided at the client’s level of
comprehension, and in the language understandable to the client.

The obligation to inform also requires that the facility make some determination of whether the
client and his or her family, or legal guardian understood the rights presented and made
additional efforts to communicate the rights if the rights were not understood.

If the facility has written “rules of the facility”, these rules must be communicated to the client,
their family and or legal guardians at the time of admission and must not be in conflict with any
of the rights listed in 42 CFR 483.420 (a) (1-13).

W124

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(2) Inform each client, parent (if the client is a minor), or legal guardian, of the
client’s medical condition, developmental and behavioral status, attendant risks of treatment,
and of the right to refuse treatment;

Guidance §483.420(a)(2)

Clients, their families or legal guardians are promptly informed of any change in the client’s
medical or behavioral needs that requires immediate alteration to programmatic or medical
intervention. Promptly is defined by the level of severity of the alteration. In each case, they
must also be informed of the attendant risks of any recommended treatments or interventions
and of their right to refuse treatment, training or services.

If parents or legal guardians wish for other members of the client’s family to be informed of
such changes, they must put this permission in writing.

The communication of this information must be provided in the manner and language
understood by the client or their family or legal guardian (language boards, sign language, etc.).

The term “attendant risks of treatment” describes the risk vs. risk and risk vs. benefit associated
with the treatment. These risks include possible side effects, other complications from
treatments including medical and drug therapy, unintended consequences of treatment, other
behavioral or psychological ramifications arising from treatment, etc.

The facility actively attempts to engage clients who refuse to participate in active treatment.
While the regulation recognizes the client’s right to refuse treatment, persistent refusal that
impacts the health and safety of the client and/or others, or the ability to provide overall active
treatment, may result in facility’s consideration of alternative placements for the client. It is
expected, however, that the facility has assessed the reason for refusal, and developed and
implemented all possible interventions to engage the client in active treatment programs prior
to referring the client to another therapeutic setting.

A client, his or her family member, or legal guardian who refuses a particular treatment (e.g., a
behavior control, seizure control medication or a particular intervention strategy) must be
offered information about acceptable alternatives to the treatment, if acceptable alternatives
are available. The client’s preference about alternatives should be elicited and considered in
deciding on the course of treatment. If the client, family member, or legal guardian also refuses
the alternative treatment, or if no alternative exists to the treatment refused, the facility must
consider the effect this refusal may have on other clients, the client himself or herself, and if
they can continue to provide services to the client consistent with these regulations.

If the facility is unable to provide services to a client due to consistent refusal to participate,
they must weigh all options including an involuntary discharge. Involuntary discharge must be
for good cause (see 483.440(b)(4)(i)).

When a client is considered for participation in experimental research the client, his/her family
and/or legal guardian must be fully informed of the nature of the experiment (e.g., what
medications or physical interventions will be utilized, the length of the research, any possible
side effects and how the information from the research will be utilized). Information regarding
the possible consequences of participating or not participating must be provided to the client,
family member or legal guardian. The written consent of the client, his/her family or legal
guardian must be received prior to participation. For a client who is a minor or who has been
adjudicated as incompetent, the written informed consent of the parents of the minor or the
legal guardian is required. The signed, informed consent documentation must be in compliance
with HHS Guidelines for Research Involving Human Subjects. The signed consent must also
include a clear discussion of what treatments will be included in the research, the time limits for
the research and should clearly inform the client, family member or legal guardian that the
client may end participation at any time without fear of recrimination. If the research protocol
indicates that clients receive compensation, then clients are compensated per the protocol.

Any research must be reviewed and approved by the Specially Constituted Committee. See
W263.

W125

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(3) Allow and encourage individual clients to exercise their rights as clients of the
facility, and as citizens of the United States, including the right to file complaints, and the right
to due process;

Guidance §483.420(a)(3)

To the extent that a client is able, choices are made on his/her own. Each client has autonomy
of decision making and choice.

They are free to move about without limitations imposed due to staff preferences or staff
convenience.

Clients are not restricted without due cause or due process.

To the extent that the client is able to make decisions for him or herself, it is inappropriate to
delegate the person’s right to others (e.g. parents, family members, etc.).

The facility has an obligation to assure client health and safety and must balance that obligation
with the rights of clients.

If the facility has implemented a restriction, the following should be in place:

• An assessment supporting the need for the restriction;

• An individualized behavior plan to reduce the need for the restriction has been
developed and implemented;

• A written informed consent for the behavior plan which includes the restriction;

• Approval of the Specially Constituted Committee; and

• Monitoring by the Committee of the progress of the training program, designed to
reduce and eventually eliminate the restriction.

Clients, families, and legal guardians have the right to register a complaint with the facility and
the State Survey Agency. If so, the facility must respond promptly and appropriately. The
facility must ensure protection of the client from any form of reprisal or intimidation as a result
of a complaint or grievance reported by the client, family, or legal guardian.

Issues involving the exercise of constitutional rights such as voting should be addressed as a
component of the IPP when the Interdisciplinary Team (IDT) determines a need for training.
Clients who have been adjudged to need guardianship or have been assessed as needing
assistance to advocate for themselves should receive assistance or support so they may exercise
their rights as citizens of the United States.

W126

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(4) Allow individual clients to manage their financial affairs and teach them to do
so to the extent of their capabilities;

Guidance §483.420(a)(4)

The regulation is clear that in those cases where a client already possesses the skills necessary to
independently manage their own financial affairs, the facility will allow the client to continue to
do so. Formal training in financial management must be provided for all other clients in the
facility to the extent of their capabilities. The regulation places the responsibility for
determining the extent of the client’s capabilities in this matter upon an assessment and
interdisciplinary process within the facility.

To reach a determination as to whether a money management program is appropriate, the
facility IDT uses the comprehensive functional assessment (CFA) to evaluate the ability of each
client to participate in such a program. Under 42 C.F.R. 483.440(c)(3), the team evaluation must
establish, through documentation, that the IDT considers all of the objective data within the
assessment in reaching their determination, especially the identification of client skills which can
be used across training programs. Examples of assessment findings that may be considered by
the IDT include skills that can be cross-utilized in training programs such as:

1. Fine motor coordination;

2. The ability to make choices;

3. The ability to identify preferences; and

4. Cognitive abilities including tracking, attention span, communication, and the client’s
ability to understand the cause and effect. (The client understands of cause and effect
is significant in the determination.)

Money management includes a broad spectrum of programs with varying levels of participation
by the client ranging from the use of choice in money expenditures, to an understanding of the
concept of money, and ultimately to actual money handling and budgeting. The IDT must not
conclude that a money management program is inappropriate based solely upon the level of
intellectual or physical disability of the client.

The CFA must be reviewed at least annually per 42 C.F.R.483.440(f)(2). As a part of this annual
review, a client’s ability to participate in money management will also be reviewed. The annual
review should always include an update to the CFA and take into consideration any changes in
the client’s circumstances since the last IPP. The need for a formal money management
program must be addressed in every client’s IPP by the IDT on an annual basis.

The determination of the appropriateness of a formal money management program is made by
the IDT and must be based upon a CFA. The IDT discussions resulting in that determination
must be established through documentation in the client’s IPP.

W127

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(5) Ensure that clients are not subjected to physical, verbal, sexual or psychological
abuse or punishment;

Guidance §483.420(a)(5)

Identification of patterns or isolated instances of physical, verbal, sexual or psychological abuse
or punishment without prompt identification and corrective action by the facility would result in
a non-compliance determination for this Standard and Condition level non-compliance.

The facility must develop and implement systems that protect clients from all forms of abuse,
neglect, or mistreatment, including client to client abuse, neglect, or mistreatment.

a. The facility is expected to ensure that staff possess and demonstrate needed
competencies to effectively and appropriately interact with clients.

b. The facility must monitor to assure that systems are effectively implemented and the
facility takes immediate actions to address circumstances where abuse, neglect, or
mistreatment have occurred and prevent reoccurrence.

c. The facility must be organized in such a manner as to proactively assure clients are free
from any threat to their physical and psychological health and safety.

d. The facility must act to prevent physical, verbal, sexual or psychological abuse.

If the facility fails to implement appropriate corrective action, the potential of additional threats
to the clients remain at the facility.

“Threat”, for the purposes of this guideline, is considered any condition/situation which could
cause or result in severe, temporary or permanent injury or harm to the mental or physical
condition of clients, or in their death.

“Abuse”, for the purposes of this guideline, is the willful infliction of injury, unreasonable
confinement, intimidation or punishment with the resulting physical harm, pain or personal
anguish.

Physical abuse refers to any action intended to cause physical harm or pain, trauma or bodily
harm (e.g., hitting, slapping, punching, kicking, pinching, etc.). It includes the use of corporal
punishment as well as the use of any restrictive, intrusive procedure to control inappropriate
behavior for purposes of punishment.

Verbal abuse refers to any use of insulting, demeaning, disrespectful, oral, written or gestured
language directed towards and in the presence of the client. Psychological abuse includes, but is
not limited to, humiliation, harassment, and threats of punishment or deprivation, sexual

coercion and intimidation (e.g. living in fear in one’s own home). Since many clients residing in
ICF/IIDs are unable to communicate feelings of fear, humiliation, etc. associated with abusive
episodes, the assumption is made that any actions that would usually be viewed as
psychologically or verbally abusive by a member of the general public, would also be viewed as
abusive by the client residing in the ICF/IID, regardless of that client’s perceived ability to
comprehend the nature of the incident.

Sexual abuse includes any incident where a client is coerced or manipulated to participate in any
form of sexual activity for which the client did not give affirmative permission (or gave
affirmative permission without the attendant understanding required to give permission) or
sexual assault against a client who is unable to defend him/herself.

The facility must implement, through policies, oversight and training, safeguards to ensure that
clients are not subjected to abuse by anyone including, but not limited to, facility staff,
consultants or volunteers, staff of other agencies serving the client, family members or legal
guardians, friends, other clients, or the general public.

The facility must take whatever action is necessary to protect the clients residing there. For
example, if a facility is forced by court order or arbitration rulings to retain or reinstate an
employee found to be abusive, the facility must take measures to protect the clients of the
facility (such as assigning the employee to an area where there is no contact with clients).

W128

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(6) Ensure that clients are free from unnecessary drugs and physical restraints and
are provided active treatment to reduce dependency on drugs and physical restraints;

Guidance §483.420(a)(6)

The facility must implement an aggressive active treatment program, which includes
appropriate replacement behaviors, to address the reduction/elimination of physical restraints
and drugs to manage behaviors.

For purposes of this Guideline drugs to manage behavior are “unnecessary” if there is evidence
the drugs are being used:

• In excessive dose (duplicate therapy);

• For excessive duration;

• Not monitored adequately;

• Without adequate indications for its use;

• With adverse consequences which indicate the dose should be reduced or discontinued;
or

• Any combination of the reasons listed above.

The long term use of a drug/physical restraint to manage behavior combined with one or more
of the following may indicate unnecessary use:

• The client’s developmental and/or behavioral needs are not being met and the
appropriateness of less restrictive approaches to manage inappropriate behaviors
should be questioned;

• Staff behavior may be prompting behaviors in clients which result in the chronic use of
physical restraints and drugs to control behavior;

• Staff may have inadequate training and/or experience to provide active treatment and
employ preventive measures;

Restraints applied for behaviors when less restrictive measures have not been tried or have been
tried and found to be just as effective.

W129

(Rev. 144, Issued: 08-14-15, Effective: 08-14-15, Implementation: 08-14-15)

§483.420(a)(7) Provide each client with the opportunity for personal privacy and

Guidance §483.420(a)(7)

The facility must provide areas within the living area in which the client can have time to be
alone, when appropriate, and to have privacy (their conversations cannot be overheard) for
personal interactions/activities. There should be a location where the client can meet privately
with family and/or friends and a telephone available where he/she can hold private telephone
conversations.

Personal privacy for clients also includes the right to have certain personal information about
them kept confidential. Staff should not discuss one client in front of others (clients, parents,
legal guardians, visitors, etc.) and should not post personal information about clients in areas
where other clients, families and the public can read the information.

Video/audio taping or live feed must not be used in place of or for the convenience of staff. The
facility may install video/audio equipment for purposes of observing client/staff interactions.
Video/audio equipment may only be installed in common areas (in no case may videotaping or
live feed be done in bathrooms or areas where private visits are conducted). The clients,
families and/or legal guardians of the clients residing in the areas where videotaping or live feed
will occur must give informed consent for the installation and must be assured that no personal
privacy will be jeopardized. The use of the equipment must be presented at and approved by
the specially constituted committee for the facility prior to the installation of video or audio
devices.

Motion sensors should not be considered cameras.

W130

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(7) ensure privacy during treatment and care of personal needs;

Guidance §483.420(a)(7)

Clients must be provided privacy during personal hygiene activities (e.g., toileting, bathing,
dressing) and during medical/nursing treatments that require exposure of one’s body.

People not involved in the care of the client should not be present without their consent while
they are being examined or treated.

Whenever possible, the facility should be sensitive to clients’ preferences for same sex care in
private situations.

W131

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(8) Ensure that clients are not compelled to perform services for the facility and

Guidance §483.420(a)(8)

Clients are not required or expected to be a source of labor for a facility. The client must not be
required or expected to do productive work for the facility, other than appropriate care of one’s
own personal space or shared responsibilities for common areas.

W132

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(8) ensure that clients who do work for the facility are compensated for their
efforts at prevailing wages and commensurate with their abilities;

Guidance §483.420(a)(8)

“Work”, as used in the regulation, means any directed activity, or series of related activities
which results in a benefit to the economy of the facility or in a contribution to its maintenance,
or in the production of a salable product. In deciding whether a particular activity constitutes
“work” as defined above, the key determinant is whether the facility would be required to hire
additional full or part-time staff (or pay overtime to existing staff) to perform the service the
client is asked to perform.

Clients volunteering to do real work that benefits the facility should give informed consent for
such practices and understand that by providing employable services they are able to be

compensated. This does not preclude a client from helping out a friend or being kind to others.
Self-care activities related to the care of one’s own person or property are not considered
“work” for purposes of compensation.

In general, participation in any household task which promotes greater independent functioning
and assists the client to prepare for less restrictive setting (and which the client has not yet
learned) is permitted as long as tasks are included in the IPP in written behavioral and
measurable terms. This participation must be supervised, and indices of performance should be
available. No task may be performed for the convenience of staff (e.g., supervising clients,
running personal errands).

“Compensated” means the client is provided with money or other forms of negotiable
compensation for work (including work performed in an occupational training program) and
such compensation is to be used at the client’s discretion.

Prevailing wage refers to the wage paid to non-disabled workers in nearby industry or the
surrounding community for essentially the same type, quality and quantity of work or work
requiring comparable skills. A client who works in the facility must be paid at least the
prevailing minimum wage, unless an appropriate certificate has been obtained by the facility in
accordance with current regulations and guidelines issued under the Fair Labor Standards Act,
as amended.

Any client performing “work”, as defined above, must be compensated in direct proportion to
his or her output. The facility should utilize Department of Labor and/or Department of
Vocational Rehabilitation formulas and techniques for determining rate of pay. A client’s pay is
not dependent on the production of other clients when he or she works in a group.

When the client’s active treatment program includes assignment to occupational or vocational
training or work, specific work objectives of anticipated progress should be included in the IPP
along with reasons for the assignments. If the training of clients on particular occupational
activities or functions involves “real work” to be accomplished for the facility, the clients must
be compensated based on ability. For example, if in the process of work training activities which
involve learning to clean a floor, the floor for a particular building is cleaned and does not
require further janitorial cleanup, then the client must be compensated for this activity at the
prevailing wage.

W133

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(9) Ensure clients the opportunity to communicate, associate and meet privately
with individuals of their choice,

Guidance §483.420(a)(9)

Privacy must be provided for both face-to-face interactions and electronic interactions.

The facility must provide opportunities for the client to communicate, through regular mail,
telephone and/or electronic mail and meet in private with persons of their choice (e.g., friends
from the community, family members, and advocates). There may be instances where legal
guardians override the wishes of the client. In these instances, the facility should be actively
working with the legal guardian and the client to reach the maximum agreeable level of
interaction for the client.

Space must be provided for clients to receive visitors in reasonable comfort and privacy.

W134

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(9) and to send and receive unopened mail;

Guidance §483.420(a)(9)

Clients must be provided the opportunity to send/receive all types of mail unopened and read
the contents themselves if able. If the staff has to open and read mail to the client, this should
be done in a private place allowing the client as much participation as possible.

Clients who have their own electronic equipment must be provided the opportunity to send,
receive, and read electronic mail with privacy.

W135

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(10) Ensure that clients have access to telephones with privacy for incoming and
outgoing local and long distance calls except as contraindicated by factors identified within
their individual program plans;

Guidance §483.420(a)(10)

Any restriction of telephone access must be explained in the IPP with a plan to advance the
client’s access. For persons with hearing loss who could benefit, Text Telephone (TTY) services
or other accommodations should be provided.

As with any other rights restriction, the restriction must be addressed in the IPP, written
informed consent obtained, and the plan must be reviewed and approved by the specially
constituted committee.

W136

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(11) Ensure clients the opportunity to participate in social, religious, and
community group activities;

Guidance §483.420(a)(11)

Clients should be offered the opportunity to participate in various types of activities in the
community (e.g., going to grocery stores, hair salons, restaurants, places of worship,
pharmacies, community meetings and events) based on their interests and choices. The facility
must make accommodations for physical issues such as hearing impairment and mobility
limitations. In addition, clients should be taught the applicable skills to participate in their
choice of activities to the fullest extent of their abilities.

It is not acceptable for all client activities to be provided in the facility.

When a client is identified to be on restriction from community integration opportunities,
interview clients, families, legal guardians and staff to determine if due process was afforded for
this restriction and whether the restriction is included in the IPP.

In the event of a court placement that restricts community access, due process does not apply.

There should be evidence that the facility assists and encourages all clients, regardless of
functioning levels, to have input into the decisions on community integration activities. It is not
acceptable to require clients to attend unwanted activities due to staffing considerations.

W137

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(12) Ensure that clients have the right to retain and use appropriate personal
possessions and clothing, and

Guidance §483.420(a)(12)

Clients should have personal possessions and clothing which meet their needs, interests and
choices.

Clients should have free access to their own possessions and clothing. When considering
whether a client has free access to their personal possessions and clothing, ensure that physical
limitations have been addressed.

Clients who are unable to access and use personal possessions and clothing appropriately are
involved in programs to learn the necessary skills to do so.

In situations where the behavior of one or more clients in a living area prevents free access to
personal possessions for each client, the facility must develop IPPs for the client with disruptive
behavior. The facility must also ensure that during the implementation of this program plan

that none of the other clients have their rights infringed upon. Clients should not be without
personal possessions because of the behavior of others with whom they live.

All client possessions, regardless of their apparent value to others are treated with respect for
what they may represent to the client. Where those choices include socially stigmatizing
materials, the facility should provide learning opportunities to make more socially appropriate
choices. The facility should encourage clients to use or display possessions of his or her choice
in a culturally normative manner.

If a method for identifying personal effects is used, it should be inconspicuous and in a manner
that will assist the client to identify them.

“Appropriate” clothing means a supply of clothing that is sufficient, in good repair, accounts for
a variety of occasions and seasons, and appropriate to age, size, gender, and level of activity.
Modification or adaptation of clothing fasteners should be considered based on the needs of a
client with a physical disability to become more independent.

As appropriate, each client’s active treatment program maximizes opportunities for choice and
self-direction with regard to choosing and shopping for clothing which enhances his or her
appearance, and selecting daily clothing in accordance with age, sex and cultural norms.

Clients are permitted to keep personal clothing and possessions for their use while in the facility.
Determine how the facility both ensures the safety of personal possessions while at the same
time providing client access to them when the client chooses.

Clients are provided the opportunity, encouraged, and trained to use age-appropriate materials.
The term “age-appropriate” refers to anything that reinforces recognition of the client as a
person of a certain chronological age. Clients who choose to keep items traditionally used by
children such as dolls or model cars are not an automatic citation. There must be evidence the
facility is encouraging the client to use these possessions in a socially appropriate, non-
stigmatizing manner. The facility’s environment must be furnished with materials and activities
that will enhance opportunities for growth.

W138

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(a)(12) ensure that each client is dressed in his or her own clothing each day; and

Guidance §483.420(a)(12)

Clothing such as pajamas, underwear, socks, hats, mittens/gloves, and coats should be the
personal property of the client and not considered “stock” items. There should be no communal
clothes. If clients are unable to do their own personal laundry the facility must ensure that
clothing is properly laundered and returned to the appropriate client.

The staff of the facility should ensure that clients dress appropriately for the season and the
occasion by implementing training programs or guidance for the client as indicated.

W139

§483.420(a)(13) Permit a husband and wife who both reside in the facility to share a room.

§483.420(b) Standard: Client Finances

(b)(1) The facility must establish and maintain a system that

W140

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(b)(1)(i) Assures a full and complete accounting of clients’ personal funds entrusted
to the facility on behalf of clients; and

Guidance §483.420(b)(1)(i)

All purchases made using client personal funds must be itemized in the accounting record with
the exception of pocket money. Pocket money given to the client does not need to be itemized.
Pocket money should be considered a nominal amount of five dollars or less at a time. Funds
provided by the facility and dispensed to a client as part of a program to train the client in
money management, and funds that are not entrusted to the facility (e.g., funds paid directly to
the client’s representative payee) do not require accounting.

In those instances where a legal guardian or the individual client is in control of their personal
funds, no accounting is necessary by the facility.

W141

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(b)(1)(ii) Precludes any commingling of client funds with facility funds or with the
funds of any person other than another client.

Guidance §483.420(b)(1)(ii)

If the facility elects to pool clients’ funds in an interest-bearing account, including common trust
accounts, it is expected to know the interest separately accrued by each client, as part of its
required accounting of funds. Interest accumulated to a client’s account belongs to the client,
not the facility.

W142

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(b)(2) The client’s financial record must be available on request to the client, parents
(if the client is a minor) or legal guardian.

Guidance §483.420(b)(2)

Those persons having legal authority to access the accounting records for personal funds such as
the client, parent, or legal guardians should be afforded access upon request unless there is
documented rationale for withholding the information.

It is not necessary that a facility furnish an annual financial statement to the client, or the
client’s parent or legal guardian, since the facility is already required to make the financial
record available at any time upon request. The client, parent, and/or legal guardian, in turn, is
free to choose to make the financial record available to anyone else.

§483.420(c)

The Facility must –

W143

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(c)(1) Promote participation of parents (if the client is a minor) and legal guardians in
the process of providing active treatment to a client unless their participation is unobtainable
or inappropriate;

Guidance §483.420(c)(1)

The facility must maintain an on-going effort to communicate with parents, family members
and/or legal guardians regarding the implementation of active treatment programs for the
client. The facility encourages and engages parents, family members and legal guardians in the
continued implementation of active treatment programs even while spending time outside of
the facility setting.

“Unobtainable”, for the purposes of this guideline, means that the facility has made a good faith
effort to seek parental or legal guardian participation in the process, even though the effort may
ultimately be unsuccessful (for example, the parent may be impossible to locate or may prove
unwilling or unable to participate).

“Inappropriate”, for the purposes of this guideline, means that behavior of the parent or legal
guardian could be disruptive or detrimental to the client’s program outcome. In this case,
determine what the facility has done to bring effective resolution to the problem.

W144

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(c)(2) Answer communications from clients’ families and friends promptly and
appropriately;

Guidance §483.420(c)(2)

It is reasonable to expect that the facility will provide at least an interim response to inquiries
from the client’s families and friends within 48 hours.

W145

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(c)(3) Promote visits by individuals with a relationship to the client (such as family,
close friends, legal guardians and advocates) at any reasonable hour, without prior notice,
consistent with the right of that client’s and other clients’ privacy, unless the interdisciplinary
team determines that the visit would not be appropriate;

Guidance §483.420(c)(3)

Any limitations on visitors must be implemented as a result of IDT evaluation and discussion and
be documented. This documentation should include evidence of approval from the specially
constituted committee. Decisions to restrict a visitor for an individual client must be reviewed
and re-evaluated each time the IPP is reviewed or at the client’s request. Broad restrictions on
visitors such as times of the day or certain days of the week are a violation of this requirement.

W146

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(c)(4) Promote visits by parents or guardians to any area of the facility that provides
direct client care services to the client, consistent with the right of that client’s and other
clients’ privacy;

W147

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(c)(5) Promote frequent and informal leaves from the facility for visits, trips, or
vacations; and

Guidance §483.420(c)(5)

The facility should assist and encourage the client to communicate with their families or legal
guardians concerning possible outside visits and vacations as frequently as possible. When the
client does schedule a trip or vacation, the facility must ensure that all necessary preparation is
completed to facilitate the departure.

The facility should not sponsor or allow clients to take a particular type of trip that would
jeopardize their safety or health without consultation with parents/legal guardians and/or the
IDT.

W148

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(c)(6) Notify promptly the client’s parents or guardian of any significant incidents, or
changes in the client’s condition including, but not limited to, serious illness, accident, death,
abuse, or unauthorized absence.

Guidance §483.420(c)(6)

“Significant” incidents or changes in the client’s condition include serious injury, unusual seizure
activity, hospitalization, serious illness, accident, death, allegations of abuse, neglect, or
mistreatment, unauthorized absence, or any notifications the parent or legal guardian’s
requests.

It is reasonable to expect the facility to contact the family or legal guardian of a client as soon as
possible after an incident occurs, but no later than 24 hours after the incident. If notification is
done via electronic mail, the facility must request a response from the e-mail recipient to
confirm notification. Telephone notification must be accomplished by talking to the person
directly. If a message is left, the facility must request a call back to confirm receipt of the
notification.

Contact by letter may be utilized as follow up confirmation, but not be the initial, primary or sole
mode of communication with the family or legal guardian.

If unable to contact the family or legal guardian, there should be evidence that the facility
attempted to reach alternate emergency contacts.

Requests from clients who are their own guardian to limit notifications to their families must be
honored.

(d) Standard: Staff treatment of clients.

W149

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(d)(1) The facility must develop and implement written policies and procedures that
prohibit mistreatment, neglect or abuse of the client.

Guidance §483.420(d)(1)

The facility, through implementation of its policies, must set up a structure that screens and
trains employees, protects clients and prevents, identifies, investigates and reports abuse,
neglect and mistreatment of clients.

The policies must designate who (either by name or title) has the authority to act in the
Administrator’s absence and take any immediate corrective actions necessary to assure a
client’s safety such as removing a staff person from direct client contact.

“Mistreatment”, for the purposes of this guideline, includes behavior or facility practices that
result in any type of client exploitation such as financial, physical, sexual, or criminal.
Mistreatment also refers to the use of behavioral management techniques outside of their use
as approved by the specially constituted committee and facility policies and procedures.

“Neglect” means failure to provide goods and services necessary to avoid physical harm, mental
anguish or mental illness. Staff failure to intervene appropriately to prevent self-injurious
behavior may constitute neglect. Staff failure to implement facility safeguards, once client to
client aggression is identified, may also constitute neglect.

Refer to W127 for definitions of abuse.

W150

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(d)(1)(i) Staff of the facility must not use physical, verbal, sexual or psychological
abuse or punishment.

W151

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(d)(1)(ii) Staff must not punish a client by withholding food or hydration that
contributes to a nutritionally adequate diet.

W152

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(d)(1)(iii) The facility must prohibit the employment of individuals with a conviction
or prior employment history of child or client abuse, neglect or mistreatment.

Guidance §483.420(d)(1)(iii)

The facility is required to screen potential employees for a prior employment history of child or
client abuse, neglect or mistreatment, as well as for any conviction based on those offenses.
The abuse, neglect or mistreatment must have been directed toward a child or a
client/resident/patient of a health care facility in order for the prohibition of employment to
apply.

No one with a conviction or substantiated allegation of child or client abuse, neglect or
mistreatment regardless of employment date, is employed by the facility. This requirement also
applies to acts of abuse, neglect or mistreatment committed by a current ICF/IID employee
outside the jurisdiction of the ICF/IID (e.g., in the community or in another health care facility).
The facility must follow state guidelines or requirements for background checks to assure that
they make every effort to check new employee’s background.

Where the facility has terminated an employee based upon confirmation that abuse, neglect or
mistreatment occurred during the employee’s performance, and the termination decision was
overturned by either arbitration finding or a court finding, the employee must be returned to a
position which does not involve direct contact between that employee and clients of the facility.

A person who abused a resident in a nursing facility, and as a result, is barred from employment
in the nursing home setting would also be prohibited from employment in the ICF/IID. While
facilities are not required to periodically screen existing employees, if the facility becomes
aware that such action has been taken against an employee, the facility is required to prohibit
continued employment. This is also true of any conviction in a court of law for child, elder, or
client (resident, patient) abuse, neglect or mistreatment. Therefore, conviction for abusing
one’s own child is also a reason employment would be prohibited.

W153

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(d)(2) The facility must ensure that all allegations of mistreatment, neglect or abuse,
as well as injuries of unknown source, are reported immediately to the administrator or to
other officials in accordance with State law through established procedures.

Guidance §483.420(d)(2)

Injuries of unknown source that give rise to a suspicion that they may be the result of abuse or
neglect, should be reported immediately.

An injury should be reported as an “injury of unknown source” when:

• The source of the injury was not witnessed by any person and the source of the injury
could not be explained by the client; and

• The injury raises suspicions of possible abuse or neglect because of the extent of the
injury or the location of the injury (e.g., the injury is located in an area not generally
vulnerable to trauma) or the number of injuries observed at one particular point in time
or the incidence of injuries over time.

It is important to note that members of the ICF/IID population are a mobile population and lead
active lives. Therefore, they experience normal day-to-day bumps and minor abrasions as they
go about their lives. These minor occurrences which are not of serious consequence to the
individual and do not present as a suspicious or repetitive injury (as discussed above) should be
recorded by the facility staff once they are aware of them and follow-up should be conducted as
indicated. For injuries that do not rise to the level of reportable “injuries of unknown source”,
the facility should follow its policies and procedures for incident recording, investigation, and
tracking.

The facility must immediately report any suspicious injuries of unknown source and all
allegations of mistreatment, neglect or abuse to a client residing in the facility regardless of who
is the alleged perpetrator (e.g., facility staff, parents, legal guardians, volunteer staff from
outside agencies serving the client, neighbors, or other clients, etc.).

If state law requires reporting to an agency or entity other than the administrator, the Centers
for Medicare & Medicaid Services (CMS) expects the administrator to be notified as well, in
order to ensure facility response to promptly safeguard the client(s).

For the purposes of this regulation “immediately” means there should be no delay between staff
awareness of the occurrence and reporting to the administrator or other officials in accordance
with State law unless the situation is unstable in which case reporting should occur as soon as
the safety of all clients is assured.

W154

(Rev. 162, Issued: 10-14-16, Effective: 10-14-16, Implementation: 10-14-16)

§483.430(d)(3) The facility must have evidence that all alleged violations are thoroughly
investigated; and

Guidance §483.430(d)(3)

In the absence of any pre-survey information that would indicate the need for a more thorough
review, the surveyors review 5 percent of the total client incidents and associated investigative
reports of all alleged violations of abuse, neglect or mistreatment, as well as injuries of unknown
source for the last three (3) months (but no less than 10).

Investigative reports are completed as indicated for all allegations.

A thorough investigation includes at a minimum:

• The collection of all interviews, statements, physical evidence and any pertinent maps,
pictures or diagrams;

• Review of all information related to the allegation;

• Resolution of any discrepancies;

• Summary of conclusions; and

• Recommendations for action both to safeguard all the clients during the investigation
and after the completion of the report.

If patterns of possible abuse, neglect, mistreatment or injuries of unknown source are identified
during the review, or the facility incident report logs for the past three (3) months indicate an

extremely high incident rate, then a full review of all alleged violations of abuse, neglect or
mistreatment, as well as injuries of unknown source for the past three (3) months should be
completed.

W155

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(d)(3) must prevent further potential abuse while the investigation is in progress.

Guidance §483.420(d)(3)

The facility must take all measures necessary to protect the client, including removal of the staff
from working with the client if indicated. See W154.

W156

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(d)(4) The results of all investigations must be reported to the administrator or
designated representative or to other officials in accordance with State law within five
working days of the incident and,

Guidance §483.420(d)(4)

Some states require that allegations of abuse must be reported to the police. A police
investigation may take longer than five (5) working days. Their investigation does not change
the requirement that the facility must complete an internal investigation report of findings
within the five day timeframe. When outside authorities are involved, the facility will still be
required to complete their investigation within five days to the extent authorized by such
entities. “Working days” means Monday through Friday, excluding state and Federal holidays.

W157

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.420(d)(4) if the alleged violation is verified, appropriate corrective action must be taken.

Guidance §483.420(d)(4)

The facility is required to ensure that clients residing in the facility are not subjected to physical,
verbal, sexual or psychological abuse or punishment.

Appropriate corrective action is required for findings of abuse, neglect or mistreatment by other
clients residing in the facility, staff of outside agencies, parents or any other person, and for
injuries to clients resulting from controllable environmental factors.

If the facility receives allegations of abuse, neglect, or mistreatment of a client during out of
facility visits with their family, they must report these allegations to the appropriate state
authority for investigation. The facility does not have to conduct an internal investigation
regarding the alleged violation.

Appropriate corrective action is defined as that action which is reasonably likely to prevent the
abuse, neglect, mistreatment or injury from recurring.

This regulation does not require staff termination as the only appropriate corrective action.

The corrective action imposed by the facility is commensurate with the violation.

When a facility is forced to re-hire a staff person, determined by the facility investigation to
have been responsible for abuse, neglect, or mistreatment, the facility continues to be
responsible for ensuring the health and safety of the clients, and ensures that those staff
members do not work directly with clients.

W158

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430 Condition of participation: Facility staffing.

(a) Standard: Qualified intellectual disability professional

W159

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(a) Each client’s active treatment program must be integrated, coordinated and
monitored by a qualified intellectual disability professional who –

Guidance §483.430(a)

The position of qualified intellectual disability professional (QIDP) is unique to the ICF/IID
program. This position can be central to the overall responsiveness and effectiveness of an active
treatment program. Whether a supervisory or non-supervisory position, the QIDP is responsible
to:

• Orchestrate all facets of the active treatment effort, including the IDT creation of relevant
IPPs tailored to meet individual client needs;

• Effectively coordinate internal and external program services and supports to facilitate
the acquisition of client skills and adaptive behaviors; and

• Promote competent interactions of residential staff with clients in program
implementation and behavior management.

Breakdowns in the provision of needed services does not automatically equate with deficient
practice with QIDP regulations. Non-compliance with QIDP regulations exist where the facility
has failed to provide a QIDP or sufficient numbers of QIDPs to effectively perform these required
functions or the QIDP(s) has failed to assertively attempt to integrate, coordinate and/or monitor
each client’s active treatment program.

Elements of integrating, coordinating and monitoring active treatment programs include:

• Routinely observing clients across settings in program areas to assess effectiveness of
program implementation and consistency of training effort to determine effectiveness of
IPPs and making timely modifications to facilitate achieving desired skills or goals.

• Routinely interacting with program staff across settings to assist in determining the
effectiveness and continued relevance of program plans in meeting identified client
needs.

• Determining the need for program revision based on client performance.

• Identifying inconsistencies in training approaches or programs not being implemented as
written and facilitating the resolution of these inconsistencies.

• Assures follow-up occurs for any recommendation for services, equipment or programs
so that needed services and supplies are provided in a timely manner to meet the client’s
needs.

The number of QIDPs will vary depending on such factors as the number of clients the facility
serves, the complexity of needs manifested by these clients, the number, qualifications and
competencies of additional professional staff members, and whether or not other duties are
assigned to the QIDP function.

The QIDP function may not be delegated to other employees even though the QIDP co-signs
their work.

W160

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(a)(1) Has at least one year of experience working directly with persons with
intellectual disability or other developmental disabilities; and

Guidance §483.430(a)(1)

“Experience” means providing professional or direct services, either paid or volunteer, in a
setting that serves persons with intellectual disabilities. The experience working directly with
persons with intellectual or other developmental disabilities can be obtained prior to or after
obtaining the qualifying degree or credentials.

§483.430(a)(2) Is one of the following:

W161

(a)(2)(i) A doctor of medicine osteopathy.

W162

(a)(2)(ii) A registered nurse.

W163

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(a)(2)(iii) An individual who holds at least a bachelor’s degree in a professional
category specified in paragraph (b)(5) of this section

Guidance §483.430(a)(2)(iii)

The individual must have at least a bachelor’s degree in one of the professions listed in §483.430
(b)(5)(i-xi).

(b) Standard: Professional program services

W164

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430 (b)(1) Each client must receive the professional program services needed to
implement the active treatment program defined by each client’s individual program plan.

Guidance §483.430 (b)(1)

The effectiveness of the active treatment effort is dependent on a facility’s assembly of a
competent team of professional program staff, with knowledge of contemporary care practices
in intellectual disabilities specific to their field of expertise, that work cooperatively as members
of an IDT. The facility is responsible for the acquisition of professional staff necessary to provide
direct and indirect professional services to meet client needs.

Professional program services are those services that meet the needs identified by a client’s CFA
that must be provided by a member of a vocation founded upon specialized education/training.

Professional staff services also include on-going monitoring of the effectiveness of programs and
plans developed by professional staff but implemented by non -professional staff.

Indirect professional staff services also include on-going, technical support to staff implementing
these programs as well as timely assessment of the need for modification of the program with
appropriate communication to the QIDP and IDT.

The needs identified in the initial CFA, as required in §483.440(c)(3)(v), should guide the team in
deciding if a particular professional’s involvement is necessary and, if so, to what extent
professional involvement must continue on a direct or indirect basis.

Since such needed professional expertise may fall within the purview of multiple professional
disciplines, based on overlapping training and experience, determine if the facility’s delivery of
professional services is adequate by the extent to which clients’ needs are aggressively and
competently addressed. Some examples in which professional expertise may overlap include,
but are not limited to:

• Physical development and health: nurse, dietitian, pharmacist.

• Nutritional status: nurse, nutritionist or dietitian.

• Sensorimotor development: educators, recreation therapists, and occupational
therapist, physical therapist.

• Affective (emotional) development: special educators, social workers, psychologists,
psychiatrists, mental health counselors, rehabilitation counselors, behavior therapists,
behavior management specialists, behavior analyst, and medical staff.

• Speech and language (communication) development: speech-language pathologists,
special educators for people who are deaf or hearing impaired, and medical staff.

• Auditory functioning: audiologists (basic or comprehensive audiologic assessment and
use of amplification equipment); speech-language pathologists (like audiologists, may
perform aural rehabilitation); special educators for clients who are hearing impaired and
medical staff.

• Cognitive development: teachers (if required by law, e.g., school aged children, or if
pursuit of GED is indicated), behavior analysts, psychologists, speech-language
pathologists.

• Vocational development: occupational therapists, vocational rehabilitation counselors,
or other work specialists (if development of specific vocational skills or work placement
is indicated).

• Social Development: teachers, professional recreation staff, social workers, behavior
analysts, psychologists (specialized training needs for social skill development).

Adaptive behaviors or independent living skills: special educators, occupational
therapists, behavior analysts, and medical staff.

W165

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(1) Professional program staff must work directly with clients

Guidance §483.430(b)(1)

Examples of professional staff working directly with clients include: performing professional
assessments of clients, provision of direct support and services and periodic monitoring by the
professional of the client working on the program. The amount and degree of direct care that
professionals must provide will depend on the needs of the client and the ability of other staff to
effectively work with clients on a day-to-day basis.

For those services that must be provided by a professional due to either law, licensure or
registration, the client receives the services directly from the professional. Professionals may
deliver services through the supervision and direction of subordinates where provided by law.

W166

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(1) and with paraprofessional, nonprofessional and other professional program
staff who work with clients.

Guidance §483.430(b)(1)

Paraprofessionals are persons in various occupational fields who are trained to assist
professionals but are themselves not licensed at the professional level.

Examples of “working with” these other staff may include, but not be limited to:

• Modeling the correct technique for interacting with clients or implementing a specific
program objective.

• Designing residential activity programs and teaching staff how to implement them.

• Conducting classes on discipline specific topics.

• Answering questions of staff related to program implementation or specific behavioral
management issues.

• Monitoring active treatment areas to identify program implementation or staff-client
interaction issues.

W167

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(2) The facility must have available enough qualified professional staff to carry out
and monitor the various professional interventions in accordance with the stated goals and
objectives of every individual program plan.

Guidance §483.430(b)(2)

There should be sufficient professional staff in the facility to ensure that:

• needed assessments by professionals are completed timely;

• direct professional services are provided when indicated;

• clients are receiving interventions as specified in the IPP;

• client outcomes are being monitored by the professional;

• assessments and outcomes are being communicated to the IDT; and

• professional staff are available to consult with team members when needed.

W168

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(3) Professional program staff must participate as members of the
interdisciplinary team in relevant aspects of the active treatment process.

Guidance §483.430(b)(3)

When a professional does an assessment and determines there are client needs which become
incorporated into the IPP, with a current prioritized objective, the professional should actively
participate on the IDT. This participation may be through written reports or verbally while
attending the IPP meeting or participating via telephone or other electronic means, to provide
team members with the opportunity to review and discuss information and recommendations
relevant to the client’s needs, and to reach decisions as a team, rather than individually, on how
best to address those needs.

W169

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(4) Professional program staff must participate in on-going staff development and
training in both formal and informal settings with other professional, paraprofessional, and
nonprofessional staff members.

Guidance §483.430(b)(4)

Professional program staff provides various types of training to staff as indicated by the IPP and
IDT.

Formal training: a specific training done at the time a program is implemented or
updated by the professional, with all staff who works with the client.

Informal training: when the professional observes the staff not correctly implementing a
program, the professional provides informal guidance on correct implementation.

Training on programs that apply to multiple clients: when a particular program applies
to several clients in a facility, a professional may provide training to several staff on a
particular topic that applies to multiple clients (such as safe transfer techniques).

Professional staff of the facility should participate in ongoing training such as conferences and
workshops to maintain current standards of practice in the field of intellectual and
developmental disabilities as required by their professional licensure or certification.

W170

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(5) Professional program staff must be licensed, certified, or registered, as
applicable, to provide professional services by the State in which he or she practices. Those
professional program staff who do not fall under the jurisdiction of State licensure,
certification, or registration requirements, specified in §483.410(b), must meet the following
qualifications:

W171

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(5)(i) To be designated as an occupational therapist, an individual must be eligible
for certification as an occupational therapist by the American Occupational Therapy
Association or another comparable body.

Guidance §483.430(b)(5)(i)

If a professional is not nationally certified, they would have to show evidence they completed
the degree and field work in their designated field and are eligible to sit for the national exam.

The American Occupational Therapy Association is now known as the National Board for
Certified Occupational Therapists (NBCOT). There is no “other comparable body.”

Eligibility means the professional must have completed a degree in their designated field,

completed all field work required for a license, must meet licensure requirements in the state
they are practicing in, and are registered or certified nationally as applicable.

W172

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(5)(ii) To be designated as an occupational therapy assistant, an individual must be
eligible for certification as a certified occupational therapy assistant by the American
Occupational Therapy Association or another comparable body.

Guidance §483.430(b)(5)(ii)

If a professional is not nationally certified, they would have to show evidence they completed
the degree and field work in their designated field and are eligible to sit for the national exam.

The American Occupational Therapy Association is now known as the National Board for
Certified Occupational Therapists (NBCOT). There is no “other comparable body.”

Eligibility means the professional must have completed a degree in their designated field,
completed all field work required for a license, must meet licensure requirements in state they
are practicing in, and are registered or certified nationally as applicable.

W173

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(5)(iii) To be designated as a physical therapist, an individual must be eligible for
certification as a physical therapist by the American Physical Therapy Association or another
comparable body.

Guidance §483.430(b)(5)(iii)

If a professional is not nationally certified, they would have to show evidence they completed
the degree and field work in their designated filed and are eligible to sit for the national exam.

W174

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(5)(iv) To be designated as a physical therapy assistant, an individual must be
eligible for registration by the American Physical Therapy Association or be a graduate of a
two year college-level program approved by the American Physical Therapy Association or
another comparable body.

Guidance §483.430(b)(5)(iv)

If a professional is not nationally certified, they would have to show evidence they completed
the degree and field work in their designated filed and are eligible to sit for the national exam.

Eligibility means the professional must have completed a degree in their designated field,
completed all field work required for a license, must meet licensure requirements in State they
are practicing in, and are registered or certified nationally as applicable.

W175

§483.430(b)(5)(v) To be designated as a psychologist, an individual must have at least a
master’s degree in psychology from an accredited school.

§483.430(b)(5)(vi) To be designated as a social worker, an individual must–

W176

§483.430(b)(5)(vi)(A) Hold a graduate degree from a school of social work accredited or
approved by the Council on Social Work Education or another comparable body; or

§483.430(b)(5)(vi)(B) Hold a Bachelor of Social Work degree from a college or university
accredited or approved by the Council on Social Work Education or another comparable body.

§483.430(b)(5)(vii) To be designated as a speech-language pathologist or audiologist, an
individual must–

W177

§483.430(b)(5)(vii)(A) Be eligible for a Certificate of Clinical Competence in Speech-Language
Pathology or Audiology granted by the American Speech-Language-Hearing Association or
another comparable body; or

§483.430(b)(5)(vii)(B) Meet the educational requirements for certification and be in the
process of accumulating the supervised experience required for certification.

W178

§483.430(b)(5)(viii) To be designated as a professional recreation staff member an individual
must have a bachelor’s degree in recreation or in a specialty area such as art, dance, music or
physical education.

W179

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(5)(ix) To be designated as a professional dietitian, an individual must be eligible
for registration by the American Dietetics Association.

Guidance §483.430(b)(5)(ix)

If a professional is not nationally registered as a dietician, they would have to show evidence
they completed the degree and field work in their designated field and are eligible to sit for the
national exam.

W180

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(5)(x) To be designated as a human services professional an individual must have
at least a bachelor’s degree in a human services field (including, but not limited to: sociology,
special education, rehabilitation counseling, and psychology).

Guidance §483.430(b)(5)(x)

Human Services is a diverse field focused on improving the quality of life of clients in
communities in which the professional serves. A human services professional works directly
with the population being served. Surveyors should see evidence that a human service
professional has a bachelor’s degree at a minimum.

W181

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(b)(5)(xi) If the client’s individual program plan is being successfully implemented by
facility staff, professional program staff meeting the qualifications of paragraph (b)(5)(i)
through (x) of this section are not required-

(A) Except for qualified intellectual disability professionals;

(B) Except for the requirements of paragraph (b)(2) of this section concerning the facility’s
provision of enough qualified professional program staff; and

Guidance §483.430(b)(5)(xi)

An individual client program may not require that professional staff perform all of the services
as outlined by the IPP (e.g. the direct support staff may be trained by the professional to safely
and effectively carry out the designed program), however, any specialized therapy must involve
evaluation, program development, and re-assessment by the appropriate professional at
periodic intervals.

W182

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(c)(1) The facility must not depend upon clients or volunteers to perform direct care
services for the facility.

Guidance §483.430(c)(1)

The facility must have sufficient staff to provide needed care and services without the use of
volunteers or enlisting the help of clients residing in the facility to perform the duties normally
performed by facility staff.

The facility may not rely on volunteers in lieu of paid staff to fill required staff positions and
perform direct care services. Volunteers are permissible, but must be in addition to the number
of paid staff required to carry out a function. Volunteers should have an orientation to the
policies and procedures of the facility and oversight is required by facility staff.

W183

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(c)(2) There must be responsible direct care staff on duty and awake on a 24-hour
basis, when clients are present, to take prompt, appropriate action in case of injury, illness,
fire or other emergency, in each defined residential living unit housing- –

(i) Clients for whom a physician has ordered a medical care plan;

(ii) Clients who are aggressive, assaultive or security risks;

(iii) More than 16 clients; or

(iv) Fewer than 16 clients within a multi-unit building.

Guidance §483.430(c)(2)

Indicators of staff not being awake in relation to the occurrence of incidents, accidents, and
injuries may include, but are not limited to:

• incidents of unplanned client absences;

• untimely reaction to a medical emergency;

• injuries from client to client aggression; or

• a pattern of injuries of unknown origin.

If even one client meets 483.430(c)(2)(i-ii) then staff must be awake on a 24-hour basis.

A client has a medical care plan when an acute or chronic occurrence requires clinical
assessment and monitoring on a scheduled basis.

W184

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(c)(3) There must be a responsible direct care staff person on duty on a 24 hour basis
(when clients are present) to respond to injuries and symptoms of illness, and to handle
emergencies, in each defined residential living unit housing- –

(i) Clients for whom a physician has not ordered a medical care plan;

(ii) Clients who are not aggressive, assaultive or security risks; and

(iii) Sixteen or fewer clients.

Guidance §483.430(c)(3)

At all times, there must be at least one staff person on-duty in the facility if even one client is
present. For purposes of this provision, “on duty” staff need not be awake during normal
sleeping hours, but do need to respond to injuries, illness, and emergencies promptly.

W185

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(c)(4) The facility must provide sufficient support staff so that direct care staff are not
required to perform support services to the extent that these duties interfere with the
exercise of their primary direct client care duties.

Guidance §483.430(c)(4)

Direct care staff should not be performing support services (e.g., making beds, cooking,
cleaning, etc.) independently which takes them away from client interaction and teaching. If
support services in the house cannot be done jointly as chores between clients, as part of their
training program, and the support staff, additional staff should be added to perform the chores.
This does not include any staff chores done during client’s sleeping hours.

“Support staff” include all personnel hired by the facility that are not either direct care staff or

professional staff. For example, support staff includes, but are not limited to, secretaries, clerks,
housekeepers, maintenance and laundry personnel.

(d) Standard: Direct care residential living unit staff

W186

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(d)(1) The facility must provide sufficient direct care staff to manage and supervise
clients in accordance with their individual program plans.

Guidance §483.430(d)(1)

“Sufficient” means enough direct care staff to effectively implement the active treatment
programs as defined in the IPP, to meet client needs, and to respond to emergencies, illness, or
injuries.

Even though minimum ratios are defined at §483.430(d)(3), active treatment may require more
staff than the minimums required ratios, therefore compliance should not be based on staffing
ratios alone.

§483.430(d)(2) Direct care staff are defined as the present on-duty staff calculated over all
shifts in a 24-hour period for each defined residential living unit.

Guidance §483.430(d)(2)

“Direct care staff” are those personnel who are assigned to work directly with the clients
providing support during activities of daily living and active treatment programs.

Professional staff who work with clients in a living unit on a periodic basis are not included in
direct care staff ratios.

Supervisors of direct care staff can be counted only if they share in the actual work of the direct
care of clients on a continuous basis (e.g. take client assignment).

Direct care supervisors whose principle assigned function is to supervise direct care staff may
not be included in direct care staff ratios although they may occasionally provide direct services
to clients.

Non-direct care staff supervisors whose principle assigned function is to supervise non-direct
care staff may not be included in direct care staff ratios.

W187

(Rev. 144, Issued: 08-14-15, Effective: 08-14-15, Implementation: 08-14-15)

§483.430(d)(3) Direct care staff must be provided by the facility in the following minimum
ratios of direct care staff to clients:

(i) For each defined residential living unit serving children under the age of 12, severely and
profoundly retarded clients, clients with severe physical disabilities, or clients who are
aggressive, assaultive, or security risks, or who manifest severely hyperactive or psychotic-like
behavior, the staff to client ratio is 1 to 3.2.

(ii) For each defined residential living unit serving moderately retarded clients, the staff to
client ratio is 1 to 4.

(iii) For each defined residential living unit serving clients who function within the range of
mild retardation, the staff to client ratio is 1 to 6.4.

Guidance §483.430(d)(3)

The minimum ratios in this standard indicate the minimum number of direct-care staff that
must be present and on duty, 24 hours a day, 365 days a year, for each discrete living unit. For
example, to calculate the minimum number of living unit staff that must be present and on duty
in a discrete living unit serving 16 individuals with multiple disabilities: divide the number of
individuals “16,” by the number corresponding to the regulation “3.2,” the result equals “5.”
Therefore, the facility must determine how many staff it must hire to ensure that at least 5 staff
will be able to be present and on duty during the 24 hour period in which those individuals are
present.

Using the living unit described above, “calculated over all shifts in a 24-hour period” means that
there are present and on duty every day of the year: one direct care staff for each eight
individuals on the first shift (1:8), one direct care staff for each eight individuals on the second
shift (1:8), and one direct care staff for each 16 individuals on the third shift (1:16). Therefore,
there are five (5) direct care staff present and on duty for each twenty-four hour day, for 16
individuals. The same calculations are made for the other ratios, whichever applies. Determine

if absences of staff for breaks and meals results in a pattern of prolonged periods in which
present and on-duty staff do not meet the ratios.

W188

§483.420(d)(4) When there are no clients present in the living unit, a responsible staff
member must be available by telephone.

§483.430(e) Standard: Staff Training Program

W189

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(e)(1) The facility must provide each employee with initial and continuing training
that enables the employee to perform his or her duties effectively, efficiently, and
competently.

Guidance §483.430(e)(1)

Newly employed staff receive a supported orientation program (mentor or ongoing supervision)
during their early employment. All staff receive continuing education on such issues as abuse
and neglect, handling emergency situations, behavior management, and treating people with
respect and dignity, etc.

The primary evidence of an effective staff training program is the observed competent
interaction between staff and clients.

§483.430(e)(2) For employees who work with clients, training must focus on skills and
competencies directed toward clients’

W190

(Rev. 144, Issued: 08-14-15, Effective: 08-14-15, Implementation: 08-14-15)

§483.430(e)(2) developmental,

Guidance §483.430(e)(2)

Staff receive training in the following areas:

• developmental programming principles and techniques (e.g. techniques to involve
clients in their programs to their highest capability, use of positive reinforcement, use of
assistive technology, use of appropriate materials and providing informal opportunities
to practice skills);

• use of adaptive equipment and augmentative communication devices and systems; and

• effective recordkeeping procedures.

W191

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(e)(2) behavioral,

Guidance §483.430(e)(2)

Staff receive training in the following areas:

• use of behavioral principles during interactions between staff and clients;

• use of accurate procedures regarding abuse detection and prevention, restraints, drugs
to manage behaviors, client safety, emergencies, etc.;

• use of least restrictive interventions;

• use of positive behavior intervention programming; and

• training clients in appropriate replacement behaviors.

W192

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(e)(2) and health needs

Guidance §483.430(e)(2)

Staff receive training in the following areas:

• signs and symptoms of the client’s changing health (e.g. constipation, urinary tract
infections, adverse drug reactions, as indicated);

• exercise and diet;

• first aid;

• infection control;

• reporting to appropriate healthcare professionals; and

• for those staff who can administer medications, how to include clients in their
medication administration by recognizing and encouraging the use of applicable skills.

W193

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(e)(3) Staff must be able to demonstrate the skills and techniques necessary to
administer interventions to manage the inappropriate behavior of clients.

Guidance §483.430(e)(3)

Staff correctly and consistently implement the interventions specified in the behavior plans of
clients with whom they are working.

Inadequate training is evident when staff do not correctly implement behavioral programs, use
inappropriate management techniques, cannot explain what intervention is to be used and how
it is to be implemented.

W194

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.430(e)(4) Staff must be able to demonstrate the skills and techniques necessary to
implement the individual program plans for each client for whom they are responsible.

Guidance §483.430(e)(4)

Staff are observed in various settings during the day correctly and consistently implementing the
specific IPPs of the clients with whom they are working.

W195

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440 Condition of participation: Active treatment services

(a) Standard: Active treatment

W196

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(a)(1) Each client must receive a continuous active treatment program, which
includes aggressive, consistent implementation of a program of specialized and generic
training, treatment, health services and related services described in this subpart, that is
directed toward-

(i) The acquisition of the behaviors necessary for the client to function with as much self-
determination and independence as possible; and

(ii) The prevention or deceleration of regression or loss of current optimal functional
status.

Active treatment embodies an individually- tailored series of daily life and living experiences
that serve as the primary opportunity for the acquisition, development and expression of
functional skills and adaptive behaviors necessary for the client to experience optimal
independence and promote purposeful “self-expression”.

The uniqueness of each client is a core consideration in the design of active treatment
programs. It is expected that individual clients are given the opportunity to provide input into
the content of their day-to-day living experiences.

An active treatment program includes the following elements as substantiated through
observation, interview and record review:

a) Each client’s needs and strengths have been accurately assessed and relevant input has
been obtained from team members; (Observations and interviews with the client by the
surveyor should be consistent with the current assessment information. Interview the
QIDP regarding any needs observed but not addressed through
assessment/programming by the facility).

b) Each client’s IPP is based on assessed needs and strengths, and addresses major life
areas such as personal skills, home living skills, community living skills, employment
skills, etc., essential to increasing independence and ensuring rights;

c) Needs identified as a priority are addressed formally and through activities which are
relevant and responsive to client need, interest and choice;

d) Active treatment is consistently implemented in all relevant settings both formally and
informally as the need arises or opportunities present themselves. It should not be
limited to specific periods of time during the day or environments. Each client should
receive aggressive and consistent training, treatments and supports in accordance with

their needs and IPP. New skills and appropriate behaviors are encouraged and
reinforced across environments and times of day. Each client has the adaptive
equipment and environmental adaptations necessary for him/her to progress toward
heightened independence as recommended and contained in their IPP. Active
treatment means taking advantage of opportunities for the practice of new skills and the
use of other skills during the normal rhythm of each client’s day.

e) Each client’s performance related to IPP objectives is accurately and consistently
measured and documented and programs are modified on an ongoing basis based on
data and major life changes; and

i. Clients with degenerative conditions receive training, treatment and services
designed to retain skills and functioning and to prevent further regression to the
extent possible.

ii. Clients may need adjustments to their active treatment programs as functional or
endurance limitations are identified associated with the aging process. In such
cases, there may be more of an emphasis on the retention of skills already attained
and reducing the rate of loss of skills, than on the acquisition of new skills.

In large part, it is this pervasive and continuous reinforcement of “formal” training through
“informal” routine daily living experiences and interactions with staff and others that makes
active treatment programs effective. Formal settings are those that are planned and specifically
structured for training on objectives and interventions. Informal settings are times that are not
anticipated or planned but that offer the opportunity for training.

Active treatment programs mirror normal living experiences such as leisure activities and social
conversation at the dinner table. It must be clear that active treatment programs are far more
than implementation of discreet formal training sessions or programs that are conducted at
prescribed times by defined personnel. Learning occurs in the process of the normal rhythm of
life and life experiences.

W197

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(a)(2) Active treatment does not include services to maintain generally independent
clients who are able to function with little supervision or in the absence of a continuous active
treatment program.

Guidance §483.440(a)(2)

All active treatment programs must be based upon assessed developmental needs which are
prohibiting the client from living in a more independent setting.

Active treatment moves clients to a more independent setting.

• When a client is in the facility simply for protective oversight and is not in need of
training for developmental deficits, this does not constitute active treatment (e.g. a
court placement to protect the community or the client from the client’s behavior).

• Programs that are simply being provided to maintain a client’s independence would
not be considered active treatment since the client is not actively being trained to live
in a more independent setting. If a client already possesses the skills that enables
them to live in a less restrictive environment, and does not require the structure,
support and resources that services that only an ICF/IID can provide, they can be
considered generally independent.

For example, a client is admitted to the ICF/IID for the primary purpose of competency
determination for a court hearing. This client lived independently prior to admission. The active
treatment programs they are receiving are focused on maintaining that independence and do
not address specific developmental deficits that inhibit independent living. This would not be
considered active treatment.

(b) Standard: Admissions, transfers, and discharge

W198

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(b)(1) Clients who are admitted by the facility must be in need of and receiving active
treatment services.

Guidance §483.440(b)(1)

All client admissions must be based upon assessed developmental deficits which are prohibiting
the client from living in a more independent setting and which require those intensive
specialized supports, services, and supervision that only an ICF/IID can provide.

The individual components of the provision of active treatment include CFA, IPP, program
implementation, program documentation, and program monitoring and change. When any of
these individual components of active treatment are not in place, resulting in the clients not
receiving active treatment, this regulation this not met.

W199

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(b)(2) Admission decisions must be based on a preliminary evaluation of the client
that is conducted or updated by the facility or by outside sources.

Guidance §483.440(b)(2)

Preliminary evaluations should support the need for an admission to an ICF/IID (e.g., deficits in
functional skills or adaptive behaviors). The information from the preliminary evaluation must
be used by the facility to make an admission decision.

Occasionally, emergency admissions of clients may occur without benefit of a preliminary
evaluation having been conducted prior to admission. When situational emergencies
necessitate admission before a preliminary evaluation can be conducted, or when pre-admission
information is incomplete, the completion of the preliminary admission evaluation within seven
(7) calendar days after admission will satisfy compliance with this requirement.

W200

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(b)(3) A preliminary evaluation must contain background information as well as
currently valid assessments of functional developmental, behavioral, social, health and
nutritional status to determine if the facility can provide for the client’s needs and if the client
is likely to benefit from placement in the facility.

Guidance §483.440(b)(3)

The preliminary evaluation contains specific information useful to determine if the facility can
meet the client’s needs and if the client can benefit from placement.

The facility makes every reasonable effort to gather all available data to assist in their
determination.

Background information would include information that gives insight into the clients’ previous
living environments and programming efforts.

The assessment must include a consideration as to whether reasonable accommodation as
required by the Americans with Disabilities Act would enable the client to benefit from
placement in facility.

§483.440(b)(4) If a client is to be either transferred or discharged, the facility must- –

W201

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(b)(4)(i) Have documentation in the client’s record that the client was transferred or
discharged for good cause; and

Guidance §483.440(b)(4)(i)

Transfer or discharge occurs only when the facility cannot meet the client’s needs, the client no
longer requires an active treatment program in an ICF/IID setting; the individual/guardian
chooses to reside elsewhere, or when a determination is made that another level of service or
living situation would be more beneficial to the client.

“Transfer” means the temporary movement of a client to another facility (e.g. another ICF/IID,
psychiatric hospital, medical hospital) with the intention of return to the original site.

“Discharge” means the permanent movement of a client to another facility or setting which
operates independently from the ICF/IID (e.g. the facility is not under the jurisdiction of the
facility’s governing body).

Documentation includes evidence of an assessment that evaluated the pros and cons of the
transfer or discharge and the rationale for the final decision.

W202

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(b)(4)(ii) Provide a reasonable time to prepare the client and his or her parents or
guardian for the transfer or discharge (except in emergencies).

Guidance §483.440(b)(4)(ii)

The client and their family or the client and their legal guardian are involved in planning for any
transfer or discharge and receive the services necessary to assist in preparing for movement,
unless an emergency (medical) situation prevents that involvement. If the client has an
advocate, the advocate should participate in the decision-making process.

Orderly, planned transfers and discharges usually take place over an extended period of time.
The IPP should reflect objectives or interventions which prepare the client for transfer or
discharge. Transfers or discharges executed on short timeframes (e.g. less than 30 days) without
“good cause” would not comply with the “reasonable” intent of the regulations.

“Reasonable” time is the time required to provide clients and their families with planned steps
and established timeframes to facilitate the successful transition. Time frames are modified
based on client needs and emergent situations.

Preparation of the client for transfer may include orientation or trial visits to the new location.
Staff should take steps to minimize potential anxiety or any behavioral reactions which could
result from the client’s transfer.

§483.440(b)(5) At the time of the discharge, the facility must-

W203

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(b)(5)(i) Develop a final summary of the client’s developmental, behavioral, social,
health and nutritional status

Guidance §483.440(b)(5)(i)

The final summary should be useful for continued services in the client’s new setting. The final
discharge summary should be entered into the client’s record, provide a summary of the client’s
course of stay in the ICF/IID, provide a final summary of the client’s developmental, behavioral,
social, health and nutritional status, and include the current status of the objectives listed in the
client’s IPP.

The status should address whether or not a clients’ skills have been maintained, deteriorated, or
improved during their stay.

W204

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(b)(5)(i) and, with the consent of the client, parents (if the client is a minor) or legal
guardian, provide a copy to authorized persons and agencies; and

Guidance §483.440(b)(5)(i)

When the client is discharged, the receiving entity (another ICF/IID, waiver home, family home,
nursing home, etc.) is provided a copy of the discharge summary. The ICF/IID should obtain
written consent to share this information with the persons who will be providing services to the
client in the future and their parents/or legal guardians. Sharing the discharge summary with
State Agencies as applicable is determined by state requirements.

W205

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(b)(5)(ii) Provide a post-discharge plan of care that will assist the client to adjust to
the new living environment.

Guidance §483.440(b)(5)(ii)

The post discharge plan of care is a component of the discharge summary.

The facility utilizes the information from the discharge summary to prepare the discharge plan
of care. The post-discharge plan of care identifies the essential supports and services necessary
for the client to successfully adjust to the new living environment and describe necessary
coordination of services. It should incorporate the client’s preferences. It should identify
specific client needs after discharge such as personal care, physical therapy, client/caregiver
education needs, and the ability of the client or caregiver to meet those needs after discharge.

W206

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(1) Each client must have an individual program plan developed by an
interdisciplinary team that represents the professions, disciplines or service areas that are
relevant to- –

i) Identifying the client’s needs, as described by the comprehensive functional
assessments required in paragraph (c)(3) of this section; and

ii) Designing programs that meet the client’s needs.

Guidance §483.440(c)(1)

If a need is identified in the CFA, the professional associated with that need will conduct an
initial evaluation for the development of the IPP.

The needs identified in the CFA determine the professional, paraprofessional, direct support
staff, disciplines or service areas that must participate in the development of the IPP.

W207

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(2) Appropriate facility staff must participate in interdisciplinary team meetings.

Guidance §483.440(c)(2)

While there is no correct number of individuals that comprise the IDT, the team should include
appropriate facility staff (professional and paraprofessional staff), that are responsible for
designing, developing, and/or implementing the client’s IPP and direct support staff who work
closely with the clients.

For any prioritized objective, the paraprofessional or professional personnel responsible for the
development and monitoring of that program should participate on the team, either through
actual attendance or written or verbal input.

Members of the IDT may change as the assessed needs of the client change (e.g. medical issues,
nutritional issues, communication needs, fine motor skill needs, gross motor skill needs, social
issues or behavioral concerns).

W208

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(2) Participation by other agencies serving the client is encouraged.

Guidance §483.440(c)(2)

The facility must make every effort to coordinate the Individual Education Plan (IEP) from the
school or the client’s program plan from outside program, work site or workshop with the IPP.
This may result in a single document, but there is no requirement for a single combined
document. There must be evidence that all applicable plans were coordinated (evidence of
discussion across the plans and observation would confirm integration of the IPP across the
various settings). The QIDP is responsible for the coordination of the plans.

The facility should communicate changes in the IPP or in the clients’ life situation with teachers
and workplace representatives either directly or through written communication.

W209

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(2) Participation by the client, his or her parent (if the client is a minor), or the
client’s legal guardian is required unless the participation is unobtainable or inappropriate.

Guidance §483.440(c)(2)

The facility should make every effort to schedule team meetings at a time that enables the client
parent or legal guardian, to attend without having to forfeit work time or pay.

It is expected that the client will routinely attend team meetings unless their participation is
unobtainable. Examples of when client participation is not available include, but are not limited
to: 1) the client is away from the facility for medical reasons or hospitalization; or 2) although
the facility has documented repeated attempts to engage the client, the client refuses to
participate.

If families/legal guardians are unable to attend a program planning meeting, the facility provides
them information regarding the meeting outcome and gives them an opportunity to discuss the
plan with the facility staff.

“Inappropriate”, for the purposes of this guideline, means that the parent or legal guardian’s
behavior is so disruptive or uncooperative that others cannot effectively participate; the client
does not wish his or her parent to participate, and the client is competent to make this decision;
or there is strong and documented evidence that the parent or legal guardian is not acting on
the client’s behalf or in the client’s best interest. In the case of the latter, determine what the
facility has done to bring effective resolution to the problem.

Instances when it is not appropriate for the client, parent or legal guardian, to attend the team
discussion are rare. If the client does not attend the meeting, the facility must document the
reason for his/her non-participation.

There may also be instances where a parent or legal guardian is considered unobtainable for a
team meeting, such as being out of the country. In these instances, the parent or legal guardian
should still be notified of the meeting, provided with information concerning the outcome of the

meeting and documentation in the client record should describe why the parent or legal
guardian could not attend and what information was provided to them.

If the client is an adult who is competent to make decisions and who is not adjudicated, parents
may not participate in the process if their participation is opposed by the client.

In the event that a non-adjudicated adult chooses not to have their family involved in the active
treatment process, the surveyor should see evidence in the record of efforts made by the facility
to understand why the client has declined family participation. If the client continues to decline
family involvement after the facility has held discussions with him/her about the importance of
this issue, the facility should honor the wishes of the client.

In general, the more involvement and communication among the team members, the client and
the parent or legal guardian the more likely the plan will be successful. The facility goal should
be to routinely include these parties unless rare circumstances exist.

W210

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3) Within 30 days after admission, the interdisciplinary team must perform
accurate assessments or reassessments as needed to supplement the preliminary evaluation
conducted prior to admission.

Guidance §483.440(c)(3)

For new admissions, the CFA is completed within 30 days after admission and is utilized as the
basis for the IPP.

New, revised or updated assessments completed within the first 30 days of admission,
accurately identify the functional abilities of the client.

“Accurate” assessments refer to assessment data that are current, relevant and valid, and the
skills, abilities, and training needs identified by the assessment correspond to the client’s actual,
observed status. Assessments must be administered with appropriate adaptations such as

specialized equipment, use of an interpreter, use of manual communication and tests designed
to measure performance in the presence of visual disability.

The content of or format of the assessments or the particular assessment tools which are to be
used for the CFA are not specified. Assessments must include identification of those functional
life skills in which the client needs to be more independent and those services needed for the
client to become more community integrated.

W211

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3) The comprehensive functional assessment must take into consideration the
client’s age (for example, child, young adult, elderly person) and the implications for active
treatment at each stage, as applicable, and must –

Guidance §483.440(c)(3)

During assessment, the client is given opportunities to participate in age-appropriate activities
to assess the person’s functioning in those activities or settings. For example, the use of baby
toys during the assessment of an adult would not be appropriate.

W212

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(i) Identify the presenting problems and disabilities and where possible, their
causes;

Guidance §483.440(c)(3)(i)

The CFA includes:

• all diagnoses and developmental deficits for the client;

• the supporting information for each; and

• each evaluation should include conclusions and recommendations which go into the
development of an active treatment program for the client.

W213

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(ii) Identify the client’s specific developmental strengths;

Guidance §483.440(c)(3)(ii)

The client’s identified developmental strengths, preferences, methods of coping/compensation,
community use and awareness, friendships and positive attributes and capabilities are clearly
described in functional terms in the assessments.

Identified strengths are consistent with the client’s observed functional status.

W214

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(iii) Identify the client’s specific developmental and behavioral management
needs;

Guidance §483.440(c)(3)(iii)

The CFA must address and identify those skill deficits/needed supports that may be amenable to
training, those that must be treated by therapy and/or provision of assistive technology, and
those that require adapting the environment and/or providing personal support. Assessment of
needed supports should be done within the context of the client’s age, gender, and culture.

“Behavioral management needs” include those behaviors that interfere with progress, prevent
assimilation into the community, decrease freedom or increase the need for restriction of
activities (e.g. spitting, pica, self-injurious behavior, aggressive behavior toward others or self-
injurious behavior).

A functional behavioral assessment is a problem-solving process for evaluating client
inappropriate behavior. It relies on a variety of techniques and strategies to identify the
purpose of the specific behavior(s) and to help the IDT select interventions to directly address
the behavior(s). A functional behavior assessment looks beyond the behavior itself. The focus
when conducting a functional behavioral assessment is on identifying significant client-specific
social, affective, cognitive, and/or environmental factors associated with the occurrence (and
non-occurrence) of specific behaviors.

The CFA must identify the specific accommodations that address the client’s needs to ensure
better opportunity for the client’s success. The identified accommodations may be assistive
technology which can help a person learn, play, complete tasks, get around, communicate, hear
or see better, control their own environment and take care of their personal needs (e.g. door
levers instead of knobs, plate switches, audio books, etc.).

W215

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(iv) Identify the client’s needs for services without regard to the actual
availability of the services needed; and

Guidance §483.440(c)(3)(iv)

Identification of needed services is based on the CFA.

In the presence of significant developmental deficits, it is not acceptable for the facility to say
that a particular professional therapy or treatment is not needed or not available if the CFA
identifies a deficit. The assessment must identify the course of specific interventions
recommended to meet the client’s needs, both through direct professional services and non-
professional services. For example, a client’s communication skill development may not require
the intensive services of a speech-language pathologist however, the direct care staff will need
to work with the client and use a pre-determined communication system.

§483.440(c)(3)(v) Include

Guidance §483.440(c)(3)(v)

The CFA should include an assessment of each of the areas listed below. Assessments should
include specific information about the person’s ability to function in different environments,
specific skills or lack of skills, and how function can be improved, either through training,
environmental adaptations, or provision of adaptive, assistive, supportive, orthotic, or
prosthetic equipment.

If assessments are done separately by professional disciplines, there should be evidence that the
assessments are brought together in an interdisciplinary approach to address the client’s various
developmental areas.

The CFA must be completed upon admission and annually as indicated. While the assessment
may not have the specific titles of the areas listed below, the surveyor must be able to identify
information within assessments from each of the areas below.

W216

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(v) physical development and health,

Guidance §483.440(c)(3)(v)

Physical development and health: This portion of the CFA includes the client’s developmental
history, results of the physical examination conducted by a licensed physician, physician
assistant, or nurse practitioner, health assessment data (including a medication and
immunization history); a review and summary of all laboratory reports since the last
comprehensive evaluation, a summary of all required medical interventions since the last CFA;
skills of the client normally associated with the monitoring and supervision of one’s own health
status, and administration and/or scheduling of one’s own medical treatments. Reports of all

specialist consultations should be included in the assessment as indicated by physical
examination results.

IDT reviews any current advanced directives that the client may have in place as part of the CFA.

W217

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(v) nutritional status,

Guidance §483.440(c)(3)(v)

Nutritional status: Nutritional status includes height and weight, the client’s eating habits and
preferences, favorite foods, determination of appropriateness of diet, adequacy of total food
intake, bowel habits, means through which the client receives nutrition (e.g. feeding tube) and
the skills associated with eating (including chewing, sucking and swallowing disorders).

W218

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(v) sensorimotor development,

Guidance §483.440(c)(3)(v)

Sensorimotor development: Sensorimotor development includes the development of
perceptual skills that are involved in observing the environment and making sense of it.
Identified sensory deficits should be evaluated in conjunction with the impact they will have on
the client’s life. A sensory deficit in eye contact may not have a detrimental effect on the
client’s life if it will not hold the client back from further accomplishments or skill acquisitions.
Motor development includes those behaviors that primarily involve: muscular, neuromuscular,
or physical skills and varying degrees of physical dexterity. Because sensory and motor
development are intimately related and because activities in these areas are functionally
inseparable, attention to these two aspects of bodily activity is often combined in the concept of

sensorimotor development. For those motor areas that are identified by the assessment as
limited, the assessment should specify the extent to which corrective, orthotic, prosthetic, or
support devices would impact on functional status and the extent of time the device is to be
used throughout the day.

W219

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(v) affective development,

Guidance §483.440(c)(3)(v)

Affective (Emotional) development: Affective or emotional development includes the
development of behaviors that relate to one’s interests, attitudes, values, morals, emotional
feelings and emotional expressions.

W220

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(v) speech and language development

Guidance §483.440(c)(3)(v)

Speech and language (communication) development: One of the most contributable causes of
behaviors, frustration by the clients, etc. is lack of effective communication. It is imperative that
the CFA identifies how the client communicates, what barriers are present, what services are
available and what programs and services will be provided to assist the client to go out into and
participate fully in the world. Observed client communication skills match the evaluation results
and that training programs are in place to address needs.

Communication development refers to the development of both verbal and nonverbal and
receptive and expressive communication skills. Assessment data identify the appropriate
intervention strategy to be applied, and which, if any, augmentative or assistive devices will

improve communication and functional status. These intervention strategies should provide the
client with a viable means of communication which is appropriate to their sensory, cognitive and
physical abilities.

W221

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(v) and auditory functioning,

Guidance §483.440(c)(3)(v)

Auditory functioning: Auditory functioning refers to the extent to which a person can hear, to
the maximum use of residual hearing if a hearing loss exists, and whether or not the client will
benefit from the use of amplification, including a hearing aid or a program of amplification.

W222

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(v) cognitive development,

Guidance §483.440(c)(3)(v)

Cognitive development: Cognitive development refers to the development of those processes
by which information received by the senses is stored, recovered, and used. It includes the
development of the processes and abilities involved in memory, reasoning and problem solving.
It is also the identification of different learning styles the client has and those best used by the
trainers. It is critical that the CFA address the individual learning style of the client in order to
best direct the way the trainers will teach formal and informal programs.

W223

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(v) social development,

Guidance §483.440(c)(3)(v)

Social Development: Social development refers to the formation of those self-help, recreation
and leisure, and interpersonal skills that enable a client to establish and maintain appropriate
roles and fulfilling relationships with others. Assessments may address family supports and
relationships, sexual awareness and sexuality, friendships, social awareness, social skills and
social interests.

W224

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(v) adaptive behaviors or independent living skills necessary for the client to be
able to function in the community,

Guidance §483.440(c)(3)(v)

Adaptive behaviors or independent living skills: Adaptive behavior refers to the effectiveness or
degree with which clients meet the standards of personal independence and social
responsibility and community orientation and integration expected of their age and cultural
group. Adaptive behaviors are those behaviors that are developed to cope with deficits in order
to be able to perform every day skills as independently as possible. Independent living skills
include, but are not limited to, such things as food shopping, meal preparation, housekeeping
and kitchen chores, laundry, bed making, and budgeting. Assessment may be performed by
anyone trained to do so. Standardized tests are not required. Standardized adaptive behavior
scales which identify all or predominantly all “developmental needs” are not sufficient to meet
this requirement, but can serve as a basis for screening.

W225

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(3)(v) and as applicable, vocational skills.

Guidance §483.440(c)(3)(v)

Vocational development, “as applicable”: Vocational development refers to work interests,
work skills, work attitudes, work-related behaviors, and present and future employment
options. The determination of whether or not a vocational assessment is “applicable” is
typically based on age (adolescents or adults more than likely require this type of assessment).
The vocational assessment for each client may address job sampling, job development, on-site
job training and long term follow-up, as appropriate to the client and determined by the IDT.

Vocational assessments should describe, for all domains, what clients can and cannot do in
terms of skills needed within the context of their daily lives and jobs.

Assessments should be individualized and based on:

• Actual performance of the client against objective criteria;

• Reports by staff/parents/legal guardians; and

Observed performance in a variety of settings.

W226

§483.440(c)(4) Within 30 days after admission, the interdisciplinary team must prepare for
each client an individual program plan

W227

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(4) that states the specific objectives necessary to meet the client’s needs, as
identified by the comprehensive assessment required by paragraph (c)(3) of this section,

Guidance §483.440(c)(4)

Objectives are developed for those needs that are identified by the CFA and which are
considered to be most likely to improve the client’s ability to independently function in his/her
daily life, as determined by the IDT.

There is a clear link between the specific objectives and the functional assessment data and
recommendations.

Objectives are developed for those needs that are observed to most likely impact the client’s
ability to function in daily life. Training objectives should be developed to address client needs
rather than staff oriented objectives.

Clients are expected to have training objectives in the areas of activities of daily living, based on
the client’s assessed needs and as prioritized by the IDT. If clients have eyeglasses, dentures
and/or other assistive devices it is expected that the team considers objectives, based upon the
assessment of client needs, addressing the care and use of such devices. However, in the area
of programs to teach the clients’ money management it is not expected that every client will
automatically have a formal training objective to participate in such a program. The decision to
prioritize such a program and to what level the program is developed is decided by the IDT
based upon the results of the CFA and in consideration of such factors as, transferable skills, the
ability to make choices, the ability to identify preferences and cognitive abilities such as
attention span and an understanding of the principle of cause and effect.

Similarly, the decision to prioritize and develop a training objective for a client to participate in a
self-administration program for medications must be made by the IDT and be based upon
information from the CFA. Formal self administration programs should not be confused with
informal efforts to include the client in the administration process such as allowing them to hold
a glass of water, identify the box where his/her medications are stored or put a pill into their
own mouth themselves under the supervision of a person who is qualified to administer
medications.

W228

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(4) and the planned sequence for dealing with those objectives.

Guidance §483.440(c)(4)

The objectives identified in W227 are organized in a logical sequence, determined by the team
that will assist the client toward the attainment of skills resulting in greater self-choice,
independence, and community integration. The logical sequencing of objectives means there is
a completion of one objective that serves as the building block for the next with relevance to the
client’s functional status. Where objectives are logically ordered but do not have relevance to
the client’s functional status, refer to 483.440(c)(4).

If the IPP is organized in a logical sequence, this requirement is met. For example, if the long
term goal is to travel independently in the community, the objective sequencing may involve
training the client to recognize traffic signs, cross the street safely, and to obtain help when
needed if lost or an emergency arises.

These objectives must –

W229

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(4)(i) Be stated separately, in terms of a single behavioral outcome;

Guidance §483.440(c)(4)(i)

Each objective clearly states one expected learning result.

“Single” behavioral outcome means that there is a separate objective assigned for each discrete
behavior that the team intends the client to learn. For example, “Mary will bake a cake and
clean the oven” are two separate behaviors and, therefore, should be stated in two separate
objectives. Completion of the morning hygiene routine includes programs for performance of
face washing, tooth brushing and hair combing which are three separate objectives; however,
the behavioral outcome for each would be the same (e.g. completion of the morning hygiene
routine).

W230

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(4)(ii) Be assigned projected completion dates;

Guidance §483.440(c)(4)(ii)

Completion dates are based on the client’s rate of learning.

Completion dates are assigned to each objective on which the client is currently working.

Completion dates are individualized (e.g. not all the same for all clients and all objectives).

The “projected date of completion” for an IPP objective is not the same as a “review” date. For
each objective assigned a priority, the team should assign a projected date (month and year) by
which it believes the client will have learned the new skill, based on all of the assessment data.
This date triggers the team to evaluate continuously whether or not the client’s progress or
learning curve is sufficient to warrant a revision to the training program.

W231

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(4)(iii) Be expressed in behavioral terms that provide measurable indices of
performance;

Guidance §483.440(c)(4)(iii)

The desired learning outcome is stated in a manner which enables all staff working with the
client to consistently identify the target behavior and to clearly identify when it is being
displayed.

The objective is stated in a manner which permits it to be measured with quantifiable data.

“Behavioral” terms include only those behaviors which are “client” rather than staff oriented
and those that any person would agree can be seen or heard. Determine if all staff who work
with the client can define the exact same outcome on which to measure the client’s
performance.

“Measurable indices of performance” are the quantifiable criteria to use in determining
successful achievement of the objective. Quantifiable criteria include various measurements of
intensity and duration. For example, “Client X will walk ten feet, with the use of her tripod
walker, on each of five (5) consecutive days.”

W232

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(4)(iv) Be organized to reflect a developmental progression appropriate to the
individual; and

Guidance §483.440(c)(4)(iv)

Objectives must be relevant to the client’s current skill sets and abilities as identified in the CFA.

The ICF/IID must consider the person’s current functional abilities and project what steps,
methods, and strategies are likely to be effective in achieving the objective.

W233

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(4)(v) Be assigned priorities.

Guidance §483.440(c)(4)(v)

Priorities are established based on the needs and in consideration of the desires of the client
and emphasize the development of greater independence, self-choice, and community
integration.

The team determines which objectives are the highest priority to be addressed, either because
the client has an immediate need or the priority objectives must be accomplished before other
priorities are addressed.

§483.440(c)(5) Each written training program designed to implement the objectives in the
individual program plan must specify:

Guidance §483.440(c)(5)

The following regulations (5) (i-iv) apply to formal training programs developed for current
implementation.

W234

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(5)(i) The methods to be used;

Guidance §483.440(c)(5)(i)

The training program provides clear directions to any staff person working with the client on
how to implement the teaching strategies. To comply with this requirement the methodologies
must be written in a clear enough manner that a substitute staff person will be able to read the
methodologies and implement them without substantial differences from a regularly assigned
staff person. Methodologies should be consistent across settings, such as when the client is in
the day program.

W235

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(5)(ii) The schedule for use of the method;

Guidance §483.440(c)(5)(ii)

Active treatment (the implementation of training programs pursuant to objectives) should be
provided in formal and informal settings throughout the rhythm of the client’s day. While there
may be structured episodes when the client works intensively and singularly on one or more
objectives (schedule), the provision of active treatment is not adequate when confined solely to
these types of formal settings but should be incorporated into all activities when appropriate
(client’s routine). For example, objectives on grasping may be as effectively carried out during
the client’s use of a toothbrush and a spoon as in an isolated session.

W236

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(5)(iii) The person responsible for the program;

Guidance §483.440(c)(4)(v)

The IPP should include the actual name of the staff person who is responsible for the ongoing
monitoring of the client’s program to ensure it is being implemented appropriately, as well as
the designated position which will implement the program.

The QIDP should be familiar with the assessment and recording requirements for each client for
each formal objective, including who is responsible for making these observations and
completing the recording, and demonstrate a familiarity with the current data recorded for each
client.

W237

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(5)(iv) The type of data and frequency of data collection necessary to be able to
assess progress toward the desired objectives;

Guidance §483.440(c)(5)(iv)

The IDT must determine the type of data necessary to judge a client’s progress on an objective,
and describe the data collection method in the written training program. The facility
determines what data to collect, but whatever system is chosen for collection must yield
accurate measurement of the criteria stated in the client’s IPP objectives. For example, if the
criteria in the client’s IPP objective specified a behavior to be measured by “accuracy,” or
“successes out of opportunities,” then it would not be acceptable for the prescribed data
collection method to record “level of prompt”.

Examples of a few data collection systems include, but are not limited to:

• level of prompt;

• successful trials completed out of opportunities given;

• frequency counts; and

• frequency sampling.

The IDT must consider and select the type and frequency of data collection for each objective
based upon the need to measure appropriately the client’s performance toward the targeted
IPP skill development. The facility should collect data with enough frequency and content to be
able to appropriately measure the client’s performance toward the targeted IPP skill
development. The frequency of data collection may vary with the objective but must be made
at sufficient intervals to allow analysis of the progress of the client.

W238

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(5)(v) The inappropriate client behavior(s), if applicable; and The inappropriate
client behavior(s), if applicable; and

Guidance §483.440(c)(5)(v)

Any specific behaviors which would interfere with the client’s ability to function in, or benefit
from the training program are identified (e.g. a fear of water could interfere with the client’s
bathing program).

W239

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(5)(vi) Provision for the appropriate expression of behavior and the replacement
of inappropriate behavior, if applicable, with behavior that is adaptive or appropriate.

Guidance §483.440(c)(5)(vi)

The training program provides specific information as to how to elicit or strengthen appropriate
behavior and what behaviors to teach reinforce or encourage which would reduce or replace
the inappropriate behavior.

If a client is exhibiting an inappropriate behavior, the CFA should discover why the behavior is
occurring and the team should develop associated training objectives to help the client develop
more appropriate behaviors. The objective for decelerating targeted inappropriate behaviors is
not solely the reduction of these behaviors. The objective should also include the positive
functional replacement behavior (adaptive behavior).

A replacement behavior allows a client to substitute an unconstructive or disruptive behavior
with something more constructive and functionally equivalent. For example, instead of throwing
work materials as a way to get a break from vocational task demands, teach the client to say or
sign for ‘break’.

§483.440(c)(6) The individual program plan must also:

W240

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(6)(i) Describe relevant interventions to support the individual toward
independence.

Guidance §483.440(c)(6)(i)

Appropriate materials, adaptations and modifications to equipment and the environment are
available in order to promote and support individual training programs. Examples may include,
but are not limited, to built-up toilet seats, adaptive eating utensils, extended reach devices, and
modification to the facility van to accommodate a wheelchair.

The IPP describes supports and services, in addition to the individual goals and objectives that
will be provided by the facility to assist the client to function with greater independence.

W241

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(6)(ii) Identify the location where program strategy information (which must be
accessible to any person responsible for implementation) can be found.

Guidance §483.440(c)(6)(ii)

This requirement refers to the training program plans, objectives, descriptions of staff
interventions and data collection tools which must be readily accessible to any staff in order for
the programs to be consistently and effectively carried out and data collected.

W242

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(6)(iii) Include, for those clients who lack them, training in personal skills essential
for privacy and independence (including, but not limited to, toilet training, personal hygiene,
dental hygiene, self-feeding, bathing, dressing, grooming, and communication of basic needs),
until it has been demonstrated that the client is developmentally incapable of acquiring them.

Guidance §483.440(c)(6)(iii)

All clients who lack the skills listed within this standard have associated training programs
developed to meet their needs according to prioritization. These programs are consistently
implemented in both formal and informal settings.

“Developmentally incapable” is a decision made by the IDT that means a client does not have
the capacity to acquire certain skill sets. The decision must be based on an assessment of the
client’s strengths, needs, and functional limitations.

The determination of developmental incapability must be accompanied by written evidence
supporting this determination.

Such evidence may include training programs which failed after many different strategies were
tried, or physical limitations that preclude the acquisition of the skill. Examples are:

1) Eye contact program was attempted using seven different methods over a two year
period;

2) An client has two frozen elbow joints which do not allow her to get her hands to her
mouth and consequently she will not be trained on any hand to mouth skills; and

3) Some clients may have insufficient neuromuscular and sensory control to ever be totally
independent in toileting skills.

Toilet scheduling alone without any plan to progress would not be considered a toilet training
program.

The components of functional skills “training” as used in this regulation means aggressive
implementation of a systematic program of formal and informal techniques, which are:

• targeted toward assisting the client achieving the measurable behavioral level of skill
competency specified in IPP objectives;

• implemented at natural occurrences of activity and training programs; ( e.g.: an
objective for a client to increase grasping may be implemented as easily in the workshop
with a built up tool as in the bathroom with a toothbrush);

• conducted by all personnel involved with the client including those outside the home
such as in day programs; and

• carried out in conversation and interaction with the client appropriate to the situation.

§483.440(c)(6)(iv) Identify mechanical supports, if needed, to achieve proper body position,
balance, or alignment. The plan must specify

Guidance §483.440(c)(6)(iv)

The use of mechanical supports are based upon an individual assessment and fitting.
Mechanical devices are used to support a client’s proper body position or alignment and may be
essential to prevent contractures or deformities. However, mechanical supports restrict
movement and the client should be released from the support periodically for exercise and free
movement. Mechanical supports may not be used as a substitute for programs or therapy. For
example, the use of a bolster to position a client upright in a sitting position without any
indication there has been an assessment for the need for muscle re-training may be an
indication of a mechanical device in lieu of programming. Some supports allow movement and
provide opportunity for more increased functioning. Some examples of devices used as
mechanical supports include splints, wedges, bolsters, lap trays, etc.

Wheelchairs are not generally used to position or align the body and would not alone constitute
a mechanical support. However, adaptations to a wheelchair which facilitate correct body
alignment by inhibiting reflexive, involuntary motor activity are mechanical supports and should
be included in the plan for the client.

W243

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(6)(iv) the reason for each support,

W244

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(6)(iv) the situations in which each is to be applied,

W245

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(6)(iv) and a schedule for the use of each support.

W246

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(6)(v) Provide that clients who have multiple disabling conditions spend a major
portion of each waking day out of bed and outside the bedroom area, moving about by
various methods and devices whenever possible.

Guidance §483.440(c)(6)(v)

Clients with sensory or physical difficulties should be given the same opportunities to move
around in their environments as clients who do not have those difficulties. Even clients who use
specialized wheelchairs should be given the opportunity to utilize other devices such as walkers,
wagons and scooters to move about and/or change their positions.

With the exception of those clients who are acutely ill (such as those who are hospitalized or
incapacitated by a “short term” illness), all clients should be out of bed and outside their
bedroom area as long as possible each day, and in proper body alignment at all times. This is a
necessity in order to prevent regression, contractures, and deformities and to provide sensory
stimulation.

Bed rest is a temporary situation associated most usually with a medical condition and must be
ordered by the medical staff of the facility. The term implies that the client will remain in
his/her bed for most of any 24-hour period. Although active treatment programs may be
carried out to some extent while the client is on bed rest, the client’s program cannot be
completed in its entirety. While there may be situations where continuous bed rest may be
necessary, these situations are rare.

For those rare instances where out-of-bed activity is a threat to a client’s health and safety (e.g.,
blood clot in the leg), active treatment adapted to the medical capacity of the client must be
continued.

W247

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(6)(vi) Include opportunities for client choice and self-management.

Guidance §483.440(c)(6)(vi)

Choice and self-management are integral components of becoming independent. Clients should
be given opportunities for choice and self-management in both formal and informal settings
through the IPP process, leisure activities, and other life choices.

The ICF/IID must incorporate opportunities into daily life experiences that promote choice
making and decision making by clients. Examples of some activities leading toward
responsibility for one’s own self-management include, but are not limited to:

1) choosing housing or roommates;

2) choosing clothing to purchase or wear;

3) choosing what, where, and how to eat (e.g., the use of family style dining, access to
condiments and second helpings).

Choices can be made by all clients. The type of choices the person makes may vary from simple
to complex, dependent upon client abilities.

Clients are provided opportunities for choice and self-management and the facility does not
limit choices by making decisions for the people being served without their input. Clients are
provided the opportunity to demonstrate skills to the degree they are capable and only assisted
by staff as indicated in their IPP. A lack of facility staffing or staff convenience must not result in
a limitation of choices of self-management for the clients.

W248

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(c)(7) A copy of each client’s individual plan must be made available to all relevant
staff, including staff of other agencies who work with the client, and to the client, parents (if
the client is a minor) or legal guardian.

Guidance §483.440(c)(7)

The client or legal representative, as well as the facility staff, and staff from outside agencies,
with appropriate consent, have, or can access, a copy of the IPP.

(d) Standard: Program implementation

W249

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(d)(1) As soon as the interdisciplinary team has formulated a client’s individual
program plan, each client must receive a continuous active treatment program consisting of
needed interventions and services in sufficient number and frequency to support the
achievement of the objectives identified in the individual program plan.

Guidance §483.440(d)(1)

There should be no delay in the development and implementation of the IPP. To promote a
team process and meaningful discussion, IPP development should take place during IDT
meetings. Any IPP objective or modification that is critical to the health and safety of any client
should be implemented immediately following IDT discussion.”

Each individual receives training and services consistent with the current IPP.

The time period between admission and the 30 day IDT meeting is primarily to assist the client
to become adjusted and acclimated to his or her new living environment and to enable the
facility to complete the CFA. During this time period the facility should also be providing those
services and activities determined during the pre-admission assessment as essential to the
client’s daily functioning.

The active treatment program for the client is consistently implemented in all relevant settings
both formally and informally as opportunities present themselves. It should not be limited to
specific periods of time during the day or specific environments.

Each client should receive aggressive and continuous training, treatments and supports in
accordance with their needs and IPP. New skills and appropriate behaviors are encouraged and
reinforced across environments and times of day.

• During observations confirm that the client activities relate directly to the strengths,
needs and objectives in the IPP for each client and are not “busy work,” generalized or
non-developmental time fillers. For example, screwing nuts on bolts and then
unscrewing them repeatedly with no goal or transferable skills is “busy work.” Screwing
nuts on bolts that will be part of a product is functional reinforcement of skill
acquisition.

• Clients use adaptive equipment, assistive devices, environmental supports, materials,
supplies, etc., as specified in each client’s IPP to assist the client to accomplish stated
objectives.

There is no specific number or frequency of interventions that meets this requirement. The
surveyors should see that the facility capitalizes on all opportunities throughout the course of
the day that promote progress toward the achievement of goals and objectives.

Informal opportunities (“teachable moments”) should be utilized to reinforce learning or
appropriate skill development and needs are addressed as they present.

Although a client may not be able to reach complete independence in a functional skill, it is
crucial that retention of their current skills be supported.

Clients may have defined periods of time where they may engage in leisure activities of their
choice which are not necessarily directly associated with their IPP goals and objectives.

W250

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(d)(2) The facility must develop an active treatment schedule that outlines the
current active treatment program and that is readily available for review by relevant staff.

Guidance §483.440(d)(2)

The schedule is individualized, consistent with the client’s objectives, and reflects normal daily
routines.

The staff working with individual clients are familiar with their daily schedules and can produce
the schedule upon request.

The active treatment schedule allows flexibility and is adjusted to the needs and preferences of
the client, as necessary. It’s a schedule of the client’s general daily plans, but can be changed.

The active treatment schedule is a functional schedule which enables client and staff to be in
the right location in order to participate in the training as scheduled by the IPP.

W251

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(d)(3) Except for those facets of the individual program plan that must be
implemented only by licensed personnel, each client’s individual program plan must be
implemented by all staff who work with the client, including professional, paraprofessional
and nonprofessional staff.

Guidance §483.440(d)(3)

All disciplines, including direct care staff, interacting with the client work together to provide a
uniform, consistent approach to implementation of the IPP.

(e) Standard: Program documentation

W252

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(e)(1) Data relative to accomplishment of the criteria specified in client individual
program plan objectives must be documented in measurable terms.

Guidance §483.440(e)(1)

“Data” are defined to be performance information collected and reported in numerical or
quantifiable form for each training objective assigned priority in the IPP.

Data are those performance measurements collected at the time the treatment, procedure,
intervention or interaction occurs with the client and recorded as soon as possible. The data
should be located in a place accessible to staff who conduct training.

Data should be collected in a form and frequency as required by the plan to enable quantitative
(frequency or numbers) analysis of the client’s progress.

Data are accurate (e.g., reflective of actual client performance.)

§483.440(e)(2) The facility must document significant events that

W253

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(e)(2) are related to the client’s individual program plan and assessments and

Guidance §483.440(e)(2)

Significant events are those events which would cause a reasonable person to be affected and
which impact a normal routine. Such events include changes in the client’s functional status,
emotional health, physical health, accomplishments, activities or needs which impact the CFA
and IPP, as well as instances of abuse, neglect or mistreatment.

The client record should contain documentation that such events are evaluated and monitored.

W254

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(e)(2) that contribute to an overall understanding of the client’s ongoing level and
quality of functioning.

(f) Standard: Program monitoring and change

§483.440(f)(1) The individual program plan must be reviewed at least by the qualified
intellectual disability professional and revised as necessary, including, but not limited to
situations in which the client- –

Guidance §483.440(f)(1)

Program implementation is a critical piece of each client’s active treatment program. The QIDP
must review or revise client programs according to 483.440(f)(1)(i-iv) and at such an interval
that any of the requirements are promptly identified and addressed.

W255

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(f)(1)(i) Has successfully completed an objective or objectives identified in the
individual program plan;

Guidance §483.440(f)(1)(i)

The QIDP ensures the program has been modified or changed in response to the client’s specific
accomplishments or need for new program.

W256

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(f)(1)(ii) Is regressing or losing skills already gained;

W257

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(f)(1)(iii) Is failing to progress toward identified objectives after reasonable efforts
have been made; or

Guidance §483.440(f)(1)(iii)

There should be evidence that the QIDP has reviewed and revised the IPP in those situations
when the client’s IPP has been consistently implemented yet the client fails to achieve their
objectives.

W258

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(f)(1)(iv) Is being considered for training towards new objectives.

§483.440(f)(2) At least annually,

Guidance §483.440(f)(2)

For the “annual” review to meet this requirement, it must be completed by at least the 365th
day following the previous review, unless in an isolated or rare instance a client or the client’s
family is not available for a projected period of time and the subsequent delay is a minimal
number of days.

W259

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(f)(2) the comprehensive functional assessment of each client must be reviewed by
the interdisciplinary team for relevancy and updated as needed;

Guidance §483.440(f)(2)

The CFA is reviewed at least annually.

The review of the CFA occurs sooner than annually if:

• indicated by the needs of the client;

• reflects any changes in the client since their last evaluation; and

• incorporates information about the client’s progress or regression with objectives.

The review of the CFA applies to all evaluations conducted for a client. It is not required that
each assessment be completely redone each year, except the physical examination. It is
required that at least annually the assessment(s) be updated when changes occur so as to
accurately reflect the client’s current status.

W260

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(f)(2) and the individual program plan must be revised, as appropriate, repeating the
process set forth in paragraph (c) of this section.

Guidance §483.440(f)(2)

The IPP reflects the functional changes for the client which occurred since the last IPP. It is
unlikely that an active treatment program will have no changes from year to year without
documentation to support not changing the plan. Question an IPP that is a duplication of the
prior year’s plan without explanation.

W261

(Rev. 144, Issued: 08-14-15, Effective: 08-14-15, Implementation: 08-14-15)

§483.440(f)(3) The facility must designate and use a specially constituted committee or
committees consisting of members of facility staff, parents, legal guardians, clients (as
appropriate), qualified persons who have either experience or training in contemporary
practices to change inappropriate client behavior, and persons with no ownership or
controlling interest in the facility to- –

Guidance §483.440(f)(3)

The facility must have a specially constituted committee whose primary function is to
proactively protect client rights by monitoring facility practices and programs. The purpose of
the committee is to assure that each client’s rights are protected utilizing a group of both
internal staff and external participants who have no vested interest in the facility as well as
clients as appropriate. There should be evidence that the committee members have been
trained annually on the rights of the clients, what constitutes a restriction of a right and the
difference between punishment and training.

Depending on size, complexity and available resources, the ICF/IID may establish more than one
specially constituted committee. However, each committee must contain the required
membership and participate regularly and perform the functions of the committee according to
the requirements. Participation on the specially constituted committee(s) must be in real time
allowing all membership to speak and discuss in an interactive mode.

The regulation does not specify the professional credentials of the “qualified persons” (who
have either experience or training in contemporary practices to change inappropriate client
behavior). There is no requirement that any specific discipline, such as nurse, physician or
pharmacist be a member of the committee.

The intent of including “persons with no ownership or controlling interest” on the committee is
to assure that, in addition to having no financial interest in the facility, at least one member of
each constituted committee is an impartial outsider in that he/she would not have an “interest”
represented by any other of the required members or the facility itself. Staff and consultants
employed by the facility or at another facility under the same governing body, cannot fulfill the
role of person with no ownership or controlling interest.

Although occasional absences from committee meetings are understandable, patterns of
absence by the required membership of the committee is not acceptable. At least a quorum of
committee members (as defined by the facility) must review, approve and monitor the
programs which involve risk to client rights and protections and that quorum must include one
person from each of the required categories.

W262

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(f)(3)(i) Review, approve, and monitor individual programs designed to manage
inappropriate behavior and other programs that, in the opinion of the committee, involve
risks to client protection and rights;

Guidance §483.440(f)(3)(i)

Any program that utilizes restrictive or intrusive techniques must be reviewed and approved by
the specially constituted committee prior to implementation. This includes, but is not limited
to:

• restraints;

• drugs to manage behavior;

• restrictions on community access;

• contingent denial of any right; or

• restrictions of materials or locations in the home.

The committee should ensure that consequences within a written behavior management
program do not violate the client’s rights.

There is no requirement for the committee to evaluate whether the proposed program is
consistent with current practices in the field. Documentation should verify that the specially
constituted committee considered factors, such as whether less intrusive methods have been
attempted, whether the severity of behavior outweighs the risks of the proposed program and
whether replacement behaviors are included within the plan.

Any revision to a behavior plan that increases the level of intrusiveness must be re-reviewed by
the specially constituted committee. The committee need not reapprove a program when
revisions are made in accordance with the approved plan. For example, if the physician changes
the dosage of a medication in accordance with the drug treatment component of the active
treatment plan to which the legally authorized person has given consent and which has already
been approved by the committee, then there is no need for the committee or the legally
authorized person to reapprove the plan. Generally, this would also apply if the medication was
changed to another within the same therapeutic class or family.

W263

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(f)(3)(ii) Insure that these programs are conducted only with the written informed
consent of the client, parents (if the client is a minor) or legal guardian; and

Guidance §483.440(f)(3)(ii)

The committee must ensure that written informed consent must be obtained prior to
implementation of any restrictive or intrusive program. In the event of an emergency, the
facility may obtain a verbal consent, which must be authenticated in writing as soon as possible
and subsequently submitted to the committee as verification.

The consent is required for the entire behavior management program not just the specific
restrictive technique.

Consent is informed when the person giving consent is fully aware of the:

• specific treatment;

• reason for treatment or procedure;;

• the attendant risks vs. benefits;

• alternatives;

• right to refuse; and

• the consequences associated with consent or refusal of the program.

Informed consent must be in writing and must be specific to the program and restrictive
practice and reflect a specific time frame. Blanket consents are not allowed. In the case of
unplanned events such as assault and property destruction requiring immediate action, verbal
consent may be obtained. However, it should be authenticated in writing as soon as reasonably
possible (within 30 days).

For clients up to the age of 18, their parent or legally appointed guardian must give consent for
him or her. At the age of 18, however, clients become adults and are assumed to be competent
unless otherwise determined by a court.

For clients who are adults and have not been adjudicated incompetent and have not been
assigned a legal guardian who may not fully understand the consequences of the program,
informed consent for use of restrictive programs, practices or procedures should be obtained
from a person or an entity in accordance with state law, to act as the representative or advocate
of the client’s interests.

The specially constituted committee must ensure that the informed and voluntary consent of
the client, parent of a minor, legal guardian, or the person or organization designated by the
state is obtained prior to each of the following circumstances:

• The involvement of the client in research activities; or

• Implementation of programs or practices that could abridge or involve risks to client
protections or rights.

W264

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.440(f)(3)(iii) Review, monitor and make suggestions to the facility about its practices and
programs as they relate to drug usage, physical restraints, time-out rooms, application of
painful or noxious stimuli, control of inappropriate behavior, protection of client rights and
funds, and any other areas that the committee believes need to be addressed.

Guidance §483.440(f)(3)(iii)

The committee has been made aware of and reviewed:

• facility policies and procedures;

• facility services;

• programs; and

• practices which may restrict or violate the rights of client.

The committee has established and uses a mechanism for monitoring clients’ rights issues and
informs the governing body of any issues of concern in a timely manner. This process is at the
discretion of the committee. There is no requirement for periodic review of the policies by the
committee.

The function of the committee is not limited to the review, approval and monitoring of
restrictive behavior management practices. Examples of issues involving client rights that might
be reviewed by the committee, in addition to behavior management, include, but are not
limited to:

1) Research proposals involving clients;

2) Abuse, neglect and mistreatment of clients;
3) Allegations dealing with theft of a client’s personal property or funds;

4) Damage to a client’s goods or denial of other client rights;

5) Client grievances;

6) Visitation procedures;
7) Guardianship/advocacy issues;

8) Rights training programs;

9) Confidentiality issues;

10) Advance directives/DNR orders;

11) Practices which restrict clients (e.g., locked doors, fenced in yards); and
12) Video monitoring.

W265

§483.440(f)(4) The provisions of paragraph (f)(3) of this section may be modified only if, in the
judgment of the State survey agency, Court decrees, State law or regulations provide for
equivalent client protection and consultation.

W266

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450 Condition of participation: Client behavior and facility practices

(a) Standard: Facility practices– Conduct toward clients

W267

(Rev.135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(a)(1) The facility must develop and implement written policies and procedures for
the management of conduct between staff and clients.

Guidance §483.450(a)(1)

The primary survey emphasis is on the implementation of the policies and procedures
developed by the facility.

Conduct between staff and clients refers to language, actions, discipline, rules, order and other
types of interactions exchanged between staff and clients or imposed upon clients by the staff
during a client’s daily experiences that affect the quality of a client’s life.

§483.450(a)(1) These policies and procedures must –

W268

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(a)(1)(i) Promote the growth, development and independence of the client;

Guidance §483.450(a)(1)(i)

Consistent with facility policies, staff is observed to be engaged in activities which promote the
client’s growth, development and independence.

1) IPPs and data support the fact that from the time of admission, clients are learning
new adaptive and functional skills while becoming more independent.

2) Interactions between clients and staff are consistent and positive.

3) Staff teach and encourage clients to interact with each other in a manner that
promotes social integration both in the facility and out in the community.

4) All opportunities to teach and reinforce skill acquisition are utilized.

5) Staff identify and remove impediments in the learning environment (e.g. client is
unable to concentrate in a room with a television because when they see the
television, they want to watch their favorite show. Staff must identify this learning
impediment and train in an environment without a television).

6) Staff encourage clients to complete tasks with as much independence as possible.

7) Staff encourage clients to take risks while providing reasonable safeguards to prevent
injury.

8) Encourage clients to make choices during their daily activities.

W269

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(a)(1)(ii) Address the extent to which client choice will be accommodated in daily
decision-making, emphasizing self-determination and self-management, to the extent
possible;

Guidance §483.450(a)(1)(ii)

Written facility policies describe how the facility will offer choice to the clients during the course
of their day.

Written policies describe how self-determination, as defined by free choice of one’s own acts
and decisions without external coercion or direction, to the extent possible and self-
management, as defined by control of one’s own routine and daily responsibilities, to the extent
possible, are incorporated into the development of program plans and daily routines.

W270

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(a)(1)(iii) Specify client conduct to be allowed or not allowed; and

Guidance §483.450(a)(1)(iii)

“Client conduct” refers to any behavior, choice, action, or activity in which a client may choose
to engage alone or with others.

Written policies and procedures which may be in the form of “house rules”, must not impinge
on individual client rights and must not be used as a substitute for the development of
individualized programs and plans.

W271

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(a)(1)(iv) Be available to all staff, clients, parents of minor children, and legal
guardians.

Guidance §483.450(a)(1)(iv)

Policies and procedures for management of conduct between staff and clients (483.450(a)(1))
should be provided to clients, parents of minor children, and legal guardians at admission and
upon request. Policies and procedures are available on the residential and program areas if
these are in separate buildings.

W272

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(a)(2) To the extent possible, clients must participate in the formulation of these
policies and procedures.

Guidance §483.450(a)(2)

“To the extent possible” does not mean that the clients are excluded due to the clients’
schedule or intellectual or developmental level. Facilities should be able to provide
documentation that substantiates that clients were offered the opportunity and participated in
the development of the policies. This could be accomplished through client committees or in
house meetings. There should be documentation of these discussions between the client
representatives and the facility.

W273

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(a)(3) Clients must not discipline other clients, except as part of an organized system
of self-government, as set forth in facility policy.

Guidance §483.450(a)(3)

Staff will promptly intervene when any clients tries to independently impose discipline upon
another client. For example, a client who is serving dessert to the group withholds dessert from
another client based upon their own evaluation of that client’s behavior.

(b) Standard: Management of inappropriate client behavior

W274

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(1) The facility must develop and implement written policies and procedures that
govern the management of inappropriate client behavior

Guidance §483.450(b)(1)

At a minimum, the facility must have written policies and procedures regarding the
management of maladaptive behaviors addressing the following:

483.450(b)(1) (W 275 – W284).

• the use of a functional behavior assessment in the development of behavior
management programs;

• a hierarchy of least to most intrusive measures; and

• incorporation of behavior management programs into the IPP.

§483.450(b)(1) These policies and procedures must be

W275

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(1) consistent with the provisions of paragraph (a) of this section.

§483.450(b)(1) These procedures must

W276

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(1)(i) Specify all facility approved interventions to manage inappropriate client
behavior;

Guidance §483.450(b)(1)(i)

All interventions for the management of inappropriate client behaviors which are approved for
use in the facility are clearly stated and described in its policy. Examples of positive
interventions include, but are not limited to, verbal praise reward systems, and prompting.
Examples of negative interventions include, but are not limited to, removal of a privilege,
implementation of restraint, and/or the use of exclusionary time out.

W277

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(1)(ii) Designate these interventions on a hierarchy to be implemented, ranging
from most positive or least intrusive, to least positive or most intrusive;

Guidance §483.450(b)(1)(ii)

Policies and procedures must include a clear progression as to how staff implement
interventions to manage inappropriate client behavior.

Facility policy and procedures must define the entire hierarchy of possible interventions from
the most positive, functionally appropriate approaches to most intrusive approaches authorized.
The facility determines at what level in the hierarchy the IPP will begin for each client based on
their individual assessment. The plan must still begin at the least intrusive technique shown
effective for that client. Individual plans should specify the specific techniques that have been
determined through assessment to be least restrictive for each client.

The facility policy for unexpected behavioral incidents must provide direction for the staff in the

utilization of the hierarchy. For clients not on a behavior plan, staff must apply the appropriate
level of intervention per the established hierarchy, including emergency measures to prevent
harm to self or others.

W278

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(1)(iii) Insure prior to the use of more restrictive techniques, that the client’s
record documents that programs incorporating the use of less intrusive or more positive
techniques have been tried systematically and demonstrated to be ineffective; and

Guidance §483.450(b)(1)(iii)

Policies must be implemented to ensure that all restrictive procedures begin at the lowest level
of the hierarchy unless there is documented evidence that less intrusive interventions have
been tried and have been found to be ineffective.

The facility is not required to justify discontinuing the use of a more restrictive technique before
initiating a less restrictive technique, since the intent of the regulation is to use the most
positive, least intrusive technique possible.

In emergency situations where an unanticipated behavior requires immediate protection of the
client or others, the technique chosen is the least restrictive appropriate technique possible.

§483.450(b)(1)(iv) Address the following:

W279

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(1)(iv)(A) The use of time-out rooms;

Guidance §483.450(b)(1)(iv)(A)

“Time-out room” is defined as a separate room that is used to remove a client from stimulation
that may be triggering and reinforcing maladaptive behavior. The facility must have written

policies and procedures for the use of time out rooms which address all the requirements of
483.450 (c) (1-4) standard: time out room.

W280

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(1)(iv)(B) The use of physical restraints;

Guidance §483.450(b)(1)(iv)(B)

“Physical restraint” is defined as any manual hold or mechanical device that the client cannot
remove easily, and which restricts the free movement of, normal functioning of, or normal
access to a portion or portions of a client’s body. Examples of mechanical devices may include
arm splints and mittens.

Policies and Procedures must address:

• the types of physical restraint that are allowed in the facility;

• the persons who apply such restraints;

• the parameters for duration of application;

• the methods that assure the health and safety of clients while in restraints; and

• the specific training required for staff allowed to apply such restraints.

W281

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(1)(iv)(C) The use of drugs to manage inappropriate behavior;

Guidance §483.450(b)(1)(iv)(C)

Applicable policies may include a discussion of:

When a drug can be used to manage inappropriate behavior;

Consistency with diagnosis;

Alternatives tried before a drug is used;

Precautions that must be followed prior to and during the use (lab values, monitoring of
side effects);

Implementation of a plan to address the behaviors for which the drug was prescribed;
and

Plan to reduce the medication as appropriate.

Drugs to manage inappropriate behavior are defined as any medication prescribed and
administered for purposes of modifying the maladaptive behavior of a client.

W282

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(1)(iv)(D) The application of painful or noxious stimuli;

Guidance §483.450(b)(1)(iv)(D)

“Application of painful or noxious stimuli” is defined as any procedure by which staff apply,
contingent upon the exhibition of maladaptive behavior, startling, unpleasant, or painful stimuli,
or stimuli that have a potentially noxious effect.

While the regulation permits the use of painful or noxious stimuli these techniques are the last
resort and can only be utilized for behaviors that are causing significant harm and have not
responded to competently administered interventions of less intrusive nature.

Facility policies must state that:

• The use of noxious stimuli is only permitted when the client exhibits behaviors so severe
that they present a potential risk for significant or even life-threatening circumstances;

• the IDT and facility must weigh the potential risk of the behavior against the risk
involved in the use of the painful or noxious techniques to manage behavior;

• that safeguards and strict oversight must be in place for consideration to use techniques
that may be painful or even unpleasant;

• techniques that may be painful or noxious must be time limited;

• the proposed use of these techniques requires scrutiny of clinical effectiveness and
specially constituted committee review; and

on-going monitoring and safeguards must be in place during implementation of the
technique.

W283

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(1)(iv)(E) The staff members who may authorize the use of specified interventions;

Guidance §483.450(b)(1)(iv)(E)

W284

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(1)(iv)(F) A mechanism for monitoring and controlling the use of interventions.

Guidance §483.450(b)(1)(iv)(F)

Facility policies must address what supervisory oversight is provided during the application of
the intervention in order to ensure that procedures were followed correctly. Procedures should
also address what retrospective analysis is done on each intervention to ensure that procedures
are being consistently followed.

W285

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(2) Interventions to manage inappropriate client behavior must be employed with
sufficient safeguards and supervision to ensure that the safety, welfare and civil and human
rights of clients are adequately protected.

§483.450(b)(3) Techniques to manage inappropriate client behavior must never be used

W286

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(3) for disciplinary purposes,

Guidance §483.450(b)(3)

No intervention, whether as a part of a formal program or in emergency situations (see W289)
may be used as punishment, retaliation or retribution. A staff member cannot employ a
behavior management technique simply because a client refuses to follow a staff request.

The implementation of all interventions, except in emergency situations, must be administered
consistent with the IPP and the specific behaviors identified in the IPP requiring the
intervention. Instances where an intervention is done as a punishment because the client did
not comply with staff instructions and not associated with the IPP include:

• Personal property confiscated for behavior at staff discretion;

• Rights restricted without approved plans; and

• Punitive house rules, such as prohibiting reentry into the kitchen for snacks if a meal is
not eaten completely.

W287

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(3) for the convenience of staff

Guidance §483.450(b)(3)

Inadequate numbers of staff, inefficient deployment of staff, and insufficient training of staff
can lead to restrictive practices used for staff convenience.

Examples of techniques used to manage client behavior for staff convenience including, but are
not limited to:

• Clients allowed to discipline other clients;

• Clients restricted to one area of the home; and

• Unauthorized use of restraints (e.g., lap trays, bean bags, gait belt, and merry walkers
for the purpose of restricting movement)

W288

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(3) or as a substitute for an active treatment program.

Guidance §483.450(b)(3)

Substitutions for active treatment programming occur when the staff utilizes interventions and
restrictive techniques on their own, either because there is not a formal behavioral program to
address the client’s behaviors or because the staff do not follow the plan as written.

W289

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(4) The use of systematic interventions to manage inappropriate client behavior
must be incorporated into the client’s individual program plan, in accordance with
§483.440(c)(4) and (5) of this subpart.

Guidance §483.450(b)(4)

The use of behavior interventions are expected to be incorporated into the IPP and be based
upon the results of the functional behavioral assessment.

However, there may be isolated and rare instances when a client exhibits unexpected behavior
that requires immediate intervention on the part of the staff. In these instances, the least
restrictive intervention must be employed and removed as soon as the client is no longer an
immediate threat to self or others. The IPP team must then discuss the need for adding a
behavioral plan into the clients program.

W290

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(b)(5) Standing or as needed programs to control inappropriate behavior are not
permitted.

Guidance §483.450(b)(5)

The staff of the facility may not maintain or use, outside of the IPPs, any list of “as needed”
interventions that can be used with any client at any time. With the exception of isolated and
rare emergency situations, all restrictive behavior interventions must be incorporated into the
formal IPP and individualized for the client.

W291

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(c)(1) A client may be placed in a room from which egress is prevented only if the
following conditions are met:

(i) The placement is a part of an approved systematic time-out program as required by
paragraph (b) of this section. (Thus, emergency placement of a client into a
time-out room is not allowed.)

(ii) The client is under the direct constant visual supervision of designated staff.

(iii) The door to the room is held shut by staff or by a mechanism requiring constant
physical pressure from a staff member to keep the mechanism engaged.

Guidance §483.450(c)(1)

Seclusion, defined as the placement of a client alone in a locked room, is never allowed.

Time out procedures allows a client to be alone in a room, but do not allow that room to be
locked. During a time out procedure, egress can only be prevented by a person standing in the

door way, or holding the door closed, but as soon as the staff move from the door way or let go
of the door the client can come out.

Use of the timeout room or procedure must be part of an approved behavioral plan and may
involve the separation of a client from a group or a particular situation, in a non-locked setting
for the purpose of calming or removing the client from the reinforcing stimuli that are sustaining
an identified maladaptive behavior.

Designated time out rooms must be set up so that the staff has continuous, direct observation
of the client at all times. Because of the danger that staff can get distracted by other events or
duties, this cannot be accomplished by a camera in lieu of the staff having direct visual of the
client.

Key locks, latch locks, and doors that open inward without an inside doorknob are not permitted
by the regulations for use in time out rooms as they do not require constant physical pressure
from a staff member to keep the door shut. In each instance where a time out room is used, the
client’s IPP must include:

• The functional behavioral assessment which resulted in a recommendation for the use
of time out procedures; and

• Instructions on how often data is to be collected during the time out period and the
criteria for release from time out.

The use of a time out room must be approved by the Specially constituted committee as part of
an approved program.

W292

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(c)(2) Placement of a client in a time-out room must not exceed one hour.

W293

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(c)(3) Clients placed in time-out rooms must be protected from hazardous conditions
including, but not limited to, presence of sharp corners and objects, uncovered light fixtures,
unprotected electrical outlets.

Guidance §483.450(c)(3)

Because placement in the time out room is typically secondary to extreme behaviors, it is
acceptable that there be no furniture in this room.

A door that opens inward can potentially be held closed, either intentionally or inadvertently, by
the client in the room, thereby denying staff immediate access to the room.

W294

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(c)(4) A record of time-out activities must be kept.

Guidance §483.450(c)(4)

The documentation in the client’s record accurately reflects planned (e.g. part of the IPP) usage
and presents a picture of events prior to, during, and following the use of time-out. The IPP
should include direction as to how often data must be collected during each use of time out for
each individual client.

(d) Standard: Physical restraints

§483.450(d)(1) The facility may employ physical restraint only- –

W295

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(1)(i) As an integral part of an individual program plan that is intended to lead to
less restrictive means of managing and eliminating the behavior for which the restraint is
applied;

Guidance §483.450(d)(1)(i)

The use of physical restraint is specified within the IPP. The plan must address:

1) The specific type of client behavior to be managed by this plan;

2) The less restrictive behavioral approaches which were previously used, but were
unsuccessful;

3) The hierarchy of measures that must be utilized prior to the application of physical
restraint;

4) The type of physical restraint;
5) The type of client behavior that would indicate that the patient is calm and can be

released from the restraint; and

6) The replacement behavior being taught to the client to reduce the need for future
restraints.

W296

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(1)(ii) As an emergency measure, but only if absolutely necessary to protect client
or others from injury; or

Guidance §483.450(d)(1)(ii)

Physical restraint may be used as an emergency intervention only in situations where the client
is exhibiting behaviors which:

1) the client has not exhibited before;

2) were not identified in the functional analysis of behavior; or

3) are harming other people or themselves.

When there are repeated episodes of the use of physical restraint as an emergency safety
measure, these episodes should be assessed for their predictability by the IDT, and revisions to
the IPP considered addressing the behaviors through a formal behavior plan in order to
reduce/eliminate the use of physical restraint.

W297

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(1)(iii) As a health-related protection prescribed by a physician, but only if
absolutely necessary during the conduct of a specific medical or surgical procedure, or only if
absolutely necessary for client protection during the time that a medical condition exists.

Guidance §483.450(d)(1)(iii)

Physical restraint during medical procedures must be utilized only when absolutely necessary
and be used as a last resort in order for the facility or practitioners to deliver needed medical
care to the client. The restraint must be released as soon as the medical procedure is
completed unless it is necessary to continue restraint for a longer period of time to continue to
deliver care or to prevent the client from displacing tubes or dressings. These restraints may
only be used as long as the physician indicates them to be necessary.

For instances where physical restraint are used by the facility or a practitioner during a medical
procedure, the client record and interviews should verify that less restrictive measures were
attempted before using physical restraint and verify whether any injuries occurred during the
use of the physical restraint. Written orders by medical personnel for the application of a
physical restraint should include the reason that the restraint is necessary, the type of restraint
to be used and the length of time the restraint will be applied.

A restraint device used to prevent a client engaging in self-injurious behavior is not considered a
restraint for medical condition.

§483.450(d)(2) Authorizations to use or extend restraints as an emergency measure must be:

Guidance §483.450(d)(2)

Facility policies should list who in the facility is allowed to authorize the emergency use of
restraints or to extend the use of an emergency restraint, and the training that is required for
those persons who may authorize. Documentation in the client record in those instances should
confirm that the facility follows that policy.

W298

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(2)(i) In effect no longer than 12 consecutive hours; and

Guidance §483.450(d)(2)(i)

This regulation does not mean that restraints may be authorized to be applied for up to a 12
hour period. The client must be released from the physical restraint as soon as the client is no
longer a risk to self or others. Once the behavior has ceased, the emergency has ended, and the
client has been released, another authorization would be required for any new emergency
situation.

The 12 consecutive hour period is the absolute maximum period of time that emergency
physical restraint may be utilized for a client during an individual behavioral incident. It is
reasonable to expect that the facility will reassess the emergency situation for any client who
remains in physical restraint for longer than one hour and reassess the situation at least every
30 minutes thereafter up to 12 hours when the physical restraint must be removed.

W299

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(2)(ii) Obtained as soon as the client is restrained or stable.

Guidance §483.450(d)(2)(ii)

There may be instances where the maladaptive behaviors of a client or clients escalate into a
serious and immediate event that must be de-escalated quickly in order to prevent harm to
clients, staff, other clients, or by standers when incidents occur in the community. In these
instances, the staff should contact the appropriate person to obtain authorization for the use of
physical restraint as soon as the situation is stable. Retrospective documentation of the incident
should confirm the need for authorization after application.

W300

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(3) The facility must not issue orders for restraint on a standing or as needed basis.

Guidance §483.450(d)(3)

All instances of physical restraint must be ordered on a case by case basis with individual
assessment of the situation and authorization based upon the individual client. Authorizations
should include the rationale for the use of the physical restraint versus other less restrictive
measures.

W301

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(4) A client placed in restraint must be checked at least every 30 minutes by staff
trained in the use of restraints,

Guidance §483.450(d)(4)

The frequency of monitoring will vary according to the type and design of the device and the

psychological and physical well-being of the client. The facility should be checking the client
often enough to adequately assess the physical status of the client (e.g., circulation, respiration
and vital signs) of the client and the need to continued restraint. The more restrictive the
intervention, the greater the risk to the client and the more often the client must be assessed.
Frequent assessment will assure that the client will be released as soon as possible, however, in
no instance may the staff go longer than 30 minutes without checking the client.

W302

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(4) released from the restraint as quickly as possible, and

Guidance §483.450(d)(4)

“As quickly as possible” means as soon as the client is no longer a danger to self or others.
Documentation should support that the client was released from restraint as soon as they
became calm.

W303

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(4) a record of these checks and usage must be kept.

§483.450(d)(5) Restraints must be designed and used

W304

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(5) so as not to cause physical injury to the client

Guidance §483.450(d)(5)

Physical restraints to include mechanical devices must be the correct size for the client and be
applied with the correct amount of pressure according to manufacturer’s directions. In addition
to observation of any physical mechanical restraint in use at the time of the survey, review
incident reports for any injuries as a result of restraint use.

W305

§483.450(d)(5) and so as to cause the least possible discomfort.

§483.450(d)(6) Opportunity for motion and exercise must be provided

W306

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(6) for a period of not less than 10 minutes during each two hour period in which
restraint is employed,

Guidance §483.450(d)(6)

This requirement does not apply to cases of medical restraints that are specifically ordered for
the immobilization of bones and joints during the physical healing process involved with
fractures, sprains, etc. (e.g. a broken bone immobilized by a cast or splint). See 331 483.460(c)
regarding surveillance of skin integrity during the use of medical restraints.

However, if a mechanical physical restraint is applied to an extremity to prevent a client from
removing post-operative sutures, the restraint must be released every two (2) hours for a period
of not less than ten (10) minutes in order to maintain adequate circulation.

Mechanical restraints placed on the client during sleeping hours must be medically based and
specifically ordered by a physician. There should be evidence in the client’s record why the
mechanical physical restraint is necessary during sleeping hours. While it is not necessary to
wake the client every two (2) hours to release the restraint and provide opportunity for
exercise, the staff must check the restraint frequently during the night to ensure that the

restraint is still properly applied and the client appears comfortable.

W307

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(6) and a record of such activity must be kept.

§483.450(d)(7) Barred enclosures

Guidance §483.450(d)(7)

A bed or play equipment with bars that prevent the client from leaving the bed or voluntarily
climbing out of the bed are barred enclosures. The use of such enclosures must be a part of the
written IPP and behavioral assessments must clearly state why such an enclosure is necessary,
the risks of using the enclosure versus not using it and what less restrictive measures have been
tried prior to the implementation of the barred enclosures.

Such devices may not be used in lieu of adequate staffing.

W308

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(7) must not be more than three feet in height and

W309

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(d)(7) must not have tops.

(e) Standard: Drug usage

§483.450(e) Standard: Drug Usage

W310

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(e)(1) The facility must not use drugs in doses that interfere with the individual
client’s daily living activities.

Guidance §483.450(e)(1)

Clients are alert and available for participation in daily living activities.

Some medications administered for medical reasons or to manage behavior may cause
drowsiness as a side effect or due to an accumulation of the drug in the client’s system. For
clients who are observed to be sleeping in chairs during their work day, their programs or
recreational times, there should be evidence that the facility staff notified the medical staff and
an assessment was performed of the client including their medication regimen. Medical staff
should make adjustments to address the issue if indicated.

§483.450(e)(2) Drugs used for control of inappropriate behavior must

W311

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(e)(2) be approved by the interdisciplinary team and

Guidance §483.450(e)(2)

The physician and other team members discuss the risks and benefits of the medication to
address the target behavior/symptoms, and approve the use of the drug as being consistent

with the active treatment program. Decisions about the necessity of the use of drugs to manage
inappropriate behavior should be made by the IDT. It is the responsibility of the IDT members to
provide the physician with sufficient information regarding the need for a client to receive a
drug for inappropriate behavior. The physician will make the ultimate decision to order the use
of the drug. The IDT should document any disagreement with the physician’s order.

In those instances where a client returns from a physician’s visit with an order for an unsolicited
drug to manage client’s inappropriate behaviors, there must be evidence (e.g. IDT meeting
notes or clients record) that the team concurred with the necessity for the order without trying
less restrictive measures first and discussed any concerns with the physician.

W312

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(e)(2) be used only as an integral part of the client’s individual program plan that is
directed specifically towards the reduction of and eventual elimination of the behaviors for
which the drugs are employed.

Guidance §483.450(e)(2)

All medications to manage behavior must be integrated into the IPP and the IPP must specify
how the specific target behavior for which the medication is prescribed will be reduced or
eliminated. This includes medications which are typically used for medical conditions that may
be used to manage behavior (e.g. 1. propranolol (Inderal), an antihypertensive used for self-
injurious behavior, and 2. carbamazepine (Tegretol), an anticonvulsant, used for aggression).

Drugs for behavior management must not be ordered on a PRN basis for a client. The facility
staff must contact the physician to obtain a one-time order if the situation necessities the use of
medication. The facility policy must address the maximum number of times a medication can be
used as an emergency prior to being incorporated in the IPP, side effects of such medications,
and the frequency of re-evaluation of ongoing behavior and its treatment.

Clients or their legal guardian have the right to choose sedation for medical and dental
procedures. However, the facility cannot do routine administration of medication for sedation
for medical and dental procedures without the agreement/consent of the client or their
parent/legal guardian and they must follow the specific orders of the healthcare practitioner

who will be providing services to the client. Decisions to order medications prior to medical and
dental procedures must be made on an individual basis. Clients who demonstrate severe
anxiety around these procedures should be considered for desensitization programs.

W313

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(e)(3) Drugs used for control of inappropriate behavior must not be used until it can
be justified that the harmful effects of the behavior clearly outweigh the potentially harmful
effects of the drugs.

Guidance §483.450(e)(3)

The risk(s) associated with the drug being used is consistent with the type and severity of the
behavior/symptoms it is intended to affect.

At the time the drug was started and incorporated into the IPP, the behaviors were discussed
and presented to team members. It was the documented decision of the team that the
behaviors were of such a severity that pharmacological intervention was required and the
physician was provided with the team information to assist him in his decision to prescribe the
medication.

§483.450(e)(4) Drugs used for control of inappropriate behavior must be- –

§483.450(e)(4)(i) Monitored closely,

W314

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(e)(4) in conjunction with the physician and the drug regimen review requirement at
§483.460(j),

Guidance §483.450(e)(4)

The physician and pharmacist must regularly review use of drugs for control of inappropriate
behavior for their effectiveness in changing the targeted behavior/symptoms, untoward side
effects, contraindications for continued use, and communicate this information to relevant staff.

W315

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(e)(4) for desired responses and adverse consequences by facility staff; and

Guidance §483.450(e)(4)

Direct support staff members are the people who most closely and most frequently observe and
record client behaviors. There should be evidence that the direct support staff receive
information via the IPP as to the behaviors to be observed, the side effects associated with the
medication, the amount and types of documentation required and the communication with
clinical staff which is indicated. See 483.430 (e)(1) for training on observations, documentation
and communication related to behavior management.

§483.450(e)(4)(ii) Gradually withdrawn

W316

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(e)(4) at least annually

Guidance §483.450(e)(4)

Clients receiving medications to control behavior must be evaluated at least annually for a
possible reduction of the medication progressing the client toward final elimination of the drug
or lowest possible therapeutic level of the drug. However, evaluation should be done earlier
than annually if observations indicate that the client’s behavior has improved to the point that

reduction may be considered as determined by the IPP, unless otherwise ordered by the client’s
physician.

W317

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.450(e)(4) in a carefully monitored program conducted in conjunction with the
interdisciplinary team, unless clinical evidence justifies that this is contraindicated.

Guidance §483.450(e)(4)

The IDT is aware of and involved in planning the drug reduction program and participates in its
implementation and monitoring.

Progress or regression of the client is monitored and taken into consideration in determining the
rate of withdrawal and whether to continue withdrawal.

In determining whether there is clinical contraindication to the annual drug withdrawal, the
physician and IDT should consider the client’s clinical history, diagnostic/behavioral status,
previous reduction/discontinuation attempts, and current regimen effectiveness.

If a client also has a diagnosis of a psychiatric condition that requires a stable level of a
psychiatric medication in order to control the symptoms associated with the psychiatric
diagnosis, the annual evaluation for reduction of that particular medication for the symptoms of
the psychiatric diagnosis would not apply. Documentation in the client’s record from their
psychiatrist or physician that medication reduction would be contraindicated or that the current
level of medications is therapeutic meets the intent of this regulation.

W318

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460 Condition of participation: Health care services

(a) Standard: Physician services

W319

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(a)(1) The facility must ensure the availability of physician services 24 hours a day.

Guidance §483.460(a)(1)

A designated physician must be available via telephone, pager, e-mail or on-site in the facility on
a 24 hour per day basis for consultation regarding both emergency and non-emergency medical
issues. If the facility employs a fulltime physician, there must be procedures in place for
coverage in the absence of the physician from the facility.

If the facility contracts with a community-based physician for 24 hour per day coverage, there
must be written arrangements in place to detail the responsibilities of the contract physician
regarding direct services to the clients, interactions with the direct support staff and the
interactions between the nursing staff of the facility and the contract physician. The contract
with the contract physician must delineate the process for coverage when he/she is not
available.

Upon interview, the staff should be aware of the procedures they are to follow to contact a
physician in the event of an illness or injury. Routinely sending clients to emergent care or the
emergency room of a hospital because there are no facility physicians available for consultation
is not consistent with the regulations.

Interview and record review verify that the physician is available and responsive 24 hours a day.

W320

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(a)(2) The physician must develop, in coordination with licensed nursing personnel, a
medical care plan of treatment for a client if the physician determines that an individual client
requires 24-hour licensed nursing care.

Guidance §483.460(a)(2)

A medical care plan of treatment is developed for those clients who are either acutely ill and
require licensed nursing care and monitoring temporarily on a 24 hour basis or clients whose
chronic medical conditions require or indicate 24 hour licensed nursing care and monitoring.
The physician determines when 24 hour nursing care is required.

The medical care plan is based upon the orders from the physician for treatments and care and
nursing standards of practice. There is evidence in the client’s record that the physician and the
nursing staff at the facility work together to ensure that the medical care plan is current and
appropriate (e.g. changes in physician written orders for care pursuant to observations from the
nursing staff and/or direct observations and interactions with the client, and nursing
documentation of care).

The fact that a client has a medical care plan in place should not preclude him/her from an
active treatment program, except in instances of acute illness where the active treatment
program is temporarily suspended. For clients with chronic medical conditions, it may be
necessary for their active treatment program to be modified due to the tolerance level of the
client or adapted to accommodate medical limitations. However, active treatment must be
provided on a continuous basis.

W321

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(a)(2) This plan must be integrated in the individual program plan.

Guidance §483.460(a)(2)

Although the medical care plan can be a separate document, it is always an integral part of the
IPP process. There should be evidence that the plans are shared and discussed at the time of all

interdisciplinary discussions and the information from the medical care plan is utilized in the
development of the IPP objectives.

§483.460(a)(3) The facility must provide or obtain

W322

(Rev. 158, Issued: 09-09-16, Effective: 09-09-16, Implementation: 09-09-16)

§483.460(a)(3) The facility must provide or obtain preventive and general care

Guidance §483.460(a)(3)

The facility has procedures in place to ensure that the clients receive general health care
services to assure optimal levels of wellness. General health care services include assessment
and treatment of acute and chronic complaints or situations; teaching relevant heath care
principles to staff and clients; and periodic surveillance of the health status of the clients.

As a result of clinical assessment, referrals are made for specialized assessment and tests.
Facility health care staff follow-up to ensure the assessments are done and the findings
incorporated into the medical care plan and/or the IPP.

The facility must have arrangements in place to provide routine or episodic laboratory, and
radiology services for the clients if not provided in-house or through the clients physician. There
must be a written agreement that specifies the responsibilities of the facility and outside
provider. (See §483.410(a)).

Preventive health care services include screening procedures designed to identify health
concerns and initiate treatment as early as possible. The facility should have a health
prevention program in place and follow the plan to address those screenings that the facility will
perform periodically that are relevant to all clients, and those screenings associated with a
particular gender or age or vulnerability.

Physician refusal to perform a test, such as a pap smear, must be consistent with guidelines for
clients, per the local standard in the community.

If the facility has a physician that refuses to provide preventative healthcare based on the
client’s level of functioning, medical staff at the facility should meet with and consult with this
physician in order to ensure that clients receive the same health services as persons living in the
local community.

Current recommended screenings for men and women can be accessed at the Agency for
Healthcare Research and Quality (AHRQ) and the Centers for Disease Control (CDC).

§483.460(a)(3) as well as annual physical examinations of each client that at a minimum
include the following:

W323

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(a)(3)(i) Evaluation of vision and hearing;

Guidance §483.460(a)(3)(i)

Information relevant to the client’s ability to see and hear is a critical component in the
development of appropriate active treatment strategies.

All clients, including clients who are non-verbal, should have evidence in his/her record that
they receive an annual evaluation of their vision and hearing which includes a screening as a
minimum, follow-up examination as indicated by the screen and timely referrals as indicated by
the examination. Screening is a gross assessment of the client’s vision and hearing and usually
does not include a measurement of acuity. Examinations are conducted to follow-up on issues
noted in the screening and are conducted by qualified professionals.

Clients who appear to have vision or hearing problems or the staff indicate that they have vision
or hearing problems and no accommodations have been made. The annual vision and hearing
evaluation verifies that clients appearing to have vision/hearing issues or if staff indicate that a
client has vision/hearing issues that these issues have been/are being addressed.

If a client’s vision or hearing can only be assessed through examinations conducted by specialists

(e.g., comprehensive ophthalmological examinations and evoked response audiometry (ERA)),
these tests need not be conducted yearly, but rather upon the specialist’s expressed
recommendations. During discussions at the annual IPP review the team reviews information
from the health professional, speech and hearing professional, and direct support staff and
makes referrals back to the specialist if indicated.

W324

(Rev. 158, Issued: 09-09-16, Effective: 09-09-16, Implementation: 09-09-16)

§483.460(a)(3)(ii) Immunizations, using as a guide the recommendations of the Public Health
Service Advisory Committee on Immunization Practices of the Committee on the Control of
Infectious Diseases of the American Academy of Pediatrics;

Guidance §483.460(a)(3)(ii)

These immunization guides may be obtained from the American Academy of Pediatrics and/or
the Centers for Disease Control (CDC).

W325

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(a)(3)(iii) Routine screening laboratory examinations as determined necessary by the
physician,

Guidance §483.460(a)(3)(iii)

The facility may have a set of routine laboratory tests which are to be done on every client
annually which is developed and approved by the facility physician. However, such a list is not
required. The physician may write orders individually for the clients based upon their medical
history, age, gender or medical vulnerabilities.

W326

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(a)(3)(iii) and special studies when needed;

W327

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(a)(3)(iv) Tuberculosis control, appropriate to the facility’s population, and in
accordance with the recommendations of the American College of Chest Physicians or the
section on diseases of the chest of the American Academy of Pediatrics, or both.

Guidance §483.460(a)(3)(iv)

The facility should have in place a system for the identification, reporting, investigation, and
control of Tuberculosis (TB) in order to prevent its transmission within the facility. This system
should include:

1) Policies and procedures for screening new employees, new clients, and other people
who interact on a consistent basis with clients residing in the facility when those
persons are volunteers or professional staff hired or utilized directly by the facility
(such as volunteers and contract professional staff);

2) Policies and procedures for subsequent screening for clients and for employees, and
other people (such as volunteers and contract professional staff) who interact on a
consistent basis with clients residing in the facility when those persons are volunteers
or professional staff hired or utilized directly by the facility per State Health
Department requirements;

3) Policies and procedures for reporting positive TB test results to the appropriate State
authorities;

4) Policies for the investigative procedures, per the local health department, that would
be put in place should a client or staff person test positive for TB;

5) Policies and procedures for treatment and precautions to be used with clients who
display TB symptoms, as substantiated by positive skin testing or x-ray results; and

6) Policies and procedures for the evaluation of the effectiveness of the surveillance
system.

When one or more clients or staff display TB symptoms, as substantiated by positive skin testing
or x-ray results, they do not return to work until a physician has cleared them to return to work.

W328

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(a)(4) To the extent permitted by State law, the facility may utilize physician
assistants and nurse practitioners to provide physician services as described in this section.

Guidance §483.460(a)(4)

Refer to the applicable State Nurse Practice Act or applicable Board of Medicine Practice Act to
determine the extent that the nurse practitioner or physician assistant may provide physician
services.

(b) Standard: Physician participation in the individual program plan

§483.460(b) A physician must participate in-

W329

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(b)(1) The establishment of each newly admitted client’s initial individual program
plan as required by §456.380 of this chapter that specifies plan of care requirements for ICFs;
and

Guidance §483.460(b)(1)

During the admission process, which takes place from the time the client is admitted to the
facility to the time the initial IPP is completed, a physician is required to ensure that an
assessment of the client’s medical status is thoroughly considered and incorporated into the IPP
planning process by the team as it develops the IPP. The physician’s input may be by means of
written reports, evaluations, and recommendations.

The physician (consistent with Medicaid Utilization Control regulations at §456.380) must
evaluate the client at the time of admission to identify all diagnoses and complaints, provide
orders for all medications and treatments and provide recommendations for restorative and
rehabilitative services.

§456.380 requires that a physician conduct this initial assessment therefore, it may not be done
by a physician extender (e.g., Physician assistant or Advanced Practice Registered Nurse).

W330

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(b)(2) If appropriate, physicians must participate in the review and update of an
individual program plan as part of the interdisciplinary team process either in person or
through written report to the interdisciplinary team.

Guidance §483.460(b)(2)

The need for physician participation on an individual client’s IPP team is determined by the
medical needs of the client. How the physician participates (whether through written report,
telephone consultation, attendance at the meeting, etc.) is to be left to the discretion of the
facility. In instances where a client has no overriding medical issues, the nurse of the facility can
represent the medical component on the IDT process or consult with the appropriate physician
and share the information with the team. However, in situations where a client’s medical
condition is unstable/fragile to the extent that it impacts the training/work that may be planned,
the physician must participate in providing guidance on the types and extent of programs that
would be appropriate considering the client’s physical/medical limitations.

If a client is noted to be having difficulty participating in the objectives set forth in his/her IPP
due to serious medical concerns, review the input that was provided by the physician into the
development of the plan and whether the IPP team requested such input.

W331

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(c) The facility must provide clients with nursing services in accordance with their
needs.

Guidance §483.460(c)

The nurse responds in a timely manner to all medical concerns reported, conducts assessments
as indicated, effects timely and appropriate interventions, communicates with the client’s
physicians and other health care professionals as indicated, provides treatments as ordered,
monitors client progress following illness or injury and provides training to clients and/or staff as
indicated.

§483.460(c) These services must include

W332

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(c)(1) Participation as appropriate in the development, review, and update of an
individual program plan as part of the interdisciplinary team process;

Guidance §483.460(c)(1)

For those clients who have had an uneventful year medically and have no medical/health
concerns at the time of the IPP meeting the facility nurse may submit a summary report to the
IDT unless the IDT determines that his/her attendance is necessary. An eventful year medically
would include a year which required unplanned hospital admissions or in which medical issues
necessitated treatment for a prolonged or continuing period. However when a client has had an
eventful year medically or current medical/health concerns, this could have an impact on their
objectives and accordingly the nurse should participate in the IDT discussion directly.

W333

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(c)(2) The development, with a physician, of a medical care plan of treatment for a
client when the physician has determined that an individual client requires such a plan;

Guidance §483.460(c)(2)

A medical care plan addresses those clinical treatments and observations that are to be done for
the client by the medical staff and other staff of the facility in order to either improve an acute
medical condition or to maintain a medically fragile client as clinically stable as possible. The
medical care plan is an adjunct to the IPP and is not considered a substitution for the IPP.

§483.460(c)(3) For those clients certified as not needing a medical care plan, a review of their
health status which must-

W334

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(c)(3)(i) Be by a direct physical examination;

Guidance §483.460(c)(3)(i)

A direct physical examination means a visual review of the body as well as
examination/assessment of body systems. This includes observations made through non-verbal

communication (including visual, tactile, nonverbal gestures, grimaces, etc.) which may be an
indication that there is a potential for further assessment and/or monitoring. A paper review of
the client’s medical record and health statistics does not meet the intent of the regulation for a
direct physical examination.

W335

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(c)(3)(ii) Be by a licensed nurse;

Guidance §483.460(c)(3)(ii)

The term “licensed nurse”, for purposes of these guidelines, means a registered nurse, a
licensed practical nurse or a licensed vocational nurse currently licensed by the State in which
the facility is located. The nurse must operate consistent with the requirements of the
applicable Nurse Practice Act. If this direct physical examination is done by a physician, it is not
necessary for the nurse to repeat the exam.

W336

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(c)(3)(iii) Be on a quarterly or more frequent basis depending on client need;

Guidance §483.460(c)(3)(iii)

“On a quarterly basis” means that the examinations are conducted approximately 90 days apart
(e.g. scheduled to be conducted approximately once every 90 days). If during the course of a
calendar year, there were three quarterly examinations conducted by a licensed nurse and in
the fourth quarter the annual physical examination was performed by a physician, the intent of
this requirement is met without the nurse performing an additional examination.

W337

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(c)(3)(iv) Be recorded in the client’s record; and

Guidance §483.460(c)(3)(iv)

The actual findings of each examination and the date conducted must be incorporated into the
client’s record.

W338

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(c)(3)(v) Result in any necessary action (including referral to a physician to address
client health problems).

Guidance §483.460(c)(3)(v)

The nursing staff document that referrals are made in a timely manner, if indicated, for any
concerns identified. Nurses must ensure all concerns they identify are communicated and
addressed appropriately, including:

• Need is fully identified in assessment;

• Appropriate referrals are made;

• Revisions are made to IPP/Medical care plan; and

• Follow-up occurs to the new plan.

W339

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(c)(4) Other nursing care as prescribed by the physician or as identified by client
needs; and

Guidance §483.460(c)(4)

Nursing interventions are implemented as indicated by the needs of the client and consistent
with either standard nursing practice principles or orders from the attending physician. Health
and wellness are actively promoted, problems are attended to before they negatively impact
the client’s health and wellness, and steps are taken to prevent the recurrence of such problems
while responding promptly to client’s needs.

Client health care complaints that are reported either directly by the client or by the direct care
staff are addressed promptly by the nursing staff. Client health care complaints and response by
nursing staff are documented in the client’s record.

§483.460(c)(5) Implementing with other members of the interdisciplinary team, appropriate
protective and preventive health measures that include, but are not limited to- –

W340

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(c)(5)(i) Training clients and staff as needed in appropriate health and hygiene
methods;

Guidance §483.460(c)(5)(i)

Nursing staff periodically provides training to clients and staff on how to care for health needs or
conditions, personal hygiene, health maintenance, and disease prevention. Nursing staff
actively participates in periodic discussions with client and staff to promote health habits in the
areas of diet, exercise and non-smoking.

Based upon individual training needs, the nursing staff provides training to individuals in areas
such as medications, family planning, prevention of sexually transmitted diseases, control of
other infectious diseases, self-monitoring of health status and self-prevention of health

problems, etc. The nurses may train clients directly on their objectives or train other staff to do
this training as appropriate.

W341

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(c)(5)(ii) Control of communicable diseases and infections, including the instruction
of other personnel in methods of infection control; and

Guidance §483.460(c)(5)(ii)

Nursing staff should actively participate in surveillance and reporting of communicable diseases
per the Centers for Disease Control (CDC) guidelines and applicable state laws. They should
teach and promote infection control techniques such as hand washing by clients and staff and
should be making periodic observations to ensure that such good infection control techniques
are consistently utilized.

W342

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(c)(5)(iii) Training direct care staff in detecting signs and symptoms of illness or
dysfunction, first aid for accidents or illness, and basic skills required to meet the health needs
of the clients.

Guidance §483.460(c)(5)(iii)

Nursing staff must train and ensure direct support staff demonstrate competency in detecting
signs and symptoms of illness, injury, or change in the client’s health baseline (e.g.
responsiveness, fatigue, irritability, constipation, diarrhea, dehydration, confusion, unexplained
weight loss, changes in endurance and changes in respiratory function).

Staff is responsive to health care needs or injuries of clients and receives instruction and support
during temporary illness of clients.

If not, review staff training records to determine whether training was provided periodically to
the involved employee. Interview direct care staff to determine their level of understanding
regarding the signs and symptoms of illness that are to be reported to the medical staff. The
records of clients with recent hospitalizations verify that staff detected and reported relevant
symptoms promptly.

(d) Standard: Nursing staff

W343

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(d)(1) Nurses providing services in the facility must have a current license to practice
in the State.

Guidance §483.460(d)(1)

The facility should have a procedure in place to ensure that any contract nursing staff members
are currently licensed prior to the provision of services. Include any contract nurses used by the
facility in the sample of nurses reviewed for licensure.

W344

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(d)(2) The facility must employ or arrange for licensed nursing services sufficient to
care for clients’ health needs including those clients with medical care plans.

Guidance §483.460(d)(2)

The facility provides for nursing services based on the health needs and conditions of clients
residing there. Examples include:

1) physician ordered treatments that require the skills of a licensed nurse;

2) preventive screenings ;

3) assessment and intervention;

4) direct physical examination and examination of body systems;

5) teaching; and

6) advocacy for the medical services needed by the client.

Client health care needs are met in a timely manner (within 24 hours) by the available nursing
staff.

If nurses who do not have experience in the care of persons with intellectual disabilities are
employed by the facility, they should be provided with a formal orientation period and on-going
educational opportunities to increase their understanding of the client population.

When one or more clients in the facility has an active medical care plan, there must be 24 hour
nursing services available to come to the facility as needed to make skilled assessments and
interventions.

W345

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(d)(3) The facility must utilize registered nurses as appropriate and required by State
law to perform the health services specified in this section.

Guidance §483.460(d)(3)

Refer to the applicable State Nurse Practice Act.

W346

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(d)(4) If the facility utilizes only licensed practical or vocational nurses to provide
health services, it must have a formal arrangement with a registered nurse to be available for
verbal or onsite consultation to the licensed practical or vocational nurse.

Guidance §483.460(d)(4)

The facility must have written arrangements with a registered nurse (RN) to provide
consultation in those instances where LPNs/LVNs provide all the direct nursing care for the
clients. Verify that the agreement requires the RN to respond promptly to all calls from the
LPN/LVN and to come on-site to the facility if necessary. The facility must also ensure registered
nurse back-up when the primary registered nurse consultant is unavailable (vacations, etc.).
Review documentation in the client records to confirm that the LPNs/LVNs of the facility are
consulting the registered nurse consultant when indicated and that she/he responds promptly
to such calls.

W347

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(d)(5) Non- licensed nursing personnel who work with clients under a medical care
plan must do so under the supervision of licensed persons.

The work of any direct support staff (caring for clients with a medical care plan) is directed by an
onsite licensed nurse). The nurse evaluates the care provided by the staff as needed, but at
least each shift. If observations of care indicate that direct care staff are not providing care as
directed by the medical care plan, then review the supervision provided by the nursing staff.

(e) Standard: Dental services

W348

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(e)(1) The facility must provide or make arrangements for comprehensive diagnostic
and treatment services for each client from qualified personnel, including licensed dentists
and dental hygienists either through organized dental services in-house or through
arrangement.

Guidance §483.460(e)(1)

It is expected that the clients will obtain dental services (both diagnostic and treatment) from
community dentists whenever possible. In some instances, there may be clients residing in the
facility who are physically unable to travel to the community for services. The facility must
secure dental services (both diagnostic and treatment) for these clients either through an in-
house program, which is part of the organizational and administrative structure of the facility, or
through a written agreement with an outside dental service to come into the facility to provide
such services.

W349

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(e)(2) If appropriate, dental professionals must participate, in the development,
review and update of an individual program plan as part of the interdisciplinary process either
in person or through written report to the interdisciplinary team.

Guidance §483.460(e)(2)

Reports of dental care may be submitted to the IDT for inclusion in their discussions surrounding
either development of the plan or update to the plan. This includes procedures a client may
have had or be having during the plan development period, such as root canal or singular
extractions. Actual attendance at the IDT meeting by the dentist may be left to the request of
the IDT.

W350

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(e)(3) The facility must provide education and training in the maintenance of oral
health.

Guidance §483.460(e)(3)

Formal or informal training in the maintenance of oral hygiene is provided to clients who require
it, and to those staff who are responsible for carrying out such activities. The IPP should include
an assessment of the client’s ability to perform oral hygiene independently and an associated
program if the client is not independent.

(f) Standard: Comprehensive dental diagnostic services

§483.460(f) Comprehensive dental diagnostic services include

W351

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(f)(1) A complete extraoral and intraoral examination, using all diagnostic aids
necessary to properly evaluate the client’s condition not later than one month after admission
to the facility (unless the examination was completed within twelve months before
admission);

Guidance §483.460(f)(1)

A “month” is defined as the interval between the date of admission and close of business of the
corresponding day in the following month.

A complete intraoral examination includes an oral cancer screen.

§483.460(f)(2) Periodic examination and diagnosis performed

W352

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(f)(2) at least annually,

Guidance §483.460(f)(2)

Dental examinations occur no less frequently than annually. Clients without teeth must receive
an annual oral cancer screening examination by a dental professional.

W353

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(f)(2) including radiographs when indicated and detection of manifestations of
systemic disease; and

Guidance §483.460(f)(2)

There should be evidence in dental reports that dentists follow current standards of practice for
the performance of x-rays in order to assist in the diagnosis and treatment of the client.

W354

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(f)(3) A review of the results of examination and entry of the results in the client’s
dental record.

Guidance §483.460(f)(3)

The entry referenced at this regulation is the dental entry into the dental record. See W359 for
requirement of copying this dental record into the facility record.

(g) Standard: Comprehensive dental treatment

§483.460(g) The facility must ensure comprehensive dental treatment services that include- –

W355

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(g)(1) The availability for emergency dental treatment on a 24-hour-a-day basis by a
licensed dentist; and

Guidance §483.460(g)(1)

The facility should be able to produce upon request, a written contract/agreement between the
facility and a licensed dentist for 24/7 guidance/provision of emergency services for the clients.
The agreement should also indicate what back-up coverage will be provided when the dentist is
not available.

W356

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(g)(2) Dental care needed for relief of pain and infections, restoration of teeth, and
maintenance of dental health.

(h) Standard: Documentation of dental services

§483.460(h)(1) If the facility maintains an in-house dental service, the facility must

W357

keep a permanent dental record for each client,

W358

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(h)(1) with a dental summary maintained in the client’s living-unit.

Guidance §483.460(h)(1)

The “dental summary” refers to the summary of each visit entered by the dental professional.
The note includes any care instructions to be followed up by facility staff as a result of
treatment.

§483.460(h)(2) If the facility does not maintain an in-house dental service, the facility must

W359

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(h)(2) obtain a dental summary of the results of dental visits

Guidance §483.460(h)(2)

The facility should receive a written report of each dentist visit for inclusion in the client’s record
at the facility and for reference by the medical and direct support staff.

W360

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(h)(2) and maintain the summary in the client’s living unit.

See guideline above at W359.

(i) Standard: Pharmacy services

W361

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(i) The facility must provide or make arrangements for the provision of routine and
emergency drugs and biologicals to its clients. Drugs and biologicals may be obtained from
community or contract pharmacists or the facility may maintain a licensed pharmacy.

Guidance §483.460(i)

The facility either has an onsite pharmacy or has formal arrangements in place for the provision
of routine, unanticipated, or emergency drugs. There are no instances where a client does not
receive needed medications due to the unavailability of drugs.

(j) Standard: Drug regimen review

W362

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(j)(1) A pharmacist with input from the interdisciplinary team must review the drug
regimen of each client at least quarterly.

Guidance §483.460(j)(1)

The primary function of the pharmacist during the quarterly drug review is to identify possible

drug interactions, check for evidence of any side effects associated with the drug usage,
determine if laboratory results associated with the drug are within normal limits and verify that
the facility is administering the medication appropriately and to comment upon the efficacy of
the drug use (e.g. blood sugar controlled, blood pressure within normal limits). In the case of
drugs used to manage behavior, the pharmacist may need information from the IDT to
determine efficacy. See Appendix PP, Indicators for Surveyor Assessment of the Performance of
Drug Regimen Reviews, to the State Operations Manual (Pharmaceutical Service Requirements
in Long Term Care Facilities).

W363

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(j)(2) The pharmacist must report any irregularities in clients’ drug regimens to the
prescribing physician and interdisciplinary team.

Guidance §483.460(j)(2)

The physician and IDT members must discuss, document and take necessary follow-up action for
any irregularities noted.

W364

§483.460(j)(3) The pharmacist must prepare a record of each client’s drug regimen reviews
and the facility must maintain that record.

W365

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(j)(4) An individual medication administration record must be maintained for each
client.

W366

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(j)(5) As appropriate the pharmacist must participate in the development,
implementation, and review of each client’s individual program plan either in person or
through written report to the interdisciplinary team.

Guidance §483.460(j)(5)

Pharmacist participation on the IDT is at the request of the team. It would not be necessary for
the pharmacist to routinely attend all team meetings when the client is on a stable drug regimen
that does not appear to be influencing his/her active treatment programs. Pharmacist
participation may be appropriate, in situations such as assisting the IDT develop the most
effective training programs for when the client is in an evolving situation with their medication.

For example:

• A client begins a new or more complex drug regimen;

• The physician orders off-label use of a medication;

• Frequent changes in the drug regimen are affecting IPP implementation.

(k) Standard: Drug administration

W367

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(k) The facility must have an organized system for drug administration that identifies
each drug up to the point of administration.

§483.460(k) The system must assure that

W368

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(k)(1) All drugs are administered in compliance with the physician’s orders;

Guidance §483.460(k)(1)

Administration errors identified in previous medication administration records qualify as non-
compliance with physician’s orders.

W369

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(k)(2) All drugs, including those that are self-administered, are administered without
error;

Guidance §483.460(k)(2)

A medication error is an observed discrepancy during the medication pass between what is
ordered and what is administered.

This also applies to self-administered medications.

For small facilities (16 beds or less), the medication administration pass will encompass a total of
eight (8) drug doses. The observations should be split between two separate drug passes 4/4
(one in the morning and one in the late afternoon or early evening). The medications observed
during the observations may or may not be for clients in the survey sample. Any concerns
regarding a medication that is about to be administered should be brought to the attention of
the person administering the medication. The record of observation should be reconciled with
the most current signed physician’s orders.

For large facilities (17 or more beds) with either single or multiple buildings, the medication
administration pass will encompass a total of 12 doses. The observations should be split

between two separate passes 6/6 (one in the morning and one in late afternoon or early
evening). Any concerns regarding a medication that is about to be administered should be
brought to the attention of the person administering the medication. The record of
observation should be reconciled with the most current signed physician’s orders.

W370

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(k)(3) Unlicensed personnel are allowed to administer drugs only if State law
permits;

Guidance §483.460(k)(3)

Unlicensed personnel administer only those forms of medication which state law permits.
Licensed nurse(s) in the facility oversee any administration of medications by unlicensed
persons and periodically evaluate their performance.

W371

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(k)(4) Clients are taught to administer their own medications if the interdisciplinary
team determines that self-administration of medications is an appropriate objective, and if
the physician does not specify otherwise;

Guidance §483.460(k)(4)

The IDT decision that a self-administration program is appropriate, as is the case for all formal
training objectives, must be based upon accurate, current, valid assessment of the client’s skills
and potential. The determination as to the appropriateness of a self-administration program
must never be made singularly on the client’s diagnosis or current functional abilities.

For clients assessed to be inappropriate for a self-administration program, but determined by
the IDT to possess the capacity to functionally, cognitively, emotionally or developmentally
benefit from participation in the drug administration process, it is expected that the facility will

provide opportunities for the client to participate in the medication administration process
under direct supervision. This participation can include but is not limited to, identifying the
medication taken, reaching/grasping a cup of water during the process and placing oral
medications in the mouth, etc.

W372

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(k)(5) The client’s physician is informed of the interdisciplinary team’s decision that
self-administration of medications is an objective for the client;

Guidance §483.460(k)(5)

While the IDT may set an objective of self administration of medication for a client, they are
required to notify the client’s physician of this proposed objective. If the client’s physician
objects on medical grounds, the team must not proceed with the objective until such time as a
discussion is held with the physician and he/she agrees to proceed after receiving additional
information.

W373

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(k)(6) No client self-administers medication until he or she demonstrates the
competency to do so;

Guidance §483.460(k)(6)

The written self-administration program for a client must detail the criteria that will be
employed by the facility staff to verify that the client successfully completes all phases of the
program and continues to comply with all necessary requirements for self administration.
Clients who self-administer medications must secure all medications in such a manner as to
protect access by other clients or visitors.

W374

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(k)(7) Drugs used by clients while not under the direct care of the facility are
packaged and labeled in accordance with State law;

Guidance §483.460(k)(7)

When clients go out of the facility for home visits, or to attend work or school, drugs they are
taking must be packaged and labeled in accordance with state law by a person authorized by
state law to package and label.

§483.460(k)(8) Drug administration errors and adverse drug reactions are

Guidance §483.460(k)(8)

Documentation of any medication error should be entered into the client’s record and should
include what error was made, who was notified of the error, the response of the medical person
notified, the physical condition of the client at the time of the notification and subsequent
observations of the clients physical condition related to the error.

W375

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(k)(8) recorded

Guidance §483.460(k)(8)

Documentation of adverse drug reactions must be entered into the client’s record and should
include all complaints made by the client or observations made by the staff following the drug
administration, the notification of medical personnel, and the response of the medical
personnel, any emergency actions that were required and all subsequent observations of the
client’s condition related to the reaction.

W376

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(k)(8) and reported immediately to a physician.

Guidance §483.460(k)(8)

“Immediately” means at the time the error or reaction is identified.

(l) Standard: Drug storage and recordkeeping

§483.460(l)(1) The facility must store drugs under proper conditions of

Guidance §483.460(l)(1)

Drugs are stored according to manufacturer’s recommendations.

W377

sanitation,

W378

temperature,

W379

light,

W380

humidity,

W381

and security.

W382

§483.460(l)(2) The facility must keep all drugs and biologicals locked except when being
prepared for administration.

W383

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(l)(2) Only authorized persons may have access to the keys to the drug storage area.

Guidance §483.460(l)(2)

“Authorized persons” is restricted to those who administer the drugs (as allowed by state law)
and nursing supervisors (if any). No other personnel should have access to these keys.

W384

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(l)(2) Clients who have been trained to self-administer drugs in accordance with
§483.460(k)(4) may have access to keys to their individual drug supply.

Guidance §483.460(l)(2)

Drugs that are self-administered do not have to be double locked. The purpose for the double
locking is to limit access to scheduled drugs. Since the client is generally the only one who has
access to his/her drug supply (with perhaps the exception of a licensed nurse or whoever has
overall responsibility for medication administration at the facility and a facility’s Director of
Nursing Services, who may have access to all of the facility’s drug supplies), there is no need to
further limit access.

W385

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(l)(3) The facility must maintain records of the receipt and disposition of all
controlled drugs.

Guidance §483.460(l)(3)

The facility must follow state requirements for the control and disposition of controlled drugs.

W386

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(l)(4) The facility must, on a sample basis, periodically reconcile the receipt and
disposition of all controlled drugs in schedules II through IV (drugs subject to the
Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. 801 et seq., as
implemented by 21 CFR Part 308).

Guidance §483.460(l)(4)

The facility should follow state requirements for the reconciliation of controlled drugs.

W387

§483.460(l)(5) If the facility maintains a licensed pharmacy, the facility must comply with the
regulations for controlled drugs

§483.460(m) Standard: Drug Labeling

§483.460(m)(1) Labeling of drugs and biologicals must

W388

§483.460(m)(1)(i) Be based on currently accepted professional principles and practices; and

W389

§483.460(m)(1)(ii) Include the appropriate accessory and cautionary instructions, as well as
the expiration date, if applicable.

§483.460(m)(2) The facility must remove from use–

W390

§483.460(m)(2)(i) Outdated drugs; and

W391

§483.460(m)(2)(ii) Drug containers with worn, illegible, or missing labels.

W392

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(m)(3) Drugs and biologicals packaged in containers designated for a particular client
must be immediately removed from the client’s current medication supply if discontinued by
the physician.

(n) Standard: Laboratory services

W393

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.460(n)(1) If a facility chooses to provide laboratory services, the laboratory must meet
the requirements specified in part 493 of this chapter.

Guidance §483.460(n)(1)

If the facility performs laboratory services, it must have a current, valid Clinical Laboratory
Improvement Amendment (CLIA) certificate for the types of tests it is performing.

For the purposes of this regulation, a “laboratory service or test” is defined as any examination
or analysis of materials derived from the human body for purposes of providing information for
the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of
the health of human beings.

W394

(Rev. 158, Issued: 09-09-16, Effective: 09-09-16, Implementation: 09-09-16)

§483.460(n)(2) If the laboratory chooses to refer specimens for testing to another laboratory,

the referral laboratory must be certified in the appropriate specialties and subspecialties of
service in accordance with the requirements of part 493 of this chapter.

Guidance §483.460(n)(2)

A facility performing any laboratory service or test must have applied to CMS, and received a
Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. An application
for a Certificate of Waiver may be made if the facility performs only those tests on the waived
list. A complete list of waived tests can be accessed at the Food and Drug Administration (FDA).

If the facility performs any test, not appearing on the waived list, a Certificate of Compliance or
Certificate of Accreditation is required. An appropriate CLIA certificate is required regardless of
the frequency with which the laboratory services or tests are conducted. When no tests are
performed, a CLIA certificate is not needed. Facilities only collecting specimens and not
performing testing do not need a certificate.

A not-for-profit, a state, or local government organization may have one certificate covering all
the facilities it operates (e.g., all the separately certified residences which fall under its governing
body), if no more than a total of 15 types of waived or moderately complex laboratory tests are
used. This exception applies only to laboratories performing limited public health testing. See
State Operations Manual (SOM) 6008. Each location where a laboratory tests are performed
must file a separate application to be separately certified unless the laboratory meets one if the
exceptions outlined at 42CFR493.35(b), 493.443(b), or 493.55(b).

Any laboratory located in a state that has a CMS-approved laboratory program is exempt from
CLIA certification. Currently there are two states with approved programs: Washington and New
York. New York has a partial exemption; therefore, if the laboratory is located in New York,
contact the New York State Agency to determine if the exemption applies.

W406

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.470 Condition of participation: Physical environment.

(a) Standard: Client living environment.

W407

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(1) The facility must not house clients of grossly different ages, developmental levels, and
social needs in close physical or social proximity unless the housing is planned to promote the
growth and development of all those housed together.

Guidance §§483.470(a)(1)

Clients of grossly different ages, functional levels, and/or social needs should not be housed
together unless all of the following documentation supports the placement:

• Assessment;

• Client program plan;

• Staff documentation of client response to training programs; and

• QIDP notes.

W408

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(2) The facility must not segregate clients solely on the basis of their physical disabilities. It
must integrate clients who have ambulation deficits or who are deaf, blind, or have seizure
disorders, etc., with others of comparable social and intellectual development.

(b)Standard: Client bedrooms.

(1) Bedrooms must- –

W409

§483.470(b)(1)(i)Be rooms that have at least one outside wall

W410

§483.470(b)(1)(ii)Be equipped with or located near toilet and bathing facilities;

W411

§483.470(b)(1)(iii) Accommodate no more than four clients unless granted a variance under
paragraph (b)(3) of this section;

§483.470(b)(1)(iv) measure

W412

At least 60 square feet per client in multiple client bedrooms

W413

And at least 80 square feet in single client bedrooms; and

W414

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(v) In all facilities initially certified, or in buildings constructed or with major renovations or
conversions on or after October 3, 1988, have walls that extend from floor to ceiling.

Guidance §483.470(b)(l)(v)

If a facility was initially certified on or after October 3, 1988 and/or is under renovations or
conversions, they must have walls that extend floor to ceiling.

W415

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(2) If a bedroom is below grade level, it must have a window that–

(i) Is usable as a second means of escape by client(s) occupying the room; and

(ii) Is no more than 44 inches (measured to the window sill) above the floor unless the facility
is surveyed under the Health Care Occupancy Chapter of the Life Safety Code, in which case
the window must be no more than 36 inches (measured to the window sill) above the floor.

Guidance §483.470(b)(2)

The intent of the regulation is to prohibit the housing of clients in basements that are entirely
below grade. Clients may be housed on the lower level of housing (e.g. a bi-level house),
provided the window height requirements are met and the window is of sufficient size to be
used as a means of escape.

W416

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(3) The survey agency may grant a variance from the limit of four clients per room only if a
physician who is a member of the interdisciplinary team and who is a qualified intellectual
disabilities professional–

(i) Certifies that each client to be placed in a bedroom housing more than four persons is so
severely medically impaired as to require direct and continuous monitoring during sleeping
hours; and

(ii) Documents the reason why housing in a room of only four or fewer persons would not be
medically feasible.

Guidance §483.470(b)(3)

The medical care plan for each client housed in a room with more than four clients should
indicate the need for continuous monitoring. The medical care plan will include:

• the physician certification that the client is severely medically impaired and requires
direct and continuous monitoring during sleeping hours; and

the reason why this housing arrangement for fewer than four people would not be
medically feasible.

(4) The facility must provide each client with—

W417

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(i) A separate bed of proper size and height for the convenience of the client;

Guidance §483.470(b)(4)(i)

The client’s preference, chronological age, and physical and medical needs are the determining
factors in bed size and height.

W418

§483.470(b)(4)(ii) A clean, comfortable, mattress;

W419

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(iii) Bedding appropriate to the weather and climate; and

W420

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(iv) Functional furniture, appropriate to the client’s needs,

Guidance §483.470(b)(4)(iv)

Client preferences and program needs should be considered in furniture selection. For clients
with physical disabilities, furniture is adapted to accommodate the client’s physical challenges
and enable the client to use the furniture with minimal support.

W421

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

and individual closet space in the client’s bedroom with clothes racks and shelves accessible to
the client.

Guidance §483.470(b)(4)(iv)

Closets should have enough space for a reasonable amount of the current season’s clothing.

Clients who use wheelchairs or have other physical challenges can reach the racks and shelves in
their closets.

The facility is permitted either to provide the client with an individualized closet or with a
designated area in a shared closet. The use of central clothing bins in a facility clothing room, in
the absence of required client closet space in the bedroom, is not an acceptable practice.

The facility must provide—

W422

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(1) Space for equipment for daily out-of-bed activity for all clients who are not yet mobile,
except those who have a short-term illness or those few clients for whom out-of-bed activity
is a threat to health and safety; and

Guidance §483.470(c)(1)

Sufficient space that permits the use of wheelchairs, walkers and other adaptive equipment
should be provided within the bedroom.

W423

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(2) Suitable storage space, accessible to clients, for personal possessions, such as TVs, radios,
prosthetic equipment and clothing.

Guidance §483.470(c)(2)

Each client should have storage in their bedroom for their personal belongings. Clients should
have free access to this storage without the assistance of staff. If it is necessary for clients’
personal belongings to be locked due to the behavior of other clients, the client must still be
provided free access to his own possessions (See W137 for requirements for locked areas).

(d) Standard: Client bathrooms

The facility must—

W424

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(1) Provide toilet and bathing facilities appropriate in number, size, and design to meet the
needs of the clients;

Guidance §483.470(d)(1)

In a home setting, the toilet facilities need to be of sufficient number to meet the needs of the
client without prolonged delay. There must be enough toilets in the living units to meet the
program needs of the clients at any given time, as well as provide for intermediate toileting
needs of the clients living in the unit.

In a home setting, it may be unrealistic to say a client would never have to wait for a shower or
bath or to brush his/her teeth.

Bathrooms and fixtures must be adapted to accommodate clients with physical disabilities.

W425

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(2) Provide for individual privacy in toilets, bathtubs, and showers; and

Guidance §483.470(d)(2)

A bathroom containing multiple toilets, showers or bathtubs, must have doors, curtains, or
some other means of protecting the client from view when fully or partially unclothed.

Clients should not be able to be seen through the door or window by passersby when they are
using the bathrooms.

Client privacy does not preclude the assistance provided by facility staff when necessitated by
the client’s condition.

W426

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(3) In areas of the facility where clients who have not been trained to regulate water
temperature are exposed to hot water, ensure that the temperature of the water does not
exceed 110 Fahrenheit.

(e) Standard: Heating and ventilation.

(1) Each client bedroom in the facility must have–

W427

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(i) At least one window to the outside; and

Guidance §483.470(e)(1)(i)

(See also W415)

W428

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(ii) Direct outside ventilation by means of windows, air conditioning, or mechanical
ventilation.

(2) The facility must—

W429

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(i) Maintain the temperature and humidity within a normal comfort range by heating, air
conditioning or other means; and

Guidance §483.470(e)(2)(i)

A “normal comfort range” in most instances is defined as not going below a temperature of 68
degrees Fahrenheit or exceeding a temperature of 80 degrees Fahrenheit in facilities in most
geographic areas of the country.

In extremely hot or extremely cold weather, precautions are taken by the facility to protect the
clients, particularly those who are medically compromised, from ill effects of the temperature.

W430

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(ii) Ensure that the heating apparatus does not constitute a burn or smoke hazard to clients.

Guidance §483.470(e)(2)(ii)

Refer to Life Safety Code Chapters 32 and 33

Unvented fuel fired heaters are prohibited. NFPA 101 2000 Edition.

32/33.2.5.23

(f) Standard: Floors.

The facility must have—

W431

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(1) Floors that have a resilient, nonabrasive, and slip-resistant surface.

W432

§483.470(f)(2) Nonabrasive carpeting, if the area used by clients is carpeted and serves clients
who lie on the floor or ambulate with parts of their bodies, other than feet, touching the floor;
and

§483.470(f)(3) Exposed floor surfaces and floor coverings that

W433

promote mobility in areas used by clients,

W434

and promote maintenance of sanitary conditions.

§483.470(g) Standard: Space and Equipment

The facility must–

W435

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(1) Provide sufficient space and equipment in dining, living, health services, recreation, and
program areas (including adequately equipped and sound treated areas for hearing and other
evaluations if they are conducted in the facility) to enable staff to provide clients with needed
services, as required by this subpart and as identified in each client’s individual program plan.

Guidance§483.470(g)(1)

Staff and clients must have the space, materials and equipment needed to implement formal
and informal active treatment programs.

There must be sufficient space to accommodate group activities, including groups with clients
who use wheelchairs.

Recreational supplies, equipment, and materials are available and reflect the interests, physical
abilities and chronological age of the clients.

W436

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(2) Furnish, maintain in good repair, and teach clients to use and to make informed choices
about the use of dentures, eyeglasses, hearing and other communications aids, braces, and
other devices identified by the interdisciplinary team as needed by the client.

Guidance §483.470(g)(2)

The term “furnish” means that the facility is responsible for obtaining or purchasing these items
once an assessment has identified the need and is responsible for making any necessary
arrangements for the client to receive them. Clients’ personal funds should not be used for
these items since this is a covered service under the ICF/IID benefit.

The term “maintain in good repair” means that the facility is responsible for ensuring that these
items are kept in good working order, and is responsible for any resulting expense that may be
incurred.

Programs must be in place, when identified by assessment and determined by the ID team, to
teach clients about the use and care for their equipment to the extent of their capabilities.

W437

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(3) Provide adequate clean linen and dirty linen storage areas.

Guidance §483.470(g)(3)

Clean linen must be is separated from dirty linen and stored in a manner which prevents
contamination.

Linen soiled with bodily fluids must be stored separately and in a manner which protects clients
from exposure to possible infectious sources.

A bedroom hamper can be an acceptable dirty linen storage “area” if kept odor free and
consistent with the infection control requirements at §483.470(1).

(h) Standard: Emergency plan and procedures.

W438

(Rev., 175, Issued: 12-22-17, Effective: 12-22-17, Implementation: 12-22-17)

(1) The facility must develop and implement detailed written plans and procedures
to meet all potential emergencies and disasters such as fire, severe weather, and
missing clients.

Guidance §483.470(h)(1)

See State Operations Manual, Appendix Z – Emergency Preparedness for All Provider
and Certified Supplier Types, Interpretive Guidance at §483.475(a)(1).

W439

(Rev., 175, Issued: 12-22-17, Effective: 12-22-17, Implementation: 12-22-17)

(2) The facility must communicate, periodically review, make the plan available, and
provide training to the staff.

Guidance §483.470(h)(2)

See State Operations Manual, Appendix Z – Emergency Preparedness for All Provider
and Certified Supplier Types, Interpretive Guidance §483.475(d).

(i) Standard: Evacuation drills.

(1) The facility must hold evacuation drills

W440

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

at least quarterly for each shift of personnel

Guidance §483.470(i)(1)

Life Safety Code NFPA 101, 2000 Edition (LSC):

Chapter 32/33 code: Clients have to participate in an evacuation drill each shift at least
quarterly.

Chapter 18/19 code: There must be an evacuation drill on each shift at least quarterly. This drill
is designed to train staff on evacuation procedures.

Review facility records to verify that evacuations drills are held each shift at least once in each 3-
month period.

Refer to (S&C 10-26-LSC)

W441

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

and under varied conditions to—

Guidance §483.470(i)(1)

Life Safety Code NFPA 101, 2000 Edition (LSC):

Chapter 32/33: Expects that all clients living in that unit are capable of self-evacuation during an
emergency. This self evacuation should be practiced under varying conditions including various
times of the day or night and in various weather conditions.

Chapter 18/19: Requires drills which simulate emergency situations which familiarize facility
staff with emergency actions they may be required to perform. The general emphasis of these
sections of the code is upon training of the staff and not upon providing practice for the client.
Drills should be practiced under varying conditions including various times of the day or night
and in various weather conditions.

W442

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(i) Ensure that all personnel on all shifts are trained to perform assigned tasks;

Guidance §483.470(i)(1)(i)

For facilities under Chapter 18/19 of the LSC

Staff should be able to verbalize the proper procedures to be followed during emergency drills.
Staff training records should document that all staff have received training on emergency drills
and evacuations.

W443

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(ii) Ensure that all personnel on all shifts are familiar with the use of the facility’s fire
protection features; and

Guidance §483.470(i)(1)(ii)

Staff on all shifts are able to express familiarity with the use of fire extinguisher, alarms, and any
other safety features in the facility.

W444

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(iii) Evaluate the effectiveness of emergency and disaster plans and procedures.

Guidance §483.470(i)(1)(iii)

See also W448. The plan(s) must be revised as needed and must be based upon analysis
completed under W448.

(2) The facility must–

W445

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(i) Actually evacuate clients during at least one drill each year on each shift;

Guidance §483.470(i)(2)(i)

All clients totally evacuate the building at least once per year per shift, regardless of the
occupancy chapter under which the building falls.

All facilities, regardless of their size require actual evacuation. “Actually evacuate”, as used in
this standard, applies to all clients. The drills are conducted not only to rehearse the clients and
staff for a fire emergency (see §483.470(i)(2)(v)), but for other disasters such as hurricanes,
tornadoes, floods, etc. Such disasters would require the entire occupancy to be evacuated, and,
therefore, the actual evacuation must be practiced, as required.

W446

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(ii) Make special provisions for the evacuation of clients with physical disabilities;

Guidance §483.470(i)(2)(ii)

Clients with physical or medical disabilities may require special procedures for evacuation,
taking into account equipment or staff that must be maintained for the client’s care at all times.
The facility’s evacuation plan should:

• identify such clients;

• clearly delineate any special evacuation procedures for those clients.

Staff should be familiar with the facility’s special evacuation procedures when working with
clients who are in need of unique provisions.

W447

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(iii) File a report and evaluation on each evacuation drill;

Guidance §483.470(i)(2)(iii)

There is a written report of each evacuation drill held.

W448

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(iv) Investigate all problems with evacuation drills, including accidents,

Guidance §483.470(i)(2)(iv)

The documentation for each evacuation drill includes an analysis of:

• The timeliness of the evacuation;

• Any difficulties observed during the drill;

• Investigates the cause of the difficulties; and

• Develops a plan to ensure the difficulties will not reoccur.

W449

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

and take corrective action; and

Guidance §483.470(i)(2)(iv)

When a problem is identified during the evacuation drill and the facility develops a plan to
prevent reoccurrence, there is evidence the facility implemented corrective action and follow-
up completed to ensure corrective action was successful.

W450

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(v) During fire drills, clients may be evacuated to a safe area in facilities certified under the
Health Care Occupancies Chapter of the Life Safety Code.

Guidance §483.470(i)(2)(v)

The Life Safety Code NFPA 101, 2000 Edition at 3.3.167 defines safe location as “a location
remote or separated from the effects of a fire so that such effects no longer pose a threat.”

W451

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(3) Facilities must meet the requirements of paragraph (i)(1) and (2) of this section for any
live-in and relief staff they utilize.

Guidance §483.470(i)(3)

In the case of live-in staff, drills must occur quarterly. Typically, live-in staff can be found in
facilities that fall under Chapter 32/33 of the LSC code. Drills should be held at varying times of
the day and night for clients to practice evacuation including morning, afternoon, evening and
the middle of the night.

(j) Standard: Fire protection.

Guidance §483.470(j)

These standards are covered by the Life Safety Code (LSC) survey. The facility must meet the
appropriate chapter of the Life Safety Code, 2000 edition.

When surveying an ICF/IID for compliance with the LSC, it is first necessary to determine
whether the facility will be surveyed under Health Care (HC) or Board and Care (BC) occupancy.

• If clients receive nursing services, or if the provider elects to use Health Care, the facility
should be surveyed as a Health Care Facility under Chapter 18 or 19 of the LSC, as
appropriate.

• If clients receive personal care and protective oversight but not continuing nursing
services, the facility is to be surveyed under Board and Care and the following three
steps should be followed:

1) Determine the size (16 or less = small; 17 or more = large);

2) Determine the Evacuation Difficulty (PROMPT, SLOW, or IMPRACTICAL) using
Appendix F of the fire safety evaluation system for board and care facilities
(FSES/BC); and

3) Survey the building using one of two methods:

a. The prescriptive requirements of Chapters 32 or 33; or

b. The FSES/BC, Appendix G.

(1) General. Except as otherwise provided in this section—

(i) The facility must meet the applicable provisions of either the Health Care Occupancies
Chapters or the Residential Board and Care Occupancies Chapter of the 2000 edition of the
Life Safety Code of the National Fire Protection Association. The Director of the Office of the
Federal Register has approved the NFPA 101®2000 edition of the Life Safety Code, issued
January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. A copy of the Code is available for inspection at the CMS Information Resource
Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records
Administration (NARA). For information on the availability of this material at NARA, call 202–
741–6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park,
Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference,
CMS will publish notice in the Federal Register to announce the changes.

(ii) Chapter 19.3.6.3.2, exception number 2 of the adopted LSC does not apply to a facility.

Guidance §483.470(j)(1)(ii)

Roller latches are prohibited on corridor doors as a latching device.

(2) The State survey agency may apply a single chapter of the LSC to the entire facility or may
apply different chapters to different buildings or parts of buildings as permitted by the LSC.

http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html

(3) A facility that meets the LSC definition of a residential board and care occupancy must
have its evacuation capability evaluated in accordance with the Evacuation Difficulty Index of
the Fire Safety Evaluation System for Board and Care facilities (FSES/BC).

Guidance §483.470(j)(3)

The evacuation capability of residents is determined using Chapter 6 of NFPA 101A, 2001
edition.

4) If CMS finds that the State has a fire and safety code imposed by State law that adequately
protects a facility’s clients, CMS may allow the State survey agency to apply the State’s fire
and safety code instead of the LSC.

5) Beginning March 13, 2006, a facility must be in compliance with Chapter 19.2.9, Emergency
Lighting.

Guidance §483.470(j)(5)

Battery powered emergency lighting must last at least 90 minutes.

6) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 does not apply to a
facility.

Guidance §483.470(j)(6)

Roller latches are prohibited on corridor doors as a latching device.

(7) Facilities that meet the LSC definition of a health care occupancy.

(i) After consideration of State survey agency recommendations, CMS may waive, for
appropriate periods, specific provisions of the Life Safety Code if the following requirements
are met:

Guidance §483.470(j)(7)(i)

Waivers may be granted only to facilities that meet the Life Safety Code definition of a Health
Care Occupancy. Waivers are not granted to facilities that met the requirements of a
Residential Board and Care Occupancy.

Waivers are recommended by the State Survey Agency and approved by the Regional Office.

(A) The waiver would not adversely affect the health and safety of the clients.

B) Rigid application of specific provisions would result in an unreasonable hardship for the
facility.

ii) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary,
a facility may install alcohol-based hand rub dispensers if—

(A) Use of alcohol-based hand rub dispensers does not conflict with any State or local codes
that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in
health care facilities;

(B) The dispensers are installed in a manner that minimizes leaks and spills that could lead to
falls;

D) The dispensers are installed in accordance with chapter 18.3.2.7 or chapter 19.3.2.7 of the
2000 edition of the Life Safety Code, as amended by NFPA Temporary Interim Amendment 00–
1(101), issued by the Standards Council of the National Fire Protection Association on April 15,
2004. The Director of the Office of the Federal Register has approved NFPA Temporary
Interim Amendment 00–1(101) for incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. A copy of the amendment is available for inspection at the CMS
Information Resource Center, 7500 Security Boulevard, Baltimore, MD and at the Office of the

Federal Register, 800 North Capitol Street NW., Suite 700, Washington, DC. Copies may be
obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA
02269; and

(E) The dispensers are maintained in accordance with dispenser manufacturer guidelines

(k) Standard: Paint.

The facility must—

W452

§483.470(k)(1) Use lead-free paint inside the facility; and

W453

§483.470(k)(2) Remove or cover interior paint or plaster containing lead so that it is not
accessible to clients.

§483.470(l) Standard: Infection Control

W454

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(1) The facility must provide a sanitary environment to avoid sources and transmission of
infections.

Guidance §483.470(l)(1)

The facility is clean and staff have eliminated opportunities for cross-contamination of
infections. Food is stored, prepared, distributed, and served in a sanitary manner to prevent
food borne illness.

W455

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

There must be an active program for the prevention, control, and investigation of infection
and communicable diseases.

Guidance §483.470(l)(1)

Facilities maintain an ongoing surveillance program of communicable disease control and
investigation of infections and an active training program that ensures the clients served receive
adequate prevention of transmission information and skills, according to needs.

The facility’s infection control program should include procedures for:

• identification of the extent of infestation or infection;

• protection of clients;

• treatment of clients;

• notification of family or legal guardian;

• reporting to the health department as indicated; and

• continued follow-up to resolution.

Both the Occupational Safety and Health Administration (OSHA) and the CDC have specific
requirements regarding human immuno-deficiency virus (HIV), TB, and hepatitis precautions.
These requirements should be incorporated into the facility’s practices when relevant to the
clients residing in the facility. Concerns about OSHA violations should be referred to OSHA.

W456

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(2) The facility must implement successful corrective action in affected problem areas.

W457

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(3) The facility must maintain a record of incidents and corrective actions related to infections.

W458

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

(4) The facility must prohibit employees with symptoms or signs of a communicable disease
from direct contact with clients and their food.

Guidance §483.470(l)(4)

The facility should have and implement a policy that clearly delineates those signs and
symptoms for which they will restrict staff access to clients or to clients’ food.

W459

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480 Condition of participation: Dietetic services

(a) Standard: Food and nutrition services

W460

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(a)(1) Each client must receive a nourishing, well balanced, diet including modified
and specially prescribed diets.

Guidance §483.480(a)(1)

“Well balanced diets” are defined as diets that contain a variety of foods from the food groups
currently recommended by the Academy of Nutrition and Dietetics (AND).

“Modified and specially-prescribed” diets are defined as diets that are altered in any way to
enable the client to eat (e.g. food that is chopped, pureed) or diets that are intended to correct
or prevent a nutritional deficiency or health problem.

Refer to W463 and W474 regarding modified and specially prescribed diets.

The following may be indicators of or may lead to compromised nutritional status:

• Unplanned significant weight gain or loss;

• Fever/infection;

• Diarrhea;

• Chronic disease;

• Chewing and Swallowing problems;

• Teeth and gum diseases;

• Excessive use of laxatives;

• Abnormal laboratory values;

• Brittle, dry hair;

• Ridged or spoon shaped nails;

• Dry flaky skin; and

• Unexplained changed in mood such as general fatigue, apathy, irritability, lack of
concentration.

If one or more of these indicators are present, determine the facility’s response through
observation, interview, and record review.

Surveyors should assure the facility is responsive to client food allergies and the potential for
adverse food/drug interactions. If surveyors suspects these may exist, investigate further.

Examples of facility responsiveness to allergies and food/drug interactions include, but are not
limited to:

• Clients on long term anticonvulsant drug regimens (e.g., phenobarbital, phenytoin,
primidone) are periodically monitored per facility policy for decreased serum levels of

folic acid and vitamin D;

• Therapeutic doses of nutrients are provided to decrease the likelihood of anemia and
prevent decreased bone density, etc.; and

• Fiber and fluids are increased in the diet of clients to decrease the likelihood of
constipation.

Guidance §483.470(a)(1)

Clients of grossly different ages, functional levels, and/or social needs should not be housed
together unless all of the following documentation support the placement:

• Assessment;

• Client program plan;

• Staff documentation of client response to training programs; and

• QIDP notes.

W461

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(a)(2) A qualified dietitian must be employed either full-time, part-time, or on a
consultant basis at the facility’s discretion.

Guidance §483.480(a)(2)

The facility employs a registered dietitian either on a part-time, full-time or on a consultant
basis.

W462

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(a)(3) If a qualified dietitian is not employed full-time, the facility must designate a
person to serve as the director of food services.

Guidance §483.480(a)(3)

Where the facility does not have a full-time qualified dietitian, verify that the director of food
services coordinates with a dietitian to assure the nutritional adequacy of meals and snacks.

The food service director coordinates with the part-time or consultant dietitian to develop client
meal plans and monitor client nutritional status.

The qualifications of the food service director may be dictated by facility policy or by state law, if
applicable.

In small group home settings where the staff and clients plan and prepare meals cooperatively,
there may not be a designated food services director. In these cases, the consultant or part-
time dietitian would meet with the available home staff to ensure adequacy of menus and diets.

§483.480(a)(4) The client’s interdisciplinary team, including a qualified dietitian and physician
must prescribe

W463

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(a)(4) all modified and special diets

W464

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(a)(4) including those used as a part of a program to manage inappropriate client
behavior.

Guidance §483.480(a)(4)

Modifying a clients’ diet must never be used as punishment.

W465

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(a)(5) Foods proposed for use as a primary reinforcement of adaptive behavior are
evaluated in light of the client’s nutritional status and needs.

Guidance §483.480(a)(5)

This regulation addresses the use of food in shaping positive adaptive behavior. Where clients
have specialized nutritional needs, these needs must be taken into consideration.

When food is used as a primary reinforcement of behavior for a client who has a dietary
restriction, these foods should be consistent with the foods allowed by the prescribed diet.

Food used as a reinforcement must be part of a behavior plan approved by the IDT and
consistent with nutritional parameters for that client. For example, a client with diabetes does
not receive concentrated sweets as a reinforcement.

W466

(Rev. 158, Issued: 09-09-16, Effective: 09-09-16, Implementation: 09-09-16)

§483.480(a)(6) Unless otherwise specified by medical needs, the diet must be prepared at
least in accordance with the latest edition of the recommended dietary allowances of the Food
and Nutrition Board of the National Research Council, National Academy of Sciences, adjusted
for age, sex, disability and activity.

Guidance §483.480(a)(6)

The suggested guidelines can be accessed at the United States Department of Agriculture
(USDA).

(b) Standard: Meal services

W467

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(b)(1) Each client must receive at least three meals daily,

Guidance §483.480(b)(1)

Meal times may be flexible and accommodate a variety of activities (e.g. holiday and weekend
activities). Clients should be offered the opportunity of three meals every day, but may be given
the choice of not participating in a meal due to their schedule or preference.

For example, a client wakes up late on a Saturday morning and decides to have brunch.

W468

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(b)(1) at regular times comparable to normal mealtimes in the community

Guidance §483.480(b)(1)

Generally, meal times conform to the norms of the community, however the clients’ schedules
and preferences may result in slight variations. Slight variations are acceptable, but gross
variations such as breakfast at 3 am would not be acceptable.

§483.480(b)(1) with –

W469

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(b)(1)(i) Not more than 14 hours between a substantial evening meal and breakfast
of the following day,

Guidance §483.480(b)(1)(i)

A “substantial evening meal” is defined as an offering of three or more items at one time, one of
which includes a high quality protein such as meat, fish, eggs, or cheese. The meal should
represent no less than 20 percent of the day’s total nutritional requirements.

W470

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(b)(1)(i) except on weekends and holidays when a nourishing snack is provided at
bedtime, 16 hours may lapse between a substantial evening meal and breakfast; and

Guidance §483.480(b)(1)(i)

A “nourishing snack” is an offering of items, single or in combination, from the basic food
groups. Snack supplies are available in the facility and are accessible to clients. Interview staff
and clients about their access to snacks.

W471

§483.480(b)(1)(ii) Not less than 10 hours between breakfast and the evening meal of the same
day, except as provided under paragraph (b)(1)(i).

§483.480(b)(2) Food must be served–

Facility Practices §483.480(b)(2)(i)

Portions served, either by staff or by the individuals themselves, closely match designated
serving sizes on menus. Slight variations are not significant enough or frequent enough to affect
individual’s health.

W472

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(b)(2)(i) In appropriate quantity;

Guidance §483.480(b)(2)(i)

Meal observations verify that portions served, either by staff or by the clients, match the
designated serving sizes on menus.

W473

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(b)(2)(ii) At appropriate temperature;

Guidance §483.480(b)(2)(ii)

Hot foods are served hot and cold foods are served cold, according to facility policy specific to
the type of food or as desired by the client. The facility follows current state requirements for
safe food temperatures.

W474

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(b)(2)(iii) In a form consistent with the developmental level of the client; and

Guidance §483.480(b)(2)(iii)

The term “form”, as used in this requirement, refers to food consistency (e.g., pureed, chopped,
ground, etc.). Food that is ground, chopped or pureed is based on assessed client need, and
only to the extent required.

Food consistency modifications due to an acute medical or dental condition are temporary and;
client’s food consistency is upgraded at the soonest possible time. Clients with chronic medical
or dental conditions are periodically reviewed and at least annually for the possibility of an
upgrade in food consistency.

Client assessments must document the justification for modified texture of the client’s diet.

W475

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(b)(2)(iv) With appropriate utensils.

Guidance §483.480(b)(2)(iv)

“Appropriate utensils” refers to eating utensils and adaptive eating equipment that enable
clients to eat as independently as possible in accordance with their highest functional level.

Commonly used utensils (fork, knife, and spoon) appropriate to the food being consumed are
provided to all clients except those using adaptive equipment instead. Clients should be
afforded the opportunity to use forks, spoons, and knives as indicated by the food served.

Utensils must be in good condition, clean, allow portion sizes appropriate to the client’s
prescribed diet and meet the client’s needs.

W476

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(b)(3) Food served to clients individually and uneaten must be discarded.

Guidance §483.480(b)(3)

This standard does not apply to food served in family-style dishes, unless the length of time the
food is on the table or other considerations (such as clients fingering or drooling in the food)
compromise the safety and nutritive value for later consumption of the food.

W477

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(c)(1)(i) Be prepared in advance;

Guidance §483.480(c)(1)(i)

The facility should be able to produce a copy of client menus prospectively to verify that meal
planning is done in advance.

W478

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(c)(1)(ii) Provide a variety of foods at each meal;

Guidance §483.480(c)(1)(ii)

A “variety” of food at each meal includes offerings from each of the food groups.

W479

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(c)(1)(iii) Be different for the same days of each week and adjusted for seasonal
changes; and

Guidance §483.480(c)(1)(iii)

Menus should make use of seasonal foods in order to capitalize on the availability of fresher
more vitamin enriched foods.

In certain portions of the country, there may be cultural preferences that influence the
frequency with which a food appears on the menu. This is acceptable in the facility if it is
acceptable in the community.

W480

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(c)(1)(iv) Include the average portion sizes for menu items.

Guidance §483.480(c)(1)(iv)

Verify the menu lists client portion sizes and observe that the portions served correspond to the
clients prescribed diet.

W481

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(c)(2) Menus for food actually served must be kept on file for 30 days.

(d) Standard: Dining areas and service

§483.480(d) The facility must –

W482

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(d)(1) Serve meals for all clients, including persons with ambulation deficits, in dining
areas, unless otherwise specified by the interdisciplinary team or a physician;

Guidance §483.480(d)(1)

For purposes of this standard, “dining areas” mean discrete eating areas located outside of
bedrooms, established, furnished, and equipped for the purpose of eating meals.

When a client is not eating in a designated dining area, there must be either a medical rationale
or this must be an isolated instance when the client has a personal reason to eat in another
area, such as a television area to watch his or her favorite program.

Interview with the client should confirm that this is not routine, but is for a particular isolated
reason.

W483

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(d)(2) Provide table service for all clients who can and will eat at a table, including
clients in wheelchairs;

Guidance §483.480(d)(2)

Clients must have the opportunity to participate in the normal dining experience with their
companions in the dining room.

Clients in wheelchairs are included in dining groupings of their peers without physical
disabilities.

Clients in wheelchairs eat at the table and not with lap trays/hospital trays unless medically
contraindicated.

W484

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(d)(3) Equip areas with tables, chairs, eating utensils, and dishes designed to meet
the developmental needs of each client;

Guidance §483.480(d)(3)

Clients use adaptive equipment or are being trained to use such equipment when the need is
identified in the IPP.

Examples of adaptive equipment that may be needed are:

• Double suction cups or other devices to anchor dishes on a table or tray for clients with
major coordination problems;

• Rocking one-handed knife-fork or knife-spoon for a client with the use of only one hand;

• Built-up or extended handles or silverware for those with problems of grasp or range of
motion;

• Plate guards or plates with raised rims to provide a surface against which the client with
a physical disability can push food onto a fork or a spoon;

• Flexible drinking straws;

• Spoon bent to a 90 degree angle at the bowl or a swivel spoon to assist a client without
normal wrist motions; and

• Any other adaptive device deemed by the team as needed by the client to eat more
independently.

W485

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(d)(4) Supervise and staff dining rooms adequately

Guidance §483.480(d)(4)

There should be sufficient staff to implement eating programs for clients who require them and
to provide necessary intervention and supervision for normalization including normal meal time
behavior.

Client mealtime should not be inadequately delayed due to insufficient staff assistance.

W486

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(d)(4) to direct self-help dining procedures,

Guidance §483.480(d)(4)

Staff is present during meal times to monitor clients who are able to eat independently,
promoting, supporting, reinforcing and encouraging them to eat in an appropriate and
normalized manner (e.g., manners, social behaviors, etc.)

W487

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(d)(4) to assure that each client receives enough food and

Guidance §483.480(d)(4)

Clients can request and receive second helpings unless contraindicated by a prescribed diet.

For clients on restrictive diets that prefer not to be on these diets or seek seconds, the facility
resolves the personal choice issues vs. health risks.

W488

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(d)(4) to assure that each client eats in a manner consistent with his or her
developmental level; and

Guidance §483.480(d)(4)

The intent of this regulation is to promote the acquisition of skills that lead to greater
independence in eating.

Clients should be actively encouraged to eat independently to the extent possible and in
accordance with their assessed abilities.

Clients should receive training to develop independent eating skills consistent with their
developmental potential as identified through the CFA.

Clients learn skills in accordance with their functional levels. Skills may include:

• Use of utensils;

• Meal preparation;

• Socialization during meals;

• Family style dining; and

• Ordering food in restaurants.

Clients’ eating programs are implemented in accordance with their training objectives.

To the maximum extent possible, staff model appropriate mealtime behavior and conversation
by sitting at the table with clients, and when possible, eating meals with clients.

W489

(Rev. 135, Issued: 02-27-15, Effective: 04-27-15, Implementation: 04-27-15)

§483.480(d)(5) Ensure that each client eats in an upright position, unless otherwise specified
by the interdisciplinary team or a physician.

Guidance §483.480(d)(5)

If a client eats in any position other than an upright position, the physician should document the
medical necessity for the position, and/or the IPP should include the program plan to teach the
client the physical skill necessary for eating upright.

This applies to all clients, including those fed by nasogastric tube or gastrostomy tube. The IPP
should identify the most appropriate position for the client to be positioned during mealtime, in
relation to the placement of the food contents.

Transmittals Issued for this Appendix

Rev # Issue Date Subject Impl Date CR#

R178SOMA 04/13/2018
Revisions to State
Operations Manual (SOM)
Appendix J, Part I – Survey
Protocol for Intermediate
Care Facilities for
Individuals with Intellectual
Disabilities (ICF/IID)

04/13/2018 N/A

R175SOMA 12/22/2017 Revisions to State Operations
Manual (SOM) Appendix J, Part II
– Interpretive Guidelines –
Responsibilities of Intermediate
Care Facilities for Individuals with
Intellectual Disabilities (ICF/IID)

12/22/2017 N/A

R162SOM 10/14/2016 Revisions to State Operations
Manual (SOM) Appendix J, Part II
– Interpretive Guidelines –
Responsibilities of Intermediate
Care Facilities for Individuals with
Intellectual Disabilities

10/14/2016 N/A

R158SOM 09/09/2016 Revisions to State Operations
Manual (SOM) Appendix J, Part II
– Interpretive Guidelines –
Responsibilities of Intermediate
Care Facilities for Individuals with
Intellectual Disabilities and Exhibit
355, Probes and Procedures for
Appendix J

09/09/2016 N/A

R144SOM 08/14/2015 Revisions to State Operations
Manual (SOM) Appendix J, Part II
– Interpretive Guidelines –
Responsibilities of Intermediate
Care Facilities for Individuals with
Intellectual Disabilities

08/14/2015 N/A

R135SOM 02/27/2015 Revisions to State Operations
Manual (SOM) Appendix J, Part II

04/27/2015 N/A

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R178SOMA

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R175SOMA

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R162SOMA

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R158SOMA

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R144SOMA

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R135SOMA

– Interpretive Guidelines –
Responsibilities of Intermediate
Care Facilities for Individuals with
Intellectual Disabilities revisions.
An addition of a New Exhibit to the
State Operations Manual (SOM) for
Intermediate Care Facilities for
Individuals with Intellectual
Disabilities (ICF/IID), Probes and
Procedures for Appendix J, Part II –
Interpretive Guidelines-
Responsibilities of Intermediate
Care Facilities for Individuals with
Intellectual Disabilities

R94SOM 12/06/2013 State Operations Manual (SOM)
Appendix J, Guidance to Surveyors:
Intermediate Care Facilities for
Individuals with Intellectual
Disabilities, nomenclature
revisions

12/06/2013 N/A

R10SOM 08/12/2005 Revisions to Appendix J 08/12/2005 N/A

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R94SOMA

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R10SOM

I – Introduction

(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

Use observation as the primary method of information gathering.

(W196, W197, W200, W210, W211, W212, W213, W214, W215, W216, W217, W218, W219, W220, W221, W222, W223, W224, W225, W259)

(W196, W209, W227, W240, W242, W247, W159)

(W196, W249, W104, W120, W159, W164, W186, 189, W190, W194, W436, W474, W488)

(W196, W252, W253, W254, W111)

(W196, W255, W256, W257, W262, W263, W258, W259, W260, W264, W104, W159, W448, W449)

II – Survey Levels

A. Focused Fundamental Survey

Table 1: Key standards and corresponding standards within the CoPs for the focused fundamental survey:

C. Full Survey

III – Entrance

(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

IV – Task One – Sample Selection

(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

Table 2: Guidance to Calculate Core Sample Size:

V – Task Two – Review of Facility Systems to Prevent Abuse, Neglect and Mistreatment and to Resolve Complaints

(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

A. Task Two Phase One

B. Task Two Phase Two:

(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

Focused Observation Areas:

VII – Task Four – Required Interviews with Individuals and/or Family/Advocate Direct Care Staff

(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

VIII – Task Five – Drug Pass Observation

(Rev. 178; Issued: 04-13-18; Effective: 04-13-18; Implementation: 04-13-18)

IX – Task Six – Visit to Each Area of Facility Serving Certified Individuals

X – Task Seven – Record Review of Individuals in the Sample

§440.150 Intermediate Care Facility Services, Other Than in Institutions for Mental Diseases

(a) Standard: Governing body

(d) Standard: Services provided under agreements with outside sources

§483.420(a) Standard: Protection of Clients’ Rights

§483.410(e) Standard: Licensure

§483.420(b) Standard: Client Finances

(b) Standard: Professional program services

(a) Standard: Active treatment

(b) Standard: Admissions, transfers, and discharge

(a) Standard: Facility practices– Conduct toward clients

§483.450(e) Standard: Drug Usage

(d) Standard: Nursing staff

(j) Standard: Drug regimen review

(k) Standard: Drug administration

§483.470(g) Standard: Space and Equipment

(a) Standard: Food and nutrition services

W484

State Operations Manual
Appendix PP – Guidance to Surveyors for

Long Term Care Facilities

Table of Contents
(Rev. 225; Issued: 08-08-24)

Transmittals for Appendix PP

INDEX

§483.5 Definitions
§483.10 Resident Rights
§483.12 Freedom from Abuse, Neglect, and Exploitation
§483.15 Admission Transfer and Discharge Rights
§483.20 Resident Assessment
§483.21 Comprehensive Person-Centered Care Plans
§483.24 Quality of Life
§483.25 Quality of Care
§483.30 Physician Services
§483.35 Nursing Services
§483.40 Behavioral health services
§483.45 Pharmacy Services
§483.50 Laboratory Radiology and Other Diagnostic Services
§483.55 Dental Services
§483.60 Food and Nutrition Services
§483.65 Specialized Rehabilitative Services
§483.70 Administration
§483.71 Facility Assessment
§483.75 Quality Assurance and Performance Improvement
§483.80 Infection Control
§483.85 Compliance and Ethics Program
§483.90 Physical Environment
§483.95 Training Requirements

NOTE: In the regulation text that is noted under the following Tags : F540, F584, F620-623,
F625, F757, F774, F842, and F868, there were minor, technical inaccuracies (spelling, cross-
references, etc.) in the 2016 Final Rule that updated the Requirements of Participation. In an
effort to ensure clarity of understanding of the guidance, the instructions to surveyors, and the
determining of compliance, we have made the appropriate correction in this guidance document.
This document is not intended to replace, modify or otherwise amend the regulatory text. Such
revisions, modifications or amendments can only be made through a Correction Notice or other
rulemaking that would be published in the Federal Register.

F540
(Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24)

§483.5 Definitions.
As used in this subpart, the following definitions apply:

Abuse. Abuse is the willful infliction of injury, unreasonable confinement, intimidation, or
punishment with resulting physical harm, pain or mental anguish. Abuse also includes the
deprivation by an individual, including a caretaker, of goods or services that are necessary
to attain or maintain physical, mental, and psychosocial well-being. Instances of abuse of
all residents, irrespective of any mental or physical condition, cause physical harm, pain or
mental anguish. It includes verbal abuse, sexual abuse, physical abuse, and mental abuse
including abuse facilitated or enabled through the use of technology. Willful, as used in this
definition of abuse, means the individual must have acted deliberately, not that the
individual must have intended to inflict injury or harm.

Adverse event. An adverse event is an untoward, undesirable, and usually unanticipated
event that causes death or serious injury, or the risk thereof.

Common area. Common areas are areas in the facility where residents may gather together
with other residents, visitors, and staff or engage in individual pursuits, apart from their
residential rooms. This includes but is not limited to living rooms, dining rooms, activity
rooms, outdoor areas, and meeting rooms where residents are located on a regular basis.

Composite distinct part.

(1) Definition. A composite distinct part is a distinct part consisting of two or more non-

contiguous components that are not located within the same campus, as defined in
§413.65(a)(2) of this chapter.

(2) Requirements. In addition to meeting the requirements of specified in the definition of
“distinct part” of this section, a composite distinct part must meet all of the following
requirements:
(i) A SNF or NF that is a composite of more than one location will be treated as a single

distinct part of the institution of which it is a distinct part. As such, the composite
distinct part will have only one provider agreement and only one provider number.

(ii) If two or more institutions (each with a distinct part SNF or NF) undergo a change
of ownership, CMS must approve the existing SNFs or NFs as meeting the

requirements before they are considered a composite distinct part of a single
institution. In making such a determination, CMS considers whether its approval or
disapproval of a composite distinct part promotes the effective and efficient use of
public monies without sacrificing the quality of care. If there is a change of
ownership of a composite distinct part SNF or NF, the assignment of the provider
agreement to the new owner will apply to all of the approved locations that comprise
the composite distinct part SNF or NF.

(iii) To ensure quality of care and quality of life for all residents, the various
components of a composite distinct part must meet all of the requirements for
participation independently in each location.

(iv) To ensure quality of care and quality of life for all residents, the various
components of a composite distinct part must meet all of the requirements for
participation independently in each location.

(v) Use of composite distinct parts to segregate residents by payment source or on a
basis other than care needs is prohibited.

Distinct part

(1) Definition. A distinct part SNF or NF is physically distinguishable from the larger

institution or institutional complex that houses it, meets the requirements of this
paragraph and of paragraph (2) of this definition, and meets the applicable statutory
requirements for SNFs or NFs in sections 1819 or 1919 of the Act, respectively. A
distinct part SNF or NF may be comprised of one or more buildings or designated parts
of buildings (that is, wings, wards, or floors) that are: In the same physical area
immediately adjacent to the institution’s main buildings; other areas and structures
that are not strictly contiguous to the main buildings but are located within close
proximity of the main buildings; and any other areas that CMS determines on an
individual basis, to be part of the institution’s campus. A distinct part must include all
of the beds within the designated area, and cannot consist of a random collection of
individual rooms or beds that are scattered throughout the physical plant. The term
“distinct part” also includes a composite distinct part that meets the additional
requirements specified in the definition of “composite distinct part” of this section.

(2) Requirements. In addition to meeting the participation requirements for long-term care
facilities set forth elsewhere in this subpart, a distinct part SNF or NF must meet all of
the following requirements:

(i) The SNF or NF must be operated under common ownership and control (that is,

common governance) by the institution of which it is a distinct part, as evidenced by
the following:
(A) The SNF or NF is wholly owned by the institution of which it is a distinct part.
(B) The SNF or NF is subject to the by-laws and operating decisions of common

governing body.
(C)The institution of which the SNF or NF is a distinct part has final responsibility

for the distinct part’s administrative decisions and personnel policies, and final
approval for the distinct part’s personnel actions.

https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=5db9bd40ffd784b4552b8e6624578853&term_occur=8&term_src=Title:42:Chapter:IV:Subchapter:G:Part:483:Subpart:B:483.5

https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=584b7ea4b6f8b168c0c7cf6fe5939e96&term_occur=3&term_src=Title:42:Chapter:IV:Subchapter:G:Part:483:Subpart:B:483.5

(D) The SNF or NF functions as an integral and subordinate part of the institution
of which it is a distinct part, with significant common resource usage of
buildings, equipment, personnel, and services.

(ii)The administrator of the SNF or NF reports to and is directly accountable to the
management of the institution of which the SNF or NF is a distinct part.

(iii) The SNF or NF must have a designated medical director who is responsible for
implementing care policies and coordinating medical care, and who is directly
accountable to the management of the institution of which it is a distinct part.

(iv) The SNF or NF is financially integrated with the institution of which it is a distinct
part, as evidenced by the sharing of income and expenses with that institution, and
the reporting of its costs on that institution’s cost report.

(v) A single institution can have a maximum of only one distinct part SNF and one
distinct part NF.

(vi) (A) An institution cannot designate a distinct part SNF or NF, but instead must
submit a written request with documentation that demonstrates it meets the criteria
set forth above to CMS to determine if it may be considered a distinct part.
(B) The effective date of approval of a distinct part is the date that CMS determines

all requirements (including enrollment with the fiscal intermediary (FI)) are met
for approval, and cannot be made retroactive.

(C) The institution must request approval from CMS for all proposed changes in the
number of beds in the approved distinct part.

Exploitation. Exploitation means taking advantage of a resident for personal gain through
the use of manipulation, intimidation, threats, or coercion.

Facility defined. For purposes of this subpart, facility means a skilled nursing facility (SNF)
that meets the requirements of section s1819(a), (b), (c), and (d) of the Act, or a nursing
facility (NF) that meets the requirements of sections 1919(a), (b), (c), and (d) of the Act.
“Facility” may include a distinct part of an institution (as defined in paragraph (b) of this
section and specified in §440.40 and §440.155 of this chapter), but does not include an
institution for individuals with intellectual disabilities or persons with related conditions
described in §440.150 of this chapter. For Medicare and Medicaid purposes (including
eligibility, coverage, certification, and payment), the “facility” is always the entity that
participates in the program, whether that entity is comprised of all of, or a distinct part of,
a larger institution. For Medicare, an SNF (see section 1819(a)(1) of the Act), and for
Medicaid, and NF (see section 1919(a)(1) of the Act) may not be an institution for mental
diseases as defined in §435.1010 of this chapter.

Fully sprinklered. A fully sprinklered long term care facility is one that has all areas
sprinklered in accordance with National Fire Protection Association 13 “Standard for the
Installation of Sprinkler Systems” without the use of waivers or the Fire Safety Evaluation
System.

Licensed health professional. A licensed health professional is a physician; physician
assistant; nurse practitioner; physical, speech, or occupational therapist; physical or
occupational therapy assistant; registered professional nurse; licensed practical nurse; or

licensed or certified social worker; or registered respiratory therapist or certified
respiratory therapy technician.

Major modification means the modification of more than 50 percent, or more than 4,500
square feet, of the smoke compartment.

Misappropriation of resident property means the deliberate misplacement, exploitation, or
wrongful, temporary, or permanent use of a resident’s belongings or money without the
resident’s consent.

Mistreatment means inappropriate treatment or exploitation of a resident.

Neglect is the failure of the facility, its employees or service providers to provide goods and
services to a resident that are necessary to avoid physical harm, pain, mental anguish, or
emotional distress.

Nurse aide. A nurse aide is any individual providing nursing or nursing-related services to
residents in a facility. This term may also include an individual who provides these services
through an agency or under a contract with the facility, but is not a licensed health
professional, a registered dietitian, or someone who volunteers to provide such services
without pay. Nurse aides do not include those individuals who furnish services to residents
only as paid feeding assistants as defined in §488.301 of this chapter.

Person-centered care. For purposes of this subpart, person-centered care means to focus on
the resident as the locus of control and support the resident in making their own choices
and having control over their daily lives.

Resident representative. For purposes of this subpart, the term resident representative
means any of the following:

(1) An individual chosen by the resident to act on behalf of the resident in order to
support the resident in decision-making; access medical, social or other personal
information of the resident; manage financial matters; or receive notifications;

(2) A person authorized by State or Federal law (including but not limited to agents
under power of attorney, representative payees, and other fiduciaries) to act on
behalf of the resident in order to support the resident in decision-making; access
medical, social or other personal information of the resident; manage financial
matters; or receive notifications; or

(3) Legal representative, as used in section 712 of the Older Americans Act; or
(4) The court-appointed guardian or conservator of a resident.
(5) Nothing in this rule is intended to expand the scope of authority of any resident

representative beyond that authority specifically authorized by the resident, State or
Federal law, or a court of competent jurisdiction.

Representative of direct care employees. A representative of direct care employees is an
employee of the facility, or a third party authorized by direct care employees at the facility to

provide expertise and input on behalf of the employees for the purposes of informing a facility
assessment.

Sexual abuse is non-consensual sexual contact of any type with a resident.

Transfer and discharge includes movement of a resident to a bed outside of the certified
facility whether that bed is in the same physical plant or not. Transfer and discharge does
not refer to movement of a resident to a bed within the same certified facility.

F550
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(a) Resident Rights.
The resident has a right to a dignified existence, self-determination, and communication
with and access to persons and services inside and outside the facility, including those
specified in this section.

§483.10(a)(1) A facility must treat each resident with respect and dignity and care for each
resident in a manner and in an environment that promotes maintenance or enhancement of
his or her quality of life, recognizing each resident’s individuality. The facility must protect
and promote the rights of the resident.

§483.10(a)(2) The facility must provide equal access to quality care regardless of diagnosis,
severity of condition, or payment source. A facility must establish and maintain identical
policies and practices regarding transfer, discharge, and the provision of services under the
State plan for all residents regardless of payment source.

§483.10(b) Exercise of Rights.
The resident has the right to exercise his or her rights as a resident of the facility and as a
citizen or resident of the United States.

§483.10(b)(1) The facility must ensure that the resident can exercise his or her rights
without interference, coercion, discrimination, or reprisal from the facility.

§483.10(b)(2) The resident has the right to be free of interference, coercion, discrimination,
and reprisal from the facility in exercising his or her rights and to be supported by the
facility in the exercise of his or her rights as required under this subpart.

INTENT §483.10(a)-(b)(1)&(2)
All residents have rights guaranteed to them under Federal and State laws and regulations. This
regulation is intended to lay the foundation for the resident rights requirements in long-term care
facilities. Each resident has the right to be treated with dignity and respect. All activities and
interactions with residents by any staff, temporary agency staff or volunteers must focus on
assisting the resident in maintaining and enhancing his or her self-esteem and self-worth and
incorporating the resident’s, goals, preferences, and choices. When providing care and services,
staff must respect each resident’s individuality, as well as honor and value their input.

GUIDANCE §483.10(a)-(b)(1)&(2)
Examples of treating residents with dignity and respect include, but are not limited to:

• Encouraging and assisting residents to dress in their own clothes, rather than hospital-
type gowns, and appropriate footwear for the time of day and individual preferences;

• Placing labels on each resident’s clothing in a way that is inconspicuous and respects his
or her dignity (for example, placing labeling on the inside of shoes and clothing or using
a color coding system);

• Promoting resident independence and dignity while dining, such as avoiding:
o Daily use of disposable cutlery and dishware;
o Bibs or clothing protectors instead of napkins (except by resident choice);
o Staff standing over residents while assisting them to eat;
o Staff interacting/conversing only with each other rather than with residents while

assisting with meals;
• Protecting and valuing residents’ private space (for example, knocking on doors and

requesting permission before entering, closing doors as requested by the resident);
• Staff should address residents with the name or pronoun of the resident’s choice,

avoiding the use of labels for residents such as “feeders” or “walkers.” Residents should
not be excluded from conversations during activities or when care is being provided, nor
should staff discuss residents in settings where others can overhear private or protected
information or document in charts/electronic health records where others can see a
resident’s information;

• Refraining from practices demeaning to residents such as leaving urinary catheter bags
uncovered, refusing to comply with a resident’s request for bathroom assistance during
meal times, and restricting residents from use of common areas open to the general public
such as lobbies and restrooms, unless they are on transmission-based isolation
precautions or are restricted according to their care planned needs.

Consider the resident’s life style and personal choices identified through their assessment
processes to obtain a picture of his or her individual needs and preferences.

Staff and volunteers must interact with residents in a manner that takes into account the physical
limitations of the resident, assures communication, and maintains respect. For example, getting
down to eye level with a resident who is sitting, maintaining eye contact when speaking with a
resident with limited hearing, or utilizing a hearing amplification device when needed by a
resident.

Pay close attention to resident or staff interactions that may represent deliberate actions to limit a
resident’s autonomy or choice. These actions may indicate abuse. See F600, Free from Abuse,
for guidance.

The facility must not establish policies or practices that hamper, compel, treat differently, or
retaliate against a resident for exercising his or her rights.

Justice Involved Residents
“Justice involved residents” includes the following three categories:

1. Residents under the care of law enforcement: Residents who have been taken into
custody by law enforcement. Law enforcement includes local and state police, sheriffs,
federal law enforcement agents, and other deputies charged with enforcing the law.

2. Residents under community supervision: Residents who are on parole, on probation, or
required to conditions of ongoing supervision and treatment as an alternative to criminal
prosecution by a court of law.

3. Inmates of a public institution: Residents currently in custody and held involuntarily
through operation of law enforcement authorities in an institution, which is the
responsibility of a governmental unit or over which a governmental unit exercises
administrative control, such as state or federal prisons, local jails, detention facilities, or
other penal settings (such as boot camps, wilderness camps).

Justice involved individuals are entitled to the same rights described in 42 CFR Part 483, Subpart
B as all other residents residing in the facility. The facility shall not establish policies or impose
conditions on the justice involved resident that result in restrictions which violate the resident’s
rights. Some Department of Corrections or law enforcement terms of release or placement may
conflict with CMS requirements. If the facility accepts responsibility for enforcing restrictive law
enforcement terms applied to a resident that are contrary to the Requirements for LTC Facilities,
the facility would not be in compliance with federal long term care requirements. In addition,
law enforcement jurisdictions may not be integrated with the operations of the facility.

While all portions of 42 CFR Part 483, Subpart B, apply to justice involved individuals, other
areas where there may be concerns specific to this population are found at §483.12, F600, Abuse,
Neglect, and Exploitation and §483.15(c), F622, Transfer and discharge. In such a case,
surveyors should cite under the specific tag associated with the concern identified. For example,
if there is a concern about a facility restricting visitors of a justice involved individual, cite such
deficiency under §483.10(f)(4)(vi), F564, Resident Right to Visitors.

See Survey & Certification Memorandum 16-21-ALL dated May 3, 2016 (Revised 12/23/16) for
additional guidance on justice involved individuals.

PROCEDURES §483.10(a)-(b)(1)&(2)
Deficient practices cited under Resident rights tags may also have negative psychosocial
outcomes for the resident. The survey team must consider the potential for both physical and
psychosocial harm when determining the scope and severity of deficiencies related to dignity.
Refer to the Psychosocial Outcome Severity Guide in Appendix P.

Surveyors shall make frequent observations on different shifts, units, floors or neighborhoods to
watch interactions between and among residents and staff. If there are concerns that staff or
others are not treating a resident with dignity or respect or are attempting to limit a resident’s
autonomy or freedom of choice, follow-up as appropriate by interviewing the resident, family, or
resident representative.

• Observe if staff show respect for each resident and treat them as an individual.

• Do staff respond in a timely manner to the resident’s requests for assistance?
• Do staff explain to the resident what care is being provided or where they are taking the

resident? Is the resident’s appearance consistent with his or her preferences and in a
manner that maintains his or her dignity?

• Do staff know the resident’s specific needs and preferences?
• Do staff make efforts to understand the preferences of those residents, who are not able to

verbalize them, due to cognitive or physical limitations?

Determine if staff members respond to residents with cognitive impairments in a manner that
facilitates communication and allows the resident the time to respond appropriately. For
example, a resident with dementia may be attempting to exit the building with the intent to meet
her/his children at the school bus. Walking with the resident without challenging or disputing
the resident’s intent and conversing with the resident about the desire (tell me about your
children) may reassure the resident in a manner consistent with the requirements of §483.10(a)
and (b).

Examples of noncompliance may include, but are not limited to:

• A resident has not been treated equally as compared to others based on his or her
diagnosis, severity of condition, or payment source.

• Prohibiting a resident from participating in group activities as a form of reprisal or
discrimination. This includes prohibiting a resident from group activities without clinical
justification or evaluation of the impact the resident’s participation has on the group.

• A resident’s rights, not addressed elsewhere (for example, religious expression, voting, or
freedom of movement outside the facility in the absence of a legitimate clinical need) are
impeded in some way by facility staff.

• Requiring residents to seek approval to post, communicate or distribute information about
the facility (for example, social media, letters to the editor of a newspaper).

• Acting on behalf of the pertinent law enforcement or criminal justice supervisory
authority by enforcing supervisory conditions or reporting violations of those conditions
to officials for justice involved residents.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION
For deficiencies regarding lack of visual privacy for a resident while that resident is receiving
treatment or ADL care from staff in the bedroom, bathroom, or bathing room, refer to
§483.10(e), F583, Privacy and Confidentiality.

For deficiencies regarding a resident’s lack of self-determination to make decisions about things
that are important in his or her life, refer to §483.10(f)(1)-(3), (8), F561, Self-determination.

For deficiencies related to failure to keep residents’ faces, hands, teeth, fingernails, hair, and
clothing clean, refer to §483.24(a)(2), F677, Activities of Daily Living (ADLs).

If there are indications that a resident is in a secured/locked area without a clinical justification
and/or placement is against the will of the resident, their family, and/or resident representative,
review regulatory requirements at §483.12 and §483.12(a), F603, Involuntary Seclusion.

F551
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(b)(3) In the case of a resident who has not been adjudged incompetent by the state
court, the resident has the right to designate a representative, in accordance with State law
and any legal surrogate so designated may exercise the resident’s rights to the extent
provided by state law. The same-sex spouse of a resident must be afforded treatment equal
to that afforded to an opposite-sex spouse if the marriage was valid in the jurisdiction in
which it was celebrated.

(i) The resident representative has the right to exercise the resident’s rights to the
extent those rights are delegated to the representative.

(ii) The resident retains the right to exercise those rights not delegated to a resident
representative, including the right to revoke a delegation of rights, except as limited
by State law.

§483.10(b)(4) The facility must treat the decisions of a resident representative as the
decisions of the resident to the extent required by the court or delegated by the resident, in
accordance with applicable law.

§483.10(b)(5) The facility shall not extend the resident representative the right to make
decisions on behalf of the resident beyond the extent required by the court or delegated by
the resident, in accordance with applicable law.

§483.10(b)(6) If the facility has reason to believe that a resident representative is making
decisions or taking actions that are not in the best interests of a resident, the facility shall
report such concerns when and in the manner required under State law.

§483.10(b)(7) In the case of a resident adjudged incompetent under the laws of a State by a
court of competent jurisdiction, the rights of the resident devolve to and are exercised by
the resident representative appointed under State law to act on the resident’s behalf. The
court-appointed resident representative exercises the resident’s rights to the extent judged
necessary by a court of competent jurisdiction, in accordance with State law.

(i) In the case of a resident representative whose decision-making authority is limited by
State law or court appointment, the resident retains the right to make those
decisions outside the representative’s authority.

(ii) The resident’s wishes and preferences must be considered in the exercise of rights
by the representative.

(iii) To the extent practicable, the resident must be provided with opportunities to
participate in the care planning process.

DEFINITIONS §483.10(b)(3)-(7)
“Court of competent jurisdiction” means any court with the authority to hear and determine a
case or suit with the matter in question.

“Resident representative” For purposes of this subpart, the term resident representative may
mean any of the following:

1. An individual chosen by the resident to act on behalf of the resident in order to support the
resident in decision-making; access medical, social or other personal information of the
resident; manage financial matters; or receive notifications;

2. A person authorized by State or Federal law (including but not limited to agents under
power of attorney, representative payees, and other fiduciaries) to act on behalf of the
resident in order to support the resident in decision-making; access medical, social or
other personal information of the resident; manage financial matters; or receive
notifications; or

3. Legal representative, as used in section 712 of the Older Americans Act; or
4. The court-appointed guardian or conservator of a resident.
5. Nothing in this rule is intended to expand the scope of authority of any resident

representative beyond that authority specifically authorized by the resident, State or
Federal law, or a court of competent jurisdiction.

GUIDANCE §483.10(b)(3)-(7)
When reference is made to “resident” in the Guidance, it also refers to any person who may,
under State law, act on the resident’s behalf when the resident is unable to act for themselves.
That person is referred to as the resident representative. If the resident has been formally
declared incompetent by a court, the representative is whomever the court appoints (for example,
a guardian or conservator).

A competent resident may wish to delegate decision-making to specific persons, or the resident
and family may have agreed among themselves on a decision-making process. To the degree
permitted by State law, the facility staff must respect the delegated resident representative’s
decisions regarding the resident’s wishes and preferences so long as the resident representative is
acting within the scope of authority contemplated by the agreement authorizing the person to act
as the resident’s representative.

In the case of a resident who has been formally declared incompetent by a court, a court
appointed resident representative may be assigned. Facility staff must confer with the appointed
resident representative.

State laws and court orders authorizing guardians, conservators, etc., vary considerably. Many
statutes and court orders limit the scope of the authority of the representative to act on behalf of
the resident.

Facility staff must obtain documentation that the resident’s representative has been delegated the
necessary authority to exercise the resident’s rights and must verify that a court-appointed
representative has the necessary authority for the decision-making at issue as determined by the
court. For example, a court-appointed representative might have the power to make financial
decisions, but not health care decisions. Additionally, the facility must make reasonable efforts
to ensure that it has access to documentation of any change related to the delegation of rights,
including a resident’s revocation of delegated rights, to ensure that the resident’s preferences, are
being upheld.

Whether a resident has or has not been judged incompetent by a court of law, if it is determined
that the resident understands the risks, benefits, and alternatives to proposed health care and
expresses a preference, then the resident’s wishes should be considered to the degree practicable,
including resident input into the care planning process.
The involvement of a representative does not relieve facility staff of their duty to protect and
promote the resident’s interests. For example, a representative does not have the right to insist
that a treatment be performed that is not medically appropriate or reject a treatment that may be
subject to State law. Surveyors must confirm delegation of resident rights to a resident
representative. Surveyors must also determine, through interview and record reviews, whether or
not the resident’s delegation of rights has been followed by facility staff.

If a resident’s representative is a same-sex spouse, he or she must be treated the same as an
opposite-sex spouse with regard to exercising the resident’s rights. In Obergefell v. Hodges, 576
U.S.___ (2015), the Supreme Court of the United States also ruled that all States must recognize
a marriage between two people of the same sex when their marriage was lawfully licensed and
performed out-of-state.

PROCEDURES §483.10(b)(3)-(7)
Surveyors must check whether there has been a delegation of resident rights or designation of a
resident representative. Surveyors must also determine, through interview and record reviews,
whether or not the resident’s delegation of rights has been followed by facility staff.

Determine through interview and record review if the resident has been found to be legally
incompetent by a court in accordance with state law.

If yes:

• Verify the appropriate legal documentation for a court-appointed resident representative
is present in the resident’s medical record.

• Review court orders or other legal documentation to determine the extent of the court-
appointed resident representative’s authority to make decision on behalf of the resident
and any limitations on that authority that may have been ordered by the court.

• Determine if the court-appointed representative is making decisions for the resident
beyond the scope of the resident representative’s decision-making authority and the
facility is relying on that authority as the basis of a practice (e.g., health care treatment,
managing resident funds, discharge decision). If so, a deficiency may be cited under this
regulation.

• Determine if the resident was involved in care planning activities and able to make
choices, to the extent possible.

• Observe resident care and daily activities (e.g., participation in activities) for adherence
to resident’s or court-appointed resident representative’s goals, choices, and preferences.
Even when there is a court-appointed resident representative, the facility should seek to
understand the resident’s goals, choices, and preferences and have honored them to the
extent legally possible.

If no:

• Determine how decisions are being made for the resident. Does the resident maintain all
of his/her rights, even if he/she has designated a representative to assist with decision-
making unless a court has limited those rights under state law, and only to the extent that
has been specified by a court under state law? Has the resident designated a resident
representative and is facility staff respecting the authority of this designate surrogate
decision-maker to act on behalf of the resident?

• Are all residents informed of their plan of care or treatment in the most understandable
manner possible, and given an opportunity to voice their views? Autonomy is also
expressed through gestures and actions and this also should be recognized. Residents
even without capacity or declared incompetent may be able to express their needs and
desires.

• Determine whether same-sex spouses are treated in the same manner as an opposite-sex
spouse in all states and territories.

• If the resident has delegated a resident representative, verify the appropriate
documentation is present in the resident’s medical record.

KEY ELEMENTS OF NONCOMPLIANCE §483.10(b)(3)-(7)
To cite deficient practice at F551, the surveyor’s investigation will generally show that the
facility failed to do any one or more of the following:

• Ensure a competent resident’s choice for a representative is honored or
• Ensure that treatment of a same-sex spouse was the same as treatment of an opposite-sex

spouse; or
• Ensure the resident representative did not make decisions beyond the extent allowed by

the court or delegated by the resident; or
• Ensure the resident’s wishes and preferences were considered when decisions were made

by the resident representative; or
• Ensure the decisions of the resident representative are given the same consideration as if

the resident made the decision themselves; or
• Honor the resident’s authority to exercise his or her rights, even when he or she has

delegated those rights, including the right to revoke a delegation of rights; or
• Ensure the resident representative was reported as State law required when not acting in

the best interest of the resident; or
• Ensure a resident who was found incompetent by the court is provided with opportunities

to participate in the care planning process.

F552
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(c) Planning and Implementing Care.
The resident has the right to be informed of, and participate in, his or her treatment,
including:

§483.10(c)(1) The right to be fully informed in language that he or she can understand of
his or her total health status, including but not limited to, his or her medical condition.

§483.10(c)(4) The right to be informed, in advance, of the care to be furnished and the type
of care giver or professional that will furnish care.

§483.10(c)(5) The right to be informed in advance, by the physician or other practitioner or
professional, of the risks and benefits of proposed care, of treatment and treatment
alternatives or treatment options and to choose the alternative or option he or she prefers.

DEFINITIONS §483.10(c)(1), (4)-(5)
“Total health status” includes functional status, nutritional status, rehabilitation and restorative
potential, ability to participate in activities, cognitive status, oral health status, psychosocial
status, and sensory and physical impairments.

“Treatment” refers to medical care, nursing care, and interventions provided to maintain or
restore health and well-being, improve functional level, or relieve symptoms.

GUIDANCE §483.10(c)(1), (4)-(5)
Health information and services must be provided in ways that are easy for the resident and/or
the resident’s representative to understand. This includes, but is not limited to, communicating
in plain language, explaining technical and medical terminology in a way that makes sense to the
resident, offering language assistance services to residents who have limited English proficiency,
and providing qualified sign language interpreters or auxiliary aids if hearing is impaired. This
does not mean that a facility is required to supply and pay for hearing aids.

The physician or other practitioner or professional must inform the resident or their
representative in advance of treatment risks and benefits, options, and alternatives. The
information should be communicated at times it would be most useful to them, such as when
they are expressing concerns, raising questions, or when a change in treatment is being proposed.
The resident or resident representative has the right to choose the option he or she prefers.

Discussion and documentation of the resident’s choices regarding future health care may take
place during the development of the initial comprehensive assessment and care plan and
periodically thereafter.

NOTE: While surveyors must only cite F552 when deficient practice is found related to
applicable program requirements as reflected in the CFR, the following information may
inform surveyors about important considerations in making compliance decisions. The
Federal Patient Self – Determination Act contained in Public Law 101-508 is the authority on
an individual’s rights and facility responsibilities related to advance directives. This
includes, the right of an individual to direct his or her own medical treatment, including
withholding or withdrawing life-sustaining treatment. If there are concerns with advance
directives, refer to §483.10(g)(12), F578.

See §483.21(a), F655 (Baseline Care Plans), Comprehensive Person-Centered Care Planning, for
additional guidance.

F553

(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(c)(2) The right to participate in the development and implementation of his or her
person-centered plan of care, including but not limited to:

(i) The right to participate in the planning process, including the right to identify
individuals or roles to be included in the planning process, the right to request
meetings and the right to request revisions to the person-centered plan of care.

(ii) The right to participate in establishing the expected goals and outcomes of care, the
type, amount, frequency, and duration of care, and any other factors related to the
effectiveness of the plan of care.

(iii) The right to be informed, in advance, of changes to the plan of care.
(iv) The right to receive the services and/or items included in the plan of care.
(v) The right to see the care plan, including the right to sign after significant changes to

the plan of care.

§483.10(c)(3) The facility shall inform the resident of the right to participate in his or her
treatment and shall support the resident in this right. The planning process must—

(i) Facilitate the inclusion of the resident and/or resident representative.
(ii) Include an assessment of the resident’s strengths and needs.
(iii) Incorporate the resident’s personal and cultural preferences in developing goals of

care.

INTENT §483.10(c)(2)-(3)
To ensure facility staff facilitates the inclusion of the resident or resident representative in all
aspects of person-centered care planning and that this planning includes the provision of services
to enable the resident to live with dignity and supports the resident’s goals, choices, and
preferences including, but not limited to, goals related to the their daily routines and goals to
potentially return to a community setting.

GUIDANCE §483.10(c)(2)-(3)
Residents and their representative(s) must be afforded the opportunity to participate in their care
planning process and to be included in decisions and changes in care, treatment, and/or
interventions. This applies both to initial decisions about care and treatment, as well as the
refusal of care or treatment. Facility staff must support and encourage participation in the care
planning process. This may include ensuring that residents, families, or representatives
understand the comprehensive care planning process, holding care planning meetings at the time
of day when a resident is functioning best, providing sufficient notice in advance of the meeting,
scheduling these meetings to accommodate a resident’s representative (such as conducting the
meeting in-person, via a conference call, or video conferencing), and planning enough time for
information exchange and decision making.

A resident has the right to select or refuse specific treatments options before the care plan is
instituted, based on the information provided as required under §483.10(c)(1), (4)-(5), F552.
While Federal regulations affirm a resident’s right to participate in care planning and to refuse
treatment, the regulations do not require the facility to provide specific medical interventions or

treatments requested by the resident, family, and/or resident representative that the resident’s
physician deems inappropriate for the resident’s medical condition.

A resident whose ability to make decisions about care and treatment is impaired, or a resident
who has been declared incompetent by a court, must, to the extent practicable, be kept informed
and be consulted on personal preferences.

The resident has the right to see the care plan and sign after significant changes are made.

PROCEDURES §483.10(c)(2)-(3)
During observations, interviews, and record reviews, surveyors must:

• Interview the resident, and/or his or her representative to determine the level of
participation in care planning.

• Identify ways staff involve residents and/or their representative(s) in care planning.
• Determine if care plan meetings are scheduled to accommodate residents and/or their

representative.
• Determine how facility staff addressed questions or concerns raised by a resident or his or

her representative, including if they are addressed at times when it would be beneficial to
the resident, such as when they are expressing concerns or raising questions.

• Determine if the resident and representative were unable to participate, did facility staff
consult them in advance about care and treatment changes.

• Interview staff to determine how they inform residents or their representative of their
rights and incorporate their personal preferences, choices, and goals into their care plan.

• When the resident request is something that facility staff feels would place the individual
at risk (i.e., the resident chooses not to use the walker, recommended by therapy), is there
a process in place to examine the risk/benefit and guide decision-making?

• Review the resident’s medical record to determine if facility staff included an assessment
of the resident’s strengths and needs and whether these, as well as the resident’s personal
and cultural preferences, were incorporated when developing his or her care plan.

• Determine how facility staff observes and responds to the non-verbal communication of a
resident who is unable to verbalize preferences (i.e., if the resident spits out food, is this
considered to be a choice and alternative meal options offered).

POTENTIAL TAGS FOR ADDITIONAL CONSIDERATION
If facility staff do not provide access to the care plan within 24 hours (excluding weekends and
holidays) or provide, if requested, a copy of the care plan in written or electronic form within
two working days of the request, see §483.10(g)(2)-(3), F573, Right to Access/Purchase Copies
of Records.

If facility staff do not provide a summary of the baseline care plan to the resident and their
representative, see §483.21(a), F655, Baseline Care Plans.

Also refer to §483.21(b), F656, Comprehensive Care Plans for more information on Care Plans.

F554
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(c)(7) The right to self-administer medications if the interdisciplinary team, as
defined by §483.21(b)(2)(ii), has determined that this practice is clinically appropriate.

GUIDANCE §483.10(c)(7)
If a resident requests to self-administer medication(s), it is the responsibility of the
interdisciplinary team (IDT) (as defined in §483.21(b), F657, Comprehensive Care Plans) to
determine that it is safe before the resident exercises that right. A resident may only self-
administer medications after the IDT has determined which medications may be self-
administered.

When determining if self-administration is clinically appropriate for a resident, the IDT should at
a minimum consider the following:

• The medications appropriate and safe for self-administration;
• The resident’s physical capacity to swallow without difficulty and to open medication

bottles;
• The resident’s cognitive status, including their ability to correctly name their medications

and know what conditions they are taken for;
• The resident’s capability to follow directions and tell time to know when medications

need to be taken;
• The resident’s comprehension of instructions for the medications they are taking,

including the dose, timing, and signs of side effects, and when to report to facility staff.
• The resident’s ability to understand what refusal of medication is, and appropriate steps

taken by staff to educate when this occurs.
• The resident’s ability to ensure that medication is stored safely and securely.

Appropriate notation of these determinations must be documented in the resident’s medical
record and care plan. If a resident is self-administering medication, review the resident’s record
to verify that this decision was made by the IDT, including the resident. The decision that a
resident has the ability to self-administer medication is subject to periodic assessment by the
IDT, based on changes in the resident’s medical and decision-making status. If self-
administration is determined not to be safe, the IDT should consider, based on the assessment of
the resident’s abilities, options that allow the resident to actively participate in the administration
of their medications to the extent that is safe (i.e., the resident may be assessed as not able to
self-administer their medications because they are not able to manage a locked box in their room,
but they may be able to get the medications from the nurse at a designated location and then
safely self-administer them).

Medication errors occurring with residents who self-administer should not be counted in the
facility’s medication error rate and should not be cited at §483.45(f)(1) F759 and §483.45(f)(2)
F760, Medication Errors. However, this may call into question the judgment of facility staff in
allowing self-administration of medication for that resident.

PROCEDURES AND PROBES §483.10(c)(7)
Determine that facility staff have a process to demonstrate that the resident has taken the self-
administered medication.

• Ask residents if they requested to self-administer medications and if they received a
response.

• How do staff determine if a resident is able to safely self-administer medications?
• If the interdisciplinary team has determined that the resident can safely self-administer

medications, was this request honored?

If the interdisciplinary team was not involved in determining whether the self-administration of
medications was clinically appropriate, cite here at F554. If other concerns related to care
planning are identified, see guidance at §483.21, Comprehensive Person-Centered Care
Planning.

F555
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(d) Choice of Attending Physician.
The resident has the right to choose his or her attending physician.

§483.10(d)(1) The physician must be licensed to practice, and

§483.10(d)(2) If the physician chosen by the resident refuses to or does not meet
requirements specified in this part, the facility may seek alternate physician participation
as specified in paragraphs (d)(4) and (5) of this section to assure provision of appropriate
and adequate care and treatment.

§483.10(d)(3) The facility must ensure that each resident remains informed of the name,
specialty, and way of contacting the physician and other primary care professionals
responsible for his or her care.

§483.10(d)(4) The facility must inform the resident if the facility determines that the
physician chosen by the resident is unable or unwilling to meet requirements specified in
this part and the facility seeks alternate physician participation to assure provision of
appropriate and adequate care and treatment. The facility must discuss the alternative
physician participation with the resident and honor the resident’s preferences, if any,
among options.

§483.10(d)(5) If the resident subsequently selects another attending physician who meets
the requirements specified in this part, the facility must honor that choice.

DEFINITIONS §483.10(d)(1)-(5)
“Attending physician” refers to the primary physician who is responsible for managing the
resident’s medical care. This does not include other physicians whom the resident may see
periodically, such as specialists.

GUIDANCE §483.10(d)(1)-(5)
The right to choose a personal physician does not mean that a resident is required to do so. It also
does not mean that the physician the resident chose is obligated to provide service to the resident.

If a resident or his or her representative declines to designate a personal physician or if a
physician of the resident’s choosing fails to fulfill their responsibilities, as specified in §483.30,
F710, Physician Services, or elsewhere as required in these regulations, facility staff may choose
another physician after informing the resident or the resident’s representative. Before consulting
an alternate physician, the medical director must have a discussion with the attending physician.
Only after a failed attempt to work with the attending physician or mediate differences may
facility staff request an alternate physician.

Facility staff may not interfere in the process by which a resident chooses his or her physician. If
a resident does not have a physician, or if the resident’s physician becomes unable or unwilling
to continue providing care to the resident, facility staff must assist the resident or the resident’s
representative in finding a replacement.

If it is a condition for admission to a nursing home contained within a Continuing Care
Retirement Community (CCRC), the requirement for free choice is met if a resident chooses a
personal physician from among those who have practice privileges at the CCRC.

A resident in a distinct part of a general acute care hospital may choose his or her own physician.
If the hospital requires that physicians who supervise residents in the distinct part have
privileges, then the resident cannot choose a physician who lacks them.

PROBES §483.10(d)(1)-(5)

• Through interviews with facility staff and residents and/or their representatives,
determine how residents or their representative are informed of and are supported in:
o His or her right to choose a physician;
o How to contact their physician and other primary care professionals responsible for

their care;
o His or her options to choose an alternate physician or other primary care professional.

• If his or her physician is unable or not willing to provide necessary care and services,
determine if facility staff worked with the resident to choose another physician.

F556
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

This tag number is in reserve for future use and there will be no citations under this tag.

F557
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.10(e) Respect and Dignity.
The resident has a right to be treated with respect and dignity, including:
§483.10(e)(2) The right to retain and use personal possessions, including furnishings, and
clothing, as space permits, unless to do so would infringe upon the rights or health and
safety of other residents.

INTENT §483.10(e)(2)

All residents’ possessions, regardless of their apparent value to others, must be treated with
respect.

GUIDANCE §483.10(e)(2)

The right to retain and use personal possessions promotes a homelike environment and supports
each resident in maintaining their independence.
If residents’ rooms have few personal possessions, ask residents, their families, or
representative(s), as well as the local ombudsman if:

• Residents are encouraged to have and to use them; and
• Residents may choose to retain personal possessions.

PROCEDURES §483.10(e)(2)

If facility staff refused to allow a resident to retain his or her personal possession(s), determine if
such a restriction was appropriate due to insufficient space, protection of health and safety, and
maintaining other resident rights, and whether the reason for the restriction was communicated to
the resident.

Examples of noncompliance may include, but are not limited to:

• Residents, their representatives, or family members have been discouraged from bringing
personal items to the facility.

• A decision to refuse to allow a resident to retain any personal belongings was not based
on space limitations or on a determination that the rights, health or safety of other
residents would be infringed.

• Facility staff searching a resident’s body or personal possessions without the resident’s
or, if applicable, the resident’s representative’s consent.

It is important for facility staff to have knowledge of signs, symptoms, and triggers of possible
illegal substance use; such as changes in resident behavior, increased unexplained drowsiness,
lack of coordination, slurred speech, mood changes, and/or loss of consciousness, etc. This may
include asking residents, who appear to have used an illegal substance (e.g., cocaine,
hallucinogens, heroin), whether or not they possess or have used an illegal substance.

If the facility determines through observation that a resident may have access to illegal
substances that they have brought into the facility or secured from an outside source, the facility
should not act as an arm of law enforcement. Rather, in accordance with state laws, these cases
may warrant a referral to local law enforcement. To protect the health and safety of residents,
facilities may need to provide additional monitoring and supervision. If facility staff identify
items or substances that pose risks to residents’ health and safety and are in plain view, they may
confiscate them. But, facility staff should not conduct searches of a resident or their personal
belongings, unless the resident, or resident representative agrees to a voluntary search and
understands the reason for the search. For concerns related to the identification of risk and the

provision of supervision to prevent accidental overdose, investigate potential non-compliance at
F689, §483.25(d) – Accidents.

For concerns related to the behavioral health services that are provided, investigate potential non-
compliance at F740, §483.40 – Behavioral Health Services.

F558
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(e)(3) The right to reside and receive services in the facility with reasonable
accommodation of resident needs and preferences except when to do so would endanger the
health or safety of the resident or other residents.

INTENT §483.10(e)(3)
The accommodation of resident needs and preferences is essential to creating an individualized,
home-like environment.

DEFINITIONS §483.10(e)(3)
“Reasonable accommodation of resident needs and preferences” means the facility’s efforts
to individualize the resident’s physical environment.

GUIDANCE §483.10(e)(3)
Reasonable accommodation(s) of resident needs and preferences includes, but is not limited to,
individualizing the physical environment of the resident’s bedroom and bathroom, as well as
individualizing common living areas as much as feasible. These reasonable accommodations
may be directed toward assisting the resident in maintaining and/or achieving independent
functioning, dignity, and well-being to the extent possible in accordance with the resident’s own
needs and preferences.

The environment must reflect the unique needs and preferences of each resident to the extent
reasonable and does not endanger the health or safety of individuals or other residents.

Common areas frequented by residents should accommodate residents’ physical limitations.
Furnishings in common areas may enhance residents’ abilities to maintain their independence.
Resident seating should have appropriate seat height, depth, firmness, and with arms that assist
residents to independently rise to a standing position. Functional furniture must be arranged to
accommodate residents’ needs and preferences.

PROCEDURES §483.10(e)(3)
Observe residents in their rooms and common areas and interview residents, if possible, to
determine if their environment accommodates their needs and preferences. Observe
staff/resident interactions to determine if staff interact in a manner that a resident with limited
sight or hearing can see and hear them. Determine if staff keep needed items within the
resident’s reach and provide necessary assistance to help maintain the resident’s independence.
Determine if the resident has the call system within reach and is able to use it if desired.

Examples of noncompliance may include, but are not limited to:

• Storing a wheelchair or other adaptive equipment out of reach of a resident who is
otherwise able to use them independently, such as a wheelchair stored across the room
for a resident who is able to self-transfer or storing eyeglasses out of reach for a resident.

• Having areas of worship inaccessible to residents with mobility limitations.
• Not providing a riser on a toilet to maintain independence.

F559
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(e)(4) The right to share a room with his or her spouse when married residents live
in the same facility and both spouses consent to the arrangement.

§483.10(e)(5) The right to share a room with his or her roommate of choice when
practicable, when both residents live in the same facility and both residents consent to the
arrangement.

§483.10(e)(6) The right to receive written notice, including the reason for the change,
before the resident’s room or roommate in the facility is changed.

GUIDANCE §483.10(e)(4)-(6)

Residents have the right to share a room with whomever they wish, as long as both residents are
in agreement. These arrangements could include opposite-sex and same-sex married couples or
domestic partners, siblings, or friends.

There are some limitations to these rights. Residents do not have the right to demand that a
current roommate is displaced in order to accommodate the couple that wishes to room together.
In addition, residents are not able to share a room if one of the residents has a different payment
source for which the facility is not certified (if the room is in a distinct part of the facility, unless
one of the residents elects to pay privately for his or her care) or one of the individuals is not
eligible to reside in a nursing home.

Moving to a new room or changing roommates is challenging for residents. A resident’s
preferences should be taken into account when considering such changes. When a resident is
being moved at the request of facility staff, the resident, family, and/or resident representative
must receive an explanation in writing of why the move is required. The resident should be
provided the opportunity to see the new location, meet the new roommate, and ask questions
about the move.

A resident receiving a new roommate should be given as much advance notice as possible. The
resident should be supported when a roommate passes away by providing time to adjust before
moving another person into the room. The length of time needed to adjust may differ depending
upon the resident. Facility staff should provide necessary social services for a resident who is
grieving over the death of a roommate.

If the survey team identifies potential compliance issues related to social services, refer to
§483.40(d), F745, Social Services.

F560
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(e)(7) The right to refuse to transfer to another room in the facility, if the purpose
of the transfer is:

(i) to relocate a resident of a SNF from the distinct part of the institution that is a SNF
to a part of the institution that is not a SNF, or

(ii) to relocate a resident of a NF from the distinct part of the institution that is a NF to
a distinct part of the institution that is a SNF.

(iii) solely for the convenience of staff.

§483.10(e)(8) A resident’s exercise of the right to refuse transfer does not affect the
resident’s eligibility or entitlement to Medicare or Medicaid benefits.

DEFINITIONS §483.10(e)(7)-(8)
“Campus”: Under §413.65(a)(2), ”Campus means the physical area immediately adjacent to the
provider’s main buildings, other areas and structures that are not strictly contiguous to the main
buildings but are located within 250 yards of the main buildings, and any other areas determined
on an individual case basis, by the CMS regional office, to be part of the provider’s campus.”

“Composite distinct part”: Under §483.5, a composite distinct part is a type of distinct part
SNF or NF consisting of two or more noncontiguous components that are not located within the
same campus, as that term is defined in §413.65(a)(2).

“Distinct Part”: A distinct part SNF or NF is part of a larger institution or institutional
complex. The distinct part SNF or NF is physically distinguishable from the larger institution or
complex and may be comprised of one or more buildings or parts of buildings (such as wings,
wards, or floors). Distinct part SNFs or NFs must be immediately adjacent or in close proximity
to the institution’s main buildings. CMS may determine, on an individual basis that other areas
are part of the institution’s campus and considered to be a distinct part SNF or NF. A distinct
part SNF or NF must include all of the beds within the designated area, and cannot consist of a
random collection of individual rooms or beds that are scattered throughout the physical plant.
The term “distinct part” also includes composite distinct part SNFs or NFs. Additional
requirements specific to distinct part SNFs or NFs are found at §483.5.

GUIDANCE §483.10(e)(7)-(8)

A resident can decline relocation from a room in one institution’s distinct part SNF or NF to a
room in another institution’s distinct part SNF or NF for purposes of obtaining Medicare or
Medicaid eligibility. Facility staff are responsible for notifying the resident or resident
representative of changes in eligibility for Medicare or Medicaid covered services and of what
the resident’s financial responsibility may be. If the resident is unable to pay for those services,
then after giving the resident a discharge notice, the resident may be transferred or discharged
under the provisions of §483.15(b), F621, Equal Access to Quality Care.

When a resident occupies a bed in a distinct part NF that is certified to participate in Medicaid
only and not in Medicare, he or she may not be moved involuntarily (or required to be moved by
the State) from that distinct part NF to another part of the larger institution (e.g., hospital or
intermediate care facility for individuals with intellectual disabilities) that houses the distinct part
solely for the purpose of assuring eligibility for Medicare payments. Such moves are only
appropriate only when they occur at the request of a resident.

A resident also has the right to refuse transfer if that transfer is solely for the convenience of
staff. For example, a resident may experience a change in condition that requires additional care.
Facility staff may wish to move the resident to another room with other residents who require a
similar level of services, because it is easier for staff to care for residents with similar needs. The
resident would have the right to stay in his or her room and refuse this transfer.

PROBES §483.10(e)(7)-(8)
For residents moved between Medicare or Medicaid approved distinct parts:

• Was the resident moved to a different room because of a change in payment source or
staff convenience?

• Did facility staff give the resident the opportunity to refuse the transfer?

POTENTIAL TAGS FOR ADDITIONAL CONSIDERATION

• 42 CFR §483.10(e)(6), F559, Notification of Roommate Change.
o Determine if the resident received prior notification of a room change.

• 42 CFR §483.10(g)(17), F582, Medicare/Medicaid Coverage.
o Determine if the resident was notified of changes in eligibility for Medicare or

Medicaid covered services, what the resident’s financial responsibility may be, and
their appeal rights.

• For additional guidance regarding admission to, discharges, or transfers from a SNF or
NF, including bed-hold policies and therapeutic leave, see §483.15, F620 Admission,
Transfer, and Discharge Rights.

F561
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.10(f) Self-determination.

The resident has the right to and the facility must promote and facilitate resident self-
determination through support of resident choice, including but not limited to the rights
specified in paragraphs (f)(1) through (11) of this section.

§483.10(f)(1) The resident has a right to choose activities, schedules (including sleeping and
waking times), health care and providers of health care services consistent with his or her
interests, assessments, and plan of care and other applicable provisions of this part.

§483.10(f)(2) The resident has a right to make choices about aspects of his or her life in the
facility that are significant to the resident.

§483.10(f)(3) The resident has a right to interact with members of the community and
participate in community activities both inside and outside the facility.

§483.10(f)(8) The resident has a right to participate in other activities, including social,
religious, and community activities that do not interfere with the rights of other residents
in the facility.

INTENT §483.10(f)(1)-(3) and (8)
The intent of this requirement is to ensure that each resident has the opportunity to exercise his
or her autonomy regarding those things that are important in his or her life. This includes the
residents’ interests and preferences.

GUIDANCE §§483.10(f)(1)-(3), (8)
It is important for residents to have a choice about which activities they participate in, whether
they are part of the formal activities program or self-directed. Additionally, a resident’s needs
and choices for how he or she spends time, both inside and outside the facility, should also be
supported and accommodated, to the extent possible, including making transportation
arrangements.

Residents have the right to choose their schedules, consistent with their interests, assessments,
and care plans. This includes, but is not limited to, choices about the schedules that are important
to the resident, such as waking, eating, bathing, and going to bed at night. Choices about
schedules and ensuring that residents are able to get enough sleep is an important contributor to
overall health and well-being. Residents also have the right to choose health care schedules
consistent with their interests and preferences, and information should be gathered to proactively
assist residents with the fulfillment of their choices. Facilities must not develop a schedule for
care, such as waking or bathing schedules, for staff convenience and without the input of the
residents.

Examples that demonstrate the support and accommodation of resident goals, preferences, and
choices include, but are not limited to:

• If a resident shares that attendance at family gatherings or external community events is
of interest to them, the resident’s goals of attending these events should be
accommodated, to the extent possible.

• If a resident mentions that his or her therapy is scheduled at the time of a favorite

television program, the resident’s preference should be accommodated, to the extent
possible.

• If a resident refuses a bath because he or she prefers a shower or a different bathing

method, such as in-bed bathing, prefers to bathe at a different time of day or on a
different day, does not feel well that day, is uneasy about the aide assigned to help or is
worried about falling, the resident’s preferences must be accommodated.

If a facility changes its policy to prohibit smoking (including electronic cigarettes), it should
allow current residents who smoke to continue smoking in an area that maintains the quality of
life for these residents and takes into account non-smoking residents. The smoking area may be
an outside area provided that residents remain safe. Residents admitted after the facility changes
its policy must be informed of this policy at admission. (See §483.10(g)(1) and §483.10(g)(16))
For further explanation of safety concerns, refer to §483.25(d), F689. For information on
smoking policies, refer to §483.90(i)(5), F926.

PROCEDURES §483.10(f)(1)-(3) and (8)

During interviews with residents or their family and/or representative(s), determine if they are
given the opportunity to choose and whether facility staff accommodate his or her preferences
for:

• Activities that interest them;
• Their sleep cycles;
• Their bathing times and methods;
• Their eating schedule;
• Their health care options; and
• Any other area significant to the resident.

Interview facility staff about what the resident’s goals, preferences, and choices are and the
location of that information. Interview facility staff to determine how they sought information
from the resident’s family and/or representative(s) regarding a resident’s preferences and choices
for residents who are unable to express their choices. Additionally, the resident’s preferences
should be accommodated by facility staff and reflected through adjustments in the care plan.
Ask the social worker or other appropriate staff how they help residents pursue activities outside
the facility.

Examples of noncompliance may include, but are not limited to:

• Residents are not given the opportunity to choose activities that interest them.
• Facility staff have a set schedule for waking residents or putting residents in bed, without

consideration of resident preference.
• Facility staff have a practice of showering all residents when a bath is available and

preferred by a resident.
• Residents are not afforded the opportunity to choose among offered healthcare options.

• Restriction of any one of these rights are placed on any resident, including a justice
involved resident solely based on their status as a justice involved individual, without
consideration of how exercising their rights affected the rights of other residents.

POTENTIAL TAGS FOR ADDITIONAL CONSIDERATION

• If other concerns are identified regarding justice involved residents, see §483.10(a),
F550, Resident Rights for further guidance.

• For issues regarding a resident’s accommodation of needs, see §483.10(e)(3), F558.
• For issues related to resident visitation, see §483.10(f)(4)(ii)-(v), F563.
• If it is determined a resident’s preferences is not honored due to possible concerns with

insufficient numbers of staff or staff competencies, see §483.35(a), F725, Sufficient
Nursing Staff.

F562
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(f)(4)(i) The facility must provide immediate access to any resident by:

(A) Any representative of the Secretary,
(B) Any representative of the State,
(C) Any representative of the Office of the State long term care ombudsman,

(established under section 712 of the Older Americans Act of 1965, as amended 2016
(42 U.S.C. 3001 et seq.),

(D) The resident’s individual physician,
(E) Any representative of the protection and advocacy systems, as designated by the

state, and as established under the Developmental Disabilities Assistance and Bill of
Rights Act of 2000 (42 U.S.C. 15001 et seq),

(F) Any representative of the agency responsible for the protection and advocacy
system for individuals with mental disorder (established under the Protection and
Advocacy for Mentally Ill Individuals Act of 2000 (42 U.S.C. 10801 et seq.), and

(G) The resident representative.

GUIDANCE §483.10(f)(4)(i)
The facility must provide immediate access to the resident by the resident’s physician,
representative, and various state and federal officials and organizations as outlined in the
regulation, which would include state and federal surveyors.

Surveyors are considered representatives of the Secretary and/or the State. Facility staff cannot
prohibit surveyors from talking to residents, family members, and resident representatives.

NOTE: If facility staff attempt to interfere with the survey process and restrict a surveyor’s
ability to gather necessary information to determine compliance with requirements, surveyors
should consult with the CMS Regional Office.

F563
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.10(f)(4) The resident has a right to receive visitors of his or her choosing at the time of
his or her choosing, subject to the resident’s right to deny visitation when applicable, and
in a manner that does not impose on the rights of another resident.

(ii) The facility must provide immediate access to a resident by immediate family and
other relatives of the resident, subject to the resident’s right to deny or withdraw
consent at any time;
(iii) The facility must provide immediate access to a resident by others who are visiting
with the consent of the resident, subject to reasonable clinical and safety restrictions
and the resident’s right to deny or withdraw consent at any time;
(iv) The facility must provide reasonable access to a resident by any entity or individual
that provides health, social, legal, or other services to the resident, subject to the
resident’s right to deny or withdraw consent at any time; and
(v) The facility must have written policies and procedures regarding the visitation
rights of residents, including those setting forth any clinically necessary or reasonable
restriction or limitation or safety restriction or limitation, when such limitations may
apply consistent with the requirements of this subpart, that the facility may need to
place on such rights and the reasons for the clinical or safety restriction or limitation.

GUIDANCE §483.10(f)(4)(ii)-(v)

“Reasonable clinical and safety restrictions” include a facility’s policies, procedures or
practices that protect the health and security of all residents and staff. These may include, but are
not be limited to:

• Restrictions placed to prevent community-associated infection or communicable disease
transmission to one or more residents. A resident’s risk factors for infection (e.g.,
immunocompromised condition) or current health state (e.g., end-of-life care) should be
considered when restricting visitors.

• In general, visitors with signs and symptoms of a transmissible infection (e.g., a visitor is
febrile and exhibiting signs and symptoms of an influenza-like illness) should defer
visitation until he or she is no longer potentially infectious (e.g., 24 hours after resolution
of fever without antipyretic medication), or according to CDC guidelines, and/or local
health department recommendations.

• Keeping the facility locked or secured at night with a system in place for allowing

visitors approved by the resident;

• Denying access or providing limited and supervised access to an individual if that
individual is suspected of abusing, exploiting, or coercing a resident until an investigation
into the allegation has been completed or has been found to be abusing, exploiting, or
coercing a resident;

• Denying access to individuals who have been found to have been committing criminal
acts such as theft;

• Denying access to individuals who are inebriated or disruptive; or

• Denying access or providing supervised visitation to individuals who have a history of
bringing illegal substances into the facility which places residents’ health and safety at
risk.

Visitation Considerations During a Communicable Disease Outbreak

Facilities may need to modify their visitation practices when there are infectious outbreaks or
pandemics to align with current CMS guidance and CDC guidelines that enables maximum
visitation, such as by:

• Offering options for outdoor or virtual visitation, or indoor designated visitation areas

• Providing adequate signage with instructions for infection prevention, i.e. hand hygiene,
cough etiquette, etc.

• Ensuring access to hand hygiene supplies

• Taking other actions that would allow visitation to continue to occur safely in spite of the
presence of a contagious infection

• Contacting their local health authorities for guidance or direction on how to structure

their visitation to reduce the risk of communicable disease transmission during an
outbreak

During an infectious disease outbreak, while not recommended, residents who are on
transmission-based precautions (TBP) can still receive visitors. In these cases, before visiting
residents who are on TBP, visitors should be made aware of the potential risk of visiting and
precautions necessary in order to visit the resident. Visitors should adhere to principles of
infection prevention.

For purposes of this regulation, immediate family is not restricted to individuals united by blood,
adoptive, or marital ties, or a State’s common law equivalent. It is important to understand that
there are many types of families, each of which being equally viable as a supportive, caring unit.
For example, it might also include a foster family where one or more adult serves as a temporary
guardian for one or more children to whom they may or may not be biologically related.

Residents have the right to define their family. During the admissions process, facility staff
should discuss this issue with the resident. If the resident is unable to express or communicate
whom they identify as family, facility staff should discuss this with the resident’s representative.

Resident’s family members are not subject to visiting hour limitations or other restrictions not
imposed by the resident, with the exception of reasonable clinical and safety restrictions,
consistent with §483.10(f)(4)(v), placed by the facility based on recommendations of CMS,
CDC, or the local health department. With the consent of the resident, facilities must provide 24-
hour access to other non-relative visitors, subject to reasonable clinical and safety restrictions.
Visitation should be person-centered, consider the residents’ physical, mental, and psychosocial
well-being, and support their quality of life.

If these familial visitation rights infringe upon the rights of other residents, facility staff must
find a location other than a resident’s room for visits. For example, if a resident’s family visits in
the late evening when the resident’s roommate is asleep, then the visit should take place
somewhere other than their shared room so that the roommate is not disturbed.

Individuals who provide health, social, legal, or other services to the resident have the right of
reasonable access to the resident. Facility staff must provide space and privacy for such visits.

Visitation and Illegal Substance Use

It is important for facility staff to have knowledge of signs, symptoms, and triggers of possible
illegal substance use such as changes in resident behavior, particularly after interaction with
visitors or leaves of absence, increased unexplained drowsiness, lack of coordination, slurred
speech, mood changes, and/or loss of consciousness, etc. Following such occurrences, this may
include asking residents, who appear to have used an illegal substance (e.g., cocaine,
hallucinogens, heroin), whether or not they possess or have used an illegal substance.

If the facility determines illegal substances have been brought into the facility by a visitor, the
facility should not act as an arm of law enforcement. Rather, in accordance with state laws, these
cases may warrant a referral to local law enforcement. To protect the health and safety of
residents, facilities may need to provide additional monitoring and supervision. Additionally,
facility staff should not conduct searches of a resident or their personal belongings, unless the
resident or resident representative agrees to a voluntary search and understands the reason for the
search. For concerns related to the identification of risk and the provision of supervision to
prevent accidental overdose, investigate potential non-compliance at F689, §483.25(d) –
Accidents.

For concerns related to the behavioral health services that are provided, investigate potential non-
compliance at F740, §483.40 – Behavioral Health Services.

PROCEDURES §483.10(f)(4)(ii)-(v)

• Through interviews with residents, their representative, family members, visitors and
others as permitted under this requirement, determine if they know that they are able to
visit 24-hours a day, subject to a resident’s choice and reasonable restrictions as defined
above.

• Review the facility’s written visitation policy and procedures to determine whether they
support the resident’s right to visitors and whether they explain those situations where
visitors may be restricted due to clinical or safety concerns.

• If a concern is identified, interview facility staff to determine how they ensure 24-hour or
immediate access as permitted under these requirements.

Examples of noncompliance may include, but are not limited to:

• Facility staff restrict visitors according to the facility’s convenience.
• Facility staff restrict the rights of a resident to receive visitors, even though this would

not affect the rights of other residents.
• Facility staff restrict visitors based on expressed wishes of an individual who is a health

care power of attorney who does not have the authority to restrict visitation.
• A posting or inclusion in the resident handbook or other information provided by the

facility, of visiting hours not in compliance with this regulation.

F564
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(f)(4)(vi) A facility must meet the following requirements:

(A) Inform each resident (or resident representative, where appropriate) of his or her
visitation rights and related facility policy and procedures, including any clinical or
safety restriction or limitation on such rights, consistent with the requirements of
this subpart, the reasons for the restriction or limitation, and to whom the
restrictions apply, when he or she is informed of his or her other rights under this
section.

(B) Inform each resident of the right, subject to his or her consent, to receive the
visitors whom he or she designates, including, but not limited to, a spouse (including
a same-sex spouse), a domestic partner (including a same-sex domestic partner),
another family member, or a friend, and his or her right to withdraw or deny such
consent at any time.

(C) Not restrict, limit, or otherwise deny visitation privileges on the basis of race, color,
national origin, religion, sex, gender identity, sexual orientation, or disability.

(D) Ensure that all visitors enjoy full and equal visitation privileges consistent with
resident preferences.

GUIDANCE §483.10(f)(4)(vi)
All residents have the right to visitors in accordance to their preferences. The facility policy for
restricting or limiting visitors must be communicated to the resident. If limitations are placed on
a resident’s visitation rights, the clinical or safety reasons for the limitations and the specific
individuals the restriction applies to must be communicated to the resident or resident
representative in a manner he or she understands.

Facility staff may not place limitations on a resident based solely on their status as a justice
involved resident or as a part of restrictive law enforcement requirements, such as conditions of
probation or parole. See §483.10(a), F550, Resident Rights for guidance on justice involved
residents.

PROCEDURES §483.10(f)(4)(vi)
Through interviews with residents and/or their representatives, determine how they were
informed of their visitation rights and related policies and procedures, including their right to
consent to receive or deny visitors he or she designates, any clinical or safety restriction, or
limitation on such rights imposed by the facility.

Determine if the facility has ensured visitation rights consistent with resident preference.

Examples of noncompliance may include, but are not limited to:

• Prohibiting a resident from having visits from his or her spouse or domestic partner,
including a same-sex spouse or partner.

• Facility staff did not inform a resident, the family, and/or resident representative of their
visitation rights, including any restrictions or limitations of these rights that may be
imposed by the facility or the resident, the family, and/or resident representative;

• Facility staff denied, limited or restricted a resident’s visitation privileges contrary to
their choices, even though there were no clinical or safety reasons for doing so.

F565
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(f)(5) The resident has a right to organize and participate in resident groups in the
facility.

(i) The facility must provide a resident or family group, if one exists, with private space;
and take reasonable steps, with the approval of the group, to make residents and
family members aware of upcoming meetings in a timely manner.

(ii) Staff, visitors, or other guests may attend resident group or family group meetings
only at the respective group’s invitation.

(iii) The facility must provide a designated staff person who is approved by the resident
or family group and the facility and who is responsible for providing assistance and
responding to written requests that result from group meetings.

(iv) The facility must consider the views of a resident or family group and act promptly
upon the grievances and recommendations of such groups concerning issues of
resident care and life in the facility.
(A) The facility must be able to demonstrate their response and rationale for such

response.
(B) This should not be construed to mean that the facility must implement as

recommended every request of the resident or family group.

§483.10(f)(6) The resident has a right to participate in family groups.

§483.10(f)(7) The resident has a right to have family member(s) or other resident
representative(s) meet in the facility with the families or resident representative(s) of other
residents in the facility.

DEFINITIONS §483.10(f)(5)-(7)
“A resident or family group” is defined as a group of residents or residents’ family members
that meets regularly to:

• Discuss and offer suggestions about facility policies and procedures affecting residents’
care, treatment, and quality of life;

• Support each other;
• Plan resident and family activities;
• Participate in educational activities; or
• For any other purpose.

GUIDANCE §483.10(f)(5)-(7)
This requirement does not require that residents organize a resident or family group. However,
whenever residents or their families wish to organize, they must be able to do so without
interference. Additionally, they must be provided space, privacy for meetings, and staff support.
The designated staff person responsible for assistance and liaison between the group and the
facility’s administration and any other staff members may attend the meeting only if invited by
the resident or family group. The resident or family group may meet without staff present. The
groups should determine how frequently they meet.

Facility staff are required to consider resident and family group views and act upon grievances
and recommendations. Facility staff must consider these recommendations and attempt to
accommodate them, to the extent practicable. This may include developing or changing policies
affecting resident care and life. Facility staff should discuss its decisions with the resident and/or
family group and document in writing its response and rationale as required under 42 CFR
§483.10(j), F585, Grievances.

PROCEDURES §483.10(f)(5)-(7)
During the entrance interview, determine:

• If there is a resident or family group;
• Who the resident or family representative is for each of these groups; and,
• Who the designated staff person is for assisting and working with each of these groups.

If residents or their families attempted to organize a group and were unsuccessful, why?

Through interviews with the representatives for the resident and family groups and staff
designated for assisting and working with these groups, determine:

• Are groups able to meet without staff present unless desired?
• If a resident wants a family member present during a resident group meeting, how is this

handled? Facility staff should not require said family member to leave the group
meeting, without the permission of the group.

• How views, grievances or recommendations from these groups are considered, addressed
and acted upon; and,

• How facility staff provide responses, actions, and rationale to the groups.

Examples of noncompliance may include, but are not limited to:

• Facility staff impede or prevent residents or family members ability to meet or organize a
resident or family group;

• Resident and/or families were not always informed in advance of upcoming meetings.
• Facility staff impede with meetings and/or operations of family or resident council by

mandating that they have a staff person in the room during meetings or assigning a staff
person to liaise with the council that is not agreeable to the council;

• Private meeting space for these groups is not provided;
• The views, grievances or recommendations from these groups have not been considered

or acted upon by facility staff;
• Facility staff does not provide these groups with responses, actions, and rationale taken

regarding their concerns;
• Facility staff are not able to demonstrate their response and rationale to grievances;
• Facility staff prevent family members or representatives from meeting with those of

another resident.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION
For concerns regarding the handling of individual grievances, refer to §483.10(j), F585,
Grievances.

F566
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(f)(9) The resident has a right to choose or refuse to perform services for the facility
and the facility must not require a resident to perform services for the facility. The resident
may perform services for the facility, if he or she chooses, when—

(i) The facility has documented the resident’s need or desire for work in the plan of
care;

(ii) The plan specifies the nature of the services performed and whether the services are
voluntary or paid;

(iii) Compensation for paid services is at or above prevailing rates; and
(iv) The resident agrees to the work arrangement described in the plan of care.

DEFINITIONS §483.10(f)(9)
“Prevailing rate” is the wage paid to the majority of workers in the community surrounding the
facility for the same type, quality, and quantity of work requiring comparable skills.

GUIDANCE §483.10(f)(9)
All work or services provided by a resident, whether voluntary or paid, must be part of his/her
care plan. Any work assignment must be agreed to and negotiated by the resident or the
resident’s representative. The resident also has the right to refuse to participate in these services
or assignments at any time.

A resident’s request to work or perform services should be discussed by the interdisciplinary
team and be clinically and psychologically appropriate for the resident.

PROCEDURES §483.10(f)(9)

• Through interviews with residents, resident representatives, and staff, determine if
residents were given a choice as to whether or not they were willing to perform services.

• During observations, note whether residents are engaged in performing these services
(such as housekeeping, laundry, meal set up, etc.).

• Review the resident’s care plan to ensure it includes;
o The nature of the services to be provided, including the resident’s desire to do so, and

the objectives for this arrangement; and,
o Whether they are provided voluntarily or paid.

Examples of noncompliance may include, but are not limited to:

• The resident or his or her representative did not agree to the work arrangements;
• The resident’s care plan does not specify the nature of the services provided by the

resident or whether or not they are voluntary or paid; or
• Compensation for paid services is not at or above prevailing rates.

F567
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(f)(10) The resident has a right to manage his or her financial affairs. This includes
the right to know, in advance, what charges a facility may impose against a resident’s
personal funds.

(i) The facility must not require residents to deposit their personal funds with the
facility. If a resident chooses to deposit personal funds with the facility, upon written
authorization of a resident, the facility must act as a fiduciary of the resident’s funds
and hold, safeguard, manage, and account for the personal funds of the resident
deposited with the facility, as specified in this section.

(ii) Deposit of Funds.
(A) In general: Except as set out in paragraph (f)( l0)(ii)(B) of this section, the

facility must deposit any residents’ personal funds in excess of $100 in an interest
bearing account (or accounts) that is separate from any of the facility’s operating
accounts, and that credits all interest earned on resident’s funds to that account.
(In pooled accounts, there must be a separate accounting for each resident’s
share.) The facility must maintain a resident’s personal funds that do not exceed
$100 in a non-interest bearing account, interest-bearing account, or petty cash
fund.

(B) Residents whose care is funded by Medicaid: The facility must deposit the
residents’ personal funds in excess of $50 in an interest bearing account (or
accounts) that is separate from any of the facility’s operating accounts, and that
credits all interest earned on resident’s funds to that account. (In pooled
accounts, there must be a separate accounting for each resident’s share.) The
facility must maintain personal funds that do not exceed $50 in a noninterest
bearing account, interest-bearing account, or petty cash fund.

INTENT §483.10(f)(10)(i)-(ii)
To assure residents who have authorized the facility in writing to manage any personal funds
have ready and reasonable access to those funds.

DEFINITIONS §483.10(f)(10)(i)-(ii)
“Hold, safeguard, manage, and account for” means that the facility must act as fiduciary of
the resident’s funds and report at least quarterly on the status of these funds in a clear and
understandable manner. Managing the resident’s financial affairs includes money that an
individual gives to the facility for the sake of providing a resident with a non-covered service. In
these instances, the facility will provide a receipt to the gift giver and retain a copy.

“Interest bearing” means a rate of return equal to or above the rate at local banking institutions
in the area. If pooled accounts are used, interest must be prorated per individual on the basis of
actual earnings or end-of quarter balance.

GUIDANCE §483.10(f)(10)(i)-(ii)
If a resident or resident representative chooses to have the facility manage the resident’s funds,
facility staff may not refuse to handle these funds. Facility staff are not expected to be familiar
with resident assets not on deposit with the facility.

Placement of residents’ personal funds of less than $100.00 ($50.00 for Medicaid residents) in an
interest bearing account is permitted. Thus, a facility may place the total amount of a resident’s
funds, including funds of $100.00 ($50.00 for Medicaid residents) or less, into an interest-
bearing account. The law and regulations are intended to assure that residents have access to
$100.00 ($50.00 for Medicaid residents) in cash within a reasonable period of time, when
requested. Requests for less than $100.00 ($50.00 for Medicaid residents) should be honored
within the same day. Requests for $100.00 ($50.00 for Medicaid residents) or more should be
honored within three banking days. Although the facility need not maintain $100.00 ($50.00 for
Medicaid residents) per resident on its premises, it is expected to maintain amounts of petty cash
on hand that may be required by residents.

If pooled accounts are used, interest must be prorated per individual on the basis of actual
earnings or end-of quarter balance.

Residents should have access to petty cash on an ongoing basis and be able to arrange for access
to larger funds. Although the facility need not maintain $100.00 ($50.00 for Medicaid residents)
per resident on its premises, it is expected to maintain petty cash on hand to honor resident
requests.

Resident requests for access to their funds should be honored by facility staff as soon as possible
but no later than:

• The same day for amounts less than $100.00 ($50.00 for Medicaid residents);
• Three banking days for amounts of $100.00 ($50.00 for Medicaid residents) or more.

Residents may make requests that the facility temporarily place their funds in a safe place,
without authorizing the facility to manage those funds. The facility must have a system to
document the date, time, amount, and who the funds were received from or dispersed to.

The facility must have systems in place to safeguard against any misappropriation of a resident’s
funds.

NOTE: Banks may charge the resident a fee for handling their funds and pass this fee on to

the resident(s). Facilities may not charge residents for managing residents’ funds
because the services are covered by Medicare or Medicaid or by the facility’s per
diem rate. Monies due residents should be credited to their respective bank accounts
within a few business days.

PROCEDURES §483.10(f)(10)(i)-(ii)
Interview:

• Residents and/or their representatives to determine if they have experienced problems
with the facility’s management of their personal funds.

• Residents and/or their representatives to determine if they have ready access to their
personal funds.

• Facility staff to determine how they manage, account for, and safeguard a resident’s
funds.

To assure facility staff are not using oral requests by residents as a way to avoid obtaining
written authorization to hold, manage, safeguard and account for resident’s funds, ensure:

• Facility staff provide the resident a receipt for these funds and retains a copy for its
records.

Review the facility records for residents selected for a comprehensive review who have
authorized the facility to handle their personal funds.

• Are residents’ funds over $100.00 ($50.00 for Medicaid residents) or, at the facility’s
option, all resident funds, in an interest bearing account(s)?

• What procedure was followed when residents requested their funds?
• How long does it take for residents to receive: (a) petty cash allotments; (b) funds

needing to be withdrawn from bank accounts?
• Were limits placed on amounts that could be withdrawn? If yes, was the reason based on

resident care needs or facility convenience?
• Are funds records treated with privacy as required at F583?

Examples of noncompliance may include, but are not limited to:

• Requiring residents to deposit their personal funds with the facility;
• Not crediting all interest earned on a resident’s funds to the resident’s account;
• Disbursing the resident’s funds to anyone without the resident’s or the resident

representative’s permission;
• Not providing a resident access to their funds as soon as possible.

F568
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(f)(10)(iii) Accounting and Records.

(A) The facility must establish and maintain a system that assures a full and complete
and separate accounting, according to generally accepted accounting principles, of
each resident’s personal funds entrusted to the facility on the resident’s behalf.

(B) The system must preclude any commingling of resident funds with facility funds or
with the funds of any person other than another resident.

GUIDANCE §483.10(f)(10)(iii)
Generally accepted accounting principles means that facility staff employ proper bookkeeping
techniques, by which it can determine, upon request, the amount of individual resident funds and,
in the case of an interest bearing account, how much interest these funds have earned for each
resident, as last reported by the banking institution to the facility.

Proper bookkeeping techniques include an individual record established for each resident on
which only those transactions involving his or her personal funds are recorded and maintained.
The record should have information on when transactions occurred, what they were, and
maintain the ongoing balance for every resident. For each transaction, the resident should be
given a receipt and the facility retains a copy.

Quarterly statements must be provided in writing to the resident or the resident’s representative
within 30 days after the end of the quarter, and upon request.

PROCEDURES §483.10(f)(10)(iii)
Through interviews with the resident or his or her representative, determine how they receive
statements regarding the status of their funds and accounts. If concerns arise based on these
interviews, review the facility’s records to determine if generally accepted accounting principles
are followed. Records must show separate accounting for each resident, including the ongoing
balance of each account, as well as the date and amount of any transaction. Additionally, the
facility’s records must include a copy of all account transactions.

Examples of noncompliance may include, but are not limited to evidence that the facility:

• Does not maintain a system that assures a complete and separate accounting of each
resident’s personal funds.

• Comingles resident funds with facility funds (for example, comingling an activity fund,
volunteer fund, and resident personal funds into one account).

• Comingles resident funds with those of someone other than a resident, such as a facility
staff member managing a resident’s personal funds through the facility staff member’s
personal bank account.

• Does not provide a financial record or quarterly statement to the resident or his or her
representative.

F569
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(f)(10)(iv) Notice of certain balances.
The facility must notify each resident that receives Medicaid benefits—

(A) When the amount in the resident’s account reaches $200 less than the SSI resource
limit for one person, specified in section 1611(a)(3)(B) of the Act; and

(B) That, if the amount in the account, in addition to the value of the resident’s other
nonexempt resources, reaches the SSI resource limit for one person, the resident
may lose eligibility for Medicaid or SSI.

§483.10(f)(10)(v) Conveyance upon discharge, eviction, or death.
Upon the discharge, eviction, or death of a resident with a personal fund deposited with the
facility, the facility must convey within 30 days the resident’s funds, and a final accounting
of those funds, to the resident, or in the case of death, the individual or probate jurisdiction
administering the resident’s estate, in accordance with State law.

PROCEDURES §483.10(f)(10)(iv)-(v)

• As part of closed record review, determine if within 30 days of discharge, eviction, or
death, facility staff conveyed the resident’s personal funds and a final accounting to the
individual or probate jurisdiction administering the individual’s estate as provided by
State law.

• Through interviews with the resident or his or her representative, determine if they lost
their SSI or Medicaid eligibility and whether this loss was a result of the facility’s staff
failure to notify them as required in this regulation.

F570
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(f)(10)(vi) Assurance of financial security.
The facility must purchase a surety bond, or otherwise provide assurance satisfactory to
the Secretary, to assure the security of all personal funds of residents deposited with the
facility.

DEFINITION §483.10(f)(10)(vi)
“Surety bond” is an agreement between the principal (the facility), the surety (the insurance
company), and the obligee (depending on State law, either the resident or the State acting on
behalf of the resident), wherein the facility and the insurance company agree to compensate the
resident (or the State on behalf of the resident) for any loss of residents’ funds that the facility
holds, safeguards, manages, and accounts for.

GUIDANCE §483.10(f)(10)(vi)

The purpose of the surety bond is to guarantee that the facility will pay the resident (or the State
on behalf of the resident) for losses occurring from any failure by the facility to hold, safeguard,
manage, or account for the resident’s funds (for example, losses occurring as a result of acts or
errors of negligence, incompetence, or dishonesty). The surety bond protects the resident or the
State, not the facility, from loss. It differs from a fidelity bond, which covers no acts or errors of
negligence, incompetence, or dishonesty. The surety bond is the commitment of the facility in
an objective manner that the facility will hold, safeguard, manage and account for the personal
funds residents have deposited with the facility. The facility assumes the responsibility to
compensate the resident or the State for the amount of the loss up to the entire amount of the
surety bond.

The surety bond is not limited to personal needs allowance funds. Any resident funds that are
entrusted to the facility for a resident must be covered by the surety bond, including refundable
deposit fees.

The facility cannot be named as a beneficiary.

Self-insurance is not an acceptable alternative to a surety bond. Likewise, funds deposited in
bank accounts protected by the Federal Deposit Insurance Corporation, or similar entity, also are
not acceptable alternatives.

PROCEDURES §483.10(f)(10)(vi)
Through interviews with residents or their representative, determine if they were compensated
for losses occurring from any failure by facility staff to hold, safeguard, manage, or account for
the residents’ funds (for example, losses occurring as a result of acts or errors of negligence,
incompetence, or dishonesty). If concerns arise based on these interviews, review the facility’s
records to determine whether these concerns are substantiated.

If the State survey agency determines that individual circumstances associated with a facility’s
surety bond or its alternative are such that the survey agency cannot determine whether or not the
facility is in compliance with these requirements, then it would be appropriate to make the
referral to the State’s fiscal department.

If a corporation has a surety bond that covers all of its facilities, there should be a separate
review of the corporation’s surety bond by the appropriate State agency, such as the State’s fiscal
department, to ensure that all the residents in the corporation’s facilities within that State are
covered against any losses due to acts or errors by the corporation or any of its facilities. The
focus of the review should be to ensure that if the corporation were to go bankrupt or otherwise
cease to operate, the funds of the residents in the corporation’s facilities would be protected.

F571
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(f)(11) The facility must not impose a charge against the personal funds of a
resident for any item or service for which payment is made under Medicaid or Medicare
(except for applicable deductible and coinsurance amounts).

The facility may charge the resident for requested services that are more expensive than or
in excess of covered services in accordance with §489.32 of this chapter. (This does not
affect the prohibition on facility charges for items and services for which Medicaid has
paid. See §447.15 of this chapter, which limits participation in the Medicaid program to
providers who accept, as payment in full, Medicaid payment plus any deductible,
coinsurance, or copayment required by the plan to be paid by the individual.)

(i) Services included in Medicare or Medicaid payment. During the course of a covered
Medicare or Medicaid stay, facilities must not charge a resident for the following
categories of items and services:
(A) Nursing services as required at §483.35.
(B) Food and Nutrition services as required at §483.60.
(C) An activities program as required at §483.24(c).
(D) Room/bed maintenance services.
(E) Routine personal hygiene items and services as required to meet the needs of

residents, including, but not limited to, hair hygiene supplies, comb, brush, bath
soap, disinfecting soaps or specialized cleansing agents when indicated to treat
special skin problems or to fight infection, razor, shaving cream, toothbrush,
toothpaste, denture adhesive, denture cleaner, dental floss, moisturizing lotion,
tissues, cotton balls, cotton swabs, deodorant, incontinence care and supplies,
sanitary napkins and related supplies, towels, washcloths, hospital gowns, over
the counter drugs, hair and nail hygiene services, bathing assistance, and basic
personal laundry.

(F) Medically-related social services as required at §483.40(d).
(G) Hospice services elected by the resident and paid for under the Medicare

Hospice Benefit or paid for by Medicaid under a state plan.
(ii) Items and services that may be charged to residents’ funds. Paragraphs (f)(11)(ii)(A)

through (L) of this section are general categories and examples of items and services
that the facility may charge to residents’ funds if they are requested by a resident, if
they are not required to achieve the goals stated in the resident’s care plan, if the
facility informs the resident that there will be a charge, and if payment is not made
by Medicare or Medicaid:
(A) Telephone, including a cellular phone.
(B) Television/radio, personal computer or other electronic device for personal use.
(C) Personal comfort items, including smoking materials, notions and novelties, and

confections.
(D) Cosmetic and grooming items and services in excess of those for which payment

is made under Medicaid or Medicare.
(E) Personal clothing.
(F) Personal reading matter.
(F) Gifts purchased on behalf of a resident.
(H) Flowers and plants.
(I) Cost to participate in social events and entertainment outside the scope of the

activities program, provided under §483.24(c).
(J) Non-covered special care services such as privately hired nurses or aides.
(K) Private room, except when therapeutically required (for example, isolation for

infection control).

(L) Except as provided in (e)(11)(ii)(L)(1) and (2) of this section, specially prepared
or alternative food requested instead of the food and meals generally prepared
by the facility, as required by §483.60.
(1) The facility may not charge for special foods and meals, including medically

prescribed dietary supplements, ordered by the resident’s physician,
physician assistant, nurse practitioner, or clinical nurse specialist, as these
are included per §483.60.

(2) In accordance with §483.60(c) through (f), when preparing foods and meals,
a facility must take into consideration residents’ needs and preferences and
the overall cultural and religious make-up of the facility’s population.

(iii) Requests for items and services.
(A) The facility can only charge a resident for any non-covered item or service if

such item or service is specifically requested by the resident.
(B) The facility must not require a resident to request any item or service as a

condition of admission or continued stay.
(C) The facility must inform, orally and in writing, the resident requesting an item

or service for which a charge will be made that there will be a charge for the
item or service and what the charge will be.

GUIDANCE §483.10(f)(11)
Residents must not be charged for universal items such as computers, telephones, television
services or other electronic devices, books, magazines or newspaper subscriptions intended for
use by all residents.

PROCEDURES §483.10(f)(11)
During interviews with residents or their representatives determine:

• How and when they were notified by facility staff regarding the items and services that
may not be covered during their stay at the facility.

• Whether or not they may have been charged for items or services they believed were
covered by the facility or their insurer. If concerns are raised review a resident’s billing
statements to determine if they were charged for covered items or services. If charges
found on these statements indicate that residents may have paid for covered items or
services, determine if these items or services are over and above what is paid by
Medicare or Medicaid.

• How and when they were informed of any items or services that would be charged to
them before these items or services are provided.

KEY ELEMENTS OF NONCOMPLIANCE §483.10(f)(11)
To cite deficient practice at F571, the surveyor’s investigation will generally show that the
facility failed to do one or more of the following:

• Made a charge against the resident’s personal funds for:
o Any item or service covered under Medicare or Medicaid (except for applicable

deductible or coinsurance amounts); or
o Charged a resident for an item or services not required to achieve the goal stated in

the resident’s care plan, without notifying the resident of the charge; or

o Charged a resident for any item or service not covered under Medicare or Medicaid,
but did not inform the resident orally and in writing of the charge; or

o Charged a resident for specially prepared or alternative food when:
• Ordered by a physician or non-physician practitioner, or
• Prepared in consideration of the resident need, or
• Prepared in consideration of the overall cultural and religious make-up of the

resident population; or
o Charged a resident for any noncovered item or service when not requested by the

resident; or
• Made the resident request any item or services as a condition of admission or continued

stay.

F572
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(g) Information and Communication.
§483.10(g)(1) The resident has the right to be informed of his or her rights and of all rules
and regulations governing resident conduct and responsibilities during his or her stay in
the facility.

§483.10(g)(16) The facility must provide a notice of rights and services to the resident prior
to or upon admission and during the resident’s stay.

(i) The facility must inform the resident both orally and in writing in a language that
the resident understands of his or her rights and all rules and regulations governing
resident conduct and responsibilities during the stay in the facility.

(ii) The facility must also provide the resident with the State-developed notice of
Medicaid rights and obligations, if any.

(iii) Receipt of such information, and any amendments to it, must be acknowledged in
writing;

INTENT §483.10(g)(1),(16)
This requirement is intended to assure that each resident knows his or her rights and
responsibilities and that facility staff communicates this information prior to or upon admission,
as appropriate during the resident’s stay, and when the facility’s rules change.

DEFINITIONS §483.10(g)(1),(16)
“All rules and regulations” relates to State and Federal requirements and facility policies.

“Both orally and in writing” means if a resident can read and understand written materials
without assistance, an oral summary, along with the written document, is acceptable.

“In a language that the resident understands” means verbally, in writing, and in a language
that is clear and understandable to the resident and/or his or her representative.

GUIDANCE §483.10(g)(1),(16)

Any time State or Federal laws or regulations relating to resident rights or facility policies
change during the resident’s stay in the facility, he/she must promptly be informed of these
changes in a manner that is clear to the resident.

A resident cannot be expected to abide by rules he/she has never been told about. Whatever
rules or policies the facility has formalized, and by which it expects residents to abide, should be
included in the residents’ statement of rights and responsibilities.

If a resident or his/her representative’s understanding of English or the predominant language of
the facility is inadequate for their comprehension, a means to communicate information in a
language or format familiar to the resident or his/her representative must be used. The facility
must have written translations, including Braille, and make the services of an interpreter
available as needed. For those residents who communicate in American Sign Language (ASL),
facility staff are expected to provide an interpreter. Large print texts of the facility’s statement of
resident rights and responsibilities may also be made available.

PROCEDURES §483.10(g)(1)(16)
During interviews, determine:

• When and how residents or their representatives are informed of their rights, services,
facility policies and procedures, and resident responsibilities;

• If this information was provided in a language and format they understood; and,
• If facility staff provide ongoing communication to residents about their rights (e.g.,

through resident and family groups, presentations from representatives of the Office of
the State Long-Term Care Ombudsman, posting of information, etc.)?

F573
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(g)(2) The resident has the right to access personal and medical records pertaining
to him or herself.

(i) The facility must provide the resident with access to personal and medical records
pertaining to him or herself, upon an oral or written request, in the form and
format requested by the individual, if it is readily producible in such form and
format (including in an electronic form or format when such records are maintained
electronically), or, if not, in a readable hard copy form or such other form and
format as agreed to by the facility and the individual, within 24 hours (excluding
weekends and holidays); and

(ii) The facility must allow the resident to obtain a copy of the records or any portions
thereof (including in an electronic form or format when such records are
maintained electronically) upon request and 2 working days advance notice to the
facility. The facility may impose a reasonable, cost-based fee on the provision of
copies, provided that the fee includes only the cost of:
(A) Labor for copying the records requested by the individual, whether in paper or

electronic form;
(B) Supplies for creating the paper copy or electronic media if the individual

requests that the electronic copy be provided on portable media; and

(C)Postage, when the individual has requested the copy be mailed.

§483.10(g)(3) With the exception of information described in paragraphs (g)(2) and (g)(11)
of this section, the facility must ensure that information is provided to each resident in a
form and manner the resident can access and understand, including in an alternative
format or in a language that the resident can understand. Summaries that translate
information described in paragraph (g)(2) of this section may be made available to the
patient at their request and expense in accordance with applicable law.

DEFINITIONS §483.10(g)(2)-(3)
“Records,” includes all records, in addition to clinical records, pertaining to the resident, such as
trust fund ledgers pertinent to the resident and contracts between the resident and the facility.

GUIDANCE §483.10(g)(2)-(3)
An oral request is sufficient to produce the resident’s personal and medical record for review.

The facility may charge a reasonable, cost-based fee for providing a copy of the requested
records, whether in paper or electronic form. This may only include the cost of labor for copying
the records, supplies for creating the paper copy or electronic media, and postage, if applicable.
Additional fees for locating the records or typing forms/envelopes may not be assessed.

KEY ELEMENTS OF NONCOMPLIANCE §483.10(g)(2)-(3)
To cite deficient practice at F573, the surveyor’s investigation will generally show that the
facility failed to do one or more of the following:

• Support the resident’s right to access his or her own personal and medical records; or
• Provide the resident access to his or her personal and medical records within 24 hours

(excluding weekends and holidays) of a written request; or
• Allow the resident to purchase a copy of his or her personal and medical records upon

request and with 2 working days advanced notice; or
• Charge a reasonable, cost-based fee, including only the cost of labor, supplies, and

postage involved in providing or sending the personal and medical records requested; or
• Ensure the information is provided:

o In a form the resident can access and understand ;or
o In a form and format agreed upon by the facility and the resident.

F574
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(g)(4) The resident has the right to receive notices orally (meaning spoken) and in
writing (including Braille) in a format and a language he or she understands, including:

(i) Required notices as specified in this section. The facility must furnish to each
resident a written description of legal rights which includes –
(A) A description of the manner of protecting personal funds, under paragraph

(f)(10) of this section;

(B) A description of the requirements and procedures for establishing eligibility for
Medicaid, including the right to request an assessment of resources under
section 1924(c) of the Social Security Act.

(C) A list of names, addresses (mailing and email), and telephone numbers of all
pertinent State regulatory and informational agencies, resident advocacy groups
such as the State Survey Agency, the State licensure office, the State Long-Term
Care Ombudsman program, the protection and advocacy agency, adult
protective services where state law provides for jurisdiction in long-term care
facilities, the local contact agency for information about returning to the
community and the Medicaid Fraud Control Unit; and

(D) A statement that the resident may file a complaint with the State Survey Agency
concerning any suspected violation of state or federal nursing facility
regulations, including but not limited to resident abuse, neglect, exploitation,
misappropriation of resident property in the facility, non-compliance with the
advance directives requirements and requests for information regarding
returning to the community.

(ii) Information and contact information for State and local advocacy organizations
including but not limited to the State Survey Agency, the State Long-Term Care
Ombudsman program (established under section 712 of the Older Americans Act of
1965, as amended 2016 (42 U.S.C. 3001 et seq) and the protection and advocacy
system (as designated by the state, and as established under the Developmental
Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15001 et seq.)

(iii) Information regarding Medicare and Medicaid eligibility and coverage;
(iv) Contact information for the Aging and Disability Resource Center (established

under Section 202(a)(20)(B)(iii) of the Older Americans Act); or other No Wrong
Door Program;

(v) Contact information for the Medicaid Fraud Control Unit; and
(vi) Information and contact information for filing grievances or complaints concerning

any suspected violation of state or federal nursing facility regulations, including but
not limited to resident abuse, neglect, exploitation, misappropriation of resident
property in the facility, non-compliance with the advance directives requirements
and requests for information regarding returning to the community.

DEFINITIONS §483.10(g)(4)
“Orally and in writing” means if a resident can read and understand written materials without
assistance, an oral summary, along with the written document, is acceptable.

“In a language he or she understands” means verbally, in writing (including Braille), and in a
language that is clear and understandable to the resident or his or her representative.

GUIDANCE §483.10(g)(4)
If a resident or his or her representative’s understanding of English or the predominant language
of the facility is inadequate for their comprehension, a means to communicate information in a
language or format familiar to the resident or his or her representative must be used. The facility
must have written translations, including Braille and make the services of an interpreter available
as needed. For those residents who communicate in American Sign Language (ASL), the facility

is expected to provide an interpreter. Large print texts of the facility’s statement of resident rights
and responsibilities should also be available.

As part of determining Medicaid eligibility, at the time of admission, a married couple has the
right to request and have the appropriate State agency assess the couple’s resources.

During interviews with residents, their representatives and facility staff determine:

• When and how information regarding rights and services are communicated; and
• If this information was provided in a language and format the resident or representative

understood.

KEY ELEMENTS OF NONCOMPLIANCE §483.10(g)(4)
To cite deficient practice at F574, the surveyor’s investigation will generally show that the
facility failed to do one or more of the following:

• Support the resident’s right to receive notices orally and in writing in a format he or she
understands; or

• Provide a written description of the resident’s legal rights, including:
o How a resident’s personal funds are protected; or
o The requirements and procedures for establishing Medicaid eligibility, including the

right to request an assessment of resources; or
o A list of names, mailing and email addresses, and telephone numbers of all pertinent

State regulatory and informational agencies and advocacy groups; or
o Informing the resident of their right to file a complaint with the State survey and

certification agency; or
• Provide information and contact information for:

o State and local advocacy organizations; or
o The Aging and Disability Resource Center or other No Wrong Door Program; or

• Inform the resident of Medicare and Medicaid eligibility and coverage; or
• Provide contact information for the Medicaid Fraud Control Unit; or
• Provide information and contact information for filing grievances or complaints

concerning any suspected violation of State or Federal nursing facility regulations.

F575
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(g)(5) The facility must post, in a form and manner accessible and understandable
to residents, resident representatives:

(i) A list of names, addresses (mailing and email), and telephone numbers of all
pertinent State agencies and advocacy groups, such as the State Survey Agency, the
State licensure office, adult protective services where state law provides for
jurisdiction in long-term care facilities, the Office of the State Long-Term Care
Ombudsman program, the protection and advocacy network, home and community
based service programs, and the Medicaid Fraud Control Unit; and

(ii) A statement that the resident may file a complaint with the State Survey Agency
concerning any suspected violation of state or federal nursing facility regulation,
including but not limited to resident abuse, neglect, exploitation, misappropriation

of resident property in the facility, and non-compliance with the advanced directives
requirements (42 CFR part 489 subpart I) and requests for information regarding
returning to the community.

F576
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(g)(6) The resident has the right to have reasonable access to the use of a telephone,
including TTY and TDD services, and a place in the facility where calls can be made
without being overheard. This includes the right to retain and use a cellular phone at the
resident’s own expense.

§483.10(g)(7) The facility must protect and facilitate that resident’s right to communicate
with individuals and entities within and external to the facility, including reasonable access
to:

(i) A telephone, including TTY and TDD services;
(ii) The internet, to the extent available to the facility; and
(iii) Stationery, postage, writing implements and the ability to send mail.

§483.10(g)(8) The resident has the right to send and receive mail, and to receive letters,
packages and other materials delivered to the facility for the resident through a means
other than a postal service, including the right to:

(i) Privacy of such communications consistent with this section; and
(ii) Access to stationery, postage, and writing implements at the resident’s own expense.

§483.10(g)(9) The resident has the right to have reasonable access to and privacy in their
use of electronic communications such as email and video communications and for internet
research.

(i) If the access is available to the facility
(ii) At the resident’s expense, if any additional expense is incurred by the facility to

provide such access to the resident.
(iii) Such use must comply with State and Federal law.

DEFINITIONS §483.10(g)(6)-(9)
“Reasonable access” means that telephones, computers and other communication devices are
easily accessible to residents and are adapted to accommodate resident’s needs and abilities, such
as hearing or vision loss.

“TTY (TeleTYpe) and TDD (Telecommunications Device for the Deaf)” are acronyms used
interchangeably to refer to any type of text-based telecommunications equipment used by a
person who does not have enough functional hearing to understand speech, even with
amplification.

GUIDANCE §483.10(g)(6)-(9)
Resident access to telephones in staff offices or at nurses’ stations alone does not meet the
provisions of this requirement. Examples of facility accommodations to provide reasonable
access to the use of a telephone without being overheard include providing cordless telephones
or having telephone jacks in residents’ rooms.

The facility is responsible for providing reasonable access to the internet to the extent it is
available onsite. Computers in public areas for general use must be located in a manner to protect
resident privacy in email, communications, and internet use.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION
If concerns are identified regarding charges to the resident for access to internet, telephone, etc.,
refer to §483.10(f)(11), F571.

If concerns are identified to indicate a resident is being denied the right to private
communication, refer to §483.10(h), F583, Privacy and confidentiality.

F577
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(g)(10) The resident has the right to-

(i) Examine the results of the most recent survey of the facility conducted by Federal or
State surveyors and any plan of correction in effect with respect to the facility; and

(ii) Receive information from agencies acting as client advocates, and be afforded the
opportunity to contact these agencies.

§483.10(g)(11) The facility must–

(i) Post in a place readily accessible to residents, and family members and legal
representatives of residents, the results of the most recent survey of the facility.

(ii) Have reports with respect to any surveys, certifications, and complaint
investigations made respecting the facility during the 3 preceding years, and any
plan of correction in effect with respect to the facility, available for any individual to
review upon request; and

(iii) Post notice of the availability of such reports in areas of the facility that are
prominent and accessible to the public.

(iv) The facility shall not make available identifying information about complainants or
residents.

DEFINITIONS §483.10(g)(10)-(11)
“Place readily accessible” is a place (such as a lobby or other area frequented by most residents,
visitors or other individuals) where individuals wishing to examine survey results do not have to
ask to see them.

“Results of the most recent survey” means the Statement of Deficiencies (Form CMS-2567)
and the Statement of Isolated Deficiencies generated by the most recent standard survey and any

subsequent extended surveys, and any deficiencies resulting from any subsequent complaint
investigation(s).

GUIDANCE §483.10(g)(10)-(11)
The survey results may not be altered by the facility unless authorized by the State agency.

F578
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.10(c)(6) The right to request, refuse, and/or discontinue treatment, to participate in or
refuse to participate in experimental research, and to formulate an advance directive.

§483.10(c)(8) Nothing in this paragraph should be construed as the right of the resident to
receive the provision of medical treatment or medical services deemed medically
unnecessary or inappropriate.

§483.10(g)(12) The facility must comply with the requirements specified in 42 CFR part
489, subpart I (Advance Directives).

(i) These requirements include provisions to inform and provide written
information to all adult residents concerning the right to accept or refuse
medical or surgical treatment and, at the resident’s option, formulate an
advance directive.

(ii) This includes a written description of the facility’s policies to implement advance

directives and applicable State law.

(iii) Facilities are permitted to contract with other entities to furnish this information
but are still legally responsible for ensuring that the requirements of this section
are met.

(iv) If an adult individual is incapacitated at the time of admission and is unable to

receive information or articulate whether or not he or she has executed an
advance directive, the facility may give advance directive information to the
individual’s resident representative in accordance with State law.

(v) The facility is not relieved of its obligation to provide this information to the

individual once he or she is able to receive such information. Follow-up procedures
must be in place to provide the information to the individual directly at the
appropriate time.

DEFINITIONS §483.10(c)(6), (c)(8), (g)(12)

“Advance care planning” is a process of communication between individuals and their
healthcare agents to understand, reflect on, discuss, and plan for future healthcare decisions for a
time when individuals are not able to make their own healthcare decisions.

“Advance directive” is “a written instruction, such as a living will or durable power of attorney
for health care, recognized under State law (whether statutory or as recognized by the courts of
the State), relating to the provision of health care when the individual is incapacitated.” See
§489.100.

“Physician Orders for Life-Sustaining Treatment (or POLST) paradigm form” is a form
designed to improve patient care by creating a portable medical order form that records patients’
treatment wishes so that emergency personnel know what treatments the patient wants in the
event of a medical emergency, taking the patient’s current medical condition into consideration.
A POLST paradigm form is not an advance directive.

“Experimental research” refers to the development, testing and use of a clinical treatment, such
as an investigational drug or therapy that has not yet been approved by the FDA or medical
community as effective and conforming to accepted medical practice.

“Health care decision-making” refers to consent, refusal to consent, or withdrawal of consent
to health care, treatment, service, or a procedure to maintain, diagnose, or treat a resident’s
physical or mental condition.

“Health care decision-making capacity” refers to possessing the ability (as defined by State
law) to make decisions regarding health care and related treatment choice.

GUIDANCE §483.10(c)(6), (c)(8), and (g)(12)

The resident has the right to request treatment; however, facility staff are not required to provide
medical treatment or services if the requested treatment or services are medically unnecessary or
inappropriate. While the resident also has the right to refuse any treatment or services, the
resident’s refusal does not absolve facility staff from providing other care that allows him/her to
attain or maintain his or her highest practicable physical, mental, and psychosocial well-being.

For example, facility staff would still be expected to provide appropriate measures for pressure
injury prevention, even if a resident has refused food and fluids and is nearing death.

If a resident (directly or through an advance directive) declines treatment (such as refuses
artificial nutrition or IV hydration, despite having lost considerable weight), the resident may not
be treated against his or her wishes. If a resident is unable to make a health care decision, a
decision by the resident’s legal representative to forego treatment may, subject to State
requirements, be equally binding on the facility. A resident may not be transferred or discharged
for refusing treatment unless the criteria for transfer or discharge are otherwise met. Facility staff
should attempt to determine the reason for the refusal of care, including whether a resident who
is unable verbalize their needs is refusing care for another reason (such as pain, fear of a staff
member, etc.), and address the concern, if possible. Any services that would otherwise be
required, but are refused, must be described in the comprehensive care plan. See F656,
Comprehensive Care Plans, for further guidance.

The resident has the right to refuse to participate in experimental research. A resident being
considered for participation in experimental research must be fully informed of the nature of the
experimental research (for example, medication or other treatment) and the possible
consequences of participating. The resident must provide informed consent prior to participation
and initiation of experimental research. If the resident is incapable of understanding the situation
and of realizing the risks and benefits of the proposed research, but a resident representative
gives consent, facility staff have a responsibility to ensure that the consent is properly obtained
and that essential measures are taken to protect the resident from harm or mistreatment. The
resident (or his or her representative if the resident lacks health care decision-making capacity)
must have the opportunity to refuse to participate both before and during the experimental
research activity.

The ability of a dying person to control decisions about medical care and daily routines has been
identified as one of the key elements of quality care at the end of life. The process of advance
care planning is ongoing and affords the resident, family, and others on the resident’s
interdisciplinary health care team an opportunity to reassess the resident’s goals and wishes as
the resident’s medical condition changes. Advance care planning is an integral aspect of the
facility’s comprehensive care planning process and assures re-evaluation of the resident’s desires
on a routine basis and when there is a significant change in the resident’s condition. The process
can help the resident, family and interdisciplinary team prepare for the time when a resident
becomes unable to make decisions or is actively dying.

The facility is required to establish, maintain, and implement written policies and procedures
regarding the residents’ right to formulate an advance directive, including the right to accept or
refuse medical or surgical treatment. In addition, the facility management is responsible for
ensuring that staff follow those policies and procedures.

The facility’s policies and procedures delineate the various steps necessary to promote and
implement these rights, including, but not limited to:

• Determining on admission whether the resident has an advance directive and, if not,
determining whether the resident wishes to formulate an advance directive;

• Providing information in a manner easily understood by the resident or resident
representative about the right to refuse medical or surgical treatment and formulate an
advanced directive. This includes a written description of the facility’s policies to
implement advance directives and applicable State law regarding advance directives.

• Determining if facility staff periodically assesses the resident for decision-making
capacity and invokes health care agent or representative if the resident is determined not
to have decision-making capacity;

• Identifying the primary decision-maker (assessing the resident’s decision-making
capacity and identifying or arranging for an appropriate representative for the resident
assessed as unable to make relevant health care decisions);

• Defining and clarifying medical issues and presenting the information regarding relevant
health care issues to the resident or his or her representative, as appropriate;

• Identifying, clarifying, and periodically reviewing, as part of the comprehensive care
planning process, the existing care instructions and whether the resident wishes to change
or continue these instructions;

• Identifying situations where health care decision-making is needed, such as a significant
decline or improvement in the resident’s condition;

• Establishing mechanisms for documenting and communicating the resident’s choices to
the interdisciplinary team and to staff responsible for the resident’s care; and

• Identifying the process (as provided by State law) for handling situations in which the
facility staff and/or physician do not believe that they can provide care in accordance
with the resident’s advance directives or other wishes on the basis of conscience.

If the resident or the resident’s representative has executed one or more advance directive(s), or
executes one upon admission, copies of these documents must be obtained and maintained in the
same section of the resident’s medical record readily retrievable by any facility staff. Facility
staff must communicate the resident’s wishes to the resident’s direct care staff and physician.

If the resident does not have an advance directive, facility staff must inform the resident or
resident representative of their right to establish one as set forth in the laws of the State and
provide assistance if the resident wishes to execute one or more directive(s). Facility staff must
document in the resident’s medical record these discussions and any advance directive(s) that the
resident executes.

The resident has the option to execute advance directives, but cannot be required to do so. As
required by 42 C.F.R. §489.102(a)(3), the facility may not condition the provision of medical
care or discriminate against a resident based on whether he or she has executed an advance
directive. Facility staff are not required to provide care that conflicts with an advance directive.
In addition, facility staff are not required to implement an advance directive if, as a matter of
conscience, the provider cannot implement an advance directive and State law allows the
provider to conscientiously object.

NOTE: Other directives a resident may choose to exercise may include, but are not limited to, a
directive to the attending physician, a medical power of attorney, a pre-existing medical
order for “do not resuscitate” (DNR), or another document that directs the resident’s
health care such as Do Not Hospitalize (DNH). Several States have adopted the use of a
portable and enduring order form that documents the resident’s choices related to life-
sustaining treatments while some States recognize documented oral instruction.

Facility staff should periodically review with the resident and resident representative the
decisions made regarding treatments, experimental research and any advance directive and its
provisions, as preferences may change over time.

PROCEDURES§483.10(c)(6), (c)(8), (g)(12)

• Observe for efforts on the part of facility staff to inform residents or their representative
of their rights and that information is communicated at times it would be most useful to
them, such as when they are expressing concerns, or raising questions.

• Interview the resident, resident’s representative and facility staff to determine if:

o Residents are informed in a manner they understand of their right to request or refuse
treatment;

o A resident has an advance directive and if staff are aware of what this directive states;
o A resident does not have an advance directive and, if so, how the resident was informed

of his or her right to develop one and was the resident provided assistance in doing so;
and

o Staff periodically assess a resident’s decision making capacity, how often and how and
by whom is this done.

• Review the resident’s medical record to determine if:

o The resident has an advance directive and a copy is located in the medical record; and
o The facility has policies and procedures to implement advance directives.

KEY ELEMENTS OF NONCOMPLIANCE §483.10(c)(6), (c)(8), (g)(12):

To cite deficient practice at F578, the surveyor’s investigation will generally show that the
facility failed to do one or more of the following:

• Provide information to the resident regarding their right to refuse medical or surgical
treatment or to formulate an advance directive once the resident was able to receive the
information; or

• Honor a resident’s, their family, and/or their representative’s decision to request, refuse,
or discontinue experimental research; or

• Ensure that a current copy of a resident’s advance directive was in the resident’s medical
record; or

• Have policies and procedures for implementing advance directives; or
• Follow policies to implement advance directives and applicable State laws regarding

advance directives.

POTENTIAL TAGS FOR ADDITIONAL CONSIDERATION

Examples of some of the related requirements that may be considered when non-compliance has
been identified include, but are not limited to, the following:

• 42 CFR §483.10(a)(3)-(7), F551 o For concerns regarding designation of resident
representative.

• 42 CFR §483.10(c)(2)-(3), F553, Right to Participate in Planning Care o For concerns
regarding the resident’s right to participate in and be informed of his or her treatment.

F579
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(g)(13) The facility must display in the facility written information, and provide to
residents and applicants for admission, oral and written information about how to apply

for and use Medicare and Medicaid benefits, and how to receive refunds for previous
payments covered by such benefits.

DEFINITIONS §483.10(g)(13)
“Refunds for previous payments” refers to refunds due as a result of Medicaid and Medicare
payments when eligibility has been determined retroactively.

GUIDANCE §483.10(g)(13)
To fulfill this requirement, facility staff may use written materials issued by the State Medicaid
agency and the Federal government relating to these benefits. Facilities may fulfill their
obligation to orally inform residents or prospective residents about how to apply for Medicaid or
Medicare by assisting them in working with the local Social Security Office or the local unit of
the State Medicaid agency. Simply providing a phone number is not sufficient in assisting
resident or the resident representative. Facilities are not responsible for orally providing detailed
information about Medicare and Medicaid eligibility rules.

F580
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(g)(14) Notification of Changes.

(i) A facility must immediately inform the resident; consult with the resident’s
physician; and notify, consistent with his or her authority, the resident
representative(s) when there is—
(A) An accident involving the resident which results in injury and has the potential

for requiring physician intervention;
(B) A significant change in the resident’s physical, mental, or psychosocial status

(that is, a deterioration in health, mental, or psychosocial status in either life-
threatening conditions or clinical complications);

(C) A need to alter treatment significantly (that is, a need to discontinue an existing
form of treatment due to adverse consequences, or to commence a new form of
treatment); or

(D) A decision to transfer or discharge the resident from the facility as specified in
§483.15(c)(1)(ii).

(ii) When making notification under paragraph (g)(14)(i) of this section, the facility
must ensure that all pertinent information specified in §483.15(c)(2) is available and
provided upon request to the physician.

(iii) The facility must also promptly notify the resident and the resident representative,
if any, when there is—
(A) A change in room or roommate assignment as specified in §483.10(e)(6); or
(B) A change in resident rights under Federal or State law or regulations as

specified in paragraph (e)(10) of this section.
(iv) The facility must record and periodically update the address (mailing and email)

and phone number of the resident representative(s).

§483.10(g)(15)

Admission to a composite distinct part. A facility that is a composite distinct part (as
defined in §483.5) must disclose in its admission agreement its physical configuration,
including the various locations that comprise the composite distinct part, and must specify
the policies that apply to room changes between its different locations under §483.15(c)(9).

DEFINITIONS §483.10(g)(14)
“A need to alter treatment significantly” means a need to stop a form of treatment because of
adverse consequences (such as an adverse drug reaction), or commence a new form of treatment
to deal with a problem (for example, the use of any medical procedure, or therapy that has not
been used on that resident before).

GUIDANCE §483.10(g)(14)
While the regulatory obligation is not limited to these symptoms, physician notification should
occur when a resident experiences symptoms such as chest pain, loss of consciousness, or other
signs or symptoms of heart attack or stroke that may signify a significant change.

Even when a resident is mentally competent, his or her designated resident representative or
family, as appropriate, should be notified of significant changes in the resident’s health status
because the resident may not be able to notify them personally, especially in the case of sudden
illness or accident.

If the resident is not capable of making decisions, facility staff must contact the designated
resident representative, consistent with his or her authority, to make any required decisions, but
the resident must still be told what is happening to him or her.

In the case of the death of a resident, the resident’s physician is to be notified immediately by
facility staff in accordance with State law.

If there is a deficiency specific to the requirement at §483.10(g)(15), do not cite here, but cite
under §483.15(a)(1)-(7), F620, regarding admission policies.

F581
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

This tag number is in reserve for future use and there will be no citations under this tag.

F582
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.10(g)(17) The facility must—

(i) Inform each Medicaid-eligible resident, in writing, at the time of admission to the
nursing facility and when the resident becomes eligible for Medicaid of—
(A) The items and services that are included in nursing facility services under the

State plan and for which the resident may not be charged;

(B) Those other items and services that the facility offers and for which the resident
may be charged, and the amount of charges for those services; and

(ii) Inform each Medicaid-eligible resident when changes are made to the items and
services specified in §483.10(g)(17)(i)(A) and (B) of this section.

§483.10(g)(18) The facility must inform each resident before, or at the time of admission,
and periodically during the resident’s stay, of services available in the facility and of
charges for those services, including any charges for services not covered under Medicare/
Medicaid or by the facility’s per diem rate.

(i) Where changes in coverage are made to items and services covered by Medicare
and/or by the Medicaid State plan, the facility must provide notice to residents of
the change as soon as is reasonably possible.

(ii) Where changes are made to charges for other items and services that the facility
offers, the facility must inform the resident in writing at least 60 days prior to
implementation of the change.

(iii) If a resident dies or is hospitalized or is transferred and does not return to the
facility, the facility must refund to the resident, resident representative, or estate, as
applicable, any deposit or charges already paid, less the facility’s per diem rate, for
the days the resident actually resided or reserved or retained a bed in the facility,
regardless of any minimum stay or discharge notice requirements.

(iv) The facility must refund to the resident or resident representative any and all
refunds due the resident within 30 days from the resident’s date of discharge from
the facility.

(v) The terms of an admission contract by or on behalf of an individual seeking
admission to the facility must not conflict with the requirements of these
regulations.

DEFINITIONS §483.10(g)(17)-(18)

“Periodically” means whenever changes are being introduced that will affect the resident’s
liability and whenever there are changes in services.

GUIDANCE §483.10(g)(17)-(18)

Residents must be told in advance when changes will occur in their bills. Providers must fully
inform the resident of services and related changes.

A Medicare beneficiary who requires services upon admission that are not covered under
Medicare may be required to submit a deposit provided the notice provisions of §483.10(g)(17)
if applicable, are met. Facility staff must notify residents of services or items that they may be
charged for, if they are not required by the resident’s care plan, such as hair salon services
beyond basic services or incontinence briefs the resident requests per personal preference in lieu
of the briefs provided by the facility. See §483.10(f)(11) for those items and services that must
be included in payment under skilled nursing and nursing facility benefits.

The facility’s responsibility regarding refunds applies to all residents for “any deposit or charges
already paid” by a resident during their nursing home stay. For residents residing in a Continuing
Care Retirement Community (CCRC), an exception can be considered for those residents who
were admitted to the CCRC’s nursing home, had deposits and charges related to the CCRC
separate from those incurred during the nursing home stay, and who were discharged/transferred
from the nursing home back to the same CCRC’s independent or assisted living residences.

Beneficiary Notices

1. Notice of Medicare Non-Coverage (NOMNC)

The NOMNC, Form CMS-10123, is given by the facility to all Medicare beneficiaries at
least two days before the end of a Medicare covered Part A stay or when all of Part B
therapies are ending. The NOMNC informs the beneficiaries of the right to an expedited
review by a Quality Improvement Organization. See also 42 CFR 405.1200 and 422.624.

The NOMNC is not given if:

• The beneficiary exhausts the SNF benefits coverage (100 days), thus exhausting their

Medicare Part A SNF benefit.
• The beneficiary initiates the discharge from the SNF.
• The beneficiary elects the hospice benefit or decides to revoke the hospice benefit and

return to standard Medicare coverage.

2. Skilled Nursing Facility Advanced Beneficiary Notice of Non-coverage (SNF ABN)

It is important to note that the SNF ABN, CMS-10055, is only issued if the beneficiary
intends to continue services and the SNF believes the services may not be covered under
Medicare. It is the facility’s responsibility to inform the beneficiary about potential non-
coverage and the option to continue services with the beneficiary accepting financial liability
for those services.

Per Ch. 30, section 70.2 of the Medicare Claims Processing Manual (IOM Pub. 100-04), a
SNFABN must be given to a beneficiary for the following triggering events:

• Initiation – In the situation in which a SNF believes Medicare will not pay for extended

care items or services that a physician has ordered, the SNF must provide a SNFABN to
the beneficiary before it furnishes those non-covered extended care items or services to
the beneficiary.

• Reduction – In the situation in which a SNF proposes to reduce a beneficiary’s extended
care items or services because it expects that Medicare will not pay for a subset of
extended care items or services, or for any items or services at the current level and/or
frequency of care that a physician has ordered, the SNF must provide a SNFABN to the
beneficiary before it reduces items or services to the beneficiary.

• Termination – In the situation in which a SNF proposes to stop furnishing all extended

care items or services to a beneficiary because it expects that Medicare will not continue

to pay for the items or services that a physician has ordered and the beneficiary would
like to continue receiving the care, the SNF must provide a SNF ABN to the beneficiary
before it terminates such extended care items or services.

The SNF ABN provides information to beneficiaries so that they can decide if they wish
to continue receiving the skilled services that may not be paid for by Medicare and
assume financial responsibility. If the SNF provides the beneficiary with the SNF ABN,
the facility has met its obligation to inform the beneficiary of his or her potential financial
liability and related standard claim appeal rights.

The SNF:

• Files a claim when requested by the beneficiary (this claim is called a “demand bill”);
and

• May not charge the beneficiary for Medicare covered Part A services during demand bill
process.

For detailed information refer to the Medicare Claims Processing Manual (IOM Pub. 100-04) at
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c30 .
SNFABN is addressed in Ch. 30, section 70 of the manual and NOMNC is addressed in section
260.

NOTE: A facility’s requirement to notify and explain via the SNFABN that the individual is no
longer receiving Medicare Part A services based on the SNF’s belief that Medicare Part A will
not pay for the resident’s stay, is separate and unrelated to the admission and discharge
requirements under 42 CFR §483.15, which outlines the notification and requirements under
which an individual may be discharged from the facility or when the transfer or discharge is not
initiated by the resident.

KEY ELEMENTS OF NONCOMPLIANCE §483.10(g)(17)-(18)

To cite deficient practice at F582, the surveyor’s investigation will generally show the facility
failed to do one or more of the following:

• Notify each Medicaid- eligible resident in writing of the items and services which are/are
not covered under Medicaid or by the facility’s per diem rate, including the cost of those
items and services:
o At the time of admission, or
o When the resident became eligible for Medicaid, or

• Inform each Medicaid-eligible resident when changes were made to the items and
services covered by Medicaid; or

• Inform each resident of services available in the facility and the charges for those services
not covered under Medicare/Medicaid or by the facility’s per diem rate:
o Before admission or at the time of admission, and periodically during the resident’s

stay; or
o As soon as reasonably possible when a change in coverage occurs; or

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c30

o At least 60 days prior to implementation of changes made to charges for other items
and services that the facility offers; or

• Refund the applicable funds to the resident, resident representative, or estate when a
resident died, or was hospitalized, or was transferred and did not return to the facility; or

• Refund any and all funds due the resident:
o Within 30 days from the date of discharge; or
o To the resident or resident representative; or

• Included terms in the admission contract that conflicted with the requirements of these
regulations.

F583
(Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24)

§483.10(h) Privacy and Confidentiality.

The resident has a right to personal privacy and confidentiality of his or her personal and
medical records.

§483.10(h)(l) Personal privacy includes accommodations, medical treatment, written and
telephone communications, personal care, visits, and meetings of family and resident
groups, but this does not require the facility to provide a private room for each resident.

§483.10(h)(2) The facility must respect the residents right to personal privacy, including the
right to privacy in his or her oral (that is, spoken), written, and electronic communications,
including the right to send and promptly receive unopened mail and other letters, packages
and other materials delivered to the facility for the resident, including those delivered
through a means other than a postal service.

§483.10(h)(3) The resident has a right to secure and confidential personal and medical
records.

(i) The resident has the right to refuse the release of personal and medical records
except as provided at §483.70(h)(2) or other applicable federal or state laws.

(ii) The facility must allow representatives of the Office of the State Long-Term Care
Ombudsman to examine a resident’s medical, social, and administrative records in
accordance with State law.

DEFINITIONS §483.10(h)

“Confidentiality” is defined as safeguarding the content of information including video, audio,
or other computer stored information from unauthorized disclosure without the consent of the
resident and/or the individual’s surrogate or representative. If there is information considered too
confidential to place in the record used by all staff, such as the family’s financial assets or
sensitive medical data, it may be retained in a secure place in the facility, such as a locked
cabinet in the administrator’s office. The record must show the location of this confidential
information.

“Promptly” means delivery of mail or other materials to the resident within 24 hours of delivery
by the postal service (including a post office box) and delivery of outgoing mail to the postal
service within 24 hours, except when there is no regularly scheduled postal delivery and pick-up
service.

“Right to personal privacy” includes the resident’s right to meet or communicate with
whomever they want without being watched or overheard. Private space may be created flexibly
and need not be dedicated solely for visitation purposes.

GUIDANCE §483.10(h)

Each resident has the right to privacy and confidentiality for all aspects of care and services. A
nursing home resident has the right to personal privacy of not only his or her own physical body,
but of his or her personal space, including accommodations and personal care.

Residents in nursing homes have varying degrees of physical/psychosocial needs, intellectual
disabilities, and/or cognitive impairments. A resident may be dependent on nursing home staff
for some or all aspects of care, such as assistance with eating, ambulating, bathing, daily
personal hygiene, dressing, and bathroom needs. Only authorized staff directly involved in
providing care and services for the resident may be present when care is provided, unless the
resident consents to other individuals being present during the delivery of care. During the
delivery of personal care and services, staff must remove residents from public view, pull
privacy curtains or close doors, and provide clothing or draping to prevent exposure of body
parts.

Photographs or recordings of a resident and/or his or her private space without the resident’s, or
designated representative’s written consent, is a violation of the resident’s right to privacy and
confidentiality. Examples include, but are not limited to, staff taking unauthorized photographs
of a resident’s room or furnishings (which may or may not include the resident), or a resident
eating in the dining room, or a resident participating in an activity in the common area. Taking
unauthorized photographs or recordings of residents in any state of dress or undress using any
type of equipment (for example, cameras, smart phones, and other electronic devices) and/or
keeping or distributing them through multimedia messages or on social media networks is a
violation of a resident’s right to privacy and confidentiality.

Personal and medical records include all types of records the facility might keep on a resident,
whether they are medical, social, fund accounts, automated, electronic, or other. Care must be
taken to protect the privacy of personal information on all residents, including gender identity
and sexual orientation.

Posting signs in residents’ rooms or in areas visible to others that include clinical or personal
information could be considered a violation of a resident’s privacy. It is allowable to post signs
with this type of information in more private locations not visible to the public. An exception
can be made in an individual case if a resident or his or her representative requests the posting of
information at the bedside (such as instructions to not take blood pressure in right arm). This

does not prohibit the display of resident names on their doors nor does it prohibit display of
resident memorabilia and/or biographical information in or outside their rooms with their consent
or the consent of his or her representative. (This does not include isolation precaution
information for public health protection, as long as the sign does not reveal the type of infection).

Personal resident information must be communicated in a way that protects the confidentiality of
the information and the dignity of residents. This includes both verbal and written
communications such as the presence of lists of residents with certain conditions such as
incontinence and pressure ulcers at nursing stations in view or in hearing of residents and
visitors. This does not include clinical information written in a resident’s record.

Privacy for visitation or meetings might be arranged by using a dining area between meals, a
vacant chapel, office or room; or an activities area when activities are not in progress.
Arrangements for private space could be accomplished through cooperation between the
facility’s administration and resident or family groups so that private space is provided for those
requesting it without infringement on the rights of other residents.

All residents have the right to privacy in their communications, including justice involved
residents. Additional guidance on mail, telephone, electronic communications and visitation
rights are addressed in §483.10(g)(6)-(9), F576 and §483.10(f)(4)(i)(A)-(G), F562. See
§483.90(e)(1)(iv), F914, for full visual privacy around beds.

With the exception of the explicit requirement for privacy curtains in all initially certified
facilities (see §483.90(e)(1)(v), F914), the facility is free to innovate to provide privacy for its
residents. This may, but need not, be through the provision of a private room.

PROCEDURES §483.10(h)

• Observe for situations where facility staff may not be honoring the resident’s privacy,
including during visits, treatment, or leaving medical records out for public view.

• During interviews with residents, their representatives, visitors or families determine if
their privacy has been honored by facility staff.

• Interview the representative of the Office of the State Long-Term Care Ombudsman who
serves residents of the facility, to determine if the facility allows him/her to examine the
resident’s records with the permission of the resident or resident representative or as
otherwise authorized by State law.

• Are there signs regarding care information posted in view in residents’ rooms? If these
are observed, determine if such signs are there by resident or resident representative
direction. If so, these signs are allowable.

• Is personal resident information communicated in a way that protects the confidentiality
of the information and the dignity of residents?

• If concerns are found, interview staff regarding facility policy or procedures regarding
protecting resident privacy and confidentiality.

F584
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.10(i) Safe Environment.

The resident has a right to a safe, clean, comfortable and homelike environment, including
but not limited to receiving treatment and supports for daily living safely.

The facility must provide—

§483.10(i)(1) A safe, clean, comfortable, and homelike environment, allowing the resident
to use his or her personal belongings to the extent possible.

(i) This includes ensuring that the resident can receive care and services safely and that
the physical layout of the facility maximizes resident independence and does not
pose a safety risk.

(ii) The facility shall exercise reasonable care for the protection of the resident’s
property from loss or theft.

§483.10(i)(2) Housekeeping and maintenance services necessary to maintain a sanitary,
orderly, and comfortable interior;

§483.10(i)(3) Clean bed and bath linens that are in good condition;

§483.10(i)(4) Private closet space in each resident room, as specified in §483.90 (e)(2)(iv);

§483.10(i)(5) Adequate and comfortable lighting levels in all areas;

§483.10(i)(6) Comfortable and safe temperature levels. Facilities initially certified after
October 1, 1990 must maintain a temperature range of 71 to 81°F; and

§483.10(i)(7) For the maintenance of comfortable sound levels.

DEFINITIONS §483.10(i)
“Adequate lighting” means levels of illumination suitable to tasks the resident chooses to
perform or the facility staff must perform.

“Comfortable lighting” means lighting that minimizes glare and provides maximum resident
control, where feasible, over the intensity, location, and direction of lighting to meet their needs
or enhance independent functioning.

“Comfortable and safe temperature levels” means that the ambient temperature should be in a
relatively narrow range that minimizes residents’ susceptibility to loss of body heat and risk of
hypothermia, or hyperthermia, or and is comfortable for the residents.

“Comfortable sound levels” do not interfere with resident’s hearing and enhance privacy when
privacy is desired, and encourage interaction when social participation is desired. Of particular
concern to comfortable sound levels is the resident’s control over unwanted noise.

“Environment” refers to any environment in the facility that is frequented by residents,
including (but not limited to) the residents’ rooms, bathrooms, hallways, dining areas, lobby,
outdoor patios, therapy areas and activity areas.

A “homelike environment” is one that de-emphasizes the institutional character of the setting,
to the extent possible, and allows the resident to use those personal belongings that support a
homelike environment. A determination of “homelike” should include the resident’s opinion of
the living environment.

“Orderly” is defined as an uncluttered physical environment that is neat and well-kept.

“Sanitary” includes, but is not limited to, preventing the spread of disease-causing organisms by
keeping resident care equipment clean and properly stored. Resident care equipment includes,
but is not limited to, equipment used in the completion of the activities of daily living.

GUIDANCE §483.10(i)

A personalized, homelike environment recognizes the individuality and autonomy of the
resident, provides an opportunity for self-expression, and encourages links with the past and
family members. The intent of the word “homelike” in this regulation is that the nursing home
should provide an environment as close to that of the environment of a private home as possible.

This concept of creating a home setting includes the elimination of institutional odors, and
practices to the extent possible. Some practices that can be eliminated to decrease the
institutional character of the environment include, but are not limited to, the following:

• Overhead paging (including frequent announcements) and piped-in music throughout the
building.

• Meal service using trays (some residents may wish to eat certain meals on trays).
• Institutional signs labeling work rooms/closets in areas visible to residents and the public.
• Medication or treatment carts (some innovative facilities store medications in locked

areas in resident rooms or in secured carts that appear like furniture).
• The widespread and long-term use of audible chair and bed alarms, instead of their

limited use for selected residents for diagnostic purposes or according to their care
planned needs. These devices can startle the resident and constrain the resident from
normal repositioning movements, which can be problematic.

• Furniture that does not reflect a home-like environment or is uncomfortable; the absence
of window treatments or drapes; the lack of textures or the absence of bedspreads or
personal items in rooms or on walls.

• Large, centrally located nursing/care team stations, including those with barriers (such as
Plexiglas) that prevent the staff from interacting with residents.

Many facilities cannot immediately make these types of changes, but it should be a goal for all
facilities that have not yet made these types of changes to work toward them. A nursing facility
is not considered non-compliant if it still has some of these institutional features, but the facility
is expected to do all it can within fiscal constraints to provide an environment that enhances
quality of life for residents, in accordance with resident preferences.

A “homelike” environment is not achieved simply through enhancements to the physical
environment. It concerns striving for person-centered care that emphasizes individualization,
relationships and a psychosocial environment that welcomes each resident and makes her/him
comfortable. It is the responsibility of all facility staff to create a “homelike” environment and
promptly address any cleaning needs.

In a facility in which most residents come for a short-term stay, residents would not typically
move his or her bedroom furniture into the room, but may desire to bring a television, chair or
other personal belongings to have while staying in the facility.

There needs to be sufficient individual closet space so that resident clothing is kept separate from
a roommate’s. Closets must be structured so the resident can get to and reach their hanging
clothing whenever they choose. Out-of-season items may be stored in alternate locations outside
the resident’s room.

Adequate lighting design has these features:

• Lighting with minimum glare in areas frequented by residents. Elimination of high levels
of glare produced by shiny flooring and from unshielded window openings;

• Even light levels in common areas and hallways, avoiding patches of low light caused by
too much space between light fixtures, within limits of building design constraints;

• Use of daylight as much as possible;
• Extra lighting, such as table and floor lamps to provide sufficient light to assist residents

with tasks such as reading;
• Lighting for residents who need to find their way from bed to bathroom at night (for

example, red colored night lights preserve night vision); and
• Dimming switches in resident rooms (where possible and when desired by the resident)

so that staff can tend to a resident at night with limited disturbances to them or a
roommate. If dimming is not feasible, another option may be for staff to use
flashlights/pen lights when they provide night care.

While facilities certified after October 1, 1990, are required to maintain an air temperature range
of 71-81°F, there may be brief periods of time where that temperature falls outside of that range
only during rare, brief periods of unseasonable weather. This interpretation would apply in cases
where it does not adversely affect resident health and safety, and facility staff took appropriate
steps to ensure resident comfort. This would enable facilities in areas of the country with
relatively cold or hot climates to avoid the expense of installing equipment that would only be
needed infrequently.

PROCEDURES §483.10(i)

Verify the air temperature above floor level in resident rooms, dining areas, and common areas.
If the temperature is out of the 71-81° F range, then ask staff what actions they take when
residents complain of heat or cold, such as, providing extra fluids during heat waves and extra
blankets and sweaters in cold.

During interviews, ask residents and families whether they think the facility is as homelike as
possible, and whether they have been encouraged to bring in personal property items (within
space constraints).

Observe bedrooms of sampled residents for personalization. Does the room tell the survey team
anything about the resident’s everyday life and interests? Observe for personal items such as
family photographs, books and magazines, etc. that belong to the residents. For residents who
have no relatives or friends, or few assets, has facility staff assisted these residents to make their
rooms homelike, if they so desire? If potential issues are discovered, ask staff about their efforts
to provide a homelike environment. Determine if the resident’s preferences are honored or is the
facility’s goal of having a sanitary, safe, and uncluttered environment preventing the resident
from having an individualized area?

Observe and question sampled residents throughout the survey and note if they are having
difficulty reading or doing tasks due to insufficient lighting, or if they are wearing sunglasses or
visors indoors due to glare, if they have difficulty seeing food on their plate, experiencing
squinting or shading their eyes from glare or other signs that lighting does not meet their needs.

PROBES §483.10(i)

• Does the resident have any concerns with lighting, noise, temperature, or anything else
that may affect their comfort?

• Are resident care areas and equipment kept clean and in good repair?
• Does the resident’s room appear cluttered and disorderly, with a lack of storage for

clothing, belongings or personal care equipment?
• Are areas of the facility used by residents designed or organized to ensure the resident

can receive care and services safely, without risk of falling or injury, while maximizing
resident independence?

• Do window treatments, bed linens, towels, privacy curtains, etc., appear clean and in
good condition?

• How does facility staff ensure resident personal property is kept safe from loss or theft?

POTENTIAL TAGS FOR ADDITIONAL CONSIDERATION
Examples of some of the related requirements that may be considered when non-compliance has
been identified include, but are not limited to, the following:

• For concerns regarding the resident’s right to have personal possessions, including
furnishings, see §483.10(e)(2), F557;

• For concerns related to misappropriation of resident property, see §483.12, F602,
Misappropriation of Resident Property;

• For issues of safety of the environment, presence of hazards and hazardous practices, see
§483.25(d), F689, Accidents;

• For kitchen sanitation, see §483.60(i), F812, Food Safety Requirements;
• For facility-wide sanitary practices affecting the quality of care, see §483.80, F880,

Infection Control.
• For issues of fire danger, see guidance provided for §483.90(a) which states, “For

additional guidance on life safety from fire and the survey procedures for these regulatory
requirements, reference Appendix I in the SOM. Concerns regarding the above regulatory
provisions would be addressed through the Life Safety Code survey (K-Tags).”; or

• For issues of cleanliness of areas of the facility used by staff only (such as the break
room, medication room, laundry, kitchen, etc.) or the public only (such as the parking
lot), see §483.90(h), F921, Other Environmental Conditions.

F585
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(j) Grievances.
§483.10(j)(1) The resident has the right to voice grievances to the facility or other agency or
entity that hears grievances without discrimination or reprisal and without fear of
discrimination or reprisal. Such grievances include those with respect to care and
treatment which has been furnished as well as that which has not been furnished, the
behavior of staff and of other residents, and other concerns regarding their LTC facility
stay.

§483.10(j)(2) The resident has the right to and the facility must make prompt efforts by the
facility to resolve grievances the resident may have, in accordance with this paragraph.

§483.10(j)(3) The facility must make information on how to file a grievance or complaint
available to the resident.

§483.10(j)(4) The facility must establish a grievance policy to ensure the prompt resolution
of all grievances regarding the residents’ rights contained in this paragraph. Upon request,
the provider must give a copy of the grievance policy to the resident. The grievance policy
must include:

(i) Notifying resident individually or through postings in prominent locations
throughout the facility of the right to file grievances orally (meaning spoken) or in
writing; the right to file grievances anonymously; the contact information of the
grievance official with whom a grievance can be filed, that is, his or her name,
business address (mailing and email) and business phone number; a reasonable
expected time frame for completing the review of the grievance; the right to obtain a
written decision regarding his or her grievance; and the contact information of
independent entities with whom grievances may be filed, that is, the pertinent State
agency, Quality Improvement Organization, State Survey Agency and State Long-
Term Care Ombudsman program or protection and advocacy system;

(ii) Identifying a Grievance Official who is responsible for overseeing the grievance
process, receiving and tracking grievances through to their conclusions; leading any

necessary investigations by the facility; maintaining the confidentiality of all
information associated with grievances, for example, the identity of the resident for
those grievances submitted anonymously, issuing written grievance decisions to the
resident; and coordinating with state and federal agencies as necessary in light of
specific allegations;

(iii) As necessary, taking immediate action to prevent further potential violations of any
resident right while the alleged violation is being investigated;

(iv) Consistent with §483.12(c)(1), immediately reporting all alleged violations involving
neglect, abuse, including injuries of unknown source, and/or misappropriation of
resident property, by anyone furnishing services on behalf of the provider, to the
administrator of the provider; and as required by State law;

(v) Ensuring that all written grievance decisions include the date the grievance was
received, a summary statement of the resident’s grievance, the steps taken to
investigate the grievance, a summary of the pertinent findings or conclusions
regarding the resident’s concerns(s), a statement as to whether the grievance was
confirmed or not confirmed, any corrective action taken or to be taken by the
facility as a result of the grievance, and the date the written decision was issued;

(vi) Taking appropriate corrective action in accordance with State law if the alleged
violation of the residents’ rights is confirmed by the facility or if an outside entity
having jurisdiction, such as the State Survey Agency, Quality Improvement
Organization, or local law enforcement agency confirms a violation for any of these
residents’ rights within its area of responsibility; and

(vii) Maintaining evidence demonstrating the result of all grievances for a period of no
less than 3 years from the issuance of the grievance decision.

INTENT §483.10(j)
To support each resident’s right to voice grievances (such as those about treatment, care,
management of funds, lost clothing, or violation of rights) and to ensure that a policy is in place
to process grievances. Facility staff are responsible for making prompt efforts to resolve a
grievance and to keep the resident appropriately apprised of progress toward resolution.

DEFINITIONS §483.10(j)
“Prompt efforts to resolve” include facility acknowledgment of a complaint/grievance and
actively working toward resolution of that complaint/grievance.

PROCEDURES §483.10(j)
If a resident’s response indicates problems in voicing grievances and getting grievances resolved,
determine how facility staff deal with and make prompt efforts to resolve resident complaints
and grievances.

• With permission from the resident council president or officer, review resident council
minutes.

• Interview staff about how grievances are handled.
• How does facility staff protect residents from discrimination or reprisal when a grievance

is voiced?

• How does facility staff ensure the right of the residents to file a grievance anonymously is
supported?

• Interview staff about communication with resident regarding progress toward resolution
of complaint/grievance.

• Review facility grievance policy to see if compliant with necessary requirements as listed
above.

• Determine how information on how to file a grievance is made available to the resident.
• Review grievance decisions to determine if required information was provided to

residents and facility documentation was maintained for at least 3 years.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION
If the facility failed to allow a resident to exercise his or her right to file a grievance, including
the right to file an anonymous grievance, without interference, coercion, discrimination, or
reprisal from the facility, see guidance at §483.10(b)(1), F550, Resident Rights and Dignity.

If facility staff failed to report all alleged violations involving neglect, abuse, including injuries
of unknown source, and/or misappropriation of resident property, see guidance at §483.12(c)(1),
(4), F609, Reporting of Alleged Violations.

KEY ELEMENTS OF NONCOMPLIANCE §483.10(j)
To cite deficient practice at F585, the surveyor’s investigation will generally show that the
facility failed to do one or more of the following:

• Support the resident’s right to voice any grievance without discrimination, reprisal, or the
fear of discrimination or reprisal; or

• Make prompt efforts to resolve the resident’s grievance; or
• Make information on how to file a grievance or complaint available to the resident; or
• Establish a grievance policy that includes:

o Notifying the resident individually or with prominent postings throughout the facility
about:
 The right to file a grievance in writing or orally;
 The right to file a grievance anonymously;
 The reasonable timeframe the resident can expect a completed review of the

grievance;
 The right to obtain the review in writing;
 The required contact information of the grievance official;
 The contact information of independent entities with whom grievances may also

be filed; or
o Identify the grievance official; or
o Prevent any further potential violation of any resident right during the grievance

review, if necessary; or
o Immediately report certain violations as required by State law to the Administrator;

or
o Ensure written grievance decisions meets documentation requirements; or
o Take appropriate corrective action in accordance with State law if the grievance is

confirmed by the facility or an outside entity having jurisdiction; or

o Maintain evidence of the result of all grievances for no less than 3 years from the date
the grievance decision was issued.

F586
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.10(k) Contact with External Entities.
A facility must not prohibit or in any way discourage a resident from communicating with
federal, state, or local officials, including, but not limited to, federal and state surveyors,
other federal or state health department employees, including representatives of the Office
of the State Long-Term Care Ombudsman and any representative of the agency
responsible for the protection and advocacy system for individuals with mental disorder
(established under the Protection and Advocacy for Mentally Ill Individuals Act of 2000 (42
U.S.C. 10801 et seq.), regarding any matter, whether or not subject to arbitration or any
other type of judicial or regulatory action.

INTENT §483.10(k)
Facility staff must ensure that residents are able to communicate freely with representatives of
these entities for whatever matter.

If concerns are identified regarding being provided contact information for representatives of
these entities, see guidance at 42 CFR §483.10(j)(4)(i), F585, Grievances.

F600
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.12 Freedom from Abuse, Neglect, and Exploitation

The resident has the right to be free from abuse, neglect, misappropriation of resident
property, and exploitation as defined in this subpart. This includes but is not limited to
freedom from corporal punishment, involuntary seclusion and any physical or chemical
restraint not required to treat the resident’s medical symptoms.

§483.12(a) The facility must—

§483.12(a)(1) Not use verbal, mental, sexual, or physical abuse, corporal punishment, or
involuntary seclusion;

INTENT §483.12(a)(1)
Each resident has the right to be free from abuse, neglect and corporal punishment of any type
by anyone.

NOTE: Refer to tag F602 for misappropriation of resident property and exploitation, and F603
for cases of involuntary seclusion.

DEFINITIONS §483.12(a)(1)

“Abuse,” is defined at §483.5 as “the willful infliction of injury, unreasonable confinement,
intimidation, or punishment with resulting physical harm, pain or mental anguish. Abuse also
includes the deprivation by an individual, including a caretaker, of goods or services that are
necessary to attain or maintain physical, mental, and psychosocial well-being. Instances of
abuse of all residents, irrespective of any mental or physical condition, cause physical harm,
pain or mental anguish. It includes verbal abuse, sexual abuse, physical abuse, and mental
abuse including abuse facilitated or enabled through the use of technology.”

“Neglect,” as defined at §483.5, means “the failure of the facility, its employees or service
providers to provide goods and services to a resident that are necessary to avoid physical harm,
pain, mental anguish or emotional distress.”

“Sexual abuse,” is defined at §483.5 as “non-consensual sexual contact of any type with a
resident.”

“Willful,” as defined at §483.5 in the definition of “abuse,” and “means the individual must
have acted deliberately, not that the individual must have intended to inflict injury or harm.”

GUIDANCE §483.12(a)(1)

NOTE: For purposes of this guidance, “staff” includes employees, the medical director,
consultants, contractors, and volunteers. Staff would also include caregivers who provide care
and services to residents on behalf of the facility, students in the facility’s nurse aide training
program, and students from affiliated academic institutions, including therapy, social, and
activity programs.

ABUSE

Sections §§1819(c)(1)(A)(ii) and 1919(c)(1)(A)(ii) of the Social Security Act provide that
each resident has the right to be free from, among other things, physical or mental abuse and
corporal punishment. The facility must provide a safe resident environment and protect
residents from abuse.

Staff to Resident Abuse of Any Type

Nursing homes have diverse populations including, among others, residents with dementia,
mental disorders, intellectual disabilities, ethnic/cultural differences, speech/language
challenges, and generational differences. When a nursing home accepts a resident for
admission, the facility assumes the responsibility of ensuring the safety and well-being of the
resident. It is the facility’s responsibility to ensure that all staff are trained and are
knowledgeable in how to react and respond appropriately to resident behavior. All staff are
expected to be in control of their own behavior, are to behave professionally, and should
appropriately understand how to work with the nursing home population. A facility cannot
disown the acts of staff, since the facility relies on them to meet the Medicare and Medicaid
requirements for participation by providing care in a safe environment. CMS does not

consider striking a combative resident an appropriate response in any situation. It is also not
acceptable for an employee to claim his/her action was “reflexive” or a “knee-jerk reaction”
and was not intended to cause harm. Retaliation by staff is abuse, regardless of whether harm
was intended, and must be cited.

NOTE: It should not be assumed that every accident or disagreement that occurs between
an employee and a resident should be considered to be abuse. Accidents that may not be
considered to be abuse include instances such as a staff member tripping and falling onto a
resident; or a staff member quickly turning around or backing into a resident that they did
not know was there.

Resident to Resident Abuse of Any Type

A resident to resident altercation should be reviewed as a potential situation of abuse. The
surveyor should not assume that every resident to resident altercation results in abuse. For
example, infrequent arguments or disagreements that occur during the course of normal
social interactions (e.g., dinner table discussions) would not constitute abuse. The surveyor
must determine whether the incident would meet the definition of abuse.

Also, when investigating an allegation of abuse between residents, the surveyor should not
automatically assume that abuse did not occur, especially in cases where either or both
residents have a cognitive impairment or mental disorder. Having a mental disorder or
cognitive impairment does not automatically preclude a resident from engaging in
deliberate or non-accidental actions. In determining whether F600-Free from Abuse and
Neglect should be cited in these situations, it is important to remember that abuse includes
the term “willful”. The word “willful” means that the individual’s action was deliberate
(not inadvertent or accidental), regardless of whether the individual intended to inflict
injury or harm. An example of a deliberate (“willful”) action would be a cognitively
impaired resident who strikes out at a resident within his/her reach, as opposed to a resident
with a neurological disease who has involuntary movements (e.g., muscle spasms,
twitching, jerking, writhing movements) and his/her body movements impact a resident
who is nearby. If it is determined that the action was not willful (a deliberate action), the
surveyor must investigate whether the facility is in compliance with the requirement to
maintain an environment as free of accident hazards as possible and that each resident
receives adequate supervision (See F689).

The facility may provide evidence that it completed a resident assessment and provided care
planning interventions to address a resident’s distressed behaviors such as physical, sexual or
verbal aggression. However, based on the presence of resident to resident altercations, if the
facility did not evaluate the effectiveness of the interventions and staff did not provide
immediate interventions to assure the safety of residents, then the facility did not provide
sufficient protection to prevent resident to resident abuse. For example, redirection alone is
not a sufficiently protective response to a resident who will not be deterred from targeting
other residents for abuse once he/she has been redirected.

Staff should monitor for any behaviors that may provoke a reaction by residents or others,
which include, but are not limited to:

• Verbally aggressive behavior, such as screaming, cursing, bossing
around/demanding, insulting to race or ethnic group, intimidating;

• Physically aggressive behavior, such as hitting, kicking, grabbing,
scratching, pushing/shoving, biting, spitting, threatening gestures, throwing
objects;

• Sexually aggressive behavior such as saying sexual things,
inappropriate touching/grabbing;

• Taking, touching, or rummaging through other’s property; and
• Wandering into other’s rooms/space.

Also, resident to resident abuse could involve a resident who has had no prior history of
aggressive behaviors, since a resident’s behavior could quickly escalate into an instance
of abuse. For example, a resident pushes away or strikes another resident who is
rummaging through his/her possessions.

Visitor to Resident Abuse of Any Type

Allegations of abuse have been reported between spouses, or residents and their parents or
children, in addition to visitors who are not members of a resident’s immediate family. The
surveyor may obtain information from the resident’s social history, to the extent possible that
identifies concerns or issues regarding relationships between the resident and relatives,
friends, and/or visitors. The surveyor should interview the social worker and review the
resident’s assessment and care plan to determine whether the facility identified and provided
interventions on how to address the concerns. (Also see F745-Medically Related Social
Services).

In addition, the survey team must review whether the facility has developed and implemented
policies and procedures related to visitor access. This would include safety restrictions, such
as denying access or providing limited and supervised access to a visitor who has been found
to be abusing, exploiting, or coercing a resident or who is suspected of abusing, exploiting, or
coercing a resident until an investigation into the allegation has been completed. Any such
restriction should be discussed with the resident or resident representative first. Also, the
resident maintains the right to deny visitation according to his/her preferences. See guidance at
F563- Visitation Rights and F564- Resident Right to Visitors.

TYPES OF ABUSE

Identified facility characteristics1 that could increase the risk for abuse include, but are not
limited to:

• Unsympathetic or negative attitudes toward residents;
• Chronic staffing problems;
• Lack of administrative oversight, staff burnout, and stressful working conditions;

• Poor or inadequate preparation or training for care giving responsibilities;
• Deficiencies of the physical environment; and
• Facility policies operate in the interests of the institution rather than the residents.

In addition, the risk for abuse may increase when a resident exhibits a behavior(s) that
may provoke a reaction by staff, residents, or others, such as2:

• Verbally aggressive behavior, such as screaming, cursing, bossing
around/demanding, insulting to race or ethnic group, intimidating;

• Physically aggressive behavior, such as hitting, kicking, grabbing,
scratching, pushing/shoving, biting, spitting, threatening gestures, throwing
objects;

• Sexually aggressive behavior such as saying sexual things,
inappropriate touching/grabbing;

• Taking, touching, or rummaging through other’s property;
• Wandering into other’s rooms/space; and
• Resistive to care and services.

Some situations of abuse do not result in an observable physical injury or the psychosocial
effects of abuse may not be immediately apparent. In addition, the alleged victim may not
report abuse due to shame, fear, or retaliation. Other residents may not be able to speak due to
a medical condition and/or cognitive impairment (e.g., stroke, coma, Alzheimer’s disease),
cannot recall what has occurred, or may not express outward signs of physical harm, pain, or
mental anguish. Neither physical marks on the body nor the ability to respond and/or verbalize
is needed to conclude that abuse has occurred.

Abuse may result in psychological, behavioral, or psychosocial outcomes including, but
not limited to, the following:

o Fear of a person or place, of being left alone, of being in the dark, and/or disturbed
sleep and nightmares;

o Extreme changes in behavior, including aggressive or disruptive behavior toward
a specific person; and

o Running away, withdrawal, isolating self, feelings of guilt and shame, depression,
crying, talk of suicide or attempts.

The guidance below identifies some characteristics of specific types of abuse.

Physical Abuse

Physical abuse includes, but is not limited to, hitting, slapping, punching, biting, and kicking.

Corporal punishment, which is physical punishment, is used as a means to correct or control
behavior. Corporal punishment includes, but is not limited to, pinching, spanking, slapping
of hands, flicking, or hitting with an object.

Possible indicators of physical abuse include an injury that is suspicious because the source
of the injury is not observed, the extent or location of the injury is unusual, or because of the
number of injuries either at a single point in time or over time.

Examples of injuries that could indicate abuse include, but are not limited to:

o Injuries that are non-accidental or unexplained;
o Fractures, sprains or dislocations;
o Burns, blisters, or scalds on the hands or torso;
o Bite marks, scratches, skin tears, and lacerations with or without bleeding,

including those that are in locations that would unlikely result from an accident;
o Bruises, including those found in unusual locations such as the head, neck, lateral

locations on the arms, or posterior torso and trunk, or bruises in shapes (e.g.,
finger imprints); and

o Facial injuries, including but not limited to, broken or missing teeth, facial
fractures, black eye(s), bruising, bleeding or swelling of the mouth or cheeks.

Deprivation of Goods and Services by Staff

Abuse also includes the deprivation by staff of goods or services that are necessary to attain
or maintain physical, mental, and psychosocial well-being. In these cases, staff has the
knowledge and ability to provide care and services, but choose not to do it, or acknowledge
the request for assistance from a resident(s), which result in care deficits to a resident(s).

Mental and Verbal Abuse

Mental abuse is the use of verbal or nonverbal conduct which causes or has the potential
to cause the resident to experience humiliation, intimidation, fear, shame, agitation, or
degradation.

Verbal abuse may be considered to be a type of mental abuse. Verbal abuse includes the
use of oral, written, or gestured communication, or sounds, to residents within hearing
distance, regardless of age, ability to comprehend, or disability.

Examples of mental and verbal abuse include, but are not limited to:

o Harassing a resident;
o Mocking, insulting, ridiculing;
o Yelling or hovering over a resident, with the intent to intimidate;
o Threatening residents, including but limited to, depriving a resident of care

or withholding a resident from contact with family and friends; and
o Isolating a resident from social interaction or activities.

NOTE: Although a finding of mental abuse indicates that a facility is not promoting an
environment that enhances a resident’s dignity, surveyors must cite a finding of mental abuse

at F600 at the appropriate severity level with consideration of the psychosocial outcome to
residents.

Mental abuse includes abuse that is facilitated or enabled through the use of technology, such
as smartphones and other personal electronic devices. This would include keeping and/or
distributing demeaning or humiliating photographs and recordings through social media or
multimedia messaging. If a photograph or recording of a resident, or the manner that it is used,
demeans or humiliates a resident(s), regardless of whether the resident provided consent and
regardless of the resident’s cognitive status, the surveyor must consider non-compliance
related to abuse at this tag. This would include, but is not limited to, photographs and
recordings of residents that contain nudity, sexual and intimate relations, bathing, showering,
using the bathroom, providing perineal care such as after an incontinence episode, agitating a
resident to solicit a response, derogatory statements directed to the resident, showing a body
part such as breasts or buttocks without the resident’s face, labeling resident’s pictures and/or
providing comments in a demeaning manner, directing a resident to use inappropriate
language, and showing the resident in a compromised position. Depending on what was
photographed or recorded, physical and/or sexual abuse may also be identified.

Sexual Abuse
“Sexual abuse” is non-consensual sexual contact of any type with a resident, as defined at
42 CFR §483.5. Sexual abuse includes, but is not limited to:

o Unwanted intimate touching of any kind especially of breasts or perineal area;
o All types of sexual assault or battery, such as rape, sodomy, and coerced nudity;
o Forced observation of masturbation and/or pornography; and
o Taking sexually explicit photographs and/or audio/video recordings of a resident(s) and

maintaining and/or distributing them (e.g. posting on social media). This would include,
but is not limited to, nudity, fondling, and/or intercourse involving a resident.

Generally, sexual contact is nonconsensual if the resident either:

o Appears to want the contact to occur, but lacks the cognitive ability to consent; or
o Does not want the contact to occur.

Other examples of nonconsensual sexual contact may include, but are not limited to,
situations where a resident is sedated, is temporarily unconscious, or is in a coma.

Any investigation of an allegation of resident sexual abuse must start with a determination of
whether the sexual activity was consensual on the part of the resident. A resident’s apparent
consent to engage in sexual activity is not valid if it is obtained from a resident lacking the
capacity to consent, or consent is obtained through intimidation, coercion or fear, whether it is
expressed by the resident or suspected by staff. Any forced, coerced or extorted sexual
activity with a resident, regardless of the existence of a pre-existing or current sexual
relationship, is considered to be sexual abuse. A facility is required to conduct an
investigation and protect a resident from non-consensual sexual relations anytime the facility
has reason to suspect that the resident does not wish to engage in sexual activity or may not
have the capacity to consent.

Non-Sexual Physical Contact with Residents

Nothing in this guidance is intended to limit a resident’s ability to receive non-sexual contact,
such as holding a resident’s hand. It is not the intent of this guidance for facilities to foster “no
contact of any type” policies/procedures/practices between staff and residents or residents and
others, assuming such contact is consistent with the resident’s preferences. It should also not be
assumed that all physical contact involving a resident would constitute sexual abuse.

Capacity and Consent

Residents have the right to engage in consensual sexual activity. However, anytime the
facility has reason to suspect that a resident may not have the capacity to consent to sexual
activity, the facility must take steps to ensure that the resident is protected from abuse. These
steps should include evaluating whether the resident has the capacity to consent to sexual
activity.

NOTE: For information related to determining consent, refer to “Assessment of Older
Adults with Diminished Capacity: A Handbook for Psychologists – © American Bar
Association Commission on Law and Aging – American Psychological Association, located
at http://www.apa.org/pi/aging/programs/assessment/capacity-psychologist-handbook
This resource includes a discussion on determining issues related to determining
consent including:

The legal standards and criteria for sexual consent vary across states (Lyden, 2007;
Stavis et al., 1999). The most widely accepted criteria, which are consistent with those
applied to consent to treatment, are: (1) knowledge of relevant information, including
risks and benefits; (2) understanding or rational reasoning that reveals a decision that is
consistent with the individual’s values (competence); and (3) voluntariness (a stated
choice without coercion) (Grisso, 2003; Kennedy, 1999; Stavis, 1991; Stavis et al.,
1999; Sundram et al., 1993).

When investigating an allegation of sexual abuse, the facility must conduct a thorough
investigation to determine the facts specific to the case investigated, including whether the
resident had the capacity to consent and whether the resident actually consented to the
sexual activity. A resident’s voluntary engagement in sexual activity may appear to mean
consent to the activity; in these instances, if the facility has reason to suspect that the
resident may not have the capacity to consent, the facility must protect the resident from
potential sexual abuse while the investigation is in progress [See §483.12(c)(3)].

Determinations of capacity to consent depend on the context of the issue and one
determination does not necessarily apply to all decisions made by the resident. For example,
the resident may not have the capacity to make decisions regarding medical treatment, but
may have the capacity to make decisions on daily activities (e.g., when to wake up in the
morning, what activities to engage in). Determinations of capacity in this context are complex
and cannot necessarily be based on a resident’s diagnosis alone. Capacity on its most basic

http://www.apa.org/pi/aging/programs/assessment/capacity-psychologist-handbook

level means that a resident has the ability to understand potential consequences and choose a
course of action for a given situation. Decisions of capacity to consent to sexual activity must
balance considerations of safety and resident autonomy, and capacity determinations must be
consistent with State law, if applicable. The facility’s policies, procedures and protocols,
should identify when, how, and by whom determinations of capacity to consent to a sexual
contact will be made and where this documentation will be recorded. See also 42 CFR
§483.10(f) [F561] for concerns related to the resident’s right to self-determination through
support of resident choice, and 42 CFR §483.10(b)(3)-(7) [F551] for concerns related to the
exercise of the resident’s rights by the resident representative.

NOTE: CMS is not requiring facilities to adopt a specific approach in determining a
resident’s capacity to consent. However, the facility administration, nursing and medical
director may wish to consider establishing an ethics committee, that includes legal
consultation, in order to assist in the development and implementation of policy related to
aspects of quality of life and/or care, advance directives, intimacy and relationships.

Cognitive functioning may change due to health issues such as, but not limited to stroke,
dementia, depression/psychiatric illnesses or other impacts such as medication(s),
hearing/visual loss, and stress. Therefore, the facility should continue to monitor and re-
evaluate a resident’s capacity to consent over time, as needed, based on the individual
resident’s physical, mental and psycho-social needs. See also 42 CFR §483.10(g)(14) [F580-
Notification of Changes].

Residents with Designated or Legally Appointed Representatives
A resident may have a representative that has been appointed legally under State law through,
for example, a power of attorney, guardian, limited guardian, or conservatorship. These legal
appointments vary in the degree that they empower the appointed representative to make
decisions on behalf of the resident. While a legal representative may have been empowered to
make some decisions for a resident, it does not necessarily mean that the representative is
empowered to make all decisions for the resident. The individual arrangements for legal
representation will have to be reviewed to determine the scope of authority of the
representative on behalf of the resident.

A resident may also have designated an individual to speak on his/her behalf for decisions
for care or other issues. However, it is necessary for the resident, his/her representative and
the facility to have a clear understanding of the types and scope of decision- making
authority the representative has been delegated.

Any decision-making power that is not legally granted to a representative under state law is
retained by the resident. It is the responsibility of the facility to ascertain what decisions the
representative is legally empowered to make on behalf of the resident.

More specifically, regarding consent for sexual activity, State law and the legal instruments
setting up resident representation may be silent on that topic. The facility must be aware of the
representative’s scope of authority regarding resident decision-making.

When a resident with capacity to consent to sexual activity and his/her representative disagree
about the resident engaging in sexual activity, the facility must honor the resident’s wishes
irrespective of that disagreement if the representative’s legal authority does not address that
type of decision-making for sexual activity. If the resident representative’s legal authority
addresses decision-making for sexual activity, then the facility must honor the resident
representative’s decision consistent with 42 CFR §483.10(b).

NOTE: See F551 at 42 CFR §483.10(b)(6)- If the facility has reason to believe that a
resident representative is making decisions or taking actions that are not in the best interests
of a resident, the facility shall report such concerns in the manner required under State law.

Indicators of Potential Sexual Abuse

In addition to reports from residents and others that sexual abuse occurred, possible physical
indicators of sexual abuse that would require investigation by the facility and survey team
include, but are not limited to:

• Bruises around the breasts, genital area, or inner thighs;
• Unexplained sexually transmitted disease or genital infections;
• Unexplained vaginal or anal bleeding; and/or
• Torn, stained, or bloody underclothing.

Literature indicates that the most prevalent psychosocial outcomes of abuse are depression,
anxiety, and posttraumatic disorder 3. Other possible outcomes of sexual abuse4,5 may include
SUDDEN OR UNEXPLAINED CHANGES in the following behaviors and/or activities such
as fear or avoidance of a person or place, of being left alone, of the dark, nightmares, and/or
disturbed sleep.

Allegations of Sexual Abuse

There are additional considerations when investigating allegations of sexual abuse involving:

o Sexual abuse by a staff member;
o Resident to resident sexual abuse; and
o Sexual abuse by a spouse or visitor.

For any alleged violation of sexual abuse, the facility must:
• Immediately implement safeguards to prevent further potential abuse;
• Immediately report the allegation to appropriate authorities;
• Conduct a thorough investigation of the allegation; and
• Thoroughly document and report the result of the investigation of the allegation.

See Tags F609 [See §§ 483.12(b)(5), 483.12(c)(1) and (c)(4)], and F610 [See §§ 483.12(c)(2),
(c)(3), and (c)(4)].

Allegations of Staff to Resident Sexual Abuse

Nursing home staff are entrusted with the responsibility to protect and care for the residents of
that facility. Nursing home staff are expected to recognize that engaging in a sexual
relationship with a resident, even an apparently willingly engaged and consensual relationship,
is not consistent with the staff member’s role as a caregiver and will be considered an abuse of
power. Also, for some health care professionals, it is prohibited by licensure or certification
requirements for professionals to have a relationship with a resident (or patient).

NOTE: Refer to applicable State professional licensure/certification requirements and/or
scope of practice.

Any sexual relationship between a staff member and a resident with or without diminished
capacity may constitute sexual abuse in the absence of a sexual relationship that existed before
the resident was admitted to the facility, such as a spouse or partner, and must be thoroughly
investigated. However, in a rare situation, it may not be considered to be sexual abuse when a
nursing home employee has a pre-existing sexual relationship with an individual, (i.e., spouse
or partner) who is then admitted to the nursing home, unless there are concerns about the
relationship not being consensual.

Allegations of Resident To Resident Sexual Abuse

Studies show that a considerable amount of unwanted sexual contact in nursing homes may be
initiated by a resident who is sexually aggressive as a result of disease processes such as brain
injuries or dementia. In addition, a resident may have a pre-occupation for sexual activity, or
have had a prior history of sexual abuse. The resident who is sexually aggressive may target a
resident who is unable to protect him/herself, and may involve various types of sexual
aggression such as fondling both over and under clothing, masturbation in the presence of
another resident and is unwanted by that other resident, forcing oral sex, or sexual intercourse.

If there is an allegation that a resident did not wish to engage in sexual activity with another
resident or may not have the capacity to consent, the facility must respond to it as an alleged
violation of sexual abuse.

Allegations of Visitor to Resident Sexual Abuse
In certain situations, sexual activity between a resident and a visitor (e.g., spouse, partner) may
not be considered to be abuse, if there was a pre-existing sexual relationship, the resident has
the capacity and ability to consent, and the resident wishes to continue with the sexual
relationship. Regardless, the nursing home must ensure that a visitor(s) is not subjecting any
resident(s) to sexual abuse. In addition, the nursing home staff must immediately act on any
allegation or suspicion that a visitor is engaging in improper sexual activity with a resident (See
F609 and F610).

Response to Alleged Violations of Sexual Abuse
If an allegation of sexual abuse has been reported, the facility must immediately protect the
alleged victim(s) involved, report the alleged violations to the Administrator and
appropriate State and local authorities, and begin an investigation of the allegation. See 42
CFR §483.12 (c)(1)-(4), F609-Reporting of Alleged Violations and F610-Response to

Alleged Violations. As the facility conducts its investigation, the facility must not tamper
with evidence. Tampering with evidence would impede completion of a thorough
investigation by the facility and other investigating authorities. Examples of tampering
include, but are not limited to: washing linens or clothing, destroying documentation,
bathing or cleaning the resident until the resident has been examined (including a rape kit,
if appropriate), or otherwise impeding a law enforcement investigation. If the surveyor
identifies that the facility has tampered with evidence, the surveyor should investigate
whether the facility is in compliance with F607 and F610.

Determination of Findings and Potential to Foresee Abuse

It has been reported that some facilities have identified that they are in compliance with F600-
Free from Abuse and Neglect because that they could not foresee that abuse would occur and
they have “done everything to prevent abuse,” such as conducted screening of potential
employees, assessed residents for behavioral symptoms, monitored visitors, provided training
on abuse prevention, suspended or terminated employment of the perpetrator, developed and
implemented policies and procedures to prohibit abuse, and met reporting requirements.
However, this interpretation would not be consistent with the regulation, which states that “the
resident has the right to be free from verbal, sexual, physical, and mental abuse…” Therefore,
if the survey team has investigated and collected evidence that abuse has occurred, it is
appropriate for the survey team to cite the current or past noncompliance at F600-Free from
Abuse and Neglect.

Determination of Past Non-Compliance

Past noncompliance occurs when noncompliance has occurred in the past, but the facility
corrects the deficiency and is in substantial compliance at the time of the current survey. Prior
to citing a deficiency as past-noncompliance, surveyors should investigate each instance
thoroughly to determine if the facility took all the appropriate actions to correct the
noncompliance, and determine the date on which the facility had returned to substantial
compliance.

More specifically, a deficiency citation at past noncompliance meets the following three
criteria:

1. The facility was not in compliance with the specific regulatory requirement(s) at the
time the situation occurred;

2. The noncompliance occurred after the exit date of the last standard (recertification)
survey and before the survey (standard, complaint, or revisit) currently being
conducted, and

3. There is sufficient evidence that the facility corrected the noncompliance and is in
substantial compliance at the time of the current survey for the specific regulatory
requirement(s), as referenced by the specific F-tag or K-tag.

The surveyors must document the facility’s corrective actions in the CMS-2567; the
facility is not required to submit a plan of correction. Refer to SOM Section 7510.1

and 7510.2 for additional guidance and information on findings of past
noncompliance.

NOTE: When a facility has identified abuse, the facility must take all appropriate steps to
remediate the noncompliance and protect residents from additional abuse immediately.
Facilities that take immediate action to correct any issues can reduce the risk of further harm
continuing or occurring to other residents, thereby potentially preventing the scope and
severity of the deficiency from increasing. Failure to take steps could result in findings of
current noncompliance and increased enforcement action, including, but are not limited to,
the following:

• Taking steps to prevent further potential abuse [See F600, 483.12(a) and F610- §
483.12(c)(3)];

• Reporting the alleged violation and investigation within required timeframes [See
F609- § 483.12(c)(1) and (c)(4)];

• Conducting a thorough investigation of the alleged violation [See F610 – §
483.12(c)(2)];

• Taking appropriate corrective action [See F610 –§ 483.12(c)(4)]; and
• The facility must revise the resident’s care plan if the resident’s medical, nursing,

physical, mental, or psychosocial needs or preferences change as a result of an
incident of abuse [See Tag F656- §483.21(b)].

NEGLECT

NOTE: For purposes of this guidance, “staff” includes employees, the medical director,
consultants, contractors, volunteers. Staff would also include caregivers who provide care and
services to residents on behalf of the facility, students in the facility’s nurse aide training
program, and students from affiliated academic institutions, including therapy, social, and
activity programs.

The Link between Noncompliance at Resident’s Rights/Quality of Care/Quality of
Life and Neglect of Goods and Services

Neglect at F600 should not automatically be cited in addition to the Resident’s Rights/Quality
of Care/Quality of Life tags. While the latter citations identify potential or actual negative
outcomes in the areas of resident’s rights, quality of care, and quality of life, neglect identifies
the facility’s failure to provide the required structures and processes in order to meet the needs
of one or more residents. This may include, but is not necessarily limited to, the facility’s
failure to provide necessary staff, supplies, services, policies, training, or staff supervision and
oversight to meet the resident’s needs.

Noncompliance at tags such as F686 and F689, do not automatically indicate noncompliance
at F600 for neglect. For example, a survey team identifies that a facility had failed to perform
a skin assessment for a resident, resulting in failure to implement interventions to prevent the
development of an avoidable Stage 2 pressure ulcer for a resident. Upon further investigation,
the survey team finds that the facility identified the pressure ulcer and treated it with no

further worsening. While the survey team would identify noncompliance at F686, the facility
would not generally be cited at F600 as well. Another example is when a resident requires
supervision when ambulating and a staff member fails to provide assistance to the resident,
resulting in a fall. In this scenario, the survey team would identify noncompliance at F689;
however, the facility would not be cited at F600 for neglect. In both of these examples, a
citation for neglect would require additional evidence that identifies that the facility knew, or
should have known, to provide the staff, supplies, services, policies, training, or staff
supervision and oversight to meet the resident’s needs, but continued to fail to take action
necessary to avoid the potential for harm, or actual harm to the resident.

Identifying Neglect

“Neglect,” is defined at §483.5 as “the failure of the facility, its employees or service
providers to provide goods and services to a resident that are necessary to avoid physical
harm, pain, mental anguish or emotional distress.” Neglect occurs when the facility is
aware of, or should have been aware of, goods or services that a resident(s) requires but the
facility fails to provide them to the resident(s), that has resulted in or may result in physical
harm, pain, mental anguish, or emotional distress. Neglect includes cases where the
facility’s indifference or disregard for resident care, comfort or safety, resulted in or could
have resulted in, physical harm, pain, mental anguish, or emotional distress. Neglect may
be the result of a pattern of failures or may be the result of one or more failures involving
one resident and one staff person.

Neglect of goods or services may occur when staff are aware, or should be aware, of
residents’ care needs, based on assessment and care planning, but are unable to meet the
identified needs due to other circumstances, such as lack of training to perform an
intervention (e.g., suctioning, transfers, use of equipment), lack of sufficient staffing to be
able to provide the services, lack of supplies, or staff lack of knowledge of the needs of the
resident. Examples include, but are not limited to:

• A nurse aide was assigned to care for several residents, who required, assistance to eat,
drink, dress, bathe, toilet, walk, and positioning in bed or chair. Due to the workload
and resident care requirements, the nurse aide is unable to respond to call lights or
complete the assignments for all of the residents that she is assigned to provide care
for. In addition, due to insufficient numbers of staff in the facility, there is no other
nurse aide available to assist her. This inability of the nurse aides in this unit to respond
to call lights and to complete resident care assignments occurs throughout the shift,
resulting in omissions in delivery of services to meet the resident’s needs. Physical
harm occurred as a result of the lack of sufficient staff to implement the care plan as
ordered and inadequate supervision to assure that care was provided as ordered and/or
as planned. In addition, staff had reported to administration their concerns about not
meeting the residents’ needs, but administration failed to respond.

• The nursing home utilizes temporary staffing agencies, but does not have processes in
place to provide orientation, or medical or care plan information for the temporary

staff regarding the individual resident’s needs on the unit to which the temporary
employee is assigned.

• The nursing home failed to respond to residents refusing to bathe/shower, based on

complaints of cold water during bathing/showering. Maintenance staff identified
equipment failures and reported them to the facility’s administrator with
recommendations to replace the water heating system. However, the administrator
did not address these failures, resulting in the diminished quality of life for residents.

Identification of Goods and Services Required by Residents

When a resident is admitted to a nursing home, the nursing home has determined that it has the
capability and capacity to provide goods and services to meet the needs of the resident by its
staff. See, for example, requirements at §483.10-Resident Rights, §483.24-Quality of Life, and
§483.25-Quality of Care. In addition, other services as needed by the resident must be
assessed and addressed by the nursing home. This does not mean that all services must be
directly provided by the nursing home, but the nursing home must assist and/or make referrals
for the resident to receive necessary services. Examples of structures and processes in the
facility include but are not limited to, the following:

• Structures – The nursing home’s capability and capacity to provide needed care
and services such as:

o A facility’s assessment to determine what resources are necessary to care for

its residents competently;
o The provision of sufficient numbers of qualified, trained staff based upon the

facility’s assessment and as needed to meet resident needs;
o An effective orientation, training, and evaluation program, which includes, but is

not limited to, nursing home resident care policies specific to resident’s identified
care needs, resident care requirements based upon assignments and duties including
types of services and treatments required for each resident, and other interventions
necessary to meet a resident(s) needs;

o Oversight and monitoring of staff performance including conducting performance
evaluations for direct care staff (nurse aides), and how weaknesses or training
needs are addressed;

o Oversight and monitoring of contracted services or services provided
under arrangement;

o Resident care policies and procedures to ensure that the facility provides care and
services in accordance with current standards of practice, that address resident’s
diagnosis, and that provide clinical and technical direction to meet the needs of
each resident admitted;

o Sufficient amounts of food to meet dietary needs;
o Availability of medications and supplies necessary to provide care;
o Implementation of an infection control and prevention program that includes

staff procedures for care including hand hygiene, standard and transmission
based precautions, including use of PPE;

o A safe and sanitary environment;
o Provision of sufficient clean linens;
o Adequate and appropriate equipment and devices and other available technology,

including procedures for how to use, clean, maintain and store equipment; and
o If admitted, the provision of specialized services for residents who require

rehabilitation services, dialysis, respiratory therapy (mechanical ventilation
or oxygen therapy), IV therapy, and hospice.

• Processes so that the needs of each resident are met, based upon:

o Initial and ongoing assessments of the clinical needs of the resident including any

acute changes in condition, such as cardio/respiratory failure, choking,
hemorrhaging, poor glycemic control, onset of delirium, behavioral emergencies,
or falls resulting in head injuries or fractures;

o The provision and implementation of a resident-specific care plan including
the ongoing evaluation and revision of the care plan as necessary; and

o Ongoing monitoring and supervision of staff to assure the implementation of the
care plan as written.

The cumulative effect of different individual failures in the provision of care and services by
staff leads to an environment that promotes neglect. Neglect occurs when the facility is aware
of, or should have been aware of, goods or services that a resident(s) requires but the facility
fails to provide them to the resident(s), resulting in, or may result in, physical harm, pain,
mental anguish, or emotional distress. Examples of individual failures include, but are not
limited, to the following:

• Failure to provide sufficient, qualified, competent staff, to meet resident’s needs;
• Failure to provide orientation and/or training to staff;
• Failure to provide training on new equipment or new procedures or medications

required for the care of a specified resident or required due to changes in acceptable
standards of practice;

• Failure to oversee the implementation of resident care policies;
• Failure to provide supervision and/or monitoring of the delivery and implementation

of care;
• Failure of staff to implement resident interventions, even when residents are assessed

and interventions are identified in the care plan;
• Failure to identify, assess, and/or contact a physician and/or prescriber for an acute

change in condition, and/or a change in condition that requires the plan of care to
be revised to meet the resident’s needs in a timely manner;

• Failure to ensure staff respond correctly to medical or psychiatric emergencies;
• Failure to implement an effective communication system across all shifts for

communicating necessary care and information between staff, practitioners, and
resident representatives;

• Failure to monitor and/or provide adequate supervision to assure that
environmental hazards are not present including but not limited to:
o Access to hot water of sufficient temperature to cause tissue injury;

o Non-functioning call system without a compensatory action;
o Improper handling/disposal of hazardous materials, chemicals and waste;
o Infestation by insects/rodents;

• Failure to provide adequate monitoring and supervision, if smoking is allowed;
• Failure to meet financial obligations for the delivery of care and the maintenance of

the facility (e.g. payment for staff, utilities, contractors);
• Failure of the Quality Assurance and Assessment committee to develop and

implement appropriation action plans to correct identified quality deficiencies;
• Failure of administration to effectively and efficiently use its resources to attain

or maintain the highest practicable physical, mental, and psychosocial well-being;
and

• Failure to provide oversight of medical services that are provided in the facility.

The failure to provide necessary care and services resulting in neglect may not only result in a
negative physical outcome, but may also impact the psychosocial well-being of the resident,
with outcomes such as mental anguish, feelings of despair, abandonment, and fear. (Refer to
Psychosocial Outcome Severity Guide)

INVESTIGATIVE SUMMARY FOR ABUSE AND
NEGLECT INVESTIGATION OF ALLEGATIONS OF
ABUSE

The process to review concerns are outlined in the Abuse Critical Element Pathway (Form
CMS- 20059).

Summary of Procedures

Identify if there is an alleged violation of abuse, physical punishment or allegations of
an individual depriving a resident of care or services.

• Refer to the Neglect Critical Element Pathway (form CMS-20130) to investigate
concerns about structures or processes leading to a resident(s) failing to receive required
care and services.

• Refer also to the Investigative Protocol for F607 – Policies and Procedures Related
to Allegations of Retaliation by the Facility Against a Covered Individual, for an
allegation of retaliation and F609-Reporting Reasonable Suspicion of a Crime, if a
covered individual did not report a reasonable suspicion of a crime.

NOTE: If you receive an unreported allegation of abuse, report this immediately to the facility
administrator or person in charge.

Use observations, interviews, and record review to gather and corroborate information
related to:

• The alleged abuse, including anything that could have placed the alleged victim at
risk for abuse, who was involved, what happened, and when and where did it
happen;

• Any injuries and/or physical/psychosocial outcomes, including
whether interventions/medical treatment was required;

• Details of actions taken, including protecting the resident(s), reporting,
investigating, and corrective actions;

• Whether there is any indication that retaliation may have occurred; and
• What types of training and/or orientation staff may have received related to abuse.

For specific allegations of abuse, the surveyor should review:

• For allegations of staff to resident abuse, staffing rosters to determine staffing at the
time of the alleged abuse, timecards for staff on duty at the time, and conduct staff
interviews to determine whether there was adequate monitoring and supervision of
staff at the time of the allegation. The surveyor should also review staff training logs to
determine whether staff was trained on abuse prevention, and review the alleged
perpetrator personnel records, including screening and disciplinary records, if any.

• For allegations of resident to resident abuse, whether there is a history of distressed
behaviors that could place residents at risk, whether resident assessments identified
concerns related to behavior, mood, cognitive status, communication, and mobility
and whether care planning addressed the concerns identified with specific
interventions, whether interventions were implemented, and whether there was
adequate monitoring and supervision of the resident(s).

• For allegations of visitor to resident abuse, whether there was any indication of risk to
the resident(s) and whether adequate monitoring and supervision were provided as
appropriate.

If Tag F600 is cited for abuse, the survey team includes the following language at the
beginning of the Deficient Practice Statement on the Form CMS-2567: “Based on
[observations/interviews/record review], the facility failed to protect the resident’s(s’) right to
be free from [Type(s) of abuse: mental abuse/verbal abuse/physical abuse/sexual
abuse/deprivation of goods and services] by [Perpetrator type: staff/a resident/a visitor]….”

INVESTIGATION FOR ALLEGATIONS OF NEGLECT

The process to review concerns are outlined in the Neglect Critical Element Pathway
(Form CMS-20130).

Use

Use the Neglect Critical Element (CE) Pathway, and the above Guidance when investigating
concerns related to structures or processes that have led to resident outcome such as unrelieved

pain, avoidable pressure injuries, avoidable dehydration, lack of continence care, or
malnourishment.

Utilize appropriate Critical Element Pathways for care issues, in order to identify whether
noncompliance for a care concern exists first and determine whether further investigation is
needed as to whether the facility has the structures and processes to provide necessary to
provide goods and services to residents.

Summary of Procedures

Interview staff and review facility policies and procedures to determine:

• How the facility monitors and provides oversight of the provision of care and
services; and

• How the facility responds when there are concerns that a resident(s) is not
receiving necessary goods and services.

If Tag F600 is cited for neglect, the survey team includes the following language at the
beginning of the Deficient Practice Statement on the Form CMS-2567: “Based on
[observations/interviews/record review], the facility failed to protect the resident’s(s’) right to
be free from neglect….”

KEY ELEMENTS OF NONCOMPLIANCE FOR ABUSE AND NEGLECT §483.12(a)(1)

To cite deficient practice at F600, the surveyor’s investigation will generally show that
the facility:

• Failed to protect a resident’s right to be free from any type of abuse, including corporal
punishment, and neglect, that results in, or has the likelihood to result in physical harm,
pain, or mental anguish; or

• Failed to ensure that a resident was free from neglect when it failed to provide the
required structures and processes in order to meet the needs of one or more residents.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION

During the investigation, the surveyor may have determined that concerns may also be
present with related outcome, process and/or structure requirements. The surveyor is
cautioned to investigate these related requirements before determining whether non-
compliance may be present. Some examples of related requirements that should be
considered include the following:

• 42 CFR §483.10(f)(4)(ii)‐(v), F563 – Visitation Rights
o Determine if the facility provided immediate access and visitation by family,

designated representatives or other individuals, subject to reasonable restrictions
and the resident’s right to deny or withdraw consent.

• 42 CFR §483.10(f)(4)(vi), F564- Resident Right to Visitors

• 42 CFR §483.10(g)(1), F572 – Notice of Rights and Rules
• 42 CFR §483.10(h), F583- Personal Privacy/Confidentiality of Records
• 42 CFR §483.12(a)(3)‐(4), F606 – Not Employ/Engage Staff with Adverse Actions
• 42 CFR §483.12(b)(1)‐(4), §483.12(b)(5), F607 – Develop/Implement Abuse/Neglect,

etc. Policies
• 42 CFR §483.12(c)(1), (4), §483.12(b)(5), F609 – Reporting of Alleged Violations
• 42 CFR §483.12(c)(2) ‐ (4), F610 – Alleged Violations-Investigate/Prevent/Correct
• 42 CFR §483.24, F675 – Quality of Life
• 42 CFR §483.25(d), F689- Free of Accident Hazards/Supervision/Devices

o Determine if the facility ensured that the resident environment remains as free
from accident hazards as is possible and each resident receives adequate
supervision to prevent accidents related to resident-to-resident altercations where
the resident’s action is not willful.

• 42 CFR §483.35, 483.35(a), and §483.35(c)- F725 and F726 – Sufficient and
Competent Staff

• 42 CFR §483.35(a)(3) and (a)(4), §483.35(c), F726 – Competent Staff
• 42 CFR §483.40(b)‐(b)(1), F742- Treatment/Svc for Mental/Psychosocial Concerns
• 42 CFR §483.75 (g)(2)(ii)- F867- QAA Activities
• 42 CFR§483.95(c), F942- Abuse, Neglect, and Exploitation Training
• 42 CFR §483.95(g), F946-Required In-Service Training for Nurse Aide

DEFICIENCY CATEGORIZATION §483.12(a)(1)

In addition to actual or potential physical harm, always consider whether psychosocial harm has
occurred when determining severity level (See Psychosocial Outcome Severity Guide).

As the Psychosocial Outcome Severity Guide, located in the Nursing Home Survey Resources
Folder, describes, to apply the reasonable person concept, the survey team should determine the
severity of the psychosocial outcome or potential outcome the deficiency may have had on a
reasonable person in the resident’s position (i.e., what degree of actual or potential harm would
one expect a reasonable person in the resident’s similar situation to suffer as a result of the
noncompliance). Generally, when applying the reasonable person concept, the survey team
should consider the following as it determines the outcome to the resident, which include, but is
not limited to:

• The resident may consider the facility to be their “home,” where there is an expectation
that he/she is safe, has privacy, and will be treated with respect and dignity.

• The resident trusts and relies on facility staff to meet his/her needs.
• The resident may be frail and vulnerable.

Determining the severity of psychosocial outcomes for abuse can present unique challenges to
surveyors. Given that the psychosocial outcome of abuse may not be apparent at the time of the
survey, it is important for the survey team to apply the reasonable person concept in evaluating
the severity of psychosocial outcomes. It is important for the surveyor to gather and document
any information that identifies any psychosocial outcomes resulting from the noncompliance; for

https://www.cms.gov/medicare/provider-enrollment-and-certification/guidanceforlawsandregulations/nursing-homes

abuse, surveyors should also consider that the psychosocial outcome of abuse may not be
apparent at the time of the survey. For example, a resident who was raped may demonstrate
indifference to the incident at the time of the survey. In addition, residents may not be able to
express themselves due to a medical condition and/or cognitive impairment (e.g., stroke, coma,
Alzheimer’s disease), not be able to recall what has occurred, or may not express outward signs
of physical harm, pain, or mental anguish. However, when a nursing home resident is treated in
any manner that does not uphold a resident’s sense of self-worth and individuality, it
dehumanizes the resident and creates an environment that perpetuates a disrespectful and/or
potentially abusive situation for the resident(s).

There are situations that are likely to cause psychosocial harm which may sometimes take
months or years to manifest and have long-term effects on the resident and his/her relationship
with others. Therefore, during a survey, “Immediate Jeopardy” or “Actual Harm,” may be
supported when there is not an observed or documented negative psychosocial outcome, or a
description of resident impact from the resident’s representative or others who know the resident.
Numerous situations involving abuse are likely to cause serious psychosocial harm (i.e.
Immediate Jeopardy) to a resident who is a victim of these types of actions; these situations
include, but are not limited to:

• Sexual assault (e.g., rape)
• Unwanted sexual touching
• Sexual harassment
• Any staff to resident physical, sexual, or mental/verbal abuse [NOTE: Sexual

abuse does not include the rare situation where a nursing home employee has a pre-
existing and consensual sexual relationship with an individual (i.e., spouse or
partner) who is then admitted to the nursing home unless there are concerns about
the relationship not being consensual]

• Staff posting or sharing demeaning or humiliating photographs or videos of
nursing home residents

• When facility staff, as punishment, threaten to take away the resident’s rights,
privileges, or preferred activities, or withhold care from the resident

• Any resident to resident physical abuse that is likely to result in fear or anxiety

According to the Social Security Act [Sections §§1819(c)(1)(A)(ii) and 1919(c)(1)(A)(ii)], every
resident has the right to be free from mental or physical abuse. A reasonable person would not
expect that they would be harmed in his/her own “home” or a health care facility and would
experience a negative psychosocial outcome (e.g. fear, anxiety, anger, humiliation, a decline
from former social patterns). In incidents in which one resident abuses another resident, if a
reasonable person would likely suffer actual harm as a result of the incident, the incident should
not be cited below Severity Level 3 (Actual Harm).

NOTE: Surveyors should refer to the guidance related to physical, mental/verbal, and sexual
abuse and deprivation of goods and services by staff.

Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident
Health or Safety include, but are not limited to:

• The facility failed to protect a resident from sexual abuse when Resident 1 was found

in Resident 2’s bedroom. Resident 1 was holding Resident 2, whose clothes had been
partially removed and her breasts were exposed. Resident 2 was severely cognitively
impaired. Resident 1 had a known history of sexually inappropriate behaviors, but
there was no evidence that the facility had assessed and revised the care plan to
identify the potential risks to other residents related to the behaviors; there was no
evidence that Resident 2 could consent to sexual activity with other residents. Based
on interview with Resident 2’s daughter, the daughter described her shock about the
incident and how her mother would have been upset. Because this type of
inappropriate, unwanted sexual contact would reasonably cause anyone to have
psychosocial harm, it can be determined that the reasonable person in the resident’s
position would have experienced severe psychosocial harm- dehumanization, and
humiliation- as a result of the sexual abuse.

• The facility failed to ensure that a resident was free from physical abuse. A resident,
who required 1:1 supervision due to physical aggression, was observed to have
escalating behaviors, resulting in striking out at staff and residents in the vicinity. The
staff failed to ensure that residents in the vicinity were safe, and the resident pushed
another resident who was walking to his/her room while unsupervised by staff, as
described by housekeeping staff who witnessed the incident. The victim fell to the
floor with a resulting fracture to her arm that required treatment at the hospital,
placement of a cast, and was in moderate pain due to the fracture. Even though there
was no significant decline in mental or physical functioning, it can be determined that
the reasonable person would have experienced severe psychosocial harm as a result of
the physical abuse, since a reasonable person would not expect to be injured in this
manner in his/her own home or a health care facility.

• The facility failed to ensure that a resident was free from mental abuse and corporal

punishment. A resident who had a cognitive disability carried a doll around with her
throughout the day. During an activity, the resident placed the doll in a chair next to
her and refused to allow another resident to use the chair. The staff slapped the
resident’s hand and removed the doll so the other resident could sit down. The staff
told the resident she could not attend any more activities with the doll, or he would get
rid of it and the resident would never see it again. The resident began to scream, cry
for her doll, and left the room. The resident will not leave her room to attend any
activities for fear that the staff person will take her doll. The resident’s behavior has
declined and now cries and expresses fear when taken for bathing and meals without
her doll. Based on the resident’s behavior, it can be determined that the resident
experienced severe psychosocial harm as a result of the mental abuse and corporal
punishment.

• The facility deprived residents of care related to the failure of staff to respond timely

to residents’ requests and treat residents with dignity and respect which resulted in
ongoing embarrassment, humiliation, and the failure to provide incontinence care as
needed to meet the needs of several residents. Based on family and resident group

interviews, other residents and their family members complained that residents often
waited a long time (up to an hour) before staff took them to the bathroom, resulting in
residents urinating in their beds and lying in urine for long periods of time. Residents
indicated that this is a problem, especially on the night shift. Residents were told by
nurse aides to just urinate on their beds and staff would change the sheets in the
morning. Two night-shift staff members confirmed that they had seen other staff
disconnect call lights in residents’ rooms so that they were not functioning. After
investigation, it was determined that the nursing home failed to provide the necessary
care. [NOTE: In this example, the surveyor had already identified noncompliance at
dignity (F550) and urinary incontinence (F690)] It can be determined that the
reasonable person in the residents’ position would have experienced severe
psychosocial harm (e.g., embarrassment, humiliation) as a result of the abuse.

• The facility deprived a resident of care by failing to provide access for resident

communication and response to resident’s requests for necessary care resulting in the
resident’s ongoing fear and anxiety. During a survey, the surveyor observed that a
resident’s call light was pinned to a privacy curtain that was out of reach of the
resident. The resident stated that the staff removes the call light at night because the
nursing staff said he used it too much and they did not have time to answer the light all
the time. The resident began crying and expressed fear that something would happen
and he would have no way of getting assistance as staff would not come if he called
out for help. Based on the resident’s behavior, it can be determined that the resident
experienced severe psychosocial harm as a result of the deprivation of care.

• The facility failed to protect a resident from sexual abuse resulting in serious

psychosocial harm. A resident, with moderate confusion and who was dependent on
staff for care, reported to staff that she was “touched down there” and identified the
alleged perpetrator. However, staff, who thought the resident was confused, did not
report her allegation to facility administration and failed to provide protection for the
resident allowing ongoing access to the resident by the alleged perpetrator. The
resident expressed recurring fear whenever the perpetrator approached the resident,
exhibited crying and agitation, and declined to leave her room. Based on the
resident’s behavior, it can be determined that the resident experienced severe
psychosocial harm as a result of the sexual abuse.

• The facility failed to protect two residents from mental abuse and extreme humiliation

perpetuated by two staff who posted videos and photographs on social media, of the
residents during bathing, using the bathroom, and grooming, which included nude
photos and photos of genitalia. In addition, on the videos, the two staff verbally
taunted and made cruel remarks to the residents including making fun of the way the
resident looked and acted. One resident who was cognitively impaired was shown on
the video to be crying in response to the remarks made to her by the staff. One
resident, who was cognitively intact, told surveyors that he was extremely humiliated
and angry when he found out that these items were posted. Based on the resident’s
behavior, it can be determined that the resident experienced severe psychosocial harm
as a result of the mental abuse.

• The facility failed to ensure that a resident was free from neglect when it did not have

the structures to provide necessary goods and services to residents. During facility tour,
the surveyor noted a strong urine odor. Residents were observed to be in bed with
soiled clothes and linens. Residents told the surveyor that they did not get out of bed or
dressed since there were not enough nurse aides to assist them. During interviews with
nurse aides, it was reported that the facility lacked supplies, such as incontinence
briefs, laundry/housekeeping supplies, gloves and food. Interview with the Director of
Nurses revealed that the medical supply vendor was suspended and no longer
providing supplies to the facility due to non-payment. Multiple staff also reported not
receiving their last paychecks. During interviews with residents, residents reported
mice in their rooms. During observation of the kitchen and interview with the dietary
manager, there was evidence of rodent infestation, including staff seeing rodents eating
and finding torn bags and crumbs on the floor. The administrator reported that the pest
control company had visited the facility recently, but there was no record of the visit or
proposal for remediation. Also, there was no sanitizer for the dishwasher and no
alternative method for sanitizing dishes. It can be determined that the reasonable
person in the residents’ position would have experienced severe psychosocial harm
(e.g., embarrassment, humiliation, anxiety) as a result of neglect.

Examples of Severity Level 3 Noncompliance Actual Harm that is not Immediate
Jeopardy include, but are not limited to:

• The facility failed to protect a resident from physical abuse when Resident 1 slapped
Resident 2 in the face. Based on resident and staff interviews, Resident 1 had
previously exhibited an aggressive tone towards other residents. Based on the
interview with the nurse aide, Resident 2 was talking loudly to Resident 1 in the
hallway. Resident 1 shouted profanity to Resident 2, followed by: “If you say one
more word, you’re going to be sorry.” The nurse aide was the only staff present in the
area and was transferring another resident; the nurse aide could not intervene and did
not call for assistance from other staff. Resident 2 continued to talk loudly. Resident 1
then reached out, slapped Resident 2 on the left side of his face, and backed his
wheelchair away from Resident 2. Based on the assessment of Resident 2, his left
cheek exhibited some redness in the area that was slapped, but there were no other
physical injuries. Based on the survey team’s interview with Resident 1, Resident 1
was also able to recall the incident and said, “He [Resident 2] just won’t stop
talking…I don’t know what came over me.” Resident 2 was moderately cognitively
impaired and when interviewed, could not recall the incident. The survey team
interviewed Resident 2’s son, who said that his father would have been mad after an
incident like this. Therefore, by using the reasonable person concept, the survey team
would conclude that Resident 2 would have experienced psychosocial harm (e.g. anger
directed at the action or at a person) as a result of the physical abuse since there is an
expectation that the resident would not be slapped in the face in the facility.

• The facility neglected to provide supervision and monitoring to assure that continence
care is provided with dignity, respect and meets the needs of a resident. During a

complaint survey, the investigation revealed that a cognitively-impaired resident had
been left with his body partially uncovered, and unattended for several hours. Also,
the investigation also identified that his catheter bag had been left lying flat on the bed
so that urine could not flow freely or drain, resulting in expressions of pain and
distress. Interview with the charge nurse revealed that she was the only nurse in the
building during the night shift and stated that the she was unable to monitor the nurse
aides’ provision of care because she was providing treatments on other units. It was
identified that insufficient nurse staffing has been reported to the administration and
that this was an ongoing concern. Based on the resident’s behavior, it can be
determined that the resident experienced psychosocial harm as a result of neglect.

Examples of Severity Level 2 Considerations Noncompliance No Actual Harm with
Potential for More Than Minimal Harm that is Not Immediate Jeopardy include, but
are not limited to:

• The facility failed to protect Resident 2 from verbal abuse. During the interview with
Resident 2, she mentioned that she does not get along with Resident 1. Based on an
interview with staff, Resident 1 previously demanded Resident 2 to sit up at the table
and that there was something wrong with her. However, staff would re-direct the
residents to separate tables to prevent any situation from escalating. According to
interviews with other residents, one weekend, residents recall that temporary staff had
placed Resident 1 and 2 at the same table for a group activity. Resident 1 yelled to
Resident 2 to sit up straight a few times. However, staff in the room would not
intervene. Resident 1 called Resident 2 a derogatory name. Upon review of Resident 1
and 2’s records, there was no documentation related to altercations. Even though
Resident 2 did not have a reaction, it can be determined that the reasonable person
would experience no actual harm with the potential for more than minimal psychosocial
harm as a result of the verbal abuse.

Severity Level 1: No Actual Harm with Potential for Minimal Harm The failure of the
facility to prevent abuse or neglect is more than minimal harm. Therefore, Severity Level 1 does
not apply for this regulatory requirement.

1 CDC. 2016. Elder Abuse: Risk and Protective Factors. June. Accessed March 21, 2017.
http://www.cdc.gov/violenceprevention/elderabuse/riskprotectivefactors.html.
2 Adapted from Lachs, Mark S, Tony Rosen, Jeanne A Teresi, Joseph P Eimicke, Mildred Ramirez, Stephanie
Silver, and Karl Pillemer. 2013. “Verbal and physical aggression directed at nursing home staff by residents.”
Journal of General Internal Medicine 660-667
3 Dong, XinQi, RuiJia Chen, E-Shien Chang, and Melissa Simon. 2013. “Elder Abuse and Psychological Well-
Being: A Systematic Review and Implications for Research and Policy–A Mini Review.” Gerontology 132-142.
4 Adapted from Burgess, Ann W, Elizabeth B Dowdell, and Robert A Prentky. 2000. “Sexual Abuse of Nursing
Home Residents.” Journal of Psychosocial Nursing & Mental Health Services 10-18.
5 Adapted from Burgess, Ann W, and Paul T Clements. 2006. “Information Processing of Sexual Abuse in Elders.”
Journal of Forensic Nursing 113-120.

F602
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.12
The resident has the right to be free from abuse, neglect, misappropriation of resident
property, and exploitation as defined in this subpart. This includes but is not limited to
freedom from corporal punishment, involuntary seclusion and any physical or chemical
restraint not required to treat the resident’s medical symptoms.

INTENT §483.12

Each resident has the right to be free from misappropriation of property and exploitation.

NOTE: Refer to F609 for requirements related to reporting of a reasonable suspicion of a
crime.

DEFINITIONS §483.12
“Exploitation,” as defined at §483.5, means “taking advantage of a resident for personal gain,

through the use of manipulation, intimidation, threats, or coercion.”

GUIDANCE §483.12

Residents’ property includes all residents’ possessions, regardless of their apparent value to
others since they may hold intrinsic value to the resident. Residents are permitted to keep
personal clothing and possessions for their use while in the facility, as long as it does not
infringe upon the rights of other residents (See F557). Examples of resident property include
jewelry, clothing, furniture, money, and electronic devices, the resident’s personal information
such as name and identifying information, credit cards, bank accounts, driver’s licenses, and
social security cards.

Examples of misappropriation of resident property include, but are not limited to:

• Identity theft;
• Theft of money from bank accounts;
• Unauthorized or coerced purchases on a resident’s credit card;
• Unauthorized or coerced purchases from resident’s funds;
• A resident who provides a gift to staff in order to receive ongoing care, based on staff’s

persuasion; and

• A resident who provides monetary assistance to staff, after staff had made the resident
believe that staff was in a financial crisis.

Facility staff are in a position that may be perceived as one of power over a resident. As such,
staff may be able to manipulate or unduly influence decisions by the resident. Staff must not
accept or ask a resident to borrow personal items or money, nor should they attempt to gain
access to a resident’s holdings, money, or personal possessions through persuasion, coercion,
request for a loan, or solicitation. For example, exploitation may include, but is not limited to,
when a resident, or resident representative, has given his/her money or belongings to staff as a
result of coercion, or because the resident, or resident representative, believes that it was
necessary (e.g., in order to receive good care). A resident’s apparent consent is not valid if it is
obtained from a resident lacking the capacity to consent, or consent is obtained through
intimidation, coercion or fear, whether it is expressed by the resident or suspected by staff.

Another example of misappropriation of resident property is the diversion of a resident’s
medication(s), including, but not limited to, controlled substances for staff use or personal
gain.

INVESTIGATIVE PROTOCOL FOR MISAPPROPRIATION OF RESIDENT
PROPERTY AND EXPLOITATION §483.12
OBJECTIVES

To determine:

• Whether a resident(s) was free from misappropriation of resident property and
exploitation (F602);

• If the facility developed, implemented and educated staff on policies and procedures that
prohibit misappropriation of resident property and exploitation (F607);

• If the facility developed and implemented pre-employment procedures (F606); and
• How the facility protects, reports, investigates, and acts upon alleged violations of

misappropriation of resident property and exploitation (F609, F610).

USE

Use this protocol during any type of survey as necessary in order to investigate an allegation
of misappropriation of property or exploitation.

PROCEDURES §483.12
OFFSITE SURVEY PREPARATION

Information related to an alleged violation may be obtained from:

• Reports from the ombudsmen or other State Agencies;
• Any related previously-cited deficiencies (CASPER Report 3); and
• A complaint and/or facility self-report including:

o Name of alleged victim(s), alleged perpetrator(s) and witnesses, if any;

o Narrative/specifics of the allegation(s) including frequency and pervasiveness of the
allegation; and

o Whether the allegation was reported by the facility and to other agencies.

ONSITE SURVEY ACTIVITIES

If a surveyor receives an allegation of misappropriation of resident property or exploitation
during the survey, he/she must immediately report this to the facility administrator, or his/her
designated representative if the administrator is not present. The survey team should
determine whether the facility then takes appropriate action in accordance with the
requirements at F609 and F610.

During the course of the investigation, if it is determined that the resident’s property was
misplaced and found and not misappropriated, or the property loss was not related to a
facility failure to protect the property (e.g., resident/family accidentally disposed of the item
or took the item home), the investigation may be stopped.

Obtain and review the facility’s policies and procedures related to misappropriation of resident
property and exploitation. It is not necessary for these items to be maintained in one document
or manual.

OBSERVATION

Depending on the nature of the incident, the surveyor should conduct observations that
are related to the allegation. Observations include, but are not limited to,

o For allegations of theft of medications, how medications are secured and accessed.
o For allegations of stolen property, where the property was stored, whether it was in a

secure area, and how the property was accessed.

Interview:

The surveyor follows the guidelines below for interviews, which include, but are not limited to:
o Conduct interviews in a private location, preferably seated in order to be able to maintain

eye contact with the individual being interviewed;
o Be impartial, use discretion, and non-judgmental language and to the extent possible, ask

open-ended, non-leading questions;

NOTE: It is important to maintain the confidentiality of the names of the person(s), to the
extent possible, who reported the allegation.

o Conduct follow up interviews, as necessary, to evaluate new information obtained,

discrepancies or changes in information; and
o Maintain documentation of interviews including dates, times, locations and names of

individuals interviewed.

NOTE: It is important to attempt to obtain as accurate information as possible, and it may be
necessary to obtain assistance from an interpreter if English is not the spoken language of the
resident or staff.

Resident/Family Interview

Interview the alleged victim privately; however, the alleged victim may request that another
person be present. If so, be aware that the alleged victim may not be comfortable speaking
openly in the presence of another person, and another interview may be necessary to follow up
on any discrepancies identified. A resident with a cognitive impairment and/or mental illness
may mistakenly be assumed to be an incompetent witness. In those situations, interview the
alleged victim, to the extent possible, and corroborate statements with other observations,
interviews and record review. During the interview, observe the resident’s emotions and tone,
as well as any nonverbal expressions or gesturing to a particular body area, in response to the
questions. Interview the resident, or resident’s representative, to determine:

o For an allegation of misappropriation of resident property:

o What is missing. If the missing item is money, how much;
o For how long the item has been gone;
o Whether the resident has any idea of what might have happened to the item;
o Whether the resident suspects a specific person(s) was involved in the loss of the

item(s) and the name, title (if any) and/or relationship to the resident;
o Whether the resident/family reported the missing property to facility staff and, if so,

when and to whom and the facility’s response;
o Whether local law enforcement or other outside agencies were notified, and if so, any

response that they are aware of; and
o How the resident feels about losing the item.

o For an allegation of exploitation:

o When and where the alleged exploitation occurred;
o What occurred prior to, during and immediately following the alleged exploitation;
o Whether he/she can identify who was involved including the alleged perpetrator

and/or any witnesses;
o Why the resident gave the item to the alleged perpetrator or allowed the alleged

perpetrator to take the item;
o How the resident values the item;
o Whether he/she reported the alleged exploitation to the facility, when and to whom

reported and the facility’s response; and
o Whether he/she feels safe, is afraid of anyone, or fearful of retaliation.

Staff Interview

Review staff attendance records from any department to determine who was working at the
time of the alleged misappropriation or exploitation and who may have had access to the
resident and/or the resident’s room to collect information about:

o Whether he/she had knowledge of the allegation and what actions, if any, he/she took in
response to the allegation;

o Any changes in the resident’s behavior as a result of the allegation;
o Whether an individual has been identified as the alleged perpetrator and how the alleged

perpetrator and resident related to one another prior to and after the incident;
o Whether he/she reported the allegation to management/administrative staff or any State

or local agencies, and if so, to whom was the allegation reported and when;
o If not reported, what prevented him/her from reporting;
o Whether he/she is fearful of retaliation;
o If he/she reported the allegation, whether he/she feels that retaliation has occurred as a

result of reporting the allegation, and if so, what actions were taken against staff; and
o Whether he/she has received training from the facility on misappropriation and

exploitation identification, prevention, and reporting requirements.

Alleged Perpetrator Interview:

If the alleged perpetrator is a staff member, the staff member may have been suspended or re-
assigned until the investigation is completed and in some situations, the facility may have
terminated the employment of the individual. In some cases, the alleged perpetrator may not
be in the facility or may refuse to be interviewed. If possible, interview the alleged
perpetrator either in person or by phone to determine:

• What information he/she can provide regarding to the allegation of missing property or
exploitation;

• Whether he/she was present in the nursing home at the time the alleged misappropriation
of property or exploitation occurred;

• Whether he/she has any information on the allegation, such as:
o When and where the alleged incident occurred; and
o If he/she has any other information that he/she wishes to share in regard to the

investigation.

Facility Investigator Interview. If the facility was aware of the allegation, identify the
staff member responsible for the initial reporting and investigation of alleged
misappropriation of resident property or exploitation. This may be the administrator in
some facilities. Obtain a copy of the investigation report. Interview the responsible staff
person to determine:

• How the facility investigated the allegation of misappropriation or exploitation;
• If the facility did not know if the resident had the property prior to the alleged loss, and

how the facility protects the resident’s property from loss or theft;
• Whether local law enforcement or other outside agencies were notified, and if so, any

response that they are aware of; and
• What findings and resolutions have occurred.

Record Review

It may be necessary to obtain copies of specific entries in the record for the period of time that
is relevant to the allegation.

Review the alleged victim’s record to obtain necessary information as applicable such as:

• The diagnosis and physician orders including medications;
• The RAI, to include the resident’s cognitive status;
• Care plan and interventions/goals;
• Physician’s, nurse’s, social worker’s and other staff members progress notes, as

applicable; (e.g. for investigation of drug diversion, whether there was indication of
unrelieved pain during certain times of the day for residents who were prescribed the
allegedly diverted medication);

• Any lists of resident valuables or resident items brought in to the facility; and
• Social and psychological history.

If staff is identified as the alleged perpetrator, review the staff member’s personnel file
for information related to:

• The allegation being investigated or history of other allegations;
• Adverse personnel actions taken relevant to exploitation or misappropriation of property;
• Screening that occurred prior to and during employment; and
• Training and orientation related to abuse and neglect prevention.

For an alleged theft of monies if the resident’s funds are managed or held by the facility,
review the accounting records for the resident’s funds, including receipts for expenditures
from the resident’s funds. Attempt to reconcile whether the items are in the resident’s
possession.

Review interdisciplinary notes that relates to the alleged exploitation or misappropriation
of property for documentation of the following:

o The date/time of the alleged exploitation/misappropriation and/or the date/time when the

alleged exploitation/misappropriation was first discovered;

o Any change in the alleged victim’s mood and demeanor before and after the alleged

misappropriation/exploitation, such as:

o Distrust;
o Fear (e.g., fear of being touched or shying away from being touched);
o Angry outbursts, tearfulness, agitation, trembling, cowering;
o Panic attacks; and
o Changes in sleeping patterns.

Reports from Other Investigatory Agencies

At the time of the survey, if another investigatory agency(ies) has completed its investigation,
the surveyor should request a copy of the report. Other investigatory agencies may include

State adult protective services, State professional licensing boards, and law enforcement/police
reports.

Interview with Person Responsible for Quality Assurance

Interview the person responsible for Quality Assurance activities. Determine how the
committee is providing monitoring and oversight of potential and/or actual reported allegations
of misappropriation of resident property and exploitation. Evaluate whether the committee has
made recommendations such as policy revision and/or training.

Administrator Interview

The administrator is responsible for the overall implementation of the facility
policies/procedures to prohibit misappropriation of resident property and exploitation. This
includes the obligation to report, investigate, protect the alleged victim, and take corrective
actions, as necessary, based upon the outcome of the investigation. Obtain and review the
copy of the investigation report, if any. NOTE that some of this information may have already
been obtained from the facility investigator. Interview the administrator to determine:

o When he/she was notified of the alleged exploitation/misappropriation, and when the

initial report was made to the required agencies and law enforcement as required;
o Who was/is responsible for the investigation, whether it has been completed and the

outcome, or whether the investigation is ongoing;
o When the results of the investigation were reported to the administrator and to the

required agencies;
o Whether the alleged perpetrator, if an employee, had previous warnings or incidents at

the facility;
o How the alleged victim and other residents at risk of exploitation/misappropriation were

protected during the investigation;
o What actions were taken to prevent misappropriation and exploitation after the

investigation was completed;
o Whether any changes were necessary to the facility’s policies and procedures;
o How the facility assures that retaliation does not occur when staff or a resident reports an

allegation of misappropriation of resident property or exploitation;
o What actions have been taken for education of staff and residents regarding the facility’s

prevention plan and reporting requirements; and
o How does the facility protect the resident’s property from loss or theft.

Provide an opportunity for the facility to provide any other information regarding the
alleged misappropriation of the resident’s property or exploitation.

Additional Investigatory Activities Related to Allegations of Drug Diversion
For allegations of drug diversion, the surveyor determines:

o If there is evidence and/or potential outcomes such as unrelieved pain. For example, there

may be evidence that on a particular shift, or when a particular staff member is working,
a resident’s pain symptoms are not relieved to the extent possible, but the pain symptoms

are relieved on other shifts, based upon validated evidence (see also tag F697 for
concerns related to pain management);

o Whether pharmacy policies at a minimum, address safeguarding and access, monitoring,
administration, documentation, reconciliation and destruction of controlled substances
(see also tag F755 for concerns related to facility procedures for pharmacy services);

o Whether the pharmacist has established a system of records of receipt and disposition of

all controlled drugs in sufficient detail to enable accurate reconciliation and that the drug
records are in order and that an account of all controlled drugs is maintained and
periodically reconciled (see also tag F755 for concerns related to responsibilities of the
licensed pharmacist); and

o Determine whether the resident’s clinical record provides accurate documentation of the

administration of a controlled medication and resident outcomes related to the medication
administration (see also tag F755 for concerns related to procedures for administration
and documentation of controlled substances).

If the surveyor, during the investigation, has determined that a resident’s medications were
diverted, the State agency (SA) should make referrals to the following agencies as
appropriate, such as:

o Drug Enforcement Administration (DEA),
o Local law enforcement,
o State Boards of Nursing, Pharmacy, and Nursing Home Administrators, and/or
o Other agencies the SA is required to notify in accordance with State law.

KEY ELEMENTS OF NONCOMPLIANCE §483.12

To cite deficient practice at F602, the surveyor’s investigation will generally show that the
facility failed to protect a resident’s right to be free from misappropriation of resident
property and/or exploitation.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION

• 42 CFR §483.10(e)(2), F557- Right to Have Personal Property
• 42 CFR §483.10(f)(10)(i)‐(ii), F567-Protection/Management of Personal Funds
• 42 CFR §483.10(i), F584 – Safe Environment
• 42 CFR §483.10(j), F585- Grievances
• 42 CFR §483.12(a)(3)‐(4), F606 – Not Employ/Engage Staff with Adverse Actions

• 42 CFR §483.12(b)(1)‐(5), F607 – Develop/Implement Abuse/Neglect, etc. Policies
• 42 CFR §483.12(b)(5), (c)(1), and (c)(4), F609 – Reporting of Alleged Violations
• 42 CFR §483.12(c)(2) ‐ (4), F610 – Alleged Violations-Investigate/Prevent/Correct
• 42 CFR §483.25(k), F697- Pain Management – Determine if there is evidence and/or

potential outcomes such as unrelieved pain. For example, evidence that on a particular
shift, or when a particular staff member is working, a resident’s pain symptoms are not
relieved to the extent possible, but the pain symptoms are relieved on other shifts, based
upon validated evidence.

• 42 CFR §483.45, §483.45(a)-(b), F755- Pharmacy Svcs/Procedures/Pharmacist/Records
and 42 CFR §483.45(g)-(h), F761- Label/Store Drugs & Biologicals – Determine whether
pharmacy policies at a minimum, address safeguarding and access, monitoring,
administration, documentation, reconciliation and destruction of controlled substances;
Determine whether the pharmacist has established a system of records of receipt and
disposition of all controlled drugs in sufficient detail to enable accurate reconciliation and
that the drug records are in order and that an account of all controlled drugs is maintained
and periodically reconciled.

• 42 CFR §483.75 (g)(2)(ii)- F867- QAA Activities
• 42 CFR §483.95(c), F942- Abuse, Neglect, and Exploitation Training
• 42 CFR §483.95(g), F946-Required In-Service Training for Nurse Aide

DEFICIENCY CATEGORIZATION §483.12
In addition to actual or potential physical harm, always consider whether psychosocial harm has
occurred when determining severity level (See Psychosocial Outcome Severity Guide).

Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident
Health or Safety include, but are not limited to:

• The facility failed to assure that a resident’s personal property was safeguarded and that
staff did not misappropriate resident’s property. A resident, who had a medical condition
in which she had loss of hair, owned two wigs which were personalized for her needs
which she used consistently during the daytime hours. Staff documented that the resident
was “crying loudly, shouting and was hysterical” and when investigated, she stated
someone had stolen her wigs over the weekend. She stated she told staff and they
discounted her complaints. The resident refused to leave her room or see anyone, was
extremely agitated, and wanted the police called. During the facility investigation, two
employees who had worked the evening shift over the weekend, were heard by other staff
members, talking and laughing about how they had taken the resident’s wigs.

Examples of Severity Level 3 Noncompliance Actual Harm that is not Immediate
Jeopardy include, but are not limited to:

• The facility had failed to protect residents from misappropriation of resident property,
had failed to immediately report and investigate alleged violations, and had failed to
implement policies and procedures for reporting the possible crime to law enforcement.

A resident reported to staff that she was missing a gold necklace. She had last seen the
necklace in a nightstand drawer next to her bed. The resident was tearful, since she had
received the necklace from her children who had purchased it for her 80th birthday. The
resident was worried that she had carelessly lost the necklace and did not want her
children to be angry at her. The resident discontinued attending activities, since she did
not want to leave her room so that she could protect her belongings. During the facility’s
investigation, during an interview, CNA #1 stated that she had noticed that CNA #2 had a
new necklace that looked familiar. CNA #1 said that CNA#2 quickly evaded questions as
to how she had acquired the necklace, until she said that a new boyfriend had given it to
her. CNA #1 stated that she did not want to cause any trouble and did not report anything
about the necklace until a week later, when it was brought to the Director of Nursing’s
attention that a resident’s necklace was missing. Also, during the investigation, the
facility received more reports from staff of stolen jewelry from five other residents, but
no staff reported any of the incidents to law enforcement or the State survey agency.

Examples of Severity Level 2 Noncompliance No Actual Harm with Potential for More
Than Minimal Harm that is Not Immediate Jeopardy include, but are not limited to:

• The facility had failed to protect a resident from misappropriation of resident property
when a radio was stolen from a resident’s room. The resident, who was cognitively
impaired, also had severe confusion and was unable to communicate. The resident had an
activity program for listening to classical music in his room. On Monday afternoon, it
was reported that the activity staff came into the resident’s room to provide the activity
but were unable to locate the radio and subsequently reported the loss to the
Administrator. Staff stated the radio had been in the room when they had left on Friday
after the afternoon activity. The Administrator contacted the resident’s son, and
confirmed that the family had not removed the radio during a visit over the weekend and
had no knowledge of where it might be. The facility replaced the radio. The
Administrator reported the incident to the SA. Although the resident could not articulate
what had occurred with the radio, the family wished to have the music therapy continue
as the resident had a lifelong interest in classical music and they felt, even though the
resident could no longer communicate and was confused, that the music provided a sense
of comfort. The facility completed the investigation, and identified that a temporary staff
member had stolen the radio. The temporary staff member was not allowed to work in the
facility again.

Severity Level 1: No Actual Harm with Potential for Minimal Harm
The failure of the facility to prevent misappropriation of resident property and exploitation is
more than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory
requirement.

F603
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.12(a)(1) The resident has the right to be free from abuse, neglect, misappropriation
of resident property, and exploitation as defined in this subpart. This includes but is not
limited to freedom from corporal punishment, involuntary seclusion and any physical or
chemical restraint not required to treat the resident’s medical symptoms.

Not use verbal, mental, sexual, or physical abuse, corporal punishment, or involuntary
seclusion;

INTENT §483.12(a)(1)

Each resident has the right to be free from involuntary seclusion.

DEFINITIONS §483.12(a)(1)

“Involuntary seclusion” is defined as separation of a resident from other residents or from
her/his room or confinement to her/his room (with or without roommates) against the
resident’s will, or the will of the resident representative.

GUIDANCE §483.12(a)(1)
NOTE: During a situation in which a resident’s behavior has escalated and immediate
interventions are required for the safety of the resident, staff and/or other residents), the facility
must immediately consult with the resident’s physician about the behavioral symptoms and the
resident’s designated representative; and provide necessary supervision of the resident to ensure
that the resident and other residents are protected.

Involuntary seclusion may take many forms, including but not limited to the confinement,
restriction or isolation of a resident. Involuntary seclusion may be a result of staff
convenience, a display of power from the caregiver over the resident, or may be used to
discipline a resident for wandering, yelling, repeatedly requesting care or services, using the
call light, disrupting a program or activity, or refusing to allow care or services such as
showering or bathing to occur.

Involuntary seclusion includes, but is not limited to, the following:

• A resident displays disruptive behaviors, such as yelling, screaming, distracting others
(such as standing and obstructing others viewing abilities for the TV or programs) and
staff remove and seclude the resident in a separate location such as in an office area or
his/her room, leaving and closing the door and without providing interventions to address
the behavioral symptoms;

• In an attempt to isolate a resident in order to prevent him/her from leaving an area, the
resident(s) is involuntarily confined to an area by staff placing furniture, carts, chairs in
front of doorways or areas of egress;

• Staff hold a door shut, from the opposite side of the door, in order to prevent egress;

• Staff place a resident in a darkened room, office, or area secluded from other staff and
residents for convenience or as punishment;

• A resident is physically placed in an area without access to call lights, and/or other

methods of communication creating an environment of seclusion and isolation for the
resident; and

• A resident placed in a secured area of the facility, but does not meet the criteria for the

unit and is not provided with access codes or other information for independent egress.

Considerations Involving Secured/Locked Areas
If a resident resides in a secured/locked area that restricts a resident’s movement throughout
the facility, the facility must ensure that the resident is free from involuntary seclusion.

A resident in a secured/locked area would not be considered to be involuntarily secluded if all
of the following are met:

• The facility has identified the clinical criteria for placing a resident in the secured/locked
area;

Placement in a secured/locked area is not:

1. Used for staff convenience or discipline;
2. Based on the resident’s diagnosis alone since the determination for placement in the

area must be made on an individualized basis; and/or
3. Based on a request from the resident’s representative or family member without

clinical justification;

For example, if the POA requests placement in the secured/locked area but the
resident declines placement and placement does not meet the clinical criteria and is
not in the best interest of the resident, then placement of the resident in the
secured/locked area would be involuntary seclusion.

• The facility involves the resident/representative in care planning, including the decision
for placement in a secured/locked area and the development of interventions based upon
the resident’s comprehensive assessment and needs; and

• The facility provides immediate access and visitation by family, resident representative or
other individuals, subject to reasonable clinical and safety restrictions and the resident’s
right to deny or withdraw consent.

It is expected that each resident’s record would include:
o Documentation of the clinical criteria met for placement in the secured/locked area by the

resident’s physician along with information provided by members of the interdisciplinary
team;

o Documentation that reflects the resident/representative’s involvement in the decision for
placement in the secured/locked area;

o Documentation that reflects whether placement in the secured/locked area is the least
restrictive approach that is reasonable to protect the resident and assure his/her health and
safety;

o Documentation by the interdisciplinary team of the impact and/or reaction of the resident,
if any, regarding placement on the unit; and

o Ongoing documentation of the review and revision of the resident’s care plan as
necessary, including whether he/she continues to meet the criteria for remaining in the
secured/locked area, and if the interventions continue to meet the needs of the resident.

NOTE: A resident who chooses to live in the secured/locked unit (e.g., the spouse of a
resident who resides in the area), and does not meet the criteria for placement, must have
access to the method of opening doors independently. The chosen method for opening doors
(e.g., distribution of access code information) is not specified by CMS. Staff should be aware
of which residents have access to opening doors and monitor their use of the access to ensure
other residents’ safety.

NOTE: See also Tags at Resident Rights for guidance related to justice-involved individuals.

Transmission Based Precautions

When used appropriately, transmission-based precautions (i.e., isolation due to infection) is
not to be considered involuntary seclusion. The facility’s policies must identify the type and
duration of the transmission-based precautions required, depending upon the infectious agent
or organism involved; and the precautions should be the least restrictive possible for the
resident based on his/her clinical situation. Furthermore, the resident’s record must contain the
rationale for the selected transmission-based precautions. However, once the resident is no
longer a risk for transmitting the infection, the removal of transmission-based precautions is
required in order to avoid unnecessary involuntary seclusion. See also 42 CFR §483.65 –
Infection Control (Tag F880).

INVESTIGATIVE PROTOCOL FOR INVOLUNTARY SECLUSION USE
§483.12(a)(1)

Use this protocol for investigating:

o An alleged violation of involuntary seclusion during a standard survey and abbreviated

surveys (complaint investigations, onsite investigations of self-reported incidents, and/or
revisits); and

o An allegation of involuntary seclusion involving a resident who resides in a
secured/locked area or who is/was on temporary transmission-based precautions.

If a surveyor determines that an act of involuntary seclusion has occurred or is occurring,
he/she must immediately report this to the Administrator, or his/her designated representative
if the Administrator is not present. The survey team should determine whether the facility then

takes appropriate action in accordance with the requirements at F607, F609, and F610,
including implementing safeguards to prevent further potential involuntary seclusion.

Review of Facility Policies and Procedures
Obtain and review the facility’s policies and procedures related to the allegation
under investigation.

Observations
Observe the physical environment in which the alleged involuntary seclusion may have
occurred. This may include observations of the following, which include, but are not limited
to:

• Room configuration;
• Location of the alleged involuntary seclusion in relation to supervised areas; and
• Objects that may have been used to obstruct residents.

Observe whether staff members make remarks and behave in a manner that may
indicate concerns with staff treatment of residents.

Interview:

Alleged Victim/Resident Representative and Witness Interviews

Interview the alleged victim/resident representative to determine as much information
regarding the alleged involuntary seclusion that he/she may be able to provide. Interview the
alleged victim privately; however, the alleged victim may request that another person be
present. If so, be aware that the alleged victim may not be comfortable speaking openly in the
presence of another person, and another interview may be necessary to follow up on any
discrepancies identified. A resident with a cognitive impairment and/or mental illness may
mistakenly be assumed to be an incompetent witness. In those situations, interview the alleged
victim, to the extent possible, and corroborate statements with other observations, interviews
and record review. During the interview, observe the resident’s emotions and tone, as well as
any nonverbal expressions or gesturing to a particular body area, in response to the questions.

Interview witnesses, including but not limited to, the assigned staff, staff in the immediate area,
staff from the shifts prior to or after the alleged involuntary seclusion; the victim’s roommate (if
any), other residents, and/or visitors. Make every attempt to maintain the confidentiality of
witnesses. It may not be appropriate to interview the person who reported the allegation first, as
that may unintentionally identify the person. The surveyor may ask the witness to re-create or
re-enact the alleged incident, to better understand the sequence of events.
Interview the alleged victim/resident representative and witnesses to
determine:

• What happened, when, where, and how often;
• Whether he/she can identify the alleged perpetrator and any witnesses;
• What occurred prior to, during and immediately following the alleged involuntary

seclusion;

• Whether he/she reported the allegation to anyone within the facility or to an outside
agency (e.g., other staff, ombudsman); if so, to whom, when and what was the response;

• For the alleged victim,
o Whether he/she feels safe, is afraid of anyone, or is fearful of retaliation; and
o Whether the alleged victim has had past encounters with the alleged perpetrator.

Staff Interview

Review staff schedules to determine who was working at the time of the alleged involuntary
seclusion. Interview staff from any department who has direct contact with the resident(s), as
appropriate, to collect information about:

• Whether he/she had knowledge of the alleged involuntary seclusion and what actions, if
any, he/she took in response to the allegation;

• Any changes in the alleged victim’s behavior as a result of the alleged involuntary
seclusion;

o How the alleged perpetrator and alleged victim related to one another prior to and after
the incident;

o Whether the alleged perpetrator had exhibited inappropriate behaviors to the alleged
victim or other residents in the past, such as using derogatory language, rough handling,
or ignored residents while giving care;

o Whether he/she reported the alleged involuntary seclusion to management/administrative
staff, or any State or local agencies, such as Adult Protective Services or local law
enforcement, and if so, to whom was the alleged involuntary seclusion reported and
when;

o If not reported, what prevented him/her from reporting;
o If he/she reported the allegation, whether he/she feels that retaliation has occurred as a

result of reporting the allegation, and if so, what actions were taken against staff; and
o Whether he/she has received training related to involuntary seclusion from the facility.

NOTE: If the staff member was a witness, refer also to the questions above under Witness
Interview.

Alleged Perpetrator Interview:

The alleged perpetrator may or may not be in the facility or may refuse to be interviewed. If
the alleged perpetrator is a staff member, the staff member may have been suspended or re-
assigned until the investigation is completed and in some situations, the facility may have
terminated the employment of the individual. If possible, interview the alleged perpetrator
either in person or by phone to determine:

o What position he/she holds and how long the alleged perpetrator has worked in the

facility;
o What type of orientation, training, work assignments, and supervision he/she receives;
o Whether he/she was present in the facility at the time of the alleged involuntary

seclusion;

o What information he/she can provide regarding the alleged involuntary seclusion such as
what happened, why was the resident separated/secluded, how often does it occur;

o What is his/her relationship to the alleged victim; and
o If he/she has any other information that he/she wishes to share in regard to the

investigation.

Other Health Care Professionals Interview

Interview the director of nursing, social worker, and physician/practitioner, as necessary,
to determine:

o Whether he/she was notified by staff of the alleged involuntary seclusion and if so, the

response;
o Whether he/she conducted an assessment of the resident for potential injuries and/or

changes in mental status, and if identified, what interventions or treatment (e.g.,
counseling) were provided and when; and

o If a resident is under transmission-based precautions, the reason why the resident is under
transmission-based precautions and when transmission-based precautions are to be
removed.

Record Review-Resident

It may be necessary to obtain copies of any relevant information in the resident’s record.
Review the alleged victim’s record to obtain necessary information, as applicable, such
as:
o The diagnosis and physician orders including medications;
o The RAI, to include the resident’s cognitive status, functional status (independent

ambulation, transfer status, uses a wheelchair, using an assistance device or requires staff
assistance for ADL’s);

o Care plan and interventions/goals;
o Physician’s, nurse’s, social worker’s and other staff members progress notes, as

applicable;
o Social and psychological history; and
o Hospital transfer/discharge information, if applicable (NOTE: the surveyor may follow

up with an interview with the treating practitioner at the hospital).

Review interdisciplinary notes within the timeframe of the alleged involuntary
seclusion for documentation that supports, clarifies, or verifies the allegation.
Determine if the record reflects:

o The date/time of the allegation and/or the date/time when the allegation was first

discovered and reported; and
o Any change in the alleged victim’s mood and demeanor before and after the alleged

incident, such as, but not limited to: Distrust, fear (e.g., fear of being left alone), angry
outbursts, tearfulness, agitation, trembling, cowering, panic attacks, withdrawal from
social interaction, changes is sleeping patterns, or symptoms similar to PTSD symptoms.

Record Review-Alleged Perpetrator’s Personnel File Review, if Staff
If staff is identified as the alleged perpetrator, review the staff member’s personnel file
for information related to:

The allegation being investigated or history of other allegations;
o Adverse personnel actions taken;
o Screening that occurred prior to and during employment; and
o Training and orientation related to abuse and neglect prevention.

Additional Activities for Investigating Possible Involuntary Seclusion for
Residents in Secured/Locked Areas

If a resident lives in an area that restricts free movement throughout the facility, the survey
team must determine the following:

o Whether the facility has developed and implemented policies and procedures related to

secured/locked areas, including criteria for placement and ongoing assessment to assure
that the resident meets the criteria;

o Whether the facility attempted alternatives prior to placement in a secured/locked area; if
so, what alternatives, and what the resident’s response was to the alternative
interventions;

o Why the resident is placed in the secured/locked area;
o Whether the resident/resident representative was involved in the placement decision;

whether the resident/resident representative agreed with the decision or not; if not, how
did the facility address this; and

• Whether the secured/locked area is accessible to other residents in the facility and
visitors, and if so, how.

Facility Investigator Interview
If the facility has investigated the alleged involuntary seclusion, identify the staff member
responsible for the initial reporting and the overall investigation of the alleged involuntary
seclusion. This may be the administrator in some facilities. Obtain a copy of the investigation
report, if any.

NOTE: Refer to F609 for further investigation if the facility does not have a copy of the
investigation report available.

Interview the facility investigator to determine:

• When he/she was notified of the allegation and by whom;
• When and what actions were taken to protect the alleged victim(s) while the investigation

was in process;
• Steps taken to investigate the allegation and a timeline of events that occurred;
• What happened as a result of the investigation;
• When and who received the results of the investigation; and

• Whether there is any related information regarding the allegation that may not be
included in the investigation report.

Administrator Interview

The administrator is responsible for the overall implementation of the facility
policies/procedures, including to prohibit involuntary seclusion. This includes the obligation
to report, investigate, protect the alleged victim, and take corrective actions, as necessary,
based upon the outcome of the investigation. Note that some of this information may have
already been obtained from the facility investigator.

Interview the administrator to determine:

• When he/she was notified of the alleged involuntary seclusion, and when the initial report
was made to the required agencies;

• Who was/is responsible for the investigation, whether it has been completed and the
outcome, or whether the investigation is ongoing;

• When the results of the investigation were reported to the administrator and to the
required agencies;

• How the alleged victim and other residents at risk were protected during the
investigation;

• If the alleged violation is verified, what corrective actions are being taken;
• Whether any changes were necessary to the facility’s policies and procedures;
• Whether the alleged perpetrator had previous warnings or incidents at the facility; and
• What information has been provided to staff and residents related to involuntary

seclusion, including reporting requirements.

Interview with Person Responsible for Quality Assurance

Interview the person responsible for quality assurance activities. Determine how the
committee is providing monitoring and oversight of potential and/or actual reported
allegations of involuntary seclusion. Evaluate whether the committee has made
recommendations such as policy revision and/or training to prohibit involuntary seclusion.

KEY ELEMENTS OF NONCOMPLIANCE §483.12(a)(1)
To cite deficient practice at F603, the surveyor’s investigation will generally show that
the facility separated or secluded a resident against the resident’s will or the resident
representative’s will without clinical justification.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION
During the investigation, the surveyor may have determined that concerns may also be
present with related outcome, process and/or structure requirements. The surveyor is
cautioned to investigate these related requirements before determining whether non-
compliance may be present. Some examples of related requirements that should be
considered include the following:

• 42 CFR §483.10, §483.10(a)(1)‐(2), §483.10(b)(1)‐(2), F550- Resident Rights and
Dignity

• 42 CFR §483.10(c)(1),(4),(5), F552- Right to be Informed/Make Treatment Decisions
• 42 CFR §483.10(c)(2)‐(3), F553 – Right to Participate Planning Care
• 42 CFR §483.10(g)(14), F580-Notify of Changes (Injury/Decline/Room,Etc)
• 42 CFR §483.10(j), F585- Grievances
• 42 CFR §483.12(a)(3)‐(4), F606 – Not Employ/Engage Staff with Adverse Actions
• 42 CFR §483.12(b)(1)‐(5), F607 – Develop/Implement Abuse/Neglect, etc. Policies
• 42 CFR §483.12(b)(5), (c)(1), (4), F609 – Reporting of Alleged Violations
• 42 CFR §483.12(c)(2) ‐ (4), F610 – Alleged Violations-Investigate/Prevent/Correct
• 42 CFR §483.20(b)(1)‐(2)(i),(2)(iii), F636-Comprehensive Assessments & Timing
• 42 CFR §483.20(b)(2)(ii), F637-Comprehensive Assess After Significant Change
• 42 CFR §483.21(b)(1), F656- Develop/Implement Comprehensive Care Plan
• 42 CFR §483.21(b)(2), F657- Care Plan Development and Revision
• 42 CFR §483.24, F675 – Quality of Life
• 42 CFR §483.95(c), F942- Abuse, Neglect, and Exploitation Training
• 42 CFR §483.95(g), F946-Required In-Service Training for Nurse Aide
• Life safety code requirements

o If there are concerns with life safety code requirements, the survey team should notify
its SA supervisor that a life safety code concern has been identified and may require a
life safety code survey.

DEFICIENCY CATEGORIZATION §483.12(a)(1)
In addition to actual or potential physical harm, always consider whether psychosocial harm has
occurred when determining severity level (See Psychosocial Outcome Severity Guide).

Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident
Health or Safety include, but is not limited to:

• The facility failed to assure that a resident was free from involuntary seclusion. The
resident with a history of suicidal ideation and displaying behavioral symptoms which
included episodic periods of yelling and screaming, especially towards the end of the day
and during the night. According to the resident’s record, after dinner last evening, the
resident was placed by staff in her recliner with a tray attached by the nurse’s station. It
was documented and corroborated by staff interviews that they heard the resident yell and
scream loudly, pounding on her tray. Several residents began complaining about the
noise. A nurse aide transferred the resident to a wheelchair, and placed the resident, who
was at risk for suicidal ideation, in a housekeeping supply room, which was used for
storage of chemicals. The nurse aide closed the door and went back to the floor. The
resident began crying loudly, banging on the doors and yelling for help. Another staff
person thought that she heard a resident yelling, but was busy completing tasks for
another resident. Afterwards, she heard the yelling continue, found the resident, and
removed the resident from the room, the resident was sweating profusely, her face was
reddened, and was shaking and sobbing incoherently. Upon interview, the nurse aide who
had secluded the resident stated that she did not have the time to deal with the yelling,

and she had to get other residents to bed. She moved the resident to the supply room to
quiet her down.

Examples of Severity Level 3 Noncompliance Actual Harm that is not
Immediate Jeopardy include, but is not limited to:

• The facility failed to assure that a resident was free from involuntary seclusion. A
resident was admitted to a secured area at the request of his representative. After
admission, the resident requested the security codes in order to go in and out of the area,
but staff refused to provide the codes. The resident then requested to be transferred, but
staff refused his request. The staff then contacted the resident’s attending physician, who
made the determination that was not any clinical reason for the resident to be located in
the secured area; once the physician made this determination, he notified the facility,
which immediately transferred the resident to a room not located in the secured area.
During interview with the resident, he stated that he was still angry that he had been
placed in the secured area against his will for his first day in the facility, and felt afraid to
leave his room except for meals or else staff would place him again in the secured area,
even though staff attempted to regain his trust.

Examples of Severity Level 2 Noncompliance No Actual Harm with Potential for More
Than Minimal Harm that is Not Immediate Jeopardy include, but is not limited to:

• The facility failed to assure that a resident was free from involuntary seclusion. Based on
resident and staff interviews, it was stated that a nurse aide was transporting him to an
activity. The resident, who was dependent on staff for mobility in his wheelchair, said
that he was annoyed that he was late to the activity. He began to insult the nurse aide. The
nurse aide transported the resident in his wheelchair to an unused shower room, instead
of to the activity room and the nurse aide told the resident that when he stopped insulting
her, she would take him to the activity. The nurse aide stood outside the door to supervise
the resident and when the resident became quiet, she took the resident back to the
activity. Afterwards, the resident reported what had happened to the activity director and
said that he did not want the aide working with him anymore. During interview, the
resident stated that this was the only time something like this happened.

Severity Level 1: No Actual Harm with Potential for Minimal Harm
The failure of the facility to prevent involuntary seclusion is more than minimal harm.
Therefore, Severity Level 1 does not apply for this regulatory requirement.

F604
(Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24)

§483.10(e) Respect and Dignity.
The resident has a right to be treated with respect and dignity, including:

§483.10(e)(1) The right to be free from any physical or chemical restraints imposed for
purposes of discipline or convenience, and not required to treat the resident’s medical
symptoms, consistent with §483.12(a)(2).

§483.12(a) The facility must—

§483.12(a)(2) Ensure that the resident is free from physical or chemical restraints imposed
for purposes of discipline or convenience and that are not required to treat the resident’s
medical symptoms. When the use of restraints is indicated, the facility must use the least
restrictive alternative for the least amount of time and document ongoing re-evaluation of
the need for restraints.

INTENT

The intent of this requirement is for each resident to attain and maintain his/her highest
practicable well-being in an environment that:

• Prohibits the use of physical restraints for discipline or convenience;
• Prohibits the use of physical restraints to unnecessarily inhibit a resident’s freedom of

movement or activity; and
• Limits physical restraint use to circumstances in which the resident has medical

symptoms that may warrant the use of restraints.

When a physical restraint is used, the facility must:

• Use the least restrictive restraint for the least amount of time; and
• Provide ongoing re-evaluation of the need for the physical restraint.

DEFINITIONS

“Convenience” is defined as the result of any action that has the effect of altering a
resident’s behavior such that the resident requires a lesser amount of effort or care, and is
not in the resident’s best interest.

“Discipline” is defined as any action taken by the facility for the purpose of punishing
or penalizing residents.

“Freedom of movement” means any change in place or position for the body or any part of
the body that the person is physically able to control.

“Manual method” means to hold or limit a resident’s voluntary movement by using
body contact as a method of physical restraint.

“Medical symptom” is defined as an indication or characteristic of a physical or
psychological condition.

“Position change alarms” are alerting devices intended to monitor a resident’s movement.
The devices emit an audible signal when the resident moves in certain ways.

“Physical restraint” is defined as any manual method, physical or mechanical
device, equipment, or material that meets all of the following criteria:

• Is attached or adjacent to the resident’s body;
• Cannot be removed easily by the resident; and
• Restricts the resident’s freedom of movement or normal access to his/her body1.

“Removes easily” means that the manual method, physical or mechanical device, equipment,
or material, can be removed intentionally by the resident in the same manner as it was
applied by the staff.

GUIDANCE

As described under Definitions, a physical restraint is any manual method, physical or
mechanical device/equipment or material that limits a resident’s freedom of movement and
cannot be removed by the resident in the same manner as it was applied by staff. The
resident’s physical condition and his/her cognitive status may be contributing factors in
determining whether the resident has the ability to remove it. For example, a bed rail is
considered to be a restraint if the bed rail keeps a resident from voluntarily getting out of bed
in a safe manner due to his/her physical or cognitive inability to lower the bed rail
independently. Similarly, a lap belt is considered to be a restraint if the resident cannot
intentionally release the belt buckle.

Examples of facility practices that meet the definition of a physical restraint include, but are
not limited to:

• Placing a chair or bed close enough to a wall that the resident is prevented from rising
out of the chair or voluntarily getting out of bed;

• Placing a resident on a concave mattress so that the resident cannot independently get
out of bed;

• Tucking in a sheet tightly so that the resident cannot get out of bed, or fastening fabric
or clothing so that a resident’s freedom of movement is restricted;

• Placing a resident in a chair, such as a beanbag or recliner, that prevents a resident from
rising independently;

• Using devices in conjunction with a chair, such as trays, tables, cushions, bars or
belts, that the resident cannot remove and prevents the resident from rising;

• Applying leg or arm restraints, hand mitts, soft ties or vests that the resident
cannot remove;

• Holding down a resident in response to a behavioral symptom or during the provision
of care if the resident is resistive or refusing the care;

• Placing a resident in an enclosed framed wheeled walker, in which the resident cannot
open the front gate or if the device has been altered to prevent the resident from exiting
the device; and

• Using a position change alarm to monitor resident movement, and the resident is
afraid to move to avoid setting off the alarm.

Physical Risks and Psychosocial Impacts Related to Use of Restraints

Research and standards of practice show that physical restraints have many negative side
effects and risks that far outweigh any benefit from their use. Physical restraints may increase
the risk of one or more of the following:

o Decline in physical functioning including an increased dependence in activities of daily
living (e.g., ability to walk), impaired muscle strength and balance, decline in range of
motion, and risk for development of contractures;

o Respiratory complications;
o Skin breakdown around the area where the restraint was applied or skin integrity issues

related to the use of the restraint (i.e., pressure ulcers/injuries);
o Urinary/bowel incontinence or constipation;
o Injury from attempts to free him/herself from the restraint; and
o Accidents such as falls, strangulation, or entrapment.

Psychosocial impact related to the use of physical restraints may include one or more of
the following:

o Agitation, aggression, anxiety, or development of delirium;
o Social withdrawal, depression, or reduced social contact due to the loss of autonomy;
o Feelings of shame;
o Loss of dignity, self‐respect, and identity;
o Dehumanization;
o Panic, feeling threatened or fearful; and
o Feelings of imprisonment or restriction of freedom of movement.

Assessment, Care Planning, and Documentation for the Use of a Physical Restraint

The regulation limits the use of any physical restraint to circumstances in which the resident
has medical symptoms that warrant the use of restraints. There must be documentation
identifying the medical symptom being treated and an order for the use of the specific type of
restraint [See §483.12(a)(2)].

However, the practitioner’s order alone (without supporting clinical documentation) is not
sufficient to warrant the use of the restraint. The facility is accountable for the process to meet
the minimum requirements of the regulation including appropriate assessment (see § 483.20 –
Resident Assessment), care planning by the interdisciplinary team (see § 483.21-
Comprehensive Person-Centered Care Planning), and documentation of the medical
symptoms and use of the physical restraint for the least amount of time possible and provide
ongoing re-evaluation [see §483.12(a)(2)].

The resident or resident representative may request the use of a physical restraint; however,
the nursing home is responsible for evaluating the appropriateness of the request, and must
determine if the resident has a medical symptom that must be treated and must include the
practitioner in the review and discussion. If there are no medical symptoms identified that
require treatment, the use of the restraint is prohibited. Also, a resident, or the resident
representative, has the right to refuse treatment; however, he/she does not have the right to
demand a restraint be used when it is not necessary to treat a medical symptom.

Facilities are responsible for knowing the effects devices have on its residents. If a device has
a restraining effect on a resident, and is not administered to treat a medical symptom, the
device is acting as a physical restraint. The restraining effects to the resident may have been
caused intentionally or unintentionally by staff, and would indicate an action of discipline or
convenience. In the case of an unintentional physical restraint, the facility did not intend to
restrain a resident, but a device is being used that has that same effect, and is not being used to
treat a medical symptom. These effects may result in convenience for the staff, as the resident
may require less effort than previously required.

The use of a restraint must be individualized and be based upon the resident’s condition and
medical symptoms that must be treated. While a physical restraint may be used to treat an
identified medical symptom for one resident, the use of the same type of restraint may not be
appropriate to treat other residents with the same medical symptom. If a resident is identified
with a physical restraint, the facility must be able to provide evidence that ensures:

o The resident’s medical symptom that requires the use of a physical restraint has been

identified;
o A practitioner’s order is in place for the use of the specific physical restraint based upon

the identified medical symptom;

NOTE: If a resident is recently admitted to the facility and a restraint was used in a
previous health care setting, the facility must still conduct an assessment to determine
the existence of medical symptoms that warrant the continued use of the restraint.

o Interventions, including less restrictive alternatives were attempted to treat the

medical symptom but were ineffective;
o The resident/representative was informed of potential risks and benefits of all options

under consideration including using a restraint, not using a restraint, and alternatives to
restraint use;

NOTE: The resident, or resident representative (if applicable), has the right to refuse the
use of a restraint and may withdraw consent to use of the restraint at any time. If so, the
refusal must be documented in the resident’s record. The facility is expected to assess
the resident and determine how resident’s needs will be met if the
resident refuses/declines treatment.

• The length of time the restraint is anticipated to be used to treat the medical symptom,

the identification of who may apply the restraint, where and how the restraint is to be
applied and used, the time and frequency the restraint should be released, and who
may determine when the medical symptom has resolved in order to discontinue use of
the restraint;

• The type of specific direct monitoring and supervision provided during the use of
the restraint, including documentation of the monitoring;

• The identification of how the resident may request staff assistance and how needs will
be met during use of the restraint, such as for re-positioning, hydration, meals, using
the bathroom and hygiene;

• The resident’s record includes ongoing re-evaluation for the need for a restraint and is
effective in treating the medical symptom; and

• The development and implementation of interventions to prevent and address any
risks related to the use of the restraint (See also the Long-Term Care Facility Resident
Assessment Instrument User’s Manual, Version 3.0, Chapter 3, Section P-Restraints
for further guidance and 42 CFR §483.25(d) [F689] for concerns related to ensuring
the resident receives adequate supervision to prevent accidents).

NOTE: Falls generally do not constitute self-injurious behavior or a medical symptom that
warrants the use of a physical restraint. Although restraints have been traditionally used as a
falls prevention approach, they have major, serious drawbacks and can contribute to serious
injuries. There is no evidence that the use of physical restraints, including, but not limited to,
bed rails and position change alarms, will prevent or reduce falls. Additionally, falls that occur
while a person is physically restrained often result in more severe injuries (e.g., strangulation,
entrapment).

The use of handcuffs, manacles, shackles, other chain-type restraint devices, or other
restrictive devices are not considered safe, appropriate health care restraint interventions for
use by a nursing home. This would not include arrests made onsite if a resident is taken into
custody and is removed from the premises by law enforcement.

NOTE: For more information regarding requirements for providing services to justice-
involved individuals in facilities, see also F550-Resident’s Rights and S&C-16-21-
https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-21 ).

Convenience and/or Discipline

A facility must not impose physical restraints for purposes of discipline or convenience [§§
483.10(e)(1) and 483.12(a)(2)]. The facility is prohibited from obtaining permission from the
resident, or resident representative, for the use of restraints when the restraint is not necessary

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-21

to treat the resident’s medical symptoms. Anecdotally, it has been reported that staff will
inform a resident, or the resident representative, that a restraint will be beneficial to the
resident to prevent a fall or to safeguard the resident who may be wandering into other
resident’s rooms. However, in these instances, the surveyor should consider whether the
restraint was used for the sake of staff convenience.

Reasons for using restraints for staff convenience or discipline may include:

o Staff state that a resident was placed in a restraint because staff are too busy to monitor

the resident, and their workload includes too many residents to provide monitoring;
o Staff believe that the resident does not exercise good judgment, including that he/she

forgets about his/her physical limitations in standing, walking, or using the bathroom
alone and will not wait for staff assistance;

o Staff state that family have requested that the resident be restrained, as they are
concerned about the resident falling especially during high activity times, such as during
meals, when the staff are busy with other residents;

o Staff have identified to management that there is not enough staff on a particular shift or
during the weekend and staffing levels were not changed;

o Staff state that new staff and/or temporary staff do not know the resident, how to
approach, and/or how to address behavioral symptoms or care needs so they apply
physical restraints;

o Lack of staff education regarding the alternatives to the use of restraints as a method for
preventing falls and accidents;

o Staff have negative feelings or a lack of respect towards the resident, and restrain the
resident to teach him/her a lesson;

o In response to a resident’s wandering behavior, staff become frustrated and restrain a
resident to a wheelchair; and

o When a resident is confused and becomes combative when care is provided and staff hold
the resident’s arms and legs down to complete the care (NOTE: This example differs
from an emergency situation where staff briefly hold a resident for the sole purpose of
providing necessary immediate medical care ordered by a practitioner).

Situations where a facility uses a physical restraint, or device acting as a physical restraint,
that is not for treating a medical symptom, whether intentionally or unintentionally by staff,
would indicate an action of discipline or convenience. An example that illustrates
unintentional use of a physical restraint for staff convenience is when a staff member places a
resident with limited mobility in a beanbag chair while other residents receive assistance
during high activity times.

Determination of Use of Restraints for a Period of Imminent Danger to the Safety and
Well- Being of the Resident

Some facilities have identified that a situation occurred in which the resident(s) is in
“imminent danger” and there was fear for the safety and well-being of the resident(s) due to
violent behavior, such as physically attacking others. In these situations, the order from the
practitioner and supporting documentation for the use of a restraint must be obtained either
during the application of the restraint, or immediately after the restraint has been applied. The

failure to immediately obtain an order is viewed as the application of restraint without an order
and supporting documentation. Facilities may have a policy specifying who can initiate the
application of restraint prior to obtaining an order from the practitioner.

If application of a restraint occurs, the facility must:

o Determine that a physical restraint is a measure of last resort to protect the safety of the

resident or others;
o Provide ongoing direct monitoring and assessment of the resident’s condition during use

of the restraint;
o Provide assessment by the staff and practitioner to address other interventions that may

address the symptoms or cause of the situation (e.g., identification of an infection process
or delirium, presence of pain);

o Ensure that the resident and other residents are protected until the resident’s behavioral
symptoms have subsided, or until the resident is transferred to another setting;

o Discontinue the use of the restraint as soon as the imminent danger ends; and
o Immediately notify the resident representative of the symptoms and temporary

intervention implemented.

Documentation must reflect what the resident was doing and what happened that presented the
imminent danger, interventions that were attempted, response to those interventions, whether
the resident was transferred to another setting for evaluation, whether the use of a physical
restraint was ordered by the practitioner, and the medical symptom(s) and cause(s) that were
identified.

Determination of Use of Bed Rails as a Restraint

Facilities must use a person-centered approach when determining the use of bed rails, which
would include conducting a comprehensive assessment, and identifying the medical
symptom being treated by using bed rails. Bed rails may have the effect of restraining one
individual but not another, depending on the individual resident’s conditions and
circumstances. (See §483.25(n) – Bed Rails).

Residents who are cognitively impaired are at a higher risk of entrapment and injury or death
caused by restraints. Residents in a bed with bed rails have attempted to exit through, between,
under, over, or around bed rails or have attempted to crawl over the foot board, which places
them at risk of serious injury or death. Serious injury from a fall is more likely from a bed
with raised bed rails than from a bed where bed rails are not used. In many cases, the risk of
using the bed rails may be greater than the risk of not using them as the risk of restraint-related
injury and death is significant. For example, a resident who has no voluntary movement may
still exhibit involuntary movements. Involuntary movements, resident weight, and gravity’s
effects may lead to the resident’s body shifting toward the edge of the bed, increasing the risk
for entrapment, when bed rails are used. Also refer to 42 CFR §483.25(n) – Bed Rails (tag
F700).

The use of partial bed rails may assist an independent resident to enter and exit the bed
independently and would not be considered a physical restraint. To determine if a bed rail is

being used as a restraint, the resident must be able to easily and voluntarily get in and out of
bed when the equipment is in use. If the resident cannot easily and voluntarily release the bed
rails, the use of the bed rails may be considered a restraint.

Determination of the Use of Position Change Alarms as Restraints

Position change alarms are any physical or electronic device that monitors resident
movement and alerts the staff when movement is detected. Types of position change alarms
include chair and bed sensor pads, bedside alarmed mats, alarms clipped to a resident’s
clothing, seatbelt alarms, and infrared beam motion detectors. Position change alarms do not
include alarms intended to monitor for unsafe wandering such as door or elevator alarms.

While position change alarms may be implemented to monitor a resident’s movements, for
some residents, the use of position change alarms that are audible to the resident(s) may have
the unintended consequence of inhibiting freedom of movement. For example, a resident may
be afraid to move to avoid setting off the alarm and creating noise that is a nuisance to the
resident(s) and staff, or is embarrassing to the resident. For this resident, a position change
alarm may have the potential effect of a physical restraint.

Examples of negative potential or actual outcomes which may result from the use of
position change alarms as a physical restraint, include:

• Loss of dignity;
• Decreased mobility;
• Bowel and bladder incontinence;
• Sleep disturbances due to the sound of the alarm or because the resident is afraid to move

in bed thereby setting off the alarm; and
• Confusion, fear, agitation, anxiety, or irritation in response to the sound of the alarm as

residents may mistake the alarm as a warning or as something they need to get away
from.

PROCEDURES §483.12 and (a)(2)-Physical Restraints

The process to review concerns are outlined in the Physical Restraints Critical Element
Pathway (Form CMS-20077).

NOTE: A resident may have a device in place that the facility has stated can be
removed by the resident. For safety reasons, do not request that the resident remove
the restraint, but rather, request that staff ask the resident to demonstrate how he/she
releases the device without staff providing specific instructions for the removal.

Use observations, interviews, and record review to gather and corroborate information
related to:

• The use of the physical restraint, including whether the facility identified a device as a
restraint, why it is used, how long it has been used, duration of use, alternatives
attempted;

• What information was provided to the resident regarding the use of the restraint and
whether the use of the restraint reflects the resident’s preferences and choices;

• Whether the physical restraint is used for, or has the effect of, staff convenience or
discipline; or

• Physical and psychosocial outcomes from the use of the restraint.

Use the Physical Restraints Critical Element (CE) Pathway, along with the above Guidance:

• When a resident’s clinical record reflects the use of a physical restraint;
• If the survey team observes a position change alarm, or other device or practice that

restricts or potentially restricts a resident’s freedom of movement (physically or
psychologically);

• If the resident or other individuals report that a restraint is being used on the resident; or
• If an allegation of inappropriate use of a physical restraint is received.

KEY ELEMENTS OF NONCOMPLIANCE

To cite deficient practice at F604, the surveyor’s investigation will generally show that
the facility has failed, in one or more areas, to do any one or more of the following:

• Ensure that the resident is free from physical restraints imposed for discipline or staff
convenience;

• Identify the medical symptom being treated when using a device or a facility practice that
meets the definition of physical restraint;

• Define and implement interventions according to standards of practice during the use of a
physical restraint that is used for treatment of a medical symptom;

• Provide the least restrictive restraint for the least time possible;
• Providing ongoing monitoring and evaluation for the continued use of a physical restraint

to treat a medical symptom; or
• Develop and implement interventions for reducing or eventually discontinuing the use of

the restraint when no longer required to treat a resident’s medical symptoms.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION

• 42 CFR §483.10, §483.10(a)(1)‐(2), §483.10(b)(1)‐(2), F550- Resident Rights and
Dignity

• 42 CFR §483.10(c)(2)‐(3), F553 – Right to Participate Planning Care

• 42 CFR §483.21(b)(1), F656- Develop/Implement Comprehensive Care Plan
• 42 CFR §483.24, F675 – Quality of Life
• 42 CFR §483.25(d), F689 – Accidents
• 42 CFR §483.25(n)(1)‐(4), F700- Special Care: Bedrails
• 42 CFR §483.35, 483.35(a), and §483.35(c)- F725 and F726 – Sufficient and Competent

Staff
• 42 CFR §483.40(b)‐(b)(1), F742- Treatment/Svc for Mental/Psychosocial Concerns
• 42 CFR §483.70(g), F841-Responsibilities of Medical Director
• 42 CFR §483.75 (g)(2)(ii)- F867- QAA Activities

DEFICIENCY CATEGORIZATION

In addition to actual or potential physical harm, always consider whether psychosocial harm has
occurred when determining severity level (See Psychosocial Outcome Severity Guide).

Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident
Health or Safety include, but are not limited to:

• The facility failed to identify the resident’s medical symptom that warranted the use of a
restraint. It was identified that a resident had repeated falls in his room usually after
meals, when he attempted to transfer from his wheelchair to the bed. The clinical record
documented that the resident repeatedly requested to be assisted to lie down after eating.
Staff recorded that the belt restraint was being applied to prevent falls as he had fallen
several times when attempting to stand up from the wheelchair after meals and lie down.
Although the resident verbalized distress at being tied down in the wheelchair, staff stated
they had informed the resident that they would put the resident in bed as soon as they
finished taking care of the other residents in the dining room. It was documented that
after staff left the room, the resident had attempted to stand up with the lap belt in place
in the wheelchair, and as a result, the wheelchair tipped over and he sustained a fracture
of his hand and had hit his head, resulting in hospitalization and treatment for multiple
head and face lacerations and a subdural hematoma.

• The facility failed to identify bed rails as a physical restraint, failed to assess the resident
for use of a bed rail, and failed to ensure that the bed rails did not pose a risk of injury
from falls. A moderately cognitively impaired resident was admitted to the facility who
required extensive assistance with bed mobility and transfer, and was not ambulatory.
The staff recorded on admission that the resident was at high risk for falls and as a
result, placed full bed rails on all open sides of the bed. No assessment was conducted
related to the use of bed rails, or the use of restraints. Documentation in the record
revealed that the resident crawled to the foot of her bed while the full bed rails were in a
raised position, attempted to stand and walk, and fell off the right side of the bed. The
resident was hospitalized for surgical repair of a femoral neck fracture.

Examples of Severity Level 3 Noncompliance Actual Harm that is not Immediate
Jeopardy include, but are not limited to:

• The facility failed to assure that a restraint was an intervention to treat a medical
symptom and was not being used for staff convenience. Facility staff had placed a
resident in a bean bag chair from which he could not rise. Based on staff interview, the
resident was ambulatory, but had fallen in the past when attempting to stand up. The
facility staff did not recognize that the bean bag was a physical restraint; thus, the staff
did not conduct any assessment to identify any medical symptoms that would
necessitate a restraint. Staff stated that they placed the resident in the bean bag chair
while caring for other residents. The resident reported being placed and left in the bean
bag chair every day in the afternoon and was not able to stand to walk to his room or to
activities. The resident said that he felt humiliated that he is not able to get out of the
chair himself, when he wants to, especially since he enjoys talking with the other
residents. The surveyor observed the resident struggling to get up, but was not able.

• The facility failed to assure that the use of a physical restraint was used to treat a
resident’s medical symptoms, and was not being used for staff convenience. A resident
was admitted with a diagnosis of dementia, and had been hospitalized due to a head
injury related to a fall at her home. The physician admission orders included an order for
a lap belt to be used when the resident was up in the wheel chair; however, there was no
identification of the medical symptom that necessitated the use of the lap belt. In a
phone interview with the physician, he indicated that staff had requested the lap belt
order due to the resident’s falls. Based on observation, the resident sat in the day room
in a wheel chair with the lap belt in place through the morning, from the breakfast
service through the end of the noon meal. Staff did not provide repositioning, assistance
with using the bathroom, or release of the lap belt for mobility. After lunch, the resident
was transported to her room in the wheelchair with the lap belt in place; however, the
lap belt was not removed and the resident remained in the same position through the
afternoon without opportunities for repositioning, assistance with using the bathroom, or
release of the lap belt for mobility. The resident was observed to be moving about
restlessly, pulling at the lap belt, and calling out for help without staff response or
intervention.

When staff prompted the resident to release the belt, the resident was not able. Observation
of the resident’s skin when put to bed after the PM shift arrived, revealed reddened areas on
the coccyx, urine soaked incontinence product with visible skin maceration. Staff
interviewed stated that the lap belt was being used as a falls prevention intervention. They
stated, and the record corroborated that there had been a decline in the resident’s mobility,
and continence since admission.

Examples of Severity Level 2 Noncompliance No Actual Harm with Potential for More
Than Minimal Harm that is Not Immediate Jeopardy include, but are not limited to:

• The facility failed to assure that a physical restraint used for one resident was for the
treatment of medical symptoms. Record review and observation revealed that the resident
was alert and responded to her name, but was identified as mildly cognitively impaired
and had fallen at home prior to her admission several weeks before. Observations
revealed that a seat belt was used intermittently when the resident was in the wheelchair,

but the resident had not attempted to rise, nor had attempted to remove the seatbelt. Staff
stated that they thought the resident could release the seatbelt, although an assessment
had not been completed regarding the use of the seatbelt. There was no documentation of
an assessment for the use of the seat belt, whether the resident could release the seat belt
or of identification of medical symptoms that would require the use of the seat belt while
in the wheelchair. The resident’s record reflected no decline in functional status.

• The facility failed to ensure that the use of a concave mattress was being used in the
treatment of medical symptoms and not for staff convenience. A resident, who could
independently transfer self from bed to wheelchair and to bathroom, was observed to
have a concave mattress. During resident interview, the resident stated that it was hard to
get out of bed. The resident’s record indicated no history of falls or injuries. During
interview, the nurse assigned to the resident verified that the concave mattress was used
to prevent the resident from exiting the bed independently. The resident’s record did not
include any information in the assessment, physician’s orders, or care plan related to the
concave mattress.

Severity Level 1: No Actual Harm with Potential for Minimal Harm

The failure of the facility to assure residents are free from physical restraints not required to treat
the resident’s symptoms is more than minimal harm. Therefore, Severity Level 1 does not apply
for this regulatory requirement.

1 See CMS Minimum Data Set Resident Assessment Instrument Manual.

F605
(Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24)

§483.10(e) Respect and Dignity.

The resident has a right to be treated with respect and dignity, including:

§483.10(e)(1) The right to be free from any physical or chemical restraints
imposed for purposes of discipline or convenience, and not required to treat the
resident’s medical symptoms, consistent with §483.12(a)(2).

§483.12
The resident has the right to be free from abuse, neglect, misappropriation of
resident property, and exploitation as defined in this subpart. This includes but is
not limited to freedom from corporal punishment, involuntary seclusion and any
physical or chemical restraint not required to treat the resident’s medical
symptoms.

§483.12(a) The facility must—

§483.12(a)(2) Ensure that the resident is free from physical or chemical restraints
imposed for purposes of discipline or convenience and that are not required to treat the
resident’s medical symptoms. When the use of restraints is indicated, the facility must
use the least restrictive alternative for the least amount of time and document ongoing
re-evaluation of the need for restraints.

INTENT

The intent of this requirement is for each person to attain and maintain his/her
highest practicable well-being in an environment that prohibits the use of chemical
restraints:

• For discipline or convenience; and
• Not required to treat a resident’s medical symptoms.

When a medication is indicated to treat a medical symptom, the facility must:

• Use the least restrictive alternative for the least amount of time;
• Provide ongoing re-evaluation of the need for the medication; and
• Not use the medication for discipline or convenience.

NOTE: The surveyor’s review of medication use is not intended to constitute the practice
of medicine. However, surveyors are expected to investigate the basis for decisions and
interventions affecting residents.

DEFINITIONS
“Chemical restraint” is defined as any drug that is used for discipline or staff convenience
and not required to treat medical symptoms.

“Discipline” is defined as any action taken by facility staff for the purpose of punishing
or penalizing residents.

“Indication for use” is defined as the identified, documented clinical rationale for
administering a medication that is based upon an assessment of the resident’s condition and
therapeutic goals

and is consistent with manufacturer’s recommendations and/or clinical practice guidelines,
clinical standards of practice, medication references, clinical studies or evidence-based
review articles that are published in medical and/or pharmacy journals.

“Medical symptom” is defined as an indication or characteristic of a medical, physical
or psychological condition.

GUIDANCE

The indication for use for any medication ordered for a resident must be identified and
documented in the resident’s record. (Also refer to F757 and/or F758.) When any medication
restricts the resident’s movement or cognition, or sedates or subdues the resident, and is not an
accepted standard of practice for a resident’s medical or psychiatric condition, the medication
may be a chemical restraint. Even if use of the medication follows accepted standards of
practice, it may be a chemical restraint if there was a less restrictive alternative treatment that
could have been given that would meet the resident’s needs and preferences or if the medical
symptom justifying its use has subsided. The facility is accountable for the process to meet the
minimum requirements of the regulation including appropriate assessment, care planning by
the interdisciplinary team, and documentation of the medical symptoms and use of a less
restrictive alternative for the least amount of time possible and provide ongoing re-evaluation.

NOTE: A medication may have been required to treat a medical symptom, and as a result, the
medical symptom is no longer present. In some cases, the clinical goal of the continued use of
the medication is to stabilize the symptoms of the disorder so that the resident can function at
the highest level possible. In other words, the clinical goal is to have no symptoms of the
disorder.

Although the symptom may no longer be present, the disease process is still present.
For example, diseases may include:

• Chronic psychiatric illness such as schizophrenia or schizoaffective disorder,
bipolar disorder, depression, or post-traumatic stress disorder;

• Neurological illness such as Huntington’s disease or Tourette’s syndrome; and
• Psychosis and psychotic episodes.

In such instances, if the medication is reduced or discontinued, the symptoms may return.
Reducing or eliminating the use of the medication may be contraindicated and must be
individualized. If the medication is still being used, the clinical record must reflect the rationale
for the continued administration of the medication. If no rationale is documented, this may meet
the criteria for a chemical restraint, such as for staff convenience (See also F758 for concerns
related to unnecessary use of a psychotropic medication and lack of gradual dose reduction).

Determination of Medical Symptoms

The clinical record must reflect whether the staff and practitioner have identified, to the
extent possible, and addressed the underlying cause(s) of distressed behavior, either before
or while treating a medical symptom. Potential underlying causes for expressions and/or
indications of distress may include, but are not limited to:

• Delirium;
• Pain;
• The presence of an adverse consequence associated with the resident’s current

medication regimen; and

• Environmental factors, such as staffing levels, over stimulating noise or activities, under
stimulating activities, lighting, hunger/thirst, alteration in the resident’s customary
location or daily routine, physical aggression leading to altercations, temperature of the
environment, and crowding.

NOTE: If it is determined that the administration of a medication is being used to treat a
medical symptom, the survey team should review to assure that the use of the medication is
supported by adequate indication and rationale for use, and is used at the correct dose and
duration, and with adequate monitoring. (See also F741, F757, and F758 for concerns related
to non-pharmacological approaches of redirecting or addressing behavior)

Determination of Indication for Medication Use

The clinical record must reflect the following:

• Whether there is an adequate indication for use for the medication (e.g., a psychotropic
medication is not administered unless the medication is used to treat a specific condition);

• Whether an excessive dose and/or duration of the medication was administered to the
resident;

• Whether there is adequate monitoring for the effectiveness of the medication in treating
the specific condition and for any adverse consequences resulting from the medication;

• Whether a resident who uses a psychotropic drug(s) is receiving gradual dose reduction
and behavioral interventions, unless clinically contraindicated; and

• Whether a resident who receives a psychotropic drug(s) pursuant to a PRN (pro re nata,
or as needed) order is not administered the medication unless the medication is necessary
to treat a diagnosed specific symptom, as documented in the clinical record.

If the practitioner orders a medication to be administered on a PRN time-limited basis for the
provision of medical treatment to address an emergency medical condition (e.g., delirium), this
would not be considered to be a chemical restraint. The dosage cannot exceed what is
prescribed by the practitioner, and if the resident does not respond to the initial administration
of the PRN medication, the practitioner must be contacted, regarding re-assessment of the
resident’s medical condition and evaluation of interventions. The administration of a PRN
medication must be discontinued when the resident does not need the medication for treatment
of the medical condition (also see §483.45(e) F758 for limitations on psychotropic and
antipsychotic medication PRN orders). If staff continue to utilize a PRN medication that
subdues or sedates a resident, and is not treating a medical condition, this would be considered
to be a chemical restraint for staff convenience or discipline.

Risks and Psychosocial Impacts Related to Use of Chemical Restraints

A medication that is used for discipline or convenience and is not required to treat
medical symptoms, may cause the resident to be:

• Subdued, sedated, or withdrawn;
• Asleep during hours that he/she would not ordinarily be asleep; or

• Limited in his/her functional capacity.

Additional effects resulting from sedating or subduing a resident may include, but are not
limited to, the following:

• Loss of autonomy, dignity, self-respect and orientation;
• Confusion, cognitive decline, withdrawal, depression;
• Decreased activity levels, including social activities;
• Decline in skin integrity;
• Decline in continence level;
• Decline in physical functioning including an increased dependence in activities of daily

living (e.g., ability to walk), impaired muscle strength and balance, decline in range of
motion, and risk for development of contractures, increased risk of falls; and

• Weight loss if missing meals.

Facilities are responsible for knowing the effects medications have on their residents. If a
medication has a sedating or subduing effect on a resident, and is not administered to treat a
medical symptom, the medication is acting as a chemical restraint. The sedating/subduing
effects to the resident may have been caused intentionally or unintentionally by staff, and
would indicate an action of discipline or convenience. In the case of an unintentional chemical
restraint, the facility did not intend to sedate or subdue a resident, but a medication is being
administered that has that effect, and is not the least restrictive alternative to treat the medical
symptom. These effects may result in convenience for the staff, as the resident may require
less effort than previously required. Even if a medication was initially administered for a
medical symptom, the continued administration of a medication in the absence of a medical
symptom, that sedates a resident or otherwise makes it easier to care for them, is a chemical
restraint.
Other examples of facility practices that indicate that a medication (ordered by a practitioner)
is being used as a chemical restraint for staff convenience or discipline include, but are not
limited to:

o Staff indicate that a medication is being administered based on the resident’s

representative’s request to administer a medication to “calm down” the resident;
o Staff have recommended to the practitioner that a resident be administered a medication

in order to prevent a resident from displaying behaviors such as wandering into other
resident’s rooms:

o Staff administer a medication to quiet the resident because the resident continually calls
out, without attempting alternative interventions;

o Staff become frustrated with a resident who continually requests staff assistance (such as
for toileting), or continually puts on the call light, and administer a medication to sedate
or subdue the resident);

o Staff administer a medication that subdues or sedates a resident when insufficient staffing
levels do not allow for the resident’s needs to be met;

o Staff administer a medication to sedate or subdue the resident, and/or to restrict the
resident to a seated or lying position, since the resident continually wanders into other
resident’s rooms or attempts to leave the unit; and

o Staff become upset with a resident who resists receiving a bath and pinches staff. The
staff had not re-assessed the resident nor revised interventions regarding how to provide
bathing care in order to meet the resident’s needs. Instead, staff administer a medication
that is used to subdue the resident prior to providing the bath, but the medication is not
used to treat an identified medical symptom.

INVESTIGATIVE PROTOCOL FOR CHEMICAL RESTRAINTS USE

Use this protocol to investigate whether the facility is using a medication as a chemical
restraint when:

• An allegation of use of a chemical restraint is received; or
• The survey team determines noncompliance with F757 and/or F758, and the resident was

or is receiving an unnecessary medication that restricts movement, or sedates or subdues
the resident

NOTE: If the survey team identifies an unnecessary medication that is acting as a

chemical restraint (sedating or subduing a resident), the noncompliance is cited at
F605 – Chemical Restraints and not cited at F757 – Unnecessary Medications.
Both tags shall not be cited for the same noncompliance.

PROCEDURES

The survey team must first use the Interpretive Guidance (Refer to F757 and F758) and
Critical Element Pathway for Unnecessary Medications, Psychotropic Medications, and
Medication Regimen Review (Form CMS-20082) to determine whether the medication is
used to treat a medical symptom.

Review the assessment, care plan, practitioner orders, and consulting pharmacist reviews to
identify facility interventions and to guide observations to be made. Corroborate observations
by interview and record review.

Gather information regarding the resident’s mental, physical, functional, and psychosocial
status and the medication-related therapeutic goals identified in the care plan as the basis
for further review.

Observation

Record observations regarding any potential environmental causes of distress to the resident,
such as staffing levels, over stimulating noise or activities, under stimulating activities,
lighting, hunger/thirst, physical aggression leading to altercations, temperature of the
environment, and crowding. In addition, observe for any alteration to the resident’s
customary location or daily routine.

Record any visible physical and psychosocial reaction to the potential use of a medication,
such as:

o Drowsiness, somnolence, excessive sedation, and hallucinations;
o Neurologic consequences such as akathisia, neuroleptic malignant syndrome (NMS),

parkinsonism, tardive dyskinesia; and/or
o Confusion, agitation, anxiety, nervousness;
o Social isolation, withdrawal, loss of self-esteem; and/or
o Lack of participation in individualized activities, according to the resident’s care plan.

Interviews

Interview the resident, and/or resident representative, to the degree possible, to identify:

o Prior to administration of the medication:

• Whether other interventions have been attempted; if so, what alternatives; and what

the response was;
• Whether staff provided information regarding why the medication was being used;
• The risks and/or benefits of using the medication; and
When and for how long the medication was going to be used.

o Who requested the medication to be used and why;
o Describe the effect of the medication on the resident’s functioning, participation in

individual and/or group activities, and how it makes them feel; and
o Describe any changes in the resident’s ability to understand, sleeping patterns, or social

involvement since receiving the medication.

Interview direct care staff and/or licensed personnel (e.g. nursing, social worker),
as appropriate, on various shifts that provide care to the resident to determine:

o Why the medication is being administered and what effect (physical and/or psychosocial)

it has on the resident;
o Depending on whether distressed behavior is expressed, how do staff respond and what

individualized, person-centered interventions are attempted;
o Prior to administration of the medication, whether other interventions have been

attempted; if so, what alternatives; and how the interventions met or failed to meet the
resident’s needs;

o How long the medication has been administered, and when it began;
o Prior to administration of the medication, what is determined to be the underlying

cause(s) of the medical symptom that is being treated; how is the cause(s) treated;
o Who and how the facility monitors for adverse consequences related to the administration

of the medication;
o How is it determined that the medical symptom is no longer present and who determines

this;
o If the medication continues to be administered and the medical symptom is no longer

present, what is the clinical rationale for continuing the use of the medication and where
is this documented;

o How staff are assigned to monitor, care for, and be familiar with residents’ behaviors
(e.g., the number, location, and consistency of staff assigned across different shifts/units);

o Who supervises the overall delivery of care to the residents to assure care planned
interventions are implemented and how supervision occurs (to assure that a chemical
restraint is not used for staff convenience); and

o Whether staff have discussed concerns with the Director of Nurses and Administrator
regarding the behavioral symptoms of specific residents and the monitoring of
interventions, and whether staff have requested more resources or changes to resident
assignments, and the response to the concerns.

Interview the practitioner regarding concerns identified during the investigation, including
when the staff contacted him/her, what concerns they identified regarding the resident’s
behavior, the response provided, including whether other interventions were attempted prior to
the use of a medication, what medical symptom is being treated with the medication, whether
the medication is considered to be the least restrictive (in type, dose, and duration) that may be
used to treat the symptom, and the plan for discontinuing and/or revising interventions.
Interview the pharmacist to identify when he/she conducted the last medication regimen
review for the resident; if the medication was administered prior to the last review and it was
not identified as a concern, whether he/she can provide information regarding the indication
for use of the medication; if the medication was administered prior to the last review and it
was identified as a concern, , whether he/she notified the practitioner, Director of Nurses,
and/or medical director and what was the response; and what is the facility’s process for
notifying the pharmacist when initiating a medication for a change in the resident’s condition,
such as when there are expressions or indications of distress, or other changes in a resident’s
psychosocial status.

Interview the social worker to determine any patterns of behaviors that may impact the
resident’s safety or care provided, whether he/she was aware of interventions attempted, how
attempts met or did not meet the resident’s needs, whether he/she was aware of what
medications are administered to the resident, whether he/she has identified any changes in the
resident’s behavior or activity level after administration of the medication, and why he/she
believes the medication is being administered.

Interview the Director of Nurses to identify his/her knowledge regarding the behavioral
symptoms of specific residents and the monitoring of interventions. Also, interview the
Director of Nurses and Administrator to identify whether staff have requested more resources
or changes to resident assignments, and the response to the concerns.

Record Review

Review the assessment, care plan, practitioner orders, progress notes, and consulting
pharmacist reviews. Determine whether there was a decline in the resident’s functional
and/or psychosocial status related to the medication that was administered. If so, the
surveyor must determine whether the decline can be attributed to disease progression or
administration of an unnecessary medication. Determine if documentation in the resident’s
record reflects:

Prior to administration of the medication, whether other interventions have been attempted;
if so, what alternatives; and how the interventions met or failed to meet the resident’s needs;

• Prior to administration of the medication, whether the facility identified, to the extent
possible, and addressed the underlying cause(s) of the medical symptom;

• Indication for use for the medication(s), including the medical symptom(s) being treated;
• Whether the record reflects any adverse consequences after administration of the

medication;
• Whether the record reflects whether there was a change in functioning and/or activity

after administration of the medication;
• If a medication used to treat medical symptoms was appropriate at one time, determine if

it was discontinued once it was no longer necessary, or if a clinical rationale to continue
the medication is documented; and

• Whether the medication is administered on a PRN basis on particular days or shifts or
when certain staff is caring for the resident and the symptoms for which the medication is
prescribed are not documented.

Facility Review

It may be necessary to interview the medical director regarding medications that are not
required to treat the resident’s medical symptoms result in the resident being subdued,
sedated, or withdrawn or limited in his/her functional capacity.

Determine whether the Quality Assessment & Assurance committee is aware of psychotropic
medication used to address resident behavioral symptoms, whether there is sufficient,
qualified staff trained to provide interventions for behavioral symptoms, and supervision of
staff to assure that medications are only used to treat a medical symptom and do not have the
effect of convenience or discipline.

KEY ELEMENTS OF NONCOMPLIANCE

To cite deficient practice at F605, the surveyor’s investigation will generally show that
the facility has failed, in one or more areas, to do any one or more of the following:

• Assure that the resident is free from restraints imposed for discipline or staff convenience
(convenience can be caused intentionally or unintentionally by staff);

• Identify medical symptoms that were being treated with the use of a chemical restraint;
• If a chemical restraint is in use, the facility:

o Provides the least restrictive alternative for the least time possible, including and as
appropriate, developing and implementing a plan for gradual dose reduction, in the
absence of identified and documented clinical contraindications;

o Monitors and evaluates the resident’s response to the medication; and
o Discontinues the use of the medication when the medical symptom is no longer being

treated, unless reducing or eliminating the use of the medication may be clinically
contraindicated.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION

• 42 CFR §483.10, §483.10(a)(1)‐(2), §483.10(b)(1)‐(2), F550- Resident Rights and
Dignity

• 42 CFR §483.10(c)(2)‐(3), F553 – Right to Participate Planning Care
• 42 CFR §483.21(b)(1), F656- Develop/Implement Comprehensive Care Plan
• 42 CFR §483.35, §483.35(a), and §483.35(c)- F725 and F726 – Sufficient and Competent

Staff
• 42 CFR §483.40(b)‐(b)(1), F742- Treatment/Svc for Mental/Psychosocial Concerns
• 42 CFR §483.45(c), F756-Drug Regimen Review, Report Irregular, Act On
• 42 CFR §483.45(d), F757- Drug Regimen is Free From Unnecessary Drugs
• 42 CFR §483.45, F758- Psychotropic Medications
• 42 CFR §483.70(g), F841-Responsibilities of Medical Director
• 42 CFR §483.75 (g)(2)(ii)- F867- QAA Activities

DEFICIENCY CATEGORIZATION

In addition to actual or potential physical harm, always consider whether psychosocial harm has
occurred when determining severity level (See Psychosocial Outcome Severity Guide).

Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident
Health or Safety includes, but is not limited to:

• The facility administered a medication to a resident for staff convenience without a
medical symptom identified. The resident was admitted to a secured area of the facility
two months prior to the survey. During observations the resident was observed lying in a
reclining chair, sleeping and staff had difficulty arousing the resident for meals. The staff
had to provide one to one assistance to assist the resident to eat. The resident was unable
to hold the utensils, and was being fed a pureed meal. The resident required a two-person
assist to transfer from bed to chair and required total assistance for activities of daily
living. The resident’s record revealed that on admission, the resident was independent in
mobility and ambulation and did not require assistance to eat. Staff interviewed stated
that they had difficulty monitoring the resident as they were taking care of other
residents. They stated that there were no identified interventions or activities to address
these behaviors. As a result, staff requested a medication from the physician for the
wandering behavior. The physician was interviewed and stated that the medication was
being administered for wandering, but that he was not aware that the resident was sedated
and the resident’s decline in walking and activities of daily living. There was no other

evidence in the resident’s record or from interviews with staff and the physician that
indicate a medical reason for the decline and sedating effect.

• The facility failed to assure that a medication it administered to a resident was being used
to treat a medical symptom and not for staff convenience. The resident was admitted for
post-surgical rehabilitation of a fractured hip. During an interview, the resident’s
representative stated that prior to admission, the resident had been alert, was able to
recognize her family members, was used to sitting with the family after the evening meal
at home, and, although pleasantly confused, enjoyed a warm bath prior to bedtime and
slept through the night. However, after admission, there had been a significant change in
the resident’s status. The resident’s record reflected that the resident, after admission, was
immediately put to bed after the evening meal every day; subsequently, the resident
began yelling out for help, wanted to get out of bed, and disrupted other residents’ sleep.
During an interview with the practitioner, staff had contacted him and requested an
antipsychotic medication to keep the resident quiet during the night hours as she was
disruptive and agitated. The practitioner ordered an antipsychotic medication twice a day,
but did not provide documentation of a medical symptom being treated with the
medication. Observations throughout the survey revealed the resident seated in a
wheelchair, subdued or sleeping, sucking on her hand, mumbling to self, and not aware of
surroundings or visitors. Staff interviewed corroborated that there had been a decline in
the resident’s condition since the administration of the medication. Due to the significant
change in the resident’s status related to the initiation and use of a chemical restraint,
serious harm occurred to the resident.

Examples of Severity Level 3 Noncompliance Actual Harm that is not Immediate
Jeopardy include, but is not limited to:

• The facility administered a medication that was not being used to treat medical
symptoms, the facility did not attempt any less restrictive interventions, and the
medication was used for the convenience of staff. As a result of this noncompliance, the
resident was sedated into the morning hours. The resident was unable to be aroused
sufficiently to eat breakfast in the dining room where he normally eats meals, and now
required assistance by staff to eat breakfast. The resident was observed to attend and
participate in his other meals and activities for the rest of the day. The record did not
indicate any falls or any decline in other activities of daily living. The resident, diagnosed
with Alzheimer’s disease, had displayed night time behaviors that frustrated other
residents and nursing staff, such as wandering into other resident’s rooms, and
rummaging through drawers and closets. To address the resident’s behavior, staff
contacted the attending physician to discuss the issue and request a long-acting anti-
anxiety medication. No other attempts of non-pharmacological interventions were
identified or implemented prior to the use of the chemical restraint. Staff stated that they
did not have the time to implement other interventions. The resident’s record did not
indicate a medical symptom being treated, nor a reduction of the medication when the
resident’s functional status declined.

Examples of Severity Level 2 Noncompliance No Actual Harm with Potential for More
Than Minimal Harm that is Not Immediate Jeopardy include, but are not limited to:

• The facility failed to assure that an antianxiety medication was being administered to
treat a medical symptom and not for the convenience of staff. Although the resident has
not experienced falls or other adverse consequences in relation to the administration of
the medication, the potential exists for more than minimal harm with the continued use of
the anti-anxiety medication in the absence of a medical symptom. Interviews and record
review revealed that the facility was giving a resident anti-anxiety medication prior to the
resident taking showers occasionally on weekends. Staff indicated that the resident had
occasionally declined showers not because she was anxious, but because she found bed
baths to be more relaxing than the shower environment. The staff interviewed stated that
the nurse aides, who worked the daytime weekend shift, were upset about the resident
refusing the shower as they did not have time to come back and shower the resident at
another time not realizing that this was not the resident’s preference. The weekend nurse
contacted the physician for a medication to alleviate the resident’s “anxiety to taking a
shower.” A nursing assistant who was assigned to provide the resident’s care during the
week, stated that sometimes the resident does not want to take a shower and on those
occasions, she would give the resident a bed bath. The nursing assistant said the resident
is not resistive or combative.

Severity Level 1: No Actual Harm with Potential for Minimal Harm

The failure of the facility to assure residents are free from chemical restraints is more than
minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement.

F606
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.12(a) The facility must—
§483.12(a)(3) Not employ or otherwise engage individuals who—

(i) Have been found guilty of abuse, neglect, exploitation, misappropriation of property,
or mistreatment by a court of law;

(ii) Have had a finding entered into the State nurse aide registry concerning abuse,
neglect, exploitation, mistreatment of residents or misappropriation of their
property; or

(iii) Have a disciplinary action in effect against his or her professional license by a state
licensure body as a result of a finding of abuse, neglect, exploitation, mistreatment
of residents or misappropriation of resident property.

§483.12(a) (4) Report to the State nurse aide registry or licensing authorities any
knowledge it has of actions by a court of law against an employee, which would indicate
unfitness for service as a nurse aide or other facility staff.

INTENT

The facility must not hire an employee or engage an individual who was found guilty of abuse,
neglect, exploitation, or mistreatment or misappropriation of property by a court of law; or who
has a finding in the State nurse aide registry concerning abuse, neglect, exploitation,
mistreatment of residents or misappropriation of resident property, or has a disciplinary action in
effect taken against his/her professional license. The facility must report knowledge of actions by
a court of law against an employee that indicates the employee is unfit for duty.

DEFINITIONS

“Found guilty … by a court of law” applies to situations where the defendant pleads guilty, is
found guilty, or pleads no contest to charges of abuse, neglect, exploitation, misappropriation of
property, or mistreatment.

“Finding” is defined as a determination made by the State that validates allegations of abuse,
neglect, exploitation, mistreatment of residents, or misappropriation of their property.

“Mistreatment,” as defined at §483.5, means “inappropriate treatment or exploitation of a
resident.”

GUIDANCE

Employment

Facilities must be thorough in their investigations of the histories of prospective staff. In
addition to inquiry of the State nurse aide registry or licensing authorities, the facility should
check information from previous and/or current employers and make reasonable efforts to
uncover information about any past criminal prosecutions. It has been reported that former
nurse aides with a finding of abuse, neglect, misappropriation of resident property, exploitation,
or mistreatment may seek employment in other departments of a facility, such as maintenance or
laundry services/department, or at another nursing home in a non-nursing capacity.

Some States may have additional requirements for criminal background checks and State law
may prohibit persons convicted of certain crimes from working in a long-term care facility. The
State Survey Agency may use its own authority for assuring facility compliance such as the use
of the National Background Check Program or specific State licensure requirements that may
address criminal background checks. In addition, some facilities may have more stringent hiring
restrictions than what is required by State or Federal law.

If a facility has not developed and/or implemented policies and procedures related to screening
procedures prior to employment, a finding of noncompliance should be considered at F607, not
F606. If it is determined that the facility employed or engaged an individual, either directly or
under contract, who was found guilty by a court of law of abuse, neglect, misappropriation of
property, exploitation or mistreatment, or had a finding entered into the State nurse aide registry
or has a disciplinary action in effect against his/her professional license concerning abuse,
neglect, mistreatment of residents or misappropriation of resident property, a finding of
noncompliance is cited at F606.

Reporting to the State Nurse Aide Registry or Licensing Authorities

A nurse aide found guilty of neglect, abuse, mistreatment, misappropriation of property, or
exploitation by a court of law, must have his/her name entered into the State nurse aide registry
[See 483.12(a)(4)]. A licensed staff member found guilty of the above must be reported to
his/her licensing board. Further, if a facility determines that actions by a court of law against an
employee are such that they indicate that the individual is unsuited to work in a nursing home,
then the facility must report that individual to the State nurse aide registry (if a nurse aide) or to
the State licensing authorities (if a licensed staff member). Examples of convictions that may
indicate unfitness to work in a nursing home include, but are not limited to, child abuse, sexual
assault, theft, and assault with a deadly weapon.

NOTE: In addition, according to 42 CFR 483.156(c)(1)(iv)(A) to (c)(1)(iv)(D), Registry of
Nurse Aides, the State must include the following information on any finding of abuse, neglect,
or misappropriation of property by the individual:

• Documentation of the State’s investigation, including the nature of the allegation and the
evidence that led the State to conclude that the allegation was valid;

• The date of the hearing, if the individual chose to have one, and its outcome; and
• A statement by the individual disputing the allegation, if he or she chooses to make one.

This information must be included in the registry within 10 working days of the finding and must
remain in the registry permanently, unless the finding was made in error, the individual was
found not guilty in a court of law, or the State is notified of the individual’s death.

Refer to the CE Pathways for Abuse (Form CMS-20059) and Neglect (Form CMS-20130)
and the Investigative Protocols for tags F602 and F603.

KEY ELEMENTS OF NONCOMPLIANCE
To cite deficient practice at F606, the surveyor’s investigation will generally show that the
facility did any one or more of the following:

• Hire or engage an individual who, unless the individual in question has appealed their
disqualification from employment in a nursing home and that appeal has been successful
under State or federal law:

o Has been found guilty of abuse, neglect, exploitation, misappropriation of property,
or mistreatment by a court of law; or

o Has had a finding entered into the State nurse aide registry concerning abuse, neglect,
exploitation, mistreatment of residents, or misappropriation of their property; or

o Has had a disciplinary action in effect against his/her professional license by a state
professional licensure body as a result of a finding of abuse, neglect, exploitation,
mistreatment of residents, or misappropriation of resident property; or

• Failed to report to the State nurse aide registry or licensing authorities any knowledge of
actions taken by a court of law that would indicate unfitness as a staff member of a
nursing home.

F607
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.12(b) The facility must develop and implement written policies and procedures that:

§483.12(b)(1) Prohibit and prevent abuse, neglect, and exploitation of residents and
misappropriation of resident property,

§483.12(b)(2) Establish policies and procedures to investigate any such allegations, and

§483.12(b)(3) Include training as required at paragraph §483.95,

§483.12(b)(4) Establish coordination with the QAPI program required under §483.75.

§483.12(b)(5) Ensure reporting of crimes occurring in federally-funded long-term care
facilities in accordance with section 1150B of the Act. The policies and procedures must
include but are not limited to the following elements.

§483.12(b)(5)(ii) Posting a conspicuous notice of employee rights, as defined at section
1150B(d)(3) of the Act.

§483.12(b)(5)(iii) Prohibiting and preventing retaliation, as defined at section 1150B(d)(1)
and (2) of the Act.

INTENT

This regulation was written to provide protections for the health, welfare and rights of each
resident residing in the facility. In order to provide these protections, the facility must develop
written policies and procedures to prohibit and prevent abuse, neglect, exploitation of residents,
and misappropriation of resident property. These written policies must include, but are not
limited to, the following components:

• Screening [See §§483.12(a)(3) and 483.12(b)(1)];
• Training [See §483.12(b)(3)];

• Prevention [See §483.12(b)(1)];
• Identification [See §483.12(b)(2)];
• Investigation [See §483.12(b)(2)];
• Protection [See §§483.12(b)(2) and 483.12(c)(3)]; and
• Reporting/response [See §§483.12(b)(2), 483.12(b)(4), 483.12(b)(5), 483.12(c)(1) and

(4)].

In order to ensure that the facility is doing all that is within its control to prevent such
occurrences, these policies must be implemented (i.e., carried out), otherwise, the policies and
procedures would not be effective. The facility is expected to provide oversight and monitoring
to ensure that its staff, who are agents of the facility, implement these policies during the
provision of care and services to each resident residing in the facility. A facility cannot disown
the acts of its staff, since the facility relies on them to meet the Medicare and Medicaid
requirements for participation by providing care in a safe environment.

DEFINITIONS
“Covered individual” is anyone who is an owner, operator, employee, manager, agent or
contractor of the facility (see section 1150B(a)(3) of the Act).

“Crime”: Section 1150B(b)(1) of the Act provides that a “crime” is defined by law of the
applicable political subdivision where the facility is located. A political subdivision would be a
city, county, township or village, or any local unit of government created by or pursuant to State
law.

“Law enforcement,” as defined in section 2011(13) of the Act, is the full range of potential
responders to elder abuse, neglect, and exploitation including: police, sheriffs, detectives, public
safety officers; corrections personnel; prosecutors; medical examiners; investigators; and
coroners.

“Serious bodily injury” means an injury involving extreme physical pain; involving substantial
risk of death; involving protracted loss or impairment of the function of a bodily member, organ,
or mental faculty; requiring medical intervention such as surgery, hospitalization, or physical
rehabilitation; or an injury resulting from criminal sexual abuse (see sections 2011(19)(A) and
(B) of the Act).

resident by force or incapacitation or through threats of harm to the resident or others or any
sexual act involving a child. Serious bodily injury also includes sexual intercourse with a
resident who is incapable of declining to participate in the sexual act or lacks the ability to
understand the nature of the sexual act.

GUIDANCE

The facility must develop and implement policies and procedures that include the following
seven components:

I. Screening:

The facility must have written procedures for screening potential employees for a history of
abuse, neglect, exploitation, or misappropriation of resident property in order to prohibit abuse,
neglect, and exploitation of resident property, and consistent with the applicable requirements at
§483.12(a)(3). This includes attempting to obtain information from previous employers and/or
current employers, and checking with the appropriate licensing boards and registries. See F729
for requirements related to registry verification and multi-State registry verification.

Additionally, a facility’s services may be furnished under arrangement, with a registry,
contracted, or temporary agency staff, or students from affiliated academic institutions. The
facility’s policies must also address how pre-screening occurs for prospective consultants,
contractors, volunteers, caregivers and students in its nurse aide training program and students
from affiliated academic institutions, including therapy, social, and activity programs. The
facility should require these individuals be subject to the same scrutiny prior to placement in the
facility, whether screened by the facility itself, the third-party agency, or academic institution.
The facility should maintain documentation of the screening that has occurred.
The facility must have written procedures for screening that may include, but are not limited to:

• For prospective employees, reviewing:

o The employment history (e.g., dates of employment position or title), particularly

where there is a pattern of inconsistency;
o Information from former employers, whether favorable or unfavorable; and/or
o Documentation of status and any disciplinary actions from licensing or registration

boards and other registries.

NOTE: If a facility has not developed and/or implemented policies and procedures related to
screening procedures prior to employment, a finding of noncompliance should be considered at
F607, not F606. If it is determined that the facility employed or engaged an individual, either
directly or under contract, who was found guilty by a court of law of abuse, neglect,
misappropriation of property, exploitation or mistreatment, or had a finding entered into the State
nurse aide registry or has a disciplinary action in effect against his/her professional license
concerning abuse, neglect, mistreatment of residents or misappropriation of resident property, a
finding of noncompliance must be cited at F606.

In addition, a facility must develop and implement policies and procedures to prohibit and prevent
both abuse and neglect. This would include screening prospective residents to determine whether
the facility has the capability and capacity to provide the necessary care and services for each
resident admitted to the facility. The facility’s written procedures may include, but are not limited
to:

• For prospective residents, reviewing:
o An assessment of the individual’s functional and mood/behavioral status;
o Medical acuity; and
o Special needs (e.g., mechanical ventilation care, dialysis, hospice).

The facility can then determine whether – in consideration of current staffing patterns, staff
qualifications, competency and knowledge, clinical resources, physical environment, and
equipment- it can safely and competently provide the necessary care to meet the resident’s needs.
For example, a resident may have a prior history of distressed behaviors such as unsafe
wandering, physically aggressive behaviors including sexually aggressive behaviors, or
mental/psychiatric illnesses. In order to provide protections and a safe environment for the
resident and other residents, the facility must determine whether it has sufficient competent and
qualified staff in order to meet the needs of the resident. If the individual is admitted, pre-
admission screening information may provide information that may be used as part of the initial
assessment and care planning data.

II. Training:

The facility must have written policies and procedures that include training new and existing
nursing home staff and in-service training for nurse aides in the following topics which include:

• Prohibiting and preventing all forms of abuse, neglect, misappropriation of resident
property, and exploitation;

• Identifying what constitutes abuse, neglect, exploitation, and misappropriation of resident
property;

• Recognizing signs of abuse, neglect, exploitation and misappropriation of resident
property, such as physical or psychosocial indicators;

• Reporting abuse, neglect, exploitation, and misappropriation of resident property,
including injuries of unknown sources, and to whom and when staff and others must
report their knowledge related to any alleged violation without fear of reprisal; and •
Understanding behavioral symptoms of residents that may increase the risk of abuse and
neglect and how to respond. These symptoms, include, but are not limited to, the
following:

o Aggressive and/or catastrophic reactions of residents;
o Wandering or elopement-type behaviors;
o Resistance to care;
o Outbursts or yelling out; and
o Difficulty in adjusting to new routines or staff.

NOTE: The provision of training on abuse prohibition alone does not relieve the nursing home
of its responsibility to assure that the resident is free from abuse. Ongoing oversight and
supervision of staff assures that its policies and procedures are implemented as written.

NOTE: Federal regulations at 42 CFR §483.95(c) and §483.95(g) specify that a facility must
develop, implement, and maintain a training program that includes staff training related to abuse,
neglect, and exploitation. If the facility fails to develop and implement policies and procedures
that include training as required at 42 CFR §483.95(c) and (g)(2), then F607 would be cited.
Refer to tag F943 if there are concerns related to the development, implementation and
maintenance of an effective training program for all new and existing staff, which includes
training on activities that constitute abuse, neglect, exploitation, and misappropriation of resident
property; procedures for reporting incidents; and dementia management. Refer to tag F947 for
concerns related to the provision of in-service training, which must include dementia
management training and resident abuse prevention training.

III. Prevention:

The facility must have and implement written policies and procedures to prevent and prohibit all
types of abuse, neglect, misappropriation of resident property, and exploitation that achieves (but
is not limited to):

• Establishing a safe environment that supports, to the extent possible, a resident’s
consensual sexual relationship and by establishing policies and protocols for preventing
sexual abuse, such as the identify when, how, and by whom determinations of capacity to
consent to a sexual contact will be made and where this documentation will be recorded;
and the resident’s right to establish a relationship with another individual, which may
include the development of or the presence of an ongoing sexually intimate relationship;

• Identifying, correcting and intervening in situations in which abuse, neglect, exploitation,
and/or misappropriation of resident property is more likely to occur. This includes the
implementation of policies that address the deployment of trained and qualified,
registered, licensed, and certified staff on each shift in sufficient numbers to meet the
needs of the residents, and assure that the staff assigned have knowledge of the individual
residents’ care needs and behavioral symptoms, if any (see also F727 related to
proficiency of nurse aides);

• Assuring that residents are free from neglect by having the structures and processes to

provide needed care and services to all residents, which includes, but is not limited to, the
provision of a facility assessment to determine what resources are necessary to care for its
residents competently;

• The identification, ongoing assessment, care planning for appropriate interventions, and
monitoring of residents with needs and behaviors which might lead to conflict or neglect,
such as:

o Verbally aggressive behavior, such as screaming, cursing, bossing around/demanding,

insulting to race or ethnic group, intimidating;

o Physically aggressive behavior, such as hitting, kicking, grabbing, scratching,
pushing/shoving, biting, spitting, threatening gestures, throwing objects;

o Sexually aggressive behavior such as saying sexual things, inappropriate
touching/grabbing;

o Taking, touching, or rummaging through other’s property;
o Wandering into other’s rooms/space;
o Residents with a history of self-injurious behaviors;
o Residents with communication disorders or who speak a different language; and
o Residents that require extensive nursing care and/or are totally dependent on staff for

the provision of care.

• Ensuring the health and safety of each resident with regard to visitors such as family
members or resident representatives, friends, or other individuals subject to the resident’s
right to deny or withdraw consent at any time and to reasonable clinical and safety
restrictions;

• Providing residents and representatives, information on how and to whom they may

report concerns, incidents and grievances without the fear of retribution; and providing
feedback regarding the concerns that have been expressed. (See F585 for further
information regarding grievances).

The facility may also develop and implement policies and procedures, which achieve the
following:

• Identifying, correcting and intervening in situations in which abuse, neglect, exploitation,
and/or misappropriation of resident property is more likely to occur. This includes an
analysis of and implementation of policies that address at a minimum:
o Features of the physical environment that may make abuse, neglect, exploitation, and

misappropriation of resident property more likely to occur, such as secluded areas of
the facility; and

o The identification of who is responsible for the supervision of staff on all shifts and

how supervision will occur in order to identify inappropriate staff behaviors, such as
using derogatory language, rough handling, ignoring residents while giving care, and
directing residents who need assistance with the bathroom to urinate or defecate in
their beds.

• Providing staff information on how and to whom they may report concerns, such as

insufficient staffing or a shortage in supplies, without the fear of retribution; and
providing feedback regarding the concerns that have been expressed.

IV. Identification:

The facility must have written procedures to assist staff in identifying abuse, neglect, and
exploitation of residents, and misappropriation of resident property. This would include

identifying the different types of abuse- mental/verbal abuse, sexual abuse, physical abuse, and
the deprivation by an individual of goods and services.

Because some cases of abuse are not directly observed, understanding resident outcomes of
abuse could assist in identifying whether abuse is occurring or has occurred. Possible indicators
of abuse include, but are not limited to:

• An injury that is suspicious because the source of the injury is not observed or the extent
or location of the injury is unusual, or because of the number of injuries either at a single
point in time or over time; and

• Sudden or unexplained changes in the following behaviors and/or activities such as fear
of a person or place, or feelings of guilt or shame.

V. Investigation:

The facility must have written procedures for investigating abuse, neglect, misappropriation, and
exploitation that include:

NOTE: See also Section VI regarding protection of the alleged victim.

• Identifying staff responsible for the investigation;
• Exercising caution in handling evidence that could be used in a criminal investigation

(e.g., not tampering or destroying evidence);
• Investigating different types of alleged violations;
• Identifying and interviewing all involved persons, including the alleged victim, alleged

perpetrator, witnesses, and others who might have knowledge of the allegations;
• Focusing the investigation on determining if abuse, neglect, exploitation, and/or

mistreatment has occurred, the extent, and cause; and
• Providing complete and thorough documentation of the investigation.

VI. Protection:

The facility must have written procedures that ensure that all residents are protected from
physical and psychosocial harm during and after the investigation. This must include:

• Responding immediately to protect the alleged victim and integrity of the investigation;
• Examining the alleged victim for any sign of injury, including a physical examination or

psychosocial assessment if needed;
• Increased supervision of the alleged victim and residents;
• Room or staffing changes, if necessary, to protect the resident(s) from the alleged

perpetrator;
• Protection from retaliation; and
• Providing emotional support and counseling to the resident during and after the

investigation, as needed.

VII. Reporting/Response:

The facility must have written procedures that must include:

• Immediately reporting all alleged violations to the Administrator, state agency, adult
protective services and to all other required agencies (e.g., law enforcement when
applicable) within specified timeframes;

• Assuring that reporters are free from retaliation or reprisal;
• Post a conspicuous notice of employee rights, including the right to file a complaint with

the State Survey Agency if they believe the facility has retaliated against an employee or
individual who reported a suspected crime and how to file such a complaint;

• Reporting to the State nurse aide registry or licensing authorities any knowledge it has of
any actions by a court of law which would indicate an employee is unfit for service;

• Taking all necessary actions as a result of the investigation, which may include, but are
not limited to, the following:
o Analyzing the occurrence(s) to determine why abuse, neglect, misappropriation of

resident property or exploitation occurred, and what changes are needed to prevent
further occurrences;

o Defining how care provision will be changed and/or improved to protect residents
receiving services;

o Training of staff on changes made and demonstration of staff competency after
training is implemented;

o Identification of staff responsible for implementation of corrective actions;
o The expected date for implementation; and
o Identification of staff responsible for monitoring the implementation of the plan.

To encourage reporting of reasonable suspicions of a crime, facilities should develop and
implement policies and procedures that promote a culture of safety and open communication in
the work environment. This may be accomplished through prohibiting retaliation against an
employee who reports a suspicion of a crime. Actions that constitute retaliation against staff
include:

• When a facility discharges, demotes, suspends, threatens, harasses, or denies a promotion
or other employment-related benefit to an employee, or in any other manner
discriminates against an employee in the terms and conditions of employment because of
lawful acts done by the employee.

• When a facility files a complaint or a report against a nurse or other employee with the
state professional licensing agency because of lawful acts done by the nurse or employee
for reporting a reasonable suspicion of a crime to law enforcement.

An example of retaliation would be if a staff member, on behalf of or as an agent of the facility,
harasses an employee who had reported a reasonable suspicion of a crime.
In addition to developing policies prohibiting retaliation for reporting suspicions of a crime, the
facility must develop and implement policies and procedures for posting notice in a conspicuous
location informing covered individuals of their rights under section 1150B of the Act, including
the right to file a complaint with the State Survey Agency if they believe the facility has
retaliated against an employee or individual who reported a suspected crime and how to file such
a complaint.

The sign may be posted in an area that is visible to employees, such as the same area where the
facility posts other employee signs, such as labor management posters. Size and type
requirements for the sign should be no less than the minimum required for any other required
employment-related signs.

VIII. Coordination with QAPI:

The facility must develop written policies and procedures that define how staff will communicate
and coordinate situations of abuse, neglect, misappropriation of resident property, and
exploitation with the QAPI program under §483.75.

Cases of physical or sexual abuse, for example by facility staff or other residents, always require
corrective action and tracking by the QAA Committee, at §483.75(g)(2).

This coordinated effort would allow the QAA Committee to determine:

• If a thorough investigation is conducted;
• Whether the resident is protected;
• Whether an analysis was conducted as to why the situation occurred;
• Risk factors that contributed to the abuse (e.g., history of aggressive behaviors,

environmental factors); and
• Whether there is further need for systemic action such as:

o Insight on needed revisions to the policies and procedures that prohibit and prevent

abuse/neglect/misappropriation/exploitation,
o Increased training on specific components of identifying and reporting that staff may

not be aware of or are confused about,
o Efforts to educate residents and their families about how to report any alleged

violations without fear of repercussions,
o Measures to verify the implementation of corrective actions and timeframes, and
o Tracking patterns of similar occurrences.

NOTE: For failures related to the development and implementation of policies and procedures to
communicate and coordinate with the QAPI program situations of abuse, neglect,
misappropriation of resident property, and exploitation, cite tag F607. For failures related to the
QAA Committee’s identification of quality deficiencies or its development and implementation
of action plans to correct identified quality deficiencies, cite tag F867.

Refer also to the CE Pathways for Abuse (Form CMS-20059) and Neglect (Form CMS-
20130) and the Investigative Protocols for tags F602 and F603.

INVESTIGATIVE PROTOCOL

FOR POLICIES AND PROCEDURES RELATED TO ALLEGATIONS OF RETALIATION
BY THE FACILITY AGAINST A COVERED INDIVIDUAL

USE

Use this protocol during any survey, if, based on a complaint or an investigation of abuse,
neglect, misappropriation of resident property, or exploitation, an allegation of retaliation by the
facility against a covered individual was received. Refer to the CE Pathways for Abuse (Form
CMS-20059) and Neglect (Form CMS-20130) and the Investigative Protocols for tags F602, and
F603, which gathers information about what information was or was not reported by covered
individuals and whether retaliation may have occurred.
The protocol below investigates whether the facility developed and implemented policies and
procedures related to:

• Posting notification of employee rights, and
• Prohibiting and preventing retaliation.

PROCEDURES

Facility Policies and Procedures
Obtain and review the facility’s policies and procedures to determine whether the facility is:

• Posting notification of employee rights, and
• Prohibiting and preventing retaliation against covered individuals who make reports of a

reasonable suspicion of a crime.

Observations

Observe whether the facility has posted notification of employee rights and whether the
notification includes all of the required components. Note the location of the notification, in
relation to whether it is likely to be noticed by all employees.

Interview of State Professional Licensing Authorities

If there is an allegation of facility retaliation against an employee, the surveyor should contact
the appropriate State licensing board to determine whether the facility had filed a complaint or
report against the employee, and if so, what information was provided in the complaint or report.

Interview Staff

For an allegation of retaliation, interview staff about what occurred, how the facility allegedly
retaliated against staff, and when.

Interview – Administrator

Interview the Administrator to determine the following:

• How the Administrator oversees the implementation of policies and procedures for
reporting of suspected crimes;

• For an allegation of retaliation:
o Whether any actions were taken against an employee, and if so, what actions and

why;
o Whether the facility had submitted a report to the State professional licensing agency

against the employee(s), and if so, why.

Review of Employee Personnel Records

If there is an allegation of retaliation against an employee or other covered individual, obtain a
copy of the employee’s personnel records, and records for other covered individuals as
applicable, to determine if the facility may have taken any action against the individual which
may be related to the report of a suspected crime.

NOTE: If the surveyor discovers a reasonable suspicion of a crime committed against a resident
of or an individual receiving services from the facility and it has not been reported by a covered
individual, the surveyor reminds the facility of the covered individuals’ obligation to report
suspected crimes pursuant to section 1150B of the Act within the required timeframes. “Covered
individual” is anyone who is an owner, operator, employee, manager, agent or contractor of the
facility as defined in section 1150B(a)(3) of the Act. If a covered individual reports the
suspected crime to local law enforcement, the surveyor must verify that the report was made
(e.g., obtain time/date of report, name of person who received report, case number, etc.). If the
covered individual refuses to report, or the surveyor cannot verify that a report was done, the
surveyor must consult with his/her supervisor immediately, and the State Agency must report the
potential criminal incident to law enforcement immediately.

KEY ELEMENTS OF NONCOMPLIANCE

To cite deficient practice at F607, the surveyor’s investigation will generally show that the
facility has failed to do one or more of the following:

• Develop and implement written policies and procedures that prohibit and prevent abuse,
neglect and exploitation of residents and misappropriation of resident property and
includes the screening of prospective employees and residents; or

• Develop and implement written policies and procedures for the investigation of
allegations of abuse, neglect and exploitation of residents and misappropriation of
resident property and includes the staff identification of abuse, neglect, exploitation, and
misappropriation of resident property, protection of residents during investigations, and
the reporting of allegations and investigative findings and taking corrective actions; or

• Develop and implement written policies and procedures that include training as required
at §483.95; or

• Develop and implement written policies and procedures that establish coordination with
the QAPI program required under §483.75; or

• Develop and implement written policies and procedures related to posting conspicuous
signage of employee rights related to retaliation against the employee for reporting a
suspected crime; and prohibiting and preventing retaliation.

F609
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.12(b) The facility must develop and implement written policies and procedures that:

(i) Annually notifying covered individuals, as defined at section 1150B(a)(3) of the
Act, of that individual’s obligation to comply with the following reporting
requirements.

(A) Each covered individual shall report to the State Agency and one or more law
enforcement entities for the political subdivision in which the facility is located
any reasonable suspicion of a crime against any individual who is a resident of,
or is receiving care from, the facility.

(B) Each covered individual shall report immediately, but not later than 2 hours
after forming the suspicion, if the events that cause the suspicion result in serious
bodily injury, or not later than 24 hours if the events that cause the suspicion do
not result in serious bodily injury.

§483.12(c) In response to allegations of abuse, neglect, exploitation, or mistreatment, the
facility must:

§483.12(c)(1) Ensure that all alleged violations involving abuse, neglect, exploitation or
mistreatment, including injuries of unknown source and misappropriation of resident
property, are reported immediately, but not later than 2 hours after the allegation is made,
if the events that cause the allegation involve abuse or result in serious bodily injury, or not
later than 24 hours if the events that cause the allegation do not involve abuse and do not
result in serious bodily injury, to the administrator of the facility and to other officials
(including to the State Survey Agency and adult protective services where state law
provides for jurisdiction in long-term care facilities) in accordance with State law through
established procedures.

§483.12(c)(4) Report the results of all investigations to the administrator or his or her
designated representative and to other officials in accordance with State law, including to
the State Survey Agency, within 5 working days of the incident, and if the alleged violation
is verified appropriate corrective action must be taken.

INTENT
The intent is for the facility to develop and implement policies and procedures that:

• Provide annual notification to each covered individual of their obligation to comply with

the reporting requirements under section 1150B(b) of the Act;
• Ensure reporting reasonable suspicion of crimes against a resident or individual receiving

care from the facility within prescribed timeframes to the appropriate entities, consistent
with Section 1150B of the Act; and

• Ensure that all covered individuals, i.e., the owner, operator, employee, manager, agent or
contractor, report reasonable suspicion of crimes, as required by Section 1150B of the
Act.

The facility should provide oversight and monitoring to ensure that implement the required
policies and procedures, per 42 CFR §483.12(b).

In addition, the facility must report alleged violations related to mistreatment, exploitation,
neglect, or abuse, including injuries of unknown source and misappropriation of resident
property and report the results of all investigations to the proper authorities within prescribed
timeframes.

DEFINITIONS

“Abuse,” is defined at §483.5 as “the willful infliction of injury, unreasonable confinement,
intimidation, or punishment with resulting physical harm, pain or mental anguish. Abuse also
includes the deprivation by an individual, including a caretaker, of goods or services that are
necessary to attain or maintain physical, mental, and psychosocial well-being. Instances of abuse
of all residents, irrespective of any mental or physical condition, cause physical harm, pain or
mental anguish. It includes verbal abuse, sexual abuse, physical abuse, and mental abuse
including abuse facilitated or enabled through the use of technology.”

“Alleged violation” is a situation or occurrence that is observed or reported by staff, resident,
relative, visitor, another health care provider, or others but has not yet been investigated and, if
verified, could be noncompliance with the Federal requirements related to mistreatment,
exploitation, neglect, or abuse, including injuries of unknown source, and misappropriation of
resident property.

“Covered individual” is anyone who is an owner, operator, employee, manager, agent or
contractor of the facility (see section 1150B(a)(3) of the Act).

“Exploitation,” as defined at §483.5, means “taking advantage of a resident for personal gain,
through the use of manipulation, intimidation, threats, or coercion.”

“Injuries of unknown source” – An injury should be classified as an “injury of unknown
source” when all of the following criteria are met:

• The source of the injury was not observed by any person; and
• The source of the injury could not be explained by the resident; and
• The injury is suspicious because of the extent of the injury or the location of the injury

(e.g., the injury is located in an area not generally vulnerable to trauma) or the number of
injuries observed at one particular point in time or the incidence of injuries over time.

“Mistreatment,” as defined at §483.5, is “inappropriate treatment or exploitation of a resident.”
“Neglect,” as defined at §483.5, means “the failure of the facility, its employees or service
providers to provide goods and services to a resident that are necessary to avoid physical harm,
pain, mental anguish or emotional distress.”

“Serious bodily injury” is defined in section 2011(19) of the Act and means an injury involving
extreme physical pain, substantial risk of death, protracted loss or impairment of the function of
a bodily member, organ, or mental faculty, or requiring medical intervention such as surgery,
hospitalization, or physical rehabilitation (see section 2011(19)(A) of the Act). Serious bodily
injury is considered to have occurred when an injury results from criminal sexual abuse (see
section 2011(19)(B) of the Act).

“Criminal sexual abuse”: In the case of “criminal sexual abuse” which is defined in section
2011(19)(B) of the Act, serious bodily injury/harm shall be considered to have occurred if the
conduct causing the injury is conduct described in section 2241 (relating to aggravated sexual
abuse) or section 2242 (relating to sexual abuse) of Title 18, United States Code, or any similar
offense under State law. In other words, serious bodily injury includes sexual intercourse with a
resident by force or incapacitation or through threats of harm to the resident or others or any
sexual act involving a child. Serious bodily injury also includes sexual intercourse with a
resident who is incapable of declining to participate in the sexual act or lacks the ability to
understand the nature of the sexual act.

“Sexual abuse,” is defined at §483.5 as “non-consensual sexual contact of any type with a
resident.”

“Willful,” is defined at §483.5 in the definition of “abuse,” and “means the individual must have
acted deliberately, not that the individual must have intended to inflict injury or harm.”

GUIDANCE REPORTING

It is the responsibility of the facility to ensure that all staff are aware of reporting requirements
and to support an environment in which covered individuals report a reasonable suspicion of a
crime, and staff and others report all alleged violations of mistreatment, exploitation, neglect, or
abuse, including injuries of unknown source, and misappropriation of resident property.
Protection of residents can be compromised or impeded if individuals are fearful of reporting,
especially if the alleged abuse has been carried out by a staff member [See §483.12(b)(5)(i)].
During investigations, some staff have stated that he/she was aware, or had knowledge, that the
incident had occurred, but did not report because he/she did not think it met the definition of
abuse, neglect, mistreatment, exploitation, or misappropriation of resident property or a
reasonable suspicion of a crime. Anecdotal reports have indicated that failure to report an
alleged violation may be due to, but not limited to, the following:

• An individual’s allegation is not believed due to a history of reporting false allegations;
• Staff fear of retaliation, or fear losing his/her job;
• Sympathy for co-workers, for example, not wanting to cause trouble for the co-worker;
• Communication, cultural, or language issues; or
• Residents/resident representatives may fear retaliation.

NOTE: Once an individual suspects that a crime has been committed, facility staff should
exercise caution when handling materials that may be used for evidence or for a criminal
investigation. Facilities should reference applicable State and local laws regarding preserving
evidence. It has been reported that some investigations were impeded due to washing linens or
clothing, destroying documentation, bathing or cleaning the resident before the resident has been
examined, or failure to transfer a resident to the emergency room for examination including
obtaining a rape kit, if appropriate.

The following table describes the different reporting requirements that are addressed under 42
CFR 483.12:

42 CFR 483.12(b)(5) and

Section 1150B of the Act
42 CFR 483.12(c)

What is to be
reported

Any reasonable suspicion of
a crime against a resident or
an individual receiving care
from the facility

1) All alleged violations of abuse, neglect,
exploitation or mistreatment, including
injuries of unknown source and
misappropriation of resident property

2) The results of all investigations of
alleged violations

Who is
required to
report

Any covered individual,
which means the owner,
operator, employee,
manager, agent or contractor
of the facility

The facility

To whom State Survey Agency (SA)
and one or more law

The facility administrator and to other
officials in accordance with State law,

42 CFR 483.12(b)(5) and
Section 1150B of the Act

42 CFR 483.12(c)

enforcement entities for the
political subdivision in which
the facility is located (i.e.,
the full range of potential
responders to elder abuse,
neglect, and exploitation
including police, sheriffs,
detectives, public safety
officers; corrections
personnel; prosecutors;
medical examiners;
investigators; and coroners)

including to the SA and the adult protective
services where state law provides for
jurisdiction in long-term care facilities

When Serious bodily injury-
Immediately but not later
than 2 hours* after forming
the suspicion

No serious bodily injury- not
later than 24 hours*

All alleged violations-
1) Immediately but not later than 2

hours*- if the alleged violation
involves abuse or results in serious
bodily injury

2) Not later than 24 hours*- if the
alleged violation involves neglect,
exploitation, mistreatment, or
misappropriation of resident
property; and does not result in
serious bodily injury

Results of all investigations of alleged
violations- within 5 working days of the
incident

* – Reporting requirements under this regulation are based on real (clock) time, not business
hours

ENSURING THE REPORTING OF A REASONABLE SUSPICION OF A CRIME

A facility’s policies and procedures for reporting under 42 CFR 483.12(b)(5) should specify the
following components, which include, but are not limited to:

• Identification of who in the facility is considered a covered individual;
• Identification of crimes that must be reported;

NOTE: Each State and local jurisdiction may vary in what is considered to be a crime
and may have different definitions for each type of crime. Facilities should consult with
local law enforcement to determine what is considered a crime.

• Identification of what constitutes “serious bodily injury;”
• The timeframe for which the reports must be made; and

• Which entities must be contacted, for example, the State Survey Agency and local law
enforcement.

There are instances where an alleged violation of abuse, neglect, misappropriation of resident
property and exploitation would be considered to be reasonable suspicion of a crime. In these
cases, the facility is obligated to report to the administrator, to the state survey agency, and to
other officials in accordance with State law (see F609). Regardless, covered individuals still
have the obligation to report the reasonable suspicion of a crime to the State Survey Agency and
local law enforcement.

Some facilities may have policies and procedures where the administrator could coordinate
timely reporting to the State Survey Agency and law enforcement on behalf of covered
individuals who choose to the report to the administrator. Risks to the covered individual for
reporting to the administrator could be mitigated if an individual has clear assurance that the
administrator is reporting it and submitting a collective report would not cause delays in
reporting according to specified timeframes. Reports should be documented and the
administrator should keep a record of the documentation. It remains the responsibility of each
covered individual to ensure that his/her individual reporting responsibility is fulfilled, so it is
advisable for any multiple-person report to include identification of all individuals making the
report. In addition, a facility cannot prohibit or circumscribe a covered individual from reporting
directly to law enforcement even if it has a coordinated internal system.

Surveyors must review whether the facility has included in its policies and procedures examples
of crimes that would be reported. Examples of situations that would likely be considered crimes
in all subdivisions would include but are not limited to:

• Murder;
• Manslaughter;
• Rape;
• Assault and battery;
• Sexual abuse;
• Theft/Robbery;
• Drug diversion for personal use or gain;
• Identity theft; and
• Fraud and forgery.

There are political subdivisions that have other examples for which instances of elder
mistreatment are considered to be crimes. Because all reasonable suspicions of crimes must be
reported, regardless of whether it is perpetrated by facility staff, residents, or visitors, it would be
especially beneficial for the facility to work with local law enforcement in determining what
would not be reported (e.g., all cases of resident to resident conflict may not rise to the level of
abuse and may not be appropriate to report to local law enforcement).

Even in the presence of a policy and procedure, failure to report a reasonable suspicion of a
crime may be indicative of failure to implement the facility’s policies and procedures. Surveyors
should investigate further and document the failure to develop and/or implement policies and

procedures for reporting suspected crimes (e.g., how the facility may not have provided
notification to its employees, how covered individuals are fearful of reporting or do not want to
get others in trouble, etc.). Facilities must ensure the reporting of a reasonable suspicion of a
crime by implementing proper policies and procedures addressing the following actions, which
should include, but are not limited to:

• Orienting new and temporary/agency/contractor staff to the reporting requirements;
• Assuring that covered individuals are annually notified of their responsibilities in a

language that they understand;
• Identifying barriers to reporting such as fear of retaliation or causing trouble for someone,

and implementing interventions to remove barriers and promote a culture of transparency
and reporting;

• Identifying which cases of abuse, neglect, and exploitation may rise to the level of a
reasonable suspicion of crime and recognizing the physical and psychosocial indicators
of abuse/neglect/exploitation;

• Working with law enforcement annually to determine which crimes are reported;
• Assuring that covered individuals can identify what is reportable as a reasonable

suspicion of a crime, with competency testing or knowledge checks;
• Providing in-service training when covered individuals indicate that they do not

understand their reporting responsibilities; and
• Providing periodic drills across all levels of staff across all shifts to assure that covered

individuals understand the reporting requirements.

Annual Notification of Reporting Obligations to Covered Individuals

The facility must develop and implement written procedures that include, but are not limited to,
notifying covered individuals annually of their obligations to report reasonable suspicion of
crimes in the facility [See §483.12(b)(5)(i)]. Policies and procedures should include, but are not
limited to, the following:

• Identification of who are the covered individuals in the facility;
• How covered individuals are notified of the reporting requirements. Notification must

include the following:

o Each covered individual’s independent obligation to report the suspicion of a crime
against a resident or individual receiving care and services from the facility directly to
local law enforcement and the State Survey Agency;

o The timeframe requirements for reporting reasonable suspicion of crimes:
 If the events that cause the reasonable suspicion result in serious bodily injury to a

resident, the covered individual must report the suspicion immediately, but not
later than 2 hours after forming the suspicion;

 If the events that cause the reasonable suspicion do not result in serious bodily
injury to a resident, the covered individual shall report the suspicion not later than
24 hours after forming the suspicion.

• Penalties associated with failure to report:

o If a covered individual fails to report within mandated timeframes, the covered
individual will be subject to a civil money penalty of not more than $200,000, as
adjusted annually under 45 CFR part 102; and the covered individual may be
excluded from participation in any Federal health care program (as defined in section
1128B(f) of the Act).

o If a covered individual fails to report within mandated timeframes and the violation
exacerbates the harm to the victim of the crime or results in harm to another
individual, the covered individual will be subject to a civil money penalty of not more
than $300,000, as adjusted annually under 45 CFR part 102; and the Secretary may
make a determination in the same proceeding to exclude the covered individual from
participation in any Federal health care program (as defined in section 1128B(f) of
the Act).

• The mechanism for documenting that all covered individuals have been notified annually
of their reporting obligations. Documentation may include a copy of a notice or letter sent
to covered individuals with confirmation that it was received or a completed
training/orientation attendance sheet documenting the individual completed training on
reporting obligations.

REPORTING ALLEGED VIOLATIONS

An alleged violation can be observed or reported by staff, resident, relative, visitor, another
health care provider, or others. For example, a receiving hospital may report to the facility
suspicious bruising of the resident near the inner thighs and groin area, which were identified
during a medical exam in the emergency department. An individual (e.g., a resident, visitor,
facility staff) who reports an alleged violation to facility staff does not have to explicitly
characterize the situation as “abuse,” “neglect,” “mistreatment,” or “exploitation” in order to
trigger the Federal requirements at §483.12(c). Rather, if facility staff could reasonably conclude
that the potential exists for noncompliance with the Federal requirements related to mistreatment,
exploitation, neglect, or abuse, including injuries of unknown source, and misappropriation of
resident property, then it would be considered to be reportable and require action under
§483.12(c). For example, if a resident is abused but does not allege abuse, the resident’s failure
or inability to provide information about the occurrence is immaterial when the abuse may be
substantiated by other supporting evidence. Another example is when a nurse aide witnesses an
act of abuse but fails to report the alleged violation; the failure to report does not support a
conclusion that the abuse did not occur and the facility would not meet the reporting
requirements.

All alleged violations, whether oral or in writing, must be reported to the administrator of the
facility and to other officials in accordance with State law through established procedures
(including to the State survey and certification agency and adult protective services where State
law provides for jurisdiction in long-term care facilities). Conformance with this provision
requires that each State Agency has a means to collect reports, even during off-duty hours (e.g.,
answering machine, voice mail, fax, electronic transmission, etc.). The facility must have
documentation of the report, including what was reported and the date and time the report was

made to the SA. The facility must submit reports that are accurate, to the best of its knowledge
at the time of submission of the report. It is important that facilities not make reports that are
misleading, such as reports that deliberately omit facts, or reports that are designed to make the
incident appear less serious than it was, or reports that misrepresent the facility’s response.
Deliberate misrepresentations or omissions could result in a deficiency at F609 or may give rise
to other deficiencies.

Initial Report- For alleged violations of abuse or if there is resulting serious bodily injury, the
facility must report the allegation immediately, but no later than 2 hours after the allegation is
made. For alleged violations of neglect, exploitation, misappropriation of resident property, or
mistreatment that do not result in serious bodily injury, the facility must report the allegation no
later than 24 hours. The facility must provide in its report sufficient information to describe the
alleged violation and indicate how residents are being protected [see §483.12(c)(3)]. It is
important that the facility provide as much information as possible, to the best of its knowledge
at the time of submission of the report, so that State agencies can initiate action necessary to
oversee the protection of nursing home residents. Please see Exhibit 358 for a sample form for
initial reporting, with examples of information.

Follow-up Investigation Report- Within 5 working days of the incident, the facility must
provide in its report sufficient information to describe the results of the investigation, and
indicate any corrective actions taken, if the allegation was verified. It is important that the
facility provide as much information as possible, to the best of its knowledge at the time of
submission of the report, so that State agencies can initiate action necessary to oversee the
protection of nursing home residents [see §483.12(c)(4)]. The facility should include any
updates to information provided in the initial report. Please see Exhibit 359 for a sample form
for investigation report, with examples of information.

In the absence of a shorter State time frame requirement, all alleged violations involving abuse or
resulting in serious bodily injury are reported immediately, but not later than 2 hours after the
allegation is made. If the alleged allegation involves neglect, misappropriation of resident
property, or exploitation and does not result in serious bodily injury, the facility must report not
later than 24 hours after the allegation is made. The facility is not prohibited from fulfilling its
reporting obligations earlier than the timeframes provided in the regulations, so that immediate
actions can be taken to protect the resident(s).

If an alleged violation has been identified and reported to the administrator/designee, the facility
must report it and provide protection for the identified resident(s) prior to conducting the
investigation of the alleged violation. In some situations, the facility may initially evaluate an
occurrence to determine whether it meets the definition of an “alleged violation.” For example,
upon discovery of an injury, the facility must take steps to evaluate whether the injury meets the
definition of an “injury of unknown source.” Similarly, if a resident states that his or her
belongings are stolen, the facility may make an initial determination whether the item has been
misplaced in the resident’s room, in the laundry, or elsewhere before reporting misappropriation
of property. However, if the alleged violation meets the definition of abuse, neglect, exploitation
or mistreatment, the facility should not make an initial determination whether the allegation is
credible before reporting the allegation.

https://www.cms.gov/medicare/provider-enrollment-and-certification/guidanceforlawsandregulations/nursing-homes

NOTE: At the conclusion of the investigation, and no later than 5 working days of the incident,
the facility must report the results of the investigation and if the alleged violation is verified, take
corrective action, in accordance with §483.12(c)(4).

The phrase “in accordance with State law” modifies the word “officials” only. State law may
stipulate that alleged violations and the results of the investigations be reported to additional
State officials beyond those specified in Federal regulations. This phrase does not modify what
types of alleged violations must be reported or the timeframes in which the reports are to be
made. States may not eliminate the obligation for any of the alleged violations (i.e.,
mistreatment, neglect, abuse, injuries of unknown source, exploitation, and misappropriation of
resident property) to be reported, nor can the State establish longer time frames for reporting than
mandated in the regulations at §§483.12(c)(1) and (4). No State can override the obligation of the
nursing home to fulfill the requirements under §483.12(c), as long as the Medicare/Medicaid
certification is in place.

Some States may have different reporting requirements that could go beyond the Federal
requirements or are more specific than the Federal requirements. For example, some States
require that all falls be reported to the SA. The SA should continue to manage and investigate
these cases under its state licensure authority. If the State determines that these occurrences do
meet the definition of abuse, neglect, mistreatment, or injuries of unknown source, as outlined in
this guidance, the SA must assess whether the nursing home has met the requirements for
reporting and investigating these cases in accordance with 42 C.F.R. §483.12(c).

If the surveyor discovers a reasonable suspicion of a crime committed against a resident of or an
individual receiving services from the facility and it has not been reported by a covered
individual, the surveyor reminds the facility of the covered individuals’ obligation to report
suspected crimes pursuant to section 1150B of the Act within the required timeframes. “Covered
individual” is anyone who is an owner, operator, employee, manager, agent or contractor of the
facility as defined in section 1150B(a)(3) of the Act. If a covered individual reports the
suspected crime to local law enforcement, the surveyor must verify that the report was made
(e.g., obtain time/date of report, name of person who received report, case number, etc.). If the
covered individual refuses to report, or the surveyor cannot verify that a report was done, the
surveyor must consult with his/her supervisor immediately, and the State Agency must report the
potential criminal incident to law enforcement immediately. (See F609)

IDENTIFICATION OF ALLEGED VIOLATIONS

The following addresses facility responsibilities for reporting allegations/occurrences involving
staff-to-resident abuse; resident-to-resident altercations; injuries of unknown source;
misappropriation of resident property/exploitation; and mistreatment. A report of an alleged
violation does not automatically indicate that a citation at F600, F602, or F603 is warranted; the
survey team must conduct a thorough investigation of the allegation. If the collected evidence
supports that abuse, neglect, or misappropriation of resident property/exploitation has occurred,
it is appropriate for the survey team to cite the current or past noncompliance at the appropriate
tag (e.g., F600-Free from Abuse and Neglect).

Section I. Staff to Resident Abuse

All allegations/occurrences of all types of staff-to-resident abuse must be reported to the
administrator and to other officials, including the State Survey Agency and adult
protective services, where state law provides for jurisdiction in nursing homes [see §
483.12(c)].
This includes, but is not limited to:

• All allegations/occurrences of physical, sexual, mental, and verbal abuse, including
deprivation of goods and services by staff, and involuntary seclusion perpetrated by staff
(See F600 and F603 for examples of types of abuse);

• Staff taking or distributing demeaning or humiliating photographs or recordings of
residents through social media or multimedia messaging; and

• All reports from residents of abuse perpetrated by staff; allegations must not be dismissed
on the basis of a resident’s cognitive impairment(s).

Section II. Resident to Resident Altercations

Resident-to-resident altercations that must be reported in accordance with the regulations include
any willful action that results in physical injury, mental anguish, or pain, as defined at §483.5.
The tables below includes examples of resident to resident altercations and whether they are
required to be reported.

NOTE: This is not an exhaustive list of all reportable types of resident to resident altercations.
There may be other incidents that are also reportable.

Examples of Mental/Verbal Conflict
Required to Report Not Required to Report

(Unless it rises to the level of
what’s described in the first
column)

• Intimidation
• Bullying- Aggressive behavior in which someone

intentionally* and repeatedly causes another resident
mental anguish or discomfort** (adapted from the
American Psychological Association 2

• Communication that is motivated by an actual or
perceived characteristic, such as race, color, religion,
sex, disability, or sexual orientation that results in
mental anguish or social withdrawal**

• Threats of violence
• Inappropriate sexual comments that are used in a

deliberately* threatening manner

• Non-targeted outbursts
• Residents with certain

conditions (e.g.,
Huntington’s/Tourette’s)
who exhibit verbalizations

• Arguments or disagreements,
which do not include any
behavior or communication
identified in the “Required to
Report” column

Required to Report Not Required to Report
(Unless it rises to the level of
what’s described in the first
column)

• Inappropriate sexual comments that offend, humiliate,
or demean a resident**;

• Taking and/or distributing demeaning or humiliating
photographs or recordings of residents through social
media or multimedia messaging

NOTE:

* Having a mental disorder or cognitive impairment does not automatically preclude a resident
from engaging in deliberate or non-accidental actions.

** There may be some situations in which the psychosocial outcome to the resident may be
difficult to determine or incongruent with what would be expected. In these situations, it is
appropriate to consider how a reasonable person in the resident’s circumstances would be
impacted by the incident.

Examples of Sexual Contact

NOTE: See also guidance at F600 related to Sexual Abuse and Capacity and Consent.
Required to Report Not Required to Report

(Unless it rises to the level of what’s
described in the first column)

• Unwanted touching of the breasts or
perineal area

• A resident who fondles or touches a
person’s sexual organs and the resident
being touched indicates the touching is
unwanted through verbal or non-verbal cues

• Sexual activities where one resident
indicates that the activity is unwanted
through verbal or non-verbal cues

• Sexual activity or fondling where one of the
resident’s capacity to consent to sexual
activity is unknown

• Sexual assault or battery (ex. rape, sodomy,
coerced nudity)

• Instances where the alleged victim is
transferred to a hospital for examination
and/or treatment of injuries resulting from
possible sexual abuse

• Consensual sexual contact between
residents who have the capacity to
consent to sexual activity

• Affectionate contact such as hand
holding or hugging or kissing a resident
who indicates that he/she consents to the
action through verbal or non-verbal cues

• Sexual activity between residents in a
relationship, married couples or
partners, unless one of the residents
indicates that the activity is unwanted
through verbal or non-verbal cues.

Required to Report Not Required to Report
(Unless it rises to the level of what’s
described in the first column)

• Forced observation of masturbation, or
pornography

• Forced, coerced or extorted sexual activity
• Other unwanted actions for the purpose of

sexual arousal or sexual gratification
resulting in degradation or humiliation of
another resident

Examples of Physical Altercations
Resident-to-resident physical altercations that must be reported include, any willful action that
results in physical injury, mental anguish, or pain. Examples include, but are not limited to, the
following:

NOTE:

* Having a mental disorder or cognitive impairment does not automatically preclude a resident
from engaging in deliberate or non-accidental actions.

WILLFUL
ACTION*
Willful actions
include, but are
not limited to,
the following:
• Hitting
• Slapping
• Punching
• Choking
• Pinching
• Biting
• Kicking
• Throwing

objects
• Grabbing
• Shoving

*The action
itself was
deliberate or
non-accidental,
not that the
individual
intended to
inflict injury or
harm

PHYSICAL INJURY
A physical injury resulting from the willful action including,
but not limited to, the following:
• Death
• Injury requiring medical attention beyond first aid (such

as a cut requiring suturing or an injury requiring transfer
to a hospital for examination and/or treatment)

• Fracture(s), subdural hematoma, concussion
• Bruises
• Facial injury(ies), such as broken or missing teeth, facial

fractures, black eye(s), bruising, bleeding or swelling of
the mouth or cheeks

MENTAL ANGUISH*
Psychosocial outcomes resulting from the willful action
including, but not limited to, the following:
• Fear of a person or place or of being left alone or of being

in the dark, disturbed sleep, nightmares
• Changes in behavior, including aggressive or disruptive

behavior toward a specific person
• Running away, withdrawal, isolating self, feelings of guilt

and shame, depression, crying, talk of suicide or attempts

* There may be some situations in which the psychosocial
outcome to the resident may be difficult to determine or
incongruent with what would be expected. In these
situations, it is appropriate to consider how a reasonable
person in the resident’s circumstances would be impacted by
the incident.

PAIN
Pain resulting from the willful action including, but not
limited to, the following:
• Complaints of pain related to the altercation
• Onset of pain evidenced by nonverbal indicators, such as

o Groaning, crying, screaming
o Grimacing, clenching of the jaw
o Resistance to being touched
o Rubbing/guarding body part

The general examples of physical altercations below illustrate possible cases that would likely
NOT need to be reported, as long as it is not a willful action that results in physical injury,
mental anguish, or pain. Every case is fact specific and all facts, circumstances and conditions
involving the event/occurrence would need to be examined.

• A resident lightly taps another resident to stop an irritating behavior or get attention, with
no resulting physical injury, mental anguish, or pain.

• A resident who is slow, impedes the pathway of another resident, such as in the dining
room, the other resident nudges the resident out of the way to get to his/her table faster,
but there is no harm to the victim.

• A resident who swats at another resident who is trying to take some food off his/her plate,
and no physical injury, mental anguish, or pain has occurred.

NOTE: Even if a physical altercation is not required to be reported, the facility should take into
consideration that physical altercations can increase the risk for abuse to occur to residents
involved in the altercation, and possibly other residents in the facility. The facility must meet
requirements related to appropriate assessment (see § 483.20 – Resident Assessment), care
planning by the interdisciplinary team (see § 483.21-Comprehensive Person-Centered Care
Planning), and provide care and services according to acceptable standards of practice [see
§483.21(b)(3)(i)- Tag F658] to prevent harm as a result of resident to resident altercations, as
well as the development and implementation of policies and procedures to prevent abuse of
residents [see § 483.12(b)(1)- Tag F607)].

Through these actions, the facility can determine areas of needed improvement in care/service
provision, staff training or staff deployment.

Section III. Reporting Suspicious Injuries of Unknown Source
“Injuries of unknown source” – An injury should be classified as an “injury of unknown
source” when ALL of the following criteria are met:

• The source of the injury was not observed by any person; and
• The source of the injury could not be explained by the resident; and
• The injury is suspicious because of:

a. The extent of the injury, or
b. The location of the injury (e.g., the injury is located in an area not generally

vulnerable to trauma), or
c. The number of injuries observed at one particular point in time, or
d. The incidence of injuries over time.

Examples of Injuries of Unknown Source

Required to Report Not Required to Report
(Unless it rises to the level of what’s
described in the first column)

• Unobserved/Unexplained fractures, sprains
or dislocations

• Unobserved/Unexplained injuries that
could have resulted from a burn, including
blisters or scalds

• Unobserved/Unexplained bite marks
• Unobserved/Unexplained scratches and

bruises found in suspicious locations such
as the head, neck, upper chest or back

• Unobserved/Unexplained swelling that is
not linked to a medical condition

• Unobserved/Unexplained lacerations with
or without bleeding

• Unobserved/Unexplained skin tears in sites
found in suspicious locations (e.g., in sites
other than the arms or legs)

• Unobserved/Unexplained skin tears in
patterns (e.g., bilateral, symmetrical skin
tears on both arms)

• Unobserved/Unexplained patterned bruises
that suggest hand marks or finger marks, or
bruising pattern caused by an object

• Unobserved/Unexplained bilateral bruising
to arms, bilateral bruising of the inner
thighs, “wrap around” bruises that encircle
the legs, arms or torso, and multicolored
bruises which would indicate that several
injuries were acquired over time.

• Unobserved/Unexplained facial injuries,
including facial fractures, black eye(s),
bruising, or bleeding or swelling of the
mouth or cheeks with or without broken or
missing teeth

• Unobserved/Unexplained bruising or other
injuries in the genital area, inner thighs, or
breasts

• Unobserved/unexplained injury requiring
transfer to a hospital for examination
and/or treatment

NOTE: Any injury that is explained and
appears to be a result of abuse must be
reported.

• Bruising in an area where the resident
has had recent medical tests/lab draws
and there is no indication of abuse or
neglect

• Injuries where the resident was able to
explain or describe how he/she received
the injury as long as there is no other
indication of abuse or neglect

• Injuries that were witnessed by staff,
where there is no indication of abuse or
neglect

NOTE: Even if the injury is not one that
requires a report, the facility should
adequately assess and monitor the
resident, notify the physician/resident
representative as appropriate, and
document the injury and investigation as a
part of the resident’s medical record.

NOTE: If there is a reasonable suspicion of a crime having occurred related to the injury,
covered individuals must report to the State Survey Agency and law enforcement under required
timeframes (See Tag F609).

Section IV. Reportable Events Related to Potential Neglect

“Neglect,” means “the failure of the facility, its employees or service providers to provide goods
and services to a resident that are necessary to avoid physical harm, pain, mental anguish or
emotional distress.” (See §483.5) In other words, neglect occurs when the facility is aware, or
should have been aware of, goods or services that a resident(s) requires but the facility fails to
provide them to the resident(s), resulting in physical harm, pain, mental anguish or emotional
distress. Alleged violations of neglect include cases where the facility demonstrates indifference
or disregard for resident care, comfort or safety, resulting in physical harm, pain, mental anguish
or emotional distress. There may be some situations in which the psychosocial outcome to the
resident may be difficult to determine or incongruent with what would be expected. In these
situations, it is appropriate to consider how a reasonable person in the resident’s position would
be impacted by the incident.

Examples of events to be reported include, but are not limited to, the following:
1. Failure to meet payroll or pay supplier bills resulting in residents not receiving goods or

services, such as

• Insufficient staff (including the night shift and weekends) resulting in the lack of

provision for resident’s care needs (e.g., residents who need continuous skilled nursing
care or supervision, residents with cognitive deficits requiring continuous supervision); or

• Lack of essential supplies or equipment such as incontinence supplies, wound care
supplies, or oxygen equipment or adaptive equipment according to the needs of the
resident(s); or

• Lack of sufficient amounts of food to meet the residents’ nutritional needs.

2. Staff repeatedly ignoring residents’ needs for assistance with activities of daily living,
resulting in residents remaining in bed when they want to be up and repeatedly missing
activities; or residents being left in fecal material or urine.

3. Failure to oversee the management of pain for a resident resulting in a resident not receiving
required medications or treatments, leading to prolonged excruciating pain.

4. Failure to implement and monitor care planned interventions, resulting in repeated failures to
provide necessary care and services to prevent the development a new avoidable pressure
ulcer that develops into a Stage 3 or 4 pressure ulcer.

NOTE: Noncompliance at the Resident’s Rights/Quality of Care/Quality of Life tag alone does
not automatically indicate noncompliance at F600, or F609. The survey team would need
additional evidence that identifies that the facility knew, or should have known, to provide
necessary staff, supplies, services, policies, training, or staff supervision and oversight to meet
the resident’s needs, but failed to take action, resulting in harm to the resident. For example, a
survey team identifies that a facility had failed to perform a skin assessment for a resident,

resulting in failure to implement interventions to prevent the development of an avoidable Stage
2 pressure ulcer for a resident. Upon further investigation, the survey team finds that the facility
identified the pressure ulcer and treated it with no further worsening. While the survey team
would identify noncompliance at F686, the facility would not be cited at F600 and the facility
would not be expected to report this as an alleged violation of neglect.

Section V. Reportable Allegations of Misappropriation of Resident Property and
Exploitation
The facility must exercise reasonable care for the protection of the resident’s property from loss
or theft. See tag F584, 42 CFR §483.10(i)(1)(ii). The facility is expected to be responsive to a
resident’s concerns about lost items.

“Exploitation,” as defined at §483.5, means “taking advantage of a resident for personal gain,
through the use of manipulation, intimidation, threats, or coercion.”

“Misappropriation of resident property,” as defined at §483.5, means “the deliberate
misplacement, exploitation, or wrongful, temporary, or permanent use of a resident’s belongings
or money without the resident’s consent.”
Examples of allegations of misappropriation of resident property and exploitation that must be
reported include, but are not limited to:

• Theft of personal property, including but not limited to jewelry, computer, phone, and
other valuable items such as eyeglasses and hearing aids;

• Unauthorized/coerced use by staff of resident’s personal property;
• Theft of money from bank accounts;
• Unauthorized or coerced purchases on a resident’s credit card;
• Unauthorized or coerced purchases from resident’s funds;
• Staff who accept money from a resident for any reason including when staff have made

the resident believe that staff was in a financial crisis or the resident believes that he/she
is in a relationship with the staff person;

• A resident who provides a gift to staff in order to receive ongoing care, based on staff’s
persuasion; and

• Missing prescription medications or diversion of a resident’s medication(s), including,
but not limited to, controlled substances for staff use or personal gain.

Examples of allegations that would not be reported are:

• Theft of nominal items with little to no monetary or sentimental value;
• Lost items that are not listed under “must be reported.”

Section VI. Reportable Allegations of Mistreatment
“Mistreatment,” as defined at §483.5, is “inappropriate treatment or exploitation of a resident.”

Allegations of mistreatment should be reported only if they meet the criteria for reporting alleged
violations of abuse and/or exploitation, which are described under the Sections above.

Refer to the CE Pathways for Abuse (Form CMS-20059) and Neglect (Form CMS-20130)
and the Investigative Protocols for tags F602 and F603.

INVESTIGATIVE PROTOCOL

FOR POLICIES AND PROCEDURES RELATED TO REPORTING OF REASONABLE
SUSPICION OF A CRIME

USE

Use this protocol during any survey, if, based on a complaint or an investigation of abuse,
neglect, misappropriation of resident property, or exploitation, a covered individual did not
report a reasonable suspicion of a crime. Refer to the CE Pathways for Abuse (Form CMS-
20059) and Neglect (Form CMS-20130) and the Investigative Protocols for tags F602, and F603,
which gathers information about what information was or was not reported by covered
individuals and whether retaliation may have occurred.
The protocol below investigates whether the facility developed and implemented policies and
procedures related to:

• Ensuring the reporting reasonable suspicion of crimes, and
• Notifying covered individuals of their reporting responsibilities.

PROCEDURES

If the surveyor discovers a reasonable suspicion of a crime being committed against a resident of
or an individual receiving services from the facility and it has not been reported by a covered
individual, the surveyor reminds the facility of the covered individuals’ obligation to report
suspected crimes pursuant to section 1150B of the Act within the required timeframes.

“Covered individual” is anyone who is an owner, operator, employee, manager, agent or
contractor of the facility as defined in section 1150B(a)(3) of the Act. If a covered individual
reports the suspected crime to local law enforcement, the surveyor must verify that the report
was made (e.g., obtain time/date of report, name of person who received report, case number,
etc.). If the covered individual refuses to report, or the surveyor cannot verify that a report was
done, the surveyor must consult with his/her supervisor immediately, and the State Agency must
report the potential criminal incident to law enforcement immediately.

Facility Policies and Procedures

Obtain and review the facility’s policies and procedures to determine whether the facility is:

• Notifying covered individuals of their reporting responsibilities, and
• Ensuring the reporting of reasonable suspicions of crimes.

Interview Staff

Interview staff who may have knowledge of the alleged incident to determine how did staff
follow facility policies and procedures, such as:

• What is his/her responsibility in reporting a reasonable suspicion of a crime,
• What is the facility’s policies and procedures for reporting,
• What actions were taken when there was a suspected crime,
• When he/she may have last received orientation, training, in-service, and/or notification

regarding the reporting of suspected crimes, and
• Whether there are any barriers to reporting.

Additional interviews with other staff across all levels and different shifts may also be
conducted.

Interview – Administrator
Interview the Administrator to determine how the Administrator oversees the implementation of
policies and procedures for reporting of suspected crimes.

Review of In-service Training/Orientation Records
Obtain and review documentation of training to determine whether covered individuals were
notified annually of their responsibility in a language that the individual would understand to
report allegations of suspected crimes against residents and individuals receiving care from the
facility.

Key Elements of Noncompliance
To cite deficient practice at F609, the surveyor’s investigation will generally show that the
facility failed to do any one or more of the following:

• Develop policies and procedures related to ensuring the reporting of suspected crimes,
within mandated timeframes (i.e., immediately but not later than two hours if the
suspected crime resulted in serious bodily injury, within 24 hours for all other cases) and
notifying covered individuals annually of their reporting obligations;

• Identify a situation as an alleged violation involving abuse, neglect, exploitation or
mistreatment, including injuries of unknown source and misappropriation of resident
property;

• Report an alleged violation involving abuse or resulting in serious bodily injury

immediately, but not later than two hours after the allegation is made, to the administrator
of the facility and to other officials, including to the State survey and certification agency
and adult protective services in accordance with State law;

• Report an alleged violation involving neglect, misappropriation of resident property,

exploitation, or mistreatment, and does not result in serious bodily injury not later than 24

hours to the administrator of the facility and to other officials, including to the State
survey and certification agency and adult protective services in accordance with State
law; or

• Report the results of all investigations within 5 working days to the administrator or

his/her designated representative and to other officials in accordance with State law
(including to the State survey and certification agency.

If Tag F609 is cited for failure to develop and/or implement policies and procedures for
ensuring the reporting of a reasonable suspicion of a crime, the survey team includes the
following language at the beginning of the Deficient Practice Statement on the Form
CMS-2567: “Based on [observations/interviews/record review], the facility failed to
develop and/or implement policies and procedures for ensuring the reporting of a
reasonable suspicion of a crime in accordance with section 1150B of the Act…”

DEFICIENCY CATEGORIZATION – ENSURING REPORTING OF A REASONABLE
SUSPICION OF A CRIME
In addition to actual or potential physical harm, always consider whether psychosocial harm has
occurred when determining severity level (See Psychosocial Outcome Severity Guide).

Example of Severity Level 4 Noncompliance Immediate Jeopardy to Resident Health or
Safety include, but are not limited to:

• The facility failed to implement policies and procedures for covered individuals to
identify and report a suspected crime to local law enforcement and the SA, resulting in
failure to protect a resident from further potential criminal activity by an alleged
perpetrator. In addition, the facility had failed to report the alleged violation of abuse to
the Administrator, as well as the State Survey Agency. A resident, with a cognitive
impairment who was dependent on staff for care, reported to family members that she
was “touched down there” and identified the alleged perpetrator. Family members
reported this to the licensed staff person on duty; however, the staff told the family that
the resident was confused. Staff did not report the family’s allegation to anyone and
failed to provide protection for the resident allowing ongoing access to the resident by the
alleged perpetrator. The resident had emotional changes including crying and agitation
and cowered with fear whenever the alleged perpetrator approached the resident. The
resident subsequently developed a sexually transmitted disease (STD). Based on
interviews with various staff members, these covered individuals were not aware of their
reporting responsibilities for a suspected crime, even though they had participated in
abuse prevention training and had received their annual notification of their reporting
obligations. Each staff member assumed that this did not need to be reported because
the resident was confused; therefore, the facility had failed to ensure reporting.

Example of Severity Level 3 Noncompliance Actual Harm that is not Immediate
Jeopardy include, but are not limited to:

• The facility failed to implement policies and procedures for covered individuals to report
to local law enforcement, the suspicion of a crime related to drug diversion. A resident
was prescribed opioid pain medication to manage severe pain following recent surgery
for a fractured hip. A resident had requested that staff review his pain medication as it
was not effective over the weekend. The resident informed staff that he was unable to
attend weekend daytime activities due to discomfort and lack of sleep from having pain at
night. The resident stated that he received a different colored pill during the weekend,
but it did not seem to work like the medication that was given during the weekdays. The
facility’s investigation revealed that the same staff nurse worked on each of the weekend
night shifts when the resident was identified to have unrelieved pain. This staff nurse had
access to the controlled medications for residents on that unit. During interview with the
nurse aide who worked on the same shift as the nurse, the nurse aide stated that she saw
the nurse coming out of the resident’s room with the medication cup, and the nurse had
told her that the resident was sleeping and she would give the medication later. The nurse
aide reported that she then saw the nurse take the medication herself. She stated that she
was afraid to report what she had seen since she did not want to jump into any
conclusions or cause any trouble for the nurse. Interviews with other staff revealed they
were not aware of facility policies or of their obligations to report a suspected crime
including possible drug diversion.

Example of Severity Level 2 Noncompliance No Actual Harm with Potential for More
Than Minimal Harm that is Not Immediate Jeopardy include, but are not limited to:

The facility failed to provide annual notification to staff on their obligations to report
suspected crimes and to post signage of employee rights related to retaliation against the
employee for reporting a suspected crime. During the investigation, the surveyors did not
see any signage related to employee rights related to retaliation. Based on interviews
with five staff members, they had not received their annual notification from the facility
regarding their obligations to report suspected crimes to law enforcement and to the State
Survey Agency, without fear of retaliation. However, the staff members were
knowledgeable about their obligations. Additionally, two other staff members who were
recently hired within the last 30 days, were not knowledgeable of their reporting
obligations or rights to report a suspected crime without retaliation.

Example of Severity Level 1: No Actual Harm with Potential for Minimal Harm

• The failure of the facility to meet the requirements under this Federal requirement is more

than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory
requirement

F610
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.12(c) In response to allegations of abuse, neglect, exploitation, or mistreatment, the
facility must:

§483.12(c)(2) Have evidence that all alleged violations are thoroughly investigated.

§483.12(c)(3) Prevent further potential abuse, neglect, exploitation, or mistreatment while
the investigation is in progress.

INTENT
The facility must take the following actions in response to an alleged violation of abuse, neglect,
exploitation or mistreatment:

• Thoroughly investigate the alleged violation;
• Prevent further abuse, neglect, exploitation and mistreatment from occurring while the

investigation is in progress; and
• Take appropriate corrective action, as a result of investigation findings.

NOTE: Refer to F609 for the requirement to report the findings of the investigation within 5
working days.

GUIDANCE
Facility’s Investigation of Alleged Violations
For all alleged violations of abuse, neglect, exploitation, misappropriation of resident property,
exploitation, and mistreatment, including injuries of unknown source, the surveyor reviews
whether the facility maintains evidence that all alleged violations are thoroughly investigated.
There is no specific investigation process that the facility must follow, but the facility must
thoroughly collect evidence to allow the Administrator to determine what actions are necessary
(if any) for the protection of residents. Depending upon the type of allegation received, it is
expected that the investigation would include, but is not limited to:

• Conducting observations of the alleged victim, including identification of any injuries as
appropriate, the location where the alleged situation occurred, interactions and
relationships between staff and the alleged victim and/or other residents, and
interactions/relationships between resident to other residents;

• Conducting interviews with, as appropriate, the alleged victim and representative, alleged
perpetrator, witnesses, practitioner, interviews with personnel from outside agencies such
as other investigatory agencies, and hospital or emergency room personnel;

• Conducting record review for pertinent information related to the alleged violation, as
appropriate, such as progress notes (Nurse, social services, physician, therapist,
consultants as appropriate, etc.), financial records, incident reports (if used), reports from
hospital/emergency room records, laboratory or x-ray reports, medication administration
records, photographic evidence, and reports from other investigatory agencies.

Even if an alleged violation was reported to law enforcement as a reasonable suspicion of a
crime committed against a resident, the facility must still conduct its own internal investigation
to the extent possible, in consultation with the law enforcement authority. When law
enforcement is contacted the facility must not impede the investigation and must maintain any
potential evidence (e.g., clothing, linens, etc.) as instructed by law enforcement. It has been
reported that some investigations were impeded due to washing linens or clothing, destroying
documentation, bathing or cleaning the resident before the resident has been examined, or failure
to transfer a resident to the emergency room for examination including obtaining a rape kit, if
appropriate.

Prevention
Depending on the nature of the alleged violation, the facility must immediately put effective
measures in place to ensure that further potential abuse, neglect, exploitation, or mistreatment
does not occur while the investigation is in process.
Examples of instances where the facility failed to provide protections include, but are not limited
to:

• The alleged perpetrator continues to have access to the alleged victim and/or other
vulnerable residents;

• Retaliation occurs against a resident who reports an alleged violation;
• A resident who continually fondles other residents is moved to another unit, where he/she

continues to exhibit the same behaviors to other residents;
• A resident with a history of striking is left unsupervised with a resident who has been

targeted in the past and/or other residents; and
• The facility conducts an inadequate investigation and ceases temporary resident

protection measures that were implemented as a result of the alleged violation.

Examples of measures to protect residents include, but are not limited to:
• Monitoring of the alleged victim and other residents at risk, such as conducting

unannounced management visits at different times and shifts;
• Evaluation of whether the alleged victim feels safe and if the he/she does not feel safe,

taking immediate steps to alleviate the fear, such as a room relocation, increased
supervision, etc.;

• Immediate assessment of the alleged victim and provision of medical treatment as
necessary;

• Immediate notification of the alleged victim’s practitioner and the family or responsible
party;

• Removal of access by the alleged perpetrator to the alleged victim and assurance that
ongoing safety and protection is provided for the alleged victim and, as appropriate, other
residents;

• Notification of the alleged violation to other agencies or law enforcement authorities; and

• Whether administrative staff, including the administrator, were informed and involved as
necessary in the investigation.

Corrective Actions
As a result of a facility’s investigation, if an alleged violation is verified, the facility must take
appropriate corrective action to protect residents. The facility should oversee the implementation
of corrective action and evaluate whether it is effective. While some corrective actions may be
limited in scope, facilities should determine whether more systemic actions may be necessary to
prevent recurrence of the situation. In addition, the Quality Assessment & Assurance committee
should monitor the reporting and investigation of the alleged violations, including assurances
that residents are protected from further occurrences and that corrective actions are implemented
as necessary.

Refer to the CE Pathways for Abuse (Form CMS-20059) and Neglect (Form CMS-20130)
and the Investigative Protocols for tags F602 and F603.

KEY ELEMENTS OF NONCOMPLIANCE
To cite deficient practice at F610, the surveyor’s investigation will generally show that the
facility failed to do any one or more of the following:

• Initiate an investigation of an alleged violation of abuse, neglect, exploitation,
misappropriation of resident property, exploitation, and mistreatment, including injuries
of unknown source; or

• Complete a thorough investigation of the alleged violation; or
• Maintain documentation that an alleged violation was thoroughly investigated; or
• Prevent further potential abuse, neglect, exploitation, or mistreatment while the

investigation of an alleged violation is in progress; or
• Take corrective action following an investigation of an alleged violation, if the allegation

was verified.

F620
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.15(a) Admissions policy.
§483.15(a)(1) The facility must establish and implement an admissions policy.

§483.15(a)(2) The facility must—

(i) Not request or require residents or potential residents to waive their rights as set
forth in this subpart and in applicable state, federal or local licensing or certification
laws, including but not limited to their rights to Medicare or Medicaid; and

(ii) Not request or require oral or written assurance that residents or potential residents
are not eligible for, or will not apply for, Medicare or Medicaid benefits.

(iii) Not request or require residents or potential residents to waive potential facility
liability for losses of personal property.

§483.15(a)(3) The facility must not request or require a third party guarantee of payment
to the facility as a condition of admission or expedited admission, or continued stay in the

facility. However, the facility may request and require a resident representative who has
legal access to a resident’s income or resources available to pay for facility care to sign a
contract, without incurring personal financial liability, to provide facility payment from
the resident’s income or resources.

§483.15(a)(4) In the case of a person eligible for Medicaid, a nursing facility must not
charge, solicit, accept, or receive, in addition to any amount otherwise required to be paid
under the State plan, any gift, money, donation, or other consideration as a precondition of
admission, expedited admission or continued stay in the facility. However,—

(i) A nursing facility may charge a resident who is eligible for Medicaid for items and
services the resident has requested and received, and that are not specified in the
State plan as included in the term ‘‘nursing facility services’’ so long as the facility
gives proper notice of the availability and cost of these services to residents and does
not condition the resident’s admission or continued stay on the request for and
receipt of such additional services; and

(ii) A nursing facility may solicit, accept, or receive a charitable, religious, or
philanthropic contribution from an organization or from a person unrelated to a
Medicaid eligible resident or potential resident, but only to the extent that the
contribution is not a condition of admission, expedited admission, or continued stay
in the facility for a Medicaid eligible resident.

§483.15(a)(5) States or political subdivisions may apply stricter admissions standards
under State or local laws than are specified in this section, to prohibit discrimination
against individuals entitled to Medicaid.

§483.15(a)(6) A nursing facility must disclose and provide to a resident or potential resident
prior to time of admission, notice of special characteristics or service limitations of the
facility.

§483.15(a)(7) A nursing facility that is a composite distinct part as defined in §483.5 must
disclose in its admission agreement its physical configuration, including the various
locations that comprise the composite distinct part, and must specify the policies that apply
to room changes between its different locations under paragraph (c)(9) of this section.

DEFINITIONS/ACRONYMS
“Composite distinct part”: A composite distinct part is a distinct part consisting of two or
more noncontiguous components that are not located within the same campus, as that term is
defined in §413.65(a)(2) of this chapter. Additional requirements specific to SNF/NF composite
distinct parts are found at §483.5.

“Campus”: Campus is defined in §413.65(a)(2) and means the physical area immediately
adjacent to the provider’s main buildings, other areas and structures that are not strictly
contiguous to the main buildings but are located within 250 yards of the main buildings, and any
other areas determined on an individual case basis, by the CMS regional office, to be part of the
provider’s campus.

“Distinct part”: A distinct part SNF or NF is physically distinguishable from the larger
institution or institutional complex that houses it, meets the requirements of this paragraph and of
paragraph (b)(2) of this section, and meets the applicable statutory requirements for SNFs or NFs
in sections 1819 or 1919 of the Act, respectively. A distinct part SNF or NF may be comprised of
one or more buildings or designated parts of buildings (that is, wings, wards, or floors) that are:
In the same physical area immediately adjacent to the institution’s main buildings; other areas
and structures that are not strictly contiguous to the main buildings but are located within close
proximity of the main buildings; and any other areas that CMS determines on an individual basis,
to be part of the institution’s campus. A distinct part must include all of the beds within the
designated area, and cannot consist of a random collection of individual rooms or beds that are
scattered throughout the physical plant. The term “distinct part” also includes a composite
distinct part that meets the additional requirements of paragraph (c) of this section. Additional
requirements specific to SNF/NF distinct parts are found at 483.5.

GUIDANCE
§483.15(a)(1) and (2) Admissions Policy/Preconditions of Admission
All facilities must establish and implement a policy or policies addressing resident admission to
the facility. First, the admissions policy must comply with the provisions at §483.15(c)(1) which
stipulate the limited conditions for transfer or discharge. The provisions at §483.15 (a)(2) –(5),
further prohibit the waiver of certain rights and preconditions for admission to, and continued
stay in the facility. Additionally, under §483.15(a)(6) – (7), the admissions policy must identify
information that must be disclosed to residents and potential residents, such as notice of special
facility characteristics, any service limitations of the facility, if applicable. Additionally, it
requires that the facility’s admission agreement disclose its physical composition, including any
composite distinct part locations, and must specify the policies that apply to room changes in a
composite distinct part (see additional guidance below). The facility must also have a process
for how it will disclose required information to residents and potential residents.

The provisions at §483.15(a)(2)(i) and (ii) prohibit both direct and indirect requests to residents
or potential residents to waive any rights under the LTC requirements and under applicable
federal, state, local licensing or certification laws, including but not limited to the waiver of
rights to Medicare or Medicaid. A direct request for waiver, for example, would require
residents to sign admissions documents explicitly promising or agreeing not to apply for
Medicare or Medicaid. An indirect request for waiver would include, for example, requiring the
resident to pay private rates for a specified period of time, such as two years (e.g., “private pay
duration of stay contract”) before Medicaid will be accepted as a payment source for the resident.
Facilities must not seek or receive any kind of assurances that residents or potential residents are
not eligible for, or will not apply for, Medicare or Medicaid benefits.

Lastly, residents must not be asked to waive facility responsibility for the loss of their personal
property or be unable to use personal property because it is only permitted in the facility if
safeguarded by the facility in a manner that makes the property essentially inaccessible to the
resident. These waivers effectively take away the residents’ right to use personal possessions and
relieve facilities from their responsibility to exercise due care with respect to residents’ personal
property. Compliance requires facilities to develop policies and procedures to safeguard
residents’ personal possessions without effectively prohibiting a resident’s use of personal

possessions. This provision is not intended to make facilities automatically liable for every loss
regardless of whether or not the facility is aware of the extent of personal property brought into
the facility. Examples of reasonable facility policies may include 1) establishing a process to
document high value personal property (particularly cash, valuables, and medical/assistive
devices) brought in by residents; and 2) establishing a process to work with residents and their
representatives/family to ensure safety as well as availability to the resident of cash and/or items
over a certain dollar value, including medical/assistive devices. For concerns related to whether
the facility takes reasonable care to protect each resident’s property from loss or theft or the
resident’s right to be free from misappropriation of property, see F584, §483.10(i) Safe
Environment and F602, §483.12 Misappropriation of Resident Property.

§483.15(a)(3) Third Party Guarantee of Payment
The facility must not request or require a third party to accept personal responsibility for paying
the facility bill out of his or her own funds as a condition of admission, expedited admission, or
continued stay in the facility. However, the facility may request and require a resident
representative with legal access to the resident’s funds available to pay for facility care to access
and use the resident’s money or other assets to pay for care, as authorized by law. The facility
may request and require this representative to sign a contract, without incurring personal
liability, to provide the facility with payment from the resident’s income or assets. A third party
guarantee is not the same as a third party payor, e.g., an insurance company; and this provision
does not preclude the facility from obtaining information about Medicare or Medicaid eligibility
or the availability of private insurance. The prohibition against third-party guarantees applies to
all residents and prospective residents in all certified long term care facilities, regardless of
payment source.

§483.15(a)(4)(i) and (ii), Medicaid – Preconditions for Admission
The requirements at §483.15(a)(4)(i) and (ii) apply only to individuals eligible for Medicaid and
therefore to Medicaid certified nursing facilities (NFs) or dually-certified SNF/NFs.
Facilities may not charge for any service that is included in the definition of “nursing facility
services” which are required to be provided as part of the daily rate (See also §483.10(f)(11)(i)) .
Facilities may not accept additional payment from residents or their families as a prerequisite to
admission or to continued stay in the facility. Additional payment includes, but is not limited to,
deposits from residents who are eligible for Medicaid or their families, or any promise to pay
private rates for a specified period of time.

NOTE: This regulation does not preclude a facility from charging a deposit fee to, or requiring
a promissory note from, an individual whose stay is not covered by Medicaid. In instances
where the deposit fee is refundable and remains as funds of the resident, the facility must have a
surety bond that covers the deposit amount– (See also §483.10(f)(10)(vi)).

A nursing facility is permitted to charge an applicant or resident for services, while his or her
Medicaid eligibility is pending. This charge may be in the form of a deposit prior to admission
and/or payment after admission. Subject to the rules of the State in which the facility is located,
Medicaid eligibility will be made retroactive up to 3 months before the month of application if
the applicant would have been eligible had he or she applied in any of the retroactive months.

NOTE: A resident cannot be discharged for nonpayment while their Medicaid eligibility is
pending (See F622, Transfer and Discharge Requirements).

In addition, the nursing facility must accept as payment in full the amounts determined by the
state for all dates the resident was both Medicaid eligible and a nursing facility resident.
Therefore, a nursing facility that charged a recipient for services between the first month of
eligibility established by the state and the date notice of eligibility was received is obligated to
refund, within 30 days from receipt of funds from a third party payor, any payments received for
that period less the state’s determination of any resident’s share of the nursing facility’s costs for
that same period. A nursing facility must prominently display written information in the facility
and provide explanation to applicants or residents in a manner they can understand about
applying for Medicaid, including how to use Medicaid benefits, and how to receive refunds for
previous payments covered by such benefits.

Under the post-eligibility process, if the resident who is eligible for Medicaid has income and is
required to make a monthly payment to the nursing facility (which is a portion of the Medicaid
payment amount), then the nursing facility is permitted to retain the amount it is legally owed.
However, the nursing facility must not charge any administrative fees.

A nursing facility may charge a beneficiary who receives Medicaid for a service the beneficiary
has requested and received, only if:

• That service is not defined in the State plan as a “nursing facility” service;
• The facility informs the resident and the resident’s representative in advance that this is

not a covered service to allow them to make an informed choice regarding the fee; and
• The resident’s admission or continued stay is not conditioned on the resident’s requesting

and receiving that service.

§483.15(a)(5) State/Local Jurisdiction Admission Standards
Surveyors are expected to refer to state and/or local laws and regulations on admissions
standards to prohibit discrimination against individuals entitled to Medicaid as applicable.

§483.15(a)(6) Facility Special Characteristics
Facilities may choose to offer specialized care or services, such as a rehabilitation, dementia, or a
mechanical ventilation unit. To enable potential residents and resident representatives to make
informed decisions in choosing a facility for admission, facilities must inform residents and
resident representatives and potential residents or representatives of any special characteristics or
service limitations the facility may have prior to admission. For example, a facility may have a
religious affiliation that guides its practices and routines which must be communicated to any
potential resident.

Likewise, if a facility has limitations in the type of medical care it can provide, this information
must be communicated prior to admission. For example, if the need for a specific type of care or
service becomes necessary, knowledge of service limitations may make the need for transfer or
discharge more predictable and understandable for the resident and/or his or her representative.

Disclosure of facility special characteristics does not relieve a facility of its responsibility to
provide required nursing and other services for which it is licensed and certified to provide. To
see the required services, refer to sections 1819(a) and 1819(b)(4)(A), and sections 1919(a) and
1919(b)(4)(A) of the Act.

§483.15(a)(7) Composite Distinct Part
If a facility does not have a composite distinct part, this provision does not apply. If there are
concerns as to whether or not a facility meets the requirements for a composite distinct part
according to §483.5(c), consult with the CMS Regional Office for clarification.

Prior to admission, facilities that have areas that meet the definition of a composite distinct part
must disclose in their admission agreements to residents:

• A description of the facility’s physical configuration, including the locations for each part
that comprise the composite distinct part.

• Policies governing room changes between its different locations.

NOTE: If there is a deficiency specific to the requirement at §483.10(g)(15), do not cite at
§483.10(g)(15), F580, but cite here at F620, regarding admission policies.

INVESTIGATIVE PROTOCOL
Objectives
The objectives of this protocol are to determine whether the facility has failed to comply with the
regulations at §483.15(a)(1) – (7) above, regarding admission policies and payment.

Use
Use this protocol when concerns regarding admissions procedures arise during record review,
interviews and/or in response to complaints.

PROCEDURES
Record Reviews
Review the facility admissions package, including admissions policies, and contracts to
determine if they contain any of, but not limited to, the following:

• Requirements or requests for residents to waive:
o their rights to current or future enrollment in Medicare or Medicaid
o claims of liability against the facility for loss of personal property

• Requirements or requests for a third party guarantee of payment as a condition of
admission or expedited admission.

• Requirements for payment for services which are covered under Medicaid as a condition
of admission, or continued stay.

In addition, if the facility has any special characteristics or service limitations, review the
admissions package to determine if they are and have been disclosed to residents and their
representative prior to admission. For composite distinct part facilities, determine if the facility
discloses and has disclosed its various locations that make up the composite distinct parts and its
policies for room changes between its different locations.

For concerns regarding a facility charging for services that may be covered by the State
Medicaid plan, surveyors are expected to review State covered services. Compare with the list
of items for which the facility charges to determine if the facility is charging for covered
services.

Interviews
Ask resident and/or their representative if there were any preconditions or requirements for
admission, such as a third party guarantee of payment, or requests for gifts, money, donations or
other considerations.
Ask resident and/or their representative if there were any other preconditions or requirements, or
limitations in care that they did not expect or know about prior to admission.
Ask resident and/or their representative if they were required to waive:

• Their rights to Medicare or Medicaid, or future enrollment in either; and/or
• Claims of liability against the facility for loss of personal property.

Interview staff about information that is provided to potential residents to help them make
informed decisions.

F621
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.15(b) Equal access to quality care.
§483.15(b)(1) A facility must establish, maintain and implement identical policies and
practices regarding transfer and discharge, as defined in §483.5 and the provision of
services for all individuals regardless of source of payment, consistent with §483.10(a)(2);

§483.15(b)(2) The facility may charge any amount for services furnished to non-Medicaid
residents unless otherwise limited by state law and consistent with the notice requirement
in §483.10(g)(18)(i) and (g)(4)(i) describing the charges; and

§483.15(b)(3) The State is not required to offer additional services on behalf of a resident
other than services provided in the State plan.

§483.15(c)(9) Room changes in a composite distinct part. Room changes in a facility that is
a composite distinct part (as defined in § 483.5) are subject to the requirements of §
483.10(e)(7) and must be limited to moves within the particular building in which the
resident resides, unless the resident voluntarily agrees to move to another of the composite
distinct part’s locations.

DEFINITIONS
“Composite Distinct Part”: A composite distinct part is a distinct part consisting of two or
more noncontiguous components that are not located within the same campus, as defined in
§413.65(a)(2) of this chapter. Additional requirements specific to SNF/NF composite distinct
parts are found at §483.5.

“Distinct Part”: A distinct part SNF or NF is physically distinguishable from the larger
institution or institutional complex that houses it, meets the requirements of this paragraph and of
paragraph (b)(2) of this section, and meets the applicable statutory requirements for SNFs or NFs
in sections 1819 or 1919 of the Act, respectively. A distinct part SNF or NF may be comprised of
one or more buildings or designated parts of buildings (that is, wings, wards, or floors) that are:
In the same physical area immediately adjacent to the institution’s main buildings; other areas
and structures that are not strictly contiguous to the main buildings but are located within close
proximity of the main buildings; and any other areas that CMS determines on an individual basis,
to be part of the institution’s campus. A distinct part must include all of the beds within the
designated area, and cannot consist of a random collection of individual rooms or beds that are
scattered throughout the physical plant. The term “distinct part” also includes a composite
distinct part that meets the additional requirements of paragraph (c) of this section. Additional
requirements specific to SNF/NF distinct parts are found at §483.5.

INTENT
To ensure residents are treated equally regarding transfer, discharge, and the provision of
services, regardless of their payment source.

GUIDANCE
All services, including but not limited to nursing services, specialized rehabilitative services,
behavioral health services, social services, dietary services, and pharmacy services, or activities,
that are mandated by the law must be provided to residents according to their individual needs,
as determined by assessments and care plans. “Identical policies and practices” concerning
services means that facilities must not distinguish between residents based on their source of
payment when providing services that are required to be provided under the law.

Notice Requirements for Changes to Medicare/Medicaid Coverage
Facilities must inform each resident in writing before or at admission, and periodically during
their stay, such as when a change in coverage occurs, of the facility’s available services and
associated costs. The facility may charge any amount for services furnished to non- Medicaid
residents unless otherwise limited by state law. Section §483.10(f)(11) and F571 provide
additional information regarding services and charges for which a facility may or may not charge
the resident. Pursuant to §483.10(g)(18)(i) and F582, the facility must provide notice of changes
in coverage for services to residents as soon as is reasonably possible.

Facility Requirements Regarding Room Changes in a Composite Distinct Part
If a facility does not have a composite distinct part this provision does not apply. If there are
concerns as to whether or not a facility meets the requirements for a distinct or composite distinct
part of a larger institution or institutional complex, consult with the CMS Regional Office for
clarification.

Room changes within either a composite distinct part SNF or a distinct part SNF are subject to
the requirements at §483.10(e)(7) and F560, which address the resident’s right to refuse
transfer/room change. For concerns regarding the resident’s right to refuse such a transfer or
room change, refer to §483.10(e)(7) and F560.

PROBES
Determine if residents are grouped in separate wings or floors for reasons other than care needs,
and if the quality of care is different between the different wings/floors.
Ask nursing home administrator, social worker, charge nurses, unit managers, and/or Director of
Nursing:

• What factors led to decisions to place residents in different wings or floors (or locations if
a SNF composed of composite distinct parts)?

• Do factors other than medical and nursing needs affect where residents are placed?

Ask representatives of the Office of the State Long-Term Care Ombudsman if they have
information that could indicate the facility treats residents differently in transfer, discharge and
covered services based on source of payment.
If concerns arise regarding equal access to care, ask the resident or representative:

• Were there any changes to care or services when their payor source changed, for example
did they notice fewer staff available to meet their needs when their payor source was due
to change or had changed?

• Did the resident receive notice of changes in charges for services?
• Were they asked to move or were they moved to a different location in the building when

their payor source changed?

F622
(Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24)

§483.15(c) Transfer and discharge-

§483.15(c)(1) Facility requirements-

(i) The facility must permit each resident to remain in the facility, and not transfer or
discharge the resident from the facility unless—
(A) The transfer or discharge is necessary for the resident’s welfare and the

resident’s needs cannot be met in the facility;
(B) The transfer or discharge is appropriate because the resident’s health has

improved sufficiently so the resident no longer needs the services provided by
the facility;

(D) The health of individuals in the facility would otherwise be endangered;
(E) The resident has failed, after reasonable and appropriate notice, to pay for (or to

have paid under Medicare or Medicaid) a stay at the facility. Nonpayment
applies if the resident does not submit the necessary paperwork for third party

payment or after the third party, including Medicare or Medicaid, denies the
claim and the resident refuses to pay for his or her stay. For a resident who
becomes eligible for Medicaid after admission to a facility, the facility may
charge a resident only allowable charges under Medicaid; or

(F) The facility ceases to operate.
(ii) The facility may not transfer or discharge the resident while the appeal is pending,

pursuant to § 431.230 of this chapter, when a resident exercises his or her right to
appeal a transfer or discharge notice from the facility pursuant to § 431.220(a)(3) of
this chapter, unless the failure to discharge or transfer would endanger the health or
safety of the resident or other individuals in the facility. The facility must document
the danger that failure to transfer or discharge would pose.

§483.15(c)(2) Documentation.

When the facility transfers or discharges a resident under any of the circumstances
specified in paragraphs (c)(1)(i)(A) through (F) of this section, the facility must ensure that
the transfer or discharge is documented in the resident’s medical record and appropriate
information is communicated to the receiving health care institution or provider.

(i) Documentation in the resident’s medical record must include:

(A) The basis for the transfer per paragraph (c)(1)(i) of this section.
(B) In the case of paragraph (c)(1)(i)(A) of this section, the specific resident need(s)

that cannot be met, facility attempts to meet the resident needs, and the service
available at the receiving facility to meet the need(s).

(ii) The documentation required by paragraph (c)(2)(i) of this section must be made
by—
(A) The resident’s physician when transfer or discharge is necessary under

paragraph (c) (1) (A) or (B) of this section; and
(B) A physician when transfer or discharge is necessary under paragraph

(c)(1)(i)(C) or (D) of this section.
(iii) Information provided to the receiving provider must include a minimum of the

following:

(A) Contact information of the practitioner responsible for the care of the resident.
(B) Resident representative information including contact information
(C) Advance Directive information
(D) All special instructions or precautions for ongoing care, as appropriate.
(E) Comprehensive care plan goals;
(F) All other necessary information, including a copy of the resident’s discharge

summary, consistent with §483.21(c)(2) as applicable, and any other
documentation, as applicable, to ensure a safe and effective transition of care.

INTENT

To specify the limited conditions under which a skilled nursing facility or nursing facility may
initiate transfer or discharge of a resident, the documentation that must be included in the
medical record, and who is responsible for making the documentation. Additionally, these
requirements specify the information that must be conveyed to the receiving provider for
residents being transferred or discharged to another healthcare setting.

DEFINITIONS

“Facility-initiated transfer or discharge”: A transfer or discharge which the resident objects
to, or did not originate through a resident’s verbal or written request, and/or is not in alignment
with the resident’s stated goals for care and preferences.

“Resident-initiated transfer or discharge”: Means the resident or, if appropriate, the resident
representative has provided verbal or written notice of intent to leave the facility (leaving the
facility does not include the general expression of a desire to return home or the elopement of
residents with cognitive impairment).

“Transfer and Discharge”: Includes movement of a resident to a bed outside of the certified
facility whether that bed is in the same physical plant or not. Transfer and discharge does not
refer to movement of a resident to a bed within the same certified facility. (See §483.5).
Specifically, transfer refers to the movement of a resident from a bed in one certified facility
to a bed in another certified facility when the resident expects to return to the original facility.
Discharge refers to the movement of a resident from a bed in one certified facility to a bed in
another certified facility or other location in the community, when return to the original
facility is not expected.

GUIDANCE

NOTE: The provisions at §483.15(c)(1) and (c)(2)(i)-(ii) only apply to transfers or discharges
that are initiated by the facility (facility-initiated discharges), not by the resident (resident-
initiated discharges). Section §483.15(c)(2)(iii) applies to both facility- and resident-initiated
transfers (for information required at discharge, refer to F661, Discharge Summary).

Surveyors must determine whether a transfer or discharge is resident- or facility-initiated.
The determination that a transfer or discharge is facility-initiated does not equate to
noncompliance if the requirements in this regulatory section are met.

Resident-initiated transfers or discharges occur when the resident or, if appropriate, his/her
representative has given written or verbal notice of their intent to leave the facility. A
resident’s expression of a general desire or goal to return to home or to the community or the
elopement of a resident who is cognitively-impaired should not be taken as a notice of intent
to leave the facility.

For resident-initiated discharges, the medical record should contain documentation or evidence

of the resident’s or resident representative’s verbal or written notice of intent to leave the
facility, a discharge care plan, and documented discussions with the resident or, if appropriate,
his/her representative, containing details of discharge planning and arrangements for post-
discharge care (See F660, Discharge Planning Process, and F661, Discharge Summary).
Additionally, the comprehensive care plan should contain the resident’s goals for admission and
desired outcomes, which should be in alignment with the discharge if it is resident-initiated.

NOTE: Situations in which residents sign out of the facility, or leave Against Medical Advice
(AMA) should be thoroughly investigated to determine if the discharge is facility- or resident-
initiated. If evidence reveals that a resident or resident representative was forced, pressured, or
intimidated into leaving AMA, the discharge would be considered a facility-initiated discharge,
requiring further investigation to determine compliance with the requirements at 483.15(c),
including the requirement to provide a notice at F623. See additional guidance on AMA
discharges at F660 and guidance on Abuse, Neglect and Exploitation at F600.

If a surveyor has concerns about whether a resident-initiated transfer or discharge was actually
a facility-initiated transfer or discharge, the surveyor should investigate further through
interviews and record review.

In certain cases, residents are admitted for short-term, skilled rehabilitation under Medicare, but,
following completion of the rehabilitation program, they communicate that they are not ready to
leave the facility. In these situations, if the facility proceeds with discharge, it is considered a
facility-initiated discharge and the requirements at §§483.15(c)(1) and (c)(2)(i)-(ii) apply to ensure
the discharge is not involuntary. These situations may require further investigation to ensure that
discrimination based on payment source has not occurred in accordance with §483.10(a)(2) (F550).
Additionally, in cases where the resident does not appear to object to the discharge, or has not
appealed it, the discharge could still be a facility-initiated discharge and be thoroughly investigated to
determine if resident-, or facility-initiated.

These regulations limit the circumstances under which a facility can initiate a transfer or
discharge, thus protecting nursing home residents from facility-initiated transfers and
discharges which violate federal regulations.

In the following limited circumstances, facilities may initiate transfers or discharges:

1. The discharge or transfer is necessary for the resident’s welfare and the facility cannot

meet the resident’s needs.
2. The resident’s health has improved sufficiently so that the resident no longer needs the

care and/or services of the facility.
3. The resident’s clinical or behavioral status (or condition) endangers the safety of

individuals in the facility.
4. The resident’s clinical or behavioral status (or condition) otherwise endangers the health

of individuals in the facility.
5. The resident has failed, after reasonable and appropriate notice to pay, or have paid under

Medicare or Medicaid, for his or her stay at the facility.
6. The facility ceases to operate.

Facilities are required to determine their capacity and capability to care for the residents they
admit. Therefore, facilities should not admit residents whose needs they cannot meet based on
the Facility Assessment requirements at §483.71 (see also F838, Facility Assessment). For
residents the facility has admitted, §483.15(c)(1)(i) provides that “The facility must permit each
resident to remain in the facility, and not transfer or discharge the resident from the facility
unless….” This means that once admitted, residents have a right to remain in the facility unless
the discharge or transfer meets one of the specified exceptions in §§483.15(c)(1)(i)(A)-(F).
Discharging a resident is a violation of this right unless the facility can demonstrate that one of
the limited circumstances listed above is met. For example, if a resident whose stay is being paid
for under Medicaid is discharged from the facility, but he or she wants to stay in the facility and
still meets a state’s requirements for a nursing home level of care, this would be a facility-
initiated discharge.

Surveyors must ensure that for discharges related to circumstances 1, 3, or 4 above, the facility
has fully evaluated the resident, and does not base the discharge on the resident’s status at the
time of transfer to the acute care facility. See additional guidance at F626,
§483.15(e)(1), Permitting Residents to Return. Facility-initiated transfers and discharges must
meet the transfer and discharge requirements at §§483.15(c)(1) – (5) by having a valid basis for
the transfer or discharge. There may be rare situations, such as when a serious crime (e.g.,
attempted murder or rape) has occurred, that a facility initiates a discharge immediately, with no
expectation of the resident’s return.

NOTE: In reviewing complaints for facility-initiated discharges that do not honor a resident’s
right to return following a hospitalization or therapeutic leave, surveyors would review both
transfer and discharge requirements because the situation begins as a transfer and then changes to
a discharge when the facility decides it will not permit the resident to return.

If transfer is due to a significant change in the resident’s condition, but not an emergency
requiring an immediate transfer, then prior to any action, the facility must conduct and document
the appropriate assessment to determine if revisions to the care plan would allow the facility to
meet the resident’s needs. (See §483.20(b)(2)(ii), F637, for information concerning assessment
upon significant change.)

A resident’s declination of treatment does not constitute grounds for discharge, unless the facility
is unable to meet the needs of the resident or protect the health and safety of others. The facility
must be able to demonstrate that the resident or, if applicable, resident representative, received
information regarding the risks of refusal of treatment, (§483.10(c)(5) and (6), F552 and F578)
and that staff conducted the appropriate assessment to determine if care plan revisions would
allow the facility to meet the resident needs or protect the health and safety of others
(§483.15(c)(2)(i)(B) and see also §§483.20 Resident Assessment and 483.35 Nursing Services).

Nonpayment as Basis for Discharge

Non-payment for a stay in the facility occurs when the resident has failed, after reasonable and
appropriate notice, to pay for a stay at the facility and also may apply:

• When the resident has not submitted the necessary paperwork for third party (including
Medicare/Medicaid) payment; or

• After the third party payor (including Medicare or Medicaid) denied the claim and the
resident refused to pay for his/her stay.

It is the responsibility of the facility to notify the resident of their change in payment status,
and the facility should ensure the resident has the necessary assistance to submit any third
party paperwork. In situations where a resident representative has failed to pay, the facility
may discharge the resident for nonpayment; however, if there is evidence of exploitation or
misappropriation of the resident’s funds by the representative, the facility should take steps
to notify the appropriate authorities on the resident’s behalf, before discharging the resident.

In situations where a resident’s Medicare coverage may be ending, the facility must comply
with the requirements at §483.10(g)(17) and (18), F582. If the resident continues to need
long-term care services, the facility, under the requirements above, should offer the resident
the ability to remain, which may include:

• Offering the resident the option to remain in the facility by paying privately for a bed;
• Providing the Medicaid-eligible resident with necessary assistance to apply for Medicaid

coverage in accordance with §483.10(g)(13), F579, with an explanation that:

o if denied Medicaid coverage, the resident would be responsible for payment for

all days after Medicare payment ended; and
o if found eligible, and no Medicaid bed became available in the facility or the

facility participated only in Medicare (SNF only), the resident would be
discharged to another facility with available Medicaid beds if the resident wants
to have the stay paid by Medicaid.

The resident cannot be discharged for nonpayment while a determination on the resident’s
Medicaid eligibility is pending.

NOTE: Surveyors should be aware of a facility’s Medicare and Medicaid certification
status and/or the presence of a distinct part as this can affect whether a resident’s discharge
for non-payment is justified and is a relevant part of the investigation.

For a resident who becomes eligible for Medicaid after admission to a facility, the facility
may charge a resident only allowable charges under Medicaid. Additionally, conversion
from a private pay rate to payment at the Medicaid rate does not constitute non-payment.

Emergency Transfers to Acute Care

When residents are sent emergently to an acute care setting, these scenarios are
considered facility-initiated transfers, NOT discharges, because the resident’s return is
generally expected.

Residents who are sent emergently to an acute care setting, such as a hospital, must be

permitted to return to the facility (§483.15(e)(1), F626). In a situation where the facility
initiates discharge while the resident is in the hospital following emergency transfer, the
facility must have evidence that the resident’s status at the time the resident seeks to return to
the facility (not at the time the resident was transferred for acute care) meets one of the criteria
at §483.15(c)(1)(i)(A) through (D). Additionally, the resident has the right to return to the
facility pending an appeal of any facility-initiated discharge unless the return would endanger
the health or safety of the resident or other individuals in the facility. The facility must
document the danger that the failure to transfer or discharge would pose. (§483.15(c)(1)(ii)).

NOTE: Residents who are sent to the acute care setting for routine treatment/planned
procedures must also be allowed to return to the facility (See F626, Permitting Residents to
Return to Facility).

§483.15(c)(1)(ii) Discharge pending appeal

When a resident chooses to appeal his or her discharge from the facility, the facility may not
discharge the resident while the appeal is pending.

If the resident, or if applicable, their representative, appeals his or her discharge while in a
hospital, facilities must allow the resident to return pending their appeal, unless there is
evidence that the facility cannot meet the resident’s needs, or the resident’s return would pose
a danger to the health or safety of the resident or others in the facility. If there are concerns
related to a facility’s determination that it cannot meet a resident’s needs, surveyors should
assess whether the facility has admitted residents with similar needs. A facility’s determination
to not permit a resident to return while an appeal of the resident’s discharge is pending must
not be based on the resident’s condition when originally transferred to the hospital.

§483.15(c)(2) Required Documentation

To demonstrate that any of the circumstances permissible for a facility to initiate a transfer or
discharge as specified in 1 – 6 above have occurred, the medical record must show
documentation of the basis for transfer or discharge.

For circumstances 1 and 2 listed above for facility-initiated transfer or discharge, the
resident’s physician must document information about the basis for the transfer or discharge.
Additionally, for circumstance 1 above (the inability to meet the resident’s needs) the
documentation made by the resident’s physician must include:

• The specific resident needs the facility could not meet;
• The facility efforts to meet those needs; and
• The specific services the receiving facility will provide to meet the needs of the

resident which cannot be met at the current facility.

In circumstances 3 and 4 above, documentation regarding the reason for the transfer or
discharge must be provided by a physician, not necessarily the attending physician.

NOTE: Documentation of the transfer or discharge may be completed by a non- physician
practitioner (NPP) in accordance with State law.

Information Conveyed to Receiving Provider

The regulations at §483.15(c)(2)(iii) address information that must be conveyed to the
receiving provider when a resident is transferred or discharged. The specific information
which must be conveyed depends upon whether the resident is transferred (expected to
return),or is discharged (not expected to return). If the resident is being transferred, and return
is expected, the following information must be conveyed to the receiving provider:

• Contact information of the practitioner who was responsible for the care of the resident;
• Resident representative information, including contact information;
• Advance directive information;
• All special instructions and/or precautions for ongoing care, as appropriate such as:

o Treatments and devices (oxygen, implants, IVs, tubes/catheters);
o Transmission-based precautions such as contact, droplet, or airborne;
o Special risks such as risk for falls, elopement, bleeding, or pressure injury and/or

aspiration precautions;
• The resident’s comprehensive care plan goals; and
• All other information necessary to meet the resident’s needs, which includes, but may

not be limited to:
o Resident status, including baseline and current mental, behavioral, and

functional status, reason for transfer, recent vital signs;
o Diagnoses and allergies;
o Medications (including when last received); and
o Most recent relevant labs, other diagnostic tests, and recent immunizations.

• Additional information, if any, outlined in the transfer agreement with the acute care

provider (See §483.70(i) for additional information).

NOTE: It may not be possible to convey all care plan information prior to urgent
transfers, however, this information must be conveyed as close as possible to the actual
time of transfer.

For residents being discharged (return not expected), the facility must convey all of the
information listed above, along with a copy of the required information found at §483.21(c)(2)
Discharge Summary, F661, as applicable. Communicating this information to the receiving
provider is one way the facility can reduce the risk of complications and adverse events during
the resident’s transition to a new setting.

Facilities may choose their own method of communicating transfer or discharge information,
such as a universal transfer form or an electronic health record summary, as long as the method
contains the required elements. The transferring or discharging facility may transmit the
information electronically in a secure manner which protects the resident’s privacy, as long as
the receiving facility has the capacity to receive and use the information. Communication of this

required information should occur as close as possible to the time of transfer or discharge.

INVESTIGATIVE PROTOCOL

Use the Critical Element (CE) Pathways for Discharge, or Hospitalization, as appropriate, along
with the above interpretive guidelines when determining if the facility meets the requirements
for, or investigating concerns related to the facility transfer or discharge requirements.

Summary of Investigative Procedure

Briefly review the most recent comprehensive assessment, comprehensive care plan, progress
notes, and orders to identify the basis for the transfer or discharge; during this review, identify
the extent to which the facility has developed and implemented interventions to avoid
transferring or discharging the resident, in accordance with the resident’s needs, goals for care
and professional standards of practice. This information will guide observations and interviews
to be made in order to corroborate concerns identified. NOTE: Always observe for visual cues
of psychosocial distress and harm (see Guidance on Severity and Scope Levels and Psychosocial
Outcome Severity Guide).

Deficiency Categorization

In addition to actual or potential physical harm, always consider whether psychosocial harm has
occurred when determining severity level (See Psychosocial Outcome Severity Guide,
https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/GuidanceforLawsAndRegulations/Nursing-Homes.html, select the Survey
Resources download and select the Psychosocial Outcome Severity Guide from the list of
resources.

Examples of Severity Level 4 Non-compliance: Immediate Jeopardy to Resident Health or
Safety include, but are not limited to:

• Facility initiated a discharge on the basis that the resident’s health had improved,
however, the resident and her family disagreed and filed an appeal. The facility did not
allow the resident to remain in the facility while the appeal was pending and dropped her
off at her daughter’s home. The resident’s daughter previously stated she could not care
for her mother at her home where needed medical equipment and wound care was not
available. The resident developed sepsis from inadequate wound management, and
remains hospitalized post-amputation of the infected limb.

• A facility initiated a discharge based on the facility’s inability to meet a resident’s needs.
However, upon complaint investigation, it was determined by interview and record
review that, while the resident was depressed and had challenging behavior requiring
staff attention, he did not have needs which could not be met in that facility, and there
was evidence that the facility was caring for other residents with similar challenging
behaviors. The resident was discharged to the street and found by a passerby in the street,
rolled up in a tarp, and in a health condition requiring immediate medical attention.

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Nursing-Homes.html

Examples of Severity Level 3 Noncompliance: Actual Harm that is not Immediate
Jeopardy include, but are not limited to:

• The facility failed to allow a resident to remain in the facility after his skilled
rehabilitation ended and while his application for Medical Assistance was pending. The
resident consequently was discharged to another facility that was located further from the
resident’s family, resulting in the resident expressing persistent sadness and withdrawal
from social activities.

• A facility initiated a resident’s discharge after the resident attempted to hit a staff member
during morning care over several days. The facility discharged the resident claiming the
resident was a danger to others. Upon investigation of a complaint, it was determined the
facility had been failing to provide the resident with pain medication prior to morning
care in accordance with the care plan. Evidence also showed the resident had never
attempted to hit staff when pain was managed according to the care plan, therefore the
resident was not actually a danger to others. There was also no documentation of the
facility’s attempts to meet the resident’s needs or what services the new receiving facility
had in order to meet the resident’s needs. During an interview with the resident, the
surveyor found the resident was not happy in the new facility and was no longer
participating in activities or therapy, resulting in a significant decreased ability to perform
ADLs.

An example of Severity Level 2 Noncompliance: No Actual Harm with Potential for More
Than Minimal Harm that is Not Immediate Jeopardy includes, but is not limited to:

• A facility transferred a resident to the hospital emergently due to a change in condition.
The facility failed to provide the hospital with contact information for the practitioner
responsible for the resident’s care leading to a delay in admitting the resident.

An example of Severity Level 1 noncompliance: The failure to permit the resident to
remain in the facility, document the resident’s transfer or discharge, and communicate
necessary information to the receiving provider places the resident at risk for more than
minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement.

F623
(Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24)

§483.15(c)(3) Notice before transfer.

Before a facility transfers or discharges a resident, the facility must—

(i) Notify the resident and the resident’s representative(s) of the transfer or discharge
and the reasons for the move in writing and in a language and manner they
understand. The facility must send a copy of the notice to a representative of the
Office of the State Long-Term Care Ombudsman.

(ii) Record the reasons for the transfer or discharge in the resident’s medical record in
accordance with paragraph (c)(2) of this section; and

(iii) Include in the notice the items described in paragraph (c)(5) of this section.

§483.15(c)(4) Timing of the notice.

(i) Except as specified in paragraphs (c)(4)(ii) and (c)(8) of this section, the notice of
transfer or discharge required under this section must be made by the facility at
least 30 days before the resident is transferred or discharged.

(ii) Notice must be made as soon as practicable before transfer or discharge when—
(A) The safety of individuals in the facility would be endangered under paragraph

(c)(1)(i)(C) of this section;
(B) The health of individuals in the facility would be endangered, under paragraph

(c)(1)(i)(D) of this section;
(C) The resident’s health improves sufficiently to allow a more immediate transfer

or discharge, under paragraph (c)(1)(i)(B) of this section;
(D) An immediate transfer or discharge is required by the resident’s urgent medical

needs, under paragraph (c)(1)(i)(A) of this section; or
(E) A resident has not resided in the facility for 30 days.

§483.15(c)(5) Contents of the notice. The written notice specified in paragraph (c)(3) of this
section must include the following:

(i) The reason for transfer or discharge;
(ii) The effective date of transfer or discharge;
(iii) The location to which the resident is transferred or discharged;
(iv) A statement of the resident’s appeal rights, including the name, address (mailing

and email), and telephone number of the entity which receives such requests; and
information on how to obtain an appeal form and assistance in completing the form
and submitting the appeal hearing request;

(v) The name, address (mailing and email) and telephone number of the Office of the
State Long-Term Care Ombudsman;

(vi) For nursing facility residents with intellectual and developmental disabilities or
related disabilities, the mailing and email address and telephone number of the
agency responsible for the protection and advocacy of individuals with
developmental disabilities established under Part C of the Developmental
Disabilities Assistance and Bill of Rights Act of 2000 (Pub. L. 106-402, codified at 42
U.S.C. 15001 et seq.); and

(vii) For nursing facility residents with a mental disorder or related disabilities, the
mailing and email address and telephone number of the agency responsible for the
protection and advocacy of individuals with a mental disorder established under the
Protection and Advocacy for Mentally Ill Individuals Act.

§483.15(c)(6) Changes to the notice.

If the information in the notice changes prior to effecting the transfer or discharge, the
facility must update the recipients of the notice as soon as practicable once the updated
information becomes available.

§483.15(c)(8) Notice in advance of facility closure

In the case of facility closure, the individual who is the administrator of the facility must
provide written notification prior to the impending closure to the State Survey Agency, the
Office of the State Long-Term Care Ombudsman, residents of the facility, and the resident
representatives, as well as the plan for the transfer and adequate relocation of the
residents, as required at § 483.70(k).

DEFINITIONS

“Facility-initiated transfer or discharge”: A transfer or discharge which the resident objects
to, did not originate through a resident’s verbal or written request, and/or is not in alignment with
the resident’s stated goals for care and preferences.

“Transfer and Discharge”: Includes movement of a resident to a bed outside of the certified
facility whether that bed is in the same physical plant or not. Transfer and discharge does not
refer to movement of a resident to a bed within the same certified facility. (See §483.5)
Specifically, transfer refers to the movement of a resident from a bed in one certified facility
to a bed in another certified facility when the resident expects to return to the original facility.
Discharge refers to the movement of a resident from a bed in one certified facility to a bed in
another certified facility or other location in the community, when return to the original
facility is not expected.

GUIDANCE

The requirements at §§483.15(c)(3)-(6) only apply to facility-initiated transfers and
discharges, not resident-initiated transfers and discharges. This guidance will address the
requirement to send a notice in situations where the facility initiates a transfer or discharge,
including discharges that occur while the resident remains in the hospital after emergency
transfer.

Facility-initiated transfers and discharges generally occur when the facility determines it
should not, or cannot provide needed care or services to a resident in accordance with F622,
Transfer and Discharge Requirements. Whether or not a resident agrees with the facility’s
decision, the requirements at §483.15(c)(3)-(6) apply whenever a facility initiates the transfer

or discharge.

A resident-initiated transfer or discharge is one in which the resident has provided written or
verbal notice of their intent to leave the facility, which is documented in the resident’s record.
A resident’s expression of a general desire to return home or to the community or elopement
of a resident who is cognitively impaired should not be taken as a notice of intent to leave.
When a resident initiates his or her transfer or discharge, the medical record should contain
documentation or evidence of the resident’s or resident representative’s verbal or written
notice of intent to leave the facility, a discharge care plan, and documented discussions with
the resident or if appropriate his/her representative, containing details of discharge planning,
and arrangements for post- discharge care (See F660, Discharge Planning Process).
Additionally, the comprehensive care plan should contain the resident’s goals for admission
and desired outcomes, which should be in alignment with the discharge if it is resident
initiated.

Therapeutic leave is a type of resident-initiated transfer (See F625 for additional guidance on
therapeutic leave). However, if the facility makes a determination to not allow the resident to
return, the transfer becomes a facility-initiated discharge.

NOTE: Situations in which residents sign out of the facility or leave Against Medical Advice
(AMA) should be thoroughly investigated to determine if the discharge is facility- or resident-
initiated. If evidence reveals that a resident or resident representative was forced, pressured,
or intimidated into leaving AMA, the discharge would be considered a facility-initiated
discharge, requiring further investigation to determine compliance with the requirements at
483.15(c), including the requirement to provide a notice at F623. See additional guidance on
AMA discharges at F660 and guidance on Abuse, Neglect and Exploitation at F600.

Notice of Transfer or Discharge and Ombudsman Notification

For facility-initiated transfers or discharges of a resident, prior to the transfer or discharge, the
facility must notify the resident and the resident’s representative(s) of the transfer or discharge
and the reasons for the move in writing and in a language and manner they understand.
Additionally, the facility must send a copy of the notice of transfer or discharge to the
representative of the Office of the State Long-Term Care (LTC) Ombudsman. The intent of
sending copies of the notice to a representative of the Office of the State LTC Ombudsman is
to provide added protection to residents from being inappropriately transferred or discharged,
provide residents with access to an advocate who can inform them of their options and rights,
and to ensure that the Office of the State LTC Ombudsman is aware of facility practices and
activities related to transfers and discharges. The facility must maintain evidence that the
notice was sent to the Ombudsman. While Ombudsman Programs vary from state to state,
facilities should know the process for ombudsman notification in their state.

Facility-Initiated Transfers and Discharges

In situations where the facility has decided to discharge the resident while the resident is still
hospitalized, the facility must send a notice of discharge to the resident and resident

representative before the discharge, and must also send a copy of the discharge notice to a
representative of the Office of the State LTC Ombudsman. Notice to the Office of the State
LTC Ombudsman must occur at the same time the notice of discharge is provided to the
resident and resident representative, even though, at the time of initial emergency transfer,
sending a copy of the transfer notice to the ombudsman only needed to occur as soon as
practicable as described below.

For any other types of facility-initiated discharges, the facility must provide notice of discharge
to the resident and resident representative along with a copy of the notice to the Office of the
State LTC Ombudsman at least 30 days prior to the discharge or as soon as possible. The copy
of the notice to the ombudsman must be sent at the same time notice is provided to the resident
and resident representative.

Emergency Transfers–When a resident is temporarily transferred on an emergency basis to an
acute care facility, this type of transfer is considered to be a facility-initiated transfer and a
notice of transfer must be provided to the resident and resident representative as soon as
practicable before the transfer, according to 42 CFR §483.15(c)(4)(ii)(D). Copies of notices for
emergency transfers must also still be sent to the ombudsman, but they may be sent when
practicable, such as in a list of residents on a monthly basis, as long as the list meets all
requirements for content of such notices at §483.15(c)(5).

Resident-Initiated Transfers and Discharges

A resident-initiated transfer or discharge means the resident or, if appropriate, the resident
representative has provided verbal or written notice of intent to leave the facility. The medical
record must contain documentation or evidence of the resident’s or resident representative’s
verbal or written notice of intent to leave the facility. While a resident’s expression of a general
desire or goal to return home or to the community or the elopement of a resident who is
cognitively impaired should be taken into consideration for the purposes of discharge planning
and community placement, it should not be taken as notice of intent to leave the facility and
does not constitute a resident- initiated transfer or discharge. For resident-initiated transfers or
discharges, sending a copy of the notice to the ombudsman is not required because the notice
requirement does not apply to resident-initiated transfers or discharges.

Surveyors must determine whether a transfer or discharge is resident or facility-initiated. The
medical record should contain documentation or evidence of the resident’s or resident
representative’s verbal or written notice of intent to leave the facility, a discharge care plan, and
documented discussions with the resident or, if appropriate, his/her representative, containing
details of discharge planning and arrangements for post-discharge care (See F660, Discharge
Planning Process, and F661, Discharge Summary). Additionally, the comprehensive care plan
should contain the resident’s goals for admission and desired outcomes, which should be in
alignment with the discharge if it is resident-initiated. If a surveyor has concerns about whether
a resident- initiated transfer or discharge was actually a facility-initiated transfer or discharge,
the surveyor should investigate further through interviews and record review.

Contents of the Notice

The facility’s notice must include all of the following at the time notice is provided:

• The specific reason for the transfer or discharge, including the basis under
§§483.15(c)(1)(i)(A)-(F);

• The effective date of the transfer or discharge;
• The specific location (such as the name of the new provider or description and/or address

if the location is a residence) to which the resident is to be transferred or discharged;
• An explanation of the right to appeal the transfer or discharge to the State;
• The name, address (mail and email), and telephone number of the State entity which

receives such appeal hearing requests;
• Information on how to obtain an appeal form;
• Information on obtaining assistance in completing and submitting the appeal hearing

request; and
• The name, address (mailing and email), and phone number of the representative of the

Office of the State Long-Term Care ombudsman.

For nursing facility residents with intellectual and developmental disabilities (or related
disabilities) or with mental illness (or related disabilities), the notice must include the name,
mailing and e-mail addresses and phone number of the state agency responsible for the
protection and advocacy for these populations.

Timing of the Notice

Generally, this notice must be provided at least 30 days prior to the transfer or discharge of the
resident. Exceptions to the 30-day requirement apply when the transfer or discharge is affected
because:

• The health and/or safety of individuals in the facility would be endangered due to the
clinical or behavioral status of the resident;

• The resident’s health improves sufficiently to allow a more immediate transfer or
discharge;

• An immediate transfer or discharge is required by the resident’s urgent medical needs; or
• A resident has not resided in the facility for 30 days.

In these exceptional cases, the notice must be provided to the resident, resident’s
representative if appropriate, and LTC ombudsman as soon as practicable before the transfer
or discharge.

Changes to the Notice

If information in the notice changes, the facility must update the recipients of the notice as
soon as practicable with the new information to ensure that residents and their representatives
are aware of and can respond appropriately. For significant changes, such as a change in the
transfer or discharge destination, a new notice must be given that clearly describes the
change(s) and resets the transfer or discharge date in order to provide 30 day advance
notification and permit adequate time for discharge planning. Surveyors should be aware that

if a change in destination indicates that the original basis for discharge has changed, a new
notice is required and additional appeal rights may exist for the resident. This situation may
require further investigation to determine whether the facility is in compliance with the
Transfer and Discharge requirements at 42 CFR 483.15(c).

Example: A facility determines it cannot meet a resident’s needs and arranges for discharge to
another nursing home which can meet the resident’s needs. Before the discharge occurs, the
receiving facility declines to take the resident and the discharging facility changes the
destination to a setting that does not appear to meet the resident’s ongoing medical needs. This
could indicate that the basis for discharge has changed, and would require further investigation.

NOTE: Federal regulations at 42 CFR Part 431, Subpart E, Fair Hearings for Applicants and
Beneficiaries, address the requirements for States to implement a fair hearing process.

Notice in Advance of Facility Closure:

Refer to §483.70(k), F845 for guidance related to evaluating Notice in Advance of
Facility Closure.

F624
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.15(c)(7) Orientation for transfer or discharge.
A facility must provide and document sufficient preparation and orientation to residents to
ensure safe and orderly transfer or discharge from the facility. This orientation must be
provided in a form and manner that the resident can understand.

DEFINITIONS

“Transfer and Discharge”: Includes movement of a resident to a bed outside of the certified
facility whether that bed is in the same physical plant or not. Transfer and discharge does not
refer to movement of a resident to a bed within the same certified facility. (See §483.5)
Specifically, transfer refers to the movement of a resident from a bed in one certified facility
to a bed in another certified facility when the resident expects to return to the original facility.
Discharge refers to the movement of a resident from a bed in one certified facility to a bed in
another certified facility or other location in the community, when return to the original
facility is not expected.

GUIDANCE

The guidance at this tag addresses the immediate orientation and preparation necessary for a
facility-initiated transfer, such as to a hospital emergency room or therapeutic leave where
discharge planning is not required because the resident will return, or for an emergent or
immediate facility-initiated discharge where a complete discharge planning process is not
practicable. For concerns related to how the facility planned for a discharge that meets a
resident’s health and safety needs, as well as their preferences and goals in circumstances

which permit a complete discharge planning process, please refer to F660, Discharge
Planning.

Sufficient preparation and orientation means the facility informs the resident where he or she
is going, and takes steps under its control to minimize anxiety. Examples of preparation and
orientation may include explaining to a resident why they are going to the emergency room or
other location or leaving the facility; working with family or resident’s representative to assure
that the resident’s possessions (as needed or requested by the resident) are not left behind or
lost; and ensuring that staff handle transfers and discharges in a manner that minimizes anxiety
or depression and recognizes characteristic resident reactions identified by the resident’s
assessment and care plan.

The facility must orient and prepare the resident regarding his or her transfer or discharge in a
form and manner that the resident can understand. The form and manner of this orientation
and preparation must take into consideration factors that may affect the resident’s ability to
understand, such as educational level, language and/or communication barriers, and physical
and mental impairments. The facility must also document this orientation in the medical
record, including the resident’s understanding of the transfer or discharge.

Other tags for consideration would be:

• F622, Transfer and Discharge Requirements, specifically the clinical information that
must be conveyed to the receiving provider, if the transfer or discharge is to another
healthcare setting; and

• F843, Transfer Agreement, for concerns related to timely transfer to the acute care
facility.

PROCEDURES

• Review nursing notes and any other relevant documentation to see if appropriate
orientation and preparation of the resident prior to transfer and discharge has occurred.

• Through record review and interviews, determine if the resident received sufficient
preparation prior to transfer or discharge, and if they understood the information
provided to them.

• Were the resident’s needed/requested possessions transferred with the resident to the
new location?

Ask resident or his or her representative if they understand why the transfer or discharge
occurred.

F625
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.15(d) Notice of bed-hold policy and return—

§483.15(d)(1) Notice before transfer. Before a nursing facility transfers a resident to a
hospital or the resident goes on therapeutic leave, the nursing facility must provide written
information to the resident or resident representative that specifies—

(i) The duration of the state bed-hold policy, if any, during which the resident is
permitted to return and resume residence in the nursing facility;

(ii) The reserve bed payment policy in the state plan, under § 447.40 of this chapter, if
any;

(iii) The nursing facility’s policies regarding bed-hold periods, which must be consistent
with paragraph (e)(1 ) of this section, permitting a resident to return; and

(iv) The information specified in paragraph (e)(1) of this section.

§483.15(d)(2) Bed-hold notice upon transfer. At the time of transfer of a resident for
hospitalization or therapeutic leave, a nursing facility must provide to the resident and the
resident representative written notice which specifies the duration of the bed-hold policy
described in paragraph (d)(1) of this section.

INTENT
To ensure that residents are made aware of a facility’s bed-hold and reserve bed payment policy
before and upon transfer to a hospital or when taking a therapeutic leave of absence from the
facility.

DEFINITIONS
“Bed-hold”: Holding or reserving a resident’s bed while the resident is absent from the facility
for therapeutic leave or hospitalization.

“Reserve Bed Payment”: Payments made by a State to the facility to hold a bed during a
resident’s temporary absence from a nursing facility.

“Therapeutic Leave”: Absences for purposes other than required hospitalization.

GUIDANCE
Notice of Bed-Hold Policy
All facilities must have policies that address holding a resident’s bed during periods of absence,
such as during hospitalization or therapeutic leave. Additionally, facilities must provide written
information about these policies to residents prior to and upon transfer for such absences. This
information must be provided to all facility residents, regardless of their payment source.

These provisions require facilities to issue two notices related to bed-hold policies. The first
notice could be given well in advance of any transfer, i.e., information provided in the admission
packet. Reissuance of the first notice would be required if the bed-hold policy under the State
plan or the facility’s policy were to change.

The second notice must be provided to the resident, and if applicable the resident’s
representative, at the time of transfer, or in cases of emergency transfer, within 24 hours. It is
expected that facilities will document multiple attempts to reach the resident’s representative in
cases where the facility was unable to notify the representative.

The notice must provide information to the resident that explains the duration of bed-hold, if any,
and the reserve bed payment policy. It should also address permitting the return of residents to
the next available bed.

When a resident residing in a skilled nursing facility under Medicare is hospitalized or takes
therapeutic leave, Medicare will not pay to hold the bed. Facility policies may allow the resident
to pay privately to hold his or her bed. While the provisions of this requirement specifically
address bed-hold under Medicaid law, facilities must make all residents aware in writing of their
policies related to holding beds during absences from the facility.

NOTE: Residents not covered by Medicare or Medicaid, may be permitted to privately provide
reserve bed payments.

Medicaid law requires each state Medicaid plan to address bed-hold policies for hospitalization
and periods of therapeutic leave. State plans vary in payment for and duration of bed-holds.
However, federal regulations do not require states to pay nursing facilities for holding beds while
the resident is away from the facility. In general, the State plan sets the length of time, if any,
that the state will pay the facility for holding a bed for a Medicaid-eligible resident. It is the
responsibility of the survey team to know the bed-hold policies of their State Medicaid plan.

Additionally, §483.15 (e)(1) and F626 require facilities to permit residents to return to the
facility immediately to the first available bed in a semi-private room.

As stated above, a participating facility must provide notice to its residents and if applicable,
their representatives, of the facility’s bed-hold policies, as stipulated in each State’s plan. This
notice must be provided prior to and upon transfer and must include information on how long a
facility will hold the bed, how reserve bed payments will be made (if applicable), and the
conditions upon which the resident would return to the facility. These conditions are:

• The resident requires the services which the facility provides; and
• The resident is eligible for Medicare skilled nursing facility services or Medicaid nursing

facility services.

Bed-hold for days of absence in excess of the State’s bed-hold limit is considered a non-covered
service which means that the resident could use his/her own income to pay for the bed-hold.
However, if a resident does not elect to pay to hold his or her bed, the resident will be permitted
to return to the next available bed, consistent with the requirements at §483.15(e).

The provision at §483.15(d)(1)(ii) references regulations for Medicaid Payments for Reserving
Beds in Institutions (§447.40), which state “Absences for purposes other than required
hospitalization (which cannot be anticipated and planned) are included in the patient’s plan of
care.” This means that therapeutic leave of absence must be consistent with the resident’s goals
for care, be assessed by the comprehensive assessment, and incorporated into the comprehensive
care plan, and cannot be a means of involuntarily discharging the resident.

INVESTIGATIVE PROTOCOL
Use the Critical Element (CE) Pathways for Community Discharge, or Hospitalization, as
appropriate, along with the above interpretive guidelines when determining if the facility meets
the requirements for, or investigating concerns related to the facility requirements for bed-hold.

Summary of Investigative Procedure
If concerns arise regarding notice of bed-hold, review the medical record for evidence of whether
a notice of bed-hold was provided both (1) prior to and (2) upon transfer. Look for
documentation such as a copy of the dated notice(s), progress notes, transfer checklist(s), or
other evidence that the notice was given. Additionally, ask to review facility policies on bed-
hold. Review the facility’s admission packet to determine if notice of bed-hold is given at
admission. If not, determine how the facility notifies residents prior to transfer.
Ask the resident, or if applicable, the resident’s representative(s), whether they received the bed-
hold notice and understand the facility’s bed-hold policy. If not, determine how the facility
notifies residents of this information prior to transfer.

F626
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.15(e)(1) Permitting residents to return to facility.
A facility must establish and follow a written policy on permitting residents to return to the
facility after they are hospitalized or placed on therapeutic leave. The policy must provide
for the following.

(i) A resident, whose hospitalization or therapeutic leave exceeds the bed-hold period
under the State plan, returns to the facility to their previous room if available or
immediately upon the first availability of a bed in a semi-private room if the
resident—

(A) Requires the services provided by the facility; and
(B) Is eligible for Medicare skilled nursing facility services or Medicaid nursing

facility services.
(ii) If the facility that determines that a resident who was transferred with an

expectation of returning to the facility, cannot return to the facility, the facility must
comply with the requirements of paragraph (c) as they apply to discharges.

§483.15(e)(2) Readmission to a composite distinct part. When the facility to which a
resident returns is a composite distinct part (as defined in § 483.5), the resident must be
permitted to return to an available bed in the particular location of the composite distinct
part in which he or she resided previously. If a bed is not available in that location at the
time of return, the resident must be given the option to return to that location upon the
first availability of a bed there.

INTENT

To ensure that facilities develop and implement policies that address permitting residents to

return to the facility after a hospitalization or therapeutic leave. Specifically, residents who are
hospitalized or on therapeutic leave are allowed to return to the facility for skilled nursing or
nursing facility care or services. When a facility does not allow the resident to return, the
facility has initiated a discharge, and the facility must comply with Transfer and Discharge
Requirements at §483.15(c). The resident must be permitted to return and resume residence in
the facility while an appeal of the discharge is pending.

DEFINITIONS

Bed-hold: Holding or reserving a resident’s bed while the resident is absent from the facility
for therapeutic leave or hospitalization.

“Composite Distinct Part”: A composite distinct part is a distinct part consisting of two or
more noncontiguous components that are not located within the same campus, as that term is
defined in §413.65(a)(2). The definition and additional requirements specific to SNF/NF
composite distinct parts are found at §483.5.

“Campus”: Campus is defined in §413.65(a)(2) and means the physical area immediately
adjacent to the provider’s main buildings, other areas and structures that are not strictly
contiguous to the main buildings but are located within 250 yards of the main buildings, and
any other areas determined on an individual case basis, by the CMS regional office, to be part
of the provider’s campus.

“Distinct Part”: A distinct part SNF or NF is physically distinguishable from the larger
institution or institutional complex that houses it, meets the requirements of paragraph (2) of
this definition at §483.5, and meets the applicable statutory requirements for SNFs or NFs in
sections 1819 or 1919 of the Act, respectively. A distinct part SNF or NF may be comprised of
one or more buildings or designated parts of buildings (that is, wings, wards, or floors) that
are: In the same physical area immediately adjacent to the institution’s main buildings; other
areas and structures that are not strictly contiguous to the main buildings but are located within
close proximity of the main buildings; and any other areas that CMS determines on an
individual basis, to be part of the institution’s campus. A distinct part must include all of the
beds within the designated area, and cannot consist of a random collection of individual rooms
or beds that are scattered throughout the physical plant. The term “distinct part” also includes a
composite distinct part that meets the additional requirements specified in the definition of
“composite distinct part” of §483.5 described above. Requirements specific to distinct part
SNFs or NFs are found at §483.5.

“Therapeutic Leave”: Resident absences for purposes other than required hospitalization.

GUIDANCE §483.15(e)

Facilities must develop and implement policies for bed-hold and permitting residents to return
following hospitalization or therapeutic leave. These policies apply to all residents,
regardless of their payment source. The facility policies must provide that residents who
seek to return to the facility within the bed-hold period defined in the State plan are allowed
to return to their previous room, if available. Additionally, residents who seek to return to the

facility after the expiration of the bed-hold period or when state law does not provide for bed-
holds are allowed to return to their previous room if available or immediately to the first
available bed in a semi-private room provided that the resident:

• Still requires the services provided by the facility; and
• Is eligible for Medicare skilled nursing facility or Medicaid nursing facility

services.

The policies must also provide that if the facility determines that a resident cannot return, the
facility must comply with the requirements of paragraph at 42 CFR 483.15(c) as they apply to
facility-initiated discharges.

Medicaid-eligible residents must be permitted to return to the first available bed even if the
residents have outstanding Medicaid balances.

Not Permitting Residents to Return

Not permitting a resident to return following hospitalization or therapeutic leave constitutes a
facility-initiated discharge and requires a facility to meet the requirements as outlined in
§483.15(c)(1)(ii). A facility must not discharge a resident unless:

1. The discharge or transfer is necessary for the resident’s welfare and the facility cannot
meet the resident’s needs.

2. The resident’s health has improved sufficiently so that the resident no longer needs the
services of the facility.

3. The resident’s clinical or behavioral status endangers the safety of individuals in the
facility.

4. The resident’s clinical or behavioral status endangers the health of individuals in the
facility.

5. The resident has failed, after reasonable and appropriate notice, to pay for (or to have
paid under Medicare or Medicaid) his or her stay at the facility which applies if:

• the resident does not submit the necessary paperwork for third party payment; or
• the third party, including Medicare or Medicaid, denies the claim and the resident

refuses to pay for his or her stay.
6. The facility ceases to operate.

For concerns related to a facility not permitting a resident to return, the surveyor should
investigate to determine if the basis for discharge meets one of the requirements listed above
which are also found at F622, §483.15(c)(1)(i)(A) through (F)).

As noted at §483.15(c)(2)(i)(B), when the facility transfers or discharges a resident for the
resident’s welfare, or because the resident’s needs cannot be met in the facility, the medical
record must contain documentation of the specific resident needs that cannot be met, facility
attempts to meet those needs, and the service available at the receiving facility to meet the needs.

Resident decisions to refuse care should not be considered a basis for transfer or discharge
unless the refusal poses a risk to the resident’s or other individuals’ health and/or safety. In
situations where a resident’s choice to refuse care or treatment poses a risk to the resident’s or
others’ health or safety, the comprehensive care plan must identify the care or service being
declined, the risk the declination poses to the resident, and efforts by the interdisciplinary team
to educate the resident and the representative, as appropriate (See F656, §483.21(b)(1)(ii),
Comprehensive Care Plans.)

If unable to resolve situations where a resident’s refusal for care poses a risk to the resident’s or
others’ health or safety, the facility administration, nursing and medical director may wish to
convene an ethics meeting, which includes legal consultation, in order to determine if the facility
can meet the resident’s needs, or if the resident should be transferred or discharged.

If a facility does not permit a resident who went on therapeutic leave to return, the facility
must meet the requirements for a facility-initiated discharge at F622. Because the facility was
able to care for the resident prior to therapeutic leave, documentation related to the basis for
discharge must clearly show why the facility can no longer care for the resident.

Additionally, facilities must not treat situations where a resident goes on therapeutic leave and
returns later than agreed upon, as a resident-initiated discharge. The resident must be permitted
to return and be appropriately assessed for any ill-effects from being away from the facility
longer than expected, and provide any needed medications or treatments which were not
administered because they were out of the building. If a resident has not returned from
therapeutic leave as expected, the medical record should show evidence that the facility
attempted to contact the resident and resident representative. The facility must not initiate a
discharge unless it has ascertained from the resident or resident representative that the resident
does not wish to return.

NOTE: Situations in which residents sign out of the facility or leave Against Medical Advice
(AMA) should be thoroughly investigated to determine if the discharge is facility- or resident-
initiated. If evidence reveals that a resident or resident representative was forced, pressured, or
intimidated into leaving AMA, the discharge would be considered a facility-initiated discharge,
requiring further investigation to determine compliance with the requirements at 483.15(c),
including the requirement to provide a notice at F623. See additional guidance on AMA
discharges at F660 and guidance on Abuse, Neglect and Exploitation at F600.

A facility may have concerns about permitting a resident to return to the facility after a hospital
stay due to the resident’s clinical or behavioral condition at the time of transfer.
The facility must not evaluate the resident based on his or condition when originally transferred
to the hospital. If the facility determines it will not be permitting the resident to return, the
medical record should show evidence that the facility made efforts to:

• Determine if the resident still requires the services of the facility and is eligible for Medicare
skilled nursing facility or Medicaid nursing facility services.

• Ascertain an accurate status of the resident’s condition—this can be accomplished via
communication between hospital and nursing home staff and/or through visits by nursing

home staff to the hospital.

• Find out from the hospital the treatments, medications, and services the facility would
need to provide to meet the resident’s needs upon returning to the facility. If the facility is
unable to provide the treatments, medications, and services needed, the facility may not be
able to meet the resident’s needs. For example, a resident now requires ventilator care or
dialysis, and the nursing home is unable to provide this same level of care.

• Work with the hospital to ensure the resident’s condition and needs are within the nursing
home’s scope of care, based on its facility assessment, prior to hospital discharge. For
example, the nursing home could ask the hospital to:
o Attempt reducing a resident’s psychotropic medication prior to discharge and

monitor symptoms so that the nursing home can determine whether it will be able to
meet the resident’s needs upon return;

o Convert IV medications to oral medications and ensure that the oral
medications adequately address the resident’s needs.

If the facility does not permit a resident’s return to the facility (i.e., initiates a discharge) based
on inability to meet the resident’s needs, documentation must be in accordance with
requirements at §483.15(c)(2)(i)(B). The facility must notify the resident, his or her
representative, and the LTC ombudsman in writing of the discharge, including notification of
appeal rights. (§483.15(c)(3) and (5)(iv)) If the resident chooses to appeal the discharge, the
facility must allow the resident to return to his or her room or an available bed in the nursing
home during the appeal process, unless there is documented evidence that the resident’s return
would endanger the health or safety of the resident or other individuals in the facility. (§483.15
(c)(1)(ii))

For concerns regarding notification of discharge, and the resident’s right to appeal the
discharge, refer to the regulation and guidance at §§483.15(c)(3)-(5)(F623).

Composite Distinct Part

If a facility does not have a composite distinct part, §483.15(e)(2) does not apply. When a
resident is returning to a composite distinct part, he/she must be allowed to return to an
available bed in the particular location of the composite distinct part in which he/she resided
previously, or the next available bed in that location.
NOTE: If there are concerns as to whether or not a facility is appropriately certified as a
distinct or composite distinct part, consult with the CMS Location for clarification.

INVESTIGATIVE PROTOCOL

Use the Critical Element (CE) Pathways for Discharge, or Hospitalization, as appropriate,
along with the above interpretive guidelines when determining if the facility meets the
requirements for, or investigating concerns related to the facility requirements to permit
residents to return following hospitalization or therapeutic leave.

Summary of Investigative Procedure

If concerns arise regarding facility failure to permit a resident to return, review the medical
record for evidence of whether a notice of transfer and discharge and notice of bed-hold
were provided. Determine the basis for discharge and how the facility evaluated the resident.
The surveyor may have to obtain hospital records for further investigation. Review any
other documentation necessary to ascertain the extent to which the facility made efforts to
enable the resident to return.

In cases where a facility did not allow a resident to return due to lack of an available bed, the
surveyor should review facility admissions beginning with when the resident was ready to
return to determine whether the facility held the resident’s bed in accordance with its bed-hold
policies, or, if the resident’s stay outside of the facility exceeded the bed-hold period, whether
there was an available bed at the time the resident sought return to the facility. If there was
not an available bed at the time the resident sought return to the facility, the surveyor should
determine whether or not the resident was allowed to return to the first available bed in a
semi-private room.

When a facility alleges they cannot meet the resident’s needs and does not allow a resident to
return, the surveyor should 1) investigate why the resident’s needs cannot be met; and 2) review
facility admissions to determine if residents with similar care needs have been admitted or
permitted to remain, which could indicate the facility has the capability to meet the needs of the
resident who is not being allowed to return and demonstrates noncompliance with this
requirement.

KEY ELEMENTS OF NONCOMPLIANCE to cite deficient practice at F626, the
surveyor’s investigation will generally show that the facility failed to:

• Establish and/or implement a policy that is in accordance with the State Medicaid plan,
and addresses returning to the facility following hospitalization or therapeutic leave; or

• Ensure that residents whose hospitalization or therapeutic leave exceeds the State’s bed-
hold period are returned to their previous room and/or the first available bed in a semi-
private room; or

• Permit a resident to return to the same composite distinct part in which they previously
resided.

DEFICIENCY CATEGORIZATION

In addition to actual or potential physical harm, always consider whether psychosocial harm
has occurred when determining severity level (See Psychosocial Outcome Severity Guide).

Examples of Severity Level 4 Non-compliance: Immediate Jeopardy to Resident
Health or Safety include, but are not limited to:

Facility failed to allow a resident to return following therapeutic leave to a family
member’s home, resulting in the resident being found living on the street, without

adequate food and shelter, and susceptible to serious accidents.

Examples of Severity Level 3 Noncompliance: Actual Harm that is not Immediate
Jeopardy include, but are not limited to:

• Facility failed to allow a resident to return to an available bed in the same location of the
composite distinct part in which they resided previously. The new location was not on
the same campus where the resident previously resided, and was farther from the
resident’s family, resulting in the resident expressing sustained and persistent sadness
and withdrawal.

• After transfer to a behavioral health hospital, a facility failed to allow a resident to
return to the facility where the resident had lived for several months. The facility then
refused to allow the resident to return to the facility when the hospitalization ended,
resulting in the resident being transferred from the hospital to a different nursing home
40 minutes away, where he did not know anyone, and where he developed increased
anxiety and depression.

An example of Severity Level 2 Noncompliance: No Actual Harm with Potential for
More Than Minimal Harm that is Not Immediate Jeopardy includes, but is not limited
to:

• Facility failed to allow a resident to return to his/her previous room (even though it was
available) upon return from the hospital, which resulted in no more than minimal harm as
the resident adjusted to the new room. This noncompliance has the potential to cause
more than minimal psychosocial harm.

An example of Severity Level 1 noncompliance: No actual harm with potential for
minimal harm includes, but is not limited to:

A facility which is a composite distinct part permitted a resident to return following
hospitalization or therapeutic leave, however, the resident returned to a different location in the
composite distinct part even though a bed was available in the same location where the resident
had resided prior to transfer. The resident did not express displeasure with the situation.

F635
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.20(a) Admission orders
At the time each resident is admitted, the facility must have physician orders for the
resident’s immediate care.

INTENT §483.20(a)
To ensure each resident receives necessary care and services upon admission.

GUIDANCE §483.20(a)
“Physician orders for immediate care” are those written and/or verbal orders facility staff need to
provide essential care to the resident, consistent with the resident’s mental and physical status

upon admission to the facility. These orders should, at a minimum, include dietary, medications
(if necessary) and routine care to maintain or improve the resident’s functional abilities until staff
can conduct a comprehensive assessment and develop an interdisciplinary care plan.

F636
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.20 Resident Assessment
The facility must conduct initially and periodically a comprehensive, accurate,
standardized reproducible assessment of each resident’s functional capacity.

§483.20(b) Comprehensive Assessments
§483.20(b)(1) Resident Assessment Instrument. A facility must make a comprehensive
assessment of a resident’s needs, strengths, goals, life history and preferences, using the
resident assessment instrument (RAI) specified by CMS. The assessment must include at
least the following:

(i) Identification and demographic information
(ii) Customary routine.
(iii) Cognitive patterns.
(iv) Communication.
(v) Vision.
(vi) Mood and behavior patterns.
(vii) Psychological well-being.
(viii) Physical functioning and structural problems.
(ix) Continence.
(x) Disease diagnosis and health conditions.
(xi) Dental and nutritional status.
(xii) Skin Conditions.
(xiii) Activity pursuit.
(xiv) Medications.
(xv) Special treatments and procedures.
(xvi) Discharge planning.
(xvii) Documentation of summary information regarding the additional assessment

performed on the care areas triggered by the completion of the Minimum Data Set
(MDS).

(xviii) Documentation of participation in assessment. The assessment process must
include direct observation and communication with the resident, as well as
communication with licensed and nonlicensed direct care staff members on all
shifts.

§483.20(b)(2) When required. Subject to the timeframes prescribed in §413.343(b) of this
chapter, a facility must conduct a comprehensive assessment of a resident in accordance
with the timeframes specified in paragraphs (b)(2)(i) through (iii) of this section. The
timeframes prescribed in §413.343(b) of this chapter do not apply to CAHs.

(i) Within 14 calendar days after admission, excluding readmissions in which there is no
significant change in the resident’s physical or mental condition. (For purposes of

this section, “readmission” means a return to the facility following a temporary
absence for hospitalization or therapeutic leave.)

***
(iii)Not less than once every 12 months.

INTENT §483.20(b)(1)-(2)(i) & (iii)
To ensure that the Resident Assessment Instrument (RAI) is used, in accordance with specified
format and timeframes, in conducting comprehensive assessments as part of an ongoing process
through which the facility identifies each resident’s preferences and goals of care, functional and
health status, strengths and needs, as well as offering guidance for further assessment once
problems have been identified.

DEFINITIONS §483.20(b)(1)-(2)(i) & (iii)
“Minimum Data Set”: The Minimum Data Set (MDS) is part of the U.S. federally mandated
process for clinical assessment of all residents in Medicare or Medicaid-certified nursing homes.
It is a core set of screening, clinical and functional status elements, including common
definitions and coding categories, which forms the foundation of a comprehensive assessment.

“Care Area Assessment (CAA) Process” is a process outlined in Chapter 4 of the MDS manual
designed to assist the assessor to systematically interpret the information recorded on the MDS.
Once a care area has been triggered, nursing home providers use current, evidence-based clinical
resources to conduct an assessment of the potential problem and determine whether or not to care
plan for it. The CAA process helps the clinician to focus on key issues identified during the
assessment process so that decisions as to whether and how to intervene can be explored with the
resident. This process has three components:

• Care Area Triggers (CATs) are specific resident responses for one or a combination of
MDS elements. The triggers identify residents who have or are at risk for developing
specific functional problems and require further assessment.

• Care Area Assessment (CAA) is the further investigation of triggered areas, to
determine if the care area triggers require interventions and care planning.

• CAA Summary (Section V of the MDS) provides a location for documentation of the
care area(s) that have triggered from the MDS, the decisions made during the CAA
process regarding whether or not to proceed to care planning, and the location and date of
the CAA documentation.

“Comprehensive Assessment” includes the completion of the MDS as well as the CAA
process, followed by the development and/or review of the comprehensive care plan.
Comprehensive MDS assessments include Admission, Annual, Significant Change in Status
Assessment and Significant Correction to Prior Comprehensive Assessment.

“Resident Assessment Instrument (RAI)” consists of three basic components: the Minimum
Data Set (MDS) version 3.0, the Care Area Assessment (CAA) process and the RAI utilization
guidelines. The utilization of these components of the RAI yields information about a resident’s
functional status, strengths, weaknesses, and preferences, as well as offering guidance on further
assessment once problems have been identified.

“Utilization Guidelines” provide instructions for when and how to use the RAI. The Utilization
Guidelines are also known as the Long-Term Care Facility Resident Assessment Instrument 3.0
User’s Manual.

GUIDANCE §483.20(b)(1)-(2(i) & (iii)
Each facility must use the RAI specified by CMS (which includes the MDS, utilization
guidelines and the CAAs) to assess each resident. The facility is responsible for addressing all
needs and strengths of residents regardless of whether the issue is included in the MDS or CAAs.
The scope of the RAI does not limit the facility’s responsibility to assess and address all care
needed by the resident.

The information required in §483.20(b)(1)(i-xviii) is incorporated into the MDS, which forms the
core of the RAI process. Additional assessment information is also gathered using triggered Care
Area Assessments (CAAs) after the completion of the comprehensive MDS.

The facility is expected to use resident observation and communication as the primary source of
information when completing the RAI. In addition to record review, direct observation and
communication with the resident, the facility must use a variety of other sources, including
communication with licensed and non-licensed staff members on all shifts and may include
discussions with the resident’s physician, the resident’s representative, family members, or
outside consultants.

At a minimum, facilities are required to complete a comprehensive assessment of each resident
within 14 calendar days after admission to the facility, when there is a significant change in the
resident’s status and not less than once every 12 months while a resident. For the purpose of this
guidance, not less than once every 12 months means within 366 days.

For additional requirements regarding a Significant Change in Status Assessment, see
§483.20(b)(2)(ii).

If a comprehensive assessment was completed, any time prior to a temporary absence for
hospitalization or a leave of absence, and upon return to the facility, the resident does not meet the
criteria for a Significant Change in Status Assessment (SCSA), as defined in §483.20(b)(2)(ii), a
comprehensive assessment is not required. For example, a resident had a comprehensive
assessment completed within 14 days of admission, four months later was hospitalized, then
returned to the facility. Upon return to the facility, the resident’s status does not meet the criteria
for a SCSA, therefore a comprehensive assessment is not required.

For additional information on assessment scheduling and completion requirements, see Chapter 2
of the Long-Term Care Facility Resident Assessment Instrument 3.0 User’s Manual. Link to the
LTCF RAI User’s Manual: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-
Assessment-Instruments/NursinghomeQualityInits/MDS30RAIManual.html.

The facility must use the RAI process to develop a comprehensive care plan, to provide the
appropriate care and services for each resident, and to modify the care plan and care/services
based on the resident’s status.

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursinghomeQualityInits/MDS30RAIManual.html

PROBES §483.20(b)(1)-(2)(i) & (iii)

• Did the facility complete a comprehensive assessment, using the CMS-specified RAI
process, within the regulatory timeframes (i.e. within 14 days after admission and at least
annually) for each resident in the sample?

• Is there evidence in the clinical record that the facility gathered and analyzed
supplemental information based on the triggered CAAs prior to developing the
comprehensive care plan? For reference a list of CAAs is found in Section V of the MDS
(Care Area Assessment Summary).

• Is there evidence of resident and/or resident representative participation in the assessment
process? Examples include participating in the resident interviews, providing
information about preferences or discharge goals.

• Ask licensed and non-licensed direct-care staff if they participate in the resident
assessment process.

• Does the facility have a system in place to assure assessments are conducted in
accordance with the specified timeframes for each resident?

F637
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.20(b)(2)(ii) Within 14 days after the facility determines, or should have determined,
that there has been a significant change in the resident’s physical or mental condition. (For
purpose of this section, a “significant change” means a major decline or improvement in
the resident’s status that will not normally resolve itself without further intervention by
staff or by implementing standard disease-related clinical interventions, that has an impact
on more than one area of the resident’s health status, and requires interdisciplinary review
or revision of the care plan, or both.)

INTENT §483.20(b)(2)(ii)
To ensure that each resident who experiences a significant change in status is comprehensively
assessed using the CMS-specified Resident Assessment Instrument (RAI) process.

DEFINITIONS §483.20(b)(2)(ii)
“Significant Change” is a major decline or improvement in a resident’s status that 1) will not
normally resolve itself without intervention by staff or by implementing standard disease-related
clinical interventions; the decline is not considered “self-limiting” (NOTE: Self-limiting is when
the condition will normally resolve itself without further intervention or by staff implementing
standard clinical interventions to resolve the condition.); 2) impacts more than one area of the
resident’s health status; and 3) requires interdisciplinary review and/or revision of the care plan.
This does not change the facility’s requirement to immediately consult with a resident’s
physician of changes as required under 42 CFR §483.10(i)(14), F580.

“Significant Change in Status Assessment (SCSA)” is a comprehensive assessment that must
be completed when the Interdisciplinary Team (IDT) has determined that a resident meets the
significant change guidelines for either major improvement or decline.

“Assessment Reference Date (ARD)” is the specific end point for the look-back periods in the
Minimum Data Set (MDS) assessment process. This look-back period is also called the
observation or assessment period.

GUIDANCE §483.20(b)(2)(ii)
A SCSA including Care Area Assessments (CAAs) must be completed within 14 days after a
determination has been made that a significant change in the resident’s status from baseline
occurred. This may be determined by comparison of the resident’s current status to the most
recent comprehensive assessment and most recent Quarterly assessment, and the resident’s
condition is not expected to return to baseline within 2 weeks. A SCSA is appropriate if there
are either two or more MDS areas of decline or two or more MDS areas of improvement or if the
IDT determines that the resident would benefit from the SCSA assessment and subsequent care
plan revision. The facility should document in the medical record when the determination is
made that the resident meets the criteria for a Significant Change in Status Assessment.

A Significant Change in Status MDS is required when:

• A resident enrolls in a hospice program; or
• A resident changes hospice providers and remains in the facility; or
• A resident receiving hospice services discontinues those services; or
• A resident experiences a consistent pattern of changes, with either two or more areas of

decline or two or more areas of improvement, from baseline (as indicated by comparison
of the resident’s current status to the most recent CMS-required MDS).

Examples of Decline include, but are not limited to:

• Resident’s decision-making ability has changed;
• Presence of a resident mood item not previously reported by the resident or staff and/or

an increase in the symptom frequency, e.g., increase in the number of areas where
behavioral symptoms are coded as being present and/or the frequency of a symptom
increases for items in Section E Behavior;

• Changes in frequency or severity of behavioral symptoms of dementia that indicate
progression of the disease process since last assessment;

• Any decline in an ADL physical functioning area (at least 1) where a resident is newly
coded as Extensive assistance, Total dependence, or Activity did not occur since last
assessment and does not reflect normal fluctuations in that individual’s functioning;

• Resident’s incontinence pattern changes or there was placement of an indwelling
catheter;

• Emergence of unplanned weight loss problem (5% change in 30 days or 10% change in
180 days).

• Emergence of a new pressure ulcer at Stage 2 or higher, a new unstageable pressure
ulcer/injury, a new deep tissue injury or worsening in pressure ulcer status;

• Resident begins to use a restraint of any type, when it was not used before;
• Emergence of a condition/disease in which a resident is judged to be unstable.

Examples of Improvement include, but are not limited to:

• Any improvement in ADL physical functioning area (at least 1) where a resident is newly
coded as Independent, Supervision, or Limited assistance since last assessment and does

not reflect normal fluctuations in that individual’s functioning;
• Decrease in the number of areas where behavioral symptoms are coded as being present

and/or the frequency of a symptom decreases;
• Resident’s decision making ability improves;
• Resident’s incontinence pattern improves;

If there is only one change, the resident may still benefit from a SCSA as determined by the IDT or
as initiated by the resident based on changes in the care plan. It is important to remember that each
resident’s situation is unique. The facility must document a rationale, in the resident’s medical
record, for completing a SCSA that does not meet the criteria for completion.

The facility may not complete a SCSA until after a Comprehensive Admission assessment has
been completed.

A Significant Change in Status MDS is considered timely when:

• The RN Assessment Coordinator signs the MDS as complete at section Z0500B &
V0200B2 by the 14th calendar day after the determination that a significant change has
occurred (determination date + 14 calendar days).

If a SCSA MDS is completed, the next annual assessment is not due until 366 days after the
ARD of the significant change in status assessment.

NOTE: For information on assessment scheduling for the MDS, see Chapter 2 of the Long-
Term Care Facility Resident Assessment Instrument 3.0 User’s Manual. Link to the LTCF RAI
User’s Manual: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/NursinghomeQualityInits/MDS30RAIManual.html.

Circumstances when a change in resident status is not significant include, but are not limited to:

• Short-term acute illness, such as a mild fever secondary to a cold from which the IDT
expects the resident to fully recover.

• Well-established, predictable cyclical patterns of clinical signs and symptoms associated
with previously diagnosed conditions (e.g., depressive symptoms in a resident previously
diagnosed with bipolar disease would not precipitate a Significant Change Assessment).

• Instances in which the resident continues to make steady progress under the current
course of care. Reassessment is required only when the condition has stabilized.

• Instances in which the resident has stabilized but is expected to be discharged in the
immediate future. The facility has engaged in discharge planning with the resident and
family, and a comprehensive reassessment is not necessary to facilitate discharge
planning.

PROBES §483.20(b)(2)(ii)

• Did the facility identify, in a timely manner, those residents who experienced a
significant change in status?

• Is there documentation in the medical record when the determination was made that the
resident met the criteria for a Significant Change in Status Assessment?

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursinghomeQualityInits/MDS30RAIManual.html

• Did the facility reassess residents who had a significant change in status, using the CMS-
specified RAI, within 14 days after determining the change was significant?

F638
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.20(c) Quarterly Review Assessment
A facility must assess a resident using the quarterly review instrument specified by the
State and approved by CMS not less frequently than once every 3 months.

INTENT §483.20(c)
To assure each resident is assessed using the standardized Quarterly Review assessment tool no
less than once every 3 months between comprehensive assessments.

DEFINITIONS §483.20(c)
“Quarterly Review Assessment” is an OBRA ‘87-required, non-comprehensive assessment that
must be completed at least every 92 days following the previous OBRA assessment of any type.
It is used to track a resident’s status between comprehensive assessments to ensure critical
indicators of gradual change in a resident’s status are monitored. As such, not all Minimum Data
Set (MDS) items appear on the Quarterly assessment.

GUIDANCE §483.20(c)
At least every 92 days, the facility shall review each resident with respect to those MDS items
specified in the CMS quarterly assessment (MDS).

A Quarterly assessment is considered timely if:

• The Assessment Reference Date (ARD) of the Quarterly MDS is within 92 days (ARD
of most recent OBRA assessment +92 days) after the ARD of the previous OBRA
assessment (Quarterly, Admission, Annual, Significant Change in Status, Significant
Correction to Prior Comprehensive or Quarterly assessment) AND

• The MDS completion date (Item Z0500B) must be no later than 14 days after the
ARD (ARD + 14 calendar days).

If the resident has experienced a significant change in status, the next quarterly review is due no
later than 3 months after the ARD of the Significant Change in Status Assessment.

For information on assessment scheduling for the MDS, see Chapter 2 of the Long-Term Care
Facility Resident Assessment Instrument 3.0 User’s Manual.

Link to the LTCF RAI User’s Manual: https://www.cms.gov/Medicare/Quality-Initiatives-
Patient-Assessment-Instruments/NursinghomeQualityInits/MDS30RAIManual.html.

NOTE: The Quarterly MDS does not require the completion of Care Area Assessments
(CAAs). However, the resident’s care plan must be reviewed and revised by the
interdisciplinary team after each assessment as required at §483.21(b)(2)(iii).

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursinghomeQualityInits/MDS30RAIManual.html

PROBES §483.20(c)
• Does the facility assess residents, using the CMS-specified quarterly review assessment, no

less than once every 3 months, between comprehensive assessments?
• Is there evidence of resident and/or resident representative participation in the assessment

process? Examples include participating in the resident interviews and providing information
about preferences or discharge goals.

F639
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.20(d) Use
A facility must maintain all resident assessments completed within the previous 15 months
in the resident’s active record and use the results of the assessments to develop, review and
revise the resident’s comprehensive care plan.

INTENT §483.20(d)
Facilities are required to maintain 15 months of assessment data in each resident’s active clinical
record.

GUIDANCE §483.20(d)
The requirement to maintain 15 months of data in the resident’s active clinical record applies
regardless of form of storage to all Minimum Data Set (MDS) records, including the Care Area
Assessment (CAA) Summary, Quarterly Assessment records, Identification Information and
Entry, Discharge and Reentry Tracking Records and MDS Correction Requests (including
signed attestation). MDS assessments must be kept in the resident’s active clinical record for 15
months following the final completion date for all assessments and correction requests. Other
assessment types require maintaining them in the resident’s active clinical record for 15 months
following:

• The entry date for tracking records including re-entry; and
• The date of discharge or death for discharge and death in facility records.

Facilities may maintain MDS data electronically regardless of whether the entire clinical record
is maintained electronically and regardless of whether the facility has an electronic signature
process in place. This is in accordance with state and local law, and when this is authorized by
the long- term care facility’s policy.

Facilities that maintain their MDS data electronically and do not utilize an electronic signature
process must ensure that hard copies of the MDS assessment signature pages are maintained for
every MDS assessment conducted in the resident’s active clinical record for 15 months. (This
includes enough information to identify the resident and type and date of assessment linked with
the particular assessment’s signature pages),

The information, regardless of form of storage (i.e., hard copy or electronic), must be kept in a
centralized location and must be readily and easily accessible. This information must be
available to all professional staff members (including consultants) who need to review the
information in order to provide care to the resident. (This information must also be made readily

and easily accessible for review by the State Survey agency and CMS.) Resident specific
information must also be available to the individual resident; if there are concerns, please refer
to F573.

After the 15-month period, RAI information may be thinned from the clinical record and stored
in the medical records department, provided that it is easily retrievable if requested by clinical
staff, the State agency, or CMS. NOTE: States may have more stringent requirements for this
process.

If there are concerns about how the results of the resident assessment are used to develop,
review and revise the resident’s comprehensive care plan – See §483.21(b)(2)(iii), F657.

F640
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.20(f) Automated data processing requirement-
§483.20(f)(1) Encoding data. Within 7 days after a facility completes a resident’s
assessment, a facility must encode the following information for each resident in the
facility:

(i) Admission assessment.
(ii) Annual assessment updates.
(iii) Significant change in status assessments.
(iv) Quarterly review assessments.
(v) A subset of items upon a resident’s transfer, reentry, discharge, and death.
(vi) Background (face-sheet) information, if there is no admission assessment.

§483.20(f)(2) Transmitting data. Within 7 days after a facility completes a resident’s
assessment, a facility must be capable of transmitting to the CMS System information for
each resident contained in the MDS in a format that conforms to standard record layouts
and data dictionaries, and that passes standardized edits defined by CMS and the State.

§483.20(f)(3) Transmittal requirements. Within 14 days after a facility completes a
resident’s assessment, a facility must electronically transmit encoded, accurate, and
complete MDS data to the CMS System, including the following:

(i)Admission assessment.
(ii) Annual assessment.
(iii) Significant change in status assessment.
(iv) Significant correction of prior full assessment.
(v) Significant correction of prior quarterly assessment.
(vi) Quarterly review.
(vii) A subset of items upon a resident’s transfer, reentry, discharge, and death.
(viii) Background (face-sheet) information, for an initial transmission of MDS data on

resident that does not have an admission assessment.

§483.20(f)(4) Data format. The facility must transmit data in the format specified by CMS
or, for a State which has an alternate RAI approved by CMS, in the format specified by the
State and approved by CMS.

INTENT §483.20(f)(1-4)
To ensure that facilities have provided resident specific information for payment and quality
measure purposes.

To enable a facility to better monitor each resident’s decline and progress over time. Computer-
aided data analysis facilitates a more efficient, comprehensive and sophisticated review of health
data.

DEFINITIONS §483.20(f)(1-4)
“Accurate” means that the encoded MDS data matches the MDS form in the clinical record.
Also refer to guidance regarding accuracy at §483.20(g), and the information accurately
reflects the resident’s status as of the Assessment Reference Date (ARD).

“Background (face-sheet) information” refers to the MDS Entry tracking record

“Capable of transmitting” means that the facility has encoded and edited according to CMS
specifications, the record accurately reflects the resident’s overall clinical status as of the assessment
reference date, and the record is ready for transmission.

“Complete” means that all items required according to the record type, and in accordance with
CMS’ record specifications and State required edits are in effect at the time the record is completed.

“Discharge subset of items” refers to the MDS Discharge assessment.

“Encoding” means entering information into the facility MDS software in the computer.

“Passing standard edits” means that the encoded responses to MDS items are consistent and
within range, in accordance with CMS-specified standards. In general, inconsistent responses
are either not plausible or ignore a skip pattern on the MDS. An example of inconsistency
would be if one or more MDS items on a list were checked as present, and the “None of the
Above” response was also checked for the same list. Out of range responses are invalid
responses, such as using a response code of 2 for an MDS item for which the valid responses
are zero or 1.

“Transmitted” means electronically transmitting to the Quality Improvement Evaluation
System (QIES) Assessment Submission and Processing (ASAP) System, an MDS record that
passes CMS’ standard edits and is accepted into the system, within 14 days of the final
completion date, or event date in the case of Entry and Death in Facility situations, of the
record.

“Transmitting data” refers to electronically sending encoded MDS information, from the
facility to the QIES ASAP System.

GUIDANCE §483.20(f)(1-4)
Facilities are required to encode MDS data for each resident in the facility.

Facilities are required to electronically transmit MDS data to the CMS System for each resident
in the facility. The CMS System for MDS data is named the QIES ASAP System.

Facilities are responsible to edit the encoded MDS data to ensure that it meets the standard edit
specifications.

For §483.20(f)(1)(v), the subset of items required upon a resident’s entry, transfer, discharge
and death are contained in the Entry and Death in Facility Tracking records and Discharge
assessments. Refer to Chapter 2 of the Long-Term Care Resident Assessment Instrument
User’s Manual for further information about these records.

All nursing homes must computerize MDS information. The facility must edit MDS
information using standard CMS-specified edits, revise the information to conform to the edits
and to be accurate, and be capable of transmitting that data to the QIES ASAP system within 7
days:

• For a comprehensive assessment (Admission, Annual, Significant Change in Status,
and Significant Correction to Prior Comprehensive), encoding must occur within 7 days
after the Care Plan Completion Date (V0200C2 + 7 days).

• For a Quarterly, Significant Correction to Prior Quarterly, Discharge, or PPS
assessment, encoding must occur within 7 days after the MDS Completion Date
(Z0500B + 7 days).

• For a tracking record, encoding should occur within 7 days of the Event Date (A1600
+ 7 days for Entry records and A2000 + 7 days for Death in Facility records).

Submission must be according to State and Federal time frames. Therefore the facility must:

• Encode the MDS and CAAs Summary (where applicable) in machine readable format;
and
o Edit the MDS and CAA Summary (where applicable) according to edits specified by

CMS. Within the 7 day time period specified above for editing, the facility must
revise any information on the encoded MDS and CAA Summary (if applicable) that
does not pass CMS-specified edits, revise any otherwise inaccurate information, and
make the information ready for submission. The MDS Vendor software used at the
facility should have an automated editing process that alerts the user to entries in an
MDS record that do not conform to the CMS-specified edits and that prompts the
facility to complete revisions within the 7-day editing and revision period. After
editing and revision, MDS information and CAA summary information (if applicable)
must always accurately reflect the resident’s overall clinical status as of the original
ARD for an assessment or the original event date for a discharge or entry.

Electronically submit MDS information to the QIES ASAP system within 14 days:

• Assessment Transmission: Comprehensive assessments must be transmitted electronically
within 14 days of the Care Plan Completion Date (V0200C2 + 14 days). All other

assessments must be submitted within 14 days of the MDS Completion Date (Z0500B + 14
days).

• Tracking Information Transmission: For Entry and Death in Facility tracking records,
information must be transmitted within 14 days of the Event Date (A1600 + 14 days for
Entry records and A2000 + 14 days for Death in Facility records).

Only CMS-required MDS assessments (e.g., OBRA and Medicare Part A PPS) are permitted to
be transmitted into the QIES ASAP System. Assessments completed to meet third party payer
(i.e. private insurance or managed care) requirements cannot be transmitted to CMS. OBRA
MDS assessments completed anytime a facility is NOT certified to participate in
Medicare/Medicaid cannot be transmitted.

PROCEDURES §483.20(f)(1-4)
If the surveyor suspects the facility is not encoding and submitting assessments as required, the
surveyor should review the facility’s MDS 3.0 NH Final Validation Report to verify assessment
submission into the QIES ASAP System.

F641
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.20(g) Accuracy of Assessments.
The assessment must accurately reflect the resident’s status.

INTENT §483.20(g)
To assure that each resident receives an accurate assessment, reflective of the resident’s status
at the time of the assessment, by staff qualified to assess relevant care areas and are
knowledgeable about the resident’s status, needs, strengths, and areas of decline.

GUIDANCE §483.20(g)
“Accuracy of Assessment” means that the appropriate, qualified health professionals correctly
document the resident’s medical, functional, and psychosocial problems and identify resident
strengths to maintain or improve medical status, functional abilities, and psychosocial status
using the appropriate Resident Assessment Instrument (RAI) (i.e. comprehensive, quarterly,
significant change in status).

Facilities are responsible for ensuring that all participants in the assessment process have the
requisite knowledge to complete an accurate assessment.

The determination of appropriate participation of health professionals must be based on the
physical, mental and psychosocial condition of each resident. This includes an appropriate level
of involvement of physicians, nurses, rehabilitation therapists, activities professionals, medical
social workers, dietitians, and other professionals, such as developmental disabilities specialists,
in assessing the resident, and in correcting resident assessments. Involvement of other
disciplines is dependent upon resident status and needs.

The assessment must represent an accurate picture of the resident’s status during the

observation period of the MDS. The Observation Period (also known as the Look-back period)
is the time period over which the resident’s condition or status is captured by the MDS
assessment and ends at 11:59 p.m. on the day of the Assessment Reference Date (ARD). Be
aware that different items on the MDS have different Observation Periods.

When the MDS is completed, only those occurrences during the observation period will be
captured on the assessment. In other words, if it did not occur during the observation period, it
is not coded on the MDS.

Note: CMS is aware of situations where practitioners have potentially misdiagnosed residents
with a condition for which antipsychotics are an approved use (e.g., new diagnosis of
schizophrenia) which would then exclude the resident from the long-stay antipsychotic quality
measure. For these situations, determine if non-compliance exists for the facility’s completion
of an accurate assessment. This practice may also require referrals by the facility and/or the
survey team to State Medical Boards or Boards of Nursing.

The initial comprehensive assessment provides starting point data for ongoing assessment of
resident progress.

PROBES §483.20(g)

• Based on your total review of the resident, observations, interviews and record reviews,
does each portion of the MDS assessment accurately reflect the resident’s status as of the
Assessment Reference Date?

• Is there evidence that the health professionals who assessed the resident had the skills and
qualifications to conduct the assessment? For example, has the resident’s nutritional
status been assessed by someone who is knowledgeable in nutrition and capable of
correctly assessing a resident?

F642
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.20(h) Coordination.
A registered nurse must conduct or coordinate each assessment with the appropriate
participation of health professionals.

§483.20(i) Certification.
§483.20(i)(1) A registered nurse must sign and certify that the assessment is completed.

§483.20(i)(2) Each individual who completes a portion of the assessment must sign and
certify the accuracy of that portion of the assessment.

§483.20(j) Penalty for Falsification.
§483.20(j)(1) Under Medicare and Medicaid, an individual who willfully and knowingly—

(i) Certifies a material and false statement in a resident assessment is subject to a civil
money penalty of not more than $1,000 for each assessment; or

(ii) Causes another individual to certify a material and false statement in a resident
assessment is subject to a civil money penalty or not more than $5,000 for each
assessment.

§483.20(j)(2) Clinical disagreement does not constitute a material and false statement.

INTENT §483.20(h)-(i)
Each resident’s assessment will be coordinated by and certified as complete by a registered nurse,
and all individuals who complete a portion of the assessment will sign and certify to the accuracy
of the portion of the assessment he or she completed.

GUIDANCE §483.20(h)-(j)
Whether Minimum Data Set (MDS) assessments are manually completed, or computer-generated
following data entry, each individual assessor is responsible for certifying the accuracy of
responses relative to the resident’s condition and discharge or entry status. Manually completed
forms are signed and dated by each individual assessor the day they complete their portion(s) of
the assessment.

Electronic Signatures
When MDS forms are completed directly on the facility’s computer (i.e., no paper form has been
manually completed), then each individual assessor signs and dates a computer-generated hard
copy, or provides an electronic signature, after they review it for accuracy of the portion(s) they
completed.

Facilities may use electronic signatures on the MDS when permitted to do so by state and local
law and when this is authorized by the facility’s policy. Additionally, the facility must have
written policies in place to ensure proper security measures are in place to protect use of an
electronic signature by anyone other than the person to which the electronic signature belongs.
The policy must also ensure access to a hard copy of clinical records is made available to
surveyors and others who are authorized access to clinical records by law, including the resident
and/or resident representative.

Facilities that are not capable of maintaining the MDS signatures electronically must adhere to
the current federal requirements at §483.20(d) addressing the need for either a hand-written copy
or a computer-generated form. All state licensure and state practice regulations continue to
apply to certified facilities.

NOTE: Where state law or regulations are more restrictive than federal requirements, the
provider needs to apply the state law standard.

Backdating Completion Dates – Backdating completion dates is not acceptable – note that
recording the actual date of completion is not considered backdating. For example, if an MDS
was completed electronically and a hard copy was printed two days later, writing the date the
MDS was completed on the hard copy is not considered backdating.

Patterns of MDS Assessment and Submissions

MDS information serves as the clinical basis for care planning and care delivery and provides
information for Medicare and Medicaid payment systems, quality monitoring and public
reporting. MDS information as it is reported impacts a nursing home’s payment rate and standing
in terms of the quality monitoring process. A willfully and knowingly-provided false assessment
may be indicative of payment fraud or attempts to avoid reporting negative quality measures.

All information recorded within the MDS Assessment must reflect the resident’s status at the
time of the Assessment Reference Date (ARD).

A pattern within a nursing home of clinical documentation or of MDS assessment or reporting
practices that result in higher Resource Utilization Group (RUG) scores, untriggering Care Area
Assessments (CAAs) or unflagging Quality Measures (QMs), where the information does not
accurately reflect the resident’s status, may be indicative of payment fraud or attempts to avoid
reporting negative quality measures. Such practices may include, but are not limited to, a pattern
or high prevalence of the following:

• Submitting MDS Assessments (including any reason(s) for assessment, routine or non
routine) or tracking records, where the information does not accurately reflect the
resident’s status as of ARD, or the Discharge or Entry date, as applicable;

• Submitting correction(s) to information in the Quality Improvement Evaluation System
Assessment Submission and Processing (QIES ASAP) where the corrected information
does not accurately reflect the resident’s status as of the original ARD, or the original
Discharge or Entry date, as applicable, or where the record it claims to correct does not
appear to have been in error;

• Submitting Significant Correction Assessments where the assessment it claims to correct
does not appear to have been in error;

• Submitting Significant Change in Status Assessments where the criteria for significant
change in the resident’s status do not appear to be met;

• Delaying or withholding MDS Assessments (including any reason(s) for assessment,
routine or non-routine), Discharge or Entry Tracking information, or correction(s) to
information in the QIES ASAP system.

PROCEDURES AND PROBES §483.20(h)-(j)

• When such patterns or practices are noticed, they should be reported by the State Agency
to the Regional Office and Medicaid Fraud Control Unit.

• Are the appropriate certifications in place, including the RN Coordinator’s certification of
completion of an MDS assessment or Correction Request, and the certification of
individual assessors of the accuracy and completion of the portion(s) of the assessment or
tracking record completed?

F644
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.20(e) Coordination.
A facility must coordinate assessments with the pre-admission screening and resident
review (PASARR) program under Medicaid in subpart C of this part to the maximum
extent practicable to avoid duplicative testing and effort. Coordination includes:

§483.20(e)(1)Incorporating the recommendations from the PASARR level II determination
and the PASARR evaluation report into a resident’s assessment, care planning, and
transitions of care.

§483.20(e)(2) Referring all level II residents and all residents with newly evident or possible
serious mental disorder, intellectual disability, or a related condition for level II resident
review upon a significant change in status assessment.

INTENT §483.20(e)
To ensure that the facility coordinates with the appropriate, State-designated authority, to ensure
that individuals with a mental disorder, intellectual disability or a related condition receives care
and services in the most integrated setting appropriate to their needs.

DEFINITIONS §483.20(e)
“Intellectual Disability (ID)” is defined in 42 CFR §483.102(b)(3), as follows:
An individual is considered to have intellectual disability (ID) if he or she has—

(i) A level of retardation (mild, moderate, severe or profound) described in the American
Association on Intellectual’s Disability Manual on Classification in Intellectual Disability
(1983);or

(ii) A related condition as defined by §435.1010 of this chapter.

“Mental Disorder (MD)” For purposes of this section, the term “mental disorder” is the
equivalent of “mental illness” used in the definition of serious mental illness in 42 CFR
§483.102(b)(1), which states:
An individual is considered to have a serious mental illness (MI) if the individual meets the
following requirements on diagnosis, level of impairment and duration of illness:

(i) Diagnosis. The individual has a major mental disorder diagnosable under the Diagnostic
and Statistical Manual of Mental Disorders, 3rd edition, revised in 1987.

This mental disorder is—
(A) A schizophrenic, mood, paranoid, panic or other severe anxiety disorder; somatoform

disorder; personality disorder; other psychotic disorder; or another mental disorder
that may lead to a chronic disability; but

(B) Not a primary diagnosis of dementia, including Alzheimer’s disease or a related
disorder, or a non-primary diagnosis of dementia unless the primary diagnosis is a
major mental disorder as defined in paragraph (b)(1)(i)(A) of this section.

(ii) Level of impairment. The disorder results in functional limitations in major life activities
within the past 3 to 6 months that would be appropriate for the individual’s
developmental stage. An individual typically has at least one of the following
characteristics on a continuing or intermittent basis:
(A) Interpersonal functioning. The individual has serious difficulty interacting

appropriately and communicating effectively with other persons, has a possible
history of altercations, evictions, firing, fear of strangers, avoidance of interpersonal
relationships and social isolation;

(B) Concentration, persistence, and pace. The individual has serious difficulty in
sustaining focused attention for a long enough period to permit the completion of

tasks commonly found in work settings or in work-like structured activities occurring
in school or home settings, manifests difficulties in concentration, inability to
complete simple tasks within an established time period, makes frequent errors, or
requires assistance in the completion of these tasks; and

(C) Adaptation to change. The individual has serious difficulty in adapting to typical
changes in circumstances associated with work, school, family, or social interaction,
manifests agitation, exacerbated signs and symptoms associated with the illness, or
withdrawal from the situation, or requires intervention by the mental health or judicial
system.

(iii) Recent treatment. The treatment history indicates that the individual has experienced at
least one of the following:
(A) Psychiatric treatment more intensive than outpatient care more than once in the past 2

years (e.g., partial hospitalization or inpatient hospitalization); or
(B) Within the last 2 years, due to the mental disorder, experienced an episode of

significant disruption to the normal living situation, for which supportive services
were required to maintain functioning at home, or in a residential treatment
environment, or which resulted in intervention by housing or law enforcement
officials.

“Persons with Related Conditions” is defined in 42 CFR §435.1010 as follows:
Persons with related conditions means individuals who have a severe, chronic disability that
meets all of the following conditions:

(a) It is attributable to—
(1) Cerebral palsy or epilepsy; or
(2) Any other condition, other than a mental illness, found to be closely related to

Intellectual Disability because this condition results in impairment of general
intellectual functioning or adaptive behavior similar to that of mentally retarded
persons, and requires treatment or services similar to those required for these persons.

(b) It is manifested before the person reaches age 22.
(c) It is likely to continue indefinitely.
(d) It results in substantial functional limitations in three or more of the following areas of

major life activity:
(1) Self-care.
(2) Understanding and use of language.
(3) Learning.
(4) Mobility.
(5) Self-direction.
(6) Capacity for independent living.

“Preadmission Screening and Resident Review (PASARR)” is a federal requirement to help
ensure that individuals who have a mental disorder or intellectual disabilities are not
inappropriately placed in nursing homes for long term care. PASARR requires that 1) all
applicants to a Medicaid-certified nursing facility be evaluated for a serious mental disorder
and/or intellectual disability; 2) be offered the most appropriate setting for their needs (in the
community, a nursing facility, or acute care setting); and 3) receive the services they need in
those settings. Regulations governing PASARR are found at 42 CFR §483.100-§483.138.

“Specialized Services for MD or ID” means the services specified by the State that exceed the
services ordinarily provided by the nursing facility (NF) under its per diem rate. These services
must be provided or arranged by the state and could include hiring additional staff or contractors
such as qualified mental health/intellectual disability professionals. When specialized services
are combined with services provided by the nursing facility, the result is a continuous and
aggressive implementation of an individualized plan of care for individuals with MD or ID. The
resident’s Level II PASARR identifies the specialized services required by the resident.

GUIDANCE §483.20(e)
With respect to the responsibilities under the Pre-Admission Screening and Resident Review
(PASARR) program, the State is responsible for conducting the screens, preparing the
PASARR report, and providing or arranging the specialized services that are needed as a result
of conducting the screens. The State is required to provide a copy of the PASARR report to the
facility. This report must list the specialized services that the individual requires and that are
the responsibility of the State to provide. All other needed services are the responsibility of the
facility to provide.

The PASARR process requires that all applicants to Medicaid-certified nursing facilities be
screened for possible serious mental disorders or intellectual disabilities and related conditions.
This initial pre-screening is referred to as PASARR Level I, and is completed prior to
admission to a nursing facility. A negative Level I screen permits admission to proceed and
ends the PASARR process unless a possible serious mental disorder or intellectual disability
arises later. A positive Level 1 screen necessitates an in-depth evaluation of the individual by
the state-designated authority, known as PASARR Level II, which must be conducted prior to
admission to a nursing facility.

PASARR Level II is a comprehensive evaluation by the appropriate state-designated authority
and determines whether the individual has MD, ID or a related condition, determines the
appropriate setting for the individual and recommends what, if any, specialized services and/or
rehabilitative services the individual needs.

The Level II evaluation report must be used by the facility when conducting assessments of the
resident, developing the care plan, and when transitions of care occur. Incorporating the Level
II information in these processes promotes comprehensive assessment and provision of care
for residents with MD or ID.

The State must provide or arrange for the provision of specialized services to all NF residents
with MD or ID in accordance with §483.120, whose needs are such that continuous supervision,
treatment and training by qualified mental health or intellectual disability personnel is necessary,
as identified in the resident’s PASARR Level II. Specialized services provided or arranged by
the State may be provided in the NF or through off-site visits arranged by the NF, while the
resident lives in the facility.

The facility must notify the state-designated mental health or intellectual disability authority
promptly when a resident with MD or ID experiences a significant change in mental or

physical status. For additional information regarding resident referral after a significant
change in status, see requirements at §483.20(k)(4), F646, MD/ID significant change
notification.

Any resident with newly evident or possible serious mental disorder, ID or a related condition
must be referred, by the facility to the appropriate state-designated mental health or intellectual
disability authority for review.

Examples of individuals who may not have previously been identified by PASARR to have MD,
ID or a related condition include: NOTE: this is not an exhaustive list. (RAI Manual 2-29)

• A resident who exhibits behavioral, psychiatric, or mood related symptoms suggesting
the presence of a mental disorder (where dementia is not the primary diagnosis).

• A resident whose intellectual disability or related condition was not previously identified
and evaluated through PASARR.

• A resident transferred, admitted, or readmitted to a NF following an inpatient psychiatric
stay or equally intensive treatment.

PROBES §483.20(e)

• For residents with a Level II determination and recommendations, has the facility
incorporated the determination and recommendations into the resident’s assessment and
care plan?

• How does the facility identify residents with newly evident or possible serious mental
disorder, ID or a related condition?

• If a resident was identified with newly evident or possible serious MD, ID or a related
condition, did the facility refer the resident to the appropriate state-designated authority
for review?

• Is there evidence that the facility provides the next care setting with the resident’s
PASARR Level II recommendations when a resident with MD or ID transitions to
another care setting?

• Has the facility arranged for the resident to receive specialized services through off-site
visits, if appropriate, to meet the resident’s needs as identified in the resident’s PASARR
Level II recommendations?

F645
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.20(k) Preadmission Screening for individuals with a mental disorder and individuals
with intellectual disability.

§483.20(k)(1) A nursing facility must not admit, on or after January 1, 1989, any new
residents with:

(i) Mental disorder as defined in paragraph (k)(3)(i) of this section, unless the State
mental health authority has determined, based on an independent physical and
mental evaluation performed by a person or entity other than the State mental
health authority, prior to admission,

(A) That, because of the physical and mental condition of the individual, the
individual requires the level of services provided by a nursing facility; and

(B) If the individual requires such level of services, whether the individual requires
specialized services; or

(ii) Intellectual disability, as defined in paragraph (k)(3)(ii) of this section, unless the
State intellectual disability or developmental disability authority has determined
prior to admission—
(A) That, because of the physical and mental condition of the individual, the

individual requires the level of services provided by a nursing facility; and
(B) If the individual requires such level of services, whether the individual requires

specialized services for intellectual disability.

§483.20(k)(2) Exceptions. For purposes of this section-

(i)The preadmission screening program under paragraph(k)(1) of this section need not
provide for determinations in the case of the readmission to a nursing facility of an
individual who, after being admitted to the nursing facility, was transferred for care
in a hospital.

(ii) The State may choose not to apply the preadmission screening program under
paragraph (k)(1) of this section to the admission to a nursing facility of an
individual-
(A) Who is admitted to the facility directly from a hospital after receiving acute

inpatient care at the hospital,
(B) Who requires nursing facility services for the condition for which the individual

received care in the hospital, and
(C) Whose attending physician has certified, before admission to the facility that the

individual is likely to require less than 30 days of nursing facility services.

§483.20(k)(3) Definition. For purposes of this section-

(i) An individual is considered to have a mental disorder if the individual has a serious
mental disorder defined in 483.102(b)(1).

(ii) An individual is considered to have an intellectual disability if the individual has an
intellectual disability as defined in §483.102(b)(3) or is a person with a related
condition as described in 435.1010 of this chapter.

INTENT §483.20(k)(1)-(3)
To ensure each resident in a nursing facility is screened for a mental disorder (MD) or
intellectual disability (ID) prior to admission and that individuals identified with MD or ID are
evaluated and receive care and services in the most integrated setting appropriate to their needs.

DEFINITIONS §483.20(k)(1)-(3)
“Intellectual Disability (ID)” is defined in 42 CFR §483.102(b)(3) as follows:
An individual is considered to have intellectual disability (ID) if he or she has—

(i) A level of retardation (mild, moderate, severe or profound) described in the American
Association on Intellectual’s Disability Manual on Classification in Intellectual Disability
(1983);or

(ii) A related condition as defined by §435.1010 of this chapter.

(i) Diagnosis. The individual has a major mental disorder diagnosable under the Diagnostic
and Statistical Manual of Mental Disorders, 3rd edition, revised in 1987.
This mental disorder is—
(A) A schizophrenic, mood, paranoid, panic or other severe anxiety disorder; somatoform

disorder; personality disorder; other psychotic disorder; or another mental disorder
that may lead to a chronic disability; but

(B) Concentration, persistence, and pace. The individual has serious difficulty in
sustaining focused attention for a long enough period to permit the completion of
tasks commonly found in work settings or in work-like structured activities occurring
in school or home settings, manifests difficulties in concentration, inability to
complete simple tasks within an established time period, makes frequent errors, or
requires assistance in the completion of these tasks; and

years (e.g., partial hospitalization or inpatient hospitalization); or
(B) Within the last 2 years, due to the mental disorder, experienced an episode of

“Persons with Related Conditions” is defined in 42 CFR §435.1010 as follows:
Persons with related conditions means individuals who have a severe, chronic disability that

meets all of the following conditions:
(a) It is attributable to—

(1) Cerebral palsy or epilepsy; or
(2) Any other condition, other than a mental illness, found to be closely related to

(b) It is manifested before the person reaches age 22.
(c) It is likely to continue indefinitely.
(d) It results in substantial functional limitations in three or more of the following areas of

major life activity:
(1) Self-care.
(2) Understanding and use of language.
(3) Learning.
(4) Mobility.
(5) Self-direction.
(6) Capacity for independent living.

“Preadmission Screening and Resident Review (PASARR)” is a federal requirement to help
ensure that individuals are not inappropriately placed in nursing homes for long term care.
PASARR requires that 1) all applicants to a Medicaid-certified nursing facility be evaluated for
serious mental disorder and/or intellectual disability; 2) be offered the most appropriate setting
for their needs (in the community, a nursing facility, or acute care setting); and 3) receive the
services they need in those settings. Regulations governing PASARR are found at 42 CFR
§483.100-§483.138.

“Rehabilitative services for MD or ID” refers to those services of lesser frequency or intensity
to be implemented by all levels of nursing facility staff that come into contact with any resident
who has as mental disorder or who has intellectual disability. These services are necessary
regardless of whether or not they are specified in the PASARR Level II documents and whether
or not the resident requires additional services to be provided or arranged for by the State.

GUIDANCE §483.20(k)(1)-(3)
The PASARR process requires that all applicants to Medicaid-certified nursing facilities be
screened for possible serious mental disorders, intellectual disabilities and related conditions.
This initial screening is referred to as Level I Identification of individuals with MD or ID
(§483.128) and is completed prior to admission to a nursing facility. The purpose of the Level
I pre-admission screening is to identity individuals who have or may have MD/ID or a related

condition, who would then require PASARR Level II evaluation and determination prior to
admission to the facility.

A negative Level I screen permits admission to proceed and ends the pre-screening process
unless possible serious mental disorder or intellectual disability arises later. A positive Level 1
screen necessitates an in-depth evaluation of the individual, by the state-designated authority,
known as Level II PASARR, which must be conducted prior to admission to the facility.

Failure to pre-screen residents prior to admission to the facility may result in the failure to
identify residents who have or may have MD, ID or a related condition. A record of the pre-
screening should be retained in the resident’s medical record.

Individuals who have or are suspected to have MD, ID or a related condition (as indicated by a
positive Level 1 screen) may not be admitted to a Medicaid-certified nursing facility unless
approved based on Level II PASARR evaluation and determination. Exceptions to this
requirement are specified in §483.20(k)(2) and may be exercised at the discretion of the State,
as specified in the State’s PASARR process.

Level II PASARR is a comprehensive evaluation conducted by the appropriate state-
designated authority that determines whether an individual has MD, ID or a related condition
as defined above, determines the appropriate setting for the individual, and recommends what,
if any, specialized services and/or rehabilitative services the individual needs. The Level II
PASARR cannot be conducted by the nursing facility.

Each State Medicaid Agency has specific processes for conducting Level I screens and Level
II PASARR evaluations and determinations. Exceptions to the pre-screening requirements are
specified in §483.20(k)(2) and may be exercised at the discretion of the State, as specified in
the State’s PASARR process. Facility staff and surveyors should be acquainted with their
States’ requirements.

If the State program permits the use of the exceptions specified in §483.20(k)(2), and the
resident remains in the facility longer than 30 days, the facility must screen the individual
using the State’s Level I screening process and refer any resident who has or may have MD,
ID or a related condition to the appropriate state-designated authority for Level II PASARR
evaluation and determination. NOTE: under 42 CFR 483.106(b)(2)(ii), If an individual who
enters a NF as an exception (an exempted hospital discharge) is later found to require more
than 30 days of NF care, the State mental health or intellectual disability authority must
conduct a Level II resident review within 40 calendar days of admission.

The State is responsible for providing or arranging for specialized services for residents with
MD or ID residing in Medicaid-certified facilities. The facility is required to provide all other
care and services appropriate to the resident’s condition. Therefore, if a facility has residents
with MD or ID, do not survey for specialized services, but survey for all other requirements,
including resident rights, quality of life, and quality of care.

PROCEDURES AND PROBES §483.20(k)(1)-(3)

• If the resident’s Level II PASSR report indicates that he or she needs specialized services
but the resident is not receiving them, the State Survey Agency would notify the State-
designated mental health or intellectual disability authority that evaluated the resident
prior to admission. NF services alone are not ordinarily of the intensity to meet the needs
of residents with MD or ID.

• Is there evidence of Level I pre-screening of residents prior to admission to the nursing
facility to identify residents who have or may have MD, ID or a related condition, who
requires Level II PASARR evaluation?

• Are residents with a positive Level I PASARR screen evaluated by the designated state-
authority, through the Level II PASARR process, and approved for admission prior to
admission to the nursing facility?

• If pre-admission screening of residents expected to be in the facility 30 days or less is not
performed, in accordance with the State PASARR process, does the facility screen
residents who have or may have MD, ID or a related condition, if the resident remains in
the facility longer than 30 days? Are residents who have a positive screen then referred
to the appropriate state-authority for Level II evaluation and determination?

If the resident has a MD or ID, did the State Mental Health or Intellectual Disabilities
Authority determine:

• Whether the residents needed the services of a nursing facility
• Whether the residents need specialized services for their MD or ID?

DEFICIENCY CATEGORIZATIONS
Severity Level 4 Considerations: Immediate Jeopardy to Resident Health or Safety
An example of Level 4, immediate jeopardy to resident health and safety, include, but is not
limited to:

• A resident with bipolar disorder was newly admitted to the facility prior to Level II
PASARR evaluation and determination. The facility’s failure to ensure the Level II
PASARR process was completed prior to admission resulted in the resident no longer
receiving needed psychotherapy 4 times per week. The interruption in receiving needed
psychotherapy services caused the resident to relapse into a depressive state, during
which the resident engaged in social withdrawal and self-cutting behaviors resulting in
hospitalization of the resident.

Severity Level 3 Considerations: Actual Harm that is not Immediate Jeopardy
An example of Level 3, actual harm that is not immediate jeopardy includes but is not limited to:

• The facility failed to ensure Level 1 pre-screening of a new resident for MD/ID or a
related condition prior to admission to the facility. The resident had cerebral palsy,
which is a related condition. The lack of pre-screening resulted in the resident’s
condition not being identified prior to admission and the resident not being evaluated
through the Level II PASARR process. The resident did not receive the specialized
rehabilitation services she needed which resulted in a decline in her function.

Severity Level 2 Considerations: No Actual Harm with Potential for More Than Minimal
Harm that is Not Immediate Jeopardy

An example of Level 2, no actual harm, with potential for more than minimal harm, that is not
immediate jeopardy, includes, but is not limited to:

• The facility failed to ensure Level 1 pre-screening of new residents for MD/ID or a
related condition, prior to admission to the facility. While the residents did not have
MD/ID or a related condition, the facility admitted the residents without knowing if the
residents had one of these conditions. The failure to determine whether the residents had
MD/ID or a related condition had the potential to cause more than minimal harm to new
and/or current residents.

Severity Level 1: No Actual Harm with Potential for Minimal Harm
Failure to ensure residents are pre-screened for MD/ID or a related condition, prior to admission
to the facility, could prevent the resident from attaining or maintaining his/her highest practicable
level or result in a decline in the resident’s physical, mental or psychosocial well-being.
Therefore, Severity Level 1 does not apply for this regulatory requirement.

F646
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.20(k)(4) A nursing facility must notify the state mental health authority or state
intellectual disability authority, as applicable, promptly after a significant change in the
mental or physical condition of a resident who has mental illness or intellectual disability
for resident review.

INTENT §483.20(k)(4)
To ensure that individuals with a mental disorder or intellectual disabilities continue to receive
the care and services they need in the most appropriate setting, when a significant change in
their status occurs.

DEFINITIONS §483.20(k)(4)
“Preadmission Screening and Resident Review (PASARR)” is a federal requirement to help
ensure that individuals who have a mental disorder or intellectual disabilities are not
inappropriately placed in nursing homes for long term care. PASARR requires that 1) all
applicants to a Medicaid-certified nursing facility be evaluated for a serious mental disorder
and/or intellectual disability; 2) be offered the most appropriate setting for their needs (in the
community, a nursing facility, or acute care setting); and 3) receive the services they need in
those settings. Regulations governing PASARR are found at 42 CFR §483.100-138.

“Significant Change” is a major decline or improvement in a resident’s status that 1) will not
normally resolve itself without intervention by staff or by implementing standard disease-related
clinical interventions; the decline is not considered “self-limiting” (NOTE: Self-limiting is when
the condition will normally resolve itself without further intervention or by staff implementing
standard clinical interventions to resolve the condition.); 2) impacts more than one area of the
resident’s health status; and 3) requires interdisciplinary review and/or revision of the care plan.
This does not change the facility’s requirement to immediately consult with a resident’s
physician of changes as required under 42 CFR §483.10(i)(14), F580.

“Significant Change in Status Assessment (SCSA)” is a comprehensive assessment for a
resident that must be completed when the Interdisciplinary Team (IDT) has determined that a
resident meets the significant change guidelines for either improvement or decline.

GUIDANCE §483.20(k)(4)
As part of the Pre-Admission Screening and Resident Review (PASARR) process, the facility is
required to notify the appropriate state mental health authority or state intellectual disability
authority when a resident with a mental disorder (MD) or intellectual disability (ID) has a
significant change in their physical or mental condition.

The nursing facility must notify the state mental health (SMH)/ID authority of significant
changes in residents with MD or ID independent of the findings of the SCSA. PASARR Level II
is to function as an independent assessment process for this population with special needs, in
parallel with the facility’s assessment process. Nursing facilities should know their State’s
PASARR policy on referral to the SMH/ID authority, so that these authorities may exercise their
expert judgment about when a Level II evaluation is needed.

Referral to the SMH/ID authority should be made as soon as the criteria indicative of a
significant change are evident — the facility should not wait until the SCSA is complete.

Facilities should look to their state PASARR program requirements for specific procedures.
PASARR contact information for the SMH/ID authorities and the State Medicaid Agency is
available at http://www.pasrrassist.org/resources/personnel/pasrr-state-lead-contact-information.

Referral for Level II resident review evaluation is required for individuals previously identified
by PASARR to have a mental disorder, intellectual disability, or a related condition who
experience a significant change. Examples of such changes include, but are not limited to:

• A resident who demonstrates increased behavioral, psychiatric, or mood-related
symptoms.

• A resident with behavioral, psychiatric, or mood-related symptoms that have not
responded to ongoing treatment.

• A resident who experiences an improved medical condition—such that the residents’ plan
of care or placement recommendations may require modifications.

• A resident whose significant change is physical, but has behavioral, psychiatric, or mood-
related symptoms, or cognitive abilities, that may influence adjustment to an altered
pattern of daily living.

• A resident whose condition or treatment is or will be significantly different than
described in the resident’s most recent PASARR Level II evaluation and determination.
(NOTE that a referral for a possible new Level II PASARR evaluation is required
whenever such a disparity is discovered, whether or not associated with a SCSA.)

Requirements for the completing a SCSA are found at §483.20(b)(2)(ii), F637, comprehensive
assessment after significant change.

http://www.pasrrassist.org/resources/personnel/pasrr-state-lead-contact-information

PROBES §483.20(k)(4)

• When a significant change in status was identified in a resident with a mental disorder or
intellectual disability, was the appropriate state mental health or intellectual disability
authority promptly notified?

• Does the facility have a process in place to notify the appropriate state mental health or
intellectual disability authority when a resident with a Level II PASARR has a significant
change in his or her mental or physical status?

F655
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.21 Comprehensive Person-Centered Care Planning
§483.21(a) Baseline Care Plans
§483.21(a)(1) The facility must develop and implement a baseline care plan for each
resident that includes the instructions needed to provide effective and person-centered care
of the resident that meet professional standards of quality care. The baseline care plan
must—

(i) Be developed within 48 hours of a resident’s admission.
(ii) Include the minimum healthcare information necessary to properly care for a

resident including, but not limited to—
(A) Initial goals based on admission orders.
(B) Physician orders.
(C) Dietary orders.
(D) Therapy services.
(E) Social services.
(F) PASARR recommendation, if applicable.

§483.21(a)(2) The facility may develop a comprehensive care plan in place of the baseline
care plan if the comprehensive care plan—

(i) Is developed within 48 hours of the resident’s admission.
(ii) Meets the requirements set forth in paragraph (b) of this section (excepting

paragraph (b)(2)(i) of this section).

§483.21(a)(3) The facility must provide the resident and their representative with a
summary of the baseline care plan that includes but is not limited to:

(i) The initial goals of the resident.
(ii) A summary of the resident’s medications and dietary instructions.
(iii) Any services and treatments to be administered by the facility and personnel acting

on behalf of the facility.
(iv) Any updated information based on the details of the comprehensive care plan, as

necessary.

INTENT §483.21(a)
Completion and implementation of the baseline care plan within 48 hours of a resident’s
admission is intended to promote continuity of care and communication among nursing home

staff, increase resident safety, and safeguard against adverse events that are most likely to occur
right after admission; and to ensure the resident and representative, if applicable, are informed of
the initial plan for delivery of care and services by receiving a written summary of the baseline
care plan.

GUIDANCE §483.21(a)
Nursing homes are required to develop a baseline care plan within the first 48 hours of admission
which provides instructions for the provision of effective and person-centered care to each
resident. This means that the baseline care plan should strike a balance between conditions and
risks affecting the resident’s health and safety, and what is important to him or her, within the
limitations of the baseline care plan timeframe.

Person-centered care means the facility focuses on the resident as the center of control, and
supports each resident in making his or her own choices. Person-centered care includes making
an effort to understand what each resident is communicating, verbally and nonverbally,
identifying what is important to each resident with regard to daily routines and preferred
activities, and having an understanding of the resident’s life before coming to reside in the
nursing home.

The baseline care plan must include the minimum healthcare information necessary to properly
care for each resident immediately upon their admission, which would address resident-specific
health and safety concerns to prevent decline or injury, such as elopement or fall risk, and would
identify needs for supervision, behavioral interventions, and assistance with activities of daily
living, as necessary. Baseline care plans are required to address, at a minimum, the following:

• Initial goals based on admission orders.
• Physician orders.
• Dietary orders.
• Therapy services.
• Social services.
• PASARR recommendation, if applicable.

The baseline care plan must reflect the resident’s stated goals and objectives, and include
interventions that address his or her current needs. It must be based on the admission orders,
information about the resident available from the transferring provider, and discussion with the
resident and resident representative, if applicable. Because the baseline care plan documents the
interim approaches for meeting the resident’s immediate needs, professional standards of quality
care would dictate that it must also reflect changes to approaches, as necessary, resulting from
significant changes in condition or needs, occurring prior to development of the comprehensive
care plan. Facility staff must implement the interventions to assist the resident to achieve care
plan goals and objectives.

Facilities may complete a comprehensive care plan instead of the baseline care plan. In this
circumstance, the completion of the comprehensive care plan will not override the RAI process,
and must be completed and implemented within 48 hours of admission and comply with the
requirements for a comprehensive care plan at §483.21(b), with the exception of the requirement
at (b)(2)(i) requiring the completion of the comprehensive care plan within 7 days of completion

of the comprehensive assessment. If a comprehensive care plan is completed in lieu of the
baseline care plan, a written summary of the comprehensive care plan must be provided to the
resident and resident representative, if applicable, and in a language that the
resident/representative can understand.

If the facility completes a comprehensive care plan instead of the baseline care plan, review the
requirements of the comprehensive care plan at §483.21(b). If the care plan does not meet the
requirements of §483.21(b), cite at the appropriate corresponding tag(s):

• F656 Develop Comprehensive Care Plan
• F657 Care Plan Timing and Revision
• F658 Services Provided Meet Professional Standards
• F659 Qualified Persons

Baseline Care Plan Summary
The facility must provide the resident and the representative, if applicable with a written
summary of the baseline care plan by completion of the comprehensive care plan. The summary
must be in a language and conveyed in a manner the resident and/or representative can
understand. This summary must include:

o Initial goals for the resident;
o A list of current medications and dietary instructions, and
o Services and treatments to be administered by the facility and personnel acting on

behalf of the facility;
The format and location of the summary is at the facility’s discretion, however, the medical
record must contain evidence that the summary was given to the resident and resident
representative, if applicable. The facility may choose to provide a copy of the baseline care plan
itself as the summary, as long as it meets all of the requirements of the summary.

Given that the baseline care plan is developed before the comprehensive assessment, it is
possible that the goals and interventions may change. In the event that the comprehensive
assessment and comprehensive care plan identified a change in the resident’s goals, or physical,
mental, or psychosocial functioning, which was otherwise not identified in the baseline care plan,
those changes must be incorporated into an updated summary provided to the resident and his or
her representative, if applicable.

As the resident remains in the nursing home, additional changes will be made to the
comprehensive care plan based on the assessed needs of the resident, however, these subsequent
changes will not need to be reflected in the summary of the baseline care plan. Once the
comprehensive care plan has been developed and implemented, and a summary of the updates
given to the resident, the facility is no longer required to revise/update the written summary of
the baseline care plan. Rather, each resident will remain actively engaged in his or her care
planning process through the resident’s rights to participate in the development of, and be
informed in advance of changes to the care plan; see the care plan; and sign the care plan after
significant changes. Refer to §483.10(c) for guidance related to Resident Rights and Facility
Responsibilities regarding Planning and Implementing Care.

INVESTIGATIVE SUMMARY AND PROBES §483.21(a)

• Use the Critical Element (CE) Pathway associated with the issue under investigation, or if
there is no specific CE Pathway, use the General CE Pathway, along with the above
interpretive guidelines when determining if the facility meets the requirements for, or
investigating concerns related to the facility’s requirement develop and implement a
Baseline Care Plan. If systemic concerns are identified with Baseline Care Plans, use the
probes below to assist in your investigation.

• Was the baseline care plan developed and implemented within 48 hours of admission to
the facility?

• Does the resident’s baseline care plan include:
o The resident’s initial goals for care;
o The instructions needed to provide effective and person-centered care that meets

professional standards of quality care;
o The resident’s immediate health and safety needs;
o Physician and dietary orders;
o PASARR recommendations, if applicable; and
o Therapy and social services.

• Was the baseline care plan revised and updated as needed to meet the resident’s needs
until the comprehensive care plan was developed?

• If the resident experienced an injury or adverse event prior to the development of the
comprehensive care plan, should the baseline care plan have identified the risk for the
injury/event (i.e., if risk factors were known or obvious)?

• Did the facility provide the resident and his or her representative, if applicable, with a
written summary of the baseline care plan that contained at least, without limitation:
o Initial goals of the resident;
o A summary of current medications and dietary instructions;
o Services and treatments to be provided or arranged by the facility and personnel

acting on behalf of the facility; and
o Any updated information based on details of the admission comprehensive

assessment.

F656
(Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24)

§483.21(b) Comprehensive Care Plans

§483.21(b)(1) The facility must develop and implement a comprehensive person-centered
care plan for each resident, consistent with the resident rights set forth at §483.10(c)(2) and
§483.10(c)(3), that includes measurable objectives and timeframes to meet a resident’s
medical, nursing, and mental and psychosocial needs that are identified in the
comprehensive assessment. The comprehensive care plan must describe the following —

(i) The services that are to be furnished to attain or maintain the resident’s highest
practicable physical, mental, and psychosocial well-being as required under §483.24,
§483.25 or §483.40; and

(ii) Any services that would otherwise be required under §483.24, §483.25 or §483.40
but are not provided due to the resident’s exercise of rights under §483.10, including
the right to refuse treatment under §483.10(c)(6).

(iii) Any specialized services or specialized rehabilitative services the nursing facility
will provide as a result of PASARR recommendations. If a facility disagrees with the
findings of the PASARR, it must indicate its rationale in the resident’s medical
record.

(iv)In consultation with the resident and the resident’s representative(s)—
(A) The resident’s goals for admission and desired outcomes.
(B) The resident’s preference and potential for future discharge. Facilities must

document whether the resident’s desire to return to the community was assessed
and any referrals to local contact agencies and/or other appropriate entities, for
this purpose.

(C) Discharge plans in the comprehensive care plan, as appropriate, in accordance
with the requirements set forth in paragraph (c) of this section.

§483.21(b)(3) The services provided or arranged by the facility, as outlined by the
comprehensive care plan, must—

(iii) Be culturally-competent and trauma–informed.

INTENT

Each resident will have a person-centered comprehensive care plan developed and implemented
to meet his or her preferences and goals, and address the resident’s medical, physical, mental and
psychosocial needs.

DEFINITIONS

“Culture” is the conceptual system that structures the way people view the world—it is the
particular set of beliefs, norms, and values that influence ideas about the nature of relationships,
the way people live their lives, and the way people organize their world. Adopted from
Substance Abuse and Mental Health Services Administration. Improving Cultural Competence.
Treatment Improvement Protocol (TIP) Series No. 59. HHS Publication No. (SMA) 14-4849.
https://store.samhsa.gov/system/files/sma14-4849 .

“Cultural Competency” is a developmental process in which individuals or institutions achieve
increasing levels of awareness, knowledge, and skills along a cultural competence continuum.
Cultural competence involves valuing diversity, conducting self-assessments, avoiding
stereotypes, managing the dynamics of difference, acquiring and institutionalizing cultural
knowledge, and adapting to diversity and cultural contexts in communities.
US Department of Health and Human Services publication: A Blueprint for Advancing and
Sustaining CLAS Policy and Practice at: https://www.thinkculturalhealth.hhs.gov/clas/blueprint.

“Resident’s Goal” refers to the resident’s desired outcomes and preferences for admission,
which guide decision-making during care planning.

https://store.samhsa.gov/system/files/sma14-4849

https://www.thinkculturalhealth.hhs.gov/assets/pdfs/EnhancedCLASStandardsBlueprint

https://www.thinkculturalhealth.hhs.gov/clas/blueprint

“Interventions” are actions, treatments, procedures, or activities designed to meet an objective.

“Measurable” is the ability to be evaluated or quantified.

“Objective” is a statement describing the results to be achieved to meet the resident’s goals.

“Person-centered care” means to focus on the resident as the locus of control and support the
resident in making their own choices and having control over their daily lives.

“Trauma-informed care” is an approach to delivering care that involves understanding,
recognizing and responding to the effects of all types of trauma. A trauma-informed approach to
care delivery recognizes the widespread impact, and signs and symptoms of trauma in residents,
and incorporates knowledge about trauma into care plans, policies, procedures and practices to
avoid re-traumatization. Adapted from: SAMHSA’s Concept of Trauma and Guidance for a
Trauma-Informed Approach, https://store.samhsa.gov/system/files/sma14-4884 .

GUIDANCE

Through the care planning process, facility staff must work with the resident and his/her
representative, if applicable, to understand and meet the resident’s preferences, choices and goals
during their stay at the facility. The facility must establish, document and implement the care and
services to be provided to each resident to assist in attaining or maintaining his or her highest
practicable quality of life. Care planning drives the type of care and services that a resident
receives. If care planning is not complete, or is inadequate, the consequences may negatively
impact the resident’s quality of life, as well as the quality of care and services received.

Facilities are required to develop care plans that describe the resident’s medical, nursing,
physical, mental and psychosocial needs and preferences and how the facility will assist in
meeting these needs and preferences. Care plans must include person-specific, measurable
objectives and timeframes in order to evaluate the resident’s progress toward his/her goal(s).

Care plans must be person-centered and reflect the resident’s goals for admission and desired
outcomes. Person-centered care means the facility focuses on the resident as the center of
control, and supports each resident in making his or her own choices. Person-centered care
includes making an effort to understand what each resident is communicating, verbally and
nonverbally, identifying what is important to each resident with regard to daily routines and
preferred activities, and having an understanding of the resident’s life before coming to reside in
the nursing home.

Residents’ goals set the expectations for the care and services he or she wishes to receive. For
example, a resident admitted for rehabilitation may have the following goal – “Receive the
necessary care and services so that I may return to independent living.” Another resident may
have a goal of receiving the necessary care and services to meet needs they cannot independently
achieve, while maintaining as much independence as possible. And yet another resident or his or
her representative, if applicable, may have a goal of receiving the necessary care and services to
keep the resident comfortable and pain-free at the end of their life. Each of these examples would

https://store.samhsa.gov/system/files/sma14-4884

be supported by measurable objectives, interventions and timeframes designed to meet each
specific resident goal.

Measurable objectives describe the steps toward achieving the resident’s goals, and can be
measured, quantified, and/or verified. For example, “Mrs. Jones, who underwent hip
replacement, will report adequate pain control (as evidenced by pain at 1-3, on a scale of 1-10)
throughout her SNF stay.” Facility staff will use this objective to monitor the resident’s progress.

The comprehensive care plan must reflect interventions to enable each resident to meet his/her
objectives. Interventions are the specific care and services that will be implemented.
Interventions for the example above, related to pain, may include, but are not limited to:

• Evaluate pain level using pain scale (0-10) 45 minutes after administering pain
medication;

• Administer pain medication 45-60 minutes prior to physical therapy.

When developing the comprehensive care plan, facility staff must, at a minimum, use the
Minimum Data Set (MDS) to assess the resident’s clinical condition, cognitive and functional
status, and use of services.

If a Care Area Assessment (CAA) is triggered, the facility must further assess the resident to
determine whether the resident is at risk of developing, or currently has a weakness or need
associated with that CAA, and how the risk, weakness or need affects the resident.
Documentation regarding these assessments and the facility’s rationale for deciding whether or
not to proceed with care planning for each area triggered must be recorded in the medical record.

There may be times when a resident risk, weakness or need is identified within the context of the
MDS assessment, but may not cause a CAA to trigger. The facility is responsible for addressing
these areas and must document the assessment of these risks, weaknesses or needs in the medical
record and determine whether or not to develop a care plan and interventions to address the area.
If the decision to proceed to care planning is made, the interdisciplinary team (IDT), in
conjunction with the resident and/or resident’s representative, if applicable (§483.21(b)(2)(ii)),
must develop and implement the comprehensive care plan and describe how the facility will
address the resident’s goals, preferences, strengths, weaknesses, and needs.

NOTE: Although Federal requirements dictate the completion of RAI assessments according to
certain time frames, standards of good clinical practice dictate that the clinical assessment
process is more fluid and should be ongoing. The lack of ongoing clinical assessment and
identification of changes in condition to meet the resident’s needs between required RAI
assessments should be addressed at §483.35 Nursing Services, F726 (competency and skills to
identify and address a change in condition), and the relevant outcome tag, such as §483.12
Abuse, §483.24 Quality of Life, §483.25 Quality of Care, and/or §483.40 Behavioral Health.

In some cases, a resident may wish to refuse certain services or treatments that professional staff
believes may be indicated to assist the resident in reaching his or her highest practicable level of
well-being or to keep the resident safe. In situations where a resident’s choice to decline care or

treatment (e.g., due to preferences, maintain autonomy, etc.) poses a risk to the resident’s health
or safety, the comprehensive care plan must identify the care or service being declined, the risk
the declination poses to the resident, and efforts by the interdisciplinary team to educate the
resident and the representative, as appropriate. The facility’s attempts to find alternative means
to address the identified risk/need should be documented in the care plan. See guidelines at
§483.10(c)(6) (F578) for additional guidance concerning the resident’s decision to refuse
treatment. Additionally, a resident’s decision-making ability may decline over time. The facility
should determine how the resident’s decisions may increase risks to health and safety, evaluate
the resident’s decision making capacity, and involve the interdisciplinary team and the resident’s
representative, if applicable, in the care planning process.

In addition to addressing preferences and needs assessed by the MDS, the comprehensive care
plan must coordinate with and address any specialized services or specialized rehabilitation
services the facility will provide or arrange as a result of PASARR recommendations. If the IDT
disagrees with the findings of the PASARR, it must indicate its rationale in the resident’s
medical record. The rationale should include an explanation of why the resident’s current
assessed needs are inconsistent with the PASARR recommendations and how the resident would
benefit from alternative interventions. The facility should also document a resident’s the
resident’s preference for a different approach to achieve goals or refusal of recommended
services.

Residents’ preferences and goals may change throughout their stay, so facilities should have
ongoing discussions with the resident and resident representative, if applicable, so that changes
can be reflected in the comprehensive care plan.

The comprehensive care plan must address a resident’s preference for future discharge, as early
as upon admission, to ensure that each resident is given every opportunity to attain his/her
highest quality of life. This encourages facilities to operate in a person-centered fashion that
addresses resident choice and preferences.

Culturally Competent Care

Cultural competency, (also known as cultural responsiveness, cultural awareness, and cultural
sensitivity) refers to a person’s ability to interact effectively with persons of cultures different
from his/her own. it means being respectful and responsive to the health beliefs, practices and
cultural and linguistic needs of diverse population groups, such as racial, ethnic, religious or
social groups (https://www.samhsa.gov/capt/applying-strategic-prevention/cultural-competence).
The interventions in the resident’s care plan must reflect the individual resident’s needs and
preferences and align with the resident’s cultural identity.

Trauma-Informed Care

Given the widespread nature and highly individualized experience of trauma, the utilization of
trauma-informed approaches is an essential part of person-centered care. Facilities must
recognize the effects of past trauma on residents and collaborate with the resident, family and
friends of the resident to identify and implement individualized interventions. Interventions for

trauma survivors should recognize the interrelation between trauma and symptoms of trauma
such as substance abuse, eating disorders, aggression, depression, anxiety, and withdrawal or
isolation from others.

Surveyors should refer to the following when investigating concerns related to culturally-
competent, trauma-informed care:

• F656: For concerns related to development or implementation of culturally competent
and/or trauma-informed care plan interventions;

• F699: For concerns related to outcomes or potential outcomes to the resident related to
culturally-competent and/or trauma-informed care;

• F726: For concerns related to the knowledge, competencies, or skill sets of nursing staff
to provide care or services that are culturally competent and trauma-informed.

• F742: For concerns related to treatment and services for resident with history of trauma
and/or history of post-traumatic stress disorder (PTSD)

INVESTIGATIVE PROCEDURES

Use the Critical Element (CE) Pathway associated with the issue under investigation, or if there
is no specific CE Pathway, use the General Critical Element Pathway, along with the above
interpretive guidelines when determining if the facility meets the requirements for, or
investigating concerns related to the facility’s requirement to develop and implement a
Comprehensive Care Plan. If systemic concerns are identified with Comprehensive Care Plans,
use the probes below to assist in your investigation

PROBES

• Does the care plan address the goals, preferences, needs and strengths of the resident,
including those identified in the comprehensive resident assessment, to assist the resident
to attain or maintain his or her highest practicable well-being and prevent avoidable
decline?

• Are objectives and interventions person-centered, measurable, and do they include time
frames to achieve the desired outcomes?

• Is there evidence of resident and, if applicable resident representative participation (or
attempts made by the facility to encourage participation) in developing person-centered,
measurable objectives and interventions?

• Does the care plan describe specialized services and interventions to address PASARR
recommendations, as appropriate?

• Does the care plan describe interventions that reflect the resident’s cultural preferences,
values and practices?

• For residents with a history of trauma, does the care plan describe corresponding
interventions for care that are in accordance with professional standards of practice and
accounting for residents’ experiences and preferences in order to eliminate or mitigate
triggers that may cause re-traumatization of the resident? (See §483.25(m))

• Is there evidence that care plan interventions were implemented consistently across all
shifts?

• Is there a process in place to ensure direct care staff are aware of and educated about the
care plan interventions?

• Determine whether the facility has provided adequate information to the resident and, if
applicable resident representative so that he/she was able to make informed choices
regarding treatment and services.

• Evaluate whether the care plan reflects the facility’s efforts to find alternative means to
address care of the resident if he or she has refused treatment.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION

• F658: for concerns regarding the delivery of care within professional standards of
practice.

If the surveyor identifies concerns about the resident’s care plan being individualized and
person-centered, the surveyor should also review requirements at:

• Resident Rights, §483.10
• Resident assessment, §483.20
• Activities, §483.24(c)
• Nursing services, §483.35
• Food and nutrition services, §483.60
• Facility assessment, §483.71
• Cultural competence and trauma-informed care, §483.25(m)
• Treatment/Services for mental/psychosocial concerns §483.40(b)(1)

KEY ELEMENTS OF NON-COMPLIANCE

To cite deficient practice at F656, the surveyor’s investigation will generally show that the
facility failed to do one or more of the following:

• Develop and implement a care plan that:

o Is comprehensive and individualized;
o Is consistent with the resident’s goals and right to be informed and participate in

his/her treatment;
o Meets each of the medical, nursing, mental and psychosocial needs identified on the

resident’s comprehensive assessment;
o Includes measurable objectives, interventions and timeframes for how staff will meet

the resident’s needs.

• Develop and implement a care plan that describes all of the following:

o Resident goals and desired outcomes;
o The care/services that will be furnished so that the resident can attain or maintain

his/her highest practicable physical, mental and psychosocial well-being;

o The specialized services to be provided as a result of the PASARR evaluation and/or
the comprehensive assessment;

o The resident’s discharge plan and any referrals to the local contact agency;
o Refusals of care and action taken by facility staff to educate the resident and resident

representative, if applicable, regarding alternatives and consequences;
o Care and services which are culturally competent and trauma-informed.

DEFICIENCY CATEGORIZATION

Examples of Level 4, immediate jeopardy to resident health and safety, include, but are not
limited to:

• A resident has a known history of inappropriate sexual behaviors and aggression, but the
comprehensive care plan did not address the resident’s inappropriate sexual behaviors or
aggression which placed the resident and other residents in the facility at risk for serious
physical and/or psychosocial injury, harm, impairment, or death.

• The facility failed to implement care plan interventions to monitor a resident with a
known history of elopement attempts, which resulted in the resident leaving the building
unsupervised, putting the resident at risk for serious injury or death.

• The facility failed to identify a resident’s cultural dietary restrictions related to eating

pork. After eating her dinner, upon realization that she had eaten pork, the resident began
crying inconsolably and screaming that this was explicitly forbidden in her culture and
faith of Islam. The resident remained tearful and inconsolable for several days, and would
not eat the food provided by the facility, which resulted in weight loss and serious
psychosocial harm.

Examples of Level 3, actual harm that is not immediate jeopardy include, but are not
limited to:

• The CAA Summary for a resident indicates the need for a care plan to be developed to
address nutritional risks in a resident who had poor nutritional intake. A care plan was not
developed, or the care plan interventions did not address the problems/risks identified.
The lack of interventions caused the resident to experience weight loss.

• Lack of care plan interventions to address a resident’s anxiety, depression, and
hallucinations resulted in psychosocial harm to the resident

Examples of Level 2, no actual harm, with potential for than more than minimal harm, that
is not immediate jeopardy, include, but are not limited to:

• During the comprehensive assessment, a resident indicated a desire to participate in
particular activities, but the comprehensive care plan did not address the resident’s
preferences for activities, which resulted in the resident complaining of being bored, and

sometimes feeling sad about not participating in activities he/she expressed interest in
attending.

• An inaccurate or incomplete care plan resulted in facility staff providing one staff to
assist the resident, when the resident required the assistance of two staff, which had the
potential to cause more than minimal harm.

An example of Level 1, no actual harm with potential for no more than a minor negative
impact on the resident, includes, but is not limited to:

For one or more care plans, the staff did not include a measurable objective, which resulted in no
more than a minor negative impact on the involved residents.

F657
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.21(b) Comprehensive Care Plans
§483.21(b)(2) A comprehensive care plan must be—

(i) Developed within 7 days after completion of the comprehensive assessment.
(ii) Prepared by an interdisciplinary team, that includes but is not limited to–

(A) The attending physician.
(B) A registered nurse with responsibility for the resident.
(C) A nurse aide with responsibility for the resident.
(D) A member of food and nutrition services staff.
(E) To the extent practicable, the participation of the resident and the resident’s

representative(s). An explanation must be included in a resident’s medical
record if the participation of the resident and their resident representative is
determined not practicable for the development of the resident’s care plan.

(F) Other appropriate staff or professionals in disciplines as determined by the
resident’s needs or as requested by the resident.

(iii)Reviewed and revised by the interdisciplinary team after each assessment, including
both the comprehensive and quarterly review assessments.

INTENT of §483.21(b)(2)
To ensure the timeliness of each resident’s person-centered, comprehensive care plan, and to
ensure that the comprehensive care plan is reviewed and revised by an interdisciplinary team
composed of individuals who have knowledge of the resident and his/her needs, and that each
resident and resident representative, if applicable, is involved in developing the care plan and
making decisions about his or her care.

DEFINITIONS
“Non-physician practitioner (NPP)” is a nurse practitioner (NP), clinical nurse specialist
(CNS), or physician assistant (PA).

GUIDANCE §483.21(b)(2)
Facility staff must develop the comprehensive care plan within seven days of the completion of
the comprehensive assessment (Admission, Annual or Significant Change in Status) and review

and revise the care plan after each assessment. “After each assessment” means after each
assessment known as the Resident Assessment Instrument (RAI) or Minimum Data Set (MDS)
as required by §483.20, except discharge assessments. For newly admitted residents, the
comprehensive care plan must be completed within seven days of the completion of the
comprehensive assessment and no more than 21 days after admission.

As used in this requirement, “Interdisciplinary” means that professional disciplines, as
appropriate, will work together to provide the greatest benefit to the resident. It does not mean
that every goal must have an interdisciplinary approach. The mechanics of how the
interdisciplinary team (IDT) meets its responsibilities in developing an interdisciplinary care
plan (e.g., a face-to-face meeting, teleconference, written communication) is at the discretion of
the facility. In instances where an IDT member participates in care plan development, review or
revision via written communication, the written communication in the medical record must
reflect involvement of the resident and resident representative, if applicable, and other members
of the IDT, as appropriate.

The IDT must, at a minimum, consist of the resident’s attending physician, a registered nurse and
nurse aide with responsibility for the resident, a member of the food and nutrition services staff,
and to the extent possible, the resident and resident representative, if applicable. If the attending
physician is unable to participate in the development of the care plan,, he/she may delegate
participation to an NPP who is involved in the resident’s care, to the extent permitted by state
law, or arrange alternative methods of providing input in the development and revision of the
care plan, such as one-on-one discussions, videoconferencing and conference calls with the IDT.

The determination of other appropriate staff or professionals participation in the IDT should be
based on the physical, mental and psychosocial condition of each resident. This includes an
appropriate level of involvement of physicians, nurses, rehabilitation therapists, activities
professionals, social workers, and other professionals, such as developmental disabilities
specialists or spiritual advisor. Involvement of other individuals is dependent upon resident
request and/or needs.

Each resident has the right to participate in choosing treatment options and must be given the
opportunity to participate in the development, review and revision of his/her care plan.
Residents also have the right to refuse treatment.

Facility staff have a responsibility to assist residents to engage in the care planning process, e.g.,
helping residents and resident representatives, if applicable understand the assessment and care
planning process; holding care planning meetings at the time of day when the resident is
functioning best; planning enough time for information exchange and decision making;
encouraging a resident’s representative to participate in care planning and attend care planning
conferences.

The facility must provide the resident and resident representative, if applicable with advance
notice of care planning conferences to enable resident/resident representative participation.
Resident and resident representative participation in care planning can be accomplished in many

forms such as holding care planning conferences at a time the resident representative is available
to participate, holding conference calls or video conferencing.

Facilities are expected to facilitate the residents’ and if applicable, the resident representatives’
participation in the care planning process. There are limited circumstances in which the
inclusion of the resident and/or resident representative may not be practicable (or feasible). An
example may be the case of a severely cognitively impaired resident who is unable to understand
or participate in care plan development, and the resident’s representative does not respond to
facility attempts to make contact. If the facility determines that the inclusion of the resident
and/or resident representative is not practicable, documentation of the reasons, including the
steps the facility took to include the resident and/or resident representative, must be included in
the medical record.

While Federal regulations at §483.10(c) affirm the resident’s right to participate in care planning,
request and/or refuse treatment, the regulations do not create the right for a resident or resident
representative, if applicable, to demand that the facility use specific medical interventions or
treatments that the facility deems not medically necessary and/or reasonable.

The resident’s care plan must be reviewed after each assessment, as required by §483.20, except
discharge assessments, and revised based on changing goals, preferences and needs of the
resident and in response to current interventions.

NOTE: Although Federal requirements dictate the completion of RAI assessments according to
certain time frames, standards of good clinical practice dictate that the clinical assessment
process is more fluid and should be ongoing. The lack of ongoing clinical assessment and
identification of changes in condition, to meet the resident’s needs between required RAI
assessments should be addressed at §483.35 Nursing Services, F726 (competency and skills to
identify and address a change in condition), and the relevant outcome tag, such as §483.12
Abuse, §483.24 Quality of Life, §483.25 Quality of Care, and/or §483.40 Behavioral Health.

For concerns related to the resident’s rights to participate in planning and implementing his or
her care, see requirements at §483.10(c).

INVESTIGATIVE SUMMARY AND PROBES §483.21(b)(2)
Use the Critical Element (CE) Pathway associated with the issue under investigation, or if there
is no specific CE Pathway, use the General Critical Element Pathway, along with the above
interpretive guidelines when determining if the facility meets the requirements for, or
investigating concerns related to the facility’s requirement for timely completion and IDT and
resident involvement in the development of the Comprehensive Care Plan. If systemic concerns
are identified with timeliness and IDT/resident involvement in the development of
Comprehensive Care Plans, use the probes below to assist in your investigation.

• Was a comprehensive plan of care developed within seven days of completion of the
resident’s comprehensive assessment?

• Is there evidence of participation in the care planning process by required IDT members?

• Ask required members of the IDT how they participate in the development, review and
revision of care plans.

• Based on the resident’s goals and needs, were other appropriate staff or professionals’
expertise utilized to develop a plan to improve the resident’s functional abilities?

For example:
a. Did an occupational therapist recommend needed adaptive equipment or a speech

therapist provide techniques to improve swallowing ability?
b. Did the dietitian and speech therapist determine the optimum textures and consistency for

the resident’s food that is nutritionally adequate and compatible with the resident’s
oropharyngeal capabilities and food preferences?

• Is there evidence of attending physician involvement in development of the care plan
(e.g., presence at care plan meetings, conversations with team members concerning the
care plan, conference calls, written communication)?

• How do staff make an effort to schedule care plan meetings at the best time of the day for
residents and if applicable, the resident representatives?

• How do staff make the care plan process understandable to the resident and resident
representative, if applicable?

• Ask the resident and resident representative, if applicable if he or she actively participates
in the care planning process? If not, what have been the barriers to participation?

• Ask the resident and if applicable, the resident representative if he or she has requested
the participation of additional individuals care planning process. If so, was the request
respected?

• In what ways does staff involve the resident and if applicable, the resident representative
in care planning? If staff determine that the resident and/or resident representative
involvement in care planning is not practicable, is the reason and the steps the facility
took to include the resident and/or resident representative documented in the medical
record?

• Is there evidence that the care plan is evaluated for effectiveness and revised following
each required assessment, except discharge assessments, and as needed?

DEFICIENCY CATEGORIZATION
An example of Level 4, immediate jeopardy to resident health or safety, includes, but is not
limited to:

• The resident’s care plan was not revised following a significant change assessment which
identified an occurrence of resident-to resident sexual abuse, placing the abused resident
and other residents at risk for serious injury, impairment or death.

An example of Level 3, actual harm that is not immediate jeopardy includes, but is not
limited to:

• The facility failed to develop the comprehensive care plan within seven days of
completion of the comprehensive assessment. This resulted in the resident sustaining a
laceration requiring stitches due to a fall because appropriate fall prevention interventions
were not implemented timely.

Examples of Level 2, no actual harm with potential for than more than minimal harm that
is not immediate jeopardy, include, but are not limited to:

• Residents and their representatives, if applicable, are not routinely invited to participate
in care planning. While the resident did not experience an actual decline in physical,
mental, or psychosocial functioning and continued to meet goals established on the care
plan, the care plan goals did not show evidence of resident and if applicable, the resident
representative input, having the potential for more than minimal harm.

• Direct-care staff were not made aware of revisions to the resident’s care plan by the IDT
for three days to assist the resident in brushing his teeth. This resulted in staff not
assisting the resident with brushing his teeth for three days, and the resident did not suffer
actual harm.

Examples of Level 1, no actual harm with potential for no more than a minor negative
impact on the resident, include, but are not limited to:

• Care plan was not reviewed by the IDT after the resident’s quarterly assessment indicated
a minor change in the resident’s status.

• A required member of the IDT did not participate in development of the resident’s care
plan, which had no more than a minor negative impact to the resident.

F658
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.21(b)(3) Comprehensive Care Plans
The services provided or arranged by the facility, as outlined by the comprehensive care
plan, must—

(i) Meet professional standards of quality.

INTENT §483.21(b)(3)(i)

The intent of this regulation is to assure that services being provided meet professional standards
of quality.

GUIDANCE §483.21(b)(3)(i)

“Professional standards of quality” means that care and services are provided according to
accepted standards of clinical practice. Standards may apply to care provided by a particular
clinical discipline or in a specific clinical situation or setting. Standards regarding quality care
practices may be published by a professional organization, licensing board, accreditation body or
other regulatory agency. Recommended practices to achieve desired resident outcomes may also
be found in clinical literature. Possible reference sources for standards of practice include:

• Current manuals or textbooks on nursing, social work, physical therapy, etc.
• Standards published by professional organizations such as the American Dietetic

Association, American Medical Association, American Medical Directors Association,
American Nurses Association, National Association of Activity Professionals, National
Association of Social Work, etc.

• Clinical practice guidelines published by the Agency for Healthcare Research and
Quality.

• Current professional journal articles.

NOTE: Although Federal requirements dictate the completion of RAI assessments according to
certain time frames, standards of good clinical practice dictate that the clinical assessment
process is more fluid and should be ongoing. The lack of ongoing clinical assessment and
identification of changes in condition, to meet the resident’s needs between required RAI
assessments should be addressed at §483.35 Nursing Services, F726 (competency and skills to
identify and address a change in condition), and the relevant outcome tag, such as §483.12
Abuse, §483.24 Quality of Life, §483.25 Quality of Care, and/or §483.40 Behavioral Health.

NOTE: CMS is aware of situations where practitioners have potentially misdiagnosed residents
with a condition for which antipsychotics are an approved use (e.g., new diagnosis of
schizophrenia) which would then exclude the resident from the long-stay antipsychotic quality
measure. For these situations, determine if non-compliance exists related to the practitioner not
adhering to professional standards of quality for assessing and diagnosing a resident. This
practice may also require referrals by the facility and/or the survey team to State Medical Boards
or Boards of Nursing.

PROCEDURES AND PROBES §483.21(b)(3)(i)

There is no requirement for the surveyor to cite a reference or source (e.g., current textbooks,
professional organizations or clinical practice guidelines) for the standard of practice that has not
been followed related to care and services provided within professional scopes of practice, such
as failure of nursing staff to assess a change in the resident’s condition. However, in cases
where the facility provides a reference supporting a particular standard of practice for which the
surveyor has concerns, the surveyor must provide evidence that the standard of practice the
facility is using is not up-to-date, widely accepted, or supported by recent clinical literature. Such
evidence should include a citation for the reference or source (e.g., current textbooks,
professional organizations or clinical practice guidelines) for the current standard of practice
from which facility deviated.

If a negative or potentially negative resident outcome is determined to be related to the facility’s
failure to meet professional standards and the team determines a deficiency has occurred, it
should also be cited under the appropriate quality of care or other relevant requirement. For
example, if a resident develops a pressure injury because the facility’s nursing staff failed to
provide care in accordance with professional standards of quality, the team should cite the
deficiency at both F658 and F686 (Skin Integrity).

• Do the services provided or arranged by the facility, as outlined in the comprehensive
care plan, reflect accepted standards of practice?

• Are the references for standards of practice, used by the facility, up to date, and accurate
for the service being delivered?

KEY ELEMENTS OF NONCOMPLIANCE:
To cite deficient practice at F658, the surveyor’s investigation will generally show that the
facility did one or more of the following:

• Provided or arranged for services or care that did not adhere to accepted standards of
quality;

• Provided a service or care when the accepted standards of quality dictate that the service
or care should not have been provided;

• Failed to provide or arrange for services or care that accepted standards of quality dictate
should have been provided.

F659
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.21(b)(3) Comprehensive Care Plans
The services provided or arranged by the facility, as outlined by the comprehensive care
plan, must—

(ii) Be provided by qualified persons in accordance with each resident’s written plan of
care.

GUIDANCE

The facility must ensure that services provided or arranged in accordance with the resident’s plan
of care are delivered by individuals who have the skills, experience and knowledge to do a
particular task or activity. This includes proper licensure or certification, if required.

INVESTIGATIVE PROCEDURES AND PROBES

NOTE: Provision of services by qualified individuals would be cited here, but implementation
of the care plan would be cited in F656.

• Are the services identified in the comprehensive care plan being provided by qualified
persons?

• Do staff assigned to the resident have the skills, experience and knowledge to provide
care and services that meet the resident’s needs?

DEFICIENCY CATEGORIZATION
An example of Level 4, immediate jeopardy to resident health or safety includes, but is not
limited to:

• The facility had no qualified staff on duty knowledgeable or competent in how to care for
a resident with a tracheostomy, posing a risk for serious injury, harm, impairment or
death for the resident.

An example of Level 3, actual harm that is not immediate jeopardy includes, but is not
limited to:

• The facility utilized a staff member who was not qualified to draw a resident’s blood,
according to the resident’s care plan, resulting in the resident sustaining extensive
bruising, swelling, pain and decreased ability to use the arm after the blood draw

An example of Level 2, no actual harm with potential for than more than minimal harm
that is not immediate jeopardy includes, but is not limited to:

• The facility failed to ensure staff were qualified to perform blood pressure (BP) readings.
During survey, staff were observed taking and reporting resident BPs that were abnormal.
After further investigation, it was determined that staff were using the incorrect size BP
cuff, yielding inaccurate BP readings, resulting in the potential for more than minimal
harm.

Non-compliance with this regulation places the resident at risk for more than minimal
harm. Therefore, Severity Level 1 does not apply for this regulatory requirement.

F660
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.21(c)(1) Discharge Planning Process
The facility must develop and implement an effective discharge planning process that
focuses on the resident’s discharge goals, the preparation of residents to be active partners
and effectively transition them to post-discharge care, and the reduction of factors leading
to preventable readmissions. The facility’s discharge planning process must be consistent
with the discharge rights set forth at 483.15(b) as applicable and—

(i) Ensure that the discharge needs of each resident are identified and result in the
development of a discharge plan for each resident.

(ii) Include regular re-evaluation of residents to identify changes that require
modification of the discharge plan. The discharge plan must be updated, as needed,
to reflect these changes.

(iii) Involve the interdisciplinary team, as defined by §483.21(b)(2)(ii), in the ongoing
process of developing the discharge plan.

(iv) Consider caregiver/support person availability and the resident’s or
caregiver’s/support person(s) capacity and capability to perform required care, as
part of the identification of discharge needs.

(v) Involve the resident and resident representative in the development of the discharge
plan and inform the resident and resident representative of the final plan.

(vi) Address the resident’s goals of care and treatment preferences.
(vii) Document that a resident has been asked about their interest in receiving

information regarding returning to the community.
(A) If the resident indicates an interest in returning to the community, the facility

must document any referrals to local contact agencies or other appropriate
entities made for this purpose.

(B) Facilities must update a resident’s comprehensive care plan and discharge plan,
as appropriate, in response to information received from referrals to local
contact agencies or other appropriate entities.

(C) If discharge to the community is determined to not be feasible, the facility must
document who made the determination and why.

(viii) For residents who are transferred to another SNF or who are discharged to a
HHA, IRF, or LTCH, assist residents and their resident representatives in selecting
a post-acute care provider by using data that includes, but is not limited to SNF,
HHA, IRF, or LTCH standardized patient assessment data, data on quality
measures, and data on resource use to the extent the data is available. The facility
must ensure that the post-acute care standardized patient assessment data, data on
quality measures, and data on resource use is relevant and applicable to the
resident’s goals of care and treatment preferences.

(ix) Document, complete on a timely basis based on the resident’s needs, and include in
the clinical record, the evaluation of the resident’s discharge needs and discharge
plan. The results of the evaluation must be discussed with the resident or resident’s
representative. All relevant resident information must be incorporated into the
discharge plan to facilitate its implementation and to avoid unnecessary delays in
the resident’s discharge or transfer.

INTENT §483.21(c)(1)
This requirement intends to ensure that the facility has a discharge planning process in place
which addresses each resident’s discharge goals and needs, including caregiver support and
referrals to local contact agencies, as appropriate, and involves the resident and if applicable, the
resident representative and the interdisciplinary team in developing the discharge plan.

DEFINITIONS §483.21(c)(1)
“Discharge Planning”: A process that generally begins on admission and involves identifying
each resident’s discharge goals and needs, developing and implementing interventions to address
them, and continuously evaluating them throughout the resident’s stay to ensure a successful
discharge.

“Home Health Agency (HHA)”: a public agency or private organization (or a subdivision of
either) which is primarily engaged in providing skilled nursing services and other therapeutic
services in the patient’s home and meets the requirements of sections 1861(o) and 1891 of the
Social Security Act.

“Inpatient Rehabilitation Facility (IRF)”: are freestanding rehabilitation hospitals or
rehabilitation units in acute care hospitals that serve an inpatient population requiring intensive
services for treatment.

“Local Contact Agency”: refers to each State’s designated community contact agencies that can
provide individuals with information about community living options and available supports and
services. These local contact agencies may be a single entry point agency, such as an Aging and

Disability Resource Center (ADRC), an Area Agency on Aging (AAA), a Center for
Independent Living (CIL), or other state designated entities.

“Long Term Care Hospital (LTCH)”: are certified as acute-care hospitals, but focus on
patients who, on average, stay more than 25 days. Many of the patients in LTCHs are transferred
there from an intensive or critical care unit. LTCHs specialize in treating patients who may have
more than one serious condition, but who may improve with time and care, and return home.

“Patient Assessment Data”: standardized, publicly available information derived from a post-
acute care provider’s patient/resident assessment instrument, e.g., Minimum Data Set (MDS),
Outcome and Assessment Information Set (OASIS).

GUIDANCE §483.21(c)(1)
Discharge Planning
Discharge planning is the process of creating an individualized discharge care plan, which is part
of the comprehensive care plan. It involves the interdisciplinary team (as defined in
§483.21(b)(2)(ii) working with the resident and resident representative, if applicable, to develop
interventions to meet the resident’s discharge goals and needs to ensure a smooth and safe
transition from the facility to the post-discharge setting. Discharge planning begins at admission
and is based on the resident’s assessment and goals for care, desire to be discharged, and the
resident’s capacity for discharge. It also includes identifying changes in the resident’s condition,
which may impact the discharge plan, warranting revisions to interventions. A well-executed
discharge planning process, without avoidable complications, maximizes each resident’s
potential to improve, to the extent possible, based on his or her clinical condition. An inadequate
discharge planning process may complicate the resident’s recovery, lead to admission to a
hospital, or even result in the resident’s death.

The discharge care plan is part of the comprehensive care plan and must:

• Be developed by the interdisciplinary team and involve direct communication with the
resident and if applicable, the resident representative;

• Address the resident’s goals for care and treatment preferences;
• Identify needs that must be addressed before the resident can be discharged, such as

resident education, rehabilitation, and caregiver support and education;
• Be re-evaluated regularly and updated when the resident’s needs or goals change;
• Document the resident’s interest in, and any referrals made to the local contact agency;
• Identify post-discharge needs such as nursing and therapy services, medical equipment

or modifications to the home, or ADL assistance

Resident Discharge to the Community
Section Q of the Minimum Data Set (MDS) requires that individuals be periodically assessed for
their interest in being transitioned to community living, unless the resident indicates otherwise.
See: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/NursingHomeQualityInits/NHQIMDS30TrainingMaterials.html.
For residents who want to be discharged to the community, the nursing home must determine if
appropriate and adequate supports are in place, including capacity and capability of the resident’s
caregivers at home. Family members, significant others or the resident’s representative should

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/NHQIMDS30TrainingMaterials.html

be involved in this determination, with the resident’s permission, unless the resident is unable to
participate in the discharge planning process.
Each situation is unique to the resident, his/her family, and/or guardian/legally authorized
representative. A referral to the Local Contact Agency (LCA) may be appropriate for many
individuals, who could be transitioned to a community setting of their choice. The nursing home
staff is responsible for making referrals to the LCA, if appropriate, under the process that the
State has established. Nursing home staff should also make the resident and if applicable, the
resident representative aware that the local ombudsman is available to provide information and
assist with any transitions from the nursing home.
For residents who have been in the facility for a longer time, it is still important to inquire, as
appropriate, whether the resident would like to talk with LCA experts about returning to the
community. New or improved community resources and supports may have become available
since the resident was first admitted which may now enable the resident to return to a community
setting.

If the resident is unable to communicate his or her preference or is unable to participate in
discharge planning, the information should be obtained from the resident’s representative.

Discharge planning must include procedures for:

• Documentation of referrals to local contact agencies, the local ombudsman, or other
appropriate entities made for this purpose;

• Documentation of the response to referrals; and
• For residents for whom discharge to the community has been determined to not be

feasible, the medical record must contain information about who made that decision and
the rationale for that decision.

Discharge planning must identify the discharge destination, and ensure it meets the resident’s
health and safety needs, as well as preferences. If a resident wishes to be discharged to a setting
that does not appear to meet his or her post-discharge needs, or appears unsafe, the facility must
treat this situation similarly to refusal of care, and must:

• Discuss with the resident, (and/or his or her representative, if applicable) and document
the implications and/or risks of being discharged to a location that is not equipped to
meet his/her needs and attempt to ascertain why the resident is choosing that location;

• Document that other, more suitable, options of locations that are equipped to meet the
needs of the resident were presented and discussed;

• Document that despite being offered other options that could meet the resident’s needs,
the resident refused those other more appropriate settings;

• Determine if a referral to Adult Protective Services or other state entity charged with
investigating abuse and neglect is necessary. The referral should be made at the time of
discharge.

As appropriate, facilities should follow their policies, or state law as related to discharges which
are Against Medical Advice (AMA).

Residents who will be discharged to another SNF/NF, HHA, IRF, or LTCH

If a resident will be discharged to another SNF, an IRF, LTCH, or HHA, the facility must assist
the resident in choosing an appropriate post-acute care provider that will meet the resident’s
needs, goals, and preferences. Assisting the resident means the facility must compile available
data on other appropriate post-acute care options to present to the resident. Information the
facility must gather about potential receiving providers includes, but is not limited to:

• Publicly available standardized quality information, as reflected in specific quality
measures, such as the CMS Nursing Home Compare, Home Health Compare, Inpatient
Rehabilitation Facility (IRF) Compare, and Long-Term Care Hospital (LTCH) Compare
websites, and

• Resource use data, which may include, number of residents/patients who are discharged
to the community, and rates of potentially preventable hospital readmissions.

The listing of potential providers and data compiled must be relevant to the resident’s needs, and
be aligned with the resident’s goals of care and treatment preferences.
Facilities must also comply with Section 1128B of the Social Security Act (the Federal Anti-
Kickback statute) when making referrals to other provider types. Section 1128B “prohibits the
knowing and willful offer, payment, solicitation, or receipt of any remuneration, in cash or in
kind, to induce or in return for referring an individual for the furnishing or arranging of any item
or service for which payment may be made under a Federal health care program,”
https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-
Education/Downloads/fwa-laws-resourceguide .
In order to emphasize resident involvement, facilities are expected to present provider
information to the resident and resident representative, if applicable, in an accessible and
understandable format. For example, the facility should provide the aforementioned quality data
on other post-acute care providers that meet the resident’s needs, goals, and preferences, and are
within the resident’s desired geographic area. Facilities must then assist residents and/or resident
representative as they seek to understand the data and use it to help them choose a post-acute
care provider, or other setting for discharge, that is best suited to their goals, preferences, needs
and circumstances. For residents who are discharged to another SNF/NF, a HHA, IRF, or LTCH
the facility must provide evidence that the resident and if applicable, the resident representative
was given provider information that includes standardized patient assessment data, and
information on quality measures and resource use (where that data is available).

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION
F624: For concerns related to the immediate orientation and preparation necessary for a transfer
which does not require discharge planning, such as transfers to a hospital emergency room or
therapeutic leave.

Summary of Investigative Procedures
Use the Community Discharge Critical Element (CE) Pathway, along with the above interpretive
guidelines when determining if the facility meets the requirements for, or investigating concerns
related to the facility’s requirement to develop and implement an effective discharge planning
process.

Briefly review the most recent comprehensive assessments, comprehensive care plan
(specifically the discharge care plan), progress notes, and orders to identify whether the facility

https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Downloads/fwa-laws-resourceguide

has identified and addressed the resident’s goals and discharge needs. This information will
guide observations and interviews to be made in order to corroborate concerns identified. If
there are concerns related to systematic discharge planning, this may trigger a review of the
nursing home’s policies and procedures for discharge assessment and care planning.

NOTE: Always observe for visual cues of psychosocial distress and harm (see Appendix P,
Guidance on Severity and Scope Levels and Psychosocial Outcome Severity Guide).

DEFICIENCY CATEGORIZATION
An example of Level 4, immediate jeopardy to resident health or safety, includes, but is not
limited to:

• The facility failed to ensure that the post-discharge destination and continuing care
provider could meet the resident’s needs prior to the discharge of a resident with a
feeding tube to a residential group facility. The surveyor discovered that within 24 hours
of discharge, the resident was transferred to the hospital for aspiration, was intubated for
respiratory distress and diagnosed with brain death. Review of medical records showed
no documentation of the resident’s tube feeding needs in the discharge plan, or whether
the nursing home informed the receiving facility of the presence of the feeding tube and
the need for aspiration precautions. It was also unclear whether the nursing home had
determined that the receiving facility had the ability to care for a resident with a feeding
tube prior to placement of the individual.

Examples of level 3, actual harm that is not immediate jeopardy include, but are not
limited to:

• The facility failed to develop and/or implement a discharge care plan for a resident who
had expressed a desire to return home as soon as possible once she completed
rehabilitation for a fractured hip. The medical record revealed the therapist had
discontinued the active treatment one week ago. The resident stated and the medical
record verified that the facility had not developed plans for her care after her discharge
and had not contacted any community providers to assist in her discharge. She indicated
that she has not slept well due to worrying about returning to her home and paying the
rent while in the facility. The resident’s home was over an hour away. She stated she was
depressed over having to remain in the nursing home, and spent most of the day in her
room as it was too far for her friends to visit.

• A facility failed to develop discharge plans to meet the needs and goals of each resident,
resulting in significant psychosocial harm, when the facility determined it would be
closing, necessitating the discharge of all residents. The facility notified residents and
resident representatives it would assist with relocation. Interviews with residents and
observations showed residents were agitated, fearful, and in tears over the impending
move. Residents indicated they were not asked their preferences and many would be
relocated far away from family. Residents also indicated they were not given
opportunities to provide input into the discharge planning process, specifically regarding
discharge location. Record review showed no evidence of interaction with residents or
resident representatives related to discharge planning. This was cross-referenced and
cited at F845, Facility Closure.

An example of Level 2, no actual harm with potential for than more than minimal harm
that is not immediate jeopardy, includes, but is not limited to:

• Facility failed to develop a discharge care plan that addressed all of the needs for a
resident being discharged home. Specifically, the care plan did not address the resident’s
need for an oxygen concentrator at home. After the resident was discharged to his home,
a family member had to contact the physician to obtain the order and make arrangements
for delivery of the equipment. Although there was a delay in obtaining the oxygen
concentrator, the resident did not experience harm, however this four-hour delay had a
potential for compromising the residents’ ability to maintain his well-being.

Severity Level 1 does not apply for this regulatory requirement. The failure of the facility to
provide appropriate discharge assessment and planning in order to meet the resident’s needs and
goals at the time of discharge from the nursing home and to ensure communication of necessary
information for a safe transition of care places the resident at risk for more than minimal harm.

F661
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.21(c)(2) Discharge Summary
When the facility anticipates discharge, a resident must have a discharge summary that
includes, but is not limited to, the following:

(i) A recapitulation of the resident’s stay that includes, but is not limited to, diagnoses,
course of illness/treatment or therapy, and pertinent lab, radiology, and
consultation results.

(ii) A final summary of the resident’s status to include items in paragraph (b)(1) of
§483.20, at the time of the discharge that is available for release to authorized
persons and agencies, with the consent of the resident or resident’s representative.

(iii) Reconciliation of all pre-discharge medications with the resident’s post-discharge
medications (both prescribed and over-the-counter).

(iv) A post-discharge plan of care that is developed with the participation of the resident
and, with the resident’s consent, the resident representative(s), which will assist the
resident to adjust to his or her new living environment. The post-discharge plan of
care must indicate where the individual plans to reside, any arrangements that have
been made for the resident’s follow up care and any post-discharge medical and
non-medical services.

INTENT of §483.21(c)(2)
To ensure the facility communicates necessary information to the resident, continuing care
provider and other authorized persons at the time of an anticipated discharge.

DEFINITIONS §483.21(c)(2)
“Anticipated Discharge”: A discharge that is planned and not due to the resident’s death or an
emergency (e.g., hospitalization for an acute condition or emergency evacuation).

“Continuing Care Provider”: The entity or person who will assume responsibility for the
resident’s care after discharge. This includes licensed facilities, agencies, physicians,
practitioners, and/or other licensed caregivers.

“Recapitulation of Stay”: A concise summary of the resident’s stay and course of treatment in
the facility.

“Reconciliation of Medications”: A process of comparing pre-discharge medications to post-
discharge medications by creating an accurate list of both prescription and over the counter
medications that includes the drug name, dosage, frequency, route, and indication for use for the
purpose of preventing unintended changes or omissions at transition points in care.

GUIDANCE §483.21(c)(2)
Overview
The discharge summary provides necessary information to continuing care providers pertaining
to the course of treatment while the resident was in the facility and the resident’s plans for care
after discharge. A discharge summary must include an accurate and current description of the
clinical status of the resident and sufficiently detailed, individualized care instructions, to ensure
that care is coordinated and the resident transitions safely from one setting to another. The
discharge summary may help reduce or eliminate confusion among the various facilities,
agencies, practitioners, and caregivers involved with the resident’s care.

In the case of discharge to a non-institutional setting such as the resident’s home, provision of a
discharge summary, with the resident’s consent, to the resident’s community-based
physicians/practitioners allows the resident to receive continuous and coordinated, person-
centered care.

For residents who are being discharged from the facility to another health care facility, the
discharge summary enables the receiving facility to provide appropriate and timely care. The
medical record must identify the receiving facilities for which or physicians/practitioners to
whom the discharge summary is provided.

Content of the Discharge Summary
Recapitulation of Resident’s Stay
Recapitulation of the resident’s stay describes the resident’s course of treatment while residing in
the facility. The recapitulation includes, but is not limited to, diagnoses, course of illness,
treatment, and/or therapy, and pertinent lab, radiology, and consultation results, including any
pending lab results.

Final Summary of Resident Status
In addition to the recapitulation of the resident’s stay, the discharge summary must include a
final summary of the resident’s status which includes the items from the resident’s most recent
comprehensive assessment identified at §483.20(b)(1)(i) – (xviii) Comprehensive Assessment.
This is necessary to accurately describe the current clinical status of the resident. Items required
to be in the final summary of the resident’s status are:

• Identification and demographic information;

• Customary routine;
• Cognitive patterns;
• Communication;
• Vision;
• Mood and Behavior patterns;
• Psychosocial well-being;
• Physical functioning and structural problems;
• Continence;
• Disease diagnoses and health conditions;
• Dental and nutritional status
• Skin condition;
• Activity pursuit;
• Medications;
• Special treatments and procedures;
• Discharge planning (as evidenced by most recent discharge care plan);,
• Documentation of summary information regarding the additional assessment performed

on the care areas triggered by the completion of the MDS; and
• Documentation of participation in assessment. This refers to documentation of who

participated in the assessment process. The assessment process must include direct
observation and communication with the resident, as well as communication with
licensed and non-licensed direct care/direct access staff members on all shifts.

NOTE: In addition to the above, pursuant to §483.15(c)(2)(iii), the facility (transferring nursing
home) must convey the following information to the receiving provider when a resident is
discharged (or transferred) from that facility:

• Contact information of the practitioner (at the transferring nursing home) responsible for
the care of the resident;

• Resident representative information, if applicable, including contact information;
• Advance directive information;
• All special instructions or precautions for ongoing care, as appropriate;
• Comprehensive care plan goals; and
• All other necessary information, including a copy of the resident’s discharge summary,

consistent with §483.21(c)(2) as applicable, and any other documentation, as applicable,
to ensure a safe and effective transition of care.

For concerns related to the above, see guidance at F622, §483.15(c)(2)(iii).

Timing of the Discharge Summary
The discharge summary contains necessary medical information that the facility must furnish at
the time the resident leaves the facility, to the receiving provider assuming responsibility for
the resident’s care after discharge. The discharge summary may be furnished in either hard copy
or electronic format, if the provider assuming responsibility for the resident’s care has the
capacity to receive and use the discharge summary in electronic format. Delays in preparing and
forwarding the discharge summary hinder the coordination required to provide optimal care to

the resident. The medical record must contain the discharge summary information and identify
the recipient of the summary.

NOTE: In situations where there is no continuing care provider (e.g., resident has no primary
care physician in the community), the facility is expected to document in the medical record
efforts to assist the resident in locating a continuing care provider.

Reconciliation of Medications Prior to Discharge
A resident’s discharge medications may differ from what the resident was receiving while
residing in the facility. Facility staff must compare the medications listed in the discharge
summary to medications the resident was taking while residing in the nursing home. Any
discrepancies or differences found during the reconciliation must be assessed and resolved, and
the resolution documented in the discharge summary, along with a rationale for any changes.
For example, a resident who was receiving rehabilitative services may have required antibiotic
therapy postoperatively but does not need to continue the antibiotic at home. The
discontinuation of the medication should be documented in the discharge summary.

Discharge instructions and accompanying prescriptions provided to the resident and if
applicable, the resident representative must accurately reflect the reconciled medication list in
the discharge summary.

Post-Discharge Plan of Care
The post-discharge plan of care details the arrangements that facility staff have made to address
the resident’s needs after discharge, and includes instructions given to the resident and his or her
representative, if applicable. The post-discharge plan of care must be developed with the
participation of the Interdisciplinary team and the resident and, with the resident’s consent, the
resident’s representative. At the resident’s request, a representative of the local contact agency
may also be included in the development of the post-discharge plan of care. The post-discharge
plan of care should show what arrangements have been made regarding:

• Where the resident will live after leaving the facility;
• Follow-up care the resident will receive from other providers, and that provider’s contact

information;
• Needed medical and non-medical services (including medical equipment);
• Community care and support services, if needed; and
• When and how to contact the continuing care provider.

Instructions to residents discharged to home
For residents discharged to their home, the medical record should contain documentation that
written discharge instructions were given to the resident and if applicable, the resident
representative. These instructions must be discussed with the resident and resident
representative and conveyed in a language and manner they will understand.

KEY ELEMENTS OF NONCOMPLIANCE
To cite deficient practice at F661, the surveyor’s investigation will generally show that the
facility failed to do one or more of the following:

• Prepare a discharge summary that includes all of the following:

o A recapitulation (containing all required components) of the resident’s stay;
o A final summary of the resident’s status (that includes the items listed in

§483.20(b)(1));
o A reconciliation of all pre and post discharge medications;
o A discharge plan of care (containing all required components); or

• Reconcile the resident’s pre-discharge medications with his/her post-discharge
medications; or

• Convey the discharge summary to the continuing care provider or receiving facility at the
time of discharge

DEFICIENCY CATEGORIZATION
An example of Level 4, immediate jeopardy to resident health or safety, includes, but is not
limited to:

• A resident experienced a stroke during the SNF stay and was started on Coumadin.
The resident was then discharged to another facility but the discharge summary did
not include the new orders for Coumadin and PT/INR monitoring. The receiving
facility did not start the resident on Coumadin and the resident experienced another
stroke.

An example of level 3, actual harm that is not immediate jeopardy includes, but is not
limited to:

• Review of a discharge summary for a discharged resident showed that the discharge
summary did not contain necessary information about the resident’s wound care care
needs and arrangements for wound care after discharge. Investigation showed that the
resident did not receive appropriate wound care at home because details of wound care
received in the facility were not conveyed in the discharge summary. The facility’s
failure to provide instructions for the care of the wound in the discharge summary
information caused the resident’s wound to worsen at home resulting in readmission to a
hospital.

An example of Level 2, no actual harm with potential for than more than minimal harm
that is not immediate jeopardy, includes, but is not limited to:

• A resident was discharged to another facility closer to her family. The transferring
facility did not send a complete discharge summary to the receiving facility until one
week after the resident was admitted to the new facility. The receiving facility had to
take additional time and use multiple sources to verify medications and other medical
orders while waiting for a complete discharge summary. This placed the resident at risk
for more than minimal harm due to the potential for inaccuracies in medication and other
orders while waiting for a complete discharge summary.

An example of Level 1, no actual harm with potential for no more than a minor negative
impact on the resident, includes, but is not limited to:

• The failure of the facility to provide in its recapitulation of the resident’s stay, the most
recent laboratory results (which were normal). This resulted in no negative impact to the
resident.

F675
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§ 483.24 Quality of life
Quality of life is a fundamental principle that applies to all care and services provided to
facility residents. Each resident must receive and the facility must provide the
necessary care and services to attain or maintain the highest practicable physical, mental,
and psychosocial well-being, consistent with the resident’s comprehensive assessment and
plan of care.

INTENT

The intent of this requirement is to specify the facility’s responsibility to create and sustain an
environment that humanizes and individualizes each resident’s quality of life by:

• Ensuring all staff, across all shifts and departments, understand the principles of quality
of life, and honor and support these principles for each resident; and

• Ensuring that the care and services provided are person-centered, and honor and support
each resident’s preferences, choices, values and beliefs.

DEFINITIONS §483.24
“Person Centered Care” – For the purposes of this subpart, person-centered care means to
focus on the resident as the locus of control and support the resident in making their own choices
and having control over their daily lives. (Definitions – §483.5)

“Pervasive” For the purposes of this guidance, pervasive means spread through or embedded
within every part of something.

“Quality of Life” refers to an individual’s “sense of well-being, level of satisfaction with life
and feeling of self-worth and self-esteem. For nursing home residents, this includes a basic sense
of satisfaction with oneself, the environment, the care received, the accomplishments of desired
goals, and control over one’s life.” Adapted from the 1986 Institute of Medicine (IOM)
published report “Improving the Quality of Care in Nursing Homes,” located at:
https://www.ncbi.nlm.nih.gov/books/NBK217548/#ddd00037

GUIDANCE §483.24

Noncompliance at F675 identifies outcomes which rise to the level of immediate jeopardy and
reflect an environment of pervasive disregard for the quality of life of the facility’s residents.
This can include the cumulative effect of noncompliance at other regulatory tags on one or more
residents. To cite noncompliance at F675, the survey team must have evidence that outcomes at
other regulatory tags demonstrate a pervasive disregard for the principles of quality of life.

Principles of Quality of Life

https://www.ncbi.nlm.nih.gov/books/NBK217548/#ddd00037

According to the 1986 Institute of Medicine (IOM) published report “Improving the Quality of
Care in Nursing Homes,” principles of Quality of Life included:

• A sense of well-being, satisfaction with life, and feeling of self-worth and self-esteem;
and

• A sense of satisfaction with oneself, the environment, the care received, the
accomplishments of desired goals, and control over one’s life.

The report also identified that a sense of well-being, self-esteem, and self-worth was enhanced
by personal control over choices, such as mealtimes, activities, clothing, and bedtime; privacy
during visits, and treatments; and “opportunities to engage in religious, political, civic,
recreational or other social activities. Based upon the regulatory requirement stating that quality
of life is an overarching principle that applies to all care and services, the principles as identified
in the IOM report above, will be used for determining whether a resident’s quality of life is being
supported and or enhanced. Refer to this link for the entire IOM report:
https://www.ncbi.nlm.nih.gov/books/NBK217548/#ddd00037

Facilities must create and sustain an environment that humanizes and promotes each resident’s
well-being, and feeling of self-worth and self-esteem. This requires nursing home leadership to
establish a culture that treats each resident with respect and dignity as an individual, and
addresses, supports and/or enhances his/her feelings of self-worth including personal control
over choices, such as mealtimes, activities, clothing, and bedtime; privacy during visits, and
treatments; and opportunities to engage in religious, political, civic, recreational or other social
activities.

Facility leadership must be aware of the culture that exists in its facility and may use various
methods to assess the attitudes and values prevalent amongst staff. These methods include,
reviewing complaints or grievances, which could reasonably impact a resident’s quality of life,
or allegations of abuse, neglect or mistreatment. In order to identify whether staff supports each
resident’s quality of life, leadership should observe and evaluate verbal and nonverbal
interactions between staff and residents. Negative observations could include staff actions such
as, but not limited to, the following:

• Verbalizing negative or condescending remarks, or refusing to provide individualized
care to a resident due to his/her age, race, or cognitive or physical impairments, his/her
political or cultural beliefs, or sexual preferences;

• Dehumanizing an individual through verbal and nonverbal actions such as talking to

others over a resident without acknowledging his/her presence, treating the resident as if
he/she were an object rather than a human being, mistreating, or physically, sexually or
mentally abusing a resident.

These types of staff actions and attitudes do not recognize nor value the individual. An
individual’s life experiences, values, needs, choices and relationships must not be diminished, to
the extent possible, due to admission to a nursing home. Treating a nursing home resident in any
manner that does not uphold a resident’s sense of self-worth, dignity and individuality

dehumanizes the resident and creates an environment that perpetuates an unhealthy, unsafe
attitude towards the resident(s).

In order to achieve a culture and environment that supports quality of life, the facility must
ensure that all staff, across all shifts and departments, understand the principles of quality of life,
and honor and support these principles for each resident and that the care and services that are
provided by the facility are person-centered, and honor and support each resident’s preferences,
choices, values and beliefs.

The Link between Noncompliance at other Regulatory Tags and Noncompliance at Quality
of Life

Quality of Life at F675 should not automatically be cited when noncompliance has been
identified in Resident’s Rights/Quality of Care/Abuse-Neglect or other regulatory tags, unless
the cumulative effect of the noncompliance creates an environment that reflects a complete
disregard of one or more residents’ well-being, and rises to the level of Immediate Jeopardy.

See below for an example of noncompliance at F675 demonstrating the cumulative effect of
noncompliance at other tags for multiple residents:

The facility failed to provide an environment which supported and enhanced each
resident’s quality of life, which was the result of the cumulative effect of noncompliance
cited at dignity, abuse, staffing, and continence care. This noncompliance was found to
be pervasive and created an environment reflecting a complete disregard of one or more
residents’ well-being and quality of life, which has caused or is likely to cause serious
harm related to one or more residents’ self-worth, self-esteem, and well-being.

A complaint investigation revealed facility staff members posted unauthorized videos and
photographs on social media of several residents during bathing, going to the bathroom,
and grooming, including nude photos and photos of genitalia. As a result, the residents
suffered public humiliation and dehumanization. Facility staff interviewed were aware of
this abuse, but did not report to administration due to fear of retaliation by the
perpetrators and fear of losing their jobs.

During a resident council meeting, several residents reported that they heard staff
describing the photos, laughing about the postings and had seen staff passing around cell
phones. As a result, the residents stated that they were afraid to take a shower or bath,
and were extremely uncomfortable when requesting assistance to go to the bathroom
because they thought it might happen to them, and that they had shared these concerns
with other resident’s in the facility. (Refer to noncompliance cited at §483.12, F600 –
Abuse)

When discussing going to the bathroom, the residents stated that in addition to being
afraid of asking for help, when they did, there were not enough staff to answer call
lights. They said that staff would ignore their call light, walk by or would answer the
light and leave without assisting the residents. This had resulted in episodes of

incontinence of urine and feces, which they stated was extremely embarrassing,
humiliating and degrading to them. (Refer to noncompliance cited at §483.10(a)(1),
F550 – Dignity; §483.35, F725 – Insufficient Staff, Nursing Services; and §483.25(e)(1),
F690 – Incontinence, Quality of Care.)

Several residents stated that they were afraid to ask for staff assistance for the need to use
the bathroom, based on their fear related to the postings on social media. In addition,
they stated that when they were receiving care, if staff pulled out a cell phone, they didn’t
know if staff were taking and posting pictures of them.

When asked if these concerns had been reported to the administration, the residents stated
that they identified the issue with the call lights and not enough staff multiple times
during council meetings, but that the administration only said, we will look into it, and
nothing was done. They said they were afraid to report the cell phone concerns. One
resident said that an aide told him/her that if they didn’t quit complaining to the
administrator, no one would help them and they would be transferred to another
facility. When the resident began to cry, the aide laughed and walked out of the room,
verbally taunting him/her for crying.

See below for an example of noncompliance at F675 demonstrating the cumulative effect of
noncompliance at other tags for one resident:

The facility failed to provide an environment which supported one resident’s quality of
life, which was the result of the cumulative effect of noncompliance cited at §483.10(a),
Dignity, and §483.10(b)(2), Freedom from discrimination, F550; §483.12(a) Abuse;
§483.10(h), Personal Privacy – F583; §483.10(f), Self-Determination – F561; §483.21(b),
Comprehensive, Person-Centered Care Planning – F656; and §483.60(c)(4), Menus and
Nutritional Adequacy – F803. This complete disregard of the residents’ quality of life,
caused serious harm related to her self-worth, self-esteem, and well-being.

The surveyor identified a resident who was admitted 6 weeks ago, and had religious
beliefs which differed from the resident population in the nursing home, and those of the
staff. During interviews, the resident and her family reported that staff continually made
derogatory remarks about the resident’s culture/religion to each other within earshot of
the resident, or while in the room providing ADL care to the resident. This occurred
during all shifts. Additionally, the resident reported that discriminatory remarks were
made by housekeeping and dietary staff as well. The resident’s family reported this was
particularly worse on weekends when facility leadership were not in the building. The
family members reported they would take turns visiting the resident on weekends, to
support the resident and assist with her care. When asked if this was reported to facility
management, the resident said her family had reported it to the Administrator on several
occasions, but that nothing had changed. Interview with the Administrator revealed that
an in-service was planned for the future. (Refer to noncompliance cited at §483.10(a)(1),
Dignity, and §483.10(b)(2) Freedom from Discrimination – F550, §483.12(a), Abuse –
F600)

The resident described frequent occurrences of disregard of her personal privacy
including not covering her body completely, allowing full view of her arms, legs and
buttocks when transporting her to the shower. The surveyor observed, on one occasion,
staff not pulling the privacy curtain when assisting her to dress, resulting in anyone
walking in the hallway being able to view her as she was dressed. (Refer to
noncompliance cited at §483.10(h), Personal Privacy – F583)

On multiple occasions, the resident reported that she was assigned a male care giver,
which is against her religious belief that a person of the opposite sex cannot provide care.
On these occasions, the resident would tearfully refuse to get dressed, or call her family
to assist her. On at least one occasion, the resident was forced to receive a shower with
the assistance of a male aide, which resulted in the resident crying uncontrollably until
her family arrived. Progress notes in her medical record noted this occasion as the
resident becoming uncontrollable while receiving a shower. Additionally, when dressing
her for the day, staff would not cover her hair, arms and legs, and would say that her scarf
was missing, only to be found when her family arrived. On interview, staff said they
were unaware that this was a violation of her religion. This noncompliance resulted in
the resident frequently refusing to shower, or, according to family, calling her family,
begging for them to come get her dressed. (Refer to noncompliance cited at §483.10(f),
Self-Determination – F561.)

The surveyor observed the meal tray set up and found it did not honor the resident’s
preferences identified on the meal tray card and care plan. The resident reported that this
happened on most days, and even if she requested an alternative, she would be given a
food item that was prohibited according to her religion, and therefore, she would not eat
that meal. The resident’s family stated that they frequently brought food in to the
resident because she could not eat what was brought to her.

On interview, dietary staff stated they did not have the time to prepare a special diet for
this one resident, and stated to the surveyor, “They should have thought of that before
they came to this country.” Additionally, the dietary staff reported that he/she was not
aware of the dietary requirements of this resident’s religion. An interview with the
consulting dietitian revealed that he/she was not aware that this resident had been
admitted to the facility, and she agreed that the menu did not meet this resident’s
religious preferences. (Refer to noncompliance cited at 483.60(c)(4), Menus and
Nutritional Adequacy – F803)

Review of the resident’s care plans revealed that there was no identification of this
resident’s preferences or dietary requirements related to her religion. (Refer to
noncompliance cited at §483.21(b), Comprehensive, Person-Centered Care Plan – F656

As the result of cumulative effect of the noncompliance identified, this resident suffered
loss of religious and cultural identity, had ongoing feelings of extreme sadness and
humiliation, and expressed a wish to die.

Noncompliance which reflects a pervasive disregard for one or more residents’ quality of
life must be carefully considered for the impact to the resident(s) affected. For concerns
which may rise to the level of Immediate Jeopardy, refer to Appendix Q

F676
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.24(a) Based on the comprehensive assessment of a resident and consistent with
the resident’s needs and choices, the facility must provide the necessary care and
services to ensure that a resident’s abilities in activities of daily living do not
diminish unless circumstances of the individual’s clinical condition demonstrate that
such diminution was unavoidable. This includes the facility ensuring that:

§483.24(a)(1) A resident is given the appropriate treatment and services to maintain
or improve his or her ability to carry out the activities of daily living, including
those specified in paragraph (b) of this section …

§483.24(b) Activities of daily living.
The facility must provide care and services in accordance with paragraph (a) for the
following activities of daily living:

§483.24(b)(1) Hygiene –bathing, dressing, grooming, and oral care,

§483.24(b)(2) Mobility—transfer and ambulation, including walking,

§483.24(b)(3) Elimination-toileting,

§483.24(b)(4) Dining-eating, including meals and snacks,

§483.24(b)(5) Communication, including

(i) Speech,
(ii) Language,
(iii) Other functional communication systems.

See Guidance at F677

F677
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.24(a)(2) A resident who is unable to carry out activities of daily living receives
the necessary services to maintain good nutrition, grooming, and personal and oral
hygiene; and

DEFINITIONS
“Oral care” refers to the maintenance of a healthy mouth, which includes not only teeth,
but the lips, gums, and supporting tissues. This involves not only activities such as
brushing of teeth or oral appliances, but also maintenance of oral mucosa.

“Speech, language or other functional communication systems” refers to the resident’s
ability to effectively communicate requests, needs, opinions, and urgent problems; to

express emotion, to listen to others and to participate in social conversation whether in
speech, writing, gesture, behavior, or a combination of these (e.g., a communication
board or electronic augmentative communication device).

“Assistance with the bathroom” refers to the resident’s ability to use the toilet room (or
commode, bedpan, urinal); transfer on/off the toilet, clean themselves, change absorbent
pads or briefs, manage ostomy or catheter, and adjust clothes.

“Transfer” refers to resident’s ability to move between surfaces – to/from: bed, chair,
wheelchair, and standing positions. (Excludes to/from bath/toilet.)

GUIDANCE
The existence of a clinical diagnosis shall not justify a decline in a resident’s ability to
perform ADLs unless the resident’s clinical picture reflects the normal progression of the
disease/ condition has resulted in an unavoidable decline in the resident’s ability to
perform ADLs. Conditions which may demonstrate an unavoidable decline in the
resident’s ability to perform ADLs include but are not limited to the following:

• The natural progression of a debilitating disease with known functional decline;
• The onset of an acute episode causing physical or mental disability while the

resident is receiving care to restore or maintain functional abilities; and
• The resident’s or his/her representative’s decision to refuse care and treatment to

restore or maintain functional abilities after efforts by the facility to inform and
educate about the benefits/risks of the proposed care and treatment; counsel
and/or offer alternatives to the resident or representative. The decision to refuse
care and treatment must be documented in the clinical record. Documentation
must include interventions identified on the care plan and in place to minimize or
decrease functional loss that were refused by the resident or resident’s
representative and any interventions that were substituted with consent of the
resident and/or representative to minimize further decline. NOTE: In some cases,
residents with dementia may resist the manner in which care is being provided, or
attempted, which can be misinterpreted as declination of care. In some cases the
resident with dementia does not understand what is happening, or may be fearful
of unfamiliar staff, or may be anxious or frustrated due to inability to
communicate. Facility staff are responsible to attempt to identify the underlying
cause of the “refusal/declination” of care.

• Note also that depression is a potential cause of excess disability and, where
appropriate, therapeutic interventions should be initiated. Follow up if the resident
shows signs/symptoms of depression even if not indicated on his or her MDS.

If it is determined that the resident’s inability to perform ADLs occurred after admission
due to an unavoidable decline, such as the progression of the resident’s disease process,
surveyors must still determine that interventions to assist the resident are identified and
implemented immediately.

Appropriate treatment and services includes all care provided to residents by staff,
contractors, or volunteers of the facility to maximize the resident’s functional abilities.

This includes pain relief and control, especially when it is causing a decline or a decrease
in the quality of life of the resident.

NOTE: For evaluating a resident’s ADLs and determining whether a resident’s abilities
have declined, improved, or stayed the same within the last twelve months, the following
definitions as specified in the State’s Resident Assessment Instrument (RAI) Manual are
used in reference to the Assessment Reference Date (ARD):

• Independent – Resident completed activity with no help or oversight every time
during the 7-day look-back period.

• Supervision – Oversight, encouragement or cueing provided 3 or more times
during the last 7 days.

• Limited Assistance – Resident highly involved in activity and received physical
help in guided maneuvering of limb(s) or other non-weight bearing assistance 3 or
more times during the last 7-days.

• Extensive Assistance – While resident performed part of activity over the last 7
days, help of following type(s) was provided 3 or more times;

a. Weight-bearing support provided 3 or more times; or
b. Full staff performance of activity during part (but not all) of last 7 days.

• Total Dependence – Full staff performance of an activity with no participation by
resident for any aspect of the ADL activity. Resident was unwilling or unable to
perform any part of the activity over entire 7-day look-back period.

PROCEDURES §483.24(b)(1, 3-5)
Use the Activities of Daily Living Critical Element (CE) Pathway, along with the
above interpretive guidelines when determining if facility practices are in place to
identify, evaluate, and intervene to, maintain, improve, or prevent an avoidable decline in
ADLs. In addition, use this pathway for the resident who is unable to perform ADLs.
Briefly review the most recent comprehensive assessment, care plan, physician orders, as
well as ADL documentation/flow sheets on various shifts, to identify whether the facility
has:

• Recognized and assessed an inability to perform ADLs, or a risk for decline in
any ability they have to perform ADLs;

• Developed and implemented interventions in accordance with the resident’s
assessed needs, goals for care, preferences, and recognized standards of practice
that address the identified limitations in ability to perform ADLs;

• Monitored and evaluated the resident’s response to care plan interventions and
treatment; and

• Revised the approaches as appropriate.

NOTE: For concerns related to facility failure to provide care, services, equipment or
assistance to a resident with limited mobility, refer to F688, Mobility.

F678

(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.24(a)(3) Personnel provide basic life support, including CPR, to a resident
requiring such emergency care prior to the arrival of emergency medical personnel
and subject to related physician orders and the resident’s advance directives.

INTENT §483.24(a)(3)
To ensure that each facility is able to and does provide emergency basic life support
immediately when needed, including cardiopulmonary resuscitation (CPR), to any
resident requiring such care prior to the arrival of emergency medical personnel in
accordance with related physicians orders, such as DNRs, and the resident’s advance
directives.

DEFINITIONS §483.24(a)(3)
“Advance directive” is defined as a written instruction, such as a living will or durable
power of attorney for health care, recognized under State law (whether statutory or as
recognized by the courts of the State), relating to the provision of health care when the
individual is incapacitated. 42 C.F.R. §489.100. Some States also recognize a
documented oral instruction.

“Basic life support” is a level of medical care which is used for victims of life-
threatening illnesses or injuries until they can be given full medical care at a hospital, and
may include recognition of sudden cardiac arrest, activation of the emergency response
system, early cardiopulmonary resuscitation, and rapid defibrillation with an automated
external defibrillator, if available.

“Cardiopulmonary resuscitation (CPR)” refers to any medical intervention used to
restore circulatory and/or respiratory function that has ceased.

“Code Status” refers to the level of medical interventions a person wishes to have started
if their heart or breathing stops.

“Do Not Resuscitate (DNR) Order” refers to a medical order issued by a physician or
other authorized non-physician practitioner that directs healthcare providers not to
administer CPR in the event of cardiac or respiratory arrest. Existence of an advance
directive does not imply that a resident has a DNR order. The medical record should
show evidence of documented discussions leading to a DNR order.

GUIDANCE §483.24(a)(3)
In keeping with the requirement at §483.24 to “provide the necessary care and services
to attain or maintain the highest practicable physical, mental, and psychosocial well-
being of the resident” facilities must ensure that properly trained personnel (and
certified in CPR for Healthcare Providers) are available immediately (24 hours per day)
to provide basic life support, including cardiopulmonary resuscitation (CPR), to
residents requiring emergency care prior to the arrival of emergency medical personnel,

and subject to accepted professional guidelines, the resident’s advance directives, and
physician orders.

The American Heart Association (AHA) publishes guidelines every five years for CPR
and Emergency Cardiovascular Care (ECC). These guidelines reflect global
resuscitation science and treatment recommendations. In the guidelines, AHA has
established evidenced-based decision-making guidelines for initiating CPR when
cardiac or respiratory arrest occurs in or out of the hospital.

The AHA urges all potential rescuers to initiate CPR unless a valid Do Not Resuscitate
(DNR) order is in place; obvious clinical signs of irreversible death (e.g., rigor mortis,
dependent lividity, decapitation, transection, or decomposition) are present; or initiating
CPR could cause injury or peril to the rescuer.

If a resident experiences a cardiac or respiratory arrest and the resident does not
show obvious clinical signs of irreversible death (e.g. rigor mortis, dependent
lividity, decapitation, transection, or decomposition), facility staff must provide basic
life support, including CPR, prior to the arrival of emergency medical services,

• in accordance with the resident’s advance directives and any related physician
order, such as code status, or

• in the absence of advance directives or a DNR order.

Facilities must have systems in place supported by policies and procedures to ensure
there are an adequate number of staff present at all times who are properly trained and/or
certified in CPR for Healthcare Providers to be able to provide CPR until emergency
medical services arrives.

Additionally, facilities should have procedures in place to document a resident’s choices
regarding issues like CPR. Physician orders to support these choices should be obtained
as soon as possible after admission, or a change in resident preference or condition, to
facilitate staff in honoring resident choices. Facility policy should also address how
resident preferences and physician orders related to CPR and other advance directive
issues are communicated throughout the facility so that staff know immediately what
action to take or not take when an emergency arises. Resident wishes expressed through a
resident representative, as defined at §483.5, must also be honored, although, again
physician orders should be obtained as soon as possible.

Facility staff should verify the presence of advance directives or the resident’s wishes
with regard to CPR, upon admission. This may be done while doing the admission
assessment. If the resident’s wishes are different than the admission orders, or if the
admission orders do not address the resident’s code status and the resident does not want
to receive CPR, facility staff should immediately document the resident’s wishes in the
medical record and contact the physician to obtain the order.

While awaiting the physician’s order to withhold CPR, facility staff should immediately
document discussions with the resident or resident representative, including, as

appropriate, a resident’s wish to refuse CPR. At a minimum, a verbal declination of
CPR by a resident, or if applicable a resident’s representative, should be witnessed by
two staff members, though individual States may have more specific requirements related
to documenting verbal directives. While the physician’s order is pending, staff should
honor the documented verbal wishes of the resident or the resident’s representative,
regarding CPR.

Advance Directives
The right to formulate an advance directive applies to each and every resident and
facilities must inform residents of their option to formulate advance directives. If a
resident has a valid Advance Directive, the facility’s care must reflect the resident’s
wishes as expressed in their Directive, in accordance with state law. (Refer to
§483.10(c)(6), F578, Residents’ Right to Formulate an Advance Directive.)

NOTE: The presence of an Advance Directive does not absolve the facility from giving
supportive and other pertinent care, including CPR and other basic life support that is not
prohibited by the Advance Directive. The presence of a “Do Not Resuscitate” (DNR)
order is not sufficient to indicate the resident is declining other appropriate treatment and
services. It only indicates that the resident should not be resuscitated if respirations and/or
cardiac function ceases.

Facility Policies
Facility policies should address the provision of basic life support and CPR, including:

• Directing staff to initiate CPR when cardiac or respiratory arrest occurs for
residents who do not show obvious clinical signs of irreversible death and:
o Who have requested CPR in their advance directives, or
o Who have not formulated an advance directive or,
o Who do not have a valid DNR order.

• Ensuring staff receive certification in performance of CPR (CPR for Healthcare
Providers).

Facility policies must not limit staff to only calling 911 when cardiac or respiratory arrest
occurs. Prior to the arrival of EMS, nursing homes must provide basic life support,
including initiation of CPR, to a resident who experiences cardiac or respiratory arrest in
accordance with that resident’s advance directives or in the absence of advance directives
or a DNR order. CPR-certified staff must be available at all times to provide CPR when
needed.

The presence of a facility-wide “no CPR” policy interferes with a resident’s right to
formulate an advance directive and should be cited at §483.10(c)(6), F578, Residents’
Right to formulate an Advance Directive. Surveyors should attempt to determine if there
were residents who could have been negatively affected by the facility’s policy, which
should be cited at §483.24(a)(3), F678.

CPR Certification
Staff must maintain current CPR certification for Healthcare Providers through a CPR
provider whose training includes hands-on practice and in-person skills assessment;
online-only certification is not acceptable. CPR certification that includes an online
knowledge component, yet still requires an in-person demonstration and skills assessment
to obtain certification or recertification, is acceptable.

For concerns related to the qualifications of staff performing CPR, the survey team
should also consider §483.21(b)(3)(ii), Services Provided by Qualified Persons, F659.

INVESTIGATIVE PROTOCOL:
Procedure
Record Review
Ask to review the facility policies for:

• CPR
• Advance Directives and/or
• Code Status

Review facility policies to ensure:
• Staff are directed to initiate CPR when cardiac or respiratory arrest occurs for

residents who do not show obvious clinical signs of irreversible death and:
o who have requested CPR in their Advance Directive; or
o who have not formulated an Advance Directive; or
o who do not have a valid DNR order;

• Staff are expected to be certified in CPR for Healthcare Providers;
Review facility records verifying staff certification in CPR for Healthcare Providers
Review the resident’s medical record to determine if:

• The resident has an advanced directive in place. If so:
o Does the resident’s code status reflect their wishes as recorded in their

Advance Directive?
o Does the MDS indicate that the resident has an advanced directive?

• The interdisciplinary team has reviewed the Advanced Directive on a regular
basis with the resident, or representative to ensure that it is current?

Interview
Interview the resident or their representative to determine:

• If they have formulated an Advance Directive (compare resident wishes to
physician’s orders);

• If staff review the Advance Directive at least quarterly (with care planning) to see
if it still reflects the resident’s wishes.

Interview nursing staff to determine:
• How they know each resident’s code status;
• Who is responsible for performing CPR;

KEY ELEMENTS OF NONCOMPLIANCE:
To cite deficient practice at F678, the surveyor’s investigation will generally show that
the facility failed to do any one of the following:

• Provide basic life support, including CPR to a resident who required emergency
life support and/or resuscitative care; or

• Ensure availability of staff who can provide CPR.
• Have appropriate policies directing staff when to initiate basic life support;
• Ensure staff is familiar with facility policies related to CPR;
• Ensure staff knows how to confirm residents’ code status in an emergency; and
• Ensure staff maintain current CPR certification for healthcare providers through a

CPR provider whose training includes hands-on practice and in-person skills
assessment.

DEFICIENCY CATEGORIZATION §483.24(a)(3)
In addition to actual or potential physical harm, always consider whether psychosocial
harm has occurred when determining severity level. (See Appendix P, Section IV, E,
Psychosocial Outcome Severity Guide).

Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident
Health or Safety include, but are not limited to:
Failure to provide, or a delay in providing, CPR to a resident with no advance directive,
who collapsed in the dining room.

Facility implementation of a No CPR policy resulting in psychosocial harm to residents
who became distraught that they would have to relocate or have to sign a DNR.

Severity Level 3 Considerations: Actual Harm that is Not Immediate Jeopardy
CMS believes that noncompliance related to any of the key elements listed above with an
actual or potential outcome to one or more residents would result in Immediate Jeopardy,
therefore no example of level 3 severity is given.

Severity Level 2 Considerations: No Actual Harm, with Potential for More than
Minimal Harm, that is Not Immediate Jeopardy
Noncompliance that results in no more than minimal physical, mental, and/or
psychosocial discomfort to the resident, and/or has the potential (not yet realized) to
compromise the resident’s ability to maintain and/or reach his/her highest practicable
physical, mental, and/or psychosocial wellbeing.

An example of a resident outcome that demonstrates severity at Level 2 may include, but
is not limited to:
Failure to ensure all facility staff received training in CPR for Healthcare Providers,
resulting in some staff responsible for providing CPR not receiving the correct CPR
training.

Severity Level 1 Considerations: No Actual Harm, with Potential for Minimal
Harm
Noncompliance that has the potential for causing no more than a minor negative impact
on the resident(s).

Severity Level 1 does not apply for this regulatory requirement because the failure of the
facility to be able to provide basic life support, including CPR, by properly trained staff
in accordance with facility policies, advance directives and related physician’s orders
creates the potential for more than minimal harm.

F679
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.24(c) Activities

§483.24(c)(1) The facility must provide, based on the comprehensive assessment and
care plan and the preferences of each resident, an ongoing program to support
residents in their choice of activities, both facility-sponsored group and individual
activities and independent activities, designed to meet the interests of and support
the physical, mental, and psychosocial well-being of each resident, encouraging both
independence and interaction in the community.

INTENT §483.24(c)

To ensure that facilities implement an ongoing resident centered activities program that
incorporates the resident’s interests, hobbies and cultural preferences which is integral to
maintaining and/or improving a resident’s physical, mental, and psychosocial well-being
and independence. To create opportunities for each resident to have a meaningful life by
supporting his/her domains of wellness (security, autonomy, growth, connectedness,
identity, joy and meaning).

DEFINITIONS §483.24(c)

“Activities” refer to any endeavor, other than routine ADLs, in which a resident
participates that is intended to enhance her/his sense of well-being and to promote or
enhance physical, cognitive, and emotional health. These include, but are not limited to,
activities that promote self-esteem, pleasure, comfort, education, creativity, success, and
independence.

NOTE: ADL-related activities, such as manicures/pedicures, hair styling, and
makeovers, may be considered part of the activities program.

GUIDANCE §483.24(c)

Opportunities for each resident to have a meaningful life may be created by supporting
his/her domains of well-being (e.g., security, autonomy, growth, connectedness, identity,
joy and meaning) as identified by the Eden Alternative philosophy of care. More
information may be found at: https://www.edenalt.org/.

Research findings and the observations of positive resident outcomes confirm that
activities are an integral component of residents’ lives. Residents have indicated that

https://www.edenalt.org/

daily life and involvement should be meaningful. Activities are meaningful when they
reflect a person’s interests and lifestyle, are enjoyable to the person, help the person to
feel useful, and provide a sense of belonging. Maintaining contact and interaction with
the community is an important aspect of a person’s well-being and facilitates feelings of
connectedness and self- esteem. Involvement in community includes interactions such as
assisting the resident to maintain his/her ability to independently shop, attend the
community theater, local concerts, library, and participate in community groups.

Activity Approaches for Residents with Dementia
All residents have a need for engagement in meaningful activities. For residents with
dementia, the lack of engaging activities can cause boredom, loneliness and frustration,
resulting in distress and agitation. Activities must be individualized and customized
based on the resident’s previous lifestyle (occupation, family, hobbies), preferences and
comforts. https://www.caringkindnyc.org/_pdf/CaringKind-PalliativeCareGuidelines

NOTE: References to non-CMS/HHS sources or sites on the Internet included above or
later in this document are provided as a service and do not constitute or imply
endorsement of these organizations or their programs by CMS or the U.S. Department of
Health and Human Services. CMS is not responsible for the content of pages found at
these sites. URL addresses were current at the date of this publication.

The facility may have identified a resident’s pattern of behavioral symptoms and may
offer activity interventions, whenever possible, prior to the behavior occurring. Once a
behavior escalates, activities may be less effective or may even cause further stress to the
resident (some behaviors may be appropriate reactions to feelings of discomfort, pain, or
embarrassment, such as aggressive behaviors exhibited by some residents with dementia
during bathing16).

Examples of activities-related interventions that a facility may provide to try to minimize
distressed behavior may include, but are not limited, to the following:

For the resident who exhibits unusual amounts of energy or walking without purpose:

• Providing a space and environmental cues that encourages physical exercise,
decreases exit-seeking behavior and reduces extraneous stimulation (such as
seating areas spaced along a walking path or garden; a setting in which the
resident may manipulate objects; or a room with a calming atmosphere, for
example, using music, light, and rocking chairs);

• Providing aroma(s)/aromatherapy that is/are pleasing and calming to the resident;
and

• Validating the resident’s feelings and words; engaging the resident in
conversation about who or what they are seeking; and using one-to-one activities,
such as reading to the resident or looking at familiar pictures and photo albums.

For the resident who engages in behaviors not conducive with a therapeutic home like
environment:

https://www.caringkindnyc.org/_pdf/CaringKind-PalliativeCareGuidelines

• Providing a calm, non-rushed environment, with structured, familiar activities

such as folding, sorting, and matching; using one-to-one activities or small group
activities that comfort the resident, such as their preferred music, walking quietly
with the staff, a family member, or a friend; eating a favorite snack; looking at
familiar pictures;

• Engaging in exercise and movement activities; and
• Exchanging self-stimulatory activity for a more socially-appropriate activity that

uses the hands, if in a public space.

For the resident who exhibits behavior that require a less stimulating environment to
discontinue behaviors not welcomed by others sharing their social space:

• Offering activities in which the resident can succeed, that are broken into simple
steps, that involve small groups or are one-to-one activities such as using the
computer, that are short and repetitive, and that are stopped if the resident
becomes overwhelmed (reducing excessive noise such as from the television);

• Involving in familiar occupation-related activities. (A resident, if they desire, can
do paid or volunteer work and the type of work would be included in the
resident’s plan of care, such as working outside the facility, sorting supplies,
delivering resident mail, passing juice and snacks (refer to §483.10(f)(9) Right to
Perform Facility Services or Refuse

• Involving in physical activities such as walking, exercise or dancing, games or
projects requiring strategy, planning, and concentration, such as model building,
and creative programs such as music, art, dance or physically resistive activities,
such as kneading clay, hammering, scrubbing, sanding, using a punching bag,
using stretch bands, or lifting weights; and

• Slow exercises (e.g., slow tapping, clapping or drumming); rocking or swinging

motions (including a rocking chair).

For the resident who goes through others’ belongings:

• Using normalizing life activities such as stacking canned food onto shelves,
folding laundry; offering sorting activities (e.g., sorting socks, ties or buttons);
involving in organizing tasks (e.g., putting activity supplies away); providing
rummage areas in plain sight, such as a dresser; and

• Using non-entry cues, such as “Do not disturb” signs or removable sashes, at the
doors of other residents’ rooms; providing locks to secure other resident’s
belongings (if requested).

For the resident who has withdrawn from previous activity interests/customary routines
and isolates self in room/bed most of the day:

• Providing activities just before or after meal time and where the meal is being

served (out of the room);
• Providing in-room volunteer visits, music or videos of choice;
• Encouraging volunteer-type work that begins in the room and needs to be

completed outside of the room, or a small group activity in the resident’s room, if
the resident agrees; working on failure-free activities, such as simple structured
crafts or other activity with a friend; having the resident assist another person;

• Inviting to special events with a trusted peer or family/friend;
• Engaging in activities that give the resident a sense of value (e.g.,

intergenerational activities that emphasize the resident’s oral history knowledge);
• Inviting resident to participate on facility committees;
• Inviting the resident outdoors; and
• Involving in gross motor exercises (e.g., aerobics, light weight training) to

increase energy and uplift mood.

For the resident who excessively seeks attention from staff and/or peers: Including in
social programs, small group activities, service projects, with opportunities for
leadership.

For the resident who lacks awareness of personal safety, such as putting foreign objects
in her/his mouth or who is self-destructive and tries to harm self by cutting or hitting self,
head banging, or causing other injuries to self:

• Observing closely during activities, taking precautions with materials (e.g.,
avoiding sharp objects and small items that can be put into the mouth);

• Involving in smaller groups or one-to-one activities that use the hands (e.g.,
folding towels, putting together PVC tubing);

• Focusing attention on activities that are emotionally soothing, such as listening to
music or talking about personal strengths and skills, followed by participation in
related activities; and

• Focusing attention on physical activities, such as exercise.

For the resident who has delusional and hallucinatory behavior that is stressful to
her/him:

• Focusing the resident on activities that decrease stress and increase awareness of
actual surroundings, such as familiar activities and physical activities; offering
verbal reassurance, especially in terms of keeping the resident safe; and
acknowledging that the resident’s experience is real to her/him.

The outcome for the resident, the decrease or elimination of the behavior, either validates
the activity intervention or suggests the need for a new approach.
The facility may use, but need not duplicate, information from other sources, such as the
RAI/MDS assessment, including the CAAs, assessments by other disciplines,
observation, and resident and family interviews. Other sources of relevant information

include the resident’s lifelong interests, spirituality, life roles, goals, strengths, needs and
activity pursuit patterns and preferences. This assessment should be completed by or
under the supervision of a qualified professional.

NOTE: Some residents may be independently capable of pursuing their own

activities without intervention from the facility. This information should be
noted in the assessment and identified in the plan of care.

Surveyors need to be aware that some facilities may take a non-traditional approach to
activities. In nursing homes where culture change philosophy has been adopted, all staff
may be trained as nurse aides or “universal workers,” (workers with primary role but
multiple duties outside of primary role) and may be responsible to provide activities,
which may resemble those of a private home. The provision of activities should not be
confined to a department, but rather may involve all staff interacting with residents.

Residents, staff, and families should interact in ways that reflect daily life, instead of in
formal activities programs. Residents may be more involved in the ongoing activities in
their living area, such as care-planned approaches including chores, preparing foods,
meeting with other residents to choose spontaneous activities, and leading an activity.
Some nursing homes may not have a traditional activities calendar, but instead focus on
community life to include activities. Instead of an “activities director,” some homes have
a Community Life Coordinator, a Community Developer, or other title for the individual
directing the activities program

For more information on activities in homes changing to a resident-directed culture, the
following websites are available as resources: www.pioneernetwork.net;
www.qualitypartnersri.org; and www.edenalt.org.

INVESTIGATIVE SUMMARY
Use the Activities Critical Element pathway and the guidance above to investigate
concerns related to activities which are based on the resident’s comprehensive assessment
and care plan, and meet the resident’s interests and preferences, and support his or her
physical, mental, and psychosocial well-being.

F680
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.24(c)(2) The activities program must be directed by a qualified professional
who is a qualified therapeutic recreation specialist or an activities professional
who—

(i) Is licensed or registered, if applicable, by the State in which practicing; and
(ii) Is:

(A) Eligible for certification as a therapeutic recreation specialist or as an
activities professional by a recognized accrediting body on or after
October 1, 1990; or

http://www.edenalt.org/

(B) Has 2 years of experience in a social or recreational program within the
last 5 years, one of which was full-time in a therapeutic activities
program; or

(C) Is a qualified occupational therapist or occupational therapy assistant; or
(D) Has completed a training course approved by the State.

INTENT §483.24(c)(2)
The intent of this regulation is to ensure that the activities program is directed by a
qualified professional.

DEFINITIONS §483.24(c)(2)
“Recognized accrediting body” refers to those organizations that certify, register, or
license therapeutic recreation specialists, activity professionals, or occupational
therapists.

Activities Director Responsibilities
An activity director is responsible for directing the development, implementation,
supervision and ongoing evaluation of the activities program. This includes the
completion and/or directing/delegating the completion of the activities component of the
comprehensive assessment; and contributing to and/or directing/delegating the
contribution to the comprehensive care plan goals and approaches that are individualized
to match the skills, abilities, and interests/preferences of each resident.

Directing the activity program includes scheduling of activities, both individual and
groups, implementing and/or delegating the implementation of the programs, monitoring
the response and/or reviewing/evaluating the response to the programs to determine if the
activities meet the assessed needs of the resident, and making revisions as necessary.

NOTE: Review the qualifications of the activities director if there are concerns with the

facility’s compliance with the activities requirement at §483.24(c)(1), F679, or
if there are concerns with the direction of the activity programs.

A person is a qualified professional under this regulatory tag if they meet the
qualifications (if applicable) of §483.24(c)(2)(i), and one (or more) of the qualifications
of §483.24(c)(2)(ii).

KEY ELEMENTS OF NONCOMPLIANCE §483.24(c)(2)
To cite deficient practice at F680, the surveyor’s investigation will generally show that
the facility failed to ensure the activities program is directed by a qualified professional,
who:

• Is licensed or registered, (if applicable); and
o Is eligible for certification as a therapeutic recreation specialist, or as an

activities professional by a recognized accrediting body on or after October 1,
1990; or

o Has 2 years of experience in a social or recreational program with the last 5
years, one of which was full-time in a therapeutic activities program; or

o Is a qualified occupational therapist or occupational therapy assistant; or
o Has completed a training course approved by the state.

NOTE: F680 is a tag that is absolute, which means the facility must have a qualified
activities professional to direct the provision of activities to the residents. Thus, it is cited
if the facility is non-compliant with the regulation, whether or not there have been any
negative outcomes to residents. In determining the Scope and Severity, surveyors must
consider the extent to which non-compliance at F679 is attributed to the lack of an
activity director or the lack of qualifications of the activity director.

F684
(Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24)

§ 483.25 Quality of care
Quality of care is a fundamental principle that applies to all treatment and care
provided to facility residents. Based on the comprehensive assessment of a resident,
the facility must ensure that residents receive treatment and care in accordance with
professional standards of practice, the comprehensive person-centered care plan,
and the residents’ choices, including but not limited to the following:

INTENT

To ensure facilities identify and provide needed care and services that are resident
centered, in accordance with the resident’s preferences, goals for care and professional
standards of practice that will meet each resident’s physical, mental, and psychosocial
needs.

DEFINITIONS

“Highest practicable physical, mental, and psychosocial well-being” is defined as the
highest possible level of functioning and well-being, limited by the individual’s
recognized pathology and normal aging process. Highest practicable is determined
through the comprehensive resident assessment and by recognizing and competently and
thoroughly addressing the physical, mental or psychosocial needs of the individual.

“Hospice Care” means a comprehensive set of services described in Section 1861(dd)(l)
of the Act, identified and coordinated by an interdisciplinary group (IDG) to provide for
the physical, psychosocial, spiritual, and emotional needs of a terminally ill patient and/or
family members, as delineated in a specific patient plan of care. (42 CFR §418.3)

“Palliative care” means patient and family-centered care that optimizes quality of life by
anticipating, preventing, and treating suffering. Palliative care throughout the continuum
of illness involves addressing physical, intellectual, emotional, social, and spiritual needs
and to facilitate patient autonomy, access to information, and choice. (§418.3)

“Terminally ill” means that the individual has a medical prognosis that his or her life
expectancy is 6 months or less if the illness runs its normal course. (§418.3)

GUIDANCE

NOTE: Although Federal requirements dictate the completion of RAI assessments
according to certain time frames, standards of good clinical practice dictate that the
clinical assessment process is more fluid and should be ongoing. The lack of ongoing
clinical assessment and identification of changes in condition, to meet the resident’s
needs between required RAI assessments should be addressed at §483.35 Nursing
Services, F726 (competency and skills to identify and address a change in condition), and
the relevant outcome tag, such as §483.12 Abuse, §483.24 Quality of Life, §483.25
Quality of Care, and/or §483.40 Behavioral Health.

Use guidance at F684 for review of concerns which have caused or have a potential to
cause a negative outcome to a resident’s physical, mental, or psychosocial health or well-
being that is not specifically addressed by any other tag at §483.25. Additionally, F684
contains guidance for end of life and hospice care.

Nursing homes must place priority on identifying what each resident’s highest practicable
well-being is in each of the areas of physical, mental and psychosocial health.
Each resident’s care plan must reflect person-centered care, and include resident choices,
preferences, goals, concerns/needs, and describe the services and care that is to be
furnished to attain or maintain, or improve the resident’s highest practicable physical,
mental and psychosocial well-being. For concerns related to the resident’s
comprehensive care plan, see F656, §483.21(b) Comprehensive Care Plans.

The following sections describe some, but not all of the care needs that are not otherwise
covered in the remaining tags of §483.25, Quality of Care.

I. Review of a Resident with Non Pressure-Related Skin Ulcer/Wound.
Residents may develop various types of skin ulceration. At the time of the assessment
and diagnosis of a skin ulcer/wound, the clinician is expected to document the clinical
basis (e.g., underlying condition contributing to the ulceration, ulcer edges and wound
bed, location, shape, condition of surrounding tissues) which permit differentiating the
ulcer type, especially if the ulcer has characteristics consistent with a pressure ulcer, but
is determined not to be one. This section differentiates some of the different types of skin
ulcers/wounds that are not considered to be pressure ulcers.

NOTE: Guidance regarding pressure ulcers is found at 42 CFR 483.25 (b)(1)F686

Skin Integrity – Pressure Ulcers. Use this tag F684 for issues regarding non-
pressure related skin ulcers/wounds. Kennedy Terminal Ulcers are considered
to be pressure ulcers that generally occur at the end of life. For concerns
related to Kennedy Terminal Ulcers, refer to F686, §483.25(b) Pressure
Ulcers.

• Arterial Ulcer: An arterial ulcer is ulceration that occurs as the result of arterial
occlusive disease when non-pressure related disruption or blockage of the arterial
blood flow to an area causes tissue necrosis. Inadequate blood supply to the
extremity may initially present as intermittent claudication. Arterial/Ischemic
ulcers may be present in individuals with moderate to severe peripheral vascular
disease, generalized arteriosclerosis, inflammatory or autoimmune disorders (such
as arteritis), or significant vascular disease elsewhere (e.g., stroke or heart attack).
The arterial ulcer is characteristically painful, usually occurs in the distal portion
of the lower extremity and may be over the ankle or bony areas of the foot (e.g.,
top of the foot or toe, outside edge of the foot). The wound bed is frequently dry
and pale with minimal or no exudate. The affected foot may exhibit: diminished
or absent pedal pulse, coolness to touch, decreased pain when hanging down
(dependent) or increased pain when elevated, blanching upon elevation, delayed
capillary fill time, hair loss on top of the foot and toes, toenail thickening;

• Diabetic Neuropathic Ulcer: A diabetic neuropathic ulcer requires that the
resident be diagnosed with diabetes mellitus and have peripheral neuropathy. The
diabetic ulcer characteristically occurs on the foot, e.g., at mid-foot, at the ball of
the foot over the metatarsal heads, or on the top of toes with Charcot deformity ;
and

• Venous or Stasis Ulcer: A venous ulcer (previously known as a stasis ulcer) is
an open lesion of the skin and subcutaneous tissue of the lower leg, often
occurring in the lower leg around the medial ankle. Venous ulcers are reported to
be the most common vascular ulceration and may be difficult to heal, may occur
off and on for several years, and may occur after relatively minor trauma. The
ulcer may have a moist, granulating wound bed, may be superficial, and may have
minimal to copious serous drainage unless the wound is infected. The resident
may experience pain that may increase when the foot is in a dependent position,
such as when a resident is seated with her or his feet on the floor. Recent literature
implicates venous hypertension as a causative factor. Venous hypertension may
be caused by one (or a combination of) factor(s) including: loss of (or
compromised) valve function in the vein, partial or complete obstruction of the
vein (e.g., deep vein thrombosis, obesity, malignancy), and/or failure of the calf
muscle to pump the blood (e.g., paralysis, decreased activity). Venous
insufficiency may result in edema and induration, dilated superficial veins, dry
scaly crusts, dark pigmented skin in the lower third of the leg, or dermatitis. The
pigmentation may appear as darkening skin, tan or purple areas in light skinned
residents and dark purple, black or dark brown in dark skinned residents.
Cellulitis may be present if the tissue is infected.

II. Review of a Resident at or Approaching End of Life and/or Receiving

Hospice Care and Services

Assessment

The resident must receive a comprehensive assessment to provide direction for the
development of the resident’s care plan to address the choices and preferences of the

resident who is nearing the end of life. In addition, in order to promote the physical,
mental, and psychosocial well-being of a resident who is approaching the end of life, the
facility and the resident’s attending physician/practitioner, should, to the extent possible:

• Identify the resident’s prognosis and the basis for that prognosis; and
• Initiate discussions/considerations regarding advance care planning and resident

choices to clarify goals and preferences regarding treatment including pain
management and symptom control, treatment of acute illness, and choices
regarding hospitalization.

Care Plan

The care plan must be based upon the resident assessment, choices and advance
directives, if any. As the resident’s status changes, the facility, attending practitioner and
the resident representative, to the extent possible, must review and/or revise care plan
goals and treatment choices. Based upon the resident’s assessment, the care plan may
include, but is not limited to addressing:

• Oral Care – The care plan should include the provision of ongoing, consistent oral
care including interventions, as necessary to provide comfort and prevent
complications associated with dry mucous membranes and compromised
dentition. (For concerns related to the provision of oral hygiene, refer to F676 or
F677 – Activities of Daily Living, and for concerns related to dental care, refer to
F790 and F791 – Dental Services.);

• Skin Integrity – The care plan should include, for a resident who has skin integrity
issues or a pressure injury or is at risk of developing a pressure injury, approaches
in accordance with the resident’s choices, including, to the extent possible,
attempting to improve or stabilize the skin integrity/tissue breakdown and to
provide treatments if a pressure injury is present. (For concerns related to
pressure injuries, refer to F686.);

• Medical Treatment/Diagnostic Testing – The resident and his/her representative
and the attending practitioner may, based on resident choices/directives, make
decisions on whether to continue medications, treatments and/or diagnostic tests.
This must be included in the resident’s record. (For concerns related to choice,
care planning decisions and right to discontinue treatments, refer to F552 and
F553.);

• Symptom Management – Symptom management may include controlling nausea,
vomiting, uncomfortable breathing, agitation, and pain. Symptom management
may include both pharmacological and nonpharmacological interventions
consistent with the resident’s choices and goals for comfort, dignity and desired
level of alertness. (For concerns related to medications, refer to F758
psychotropic medications and F757 unnecessary medications.);

• Nutrition and Hydration- The resident may experience a decline in appetite or
have difficulty eating or swallowing. Care plan interventions, regarding
nutrition/hydration, must be based upon the resident’s assessment, disease
processes, and resident choices/directives and include amount, type, texture and
frequency for food and fluids. Dietary restrictions and/or weight measurements

may be revised/discontinued based upon resident/representative and attending
practitioner decisions, and must be included in the medical record. If the
resident’s condition has declined to the point where he/she may no longer
swallow food or fluids, the determination of whether to use artificial
nutrition/hydration, based upon resident choices/directives, is made by the
resident/ representative and the attending practitioner, and consistent with
applicable State law and regulation. (For concerns related to nutrition, refer to
F692, for concerns related to nutrition/hydration, and for concerns related to
feeding tubes, refer to F693.); and/or

• Activities/Psychosocial Needs – Care plan interventions for activities must be
based on the resident’s assessment and include the resident’s choices, personal
beliefs, interests, ethnic/cultural practices and spiritual values, as appropriate. In
addition, the resident’s assessment may identify psychosocial needs, such as fear,
loneliness, anxiety, or depression. Interventions to address the needs must be
included in the plan of care. (For concerns related to the provision of activities,
refer to F679. For concerns regarding medically related social services, refer to
F745.)

For concerns related to developing and implementing the care plan, refer to F656,
Comprehensive Care Plans; and for revision of care plans refer to F657, Comprehensive
Care Plan Revision.

Resident Care Policies

The facility in collaboration with the medical director must develop and implement
resident care policies that are consistent with current professional standards of practice
for not only pain management and symptom control, but for assessing residents’ physical,
intellectual, emotional, social, and spiritual needs as appropriate. In addition, if the
facility has a written agreement with a Medicare-certified hospice, the policies must
identify the ongoing collaboration and communication processes established by the
nursing home and the hospice. (Refer to F841 – §483.70(g) Medical Director, or for the
written agreement, to F849, §483.70(n) Hospice Services)

NOTE: If the resident has elected or is revoking the Medicare hospice benefit, a
Significant Change in Status Assessment (SCSA) must be conducted as noted in the
“Long Term Care Facility Resident Assessment Instrument User’s Manual” (Version 3.0)
Chapter 2:

• If a resident was admitted on the hospice benefit (i.e. the resident is coming into
the facility having already elected the hospice benefit), the facility completes the
required MDS admission assessment;

• If a terminally ill resident elects the hospice benefit after admission, a SCSA must
be performed regardless of whether an MDS assessment was recently conducted
on the resident. This is to ensure a coordinated care plan between the hospice and
nursing home is in place; and

• A SCSA is required to be performed when a resident is receiving hospice services
and decides to discontinue those services (revocation of the hospice benefit).
(Refer to F637 significant change in status assessment)

Hospice Care and Services Provided by a Medicare-certified Hospice

Hospice care and services are based upon a written agreement between the nursing home
and the Medicare-certified hospice (hereafter referred to as hospice or hospice services).
(See F849 – Hospice Services). This section discusses the collaborative services provided
by the nursing home and the hospice for a resident who is receiving hospice care and
services.

A nursing home resident at the end of life may choose to elect the Medicare hospice
benefit, or may choose to continue to receive the care and services provided by the
nursing home. The resident considering election of the hospice benefit must meet the
hospice eligibility requirements. According to 42 CFR §418.20, in order to be eligible to
elect hospice care under Medicare, an individual must be –

(a) Entitled to Part A of Medicare; and
(b) Certified as being terminally ill in accordance with §418.22.

NOTE: Hospice is also an optional state plan benefit in the Medicaid program. If a
resident who receives Medicaid chooses to elect the hospice benefit, the physician must
provide written certification that the individual is terminally ill. (Refer to SSA
Sec. 1905(o)(1)(A). [42 U.S.C. 1396d(o)(1)(A)]) If the resident is eligible for both
Medicare and Medicaid, he/she must elect the hospice benefit simultaneously under both
programs; and if the resident chooses to revoke the hospice benefit, he/she must revoke
the benefit simultaneously under both of the programs.

There is no requirement that a nursing home offer hospice services. Although a resident
may meet the eligibility requirements and may choose to elect the hospice benefit, the
nursing home may or may not have an arrangement with a hospice to provide hospice
care and services. If the nursing home has an agreement with a hospice, it must,
consistent with F552, inform each resident before or at the time of admission, and
periodically during the resident’s stay, of hospice services available in the nursing home.

If a nursing home allows one or more hospice providers to provide services, there must
be a written agreement between each hospice and the nursing home that describes their
responsibilities prior to the hospice initiating care for the resident. (For the written
agreement refer to F849 – Hospice Services.)

If the resident chooses to elect the hospice benefit, but has not chosen a hospice provider,
and the nursing home does not have an agreement with a hospice provider:

• If the resident wishes, the nursing home must assist the resident with a transfer to
another facility or appropriate setting where hospice services are provided; or

• The nursing home may choose to establish a written agreement with a hospice.

Coordinated Care Plan

The nursing home retains primary responsibility for implementing those aspects of care
that are not related to the duties of the hospice. It is the nursing home’s responsibility to
continue to furnish 24-hour room and board care, meeting the resident’s personal care
and nursing needs. The facility’s services must be consistent with the care plan developed
in coordination with the hospice, and the facility must offer the same services to its
residents who have elected the hospice benefit as it furnishes to its residents who have
not elected the hospice benefit. Therefore, the nursing home resident should not
experience any lack of services or personal care because of his or her status as a hospice
patient. This includes what would normally be provided to a resident in the nursing home,
including but not limited to the following: conducting the comprehensive assessments
which includes the Resident Assessment Instrument (RAI), providing personal care,
activities, medication administration, required physician visits, monthly medication
regimen review, support for activities of daily living, social services as appropriate,
nutritional support and services, and monitoring the condition of the resident. The facility
is required to develop and update the care plan in accordance with Federal, State or local
laws governing the facility.

The hospice retains primary responsibility for the provision of hospice care and services,
based upon the resident’s assessments, including but not limited to the following:
providing medical direction and management of the resident; nursing,(including
assigning a hospice aide as needed to support the resident’s ongoing care); counseling
(including spiritual, dietary, and bereavement); social work; providing medical supplies,
durable medical equipment, and drugs necessary for the palliation of pain and symptoms
associated with the terminal illness and related conditions; and all other hospice services
that are necessary for the care of the resident’s terminal illness and related conditions.
See 42 C.F.R. §418.112(c)(6).

NOTE: If there is an issue related to the provision of care by the hospice, the survey
team may request the written agreement and review to see the steps the nursing home has
taken to resolve the resident care issues. The written agreement should include how
differences are resolved between the nursing home and the hospice, and the nursing home
and hospice liaisons may need to be interviewed regarding the identified concerns. If
there are concerns related to the provision of care based upon the failure of the
implementation of the written agreement or the lack of a written agreement, refer to
F849.

The resident/representative must be included in the development of the care plan, which
must reflect the resident’s choices to the extent possible. In order to address
communication regarding the resident’s care between the nursing home and the hospice,
the nursing home must designate a staff person to participate in the ongoing
communication and include the resident representative in decision-making. The nursing
home should provide the name of the designated staff member/or designee to the

resident/representative for ongoing communication regarding care or concerns. (Refer to
F849 – Designated member of Interdisciplinary Group (IDG))

In order to provide continuity of care, the hospice, nursing home, and
resident/representative must collaborate in the development of a coordinated care plan
which includes, but is not limited to, the following:

• Resident/representative choices regarding care;
• The hospice philosophy of care and all services necessary for the palliation and

management of the terminal illness and related conditions;
• Measurable goals and interventions based on comprehensive and ongoing

assessments;
• Interventions that address, as appropriate, the identification of timely, pertinent

non-pharmacologic and pharmacological interventions to manage pain and other
symptoms of discomfort;

• The hospice portion that governs the actions of the hospice and describes the
services that are needed to care for the resident;

• Identification of the services the nursing home will continue to provide; and
• The identification of the provider responsible for performing specific

services/functions that have been agreed upon.

The structure of the care plan is established by the nursing home and the hospice. The
care plan may be divided into two portions, one maintained by the nursing home and the
other maintained by the hospice. The nursing home and the hospice must be aware of the
location and content of the coordinated care plan (which includes the nursing home
portion and the hospice portion) and the plan must be current and internally consistent in
order to assure that the needs of the resident for both hospice care and nursing home care
are met at all times. Any changes to the plan(s) must be discussed and approved by the
nursing home, hospice staff and, to the extent possible, the resident and/or representative.

As the condition of the resident declines, the hospice and nursing home must continue a
joint collaborative effort, which includes ongoing communication with and input from the
resident/ representative, to assure that the care provided addresses concerns as identified
in the ongoing assessments.

Physician Services

When a hospice patient is a resident of a nursing home, that resident’s hospice care plan
must be established and maintained in consultation with the resident’s attending
physician/practitioner, representatives of the nursing home and the
resident/representative, to the extent possible. (See F710 – Physician supervision of care)
In a nursing home, a physician’s assistant may not act as the hospice attending physician,
however, the resident’s attending physician at the nursing home may delegate tasks to a
physician’s assistant. See F714 – physician delegation of tasks.

NOTE: For informational purposes, the definition of an attending physician as identified
in the hospice federal regulations is provided below. This clarifies that a doctor of
medicine, osteopathy or nurse practitioner, if meeting the listed requirements, may
function as the “attending physician” in a hospice. The hospice regulations do not
provide for a physician assistant to function in this category.

§418.3 Definitions. For the purposes of this part — “Attending physician” means
a —
(1)(i) Doctor of medicine or osteopathy legally authorized to practice medicine
and surgery by the State in which he or she performs that function or action; or
(ii) Nurse practitioner who meets the training, education, and experience
requirements as described in §410.75 (b) of this chapter.
(2) Is identified by the individual, at the time he or she elects to receive hospice
care, as having the most significant role in the determination and delivery of the
individual’s medical care.

Communication

Nursing home staff must immediately contact and communicate with the hospice staff
regarding any significant changes in the resident’s status, clinical complications or
emergent situations. These situations may include but are not limited to changes in
cognition or sudden unexpected decline in condition, a fall with a suspected fracture or
adverse consequences to a medication or therapy, or other situations requiring a review or
revision to the care plan. The immediate notification to hospice does not change the
requirement that a nursing home also immediately notify the resident’s attending
physician/practitioner and the family resident representative of significant changes in
condition or a need to change the care plan. (Refer to F580 – Notification of Changes)
Prior to care plan or order changes, the hospice and the resident’s attending
physician/practitioner may need to collaborate to address this change and to assure the
resident’s immediate needs and treatment decisions are met, including situations which
could require a potential transfer to an acute care setting. This decision making must be
consistent with the resident’s wishes. (Refer to F849 – Hospice Services.) Additionally,
the communication of necessary information to the receiving provider must include those
items required at§483.15(c)(2)(iii), F622.

If there is a conflict between the hospice and the resident’s attending
physician/practitioner regarding the care plan, there must be communication between the
hospice and the nursing home regarding the issue. This communication should be timely
and include the hospice medical director and the nursing home medical director as well as
other pertinent hospice and facility staff, as needed.

The care of the resident receiving hospice services must reflect ongoing communication
and collaboration between the nursing home and the hospice staff. It is essential that a
communication process be established between the nursing home and the hospice to be
used 24-hours a day and that it include how the communication will be documented to
reflect concerns and responses. (Refer to F849 – which requires that the written

agreement specify the process for hospice and nursing home communication of necessary
information regarding the resident’s care.)

Review of Facility Practices/Written Agreement for Hospice Services
Any concerns identified by the survey team related to end of life and/or care provided by
a hospice should trigger a review of the facility’s policies and procedures on end of life
and hospice care and/or related policies (e.g., advance directives). In addition, the survey
team should request a copy of the written agreement between the nursing home and the
hospice. If there is a failure to develop and or implement portions of the written
agreement with a hospice, refer to F849 – Hospice Services.

NOTE: Surveyors should refer the following concerns, as a complaint, to the State
agency responsible for oversight of hospice for residents receiving Medicare-certified
hospice services;

• Hospice failure to address and resolve concerns made known to them by the
nursing facility which are related to coordination of care or implementation of
appropriate services; and/or

• Hospice failure to provide services in accordance with the coordinated plan of
care regardless of notice from the facility.

In addition, if the hospice was advised of the concerns, and failed to resolve
issues related to the management of a resident’s care, coordination of care, or
implementation of appropriate services, review the nursing home/hospice written
agreement to determine whether there is a failure by the nursing home related to
the implementation of the agreement at F849.

The survey team must refer the complaint to the State agency responsible for oversight of
hospice, identifying the specific resident(s) involved and the concerns identified. If the
hospice was advised of the concerns, and failed to resolve issues related to the
management of a resident’s care, coordination of care, or implementation of appropriate
services, review the appropriate portions of F849 regarding the written agreement and
determine whether there is a failure by the nursing home related to the implementation of
the agreement.

INVESTIGATIVE PROTOCOL for F684 – Quality of Care Use

Use the General Critical Element (CE) Pathway, or if applicable, the Hospice and End of
Life Care and Services CE Pathway, along with the above interpretive guidelines, or
applicable professional standards of practice for investigating concerns related to the
facility’s requirement to provide treatment and care in accordance with professional
standards of practice, the comprehensive person-centered care plan, and the residents’
choices – for which there is no other Quality of Care tag that would address the issue.

Summary of Investigative Procedure

Briefly review the most recent comprehensive assessments, comprehensive care plan and
orders to identify whether the facility has recognized and assessed concerns or resident
care needs under investigation. If the resident has been in the facility for less than 14
days (before completion of all the Resident Assessment Instrument (RAI) is required),
review the baseline care plan which must be completed within 48 hours to determine if
the facility is providing appropriate care and services based on information available at
the time of admission.

This information will guide observations and interviews to be made in order to
corroborate concerns identified. Make note of whether the comprehensive care plan is
evaluated and revised based on the resident’s response to interventions. Always observe
for visual cues of psychosocial distress and harm (see Appendix P, Guidance on Severity
and Scope Levels and Psychosocial Outcome Severity Guide).

During the investigation, identify the extent to which the facility has developed and
implemented interventions in accordance with the resident’s needs, goals for care and
professional standards of practice for the specific condition or concern being investigated.
In any instance in which the surveyor has identified a lack of improvement or a decline, it
must be determined whether this was unavoidable or avoidable. In order to make a
determination of unavoidable decline or failure to reach highest practicable well-being,
the facility must have:

• Conducted an accurate and comprehensive assessment (see §483.20 Resident
Assessment) including evaluating the resident’s clinical condition and risk factors
for the concern being investigated;

• Based on information gathered through resident assessments, with
resident/representative input, developed a person centered care plan, defined and
implemented interventions that are consistent with resident needs, goals, and
recognized standards of practice;

• Implemented the care plan, and monitored resident responses to the interventions;
and

• Provided ongoing review and revision of the care plan and interventions as
necessary.

If the facility has not done one or more of the above bulleted items, and a decline or
failure to reach his/her highest practicable well-being occurred, this would be considered
an avoidable decline.

NOTE: During the investigation of services provided to a resident from a Medicare-
certified hospice determine whether:

• The hospice was advised of concerns by the nursing home and failed to address
and resolve issues related to coordination of care or implementation of
appropriate services; and/or

• The hospice failed to provide services in accordance with the coordinated care
plan, regardless of notice from the facility.

The survey team must refer the above concerns as complaints to the State agency
responsible for oversight of hospice, identifying the specific resident(s) involved
and the concerns identified. If the hospice was advised of the concerns, and
failed to resolve issues related to the management of a resident’s care,
coordination of care, or implementation of appropriate services, review the
appropriate portions of F849 regarding the written agreement and determine
whether there is a failure by the nursing home related to the implementation of
the agreement.

KEY ELEMENTS OF NONCOMPLIANCE

To cite deficient practice at F684, the surveyor’s investigation will generally show that
the facility failed to do any one of the following:

• Provide needed care or services resulting in an actual or potential decline in one
or more residents’ physical, mental, and/or psychosocial well-being;

• Provide needed care or services (i.e., manage symptoms) resulting in one or more
residents’ failure to improve and/or attain their highest practicable physical,
mental, and/or psychosocial well-being;

• Recognize and/or assess risk factors placing the resident at risk for specific
conditions and/or problems;

• Implement resident-directed care and treatment consistent with the resident’s
comprehensive assessment and care plan, preferences, choices, rights, advance
directives (if any, and if applicable, according to State law), goals, physician
orders, and professional standards of practice, causing a negative outcome, or
placing the resident at risk for specific conditions and/or problems.;

• Monitor, evaluate the resident’s response to interventions, and/or revise the
interventions as appropriate, causing a negative outcome, or placing the resident
at risk for specific conditions and/or problems; and

• Inform and educate the resident who decides to decline care about risks/benefits
of such declination; and offer alternative care options and take steps to minimize
further decline, causing a negative outcome, or placing the resident at risk for
specific conditions and/or problems.

NOTE: Most noncompliance related to the failure to provide care and services needed
for residents to attain or maintain the highest practicable physical, mental, and
psychosocial well-being can also be cited at other regulations (e.g., assessment, care
planning, accommodation of needs, and physician supervision). Surveyors should
evaluate compliance with these regulations and cite deficiencies at F684 only when other
regulations do not address the deficient practice. Refer to F697 for pain management,
and if there is a failure to develop and or implement portions of the written agreement
with a hospice, refer to F849 – Hospice Services.

DEFICIENCY CATEGORIZATION

In addition to actual or potential physical harm, always consider whether psychosocial
harm has occurred when determining severity level (See Appendix P, Section IV, E,
Psychosocial Outcome Severity Guide).

Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident
Health or Safety include but are not limited to:

• The facility failed to promptly identify and intervene for an acute change in a
resident’s condition related to congestive heart failure (CHF), resulting in the
family calling 911 to transport the resident to the hospital. The resident was
admitted to the hospital with respiratory distress, pulmonary edema, and
complications of CHF.(Also cross-referenced and cited at F580, Notification of
Changes.)

• As a result of the facility’s continuous or repeated failure to implement comfort
measures in accordance with the care plan, the resident experienced serious harm
related to uncontrolled vomiting and nausea.

Examples of Severity Level 3 Noncompliance Actual Harm that is Not Immediate
Jeopardy include, but are not limited to:

• The facility failed to provide care for a resident with a stasis ulcer as identified on
the resident’s care plan and physician’s orders, resulting in worsening of the stasis
ulcer, as evidenced by a large area of the skin surrounding the ulcer being
reddened, swollen and, according to the nurse, warm to touch. There was exudate
and slough on the wound bed, and according to measurements, the wound had
increased in size.

• The facility failed to implement a resident’s hospice/nursing home coordinated
care plan that specified the resident not being transferred to the hospital for
treatment. The facility transferred the resident to the hospital for treatment related
to a urinary tract infection even though the resident and the coordinated care plan
indicated the resident did not wish to be hospitalized and preferred treatment at
the facility. The facility did not contact the hospice prior to initiating the transfer
to the hospital. The resident experienced increased pain during the transfer to the
hospital and continued to express emotional distress (tearful/crying) over the
transfer.

• The resident had requested and the care plan included a symptom management
plan with the use of medication to reduce the resident’s symptoms but not to the
point that the resident was symptom free so that the resident could be alert and
able to participate in visits with family/friends. However, the facility failed to
administer the medications as indicated in the plan of care. The resident
experienced lethargy and somnolence and was unable to converse/relate to
family/friends during visits.

Examples of Severity Level 2 Noncompliance: No Actual Harm, with Potential for
More than Minimal Harm, that is Not Immediate Jeopardy include, but are not
limited to:

Failure to follow physician orders to obtain daily weights for a resident with a diagnosis
of congestive heart failure, as evidenced by no documented daily weights on three
consecutive weekends. Although this noncompliance resulted in no actual harm to the
resident, it has a potential for more than minimal harm if the practice is not corrected.

The resident receiving the hospice benefit was on a pain management program utilizing
opioids. The resident was experiencing episodic minimal discomfort related to the
facility’s failure to consistently implement the bowel management plan as identified in
the coordinated care plan.

Severity Level 1 Noncompliance: No Actual Harm, with Potential for Minimal
Harm

Failure to provide appropriate care and services to meet the resident’s physical, mental
and/or psychosocial needs places the resident at risk for more than minimal harm.
Therefore, Severity Level 1 does not apply for this regulatory requirement.

F685
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.25(a) Vision and hearing
To ensure that residents receive proper treatment and assistive devices to maintain
vision and hearing abilities, the facility must, if necessary, assist the resident—

§483.25(a)(1) In making appointments, and

§483.25(a)(2) By arranging for transportation to and from the office of a
practitioner specializing in the treatment of vision or hearing impairment or the
office of a professional specializing in the provision of vision or hearing assistive
devices.

INTENT
The intent of this regulation is to ensure the facility assists the resident in gaining access
to vision and hearing services by making appointments and by arranging for
transportation.

DEFINITIONS
Assistive devices to maintain vision include, but are not limited to, glasses, contact
lenses, magnifying lens or other devices that are used by the resident.

Assistive devices to maintain hearing include, but are not limited to, hearing aids, and
amplifiers.

INTERPRETIVE GUIDANCE
This requirement does not mean that the facility must provide refraction, glasses, contact
lenses or other assistive devices, conduct comprehensive audiological evaluations (other
than the screening that is a part of the required assessment in §483.20(b)) or provide
hearing aids or other devices.

The facility’s responsibility is to assist residents and their representatives in locating and
utilizing any available resources (e.g., Medicare or Medicaid program payment, local
health organizations offering items and services which are available free to the
community) for the provision of the services the resident needs. This includes making
appointments and arranging transportation to obtain needed services.

In situations where the resident has lost their device, facilities must assist residents and
their representative in locating resources, as well as in making appointments, and
arranging for transportation to replace the lost devices.

Investigative Summary:
Use the Activities of Daily Living and Communication-Sensory Critical Element (CE)
Pathways along with the above interpretive guidelines when determining if the facility
meets requirements to ensure that residents receive proper treatment and assistive devices
to maintain vision and hearing abilities.

Summary of Vision and Hearing Investigative Procedure
Briefly review the most recent comprehensive assessments, comprehensive care plan, and
physician orders to determine if the facility assists residents in gaining access to vision
and hearing services by making appointments, and arranging for transportation.
Observations, interviews, and record reviews should be utilized to corroborate concerns
identified. If the resident has been in the facility for less than 14 days (before completion
of all the Resident Assessment Instrument (RAI) is required), review the baseline care
plan which must be completed within 48 hours to determine if the facility is providing
appropriate care and services based on information available at the time of admission.

F686
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.25(b) Skin Integrity
§483.25(b)(1) Pressure ulcers.
Based on the comprehensive assessment of a resident, the facility must ensure that—

(i) A resident receives care, consistent with professional standards of practice, to
prevent pressure ulcers and does not develop pressure ulcers unless the
individual’s clinical condition demonstrates that they were unavoidable; and

(ii) A resident with pressure ulcers receives necessary treatment and services,
consistent with professional standards of practice, to promote healing,
prevent infection and prevent new ulcers from developing.

INTENT

The intent of this requirement is that the resident does not develop pressure
ulcers/injuries (PU/PIs) unless clinically unavoidable and that the facility provides care
and services consistent with professional standards of practice to:

• Promote the prevention of pressure ulcer/injury development;
• +Promote the healing of existing pressure ulcers/injuries (including prevention of

infection to the extent possible); and
• Prevent development of additional pressure ulcer/injury.

NOTE: CMS is aware of the array of terms used to describe alterations in skin integrity
due to pressure. Some of these terms include: pressure ulcer, pressure injury, pressure
sore, decubitus ulcer and bed sore. Clinicians may use and the medical record may reflect
any of these terms, as long as the primary cause of the skin alteration is related to
pressure. For example, the medical record could reflect the presence of a Stage 2 pressure
injury, while the same area would be coded as a Stage 2 pressure ulcer on the MDS.

CMS often refers to the National Pressure Ulcer Advisory Panel’s (NPUAP) terms and
definitions, which it has adapted, within its patient and resident assessment instruments
and corresponding assessment manuals, which includes the Minimum Data Set (MDS).
We intend to continue our adaptation of NPUAP terminology for coding the resident
assessment instrument while retaining current holistic assessment instructions definitions
and terminology. The adapted terminology was used in the development of this
guidance.

Additional information can be found on the NPUAP website at
https://www.npuap.org/resources/educational-and-clinical-resources.

DEFINITIONS

Definitions are provided to clarify clinical terms related to pressure injuries and their
evaluation and treatment.

“Pressure Ulcer/Injury (PU/PI)” refers to localized damage to the skin and/or
underlying soft tissue usually over a bony prominence or related to a medical or other
device. A pressure injury will present as intact skin and may be painful. A pressure ulcer
will present as an open ulcer, the appearance of which will vary depending on the stage
and may be painful. The injury occurs as a result of intense and/or prolonged pressure or
pressure in combination with shear. Soft tissue damage related to pressure and shear may

also be affected by skin temperature and moisture, nutrition, perfusion, co-morbidities
and condition of the soft tissue.

Avoidable/Unavoidable

• “Avoidable” means that the resident developed a pressure ulcer/injury and that the
facility did not do one or more of the following: evaluate the resident’s clinical
condition and risk factors; define and implement interventions that are consistent
with resident needs, resident goals, and professional standards of practice;
monitor and evaluate the impact of the interventions; or revise the interventions as
appropriate.

• “Unavoidable” means that the resident developed a pressure ulcer/injury even
though the facility had evaluated the resident’s clinical condition and risk factors;
defined and implemented interventions that are consistent with resident needs,
goals, and professional standards of practice; monitored and evaluated the impact
of the interventions; and revised the approaches as appropriate.

Colonized/Infected

• “Colonized” refers to the presence of micro-organisms on the surface or in the
tissue of a wound without the signs and symptoms of an infection.

• “Infected” refers to the presence of micro-organisms in sufficient quantity to
overwhelm the defenses of viable tissues and produce the signs and symptoms of
infection.

Debridement- Debridement is the removal of devitalized/necrotic tissue and foreign
matter from a wound to improve or facilitate the healing process. Debridement methods
may include a range of treatments such as the use of enzymatic dressings to surgical
debridement in order to remove tissue or matter from a wound to promote healing.

Eschar/Slough

• “Eschar” is dead or devitalized tissue that is hard or soft in texture; usually black,
brown, or tan in color, and may appear scab-like. Necrotic tissue and eschar are
usually firmly adherent to the base of the wound and often the sides/ edges of the
wound.

• “Slough” is non-viable yellow, tan, gray, green or brown tissue; usually moist,

can be soft, stringy and mucinous in texture. Slough may be adherent to the base
of the wound or present in clumps throughout the wound bed.

Exudate

• “Exudate” is any fluid that has been forced out of the tissues or its capillaries
because of inflammation or injury. It may contain serum, cellular debris, bacteria
and leukocytes.

• “Purulent exudate/drainage/discharge” is any product of inflammation that
contains pus (e.g., leukocytes, bacteria, and liquefied necrotic debris).

• “Serous drainage or exudate” is watery, clear, or slightly yellow/tan/pink fluid
that has separated from the blood and presents as drainage.

Friction/Shearing

• “Friction” is the mechanical force exerted on skin that is dragged across any
surface.

• “Shearing” occurs when layers of skin rub against each other or when the skin
remains stationary and the underlying tissue moves and stretches and angulates or
tears the underlying capillaries and blood vessels causing tissue damage.

Granulation Tissue – “Granulation tissue” is the pink-red moist tissue that fills an open
wound, when it starts to heal. It contains new blood vessels, collagen, fibroblasts, and
inflammatory cells.

Tunnel/Sinus Tract/Undermining – The terms tunnel and sinus tract are often used
interchangeably.

• A “tunnel” is a passageway of tissue destruction under the skin surface that has an
opening at the skin level from the edge of the wound.

• A “sinus tract” is a cavity or channel underlying a wound that involves an area
larger than the visible surface of the wound.

• “Undermining” is the destruction of tissue or ulceration extending under the skin
edges (margins) so that the pressure ulcer is larger at its base than at the skin
surface. Undermining often develops from shearing forces and is differentiated
from tunneling by the larger extent of the wound edge involved and the absence
of a channel or tract extending from the pressure ulcer under the adjacent intact
skin.

GUIDANCE STAGING

Staging of a PU/PI is performed to indicate the characteristics and extent of tissue injury,
and should be conducted according to professional standards of practice. Determining
whether damage to the skin and underlying tissue is a PI or PU depends on the staging of
the damaged tissue. See stages below.

NOTE: Regardless of the staging system or wound definitions used by the facility, the
facility is responsible for completing the MDS utilizing the staging guidelines found in
the RAI Manual.

Stage 1 Pressure Injury: Non-blanchable erythema of intact skin

Intact skin with a localized area of non-blanchable erythema (redness). In darker skin
tones, the PI may appear with persistent red, blue, or purple hues. The presence of
blanchable erythema or changes in sensation, temperature, or firmness may precede
visual changes. Color changes of intact skin may also indicate a deep tissue PI (see
below).

Stage 2 Pressure Ulcer: Partial-thickness skin loss with exposed dermis

Partial-thickness loss of skin with exposed dermis, presenting as a shallow open ulcer.
The wound bed is viable, pink or red, moist, and may also present as an intact or
open/ruptured blister. Adipose (fat) is not visible and deeper tissues are not visible.
Granulation tissue, slough and eschar are not present. This stage should not be used to
describe moisture associated skin damage including incontinence associated dermatitis,
intertriginous dermatitis (inflammation of skin folds), medical adhesive related skin
injury, or traumatic wounds (skin tears, burns, abrasions).

Stage 3 Pressure Ulcer: Full-thickness skin loss

Full-thickness loss of skin, in which subcutaneous fat may be visible in the ulcer and
granulation tissue and epibole (rolled wound edges) are often present. Slough and/or
eschar may be visible but does not obscure the depth of tissue loss. The depth of tissue
damage varies by anatomical location; areas of significant adiposity can develop deep
wounds. Undermining and tunneling may occur. Fascia, muscle, tendon, ligament,
cartilage and/or bone are not exposed. If slough or eschar obscures the wound bed, it is an
Unstageable PU/PI.

Stage 4 Pressure Ulcer: Full-thickness skin and tissue loss

Full-thickness skin and tissue loss with exposed or directly palpable fascia, muscle,
tendon, ligament, cartilage or bone in the ulcer. Slough and/or eschar may be visible on
some parts of the wound bed. Epibole (rolled edges), undermining and/or tunneling often
occur. Depth varies by anatomical location. If slough or eschar obscures the wound bed,
it is an unstageable PU/PI.

Unstageable Pressure Ulcer: Obscured full-thickness skin and tissue loss

Full-thickness skin and tissue loss in which the extent of tissue damage within the ulcer
cannot be confirmed because the wound bed is obscured by slough or eschar. Stable
eschar (i.e. dry, adherent, intact without erythema or fluctuance) should only be removed
after careful clinical consideration and consultation with the resident’s physician, or nurse
practitioner, physician assistant, or clinical nurse specialist if allowable under state
licensure laws. If the slough or eschar is removed, a Stage 3 or Stage 4 pressure ulcer will
be revealed. If the anatomical depth of the tissue damage involved can be determined,
then the reclassified stage should be assigned. The pressure ulcer does not have to be
completely debrided or free of all slough or eschar for reclassification of stage to occur.

Other staging considerations include:

• Deep Tissue Pressure Injury (DTPI): Persistent non-blanchable deep red,
maroon or purple discoloration

Intact skin with localized area of persistent non-blanchable deep red, maroon,
purple discoloration due to damage of underlying soft tissue. This area may be
preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as
compared to adjacent tissue. These changes often precede skin color changes and
discoloration may appear differently in darkly pigmented skin. This injury results
from intense and/or prolonged pressure and shear forces at the bone-muscle
interface. The wound may evolve rapidly to reveal the actual extent of tissue
injury, or may resolve without tissue loss. If necrotic tissue, subcutaneous tissue,
granulation tissue, fascia, muscle or other underlying structures are visible, this
indicates a full thickness pressure ulcer. Once a deep tissue injury opens to an
ulcer, reclassify the ulcer into the appropriate stage. Do not use DTPI to describe
vascular, traumatic, neuropathic, or dermatologic conditions.

• Medical Device Related Pressure Ulcer/Injury: Medical device related PU/PIs
result from the use of devices designed and applied for diagnostic or therapeutic
purposes. The resultant pressure injury generally conforms to the pattern or shape
of the device. The injury should be staged using the staging system.

• Mucosal Membrane Pressure Ulcer/Injury: Mucosal membrane PU/PIs are
found on mucous membranes with a history of a medical device in use at the
location of the injury. Due to the anatomy of the tissue, these ulcers cannot be
staged.

PREVENTION OF PRESSURE ULCERS/NJURIES
A pressure ulcer/injury (PU/PI) can occur wherever pressure has impaired circulation to
the tissue. A facility must:

• Identify whether the resident is at risk for developing or has a PU/PI upon
admission and thereafter;

• Evaluate resident specific risk factors and changes in the resident’s condition that
may impact the development and/or healing of a PU/PI;

• Implement, monitor and modify interventions to attempt to stabilize, reduce or
remove underlying risk factors; and

• If a PU/PI is present, provide treatment and services to heal it and to prevent
infection and the development of additional PU/PIs.

The first step in the prevention of PU/PIs, is the identification of the resident at risk of
developing PU/PIs. This is followed by implementation of appropriate individualized
interventions and monitoring for the effectiveness of the interventions.

ASSESSMENT

An admission evaluation helps identify residents at risk of developing a PU/PI, and
residents with existing PU/PIs. Because a resident at risk can develop a PU/PI within
hours of the onset of pressure, the at-risk resident needs to be identified and have
interventions implemented promptly to attempt to prevent PU/PI. The admission
evaluation helps define those initial care approaches.

In addition, the admission evaluation may identify pre-existing signs suggesting that
tissue damage has already occurred and additional tissue loss may occur. For example, a
deep tissue pressure injury identified on admission could lead to the appearance of an
unavoidable Stage 3 or 4 pressure ulcer. A Stage 1 PI can progress to an ulcer with
eschar or exudate within days after admission. Some situations, which may have
contributed to this tissue damage prior to admission, include pressure resulting from
immobility during hospitalization or surgical procedures, during prolonged ambulance
transport, or while waiting to be assisted after a debilitating event, such as a fall or a
cerebral vascular accident.

It may be harder to identify erythema in a resident with darkly pigmented skin, putting
those residents more at risk for developing PU/PIs. It may be necessary, in darker skinned
residents to focus more on other evidence of PU/PI development such as changes in
sensation, skin temperature or firmness.

Multiple factors, including pressure intensity, pressure duration, and tissue tolerance,
significantly affect the potential for the development and healing of PUs/PIs. The
comprehensive assessment, which includes the RAI, evaluates the resident’s intrinsic
risks, the resident’s skin condition, and other factors (including causal factors) which
place the resident at risk for the development of or hinder the healing of PU/PIs. An
individual may also have various intrinsic risks due to aging, such as decreased
subcutaneous tissue and lean muscle mass, decreased skin elasticity, and impaired
circulation or sensation.

The comprehensive assessment should address those factors that have been identified as
having an impact on the development, treatment and/or healing of PU/PIs, including, at a
minimum: risk factors, pressure points, under-nutrition and hydration deficits, and
moisture and the impact of moisture on skin. The assessment also helps identify the
resident who has multi-system organ failure or an end-of-life condition or who is refusing
care and treatment. If the resident is refusing care, an evaluation of the basis for the
refusal, and the identification and evaluation of potential alternatives is indicated.

Risk Factors

Not all risk factors are fully modifiable or can be completely addressed. Some risk
factors, such as a permanent lack of sensation to an area, may not be modifiable. Some
potentially modifiable risk factors, such as malnutrition or uncontrolled blood sugars,
may take time to correct, despite prompt intervention. Other risk factors, such as

pressure, can be modified promptly. Many studies and professional literature identify
risk factors that increase a resident’s susceptibility to develop or to not heal pressure
PU/PIs.

Examples of these risk factors include, but are not limited to:

• Impaired/decreased mobility and decreased functional ability;
• Co-morbid conditions, such as end stage renal disease, thyroid disease or diabetes

mellitus;
• Drugs such as steroids that may affect healing;
• Impaired diffuse or localized blood flow, for example, generalized atherosclerosis

or lower extremity arterial insufficiency;
• Resident refusal of some aspects of care and treatment;
• Cognitive impairment;
• Exposure of skin to urinary and fecal incontinence;
• Under nutrition, malnutrition, and hydration deficits; and
• The presence of a previously healed PU/PI. The history of any healed PU/PI, its

origin, treatment, its stages [if known] is important assessment information, since
areas of healed Stage 3 or 4 PU/PIs are more likely to have recurrent breakdown.

Although the requirements do not mandate the use of any specific assessment tool (other
than the RAI), many validated instruments are available to aid in assessing the risk for
developing PU/PIs. It is important to keep in mind that research has shown that in a
skilled nursing facility, 80 percent of PU/PIs develop within two weeks of admission and
96 percent develop within three weeks of admission. (Reference: Lyder CH, Ayello EA.
Pressure Ulcers: A Patient Safety Issue. In: Hughes RG, editor. Patient Safety and
Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for
Healthcare Research and Quality (US); 2008 Apr. Chapter 12. Available from:
http://www.ncbi.nlm.nih.gov/books/NBK2650/)

Many clinicians utilize a standardized pressure ulcer/injury risk assessment tool to assess
a resident’s PU/PI risks upon admission, weekly for the first four weeks after admission,
then quarterly or whenever there is a change in the resident’s condition.

A resident’s risk may increase due to an acute illness or condition change (e.g., upper
respiratory infection, pneumonia, or exacerbation of underlying congestive heart failure)
and may require additional evaluation. The frequency of assessment should be based
upon each resident’s specific needs.

Regardless of any resident’s total risk score on an assessment tool, clinicians are
responsible for evaluating each existing and potential risk factor for developing a
pressure injury and determining the resident’s overall risk. It is acceptable if the
clinician’s assessment places the resident at a higher risk level than the overall score of
the assessment tool based on assessment factors that are not captured by the tool.
Documentation of the clinician’s decision should be placed in the medical record.

http://www.ncbi.nlm.nih.gov/books/NBK2650/

Pressure Points and Tissue Tolerance

Assessment of a resident’s skin condition helps define prevention strategies. The skin
assessment should include an evaluation of the skin integrity.

Tissue closest to the bone may be the first tissue to undergo changes related to pressure.
PU/PIs are usually located over a bony prominence, such as the sacrum, heel, the greater
trochanter, ischial tuberosity, fibular head, scapula, and ankle (malleolus).

An at-risk resident who sits too long in one position may be more prone to developing an
ulcer/injury over the ischial tuberosity. Slouching in a chair may predispose an at-risk
resident to pressure ulcers/injuries of the spine, scapula, or elbow. Elbow pressure injury
is often related to arm rests or lap boards. Friction and shearing are also important
factors in tissue ischemia, necrosis and PU/PI formation.

PU/PIs may develop at other sites where pressure has impaired the circulation to the
tissue, such as pressure from positioning or use of medical devices applied for diagnostic
or therapeutic purposes. The resultant PU/PI generally conforms to the pattern or shape of
the device. Mucosal membrane PU/PIs are found on mucous membranes with a history of
a medical device in use at the location of the injury. Due to the anatomy of mucous
membranes, these ulcers cannot be staged.

PU/PIs on the sacrum and heels are most common. PU/PIs may also develop from
pressure on an ear lobe related to positioning of the head; on areas (for example, nares,
urinary meatus, extremities) caused by tubes, casts, orthotics, braces, cervical collars, or
other medical devices; pressure on the labia or scrotum related to positioning (for
example, against a pommel type cushion); the foot related to ill-fitting shoes causing
blistering; or on legs, arms and fingers due to contractures or deformity.

Nutrition and Hydration

Adequate nutrition and hydration are essential for overall functioning. Nutrition provides
vital energy and building blocks for all of the body’s structures and processes. Any organ
or body system may require additional energy or structural materials for repair or
function. The skin is the body’s largest organ system. It may affect, and be affected by,
other body processes and organs. Skin condition reflects overall body function therefore,
the presence of skin breakdown may be the most visible evidence of a health issue.

Weight reflects a balance between intake and utilization of energy. Significant
unintended weight loss may indicate under-nutrition or worsening health status. Weight
stability (in the absence of fluid excess or loss) is a useful indicator of overall caloric
balance. Severely impaired organs (heart, lungs, kidneys, liver, etc.) may be unable to
use nutrients effectively. A resident with a PU/PI who continues to lose weight either
needs additional caloric intake or correction (where possible) of conditions that are
creating a hypermetabolic state. Continuing weight loss and failure of a PU/PI to heal
despite reasonable efforts to improve caloric and nutrient intake may indicate the resident

is in multi-system failure or an end-stage or end-of-life condition warranting an
additional assessment of the resident’s overall condition.

Before instituting a nutritional care plan, it helps to summarize resident specific evidence,
including: severity of nutritional compromise, rate of weight loss or appetite decline,
probable causes, the individual’s prognosis and projected clinical course, and the
resident’s wishes and goals. Because there are no wound-specific nutritional measures,
the interdisciplinary team should develop nutritional goals for the whole person and
address nutritional status and needs in the care plan as appropriate.

NOTE: Although some laboratory tests may help clinicians evaluate nutritional issues

in a resident with PU/PIs, no laboratory test is specific or sensitive enough to
warrant serial/repeated testing. A practitioner may order test(s) that provide
useful additional information or help with management of treatable conditions
at their discretion

Water is essential to maintain adequate body functions. As a major component of blood,
water dissolves vitamins, minerals, glucose, amino acids, etc.; transports nutrients into
cells; removes waste from the cells; and helps maintain circulating blood volume as well
as fluid and electrolyte balance. It is critical that each resident at risk for hydration deficit
or imbalance, including the resident who has or is at risk of developing a PU/PI, be
identified and assessed to determine appropriate interventions.

NOTE: The surveyor should refer to the Guidance at 42 CFR 483.25(g), F692, Assisted
Nutrition and Hydration, for investigation of potential non-compliance with the nutrition
and hydration requirements. A low albumin level combined with the facility’s lack of
supplementation, for example, is not by itself sufficient to cite a nutrition related
deficiency.

Moisture

Both urine and feces contain substances that may irritate the epidermis and may make the
skin more susceptible to breakdown and moisture-related skin damage. Fecal
incontinence may pose a greater threat to skin integrity, due to bile acids and enzymes in
the feces. Irritation or maceration resulting from prolonged exposure to urine and feces
may hasten skin breakdown, and moisture may make skin more susceptible to damage
from friction and shear during repositioning.

It may be difficult to differentiate dermatitis related to incontinence from partial thickness
PU/PI. This differentiation should be based on the clinical evidence and review of
presenting risk factors. The dermatitis may occur in the area where the incontinence brief
or underpad has been used.

Prevention and Treatment Strategies

The comprehensive assessment should provide the basis for defining approaches to
address residents at risk of developing or already having a PU/PI. A determination that a
resident is at risk for developing a PU/PI has significant implications for preventive and
treatment strategies, but does not by itself indicate that development of a PU/PI was
unavoidable. Effective prevention and treatment are based upon consistently providing
routine and individualized interventions.

Based upon the assessment and the resident’s clinical condition, choices and identified
needs, basic or routine care could include, but is not limited to, interventions to:

• Redistribute pressure (such as repositioning, protecting and/or offloading heels,
etc.);

• Minimize exposure to moisture and keep skin clean, especially of fecal
contamination;

• Provide appropriate, pressure-redistributing, support surfaces;
• Provide non-irritating surfaces; and
• Maintain or improve nutrition and hydration status, where feasible. Adverse drug

reactions related to the resident’s drug regimen may worsen risk factors for
development of, or for non-healing PU/PIs (for example, by causing lethargy or
anorexia or creating/increasing confusion) and should be identified and addressed.
These interventions should be incorporated into the plan of care and revised as the
condition of the resident indicates.

Resident Choices

In the context of the resident’s choices, clinical condition, and physician input, the
resident’s care plan should establish relevant goals and approaches to stabilize or improve
co-morbidities, such as attempts to minimize clinically significant blood sugar
fluctuations, and other interventions aimed at limiting the effects of risk factors
associated with PU/PIs. Alternatively, facility staff and practitioners should document
clinically valid reasons why such interventions were not appropriate or feasible.

In order for a resident to exercise his or her right appropriately to make informed choices
about care and treatment or to decline treatment, the facility and the resident (or if
applicable, the resident representative) must discuss the resident’s condition, treatment
options, expected outcomes, and consequences of refusing treatment. The facility is
expected to address the resident’s concerns and offer relevant alternatives, if the resident
has declined specific treatments. (See §483.10(c), F552, Planning and implementing
care.)

Pressure Injuries at End of Life

Residents at the end of life, in terminal stages of an illness or having multiple system
failures may have written directions for his or her treatment goals (or a decision has been
made by the resident’s representative, in accordance with State law). The facility’s care

must reflect the resident’s goals for care and wishes as expressed in a valid Advance
Directive, if one was formulated, in accordance with State law. However, the presence of
an Advance Directive does not absolve the facility from giving supportive and other
pertinent care that is not prohibited by the resident’s Advance Directive. It is important
for surveyors to understand that when a facility has implemented individualized
approaches for end-of-life care in accordance with the resident’s wishes, the
development, continuation, or worsening of a PU/PI may be considered unavoidable. If
the facility has implemented appropriate efforts to stabilize the resident’s condition (or
indicted why the condition cannot or should not be stabilized) and has provided care to
prevent or treat existing PU/PIs (including pertinent, routine, lesser aggressive
approaches, such as, cleaning, turning, repositioning), the PU/PI may be considered
unavoidable and consistent with regulatory requirements.

The Kennedy Terminal Ulcer (KTU)

The facility is responsible for accurately assessing and classifying an ulcer as a KTU or
other type of PU/PI and demonstrate that appropriate preventative measures were in place
to prevent non-KTU pressure ulcers.

KTUs have certain characteristics which differentiate them from pressure ulcers such as
the following:

• KTUs appear suddenly and within hours;
• Usually appear on the sacrum and coccyx but can appear on the heels, posterior

calf muscles, arms and elbows;
• Edges are usually irregular and are red, yellow, and black as the ulcer progresses,

often described as pear, butterfly or horseshoe shaped; and
• Often appear as an abrasion, blister, or darkened area and may develop rapidly to

a Stage 2, Stage 3, or Stage 4 injury.

Repositioning

Repositioning or relieving constant pressure is a common, effective intervention for an
individual with a PU/PI or who is at risk of developing one. Assessment of a resident’s
skin integrity after pressure has been reduced or redistributed should guide the
development and implementation of repositioning plans. Such plans should be addressed
in the comprehensive care plan consistent with the resident’s need and goals.
Repositioning is critical for a resident who is immobile or dependent upon staff for
repositioning, as the resident is unable to make small movements on their own that would
help to relieve prolonged pressure to one area. The care plan for a resident at risk of
friction or shearing during repositioning may require the use of lifting devices for
repositioning. Positioning the resident on an existing PU/PI should be avoided since it
puts additional pressure on tissue that is already compromised and may impede healing.

Determine repositioning frequency with consideration to the individual’s:

• Level of activity and mobility,
• General medical condition,
• Overall treatment objectives,
• Skin condition, and
• Comfort.

The resident’s skin condition and general comfort should be regularly assessed. The
efficacy of repositioning must be monitored and revisions to the care plan considered, if
the individual is not responding as expected to the repositioning interventions.

Facilities should consider the following repositioning issues:

1. The time an individual spends seated in a chair without pressure relief should be

limited. Seated individuals should be repositioned so as to maintain stability and full
range of activities. An acceptable seated posture minimizes the pressure and shear
exerted on the skin and soft tissues, which may involve using pressure relieving
devices/cushions or adjusting the seat tilt, foot rests, elevated leg rests and other
support devices to prevent prolonged pressure to areas of the body that may be at
particular risk for developing a PU/PI.

2. If able, the resident should be taught to shift his or her weight while sitting in a

chair. A resident who can change positions independently may need supportive
devices to facilitate position changes. The resident also may need instruction
about why repositioning is important and how to do it, encouragement to change
positions regularly, and monitoring of frequency of repositioning.

3. Many clinicians recommend a position change “off – loading” hourly for
dependent residents who are sitting or who are in a bed or a reclining chair with
the head of the bed or back of the chair raised 30 degrees or more. The resident
may require more frequent position changes based on an assessment of their skin
condition or their comfort. A “microshift,” meaning a small change in the
resident’s position for a short period of time, may not be adequate since this
approach does not allow sufficient capillary refill and tissue perfusion for a
resident at risk of developing PU/PI’s. Ongoing monitoring of the resident’s
skin integrity and tissue tolerance is critical to prevent development or
deterioration of PU/PI’s.

4. Wheelchairs are often used for transporting residents, but they may severely

limit repositioning options and increase the risk of PU/PI development.
Therefore, wheelchairs with sling seats may not be optimal for prolonged sitting
during activities or meals, etc. However, available modifications to the seating
can provide a more stable surface and provide better pressure reduction.

5. The care plan for a resident who is reclining and is dependent on staff for

repositioning should address position changes to maintain the resident’s skin
integrity. This may include repositioning at least every 2 hours or more frequently

depending upon the resident’s condition and specific needs. Depending on the
individualized assessment, more frequent repositioning may be warranted for
individuals who are at higher risk for PU/PI development or who show evidence that
repositioning at 2-hour intervals is inadequate. With rare exception (such as when
both sacral and ischial PU/PI’s are present) the resident should not be placed directly
on the greater trochanter for more than momentary placement. Elevating the head of
the bed or the back of a reclining chair to or above a 30 degree angle creates pressure
comparable to that exerted while sitting, and requires the same considerations
regarding repositioning as those for a dependent resident who is seated.

Support Surfaces and Pressure Redistribution

Pressure redistribution refers to the function or ability to distribute a load over a surface
or contact area. Redistribution results in shifting pressure from one area to another and
requires attention to all affected areas. Pressure redistribution has incorporated the
concepts of both pressure reduction and pressure relief.

Appropriate support surfaces or devices should be chosen by matching a device’s
potential therapeutic benefit with the resident’s specific situation; such as multiple
injuries, limited turning surfaces, ability to maintain position. The effectiveness of
pressure redistribution devices (such as gel mattresses, air fluidized mattresses, and low
loss air mattresses) is based on their potential to address the individual resident’s risk, the
resident’s response to the product, and the characteristics and condition of the product.
For example, an overinflated overlay product, or one that “bottoms out” (when the
overlay is underinflated or loses inflation creating less than one inch between the resident
and support material) is unlikely to effectively reduce the pressure risk. These products
are more likely to reduce pressure effectively if they are used in accord with the
manufacturer’s instructions. The effectiveness of each product used needs to be
evaluated on an ongoing basis. Surveyors should consider the following pressure
redistribution issues:

• Static pressure redistribution devices (such as a gel mattress) may be indicated
when a resident is at risk for PU/PI development or delayed healing. A
specialized pressure redistribution cushion or surface, for example, might be used
to extend the time a resident is sitting in a chair; however, the cushion does not
eliminate the necessity for periodic repositioning and skin assessment.

• Dynamic pressure reduction surfaces may be helpful when:

o The resident cannot assume a variety of positions without bearing weight on a

PU/PI;
o The resident completely compresses a static device that has retained its

original integrity; or
o The PU/PI is not healing as expected, and it is determined that pressure may

be contributing to the delay in healing.
• Because the heels and elbows have relatively little surface area, it is difficult to

redistribute pressure on these two surfaces. Therefore, it is important to pay

particular attention to reducing the pressure on these areas for the resident at risk
in accord with resident’s overall goals and condition. Pillows used to support the
entire lower leg may effectively raise the heel from contact with the bed, but use
of the pillows needs to take into account the resident’s other conditions. The use
of donut-type cushions is not recommended by the clinicians.

• A resident with severe flexion contractures also may require special attention to
effectively reduce pressure on bony prominences or prevent breakdown from
skin-to-skin contact.

Some products serve mainly to provide comfort and reduce friction and shearing forces,
e.g., sheepskin, heel and elbow protectors. Although these products are not effective at
redistributing pressure, they (in addition to pillows, foam wedges, or other measures)
may be employed to prevent bony prominences from rubbing together or on other
surfaces, such as armrests, the bed, or side rails.

Monitoring

Staff should remain alert to potential changes in the skin condition and should evaluate,
report and document changes as soon as identified. For example, a resident’s complaint
about pain or burning at a site where there has been pressure or observation during the
resident’s bath that there is a change in skin condition should be reported so that the
resident may be evaluated further.

After completing a thorough evaluation, the interdisciplinary team should develop a
relevant care plan that includes measurable goals for prevention and management of
PU/PIs with appropriate interventions. Many clinicians recommend evaluating skin
condition (skin color, moisture, temperature, integrity, and turgor) at least weekly, or
more often if indicated, such as when the resident is using a medical device that may
cause pressure. Defined interventions should be implemented and monitored for
effectiveness.

Assessment and Treatment of Pressure Ulcers/Injuries

It is important that each existing PU/PI be identified, whether present on admission or
developed after admission, and that factors that influenced its development, the potential
for development of additional PU/PIs or the deterioration of the PU/PIs be recognized,
assessed and addressed. Any new PU/PI suggests a need to reevaluate the adequacy of
prevention measures in the resident’s care plan.

When assessing the PU/PI itself, it is important that documentation addresses:

• The type of injury (pressure-related versus non-pressure-related) because
interventions may vary depending on the specific type of injury;

• The PU/PI’s stage;
• A description of the PU/PI’s characteristics;

• The progress toward healing and identification of potential complications;
• If infection is present;
• The presence of pain, what was done to address it, and the effectiveness of the

intervention; and
• A description of dressings and treatments.

Types of Injuries

Three of the more common types of skin injuries are pressure, vascular
insufficiency/ischemia (venous stasis and arterial ischemic ulcers) and neuropathic. See
§483.25, F684, Quality of Care, for definition and description of injury types other than
PU/PIs.

At the time of the assessment, clinicians (physicians, advance practice nurses, physician
assistants, and certified wound care specialists, etc.) should document the clinical basis
(for example, type of skin injury, location, shape, edges and wound bed, condition of
surrounding tissues) for any determination that an injury is not pressure-related,
especially if the injury has characteristics consistent with a pressure injury, but is
determined not to be one.

Pressure Ulcer/Injury Characteristics

It is important that the facility have a system in place to assure that the protocols for daily
monitoring and for periodic documentation of measurements, terminology, frequency of
assessment, and documentation are implemented consistently throughout the facility.

When a PU/PIis present, daily monitoring, (with accompanying documentation, when a
complication or change is identified), should include:

• An evaluation of the PU/PI, if no dressing is present;
• An evaluation of the status of the dressing, if present (whether it is intact and

whether drainage, if present, is or is not leaking);
• The status of the area surrounding the PU/PI (that can be observed without

removing the dressing);
• The presence of possible complications, such as signs of increasing area of

ulceration or soft tissue infection (for example: increased redness or swelling
around the wound or increased drainage from the wound); and

• Whether pain, if present, is being adequately controlled.

The amount of observation possible will depend upon the type of dressing that is used,
since some dressings are meant to remain in place for several days, according to
manufacturers’ guidelines.

With each dressing change or at least weekly (and more often when indicated by wound
complications or changes in wound characteristics), an evaluation of the PU/PI should be
documented. At a minimum, documentation should include the date observed and:

• Location and staging;
• Size (perpendicular measurements of the greatest extent of length and width of the

PU/PI), depth; and the presence, location and extent of any undermining or
tunneling/sinus tract;

• Exudate, if present: type (such as purulent/serous), color, odor and approximate
amount;

• Pain, if present: nature and frequency (e.g., whether episodic or continuous);
• Wound bed: Color and type of tissue/character including evidence of healing

(e.g., granulation tissue), or necrosis (slough or eschar); and
• Description of wound edges and surrounding tissue (e.g., rolled edges, redness,

hardness/induration, maceration) as appropriate.

Photographs may be used to support this documentation, if the facility has developed a
protocol consistent with professional standards and issues related to resident privacy and
dignity are considered and maintained.

Healing Pressure Ulcers/Injuries

Ongoing evaluation and research have indicated that PU/PIs do not heal in a reverse
sequence, that is, the body does not replace the types and layers of tissue (muscle, fat and
dermis) that were lost during development. The healing process varies depending on the
stage of the pressure injury.

There are different types of clinical documentation to describe the progression of the
healing PU/PI. Facilities are required to use the RAI. Directions on describing PU/PIs
can be found in the RAI manual – these are intended for coding purposes of the MDS.
(NOTE: Information on coding for the MDS is located on the CMS MDS website
(http://www.cms.gov/NursingHomeQualityInits/45_NHQIMDS30TrainingMaterials.asp#Top
OfPage)

It is important to evaluate and modify interventions for a resident with an existing PU/PI
such as the following:

• Residents with PU/PIs on the sacrum/coccyx or ischia should limit sitting to three
times a day in periods of 60 minutes or less. Consult a seating specialist to
prescribe an appropriate seating surface and/or positioning techniques to avoid or
minimize pressure on the PU/PI. While sitting is important for overall health,
every effort should be made to avoid or minimize pressure on the PU/PI.

• Residents with an ischial injury should not be seated in a fully erect posture in
chair or in bed. Modify sitting time schedules and re-evaluate the seating surface
and the individual’s posture if the PU/PI worsens or fails to improve.

If a PU/PI fails to show some evidence of progress toward healing within 2-4 weeks, the
area and the resident’s overall clinical condition should be reassessed. Re-evaluation of

http://www.cms.gov/NursingHomeQualityInits/45_NHQIMDS30TrainingMaterials.asp#TopOfPage

the treatment plan includes determining whether to continue or modify the current
interventions. Results may vary depending on the resident’s overall condition and
interventions/treatments used. The complexity of the resident’s condition may limit
responsiveness to treatment or tolerance for certain treatment modalities. The clinicians,
if deciding to retain the current regimen, should document the rationale for continuing the
present treatment to explain why some, or all, of the plan’s interventions remain relevant
despite little or no apparent healing.

Pressure ulcers/injuries may progress or may be associated with complications, such as
infection of the soft tissues around the wound (cellulitis), infection of the bone
(osteomyelitis), infection of a joint (septic arthritis), abscess, spread of bacteria into the
bloodstream (bacteremia/septicemia), chronic infection, or development of a sinus tract.
Sometimes these complications may occur despite apparent improvement in the PU/PI
itself. The physician’s involvement is integral whenever significant changes in the nature
of the wound or overall resident condition are identified.

Infections

A PU/PI infection may be acute or chronic. In acute wounds, the classic signs of
inflammation (redness, edema, pain, increased exudate, and periwound surface warmth)
persist beyond the normal time frame of three to four days. In residents who are
immunosuppressed, the signs of inflammation often are diminished or masked because of
an ineffective immune response. Often the only observable symptom of infection is a
complaint of pain.

All chronic wounds, including PU/PIs, have bacteria. Since bacteria reside in non-viable
tissue, debridement of this tissue and wound cleansing are important to reduce bacteria
and avoid adverse outcomes such as sepsis.

The first sign of infection may be a delay in healing and an increase in exudates. In a
chronic wound, the signs of infection may be more subtle. Signs may include the
following:

• Increase in amount or change in characteristics of exudate,
• Decolorization and friability of granulation tissue,
• Undermining,
• Abnormal odor,
• Epithelial bridging (a bridge of epithelial tissue across a wound bed) at the base of

the wound, or
• Sudden pain.

The physician diagnosis of infections present in a PU/PI are based on resident history and
clinical findings, such as a wound culture. Pus, slough or necrotic tissue should not be
cultured. Findings such as an elevated white blood cell count, bacteremia, sepsis, or
fever may signal an infection related to a PU/PI area or a co-existing infection from a

different source. The treatment of an infection will depend on the type of infection
present.

Pain

The assessment and treatment of a resident’s pain are integral components of PU/PI
prevention and management. Pain that interferes with movement and/or affects mood
may contribute to immobility and contribute to the potential for developing or for delayed
healing or non-healing of an already existing PU/PI. Refer to §483.25(k), F697, for
additional guidance related to Pain Management.

Dressings and Treatments

Determination of the need for treatment for a PU/PI is based upon the individual
practitioner’s clinical judgment, facility protocols, and current professional standards of
practice.

Product selection should be based upon the relevance of the specific product to the
identified PU/PI(s) characteristics, the treatment goals, and the manufacturer’s
recommendations for use. Current literature does not indicate significant advantages of
any single specific product over another, but does confirm that not all products are
appropriate for all PU/PIs. Wound characteristics should be assessed throughout the
healing process to assure that the treatments and dressings being used are appropriate to
the nature of the wound.

Evidenced-based practice suggests that PU/PI dressing protocols may use clean technique
rather than sterile, but that appropriate sterile technique may be needed for those wounds
that recently have been surgically debrided or repaired. Clean technique (also known as
non-sterile) involves approved hand hygiene and glove use, maintaining a clean
environment by preparing a clean field, using clean instruments, and preventing direct
contamination of materials and supplies. Clean technique is considered most appropriate
for long-term care; for residents who are not at high risk for infection; and for residents
receiving routine dressings for chronic wounds such as venous ulcers, or wounds healing
by secondary intention with granulation tissue.

A facility should be able to show that its treatment protocols are based upon current
professional standards of practice and are in accord with the facility’s policies and
procedures as developed with the medical director’s review and approval.

INVESTIGATIVE PROTOCOL

Use
Use the Pressure Ulcer Critical Element (CE) Pathway, along with the above interpretive
guidelines when determining if the facility meets requirements to ensure a resident
receives care consistent with professional standards of practice, to prevent pressure

ulcers/injuries development, prevent the development of additional pressure
ulcers/injuries, and to promote the healing of existing pressure ulcers/injuries.

Summary of Skin Integrity Investigative Procedure

Briefly review the comprehensive assessments, care plans, and physician orders to
identify whether the facility has practices in place to identify if a resident is at risk for a
pressure ulcer/injury, evaluate a resident for pressure ulcers/injuries, and intervene to
prevent and/or heal pressure ulcers. During this review, identify the extent to which the
facility has developed and implemented interventions in accordance with ensuring a
resident receives care consistent with professional standards of practice. If the resident
has been in the facility for less than 14 days (before completion of all the Resident
Assessment Instrument (RAI) is required), review the baseline care plan which must be
completed within 48 hours to determine if the facility is providing appropriate care and
services based on information available at the time of admission.
This information will guide observations and interviews to be made to corroborate
concerns identified.

KEY ELEMENTS OF NONCOMPLIANCE
To cite deficient practice at F686, the surveyor’s investigation will generally show that
the facility failed to do one or more of the following:

• Provide preventive care, consistent with professional standards of practice, to
residents who may be at risk for development of pressure injuries; or

• Provide treatment, consistent with professional standards of practice, to an

existing pressure injury; or
• Ensure that a resident did not develop an avoidable PU/PI.

NOTE: To cite F686, it is not necessary to prove that a PU/PI developed. F686 can be
cited when it has been determined that the provider failed to implement interventions to
prevent the development of a PU/PI for a resident identified at risk.

DEFICIENCY CATEGORIZATION

Examples of Severity Level 4 Noncompliance: Immediate Jeopardy to Resident
Health or Safety include, but are not limited to:

• The facility failed to implement interventions to prevent PU/PI development for a
resident who was admitted without PU/PIs, but who had multiple co-morbidities
and was totally dependent on staff, placing her at increased risk for PU/PI
development; and failed to provide ongoing skin assessments for the same

resident. The resident developed a stage IV pressure ulcer on her heel within three
weeks of her admission.

• Development of avoidable Stage IV pressure ulcer(s): As a result of the facility’s
non-compliance, permanent tissue damage (whether or not healing occurs) has
compromised the resident, increasing the potential for serious complications
including osteomyelitits and sepsis.

• Admitted with a Stage IV pressure ulcer(s) that has shown no signs of healing or

shows signs of deterioration: As a result of the facility’s non-compliance, a Stage
IV pressure ulcer has shown signs of deterioration or a failure to progress towards
healing with an increased potential for serious complications including
osteomyelitis and sepsis.

• Stage III or IV pressure ulcers with associated soft tissue or systemic infection:

As a result of the facility’s failure to assess or treat a resident with an infectious
complication of a pressure ulcer, the resident developed Stage III or IV pressure
ulcers with associated soft tissue or systemic infection. (See discussion in
guidelines and definitions that distinguishes colonization from infection.)

• Extensive failure in multiple areas of pressure ulcer care: As a result of the

facility’s extensive noncompliance in multiple areas of pressure ulcer care, the
resident developed recurrent and/or multiple, avoidable Stage III or Stage IV
pressure ulcer(s).

Examples of Severity Level 3 Noncompliance Actual Harm that is not Immediate
Jeopardy include, but are not limited to:

• The facility failed to provide necessary equipment, interventions, monitoring, and
care, for a resident who was identified to be at risk for developing PU/PIs due to
the presence of contractures and had no PU/PIs upon admission. The facility’s
occupational therapist (OT) assessed the resident and provided a pressure
relieving device for use on the resident’s left hand, which was to be in place at all
times except when daily hygiene was being provided. The interventions were not
recorded on the resident’s care plan. During observation and interviews with staff,
the assistive device was unable to be located and was not in use. This resulted in
the resident developing a Stage III pressure injury.

• The development of recurrent or multiple avoidable Stage II pressure ulcer(s): As
a result of the facility’s non-compliance, the resident developed multiple and/or
recurrent avoidable Stage II ulcers.

• Failure to implement the comprehensive care plan for a resident who has a

pressure ulcer: As a result of a facility’s failure to implement a portion of an
existing plan related to pressure ulcer care, such as failure to provide for pressure
redistribution, or inappropriate treatment/dressing changes, a wound increased in

size or failed to progress towards healing as anticipated, or the resident
experienced untreated pain.

Examples of Severity Level 2 Noncompliance No Actual Harm with Potential for
More Than Minimal Harm that is Not Immediate Jeopardy include, but are not
limited to:

• The facility failed to assure that a resident with a healed Stage I PI in the coccyx
area received care to prevent the development of another PU/PI. The resident’s
care plan identified the use of a pressure-relieving device while up in the chair
and repositioning every 30 minutes. During observations, the pressure relieving
device was not present on the seat of the wheelchair but staff did reposition
resident every 30 minutes. The device was available, but the staff person
interviewed stated that although it was usually on his wheelchair, it had not been
placed that day. The resident’s skin was intact and did not indicate the presence of
a stage I PI based on observation, but the likelihood existed of a PU/PI developing
as a result of not implementing care as identified in the plan of care.

• The facility failed to assess the skin condition of a resident who used continual
oxygen for management of a chronic respiratory disease. The resident’s oxygen
was provided via nasal cannula and the resident voiced discomfort and irritation
with the tubing on his nares. There was a small reddened area where the tubing
contacted the nares. The resident had mentioned this to the staff, but was not
addressed, and the resident continued to experience discomfort and irritation.

• Failure to implement an element of the care plan for a resident who has a pressure

ulcer however, there has been no evidence of decline or failure to heal.

• Failure to recognize or address the potential for developing a pressure ulcer: As a
result of the facility’s non-compliance, staff failed to identify the risks, develop a
plan of care and/or consistently implement a plan that has been developed to
prevent pressure ulcers.

Severity Level 1: No Actual Harm with Potential for Minimal Harm

The failure of the facility to provide appropriate care and services to prevent pressure
ulcers/injuries or heal existing pressure ulcers/injuries is more than minimal harm.
Therefore, Severity Level 1 does not apply for this regulatory requirement.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION
During the investigation of F686, the surveyor may have determined that concerns may
also be present with related outcome, process and/or structure requirements. The surveyor
is cautioned to investigate these related requirements before determining whether non-
compliance may be present. Some examples of related requirements that should be
considered include §483.20 Resident Assessment, §483.21 Comprehensive Person-

Centered Care Planning, §483.24 Quality of Life, §483.30 Physician Services, §483.35
Nursing Services, §483.70 Administration, and §483.75 QAPI.

F687
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.25(b)(2) Foot care.
To ensure that residents receive proper treatment and care to maintain mobility and
good foot health, the facility must:

(i) Provide foot care and treatment, in accordance with professional standards of
practice, including to prevent complications from the resident’s medical
condition(s) and

(ii) If necessary, assist the resident in making appointments with a qualified
person, and arranging for transportation to and from such appointments.

INTENT
To ensure that the foot care provided is consistent with professional standards of practice
and to clarify that foot care includes treatment to prevent complications from conditions
such as diabetes, peripheral vascular disease, or immobility. Also includes assisting the
resident in making necessary appointments with qualified healthcare providers such as
podiatrists and arranging for transportation to and from such appointments.

GUIDANCE
Facilities are responsible for providing the necessary treatment and foot care to residents.
Treatment also includes preventive care to avoid podiatric complications in residents with
diabetes and circulatory disorders who are prone to developing foot problems. Foot care
that is provided in the facility, such as toe nail clipping for residents without complicating
disease processes, should be provided by staff who have received education and training
to provide this service. Foot care and treatment must be provided within professional
standards of practice and state scope of practice, as applicable. Residents requiring foot
care who have complicating disease processes must be referred to qualified professionals
such as those listed as examples below.

Facilities are also responsible for providing residents access to qualified professionals
who can treat foot disorders, by making necessary appointments and arranging
transportation. Examples include podiatrist, Doctor of Medicine, and Doctor of
Osteopathy. Foot disorders which may require treatment include, but are not limited to:
corns, neuromas, calluses, hallux valgus (bunions), digiti flexus (hammertoe), heel spurs,
and nail disorders. The facility is also responsible for assisting residents in making
appointments and arranging transportation to obtain needed services.

Facility staff must follow proper infection prevention practices for foot care
equipment/devices, including but not limited to nail clippers, scalers, files, and burr tools.
Facility staff must separate used or contaminated foot care equipment from clean
equipment. Reusable medical devices (e.g., scalers, electronic nail file, and surgical
instruments) that are used on one resident must be cleaned and reprocessed (disinfection

or sterilization) for use according to manufacturer’s instructions prior to use on another
resident. If the manufacturer does not provide such instructions, the device may not be
suitable for multi-patient use. Recommendations for the cleaning, disinfection, and
sterilization of medical devices are available in CDC’s Guideline for Disinfection and
Sterilization in Healthcare Facilities, 2008 (available at:
https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html). Please see
guidance at §483.80, Infection Control, for more information.

NOTE: For purposes of this guidance, “staff” includes employees, the medical director,
podiatrists, consultants, contractors, and volunteers. Staff would also include caregivers
who provide care and services to residents on behalf of the facility, students in the
facility’s nurse aide training program, and students from affiliated academic institutions,
including therapy, social, and activity programs.

PROBES: For residents selected for review, determine the following:

• According to the medical record, does the resident have a diagnosis or condition
that poses a risk to foot health (e.g., diabetes, peripheral vascular disease, ingrown
toenails)?

• Does the comprehensive care plan adequately address the resident’s risk with
appropriate interventions?

• Observe residents’ feet for lack of nail care, presence of calluses, and/or other
foot problems.

• Are residents with foot concerns seen either within the facility or community by a
qualified foot care specialist? Do residents with mobility concerns have foot care
concerns, and did the facility address these concerns?

• Are qualified healthcare providers available to see residents either in the facility
or in the community?

• What preventive foot care do staff provide and to what resident population?
• Are staff providing foot care to the resident when needed and ordered?
• Do staff maintain separation of clean and contaminated podiatry equipment? If

no, refer to §483.80, Infection Control F880.

F688
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.25(c) Mobility.
§483.25(c)(1) The facility must ensure that a resident who enters the facility without
limited range of motion does not experience reduction in range of motion unless the
resident’s clinical condition demonstrates that a reduction in range of motion is
unavoidable; and

§483.25(c)(2) A resident with limited range of motion receives appropriate
treatment and services to increase range of motion and/or to prevent further
decrease in range of motion.

https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html

§483.25(c)(3) A resident with limited mobility receives appropriate services,
equipment, and assistance to maintain or improve mobility with the maximum
practicable independence unless a reduction in mobility is demonstrably
unavoidable.

To review the impact of the physical, mental, and/or psychosocial aspects of the
resident’s ability to maintain, improve or prevent avoidable decline in range of motion
and mobility, the surveyor must review the provision of care and services and
implementation of interventions under this tag.

INTENT §483.25(c)
To review the impact of the physical, mental, and/or psychosocial aspects of the
resident’s ability to maintain, improve or prevent avoidable decline in range of motion
and mobility, the surveyor must review the provision of care and services and
implementation of interventions under this tag.

The intent of this regulation (F688) is to ensure that the facility provides the services,
care and equipment to assure that:

• A resident maintains, and/or improves to his/her highest level of range of motion
(ROM) and mobility, unless a reduction is clinically unavoidable; and

• A resident with limited range of motion and mobility maintains or improves
function unless reduced Range of Motion (ROM)/mobility is unavoidable based
on the resident’s clinical condition.

DEFINITIONS §483.25(c)
“Active ROM” means the performance of an exercise to move a joint without any
assistance or effort of another person to the muscles surrounding the joint.

“Active Assisted ROM” means the use of the muscles surrounding the joint to perform
the exercise but requires some help from the therapist or equipment (such as a strap).
Mobility refers to all types of movement, including walking, movement in a bed,
transferring from a bed to a chair, all with or without assistance or moving about an area
either with or without an appliance (chair, walker, cane, crutches, etc.).

“Muscle atrophy” means the wasting or loss of muscle tissue.

“Passive ROM” means the movement of a joint through the range of motion with no
effort from the patient.

“Range of motion (ROM)” means the full movement potential of a joint.

GUIDANCE §483.25(c)
Assessment for Range of Motion:
The resident’s comprehensive assessment should include and measure, as appropriate, a
resident’s current extent of movement of his/her joints and the identification of
limitations, if any and opportunities for improvement. The assessment should address

whether the resident had previously received treatment and services for ROM and
whether he/she maintained his/her ROM, whether the ROM declined, and why the
treatment/services were stopped. In addition, the assessment should address, for a
resident with limited ROM, if he/she is not receiving services, the reason for the services
to not be provided.

The resident-specific, comprehensive assessment should identify individual risks which
could impact the resident’s range of motion including, but not limited to:

• Immobilization (e.g., bedfast, reclining in a chair or remaining seated in a
chair/wheelchair);

• Neurological conditions causing functional limitations such as cerebral vascular
accidents, multiple sclerosis, Amyotrophic Lateral Sclerosis (ALS ) or Lou
Gehrig’s disease, Guillain-Barre syndrome, Muscular Dystrophy, or cerebral
palsy, etc.;

• Any condition where movement may result in pain, spasms or loss of movement
such as cancer, presence of pressure ulcers, arthritis, gout, late stages of
Alzheimer’s, contractures, dependence on mechanical ventilation, etc.; or

• Clinical conditions such as immobilized limbs or digits because of injury,
fractures, or surgical procedures including amputations.

Assessment for Mobility:
The resident’s comprehensive assessment should include and measure, as appropriate, a
resident’s current mobility status, the identification of limitations, if any and
opportunities for improvement. The MDS tool provides an assessment of the resident’s
ability for movement including to and from the lying position, turning and side to side
movement in bed, positioning of the body, transfers between surfaces such as to and from
bed or chair, standing, and walking. The resident’s comprehensive assessment should
also address whether the resident had previously received treatment and services for
mobility and whether he/she maintained his/her mobility, whether there was a decline,
and why the treatment/services were stopped. In addition, the assessment should address,
for a resident with limited mobility, if he/she is not receiving services, the reason for the
services to not be provided. In addition, the resident specific comprehensive assessment
may identify individual risks which could impact the resident’s mobility including, but
not limited to include the risk factors in the above section for range of motion.

Care Plan for ROM and/or Mobility
Based upon the comprehensive assessment, the resident’s care plan must include specific
interventions, exercises and/or therapy to maintain or improve the ROM and mobility, or
to prevent, to the extent possible, declines or further declines in the resident’s ROM or
mobility. The resident/representative must be included in the development of the
restorative/rehabilitative care plan and provided the risks and benefits of the treatments.
The comprehensive assessment must identify the current status of the resident’s ROM
and mobility capabilities, which must be used to develop interventions. The decision on
what type of treatments includes an evaluation of the cognitive ability of the resident to
be able to independently participate, whether the resident requires assistance due to
medical condition or cognitive impairments or loss of ability to follow treatment

instructions. Care plan interventions may be delivered through the facility’s restorative
program, or as ordered by the attending practitioner, through specialized rehabilitative
services. (Also see F825 for specialized rehabilitative services.)

Based upon the assessment, the care plan interventions must include the provision of
necessary equipment and/or services necessary, adapting the environment to meet the
needs of the resident, the use of equipment for bed mobility, walkers, canes, splints,
braces or other rehabilitative equipment as prescribed by the attending practitioner and/or
as allowed by state law, and PT/OT. Examples of interventions may include treatments
such as active, passive, and/or active-assisted ROM, muscle strengthening and stretching
exercises, land and/or water based activities, and/or specific physical and/or occupational
therapies.

The care plan must identify the type of treatments, frequency, and duration, as well as the
measurable objectives and resident goals. The measurable objectives describe what the
resident is expected to achieve, such as mobility goals, and/or ROM measurements to be
achieved within a specific timeframe. This enables the interdisciplinary team to
determine progress including whether or not a resident has been able to maintain or
increase range of motion and/or mobility. The facility must assure that the care plan
provides for increasing and/or promoting independence to the extent clinically possible
for the resident in the areas of both ROM and mobility. The care plan must address the
presence of any contractures and interventions required, and any dependence and/or
declines in mobility and ROM.

In some clinical conditions, a decline/reduction in ROM and/or mobility may occur even
though the facility provides ongoing assessment, appropriate resident specific care
planning and provides ongoing preventive care and interventions. Documentation must
reflect the attempts made by the facility to implement the care plan and revise
interventions to address the changing needs of the resident. In this type of situation,
declines in ROM/mobility may be considered to be unavoidable.

The comprehensive assessment may identify specific resident risks for complications.
Examples of complications that may be related to decreased ROM and/or mobility may
include, but are not limited to, the following:

• Pain;
• Skin integrity issues;
• Deconditioning including decreased muscle strength and atrophy;
• Unsteady gait and balance resulting in potential falls and fractures;
• Contractures; or
• Respiratory and circulatory complications, such as postural hypotension, deep

vein thrombosis, pneumonia; potential urinary incontinence, bowel
constipation/impactions, etc.

The care plan should reflect the specific resident risks for complications and include
interventions to mitigate, to the extent possible, the potential complications. If resident
specific complications related to a decrease in ROM/mobility are present, the care plan

must provide interventions to address the complications.

Administrative Review
The facility must develop resident care policies in collaboration with the medical
director, director of nurses, and as appropriate, physical/occupational therapy consultant.
This includes policies on restorative/rehabilitative treatments/services, based on
professional standards of practice, including who may provide specific treatments and
modalities according to applicable State law and/or practice acts. Refer to F841, Medical
Director. These policies should also address equipment use, cleaning, and storage.

In situations where the survey team has concerns related to patterns or widespread
noncompliance within the requirements for Mobility, please see guidance at §483.75,
QAPI/QAA.

KEY ELEMENTS OF NONCOMPLIANCE
To cite deficient practice at F688, the surveyor’s investigation will generally show that
the facility failed to provide treatment/services, equipment, supplies and/or assistance to:

• Prevent an avoidable reduction of ROM and/or mobility in residents admitted
with full ROM and/or mobility status; or

• Increase ROM or mobility status or prevent further avoidable reduction of ROM
and mobility; or

• Maintain or improve ROM/mobility.

INVESTIGATIVE SUMMARY
Use – Use the Positioning, Mobility & Range of Motion (ROM) Critical Element (CE)
Pathway, along with the above interpretive guidelines when determining if the facility
provides the necessary care and services to meet the resident’s needs.

Summary of Procedure
Briefly review the most recent comprehensive assessments, comprehensive care plan and
orders to identify whether the facility has assessed and developed an individualized care
plan based on professional standards of practice and provided by qualified, competent
staff. During this review, identify the extent to which the facility has implemented
interventions in accordance with the resident’s needs, goals for care and professional
standards of practice, consistently across all shifts. This information will guide
observations and interviews to be made in order to corroborate concerns identified.

NOTE: Always observe for visual cues of psychosocial distress and harm (see Appendix
P, Guidance on Severity and Scope Levels and Psychosocial Outcome Severity Guide).

F689
(Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24)

§483.25(d) Accidents.

The facility must ensure that –
§483.25(d)(1) The resident environment remains as free of accident hazards as is
possible; and

§483.25(d)(2) Each resident receives adequate supervision and assistance devices to
prevent accidents.

INTENT: 483.25(d)

The intent of this requirement is to ensure the facility provides an environment that is free
from accident hazards over which the facility has control and provides supervision and
assistive devices to each resident to prevent avoidable accidents. This includes:

• Identifying hazard(s) and risk(s);
• Evaluating and analyzing hazard(s) and risk(s);
• Implementing interventions to reduce hazard(s) and risk(s); and
• Monitoring for effectiveness and modifying interventions when necessary.

DEFINITIONS 483.25(d)

Definitions are provided to clarify terms related to providing supervision and other
interventions to prevent accidents.

“Accident” refers to any unexpected or unintentional incident, which results or may
result in injury or illness to a resident. This does not include other types of harm, such as
adverse outcomes that are a direct consequence of treatment or care that is provided in
accordance with current professional standards of practice (e.g., drug side effects or
reaction).

“Avoidable Accident” means that an accident occurred because the facility failed to:

• Identify environmental hazards and/or assess individual resident risk of an
accident, including the need for supervision and/or assistive devices; and/or

• Evaluate and analyze the hazards and risks and eliminate them, if possible, or, if
not possible, identify and implement measures to reduce the hazards/risks as
much as possible; and/or

• Implement interventions, including adequate supervision and assistive devices,
consistent with a resident’s needs, goals, care plan and current professional
standards of practice in order to eliminate the risk, if possible, and, if not, reduce
the risk of an accident; and/or

• Monitor the effectiveness of the interventions and modify the care plan as
necessary, in accordance with current professional standards of practice.

“Unavoidable Accident” means that an accident occurred despite sufficient and
comprehensive facility systems designed and implemented to:

• Identify environmental hazards and individual resident risk of an accident,
including the need for supervision; and

• Evaluate and analyze the hazards and risks and eliminate them, if possible and, if
not possible, reduce them as much as possible;

• Implement interventions, including adequate supervision, consistent with the
resident’s needs, goals, plan of care, and current professional standards of practice
in order to eliminate the risk, if possible, and, if not, reduce the risk of an
accident; and

• Monitor the effectiveness of the interventions and modify the interventions as
necessary, in accordance with current professional standards of practice.

“Assistance Device” or “Assistive Device” refers to any item (e.g., fixtures such as
handrails, grab bars, and mechanical devices/equipment such as stand-alone or overhead
transfer lifts, canes, wheelchairs, and walkers, etc.) that is used by, or in the care of a
resident to promote, supplement, or enhance the resident’s function and/or safety.

NOTE: The currently accepted nomenclature refers to “assistive devices.” Although the
term “assistance devices” is used in the regulation, the Guidance provided in this
document will refer to “assistive devices.” These terms mean the same thing, and may be
used interchangeably.

“Environment” refers to any environment or area in the facility that is frequented by or
accessible to residents, including (but not limited to) the residents’ rooms, bathrooms,
hallways, dining areas, lobby, outdoor patios, therapy areas and activity areas.

“Fall” refers to unintentionally coming to rest on the ground, floor, or other lower level,
but not as a result of an overwhelming external force (e.g., resident pushes another
resident). An episode where a resident lost his/her balance and would have fallen, if not
for another person or if he or she had not caught him/herself, is considered a fall. A fall
without injury is still a fall. Unless there is evidence suggesting otherwise, when a
resident is found on the floor, a fall is considered to have occurred (refer to Resident
Assessment Instrument User’s Manual. Version 3.0, Chapter 3, page J-27).

“Hazards” refer to elements of the resident environment that have the potential to cause
injury or illness.

• “Hazards over which the facility has control” are those hazards in the resident
environment where reasonable efforts by the facility could influence the risk for
resulting injury or illness.

• “Free of accident hazards as is possible” refers to being free of accident hazards
over which the facility has control.

“Position change alarms” are alerting devices intended to monitor a resident’s
movement. The devices emit an audible signal when the resident moves in a certain way.
Types of position change alarms include chair and bed sensor pads, bedside alarmed
mats, alarms clipped to a resident’s clothing, seatbelt alarms, and infrared beam motion
detectors.1 Position change alarms do not include alarms intended to monitor for unsafe
wandering such as door or elevator alarms.

“Risk” refers to any external factor, facility characteristic (e.g., staffing or physical
environment) or characteristic of an individual resident that influences the likelihood of
an accident.

“Supervision/Adequate Supervision” refers to an intervention and means of mitigating
the risk of an accident. Facilities are obligated to provide adequate supervision to prevent
accidents. Adequate supervision is determined by assessing the appropriate level and
number of staff required, the competency and training of the staff, and the frequency of
supervision needed. This determination is based on the individual resident’s assessed
needs and identified hazards in the resident environment. Adequate supervision may
vary from resident to resident and from time to time for the same resident.

GUIDANCE OVERVIEW §483.25(d)
Numerous and varied accident hazards exist in everyday life. Not all accidents are
avoidable. The frailty of some residents increases their vulnerability to hazards in the
resident environment and can result in life-threatening injuries. It is important that all
facility staff understand the facility’s responsibility, as well as their own, to ensure the
safest environment possible for residents.

The facility is responsible for providing care to residents in a manner that helps promote
quality of life. This includes respecting residents’ rights to privacy, dignity and self-
determination, and their right to make choices about significant aspects of their life in the
facility.

An effective way for the facility to avoid accidents is to develop a culture of safety and
commit to implementing systems that address resident risk and environmental hazards to
minimize the likelihood of accidents. A facility with a commitment to safety:

• Acknowledges the high-risk nature of its population and setting;
• Develops effective communication, including a reporting system that does not

place blame on the staff member for reporting resident risks and environmental
hazards;

• Engages all staff, residents and families in training on safety, and promotes
ongoing discussions about safety with input from staff at all levels of the
organization, as well as residents and families;

• Encourages the use of data to identify potential hazards, risks, and solutions
related to specific safety issues that arise;

• Directs resources to address safety concerns; and
• Demonstrates a commitment to safety at all levels of the organization.

A SYSTEMS APPROACH

Processes in a facility’s interdisciplinary systematic approach may include:

• Identification of hazards, including inadequate supervision, and a resident’s risks
of potentially avoidable accidents in the resident environment;

• Evaluation and analysis of hazards and risks;
• Implementation of individualized, resident-centered interventions, including

adequate supervision and assistive devices, to reduce individual risks related to
hazards in the environment; and

• Monitoring for effectiveness and modification of interventions when necessary.

A key element of a systematic approach is the consistent application of a process to
address identified hazards and/or risks. Risks may pertain to individual residents, groups
of residents, or the entire facility. Hazards may include, but are not limited to, aspects of
the physical plant, equipment, and devices that are defective or are not used properly (per
manufacturer’s specifications), are disabled/removed, or are not individually adapted or
fitted to the resident’s needs. An effective system not only proactively identifies
environmental hazards and the resident’s risk for an avoidable accident, but also
evaluates the resident’s need for supervision.

Identifying and addressing risks, including the potential for accidents, includes
consideration of the environment, the resident’s risk factors, and the need for supervision,
care, and assistive devices. This will allow the facility to communicate information about
observed hazards, identify resident-specific information, develop and implement an
individualized care plan based on the Resident Assessment Instrument (RAI) to address
each resident’s needs and goals, and to monitor the results of the planned interventions.
The care plan should strive to balance the resident’s wishes with the potential impact on
the safety of the resident and other residents.

A systematic approach enables the facility to evaluate safety throughout its environment
and among all staff, and make appropriate adjustments in training and competency testing
as required. Each resident and their family members or representatives should be aware
of the risks and potential hazards related to falls and of various devices used to reduce fall
risk. Furthermore, a systematic approach enables leadership and direct care staff to work
together to revise policies and procedures, based on feedback from workers who are most
familiar with the residents and care processes. Effective facility systems address how to:

• communicate the observations of hazards,
• record resident specific information, and
• monitor data related to care processes that potentially lead to accidents.

Identification of Hazards and Risks

Identification of hazards and risks is the process through which the facility becomes
aware of potential hazards in the resident environment and the risk of a resident having
an avoidable accident. All staff (e.g., professional, administrative, maintenance, etc.) are
to be involved in observing and identifying potential hazards in the environment, while
taking into consideration the unique characteristics and abilities of each resident. The
facility should make a reasonable effort to identify the hazards and risk factors for each
resident. Various sources provide information about hazards and risks in the resident
environment. These sources may include, but are not limited to, Quality Assessment and
Assurance (QAA) activities, environmental rounds, MDS/CAAs data, medical history
and physical exam, facility assessment as required in F838, and individual observation.
This information is to be documented and communicated across all disciplines.

Evaluation and Analysis

Evaluation and analysis is the process of examining data to identify specific hazards and
risks and to develop targeted interventions to reduce the potential for accidents.
Interdisciplinary involvement is a critical component of this process. Analysis may
include, for example, considering the severity of hazards, the immediacy of risk, and
trends such as time of day, location, etc.

Both the facility-centered and resident-directed approaches include evaluating hazards
and accident risk data which includes prior accidents/incidents, analysis to identify the
root causes of each hazard and accident risk, and identifying or developing interventions
based on the severity of the hazards and immediacy of risk. Evaluations also look at
trends such as time of day, location, etc.

Implementation of Interventions

Implementation refers to using specific interventions to try to reduce a resident’s risks
from hazards in the environment. The process includes: Communicating the
interventions to all relevant staff, assigning responsibility, providing training as needed,
documenting interventions (e.g., plans of action developed through the QAA committee
or care plans for the individual resident), and ensuring that the interventions are put into
action.

Interventions are based on the results of the evaluation and analysis of information about
hazards and risks and are consistent with professional standards, including evidence-
based practice. Development of interim safety measures may be necessary if
interventions cannot immediately be implemented fully.

Facility-based interventions may include, but are not limited to, educating staff, repairing
the device/equipment, and developing or revising policies and procedures. Resident-
directed approaches may include implementing specific interventions as part of the plan

of care, supervising staff and residents, etc. Facility records document the
implementation of these interventions.

Monitoring and Modification

Monitoring is the process of evaluating the effectiveness of care plan interventions.
Modification is the process of adjusting interventions as needed to make them more
effective in addressing hazards and risks.

Monitoring and modification processes include:

• Ensuring that interventions are implemented correctly and consistently;
• Evaluating the effectiveness of interventions;
• Modifying or replacing interventions as needed and
• Evaluating the effectiveness of new interventions.

An example of facility-specific modification is additional training of staff when
equipment has been upgraded, while a resident-specific modification is revising the care
plan to reflect the resident’s current condition and risk factors that may have changed
since the previous assessment.

For example, a facility implements a position change alarm for a newly admitted resident
with a history of falls. After completing a comprehensive assessment of the resident,
facility staff identify the resident’s routines and patterns, remove the alarm, and
implement more individualized interventions that address the actual cause of why a
resident may be changing position (e.g. has been in one position too long or is trying to
reach for a personal item) which could lead to a fall.

Supervision

Supervision is an intervention and a means of mitigating accident risk. Facilities are
obligated to provide adequate supervision to prevent accidents. Adequacy of supervision
is defined by type and frequency, based on the individual resident’s assessed needs, and
identified hazards in the resident environment. Adequate supervision may vary from
resident to resident and from time to time for the same resident. Devices such as position
change alarms may help to monitor a resident’s movement temporarily, but do not
eliminate the need for adequate supervision.

The resident environment may contain temporary hazards (e.g., construction, painting,
housekeeping activities, etc.) that warrant additional supervision or alternative measures
such as barriers to prevent access to affected areas of the resident environment.

Adequate supervision to prevent accidents is enhanced when the facility:

• Accurately assesses a resident and/or the resident environment to determine
whether supervision to avoid an accident is necessary; and/or

• Determines that supervision of the resident was necessary and provides
supervision based on the individual resident’s assessed needs and the risks
identified in the environment.

Resident Smoking

Some facilities permit residents to smoke tobacco products. In these facilities,
assessment of the resident’s capabilities and deficits determines whether or not
supervision is required. If the facility identifies that the resident needs assistance and
supervision for smoking, the facility includes this information in the resident’s care plan,
and reviews and revises the plan periodically as needed.

The facility may designate certain areas for resident smoking. The facility must ensure
precautions are taken for the resident’s individual safety, as well as the safety of others in
the facility. Such precautions may include smoking only in designated areas, supervising
residents whose assessment and care plans indicate a need for assisted and supervised
smoking, and limiting the accessibility of matches and lighters by residents who need
supervision when smoking for safety reasons. Smoking by residents when oxygen is in
use is prohibited, and any smoking by others near flammable substances is also
problematic. Additional measures may include informing all visitors of smoking policies
and hazards.

Guidance concerning resident smoking regulations can be found in NFPA 101, 2012
edition, the Life Safety Code at 19.7.4, Smoking, including requirements for signage,
prohibiting smoking by residents classified as not responsible, and disposal of smoking
materials.

Electronic cigarettes – While electronic cigarettes (e-cigs), or vapor pens, are not
considered smoking devices, and their heating element does not pose the same dangers of
ignition as regular cigarettes, they are not without risk. A review of literature by the
Centers for Disease Control and Prevention (CDC), Food and Drug Administration
(FDA), and Federal Emergency Management Agency (FEMA) shows that as electronic
cigarette use has increased, risks associated with their use have also increased. Risks and
concerns include:

• Potential health effects for the smoker, such as respiratory illness or lung injury
which may present with symptoms of breathing difficulty, shortness of breath,
chest pain, mild to moderate gastrointestinal illness, fever or fatigue;

• Second-hand aerosol exposure;
• Nicotine overdose by ingestion or contact with the skin; and
• Explosion or fire caused by the battery.

Because these devices are not without risk and have accidents associated with them,
facilities have a responsibility to oversee their use and provide supervision to maintain an
accident-free environment.

In August 2016, the World Health Organization recommended that electronic cigarettes
be banned indoors or where smoking is prohibited because of the second-hand exposure
to potentially toxic chemicals, and many local and state jurisdictions have begun enacting
laws that prohibit electronic cigarette use everywhere that smoking is banned.
Facilities that decide, in accordance with State and local laws, to allow e-cigarette use,
should develop and implement policies for safe use of e-cigarettes, along with policies for
traditional cigarettes. Policies should include where e-cigarettes can be used and how to
handle the devices, batteries and refill cartridges. The FDA has published
recommendations for safe handling at the following link:
https://www.fda.gov/tobaccoproducts/labeling/productsingredientscomponents/ucm5393
62.htm#blue.

Residents who wish to use e-cigarettes should be assessed for their ability to safely
handle the device. Concerns related to resident safety with use of e-cigarettes should be
investigated using the guidance at 42 CFR 483.25(d), F689, Accidents and
Supervision. Surveyors should also consider how facilities balance resident safety with a
resident’s right to use these devices while also considering the rights of residents who do
not want to be exposed to second-hand aerosol. For concerns related to resident choice to
use e-cigarettes in facilities where the devices are permitted and for residents who do not
wish to be exposed to second-hand aerosol, surveyors should use guidance at 42 CFR
483.10(c)(3) Right to Participate in Planning Care, F553 and 483.10(f), F561, Self-
Determination. For concerns about a facility’s policies for e-cigarettes, use F926,
483.90(i)(5), Smoking Policies.

Resident-to-Resident Altercations

NOTE: A resident to resident altercation should be reviewed as a potential situation of

abuse which should be investigated under the guidance for 42 CFR §483.12,
(F600). The surveyor should not automatically assume that abuse did not
occur for a resident identified as having a cognitive impairment or mental
disorder, as it does not preclude the resident from deliberate (willful) or non-
accidental actions. “Willful” as defined at §483.5 and as used in the
definition of “abuse,” “means the individual must have acted deliberately, not
that the individual must have intended to inflict injury or harm.” Even though
a resident may have a cognitive impairment, he/she could still commit a
willful act. If during the investigation of an allegation of abuse, it is
determined that the action was not willful, the surveyor must investigate
whether the facility is in compliance with the requirement to maintain an
environment as free of accident hazards as possible, and that each resident
receives adequate supervision using guidance at this tag, F689, Accidents.

It is important that a facility take reasonable precautions, including providing adequate
supervision, when the risk of resident-to-resident altercation is identified, or should have
been identified. Certain situations or conditions may increase the potential for such
altercations, including, but not limited to:

https://www.fda.gov/tobaccoproducts/labeling/productsingredientscomponents/ucm539362.htm#blue

• A history of aggressive behaviors including striking out, verbal outbursts, or
negative interactions with other resident(s); and/or

• Behavior that may disrupt or annoy others such as constant verbalization (e.g.,
crying, yelling, calling out for help), making negative remarks, restlessness,
repetitive behaviors, taking items that do not belong to them, going into other
residents’ rooms, drawers, or closets, and undressing in inappropriate areas.
Although these behaviors may not be aggressive in nature, they may precipitate a
negative response from others, resulting in verbal, physical, and/or emotional
harm.

The facility is responsible for identifying residents who have a history of disruptive or
intrusive interactions, or who exhibit other behaviors that make them more likely to be
involved in an altercation. The facility should identify the factors (e.g., pain, specific
triggers in the environment, etc.) that increase the risks associated with individual
residents, including those that could trigger an altercation. The interdisciplinary team
reviews the assessment along with the resident and/or his/her representative, in order to
address the underlying reasons for the behavioral manifestations and to identify
interventions to try to prevent altercations.

The interventions listed below include supervision and other actions that could address
potential or actual negative interactions:

• Evaluating staffing levels to ensure adequate supervision (if it is adequate, it is
meeting the resident’s needs) (refer to F725, §483.35(a)(1)(2), to evaluate staffing
levels for any nursing services not related to behavioral health care or dementia
care and F741, §483.40, for any staff caring for residents with dementia, mental
and psychosocial disorder, substance use disorder, or a history of trauma and/or
post-traumatic stress disorder);

• Evaluating staffing assignments to ensure consistent staff who are more familiar
with the resident and who thus may be able to identify changes in a resident’s
condition and behavior;

• Providing safe supervised areas for unrestricted movement;
• Eliminating or reducing underlying causes of distressed behavior such as boredom

and pain;
• Monitoring environmental influences such as temperatures, lighting, and noise

levels; and
• Ongoing staff training, competencies and supervision, including how to approach

a resident who may be agitated, combative, verbally or physically aggressive, or
anxious, and how and when to obtain assistance in managing a resident with
behavior symptoms (refer to F726, §483.35(a)(3)(4)(c), to evaluate staff
competency for any nursing services not related to behavioral health care or
dementia care and F741, §483.40, for any staff caring for residents with dementia,
mental and psychosocial disorder, substance use disorder, or a history of trauma
and/or post-traumatic stress disorder).

RISKS AND ENVIRONMENTAL HAZARDS

This section discusses common, but not all, potential risks and hazards found in the
resident environment.

NOTE: The information included in the following sections is based on current

professional standards of practice or “best practice” models as described in the
literature.

The physical plant, devices, and equipment described in this section may not be hazards
by themselves but can become hazardous when a vulnerable resident interacts with them.
Some temporary hazards in the resident environment can affect most residents who have
access to them (e.g., construction, painting, and housekeeping activities). Other
situations may be hazardous only for certain individuals (e.g., accessible smoking
materials).

In order to be considered hazardous, an element of the resident environment must be
accessible to a vulnerable resident. Resident vulnerability is based on risk factors
including the individual resident’s functional status, medical condition, cognitive
abilities, mood, and health treatments (e.g., medications). Resident vulnerability to
hazards may change over time. Ongoing assessment helps identify when elements in the
environment pose hazards to a particular resident.

Certain sharp items, such as scissors, kitchen utensils, knitting needles, or other items,
may be appropriate for many residents but hazardous for others with cognitive
impairments. Handrails, assistive devices, and any surface that a resident may come in
contact with may cause injury, if the surface is not in good condition, free from sharp
edges or other hazards or not installed properly.

Improper actions or omissions by staff can create hazards in the physical plant (e.g.,
building and grounds), environment, and/or with devices and equipment. Examples of
such hazards might include fire doors that have been propped open, disabled locks or
latches, nonfunctioning alarms, buckled or badly torn carpets, cords on floors, irregular
walking surfaces, improper storage and access to toxic chemicals, exposure to unsafe
heating unit surfaces, and unsafe water temperatures. Other potential hazards may
include furniture that is not appropriate for a resident (e.g., chairs or beds that are not the
proper height or width for the resident to transfer to and from safely or unstable as to
present a fall hazard) and lighting that is either inadequate or so intense as to create glare.
Devices for resident care, such as pumps, ventilators, and assistive devices, may be
hazardous when they are defective, disabled, or improperly used (i.e., used in a manner
that is not per manufacturer’s recommendations or current professional standards of
practice).

Resident Vulnerabilities

The responsibility to respect a resident’s choices is balanced by considering the resident’s
right to direct the care they receive with the potential impact of these choices on their
well-being, other residents, and on the facility’s obligation to protect residents from
harm. The facility has a responsibility to educate a resident, family, and staff regarding
significant risks related to a resident’s choices. When a resident’s choice poses some risk,
staff should work with the resident to understand reasons for the choice, and discuss
options for the facility to honor the choice. For example, a resident may express a desire
to use a cane instead of a walker or wheelchair in order to maintain dignity and self-
esteem. This preference should be discussed to review potential positive and negative
consequences of possible courses of action (including potential negative consequences
that may result from preventing the choice) and to find ways to develop a care plan in
which staff honor the choice while mitigating risks. For resources on care planning to
mitigate risk, see A Process for Care Planning Resident Choice at
https://www.pioneernetwork.net/wp-content/uploads/2016/10/Process-for-Care-Planning-
for-Resident-Choice- .

Verbal consent or signed consent/waiver forms do not eliminate a facility’s responsibility
to protect a resident from an avoidable accident, nor does it relieve the provider of its
responsibility to assure the health, safety, and welfare of its residents. While Federal
regulations affirm the resident’s right to participate in care planning and to refuse
treatment, the regulations do not create the right for a resident or representative to
demand the facility use specific medical interventions or treatments that the facility
deems inappropriate. The regulations hold the facility ultimately accountable for the
resident’s care and safety.

Falls and unsafe wandering/elopement are of particular concern. The following section
reviews these issues along with some common potential hazards.

Falls – The MDS defines a fall as unintentionally coming to rest on the ground, floor, or
other lower level but not as a result of an overwhelming external force (e.g., resident
pushes another resident). An episode where a resident lost his/her balance and would
have fallen, if not for another person or if he or she had not caught him/herself, is
considered a fall. A fall without injury is still a fall. Unless there is evidence suggesting
otherwise, when a resident is found on the floor, a fall is considered to have occurred.

NOTE: Challenging a resident’s balance and training him/her to recover from loss of
balance is an intentional therapeutic intervention. The losses of balance that occur during
supervised therapeutic interventions are not considered a fall.

Some factors that may result in resident falls include, but are not limited to:

• Environmental hazards, such as wet floors, poor lighting, incorrect bed height
and/or width, or improperly fitted or maintained wheelchairs;

• Unsafe or absent footwear and loose or improperly worn clothing;
• Underlying chronic medical conditions, such as arthritis, heart failure, anemia and

neurological disorders;

https://www.pioneernetwork.net/wp-content/uploads/2016/10/Process-for-Care-Planning-for-Resident-Choice-

• Acute change in condition such as fever, infection, delirium;
• Medication side effects;
• Orthostatic hypotension;
• Lower extremity weakness;
• Balance disorders;
• Poor grip strength;
• Functional impairments (difficulty rising from a chair, getting on or off toilet,

etc.);
• Gait disorders;
• Cognitive impairment;
• Visual deficits;
• Pain; and
• Incontinence.

Older persons have both a high incidence of falls and a high susceptibility to injury.2
Serious potential consequences of falls include physical injuries, pain, increased risk of
death, impaired function, fear of falling, and self-imposed limitations on activities leading
to social isolation.3 Evaluation of all of the causal factors leading to a resident fall assists
the facility in developing and implementing relevant, consistent, and individualized
interventions to prevent future occurrences. Proper actions following a fall include:

• Ascertaining if there were injuries, and providing treatment as necessary;
• Determining what may have caused or contributed to the fall, including

ascertaining what the resident was trying to do before he or she fell;
• Addressing the risk factors for the fall such as the resident’s medical

conditions(s), facility environment issues, or staffing issues; and
• Revising the resident’s plan of care and/or facility practices, as needed, to reduce

the likelihood of another fall.

NOTE: A fall by a resident does not necessarily indicate a deficient practice because not

every fall can be avoided.

Position Change Alarms:

Facilities often implement position change alarms as a fall prevention strategy or in
response to a resident fall. The alarms are designed to alert staff that the resident has
changed position, increasing the risk for falling. However, the efficacy of alarms to
prevent falls has not been proven and a study of hospitalized patients concluded these
devices may only alert staff that a fall has already occurred. The same study also noted
false alarms are a common problem leading to “alarm fatigue,” where staff no longer
respond to the sound of an alarm.4 A study on bed-exit alarms concluded the alarms are
not a substitute for staff assisting residents and bed-exit alarms may not always function
reliably for residents who weigh less than 100 pounds or who are restless.5 Individual
facility efforts to reduce use of alarms have shown falls actually decrease when alarms
are eliminated, and replaced with other interventions such as purposeful checks to

proactively address resident needs, adjusting staff to cover times of day when most falls
occur, assessing resident routines, and making individualized environmental or care
changes that suit each resident. 6 For example, brighter lighting might help a resident with
macular degeneration ambulate more easily in his or her room but would cause glare and
make walking more difficult for a resident with cataracts.7

Facilities must implement comprehensive, resident-centered fall prevention plans for
each resident at risk for falls or with a history of falls. While position change alarms are
not prohibited from being included as part of a plan, they should not be the primary or
sole intervention to prevent falls. If facility staff choose to implement alarms, they should
document their use aimed at assisting the staff to assess patterns and routines of the
resident. Use of these devices, like any care planning intervention, must be based on
assessment of the resident and monitored for efficacy on an on-going basis. Position
change alarms have been used to monitor a resident’s movement in chairs or beds, etc.
However, there must be sufficient staff and supervision to meet the resident’s needs and
staff must be vigilant in order to respond to alarms in a timely manner. Alarms do not
replace necessary supervision. Facilities must take steps to identify issues that place the
resident at risk for falls and implement approaches to address those risks in a manner that
enables the resident to achieve or maintain his or her highest practicable physical, mental,
and psychosocial well-being.

Wandering and Elopement – Wandering is random or repetitive locomotion. This
movement may be goal-directed (e.g., the person appears to be searching for something
such as an exit) or may be non-goal-directed or aimless. Non-goal-directed wandering
requires a response in a manner that addresses both safety issues and an evaluation to
identify root causes to the degree possible. Moving about the facility aimlessly may
indicate that the resident is frustrated, anxious, bored, hungry, or depressed. Goal-
directed wandering may fulfill a resident’s need for exercise or provide sensory
stimulation. This goal directed wandering should also require staff supervision and a
facility response to address safety issues.

Wandering may become unsafe when a resident becomes overly tired or enters an area
that is physically hazardous or that contains potential safety hazards (e.g., chemicals,
tools, and equipment, etc.). Entering into another resident’s room may lead to an
altercation or contact with hazardous items. Unsafe wandering can be associated with an
increased risk for falls and injuries.

While wander, door, or building alarms can help to monitor a resident’s activities, staff
must be vigilant in order to respond to them in a timely manner. Alarms do not replace
necessary supervision, and require scheduled maintenance and testing to ensure proper
functioning.

A situation in which a resident leaves the premises or a safe area without the facility’s
knowledge and supervision, if necessary, would be considered an elopement. This
situation represents a risk to the resident’s health and safety and places the resident at risk

of heat or cold exposure, dehydration and/or other medical complications, drowning, or
being struck by a motor vehicle.

Facility policies that clearly define the mechanisms and procedures for assessing or
identifying, monitoring and managing residents at risk for elopement can help to
minimize the risk of a resident leaving a safe area without the facility’s awareness and/or
appropriate supervision. In addition, the resident at risk should have interventions in
their comprehensive plan of care to address the potential for elopement. Furthermore, a
facility’s disaster and emergency preparedness plan should include a plan to locate a
missing resident.

Safety for Residents with Substance Use Disorder (SUD)

Residents with a history of substance use disorder may be at increased risk for leaving the
facility without notification and/or for illegal or prescription drug overdose if the resident
continues using substances while residing in the nursing home. Residents with a history
of substance use disorder should be assessed for these risks and care plan interventions
should be implemented to ensure the safety of all residents.

For example, residents with substance use disorder may leave the facility to satisfy an
addiction to alcohol, prescription drugs, or illegal substances. Care planning
interventions should address this risk by providing appropriate diversions for residents
and encouraging residents to seek out facility staff to discuss their plan of care, including
discharge planning, rather than leaving to seek out substances which could endanger the
resident’s health and/or safety. The facility should advise residents of the risks of leaving
the facility to seek out substances and/or early, unplanned discharge, and provide
appropriate referrals and discharge instructions whenever possible.

Facilities are responsible for identifying and assessing a resident’s risk for leaving the
facility without notification to staff and developing interventions to address this risk. A
situation in which a resident with decision-making capacity leaves the facility
intentionally would generally not be considered an elopement unless the facility is
unaware of the resident’s departure and/or whereabouts. A resident who leaves the
facility prior to his or her planned discharge, but with facility knowledge of the departure
and despite facility efforts to explain the risks of leaving, would be leaving against
medical advice (AMA). Documentation in the medical record should show that facility
staff attempted to provide other options to the resident and informed the resident of
potential risks of leaving AMA. Documentation should also identify the time the facility
became aware of the resident leaving the facility.

NOTE: This guidance is not intended to restrict a resident’s ability to leave and return to
the facility in accordance with the resident’s medical orders, care plan, facility policy and
§§483.10(c)(6), (f)(3), and (f)(8).

Additionally, residents with SUD may try to continue using substances during their stay
in the nursing home. Facility staff should assess the resident for the risk for substance

use in the facility and have knowledge of signs and symptoms of possible substance use
such as: frequent leaves of absence with or without facility knowledge, odors, new
needle marks, and changes in resident behavior such as unexplained drowsiness, slurred
speech, lack of coordination, and mood changes, particularly after interaction with
visitors or absences from the facility. Efforts to prevent substance use may include
providing substance use treatment services, such as behavioral health services,
medication-assisted treatment (MAT), alcoholic/narcotics anonymous meetings, working
with the resident and the family, if appropriate, to address goals related to their stay in the
nursing home, and increased monitoring and supervision.

When investigating overdose occurrences, surveyors should evaluate whether the facility
assessed and identified that the resident who experienced an overdose had a history of
substance use and was at risk for using substances which could lead to an overdose while
in the facility. If there is a history of SUD, the resident’s comprehensive care plan should
contain interventions, if appropriate, to prevent substance use in the facility as well as
interventions for when substance use is suspected or identified. Facility staff should
implement care plan interventions which should include increased monitoring and
supervision of the resident, increased supervision of visitors, and notification of the
resident’s physician or non-physician practitioner. For example, a resident displays
changes in behavior or unexplained lethargy after his or her visitors leave or other
residents report observing the use of substances. When substance use is suspected, (in
the facility or upon return from an absence from the facility) which could lead to
overdose, facility staff should implement the care plan interventions.

Facilities and surveyors should be aware that relapses of substance use can be common in
individuals with SUD, and may result in a drug overdose. Facilities that accept residents
with SUD are typically doing so to treat a medical-related issue, and are not expected to
fully cure individuals with SUD of their underlying addictive behaviors while in the
facility. However, facility staff should be prepared to address emergencies related to
substance use by providing increased monitoring, maintaining and having knowledge of
administering opioid reversal agents like naloxone, initiating CPR as appropriate, and
contacting emergency medical services as soon as possible. The United States Surgeon
General has recommended that naloxone be kept on hand where there is a risk for an
opioid overdose. Information on safe naloxone administration may be found on this
document developed by the Substance Abuse and Mental Health Administration
(SAMHSA), https://store.samhsa.gov/system/files/sma18-4742 .

NOTE: Surveyors should be aware that the occurrence of an overdose does not
automatically mean that noncompliance exists. As noted above, drug overdoses can be
expected with individuals with SUD and facilities are not expected to fully cure these
residents of their underlying disease or SUD. For example, a resident with a known
history of SUD and drug seeking behaviors when offsite, returns from an absence from
the facility. Evidence shows the facility took steps to increase its monitoring of the
resident, and despite this effort, the resident overdosed between checks or immediately
upon return before increased monitoring had begun. Additionally, the facility attempted
CPR and administered naloxone. This example demonstrates a negative outcome,

https://store.samhsa.gov/system/files/sma18-4742

however, noncompliance with this requirement does not exist. Conversely, if the same
resident returns from an absence but the facility did not take steps to increase monitoring,
noncompliance with the requirements at §483.25(d) may exist due to failure to identify
the resident’s risk for overdose and implement interventions.

Physical Plant Hazards

NOTE: Refer to guidance at 483.71 (F838) for facility responsibilities regarding the

facility’s physical environment.

Supervision and/or containment of hazards are needed to protect residents from harm
caused by environmental hazards. Examples of such hazards can range from common
chemical cleaning materials to those caused by adverse water temperatures or improper
use of electrical devices.

Chemicals and Toxins – Various materials in the resident environment can pose a
potential hazard to residents. Hazardous materials can be found in the form of solids,
liquids, gases, mists, dusts, fumes, and vapors. The routes of exposure for toxic materials
may include inhalation, absorption, or ingestion.

For a material to pose a safety hazard to a resident, it must be toxic, caustic, or allergenic;
accessible and available in a sufficient amount to cause harm. Toxic materials that may
be present in the resident environment are unlikely to pose a hazard unless residents have
access or are exposed to them. Some materials that would be considered harmless when
used as designed could pose a hazard to a resident who accidentally ingests or makes
contact with them.

Examples of materials that may pose a hazard to a resident include (but are not limited
to):

• Chemicals used by the facility staff in the course of their duties (e.g.,
housekeeping chemicals, cleaning and sanitizing agents) and chemicals or other
materials brought into the resident environment by staff, other residents, or
visitors;

• Drugs and therapeutic agents;
• Plants and other “natural” materials found in the resident environment or in the

outdoor environment (e.g., poison ivy).

One source of information concerning the hazards of a material that a facility may obtain
is the Safety Data Sheet (SDS).8 The Occupational Safety and Health Administration
(OSHA) requires employers to have a SDS available for all hazardous materials that staff
use while performing their duties.9 SDSs are available on-line for numerous chemicals
and non-toxic materials, and should be reviewed carefully to determine if the material is
toxic and poses a hazard. Poison control centers are another source of information for
potential hazards, including non-chemical hazards such as plants.

NOTE: Toxicological profiles for a limited number of hazardous materials are
accessible on the Agency for Toxic Substances & Disease Registry Web site at
http://www.atsdr.cdc.gov/.

Water Temperature – Water may reach hazardous temperatures in hand sinks, showers,
tubs, and any other source or location where hot water is accessible to a resident. Burns
related to hot water/liquids may also be due to spills and/or immersion. Many residents
in long-term care facilities have conditions that may put them at increased risk for burns
caused by scalding. These conditions include: decreased skin thickness, decreased skin
sensitivity, peripheral neuropathy, decreased agility (reduced reaction time), decreased
cognition or dementia, decreased mobility, and decreased ability to communicate.10

The degree of injury depends on factors including the water temperature, the amount of
skin exposed, and the duration of exposure. Some States have regulations regarding
allowable maximum water temperature. Table 1 illustrates damage to skin in relation to
the temperature of the water and the length of time of exposure.11

Table 1. Time and Temperature Relationship to Serious Burns

Water
Temperature

Time Required for a 3rd Degree
Burn to Occur

155°F
148°F
140°F
133°F
127°F
124°F
120°F
100°F

68°C
64°C
60°C
56°C
52°C
51°C
48°C
37°C

1 sec
2 sec
5 sec
15 sec
1 min
3 min
5 min

Safe Temperatures
for Bathing (see Note)

NOTE: Burns can occur even at water temperatures below those identified in

the table, depending on an individual’s condition and the length of
exposure.

Based upon the time of the exposure and the temperature of the water, the severity of the
harm to the skin is identified by the degree of burn, as follows.12

• First-degree burns involve the top layer of skin (e.g., minor sunburn). These may
present as red and painful to touch, and the skin will show mild swelling.

• Second-degree burns involve the first two layers of skin. These may present as

deep reddening of the skin, pain, blisters, glossy appearance from leaking fluid,
and possible loss of some skin.

http://www.atsdr.cdc.gov/

• Third-degree burns penetrate the entire thickness of the skin and permanently
destroy tissue. These present as loss of skin layers, often painless (pain may be
caused by patches of first- and second-degree burns surrounding third-degree
burns), and dry, leathery skin. Skin may appear charred or have patches that
appear white, brown, or black.

Electrical Safety – Any electrical device, whether or not it needs to be plugged into an
electric outlet, can become hazardous to the residents through improper use or improper
maintenance. Electrical equipment such as electrical cords can become tripping hazards.
Halogen lamps or heat lamps can cause burns or fires if not properly installed away from
combustibles in the resident environment. The Life Safety Code prohibits the use of
portable electrical space heaters in resident areas.

Extension cords should not be used to take the place of adequate wiring in a facility. If
extension cords are used, the cords should be properly secured and not be placed
overhead, under carpets or rugs, or anywhere that the cord can cause trips, falls, or
overheat. Extension cords should be connected to only one device to prevent overloading
of the circuit. The cord itself should be of a size and type for the expected electrical load
and made of material that will not fray or cut easily. Electrical cords including extension
cords should have proper grounding if required and should not have any grounding
devices removed, or should not be used without the grounding devices.

Power strips may not be used as a substitute for adequate electrical outlets in a facility.
Power strips may be used for a computer, monitor, and printer. Power strips are not
designed to be used with medical devices in patient care areas. Precautions needed if
power strips are used include: installing internal ground fault and over-current protection
devices; preventing cords from becoming tripping hazards; and using power strips that
are adequate for the number and types of devices used. Overload on any circuit can
potentially cause overheating and fire. The use of ground fault circuit interruption
(GFCIs) may be required in locations near water sources to prevent electrocution of staff
or residents.13

The proper use of electric blankets and heating pads is essential to avoid thermal injuries.
These items should not be tucked in or squeezed. Constriction can cause the internal
wires to break. A resident should not go to sleep with an electric blanket or heating pad
turned on. Manufacturer’s instructions for use should be followed closely. Injuries and
deaths have been related to burns and fires related to the use of heating pads. Most
deaths are attributable to heating pads that generated fires, but most injuries are burns
from prolonged use or inappropriate temperature setting. Prolonged use on one area of
the body can cause a severe burn, even when the heating pad is at a low temperature
setting.

Lighting – The risk of an accident increases when there is insufficient light or too much
light, which often results in glare. Vision among older persons varies widely; therefore,
no single level of illumination can ensure safety for all residents. The proper amount of
light depends on the resident’s visual needs and the task he/she is performing. An older

person typically needs more light to see. However, a resident with cataracts or glaucoma
may be overly sensitive to bright light, and excessive lighting could make it more
difficult to see clearly and thereby increase his/her fall risk.14 Creating transitional zones
between light and dark spaces helps to improve sight recovery and enable safer mobility.
Providing extra visual cues that clearly define needed items or spaces in areas with
limited or variable light can help to enable safe performance of tasks (e.g., turning on a
light). Providing supplemental light near beds for residents who are mobile may assist in
safe mobility at night.15

NOTE: Refer to guidance under 42 CFR 483.10(i)(5), F584, Safe Environment

regarding adequate and comfortable lighting.

Assistive Devices/Equipment Hazards

Assistive devices also can help to prevent accidents. Assistive devices and equipment
can help residents move with increased independence, transfer with greater comfort, and
feel physically more secure. However, there are risks associated with the use of such
devices and equipment, particularly if or when they are not properly maintained and these
risks need to be balanced with the benefits gained from their use. Training of staff,
residents, family members and volunteers on the proper use of assistive
devices/equipment is crucial to prevent accidents. It is also important to communicate
clearly the approaches identified in the care plan to all staff, including temporary staff. It
is important to train staff regarding resident assessment, safe transfer techniques, and the
proper use of mechanical lifts including device weight limitations.

NOTE: The Safe Medical Devices Act of 1990 (SMDA) requires hospitals, nursing
homes, and other user facilities to report deaths, serious illnesses, and injuries associated
with the use of medical devices to manufacturers and the Food and Drug Administration.

Assistive Devices for Mobility – Mobility devices include all types of assistive devices,
such as, but not limited to, canes, standard and rolling walkers, manual or non-powered
wheelchairs, and powered wheelchairs. Three primary factors that may be associated
with an increased accident risk related to the use of assistive devices include:

1. Resident Condition. Lower extremity weakness, gait disturbances, decreased
range of motion, and poor balance may affect some residents. These conditions
combined with cognitive impairment can increase the accident risks of using
mobility devices. Unsafe behavior, such as failure to lock wheelchair brakes and
trying to stand or transfer from a wheelchair unsafely, can result in falls and
related injuries;

2. Personal Fit and Device Condition. Devices can pose a hazard if not fitted and/or

maintained properly.16 Personal fit, or how well the assistive device meets the
individual needs of the resident, may influence the likelihood of an avoidable
accident; and

3. Staff Practices. Mobility devices that a resident cannot readily reach may create a
hazardous situation. Unsafe transfer technique used by staff may result in an
accident. Inadequate supervision by staff of a resident during the initial trial
period of assistive device use or after a change in the resident’s functional status
can increase the risk of falls and/or injury. Additionally, staff needs to ensure
assistive devises properly fit the resident and the resident has received proper
training in the use of the assistive device.

Assistive Devices for Transfer – Mechanical assistive devices for transfer include, but are
not limited to, portable and stationary total body lifts, sit-to-stand devices, and transfer or
gait belts. The resident assessment helps to determine the resident’s degree of mobility
and physical impairment and the proper transfer method; for example, whether one or
more caregivers or a mechanical device is needed for a safe transfer. Residents who
become frightened during transfer in a mechanical lift may exhibit resistance movements
that can result in avoidable accidents. Communicating with the resident and addressing
the resident’s fear may reduce the risk.

Factors that may influence a resident’s risk of accident during transfer include staff
availability, resident abilities, staff training and competency. The resident’s ability to
communicate and identify physical limitations or to aid in the transfer will help determine
the need for an assistive device, such as a mechanical lift. The Occupational Safety and
Health Administration (OSHA) provides information and guidelines on identifying
problems and implementing solutions relating to handling residents during transfers.17

Devices Associated with Entrapment Risks – Devices can be therapeutic and beneficial;
however, devices are not necessarily risk free so it is important to weigh the relative risks
and benefits of using certain devices. For example, while physical restraints may be used
to treat a resident’s medical symptom, the devices may create a risk for entrapment.
Physical restraints are defined as any manual method, physical or mechanical
device/equipment or material that meets all of the following criteria:

• Is attached or adjacent to a resident’s body;
• Cannot be removed easily by the resident; and
• Restricts the resident’s freedom of movement or normal access to his/her body.

Serious injuries, as well as death, have been reported as a result of using physical
restraints. Some physical restraints carry a risk of severe injury, strangulation, and
asphyxiation. Restrained residents may be injured or die when they try to remove
restraints, to ambulate while restrained, or due to an improperly fitted or used device.
Evidence shows that physical restraints cause more harm than good and seriously infringe
upon a person’s autonomy as explained in this article in the Journal of Medical Ethics,
“Use of physical restraint in nursing homes: clinical-ethical considerations.”18 The Food
and Drug Administration (FDA) also provides guidance on bed rail safety and reducing
entrapment:

• https://www.fda.gov/medical-devices/hospital-beds/guide-bed-safety-bed-rails-
hospitals-nursing-homes-and-home-health-care-facts, A Guide to Bed Safety
Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts

• https://www.fda.gov/medical-devices/bed-rail-safety/recommendations-health-

care-providers-about-bed-rails, Recommendations for Health Care Providers
About Bed Rails

• https://www.fda.gov/regulatory-information/search-fda-guidance-

documents/hospital-bed-system-dimensional-and-assessment-guidance-reduce-
entrapment, Guidance for Industry and FDA Staff: Hospital Bed System
Dimensional and Assessment Guidance to Reduce Entrapment.

Regardless of the purpose for use, bed rails (also referred to as “side rails,” “bed side
rails,” and “safety rails”) and other bed accessories (e.g. transfer bar, bed enclosures),
while assisting with transfer and positioning, can increase resident safety risk. Bed rails
include rails of various sizes (e.g., full length rails, half rails, quarter rails) that may be
positioned in various locations on the bed. Residents most at risk for entrapment are those
who are frail or elderly or those who have conditions such as agitation, delirium,
confusion, pain, uncontrolled body movement, hypoxia, fecal impaction, acute urinary
retention, etc. that may cause them to move about the bed or try to exit from the bed. The
failure to provide timely assistance with using the bathroom, inappropriate bed
positioning, and other care-related activities can contribute to the risk of entrapment. The
FDA provides detailed information about bed rails, including recommendations for health
care providers.19

Entrapment may occur when a resident is caught between the mattress and bed rail or in
the bed rail itself. Technical issues, such as the proper sizing of mattresses, fit and
integrity of bed rails or other design elements (e.g., wide spaces between bars in the bed
rails) can also affect the risk of resident entrapment.20

NOTE: §483.25(n) (F700) requires that facilities attempt appropriate alternatives before

installing/ using bed rails, and if a bed or side rail is used, the facility must
ensure correct installation, use, and maintenance of bed rails.

The use of a specialty air-filled mattress or a therapeutic air-filled bed may also present
an entrapment risk that is different from rail entrapment with a regular mattress. The
high compressibility of an air-filled mattress compared to a regular conventional mattress
requires appropriate precautions when used for a resident at risk for entrapment. An air-
filled mattress compresses on the side to which a person moves, thus raising the center of
the mattress and lowering the side. This may make it easier for a resident to slide off the
mattress or against the rail. Mattress compression widens the space between the mattress
and rail. When a resident is between the mattress and rail, the mattress can re-expand and
press the chest, neck, or head against the rail. While using air therapy to prevent and treat
pressure ulcer/injuries, facilities should also take precautions to reduce the risk of

https://www.fda.gov/medical-devices/hospital-beds/guide-bed-safety-bed-rails-hospitals-nursing-homes-and-home-health-care-facts

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hospital-bed-system-dimensional-and-assessment-guidance-reduce-entrapment

entrapment. Precautions may include following manufacturer equipment alerts and
increasing supervision.21

NOTE: §483.12 (F604), applies to the use of physical restraints. This guidance at

§483.25(d), (F689) applies to assistive devices that create hazards (e.g., devices
that are defective; not used properly or according to manufacturer’s
specifications; disabled or removed; not provided or do not meet the resident’s
needs (poor fit or not adapted); and/or used without adequate supervision when
required). §483.25(n) (F700) applies to the installation of bed rails.

KEY ELEMENTS OF NONCOMPLIANCE

To cite deficient practice at F689, the surveyor’s investigation will generally show that
the facility failed to do one or more of the following:

• Identify and eliminate all known and foreseeable accident hazards in the
resident’s environment, to the extent possible; or

• To the extent possible, reduce the risk of all known or foreseeable accident
hazards that cannot be eliminated; or

• Provide appropriate and sufficient supervision to each resident to prevent an
avoidable accident; or

• Provide assistance devices necessary to prevent an avoidable accident from
occurring.

INVESTIGATIVE SUMMARY

Use

Use the Accidents Critical Element (CE) Pathway along with the above interpretive
guidelines when determining if the facility meets the requirements to ensure that the
resident’s environment remains as free from accident hazards as possible and that each
resident receives adequate supervision and assistance devices to prevent accidents.

Summary of Accident and Supervision Investigative Procedure

Observe the general environment of the facility to determine if the facility provides an
environment that is free from accident hazards over which the facility has control and
provides supervision and assistive devices to each resident to prevent avoidable
accidents. During observation of the facility, the survey team should observe the
environment for the presence of potential/actual hazards. For a resident with an identified
concern, briefly review the assessment and plan of care to determine whether the facility
identified resident risks and implemented interventions as necessary.

If the resident has been in the facility for less than 14 days (before completion of all the
Resident Assessment Instrument (RAI) is required), review the baseline care plan which

must be completed within 48 hours to determine if the facility is providing appropriate
care and services based on information available at the time of admission.

DEFICIENCY CATEGORIZATION

In addition to actual or potential physical harm, always consider whether psychosocial
harm has occurred when determining severity level (See Psychosocial Outcome Severity
Guide).

Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident
Health or Safety include, but are not limited to:

• The facility failed to keep corrosive cleaning supplies out of the reach of
ambulatory residents with dementia, resulting in one resident ingesting drain
opener and sustaining esophageal damage.

• The facility failed to provide supervision to a unit which had ambulatory
cognitively impaired residents. The facility failed to keep these residents from
gaining access to the employee locker room. When the surveyor conducted her
tour of the facility, she found a confused resident who was trapped in the
employee locker room.

• The facility failed to keep a resident free from hazards and provide the necessary

monitoring and supervision for a resident with known substance use disorder and
history of using illicit substances when outside of the facility. Through an
interview with a certified nurse aide (CNA), the surveyor discovered the resident
left the facility for approximately five hours with facility knowledge of the
absence. Upon return to the facility, the resident went to his room. Facility staff
did not assess the resident’s condition for several hours and then found the
resident unresponsive. Medical records showed that the resident had sustained an
overdose.

Examples of Severity Level 3 Noncompliance Actual Harm that is Not Immediate
Jeopardy include, but are not limited to:

• The facility failed to apply a smoking apron to a resident while smoking, which
was necessary and documented on the care plan. The resident sustained a 2nd
degree burn after the cigarette fell onto his/her lap.

• The facility failed to use a two-person transfer, as determined necessary by the
comprehensive care plan, during a transfer from the resident’s bed to wheelchair,
resulting in the resident falling to the floor, sustaining a laceration requiring
sutures.

Examples of Severity Level 2 Noncompliance No Actual Harm with Potential for
More Than Minimal Harm that is Not Immediate Jeopardy include, but are not
limited to:

• The facility failed to remove clutter and building materials from a construction
area, immediately adjacent to a walkway used by residents and their families,
creating a hazard which poses a risk for more than minimal harm.

• A cognitively intact resident with known SUD but no other safety concerns was
observed lingering by doors that were not monitored. After interviewing staff, the
survey team identified that the facility did not have a consistent process for how
residents notify the facility when they leave the facility, or have a process to
identify when residents leave the facility if the resident does not notify facility
staff.

Severity Level 1 Noncompliance No Actual Harm with Potential for Minimal Harm

The failure of the facility to provide a safe environment and adequate supervision places
residents at risk for more than minimal harm. Therefore, Severity Level 1 does not apply
for this regulatory requirement.

Falls
National Council on Aging National Falls Prevention Resource Center at

https://www.ncoa.org/professionals/health/center-for-healthy-aging/national-falls-
prevention-resource-center

Centers for Disease Control and Prevention at
http://www.cdc.gov/homeandrecreationalsafety/falls/

World Health Organization Fall Prevention in Older Age at
https://www.who.int/publications/i/item/9789241563536

National Institute on Aging, Falls and Fall Prevention,
https://www.nia.nih.gov/health/topics/falls-and-falls-prevention

Wandering and Elopement Resources
National Council of Certified Dementia Practitioners at http://www.nccdp.or

2 Bressler, K., Redfern, R.E., and Brown, M.(2011). Elimination of position-change alarms in
anAlzheimer’s and dementia long-term care facility. Am J Alzheimers Dis Other Demen 26(8), 599.

3 Panel on Prevention of Falls in Older Persons, American Geriatrics Society and British Geriatrics. (2010).
Summary of the updated American Geriatrics Society/British Geriatrics Society clinical practice guideline
for prevention of falls in older persons. J Am Geriatr Soc, 2011, 59(1), 148-57.
4 Taylor, J.A., Parmelee, P., Brown, H., and Ouslander, J. The Falls Management Program: A Quality

https://www.ncoa.org/professionals/health/center-for-healthy-aging/national-falls-prevention-resource-center

http://www.cdc.gov/homeandrecreationalsafety/falls/

https://www.who.int/publications/i/item/9789241563536

https://www.nia.nih.gov/health/topics/falls-and-falls-prevention

Improvement Initiative for Nursing Facilities. Agency for Healthcare Research and Quality, 2005,
https://www.ahrq.gov/patient-safety/settings/long-term-care/resource/injuries/fallspx.html

5 Shorr, R.I., Chandler, M., Mion, L.C., Waters, T.M., Liu, M., Daniels, M.J., Kessler, L.A., and Miller,
S.T. (2012). Effects of an intervention to increase bed alarm use to prevent falls in hospitalized patients.
Annals of Internal Medicine 157(10), 698.
6 Capezuti, E., Brush, B.L., Lane, S., Rabinowitz, H.U., and Secic, M. (2009). Bed-exit alarm

effectiveness. Arch Gerontol Geriatr 49(1) 27-31.

7 MASSPRO (n.d.). Nursing home alarm elimination program: It’s possible to reduce falls by eliminating

resident alarms.
8 Becker, C., Rapp, K. (2010) Fall Prevention in Nursing Homes. Clinics in Geriatric Medicine 26(4)693-

704.
9US Dept. of Health and Human Services, Agency for Toxic Substances & Disease Registry, Toxicological

Profiles, http://www.atsdr.cdc.gov/toxprofiles/index.asp.
10 US Dept. of Labor, Occupational Safety and Health Standards, 29 CFR 1910.1200 (g)(1) and (2).
11 Katcher, L.K. (1981). Scald Burns from Hot Tap Water. Journal of Am Med Assoc., 246(11), 1219-1222.
12 Moritz, A.R., Henriques F.C. Jr. (1947). Studies of Thermal Injury: II. The Relative Importance of Time
and Surface Temperatures in the Causation of Cutaneous Burns. Am J Pathology, 23, 695-720.
13US Dept. of Health and Human Services. Centers for Disease Control and Prevention. Emergency
Preparedness & Response, https://www.cdc.gov/masstrauma/factsheets/public/burns .
14Electrical Safety Foundation International Resource Library.
15 Tideiksaar, R. (1998). Falls in Older Persons: Prevention and Management (2nd Edition). Baltimore,
MD: Health Profession Press.
16 Warren, M. (2001), Occupational Therapy Practice Guidelines for Adults with Low Vision, The
American Occupational Therapy Association, Inc.
17Taylor, J.A., Brown, A.K., Meredith, S., Ray, W.A. (2002). The fall reduction program: a comprehensive
program for reduction of falls and injuries in long-term care residents. Nashville, TN: Department of
Preventive Medicine, Vanderbilt University School of Medicine.
18 US Department of Labor, , Occupational Safety & Health Administration. Guidelines for Nursing Homes
(Revised March 2009),
https://www.osha.gov/ergonomics/guidelines/nursinghome/final_nh_guidelines.html.
19 Gastmans, C. and Milisens, K. (March 2006). Use of physical restraint in nursing homes: clinical‐ethical
considerations. J Med Ethics, 32(3), 148–152.
20 US Dept. of Health and Human Services. Food and Drug Administration, Bed Rail Safety,
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/
HospitalBeds/ucm123676.htm.
21 US Dept. of Health and Human Services, Food and Drug Administration, Recommendations for
Consumers and Caregivers about Bed Rails.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/Consumer
Products/BedRailSafety/ucm362843.htm.
22 Miles, S. (June 2002). Death between bedrails and air pressured mattresses. J Am Geriatr Soc, 50(6),
1124-5

https://www.ahrq.gov/patient-safety/settings/long-term-care/resource/injuries/fallspx.html

http://www.atsdr.cdc.gov/toxprofiles/index.asp

https://www.cdc.gov/masstrauma/factsheets/public/burns

https://www.osha.gov/ergonomics/guidelines/nursinghome/final_nh_guidelines.html

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2564468/

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/HospitalBeds/ucm123676.htm

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BedRailSafety/ucm362843.htm

F690
(Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22)

§483.25(e) Incontinence.
§483.25(e)(1) The facility must ensure that a resident who is continent of bladder
and bowel on admission receives services and assistance to maintain continence
unless his or her clinical condition is or becomes such that continence is not possible
to maintain.

§483.25(e)(2) For a resident with urinary incontinence, based on the resident’s
comprehensive assessment, the facility must ensure that—

(i) A resident who enters the facility without an indwelling catheter is not
catheterized unless the resident’s clinical condition demonstrates that
catheterization was necessary;

(ii) A resident who enters the facility with an indwelling catheter or subsequently
receives one is assessed for removal of the catheter as soon as possible unless
the resident’s clinical condition demonstrates that catheterization is
necessary; and

(iii) A resident who is incontinent of bladder receives appropriate treatment and
services to prevent urinary tract infections and to restore continence to the
extent possible.

§483.25(e)(3) For a resident with fecal incontinence, based on the resident’s
comprehensive assessment, the facility must ensure that a resident who is
incontinent of bowel receives appropriate treatment and services to restore as much
normal bowel function as possible.

INTENT

The intent of this requirement is to ensure that:

• Each resident who is continent of bladder receives the necessary services and
assistance to maintain continence, unless it is clinically not possible.

• Each resident who is incontinent of urine is identified, assessed and provided
appropriate treatment and services to achieve or maintain as much normal bladder
function as possible;

• An indwelling catheter is not used unless there is valid medical justification for
catheterization and the catheter is discontinued as soon as clinically warranted;

• A resident, with or without an indwelling catheter, receives the appropriate care
and services to prevent urinary tract infections to the extent possible;

• Services are provided to restore or improve normal bladder function to the extent
possible, after the removal of the indwelling catheter; and

• A resident with fecal incontinence is identified, assessed and provided appropriate
treatment and services to restore as much normal bowel function as possible,
unless it is not clinically possible;

NOTE: F690 includes the appropriate treatment and services to restore bowel function
for a resident with fecal incontinence, however, for concerns related to bowel
management (such as constipation, fecal impaction), refer to F684 – Quality of care

DEFINITIONS
“Bacteremia” is the presence of bacteria in the bloodstream.

“Bacteriuria” is defined as the presence of bacteria in the urine.

“Continence” refers to any void that occurs voluntarily, or as the result of prompted,
assisted, or scheduled use of the bathroom.

“Sepsis” is the body’s overwhelming and life-threatening response to an infection which
can lead to tissue damage, organ failure, and death.

“Urinary Incontinence” is the involuntary loss or leakage of urine.

“Urinary Retention” is the inability to completely empty the urinary bladder by
micturition.

“Urinary Tract Infection (UTI)” is a clinically detectable condition associated with
invasion by disease causing microorganisms of some part of the urinary tract, including
the urethra (urethritis), bladder (cystitis), ureters (ureteritis), and/or kidney
(pyelonephritis). An infection of the urethra or bladder is classified as a lower tract UTI
and infection involving the ureter or kidney is classified as an upper tract UTI.

GUIDANCE §483.25(e)
A resident who is continent of bladder on admission must receive care, including
assistance, and services to maintain continence unless his/her clinical condition is or
becomes such that continence is not possible to maintain. If a resident is admitted with
incontinence of bladder, he/she receives appropriate treatment and services to prevent
urinary tract infections and to restore as much normal bladder function as possible.

Urinary incontinence generally involves a number of transitory or progressive factors that
affect the bladder and/or the urethral sphincter. Any condition, medication, or factor that
affects lower urinary tract function, bladder capacity, urination, or the ability to toilet can
predispose residents to urinary incontinence and may contribute to incomplete bladder
emptying.

Assessment
A resident should be assessed at admission regarding continence status and whenever
there is a change in urinary tract function, such as if a resident is admitted who is

continent of urine, and subsequently becomes incontinent. The identification of
reversible and irreversible (e.g., bladder tumors, spinal cord disease) causes of
incontinence, including the type of incontinence, provides direction for the development
of appropriate interventions. It is important that staff, when completing the
comprehensive assessment, consider the following:

• Prior history of bladder functioning, including status of continence, history of
urinary incontinence, including onset, duration and characteristics, precipitants of
urinary incontinence, associated symptoms (e.g., dysuria, polyuria, hesitancy) and
previous treatment and/or management, including the response to the
interventions and the occurrence of persistent or recurrent UTI;

• Voiding patterns (such as frequency, volume, nighttime or daytime, quality of
stream) and, for those already experiencing urinary incontinence, voiding patterns
over several days;

• Medication review, particularly those that might affect continence, such as
medications with anticholinergic properties (may cause urinary retention and
possible overflow incontinence), sedative/hypnotics (may cause sedation leading
to functional incontinence), diuretics (may cause urgency, frequency, overflow
incontinence), narcotics, alpha-adrenergic agonists (may cause urinary retention
in men) or antagonists (may cause stress incontinence in women) calcium channel
blockers (may cause urinary retention);

• Patterns of fluid intake, such as amounts, time of day, alterations and potential
complications, such as decreased or increased urine output;

• Use of urinary tract stimulants or irritants (e.g., frequent caffeine intake);
• Pelvic and rectal examination to identify physical features that may directly affect

urinary continence, such as prolapsed uterus or bladder, prostate enlargement,
significant constipation or fecal impaction, use of a urinary catheter, atrophic
vaginitis, distended bladder, or bladder spasms;

• Functional and cognitive capabilities that could enhance urinary continence and
limitations that could adversely affect continence, such as impaired cognitive
function or dementia, impaired immobility, decreased manual dexterity, the need
for task segmentation, decreased upper and lower extremity muscle strength,
decreased vision, pain with movement;

• Type and frequency of physical assistance necessary to assist the resident to
access the toilet, commode, urinal, etc. and the types of prompting needed to
encourage urination;

• Pertinent diagnoses such as congestive heart failure, stroke, diabetes mellitus,
obesity, and neurological disorders (e.g., Multiple Sclerosis, Parkinson’s Disease
or tumors) that could affect the urinary tract or its function);

• Identification of and/or potential of developing complications such as skin
irritation or breakdown;

• Tests or studies indicated to identify the type(s) of urinary incontinence (e.g.,
post-void residual(s) for residents who have, or are at risk of, urinary retention,
results of any urine culture if the resident has clinically significant systemic or
urinary symptoms), or evaluations assessing the resident’s readiness for bladder
rehabilitation programs; and

• Environmental factors and assistive devices that may restrict or facilitate a
resident’s ability to access the toilet (e.g., grab bars, raised or low toilet seats,
inadequate lighting, distance to toilet or bedside commodes, and availability of
urinals, use of bed rails or restraints, or fear of falling).

Types of Urinary Incontinence
Identifying the nature of the incontinence is a key aspect of the assessment and helps
identify the appropriate program/interventions to address incontinence. There are several
types of urinary incontinence, and the individual resident may experience more than one
type at a time. Some of the more common types include:

• Urge Incontinence is associated with detrusor muscle over activity (excessive
contraction of the smooth muscle in the wall of the urinary bladder) resulting in a
sudden, strong urge (also known as urgency) to expel moderate to large amounts
of urine before the bladder is full). It is characterized by abrupt urgency,
frequency, and nocturia (part of the overactive bladder diagnosis). It may be age-
related or have neurological causes (e.g., stroke, diabetes mellitus, Parkinson’s
disease, multiple sclerosis) or other causes such as bladder infection, urethral
irritation, etc. The resident can feel the need to void, but is unable to inhibit
voiding long enough to reach and sit on the commode. It is the most common
cause of urinary incontinence in elderly persons.

• Stress Incontinence (outlet incompetence) is associated with impaired urethral
closure (malfunction of the urethral sphincter) which allows small amounts of
urine leakage when intra-abdominal pressure on the bladder is increased by
sneezing, coughing, laughing, lifting, standing from a sitting position, climbing
stairs, etc. Urine leakage results from an increase in intra-abdominal pressure on
a bladder that is not over distended and is not the result of detrusor contractions.
It is the second most common type of urinary incontinence in older women.

• Mixed Incontinence is the combination of urge incontinence and stress
incontinence. Many elderly persons (especially women) will experience
symptoms of both urge and stress.

• Overflow Incontinence is associated with leakage of small amounts of urine
when the bladder has reached its maximum capacity and has become distended
from urine retention. Symptoms of overflow incontinence may include: weak
stream, hesitancy, or intermittency; dysuria; nocturia; frequency; incomplete
voiding; frequent or constant dribbling. Urine retention may result from outlet
obstruction (e.g., benign prostatic hypertrophy (BPH), prostate cancer, and
urethral stricture), hypotonic bladder (detrusor under activity) or both. Hypotonic
bladder may be caused by outlet obstruction, impaired or absent contractility of
the bladder (neurogenic bladder) or other causes. Neurogenic bladder may also
result from neurological conditions such as diabetes mellitus, spinal cord injury,
or pelvic nerve damage from surgery or radiation therapy. In overflow
incontinence, post void residual (PVR) volume (the amount of urine remaining in
the bladder within 5 to 10 minutes following urination) exceeds 200 milliliters
(ml). Normal PVR is usually 50 ml. or less. A PVR of 150 to 200 may suggest a
need for retesting to determine if this finding is clinically significant. Overflow

incontinence may mimic urge or stress incontinence but is less common than
either of those.

• Functional Incontinence refers to loss of urine that occurs in a resident whose
urinary tract function is sufficiently intact that he/she should be able to maintain
continence, but who cannot remain continent because of external factors other
than inherently abnormal urinary tract function. Examples may include the failure
of staff to respond to a request for assistance to the toilet, or the inability to utilize
the toilet facilities in time. It may also be related to:

o Physical weakness or poor mobility/dexterity (e.g., due to poor eyesight,

arthritis, deconditioning, stroke, contracture);
o Cognitive problems (e.g., confusion, dementia, unwillingness to toilet);
o Medications (e.g., anti-cholinergics, diuretics); or
o Environmental impediments including excessive distance from the toilet

facilities, poor lighting, low chairs that are difficult to get out of, physical
restraints and toilets that are difficult to access.

Refer to §483.10(e) (3), F558, Accommodation of Needs for issues regarding
unmet environmental needs (e.g., handicap toilet, lighting, assistive devices.

NOTE: Treating the physiological causes of incontinence, without attending to
functional components that may have an impact on the resident’s continence, may
fail to solve the incontinence problem.

• Transient Incontinence refers to temporary or occasional incontinence that may

be related to a variety of causes, for example: delirium, infection, atrophic
urethritis or vaginitis, some pharmaceuticals (such as sedatives/hypnotics,
diuretics, anticholinergic agents), increased urine production, restricted mobility
or fecal impaction. The incontinence is transient because it is related to a
potentially improvable or reversible cause.

Interventions

A number of factors may contribute to the development of incontinence, or decline or
lack of improvement in urinary continence, such as an underlying medical condition.an
inaccurate assessment of the resident’s type of incontinence, or lack of knowledge about
the resident’s voiding patterns. This may contribute to inappropriate interventions or
unnecessary use of an indwelling catheter. Facility practices that may promote achieving
the highest practicable level of functioning, may prevent the development of
incontinence, or minimize a decline or lack of improvement in degree of continence
include providing treatment and services to address factors that are potentially
modifiable, such as:

• Managing pain and/or providing adaptive equipment to improve function for
residents suffering from arthritis, contractures, neurological impairments, etc.;

• Removing or improving environmental impediments that affect the resident’s
level of continence (e.g., improved lighting, use of a bedside commode or
reducing the distance to the toilet);

• Treating underlying conditions that have a potentially negative impact on the
degree of continence (e.g., delirium causing urinary incontinence related to acute
confusion);

• Possibly adjusting medications affecting continence (e.g., medication cessation,
dose reduction, selection of an alternate medication, change in time of
administration); and

• Implementing a fluid and/or bowel management program to meet the assessed
needs.

Options for managing urinary incontinence in nursing home residents include primarily
behavioral programs and medication therapy. Other measures and supportive devices
used in the management of urinary incontinence and/or urinary retention may include
intermittent catheterization; pelvic organ support devices (pessaries); biofeedback; the
use of incontinence products, garments and an external collection system for men and
women; and environmental accommodation and/or modification.

Behavioral Programs
Interventions involving the use of behavioral programs are among the least invasive
approaches to address urinary incontinence and have no known adverse complications.
Behavior programs involve efforts to modify the resident’s behavior and/or environment.
Critical aspects of a successful behavioral program include education of the caregiver and
the resident, availability of the staff and the consistent implementation of the
interventions.

NOTE: It is important for the comprehensive assessment to identify the essential skills

the resident must possess, such as the resident’s ability to: comprehend and
follow instructions; identify urinary urge; control the urge to void until
reaching a toilet; and/or respond to prompts to void. Voiding records help
detect urinary patterns or intervals between incontinence episodes and
facilitate planning care to avoid or reduce the frequency of episodes.

Programs that require the resident’s cooperation and motivation in order for learning and
practice to occur include the following:

• “Bladder Rehabilitation/Bladder Retraining” is a behavioral technique that
requires the resident to resist or inhibit the sensation of urgency (the strong desire
to urinate), to postpone or delay voiding, and to urinate according to a timetable
rather than to the urge to void. Depending upon the resident’s successful ability
to control the urge to void, the intervals between voiding may be increased
progressively. Bladder training generally consists of education, scheduled
voiding with systematic delay of voiding, and positive reinforcement. This
program is difficult to implement in cognitively impaired residents and may not
be successful in frail, elderly, or dependent residents. The resident who may be

appropriate for a bladder rehabilitation (retraining) program is usually fairly
independent in activities of daily living, has occasional incontinence, is aware of
the need to urinate (void), may wear incontinence products for episodic urine
leakage, and has a goal to maintain his/her highest level of continence and
decrease urine leakage. Successful bladder retraining usually takes at least
several weeks. Residents who are assessed with urge or mixed incontinence and
are cognitively intact may be candidates for bladder retraining. This is not to be
confused with habit training/scheduled voiding (see below); and

• “Pelvic Floor Muscle Rehabilitation,” also called Kegel and pelvic floor muscle
exercise, is performed to strengthen the voluntary periuretheral and perivaginal
muscles that contribute to the closing force of the urethra and the support of the
pelvic organs. These exercises are helpful in dealing with urge and stress
incontinence. Pelvic floor muscle exercises (PFME) strengthen the muscular
components of urethral supports and are the cornerstone of noninvasive treatment
of stress urinary incontinence. PFME requires residents who are able and willing
to participate and the implementation of careful instructions and monitoring
provided by the facility. Poor resident adherence to the exercises may occur even
with close monitoring.

Programs that are dependent on staff involvement and assistance, as opposed to resident
function, include the following:

• “Prompted Voiding” is a behavioral technique appropriate for use with
dependent or more cognitively impaired residents. Prompted voiding has three
components: regular monitoring with encouragement to report continence status;
prompting to toilet on a scheduled basis; and praise and positive feedback when
the resident is continent and attempts to toilet. These methods require training,
motivation and continued effort by the resident and caregivers to ensure continued
success. Prompted voiding focuses on teaching the resident, who is incontinent,
to recognize bladder fullness or the need to void, to ask for help, or to respond
when prompted to toilet.

Residents who are assessed with urge or mixed incontinence and are cognitively

impaired may be candidates for prompted voiding. As the resident’s cognition
changes, the facility should consider other factors, such as mobility, when
deciding to conduct a voiding trial to determine feasibility of an ongoing program
to use the bathroom; and

• “Habit Training/Scheduled Voiding” is a behavioral technique that calls for

scheduled use of the bathroom at regular intervals on a planned basis to match the
resident’s voiding habits. Unlike bladder retraining, there is no systematic effort
to encourage the resident to delay voiding and resist urges. This is not considered
to be a bladder rehabilitation/retraining program. Habit training includes timed
voiding with the interval based on the resident’s usual voiding schedule or
pattern. Scheduled voiding is timed voiding, usually every three to four hours

while awake. Residents who cannot self-toilet may be candidates for habit
training or scheduled voiding programs.

Intermittent Catheterization
Sterile insertion and removal of a catheter through the urethra every 3-6 hours for bladder
drainage may be appropriate for the management of acute or chronic urinary retention.
See additional discussion below in “Catheterization”.

Medication Therapy

Medications are often used to treat specific types of incontinence, including stress
incontinence and those categories associated with an overactive bladder, which may
involve symptoms including urge incontinence, urinary urgency, frequency and nocturia.
The current literature identifies classifications and names of medications used for various
types of incontinence. When using medications, potentially problematic anticholinergic
and other side effects must be recognized. The use of medication therapy to treat urinary
incontinence may not be appropriate for some residents because of potential adverse
interactions with their other medications or other co-morbid conditions. The
resident/representative must be provided with the risks and benefits of using medications
for continence management.

Pessary
A pessary is an intra-vaginal device used to treat pelvic muscle relaxation or prolapse of
pelvic organs. Women whose urine retention or urinary incontinence is exacerbated by
bladder or uterine prolapse may benefit from placement of a pessary. Female residents
may be admitted to the nursing home with a pessary device. The assessment should note
whether the resident has a pessary in place or has had a history of successful pessary use.
If a pessary is used, the plan of care must address the use, care and ongoing management
of the pessary including monitoring for complications.

Absorbent Products, Devices, and External Collection Devices
Absorbent incontinence products include perineal pads or panty liners for slight leakage,
undergarments and protective underwear for moderate to heavy leakage, guards and drip
collection pouches for men, and products (called adult briefs) for moderate or heavy loss.
Absorbent products can be a useful, rational way to manage incontinence; however, every
absorbent product has a saturation point. Factors contributing to the selection of the type
of product to be used should include the severity of incontinence, gender, fit, and ease of
use.

Advantages of using absorbent products to manage urinary incontinence include the
ability to contain urine (some may wick the urine away from the skin), provide protection
for clothing, and preserve the resident’s dignity and comfort.

NOTE: Although many residents have used absorbent products prior to admission to

the nursing home and the use of absorbent products may be appropriate,
absorbent products should not be used as the primary long term approach to

continence management until the resident has been appropriately evaluated
and other alternative approaches have been considered.

It is important that residents using various devices, absorbent products, external
collection devices, etc., be checked (and changed as needed) on a schedule based upon
the resident’s voiding pattern, professional standards of practice, and the manufacturer’s
recommendations.

Skin-Related Complications
Skin problems associated with incontinence and moisture can range from irritation to
increased risk of skin breakdown. Moisture may make the skin more susceptible to
damage from friction and shear during repositioning. For a resident with an external
catheter, compromise to the skin may also occur.

One form of early skin breakdown is maceration or the softening of tissue by soaking.
Macerated skin has a white appearance and a very soft, sometimes “soggy” texture. The
persistent exposure of perineal skin to urine and/or feces can irritate the epidermis and
can cause severe dermatitis, skin erosion and/or ulcerations. Skin erosion is the loss of
some or all of the epidermis (comparable to a deep chemical peel) leaving a slightly
depressed area of skin.

Because frequent washing with soap and water can dry the skin, the use of a perineal
rinse may be indicated.

CATHETERIZATION

Sections 483.25(e)(2)(i) and (ii), Incontinence, requires that a resident who enters the
facility without an indwelling catheter is not catheterized unless the resident’s clinical
condition demonstrates that catheterization was necessary; or that a resident who enters
the facility with an indwelling urinary catheter or subsequently receives one is assessed
for removal of the catheter as soon as possible unless the resident’s clinical condition
demonstrates that catheterization is necessary. The facility is responsible for the
assessment of the resident at risk for urinary catheterization and the ongoing assessment
for the resident who currently has a catheter, including the removal of the catheter as
soon as possible when the resident’s clinical condition demonstrates the catheter is no
longer necessary. While the use of a catheter may promote skin integrity and assessment
of output, it is also associated with the increase risk of catheter associated urinary tract
infections (CAUTI), including the development of sepsis.

A catheter that is used for appropriate indications and in a dignified manner may enhance
an individual’s independence and dignity. Conversely, an improperly or indiscreetly used
catheter may negatively impact independence and dignity.

NOTE: For concerns related to the care for a resident with a urostomy or nephrostomy,
refer to §483.25(f) – Colostomy, urostomy, or ileostomy care at tag F691.

In addition, according to the Centers for Disease Control and Prevention (CDC), the
definition of a suprapubic catheter is one that “is surgically inserted into the bladder
through an incision above the pubis. For care of a resident with a suprapubic catheter,
refer to current professional guidelines.

Assessment
Regardless of the admission status, a comprehensive assessment should address those
factors that predispose the resident to the development of urinary incontinence and the
use of an indwelling urinary catheter. An admission evaluation of the resident’s medical
history and a physical examination helps identify the resident at risk for requiring the use
of an indwelling urinary catheter. This evaluation is to include detection of reversible
causes of incontinence and identification of individuals with incontinence caused by
conditions that may not be reversible, such as bladder tumors and spinal cord diseases.

The assessment of continence/incontinence is based upon a comprehensive,
interdisciplinary review and assessment. The comprehensive assessment should include
identifying the underlying factors which support the clinical indication for the initiation
and continuing need for catheter use, determination of which factors can be modified or
reversed (or rationale for why those factors should not be modified), and the development
of a plan for removal. The clinician’s decision to use an indwelling catheter in the
elderly should be based on valid clinical indicators.

For the resident with an indwelling catheter, the facility’s documented assessment and
staff knowledge of the resident should include information to support the use of an
indwelling catheter. Because of the risk of substantial complications with the use of
indwelling urinary catheters, they should be reserved primarily for short-term
decompression of acute urinary retention. The assessment should include consideration
of the risks and benefits of an indwelling (suprapubic or urethral) catheter; the potential
for removal of the catheter; and consideration of complications resulting from the use of
an indwelling catheter, such as symptoms of blockage of the catheter with associated
bypassing of urine, expulsion of the catheter, pain, discomfort and bleeding.

Intermittent Catheterization
Intermittent catheterization can often manage overflow incontinence effectively.
Residents who have new onset incontinence from a transient, hypotonic/atonic bladder
(usually seen following indwelling catheterization in the hospital) may benefit from
intermittent bladder catheterization until the bladder tone returns (e.g., up to
approximately 7 days). A voiding trial and post void residual can help identify when
bladder tone has returned.

Indwelling Urinary Catheter Use
If the facility provides care for a resident with an indwelling catheter, in collaboration
with the medical director and director of nurses, and based upon current professional
standards of practice, resident care policies and procedures must be developed and
implemented that address catheter care and services, including but not limited to:

• Documentation of the involvement of the resident and/or resident representative
in the discussion of the risks and benefits of the use of a catheter, removal of the
catheter when criteria or indication for use is no longer present, and the right to
decline the use of the catheter;

• Timely and appropriate assessments related to the indication for use of an
indwelling catheter;

• Identification and documentation of clinical indications for the use of a catheter;
as well as criteria for the discontinuance of the catheter when the indication for
use is no longer present;

• Insertion, ongoing care and catheter removal protocols that adhere to professional
standards of practice and infection prevention and control procedures;

• Response of the resident during the use of the catheter; and
• Ongoing monitoring for changes in condition related to potential CAUTI’s and

recognizing, reporting and addressing such changes.

(See NOTE below for examples of clinical indications for use.)

The resident’s record must include how and when the resident/representative was
involved and informed of care and treatment including the potential use and indications
for the need for a catheter, how long use is anticipated, and when and why a catheter
must be removed. The resident/representative must be included in the development of
the care plan including the use of the catheter and associated interventions. In addition,
the resident/representative has the right to decline the treatment. Based on current
professional standards of practice, information and education of the
resident/representative on the identification of risks and benefits for the use of a catheter
must be documented.

Anecdotally, it has been reported that residents or their representatives have requested the
use of and/or declined to allow the removal of an indwelling urinary catheter. The record
must contain documentation as to why a resident/representative chooses to have or
chooses to continue to use a catheter in the absence of clinical indications for use. After
determining the reasons, staff and the attending practitioner must document the provision
of counseling to assist the resident in understanding the clinical implications and risks
associated with the use of a catheter without an indication for continued use. The care
plan must be revised to address the education being provided, including interventions to
restore as much urinary function as possible without the use of catheter.

Documentation in the resident’s record must reflect the attending practitioner’s valid
clinical indication to support the use of an indwelling catheter.

NOTE: The following Table from the CDC, includes examples for appropriate
indications for indwelling catheter use and includes both acute and long term care. This
table has been adapted to include only those examples relevant for a long term care
setting. For the full table and for guidance related to indwelling catheter management and
care refer to: http://www.cdc.gov/hicpac/cauti/02_cauti2009_abbrev.html

http://www.cdc.gov/hicpac/cauti/02_cauti2009_abbrev.html

A. Examples of Appropriate Indications for Indwelling Urethral Catheter Use
• Resident has acute urinary retention or bladder outlet obstruction;
• Need for accurate measurements of urinary output;
• To assist in healing of open sacral or perineal wounds in incontinent residents;
• Resident requires prolonged immobilization (e.g., potentially unstable thoracic or

lumbar spine, multiple traumatic injuries such as pelvic fractures); and
• To improve comfort for end of life care, if needed.

B. Examples of Inappropriate Uses of Indwelling Catheters
• As a substitute for nursing care of the resident with incontinence; and
• As a means of obtaining urine for culture or other diagnostic tests when the

resident can voluntarily void.

NOTE: These above indications are based on expert consensus.

Additional care practices related to catheterization include:

• Recognizing and assessing for complications and their causes, and maintaining a
record of any catheter-related problems;

• Attempts to remove the catheter as soon as possible when no indications exist for
its continuing use;

• Monitoring for excessive post void residual, after removing a catheter that was
inserted for obstruction or overflow incontinence;

• Keeping the catheter anchored to prevent excessive tension on the catheter, which
can lead to urethral tears or dislodging the catheter; and

• Securing the catheter to facilitate flow of urine, preventing kinking of the tubing
and position below the level of the bladder. (Also refer to F880 – Infection
Control for policies and procedures related to care of the catheter and equipment,
such as tubing, bags, etc.).

NOTE: Refer to the CDC site for current information on catheter use, management and
care at: http://www.cdc.gov/HAI/ca_uti/uti.html

Catheter-Related Complications
An indwelling catheter may be associated with significant complications, including
bacteremia, febrile episodes, bladder stones, fistula formation, erosion of the urethra,
epididymitis, chronic renal inflammation and pyelonephritis and sepsis related to urinary
tract infections. In addition, indwelling catheters are prone to blockage. Risk factors for
catheter blockage include alkaline urine, poor urine flow, proteinuria, and preexisting
bladder stones.

Some residents with indwelling catheters experience persistent leakage around the
catheter. Examples of factors that may contribute to leakage include irritation by a large
balloon or by catheter materials, excessive catheter diameter, fecal impaction, and
improper catheter positioning. Changing indwelling catheters or drainage bags at routine,
fixed intervals is not recommended.
(Refer to: https://www.cdc.gov/hicpac/pdf/CAUTI/CAUTIguideline2009final )

http://www.cdc.gov/HAI/ca_uti/uti.html

Catheterization is an important, potentially modifiable, risk factor for UTI. The potential
for complications can be reduced by:

• Identifying specific clinical indications for the use of an indwelling catheter;
• Assessing whether other treatments and services would appropriately address

those conditions; and
• Assessing whether residents are at risk for other possible complications resulting

from the continuing use of the catheter, such as obstruction resulting from
catheter encrustation, urethral erosion, bladder spasms, hematuria, and leakage
around the catheter.

URINARY TRACT INFECTIONS

Catheter-Related Bacteriuria and UTIs
Bacteriuria (e.g., pyuria) alone in a catheterized individual should not be treated with
antibiotics. Someone with nonspecific symptoms such as a change in function or mental
status, foul smelling or cloudy urine and/or, bacteriuria (e.g. pyuria), does not necessarily
warrant antibiotic treatment. The decision to treat a UTI is based upon the attending
practitioner conducting a thorough evaluation and assessment of the resident and
providing documentation of a rationale for the indication of use of an antibiotic.

NOTE: For a non-catheterized resident with symptoms associated with a UTI, the
attending practitioner should order a urine culture prior to the initiation of antibiotic
therapy to help guide treatment. According to current standard of practice, an accurate
urine culture for a non-catheterized resident should be obtained by a clean catch or mid-
stream specimen for residents who are able to follow instructions. For those unable to
provide a clean-catch, a specimen may be obtained preferably by a freshly placed
condom catheter for males, or in and out catheterization for females or males unable to
provide a specimen by a condom catheter. If the resident has a long-term indwelling
urethral catheter, a specimen should be obtained from a freshly placed indwelling
catheter. Reference – the IDSA Guidelines for Evaluation of Fever and Infection in
Older Adult Residents of Long-Term Care Facilities. (High et al. Clinical Infectious
Diseases, 2009:48-149-71).

The surveyor should determine if facility policy for obtaining urine for cultures is based
upon current standards of practice, understanding that these standards may be revised and
updated over time. The facility should be able to provide the most current standard that
supports the policy that they have developed and implemented. (Also refer to F880
Infection Control and F881 for antibiotic stewardship program for infection assessment
tools.)

Unnecessary treatment of a UTI with antibiotics may lead to the development of multi
drug resistant organisms (e.g., Methicillin-Resistant Staphylococcus Aureus) and other
complications such as the development of clostridium-difficile infection, which may
predispose the person to prolonged treatment potential hospitalization and may pose a

threat of infection to other residents. (Also refer to F881 for antibiotic stewardship
program for infection assessment tools.)

NOTE: Standards of practice may be revised and updated over time.

One current professional standard of practice that addresses criteria for use of antibiotics
for UTI’s, includes:

“Minimum criteria for initiating antibiotics for an indication of urinary tract infection
were considered for residents with no indwelling urinary catheters and for residents with
chronic indwelling catheters.

1. 2. For residents who do not have an indwelling catheter, minimum criteria for
initiating antibiotics include: >105 CFU/mL (positive)or pending urine culture and
dysuria alone or two or more of the following: fever (>37.9ºC [100ºF] or 1.5ºC
[2.4ºF] increase above baseline temperature on two occasions over last 12 hours),
new or worsening urgency, frequency, suprapubic pain, gross hematuria,
costovertebral angle tenderness (flank pain), urinary incontinence, or shaking
chills.

2. For residents who have an indwelling catheter or a suprapubic catheter), minimum
criteria for initiating antibiotics include the presence of: >105 CFU/mL (positive)
or pending urine culture and one or more of the following: fever (>37.9ºC [100ºF]
or 1.5ºC [2.4ºF] increase above baseline temperature on two occasions over last
12 hours), new costovertebral tenderness, rigors (shaking chills), or new onset of
delirium.”Reference – Loeb M, Brazil K, Lohfeld L, et al. Effect of a multifaceted
intervention on number of antimicrobial prescriptions for suspected urinary tract
infections in residents of nursing homes: cluster randomised controlled trial. BMJ.
2005;331:669. [PMC free article] [PubMed]

NOTE: Reference – Loeb M, Brazil K, Lohfeld L, et al. Effect of a multifaceted
intervention on number of antimicrobial prescriptions for suspected urinary tract
infections in residents of nursing homes: cluster randomised controlled
trial. BMJ. 2005;331:669. [PMC free article] [PubMed]

Follow-Up of UTIs

The goal of treating a UTI is to alleviate systemic or local symptoms, not to eradicate all
bacteria. Therefore, a post-treatment urine culture is not necessary but may be useful if
UTI signs and symptoms continue or do not respond to antibiotic treatment. Continued
bacteriuria without residual symptoms does not warrant repeat or continued antibiotic
therapy. Recurrent UTIs (2 or more in 6 months) in a noncatheterized individual may
warrant additional evaluation (such as a determination of an abnormal post void residual
(PVR) urine volume or a referral to a urologist) to rule out structural abnormalities such
as enlarged prostate, prolapsed bladder, periurethral abscess, strictures, bladder calculi,
polyps and tumors.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1226247/

https://www.ncbi.nlm.nih.gov/pubmed/16150741

Recurrent UTIs in a catheterized individual should lead the facility to look for possible
impairment of free urine flow through the catheter, to re-evaluate the techniques being
used for catheter care and for perineal hygiene including the removal of fecal soiling, and
to reconsider the relative risks and benefits of continuing the use of an indwelling
catheter.

Because the major factors (other than an indwelling catheter) that predispose individuals
to bacteriuria, including physiological aging changes and chronic comorbid illnesses,
cannot be modified readily, the facility should demonstrate that they:

• Employ infection prevention and control practices (e.g. Standard Precautions) in
managing catheters and associated drainage system;

• Keep the resident and catheter clean of feces to minimize bacterial migration into
the urethra and bladder (e.g., cleaning fecal material away from, rather than
towards, the urinary meatus), however, routine perineal care with an antiseptic is
not recommended;

• Maintain free urine flow through any indwelling catheter; and
• Assess for fluid needs and implement a fluid management program (using

alternative approaches as needed) based on those assessed needs.

FECAL INCONTINENCE

Fecal incontinence (FI) involves the unintentional loss of solid or liquid stool. A resident
experiencing FI may experience feelings of shame, embarrassment, loss of independence,
may tend to isolate himself/herself creating a decrease in social interactions/activities due
to fear of “accidents” with associated odors, leakage and soiling of clothing or
furnishings. It is important for the facility and the attending practitioner to complete a
comprehensive assessment and determine, with the resident/representative, potential
treatment and care plan interventions, and to provide ongoing evaluation of the response
to those interventions. The resident should be re-evaluated whenever there is a change in
bowel function. If the resident has FI that has already been investigated, documented,
and determined to be irreversible or not significantly improvable, additional studies may
be of limited value, unless there has been advancement in available treatments.

Risk factors for Fecal Incontinence
Risk factors for FI may include, aging and dependency in daily activities, smoking and
pulmonary disease, arthritis in adults over 75 years of age, older adults with rectal cancer,
comorbidities such as kidney disease, transient ischemic attacks in men, women with
arterial hypertension, acute stroke (FI may depend on the severity of a stroke), functional
dependency and need for assistance with toilet access 3 months after stroke in men and
women, and poor general health and dementia.
http://archive.ahrq.gov/downloads/pub/evidence/pdf/fuiad/fuiad

Assessment:
To ensure that a resident who is incontinent of bowel receives appropriate treatment and
services, the facility must conduct an assessment to identify the presenting symptoms and

http://archive.ahrq.gov/downloads/pub/evidence/pdf/fuiad/fuiad

type of FI, including the potential reversible/irreversible causes and risks. Symptoms or
types of FI may include (as noted in
http://s3.gi.org/physicians/guidelines/FecalIncontinence ):

• “Passive incontinence —which is the involuntary discharge of fecal matter or
flatus without any awareness. This suggests a loss of perception and/or impaired
rectoanal reflexes either with or without sphincter dysfunction;

• Urge incontinence — which is the discharge of fecal matter or flatus in spite of
active attempts to retain these contents. Here, there is a predominant disruption of
the sphincter function or the rectal capacity to retain stool; and/or

• Fecal seepage — which is the undesired leakage of stool, often after a bowel
movement with otherwise normal continence and evacuation. This condition is
mostly due to incomplete evacuation of stool and/or impaired rectal sensation.
The sphincter function and pudendal nerve function are mostly intact”.

Causes and Treatment of Fecal Incontinence

For reference, the following potential causes and treatments of FI have been adapted from
the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to
address the long term care setting. For the full description of causes and treatment for FI,
refer to:
https://www.niddk.nih.gov/health-information/digestive-diseases/bowel-control-
problems-fecal-incontinence/

Potential causes for FI may include:

• Diarrhea;
• Constipation Muscle Damage or Weakness;
• Trauma, childbirth injuries, cancer surgery, and hemorrhoid surgery;
• Nerve Damage;
• Loss of Stretch in the Rectum;
• Childbirth by Vaginal Delivery;
• Hemorrhoids and Rectal Prolapse;
• Rectocele and;
• Inactivity

Potential treatment/interventions for FI should be based upon the type of FI. Potential
treatment options and interventions may include:

• Eating increased amounts of fiber;
• Drinking sufficient liquids;
• Use of medications to develop more solid stools that are easier to control;
• Pelvic Floor Exercises and Biofeedback that strengthen the pelvic floor muscles

may improve bowel control. Success with pelvic floor exercises depends on the
cause of fecal incontinence, its severity, and the person’s motivation and ability to
follow the health care provider’s recommendations;

http://s3.gi.org/physicians/guidelines/FecalIncontinence

https://www.niddk.nih.gov/health-information/digestive-diseases/bowel-control-problems-fecal-incontinence/

• Surgery may be an option for fecal incontinence that fails to improve with other
treatments or for fecal incontinence caused by pelvic floor or anal sphincter
muscle injuries;

• Electrical Stimulation also called sacral nerve stimulation or neuromodulation,
involves placing electrodes in the sacral nerves to the anus and rectum and
continuously stimulating the nerves with electrical pulses.

Care Plan

For the resident with fecal incontinence, the care plan must reflect the results of the
resident’s assessment and include resident specific interventions for any potential
reversible causes and, if irreversible, appropriate interventions for management of fecal
incontinence. Interventions and the provision of care should address treating the resident
with respect, enhancing dignity and self-worth and reducing embarrassment and shame in
relation to FI. Based upon the increased risk for transmission of infection resulting from
fecal contamination, the care plan should also identify the PPE appropriate for use during
the delivery of care.

Complications Potentially Related to Fecal Incontinence
Complications related to fecal incontinence may include, but are not limited to, emotional
distress, loss of self-esteem, social isolation, physical complications such as skin
irritation/excoriation, itching, pain, and in addition, frequent loose stool may be an
indicator of fecal impaction.

KEY ELEMENTS OF NONCOMPLIANCE
To cite deficient practice at F690, the surveyor’s investigation will generally show that
the facility failed to do one or more of the following:

• Provide appropriate and sufficient services and assistance to:
o Maintain bladder continence and/or bowel function in continent residents; or
o Restore bladder continence and/or bowel function as possible, based on a

comprehensive assessment and clinical condition; or
o Prevent urinary tract infections to the extent possible;

• Ensure that a resident is not catheterized unless required by his/her clinical
condition; or

• Ensure that a urinary catheter is removed as soon as possible unless the catheter is
necessary because of the residents’ clinical condition.

INVESTIGATIVE PROTOCOL

Use

Use the Bladder and Bowel Incontinence Critical Element (CE) Pathway, and/or Urinary
Catheter and UTI CE Pathway, for the condition being evaluated, along with the above
interpretive guidelines when determining if the facility provides the necessary care and
services to meet the resident’s needs.

Summary of Procedure

Briefly review the most recent comprehensive assessments, comprehensive care plan and
orders to identify whether the facility has assessed and developed an individualized care
plan based on professional standards of practice and provided by qualified, competent
staff. During this review, identify the extent to which the facility has implemented
interventions in accordance with the resident’s needs, goals for care and professional
standards of practice, consistently across all shifts. This information will guide
observations and interviews to be made in order to corroborate concerns identified.

NOTE: Always observe for visual cues of psychosocial distress and harm (see Appendix
P, Guidance on Severity and Scope Levels and Psychosocial Outcome Severity Guide).

DEFICIENCY CATEGORIZATION

An example of Severity Level 4 Noncompliance Immediate Jeopardy to Resident
Health or Safety includes but is not limited to:

• The facility failed to ensure that a resident who entered the facility with an
indwelling catheter was assessed for removal of the catheter as soon as possible,
resulting in the resident continuing to have the catheter in place for three weeks
and developing a urinary tract infection, leading to sepsis. The facility failed to
provide appropriate treatment and services for a resident with fecal incontinence,
resulting in the resident having severely excoriated and ulcerated areas of skin
around the rectal area, with odor, and purulent exudate. The resident expressed
severe pain and refused to leave her room.

Examples of Severity Level 3 Noncompliance Actual Harm that is not Immediate
Jeopardy includes but is not limited to:

• The facility failed to assure that a resident who entered the facility with an
indwelling catheter was assessed for removal of the catheter as soon as possible,
unless the resident’s clinical condition demonstrates that catheterization is
necessary. During the survey, a resident was identified as having an indwelling
urinary catheter in place for several months. The resident was currently being
treated with an antibiotic for a symptomatic urinary tract infection. Staff
interviewed were unable to provide the clinical indication for use for the catheter,
and the record did not contain documentation for the initial use of the catheter or
for the continued use of a urinary catheter. The resident was unable to be
interviewed, but his representative was interviewed but did not know why the
catheter was in place, except that the resident had a problem with incontinence.

Record review indicated that the resident had experienced repeated complications
such as recurrent symptomatic UTIs which required treatment with antibiotics.

• The facility failed to assure that a resident who was incontinent of bladder
received the appropriate treatment and services to restore continence to the extent
possible. A resident was identified as incontinent of bladder. Based upon the
resident’s assessment and identification of the type of urinary incontinence, the
facility developed interventions for a restorative program to restore continence.
However, based on observations, staff were not implementing the interventions on
the care plan, did not respond to the resident’s request for assistance with use of
the bathroom, and were not monitoring the progress of the interventions. The
resident stated that she was frustrated and embarrassed regarding the odors and
wetness that occurred as a result of the incontinence episodes. She also stated that
she did not attend activities or go for meals as she needed close access to the
toilet, and that she didn’t want to be around others when she had incontinent
episodes. She stated that she felt that she was not improving with her bladder
continence, and that it was worse now than when she started the restorative
program. Staff interviewed stated that they were aware of the program, but they
were not able to implement the program, consistently on all shifts, as they had
other resident’s and duties assigned during their shifts and were unable to
respond. The record reflected a decline in continence since the program began.
(Also cited at sufficient staffing at F726)

Examples of Severity Level 2 Considerations: No Actual Harm with Potential for
More Than Minimal Harm that is Not Immediate Jeopardy include but are not
limited to:

• The facility failed to provide appropriate treatment and services for care of a
resident with a clinically-justified indwelling catheter. During observations of
care for a resident with an indwelling catheter, urine was noted to be leaking.
Staff interviewed stated that they were not sure why the catheter leaked, but that
they kept the resident as dry as possible. In addition, it was observed several
times throughout the survey, that the catheter drainage bag and tubing were
placed directly on the floor in the resident’s room. There were no indications of
skin maceration and/or irritation, or symptoms of a UTI symptoms.

• The facility failed to provide appropriate treatment and services for care of a
resident who had intermittent fecal incontinence. During the survey, a resident
was observed to stay in her room, did not attend activities and had meals served in
her room. The resident was identified as alert and aware of her care needs. She
stated that she had problems with intermittent fecal incontinence and was on a
bowel management program that included extra fiber and liquids. She stated that
recently there were changes in meal service and she was not receiving the extra
fiber. She also stated that staff were to assist her with hygiene when incontinence
episodes occurred, but they had not consistently provided the care. She stated that
when she had the fecal incontinence episodes, she did not attend activities she

enjoyed attending, and was irritated that she was unable to attend due to not
receiving hygiene when needed.

Severity Level 1: No actual harm with potential for minimal harm

The failures of the facility to provide appropriate care and services to maintain or
improve continence, manage indwelling catheters, and minimize negative outcome places
residents at risk for more than minimal harm. Therefore, Severity Level 1 does not apply
for this regulatory requirement.

Resources

Research into appropriate practices to prevent, manage, and treat urinary incontinence,
urinary catheterization, and UTI continues to evolve. Many recognized clinical resources
on the prevention and management of urinary incontinence, infection, and urinary
catheterization exist. Some of these resources include:

• https://www.vumc.org/cqa/sites/vumc.org.cqa/files/public_files/Vanderbilt%20In
continence%20Management%20Module

• Association for Professionals in Infection Control and Epidemiology (APIC) at
www.apic.org;

• Centers for Disease Control at www.cdc.gov;
• The Annals of Long Term Care publications:

http://www.annalsoflongtermcare.com/search?keywords=urinary%20catheters
• Urology Care Foundation – The Official Foundation of the American Urological

Association – http://www.urologyhealth.org/
• The American Geriatrics Society at www.americangeriatrics.org
• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538836/

Surveillance Definitions of Infections in Long-Term Care Facilities: Revisiting
the McGeer Criteria

Resources for Fecal Incontinence:

• https://www.fascrs.org
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2614622/

F691
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.25(f) Colostomy, urostomy, or ileostomy care.
The facility must ensure that residents who require colostomy, urostomy, or
ileostomy services, receive such care consistent with professional standards of
practice, the comprehensive person-centered care plan, and the resident’s goals and
preferences.

INTENT §483.25(f)

https://www.vumc.org/cqa/sites/vumc.org.cqa/files/public_files/Vanderbilt%20Incontinence%20Management%20Module

Home

http://www.cdc.gov/

http://www.annalsoflongtermcare.com/search?keywords=urinary%20catheters

http://www.urologyhealth.org/

http://www.americangeriatrics.org/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538836/

https://www.fascrs.org/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2614622/

The intent of this provision is that the resident receives the necessary care and treatment
including medical and nursing care and services when they need colostomy, urostomy, or
ileostomy care.

PROCEDURES AND PROBES §483.25(f)
Refer to appropriate sections of the MDS, as applicable.
Identify if the resident triggers any Care Area Assessments for urinary incontinence,
nutritional status, and/or pressure injuries (skin care).

• If appropriate, is the resident provided with self-care instructions?
• Does the staff member observe and respond to any signs of the resident’s

discomfort about the ostomy or its care?
• Is skin surrounding the ostomy free of excoriation (abrasion, breakdown)?
• If excoriation is present, does the clinical record indicate an onset and a plan to

treat the excoriation?
F692
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.25(g) Assisted nutrition and hydration.
(Includes naso-gastric and gastrostomy tubes, both percutaneous endoscopic
gastrostomy and percutaneous endoscopic jejunostomy, and enteral fluids). Based
on a resident’s comprehensive assessment, the facility must ensure that a resident—

§483.25(g)(1) Maintains acceptable parameters of nutritional status, such as usual
body weight or desirable body weight range and electrolyte balance, unless the
resident’s clinical condition demonstrates that this is not possible or resident
preferences indicate otherwise;

§483.25(g)(2) Is offered sufficient fluid intake to maintain proper hydration and
health;

§483.25(g)(3) Is offered a therapeutic diet when there is a nutritional problem and
the health care provider orders a therapeutic diet.

INTENT §483.25(g)
The intent of this requirement is that the resident maintains, to the extent possible,
acceptable parameters of nutritional and hydration status and that the facility:

• Provides nutritional and hydration care and services to each resident, consistent
with the resident’s comprehensive assessment;

• Recognizes, evaluates, and addresses the needs of every resident, including but
not limited to, the resident at risk or already experiencing impaired nutrition and
hydration; and

• Provides a therapeutic diet that takes into account the resident’s clinical condition,
and preferences, when there is a nutritional indication.

DEFINITIONS §483.25(g)
Definitions are provided to clarify clinical terms related to nutritional status.

“Acceptable parameters of nutritional status” refers to factors that reflect that an
individual’s nutritional status is adequate, relative to his/her overall condition and
prognosis, such as weight, food/fluid intake, and pertinent laboratory values.

“Artificial nutrition and hydration” are medical treatments and refer to nutrition that is
provided through routes other than the usual oral route, typically by placing a tube
directly into the stomach, the intestine or a vein.

“Clinically significant” refers to effects, results, or consequences that materially affect
or are likely to affect an individual’s physical, mental, or psychosocial well-being either
positively by preventing, stabilizing, or improving a condition or reducing a risk, or
negatively by exacerbating, causing, or contributing to a symptom, illness, or decline in
status.
“Dietary supplements” refers to herbal and alternative products that are not regulated by
the Food and Drug Administration and their composition is not standardized. Dietary
supplements must be labeled as such and must not be represented for use as a
conventional food or as the sole item of a meal or the diet.

“Health Care Provider” includes a physician, physician assistant, nurse practitioner, or
clinical nurse specialist, or a qualified dietitian or other qualified nutrition professional
acting within their state scope of practice and to whom the attending physician has
delegated the task. For issues related to delegation to dietitians, refer to §483.60(e)(2),
F808.

“Nutritional status” includes both nutrition and hydration status.

“Nutritional Supplements” refers to products that are used to complement a resident’s
dietary needs (e.g., calorie or nutrient dense drinks, total parenteral products, enteral
products, and meal replacement products).

“Therapeutic diet” refers to a diet ordered by a physician or other delegated provider
that is part of the treatment for a disease or clinical condition, to eliminate, decrease, or
increase certain substances in the diet (e.g., sodium or potassium), or to provide
mechanically altered food when indicated.

“Tube feeding” refers to the delivery of nutrients through a feeding tube directly into the
stomach, duodenum, or jejunum. It is also referred to as an enteral feeding.

GUIDANCE §483.25(g)
It is important to maintain adequate nutritional status, to the extent possible, to ensure
each resident is able to maintain the highest practicable level of well-being. The early
identification of residents with, or at risk for, impaired nutrition or hydration status may
allow the interdisciplinary team to develop and implement interventions to stabilize or
improve nutritional status before complications arise. Body weight and laboratory results
can often be stabilized or improved with time, but may not be correctable in some

individuals. Intake alone is not the only factor that can affect nutritional status. Resident
conditions and co-morbidities may prevent improved nutritional or hydration status,
despite improved intake.

Many factors can influence weight and nutritional status as one ages. The body may not
absorb or use nutrients as effectively, there may be changes in the ability to taste food2, or
there may be a decreased sensation for thirst or hunger. The resident’s medical condition
can also affect how well they maintain weight, such as changes in muscle mass3,
cognitive status4, nearing end of life, or a disease process, such as kidney disease or
congestive heart failure, which may cause the resident to retain fluids in the body. While
impaired nutritional status is not necessarily expected as one ages, there could be times
where efforts to maintain good nutrition may pose extra challenges.

Failure to identify residents at risk for compromised nutrition and hydration may be
associated with an increased risk of mortality and other negative outcomes, such as
impairment of anticipated wound healing, decline in function, fluid and electrolyte
imbalance/dehydration, and unplanned weight change.5. While food intake may be
considered, ensuring a resident receives the fluids they require can more easily be
overlooked. Individuals who do not receive adequate fluids are more susceptible to
urinary tract infections, pneumonia, pressure injuries, skin infections, confusion, and
disorientation.

A systematic approach can help staff’s efforts to optimize a resident’s nutritional status.
This process includes identifying and assessing each resident’s nutritional status and risk
factors, evaluating/analyzing the assessment information, developing and consistently
implementing pertinent approaches, and monitoring the effectiveness of interventions and
revising them as necessary. Weight loss, poor nutritional status, or dehydration should be
considered avoidable unless the facility can prove it has assessed/reassessed the
resident’s needs, consistently implemented related care planned interventions, monitored
for effectiveness, and ensured coordination of care among the interdisciplinary team.

ASSESSMENT
A comprehensive nutritional assessment should be completed on any resident identified
as being at risk for unplanned weight loss/gain and/or compromised nutritional status.
Through a comprehensive nutritional assessment, the interdisciplinary team clarifies
nutritional issues, needs, and goals in the context of the resident’s overall condition.
Completion of the RAI does not remove the facility’s responsibility to document a more
detailed resident assessment, when indicated, to identify possible effective interventions.
The nutritional assessment may utilize existing information from sources, such as the
RAI, assessments from other disciplines, the existing medical record, observation, direct
care staff interviews, and resident and family interviews. The assessment should identify
those factors that place the resident at risk for inadequate nutrition/hydration. The
nutritional assessment may include the following information:

General Appearance: General appearance includes a description of the resident’s
overall appearance (e.g., robust, thin, obese, or cachectic). Other findings that may affect

or reflect a resident’s nutritional status may be included, such as the resident’s cognitive
status, affect, oral health and dentition, ability to use the hands and arms, and the
condition of hair, nails, and skin.

Height: Measuring a resident’s height provides information that is relevant (in
conjunction with his or her weight) to his/her nutritional status. There are various ways
to estimate height if standing height cannot be readily measured.6 A protocol for
determining height helps to ensure that it will be measured as consistently as possible.

Weight: Weight can be a useful indicator of nutritional status, when evaluated within the
context of the individual’s personal history and overall condition. Weight goals should be
based on a resident’s usual body weight or desired body weight. The facility should have
a procedure in place that includes, but is not limited to, establishing a consistent method
of weighing a resident (e.g. using the same scale, wearing the same clothes, weighing at
the same time of day, adjusting for use of a prosthetic, etc.), verifying the resident’s
weight upon admission, monitoring a resident’s weight over time to identify weight
loss/gain, verifying weight measurements when changes in weight occur, and reassessing
interventions when appropriate.

Current professional standards of practice recommend weighing the resident on
admission or readmission (to establish a baseline weight), weekly for the first 4 weeks
after admission and at least monthly thereafter to help identify and document trends such
as slow and progressive weight loss. Weighing may also be pertinent if there is a
significant change in condition, food intake has declined and persisted (e.g., for more
than a week), or there is other evidence of altered nutritional status or fluid and
electrolyte imbalance. In some cases, weight monitoring is not indicated (e.g., the
individual is terminally ill and requests only comfort care).

Examples of other factors that may impact weight and the significance of apparent weight
changes include the resident’s usual weight through adult life, current medical conditions,
diet and supplement orders, recent changes in dietary intake, and edema.

Suggested parameters for evaluating significance of unplanned and undesired weight loss
are:

Interval Significant Loss Severe Loss

1 month 5% Greater than 5%

3 months 7.5% Greater than 7.5%

6 months 10% Greater than 10%

The following formula determines percentage of weight loss:
% of body weight loss = (usual weight – actual weight) / (usual weight) x 100

Interviews with key staff members: The facility may identify key individuals who
should participate in the assessment of nutritional status and related causes and
consequences. For example, nursing staff provide details about the resident’s nutritional
intake. Physicians and non-physician practitioners help identify relevant diagnoses,
identify causes of weight changes, tailor interventions to the resident’s specific causes
and situation, and monitor the continued relevance of those interventions. Qualified
dietitians help identify nutritional risk factors and recommend nutritional interventions,
based on each resident’s medical condition, needs, preferences, and goals. Consultant
pharmacists can help the staff and practitioners identify medications and medication
interactions that may affect nutrition.

Food and fluid intake: The nutritional assessment includes an estimate of calorie,
nutrient and fluid needs, and whether intake is adequate to meet those needs. It also
includes information such as the route (oral, enteral or parenteral) of intake, any special
food formulation, meal and snack patterns (including the time of supplement or
medication consumption in relation to the meals), dislikes, and preferences (including
ethnic foods and form of foods such as finger foods); meal/snack patterns, and preferred
portion sizes. While there is no reliable calculation to determine an individual’s fluid
needs, an assessment should take into account those characteristics pertinent to the
resident, such as age, medical diagnoses, activity level, etc.

Fluid loss or retention: Fluid loss or retention can cause short term weight change.
Much of a resident’s daily fluid intake comes from meals; therefore, when a resident has
decreased appetite, it can result in fluid/electrolyte imbalance. Abrupt weight changes,
change in food intake, or altered level of consciousness are some of the clinical
manifestations of fluid and electrolyte imbalance. Laboratory tests (e.g., electrolytes,
BUN, creatinine and serum osmolality) can help greatly to identify, manage, and monitor
fluid and electrolyte status.7

Altered Nutrient intake, absorption, and utilization: Poor intake, continuing or
unabated hunger, or a change in the resident’s usual intake that persists for multiple
meals, may indicate an underlying condition or illness. Examples of causes include, but
are not limited to:

• The inability to consume meals provided as a result of cognitive or functional
decline;

• Difficulty with chewing or swallowing food;
• An inadequate amount of food or fluid, including insufficient tube feedings;
• An uncomfortable or disruptive dining environment;
• The lack of adequate assistance or supervision;
• Adverse consequences related to medications; and
• Diseases and conditions such as cancer, diabetes mellitus, advanced or

uncontrolled heart or lung disease, infection and fever, liver disease, kidney
disease, hyperthyroidism, mood disorders, gastrointestinal disorders, pressure
injuries or other wounds, and repetitive movement disorders (e.g., wandering,
pacing, or rocking).

The use of diuretics and other medications may cause weight loss that is not associated
with nutritional issues. This may result in a planned weight loss (e.g. the reduction of
edema), but can also cause fluid and electrolyte imbalance/dehydration that causes a loss
of appetite and weight if unmonitored.

Early identification of these factors, regardless of the presence of any associated weight
changes, can help the facility choose appropriate interventions to minimize any
subsequent complications. Often, several of these factors affecting nutrition coexist.

Laboratory/Diagnostic Evaluation: Laboratory tests are sometimes useful to help
identify underlying causes of impaired nutrition or when the clinical assessment alone is
not enough to define someone’s nutritional status. An additional assessment of other
resident risk factors is often needed to confirm if a treatable clinical problem exists8. For
example, low serum albumin levels may indicate malnutrition, but may also be the result
of an acute illness for reasons unrelated to nutrition. Therefore, albumin levels may not
improve, despite consumption of adequate amounts of calories and protein.

The decision to order laboratory tests by the health care provider and the interpretation of
subsequent results, is best done in light of a resident’s overall condition and prognosis.9

Although laboratory tests such as albumin and pre-albumin may help in some cases in
deciding to initiate nutritional interventions, there is no evidence that they are useful for
the serial follow-up of undernourished individuals.9

NOTE: If laboratory tests were done prior to or after admission to the facility and the test
results are abnormal, the physician or other licensed health care practitioner, in
collaboration with the interdisciplinary team, reviews the information and determines
whether to intervene or order additional diagnostic testing.

CARE PLANNING
Information gathered from the nutritional assessment and current dietary standards of
practice are used to develop an individualized care plan to address the resident’s specific
nutritional concerns and preferences. The care plan must address, to the extent possible,
identified causes of impaired nutritional status, reflect the resident’s personal goals and
preferences, and identify resident-specific interventions and a time frame and parameters
for monitoring. The care plan should be updated as needed, such as when the resident’s
condition changes, goals are met, interventions are determined to be ineffective, or as
new causes of nutrition-related problems are identified. If nutritional goals are not
achieved, the care planned interventions must be reevaluated for effectiveness and
modified as appropriate.

Examples of goals may include, but are not limited to:

• A target weight range.
• Desired fluid intake.
• The management of an underlying medical condition (e.g. diabetes, kidney

disease, wound healing, heart failure, or infection.)
• The prevention of unintended weight loss or gain.

Weight stability, rather than weight gain, may sometimes be the most pertinent short-term
or long-term objective for the nutritionally at-risk or compromised resident. After an
acute illness or as part of an advanced or end-stage medical condition, the resident’s
weight and other nutritional parameters may not return to previous levels and may
stabilize at a lower level, sometimes indefinitely.

NOTE: There should be a documented clinical basis for any conclusion that nutritional
status or significant weight change are unlikely to stabilize or improve (e.g., physician’s
documentation as to why weight loss is medically unavoidable).

The resident and/or the resident’s representative’s involvement in the development of the
care plan helps to ensure it is individualized and meets their personal goals and
preferences. See F551, Resident Representative; F553, Right to Participate in Care
Planning, or §483.21, Comprehensive Resident-Centered Care Plans, for additional
guidance.

When preferences are not specified in an advanced directive, decisions related to the
possible provision of supplemental or artificial nutrition should be made in conjunction
with the resident, the resident’s family, and/or representative in accordance with state
law, taking into account relevant considerations such as condition, prognosis, and the
resident’s known values and choices.

NOTE: The presence of a “Do Not Resuscitate” (DNR) order does not by itself indicate

that the resident is declining other appropriate treatment and services. It only
indicates that the resident has chosen not to be resuscitated if cardiopulmonary
functions cease.

INTERVENTIONS
Interventions related to a resident’s nutritional status must be individualized to address
the specific needs of the resident. Examples of care plan development considerations can
include, but are not limited to:

Diet Liberalization: Based on the resident’s assessment, it could be beneficial to
minimize restrictions, such as therapeutic or mechanically altered diets, and provide
preferred foods before using supplementation. However, it is the responsibility of the
facility to:

• Talk with the resident, their family and representative (whenever possible) and
provide information pertaining to the risks and benefits of a liberalized diet;

• Work with the resident’s physician and other nursing home professionals (dietary
manager, nurses, speech therapists, etc.), using the care planning process, to
determine the best plan for the resident; and

• Accommodate the resident’s needs, preferences, and goals.

Weight-Related Interventions: For at risk residents, the care plan should include
nutritional interventions to address underlying risks and causes of unplanned weight loss

or unplanned weight gain, based on the comprehensive or any subsequent nutritional
assessment. The development of these interventions should involve the resident and/or
the resident representative to ensure the resident’s needs, preferences and goals are
accommodated.

Environmental Factors: Appetite is often enhanced by the appealing aroma, flavor,
form, and appearance of food. Resident-specific facility practices that may help improve
intake include providing a pleasant dining experience (e.g., flexible dining environments,
styles and schedules), providing meals that are palatable, attractive and nutritious (e.g.,
prepare food with seasonings, serve food at proper temperatures, etc.), and making sure
that the environment where residents eat (e.g., dining room and/or resident’s room) is
conducive to dining.

Disease Processes: A resident’s clinical condition may have a significant impact on the
types of interventions considered. The facility is responsible for identifying relevant
diagnoses (e.g. wound healing, anorexia, end-of-life, etc.) and appropriate interventions
to address specific needs, as applicable.

Functional Factors: These include resident conditions that interfere with their ability to
physically perform the task of eating or drinking adequately, such as the ability to use
one’s hands, vision, chewing and swallowing capabilities, or the ability to reposition
one’s self at the table. The underlying causes should be assessed to identify which
interventions may be most effective. For example, a resident may experience a decline in
his or her ability to chew food. If the underlying cause is poorly fitting dentures that are
causing pain or are loose in the mouth, the intervention of modifying the food texture
would not address the primary cause.

The interventions used to address functional factors will depend on the resident’s specific
areas of concern and can vary. Some interventions used to address functional factors
include using specialized dishes and utensils, having eye glasses or hearing aids in use,
ensuring dentures are securely placed, participating in a restorative eating program, or
having direct assistance by staff or family. Other interventions may include ensuring food
and drinks are readily accessible and in close physical proximity to individuals with
mobility impairments.

Modification of food and fluid consistency may be an appropriate intervention, however
it may unnecessarily decrease quality of life and impair nutritional status by affecting
appetite and reducing intake.12 Many factors influence whether a swallowing abnormality
eventually results in clinically significant complications, such as aspiration pneumonia.13
Identification of a swallowing abnormality alone does not necessarily warrant dietary
restrictions or food texture modifications. No interventions consistently prevent
aspiration and no tests consistently predict who will develop aspiration pneumonia.14 For
example, tube feeding may be associated with aspiration, and is not necessarily a
desirable alternative to allowing oral intake, even if some swallowing abnormalities are
present.15,16

Medications: Medications may be helpful in improving a resident’s nutritional status.
Some ways medications may help a resident can be to increase appetite, reduce acid
reflux, or reduce nausea. Some medications may have the unintended effect of impairing
a resident’s nutritional or hydration status and the resident may experience a lack of
appetite, nausea, dry mouth, or other unintended effects. Interventions may be required to
address these. For example, a resident may require frequent sips of a drink during a meal
if they experience dry mouth. It may also be appropriate to consider changing, stopping,
or reducing the doses of those medications as appropriate17. For additional guidance
related to medications, refer to §483.45(d), F757, Unnecessary Drugs, or §483.45(e),
F758, Psychotropic Drugs.

Food Intake: Improving intake with wholesome foods is generally preferable to adding
nutritional supplements. However, if the resident is not able to eat recommended
portions at meal times, to consume between-meal snacks/nourishments, or if he/she
prefers the nutritional supplement, supplements may be tried to increase calorie and
nutrient intake. Taking a nutritional supplement during medication administration may
also increase caloric intake without reducing the resident’s appetite at mealtime.

Examples of other interventions to improve food intake include:

• Fortification of foods (e.g., adding protein, fat, and/or carbohydrate to foods such
as hot cereal, mashed potatoes, casseroles, and desserts);

• Offering smaller, more frequent meals;
• Providing between-meal snacks or nourishments; or
• Increasing the portion sizes of a resident’s favorite foods and meals; and

providing nutritional supplements.

To date, the evidence is limited about benefits from appetite stimulants. While their use
may be appropriate in specific circumstances, they are not a substitute for appropriate
investigation of potentially modifiable risk factors and underlying causes of weight loss.

Maintaining Fluid and Electrolyte Balance: Poor fluid intake, abnormal lab values for
electrolytes, some medications, and resident conditions may all affect a resident’s
fluid/electrolyte balance. Offering a variety of fluids during and between meals, assisting
residents with drinking, keeping beverages available and within reach, and evaluating
medications for placing a resident at risk for dehydration are examples of interventions
that may be used to improve a resident’s fluid balance. Alternate fluids, such as
popsicles, gelatin, and ice cream, may also be offered. For some residents, a fluid
restriction may be required to address conditions, such as edema or congestive heart
failure, and may place them at greater risk for dehydration.

Feeding Tubes: Feeding tubes may be used to provide adequate nutrition to a resident
who is not able to achieve it with other interventions. The liquid nourishment that is
administered through a feeding tube is complete nourishment that must be prescribed to
meet all the nutritional needs of the resident. Use F692 to guide the investigation into
concerns regarding the nutritional adequacy of the prescribed formula. Concerns

regarding care of feeding tubes, and/or complications related to their use should be
investigated at F693.

NOTE: For residents with end stage dementia, the use of tube feeding does not
necessarily extend life, prevent aspiration pneumonia, improve function or limit
suffering. For additional guidance related to feeding tubes, see 42 CFR §483.25(g)(4)-(5),
F693, Enteral Nutrition.

Total Parenteral Nutrition (TPN): TPN is a method of providing nutrition where a
liquid formula is given into a vein through an intravenous catheter (IV) to provide most
of the nutrients a resident needs. This method is used when a resident cannot or should
not eat or drink by mouth. A resident with TPN may require additional monitoring, such
as more frequent weights, to ensure the treatment is effective. For additional guidance,
see 42 CFR §483.25(h), F694, Parenteral Fluids.

NOTE: If the resident and/or the resident’s representative exercises his/her right to

choose and declines interventions designed to improve or maintain their
nutritional or hydration status, the facility is responsible for discussing the risks
and benefits associated with that decision and offer alternatives, as appropriate.
The comprehensive care plan should describe any interventions offered, but
declined by the resident or resident’s representative. See F656, Comprehensive
Care Plans.

MONITORING
On-going monitoring of care planned interventions is necessary for all residents. On-
going monitoring should include, but is not limited to:

• Interviewing the resident and/or resident representative to determine if their
personal goals and preferences are being met.

• Directly observing the resident.
• Interviewing direct care staff to gain information about the resident, the

interventions currently in place, what their responsibilities are for reporting on
these interventions, and possible suggestions for changes, if necessary.

• Reviewing the resident-specific factors identified as part of the comprehensive
resident assessment and any supplemental nutrition assessment, as needed to
determine if they are still relevant or if new concerns have emerged, such as new
diagnoses or medications.

• Evaluating the care plan to determine if current interventions are being
implemented and are effective. This can include reviewing weight records, meal
monitors, intake and output logs, nurses’ notes, lab values, and physician or
dietitian assessments.

INVESTIGATIVE PROTOCOL
Use the Nutrition and Hydration Critical Element (CE) Pathway, for the concerns being
evaluated, along with the above interpretive guidelines when determining if the facility
provides the necessary care and services to meet the resident’s needs.

Summary of Procedure
Briefly review the most recent comprehensive assessments, comprehensive care plan and
orders to determine whether the facility has assessed, identified and addressed as
appropriate, the resident’s nutritional and hydration needs. This information will guide
observations and interviews to be made in order to corroborate concerns identified.
NOTE: Always observe for visual cues of psychosocial distress and harm (see Appendix
P, Guidance on Severity and Scope Levels and Psychosocial Outcome Severity Guide).

KEY ELEMENTS OF NONCOMPLIANCE
To cite deficient practice at F692, the surveyor’s investigation will generally show that
the facility failed to do one or more of the following:

• Accurately and consistently assess a resident’s nutritional status on admission and
as needed thereafter;

• Identify a resident at nutritional risk and address risk factors for impaired
nutritional status, to the extent possible;

• Identify, implement, monitor, and modify interventions (as appropriate),
consistent with the resident’s assessed needs, choices, preferences, goals, and
current professional standards of practice, to maintain acceptable parameters of
nutritional status;

• Notify the physician as appropriate in evaluating and managing causes of the
resident’s nutritional risks and impaired nutritional status;

• Identify and apply relevant approaches to maintain acceptable parameters of
residents’ nutritional status, including fluids;

• Provide a therapeutic diet when ordered;
• Offer sufficient fluid intake to maintain proper hydration and health.

NOTE: Weight loss, abnormal protein and electrolyte lab values, and dehydration are
not, by themselves, sufficient to support noncompliance at F692. Additionally, a
resident does not need to experience weight loss, abnormal protein levels, D or
dehydration to show noncompliance.

DEFICIENCY CATEGORIZATION
In addition to actual or potential physical harm, always consider whether psychosocial
harm has occurred when determining severity level (See Appendix P, Section IV, E,
Psychosocial Outcome Severity Guide).

Examples of Severity Level 4 Noncompliance: Immediate Jeopardy to Resident
Health or Safety include but are not limited to:

• Repeated, systemic failure to assess and address a resident’s nutritional status and
to implement pertinent interventions based on such an assessment resulted in
continued significant or severe weight loss and functional decline;

Repeated failure to assist a resident who required assistance with meals and drink
resulted in or made likely the development of life-threatening symptom(s), or the
development or continuation of severely impaired nutritional status;

• Dietary restrictions or downgraded diet textures, such as mechanical soft or
pureed textures, were provided by the facility against the resident’s expressed

preferences and resulted in substantial and ongoing decline in food intake
resulting in significant or severe unplanned weight loss with accompanying
irreversible functional decline to the point where the resident was placed on
Hospice; or

• The failure to provide an ordered potassium restricted therapeutic diet resulted in
evidence of cardiac dysrhythmias or other changes in medical condition due to
hyperkalemia.

Examples of Severity Level 3 Noncompliance: Actual Harm that is not Immediate
Jeopardy includes but are not limited to:

• The failure to revise and/or implement the care plan addressing the resident’s
impaired ability to feed him/herself resulted in significant, not severe, unplanned
weight change and impaired wound healing (not attributable to an underlying
medical condition);

• The failure to identify a decrease in food intake, which resulted in a significant,
unintended weight loss from declining food and fluids, which resulted in the
resident becoming weakened and unable to participate in activities of daily living;

• The failure to assess the relative risks and benefits of restricting or downgrading
diet and food consistency or to accommodate a resident’s choice to accept the
related risk resulted in declining food/fluid intake and significant weight loss;

• The failure to accommodate documented resident food dislikes and preferences
resulted in poor food/fluid intake and a decline in function; or

• The failure to provide a gluten-free diet (one free of wheat, barley, and rye
products) as ordered for a resident with known celiac disease (damage to the
small intestine related to gluten allergy) resulted in the resident developing
persistent gastrointestinal symptoms including significant, not severe, weight loss,
chronic diarrhea, and occasional vomiting.

Examples of Severity Level 2 Noncompliance: No Actual Harm with Potential for
More Than Minimal Harm that is Not Immediate Jeopardy include but are not
limited to:

• Failure to obtain accurate weight(s) and to verify weight(s) as needed;
• The facility’s intermittent failure to provide required assistance with eating

resulted in poor intake, however, the resident met identified weight goals;
• Failure to provide additional nourishment when ordered for a resident, however,

the resident did not experience significant or severe weight loss; and
• Failure to provide a prescribed sodium-restricted therapeutic diet (unless declined

by the resident or the resident’s representative or not followed by the resident);
however, the resident did not experience medical complications such as heart
failure related to sodium excess.

Severity Level 1: No Actual Harm with Potential for Minimal Harm

• The failure of the facility to provide appropriate care and services to maintain
acceptable parameters of nutritional status, which includes hydration, and
minimize negative outcomes places residents at risk for more than minimal harm.
Therefore, Severity Level 1 does not apply for this regulatory requirement.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION
During the investigation of F692, the surveyor may have determined that concerns may
also be present with related outcome, process and/or structure requirements. The
surveyor is cautioned to investigate these related requirements before determining
whether non-compliance may be present. Some examples of related requirements that
should be considered include §483.20 Resident Assessment, §483.21 Comprehensive
Person-Centered Care Planning, §483.24 Quality of Life, §483.30 Physician Services,
§483.35 Nursing Services, §483.60 Food and Nutrition Services, §483.70 Administration,
and §483.75 QAPI.

F693
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)

§483.25(g) Assisted nutrition and hydration.
(Includes naso-gastric and gastrostomy tubes, both percutaneous endoscopic
gastrostomy and percutaneous endoscopic jejunostomy, and enteral fluids). Based on a
resident’s comprehensive assessment, the facility must ensure that a resident—

§483.25(g)(4)-(5) Enteral Nutrition
§483.25(g)(4) A resident who has been able to eat enough alone or with assistance is
not fed by enteral methods unless the resident’s clinical condition demonstrates that
enteral feeding was clinically indicated and consented to by the resident; and

§483.25(g)(5) A resident who is fed by enteral means receives the appropriate
treatment and services to restore, if possible, oral eating skills and to prevent
complications of enteral feeding including but not limited to aspiration pneumonia,
diarrhea, vomiting, dehydration, metabolic abnormalities, and nasal-pharyngeal
ulcers.

DEFINITIONS §483.25(g)(4)-(5)
“Bolus feeding” is the administration of a limited volume of enteral formula over brief
periods of time.

“Continuous feeding” is the uninterrupted administration of enteral formula over
extended periods of time.

“Enteral feeding” (also referred to as “tube feeding”) is the delivery of nutrients through
a feeding tube directly into the stomach, duodenum, or jejunum.

“Feeding tube” refers to a medical device used to provide liquid nourishment, fluids,
and medications by bypassing oral intake. There are two basic categories, naso-grastric
and gastrostomy. The type of feeding tube used must be based on clinical assessment and
needs of the resident since there are various kinds of feeding tubes within each category.

“Gastrostomy tube” (“G-tube”) is a tube that is placed directly into the stomach through
an abdominal wall incision for administration of food, fluids, and medications. The most
common type is a percutaneous endoscopic gastrostomy (PEG) tube

“Jejunostomy tube” (a.k.a. “percutaneous endoscopic jejunostomy” (PEJ or “J-tube”) is
a feeding tube placed directly into the small intestine.

“Naso-gastric feeding tube” (“NG tube”) is a tube that is passed through the nose and
down through the nasopharynx and esophagus into the stomach.

“Transgastric jejunal feeding tube” (“G-J tube”) is a feeding tube that is placed
through the stomach into the jejunum and that has dual ports to access both the stomach
and the small intestine.

GUIDANCE §483.25(g)(4)-(5)
A decision to use a feeding tube has a major impact on a resident and his or her quality of
life. It is important that any decision regarding the use of a feeding tube be based on the
resident’s clinical condition and wishes, as well as applicable federal and state laws and
regulations for decision making about life-sustaining treatments

CONSIDERATIONS REGARDING THE USE OF FEEDING TUBES
The regulations at §483.25(g)(4) require that a feeding tube is not used unless there is a
valid, clinical rationale, and the resident or if applicable, his/her representative has
consented to its use. Consent implies that a discussion has occurred between the resident
or representative and the physician, or other member of the treatment team, explaining
the process of receiving the tube, and the risks and benefits.

Several factors may be involved in the decision to use a feeding tube including medical
conditions that impair the resident’s ability to maintain appropriate nutritional parameters
(e.g., cerebrovascular accident, esophageal cancer, delirium, reconstructive facial or oral
surgery). The need to improve the resident’s nutritional status or level of comfort are also
factors that may be involved in the decision to use a feeding tube. The duration of use of
a feeding tube may vary, depending on the clinical situation and resident choice.

The interdisciplinary team, with support and guidance from the physician, is responsible
for assuring the ongoing review, evaluation and decision-making regarding the
continuation or discontinuation of all treatments, devices or approaches implemented to
care for the resident. Involving the resident, family, and/or the resident’s representative
in discussions about the indications, use, potential benefits and risks of tube feeding,
types of approaches, and alternatives helps support the resident’s right to make an
informed decision to use or not use artificial nutrition and hydration.
A clinically pertinent rationale for using a feeding tube includes, but is not limited to:

• An assessment of the resident’s nutritional status, which may include usual food
and fluid intake, pertinent laboratory values, appetite, and usual weight and
weight changes;

• An assessment of the resident’s clinical status, which may include the ability to
chew, swallow, and digest food and fluid; underlying conditions affecting those
abilities (e.g., coma, stroke, esophageal stricture, potentially correctable
malnutrition that cannot be improved sufficiently by oral intake alone); factors
affecting appetite and intake (e.g., medications known to affect appetite, taste, or
nutrition utilization); and prognosis;

• Relevant functional and psychosocial factors (e.g., inability to sufficiently feed
self, stroke or neurological injury that results in loss of appetite, psychosis that
prevents eating); and

• Interventions attempted prior to the decision to use a feeding tube and the
resident’s response to them.

The use of a feeding tube may potentially benefit or may adversely affect a resident’s
clinical condition and/or psychosocial well-being. Examples of some possible benefits of
using a feeding tube may include:

• Addressing malnutrition and dehydration;
• Promoting wound healing; and
• Allowing the resident to gain strength, receive appropriate interventions that may

help restore the resident’s ability to eat and, perhaps, return to oral feeding.

Examples of some possible adverse effects of using a feeding tube may include:

• Diminishing socialization, including, but not limited to, the close human contact
associated with being assisted to eat or being with others at mealtimes;

• Not having the opportunity to experience the taste, texture, and chewing of foods;
• Causing tube-associated complications; and
• Reducing the freedom of movement related to efforts to prevent the resident from

pulling on the tube or other requirements related to the tube or the tube feeding.

In order to assure that the resident being fed by a feeding tube maintains the highest
degree of quality of life possible, it is important to minimize possible social isolation or
negative psychosocial impact to the degree possible (e.g., continuing to engage in
appropriate activities, socializing in the dining room). Because of the possible side-
effects and discomfort associated with the use of nasogastric tubes, there should be
clinically pertinent documentation for extended use of nasogastric tubes (e.g., greater
than 30 days).
Nutrition and feeding issues and their underlying causes in the resident with advanced
dementia or other chronic neurological disorders such as Parkinson’s disease present a
particular set of issues and considerations that are discussed in F692. The extended use of
enteral feeding tubes in individuals with advanced dementia does not necessarily extend
life and remains controversial. The literature regarding enteral feeding of these
individuals suggests that there is little evidence that enteral feeding improves clinical
outcomes (e.g., prevents aspiration or reduces mortality).

CONSENT
A feeding tube should not be placed unless consented to by the resident or if applicable,
appropriately authorized resident representative. The resident has the right to make an

informed decision about the treatment they receive. If a resident had a feeding tube
placed prior to admission or in another care setting the physician and interdisciplinary
care team must review the basis (e.g., precipitating illness or condition change) for the
initial placement of the feeding tube and the resident’s current condition. This is to
determine if there is a continued rationale for its use and to ensure that its continued use
is consistent with the resident’s treatment goals and wishes. Decisions to continue or
discontinue the use of a feeding tube are made through collaboration between the resident
(or a representative for a resident who lacks capacity to make and communicate such
decisions), the physician, and the interdisciplinary care team. This includes a discussion
of the relevance of a feeding tube to attaining a resident’s goals (e.g., whether the
nutritional intervention is likely to have a significant impact on the individual’s
underlying condition or overall status).

TECHNICAL AND NUTRITIONAL ASPECTS OF FEEDING TUBES
It is important that staff providing care and services to the resident who has a feeding
tube are aware of, competent in, and utilize facility protocols regarding feeding tube
nutrition and care. These protocols are required to be developed with the medical
director in order to assure staff implement and provide care and services according to
resident needs and professional standards of practice.

Facility policies and procedures regarding the technical aspects of feeding tubes must be
developed and implemented, which address:

Monitoring the feeding tube
How to verify that the tube is functioning before beginning a feeding and before
administering medications, which may include:

• Checking gastric residual volume (GRV)
o Not recommended for individuals who are alert and able to report symptoms

that indicate a feeding is not well tolerated.
o May be appropriate when initiating tube feedings or for individuals who are

unable to report symptoms such as bloating, nausea, or abdominal pain.
o Actions to take based upon the amount of GRV vary depending on the

individual and the clinical condition.
o pH of GRV may indicate correct placement i.e. pH < 5 generally indicates gastric contents versus intestinal contents but medications and feeding formulas can alter pH levels. o Changes in GRV appearance may also be helpful in confirming placement but should not be used in isolation. • Observing changes in external length of tubing may indicate a change in position but can only be used if the exit site was marked upon initial placement; this method does not apply to low profile G tubes (tube that sits at skin level). NOTE: Auscultation is no longer recommended for checking placement of the feeding tube. Movement of air would likely be heard whether the tube was in the correct or incorrect location. X-ray confirmation is the most accurate method for verification of tube placement when concerns arise regarding dislodgement or placement. Additional information regarding monitoring of feeding tubes may be found at, https://www.ismp.org/tools/articles/ASPEN NOTE: References to non-CMS/HHS sources or sites on the Internet included above or later in this document are provided as a services and do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services. CMS is not responsible for the content of pages found at these sites. URL addresses were current at the date of this publication. Care of the feeding tube • Securing a feeding tube externally; • Providing needed personal, skin, oral, and nasal care to the resident; • Examining and cleaning the insertion site in order to identify, lessen or resolve possible skin irritation and local infection; • Using infection control precautions and related techniques to minimize the risk of contamination; for example, in connecting the tube and the tube feeding; and • Defining the frequency of and volume used for flushing, including flushing for medication administration, and when a prescriber’s order does not specify. Feeding tube replacement. Direction for staff regarding the conditions and circumstances under which a tube is to be changed, such as: • When to replace and/or change a feeding tube (generally replaced either as planned/scheduled or as needed such as when a long-term feeding tube comes out unexpectedly or a tube is worn or clogged); • How and when to examine a feeding tube and the infusion plug to identify splits or cracks that could produce leakage; • Instances when a tube can be replaced within the facility and by whom; • Instances when a tube must be replaced in another setting (e.g., hospital, ambulatory surgery center); and • Notification of the practitioner when the need for a tube change arises unexpectedly. Nutritional Aspects of Feeding Tubes When a resident is receiving nutrition via a feeding tube, the practitioner and the interdisciplinary team identify the resident’s nutritional needs and facility procedures that direct staff in providing care and services to the resident. The practitioner’s orders related to tube feeding typically include the following components: kind of feeding and its caloric value; volume, duration, and mechanism of administration (e.g., gravity or pump); and frequency of flush. Facility procedures regarding the nutritional aspects of feeding tubes include, but are not limited to: Enteral nutrition. Direction to staff regarding the nutritional product and meeting the resident’s nutritional needs such as: • Types of enteral nutrition formulas available for use; https://www.ismp.org/tools/articles/ASPEN • How to determine whether the tube feedings meet the resident’s nutritional needs and when to adjust them accordingly; • How to balance essential nutritional support with efforts to minimize complications related to the feeding tube; • Ensuring that the selection and use of enteral nutrition is consistent with manufacturer’s recommendations; • Ensuring that the administration of enteral nutrition is consistent with and follows the practitioner’s orders; and • Ensuring that the product has not exceeded the expiration date; • Ensuring that additional water ordered for flushes or for additional hydration is administered per orders. Flow of feeding. Direction for staff regarding how to manage and monitor the rate of flow, such as: • Use of gravity flow; • Use of a pump; • Periodic evaluation of the amount of feeding being administered for consistency with practitioner’s orders; • Calibration of enteral feeding pumps to ensure that pump settings accurately provide the rate and volume consistent with the resident’s care plan; and • Periodic maintenance of feeding pumps consistent with manufacturer’s instructions to ensure proper mechanical functioning. Complications Related to the Feeding Tube An enteral feeding tube may be associated with significant complications, including aspiration, leaking around the insertion site, abdominal wall abscess, or erosion at the insertion site including the nasal areas. Feeding tubes can perforate the stomach or small intestine, with resultant peritonitis. Esophageal complications of feeding tubes may also occur including esophagitis, ulcerations, strictures, and tracheoesophageal fistulas. The use of tubes not designed or intended for enteral feeding may increase the risk of complications.16, 17 Tubes may clog for various reasons, including plugging by formula, pill fragments, or the precipitation of medications incompatible with the formula.18 Flushing feeding tubes regularly and in association with medication administration, as indicated by current professional standards of practice and provided in the resident care policies, can help reduce the risk of clogging. Complications Related to the Administration of the Enteral Nutrition Product The administration of an enteral nutrition product may be associated with other complications including, but not limited to, nausea, vomiting, diarrhea, abdominal cramping, inadequate nutrition and aspiration. Additionally, interactions between the formula and various medications can affect the absorption and/or effectiveness of the medication. For example, the effectiveness of phenytoin sodium (Dilantin, Phenytek) may be reduced by the drug binding with the enteral feeding's protein component, leading to less free drug availability and possibly inadequate therapeutic levels. Metabolic complications related to tube feeding may include inadequate calorie or protein intake, altered hydration, hypo- or hyperglycemia, and altered electrolyte and nutrient levels. These risks may be reduced by calculating the nutritional needs of the resident, taking into account comorbid conditions and medications that affect these balances, monitoring for adequate nutritional status and complications, and adjusting the tube feeding accordingly. While a feeding tube may be initiated with the intent to address certain medical conditions, the use of a feeding tube does not necessarily decrease the risk of aspiration for individuals with other risk factors, such as moderate or less severe swallowing abnormalities. Aspiration risk may potentially be affected by factors such as diminished level of consciousness, improper positioning of the resident during administration of the feeding, and failure to assure the feeding tube is correctly positioned within the stomach or intestine. The evidence is inconsistent and conflicting regarding any connection between gastric residual volume (GRV) and the risk or occurrence of aspiration.19 Risk of aspiration should be assessed individually and appropriate interventions (e.g., proper positioning, rate of flow) implemented accordingly. There may be situations where other coexisting factors influence decisions about elevating the head of the bed; for example, a resident being fed by a tube who may be at risk for shearing by sliding down the sheets when the head of the bed is elevated to a recommended angle. Complications Management The facility is expected to identify and address actual or potential complications related to the feeding tube or tube feeding and to notify and involve the practitioner in evaluating and managing care to address these complications and risk factors. PROCEDURES §483.25(g)(4)-(5) Use the Tube Feeding Critical Element (CE) Pathway along with the above guidance when determining if the facility utilized a feeding tube only after adequate assessment of the resident’s clinical condition to ensure this intervention is medically necessary and with the resident’s consent. The surveyor(s) should use the following: observations, interviews and record reviews to determine if a feeding tube is utilized only if the resident’s clinical condition makes this intervention medically necessary and with the resident’s consent. The surveyor must determine if a feeding tube is utilized in accordance with current professional standards of practice and if services are provided to prevent complications to the extent possible. Additionally, for a resident whose goal is to restore normal eating skills to the extent possible, the surveyor must determine if the necessary care and services were provided to reach this goal. If there are concerns regarding the facility’s use and care of feeding tubes, review facility policies and practices with regard to the use and care of feeding tubes. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F693, the surveyor's investigation will generally show that the facility failed to do one or more of the following: • Ensure enteral feeding was clinically indicated; or • Ensure enteral feeding was consented to by the resident; or • Ensure a resident receiving enteral feeding received appropriate care and services to restore oral eating skills, if possible, or • Ensure a resident receiving enteral feeding received appropriate care and services to prevent complications of enteral feeding. DEFICIENCY CATEGORIZATION In addition to actual or potential physical harm, always consider whether psychosocial harm has occurred when determining severity level (See Appendix P, Section IV, E, Psychosocial Outcome Severity Guide). An example of Severity Level 4 Noncompliance : Immediate Jeopardy to Resident Health or Safety, includes but is not limited to: • The facility failed to properly set up the tube feeding pump and to monitor a cognitively impaired resident receiving the tube feeding, resulting in the resident receiving too much liquid nourishment at a rate too fast to be absorbed. The resident was found to be unresponsive with excess liquid nourishment coming from his or her nose and mouth. An example of Severity Level 3 Considerations: Actual Harm that is Not Immediate Jeopardy includes, but is not limited to: • The facility failed to monitor for complications related to a resident’s feeding tube and tube feeding. As a result, the resident experienced significant but not serious tube feeding-related complications; or Examples of Severity Level 2 Noncompliance: No Actual Harm with Potential for More than Minimal Harm that is Not Immediate Jeopardy includes, but is not limited to: • As a result of staff failure to anchor a feeding tube properly, the resident had leakage and irritation around the tube insertion site that required topical treatment and resolved without complications; • As a result of staff failure to manage a tube feeding pump properly, the resident did not receive the calculated amount of tube feeding, without resulting in significant weight loss or other GI complications; or • As a result of staff failure to consistently flush a resident’s feeding tube as ordered, the tube clogged and had to be replaced, but there were no other complications. Severity Level 1: No Actual Harm with Potential for Minimal Harm The failure of the facility to provide appropriate care and services for feeding tubes, places the resident at risk for more than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION If there are concerns identified regarding the resident receiving adequate nutrition/hydration when receiving tube feeding, review F692, Assisted Nutrition and Hydration, for further investigation. If there is lack of consent related to the placement of a feeding tube, cite those deficiencies here instead of the Resident Rights since this regulatory language is specific to consent for a feeding tube. F694 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.25(h) Parenteral Fluids. Parenteral fluids must be administered consistent with professional standards of practice and in accordance with physician orders, the comprehensive person- centered care plan, and the resident’s goals and preferences. INTENT §483.25(h) The intent of this requirement is that the facility assures that each resident receives care and services for the provision of parenteral fluids consistent with professional standards of practice in order to provide: • Safe administration of parenteral fluids by qualified, competent and trained staff in accordance with State laws/practice acts; • Care consistent with the resident’s input, goals and preferences, as delineated in the care plan; and • Ongoing support of the resident, during parenteral treatments, including monitoring the resident’s status, monitoring for complications and assuring the provision of appropriate infection control practices. DEFINITION §483.25(h) Parenteral fluid is the delivery of fluid or medication through an intravenous, subcutaneous, intramuscular, or mucosal route (Taber’s Online Medical Dictionary, https://www.tabers.com/tabersonline/) to maintain adequate hydration, restore and/or maintain fluid volume, reestablish lost electrolytes, or provide nutrition which includes Total Parenteral Nutrition (TPN). Intravenous (IV) therapy is the administration of parenteral fluids or medications through an IV catheter to treat a condition. NOTE: References to non-CMS/HHS sources or sites on the Internet included above or later in this guidance are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services. CMS is not responsible for the content of pages found at these sites. URL addresses were current at the date of this publication. https://www.tabers.com/tabersonline/ GUIDANCE §483.25(h) There is no requirement that a facility must offer IV therapy. If the facility has an arrangement with an outside contractor for the provision of IV therapy, the facility must inform each resident before or at the time of admission, and periodically during the resident’s stay, of such services if available in the facility. Residents of a facility may receive IV therapy through options such as the following: • The facility provides the IV therapy either directly or under contract with individuals to provide the services; however, these individuals must be qualified, trained and competent in accordance with professional standards of practice, licensure and State practice acts/laws; or • If a current resident needs and agrees to receive IV therapy and the facility does not allow such services to be administered onsite, the facility must assist the resident with the transfer to another facility or with the relocation to another setting (e.g. private home, or residential/assisted living facility) of his/her choice that provides IV therapy. For facilities who offer IV therapy, the facility must develop and implement resident care policies based upon current professional standards of practice for the preparation, insertion, administration, maintenance and discontinuance of an IV, as well as for the prevention of infection at the site to the extent possible. The procedures must include the care and use of all equipment, such as pumps, tubing, syringes, fluids, etc. The facility minimizes risks to a resident receiving IV therapy by developing and implementing policies that adhere to professional standards of practice, which may include, but are not limited to: • Use of appropriate hand hygiene during all aspects of IV therapy; • Use of aseptic technique when placing a venous access device; • Use of appropriate antiseptic (e.g., chlorhexidine, povidone iodine, an iodophor, or 70 percent alcohol, which is recommended in CDC guidelines) to scrub IV ports, needleless connectors, and hubs prior to access or use. • Use of personal protective equipment (PPE) (based on potential for exposure to blood, bodily fluids, and infectious agents); • Competency of staff to: o Use infusion equipment; o Accurately perform IV insertion, and maintain vascular access; and o Assess for complications. • Administration of solutions according to orders (correct solution, administration route (central/peripheral line), duration, frequency, and infusion rate); • Labeling and dating, as appropriate, infusion fluids and lines; • Frequency of assessment of IV catheter to assess the insertion site for signs and symptoms of infection or inflammation (i.e., at least daily or with each use). Frequency may depend upon such factors as the: o Ability of resident to report symptoms of pain, redness, etc. o Type of infusion—is it an irritant or vesicant? o Location of IV catheter—is it inserted in an area of flexion; and o Facility policy based on long-term care pharmacy IV policies and procedures. • Assessment of continued need for the catheter if not being used for IV fluids or medications. According to the CDC, the following terminology has been used to describe IV catheters: “Terminology and Estimates of Risk - The terminology used to identify different types of catheters is confusing, because many clinicians and researchers use different aspects of the catheter for informal reference. A catheter can be designated by: • The type of vessel it occupies (e.g., peripheral venous, central venous, or arterial); • Its intended life span (e.g., temporary or short-term versus permanent or long- term); • Its site of insertion (e.g., subclavian, femoral, internal jugular, peripheral, and midline or peripherally inserted central catheter [PICC]); • Its pathway from skin to vessel (e.g., tunneled versus nontunneled); • Its physical length (e.g., long versus short); or • Some special characteristic of the catheter (e.g., presence or absence of a cuff, impregnation with heparin, antibiotics or antiseptics, and the number of lumens). To accurately define a specific type of catheter, all of these aspects should be described (Table 1).” - https://www.cdc.gov/hai/pdfs/bsi-guidelines-2011 . Complications/Risks of Intravenous Fluid Administration Administration of IV fluids may be required to restore or maintain adequate hydration, replace electrolytes, or provide partial nutrition. However, because it is invasive, administration of IV fluids has associated risks such as: • Infiltration; • Bruising; • Embolism (Air or Blood); • Phlebitis; • Fluid overload; • Electrolyte imbalance; and • Infections (Cellulitis, Septicemia). NOTE: Refer to Centers for Disease Control (CDC) guidelines for the prevention of intravascular catheter related infections found at: https://www.cdc.gov/hai/pdfs/bsi- guidelines-2011 . In addition to adhering to professional standards of practice, facilities are responsible to administer IV therapy according to the resident-centered care plan and in accordance with physician’s orders and the resident’s goals, preferences, and advance directives, as applicable and according to State law. INVESTIGATIVE PROCEDURES https://www.cdc.gov/hai/pdfs/bsi-guidelines-2011 https://www.cdc.gov/hai/pdfs/bsi-guidelines-2011 https://www.cdc.gov/hai/pdfs/bsi-guidelines-2011 Observations: Observe the resident to determine: • Are there signs of inflammation or infiltration at the insertion site and has site been changed according to current, professional standards of practice? • If the rate of parenteral fluid being administered reflects that which was ordered by the physician. • If the resident received the amount of fluid during the past 24 hours that he/she should have received according to the physician’s orders (allow flexibility up to 150cc unless an exact fluid intake is critical for the resident)? Observe staff accessing the port and changing the IV site, tubing, or bottle/bag, if possible. Determine if the central venous or peripheral access port, needleless connector, and hub was scrubbed with an appropriate antiseptic prior to access or use. Determine whether aseptic technique is maintained in accordance with current, professional standards of practice. Record Review: Review the medical record and comprehensive care plan (or baseline if the resident’s admission was within 14 days of the review) for residents receiving IV therapy to determine: • If the clinical record includes documentation to support the need for IV therapy; • If the resident has orders for parenteral fluid, Note the solution type, administration route, frequency, and infusion rate to compare to observations. • How frequently staff are to change IV tubing. Review facility policies and procedures related to IV therapy to determine if policies and/or procedures address: • Aseptic technique for IV insertion; • Maintenance of IV site; • Frequency of IV site, tubing, and bag changes, and do they reflect current, professional standards of practice? • Documentation for the continued need for the IV catheter if no longer being used for IV fluid or medication. Interviews: Interview the resident or, if applicable, the resident representative to determine: • If they understand why the resident is receiving parenteral fluid; • If the resident has had any complications or concerns related to the IV therapy Interview staff to determine if there are specific qualifications and/or competencies required for staff who perform IV insertion, IV maintenance, and parenteral fluid administration. DEFICIENCY CATEGORIZATION §483.25(h) Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident Health or Safety include, but are not limited to: • Facility’s failure to adhere to sterile technique during maintenance of IV therapy that lead to sepsis and resulted in the resident’s hospitalization or death. • Facility’s failure to monitor administration of fluid that resulted in overload of cardiovascular system, resulting in hospitalization or death. Examples of Severity Level 3 Noncompliance Actual Harm that is Not Immediate Jeopardy include, but are not limited to: • Facility’s failure to monitor for complications related to IV therapy, resulting in infiltration of the IV, causing the resident to experience pain and swelling. • Facility’s failure to ensure a resident received fluids as ordered, resulting in dehydration, which was later reversed after staff became aware. Examples of Severity Level 2 Noncompliance No Actual Harm with Potential for More Than Minimal Harm that is Not Immediate Jeopardy include, but are not limited to: • Facility’s failure to consistently flush a resident’s IV site, resulting in the IV becoming clogged and requiring replacement. • Facility’s failure to anchor the IV needle and tubing, resulting in leakage around the IV site that required topical treatment and resolved without complications. Severity Level 1 Noncompliance No Actual Harm with Potential for Minimal Harm: The failures of the facility to provide appropriate care and services related to parenteral fluids places the resident at risk for more than minimal harm. Therefore, Severity level 1 does not apply for this regulatory requirement. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION: • If noncompliance with parenteral therapy is related to staff competency issues, also consider F725, §483.35(a)(3), Nursing Services • If noncompliance with parenteral therapy is related to accuracy of fluid type, or amount, also consider F755, §483.45 Pharmacy Services. • If noncompliance with parenteral therapy is related to lack of equipment such as IV tubing, pumps, etc., also consider F907 §483.90(d) Space and equipment. If noncompliance with parenteral therapy is related to the provision of adequate nutrition/hydration, also consider F692 §483.25(g), Assisted Nutrition and Hydration. F695 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.25(i) Respiratory care, including tracheostomy care and tracheal suctioning. The facility must ensure that a resident who needs respiratory care, including tracheostomy care and tracheal suctioning, is provided such care, consistent with professional standards of practice, the comprehensive person-centered care plan, the residents’ goals and preferences, and 483.65 of this subpart. INTENT §483.25 (i) The intent of this provision is that each resident receives necessary respiratory care and services that is in accordance with professional standards of practice, the resident’s care plan, and the resident’s choice. DEFINITIONS §483.25 (i) “Automatic self-adjusting positive airway pressure (APAP)”. APAP is a non-invasive ventilation machine that automatically adjusts the air pressure according to the patient's requirement at a particular time. “Bi-level positive airway pressure (BiPAP)”. BiPAP is a non-invasive ventilation machine that is capable of generating two adjustable pressure levels - Inspiratory Positive Airway Pressure (IPAP) - high amount of pressure, applied when the patient inhales and a low Expiratory Positive Airway Pressure (EPAP) during exhalation. “Continuous positive airway pressure (CPAP)”. CPAP is a non-invasive ventilation machine that involves the administration of air usually through the nose by an external device at a predetermined level of pressure. “Hypoxia” means decreased perfusion of oxygen to the tissues. “Hypoxemia” means decreased oxygen level in arterial blood. “Intermittent positive pressure breathing (IPPB)” is a technique used to provide short term or intermittent mechanical ventilation for the purpose of augmenting lung expansion, delivering aerosol medication, or assisting ventilation and can include pressure- and time-limited as well as pressure, time, and flow-cycled ventilation, and may be delivered to artificial airways and non-intubated patients. “Mechanical Ventilation” may be defined as a life support system designed to replace or support normal ventilatory lung function.1 “Noninvasive ventilation (NIV)” refers to the administration of ventilatory support without using an invasive artificial airway (endotracheal tube or tracheostomy tube). 1 “Obstructive Sleep Apnea (OSA” refers to apnea syndromes due primarily to collapse of the upper airway during sleep. “Oxygen therapy” is the administration of oxygen at concentrations greater than that in ambient air (20.9%) with the intent of treating or preventing the symptoms and manifestations of hypoxia. “Respiratory Therapy Service” are-services that are provided by a qualified professional (respiratory therapists, respiratory nurse) for the assessment, treatment, and monitoring of residents with deficiencies or abnormalities of pulmonary function (See §483.65, Specialized Rehabilitative Services). “Tracheotomy or Tracheostomy” is an opening surgically created through the neck into the trachea (windpipe) to allow direct access to the breathing tube and is commonly done in an operating room under general anesthesia. A tube is usually placed through this opening to provide an airway and to remove secretions from the lungs. Breathing is done through the tracheostomy tube rather than through the nose and mouth. The term “tracheotomy” refers to the incision into the trachea (windpipe) that forms a temporary or permanent opening, which is called a “tracheostomy,” however the terms are sometimes used interchangeably. “Ventilator Assisted Individual (VAI)” requires mechanical aid for breathing to augment or replace spontaneous ventilatory efforts to achieve medical stability or maintain life. 2 GUIDANCE §483.25(i) Changes in the respiratory system related to aging may lead to the development of and/or difficulty/challenges in treating diseases in the respiratory system, and may impact treatments/interventions. The Minimum Data Set (MDS) has identified the most frequent respiratory diseases/syndromes that a resident may have been admitted with or required after admission to a nursing home, including but not limited to pneumonia, asthma, chronic obstructive pulmonary disease (COPD), chronic lung disease (chronic bronchitis and restrictive lung diseases such as asbestosis), respiratory failure, shortness of breath (dyspnea) with exertion, or when sitting at rest, lying flat, or during an illness such as influenza. In addition, residents have been admitted with or previously had acute respiratory distress syndrome (ARDS), lung cancer, obstructive sleep apnea or a history of tuberculosis. Various modalities/treatments for respiratory care identified on the MDS include respiratory treatments/therapy, oxygen therapy, the use of BiPAP/CPAP, tracheostomy and/or suctioning, and some facilities provide chest tube and mechanical ventilation services/care. Based upon its facility assessment, the resident population, diagnosis, staffing, resources and staff skills/knowledge, the facility must determine whether it has the capability and http://www.hopkinsmedicine.org/tracheostomy/resources/glossary.html#Tracheotomy capacity to provide the needed respiratory care/services for a resident with a respiratory diagnosis or syndrome that requires specialized respiratory care and/or services. This includes at a minimum, sufficient numbers of qualified professional staff, established resident care policies and staff trained and knowledgeable in respiratory care before admitting a resident that requires those services. Resident Care Policies The facility, in collaboration with the medical director, director of nurses, and respiratory therapist, as appropriate, must assure that resident care policies and procedures for respiratory care and services, are developed, according to professional standards of practice, prior to admission of a resident requiring specific types of respiratory care and services. (Also refer to F841, §483.70(g) Medical Director) The policies and procedures, based on the type of respiratory care and services provided, may include, but are not limited to: • Oxygen services, including the safe handling, humidification, cleaning, storage, and dispensing of oxygen; • Types of respiratory exercises provided such as coughing/deep breathing and if provided therapeutic percussion/vibration and bronchopulmonary drainage; • Aerosol drug delivery systems (nebulizers/metered-dose inhalers) and medications (preparation and/or administration) used for respiratory treatments; • BiPAP/CPAP treatments; • Delineation for all aspects of the provision of mechanical ventilation/tracheostomy care, including monitoring, oversight and supervision of mechanical ventilation, tracheostomy care and suctioning, and how to set, monitor and respond to ventilator alarms; • Emergency care which includes staff training and competency for implementation of emergency interventions for, at a minimum, cardiac/respiratory complications, and include provision of appropriate equipment at the resident’s bedside for immediate access, such as for unplanned extubation; • Procedures to follow in the advent of adverse reactions to respiratory treatments or interventions, including mechanical ventilation, tracheostomy care and provision of oxygen; • Respiratory assessment including who can conduct each aspect of the assessment, what is contained in an assessment, when and how it is conducted, the type of documentation required; • Maintenance of equipment for respiratory care in accordance with the manufacturer specifications and consistent with federal, state, and local laws and regulations, such as oxygen equipment, or equipment for mechanical ventilation if provided, how and by whom the equipment is serviced and how it is maintained; • Emergency power for essential equipment such as mechanical ventilation, if provided; • Infection control measures during implementation of care, handling, cleaning, storage and disposal of equipment, supplies, biohazardous waste and including infection control practices for mechanical ventilation/tracheostomy care including the use of humidifiers; and • Posting of cautionary and safety signs indicating the use of oxygen; and Staffing and Qualified Personnel Refer to §483.65 specialized rehabilitative services, for review of provision of services by qualified personnel. When providing respiratory care, the facility must, based on professional standards of practice: • Have sufficient numbers of trained, competent, qualified staff, consistent with State practice acts/laws; and • Identify who is authorized to perform each type of respiratory care service, such as responding to mechanical ventilator alarms, suctioning and tracheostomy care. NOTE: Surveyors are expected to determine the scope of practice and state laws regarding who may provide mechanical ventilation and/or tracheostomy care in their state. Monitoring and Documentation of Respiratory Services/Response Staff should document, based on current professional standards of practice, the assessment and monitoring of the resident’s respiratory condition, including response to therapy provided, and any changes in the respiratory condition. Depending on the type of respiratory services the resident receives, physician orders and the individualized respiratory care plan, documentation should include, as appropriate: • Vital signs, including the respiratory rate; • Chest movement and respiratory effort, and the identification of abnormal breath sounds; • Signs of dyspnea, cyanosis, coughing, whether position affects breathing, characteristics of sputum, signs of potential infection, or the presence of behavioral changes that may reflect hypoxia including anxiety, apprehension, level of consciousness; and • Instructions for the resident on how to participate/assist in the respiratory treatments as appropriate. The attending practitioner must be immediately notified of significant changes in condition, and the medical record must reflect the notification, response and interventions implemented to address the resident’s condition. Also, refer to §483.10(g)(14) F580 for notification of physician, family of significant changes. Modalities/Respiratory Therapy/Care/Services A variety of respiratory therapy modalities and care may be provided in the nursing home, including coughing/deep breathing, therapeutic percussion/vibration and postural drainage, aerosol/nebulizers, humidification, and therapeutic gas administration, BiPAP or CPAP, tracheostomy care and tracheal suctioning, and mechanical ventilation and oxygenation support. Coughing/deep breathing, therapeutic percussion/vibration and bronchopulmonary drainage If a resident has written orders for postural drainage, chest percussion, and vibration to increase the mobility of pulmonary secretions, the care plan must include, based upon the resident’s assessments and identified needs, the type of exercise, including when and how often provided. The resident’s record should reflect how staff are monitoring the condition of the resident prior to, during and after the treatments, and, as appropriate, vital signs including the respiratory rate, pulse oximetry, presence of dyspnea, and/or signs of infection. The record should reflect the resident’s response to the treatment and notification of the practitioner if necessary for a change in the resident’s condition or as necessary, the need to revise or alter the respiratory care provided. Refer to §483.10(g)(14) F580 for notification of physician of significant changes. Respiratory medications via aerosol generators There are three common types of aerosol generators used for inhaled drug delivery: • A small-volume nebulizer (SVN); • A pressurized metered-dose inhaler (pMDI); and • A dry-powder inhaler (DPI). NOTE: For information related to aerosol delivery devices include, for example, the specific devices’ manufacturers guidelines for use; and “ Guide to Aerosol Delivery Devices for Physicians, Nurses, Pharmacists and Other Health Care Professionals” American Association for Respiratory Care 2013 http://www.aarc.org//app/uploads/2014/08/aerosol_guide_pro Oxygen (O2) Therapy Oxygen therapy may be provided through various types of supply and delivery systems. Equipment may include the provision of oxygen through nasal cannulas, trans-tracheal oxygen catheters, oxygen canisters, cylinders or concentrators. For a resident receiving oxygen therapy, the resident’s record must reflect ongoing assessment of the resident’s respiratory status, response to oxygen therapy and include, at a minimum, the attending practitioner’s orders and indication for use. In addition, the record should include the type of respiratory equipment to use, baseline SpO2 levels and to initiate and/or discontinue oxygen therapy. If the resident is ambulatory with his/her oxygen delivery system, the resident must be informed of safety precautions and prohibitions for oxygen, such as where smoking is allowed or other hazardous areas, and staff should monitor to assure the resident adheres to the safety rules for oxygen. The http://www.aarc.org/app/uploads/2014/08/aerosol_guide_pro resident’s care plan should identify the interventions for oxygen therapy, based upon the resident’s assessment and orders, such as, but not limited to: • The type of oxygen delivery system; • When to administer, such as continuous or intermittent and/or when to discontinue; • Equipment settings for the prescribed flow rates; • Monitoring of SpO2 levels and/or vital signs, as ordered; and • Based upon the individual resident’s risks, if applicable, monitoring for complications, such as skin integrity issues related to the use of a nasal cannula. NOTE: For reference, American Association for Respiratory Care Clinical Practice Guideline -Oxygen Therapy in the Home or Alternate Site Health Care Facility —2007 Revision & Update P1063-1067- http://www.rcjournal.com/cpgs/pdf/08.07.1063 Obstructive Sleep Apnea Obstructive sleep apnea (OSA) refers to apnea syndromes due primarily to collapse of the upper airway during sleep. Nonpharmacologic medical treatments may include weight reduction, tongue-retaining devices, positive airway pressure modalities such as continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP). CPAP involves the administration of air usually through the nose by an external device at a fixed pressure to maintain the patency of the upper airway. BiPAP is similar to CPAP but the devices are capable of generating two adjustable pressure levels. Other treatment methods for OSA may include the use of medications surgical procedures. For a resident with OSA, the resident’s record must reflect ongoing assessment of the resident’s respiratory status, response to therapy and include, at a minimum, the attending practitioner’s orders and indication for use. In addition, the record should include the equipment settings, when to use the equipment and humidification as appropriate. The care plan should identify the interventions for OSA, based upon the resident’s assessment and orders, such as, but not limited to: • The type of equipment and settings, and • When to administer; and; • Based upon the individual resident’s risks, if applicable, monitoring for complications. Respiratory Services for Mechanical Ventilation and/or Tracheostomy/Tracheotomy Care The guidance related to care of residents receiving mechanical ventilation applies to facilities who provide this type of care. Mechanical ventilation is defined as a life support system designed to replace and/or support normal ventilatory lung function. A ventilator- assisted individual (VAI) may require mechanical aid for breathing to augment or replace http://www.rcjournal.com/cpgs/pdf/08.07.1063 spontaneous ventilatory efforts to achieve medical stability or maintain life. Persons requiring long term invasive ventilatory support have demonstrated: • An inability to become completely weaned from invasive ventilatory support; or • A progression of disease etiology that requires increasing ventilatory support. Due to the clinically complex nature of the provision of care for a resident receiving mechanical ventilation, there must be an active, ongoing interdisciplinary approach to the resident’s care, including but not limited to participation as needed, by the physician/practitioner, pulmonologist, registered nurse, pharmacist, dietitian, speech therapist, respiratory therapist, physical and/or occupational therapist, and the resident/representative. The facility, in collaboration with the attending practitioner, must provide a comprehensive assessment of the resident’s respiratory needs. The facility must provide an assessment of resident specific communication methodologies, including assessing current visual/hearing needs, cognition, level of consciousness, and identifying potential methods for communication such as writing, communication cards/boards, and/or computer access. The results of the assessment must be used in the development and implementation of a person centered care plan. A resident receiving mechanical ventilation and/or tracheostomy care is dependent on staff to provide care according to the practitioner’s orders, the comprehensive assessment and individualized care plan, including, but not limited to communication, positioning and range of motion, nutrition, hydration, ADL’s, bladder and bowel management, monitoring for resident specific risks for possible complications, psychosocial needs, as well as mechanical ventilation and tracheostomy care including suctioning as appropriate. The facility must provide consistent, implementation of all aspects of care related to the provision of mechanical ventilation and tracheostomy care, in accordance with accepted professional standards of practice, including emergency interventions as appropriate. Staff must be trained and competent in application of life support interventions in case of emergency situations such as cardiac and/or respiratory complications related to mechanical ventilation and environmental emergencies such as power outages. Care plan for Mechanical Ventilation/Tracheostomy Care Based upon the resident assessment, attending practitioner’s orders, and professional standards of practice, the facility, including the resident/representative, to the extent possible, must develop and implement a care plan that includes appropriate interventions for respiratory care. The facility must develop a care plan based on the resident’s individualized assessment that may include: • Communication needs and methods; • Positioning, skin Integrity and redistribution of pressure (i.e., use of specialized mattresses/equipment/positioning); • Nutritional support (specialized care such as enteral nutrition); • Bowel and bladder management; • Provision of oral and eye care; • Monitoring for psychosocial needs such as depression or anxiety; • As ordered by the practitioner, and/or as appropriate, monitoring respirations and respiratory rates, heart rates, presence of cyanosis, dusky coloring or other color changes related to respiratory/circulatory conditions, symmetry of chest expansion/movement, diaphoresis, lethargy, vital signs and parameters including pulse oximetry; • Care of a resident who is cognitively impaired and may exhibit restlessness and pulling at tubing; • Adjunctive interventions, as appropriate, such as medications, aerosol (bronchodilators), chest physiotherapy, oxygen therapy, and/or secretion clearance devices; and • Identification of resident specific risks for possible complications, that may include: o Unplanned extubation; o Aspiration and the potential for respiratory infection (tracheal bronchitis, ventilator associated pneumonia (VAP)); o Nutritional complications related to tube feedings, gastric distress; o Increased or decreased CO2 levels; o Development of oral or ocular ulcers, o Barotrauma; o Deep vein thrombosis due to immobility; and/or o Airway complications such as tracheal infections, mucous plugging, tracheal erosion and/or stenosis; • Advance directives, if any; • Type of ventilator equipment, settings, and alarms, (Refer to physicians orders, and manufacturers specifications for use and care); and • Type and size of airway and care of artificial airway. PROCEDURE: §483.25(i) Use the Respiratory Care Critical Element (CE) Pathway, along with the above interpretive guidelines when determining if the facility provides the necessary care and services to ensure that a resident receives the respiratory care and services as ordered to meet his/her needs. Surveyors should use the guidance above as general information about the professional standards of practice regarding the provision of care under this tag. It is not intended to prescribe a clinical course for a specific resident. Summary of Procedure Briefly review the most recent comprehensive assessments, comprehensive care plan and orders to identify whether the facility has assessed and developed an individualized care plan based on professional standards of practice and provided by qualified, competent staff. During this review, identify the extent to which the facility has implemented interventions in accordance with the resident’s needs, goals for care and professional standards of practice, consistently across all shifts. This information will guide observations and interviews to be made in order to corroborate concerns identified. NOTE: Always observe for visual cues of psychosocial distress and harm (see Appendix P, Guidance on Severity and Scope Levels and Psychosocial Outcome Severity Guide). NOTE: If noncompliance with respiratory care provided by nursing services is related to staff competency issues, also consider F725, §483.35(a)(3), Nursing Services KEY ELEMENTS OF NONCOMPLIANCE §483.25(i) To cite deficient practice at F695, the surveyor's investigation will generally show that the facility failed to do one or more of the following: • Provide necessary respiratory care and services, such as oxygen therapy, treatments, mechanical ventilation, tracheostomy care, and/or suctioning; or • Provide necessary respiratory care consistent with professional standards of practice, the resident’s care plan, goals and preferences. DEFICIENCY CATEGORIZATION §483.25(i) In addition to actual or potential physical harm, always consider whether psychosocial harm has occurred when determining severity level (See Appendix P, Section IV, E, Psychosocial Outcome Severity Guide). Examples of Severity Level 4 Noncompliance: Immediate Jeopardy to Resident Health or Safety includes but is not limited to: • The facility failed to assure that staff provided appropriate tracheostomy care including suctioning as ordered by the resident's physician and based on professional standards of practice, to use the appropriate suctioning technique. During observations the resident experienced respiratory distress, and expressed ongoing anxiety and fear related to difficulty breathing. Staff interviewed was not aware of the physician’s orders for tracheal suctioning and were not aware of the techniques to use during the suctioning treatment. Staff stated this was the first time they were scheduled to work in this unit, and had no prior experience in providing ventilator or tracheostomy care. This lack of knowledge of how to provide this specialized care including the technique for suctioning increases the likelihood for psychosocial harm, respiratory distress, obstruction of airways, and potentially death. • The facility failed to provide emergency equipment available for accidental extubation for a resident on mechanical ventilation with a tracheostomy. (An extubation creates an emergency situation that requires that an obturator be readily available that can be used by competent staff for reinsertion). Upon interview, staff were not aware of the location of emergency equipment or how to use it in case of accidental extubation. As a result, it is likely any resident who experienced an accidental extubation would suffer serious harm or death. Examples of Severity Level 3 Noncompliance, Actual Harm that is not Immediate Jeopardy includes but is not limited to: • The facility failed to provide consistent oxygen therapy for a resident who required oxygen during periods of activity. Over a weekend, a resident’s oxygen supply was depleted, and staff failed to order replacement oxygen. As a result, the resident experienced dyspnea when dressing, expressed increasing anxiety due to difficulty in “getting his/her breath when ambulating, and refused to go to the dining room for meals, or to take a shower, due to being short of breath. • Facility failed to consistently implement a method for communication that had been established with a resident who was unable to verbally communicate due to being on a mechanical ventilator. The resident had indicated that a clipboard be used for him to write down requests and/or concerns, but night staff cleaning the room, removed it from the resident’s bedside and placed it in an area inaccessible by the resident. This had occurred several times, according to the resident who expressed anger to the surveyor when he was interviewed and provided the clipboard. He wrote that staff told him/her to relax and calm down when he could not access the communication board. The resident wrote that he feels isolated, afraid and upset when he cannot use the preferred communication method. He indicated that he did not feel as if staff could be trusted to meet his concerns, and began to cry. Examples of Severity Level 2 Noncompliance: No Actual Harm with Potential for More Than Minimal Harm that is Not Immediate Jeopardy include but are not limited to: • The facility failed to assure that a resident had a portable supply of oxygen to take along when attending activities as ordered by the attending practitioner. The resident stayed in her room on oxygen and missed the activity programs she usually participated in. The resident stated that she was upset to have to miss the programs because staff failed to order her portable supply of oxygen. • The facility failed to consistently perform coughing/deep breathing exercises as ordered for a resident, however, no increase or exacerbation of respiratory symptoms as a result of the lack of exercises was identified. Severity Level 1: No actual harm with potential for minimal harm The failures of the facility to provide appropriate care and services to provide respiratory care, including oxygen therapy, respiratory treatments and/or mechanical ventilation and tracheostomy care places a resident at risk for more than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement. F696 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.25(j) Prostheses The facility must ensure that a resident who has a prosthesis is provided care and assistance, consistent with professional standards of practice, the comprehensive person-centered care plan, the residents’ goals and preferences, to wear and be able to use the prosthetic device. GUIDANCE §483.25(j) The non-availability of program funding does not relieve a facility of its obligation to ensure that its residents receive all needed services listed in §1819(b)(4)(A) of the Social Security Act for Medicare and §1919(b)(4)(A) of the Act for Medicaid. For services not covered under Medicare or Medicaid, a facility is required to assist the resident in securing any available resources to obtain the needed services. This requirement does not mean that the facility must purchase or provide funding for the prosthetic. PROBES §483.25(j) Refer to appropriate sections of the RAI/MDS, as applicable. For residents selected for review, as appropriate: • Is resident able to apply the prosthesis by himself/herself or with some assistance? • Are residents wearing their prostheses? • Does the prosthesis fit correctly? • Is skin/mucous membrane in contact with the prosthesis free of abrasions, wounds, irritation? • Is the prosthesis in good condition and functioning as intended? • Is the prosthesis in need of repair? F697 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.25(k) Pain Management. The facility must ensure that pain management is provided to residents who require such services, consistent with professional standards of practice, the comprehensive person-centered care plan, and the residents’ goals and preferences. INTENT §483.25(k) Based on the comprehensive assessment of a resident, the facility must ensure that residents receive the treatment and care in accordance with professional standards of http://www.cms.hhs.gov/regulations/ http://www.cms.hhs.gov/regulations/ practice, the comprehensive care plan, and the resident’s choices, related to pain management. DEFINITIONS §483.25(k) “Adjuvant Medication” describes any medication with a primary indication other than pain management but with analgesic properties in some painful conditions.2 “Adverse Consequence” is an unpleasant symptom or event that is due to or associated with a medication, such as impairment or decline in a resident’s mental or physical condition or functional or psychosocial status. It may include various types of adverse drug reactions and interactions (e.g., medication-medication, medication-food, and medication-disease). "Medication Assisted Treatment” (MAT) is the use of medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach to the treatment of substance use disorders. (From the Substance Abuse and Mental Health Services Administration (SAMHSA)). "Opioid Use Disorder" (OUD) is a problematic pattern of opioid use leading to clinically significant impairment or distress. Additional criteria used to assess and diagnose OUD can be found in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). NOTE: Adverse drug reaction (ADR) is a form of adverse consequences. It may be either a secondary effect of a medication that is usually undesirable and different from the therapeutic effect of the medication or any response to a medication that is noxious and unintended and occurs in doses for prophylaxis, diagnosis, or treatment. The term “side effect” is often used interchangeably with ADR; however, side effects are but one of five ADR categories, the others being hypersensitivity, idiosyncratic response, toxic reactions, and adverse medication interactions. A side effect is an expected, well-known reaction that occurs with a predictable frequency and may or may not constitute an adverse consequence. GUIDANCE §483.25(k) Recognition and Management of Pain - In order to help a resident attain or maintain his or her highest practicable level of well-being and to prevent or manage pain, the facility, to the extent possible: • Recognizes when the resident is experiencing pain and identifies circumstances when pain can be anticipated; • Evaluates the existing pain and the cause(s), and • Manages or prevents pain, consistent with the comprehensive assessment and plan of care, current professional standards of practice, and the resident’s goals and preferences. https://www.samhsa.gov/medication-assisted-treatment/treatment#counseling-behavioral-therapies Overview of Pain Recognition and Management Nursing home residents are at high risk for having pain that may affect function, impair mobility, impair mood, or disturb sleep, and diminish quality of life. It is important, therefore, that a resident’s reports of pain, or nonverbal signs suggesting pain, be evaluated. The resident’s needs and goals as well as the etiology, type, and severity of pain are relevant to developing a plan for pain management. It should be noted that while analgesics can reduce pain and enhance the quality of life, they do not necessarily address the underlying cause of pain. It is important to consider treating the underlying cause, where possible. Strategies for Pain Management Strategies for the prevention and management of pain may include but are not limited to the following: • Assessing the potential for pain, recognizing the onset, presence and duration of pain, and assessing the characteristics of the pain; • Addressing/treating the underlying causes of the pain, to the extent possible; • Developing and implementing both non-pharmacological and pharmacological interventions/approaches to pain management, depending on factors such as whether the pain is episodic, continuous, or both; • Identifying and using specific strategies for preventing or minimizing different levels or sources of pain or pain-related symptoms based on the resident-specific assessment, preferences and choices, a pertinent clinical rationale, and the resident’s goals and; using pain medications judiciously to balance the resident’s desired level of pain relief with the avoidance of unacceptable adverse consequences; • Monitoring appropriately for effectiveness and/or adverse consequences (e.g., constipation, sedation) including defining how and when to monitor the resident’s symptoms and degree of pain relief; and • Modifying the approaches, as necessary. Use of Opioids for Pain Management—Prescribing practitioners may find that opioid medications are the most appropriate treatment for acute pain as well as chronic pain in some residents. However, because of increasing opioid addiction, abuse, and overdoses, prescribers should use caution when prescribing opioids, and consider using alternative pain management approaches, when appropriate. When opioids are used, the lowest possible effective dosage should be prescribed for the shortest amount of time possible after considering all medical needs and the resident should be monitored for effectiveness and any adverse effects. Long-acting opioids may provide more consistent pain relief with less breakthrough pain. However, if using opioids in residents with dementia, immediate release forms of opioids are generally preferred over long-acting forms to reduce overdose risk, unless clinically indicated. Due to the risk of fatal respiratory depression, combining opioids and benzodiazepines should be avoided unless clinically indicated for an individual resident. Risks related to combining these medications are even greater for adults aged 65 and older and include falls and hip fractures, cognitive impairment/confusion, daytime fatigue, and delirium. If concurrent use of opioids and benzodiazepines is clinically indicated for an individual resident, the resident should be closely monitored for adverse consequences. Medication regimens for residents receiving end of life, palliative, or hospice care may include opioids alone or combining opioids and benzodiazepines; their use must be consistent with accepted standards of practice for this specialty of care. For additional information, refer to: • Exposure-Response Association Between Concurrent Opioid and Benzodiazepine Use and Risk of Opioid-Related Overdose in Medicare Part D Beneficiaries, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2685628. • National Institute on Drug Abuse Benzodiazepines and Opioids, https://www.drugabuse.gov/drugs-abuse/opioids/benzodiazepines-opioids • Geriatricpain.org, Resources and Tools for Quality Pain Care, https://geriatricpain.org/ • The Society for Post-Acute and Long-Term Care Medicine (AMDA) opioid • The Society for Post-Acute and Long-Term Care Medicine (AMDA) Opioids in Nursing Homes , https://paltc.org/opioids%20in%20nursing%20homes Additionally, the Centers for Disease Control and Prevention website has resources specifically related to the use of opioids in treating chronic pain (pain lasting longer than three months or past the time of normal tissue healing) available at https://www.cdc.gov/opioids/patients/guideline.html These guidelines do not apply to individuals being treated for pain related to active cancer treatment, palliative care, and end-of-life care. Individual states also have initiatives and requirements related to opioid use for acute and chronic pain. When treating pain in a resident with an addiction history or opioid use disorder (OUD), strategies must be used to relieve pain while also considering the OUD or addiction history. These strategies may include continuation of medication assisted treatment (MAT), if appropriate, non-opioid pain medications, and non-pharmacological approaches. Pain Recognition Because pain can significantly affect a person’s well-being, it is important that the facility recognize and address pain promptly. The facility’s evaluation of the resident at admission and during ongoing assessments helps identify the resident who is experiencing pain or for whom pain may be anticipated during specific procedures, care, or treatment. In addition, it is important that a resident be monitored for the presence of pain and be evaluated when there is a change in condition and whenever new pain or an https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2685628 http://www.integration.samhsa.gov/clinical-practice/trauma https://geriatricpain.org/ https://paltc.org/?q=opioids%20in%20nursing%20homes#:%7E:text=AMDA%20%E2%80%93%20The%20Society%20for%20Post-Acute%20and%20Long-Term,Promote%20opioid%20tapering%2C%20discontinuation%20and%20avoidance%20of%20opioids https://paltc.org/?q=opioids%20in%20nursing%20homes#:%7E:text=AMDA%20%E2%80%93%20The%20Society%20for%20Post-Acute%20and%20Long-Term,Promote%20opioid%20tapering%2C%20discontinuation%20and%20avoidance%20of%20opioids https://www.cdc.gov/opioids/patients/guideline.html exacerbation of pain is suspected. As with many symptoms, pain in a resident with moderate to severe cognitive impairment may be more difficult to recognize and assess. Expressions of pain may be verbal or nonverbal and are subjective. A resident may avoid the use of the term “pain.” Other words used to report or describe pain may differ by culture, language and/or region of the country. Examples of descriptions may include heaviness or pressure, stabbing, throbbing, hurting, aching, gnawing, cramping, burning, numbness, tingling, shooting or radiating, spasms, soreness, tenderness, discomfort, pins and needles, feeling “rough,” tearing or ripping. Verbal descriptions of pain can help a practitioner identify the source, nature, and other characteristics of the pain. Nonverbal indicators which may represent pain need to be viewed in the entire clinical context with consideration given to pain as well as other clinically pertinent explanations. Examples of possible indicators of pain include, but are not limited to the following: • Negative verbalizations and vocalizations (e.g., groaning, crying/whimpering, or screaming); • Facial expressions (e.g., grimacing, frowning, fright, or clenching of the jaw); • Changes in gait (e.g., limping), skin color, vital signs (e.g., increased heart rate, respirations and/or blood pressure), perspiration; • Behavior such as resisting care, distressed pacing, irritability, depressed mood, or decreased participation in usual physical and/or social activities; • Loss of function or inability to perform Activities of Daily Living (ADLs) (e.g., rubbing a specific location of the body, or guarding a limb or other body parts); • Difficulty eating or loss of appetite; and • Difficulty sleeping (insomnia). In addition to the pain item sections of the MDS, many sections such as sleep cycle, change in mood, decline in function, instability of condition, weight loss, and skin conditions can be potential indicators of pain. Any of these findings may indicate the need for additional and more thorough evaluation. Many residents have more than one active medical condition and may experience pain from several different causes simultaneously. Many medical conditions may be painful such as pressure injuries, diabetes with neuropathic pain, immobility, amputation, post- CVA, venous and arterial ulcers, multiple sclerosis, oral health conditions, and infections. In addition, common procedures, such as moving a resident or performing physical or occupational therapies or changing a wound dressing may be painful. Understanding the underlying causes of pain is an important step in determining optimal approaches to prevent, minimize, or manage pain. Observations at rest and during movement, particularly during activities that may increase pain (such as dressing changes, exercises, turning and positioning, bathing, rising from a chair, walking) can help to identify whether the resident is having pain. Observations during eating or during the provision of oral hygiene may also indicate dental, mouth and/or facial pain. Recognizing the presence of pain and identifying those situations where pain may be anticipated involves the participation of health care professionals and direct care and ancillary staff who have contact with the resident. Information may be obtained by talking with the resident, directly examining the resident, and observing the resident’s behavior. Staffing consistency and familiarity with the residents has a significant effect on the staff’s ability to identify and differentiate pain-related behavior from other behavior of cognitively impaired residents. Nursing assistants may be the first to notice a resident’s symptoms; therefore, it is important that they are able to recognize a change in the resident and the resident’s functioning and to report the changes to a nurse for follow-up. Family members or friends may also recognize and report when the resident experiences pain and may provide information about the resident’s pain symptoms, pain history and previously attempted interventions. Other staff, e.g., dietary, activities, therapy, housekeeping, who have direct contact with the resident may also report changes in resident behavior or resident complaints of pain. Assessment In addition to the Resident Assessment Instrument (RAI), it is important that the facility identifies how they will consistently assess pain. Some facilities may use assessment tools that are appropriate for use with their resident population. There are many reliable and valid evidenced based practice tools available to facility staff to assist in the assessment of pain. Pain assessment tools that can be used with cognitively intact and impaired residents can be obtained on the Geriatric Pain website at https://geriatricpain.org/clinicians/pain-assessment-information. An assessment or an evaluation of pain based on professional standards of practice may necessitate gathering the following information, as applicable to the resident: • History of pain and its treatment (including non-pharmacological and pharmacological treatment and whether or not each treatment has been effective); • History of addiction, past and/or ongoing and related treatment for OUD; • Characteristics of pain, such as: (intensity, pattern, location, frequency and duration) • Impact of pain on quality of life (e.g., sleeping, functioning, appetite, and mood); • Factors such as activities, care, or treatment that precipitate or exacerbate pain as well as those that reduce or eliminate the pain; • Additional symptoms associated with pain (e.g., nausea, anxiety); • Physical and psychosocial issues (physical examination of the site of the pain, movement, or activity that causes the pain, as well as any discussion with resident about any psychological or psychosocial concerns that may be causing or exacerbating the pain); • Current medical conditions and medications including medication assisted treatment for OUD; and https://geriatricpain.org/clinicians/pain-assessment-information • The resident’s goals for pain management and his or her satisfaction with the current level of pain control. While it may be difficult to conduct a thorough assessment of all of the above factors in a cognitively impaired or non-responsive resident, the facility staff is responsible for obtaining as much information as possible and evaluating the resident’s pain through all available means. Observing the resident during care, activities, and treatments helps not only to detect whether pain is present, but also to potentially identify its location and the limitations it places on the resident. Management of Pain Based on the evaluation, the facility, in collaboration with the attending physician/prescriber, other health care professionals, and the resident and/or his/her representative, develops, implements, monitors and revises as necessary interventions to prevent or manage each individual resident’s pain, beginning at admission. These interventions may be integrated into components of the comprehensive care plan, addressing conditions or situations that may be associated with pain, or may be included as a specific pain management need or goal. The interdisciplinary team and the resident and/or representative collaborate to arrive at pertinent, realistic and measurable goals for treatment, such as reducing pain sufficiently to allow the resident to ambulate comfortably to the dining room for each meal or to participate in 30 minutes of physical therapy. Depending on the situation and the resident’s wishes, the target may be to reduce the pain level, but not necessarily to become pain-free. To the extent possible, the interdisciplinary team educates the resident and/or representative about the need to report pain when it occurs and about the various approaches to pain management and the need to monitor the effectiveness of the interventions used. The basis for effective interventions includes several considerations, such as the resident’s needs and goals; the source(s), type and severity of pain (recognizing that the resident may experience pain from one or more sources either simultaneously or at different times) and awareness of the available treatment options. Often, sequential trials of various treatment options are needed to develop the most effective approach. It is important for pain management approaches to follow pertinent professional standards of practice and to identify who is to be involved in managing the pain and implementing the care or supplying the services (e.g., facility staff, such as RN, LPN, CNA; attending physician or other practitioner; certified hospice; or other contractors such as therapists). Pertinent current professional standards of practice may provide recommended approaches to pain management even when the cause cannot be or has not been determined. Non-pharmacological interventions Research supports physical activity and exercise as a part of most treatment programs for chronic pain. Activity can be supported by conventional physical therapy and exercise approaches, or by a wide range of movement therapies. Some non-pharmacologic interventions may need to be ordered by the provider while others can be provided by facility staff during routine care. Examples of non- pharmacological interventions may include, but are not limited to: • Altering the environment for comfort (such as adjusting room temperature, tightening and smoothing linens, using pressure redistributing mattress and positioning, comfortable seating, and assistive devices); • Physical modalities, such as ice packs or cold compresses (to reduce swelling and lessen sensation), mid heat (to decrease joint stiffness and increase blood flow to an area), neutral body alignment and repositioning, baths, transcutaneous electrical nerve stimulation (TENS), massage, acupuncture/acupressure, chiropractic, or rehabilitation therapy; • Exercises to address stiffness and prevent contractures as well as restorative nursing programs to maintain joint mobility; and • Cognitive/Behavioral interventions (e.g., relaxation techniques, reminiscing, diversions, activities, music therapy, offering spiritual support and comfort, as well as teaching the resident coping techniques and education about pain). Pharmacological interventions The interdisciplinary team (nurses, practitioner, pharmacists, etc.) is responsible for developing a pain management regimen that is specific to each resident who has pain or who has the potential for pain, such as during a treatment. The regimen considers factors such as the causes, location, and severity of the pain, the potential benefits, risks and adverse consequences of medications; and the resident’s desired level of relief and tolerance for adverse consequences. The resident may accept partial pain relief in order to experience fewer significant adverse consequences (e.g., desire to stay alert instead of experiencing drowsiness/confusion). The interdisciplinary team works with the resident to identify the most effective and acceptable route for the administration of analgesics, such as orally, rectally, topically, by injection, by infusion pump, and/or transdermally. It is important to follow a systematic approach for selecting medications and doses to treat pain. Developing an effective pain management regimen may require repeated attempts to identify the right interventions. General guidelines for choosing appropriate categories of medications in various situations are widely available to the provider, pharmacist and nurses. Factors influencing the selection and doses of medications include the resident’s medical condition, current medication regimen, nature, severity, and cause of the pain and the course of the illness. Analgesics may help manage pain; however, they often do not address the underlying cause of pain. Examples of different approaches may include, but are not limited to: administering lower doses of medication initially and titrating the dose slowly upward, administering medications “around the clock” rather than “on demand” (PRN); or combining longer acting medications with PRN medications for breakthrough pain. Recurrent use of or repeated requests for PRN medications may indicate the need to reevaluate the situation, including the current medication regimen. Some clinical conditions or situations may require using several analgesics and/or adjuvant medications (e.g., antidepressants or anticonvulsants) together. Documentation helps to clarify the rationale for a treatment regimen and to acknowledge associated risks. Opioids or other potent analgesics have been used for residents who are actively dying, those with complex pain syndromes, and those with more severe acute or chronic pain that has not responded to non-opioid analgesics or other measures. Opioids should be selected and dosed in accordance with current professional standards of practice and manufacturers’ guidelines in order to optimize their effectiveness and minimize their adverse consequences. Adverse consequences may be especially problematic when the resident is receiving other medications with significant effects on the cardiovascular and central nervous systems. Therefore, careful titration of dosages based on monitoring/evaluating the effectiveness of the medication and the occurrence of adverse consequences is necessary. The clinical record should reflect the ongoing communication between the prescriber and the staff is necessary for the optimal and judicious use of pain medications. Other interventions have been used for some residents with more advanced, complex, or poorly controlled pain such as radiation therapy, neurostimulation, spinal delivery of analgesics (implanted catheters and pump systems), and neurolytic procedures (chemical or surgical) that are administered under the close supervision of expert practitioners. Referrals to pain management clinics and pain management specialists may also be appropriate in these situations. Monitoring, Reassessment, and Care Plan Revision Monitoring the resident over time helps identify the extent to which pain is controlled, relative to the individual’s goals and the availability of effective treatment. The ongoing evaluation of the status (presence, increase or reduction) of a resident’s pain is vital, including the status of underlying causes, the response to interventions to prevent or manage pain, and the possible presence of adverse consequences of treatment. Adverse consequences related to analgesics can often be anticipated and to some extent prevented or reduced. For example, opioids routinely cause constipation, which may be minimized by an appropriate bowel regimen. Identifying target signs and symptoms (including verbal reports and non-verbal indicators from the resident) and using standardized assessment tools can help the interdisciplinary team evaluate the resident’s pain and responses to interventions and determine whether the care plan should be revised, for example: • If pain has not been adequately controlled, it may be necessary to reconsider the current approaches and revise or supplement them as indicated; or • If pain has resolved or there is no longer an indication or need for pain medication, the facility works with the practitioner to discontinue or taper (as needed to prevent withdrawal symptoms) analgesics. Additionally, a facility should evaluate whether there is a time or day pattern to a resident’s reports or signs of increased pain to ensure that the problem is not due to drug diversion. The CDC describes a number of side effects which prescription opioids can cause even when given as directed. Some side effects for which residents should be monitored include: • Tolerance, meaning more medication may be needed to achieve the same level of pain relief; • Physical dependence which causes symptoms of withdrawal when opioid medication is stopped, or a dose is held or missed; • Increased sensitivity to pain; • Constipation; • Nausea, vomiting, and dry mouth; • Sleepiness, dizziness, and/or confusion; • Depression; and • Itching and sweating. According to the Substance Abuse and Mental Health Administration (SAMHSA), opioid overdose deaths can be prevented by administering naloxone, a medication approved by the Food and Drug Administration to reverse the effects of opioids. The United States Surgeon General has recommended that naloxone be kept on hand where there is a risk for an opioid overdose. Facilities should have a written policy to address opioid overdoses. The SAMHSA website houses a number of resources related to opioid management including this document intended for prescribers which addresses appropriate prescribing, monitoring for adverse effects, and treating overdoses: SAMHSA Opioid Overdose Prevention Toolkit: Information for Prescribers, https://www.samhsa.gov/resource/ebp/opioid-overdose-prevention-toolkit. For concerns related to staff monitoring for adverse effects of opioid use, see F757, Unnecessary Medications. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F697, the surveyor's investigation will generally show that the facility failed to do one or more of the following: • Provide pain management to a resident experiencing pain; or • Provide pain management that met professional standards of practice; or https://www.samhsa.gov/resource/ebp/opioid-overdose-prevention-toolkit • Provide pain management that was in accordance with the resident’s comprehensive care plan, and the resident’s goals for care and preferences. INVESTIGATIVE SUMMARY Use the Pain Recognition and Management Critical Element (CE) Pathway, along with the above interpretive guidelines when determining if the facility provides pain management that meets professional standards of practice; and that is in accordance with the resident’s comprehensive care plan, goals for care and preferences. Summary of Procedure Briefly review the most recent comprehensive assessments, comprehensive care plan and orders to identify whether the facility has assessed and developed an individualized care plan based on professional standards of practice and provided by qualified, competent staff. During this review, identify the extent to which the facility has implemented interventions in accordance with the resident’s needs, goals for care and professional standards of practice, consistently across all shifts. This information will guide observations and interviews to be made in order to corroborate concerns identified. NOTE: Always observe for visual cues of psychosocial distress and harm (see Guidance on Severity and Scope Levels and Psychosocial Outcome Severity Guide). DEFICIENCY CATEGORIZATION An example of Severity Level 4 Noncompliance: Immediate Jeopardy to Resident Health or Safety includes, but is not limited to: • Facility failed to implement an effective pain management regime for a resident who sustained a fracture of the hip and was determined to not be a surgical candidate. Resident stated that pain medication was not effective, and she was in continuous pain. She indicated she had notified staff of the pain, but nothing was done. Interview of staff indicated no one had contacted the practitioner to discuss the ineffective pain relief. The staff stated that they were concerned regarding the amount of pain medication the resident was receiving and that they were concerned that she would become increasingly tolerant and addicted to the medication. They stated they were aware that the resident declined assistance with ADL’s due to “pain” and felt that the resident was not having the amount of pain that she stated she had. The resident was observed on multiple occasions to, holding her hip area, moaning and crying out, sweating, and striking out when staff attempted to move her. An example of Severity Level 3 Noncompliance: Actual Harm that is not Immediate Jeopardy includes, but is not limited to: • The facility failed to provide effective pain management to a resident with a diagnosis of bone cancer. Record review revealed the resident only had PRN (as needed) pain medication every six hours. According to the resident this pain regime was not effective resulting in excruciating breakthrough pain multiple times each day. The resident said that staff would tell her she had to wait, and often would not get the PRN medicine promptly when it was due. The surveyor observed the resident to be tearful and unable to participate in activities. Examples of Severity Level 2 Noncompliance: No Actual Harm with potential for more than minimal harm that is Not Immediate Jeopardy includes, but is not limited to: • Facility failed to provide an effective pain management treatment per the resident’s choice and preference. A resident request a hot shower on the evening shift as an effective intervention for back pain. The staff member assigned to her informed her that she would not be able to be showered until later in the evening. A staff member who understood what the resident was experiencing quickly intervened and gave her a hot shower relieving her back pain. • The facility staff failed to consistently evaluate the effectiveness of regularly scheduled pain medication on a resident. The resident was receiving the pain medication on a routine basis; however, the record did not reflect the resident’s response to the administration of the pain medication. In interviews, the resident stated that her pain was being managed for the most part, but that staff did not ask her if she received relief from the medication. She stated that occasionally, she would not attend an activity due to discomfort, but this did not routinely occur. When she mentioned it to staff, they would tell her to lie down for a while and would check on her later. However, she stated that they usually did not recheck her. Staff interviewed stated they didn’t have the time to go back, check, and record the resident’s response, but, if she complained, they would recheck her and see if she needed anything else. Severity Level 1 noncompliance: No actual harm with potential for minimal harm includes, The failure of the facility to provide appropriate care and services related to pain management places the resident at risk for more than minimal harm. Therefore Severity 1 does not apply for this regulatory requirement. F698 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.25(l) Dialysis. The facility must ensure that residents who require dialysis receive such services, consistent with professional standards of practice, the comprehensive person- centered care plan, and the residents’ goals and preferences. INTENT: §483.25(l) The intent of this requirement is that the facility assures that each resident receives care and services for the provision of hemodialysis and/or peritoneal dialysis consistent with professional standards of practice including the: • Ongoing assessment of the resident’s condition and monitoring for complications before and after dialysis treatments received at a certified dialysis facility; • Safe administration of hemodialysis at the bedside and/or peritoneal dialysis in the nursing home provided by qualified trained staff/caregivers, in accordance with State and Federal laws and regulations; • Ongoing assessment and oversight of the resident before, during and after dialysis treatments, including monitoring the resident’s condition during treatments, monitoring for complications, implementing appropriate interventions, and using appropriate infection control practices; and • Ongoing communication and collaboration with the dialysis facility regarding dialysis care and services. DEFINITIONS: §483.25(l) “End-Stage Renal Disease (ESRD)” - The stage of renal impairment that appears irreversible and permanent, and requires a regular course of dialysis or kidney transplantation to maintain life. (42 CFR, Part §405 - §405.2102) “Dialysis” - A process by which dissolved substances are removed from a patient’s body by diffusion from one fluid compartment to another across a semipermeable membrane. The two types of dialysis that are currently in common use are hemodialysis (HD) and peritoneal dialysis (PD). (§405.2102) “Dialysis facility” - means an entity that provides outpatient maintenance dialysis services or home dialysis training and support services, or both. (§494.10 Definitions) “Home Dialysis” - Home dialysis means dialysis performed at home by an ESRD patient or caregiver who has completed an appropriate course of training as described in §494.100(a) of this part. NOTE: For the purposes of this guidance the term “nursing home” refers to a long-term care facility and dialysis facility refers to a Medicare certified dialysis facility. Home hemodialysis will be referenced as HHD. INTERPRETIVE GUIDANCE: §483.25(l) There is no requirement that a nursing home must offer dialysis services. If the nursing home has an arrangement with a dialysis facility for the provision of dialysis services, the nursing home must inform each resident before or at the time of admission, and periodically thereafter during the resident’s stay, of dialysis services, if available in the nursing home. Residents of a nursing home may receive dialysis treatments through two main options: • Medicare Certified Dialysis Facility: This may involve either: o Transporting to and from an off-site certified dialysis facility for dialysis treatments; or o Transporting to a location within or proximate to the nursing home building which is dedicated for and separately certified as a dialysis facility providing in-center dialysis; and/or • Dialysis in a Nursing Home: Receive home hemodialysis (HHD) or peritoneal dialysis (PD) treatments in the nursing home, by trained and qualified staff who have received training and competency from the dialysis facility. If a current resident has been identified as meeting the criteria for HHD/PD by the dialysis facility team, and the nephrologist or the physician prescribing dialysis, and chooses to receive either HHD/PD, and the nursing home does not allow for these onsite services, the nursing home must assist the resident with the transfer to a nursing home or in the relocation to a setting (e.g. private home, or residential/assisted living facility) of his/her choice that provides HHD/PD services. NOTE: The long-term care survey team does not have the authority under Federal nursing home regulations to review the care and services provided directly within a Medicare-certified dialysis facility located either on or offsite. If at any time during the survey, a concern or issue arises regarding the dialysis services provided to a sampled resident by the dialysis facility, the survey team should report this as a complaint to the State Agency survey unit responsible for oversight of the Medicare certified ESRD entity. The survey team must identify the specific resident(s) involved and the concerns identified. Responsibilities for the Provision of Dialysis Care/Services If the nursing home has made the decision to provide dialysis care and services according to the options above, there must be, in accordance with current standards of practice, coordination and collaboration between the nursing home and the dialysis facility to assure that: • The resident’s needs related to dialysis treatments are met; • Only trained and qualified staff/caregivers administer the dialysis treatments; • The provision of the dialysis treatments and care of the resident meets current standards of practice for the safe administration of the dialysis treatments; • Documentation requirements are met to assure that treatments are provided as ordered by the nephrologist, attending practitioner and dialysis team; and • There is ongoing communication and collaboration for the development and implementation of the dialysis care plan by nursing home and dialysis staff. The nursing home remains responsible for the overall quality of care the resident receives and must provide the same services to a resident who is receiving dialysis as it furnishes to its residents who are not. This includes the ongoing provision of assessment, care planning and provision of care. There must be a coordinated plan for dialysis treatments developed with input from both the nursing home and dialysis facility. The resident should not experience any lack of nursing home services or care because of his or her dialysis status. The nursing home staff must be aware and identify changes in resident’s behavior, especially for a cognitively impaired resident, that may impact the safe administration of dialysis, including, resistance to care, and pulling on tubes/access sites and inform the attending practitioner and dialysis facility of the changes. This requires more frequent and increased observations and monitoring for this resident before, during (if dialysis is provided by nursing home staff/caregivers or the resident) and after dialysis treatments. NOTE: The nursing home may wish to designate a staff person to coordinate activities and communications with each dialysis facility that they have arrangements with to provide dialysis services. The dialysis facility is responsible for the medical management for the end stage renal disease including dialysis treatments, performed offsite or onsite. It is the responsibility of the dialysis facility to provide all necessary equipment and supplies for the provision of the dialysis treatments, including maintenance and repair as needed, testing/monitoring water and dialysate quality for the dialysis treatment, and for the training of individuals providing the HHD/PD. Shared Communication between the Nursing Home and the Dialysis facility It is essential that a communication process be established between the nursing home and the dialysis facility to be used 24-hours a day. The care of the resident receiving dialysis services must reflect ongoing communication, coordination and collaboration between the nursing home and the dialysis staff. The communication process should include how the communication will occur, who is responsible for communicating, and where the communication and responses will be documented in the medical record, including but not limited to: • Timely medication administration (initiated, administered, held or discontinued) by the nursing home and/or dialysis facility; Physician/treatment orders, laboratory values, and vital signs; • Advance Directives and code status; specific directives about treatment choices; and any changes or need for further discussion with the resident/representative, and practitioners; • Nutritional/fluid management including documentation of weights, resident compliance with food/fluid restrictions or the provision of meals before, during and/or after dialysis and monitoring intake and output measurements as ordered; • Dialysis treatment provided and resident’s response, including declines in functional status, falls, the identification of symptoms such as anxiety, depression, confusion, and/or behavioral symptoms that interfere with treatments; • Dialysis adverse reactions/complications and/or recommendations for follow up observations and monitoring, and/or concerns related to the vascular access site/PD catheter; • Changes and/or decline in condition unrelated to dialysis. This would include communication related to care concerns such as a resident who is at risk for or who has a pressure ulcer, receiving appropriate interventions; and • The occurrence or risk of falls and any concerns related to transportation to and from the dialysis facility. Coordination of Physician Services between the Nursing Home and Dialysis facility For a resident receiving dialysis, the nursing home staff must immediately contact and communicate with the attending physician/practitioner, resident/resident representative, and designated dialysis staff (i.e., nephrologist, registered nurse) regarding any significant changes in the resident’s status related to clinical complications or emergent situations that may impact the dialysis portion of the care plan. (Refer to F580 – Notification of Changes in condition) These situations may include but are not limited to changes in cognition or sudden unexpected decline in condition, dialysis complications such as bleeding, hypotension, or adverse consequences to a medication or therapy, or other situations. Any changes in the resident’s care initiated by the dialysis facility must be communicated to the resident’s nursing home attending physician/practitioner. Hospital Transfer The dialysis facility must ensure access to a hospital for emergency services that has the capacity to provide emergency dialysis care (ESRD Conditions for Coverage (CfC) at V770 - §494.180). In order to assure that the dialysis needs of the resident are met in the case of an emergency, the care plan should identify acute care settings that would be able to meet the resident’s need for dialysis. In case of the need to transfer to an acute care facility to manage dialysis complications or other care concerns, the nursing home must have ongoing communication with the dialysis facility and have knowledge of the location and how to access the hospital that has the capacity to provide emergency dialysis care, as identified by the dialysis facility. NOTE: According to the ESRD regulations at V770 - §494.180 - The dialysis facility must have an agreement with a hospital that can provide inpatient care, routine and emergency dialysis and other hospital services, and emergency medical care which is available 24 hours a day, 7 days a week. The agreement must: (i) Ensure that hospital services are available promptly to the dialysis facility’s patients when needed. (ii) Include reasonable assurances that patients from the dialysis facility are accepted and treated in emergencies. Resident Care Policies and Staffing Specific to Dialysis Care and Services Some State licensure rules don’t allow for the provision of HHD in a nursing home and/or a State’s nurse practice act or scope of practice may preclude certain health care workers from performing HHD treatments. Some State licensing rules may have specific regulations related to the provision of HHD/PD in a nursing home, such as specifying patient to staff ratio requirements. The nursing home must identify who is allowed to provide HHD/PD treatments to a resident, such as a licensed nurse or nurse aide. The dialysis facility is responsible for providing training and assuring the competency of staff or individuals that are allowed to initiate, access and discontinue dialysis treatments. The nursing home must maintain documentation of completion of training/competency for staff or other individuals providing the dialysis treatments. NOTE: Anecdotally, it has been reported that some nursing homes provide dialysis for multiple residents at a time in a single area/den setting. The facility must assure that compliance is maintained for providing dialysis in a location that promotes dignity, individual privacy during treatments, sufficient staff, access to a call system and hand washing facilities, availability of emergency equipment and supplies, secured medication storage and preparation area, including a refrigerator as necessary, soiled utility area, disposal of equipment and supplies, and based upon professional standards of practice, the maintenance of effective infection control practices and measures. This includes ensuring that a resident who is hepatitis B+ is not dialyzed in the same location as resident who is not hepatitis B+. Consideration should be given to implementing appropriate infection control practices related to care of a resident who is hepatitis B+, such as using dedicated staff, a dedicated machine, equipment, instruments, and supplies that will not be used by other resident’s including a resident who is not hepatitis B+. If PD treatments are provided, the treatments may only be administered by an individual trained by the qualified dialysis trainer from the certified dialysis facility. An LPN/LVN may administer the PD treatment if not in conflict with the States Nurse Practice Act/Scope of practice. A nursing home, that provides dialysis treatments, in collaboration with the nursing home medical director and the dialysis facility, must develop dialysis specific policies/procedures, based upon current standards of practice. This includes the care of a resident receiving dialysis services whether in the facility or at an offsite location. (Refer to F841 – Responsibilities of Medical Director.) At a minimum, these policies must include, but are not limited to the following: • The identification of all staff or contracted individuals who are allowed to provide HHD/PD and the training required. An RN, LPN/LVN, a nurse aide or a trained technician can provide dialysis treatments if not in conflict with the States Nurse Practice Act/Scope of practice and only if the individual has received training from a qualified dialysis trainer from a certified dialysis facility for the individual resident receiving HHD/PD; • The documentation of training and competency requirements for individuals providing dialysis treatments; • If the facility allows a resident/family member or other individual to provide HHD or PD treatments, documentation that training and competency was provided by the certified dialysis facility; • Procedures for the initiation, administration and discontinuation of HHD/PD treatments, type of monitoring required before, during and after the treatments, including documentation requirements; • Procedures for methods of communication between the nursing home and the dialysis facility including how it will occur, with whom, and where the communication and responses will be documented; • The development and implementation of a coordinated comprehensive care plan(s) that identifies nursing home and dialysis responsibilities and provides direction for nursing home staff; and • The development and implementation of interventions, based upon current standards of practice including, but not limited to documentation and monitoring of complications, pre-and post-dialysis weights, access sites, nutrition and hydration, lab tests, vital signs including blood pressure and medications; • Management of dialysis emergencies including procedures for medical complications, and for equipment and supplies necessary; • The provision of medications on dialysis treatment days; • Procedures for monitoring and documenting nutrition/hydration needs, including the provision of meals on days that dialysis treatments are provided; • Assessing, observing and documenting care of access sites, as applicable, such as: o Auscultation/palpation of the AV fistula (pulse, bruit and thrill) to assure adequate blood flow; o Significant changes in the extremity when compared to the opposite extremity (edema, pain, redness); o Steal Syndrome (pain, numbness, discoloration, or cold to touch in the fingers or hand indicating inadequate arterial flow); o Skin integrity (waxy skin, ulcerations, drainage from incisions); o Bruising/hematoma; o Collateral vein distension (veins in access arm close to AV fistula becoming larger); o Complaints of pain or numbness; or o Evidence of infection at the surgical site, such as drainage, redness, tenderness at incision site, fever. • Safe and sanitary care and storage of dialysis equipment and supplies; • Responsibility for reporting adverse events, including who to report to, investigating the event and correcting identified problems; • Response and management of technical problems related to HHD and/or PD treatments, such as power outages or: o For PD, how to recognize impaired flow and drainage or failure of the PD cycler; o For failure of HHD machines: clotting of the hemodialysis circuit, dialyzer blood leak, or line disconnection; and o For HHD/PD: how and when to stop dialysis and/or seek help when there are significant issues. NOTE: The dialysis facility is responsible for the overall provision and maintenance of the dialysis equipment and monitoring source water. The nursing home staff should be aware of any issues with the source water, and the care plan should address these issues. The nursing home trained and qualified staff responsible for providing the dialysis treatment, must know how to use the dialysis equipment and identify if there are issues in order to provide safe treatments. • Dialysis specific infection control policies, including but not limited to: o Transmission based precautions including blood borne precautions, placement/location (cohorting), staff/visitor personal protection equipment (PPE) requirements, indications for the use of gloves, masks, and hand hygiene; o Potential health care associated infections (HAI) including Hepatitis B and tuberculosis; o Restrictions for visitors/roommate, if any, during provision of HHD/PD; o Handling, using, and disposing of equipment/supplies, medications or other products in accordance with manufacturer’s instructions, and in accordance with all applicable Federal, State and local laws and regulations; NOTE: Nursing home staff who have been trained to provide dialysis treatments for a resident, must understand how to properly dispose of needles, effluents, disposable items, blood tubing and dialyzers to minimize risks of infection or injury to self and others and to prevent environmental contamination (e.g. using impervious puncture resistant containers for disposal of sharps, placing empty dialysate bags and dialysis tubing and other contaminated items in specific biohazard container(s) or bag(s) before discarding. o Obtaining and reviewing dialysis facility monitoring for the dialysis water and dialysate quality, including total chlorine testing and at least quarterly testing of water and dialysate bacterial and endotoxin as applicable to the HHD equipment in use; o Types of furnishings allowed (such as a recliner used during the dialysis treatment), based on infection control standards and the cleaning/sanitizing of these furnishings that have the potential to become contaminated with blood/blood products; o Access to clean sink for hand washing, in addition, disposal needs to be addressed for dialysis by-products from the dialysis treatment; o Housekeeping/laundry policies for cleaning/sanitizing the location(s) where treatments are provided, including linen handling and waste disposal; o Vascular access or peritoneal catheter care and dressing changes; and o Cleaning and disinfecting dialysis equipment, including procedures for spills and splashes of blood or effluent on furnishings, equipment, floors and supplies. NOTE: For information regarding home dialysis guidance see ESRD CFR §494.100 – V580 Care at Home. This condition also provides information regarding the provision of home dialysis including water treatment and quality testing and other requirements of the ANSI/AAMI RD52:2004. For information related more specifically to water testing and treatment refer to: • V-253 -ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR §494.40 (a)7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/frequency. Culture …dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution; and • V 278 - In-center preconfigured HD: quarterly cultures/LALs Moreover, the facility must perform bacteriological and endotoxin testing on a quarterly, or more frequent basis, as needed, to ensure that the water and dialysate are within AAMI limits. Some portable dialysis machines may have a self-check system and more stringent requirements may need to be followed as recommended by the manufacturer. Dialysis Provided at a Medicare Certified Dialysis Facility Located Offsite or Onsite A resident may choose to receive dialysis at a dialysis facility located off site or in a separately certified dialysis unit located within the facility. The choice of the dialysis provider is made by the resident/resident representative. The nursing home must assist the resident to assure that arrangements are provided for safe transportation to and from the dialysis facility. (See F745 – Social Services). The nursing home staff must provide immediate monitoring and documentation of the status of the resident’s access site(s) upon return from the dialysis treatment to observe for bleeding or other complications. The nursing home and dialysis facility dietitians should coordinate the nutritional care including monitoring, documenting, and deciding how and when to address weight changes and nutrition issues. This includes identifying weight fluctuations due to fluid retention between dialysis sessions, possible fluid volume depletion in the immediate post-dialysis period or associated with anorexia which may be due to renal failure. Staff must weigh the resident and document the findings based on orders. If weight loss occurs, the facility must notify the attending practitioner and dialysis facility practitioner regarding the management for causes of anorexia and weight loss other than fluid loss that might present. Home Hemodialysis provided by Nursing Home Staff The nursing home must continue to meet the nursing home requirements found throughout 42 CFR Part §483 to assure the residents health, safety and well-being. The facility must be able to demonstrate in collaboration with the dialysis facility, the arrangements in place in order to provide safe HHD/HPD through qualified trained staff/caregivers and assure that the resident receives the dialysis treatments as ordered. The nursing home is responsible for the ongoing coordination of dialysis care in collaboration with the Medicare certified ESRD entity. The nursing home resident who receives dialysis is entitled to the same rights, services, and efforts to achieve expected outcomes as a person receiving dialysis at a dialysis facility. NOTE: According to 42 CFR §494.100 - V581, a dialysis facility that is certified to provide services to home patients must ensure through its interdisciplinary team, that home dialysis services are at least equivalent to those provided to in-facility patients and meet all applicable conditions part 494. This does not imply that the nursing home surveyor surveys to or applies ESRD regulations. • Provision of HHD Treatments The nursing home and the dialysis facility must have ongoing communication to coordinate the care and manage any changes/issues that arise. The nursing home staff must use appropriate infection precautions, including blood-borne precautions, for all aspects of dialysis care. In addition, if the HHD is provided in a semi-private resident room, adherence to the right of privacy during treatment is required. The nursing home staff must have specific written guidance for identifying and handling complications and emergencies before, during and after the provision of HHD. The nursing home must have a system in place for staff to contact the dialysis facility immediately with any concerns/issues regarding dialysis. This includes who to communicate with, such as the dialysis staff, attending practitioner, or nephrologist regarding HHD. The nursing home must have dialysis facility contact numbers readily accessible to licensed nursing home staff that assures the on-call dialysis qualified licensed professional staff is available by phone 24 hours a day 7 days a week. HHD may be performed by either the resident (if physically and cognitively capable) or an individual, such as a family member (if allowed by the nursing home), nursing home staff or a contracted individual, such as a licensed nurse or dialysis technician, who has completed training/competency by a qualified trainer from a Medicare certified dialysis facility in accordance with State licensure, Scope of Practice for Nursing. The required training for staff providing HHD (and PD) treatments in nursing homes must be individualized and resident specific and provided directly by the Medicare certified dialysis facility that is responsible for the provision of the resident’s overall dialysis care. This training cannot be provided by nursing home staff even if they have previously received the training for dialysis by this or another dialysis facility for another resident. The nursing home must have documentation of the completion of resident specific dialysis training by the dialysis facility for each nursing home staff member providing dialysis treatments for the resident. While a nursing home may allow a resident and/or a dialysis trained caregiver to provide the dialysis treatment, the nursing home nonetheless remains responsible for the resident’s care and services. The facility must maintain documentation of the required ongoing dialysis training in order to assure qualified staff/caregivers are capable of providing the HHD treatments. (Refer to F658) Training based upon current standards of practice must include, but not be limited to, the following: • Specific (step-by step) instructions on how to use the resident’s prescribed dialysis equipment (e.g. hemodialysis machine and water treatment components); • Specific (step-by step) instructions in home dialysis procedures to facilitate adequate dialysis as prescribed by the physician; • Training in proper storage and administration of Erythropoiesis-Stimulating Agents (ESAs), if applicable and in accordance with State laws and State scope of practice. ESAs are medications that may be used to treat anemia in a resident with a diagnosis of ESRD; • How to identify/recognize medical emergencies, implement immediate responses/actions and methods for contacting emergency medical systems. Medical emergencies may include, but are not limited to, cardiac arrest, air embolism, drug reactions, suspected pyrogen reactions, profound hypotension or hypertension and significant blood loss; • How to recognize, manage and report such potential complications as vascular access problems such as difficulty with cannulation, a change in bruit or thrill, or bleeding, and infections, hypertension or hypotension, hyperkalemia, etc; • Infection control practices, including indications for the use of gloves, masks, and other personal protective equipment, methods for hand hygiene, vascular access and dressing changes, cleaning and disinfecting dialysis equipment, cleaning and disinfection procedures for spills and splashes of blood or effluent; • Identifying symptoms associated with water and dialysate contamination that cannot be readily attributed to other causes. Clinical symptoms may include, but are not limited to, chills, shaking, fever, vomiting, headache, dizziness, muscle weakness, skin flushing, itching, diarrhea, hyper/hypotension, hemolysis and anemia. If such symptoms are present, the facility must notify the attending practitioner and dialysis team to determine appropriate action; and • Recognizing, managing and reporting power outages, failure of the HD machine, failure of water treatment components (e.g., chlorine/chloramine breakthrough), clotting of the hemodialysis circuit, dialyzer blood leaks, line disconnection, water supply problems or leaks, and problems with supply delivery. The nursing home must have orders for the provision of the dialysis treatments, including individualized dialysis prescription such as, at a minimum, the number of treatments per week, length of treatment time, the type of dialyzer, and specific parameters of the dialysis delivery system (e.g., electrolyte composition of the dialysate, blood flow rate, and dialysate flow rate), anticoagulation, and the resident’s target weight. The resident’s care plan must, based on standards of practice, identify the resident specific parameters for blood pressure, weights and other vital signs. The resident’s blood pressures must be monitored pre, during, and post treatment and abnormal values must be addressed. Excessively high or low blood pressure measurements during treatment without evidence of assessment and action to address those values would indicate the care plan for this parameter was either not developed or not implemented. The nursing home staff must provide ongoing assessment of the resident during dialysis, including vital signs, level of consciousness, muscle cramping, itching and comfort or distress; and must report identified or suspected complications to the attending practitioner and identified dialysis staff to enable timely interventions. In addition, staff must ensure that a resident who is hepatitis B+ is not dialyzed in the same location as resident who is not hepatitis B+. Consideration should be given to implementing appropriate infection control practices related to care of a resident who is hepatitis B+, such as using dedicated staff, a dedicated machine, equipment, instruments, and supplies that will not be used by other resident’s including a resident who is not hepatitis B+. NOTE: According to the interpretive guidelines at ESRD regulation V581 - CFR §494.100 Condition: Care at Home – “Home dialysis patients are considered part of the census of the ESRD facility and are entitled to the same rights, services, and efforts to achieve expected patient outcomes as the in-center dialysis patients of the facility.” After receiving dialysis, staff must obtain vital signs, assess the resident’s stability and monitor for post-dialysis complications and symptoms such as but not limited to dizziness, nausea, vomiting, fatigue or hypotension. The resident receiving HHD must be under direct observation of the trained caregiver who must be physically present in the room with the resident throughout the entire HHD treatment in the immediate location where the HHD is being provided. NOTE: Nursing home staff assigned to provide an HHD treatment, must not have assignments for additional residents throughout the duration of the HHD treatment and after completed until the resident is determined stable according to accepted standards of practice. The resident’s vascular access site and bloodline connections must be able to be seen by the trained caregiver throughout the dialysis treatment. Allowing a resident to cover access sites and line connections provides an opportunity for accidental needle dislodgement or a line disconnection to go undetected. This dislodgement or disconnection could result in exsanguination and death in minutes. The medical record should reflect the care and monitoring of the access site, including but not limited to examining the arteriovenous fistula (AV fistula) and/or surgical incisions to detect problems that require immediate notification of the attending practitioner. Peritoneal Dialysis (PD) Provided by Nursing Home Staff If the nursing home provides PD on site, it is responsible for the ongoing coordination of dialysis care in collaboration with the Medicare certified dialysis facility. The nursing home staff must have specific written guidance for the provision of treatments, and handling complications and emergencies during the provision of PD. The nursing home must have contact information available for staff to assure that dialysis qualified licensed professional staff is available by phone 24 hours a day 7 days a week, including who to communicate with regarding PD related issues. PD may be performed by either the resident (if physically and cognitively capable) or an individual, such as a family member (if allowed by the nursing home), nursing home staff or a contracted caregiver who has completed training/competency by a qualified trainer from a Medicare certified dialysis facility. While a nursing home may allow a resident and/or a dialysis trained caregiver to provide the dialysis treatment, the nursing home nonetheless remains responsible for the resident’s care and services. The facility must maintain documentation of the required ongoing dialysis training in order to assure qualified staff/caregivers are capable of providing the PD treatments. (Refer to F658 – Meeting professional standards) Training based upon current standards of practice must include, but not be limited to, the following: • Specific (step-by step) instructions on how to use the resident’s prescribed dialysis equipment (e.g. peritoneal dialysis cycler) and instructions in home dialysis procedures for PD to facilitate adequate dialysis as prescribed by the practitioner; • Training in proper storage and administration of Erythropoiesis-Stimulating Agents (ESAs), if applicable; • How to identify/recognize medical emergencies, implement immediate responses/actions and methods for contacting emergency medical systems. Medical emergencies may include, but are not limited to, cardiac arrest, drug reactions, suspected pyrogen reactions, profound hypotension or hypertension and significant blood loss; • How to recognize, manage and report dialysis complications, including catheter, tunnel or exit site infection; peritonitis; catheter dislodgement; hypotension; hypokalemia; failure of sufficient dialysate to drain from the peritoneal space; protein malnutrition; • Indications for the use of gloves, masks, and other personal protective equipment, methods for hand hygiene, peritoneal catheter care and dressing changes, cleaning and disinfecting dialysis equipment, cleaning and disinfection procedures for spills and splashes of effluent; • How to properly dispose of needles, effluents, disposable items, and tubing and to minimize risks of infection or injury to self and others and to prevent environmental contamination (e.g. using impervious puncture resistant containers for disposal of sharps, placing empty dialysate bags and tubing in intact plastic bags before discarding.); and • Recognizing, managing and reporting power outages, failure of the PD cycler. Provision of PD Treatment PD may be provided via the following modalities: • Continuous ambulatory peritoneal dialysis (CAPD) is a treatment in which dialysis solution is introduced through a catheter into the abdomen via gravity and the bag is disconnected. After a specified period of time, the catheter is reconnected and drains the solution containing wastes back into the bag. CAPD does not require a machine; the process uses gravity to fill and empty the abdomen. CAPD may be provided during three or four exchanges during the day and one overnight. A mini-cycler machine may be used to exchange the dialysis solution overnight as the resident sleeps; or • Continuous cycler-assisted peritoneal dialysis (CCPD) uses a machine to fill and empty the abdomen three to five times during the night. In the morning, the last fill remains in the abdomen with a dwell time that is individualized according to the resident’s needs. In some cases, an additional exchange is done in the mid- afternoon to increase the amount of waste removed and to prevent excess fluid absorption. For a resident receiving PD, the practitioner orders for the individualized prescription must include at least the number of exchanges or cycles to be done during each dialysis session, the volume of fluid with each exchange, duration of fluid in the peritoneal cavity, the concentration of glucose or other osmotic agent to be used for fluid removal, and the use of an automated, manual, or combined techniques. Before, during and after receiving the PD, nursing home staff must, based on practitioner’s orders and professional standards of practice, obtain vital signs, weights, assess the resident’s stability level of consciousness, and comfort or distress; and monitor for post-dialysis complications and symptoms such as but not limited to dizziness, nausea, fatigue or hypotension. The staff must report identified or suspected complications immediately to the attending practitioner and dialysis staff to enable timely interventions. The resident’s record must include documentation of ongoing evaluation of the peritoneal catheter, including assessment of catheter related infections (For example, exit site acute and chronic infections) and tunnel for condition, monitoring for patency, leaks, infection, and bleeding at the site. In addition, staff should be monitoring for complications such as peritonitis (For example, abdominal pain/tenderness/distention, cloudy PD fluid, fever, nausea and vomiting). NOTE: For more information related to PD related infections, refer to https://www.cdc.gov/disasters/icfordialysis.html Interim and Emergency Medications for Residents Receiving Dialysis Nursing homes must have access to medications and treatments such as antibiotics and intravenous fluids to treat common complications of dialysis. The nursing home staff must collaborate with the medical director, consultant pharmacist and dialysis facility to develop policies and procedures to address common complications and to ensure access to needed medications. The attending practitioner and dialysis team may have prescribed Erythropoiesis- Stimulating Agents (ESAs), which are medications that may be used to treat anemia in a resident with a diagnosis of ESRD. These medications act similarly to erythropoietin to stimulate the production of red blood cells and are administered either intravenously or subcutaneously. Commonly used ESAs include Epogen (epoetin alfa) 2 and Aranesp (darbepoetin alfa). Other causes of anemia unrelated to kidney disease (e.g., hemolytic anemia and blood loss anemia) may also occur in individuals with ESRD. Additionally, many anemic individuals with ESRD are also treated with iron supplements because iron is necessary for the production of red blood cells. These include iron supplements such as Venofer (iron sucrose) and Ferrlecit (sodium ferric gluconate complex) to treat iron- deficiency anemia. NOTE: ESAs were approved by the FDA starting with Epogen for the treatment of anemia in 1989 and Aranesp in 2001. Since the approval, the product labeling for this https://www.cdc.gov/disasters/icfordialysis.html class of medications has been updated several times to incorporate new safety information. The FDA approved-new labeling for both drugs in March 2007 that included a warning that ESAs can increase the risk for death and serious cardiovascular events (including myocardial infarction, stroke, heart failure) when they are dosed to achieve a target hemoglobin of greater than 12 g/dL. For individuals with chronic kidney disease on dialysis, FDA approved labels for ESAs now recommend that health care professionals initiate ESA treatment when the hemoglobin level is less than 10 g/dL and that the dose be reduced or interrupted if the hemoglobin approaches or exceeds 11 g/dL,. Ongoing monitoring is mandated to ensure efficacy as well as safety and reimbursement of the medication(s). http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandpro viders/ucm109375.htm Depending on the dialysis method and the resident’s comorbidities, medication administration may need to be modified. The attending practitioner and nephrologist determine which medications are to be administered during dialysis, which are to be held prior to dialysis (e.g., because of excessive hypotension during dialysis), whether any specific medications are to be given prior to dialysis and any medications (such as antibiotics or ESA’s) that are to be given by dialysis staff. All such medication administration must be coordinated, communicated and documented between dialysis staff, nursing home staff, and practitioners. (For issues related to medications and or pharmacy review, refer to F757 Unnecessary Medications, and/or F755 Pharmacy Services and/or F756 – Pharmacy Review.) Canceling or Postponing Dialysis (Either HD, HHD and/or PD) The nephrologist/dialysis team, the resident’s attending practitioner must be notified of the canceled or postponed dialysis treatment and responses to the change in treatment must be documented in the resident’s medical record. If dialysis is canceled or postponed, the nursing home and dialysis staff should provide or obtain ongoing monitoring and medical management for changes such as fluid gain, respiratory issues, review of relevant lab results, and any other complications that occur until dialysis can be rescheduled based on resident assessment, stability and need. • Lack of sufficient trained and qualified staff to provide treatments In the event circumstance do not allow dialysis to be provided by the designated trained and qualified individual, the nursing home must immediately notify the dialysis facility in order to make arrangements to assure that no dialysis treatments are missed. • Equipment Failure for HHD/PD Dialysis may be stopped, postponed, or delayed due to dialysis equipment failure. If this happens during dialysis, the staff and practitioner must assess the resident immediately to assure that urgent medical needs are met, identify and manage any consequences, contact the dialysis facility and reschedule the dialysis as appropriate and/or transport the resident to the off-site certified dialysis facility to receive the required dialysis treatments. The staff must check the equipment and http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm109375.htm http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm109375.htm supplies to identify what happened, and why, and arrange with the dialysis facility for the repair/replace the equipment and supplies as necessary. • Resident Declines or Acute Illness, Or Resident Complications Dialysis may be stopped, postponed or delayed due to a resident’s declines of the dialysis treatment or the presence of acute illness or complications to the resident before, during, after, and in between dialysis sessions. As part of care coordination between the nursing home and the dialysis facility, there must be a systematic approach to handling situations where the resident has a condition change and/or becomes ill or unstable during dialysis. This approach includes knowing who is to be contacted, who decides whether to stop dialysis, who documents the situation, under what circumstances dialysis may be terminated and when the dialysis treatment may be restarted or the next treatment scheduled. The record must reflect the how the missed treatments will be addressed in order to prevent an avoidable decline and/or potential complications. If a resident wants to decline the dialysis treatment(s), the nursing home and dialysis facility social workers, should coordinate services to assess psychosocial concerns related to the resident’s desire to discontinue dialysis treatments. The nursing home and dialysis staff must coordinate their approaches in order to provide immediate care for possible emergencies and complications, such as cardiac arrest during dialysis. Any orders related to cardio-pulmonary resuscitation (CPR) and any documents that might be needed (e.g., practitioner orders for life-sustaining treatment, advance directives including code status) must be available for both the nursing home and the dialysis staff. Knowledge of existing advance directives, including specific directives about treatment choices and code status, must be communicated between dialysis and nursing home staff to ensure that there is a uniform approach, consistent with State laws and regulations. (Refer to F678 – Advance Directives) ADMINISTRATIVE REVIEW OF NURSING HOME PRACTICES As appropriate, the administrator, nursing director, medical director, and pharmacist, and the QAA committee should review the nursing home’s dialysis care and services on an ongoing basis including: • The communication, training, supervision and care coordination between the nursing home and the participating dialysis facility; • Whether policies and procedures for the types of dialysis that are provided in the nursing home are consistent with current standards of practice and are being followed consistently; • Any complications associated with dialysis provision, such as those associated with potential breeches in infection control, those resulting in hospitalization and those due to equipment, technique, process failures, or supplies; • Provision of ongoing staff training which is individualized to meet the needs of each HHD/PD resident. Staff training must be provided by qualified dialysis facility instructors and include how to address emergencies; and • Communication and coordination between the nursing home and the dialysis facility in sharing data about outcomes and processes and reviewing quality indicators and care issues. Investigative Summary for Dialysis Care and Services Use Use the Dialysis Critical Element (CE) Pathway, along with the interpretive guidelines when determining if the facility meets the requirements for providing care and services for a resident receiving dialysis services, in accordance with professional standards of practice, and the comprehensive person-centered care plan, Summary of Investigative Procedure Briefly review the most recent comprehensive assessments, comprehensive care plan and orders to identify whether the facility has recognized, assessed, provided interventions and implemented care and services according to professional standards of practice in order to meet the resident’s dialysis care needs under investigation. This information will guide observations and interviews to be made in order to corroborate concerns identified. In addition, investigate to assure that there are sufficient numbers of trained, qualified and competent staff to provide the interventions identified for a resident receiving dialysis care and services. If the resident has been in the facility for less than 14 days (before completion of all the Resident Assessment Instrument (RAI) is required), review the baseline care plan which must be completed within 48 hours to determine if the facility is providing appropriate care and services based on information available at the time of admission. In addition, review to determine whether the comprehensive care plan is evaluated and revised based on the resident’s response to interventions. NOTE: Always observe for visual cues of psychosocial distress and harm (see Appendix P, Guidance on Severity and Scope Levels and Psychosocial Outcome Severity Guide). In addition, if noncompliance at this tag demonstrates a pervasive disregard for the resident’s quality of life, consider investigating concerns at F675 – Quality of Life. OTHER TAGS, CARE AREAS (CA) AND TASKS TO CONSIDER: Dignity CA (F550); Right to be informed and make treatment decisions (F552); Right to refuse (F578); Advance Directives CA (F561); Notification of change (F580); Accommodation of needs, call system (Environment task & F558); Be provided by qualified persons (F659); Pressure ulcer CA (F686); Nutrition CA(F692); Hydration CA (F692); Sufficient and Competent Staffing (Task & F725); Unnecessary Medications CA (F757); Infection Control (Task & F880); Medical director (F841); Resident Records (F842); and QA&A QAPI (Task F868); DEFICIENCY CATEGORIZATION (Part IV, Appendix P) NOTE: The death or transfer of a resident, who was harmed as a result of nursing home practices, does not remove a finding of immediate jeopardy. The nursing home is required to implement specific actions to correct the deficient practices which allowed or caused the immediate jeopardy. Examples that demonstrate severity at Level 4 include, but are not limited to: • The nursing home failed to ensure that the nursing home staff provided adequate monitoring for a resident after returning from receiving an offsite HHD treatment at an ERSD unit. The resident was found to have pulled out the hemodialysis catheter and was found by staff over an hour later to be profusely bleeding which led to death. • The nursing home failed to ensure that nursing home staff providing the HHD monitored and identified complications during a dialysis treatment. The resident’s vital signs were not monitored during the dialysis treatment and as a result, the resident experienced serious hypotensive complications resulting in an emergency transfer and admission to the hospital. • The nursing home failed to ensure that the nursing home staff monitored the PD catheter site for complications. The nursing home staff providing the PD treatments, failed to monitor the condition of the PD catheter site and identify signs of infection. As a result of the infection at the catheter site, the resident required medical intervention for removal of the catheter and initiation of hemodialysis. Examples that demonstrate severity at Level 3 may include, but are not limited to: • The nursing home failed to notify the attending practitioner and dialysis team of changes in a resident’s behavior and failed to assure the treatments were provided according to the orders. A cognitively impaired resident was observed during a HHD treatment to exhibit combative and resistive behaviors, such as pulling at the tubing and access site. The resident had a history of previously dislodging the catheter, causing bleeding. The resident was observed trying to remove his/her shoes and trying to stand up from the dialysis chair and requires constant supervision during the treatment. The staff attributed the behavioral symptoms to dementia and administered a benzodiazepine to try to sedate the resident. Due to the behavioral symptoms, the HHD treatment had to be discontinued but the practitioner wasn’t contacted regarding discontinuing the treatment. This had occurred several times, however the nursing home staff failed to contact the practitioner, identify underlying causes, such as delirium or medication side effects and did not attempt to consider environmental or other non- pharmacological measures to try to reduce the restlessness during dialysis. As a result of the treatments being discontinued early, the resident had electrolyte imbalance and fluid retention. Examples that demonstrate Severity Level 2 include, but are not limited to: • The nursing home failed to ensure that the nursing home staff provided PD treatments as ordered. The nursing home staff providing the PD failed to follow the orders for the duration of fluid in the peritoneal cavity however, the resident’s status was stable. • The nursing home failed to ensure that the nursing home staff provided PD treatments as ordered. The nursing home staff failed to identify a recent change in a resident’s dialysis order for an increase in the number of daily PD treatments; however, the resident’s status was stable. Severity Level 1: No actual harm with potential for minimal harm The failure of the nursing home to provide appropriate care and services to a resident who is receiving dialysis care and services is more than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement. F699 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.25(m) Trauma-informed care The facility must ensure that residents who are trauma survivors receive culturally competent, trauma-informed care in accordance with professional standards of practice and accounting for residents’ experiences and preferences in order to eliminate or mitigate triggers that may cause re-traumatization of the resident. INTENT The intent of this requirement is to ensure that facilities deliver care and services which, in addition to meeting professional standards, are delivered using approaches which are culturally-competent and account for experiences and preferences, and address the needs of trauma survivors by minimizing triggers and/or re-traumatization. DEFINITIONS “Culture” is the conceptual system that structures the way people view the world—it is the particular set of beliefs, norms, and values that influence ideas about the nature of relationships, the way people live their lives, and the way people organize their world. Adopted from Substance Abuse and Mental Health Services Administration. Improving Cultural Competence. Treatment Improvement Protocol (TIP) Series No. 59. HHS Publication No. (SMA) 14- 4849. https://store.samhsa.gov/system/files/sma14-4849 . “Cultural competency” is a developmental process in which individuals or institutions achieve increasing levels of awareness, knowledge, and skills along a cultural competence continuum. Cultural competence involves valuing diversity, conducting self- assessments, avoiding stereotypes, managing the dynamics of difference, acquiring and institutionalizing cultural knowledge, and adapting to diversity and cultural contexts in communities. US Department of Health and Human Services publication: A Blueprint for Advancing and Sustaining CLAS Policy and Practice at: https://thinkculturalhealth.hhs.gov/clas/blueprint#:~:text=A%20Blueprint%20for%20Adv https://store.samhsa.gov/system/files/sma14-4849 https://thinkculturalhealth.hhs.gov/clas/blueprint#:%7E:text=A%20Blueprint%20for%20Advancing%20and%20Sustaining%20CLAS%20Policy,culturally%20and%20linguistically%20appropriate%20services%20within%20your%20organization ancing%20and%20Sustaining%20CLAS%20Policy,culturally%20and%20linguistically %20appropriate%20services%20within%20your%20organization . “Trauma” results from an event, series of events, or set of circumstances that is experienced by an individual as physically or emotionally harmful or life threatening and that has lasting adverse effects on the individual’s functioning and mental, physical, social, emotional, or spiritual well-being (“Trauma.” SAMHSA-HRSA Center for Integrated Health Solutions. Substance Abuse and Mental Health Services Administration. 30 Nov 2016. Accessed at: https://www.samhsa.gov/resource/dbhis/samhsas-concept-trauma-guidance-trauma- informed-approach. “Trauma-informed care” is an approach to delivering care that involves understanding, recognizing and responding to the effects of all types of trauma. A trauma-informed approach to care delivery recognizes the widespread impact and signs and symptoms of trauma in residents, and incorporates knowledge about trauma into care plans, policies, procedures and practices to avoid re-traumatization. Referred to variably as “trauma- informed care” or “trauma-informed approach.” Adapted from Concept of Trauma and Guidance for a Trauma-Informed Approach: https://store.samhsa.gov/system/files/sma14-4884 GUIDANCE: §483.25(m) Background: Increasingly diverse demographics among nursing home residents require nursing homes to provide culturally competent care. Cultural competency, which includes language, and cultural preferences, and other cultural aspects such as thoughts, communications, actions, customs, beliefs, values, and institutions of racial, ethnic, religious, or social groups, is an important aspect of person-centered care. These elements influence the beliefs surrounding health, healing, wellness and the delivery of health services and are critical to reducing health disparities. “Cultural competence has emerged as an important issue for three practical reasons. First, as the United States becomes more diverse, practitioners will increasingly see people with a broad range of perspectives on health, often influenced by their social or cultural backgrounds. Second, research has shown that provider-patient communication is linked to health outcomes. 1 And third, two landmark Institute of Medicine (IOM) reports—Crossing the Quality Chasm and Unequal Treatment—highlight the importance of patient-centered care and cultural competence in improving quality and eliminating health disparities.2 According to the Substance Abuse and Mental Health Services Administration (SAMHSA), seventy percent (70%) of adults in the United States have experienced some type of traumatic event, at least once in their lives. There is a direct correlation between trauma and physical health conditions such as diabetes, chronic obstructive pulmonary disease (COPD), heart disease, cancer, and high blood pressure. While care and services must always be person-centered and honor residents’ choice and preferences, what is different about providing care and services to a trauma survivor is that these residents may have lost the ability to trust caregivers, and to feel safe in their https://thinkculturalhealth.hhs.gov/clas/blueprint#:%7E:text=A%20Blueprint%20for%20Advancing%20and%20Sustaining%20CLAS%20Policy,culturally%20and%20linguistically%20appropriate%20services%20within%20your%20organization https://thinkculturalhealth.hhs.gov/clas/blueprint#:%7E:text=A%20Blueprint%20for%20Advancing%20and%20Sustaining%20CLAS%20Policy,culturally%20and%20linguistically%20appropriate%20services%20within%20your%20organization https://www.samhsa.gov/resource/dbhis/samhsas-concept-trauma-guidance-trauma-informed-approach https://www.samhsa.gov/resource/dbhis/samhsas-concept-trauma-guidance-trauma-informed-approach https://store.samhsa.gov/system/files/sma14-4884 environment. As a result, the principles of trauma-informed care must be addressed and applied purposefully. The following principles pertaining to trauma-informed care have been adapted from SAMHSA’s Concept of Trauma and Guidance for a Trauma-Informed Approach, located at https://store.samhsa.gov/system/files/sma14-4884 • Safety – Ensuring residents have a sense of emotional and physical safety. • Trustworthiness and transparency – Efforts to establish a relationship based on trust, and clear and open communication between the staff and the resident. • Peer support and mutual self-help – If practicable, it may be appropriate to assist the resident in locating and arranging to attend support groups which are organized by qualified professionals. It may be possible for the group to meet in the facility. • Collaboration – There is an emphasis on partnering between a resident and/or his or her representative, and all staff and disciplines involved in the resident’s care in developing the plan of care. There is recognition that healing happens in relationships and in the meaningful sharing of power and decision-making. • Empowerment, voice, and choice – Ensuring that resident’s choice and preferences are honored and that residents are empowered to be active participants in their care and decision-making, including recognition of, and building on resident’s strengths. Assessment Facilities should use a multi-pronged approach to identifying a resident’s history of trauma as well as his or her cultural preferences. This would include asking the resident about triggers that may be stressors or may prompt recall of a previous traumatic event, as well as screening and assessment tools such as the Resident Assessment Instrument (RAI), Admission Assessment, the history and physical, the social history/assessment, and others. There are many psychosocial screening and assessment tools available including assessment tools from the United States Department of Veterans Affairs site PTSD: National Center for PTSD, https://www.ptsd.va.gov/professional/index.asp . Trauma Residents of long-term care facilities may include, but are not limited to, trauma survivors such as military veterans, survivors of large-scale natural and human-caused disasters, Holocaust survivors, survivors of physical, sexual, and/or mental abuse (past or current), or other violent crime, as well as residents with a history of imprisonment, homelessness, or who have suffered the traumatic loss of a loved one. The history and physical assessment done by the attending physician can reveal many clues to a resident’s history of trauma. Scars and other signs of physical trauma should be explored to determine the cause if the resident is comfortable/agreeable with https://store.samhsa.gov/system/files/sma14-4884 https://www.ptsd.va.gov/professional/index.asp discussing them. Numerical tattoos may be an indicator of World War II Holocaust survivors. Residents with a history of trauma may have diagnoses such as anxiety, depression, or may have substance abuse issues such as alcoholism, and/or may abuse prescription medications or street drugs. Evidence of physical and/or psychological trauma can be revealed during a comprehensive social history or assessment by the social worker. Triggers Facilities must identify triggers which may re-traumatize residents with a history of trauma. A trigger is a psychological stimulus that prompts recall of a previous traumatic event, even if the stimulus itself is not traumatic or frightening. For many trauma survivors, the transition to living in an institutional setting (and the associated loss of independence) can trigger profound re-traumatization. While most triggers are highly individualized, some common triggers may include: • Experiencing a lack of privacy or confinement in a crowded or small space; • Exposure to loud noises, or bright/flashing lights; • Certain sights, such as objects that are associated with those that used to abuse, and/or • Sounds, smells, and even physical touch. Culture As mentioned in the Background section above, the increasingly changing demographics of nursing homes has led to the need to provide culturally competent care. In addition to racial and ethnic diversity, this also includes religious preference, sexual orientation, and gender identity. There are several tools that facilities may use in addition to the Resident Assessment Instrument (RAI) to assist them in identifying a resident’s cultural preferences. Chapter 3 of the RAI gives guidance on completing Minimum Data Set (MDS) items in section A that addresses Race, Ethnicity, and Language with which the resident most closely identifies. These MDS items may be indicators of a resident’s culture and may indicate further assessment is necessary to determine if there are any cultural preferences which should be honored while the resident is in the facility. The categories in this classification are socio-political constructs and should not be interpreted as being scientific or anthropological in nature. They provide demographic race/ethnicity specific health trend information. These categories are NOT used to determine eligibility for participation in any Federal program. MDS Section A identifies whether the resident wants or needs an interpreter and the resident’s preferred language. Inability to make needs known and to engage in social interaction because of a language barrier can result in isolation, depression, and unmet needs. Language barriers can interfere with accurate assessment. Facilities must use their Facility Assessment (See F838 for additional guidance related to Facility Assessment) to identify resident populations having unique cultural characteristics, such as language (including American Sign Language), religious or cultural practices, values, and preferences. This facilitates a facility-wide and department-wide understanding of cultural differences and how to approach the provision of care and services with dignity and respect for the individual. (Also see, F675, Quality of Life, for further discussion of the impact of cultural differences on residents and staff.) NOTE: Facilities are required to communicate effectively, both verbally and in writing, with residents in a language and manner they can understand. For additional information see F552, Right to be Informed/Make Treatment Decisions; F572, Notice of Rights and Rules; and F573, Right to Access/Purchase Copies of Records. Cultural Competencies Cultural competencies help staff communicate effectively with residents and their families and help provide care that is appropriate to the culture and the individual. Cultural competence (also known as cultural responsiveness, cultural awareness, and cultural sensitivity) refers to a person’s ability to interact effectively with persons of cultures different from his/her own. With regard to health care, cultural competence is a set of behaviors and attitudes held by clinicians that allows them to communicate effectively with individuals of various cultural backgrounds and to plan for and provide care that is appropriate to the culture and to the individual. The following resources are intended for informational purposes only: • The National Center for Cultural Competence https://nccc.georgetown.edu • The National Standards for Culturally and Linguistically appropriate Services in Health and Health Care (developed by the Office of Minority Health in HHS)https://www.thinkculturalhealth.hhs.gov/clas/blueprint • Office of Minority Health “Think Cultural Health” website https://www.thinkculturalhealth.hhs.gov • Georgetown University publication: Cultural Competence in Health Care: Is it important for people with chronic conditions https://hpi.georgetown.edu/agingsociety/pubhtml/cultural/cultural.html Care Planning to Address Past Trauma The facility should collaborate with resident trauma survivors, and as appropriate, the resident’s family, friends, and any other health care professionals (such as psychologists, mental health professionals) to develop and implement individualized interventions. In some cases, if a facility has more than one trauma survivor, social services might consider establishing a support group that is run by a qualified professional, or allowing a support group to meet in the facility. In situations where a trauma survivor is reluctant to share his or her history, facilities are still responsible to try to identify triggers which may https://nccc.georgetown.edu/ https://www.thinkculturalhealth.hhs.gov/clas/blueprint https://www.thinkculturalhealth.hhs.gov/ https://hpi.georgetown.edu/agingsociety/pubhtml/cultural/cultural.html re-traumatize the resident, and develop care plan interventions which minimize or eliminate the effect of the trigger on the resident. Trigger-specific interventions should identify ways to decrease the resident’s exposure to triggers which re-traumatize the resident, as well as identify ways to mitigate or decrease the effect of the trigger on the resident. Examples of trigger-specific interventions include, but are not limited to the following: Trigger Intervention Showers/shower fixtures Provide alternative methods for bathing such as tubs, sponge bath. Confinement in small/crowded spaces Offer individual or small group activities Loud noises Decrease/eliminate exposure to loud noises during holiday celebrations (July 4th, New Year’s Eve); and/or decrease volume of, or eliminate overhead paging systems Removal of clothing Consideration should be given to methods of assistance given to resident such as: • Consistent staffing/same-sex care giver • Removing clothing slowly • Explanation of what is happening Exposure to smoke or fire • Remove from areas where smoking is permitted, or cookouts occur; • Provide alternative meals inside facility Additionally, trauma-specific interventions should recognize the interrelation between trauma and symptoms of trauma such as substance abuse, eating disorders, depression, and anxiety. Trauma-specific interventions generally recognize the survivor's need to be respected, informed, connected, and hopeful regarding their own recovery. Trauma survivors may need access to support groups either in the facility or in the community, if appropriate and feasible. Care Planning to address Cultural Preferences When a facility admits a resident, it has determined that it can provide the individualized care and services that resident requires. Facilities must create and sustain an environment that humanizes and promotes each resident’s well-being and feeling of self-worth and self-esteem. This requires nursing home leadership to establish a culture that treats each resident with respect and dignity as an individual, and addresses, supports and/or enhances his/her feelings of self-worth including personal control over choices and cultural preferences. It is important for facilities to be aware of the impact of culture and cultural preferences on the provision of care and have an understanding of the cultural norms and practices of the individuals they care for. For example, in some cultures, it may be considered taboo to direct care at end of life; or in other cultures care must be provided by caregivers of the same sex as the resident. In order to provide culturally competent care, staff must understand the cultural preferences of the individual and how it impacts the delivery of care. A key component is identifying how to communicate with the resident, in order to be able to identify physical concerns and issues, and for developing a trusting relationship with staff. For example, if the resident is non-English speaking, or has limited understanding of English, the facility should identify how communication will occur with the resident. The care plan should identify the language spoken and what tools are available to communicate, whether it be with a communication board or other systems, or through translators. If communication systems are used, all staff interacting with the resident must know where those materials are kept, must understand how to use them, and consistently implement use of those methods. Staff must demonstrate proficiency in communicating with the resident to assure that critical information can be conveyed, such as a change in condition, the presence of pain, explanation of routine care, and the ability to refuse care and services. The facility must provide sufficient guidance for staff, including temporary staff, on how to communicate and deliver care for the resident. See also §483.10(c)(1), Resident Rights and §483.21(b)(3)(iii) Comprehensive Person-Centered Care Planning. There are many aspects of cultural preferences which may impact the delivery of care, such as: • Food preparation and choices; • Clothing preferences such as covering hair or exposed skin; • Physical contact or provision of care by a person of the opposite sex; or • Cultural etiquette, such as avoiding eye contact or not raising the voice. Additionally, facilities should consider: • Offering activities that are culturally relevant to resident populations within the facility; • Group activities with both sexes may not be permitted or appropriate in some cultures, or the type of programming may be in conflict with his/her cultural preferences; • Providing reading materials, movies, newspapers in the resident’s preferred language may help orient a resident to date, times and events; • Allowing the performance of religious rites at end of life to the extent possible; and • Certain medications, procedures or treatments may be prohibited. Social services and facility administration may need to evaluate how forms, including informed consent forms, are provided in the language used by the resident. As mentioned above, this is a facility-wide opportunity to provide a culturally diverse environment, respecting and treating each resident with dignity. Assisting the resident and his/her representative with daily schedules, developed with input by the resident/representative, ahead of time may alleviate fear and frustration. Resident-specific approaches must be developed and included in the resident’s care plan. These interventions must be provided consistently, and supervising staff should monitor the delivery of care and staff interactions with the resident to assure they are implemented as written. Using consistent staff, to the extent possible, will assist the resident in feeling more comfort in the facility. If concerns related to culturally competent and/or trauma- informed care planning are identified, see additional guidance at §483.21(b) in F656. Monitoring Delivery of Care and Services As required with any care plan interventions, facilities must monitor the effects of their approaches to ensure they are implemented as intended, and are having the desired effect to achieve the measurable objectives and the resident’s goals for care. For residents with a history of trauma in particular, facilities must evaluate whether the interventions have been able to mitigate (or reduce) the impact of identified triggers on the resident that may cause re-traumatization. It is critical to involve the resident and/or his or her family or representative in this evaluation to ensure clear and open discussion and better understand if interventions must be modified. It may be necessary to engage the services of an interpreter to monitor or evaluate the effect of cultural interventions for non-English speaking residents. As noted above, it is critical to involve the resident and/or his or her family in evaluating the effectiveness of cultural interventions in achieving measurable objectives and resident goals. Surveyors should refer to the following when investigating concerns and citing noncompliance related to culturally-competent, trauma-informed care: • F656: For concerns related to development or implementation of culturally competent and/or trauma-informed care plan interventions; • F699: For concerns related to outcomes or potential outcomes to the resident related to culturally-competent and/or trauma-informed care; • F726: For concerns related to the knowledge, competencies, or skill sets of nursing staff to provide care or services that are culturally competent and trauma- informed. • F742: For concerns related to treatment and services for resident with history of trauma and/or history of post-traumatic stress disorder (PTSD) KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F699, the surveyor's investigation will generally show that the facility failed to do any one of the following: • Identify cultural preferences of residents who are trauma survivors; • Identify a resident’s past history of trauma, and/or triggers which may cause re- traumatization; • Consistently use approaches that are culturally competent and/or are trauma- informed INVESTIGATIVE SUMMARY Use the General Critical Element (CE) Pathway along with the above interpretive guideline when determining if the facility meets the requirements to provide culturally competent, trauma-informed care in accordance with professional standards of practice and accounting for residents’ experiences and preferences in order to eliminate or mitigate triggers that may cause re-traumatization of the resident. DEFICIENCY CATEGORIZATION An example of Severity Level 4 Noncompliance: Immediate Jeopardy to Resident Health or Safety includes, but is not limited to: A resident was admitted with a history of sexual abuse by a male and a diagnosis of post- traumatic stress disorder. The resident requested only female staff provide perineal care due to her severe trauma. A male staff person answered the resident’s call light for assistance to the bathroom and insisted on performing perineal care as he was the only staff member available at the time. She refused his assistance and began to get visibly upset and requested that a female staff member be called in. The resident stated that the male staff member insisted on performing perineal hygiene after she had toileted despite the residents past trauma. After returning her to her bed, she was crying and distraught and stated that she was afraid to request assistance with perineal care as he might return. She stated she cried all night and that she had profuse sweating, fearing that someone was outside her door, waiting to come in if she fell asleep. Eventually the resident fell asleep but awakened screaming, kicking and throwing objects, re-living her previous sexual assault. She told staff who came into her room that she was fearful for her life, felt dirty and demeaned, that she wasn’t respected, and there was no reason to go on living. An example of Severity Level 3 Noncompliance: Actual Harm that is not Immediate Jeopardy includes, but is not limited to: Residents were gathered to watch July 4th fireworks on television. A resident with a known history of surviving a mass shooting several years ago was placed in the activity room to watch the fireworks. When the show began, the resident became tearful and frightened when he heard the sound of the fireworks which resembled the sound of gun shots. The facility staff noticed that the resident was tearful and appeared frightened. When asked what was wrong, the resident shared that he was having flashbacks from the mass shooting he survived years ago. The staff member rubbed the resident’s back and said “it will be okay \\\\\, the show is only 30 minutes long.” The resident remained in the activity room for the duration of the fireworks and continued to be tearful. In the following weeks, the resident decreased his attendance at activities that he previously enjoyed. An example of Severity Level 2 Noncompliance: No Actual Harm with potential for more than minimal harm that is not Immediate Jeopardy includes, but is not limited to: Facility staff escorted residents to a local baseball game. One of the residents was a survivor of a refugee camp and is not comfortable in highly populated areas. Prior to leaving for the game, facility staff failed to consider the resident’s discomfort with crowded areas due to his time in a refugee camp. Upon arriving to the baseball game, there were hundreds of fans that came to watch the game. While watching the game, the resident informed one of the facility staff members that he was not enjoying himself because he was feeling anxious in the stadium with so many people around him and often has panic attacks when he is in crowded areas too long. The facility staff member immediately escorted the resident out of the stadium and onto the bus where his anxiety resolved. An example of Severity Level 1 noncompliance: No actual harm with potential for minimal harm: Because of the potential for psychosocial harm, noncompliance at F699 should generally not be cited at severity level 1. 1 Lurie, N., Jung, M., & Lavizzo-Mourey, R. (2005). Disparities and quality improvement: Federal policy levers. Health Affairs, 24(2), 354- 364. 2 Betancourt, J. R., Green, A. R., Carillo, J. E., & Park, E. R. (2005). Cultural competence and health care disparities: Key perspectives and trends. Health Affairs, 24(2), 499-505. F700 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.25(n) Bed Rails. The facility must attempt to use appropriate alternatives prior to installing a side or bed rail. If a bed or side rail is used, the facility must ensure correct installation, use, and maintenance of bed rails, including but not limited to the following elements. §483.25(n)(1) Assess the resident for risk of entrapment from bed rails prior to installation. §483.25(n)(2) Review the risks and benefits of bed rails with the resident or resident representative and obtain informed consent prior to installation. §483.25(n)(3) Ensure that the bed’s dimensions are appropriate for the resident’s size and weight. §483.25(n)(4) Follow the manufacturers’ recommendations and specifications for installing and maintaining bed rails. INTENT §483.25(n) The intent of this requirement is to ensure that prior to the installation or use of bed rails, the facility attempts to use alternatives. If the attempted alternatives were not adequate to meet the resident’s needs, the resident is assessed for the use of bed rails, which includes a review of risks including entrapment; and informed consent is obtained from the resident or if applicable, the resident representative. The facility must ensure the bed is appropriate for the resident and that bed rails are properly installed and maintained. DEFINITIONS §483.25(n) "Entrapment" is an event in which a resident is caught, trapped, or entangled in the space in or about the bed rail. “Bed rails” are adjustable metal or rigid plastic bars that attach to the bed. They are available in a variety of types, shapes, and sizes ranging from full to one-half, one- quarter, or one-eighth lengths. Also, some bed rails are not designed as part of the bed by the manufacturer and may be installed on or used along the side of a bed. Examples of bed rails include, but are not limited to: • Side rails, bed side rails, and safety rails; and • Grab bars and assist bars. GUIDANCE §483.25(n) Even when bed rails are properly designed to reduce the risk of entrapment or falls, are compatible with the bed and mattress, and are used appropriately, they can present a hazard to certain individuals, particularly to people with physical limitations or altered mental status, such as dementia or delirium. Resident Assessment After a facility has first attempted to use appropriate alternatives to bed rails and determined that these alternatives do not meet the resident’s needs, the facility must assess the resident for the risks of entrapment and review possible risks and benefits of bed rails prior to installation or use. In determining whether to use bed rails to meet the needs of a resident, the following components of the resident assessment should be considered including, but not limited to: • Medical diagnosis, conditions, symptoms, and/or behavioral symptoms; • Size and weight; • Sleep habits; • Medication(s); • Acute medical or surgical interventions; • Underlying medical conditions; • Existence of delirium; • Ability to toilet self safely; • Cognition; • Communication; • Mobility (in and out of bed); and • Risk of falling. In addition, the resident assessment must include an evaluation of the alternatives that were attempted prior to the installation or use of a bed rail and how these alternatives failed to meet the resident’s assessed needs. The facility must also assess the resident’s risk from using bed rails. The following includes examples of the potential risks with the use of bed rails, as identified by the Food and Drug Administration’s Hospital Bed Safety Workgroup Clinical Guidance For the Assessment and Implementation of Bed Rails In Hospitals, Long Term Care Facilities, and Home Care Settings (April 2003), and that have been adapted for surveyor guidance: • Accident hazards o The resident could attempt to climb over, around, between, or through the rails, or over the foot board, o A resident or part of his/her body could be caught between rails, the openings of the rails, or between the bed rails and mattress. • Barrier to residents from safely getting out of bed o A resident could crawl over rails and fall from greater heights increasing the risk for serious injury o A resident could attempt to get out of bed over the foot board • Physical restraint o Hinders residents from independently getting out of bed thereby confining them to their beds o Creates a barrier to performing routine activities such as going to the bathroom or retrieving items in his/her room • Other potential negative physical outcomes o Decline in resident function, such as muscle functioning/balance o Skin integrity issues o Decline in other areas of activities of daily living such as using the bathroom, continence, eating, hydration, walking, and mobility • Other potential negative psychosocial outcomes o Creates an undignified self-image and alter the resident’s self-esteem o Contributes to feelings of isolation o Induces agitation or anxiety These potential risks can be exacerbated by improper match of the bed rail to bed frame, improper installation and maintenance, and use with other devices or supports that remain when the bed rail is removed. Entrapment may occur when a resident is caught between the mattress and bed rail or in the bed rail itself. Although not all bed rails create a risk for entrapment, injury may still occur and is varied depending on the resident. Residents most at risk for entrapment are those who are frail or elderly or those who have conditions such as agitation, delirium, confusion, pain, uncontrolled body movement, hypoxia, fecal impaction, acute urinary retention, etc. that may cause them to move about the bed or try to exit from the bed. The untimeliness of assistance using the bathroom and inappropriate positioning or other care-related activities can contribute to the risk of entrapment. Informed Consent • After appropriate alternatives have been attempted and prior to installation, the facility must obtain informed consent from the resident or the resident representative for the use of bed rails. The facility should maintain evidence that it has provided sufficient information so that the resident or resident representative could make an informed decision. Information that the facility should provide to the resident, or resident representative include, but are not limited to: • What assessed medical needs would be addressed by the use of bed rails; • The resident’s benefits from the use of bed rails and the likelihood of these benefits; • The resident’s risks from the use of bed rails and how these risks will be mitigated; and • Alternatives attempted that failed to meet the resident’s needs and alternatives considered but not attempted because they were considered to be inappropriate. The information should be presented to the resident or the resident representative, so that it could be understood and that consent can be given voluntarily, free from coercion. Appropriate Alternatives Facilities must attempt to use appropriate alternatives prior to installing or using bed rails. CMS encourages facilities to refer to published information from recognized authorities such as the Food and Drug Administration, which has identified the following alternatives to bed rail use: “Alternatives include: roll guards, foam bumpers, lowering the bed and using concave mattresses that can help reduce rolling off the bed.” This and more information may be found at https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandCo nsumer/ConsumerProducts/BedRailSafety/ucm362843.htm. This webpage was last updated in December, 2017. See also, Clinical Guidance for Assessment and Implementation of Bed Rails in Hospitals, Long Term Care Facilities, and Home Care Settings: https://www.fda.gov/media/88765/download Recommendations for Health Care Providers about bed rails; https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandCo nsumer/ConsumerProducts/BedRailSafety/ucm362848.htm Additionally, alternatives that are attempted should be appropriate for the resident, safe and address the medical conditions, symptoms or behavioral patterns for which a bed rail was considered. For example, a low bed or concave mattress may not be an appropriate alternative to enable movement in bed for a resident receiving therapy for hip- replacement. If no appropriate alternative was identified, the medical record would have to include evidence of the following: • purpose for which the bed rail was intended and evidence that alternatives were tried and were not successful • assessment of the resident, the bed, the mattress, and rail for entrapment risk (which would include ensuring bed dimensions are appropriate for resident size/weight), and • risks and benefits were reviewed with the resident or resident representative, and informed consent was given before installation or use. Installation and Maintenance of Bed Rails Assuring the correct installation and maintenance of bed rails is an essential component in reducing the risk of injury resulting from entrapment or falls. The FDA and the United States Consumer Product Safety Commission (CPSC) has recommended the following initial and ongoing actions to prevent deaths and injuries from entrapment and/or falls from bed rails: • Before bed rails are installed, the facility should: o Check with the manufacturer(s) to make sure the bed rails, mattress, and bed frame are compatible, since most bed rails and mattresses are purchased separately from the bed frame. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BedRailSafety/ucm362843.htm https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BedRailSafety/ucm362843.htm https://www.fda.gov/media/88765/download https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BedRailSafety/ucm362848.htm https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BedRailSafety/ucm362848.htm NOTE: The FDA has published (1) the Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment as a resource to reduce entrapments resulting from hospital beds and (2) Practice Hospital Bed Safety as to the proper dimensions and distance of various parts of the beds (i.e., distance between bed frames and mattresses, bed rails and mattresses, etc.) o Rails should be selected and placed to discourage climbing over rails, which could lead to falling over bed rails. • When installing and using bed rails, the facility should: o Ensure that the bed’s dimensions are appropriate for the resident. o Confirm that the bed rails to be installed are appropriate for the size and weight of the resident using the bed. o Install bed rails using the manufacturer's instructions and specifications to ensure a proper fit. o Inspect and regularly check the mattress and bed rails for areas of possible entrapment. o Regardless of mattress width, length, and/or depth, the bed frame, bed rail and mattress should leave no gap wide enough to entrap a resident’s head or body. Gaps can be created by movement or compression of the mattress which may be caused by resident weight, resident movement or bed position, or by using a specialty mattress, such as an air mattress, mattress pad or water bed. o Check bed rails regularly to make sure they are still installed correctly as rails may shift or loosen over time. In addition, ongoing precautions may include following manufacturer equipment alerts and recalls and increasing resident supervision. The use of a specialty air-filled mattress or a therapeutic air-filled bed may also present an entrapment risk that is different from rail entrapment with a regular mattress. The high compressibility of an air-filled mattress compared to a regular conventional mattress requires appropriate precautions when used for a resident at risk for entrapment. An air- filled mattress compresses on the side to which a person moves, thus raising the center of the mattress and lowering the side. This may make it easier for a resident to slide off the mattress or against the rail. Mattress compression widens the space between the mattress and rail. When a resident is between the mattress and rail, the mattress can re-expand and press the chest, neck, or head against the rail. While using air therapy to prevent and treat pressure injuries, facilities should also take precautions to reduce the risk of entrapment. Precautions may include following manufacturer equipment alerts and increasing supervision. Facilities must also conduct routine preventive maintenance of beds and bed rails to ensure they meet current safety standards and are not in need of repair. CMS recognizes that there are many different types of beds, some with bed rails pre- installed, or bed rails with the call button and lights incorporated into the rail, and others without bed rails pre-installed for which a separate rail could be installed. Facilities should have a process for determining whether beds, including mattresses and rails, are appropriate and safe for their residents. For beds with rails that are incorporated or pre-installed, the facility must determine whether or not disabling the bed rail poses a risk for the resident. Some considerations would include, but are not limited to, the following: • Could the rail simply be moved to the down position and tucked under the bed frame? • When in the down position, does it pose a tripping or entrapment hazard? • Would it have to be physically removed to eliminate a tripping or entrapment hazard? Facilities should follow manufacturers’ recommendations/instructions regarding disabling or tying rails down. CMS regulations do not specify that bed rails must be removed or disabled when not in use. However, if bed rails are not appropriate for the resident and the facility chooses to keep the bed rail on the bed, but in the down position, raising the rail even for episodic use during care would be considered noncompliance if all of the requirements (assessment, informed consent, appropriateness of bed, and inspection and maintenance) are not met prior to the episodic bedrail use for the resident. Ongoing Monitoring and Supervision Assuring the correct use of an installed bed rail and maintenance of bed rails is an essential component in reducing the risk of injury. After the installation of bed rails, it is expected that the facility will continue to provide necessary treatment and care to the resident in accordance with professional standards of practice and the resident’s choices. This should be evidenced in the resident’s records, including their care plan, including, but not limited to, the following information: • The type of specific direct monitoring and supervision provided during the use of the bed rails, including documentation of the monitoring; • The identification of how needs will be met during use of the bed rails, such as for re-positioning, hydration, meals, use of the bathroom and hygiene; • Ongoing assessment to assure that the bed rail is used to meet the resident’s needs; • Ongoing evaluation of risks; • The identification of who may determine when the bed rail will be discontinued; and • The identification and interventions to address any residual effects of the bed rail (e.g., generalized weakness, skin breakdown). KEY ELEMENTS OF NONCOMPLIANCE §483.25(n) To cite deficient practice at F700, the surveyor's investigation will generally show that the facility failed to do one or more of the following: • Identify and use appropriate alternative(s) prior to installing or using a side or bed rail; • Assess the resident for risk of entrapment prior to installing or using a bed rail; • Assess the risk versus benefits of using a bed rail and review them with the resident or the resident’s representative; • Obtain informed consent for the installation and use of bed rails prior to use. • Ensure appropriate dimensions of the bed based on the resident’s size and weight; • Ensure correct installation of bed rails, including adherence to manufacturer’s recommendations and/or specifications; • Ensure correct use of an installed bed or side rail; and • Ensure scheduled maintenance of any bed rail in use according to the manufacturer’s recommendations and specifications. NOTE: If a facility is unable to identify the manufacturer and access the manufacturer information and guidance for bed rails that they use, they would not meet requirements to follow the manufacturers’ recommendations and specifications for installing and maintaining bed rails at 483.25(n)(4). INVESTIGATIVE PROTOCOL §483.25(n) Use this protocol for: • A sampled resident who has MDS data that indicates a bed/side rail is used; • Surveyor observation of the use of a bed/side rail for a resident; and/or • An allegation of inappropriate use of a bed/side rail received by the State Survey Agency. PROCEDURES §483.25(n) Briefly review the assessment, care plan, and orders of the resident to identify facility interventions and to guide observations to be made. Corroborate observations by interview and record review. Observation- Resident During observations of a resident who has bed/side rails, determine: • What type of bed rail is installed or used and for how long the bed rail has been in use; • If the bed rail in good working order; • Frequency of use of the bed rail; • Any physical or psychosocial reaction to the bed rail, such as attempts to release/remove the bed rail, verbalizing anger/anxiety; • Who raises and lowers the bed rail and how often monitoring is provided; • How the resident is positioned in the bed relative to the bed rails and how the resident moves in bed; • How the resident requests staff assistance (e.g., access to the call light); • Whether the resident is toileted, ambulated or provided exercises or range of motion when the bed rails are released, who released the bed rails and for how long; NOTE: A resident may have a device in place that the facility has stated can be removed by the resident. For safety reasons, do not request that the resident remove the bed rails, but rather request that staff ask the resident to demonstrate how he/she releases the bed rails. Interview-Resident or Resident Representative Interview the resident, or if applicable, the resident representative, to the degree possible to identify: • Who requested the bed rail to be installed or used, • Prior to the use of the bed rail, whether staff provided information regarding how the bed rail would address a resident need, the risks and benefits, and alternatives to bed rails, when and how long the bed rails were going to be used; • Whether the interdisciplinary team provided interventions for monitoring and release of the bed rails for activities, such as use of the bathroom, walking and range of motion; • Whether staff discussed mobility issues with the resident, or resident’s representative, when the bed rail is in use and/or other impacts on activities of daily living and involvement in activities; and • How the resident can request staff assistance when the bed rail is in use. Interviews-Staff Interview direct care and licensed nursing staff on various shifts who provide care to the resident to determine: • Knowledge of specific interventions related to the use of the bed rails for the resident, including: o When use of the bed rail was initiated; o The rationale for selecting the bed rail for use; o Identifying the benefits and risks of using the bed rail; • What is the resident’s functional ability, such as bed mobility and ability to transfer between positions, to and from bed or chair, to toilet and to ability to stand; • Whether there have been any physical and/or psychosocial changes related to the use of the bed rail, such as increased incontinence, decline in ADLs or ROM, increased confusion, agitation, and depression; • Whether other interventions have been attempted to minimize or eliminate the use of the bed rails; and • Whether there are facility guidelines/protocols for the use of bed rails. Interview the charge nurse, to gather the following additional information: • How the implementation of the use of bed rails is monitored and who is responsible for the monitoring; • Who evaluates and assesses the resident to determine the ongoing need for bed rails; • Whether bed rail use should be gradually decreased; and • How the modifications for the interventions are evaluated for effectiveness in discontinuing the use of the bed rails. Record Review Review the MDS, assessments, physician orders, therapy and nursing notes and other progress notes that may have assessment information related to use of the bed rail. Determine whether identified decline can be attributed to a disease progression or use of bed rails. Determine whether the assessment information accurately and comprehensively reflects the status of the resident for: • The identification of specific medical symptom(s) for which the bed rail is used; • Functional ability, including strength and balance (such as bed mobility and ability to transfer between positions, to and from bed or chair, and to stand and the ability to toilet); • Identification of the resident’s risks such as physical/functional decline and psychosocial changes, and benefits, if any, due to the use of the bed rails; • Attempts at using alternatives to bed rails, including how the alternatives did not meet the resident’s medical or safety need or were inappropriate; • Identification of any injuries, or potential injuries, that occurred during the use of bed rails. When the interdisciplinary team has determined that a resident may benefit from the use of a device for mobility or transfer, whether the assessment includes a review of the resident’s: • Bed mobility; and • Ability to transfer between positions, to and from bed or chair, to stand and the ability to toilet. Review the resident’s care plan to determine if it is consistent with the resident’s specific conditions, risks, needs, behaviors, preferences, current professional standards of practice, and included measurable objectives and timetables, with specific interventions/services for use of the bed rail. The care plan may include: • Which medical need would be met through the use of bed rails; • How often the bed rail is applied, duration of use, and the circumstances for when it is to be used; • How monitoring is provided, and when and how often the bed rail is to be released and assistance provided for use of the bathroom, walking and range of motion; • What the resident’s functional ability is, such as bed mobility and ability to transfer between positions, to and from bed or chair, and to stand and toilet and staff required for each function that requires assistance; • Identification of interventions to address any potential complications such as physical and/or psychosocial changes related to the use of the bed rails, such as increased incontinence, decline in ADLs or ROM, increased confusion, agitation, and depression; • Identification of interventions to minimize or eliminate the use of the bed rails; and • Who monitors for the implementation of the use of the bed rails, and who evaluates and assesses the resident to determine the ongoing need for bed rails, whether the bed rail use should be gradually decreased, and how the modifications for the interventions are evaluated for effectiveness in discontinuing the use of the bed rail. DEFICIENCY CATEGORIZATION §483.25(n) Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident Health or Safety include, but are not limited to: • A facility failed to attempt to use alternatives to bed rails and assess a resident for risk of entrapment. The resident was assessed to be at risk of falls when she made repeated attempts to self-transfer off of her bed. All of the falls occurred when a half side rail was in use. According to a facility accident report, the resident was found on the floor with her back against the bed, holding onto one of the half side rails with both hands, with her neck wedged between the half side rails. The resident was able to remove herself from between the mattress and the bed rail, and did not sustain any injuries from the fall. After this incident, the facility performed a bed rail assessment, which did not indicate the risks/benefits of using bed rails. However, no changes were made to the resident’s care plan, nor was there any documentation that the facility considered discontinuing use of the bed rails. Nine months later, the resident was found dead on the floor next to her bed, with her head wedged between the half side rail and the mattress. The resident’s death certificate listed the cause to be asphyxiation-positional, extrinsic compression of the neck, and neck trapped under the bed rail. • The facility failed to assess the resident for use of a bed rail, and failed to ensure that the bed rails did not pose a risk of entrapment or injury from falls. A moderately cognitively impaired resident was admitted to the facility who required extensive assistance with bed mobility and transfer, and was not ambulatory. The nursing assessment completed on admission indicated that the resident was at high risk for falls and full bed rails were used on all open sides of the bed. No assessment related to the use of bed rails was completed. A facility investigation report revealed that the resident crawled to the foot of his bed with the full bed rails in a raised position, tried to stand and ambulate, and fell off the right side of the bed. The resident sustained a femoral neck fracture and was hospitalized. • A facility failed to attempt to use alternatives to bed rails and assess a resident for risk of entrapment. A bed rail assessment indicated that two half side rails would be used for the resident to promote independence. There was no evidence that the facility evaluated risks associated with bed rail use when the facility changed the bed mattress to an air mattress. A facility accident report indicated that a nurse aide discovered the resident on the floor, with his/her head positioned between the side rail and the air mattress. The resident had visible bruising to the neck, had no pulse, or blood pressure. Examples of Severity Level 3 Noncompliance Actual Harm that is Not Immediate Jeopardy include, but are not limited to: An example of noncompliance that demonstrates severity at level three includes, but is not limited to: • A facility failed to ensure the resident’s bed dimensions were appropriate for the resident’s size and weight. An extremely obese resident fell out of bed and sustained an injury while using the bed rail as an enabler to turn on his side. The bed was narrow and the bed rail could not sustain his weight and broke. The bed was meant to sustain the size and weight of a smaller person per manufacturer’s directions. Example of Severity Level 2 Noncompliance No Actual Harm with Potential for More Than Minimal Harm that is Not Immediate Jeopardy include, but are not limited to: An example of noncompliance that demonstrates severity at level two includes, but is not limited to: • The facility failed to inform a resident/representative of the risks and benefits of using side rails, prior to installing or using them on the resident’s bed. The resident was cognitively impaired and was unable to comprehend, however, the staff did not contact the resident’s representative to provide the information. Examples of Severity Level 1 Noncompliance No Actual Harm with Potential for Minimal Harm include, but are not limited to: Facility failed to have a schedule for routine maintenance of its four beds with bed rails, which were newly installed two years ago. There is no evidence of incidents or injuries in those two years, the relevant resident care plans appear appropriate regarding bedrail usage, and the facility provides evidence of checks by staff on the impacted residents and appropriate use and installation of bed rails. NOTE: References to non-CMS/HHS sources or sites on the Internet included above or later in this document are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services. CMS is not responsible for the content of pages found at these sites. URL addresses were current as of the date of this publication. Other resources which may be useful: Falls National Council on Aging National Falls Prevention Resource Center at https://ncoa.org/professionals/health/center-for-healthy-aging/national-falls-prevention- resource-center Centers for Disease Control and Prevention at https://www.cdc.gov/falls/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.go v%2Fhomeandrecreationalsafety%2Ffalls%2Findex.html World Health Organization Fall Prevention in Older Age at https://www.who.int/publications/i/item/9789241563536 National Institute of Health- Senior Health at https://www.nia.nih.gov/health/topics/falls- and-falls-prevention. Wandering and Elopement Resources U.S. Department of Veterans Affairs VHA National Center for Patient Safety at https://patientsafety.va.gov/A_Toolkit_Patients_At_Risk_for_Wandering.asp F710 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.30 Physician Services A physician must personally approve in writing a recommendation that an individual be admitted to a facility. Each resident must remain under the care of a physician. A physician, physician assistant, nurse practitioner, or clinical nurse specialist must provide orders for the resident’s immediate care and needs. §483.30(a) Physician Supervision. The facility must ensure that— §483.30(a)(1) The medical care of each resident is supervised by a physician; §483.30(a)(2) Another physician supervises the medical care of residents when their attending physician is unavailable. INTENT §483.30(a) https://ncoa.org/professionals/health/center-for-healthy-aging/national-falls-prevention-resource-center https://ncoa.org/professionals/health/center-for-healthy-aging/national-falls-prevention-resource-center https://www.cdc.gov/falls/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fhomeandrecreationalsafety%2Ffalls%2Findex.html https://www.cdc.gov/falls/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fhomeandrecreationalsafety%2Ffalls%2Findex.html https://www.who.int/publications/i/item/9789241563536 https://www.nia.nih.gov/health/topics/falls-and-falls-prevention https://www.nia.nih.gov/health/topics/falls-and-falls-prevention https://patientsafety.va.gov/A_Toolkit_Patients_At_Risk_for_Wandering.asp The intent of this regulation is to ensure the medical supervision of the care of each resident by a physician and that orders for the resident’s immediate care and needs are provided throughout the resident’s stay. DEFINITIONS §483.30(a) “Attending physician” refers to the primary physician who is responsible for managing the resident’s medical care. This does not include other physicians whom the resident may see periodically, such as specialists. “Non-physician practitioner (NPP)” is a nurse practitioner (NP), clinical nurse specialist (CNS), or physician assistant (PA). “Nurse practitioner” is a registered professional nurse currently licensed to practice in the State and who meets the State’s requirements governing the qualification of nurse practitioners. “Clinical nurse specialist” is a registered professional nurse currently licensed to practice in the State and who meets the State’s requirements governing the qualifications of clinical nurse specialists. “Physician assistant” is a person who meets the applicable State requirements governing the qualifications for assistants to primary care physicians. GUIDANCE §483.30(a) A physician’s personal approval of an admission recommendation must be in written form. The written recommendation for admission to the facility must be provided by a physician and cannot be provided by a NPP. This may be accomplished through a hospital transfer summary written by a physician, paperwork completed by the resident’s physician in the community, or other written form by a physician. If a physician does not provide a written recommendation that the individual be admitted to the facility prior to the resident’s admission, the physician’s admission orders for the resident’s immediate care as required in §483.20(a) will be accepted as “personal approval” of the admission if the orders are provided by a physician. Admission orders in lieu of a physician’s written recommendation for admission to the facility cannot be provided by a NPP. Generally, the term “attending physician” or “physician” may also include a NPP involved in the management of the resident’s care, to the extent permitted by State law. However, when the regulation specifies a task to be completed “personally” by the physician, that task may not be delegated to a NPP. Supervising the medical care of residents means participating in the resident’s assessment and care planning, monitoring changes in resident’s medical status, and providing consultation or treatment when contacted by the facility. It also includes, but is not limited to, prescribing medications and therapy, ordering a resident’s transfer to the hospital, conducting required routine visits or delegating to and supervising follow-up visits by NPPs. http://www.cms.hhs.gov/regulations/ It is the responsibility of the facility to ensure that another physician supervises the care of residents when the attending physician is unavailable. The attending physician may designate another physician to act on his/her behalf when unavailable. If the attending physician is unavailable and does not designate another physician to act on his/her behalf, or the designated physician is unavailable, the facility must have a physician available who will supervise the care of the attending physician’s residents. There may be examples of physician orders in the medical record that would not impact a resident’s medical care, such as instructions to contact a family member or providing date/time of an order; concerns related to these types of orders do not fall under the category of a physician’s supervision of medical care and would not be cited here. PROBES §483.30(a) • Is there evidence that the attending physician supervises the resident’s medical care? If not, what did the facility do? • If the physician makes a change to the residents’ plan of care, e.g. orders a new medication or changes a medication, is there evidence that the physician re- evaluated the effectiveness of the intervention and the resident’s response? NOTE: the timing of the re-evaluation may vary depending upon the type of change, type of medication. • If staff reported a change in medical status to the physician, how did the physician respond? • If the attending physician was unavailable and could not respond, did the facility have a physician available to supervise the medical care of the resident? How did this physician respond? • When a NPP performs a delegate physician visit, and determines that the resident’s condition warrants direct contact between the physician and the resident, does the physician follow-up promptly with a personal visit? POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION The facility must ensure each resident has the right to designate an attending physician For potential concerns related to the resident having the choice of attending physician who is able and willing to meet the physician services requirements, see §483.10(d), F555, for additional guidance. For concerns related to admission orders, see §483.20(a), F635. At the time each resident is admitted, the facility must have physician’s orders for the resident’s immediate care. For concerns related to physician availability for emergencies 24 hours a day, see §483.30(d), F713. DEFICIENCY CATEGORIZATION §483.30(a) Examples of Level 4, immediate jeopardy to resident health and safety include, but are not limited to: http://www.cms.hhs.gov/regulations/ • The facility failed to ensure the physician conducted a medical evaluation of a resident with a new onset of seizures. As a result, anticonvulsant medications were prescribed, but the primary cause of the seizures was not evaluated to determine if it was neurological or secondary to another condition, such as infection or drug interaction. This placed the resident at risk for serious harm or death. • The physician failed to provide laboratory orders for routine monitoring for a resident receiving anticoagulant medication, placing the resident at risk for significant adverse side effects including the risk for serious injury or death, such as gastrointestinal bleeding or stroke. The facility failed to follow up with the physician regarding the absence of laboratory orders and administered the anticoagulant medication as ordered. An example of level 3, actual harm that is not immediate jeopardy includes, but is not limited to: • The facility failed to ensure the physician supervised the resident’s medical care, when the physician did not evaluate the effectiveness of treatments ordered for a skin condition, resulting in the development of a localized skin infection causing significant pain for the resident. An example of Level 2, no actual harm, with potential for no more than minimal harm, that is not immediate jeopardy includes, but is not limited to: • The facility failed to follow-up on recommendations from the dietitian for diet liberalization for a resident whose attending physician did not respond to phone calls. The facility then failed to contact another physician to assist with providing care for the resident when the facility was unable to reach the attending physician. An example of Level 1, no actual harm with potential for no more than a minor negative impact on the resident includes, but is not limited to: • The failure of the facility to ensure a resident’s medical care is supervised by a physician or to ensure that the resident has orders for immediate care and needs always places the resident at risk for more than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement. F711 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.30(b) Physician Visits The physician must— §483.30(b)(1) Review the resident’s total program of care, including medications and treatments, at each visit required by paragraph (c) of this section; §483.30(b)(2) Write, sign, and date progress notes at each visit; and §483.30(b)(3) Sign and date all orders with the exception of influenza and pneumococcal vaccines, which may be administered per physician-approved facility policy after an assessment for contraindications. INTENT §483.30(b) The intent of this regulation is to have the physician take an active role in supervising the care of the residents. Physician visits should not be superficial visits, but must include an evaluation of the resident’s condition and total program of care, including medications and treatments, and a decision about the continued appropriateness of the resident’s current medical regimen. GUIDANCE §483.30(b) Except where the regulation specifies the task must be completed personally by the physician, the term “attending physician” or “physician” also includes a non-physician practitioner (NPP) involved in the management of the resident’s care, to the extent permitted by State law. Total program of care includes all care the facility provides residents to maintain or improve their highest practicable physical, mental and psychosocial well-being, as defined by the comprehensive assessment and plan of care. Care includes medical services and medication management, physical, occupational, and speech/language therapy, nursing care, nutritional interventions, social work and activity services that maintain or improve psychosocial functioning. During required visits, the physician must document a review of the resident’s total program of care, including the resident’s current condition, progress and problems in maintaining or improving their physical, mental and psychosocial well-being and decisions about the continued appropriateness of the resident’s current medical regimen. The physician need not review the total plan of care at each visit, but must review the total plan of care at visits required by §483.30(c), F712. Progress notes must be written, signed and dated at each physician visit, which may be done in a physical chart or electronic record, in keeping with facility practices. During visits, the physician must also sign and date all orders, with the exception of influenza and pneumococcal vaccinations, which may be administered per physician- approved facility policy after an assessment for contraindications. This includes co- signing orders written by NPPs, qualified dietitians, other clinically qualified nutrition professionals and qualified therapists, as required by state law. In cases where facilities have created the option for a resident’s record to be maintained by computer, rather than hard copy, electronic signatures are acceptable. See Guidelines for §483.70(h)(1), F842, for information on facility safeguards concerning electronic signatures. Physician orders may be transmitted by facsimile machine if the following conditions are met: • The physician should have signed and retained the original order from which the facsimile was transmitted and be able to provide it upon request. Alternatively, the original may be sent to the facility at a later time and substituted for the facsimile. • The facility should photocopy the faxed order, if the faxed order is subject to fading over time. The facsimile copy can be discarded after facility photocopies it. • It is not necessary for a physician to re-sign the facsimile order when he/she visits the facility. When rubber stamp signatures are authorized by the facility’s management, the individual whose signature the stamp represents shall place in the administrative offices of the facility a signed statement to the effect that he/she is the only one who has the stamp and uses it. A list of computer codes, identification numbers and/or written signatures must be readily available and maintained under adequate safeguards. Adequate safeguards may include, but are not limited to, locked in a drawer; locked in a location that is accessible only by appropriate staff as defined by the facility; or available on a protected electronic site accessible by appropriate staff as defined by the facility. PROBES §483.30(b) • Are physician progress notes written, signed and dated during each physician visit? • For visits required by §483.30(c), do physician progress notes reflect a review of the resident’s total program of care and current condition, including medications and treatments? • Do physician progress notes reflect the physician’s decisions about the continued appropriateness of the resident’s current medical regimen? • Does the physician sign and date all physician orders, during visits, with the exception of influenza and pneumococcal vaccines as outlined above? • If the physician has not met the requirements of physician visits, how has the facility worked with the physician or sought alternate physician participation to assure that the resident receives appropriate care and treatment? • If facility management allows for the use of rubber stamp signatures, are adequate safeguards in place to ensure the security of the stamps? POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION If concerns regarding physician supervision of the resident’s care are identified, investigate §483.30(a), F710. For concerns related to admission orders, see §483.20(a), F635. For concerns related to the frequency of physician visits, see §483.30(c), F712. For concerns related to the medical director’s follow-up on clinical issues or physician activities, see §483.70(g), F841. DEFICIENCY CATEGORIZATION §483.30(b) Examples of Level 4, immediate jeopardy to resident health and safety, include, but are not limited to: • After a recent hospitalization, the facility failed to ensure the attending physician reviewed the hospital discharge summary or hospital progress notes. This lack of review of the resident’s total program of care, including medications and treatments, resulted in the resident not receiving orders for new medications essential to the resident’s medical treatment. As a result of the lack of essential medications, serious harm or death occurred or was likely to occur. • Facility staff contacted the physician on multiple occasions regarding the resident’s elevated blood sugar levels. During a visit, the physician did not review the resident’s recorded blood sugar values, or talk to the nurse regarding the resident’s status or order changes to the resident’s treatment regimen. The facility’s failure to intervene when the physician was onsite or to seek alternate intervention resulted in the resident experiencing diabetic ketoacidosis which required hospitalization for management. Example of level 3, actual harm that is not immediate jeopardy, includes, but is not limited to: • The facility failed to ensure the physician completed a medical evaluation of a resident's condition and review the appropriateness of the resident's medical regimen. Specifically, a resident who had executed a Living Will at a time when he had capacity, indicated that it was his desire to refuse any treatment, other than comfort measures, in the event of an irreversible terminal illness from which there was no hope of recovery. Despite documentation from the pulmonologist that there was no expectation that the resident could survive without artificial means and contrary to the resident's wishes, the attending physician ordered, and the facility provided, aggressive, life-sustaining treatment including artificial ventilation and feeding. As a result, the resident received unwanted treatment in the facility. Examples of Level 2, no actual harm, with potential for than more than minimal harm, that is not immediate jeopardy, include, but are not limited to: • While the physician reviewed areas identified as high priority for the physician to address in the resident’s program of care, the facility failed to ensure the physician reviewed the resident’s total program of care or wrote, signed and dated progress notes with each visit. • The facility failed to ensure physician progress notes that documented the physician's involvement in the assessment and care of residents were completed as required. Example of Level 1, no actual harm with potential for no more than a minor negative impact on the resident, includes, but is not limited to: • During a physician visit, the physician failed to sign and date new orders, however the orders were followed as intended and no adverse outcome was experienced by the resident. F712 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.30(c) Frequency of physician visits. §483.30(c)(1) The resident must be seen by a physician at least once every 30 days for the first 90 days after admission, and at least once every 60 days thereafter. §483.30(c)(2) A physician visit is considered timely if it occurs not later than 10 days after the date the visit was required. §483.30(c)(3) Except as provided in paragraphs (c)(4) and (f) of this section, all require physician visits must be made by the physician personally. DEFINITIONS §483.30(c) Must be seen, for purposes of the visits required by §483.30(c)(1), means that the physician or NPP must make actual face-to-face contact with the resident, and at the same physical location, not via a telehealth arrangement. There is no requirement for this type of contact at the time of admission, since the decision to admit an individual to a nursing facility (whether from a hospital or from the individual’s own residence) generally involves physician contact during the period immediately preceding the admission. “Non-physician practitioner (NPP)” means a nurse practitioner (NP), clinical nurse specialist (CNS) or physician assistant (PA). GUIDANCE §483.30(c) The timing of physician visits is based on the admission date of the resident. In a SNF, the first physician visit (this includes the initial comprehensive visit) must be conducted within the first 30 days after admission, and then at 30 day intervals up until 90 days after the admission date. After the first 90 days, visits must be conducted at least once every 60 days thereafter. Permitting up to 10 days’ slippage of a due date will not affect the next due date. However, do not specifically look at the timetables for physician visits unless there is indication of inadequate medical care. The regulation states that the physician (or his/her delegate) must visit the resident at least every 30 or 60 days. There is no provision for physicians to use discretion in visiting at intervals longer than those specified at §483.30(c), F712. Although the physician may not delegate the responsibility for conducting the initial visit in a SNF, NPPs may perform other medically necessary visits prior to and after the physician’s initial visit, as allowed by State law. After the initial physician visit in SNFs, where States allow their use, an NPP may make every other required visit. (See §483.30(e), F714 Physician delegation of tasks in SNFs.) These alternate visits, as well as medically necessary visits, may be performed and signed by the NPP. (Physician co-signature is not required, unless required by State law). In a NF, the physician visit requirement may be satisfied in accordance with State law by an NPP who is not an employee of the facility but who is working in collaboration with a physician and who is licensed by the State and performing within the state’s scope of practice. (See §483.30(f)). In a NF, medically necessary visits performed by NPPs employed by the facility, may not take the place of physician required visits, nor may the visit count towards meeting the physician visit schedule prescribed at §483.20(c)(1). In SNFs and NFs, facility policy that allows NPPs to conduct required visits, and/or allows a 10-day slippage in the time of the required visit, does not relieve the physician of the obligation to visit a resident personally when the resident’s medical condition makes that visit necessary. Table 1: Authority for Non-Physician Practitioners to Perform Visits, Sign Orders and Sign Medicare Part A Certifications/Re-certifications when Permitted by the State Initial Comprehensive Visit Admission Orders* Other Required Visits & Orders^ Other Medically Necessary Visits & Orders+ Certification/ Recertification ± SNFs PA, NP & CNS employed by the facility May not perform May not provide May perform alternate visits and sign May perform and sign May not sign PA, NP & CNS not a facility employee May not perform May not provide May perform alternate visits and sign May perform and sign May sign as permitted under State laws. NFs PA, NP, & CNS employed by the facility May not perform May not provide May not perform or sign May perform and sign Not applicable PA, NP, & CNS not a facility employee May perform May provide* May perform and sign May perform and sign Not applicable *A NPP may provide admission orders if a physician personally approved in writing a recommendation for admission to the facility prior to the resident’s admission. For additional requirements on physician recommendation for admission and admission orders, see §483.30(a), F710. ^ Other required visits are the physician visits required by §483.30(c)(1) other than the initial comprehensive visit. + Medically necessary visits are independent of required physician visits §483.30(c)(1) and may be performed prior to the initial comprehensive visit as permitted under state laws. ±Though not part of a compliance determination for this section, this column is provided for clarification and relates specifically to coverage of a Part A Medicare stay requirements, which can take place only in a Medicare-certified SNF. In a facility where beds are dually-certified under Medicare and Medicaid, the facility must determine how the particular resident stay is being paid in order to identify whether physician delegation of tasks is permissible and if an NPP may perform the tasks. For example: • For residents in a Part A Medicare stay, the NPP must follow the requirements for physician services in a SNF. This includes, at the option of a physician, required physician visits alternated between personal visits by the physician and visits by an NPP after the physician makes the initial comprehensive visit; and • For residents in a Medicaid stay, the NPP must follow the requirements for physician services in a NF. An NPP who is not employed by the facility and is working in collaboration with a physician may perform any required physician task for a resident in a Medicaid-stay, at the option of the State. (NPPs employed by the facility may not perform required physician visits but may perform other medically necessary visits) It is expected that visits will occur at the facility rather than the doctor’s office unless office equipment is needed or a resident specifically requests an office visit. If the facility has established policy that residents leave the grounds for medical care, the resident does not object, and this policy does not infringe on his/her rights including the right to privacy, there is no prohibition to this practice. The facility should inform the resident of this practice, in accordance with §483.10(g)(16), F581, Notice of rights and services. Certifications/Re-certifications in SNFs: Under 42 CFR §424.20, certifications and re- certifications are required to verify that a resident requires daily skilled nursing care or rehabilitation services. NPs, CNSs, and PAs who are not employed by the facility and who are working in collaboration with a physician may sign the required initial certification and re- certifications when permitted under the scope of practice for the State. 42 CFR §424.20(e)(2). PROBES §483.30(c) • Does the scheduling and frequency of physician visits relate to any identified quality of care problems? • If the resident is admitted under a SNF stay, did the physician conduct the initial comprehensive visit, in-person, within the first 30 days? • If the resident is admitted under a NF stay, did the physician or an NPP who is not employed by the facility but who is working in collaboration with a physician conduct the initial comprehensive visit, in-person, within the first 30 days? • Are physician visits conducted at the required intervals, with no more than 10 days slippage from the due date? • In a SNF, if the physician delegates required visits to an NPP, does the physician personally conduct alternate visits with the NPP as required? • Does the resident or resident representative report meeting with the physician? If so, how often? POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION If the failure of the physician to visit the resident at the required intervals resulted in a negative outcome to the resident, also investigate compliance with §483.30(a), F710, Resident’s care supervised by a physician. DEFICIENCY CATEGORIZATION An example of Level 4, immediate jeopardy to resident health and safety, includes, but is not limited to: • The facility failed to ensure the attending physician conducted required visits for several consecutive months in the facility. The physician responded to phone calls and provided verbal orders during this time-frame, however did not visit and make face-to-face contact with the resident, who experienced a significant negative change in status. No other physicians or NPPs visited the resident. This placed the resident at risk for serious harm or death. An example of level 3, actual harm that is not immediate jeopardy, includes, but is not limited to: • A resident newly admitted to the facility and determined to be at high risk of developing a pressure ulcer/injury, developed an unstageable pressure ulcer during the first 30 days. While the physician was consulted by telephone, the facility failed to ensure the physician conducted an initial comprehensive visit for over 40 days, contributing to the decline in the resident’s skin status. Examples of Level 2, no actual harm, with potential for than more than minimal harm, that is not immediate jeopardy, includes, but is not limited to: • The facility failed to ensure the physician personally conducted an initial comprehensive visit within the first 30 days after admission, for a resident under a Medicare Part A stay. An example of Level 1, no actual harm with potential for no more than a minor negative impact on the resident, includes, but is not limited to: • The facility failed to ensure that the attending physician alternated required monthly visits with the Nurse Practitioner (NP) as required for a resident under a SNF stay. A review of the Progress Notes revealed that notes were written, signed and dated by the NP for several consecutive visits, and all of the resident’s needs were met. No documentation was found to indicate that the attending physician had visited and examined the resident at least once every 30 days for the first 90 days after admission or at least once every 60 days thereafter during this time. F713 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.30(d) Availability of physicians for emergency care The facility must provide or arrange for the provision of physician services 24 hours a day, in case of emergency. GUIDANCE §483.30(d) If a resident’s attending physician is unavailable, the facility should attempt to contact the physician covering for the attending physician before assuming the responsibility of contacting another physician. Arranging for physician services may include assuring resident transportation to a hospital emergency room or other medical facility if the facility is unable to meet the particular medical need at the facility. The provision of transportation does not remove the facility’s responsibility to have a physician available, 24 hours a day, to respond to emergencies that do not require medical care in an alternative setting. PROBES §483.30(d) • Does the facility have a physician on-call for medical emergencies? Does this physician respond? • In emergency situations, are residents unnecessarily sent to hospital emergency rooms due to the lack of physician availability or inability to contact a physician? Consider whether the resident’s needs could have been met in the facility had the facility had a physician available. • If the facility did not arrange for the provision of physician services 24 hours a day, for emergencies, what was the impact on residents? DEFICIENCY CATEGORIZATION §483.30(c) Example of Level 4, immediate jeopardy to resident health and safety, includes, but is not limited to: • The attending physician, who was the only physician of the facility and the medical director, failed to have an alternate physician or non-physician practitioner available for the residents in case of an emergency, when he left the country. The facility did not have an agreement with another physician to provide physician services in the absence of the attending physician. When a resident with a known history of congestive heart failure developed edema in the lower extremities, the facility did not have a physician to contact for consultation and new orders for interventions, resulting in hospitalization of the resident. Example of level 3, actual harm that is not immediate jeopardy includes, but is not limited to: • The facility received laboratory results indicating that a resident had a urinary tract infection (UTI). Attempts to contact the attending physician were unsuccessful, and the facility did not have an alternate physician on-call for emergencies. The facility did not secure timely medical treatment at the local hospital or alternate medical facility for the resident resulting in progression of the infection before interventions were implemented. Example of Level 2, no actual harm, with potential for than more than minimal harm, that is not immediate jeopardy, includes, but is not limited to: • The facility failed to ensure the physician responded promptly to notification of a resident’s fall. Phone calls from the licensed nurses about the fall and the swelling of the left ankle were not returned for 24-hours and the facility did not secure alternate medical intervention for the resident during this time. Example of Level 1, no actual harm with potential for no more than a minor negative impact on the resident, includes, but is not limited to: • The failure of the facility to provide physician services 24-hours a day, in case of an emergency, places the resident at risk for more than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement. F714 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.30(e) Physician delegation of tasks in SNFs. §483.30(e)(1) Except as specified in paragraph (e)(4) of this section, a physician may delegate tasks to a physician assistant, nurse practitioner, or clinical nurse specialist who— (i) Meets the applicable definition in §491.2 of this chapter or, in the case of a clinical nurse specialist, is licensed as such by the State; (ii) Is acting within the scope of practice as defined by State law; and (iii) Is under the supervision of the physician. *** §483.30(e)(4) A physician may not delegate a task when the regulations specify that the physician must perform it personally, or when the delegation is prohibited under State law or by the facility’s own policies. §483.30(f) Performance of physician tasks in NFs. At the option of State, any required physician task in a NF (including tasks which the regulations specify must be performed personally by the physician) may also be satisfied when performed by a nurse practitioner, clinical nurse specialist, or physician assistant who is not an employee of the facility but who is working in collaboration with a physician. INTENT §483.30(e)(1)&(4) To allow the physician, under certain conditions, to delegate tasks to a nurse practitioner, clinical nurse specialist or physician assistant, working under the physician’s supervision. DEFINITIONS §483.30(e)(1) & (4) “Clinical nurse specialist” is a registered professional nurse currently licensed to practice in the State and who meets the State’s requirements governing the qualifications of clinical nurse specialists. “Nurse practitioner” is a registered professional nurse who is currently licensed to practice in the State, who meets the State’s requirements governing the qualification of nurse practitioners and who meets one of the following conditions: (1) is currently certified as a primary care nurse practitioner by the American Nurses’ Association or by the National Board of Pediatric Nurse Practitioners and Associates; or (2) has satisfactorily completed a formal 1 academic year educational program that (i) prepares registered nurses to perform an expanded role in the delivery of primary care; (ii) includes at least 4 months (in the aggregate) of classroom instruction and a component of supervised clinical practice; and (iii) awards a degree, diploma or certificate to persons who successfully complete the program; or (3) has successfully completed a formal educational program (for preparing registered nurses to perform an expanded role in the delivery of primary care) that does not meet the requirements above and has been performing an expanded role in the delivery of primary care for a total of 12 months during the 18-month period immediately preceding September 22, 2006. “Physician assistant” is a person who meets the applicable State requirements governing the qualifications for assistants to primary care physicians, and who meets at least one of the following conditions: (1) is currently certified by the National Commission on Certification of Physician Assistants to assist primary care physicians; or (2) has satisfactorily completed a program for preparing physician’s assistants that (i) was at least 1 academic year in length; (ii) consisted of supervised clinical practice and at least 4 months (in the aggregate) of classroom instruction directed toward preparing students to deliver health care; and (iii) was accredited by the American Medical Association’s Committee on Allied Health Education and Accreditation; or (3) Has satisfactorily completed a formal educational program (for preparing physician assistants) that does not meet the requirements above and has been assisting physicians for a total of 12 months during the 18-month period that ended on December 31, 1986. “Non-physician practitioner (NPP)” is a nurse practitioner (NP), clinical nurse specialist (CNS), or physician assistant (PA) as defined above. GUIDANCE §483.30(e)(1) & (4) The extent to which physician services may be delegated to NPPs in SNFs is governed by the provisions of §483.30(e), while the extent to which these services may be performed by NPPs in NFs is governed by the provisions of §483.30(f). (Refer to table in F712). In SNFs, when personal performance of a particular task by a physician is specified in the regulations, performance of that task cannot be delegated to anyone else. The tasks of examining the resident, reviewing the resident’s total program of care, writing progress notes, and signing orders may be delegated unless prohibited by State law or facility policies. PROBES §483.30(e)(1) & (4) • Do the attending physicians delegate tasks to NPPs? • If the physician delegates tasks to NPs or PAs, does the NP or PA meet the requirements in §491.2? • If the physician delegates tasks to CNSs, is the CNS licensed as such by the State? • Do NPPs follow the scope of practice allowed by State law in conducting examinations, evaluations, writing progress notes and orders? • Does the physician supervise the NPP in the SNF? Examples of supervision may include face-to-face encounters, clinical record reviews, telephone consults, e- mail, telehealth, and electronic health records. DEFINITIONS §483.30(f) “Collaboration” is a process often governed by the laws of a given State in which a non- physician practitioner (NPP) works with one or more physicians to deliver health care services within the scope of the NPP’s expertise, with medical direction and appropriate supervision as provided for in jointly developed guidelines or other mechanisms. In the absence of State law governing collaboration, such collaboration is to be evidenced by NPPs documenting the NPP’s scope of practice and indicating the relationships that they have with physicians to deal with issues outside their scope of practice. The collaborating physician does not need to be present with the NPP when the services are furnished or to make an independent evaluation of each resident who is seen by the NPP. GUIDANCE §483.30(f) At the option of the State, NPPs in a NF, who are not employees of the facility, may perform physician tasks including performing examinations, evaluations, required visits and writing orders. If the physician delegates the task of performing visits to the NPP, the NPP must meet all of the requirements for • §483.30(a), F710, physician supervision • §483.30(b), F711, physician visits • §483.30(c), F712, physician frequency and timeliness of visits NOTE: If concerns are identified regarding the NPP meeting the requirements for physician supervision, physician visits or frequency and timeliness of visits, investigate under the corresponding regulation. Orders written by a NPP who is employed by the NF and are written during visits that are not required visits, and are therefore “other medically necessary visits,” do not require physician co-signature except as mandated by State law. PROBES: §483.30(f) • If the physician delegates the performance of required physician tasks to the NPP in the NF, is the delegation allowed by the State? • When performing physician tasks in the NF, is the NPP functioning within their scope of practice as permitted in their State? • If a NPP is performing required physician visits in the NF, is the NPP an employee of the facility? (Facility employees are prohibited from serving in this capacity.) • How does the facility ensure the NPP is working in collaboration with the physician? F715 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.30(e)(2) A resident’s attending physician may delegate the task of writing dietary orders, consistent with §483.60, to a qualified dietitian or other clinically qualified nutrition professional who— (i) Is acting within the scope of practice as defined by State law; and (ii) Is under the supervision of the physician. §483.30(e)(3) A resident’s attending physician may delegate the task of writing therapy orders, consistent with §483.65, to a qualified therapist who— (i) Is acting within the scope of practice as defined by State law; and (ii) Is under the supervision of the physician INTENT §483.30(e)(2)-(3) To provide physicians with the flexibility to delegate to a qualified dietitian/other clinically qualified nutrition professional the task of writing dietary orders, and to delegate to a qualified therapist the task of writing therapy orders. This flexibility is beneficial to the physician and the resident, allowing the physician to determine how to best use his or her time and allowing the resident to have more frequent adjustments to nutritional needs and therapy as his or her condition or abilities change. DEFINITIONS §483.30(e)(2)-(3) “Qualified dietitian” – is defined in §483.60 as follows: §483.60(a)(1) A qualified dietitian or other clinically qualified nutrition professional either full-time, part-time, or on a consultant basis. A qualified dietitian or other clinically qualified nutrition professional is one who— (i) Holds a bachelor’s or higher degree granted by a regionally accredited college or university in the United States (or an equivalent foreign degree) with completion of the academic requirements of a program in nutrition or dietetics accredited by an appropriate national accreditation organization recognized for this purpose. (ii) Has completed at least 900 hours of supervised dietetics practice under the supervision of a registered dietitian or nutrition professional. (iii) Is licensed or certified as a dietitian or nutrition professional by the State in which the services are performed. In a State that does not provide for licensure or certification, the individual will be deemed to have met this requirement if he or she is recognized as a “registered dietitian” by the Commission on Dietetic Registration or its successor organization, or meets the requirements of paragraphs (a)(1)(i) and (ii) of this section. (iv) For dietitians hired or contracted with prior to November 28, 2016, meets these requirements no later than 5 years after November 28, 2016 or as required by state law. “Qualified therapist” – professional staff, licensed, certified or registered to provide specialized therapy/rehabilitative services in accordance with State laws. Includes: Physical, Occupational, and Respiratory therapists and Speech-Language Pathologists. GUIDANCE §483.30(e)(2)-(3) Physicians and NPPs may delegate the task of writing orders to qualified dietitians or clinically qualified nutrition professionals and qualified therapists if the State practice act allows the delegation of the task, and the State practice act for the qualified individual being delegated the task of writing orders permits such performance. Delegation of this task does not relieve the physician of the obligation to supervise the medical care of his/her residents. Physician responsibilities related to physician supervision of resident care are located in §483.30(a), F710, and physician obligations for conducting resident visits are located at §483.30(b), F711. Dietary orders written by a qualified dietitian/clinically qualified nutritional professional, or therapy orders written by therapists, do not require physician co-signature, except as required by State law. PROBES 483.30(e)(2)-(3) • If the dietitian/other clinically qualified nutrition professional is writing dietary orders, or a qualified therapist is writing therapy orders, did the attending physician delegate this task? • If State law allows dietitians or other clinically qualified nutrition professionals to write dietary orders, are they functioning within the scope of practice defined by State law? • If State law allows therapists to write therapy orders, are they functioning within the scope of practice defined by State law? • Do physicians cosign dietitian/other clinically qualified nutrition professional orders and/or therapists orders, if required by State law? • Is there evidence of physician supervision of dietitians/other clinically qualified nutritional professionals and/or qualified therapists who write orders? Examples of supervision may include face-to-face encounters, clinical record reviews, telephone consults, e-mail, telehealth, and electronic health records. • When facility policy and State law allows physicians to delegate the task of writing orders to qualified dietitians, other clinically qualified nutrition professionals and qualified therapists, how does the facility ensure the physician supervision of individuals performing these tasks? §483.35 Nursing Services The facility must have sufficient nursing staff with the appropriate competencies and skills sets to provide nursing and related services to assure resident safety and attain or maintain the highest practicable physical, mental, and psychosocial well- being of each resident, as determined by resident assessments and individual plans of care and considering the number, acuity and diagnoses of the facility’s resident population in accordance with the facility assessment required at §483.71. Always, review nursing services requirements under §483.35 during a standard or extended survey, when a waiver of RN and/or licensed nurse (RN/LPN) staffing has been requested or granted, or if a complaint has been received regarding nursing services. If the survey investigation reveals that there are not sufficient or competent staff refer to: • F725 or 726, §483.35(a),(c) for any nursing services not related to behavioral health care or dementia care; • F741, §483.40(a) for any staff caring for residents with dementia or a history of trauma and/or post-traumatic stress disorder; • F801, §483.60(a) for Food and Nutrition staff; • F826, §483.65(b), Specialized rehabilitative services; • F839, §483.70(e), Administration for any other staff not referenced above. Potential Requirements for Additional Investigation If noncompliance with §483.35 has been identified, the surveyor may have identified concerns with related structure, process, and/or outcome requirements. If any additional concerns have been identified, the surveyor must investigate the identified concern. Do not cite any related or associated requirements before first investigating to determine compliance or noncompliance with the related or associated requirement. Examples include, but are not limited to, the following: • Freedom from abuse, neglect, and exploitation, §483.12; • Quality of Life, §483.24; • Quality of Care, §483.25; • Behavioral Health Services, §483.40; • Administration §483.70, Staff Qualifications §483.70(e), or Use of Outside Resources §483.70(f); • §483.71 Facility Assessment • Quality Assurance and Performance Improvement §483.75; • Training, §483.95. F725 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.35 Nursing Services The facility must have sufficient nursing staff with the appropriate competencies and skills sets to provide nursing and related services to assure resident safety and attain or maintain the highest practicable physical, mental, and psychosocial well- being of each resident, as determined by resident assessments and individual plans of care and considering the number, acuity and diagnoses of the facility’s resident population in accordance with the facility assessment required at §483.71. §483.35(a) Sufficient Staff. §483.35(a)(1) The facility must provide services by sufficient numbers of each of the following types of personnel on a 24-hour basis to provide nursing care to all residents in accordance with resident care plans: (i) Except when waived under paragraph (e) of this section, licensed nurses; and (ii) Other nursing personnel, including but not limited to nurse aides. §483.35(a)(2) Except when waived under paragraph [(e)] of this section, the facility must designate a licensed nurse to serve as a charge nurse on each tour of duty. INTENT §483.35(a)(1)-(2) To assure that there is sufficient qualified nursing staff available at all times to provide nursing and related services to meet the residents’ needs safely and in a manner that promotes each resident’s rights, physical, mental and psychosocial well-being. DEFINITIONS §483.35(a)(1)-(2) “Nurse Aide,” as defined in §483.5, is any individual providing nursing or nursing- related services to residents in a facility. This term may also include an individual who provides these services through an agency or under a contract with the facility, but is not a licensed health professional, a registered dietitian, or someone who volunteers to provide such services without pay. Nurse aides do not include those individuals who furnish services to residents only as paid feeding assistants as defined in §488.301. GUIDANCE §483.35(a)(1)-(2) NOTE: Cite this Tag only if there are deficiencies related to the sufficiency of nursing staff. If the survey investigation reveals that there are not sufficient staff in areas other than Nursing Services, refer to: • F741, §483.40(a) for any staff caring for residents with dementia or a history of trauma and/or post-traumatic stress disorder; • F801, §483.60(a) for Food and Nutrition staff; • F826, §483.65(b) for Specialized rehabilitative services; and • F839, §483.70(e) for Administration for any other staff not referenced above. NOTE: The actual or potential physical, mental, or psychosocial resident outcomes related to noncompliance cited at F725 should be investigated at the relevant tags, such as Abuse at §483.12, Quality of Life at §483.24, and/or Quality of Care at §483.25. Many factors must be considered when determining whether or not a facility has sufficient nursing staff to care for residents’ needs, as identified through the facility assessment, resident assessments, and as described in their plan of care. A staffing deficiency under this requirement may or may not be directly related to an adverse outcome to a resident’s care or services. It may also include the potential for physical or psychosocial harm. As required under Administration at F838, §483.71 an assessment of the resident population is the foundation of the facility assessment and determination of the level of sufficient staff needed. It must include an evaluation of diseases, conditions, physical or cognitive limitations of the resident population’s, acuity (the level of severity of residents’ illnesses, physical, mental and cognitive limitations and conditions) and any other pertinent information about the residents that may affect the services the facility must provide. The assessment of the resident population should drive staffing decisions and inform the facility about what skills and competencies staff must possess in order to deliver the necessary care required by the residents being served. PROCEDURE: §483.35(a)(1)-(2) Although federal regulations do not define minimum nursing staff ratios, many States do. If a facility does not meet State regulations for staffing, do NOT cite that as a deficiency here, but refer to Administration, F836, §483.70(b). In addition, even if a facility meets the State’s staffing regulations that is not, by itself, sufficient to demonstrate that the facility has sufficient staff to care for its residents. Compliance with State staffing standards is not necessarily determinative of compliance with Federal staffing standards that require a sufficient number of staff to meet all of the residents’ basic and individualized care needs. A facility may meet a state’s minimum staffing ratio requirement, and still need more staff to meet the needs of its residents. Additionally, the facility is required to provide licensed nursing staff 24 hours a day, 7 days a week. Surveyors must determine through information obtained by observations, interviews and verified by record reviews, whether the facility employed sufficient staff to provide care and services in assisting residents to attain or maintain their highest practicable level of physical, mental, and psycho-social well-being. The facility is responsible for submitting staffing data through the CMS Payroll-Based Journal (PBJ) system (Refer to F851, §483.70(p)). This data can be obtained through the Certification and Survey Provider Enhanced Reports (CASPER) reporting system. This PBJ Staffing Data Report contains information about overall direct care staffing levels, including nurse staffing. Surveyors will utilize the P B J Staffing Data Report available through CASPER reporting system to identify concerns with staffing. The Long Term Care Survey Process (LTCSP) software application will alert the surveyors of specific dates that require further investigation related to staffing. Surveyors are expected to verify infraction dates indicated on the PBJ staffing data report. If concerns were identified on this report, as well as from other sources, refer to the critical element pathway of Sufficient and Competent Staffing, and the probes noted below. PROBES: • When interviewing staff, residents and others, are concerns raised with the amount of time staff are available to provide care and services, such that there is not sufficient time allowed to provide the necessary care and services to a resident? If so, verify these concerns through observations and record review if necessary. • Does the facility assessment describe the type and level of staff required to meet each resident’s needs as assessed under §483.71. Does the type and level of the staff onsite reflect the expectations described in the facility assessment? • Does the workload or assignments of the nursing staff allow them time to participate in team meetings, care planning meetings, attend training, spend time caring for residents and take time for breaks including meal breaks? • Are the numbers of licensed staff sufficient such that those staff members have enough time to provide direct services to residents as well as to assist and monitor all of the aides they are responsible for supervising? • Do residents and families report that nursing staff are responsive to residents’ request for assistance, such as call bells typically answered promptly? Do they feel that they can have a conversation with a direct caregiver and not feel rushed? • Are there any indications of delays in responsiveness for staff such as pungent odors, residents calling out, or residents wandering with inadequate supervision? • Are there any indications of inappropriate use of devices or practices to manage residents’ behaviors or activities that may suggest facility staff are using these devices or practices to compensate for lack of sufficient staff? Examples include high numbers and/or inappropriate use of position-change alarms, positioning residents in chairs that limit their movement, or residents who are subdued or sedated? • Are residents who are unable to use call bells or otherwise communicate their needs checked frequently (e.g., each half hour) for safety, comfort, bathroom needs positioning, and offered fluids and other provisions of care? Have care problems associated with a specific unit, day or tour of duty been identified by the facility? For example, does documentation show that skin integrity issues are identified more on days following a long weekend? Does the facility have adequate staff to monitor residents at risk for wandering? • Has the use of overtime hours increased? (If overtime hours have increased substantially, it can indicate that there is not sufficient staff or a back-up plan when staff call-out). • When there are staff call-outs, did the facility fill those positions in a timely manner? Does the facility have licensed nursing staff 24 hours a day? • If the surveyor is made aware of the absences of licensed nursing staff in a 24 hour period: o Interview direct care staff; • Are you ever made aware of the absence of licensed nursing staff during your shift? • When was the last time that licensed staff was not available during your shift? • How often does this occur? • How does this impact residents in the facility? • Are you aware of any residents that missed medications or treatments due to no available licensed nurse? • Who do you notify in the event of an emergency and there is no licensed nurses available? o Interview the Director of Nursing or Administrator; • When was the last time that licensed nursing staff were not available on a shift? • How often does the facility not have licensed nursing staff at all times? • What is the facility’s policy when there is not a licensed nurse available in a 24 hour period? • How does the facility provide care to residents that require a licensed nurse if one is not available to work? • How does this impact residents in the facility? Concerns such as falls, weight loss, dehydration, pressure ulcers, as well as the incidence of elopement and resident altercations can also offer insight into the sufficiency of the numbers of staff. Surveyors must investigate if these adverse outcomes are related to sufficient staffing. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F725, the surveyor’s investigation will generally show that the facility failed to do any one of the following: • Ensure there are a sufficient number of skilled licensed nurses, nurse aides, and other nursing personnel to provide care and respond to each resident’s basic needs and individual needs as required by the resident’s diagnoses, medical condition, or plan of care; or • Ensure licensed nurse coverage 24 hours a day, except when waived; or • Ensure a licensed nurse is designated to serve as a charge nurse on each tour of duty, except when waived. DEFICIENCY CATEGORIZATION Once the survey team has completed its investigation, analyzed the data, reviewed the regulatory requirements, and determined that noncompliance exists, the team must determine the severity of each deficiency, based on the harm or potential for harm to the resident. An example of Level 4, immediate jeopardy to resident health and safety includes, but is not limited to: • A resident with a Stage 4 pressure injury, did not receive skin assessments and treatments for two weeks due to the absence of the only trained wound nurse on the resident’s scheduled skin assessment days. No accommodations were made for coverage in the absence of this wound nurse and no other nursing staff were trained to provide this care. The pressure injury became infected during this timeframe and resulted in the resident being hospitalized requiring IV antibiotics for sepsis. Failure to provide sufficient staff with the necessary skill set to provide skin assessments and treatments created the likelihood for serious injury, harm, impairment or death for the resident. • A resident had complained of chest pain and shortness of breath after eating their evening meal. The nursing assistant stated they would inform the licensed nurse. The nursing assistant was informed there would be no licensed nurse available onsite. At 10:00 p.m. the resident was found unresponsive with minimal respirations. Because there was no licensed nurse on duty at that time, the nursing assistant called 911 and the resident was sent to the emergency room. • The survey team was made aware the facility had 4 days in the previous quarter of PBJ submission when there were no licensed nurses in the facility for all 24 hours of each day. After a thorough investigation, the team determined the absences of a licensed nurse in the facility created the likelihood for serious injury, harm, impairment or death for all residents. Examples of Level 3, actual harm (physical or psychosocial) that is not immediate jeopardy includes, but are not limited to: • A resident’s room has a strong smell of urine. Upon further investigation, the surveyor discovers the resident is incontinent and has soiled undergarments. Upon interview, the resident stated he called for help about an hour ago and was told by staff that they were short-staffed today and would get to him as soon as they could. He also mentioned that this happens almost every day and he is embarrassed to ask staff for help to clean himself up, so he remains withdrawn in his room until a staff member can assist him. Refer to the Psychosocial Outcome Guide for additional direction. • A resident was admitted to the facility with a recently repaired hip fracture and required assistance with ambulation. The resident used the calling device to request assistance to the bathroom. After several minutes no help arrived so the resident attempted to ambulate with a walker to the bathroom without assistance. The resident subsequently fell and was found by nursing assistants. The resident was assisted back to bed by the nursing assistants and complained of pain in the area of the recently repaired hip fracture. There was no licensed nurse on duty to assess the resident for any injuries or provide medication for pain. The next morning the resident complained of increased pain in the area of the repaired hip fracture. After assessment by the day shift licensed nurse the resident was sent to the hospital. The resident was admitted and required surgery to repair the re- fractured hip. Examples of Level 2, no actual harm, with potential for more than minimal harm, that is not immediate jeopardy includes, but are not limited to: A resident’s family complained that their loved one’s personal hygiene was never completed in a timely manner due to lack of staff. When interviewed, staff stated that they typically assist this resident once the care is completed for all other residents in their assignment since it takes longer to provide care for him. This resulted in the resident occasionally missing occupational therapy. There has been no recent documented decline in ADL function but there is a potential for decline. • Residents complain that they are not allowed choices such as receiving showers consistently on the days or at times they prefer due to inadequate staffing. Review of staffing data submitted via the PBJ system revealed the facility had a one-star staffing quality rating. Follow up interviews with the staffing coordinator revealed that only one CNA was available to provide showers, and therefore residents’ preferences for timing of showering could not be met cause anxiety. Refer to the Psychosocial Outcome Guide for additional direction. Severity Level 1: No Actual Harm with Potential for Minimal Harm The failure of the facility to provide sufficient staffing including licensed nurses creates a risk that is more than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement F726 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.35 Nursing Services The facility must have sufficient nursing staff with the appropriate competencies and skills sets to provide nursing and related services to assure resident safety and attain or maintain the highest practicable physical, mental, and psychosocial well- being of each resident, as determined by resident assessments and individual plans of care and considering the number, acuity and diagnoses of the facility’s resident population in accordance with the facility assessment required at §483.71. §483.35(a)(3) The facility must ensure that licensed nurses have the specific competencies and skill sets necessary to care for residents’ needs, as identified through resident assessments, and described in the plan of care. §483.35(a)(4) Providing care includes but is not limited to assessing, evaluating, planning and implementing resident care plans and responding to resident’s needs. §483.35(c) Proficiency of nurse aides. The facility must ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for residents’ needs, as identified through resident assessments, and described in the plan of care. INTENT §483.35(a)(3)-(4),(c) To assure that all nursing staff possess the competencies and skill sets necessary to provide nursing and related services to meet the residents’ needs safely and in a manner that promotes each resident’s rights, physical, mental and psychosocial well-being. DEFINITIONS §483.35 “Competency” is a measurable pattern of knowledge, skills, abilities, behaviors, and other characteristics that an individual needs to perform work roles or occupational functions successfully. GUIDANCE §483.35(a)(3)-(4),(c) Cite this Tag only if there are deficiencies related to the competency of nursing staff. If the survey investigation reveals that there are concerns with the competency of staff in areas other than Nursing Services refer to; • F741, §483.40(a) for any staff caring for residents with dementia or a history of trauma and/or post-traumatic stress disorder; • F801, §483.60(a) for Food and Nutrition staff; • F826, §483.65(b), Specialized rehabilitative services; • F839, §483.70(e), Administration for any other staff not referenced above. NOTE: The actual or potential physical, mental, or psychosocial resident outcomes related to noncompliance cited at F726, should be investigated at the relevant tags, such as Abuse, Quality of Life, and/or Quality of Care. All nursing staff must also meet the specific competency requirements as part of their license and certification requirements defined under State law or regulations. Many factors must be considered when determining whether or not facility staff have the specific competencies and skill sets necessary to care for residents’ needs, as identified through the facility assessment, resident-specific assessments, and described in their plan of care. A staff competency deficiency under this requirement may or may not be directly related to an adverse outcome to a resident’s care or services. It may also include the potential for physical and psychosocial harm. As required under F838, §483.71, the facility’s assessment must address/include an evaluation of staff competencies that are necessary to provide the level and types of care needed for the resident population. Additionally, staff are expected to demonstrate competency with the activities listed in the training requirements per §483.95, such as preventing and reporting abuse, neglect, and exploitation, dementia management, and infection control. Also, nurse aides are expected to demonstrate competency with the activities and components that are required to be part of an approved nurse aide training and competency evaluation program, per §483.152. Competency in skills and techniques necessary to care for residents’ needs includes but is not limited to competencies in areas such as; • Resident Rights; • Person centered care; • Communication; • Basic nursing skills; • Basic restorative services; • Skin and wound care; • Medication management; • Pain management; • Infection control; • Identification of changes in condition; • Cultural competency. Staff Competencies in Identifying Changes in Condition A key component of competency is a nurse’s (CNA, LPN, RN) ability to identify and address a resident’s change in condition. Facility staff should be aware of each resident’s current health status and regular activity, and be able to promptly identify changes that may indicate a change in health status. Once identified, staff should demonstrate effective actions to address a change in condition, which may vary depending on the staff who is involved. For example, a CNA who identifies a change in condition may document the change on a short form and report it to the RN manager. Whereas an RN who is informed of a change in condition may conduct an in-depth assessment, and then call the attending practitioner. These competencies are critical in order to identify potential issues early, so interventions can be applied to prevent a condition from worsening or becoming acute. Without these competencies, residents may experience a decline in health status, function, or need to be transferred to a hospital. Not all conditions, declines of health status, or hospitalizations are preventable. However, through the facility assessment (§483.71), facilities are required to address the staff competencies that are necessary to provide the level and types of care needed for the resident population considering the types of diseases, conditions, physical and cognitive disabilities, overall acuity, and other pertinent facts that are present within that population. Furthermore, per §483.95, facilities must determine the amount and types of training based on the facility assessment. We also note that the curriculum of a nurse aide training program must include training on recognizing abnormal changes in body functioning and the importance of reporting such changes to a supervisor (§483.152(b)(2)(iv)).Therefore, facility staff are expected to know how to identify residents’ changes in conditions, and what to do once one is identified. Facilities may adopt certain tools to aid staff with these competencies, as these tools have proven to be effective. For example, the Agency for Healthcare Research and Quality (AHRQ) has training modules for detecting and communicating resident changes in condition https://www.ahrq.gov/professionals/systems/long-term- care/resources/facilities/ptsafety/ltcmodule1.html. Also, Interventions to Reduce Acute Care Transfers (INTERACT) is a program with several resources aimed at improving staff competencies in this area https://interact2.net/tools_v4.html. Staff may inform surveyors of the tools they use to help show evidence of the required competencies. However, merely stating or referencing the tools is not enough on its own to verify compliance. Staff must also demonstrate that they possess the competency to use the tools in a manner that accomplishes their purpose, of aiding to effectively identify and address resident changes in condition. Cultural Competencies Cultural competencies help staff communicate effectively with residents and their families and help provide care that is appropriate to the culture and the individual. The term cultural competence (also known as cultural responsiveness, cultural awareness, and cultural sensitivity) refers to a person’s ability to interact effectively with persons of cultures different from his/her own. With regard to health care, cultural competence is a https://www.ahrq.gov/professionals/systems/long-term-care/resources/facilities/ptsafety/ltcmodule1.html https://www.ahrq.gov/professionals/systems/long-term-care/resources/facilities/ptsafety/ltcmodule1.html https://interact2.net/tools_v4.html set of behaviors and attitudes held by clinicians that allows them to communicate effectively with individuals of various cultural backgrounds and to plan for and provide care that is appropriate to the culture and to the individual. The following resources are intended for informational purposes only: • The National Center for Cultural Competency https://nccc.georgetown.edu/index.html • The National Standards for Culturally and Linguistically appropriate Services in Health and Health Care (developed by the Office of Minority Health in HHS) https://www.thinkculturalhealth.hhs.gov/pdfs/EnhancedCLASStandardsBlueprint. pdf NOTE: References to non-CMS sources do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services and were current as of the date of this publication. Demonstration of Competency Competency may not be demonstrated simply by documenting that staff attended a training, listened to a lecture, or watched a video. A staff’s ability to use and integrate the knowledge and skills that were the subject of the training, lecture or video must be assessed and evaluated by staff already determined to be competent in these skill areas. Examples for evaluating competencies may include but are not limited to: • Lecture with return demonstration for physical activities; • A pre- and post-test for documentation issues; • Demonstrated ability to use tools, devices, or equipment that were the subject of training and used to care for residents; • Reviewing adverse events that occurred as an indication of gaps in competency; or • Demonstrated ability to perform activities that is in the scope of practice an individual is licensed or certified to perform. Nursing leadership with input from the Medical Director should delineate the competencies required for all nursing staff to deliver, individualize, and provide safe care for the facility’s residents. There should also be a process to evaluate staff skill levels, and to develop individualized competency-based training, that ensure resident safety and quality of care and service being delivered. A competency-based program might include the following elements: a. Evaluates current staff training programming to ensure nursing competencies (e.g. skills fairs, training topics, return demonstration). https://nccc.georgetown.edu/index.html https://www.thinkculturalhealth.hhs.gov/pdfs/EnhancedCLASStandardsBlueprint https://www.thinkculturalhealth.hhs.gov/pdfs/EnhancedCLASStandardsBlueprint b. Identifies gaps in education that is contributing to poor outcomes (e.g. potentially preventable re-hospitalization) and recommends educational programing to address these gaps. c. Outlines what education is needed based on the resident population (e.g. geriatric assessment, mental health needs) with delineation of licensed nursing staff verses non-licensed nursing and other staff member of the facility. d. Delineates what specific training is needed based on the facility assessment (e.g. ventilator, IV’s, trachs). e. Details the tracking system or mechanism in place to ensure that the competency- based staffing model is assessing, planning, implementing, and evaluating effectiveness of training. f. Ensures that competency-based training is not limited to online computer based but should also test for critical thinking skills as well as the ability to manage care in complex environments with multiple interruptions. PROCEDURES AND PROBES §483.35(a)(3)-(4),(c) For specific survey procedures see the Sufficient and Competent Staffing Critical Element Pathway. Surveyors must determine through information obtained by observations, interviews and verified by record reviews, whether the facility employs competent nursing staff to provide care and services in assisting residents to attain or maintain their highest practicable level of physical, mental, functional and psychosocial well-being. • How are staff competencies and skill sets evaluated upon their initial hire and routinely thereafter and when new technologies/equipment are put into use? • Does the facility assessment describe the type of competencies required to meet each resident’s needs as required under §483.71. Do the competencies of the staff reflect the expectations described in the facility assessment? • Is there evidence that staff are able to identify and address resident changes in condition? What are the practices or tools used that demonstrate this ability? Is there evidence of a lack of competency, such as: o Adverse events that could have been prevented; o Conditions that occurred that could have been identified and addressed earlier to prevent them from worsening; or o Hospital transfers that could have been potentially avoided if the reason for the transfer had been identified and addressed earlier. • How are staff evaluated to determine that they demonstrate knowledge of individual residents and how to support resident preferences? • When observing the provision of care, does the nursing staff demonstrate: o Necessary competencies and skill sets in accordance with current standards of practice? For example, if the resident requires a manual lift for transferring, do staff demonstrate knowledge and skill in the proper use of the lift and perform the activity in a safe manner? o The use of techniques and skills that maintain or improve the resident’s physical, mental or psychosocial functioning as identified through required assessments and the care plan such as, but not limited to, the following: 1. Providing mobility assistance, such as assistance with walking and transferring. 2. Assisting with Activities of Daily Living: eating, bathroom needs, bed mobility, bathing, oral care, incontinence care, dressing, etc. 3. Providing care to residents with communication needs and ensuring that devices are utilized per the care plan. 4. Demonstrating knowledge about residents’ condition and behavior and when to report changes to the licensed or registered nurse. • Determine how agency/contract staff have been evaluated to ensure their competencies and skills to care for the facility’s resident population. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION §483.35(a)(3)-(4),(c) If there are concerns with staff skills and competencies it may be necessary to review the facility’s assessment as required at F838, §483.71 to determine how competencies are evaluated. Also, review the facility’s process for assessing these competencies and skills and addressing staff performance for the effective application of knowledge and skill in the practice setting. It may also be necessary to review the Training requirements at §483.95. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F726, the surveyor’s investigation will generally show that the facility failed to do the following: • Ensure the licensed nurses and other nursing personnel have the knowledge, competencies and skill sets to provide care and respond to each resident’s individualized needs as identified in his/her assessment and care plan. DEFICIENCY CATEGORIZATION Once the survey team has completed its investigation, analyzed the data, reviewed the regulatory requirements, and determined that noncompliance exists, the team must determine the severity of each deficiency, based on the harm or potential for harm to the resident. Examples of Level 4, immediate jeopardy to resident health and safety includes, but are not limited to: • A resident sustained a serious injury that required hospitalization and surgery resulting from a fall from a mechanical lift due to an unsafe transfer by one staff member. When interviewed, this staff member stated that she was not familiar with how to use the mechanical lift. The facility failed to ensure the staff was competent to operate the equipment. • Staff did not demonstrate competency in maintaining the airway of a resident with a tracheostomy when it became obstructed by a mucous plug. Staff were unable to act immediately to the situation resulting in the resident experiencing a respiratory arrest. Staff did not have the necessary skills to adequately meet the needs of the resident resulting in a life-threatening situation for the resident. • A new resident was recently admitted to the nursing home with a diagnosis of diabetes. Upon interview several staff stated that they were not familiar with using this new blood sugar monitor. As a result the resident’s blood sugar levels were inaccurate and not reliable. The levels continued to fluctuate from very high to very low and in each case the amount of insulin administered to the resident was adjusted based on these results. As a result after 3 days the resident went into diabetic shock and was hospitalized. • The facility failed to ensure that licensed nurses had the skills and knowledge to detect changes in a resident’s condition. After the nurse’s aide notified the nurse on duty that the resident has swelling in her feet, the nurse determined that the resident has 2+ pitting edema and documented the finding in the medical record. No further action was taken. The nurse did not review the medical record which identified the resident’s history of congestive heart failure (CHF). The next day the resident’s edema increased, the nurse notified the attending physician but did not inform the physician of the resident’s history of CHF. The nurse did not conduct any further assessment of the resident, secure orders from the physician, or document a request for intervention from the physician. On day three the resident experienced respiratory distress and was admitted to the hospital with CHF exacerbation. The inability of the nursing staff to conduct a thorough assessment and to recognize the signs and symptoms of CHF resulted in heart failure and placed the resident at risk for serious harm or death. Examples of Level 3 actual harm that is not immediate jeopardy includes but are not limited to: • An increase in facility acquired Stage 2 pressure injuries was noted over the past two months for residents with darker pigmentation. When interviewed, several nursing staff, including the Director of Nursing, stated that in residents with darker pigmentation, staff cannot identify pressure injuries until the skin is no longer intact. The facility failed to provide staff with the necessary skill set to identify and prevent pressure injuries and meet the residents’ needs. • A resident who usually gets up at 6am and eats breakfast in the dining room every day has been getting up at 8am for the past few days. When interviewed he says he doesn’t want to eat breakfast and just wants to sleep. Staff have been letting him continue to sleep throughout the day. When interviewed they said they think he is just tired and this went on for several days. The resident then began to decline to eat dinner and seems confused about his whereabouts. The nurse stated she thinks he is just tired and continues to let him sleep. In the morning, the resident is falling in and out of sleep, is incoherent and has a fever. The facility orders a hospital transfer where the resident is admitted with a high fever and a positive lab result for a Urinary Tract Infection. • A 78 year old with a diagnosis of hypertension, Peripheral Vascular Disease, Diabetes and CVA (cerebrovascular accident) receives anticoagulant therapy. The resident developed a nose bleed. Since the resident is on anticoagulant therapy the MD was notified and an order for PT/INR was ordered and obtained. The INR was noted to be elevated requiring the resident to receive an injection of Vitamin K. When staff were interviewed CNA #1 stated that two days prior she had noted the resident’s gums were bleeding during oral care and thought that maybe he just needed his teeth cleaned but she did mention it to the nurse. CNA #2 reports that the resident had a medium black tarry stool the night before but she became busy and forgot to report it to the Charge Nurse. The facility failed to provide staff with the necessary skill set to identify residents at risk for bleeding related to anticoagulant therapy so therefore the facility staff did not meet the needs of the resident. An example of Level 2 no actual harm with a potential for more than minimal harm that is not immediate jeopardy includes but is not limited to: • Resident did not have pacemaker check performed via telephone due to lack of knowledge by staff on procedure. Level 1 - Severity 1 does not apply for this regulatory requirement. F727 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.35(b) Registered nurse §483.35(b)(1) Except when waived under paragraph (e) or (f) of this section, the facility must use the services of a registered nurse for at least 8 consecutive hours a day, 7 days a week. §483.35(b)(2) Except when waived under paragraph (e) or (f) of this section, the facility must designate a registered nurse to serve as the director of nursing on a full time basis. §483.35(b)(3) The director of nursing may serve as a charge nurse only when the facility has an average daily occupancy of 60 or fewer residents. DEFINITIONS §483.35(b) “Full-time” is defined as working 40 or more hours a week. “Charge Nurse” is a licensed nurse with specific responsibilities designated by the facility that may include staff supervision, emergency coordinator, physician liaison, as well as direct resident care. PROCEDURE AND GUIDANCE §483.35(b) Nurse staffing in nursing homes has a substantial impact on the quality of care and outcomes that residents experience. A registered nurse (RN) is typically responsible for overseeing the care provided to nursing home residents by other staff such as Licensed Practical Nurses (LPN) or Certified Nurse Aides (CNA). The RN is generally responsible for more advanced care activities such as resident assessments, consulting with physicians, and administering intravenous fluids or medications. Facilities are responsible for ensuring they have an RN providing services at least 8 consecutive hours a day, 7 days a week. However, per Facility Assessment requirements at F838, §483.71, facilities are expected to identify when they may require the services of an RN for more than 8 hours a day based on the acuity level of the resident population. If it is determined the services of an RN are required for more than 8 hours a day, refer to the guidance at F725 related to sufficient nurse staffing for further investigation. Facilities may choose to have differing tours of duty (e.g. 8 hour- or 12-hour shifts) for their licensed nursing staff. Regardless of the approach, the facility is responsible for ensuring the 8 hours worked by the RN are consecutive within each 24-hour period. The facility must designate a registered nurse (RN) to serve as the DON on a full-time basis. The facility can only be waived from this requirement if it has obtained a waiver under subsections §483.35(e) or (f). The facility may permit the DON to serve as a charge nurse only when the facility has an average daily occupancy of 60 or fewer residents. The facility is responsible for submitting staffing data through the PBJ (Refer to F851, §483.70 (p). This data is available through PBJ reports that can be obtained through the Certification and Survey Provider Enhanced Reports (CASPER) reporting system. These reports, titled PBJ Staffing Data Report will be utilized by surveyors and contains information about overall direct care staffing levels as well as licensed nurse staffing, and if an RN was onsite for 8 hours a day, 7 days a week. If concerns were identified on this report, as well as from other sources, refer to the Critical Element pathway Sufficient and Competent Staffing, and the probes noted below. Probes: • Review the facility’s posted daily staffing data. • Does the facility have an RN on duty at least 8 consecutive hours a day, 7 days a week? • Does the facility have an RN to serve as the DON on a full time basis? • Does the facility ensure that the DON serves as a charge nurse only when the facility has an average daily occupancy of 60 or fewer residents? • If there is no RN coverage for at least 8 consecutive hours each day, (e.g., as indicated by the PBJ Staffing Report), interview: o front line staff (i.e., nurse aides, LPNs/LVNs)  Is there an RN providing services to the residents for at least 8 consecutive hours in the day?  Are you ever made aware when there is no RN available in the facility?  Are you ever aware of a resident who needed care or services only performed by an RN (i.e., intravenous medications, assessment) and did not receive it? o Director of Nursing or Administrator;  How often are there days with no RN onsite?  What does the facility do when there is not an RN available to work the required 8 consecutive hours each day?  How does the facility provide care to residents that require an RN if one is not available to work? Deficiency Categorization: Example of Severity Level 4 Noncompliance: Immediate Jeopardy to Resident Health or Safety includes but is not limited to: • The annual recertification survey of a facility indicates that it provides care for residents with high acuity needs including residents that receive medications and fluids via central intravenous lines (IV) and ventilator dependent residents. The investigation revealed an RN was not onsite for at least 8 consecutive hours during the day. During the period when there was no RN, the LPN had to perform assessments and maintain central line (IV) infusions, which is out of the scope of practice for an LPN in the absence of supervision of the RN. The facility’s failure to have an RN on duty for at least 8 consecutive hours a day as required by the regulation, created the likelihood for serious injury, harm, impairment or death. Specifically, the RN was not present to meet the critical needs of these high acuity residents. Example of Severity Level 3 Noncompliance: Actual Harm that is not Immediate Jeopardy includes, but is not limited to: • Investigation of falls occurring in the facility with a census greater than 60 residents revealed the monthly fall evaluation for one resident was not completed with the interdisciplinary team after the resident experienced 2 falls. Interview with the Director of Nursing (DON) revealed this was the DON’s responsibility; however, because she had been serving as the charge nurse, there was no time to complete the evaluation for this resident who experienced another fall resulting in a sprained wrist. Record review revealed that the resident experienced a fall after the DON failed to complete the fall evaluation in response to the two initial falls. Staff ultimately determined the resident was falling due to a change in the resident’s condition (deteriorating eyesight) that was not timely identified because of the DON’s failure to complete a monthly fall evaluation. Example of Severity Level 2 Noncompliance: No Actual Harm with Potential for More Than Minimal Harm that is Not Immediate Jeopardy includes, but is not limited to: • Review of the PBJ Staffing Data Report revealed concerns related to the facility’s requirement to have a Registered Nurse on duty for at least 8 consecutive hours a day. The surveyor verified an RN was routinely on duty for only 7 consecutive hours a day last quarter. No actual harm to residents was identified. However, there was a potential for more than minimal harm due to the facility’s failure to have an RN on duty for at least 8 consecutive hours a day, 7 days a week in order to ensure that all the residents’ clinical needs were met either directly by the RN or indirectly by the LPNs or CNAs for whom the RN was responsible for overseeing resident care. • Review of the PBJ Staffing Data Report, other staffing documentation, and staff interviews revealed that the Director of Nursing routinely served as a charge nurse when the facility had an average daily occupancy of between 65-70 residents. No actual harm to residents was identified. However, there was a potential for more than minimal harm resulting from the Registered Nurse’s dual role in simultaneously serving as both the Director of Nursing and the Charge Nurse for greater than 60 residents. Severity Level 1: No Actual Harm with Potential for Minimal Harm • The failure of the facility to provide an RN creates a risk that is more than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement. F728 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.35(d) Requirement for facility hiring and use of nurse aides- §483.35(d)(1) General rule. A facility must not use any individual working in the facility as a nurse aide for more than 4 months, on a full-time basis, unless— (i) That individual is competent to provide nursing and nursing related services; and (ii)(A) That individual has completed a training and competency evaluation program, or a competency evaluation program approved by the State as meeting the requirements of §483.151 through §483.154; or (B) That individual has been deemed or determined competent as provided in §483.150(a) and (b). §483.35(d)(2) Non-permanent employees. A facility must not use on a temporary, per diem, leased, or any basis other than a permanent employee any individual who does not meet the requirements in paragraphs (d)(1)(i) and (ii) of this section. §483.35(d)(3) Minimum Competency A facility must not use any individual who has worked less than 4 months as a nurse aide in that facility unless the individual— (i) Is a full-time employee in a State-approved training and competency evaluation program; (ii) Has demonstrated competence through satisfactory participation in a State- approved nurse aide training and competency evaluation program or competency evaluation program; or (iii) Has been deemed or determined competent as provided in §483.150(a) and (b). DEFINITIONS §483.35(d)(1-3) A “permanent employee” is defined as any employee the facility expects to continue working on an ongoing basis. GUIDANCE §483.35(d)(1-3) Any individual who successfully completed either a nurse aide training or competency evaluation program (NATCEP) or a competency evaluation program (CEP) or has been deemed or determined competent as provided in §483.150(a) and (b) may be employed as a nurse aide. If an individual has not successfully completed a NATCEP program at the time of employment, that individual may only function as a nurse aide if the individual is currently in a NATCEP (not a competency evaluation program (CEP) alone) and is a permanent employee in his or her first four months of employment in the facility. PROCEDURES AND PROBES §483.35(d)(1-3) • If there are concerns with a nurse aide’s competency or qualification determine whether he/she successfully completed an approved NATCEP or a CEP. If not, are these individuals’ permanent employees who have worked in the facility for 4 months or less enrolled in a NATCEP? • Interview those aides to determine where they received their NATCEP training, how long the training was and how long they have worked in the facility as a nurse aide. If you identify deficient care practices by nurse aides who do not have evidence of having successfully completed a NATCEP/CEP, determine: • If the aide is currently receiving training in a State-approved NATCEP; and • If the aide has been trained, has demonstrated proficiency and determined to be proficient for the tasks to which he or she is assigned. See §483.152 for specific training that the aide is to receive. For specific procedures for NATCEP/CEP refer to the State Operations Manual (SOM), Chapters 4 and 7. F729 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.35(d)(4) Registry verification. Before allowing an individual to serve as a nurse aide, a facility must receive registry verification that the individual has met competency evaluation requirements unless— (i) The individual is a full-time employee in a training and competency evaluation program approved by the State; or (ii)The individual can prove that he or she has recently successfully completed a training and competency evaluation program or competency evaluation program approved by the State and has not yet been included in the registry. Facilities must follow up to ensure that such an individual actually becomes registered. §483.35(d)(5) Multi-State registry verification. Before allowing an individual to serve as a nurse aide, a facility must seek information from every State registry established under sections 1819(e)(2)(A) or 1919(e)(2)(A) of the Act that the facility believes will include information on the individual. §483.35(d)(6) Required retraining. If, since an individual’s most recent completion of a training and competency evaluation program, there has been a continuous period of 24 consecutive months during none of which the individual provided nursing or nursing-related services for monetary compensation, the individual must complete a new training and competency evaluation program or a new competency evaluation program. GUIDANCE §§483.35(d)(4)-(6) If the nurse aide provides documentation to verify that he or she performed nursing or nursing-related services for monetary compensation (including providing assistance with activities of daily living (ADL) care) for at least one documented day (e.g., 8 consecutive hours) during the previous 24 months, he/she is not required to take a new nurse aide training and competency evaluation program or a new competency evaluation program (NATCEP/CEP). It is not required that these services be provided in a nursing home setting so long as the nurse aide was performing nursing or nursing-related services, including assisting with ADLs, for monetary compensation. The State is required to remove the individual’s name from the registry if the services are not provided for monetary compensation during the 24-month period. PROCEDURE If concerns are identified with Nurse Aide Services at F725 and F726, review a minimum of five nurse aide personnel files including any specific staff members with whom concerns were identified. • Review the nurse aide personnel folder to determine if the facility received registry verification that the individual has met competency evaluation requirements before the employee’s start date unless an exception applies as noted in §483.35(d)(4). • Review the nurse aide personnel folder to determine if the facility verified information from every State registry that the facility believes will include information concerning that individual before the employee’s start date. • If records reveal a nurse aide has not provided nursing related services for monetary compensation over a 24-month period, did the individual complete a new training and competency evaluation program? F730 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.35(d)(7) Regular in-service education. The facility must complete a performance review of every nurse aide at least once every 12 months, and must provide regular in-service education based on the outcome of these reviews. In-service training must comply with the requirements of §483.95(g). INTENT §483.35(d)(7) To focus on the performance review requirement and specific in-service education based on the outcome of those reviews for each individual nurse aide. GUIDANCE §483.35(d)(7) NOTE: Cite this Tag only when a performance review of a nurse aide is not conducted at least every 12 months or if the in-service education provided to an aide is not based on his/her performance review. Each nurse aide must have no less than twelve hours of in-service education per year based on their individual performance review. Calculate the date by which a nurse aide must receive annual in-service education by their employment date rather than the calendar year. For specific requirements regarding the content and requirements of training for nurse aides DO NOT cite here but refer to F947, §483.95(g). PROBES §483.35(d)(7) Surveyors should determine through information obtained by observations, interviews and verified by record reviews, whether a performance review of every nurse aide was conducted at least once every 12 months and if the regular in-service education was based on the outcome of these individual reviews. • What is the process for reviewing the performance review of nurse aides? • How are these reviews documented and does the documentation reflect at least twelve hours of in-service training per year based on an aide’s individual performance review? • What evidence can the facility produce that demonstrates the in-service education provided addresses areas of weakness identified in performance reviews, special resident needs, and needs of residents with cognitive impairments? F731 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.35(e) Nursing facilities Waiver of requirement to provide licensed nurses on a 24-hour basis. To the extent that a facility is unable to meet the requirements of paragraphs (a)(2) and (b)(1) of this section, a State may waive such requirements with respect to the facility if— §483.35(e)(1) The facility demonstrates to the satisfaction of the State that the facility has been unable, despite diligent efforts (including offering wages at the community prevailing rate for nursing facilities), to recruit appropriate personnel; §483.35(e)(2) The State determines that a waiver of the requirement will not endanger the health or safety of individuals staying in the facility; §483.35(e)(3) The State finds that, for any periods in which licensed nursing services are not available, a registered nurse or a physician is obligated to respond immediately to telephone calls from the facility; §483.35(e)(4) A waiver granted under the conditions listed in paragraph (e) of this section is subject to annual State review; §483.35(e)(5) In granting or renewing a waiver, a facility may be required by the State to use other qualified, licensed personnel; §483.35(e)(6) The State agency granting a waiver of such requirements provides notice of the waiver to the Office of the State Long-Term Care Ombudsman (established under section 712 of the Older Americans Act of 1965) and the protection and advocacy system in the State for individuals with a mental disorder who are eligible for such services as provided by the protection and advocacy agency; and §483.35(e)(7) The nursing facility that is granted such a waiver by a State notifies residents of the facility and their resident representatives of the waiver. §483.35(f) SNFs Waiver of the requirement to provide services of a registered nurse for more than 40 hours a week. §483.35(f)(1) The Secretary may waive the requirement that a SNF provide the services of a registered nurse for more than 40 hours a week, including a director of nursing specified in paragraph (b) of this section, if the Secretary finds that— (i) The facility is located in a rural area and the supply of skilled nursing facility services in the area is not sufficient to meet the needs of individuals residing in the area; (ii) The facility has one full-time registered nurse who is regularly on duty at the facility 40 hours a week; and (iii) The facility either— (A) Has only patients whose physicians have indicated (through physicians’ orders or admission notes) that they do not require the services of a registered nurse or a physician for a 48-hours period or; (B) Has made arrangements for a registered nurse or a physician to spend time at the facility, as determined necessary by the physician, to provide necessary skilled nursing services on days when the regular full-time registered nurse is not on duty; (iv) The Secretary provides notice of the waiver to the Office of the State Long- Term Care Ombudsman (established under section 712 of the Older Americans Act of 1965) and the protection and advocacy system in the State for individuals with developmental disabilities or mental disorders; and (v) The facility that is granted such a waiver notifies residents of the facility and their resident representatives of the waiver. §483.35(f)(2) A waiver of the registered nurse requirement under paragraph (f)(1) of this section is subject to annual renewal by the Secretary. INTENT §483.35(e)-(f) To give the facility flexibility, in limited circumstances, when the facility cannot meet nurse staffing requirements. GUIDANCE §483.35(e)-(f) If the facility is Medicaid-certified only, the State has the authority to grant a waiver of the RN requirement, and/or the 24-hour licensed nurse requirement. CMS is delegated the waiver authority for SNFs, including dually-participating facilities (SNF/NFs). The Medicare waiver authority is far more limited than is the States’ authority under Medicaid since a State may waive any element of the nurse staffing requirement, whereas the Secretary (CMS) may only waive the RN requirement. The requirements that a registered nurse provide services for 8 hours a day, 7 days a week (more than 40 hours a week), and that there be an RN designated as director of nursing on a full-time basis, may be waived by the Secretary (CMS) in the following circumstances: • The facility is located in a rural area with an inadequate supply of SNF services to meet area needs. Rural is defined as “all areas not delineated as `urban`” by the Bureau of Census, based on the most recent census; • The facility has one full-time registered nurse regularly working 40 hours a week. This may be the same individual, or part-time individuals. This nurse may or may not be the DON, and may perform some DON and some clinical duties if the facility so desires; and either; o The facility has only residents whose physicians have noted, in writing, do not need RN or physician care for a 48-hour period. This does not relieve the facility from responsibility for providing for emergency availability of a physician, when necessary, nor does it relieve the facility from being responsible for meeting all needs of the residents during those 48 hours; OR o A physician or RN will spend the necessary time at the facility to provide care residents need during the days that an RN is not on duty. This requirement refers to clinical care of the residents that need skilled nursing services. • If a waiver of this requirement has been granted, conduct a survey of nursing services during each certification survey. Dually-participating facilities must meet the waiver provisions of the SNF. A survey of Nursing Services must be conducted if a waiver has been granted or requested. PROBES §483.35(e)-(f) Before granting a continuation of this waiver, or during the annual review, coordinate with the State Survey Agency, and at a minimum, determine: • The facility’s recruitment efforts and its results. • How the facility ensures residents’ needs are being met in the absence of a licensed nurse. • How all nursing policies and procedures are followed on each shift during times when licensed services are waived? • If there is a qualified licensed nurse to assess, evaluate, plan and implement resident care. • If care is being carried out according to professional practice standards on each shift. • Whether the survey team can assure the State that the absence of licensed nurses will not endanger the health or safety of residents. • Whether there are trends in the facility, which might be indicators of decreased quality of care as a result of insufficient staffing to meet resident needs (e.g., increases in incident reports, the infection rate, hospitalizations, loss of function, etc.). • Whether there is evidence that preventive measures (e.g., turning, ambulating) are taken to avoid poor quality of care outcomes and avoidable sudden changes in health status. • Whether there is evidence that sudden changes in resident health status and emergency needs are being properly identified and managed by appropriate facility staff and in a timely manner. • Whether the residents or resident representatives been notified that the facility has a waiver to provide licensed nurses on a 24-hour basis. • Whether there is an increase in hospitalizations because licensed personnel are not available to provide appropriate services. • Whether the facility meets all applicable requirements to continue to receive a waiver. • Whether the staff indicates that an RN or physician is available to respond immediately to telephone calls when licensed nurses are not available. If the SNF has a waiver of the more than 40 hours a week RN requirement: • Is there an RN on duty 40 hours a week? • If more than one RN provides the 40 hour per week coverage, how is information exchanged that maintains continuity of resident care? • Does each resident’s clinical record have documentation by the physician that the resident does not need services of a physician or an RN for a 48-hour period each week? • Are there any emergency or routine services that should be, but are not, provided to residents during the days that a registered nurse is not on duty? • If specific skilled care is necessary for a resident during the time that an RN is not on duty, does an RN or physician provide that service on an “as needed” basis? • Did the facility notify the residents of the facility and their resident representatives of the waiver? If the SNF requests continuation of the waiver to provide the services of a registered nurse for more than 40 hours a week, the survey team is to provide the CMS Regional Office with information needed to grant this continuation. • Does the SNF meet all requirements necessary for continuation of the waiver? PROCEDURES §483.35(e)-(f) The following procedure should be used to document that a facility has a waiver of nurse staffing requirements. When a facility does not meet the nurse staffing requirements, cite the appropriate tag. If the facility does have a waiver, reference the tag number based on the type of facility. The type of facility (SNF, NF, or SNF/NF) determines what type of waiver is granted: • For SNFs and SNF/NFs which may be waived from the requirement to provide more than 40 hours of registered nurse services a week, and for NFs which have been granted a waiver from the 56-hour registered nurse requirement, cite F727; o For NFs that have a waiver of the 24-hour licensed nursing requirement, cite F725, or o Both facility types could be waived for the requirement to designate a registered nurse as the director of nursing on a full-time basis. Cite F731. If the facility has an approved nurse staffing waiver, it is not considered a deficiency. The facility does not need to submit a Plan of Correction. F732 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.35(g) Nurse Staffing Information. §483.35(g)(1) Data requirements. The facility must post the following information on a daily basis: (i) Facility name. (ii) The current date. (iii) The total number and the actual hours worked by the following categories of licensed and unlicensed nursing staff directly responsible for resident care per shift: (A) Registered nurses. (B) Licensed practical nurses or licensed vocational nurses (as defined under State law). (C) Certified nurse aides. (iv) Resident census. §483.35(g)(2) Posting requirements. (i) The facility must post the nurse staffing data specified in paragraph (g)(1) of this section on a daily basis at the beginning of each shift. (ii) Data must be posted as follows: (A) Clear and readable format. (B) In a prominent place readily accessible to residents and visitors. §483.35(g)(3) Public access to posted nurse staffing data. The facility must, upon oral or written request, make nurse staffing data available to the public for review at a cost not to exceed the community standard. §483.35(g)(4) Facility data retention requirements. The facility must maintain the posted daily nurse staffing data for a minimum of 18 months, or as required by State law, whichever is greater. INTENT §483.35(g) To make nurse staffing information readily available in a readable format to residents and visitors at any given time. GUIDANCE §483.35(g) The facility’s staffing data “document” may be a form or spreadsheet, as long as all the required information is displayed clearly and in a visible place. The information should be displayed in a prominent place that is readily accessible to residents and visitors and presented in a clear and readable format. This information posted must be up-to-date and current. The facility is required to list the total number of staff and the actual hours worked by the staff to meet this regulatory requirement. The information should reflect staff absences on that shift due to call-outs and illness. Staffing must include all nursing staff who are paid by the facility (including contract staff). The nursing home is not required to include in the posting the data for staff who are paid for through other sources; examples include hospice staff covered by the hospice benefit, or individuals hired by families to provide companionship or assistance to a specific resident. Probes: PROCEDURES AND PROBES §483.35(g) Surveyors must determine through information obtained by observations and verified by record reviews the following: • The facility posts the following information on a daily basis 1. Facility name 2. The current date 3. The total number and actual hours worked by the following categories of licensed and unlicensed nursing staff directly responsible for resident care per shift: registered nurses, licensed practical nurses or licensed vocational nurses, and certified nurse aides. 4. Resident census • The facility must post the nurse staffing data mentioned above on a daily basis at the beginning of each shift. • The data must be posted in a clear and readable format and in a prominent place readily accessible to residents and visitors. • The facility must upon oral or written request make nurse staffing data available to the public for review at a cost not to exceed the community standard. • The facility must maintain the posted daily nurse staffing data for a minimum of 18 months, or as required by State law, whichever is greater. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F732, the surveyor’s investigation will generally show that the facility failed to do any one of the following: • Ensure staffing information was posted in a prominent place readily accessible to residents and visitors; or • Ensure staffing information was accurate and current; or • Ensure staffing information was complete and was not missing information (e.g. specific units were not reflected on the posting); or • Make daily staffing available to the public for review upon request: or Maintain the posted daily nurse staffing data for a minimum of 18 months, or as required by State law, whichever is greater. F740 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.40 Behavioral health services. Each resident must receive and the facility must provide the necessary behavioral health care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care. Behavioral health encompasses a resident’s whole emotional and mental well-being, which includes, but is not limited to, the prevention and treatment of mental and substance use disorders. DEFINITIONS §483.40 Definitions are provided to clarify terminology related to behavioral health services and the attainment or maintenance of a resident’s highest practicable well-being. “Highest practicable physical, mental, and psychosocial well-being” is defined as the highest possible level of functioning and well-being, limited by the individual’s recognized pathology and normal aging process. Highest practicable is determined through the comprehensive resident assessment and by recognizing and competently and thoroughly addressing the physical, mental or psychosocial needs of the individual. “Mental disorder” is a syndrome characterized by a clinically significant disturbance in an individual's cognition, emotion regulation, or behavior that reflects a dysfunction in the psychological, biological, or developmental processes underlying mental functioning. Mental disorders are usually associated with significant distress or disability in social, occupational, or other important activities. American Psychiatric Association. “Diagnostic and Statistical Manual of Mental Disorders - Fifth edition.” 2013. “Substance use disorder” (“SUD”) is defined as recurrent use of alcohol and/or drugs that causes clinically and functionally significant impairment, such as health problems, disability, and failure to meet major responsibilities at work, school, or home. Adapted from Substance Abuse and Mental Health Services Administration (SAMHSA). “Mental Health and Substance Use Disorders.” Accessed March 2, 2021. https://www.samhsa.gov/find-help/disorders. GUIDANCE §483.40 Providing behavioral health care and services is an integral part of the person-centered environment. This involves an interdisciplinary approach to care, with qualified staff that demonstrate the competencies and skills necessary to provide appropriate services to the resident. Individualized approaches to care (including direct care and activities) are provided as part of a supportive physical, mental, and psychosocial environment, and are directed toward understanding, preventing, relieving, and/or accommodating a resident’s distress or loss of abilities. The behavioral health care needs of those with a SUD or other serious mental disorder should be part of the facility assessment under §483.71 (F838) and the facility should determine if they have the capacity, services, and staff skills to meet the requirements as discussed in F741. Surveyors should be aware that all residents are screened for possible serious mental disorders or intellectual disabilities and related conditions prior to admission to determine if specialized services under Preadmission Screening and Resident Review (PASARR) requirements are necessary. If a resident qualifies for specialized Level II services under PASARR, please refer to §483.20(k) (F645), as well as §483.20(e) (F644). If the resident does not qualify for specialized services under PASARR, but requires more intensive behavioral health services (e.g., individual counseling), the facility must demonstrate reasonable attempts to provide for and/or arrange for such services. This would include ensuring that the type(s) of service(s) needed is clearly identified based on the individual assessment, care plan and strategies to arrange such services. Behavioral health care and services could include: • Ensuring that the necessary care and services are person-centered and reflect the resident’s goals for care, while maximizing the resident’s dignity, autonomy, privacy, socialization, independence, choice, and safety; • Ensuring that direct care staff interact and communicate in a manner that promotes mental and psychosocial well-being. • Providing meaningful activities which promote engagement, and positive meaningful relationships between residents and staff, families, other residents and the community. Meaningful activities are those that address the resident’s customary routines, interests, preferences, etc. and enhance the resident’s well- being. Residents living with mental health and SUDs may require different activities than other nursing home residents. Facilities must ensure that activities are provided to meet the needs of their residents. NOTE: For concerns related to the facility’s activity program, or activities which do not address the needs of the resident, refer to §483.24(c), F679, Activities Meet Interest /Needs of Each Resident. • Providing an environment and atmosphere that is conducive to mental and psychosocial well-being; • Ensuring that pharmacological interventions are only used when non- pharmacological interventions are ineffective or when clinically indicated. For concerns about the use of pharmacological interventions, see Pharmacy Services requirements at §483.45. Individualized Assessment and Person-Centered Planning: In addition to the facility-wide approaches that address residents’ emotional and psychosocial well-being, facilities are expected to ensure that residents’ individualized behavioral health needs are met, through the Resident Assessment Instrument (RAI) Process. All areas are to be addressed through the: • Minimum Data Set (MDS); • Care Area Assessment Process; • Care Plan Development; • Care Plan Implementation; and • Evaluation. Sections of the MDS related to behavioral health needs that may be helpful include, but are not limited to: • Section C. Cognitive Patterns; • Section D. Mood; • Section E. Behavior; and • Section F. Activities. Utilizing Care Areas such as Psychosocial Well-Being, Mood State, and Behavioral Symptoms will also help to ensure the assessment and care planning processes are accomplished. It is also important for the facility to use an interdisciplinary team (IDT) approach that includes the resident, their family, or resident representative. For residents with an assessed history of a mental disorder or SUD, the care plan must address the individualized needs the resident may have related to the mental disorder or the SUD. Some facilities may use behavioral contracts as part of the individualized care plan to address behaviors which could endanger the resident, other residents and staff. Behavioral contracts may be a method for encouraging residents to follow their plan of care. However, in some circumstances, using them to impose a system of rewards and/or punishments could be construed as meeting the definition of abuse which includes the willful infliction of punishment and/or the deprivation of goods and services. Please refer to §483.5 for the definition of abuse and §483.12 for requirements pertaining to abuse, neglect, and exploitation. Additionally, behavioral contracts are only intended to be used for residents who have the capacity to understand them. The contract cannot conflict with resident rights or other requirements of participation (i.e., requirements at §483.15 related to admission, transfer, and discharge), but may address issues such as: • Residents with mental disorder and/or SUD may be at increased risk for leaving the facility without facility knowledge (which could be considered an elopement) at various times throughout their treatment, or if going through active withdrawal. The facility should explain the resident’s right to have a leave of absence and also explain the health and safety risks of leaving without facility knowledge or leaving against medical advice (AMA). The facility cannot restrict a resident’s right to leave the facility, but a contract can distinguish between a leave of absence, elopement, and leaving AMA. (For concerns related to inadequate supervision resulting in elopement, see F689 - Free of Accidents Hazards/Supervision/Devices); • Facility efforts to help residents with mental disorder and/or SUD, such as individual counseling services, access to group counseling, or access to a Medication Assisted Treatment program, if applicable; • Steps the facility may take if substance use is suspected, which may include: o Increased monitoring and supervision in the facility to maintain the health and safety of the resident suspected of substance use, as well as all residents; o Restricted or supervised visitation, if the resident’s visitor(s) are deemed to be a danger to the resident, other residents, and/or staff (See F563 - Right to receive/deny visitors); o Voluntary drug testing if there are concerns that suspected drug use could adversely affect the resident’s condition; o Voluntary inspections, if there is reasonable suspicion of possession of illegal drugs, weapons or other unauthorized items which could endanger the resident or others (See F557- Respect, Dignity/Right to have Personal Property); and • Referral to local law enforcement for suspicion of a crime in accordance with state laws, such as possession of illegal substances, paraphernalia or weapons (See F557- Respect, Dignity/Right to have Personal Property). Refusal to accept or non-adherence to the terms of a behavioral contract cannot be the sole basis for a denial of admission, a transfer or discharge. A facility may only transfer or discharge a resident for one of the reasons listed in F622, §483.15(c)(1)(i)(A)-(F). Rather, non-adherence to the contract should be treated like any care plan intervention that needs attention or needs to be altered to meet the needs of the resident. The IDT should work with the resident and resident representative to revise the care plan and contract. The following section discusses general information pertaining to conditions that are frequently seen in nursing home residents and may require facilities to provide specialized services and supports that vary, based upon residents’ individual needs. Depression Although people experience losses, it does not necessarily mean that they will become depressed. Depression (major depressive disorder or clinical depression) is a common and serious mood disorder. Symptoms may include fatigue, sleep and appetite disturbances, agitation, and expressions of guilt, difficulty concentrating, apathy, withdrawal, and suicidal ideation. Depression is not a natural part of aging, however, older adults in the nursing home setting are more at risk than older adults in the community. Late life depression may be harder to identify due to a resident’s cognitive impairment, loss of functional ability, the complexity of multiple chronic medical problems that compound the problem, and the loss of significant relationships and roles in their life. Depression presents differently in older adults and it is the responsibility of the facility to ensure that an accurate diagnosis is established. Adapted from the American Psychiatric Association. “Diagnostic and Statistical Manual of Mental Disorders - Fifth edition.” 2013. Anxiety and Anxiety Disorders Anxiety is a common reaction to stress that involves occasional worry about circumstantial events. Anxiety disorders, however, could include symptoms such as excessive fear, intense anxiety, significant distress, and may cause debilitating symptoms. The distinction between general anxiety and an anxiety disorder is subtle and can be difficult to identify. Accurate diagnosis by a qualified professional is essential. Anxiety can be triggered by loss of function, changes in relationships, relocation, or medical illness. Importantly, anxiety may also be a symptom of other disorders, such as depression and dementia in older adults, and care must be taken to ensure that other disorders are not inadvertently misdiagnosed as an anxiety disorder (or vice versa). There are many types of anxiety disorders, each with different symptoms. The most common types of anxiety disorders include Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Phobias and Post-traumatic Stress Disorder. Adapted from the American Psychiatric Association. “Diagnostic and Statistical Manual of Mental Disorders - Fifth edition.” 2013. Schizophrenia Schizophrenia is a serious mental disorder that may interfere with a person’s ability to think clearly, manage emotions, make decisions and relate to others. It is uncommon for schizophrenia to be diagnosed in a person younger than 12 or older than 40. Schizophrenia must be diagnosed by a qualified practitioner, using evidence-based criteria and professional standards, such as the Diagnostic and Statistical Manual of Mental Disorders - Fifth edition (DSM-5), and documented in the resident’s medical record. Symptoms of Schizophrenia include delusions, hallucinations, disorganized speech (e.g., frequent derailment or incoherence), grossly disorganized or catatonic behavior, and diminished expression or initiative. Delusions refer to false beliefs that don’t change even when the person who holds them is presented with new ideas or facts. Hallucinations include a person hearing voices, seeing things, or smelling things others can’t perceive. Adapted from the: • National Alliance on Mental Illness (NAMI). “Schizophrenia.” Accessed March 2, 2021. https://www.nami.org/Learn-More/Mental-Health- Conditions/Schizophrenia. • American Psychiatric Association. “Diagnostic and Statistical Manual of Mental Disorders - Fifth edition.” 2013. Bipolar Disorder Bipolar disorder is a mental disorder that causes dramatic shifts in a person’s mood or energy, and may affect the ability to think clearly. People with bipolar experience high and low moods—known as mania and depression—which differ from the typical ups- and-downs most people experience. Symptoms and their severity can vary. A person with bipolar disorder may have distinct manic or depressed states but may also have extended periods—sometimes years—without symptoms. A person can also experience both extremes simultaneously or in rapid sequence. Adapted from NAMI. “Bipolar Disorder.” Accessed March 2, 2021. https://www.nami.org/Learn-More/Mental-Health-Conditions/Bipolar-Disorder. KEY ELEMENTS OF NONCOMPLIANCE §483.40 The facility is responsible for providing behavioral health care and services that create an environment that promotes emotional and psychosocial well-being, meets each resident’s needs, and includes individualized approaches to care. To cite deficient practice at F740, the surveyor’s investigation will generally show that the facility failed to: • Identify, address, and/or obtain necessary services for the behavioral health care needs of residents; • Develop and implement person-centered care plans that include and support the behavioral health care needs, identified in the comprehensive assessment; • Develop individualized interventions related to the resident’s diagnosed conditions (e.g., assuring residents have access to community substance use services); • Review and revise behavioral health care plans that have not been effective and/or when the resident has a change in condition; • Learn the resident’s history and prior level of functioning in order to identify appropriate goals and interventions; • Identify individual resident responses to stressors and utilize person-centered interventions developed by the IDT to support each resident; or • Achieve expected improvements or maintain the expected stable rate of decline based on the progression of the resident’s diagnosed condition. https://www.nami.org/Learn-More/Mental-Health-Conditions/Schizophrenia https://www.nami.org/Learn-More/Mental-Health-Conditions/Schizophrenia https://www.nami.org/Learn-More/Mental-Health-Conditions/Bipolar-Disorder Investigating Concerns Related to Behavioral Health Services Use the Behavioral and Emotional Status Critical Element Pathway (CMS-20067), along with guidance, when determining if the facility meets the requirements pertaining to the behavioral health care needs of their residents. The facility must provide the necessary behavioral health care and services to support the resident in attaining or maintaining the highest practicable physical, mental, and psychosocial well-being. Review, as needed, all appropriate resident assessments, associated care planning and care plan revisions, along with physician’s orders to identify initial concerns and guide the investigation. Review the Minimum Data Set (MDS) and other supporting documentation to help determine if the facility is in compliance. Observe for evidence that behavioral health care needs are met and related services are provided. Staff are expected to assess and provide appropriate care for residents with behavioral health care needs. Interview the resident, his/her family, and/or representative and the IDT, as needed, to gather information about the behavioral health care and services in the nursing home. Corroborate the information obtained and any concerns noted during the survey, by building upon the investigation through additional observations, interviews, and record review. For additional guidance, see also the Psychosocial Severity Outcome Guide at the CMS Nursing Homes Survey Resources website that can be accessed by visiting https://www.cms.gov/files/zip/survey-resources-10262022.zip. DEFICIENCY CATEGORIZATION §483.40 An example of Severity Level 4 Non-compliance: Immediate Jeopardy to Resident Health or Safety includes, but is not limited to: • A resident was admitted to the facility one month ago with diagnoses of major depression, SUD, and a history of a suicide attempt. After admission, the resident continuously expressed wanting to die and often yelled and cursed at staff members. The attending physician ordered a psychological evaluation, an antidepressant, and 30 minute checks which were implemented by the facility. Record review showed that the psychological evaluation recommended the use of several non-pharmacological behavioral health interventions, which were not implemented. During additional record review and an interview with the nurse it was revealed that the resident was found hanging from his closet bar with a sheet tied around his neck, and no pulse. CPR was started and the resident was resuscitated. The facility failed to adequately meet a resident’s mental health needs when it did not address non-pharmacological approaches to care. An example of Severity Level 3 Non-compliance: Actual Harm that is not Immediate Jeopardy includes, but is not limited to: • A resident was admitted to the facility with a diagnosis of post-traumatic stress disorder, from war related trauma. The resident assessment identified that certain environmental triggers such as loud noises and being startled caused the resident distress and provoked screaming. The resident’s care plan identified that his environment should not have loud noises and that staff should speak softly to the resident. Observations in the home revealed that the entry and exit doors had alarms that sounded with a loud horn each time they were opened. Additionally, staff were observed approaching the resident from behind and shaking his shoulder to get his attention. The resident was startled and screamed for fifteen minutes. The director of nursing (DON) stated that they hoped he would eventually get used to living in the home. The facility identified triggers that were known to cause the resident distress and developed a care plan to support the resident’s behavioral health care needs. However, the facility failed to implement the care planned approaches to care. Examples of Severity Level 2: No Actual Harm with Likelihood for More Than Minimal Harm that is Not Immediate Jeopardy, include: • A resident with a diagnosed anxiety disorder preferred staff to announce themselves before entering his room. His care plan identified the non- pharmacological approach of staff knocking on his door and requesting permission before entering. This had proved effective in reducing his anxiety. When interviewed, the resident indicated that facility staff usually followed this direction. He feels anxious on weekends when the workers from a temporary staffing agency provide care, because they frequently enter his room without asking permission. Although this increases his anxiety, he tries to live with it, but wished the nursing home would do something about it. During an interview, the DON mentioned that he was not aware of the resident’s concern and that it was difficult to control all staff interactions with the resident. However, the DON agreed to investigate the situation and work to find a resolution. The facility failed to ensure that all staff members, both those employed by the nursing home and those from the staffing agency, respected the privacy of each resident by announcing themselves prior to entering resident rooms. This led to increased anxiety for the resident. Severity Level 1: No Actual Harm with Likelihood for Minimal Harm Severity Level 1 does not apply for this regulatory requirement because any facility practice that results in a reduction of psychosocial well-being diminishes the resident’s quality of life. Because more than minimal harm is likely, any deficiency for this requirement is at least a Severity Level 2. For additional guidance, see also the Psychosocial Outcome Severity Guide at the CMS Nursing Homes Survey Resources website that can be accessed by visiting https://www.cms.gov/files/zip/survey-resources-10262022.zip. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION: If there are concerns regarding the provision of dementia care treatment and services, review regulatory requirements at §483.40(b)(3) (F744). If there are indications that a resident is in a secured/locked area without a clinical justification and/or placement is against the will of the resident, their family, and/or resident representative, review regulatory requirements at §483.12 and §483.12(a) (F603), Involuntary Seclusion. If there are concerns about the resident assessment process to review for mood and psychosocial well-being see §483.20 (F636, F637, or F641), Resident Assessment. Some resources pertaining to behavioral health care and services can be found by visiting: • SAMHSA. Accessed March 2, 2021. http://www.samhsa.gov/. This website provides numerous resources with the mission to reduce the impact of substance abuse and mental illness on America's communities. • NAMI. Accessed March 2, 2021. https://www.nami.org/. This website provides resources dedicated to building better lives for the millions of Americans affected by mental illness. • National Institute of Mental Health (NIMH). Accessed November 9, 2022.https://www.nimh.nih.gov/. This website provides resources for the understanding and treatment of mental illnesses. • National Long-term Care Ombudsman Resource Center. Accessed March 2, 2021. https://ltcombudsman.org/. This website is filled with information, resources, and news from Ombudsman programs to support and inform programs across the country. • MentalHealth.gov. Accessed March 2, 2021. https://www.mentalhealth.gov/. This website provides one-stop access to U.S. government mental health and mental health problems information. • SAMSHA. “Anger Management for Substance Use Disorder and Mental Health Clients: Participant Workbook.” Accessed March 2, 2021. https://store.samhsa.gov/sites/default/files/d7/priv/anger_management_workbook _508_compliant . This workbook is designed for people living with a mental illness and/or substance use disorder who participate in group cognitive behavioral therapy sessions pertaining to anger management. It summarizes core concepts for each session, and includes worksheets and homework assignments. • NIMH. “Schizophrenia.” Accessed November 9, 2022. https://www.nimh.nih.gov/health/topics/schizophrenia. This brochure describes symptoms, causes, and treatments for schizophrenia with information on ways to get help and cope effectively. • NIMH. “Bipolar Disorder.” Accessed November 9, 2022. https://www.nimh.nih.gov/health/topics/bipolar-disorder. http://www.samhsa.gov/ https://www.nami.org/ https://ltcombudsman.org/ https://www.mentalhealth.gov/ https://store.samhsa.gov/sites/default/files/d7/priv/anger_management_workbook_508_compliant https://store.samhsa.gov/sites/default/files/d7/priv/anger_management_workbook_508_compliant This brochure describes symptoms, causes, and treatments for bipolar disorder with information on ways to get help and cope effectively. • NIMH. “Post-Traumatic Stress Disorder.” Accessed November 9, 2022. https://www.nimh.nih.gov/health/topics/post-traumatic-stress-disorder-ptsd. This brochure describes symptoms, causes, and treatments for post-traumatic stress disorder with information on ways to get help and cope effectively. • NIMH. “Anxiety Disorders.” Accessed November 9, 2022. • https://www.nimh.nih.gov/health/topics/anxiety-disorders. This brochure describes symptoms, causes, and treatments for anxiety disorders with information on ways to get help and cope effectively. • NIMH. “Depression.” Accessed November 9, 2022. https://www.nimh.nih.gov/health/topics/depression. This brochure describes symptoms, causes, and treatments for depression with information on ways to get help and cope effectively. • NIMH.“Generalized Anxiety Disorder (GAD): When Worry Gets Out of Control.” Accessed November 9, 2022. https://www.nimh.nih.gov/health/publications/generalized-anxiety-disorder-gad. This brochure discusses signs and symptoms, diagnosis, and treatment options for GAD References to non-CMS sources are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services. CMS is not responsible for the content of pages found at these sites. URL addresses were current as of the date of this publication. F741 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.40(a) The facility must have sufficient staff who provide direct services to residents with the appropriate competencies and skills sets to provide nursing and related services to assure resident safety and attain or maintain the highest practicable physical, mental and psychosocial well-being of each resident, as determined by resident assessments and individual plans of care and considering the number, acuity and diagnoses of the facility’s resident population in accordance with §483.71. These competencies and skills sets include, but are not limited to, knowledge of and appropriate training and supervision for: §483.40(a)(1) Caring for residents with mental and psychosocial disorders, as well as residents with a history of trauma and/or post-traumatic stress disorder, that have been identified in the facility assessment conducted pursuant to §483.71, and §483.40(a)(2) Implementing non-pharmacological interventions. INTENT §483.40(a), (a)(1) & (a)(2) https://www.nimh.nih.gov/health/topics/anxiety-disorders The intent of this requirement is to ensure that the facility has sufficient staff members who possess the basic competencies and skills sets to meet the behavioral health needs of residents for whom the facility has assessed and developed care plans. The facility must consider the acuity of the population and its assessment in accordance with §483.71. This includes residents with mental disorders, psychosocial disorders, or substance use disorders (SUDs), and those with a history of trauma and/or post-traumatic stress disorder (PTSD), as reflected in the facility assessment. Facility staff members must implement person-centered care approaches designed to meet the individual goals and needs of each resident. Additionally, for residents with behavioral health needs, non-pharmacological interventions must be developed and implemented. NOTE: For sufficient staffing concerns that fall outside the scope of behavioral health care, review regulatory requirements at §483.35(a) (F725), Sufficient Nursing Staff and §483.35(a)(3) (F726), Competent Nursing Staff. DEFINITIONS §483.40(a), (a)(1) & (a)(2) Definitions are provided to clarify terminology related to behavioral health services and the attainment or maintenance of a resident’s highest practicable well-being. “Mental disorder” is a syndrome characterized by a clinically significant disturbance in an individual's cognition, emotion regulation, or behavior that reflects a dysfunction in the psychological, biological, or developmental processes underlying mental functioning. Mental disorders are usually associated with significant distress or disability in social, occupational, or other important activities. American Psychiatric Association. “Diagnostic and Statistical Manual of Mental Disorders - Fifth edition. 2013. “Substance use disorder” (“SUD”) is defined as recurrent use of alcohol and/or drugs that causes clinically and functionally significant impairment, such as health problems, disability, and failure to meet major responsibilities at work, school, or home. Adapted from Substance Abuse and Mental Health Services Administration (SAMHSA). “Mental Health and Substance Use Disorders.” Accessed March 2, 2021. https://www.samhsa.gov/find-help/disorders. “Trauma” results from an event, series of events, or set of circumstances that is experienced by an individual as physically or emotionally harmful or life threatening and that has lasting adverse effects on the individual’s functioning and mental, physical, social, emotional, or spiritual well-being. SAMHSA.“SAMHSA’s Concept of Trauma and Guidance for a Trauma-Informed Approach.”July 2014. Accessed February 25, 2021. https://ncsacw.samhsa.gov/userfiles/files/SAMHSA_Trauma . “Post-traumatic stress disorder” occurs in some individuals who have encountered a shocking, scary, or dangerous situation. Symptoms usually begin early, within three months of the traumatic incident, but sometimes they begin years afterward. Symptoms https://www.samhsa.gov/find-help/disorders https://ncsacw.samhsa.gov/userfiles/files/SAMHSA_Trauma must last more than a month and be severe enough to interfere with relationships or work to be considered PTSD. National Institute of Mental Health. “Post-Traumatic Stress Disorder.” Accessed November 9, 2022, https://www.nimh.nih.gov/health/topics/post-traumatic-stress- disorder-ptsd. This brochure describes symptoms, causes, and treatments for post- traumatic stress disorder with information on ways to get help and cope effectively. “Non-pharmacological intervention” refers to approaches to care that do not involve medications, generally directed towards stabilizing and/or improving a resident’s mental, physical, and psychosocial well-being. GUIDANCE §483.40(a), (a)(1) & (a)(2) Sufficient Staff to Provide Behavioral Health Care and Services The facility must address in its facility assessment under §483.71 (F838), the behavioral health needs that can be met and the numbers and types of staff needed to meet these needs. If a resident qualifies for specialized Level II services under PASARR, please refer to §483.20(k) (F645). If the resident does not qualify for specialized services under PASARR, but requires more intensive behavioral health services (e.g., individual counseling), the facility must demonstrate reasonable attempts to provide for and/or arrange for such services. This would include ensuring that the types of service(s) needed is clearly identified based on the individual assessment, care plan and strategies to arrange such services. Facilities must have sufficient direct care staff (nurse aides and licensed nurses) with knowledge of behavioral health care and services in accordance with the care plans for all residents, including those with mental or psychosocial disorders, SUDs, as well as residents with a history of trauma and/or PTSD. Facilities may be concerned about accessing sufficient professional behavioral health resources (e.g., psychiatrists) to meet these requirements due to shortages in behavioral and mental health providers in their area. A facility will not be cited for non-compliance if there are demonstrated attempts to access such services. Facilities are not expected to provide services that are not covered by Medicare or Medicaid. They are expected to take reasonable steps to seek alternative sources (state, county or local programs) but if they are not successful, it is not the basis for a deficient practice. Skill and Competency of Staff The facility must identify the skills and competencies needed by staff to work effectively with residents (both with and without mental disorders, psychosocial disorders, SUDs, a history of trauma, and/or PTSD). Staff need to be knowledgeable about implementing non-pharmacological interventions. The skills and competencies needed to care for residents should be identified through the facility assessment. The facility assessment must include an evaluation of the overall number of facility staff needed to ensure that a sufficient number of qualified staff are available to meet each resident’s needs. Furthermore, the assessment should include a competency-based approach to determine the knowledge and skills required among staff to ensure residents are able to maintain or attain their highest practicable physical, functional, mental, and psychosocial well-being and meet current professional standards of practice. This also includes any ethnic, cultural, or religious factors that may need to be considered to meet resident needs, such as activities, food preferences, and any other aspect of care identified. Once the necessary skills and competencies are identified, staff must be aware of those disease processes and disorders (e.g. SUDs) that are relevant to each resident to enhance the resident’s psychological and emotional well-being. Competency is established by observing the staff’s ability to use this knowledge through the demonstration of skill and the implementation of specific, person-centered interventions identified in the care plan to meet residents’ behavioral health care needs. Additionally, competency involves staff’s ability to communicate and interact with residents in a way that promotes psychosocial and emotional well-being, as well as meaningful engagements. Under §483.152, Requirements for approval of a nurse aide training and competency evaluation program, nurse aides are required to complete and provide documentation of training that includes, but is not limited to, competencies in areas such as: • Communication and interpersonal skills; • Promoting residents' independence; • Respecting residents' rights; • Caring for the residents' environment; • Mental health and social service needs; and • Care of cognitively impaired residents. All staff must have knowledge and skills sets to effectively interact with residents (communication, resident rights, meaningful activities.) Person-centered approaches to care should be implemented based upon the comprehensive assessment, in accordance with the resident’s customary daily routine, life-long patterns, interests, preferences, and choices, and should involve the interdisciplinary team (IDT), the resident, resident’s family, and/or representative(s). The IDT should be aware of potential underlying causes and/or triggers that may lead to expressions or indications of distress and/or re- traumatization. Identifying the frequency, intensity, duration, and impact of a resident’s expressions or indications of distress, as well as the location, surroundings or situation in which they occur, may help the IDT identify individualized interventions or approaches to care to support the resident’s goals and needs. Individualized, person-centered approaches to care must be implemented to address expressions or indications of distress. Staff must also monitor the effectiveness of the interventions, changing those approaches, if needed, in accordance with current standards of practice. Additionally, they must accurately document these actions in the resident’s medical record and provide ongoing assessment as to whether they are improving or stabilizing the resident’s status or causing adverse consequences. The following discussion of non-pharmacological interventions supports all residents, however, residents living with behavioral health needs may require a more formalized, documented intervention plan. Non-pharmacological Interventions Examples of individualized, non-pharmacological interventions to help meet behavioral health needs of all ages may include, but are not limited to: • Ensuring adequate hydration and nutrition (e.g., enhancing taste and presentation of food, addressing food preferences to improve appetite and reduce the need for medications intended to stimulate appetite); exercise; and pain relief; • Individualizing sleep and dining routines, as well as schedules to use the bathroom, to reduce the occurrence of incontinence, taking into consideration the potential need for increased dietary fiber to prevent or reduce constipation, and avoiding, where clinically inappropriate, the use of medications that may have significant adverse consequences (e.g., laxatives and stool softeners); • Adjusting the environment to be more individually preferred and homelike (e.g., using soft lighting to avoid glare, providing areas that stimulate interest or allow safe, unobstructed walking, eliminating loud noises thereby reducing unnecessary auditory environment stimulation); • Assigning staff to optimize familiarity and consistency with the resident and their needs (e.g., consistent caregiver assignment); • Supporting the resident through meaningful activities that match his/her individual abilities (e.g., simplifying or segmenting tasks for a resident who has trouble following complex directions), interests, goals, and needs, based upon the comprehensive assessment, and that may be reminiscent of lifelong work or activity patterns (e.g., providing an early morning activity for a farmer used to waking up early); • Assisting the resident outdoors in the sunshine and fresh air (e.g. in a non- smoking area for a non-smoking resident); • Providing access to pets or animals for the resident who enjoys pets (e.g. a cat for a resident who used to have a cat of their own); • Assisting the resident to participate in activities that support their spiritual needs; • Assisting with the opportunity for meditation and associated physical activity (e.g. chair yoga); • Focusing the resident on activities that decrease stress and increase awareness of actual surroundings, such as familiar activities; offering verbal reassurance, especially in terms of keeping the resident safe; and acknowledging that the resident’s experience is real to her/him; • Utilizing techniques such as music, art, electronics/computer technology systems, massage, essential oils, reminiscing; • Assisting residents with SUDs to access counseling (e.g., individual or group counseling services, 12-step programs, and support groups) to the fullest degree possible; • Assisting residents with access to therapies, such as psychotherapy, behavior modification, cognitive behavioral therapy, and problem solving therapy; and • Providing support with skills related to verbal de-escalation, coping skills, and stress management. For additional guidance and examples of individualized non-pharmacological interventions, see §483.24(c) (F679), Activities. While there may be situations where a pharmacological intervention is indicated first, these situations do not negate the obligation of the facility to also develop and implement appropriate non-pharmacological interventions. NOTE: This guidance is not intended to exclude the use of pharmacological interventions when they are clinically necessary and appropriate. Please see the Pharmacy Services section under §483.45(d) (F757), Unnecessary Drugs and §483.45(e) (F758), Psychotropic Drugs for additional guidance. INVESTIGATIVE PROTOCOL §483.40(a), (a)(1) & (a)(2) Determination of Sufficient Staffing One factor used to determine sufficiency of staff (including both quantity and competency of staff) is the facility’s ability to provide needed care for residents as determined by resident assessments and individual care plans. A staffing deficiency must be supported by examples of care deficits caused by insufficient quantity or competency of staff. The surveyor’s investigation will include whether inadequate quantity or competency of staff prevented residents from reaching the highest practicable level of well-being. A deficiency of insufficient staffing is determined through observations, interviews, and/or record reviews. Information gathered through these sources will help the surveyor in determining non-compliance. Concerns such as expressions or indications of distress by residents or family members, residents living with mental, psychosocial, and/or SUDs, as well as residents with a history of trauma and/or PTSD who lack care plan interventions to address their individual goals, needs, lack of resident engagement, and the incidence of elopement and resident altercations, can also offer insight into the sufficiency and competency of staff and the adequacy of training provided to them to care for residents with behavioral health needs. Determination of Staff Competencies As required under §483.71 (F838), the facility’s assessment must include an evaluation of staff competencies that are necessary to provide the level and types of care needed for the resident population. The facility must have a process for evaluating these competencies. If sufficient and/or competent staffing concerns are present during the surveyor’s investigation or while completing the Sufficient and Competent Staffing Facility Task, refer to the Behavioral and Emotional Status (CMS-20067) Critical Element Pathway. KEY ELEMENTS OF NONCOMPLIANCE §483.40(a), (a)(1) & (a)(2) To cite deficient practice at F741, the surveyor’s investigation will generally show that the facility failed to: • Rule out underlying causes for the resident’s behavioral health care needs through assessment, diagnosis, and treatment by qualified professionals, such as physicians, including psychiatrists or neurologists; • Identify competencies and skills sets needed in the facility to work effectively with residents with mental disorders and other behavioral health needs; • Identify the signs and symptoms of substance use in a resident with SUD; • Provide care, in accordance with the individualized care plan, that meets the needs of residents with mental disorders, substance use disorders, a history of past trauma, and other behavioral health needs; • Provide sufficient staff who have the knowledge, training, competencies, and skills sets to address behavioral health care needs; • Demonstrate reasonable attempts to secure professional behavioral health services, when needed; • Utilize and implement non-pharmacological approaches to care, based upon the comprehensive assessment and plan of care, and in accordance with the resident’s abilities, customary daily routine, life-long patterns, interests, preferences, and choices; • Monitor and provide ongoing assessment of the resident’s behavioral health needs, as to whether the interventions are improving or stabilizing the resident’s status or causing adverse consequences; or • Attempt alternate approaches to care for the resident’s assessed behavioral health needs, if necessary. NOTE: In the case of a negative resident outcome, the surveyor must investigate whether or not the facility considered all relevant factors that may have contributed to the outcome. Doing so, while also using the points described in the key elements, will assist the survey team in determining if an identified concern was avoidable or unavoidable. DEFICIENCY CATEGORIZATION §483.40(a), (a)(1) & (a)(2) An example of Severity Level 4 Non-compliance: Immediate Jeopardy to Resident Health or Safety includes, but is not limited to: • The care plan of a resident, diagnosed with depression and suicidal ideation, included close supervision and one-on-one activities with staff. Based upon documentation in the resident’s record, the resident was often isolated in her room and increasingly spoke of wanting to die. Additionally, the resident had recently been transported to an acute care facility for a psychiatric evaluation, when she threatened to harm herself and was deemed inconsolable by facility staff. During an interview, the Director of Nursing (DON) indicated that on many evening and weekend shifts the facility did not have enough staff to provide close supervision or one-on-one activities for the resident. No other alternative arrangements had been developed, care planned, or implemented to ensure the resident’s behavioral health needs were met. The facility lacked sufficient staff with the required skills sets to implement the resident’s care planned interventions. This led to increased expressions of distress and a threat of personal harm, resulting in the deterioration of the resident’s mental and psychosocial well-being. An example of Severity Level 3 Non-compliance: Actual Harm that is not Immediate Jeopardy includes, but is not limited to: • Facility staff failed to intervene when a visibly agitated and confused resident was pacing the hallways. Record review showed that these expressions of distress had occurred during the late afternoon and early evening for the past three weeks. A CNA told the surveyor that the DON said the resident had “sundowning;” however, when asked, she was unable to explain what that meant or what individualized interventions should be implemented. She was told to leave the resident alone and let him tire himself out. The facility lacked competent staff with the knowledge and skills sets to support and assist the resident who was experiencing agitation and confusion on a daily basis. This resulted in increased distress over the course of several weeks, without the development and implementation of individualized, non-pharmacological approaches to care. An example of Severity Level 2 Non-compliance: No Actual Harm with Likelihood for More Than Minimal Harm that is Not Immediate Jeopardy includes, but is not limited to: • The facility failed to have sufficient numbers of staff who had the skills and competencies to monitor a resident with SUD and who had just returned from a leave of absence (LOA). The resident had a history of substance abuse when on LOA, and had care plan interventions indicating to monitor every 15 minutes for signs and symptoms of substance use, which included changes in behavior, slowed respirations and somnolence. Upon interview of the nurse’s aide assigned to monitor this resident, the aide did not know what somnolence was, and could not state what a normal respiratory rate was. The aide also stated that he or she had never been assigned to this resident before and was unaware of what the resident’s baseline behaviors were. Therefore, the aide could not state if he or she had observed any changes in the resident’s behaviors. This was the only aide working the unit when the resident returned from LOA. • A surveyor heard a resident complaining to nursing home staff that he was late for his meeting again. The resident told the surveyor that he has missed his weekly Alcoholics Anonymous (AA) meeting held at the local church for the last three weeks and that this made him angry. Record review showed that attendance at these meetings was a part of his care plan. During an interview, a CNA, who helps the resident with his activities of daily living (ADL) on a consistent basis, stated that she was busy and did her best to make sure he was ready when his transportation arrived. The facility failed to implement the resident’s care planned interventions, causing him to consistently miss his AA meetings. This led to feelings of anger and had the potential to jeopardize the resident’s sobriety. Severity Level 1: No Actual Harm with Likelihood for Minimal Harm Severity Level 1 does not apply for this regulatory requirement because any facility practice that results in a reduction of psychosocial well-being diminishes the resident’s quality of life. Because more than minimal harm is likely, any deficiency for this requirement is at least a Severity Level 2. For additional guidance, see also the Psychosocial Outcome Severity Guide the CMS Nursing Homes Survey Resources website that can be accessed by visiting https://www.cms.gov/files/zip/survey-resources-10262022.zip. References to non-CMS sources are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services. CMS is not responsible for the content of pages found at these sites. URL addresses were current as of the date of this publication. F742 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.40(b) Based on the comprehensive assessment of a resident, the facility must ensure that— §483.40(b)(1) A resident who displays or is diagnosed with mental disorder or psychosocial adjustment difficulty, or who has a history of trauma and/or post-traumatic stress disorder, receives appropriate treatment and services to correct the assessed problem or to attain the highest practicable mental and psychosocial well-being; DEFINITIONS §483.40(b) & §483.40(b)(1) Definitions are provided to clarify terminology related to behavioral health services and the attainment or maintenance of a resident’s highest practicable well-being. https://www.cms.gov/files/zip/survey-resources-10262022.zip “Mental disorder and psychosocial adjustment difficulty” refers to the development of emotional and/or behavioral symptoms in response to an identifiable stressor(s) that has not been the resident’s typical response to stressors in the past or an inability to adjust to stressors as evidenced by chronic emotional and/or behavioral symptoms. (Adapted from Diagnostic and Statistical Manual of Mental Disorders - Fifth edition. 2013, American Psychiatric Association.). INTENT §483.40(b) & §483.40(b)(1) The intent of this regulation is to ensure that a resident who upon admission, was assessed and displayed or was diagnosed with a mental or psychosocial adjustment difficulty or a history of trauma and/or post-traumatic stress disorder (PTSD), receives the appropriate treatment and services to correct the initial assessed problem or to attain the highest practicable mental and psychosocial well-being. Residents who were admitted to the nursing home with a mental or psychosocial adjustment difficulty, or who have a history of trauma and/or PTSD, must receive appropriate person-centered and individualized treatment and services to meet their assessed needs. GUIDANCE §483.40(b) & §483.40(b)(1) Residents who experience mental or psychosocial adjustment difficulty, or who have a history of trauma and/or post-traumatic stress disorder (PTSD) require specialized care and services to meet their individual needs. The facility must ensure that an interdisciplinary team (IDT), which includes the resident, the resident’s family and/or representative, whenever possible, develops and implements approaches to care that are both clinically appropriate and person-centered. Expressions or indications of distress, lack of improvement or decline in resident functioning should be documented in the resident’s record and steps taken to determine the underlying cause of the negative outcome. For additional information regarding non-pharmacological interventions, see §483.40(a)(2) (F741), Implementing non-pharmacological interventions. What is appropriate treatment and services to correct the assessed problem or to attain the highest practicable mental and psychosocial well-being? The facility must provide the “appropriate treatment and services” to correct the assessed problem or to attain the highest practicable mental and psychosocial well-being. The determination of what is “appropriate” is person-centered and would be based on the individualized assessment and comprehensive care plan. To the extent that the care plan identifies particular treatment and services, the facility must make reasonable attempts to provide these services directly or assist residents with accessing such services. A facility must determine through its facility assessment what types of behavioral health services it may be able to provide. Some examples of treatment and services for psychosocial adjustment difficulties may include providing residents with opportunities for autonomy; arrangements to keep residents in touch with their communities, cultural heritage, former lifestyle, and religious practices; and maintaining contact with friends and family. The coping skills of a person with a history of trauma or PTSD will vary, so assessment of symptoms and implementation of care strategies should be highly individualized. Facilities should use evidence-based interventions, if possible. Background on Trauma and PTSD A close relationship exists between mental and psychosocial adjustment difficulties, histories of trauma, and PTSD. • Adjustment difficulties: o Occur within 3 months of the onset of a stressor and last no longer than 6 months after the stressor or its consequences have ended; o Are characterized by distress that is out of proportion to the severity or intensity of the stressor, taking into account external context and cultural factors, and/or a significant impairment in social, occupational, or other important areas of functioning; o May be related to a single event or involve multiple stressors and may be recurrent or continuous; o May cause a depressed mood, anxiety, and/or aggression; o May be diagnosed following the death of a loved one when the intensity, quality, or persistence of grief exceeds what normally might be expected; and o Can occur for individuals with or without PTSD or a history of trauma. • History of trauma: o Involves psychological distress, following a traumatic or stressful event, that is often variable; o May be connected to feelings of anxiety and/or fear; o Often involves expressions of anger or aggressiveness; and o Some individuals who experience trauma will develop PTSD. • PTSD: o Involves the development of symptoms following exposure to one or more traumatic, life-threatening events; o Usually develops within the first 3 months after the trauma occurs, although there may be a delay in months or even years; o Symptoms may include, but are not limited to, the re-experiencing or re-living of the stressful event (e.g., flashbacks or disturbing dreams), emotional and behavioral expressions of distress (e.g., outbursts of anger, irritability, or hostility), extreme discontentment or inability to experience pleasure, as well as dissociation (e.g., detachment from reality, avoidance, or social withdrawal), hyperarousal (e.g., increased startle response or difficulty sleeping); and o May be severe or long-lasting when the stressor is interpersonal and intentional (e.g., torture or sexual violence). (Adapted from American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth edition. Arlington, VA: American Psychiatric Association Publishing, 2013.) Although PTSD is commonly viewed as a disorder experienced only by military veterans, it is not exclusively a consequence of combat or war zone exposure. Individuals who have been physically or sexually assaulted or who experienced a terrorist attack or natural disaster, among other things may also be affected by PTSD. Additionally, some older nursing home residents may have lived through a time of genocide and witnessed or been subjected to the intentional and systematic destruction of a racial, political, or cultural group such as that which occurred during the Holocaust in World War II. Moving from the community into a long-term care facility, for an individual with a history of trauma or PTSD, can be a very difficult transition and cause worsening or reemergence of symptoms. Additionally, the structured environment of the nursing home can trigger memories of traumatic events and coping with these memories may be more difficult for older adults. KEY ELEMENTS OF NONCOMPLIANCE §483.40(b) & §483.40(b)(1) To cite deficient practice at F742, the surveyor’s investigation will generally show that the facility failed to: • Assess the resident’s expressions or indications of distress to determine if services were needed; • Provide services and individualized care approaches that address the assessed needs of the resident and are within the scope of the resources in the facility assessment; • Develop an individualized care plan that addresses the assessed emotional and psychosocial needs of the resident; • Assure that staff consistently implement the care approaches delineated in the care plan; • Monitor and provide ongoing assessment as to whether the care approaches are meeting the emotional and psychosocial needs of the resident; or • Review and revise care plans that have not been effective and/or when the resident has a change in condition and accurately document all of these actions in the resident’s medical record. NOTE: For behavioral health care concerns that do not pertain to residents who display or are diagnosed with a mental disorder or psychosocial adjustment difficulty, or who have a history of trauma and/or post-traumatic stress disorder, review regulatory requirements at §483.40 (F740), Behavioral Health Services. INVESTIGATIVE PROTOCOL §483.40(b) & §483.40(b)(1) Objectives The objectives of this protocol are to determine, based on the comprehensive assessment of a resident, that the facility ensured that the resident who displays or is diagnosed with a mental or psychosocial adjustment difficulty, or who has a history of trauma and/or PTSD receives the care and services necessary to reach and maintain the highest level of mental and psychosocial functioning. Procedures In order to guide observations, briefly review the comprehensive assessment and interdisciplinary care plan. Observations Observe for manifestations related to mental and psychosocial adjustment difficulties, a history of trauma and/or PTSD which may, over a period of time, include: • Impaired verbal communication without physiological cause; • Social isolation and withdrawal inconsistent with the resident’s usual demeanor; • Sleep pattern disturbance (e.g., disruptive change in sleep/rest pattern as related to one’s biological and emotional needs); • Deviation from past spiritual beliefs or rituals (alterations in one’s belief system); • Inability to control behavior, anger, and the potential for physical harm to oneself or others; and • Stereotyped response to any stressor (i.e., the same characteristic response, regardless of the stimulus). NOTE: Observe staff interactions with the resident in formal and informal situations and determine whether or not they implement interventions in accordance with the care plan. Interviews Resident/Resident Representative Interview the resident, resident’s family, or representative(s), to the degree possible, to determine: • Awareness of the current condition(s) or history of the condition(s) or diagnosis/diagnoses; • Participation in the development of a person-centered care plan; • Whether or not resident choices and preferences are considered; and • Validity of observations and data collection. Staff Interviews Interview IDT member(s) as necessary to determine: • Whether or not care provided is consistent with the care plan; and • That staff are knowledgeable about how to support the resident when they are expressing or indicating feelings of distress; Additionally, speaking to staff on various shifts can help to determine: • Staff knowledge of facility-specific guidelines and protocols related to the treatment of mental disorders and psychosocial adjustment difficulties, history of trauma, and PTSD; • Whether certified nurse aides (CNA) know how, what, when, and to whom to report changes in condition; • How facility staff monitor care plan implementation, and changes in condition; and • How changes in both the care plan and the resident’s condition are communicated to the staff. Record Review • Identify if the resident triggers Care Area Assessments (CAA) for activities, mood state, psychosocial well-being, and psychotropic drug use. o Consider whether the CAA process was used to assess the causal factors for decline, potential for decline, or lack of improvement. • Review the resident’s care plan for interventions to address the assessed problem. • How are mental and psychosocial adjustment difficulties, a history of trauma, and/or PTSD addressed in the care plan? o Does it describe the expressions or indications of distress that the resident has experienced because of the assessed problem? o Does it describe the programs and activities that have been implemented to assist the resident in reaching and maintaining the highest level of mental and psychosocial functioning? o Is the care plan written in measurable language that allows assessment of its effectiveness? • Are the data to be collected to evaluate the effectiveness of the care plan identified? • Are the data collection done according to the care plan? • Is there an assessment of the resident’s usual and customary routines and preferences? o Are accommodations made by the facility to support the resident by incorporating these routines and preferences in the care plan? • Does record review indicate that the care and services outlined in the care plan are effective in decreasing the resident’s expressions or indications of distress? • If the data collected indicate that expressions or indications of distress are unchanged in frequency or severity over two or more assessment periods, is the plan reassessed and intervention approaches revised to support the resident in attaining the highest practicable mental and psychosocial well-being? NOTE: Clinical conditions that may produce apathy, malaise, and decreased energy levels that can be mistaken for depression associated with mental or psychosocial adjustment difficulty may include, but are not limited to: • Metabolic or endocrine disorders (e.g., Cushing’s disease, diabetes/hypoglycemia, hypothyroidism); • Central nervous system disorders (e.g., tumors and other mass lesions, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease); • Miscellaneous conditions (e.g., pernicious anemia, pancreatic disease, malignancy, infections, congestive heart failure, hypotension, dehydration, circadian rhythm disruption); • Over-medication for treatment of other conditions; and • Use of restraints. DEFICIENCY CATEGORIZATION §483.40(b) & §483.40(b)(1) An example of Severity Level 4 Non-compliance: Immediate Jeopardy to Resident Health or Safety includes, but is not limited to: • A surveyor observed a resident, who was crying and exhibiting signs of distress, lying in bed in her room. During an interview, the resident told the surveyor that she had lost all hope, felt betrayed by her family and her faith, and was ready to die. The resident shared that her children sold her house before she came to the nursing home, but that she had planned to go back there to live once her health improved. The resident added that she had lived in that house for 55 years, raising her children and enjoying life. Record review showed that upon admission, the resident indicated her goal was to return home, but also that her house had been sold by her family. Facility progress notes documented increased anxiety and depressive mood, as well as isolation from activities she had previously enjoyed, including attendance at religious services. Additionally, the resident had stopped eating or drinking. She was receiving IV fluids and the insertion of a feeding tube was being considered. An interview with the Care Plan Coordinator confirmed that the facility failed to develop an individualized care plan that addressed the assessed emotional and psychosocial needs of the resident. During an interview with the social worker, she indicated that she had been aware the house sold, but did not realize the resident was so distraught about it. The facility failed to acknowledge and assess the underlying causes of the resident’s expressions of distress or develop and implement a care plan that addressed this distress. This resulted in the deterioration of the resident’s physical, mental, and psychosocial well-being. An example of Severity Level 3 Non-compliance Actual Harm that is not Immediate Jeopardy includes, but is not limited to: • The facility determined that a resident’s resistance to receiving staff assistance in the shower was a result of a traumatic event that occurred at home years ago when a home health aide left her in the shower unattended and she fell, fracturing her hip. The resident has never been able to return home since the event and is distrustful of the nursing home staff. Interventions listed on the care plan specified that she is to be assisted by two staff members in the shower. The resident is to be approached in an unhurried manner, with calm voices and soft lighting. The surveyor observed the resident in the shower with only one certified nurse aide (CNA) in attendance and harsh lighting. During the shower the resident demonstrated anxiety and fear. She was yelling, crying, restless, and tried to get out of the shower chair many times during care. When observed 30 minutes after her shower, the resident was no longer yelling, however she still appeared fearful and her crying was just beginning to resolve. An interview with the CNA and director of nursing confirmed that the care plan interventions had not been followed. The facility failed to ensure that a resident, who has a history of trauma, received the appropriate treatment and services to reduce her anxiety and fear in the shower. Care planned interventions were not implemented, leading to increased expressions of distress by the resident and a decline in her mental and psychosocial well-being. An example of Severity Level 2 Non-compliance: No Actual Harm with Likelihood for More Than Minimal Harm that is Not Immediate Jeopardy includes, but is not limited to: • A surveyor heard a resident yelling for help. Facility staff and the surveyor followed the sound to the resident’s room where they found her lying in bed in a darkened room, clinging tightly to her wallet and blanket. The staff turned on the lights to assist in calming her down. During an interview later that day, the resident shared that she had been robbed at knife point in her own home prior to being admitted to the nursing home last year. She also mentioned that, although she felt secure in the nursing home, she still had nightmares sometimes and the nurses are supposed to leave her bathroom light on at night. The resident also asked to be moved to a room closer to the nursing station, but that had not happened yet. Record review of the resident’s assessment and care plan documented that the resident did have care planned interventions regarding her increased need for reassurance, due to the robbery prior to admission. Interventions included leaving the resident’s bathroom light on at night. Interviews with facility staff confirmed that they sometimes forget to leave the bathroom light on at night for the resident. Additionally, the social worker confirmed that the possibility of a room closer to the nursing station had not yet been investigated. The facility failed to implement person-centered, non-pharmacological approaches to care for a resident, with a history of trauma, causing the resident increased distress and fear. Severity Level 1: No Actual Harm with Likelihood for Minimal Harm Severity Level 1 does not apply for this regulatory requirement because any facility practice that results in a reduction of psychosocial well-being diminishes the resident’s quality of life. Because more than minimal harm is likely, any deficiency for this requirement is at least a Severity Level 2. For additional guidance, see also the Psychosocial Outcome Severity Guide at the CMS Nursing Homes Survey Resources website that can be accessed by visiting https://www.cms.gov/files/zip/survey-resources- 10262022.zip. F743 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.40(b)(2) A resident whose assessment did not reveal or who does not have a diagnosis of a mental or psychosocial adjustment difficulty or a documented history of trauma and/or post- traumatic stress disorder does not display a pattern of decreased social interaction and/or increased withdrawn, angry, or depressive behaviors, unless the resident's clinical condition demonstrates that development of such a pattern was unavoidable; and INTENT §483.40(b)(2) The intent of this regulation is to ensure that a resident who, upon admission was not assessed or diagnosed with a mental or psychosocial adjustment difficulty or a documented history of trauma and/or post-traumatic stress disorder (PTSD), does not develop patterns of decreased social interaction and/or increased withdrawn, angry, or depressive behaviors while residing in the facility. However, after admission, if the resident is diagnosed with a condition that typically manifests a similar pattern of behaviors, documentation must validate why the pattern was unavoidable (e.g., symptoms did not initially manifest, family was unaware of previous trauma or were unavailable for interview, etc.). Development of an unavoidable pattern of behaviors refers to a situation where the interdisciplinary team, including the resident, their family, and/or resident representative, has completed comprehensive assessments, developed and implemented individualized, person-centered approaches to care through the care-planning process, revised care plans accordingly, and behavioral patterns still manifest. GUIDANCE §483.40(b)(2) Nursing home admission can be a stressful experience for a resident, his/her family, and/or representative. Behavioral health is an integral part of a resident’s assessment https://www.cms.gov/files/zip/survey-resources-10262022.zip https://www.cms.gov/files/zip/survey-resources-10262022.zip process and care plan development. The assessment and care plan should include goals that are person-centered and individualized to reflect and maximize the resident’s dignity, autonomy, privacy, socialization, independence, choice, and safety. Facility staff must: • Monitor the resident closely for expressions or indications of distress; • Assess and plan care for concerns identified in the resident’s assessment; • Accurately document the changes, including the frequency of occurrence and potential triggers in the resident’s record; • Share concerns with the interdisciplinary team (IDT) to determine underlying causes, including differential diagnosis; • Ensure appropriate follow-up assessment, if needed; and • Discuss potential modifications to the care plan. For additional information regarding non-pharmacological interventions, see §483.40(a)(2) (F741), Implementing non-pharmacological interventions. KEY ELEMENTS OF NONCOMPLIANCE §483.40(b)(2) To cite deficient practice at F743, the surveyor’s investigation will generally show the facility failed to: • Identify that a resident developed decreased social interaction and/or increased withdrawn, angry, or depressive behaviors, and may have made verbalizations indicating these; • Evaluate whether the resident’s distress was attributable to their clinical condition and demonstrate that the change in behavior was unavoidable; • Ensure an accurate diagnosis of a mental disorder or psychosocial adjustment difficulty, or PTSD was made by a qualified professional; • Adequately assess and/or develop care plans for services and individualized care • approaches that support the needs of residents who develop these patterns; • Provide services with an individualized care approach that support the needs of residents with these indicators; • Provide staff with training opportunities related to the person-centered care approaches that have been developed and implemented; • Assure that staff consistently implement the approaches delineated in the care plan; • Monitor and provide ongoing assessment as to whether the care approaches are meeting the needs of the resident; or • Review and revise care planned interventions and accurately document the reason for revision in the resident’s medical record. INVESTIGATIVE PROTOCOL §483.40(b)(2) Objectives The objective of this protocol is to determine whether or not the facility meets the regulatory requirements for a resident who has displayed a pattern of decreased social interaction and/or increased withdrawn, angry, or depressive expressions or indications of distress. Procedures Briefly review the comprehensive assessment and interdisciplinary care plan to guide observations. Observations Observe residents who appear to be isolated, withdrawn, angry, or have other expressions or indications of mental or psychosocial difficulties, a history of trauma and/or PTSD. Additionally, observations may include, but are not limited to: • Staff and resident interactions; • Demonstration of the staff’s understanding, responsiveness, and proactive care for residents’ needs; and • Implementation of care plan interventions by staff. Interviews Resident/Resident Representative Interview the resident, resident’s family, or representative(s), to the degree possible, to determine: • The level of social interaction and distress that was present upon admission; • Whether social interaction has diminished or increased since admission; • If withdrawal, anger, and depressive expressions or indications of distress have increased without a change in the resident’s clinical condition; • Participation in the development of a person-centered care plan; and • Whether or not resident choices and preferences are considered. Staff Interviews In the case where staff members have noted changes in a resident’s social interactions and behaviors after admission to the facility, and the care plan does not reflect these changes, the surveyor must: Interview IDT member(s) as necessary to determine: • Whether or not facility staff are aware of changes in the resident’s social interactions and/or behavior; • That staff are knowledgeable about how to support the resident when they are expressing or indicating feelings of distress; • Whether or not facility staff, including the resident, their family, and/or resident representative have reviewed the resident’s care plan and revised it as necessary, to reflect the resident’s current needs and goals. Additionally, speaking to staff on various shifts can help to determine: • Their knowledge of facility-specific guidelines and protocols related to the treatment of mental disorders and psychosocial adjustment difficulties, history of trauma, and PTSD; • Whether certified nurse aides know how, what, when, and to whom to report changes in condition, including changes in a resident’s social interactions and behaviors (e.g., residents who have begun to withdraw, express anger, and/or depression); • How facility staff monitor the implementation of the care plan, and respond to changes in the resident’s social interactions and behaviors; and • How changes in both the care plan and the resident’s condition are communicated to the staff. Record Review • Determine whether or not upon admission, the resident had a diagnosis of or displayed a mental or psychosocial adjustment difficulty or a documented history of trauma and/or PTSD. • Review the resident’s medical record for documentation related to a pattern of decreased social interaction and/or increased withdrawn, angry, or depressive expressions or indications of distress. Review nursing, social service, mental health notes, or other discipline notes for description of the distress. • Review the Resident Assessment Instrument (RAI) and identify if the Minimum Data Set (MDS) captures and was used to assess the resident’s conditions. Look to see that the resident Care Area Assessments (CAA) for activities, mood state, psychosocial well- being, and psychotropic drug use trigger for any reason in the absence of related diagnoses or difficulties, or history of trauma and/or PTSD. • Consider whether the CAA process was used to identify and assess the reason and causal factors for decline, potential for decline, or lack of improvement. • Is there an assessment of the resident’s usual and customary routines and preferences? o Are accommodations made by the facility to support the resident by incorporating these routines and preferences in the care plan? • Review the resident’s care plan to determine if interventions are in place to alleviate the assessed distress. o Does it thoroughly describe the distress from a person-centered perspective? o Does it describe the programs and activities that have been implemented to assist the resident in reaching and maintaining the highest level of mental and psychosocial functioning? o Is the care plan written in measurable language that allows assessment of its effectiveness? o Does the record review indicate that the care and services outlined in the care plan are effective? DEFICIENCY CATEGORIZATION §483.40(b)(2) An example of Severity Level 4 Non-compliance: Immediate Jeopardy to Resident Health or Safety includes, but is not limited to: • The facility failed to identify signs of distress exhibited by a resident who, according to the medical record, for the past month had begun rising from bed mid-morning and returning to bed immediately after dinner. This was a departure from her previous morning and night sleep patterns. Upon interview, staff communicated that as people age, they grow tired more easily and require more sleep. The staff also noted that the resident was often very tearful and seemed depressed, but again they felt that this was normal for older adults. Even though she experienced a significant weight loss and did not want to speak to a social worker when approached about these noted changes, the staff honored her wish to be left in bed. During the resident interview, she stated that she was tired and just wanted to sleep. She informed the surveyor that the last of her friends had just died, leaving her with no other childhood contacts or meaningful social relationships other than her family. She began crying and stated that she often cried, but tried not to in front of the staff because she was too proud. She felt that by sleeping a lot, she wouldn’t have to face the fact that she also would die soon. The facility’s failure to identify that the resident was in distress and needed a mental health assessment caused a delay in receiving appropriate services and a deterioration in the resident’s psychosocial well-being. An example of Severity Level 3: Actual Harm that is not Immediate Jeopardy includes, but is not limited to: • During the tour of the facility, the surveyor noticed a resident sitting by the front door of the facility wringing his hands and staring out the window. While engaged in conversation, he stated that he was afraid that he would miss his group again. He had to come to the nursing home after his wife’s death and was having a hard time adjusting to the change. He stated that he joined a grief support group that he was finding helpful, but had not been able to attend for a few weeks. He was unable to sleep at night because of the worry about missing the group sessions. His care plan indicated that the only intervention to address his grief was participation in a weekly support group meeting at the senior center. His goal was to attend group sessions, so he could better cope with the multiple losses he had experienced. An interview with the facility administrator revealed that the resident had been unable to attend group sessions for six weeks because the facility’s only van was in the shop. During those weeks, the facility failed to provide alternative interventions and address the distress caused by the missed meetings. The resident’s medical record reflected that in the past month, he appeared more anxious, depressed, and angry and staff described him as “not his pleasant self.” The resident suffered a decline as a direct result of being unable to attend his weekly support group meetings and the facility did not seek any alternatives when transportation was unavailable. An example of Severity Level 2: No Actual Harm with Likelihood for More Than Minimal Harm that is Not Immediate Jeopardy includes, but is not limited to: • After falling at home and fracturing her femur, a resident was admitted to the skilled nursing facility for rehabilitation services. She had no history of mental or psychosocial adjustment difficulty, trauma (other than the fall), and/or PTSD. When she was first admitted she was very involved in facility events and activities, and participated enthusiastically in therapy. During observation of the breakfast meal, the surveyor noticed that the resident appears quite tired and asked the physical therapist if therapy could be postponed until later in the afternoon so she could go back to bed. When questioned, the resident stated that she has not had a good night’s sleep since admission, due to the woman in the next room yelling most of the night. The resident also stated that she does not want to complain since she knows that the woman yelling has dementia. However, it is getting harder for her to get enough rest and she finds herself feeling irritable and depressed from her lack of sleep. The physical therapist reported that the resident has not been progressing as well as she was when she was first admitted and when she attends therapy, she tires and becomes frustrated easily. The resident’s lack of rest and feeling of sadness stemmed from the staff’s inability to realize that the distress of another resident was affecting other residents. The resident’s sleep pattern had already been disrupted for several nights and she was too tired to participate in therapy. If the situation continues, it could lead to a decline in the resident’s clinical condition. Severity Level 1: No Actual Harm with Likelihood for Minimal Harm Severity Level 1 does not apply for this regulatory requirement because any facility practice that results in a reduction of psychosocial well-being diminishes the resident’s quality of life. Because more than minimal harm is likely, any deficiency for this requirement is at least a Severity Level 2. For additional guidance, see also the Psychosocial Outcome Severity Guide at the CMS Nursing Homes Survey Resources website that can be accessed by visiting https://www.cms.gov/files/zip/survey-resources- 10262022.zip. F744 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) https://www.cms.gov/files/zip/survey-resources-10262022.zip https://www.cms.gov/files/zip/survey-resources-10262022.zip §483.40(b)(3) A resident who displays or is diagnosed with dementia, receives the appropriate treatment and services to attain or maintain his or her highest practicable physical, mental, and psychosocial well-being. DEFINITIONS §483.40(b)(3) Definitions are provided to clarify terminology related to dementia and the attainment or maintenance of a resident’s highest practicable well-being. “Dementia” is a general term to describe a group of symptoms related to loss of memory, judgment, language, complex motor skills, and other intellectual function, caused by the permanent damage or death of the brain's nerve cells, or neurons. However, dementia is not a specific disease. There are many types and causes of dementia with varying symptomology and rates of progression. (Adapted from: “About Dementia.” Alzheimer’s Foundation of America. 30 Nov 2016. Accessed at: https://www.alzfdn.org/AboutDementia/definition.html) “Highest practicable physical, mental, and psychosocial well-being” is defined as the highest possible level of functioning and well-being, limited by the individual’s recognized pathology and normal aging process. Highest practicable is determined through the comprehensive resident assessment and by recognizing and competently and thoroughly addressing the physical, mental or psychosocial needs of the individual. GUIDANCE §483.40(b)(3) Providing care for residents living with dementia is an integral part of the person- centered environment, which is necessary to support a high quality of life with meaningful relationships and engagement. Fundamental principles of care for persons living with dementia involve an interdisciplinary approach that focuses holistically on the needs of the resident living with dementia, as well as the needs of the other residents in the nursing home. Additionally, it includes qualified staff that demonstrate the competencies and skills to support residents through the implementation of individualized approaches to care (including direct care and activities) that are directed toward understanding, preventing, relieving, and/or accommodating a resident’s distress or loss of abilities. If there are staffing concerns related to the provision of behavioral health services, refer to §483.40(a) (F741), Sufficient and Competent Staff. The facility must provide dementia treatment and services which may include, but are not limited to, the following: • Ensuring adequate medical care, diagnosis, and supports based on diagnosis; • Ensuring that the necessary care and services are person-centered and reflect the resident’s goals, while maximizing the resident’s dignity, autonomy, privacy, socialization, independence, choice, and safety; and • Utilizing individualized, non-pharmacological approaches to care (e.g., purposeful and meaningful activities). Meaningful activities are those that address the resident’s customary routines, interests, preferences, and choices to enhance the resident’s well-being. It is expected that a facility’s approach to care for a resident living with dementia follows a systematic care process. In order to ensure that residents’ individualized dementia care needs are met, the facility is expected to assess, develop, and implement care plans through an interdisciplinary team (IDT) approach that includes the resident, their family, and/or resident representative, to the extent possible. Care plan goals must be achievable and the facility must provide those resources necessary for an individual resident to be successful in reaching those goals. Surveyors must determine whether the failure to attain or maintain the highest practicable physical, mental, and psychosocial well-being (in accordance with the comprehensive assessment and care plan) was avoidable or unavoidable. An unavoidable facility failure refers to a situation where the IDT has completed comprehensive assessments, developed and implemented individualized, person-centered approaches to care through the care-planning process, revised care plans accordingly, and residents are unable to attain or maintain their highest practicable physical, mental, and psychosocial well-being. Residents living with dementia require specialized services and supports, (e.g., specialized activities, nutrition, and environmental modifications) that vary, based on the individual’s abilities and challenges related to their condition. Dementia causes significant intellectual functioning impairments that interfere with life, including activities and relationships. People living with dementia may lose their ability to communicate, solve problems, and cope with stressors. They may also experience fear, confusion, sadness, and agitation. While memory loss is a common indication of dementia, memory loss by itself does not mean that a person has dementia. Although it is common in very elderly individuals, dementia is not a normal part of the aging process. There are several diseases that can cause symptoms of dementia (e.g., Alzheimer’s disease, vascular dementia, Lewy body dementia). Other conditions can also cause dementia or dementia-like symptoms (including, e.g., reactions to medications, metabolic problems and endocrine abnormalities, nutritional deficiencies, and heart and lung problems). Some individuals living with dementia may have co-existing symptoms, such as paranoia, delusions or hallucinations or psychiatric conditions, such as depression or bipolar affective disorder. Progressive dementia may exacerbate these symptoms and conditions. Behavioral or psychological expressions are occasionally related to the brain disease in dementia; however, they may also be caused or exacerbated by environmental triggers. Such expressions or indications of distress often represent a person’s attempt to communicate an unmet need, discomfort, or thoughts that they can no longer articulate. Medications may be unnecessary and are likely to cause harm when given without a clinical indication, at too high of a dose, for too long after the resident’s distress has been resolved, or if the medications are not monitored. However, medications may be effective when the underlying cause of a resident’s distress has been determined and non- pharmacologic approaches to care have been ineffective or for expressions of distress that have worsened. All approaches to care, non-pharmacological and pharmacological, need to be person-centered, monitored for efficacy, risks, benefits, and harm, and revised as necessary. If there are concerns about medication use in dementia, refer to §483.45(d) (F757), Unnecessary Drugs and §483.45(e) (F758), Psychotropic Drugs. KEY ELEMENTS OF NONCOMPLIANCE §483.40(b)(3) To cite deficient practice at F744, the surveyor’s investigation will generally show that the facility failed to: • Assess resident treatment and service needs through the Resident Assessment Instrument (RAI) process; • Identify, address, and/or obtain necessary services for the dementia care needs of residents; • Develop and implement person-centered care plans that include and support the dementia care needs, identified in the comprehensive assessment; • Develop individualized interventions related to the resident’s symptomology and rate of progression (e.g., providing verbal, behavioral, or environmental prompts to assist a resident with dementia in the completion of specific tasks); • Review and revise care plans that have not been effective and/or when the resident has a change in condition; • Modify the environment to accommodate resident care needs; or • Achieve expected improvements or maintain the expected stable rate of decline. Investigating Concerns Related to Dementia Care Treatment and Services Use the Dementia Care Critical Element Pathway (CMS-20133), along with guidance, when determining if the facility meets the requirements pertaining to the treatment and services for a resident who displays or is diagnosed with dementia. Treatment and services must meet the resident’s highest practicable physical, mental, and psychosocial well-being. Review, as needed, all appropriate resident assessments, associated care planning and care plan revisions, along with physician’s orders to identify initial concerns and guide the investigation. Review the Minimum Data Set (MDS) and other supporting documentation to help determine if the facility is in compliance. Observe for evidence that dementia care needs are met and related services are provided. Staff are expected to assess and provide appropriate care for residents with dementia. Interview the resident, their family, and/or representative(s) and the IDT, as needed to gather information about dementia care in the nursing home. Corroborate the information obtained and any concerns noted during the survey, by building upon the investigation through additional observations, interviews, and record review. In determining compliance, additionally refer to the Psychosocial Severity Outcome Guide at the CMS Nursing Homes Survey Resources website that can be accessed by visiting https://www.cms.gov/files/zip/survey- resources-10262022.zip. DEFICIENCY CATEGORIZATION §483.40(b)(3) An example of Severity Level 4: Immediate Jeopardy to Resident Health or Safety includes, but is not limited to: • Based upon a comprehensive assessment by a qualified professional, it was identified that a resident living with dementia required close supervision to prevent injury. The resident’s care plan indicated that the facility had developed individualized interventions to support him. However, documentation in the resident’s record provided information about an incident that had occurred recently as a result of lack of supervision. When left alone in the bathroom, the resident sustained second degree burns to his hand from hot water, requiring treatment at the emergency room. Following the incident, no revisions were made to the resident’s care plan. The facility failed to implement individualized interventions, as well as revise the care plan accordingly, to address the resident’s dementia care needs, resulting in injury, as evidenced by observation, record review, and/or interview. An example of Severity Level 3: Actual Harm that is not Immediate Jeopardy includes, but is not limited to: • The care plan for a resident with an identified diagnosis of dementia included the need for close supervision to prevent the resident from wandering into the rooms of other residents. However, the review of the care plan indicated that the facility had failed to develop person-centered interventions to prevent the resident from wandering. The record review also provided information about a resident-to- resident altercation that had occurred a week prior to the survey. The altercation involved a sweater that was removed from the room of another resident, who slapped and scratched the resident living with dementia, because she refused to return the garment. The resident received minor lacerations and bruising, which was cared for by the direct care staff at the nursing home. The care plan was revised to reflect the need to closely supervise. During the survey, the resident was observed wandering in and out of resident rooms. When questioned, direct care staff were unaware that the resident required close supervision. The facility failed to develop and implement interventions to address the resident’s dementia care needs, resulting in the resident’s inability to achieve her highest level of functioning. An Example of Severity Level 2: No Actual Harm with Likelihood for More Than Minimal Harm that is Not Immediate Jeopardy • A resident was observed standing in her doorway asking what day of the week it was. Two staff members were within hearing distance, but did not reply to the resident. The surveyor also noticed that there was no calendar in the resident’s room. Review of the resident’s record showed that she had a diagnosis of dementia. The care plan noted that the resident has a tendency to forget what day of the week it is and can become anxious when not reminded. Interventions include that staff are to ensure that a current calendar is on her bedroom wall and remind the resident what day it is when she wakes up each morning and when facility staff are asked. The facility failed to support the resident and implement care planned interventions to reduce her confusion, which had the potential to cause the resident anxiety. Severity Level 1: No Actual Harm with Likelihood for Minimal Harm Severity Level 1 does not apply for this regulatory requirement because any facility practice that results in a reduction of psychosocial well-being diminishes the resident’s quality of life. Because more than minimal harm is likely, any deficiency for this requirement is at least a Severity Level 2. For additional guidance, see also the Psychosocial Outcome Severity Guide at the CMS Nursing Homes Survey Resources website that can be accessed by visiting https://www.cms.gov/files/zip/survey-resources- 10262022.zip. NOTE: If there are indications that a resident is in a secured/locked area without a clinical justification and/or placement is against the will of the resident, their family, and/or resident representative, review regulatory requirements at §483.12 and §483.12(a) (F603), Involuntary Seclusion. [End of Tag F744.] F745 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.40(d) The facility must provide medically-related social services to attain or maintain the highest practicable physical, mental and psychosocial well-being of each resident. INTENT §483.40(d) To assure that sufficient and appropriate social services are provided to meet the resident’s needs. DEFINITIONS §483.40(d) Definitions are provided to clarify terminology related to behavioral health services and the attainment or maintenance of a resident’s highest practicable well-being. “Medically-related social services” means services provided by the facility’s staff to assist residents in attaining or maintaining their mental and psychosocial health. GUIDANCE §483.40(d) All facilities are required to provide medically-related social services for each resident. Facilities must identify the need for medically-related social services and ensure that these services are provided. It is not required that a qualified social worker necessarily provide all of these services, except as required by State law. If there are concerns about requirements involving qualified social workers, refer to §483.70(o) (F850), Social worker. Examples of medically-related social services include, but are not limited to the following: • Advocating for residents and assisting them in the assertion of their rights within the facility in accordance with §483.10, Resident Rights, §483.12, Freedom from Abuse, Neglect, and Exploitation, §483.15, Transitions of Care, §483.20, Resident Assessments (PASARR), and §483.21, Comprehensive Person-Centered Care Planning; • Assisting residents in voicing and obtaining resolution to grievances about treatment, living conditions, visitation rights, and accommodation of needs; • Assisting or arranging for a resident’s communication of needs through the resident’s primary method of communication or in a language that the resident understands; • Making arrangements for obtaining items, such as clothing and personal items; • Assisting with informing and educating residents, their family, and/or representative(s) about health care options and ramifications; • Making referrals and obtaining needed services from outside entities (e.g., talking books, absentee ballots, community wheelchair transportation); • Assisting residents with financial and legal matters (e.g., applying for pensions, referrals to lawyers, referrals to funeral homes for preplanning arrangements); • Transitions of care services (e.g., assisting the resident with identifying community placement options and completion of the application process, arranging intake for home care services for residents returning home, assisting with transfer arrangements to other facilities); • Providing or arranging for needed mental and psychosocial counseling services; • Identifying and seeking ways to support residents’ individual needs through the assessment and care planning process; • Encouraging staff to maintain or enhance each resident’s dignity in recognition of each resident’s individuality; • Assisting residents with advance care planning, including but not limited to completion of advance directives (For additional information pertaining to advance directives, refer to §483.10(g)(12) (F578)), Advance Directives); • Identifying and promoting individualized, non-pharmacological approaches to care that meet the mental and psychosocial needs of each resident; and • Meeting the needs of residents who are grieving from losses and coping with stressful events. Situations in which the facility should provide social services or obtain needed services from outside entities include, but are not limited to the following: • Lack of an effective family or community support system or legal representative; • Expressions or indications of distress that affect the resident’s mental and psychosocial well-being, resulting from depression, chronic diseases (e.g., Alzheimer’s disease and other dementia related diseases, schizophrenia, multiple sclerosis), difficulty with personal interaction and socialization skills, and resident to resident altercations; • Abuse of any kind (e.g., alcohol or other drugs, physical, psychological, sexual, neglect, exploitation); • Difficulty coping with change or loss (e.g., change in living arrangement, change in condition or functional ability, loss of meaningful employment or activities, loss of a loved one); and • Need for emotional support. NOTE: When needed services are not covered by Medicaid, nursing facilities are still required to attempt to obtain these services on behalf of the resident (e.g., arranging transportation services). F755 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.45 Pharmacy Services The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in §483.70(f). The facility may permit unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse. §483.45(a) Procedures. A facility must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident. §483.45(b) Service Consultation. The facility must employ or obtain the services of a licensed pharmacist who-- §483.45(b)(1) Provides consultation on all aspects of the provision of pharmacy services in the facility; §483.45(b)(2) Establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and §483.45(b)(3) Determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled. INTENT §483.45(a) and (b)(1), (2), and (3) The intent of this requirement is that: • In order to meet the needs of each resident, the facility accurately and safely provides or obtains pharmaceutical services, including the provision of routine and emergency medications and biologicals, and the services of a licensed pharmacist; • The facility utilizes only persons authorized by state or local, regulation, or other guidance to administer medications during the course of employment by a facility; • The licensed pharmacist collaborates with facility leadership and staff to coordinate pharmaceutical services within the facility, guide development and evaluation of pharmaceutical services procedures, and help the facility identify, evaluate, and resolve pharmaceutical concerns which affect resident care, medical care or quality of life such as the: o Provision of consultative services by a licensed pharmacist as necessary; and o Coordination of the pharmaceutical services if multiple pharmaceutical service providers are utilized (e.g., pharmacy, infusion, hospice, prescription drug plans [PDP]). • The facility, in coordination with the licensed pharmacist, provides for: o A system of medication records that enables periodic accurate reconciliation and accounting for all controlled medications; o Prompt identification of loss or potential diversion of controlled medications; and o Determination of the extent of loss or potential diversion of controlled medications. NOTE: Although the regulatory language refers to “drugs,” the guidance in this document generally will refer to “medications,” except in those situations where the term “drug” has become part of an established pharmaceutical term (e.g., adverse drug event, adverse drug reaction or consequence). For purposes of this guidance, references to “the pharmacist” mean the licensed pharmacist, whether employed directly by the facility or through arrangement. DEFINITIONS §483.45 Definitions are provided to clarify terminology related to pharmaceutical services and the management of each resident’s medication regimen for effectiveness and safety. “Acquiring medication” is the process by which a facility requests and obtains a medication. “Biologicals” are made from a variety of natural sources––human, animal, or microorganisms. Biologicals are used to treat, prevent, or diagnose diseases and medical conditions. They may include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. “Controlled Medications” are substances that have an accepted medical use (medications which fall under US Drug Enforcement Agency (DEA) Schedules II—V), have a potential for abuse, ranging from low to high, and may also lead to physical or psychological dependence. “Dispensing” is a process that includes the interpretation of a prescription; selection, measurement, and packaging or repackaging of the product (as necessary); and labeling of the medication or device pursuant to a prescription/order. “Disposition” is the process of returning and/or destroying unused medications. “Diversion of medications” is the transfer of a controlled substance or other medication from a lawful to an unlawful channel of distribution or use, as adapted from the Uniform Controlled Substances Act. “Pharmaceutical Services” refers to: • The process (including documentation, as applicable) of receiving and interpreting prescriber’s orders; acquiring, receiving, storing, controlling, reconciling, compounding (e.g., intravenous antibiotics), dispensing, packaging, labeling, distributing, administering, monitoring responses to, using and/or disposing of all medications, biologicals, chemicals (e.g., povidone iodine, hydrogen peroxide); • The provision of medication-related information to health care professionals and residents; • The process of identifying, evaluating and addressing medication-related issues including the prevention and reporting of medication errors; and • The provision, monitoring and/or the use of medication-related devices. “Pharmacy assistant or technician” refers to the ancillary personnel who work under the supervision and delegation of the pharmacist, consistent with state requirements. “Receiving medication”—for the purpose of this guidance—is the process that a facility uses to ensure that medications, accepted from the facility’s pharmacy or an outside source (e.g., vending pharmacy delivery agent, Veterans Administration, family member), are accurate (e.g., doses, amount). “Reconciliation”—for the purpose of this guidance—refers to a system of recordkeeping that ensures an accurate inventory of medications by accounting for controlled medications that have been received, dispensed, administered, and/or, including the process of disposition. Guidance §483.45 The provision of pharmaceutical services is an integral part of the care provided to nursing home residents. The management of complex medication regimens is challenging and requires diverse pharmaceutical services and formal mechanisms to safely handle and control medications, to maintain accurate and timely medication records, and to minimize medication-related adverse consequences or events. The overall goal of the pharmaceutical services system within a facility is to ensure the safe and effective use of medications. Preventable medication-related adverse consequences and events are a serious concern in nursing homes. The U.S. Department of Health and Human Services (HHS) Office of the Inspector General issued a report in February 2014, Adverse Events in Skilled Nursing Facilities: National Incidence among Medicare Beneficiaries (OEI-06-11-00370). The OIG found that one in three SNF residents experienced an adverse event or temporary harm event. Thirty-seven percent of these adverse events were related to medications and 66% of all medication-related events were preventable. Medication-related adverse events included excessive bleeding due to anticoagulant use without adequate monitoring and acute hypoglycemia. Consequences of medication-related adverse events included a prolonged SNF stay, hospitalization, life sustaining interventions, permanent harm, and death. Factors that increase the risk of adverse consequences associated with medication use in the nursing home setting include complex medication regimens, numbers and types of medication used, physiological changes accompanying the aging process, as well as multiple comorbidities. The consultative services of a pharmacist can promote safe and effective medication use. A pharmacist, in collaboration with facility staff, establishes, evaluates and coordinates all aspects of pharmaceutical services provided to all residents within a facility by all providers (e.g., pharmacy, prescription drug plan, prescribers). A pharmacist can also help in the development of medication-related documentation procedures, such as identification of abbreviations approved for use in the facility and can help guide the selection and use of medications in accordance with the authorized prescriber’s orders, applicable state and federal requirements, manufacturers’ specifications, characteristics of the resident population, and individual resident conditions. Providing pharmaceutical consultation is an ongoing, interactive process with prospective, concurrent, and retrospective components. To accomplish some of these consultative responsibilities, pharmacists can use various methods and resources, such as technology, additional personnel (e.g., dispensing pharmacists, pharmacy technicians), and related policies and procedures. Numerous recognized resources address different aspects of pharmaceutical services and medication utilization, such as: • US Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) Find Information about a Drug, Information on FDA- approved drugs released for sale on the market; • The American Society of Health System Pharmacists (ASHP) http://www.ashp.org; • The National Institutes of Health U.S. National Library of Medicine Medline Plus, https://medlineplus.gov/druginformation.html. • AMDA - The Society for Post-Acute and Long-Term Care Medicine (American Medical Directors Association) https://paltc.org/; • The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP), https://www.nccmerp.org/; • American Society for Parenteral and Enteral Nutrition (ASPEN), https://www.nutritioncare.org/. NOTE: References to non-CMS sources do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services and were current as of the date of this publication. A. PROVISION OF ROUTINE AND/OR EMERGENCY MEDICATIONS The regulation at 42 CFR 483.45 requires that the facility provide or obtain routine and emergency medications and biologicals in order to meet the needs of each resident. Facility procedures and applicable state laws may allow the facility to maintain a limited supply of medications in the facility for use during emergency or after-hours situations. Whether prescribed on a routine, emergency, or as needed basis, medications should be administered in a timely manner. Delayed acquisition of a medication may impede timely administration and adversely affect a resident’s condition. Factors that may help determine timeliness and guide acquisition procedures include: • Availability of medications to enable continuity of care for an anticipated admission or transfer of a resident from acute care or other institutional settings; • Condition of the resident including the severity or instability of his/her condition, a significant change in condition, discomfort, risk factors, current signs and symptoms, and the potential impact of any delay in acquiring the medications; • Category of medication, such as antibiotics or analgesics; • Availability of medications in emergency supply, if applicable; and • Ordered start time/date for a medication. Procedures should identify how staff, who are responsible for medication administration: • Ensure each resident has a sufficient supply of his or her prescribed medications (for example, a resident who is on pain management has an adequate supply of medication available to meet his or her needs). At a minimum, the system is https://www.fda.gov/drugs/information-consumers-and-patients-drugs/find-information-about-drug https://www.fda.gov/drugs/information-consumers-and-patients-drugs/find-information-about-drug http://www.ashp.org/ https://medlineplus.gov/druginformation.html https://paltc.org/ https://www.nccmerp.org/ https://www.nutritioncare.org/ expected to include a process for the timely ordering and reordering of a medication; • Monitor the delivery and receipt of medications when they are ordered; and • Determine the appropriate action, e.g., contact the prescriber or pharmacist, when a resident’s medication(s) is not available for administration. NOTE: Facility staff may encounter situations in which a medication is not available in the resident’s supply or the facility’s emergency medication supply and then decide to “borrow” medications from another resident’s supply. This practice of borrowing medications from other residents’ supplies is not consistent with professional standards and contributes to medication errors. Concerns about whether the facility has a system in place to ensure each resident has a sufficient supply of medications for timely administration should be cited under this tag Pharmacy Services (F755). However, if staff borrow any medication from another resident’s supply due to failure to order the medication and/or not following the facility’s system for reordering medications, refer to §483.21(b)(3), F658, Services Provided Meet Professional Standards. Instances of “borrowing,” as described in this paragraph, would not be considered to be drug diversion. Foreign Acquired Medications It has been reported that some residents and/or facilities may be obtaining medications from foreign sources. Medications obtained from foreign sources may present safety issues since they have been manufactured or held outside of the jurisdiction of the United States (U.S.) regulatory system. These medications may not be safe and effective for their intended uses. The Federal Food, Drug, and Cosmetic Act (FFDCA) strictly limits the types of drugs that may be imported into the U.S. Medications imported into the U.S. may violate the FFDCA if they are unapproved by the FDA, labeled incorrectly, or dispensed without a valid prescription. The facility should, in collaboration with the pharmacist, assure that medications are provided or obtained from approved sources and do not violate the FFDCA. If it is determined that the facility is providing/obtaining foreign medications that are not FDA approved for use by the residents, the State Agency must make referrals to appropriate agencies, such as the FDA; depending on the medication classification, the Drug Enforcement Administration; State Board of Nursing; State Board of Pharmacy; and the State Licensure Board for Nursing Home Administrators. B. PHARMACEUTICAL SERVICES PROCEDURES The pharmacist, in collaboration with the facility and medical director, helps develop and evaluate the implementation of pharmaceutical services procedures that address the needs of the residents, are consistent with state and federal requirements, and reflect current standards of practice. These procedures address, but are not limited to, acquiring; receiving; dispensing; administering; disposing; labeling and storage of medications; and personnel authorized to access or administer medications. Acquisition of Medications Examples of procedures addressing acquisition of medications include: • Availability of an emergency supply of medications, if allowed by state law, including the types or categories of medications; amounts, dosages/strengths to be provided; location of the supply; personnel authorized to access the supply; record keeping; monitoring for expiration dates; and the steps for replacing the supply when medications are used; • When, how to, and who may contact the pharmacy regarding acquisition of medications and the steps to follow for contacting the pharmacy for an original routine medication order, emergency medication order, and refills; • The availability of medications when needed, that is, the medication is either in the facility (in the emergency supply) or obtained from a pharmacy that can be reached 24 hours a day, seven days a week; • The receipt, labeling, storage, and administration of medications dispensed by the prescriber, if allowed by state requirements; • Verification or clarification of an order to facilitate accurate acquisition of a medication when necessary (e.g., clarification when the resident has allergies to, or there are contraindications to the medication being prescribed); • Procedure when delivery of a medication will be delayed or the medication is not or will not be available; and • Transportation of medications from the dispensing pharmacy or vendor to the facility consistent with manufacturer’s specifications, state and federal requirements, and standards of professional practice to prevent contamination, degradation, and diversion of medications. Receiving Medication(s) Examples of procedures addressing receipt of medications include: • How the receipt of medications from dispensing pharmacies (and family members or others, where permitted by state requirements) will occur and how it will be reconciled with the prescriber’s order and the requisition for the medication; • How staff will be identified and authorized in accordance with applicable laws and requirements to receive the medications and how access to the medications will be controlled until the medications are delivered to the secured storage area; and • Which staff will be responsible for assuring that medications are incorporated into the resident’s specific allocation/storage area. Dispensing Medication(s) Examples of procedures to assure compatible and safe medication delivery, to minimize medication administration errors, and to address the facility’s expectations of the in- house pharmacy and/or outside dispensing pharmacies include: • Delivery and receipt; • Labeling; and • The types of medication packaging (e.g., unit dose, multi-dose vial, blister cards). Administering Medications Examples of procedures addressing administration of medications include: • Providing continuity of staff to ensure that medications are administered without unnecessary interruptions; • Reporting medication administration errors, including how and to whom to report; • Authorizing personnel, consistent with state requirements, to administer the medications, including medications needing intravenous administration (see Authorized Personnel section within this document); • Assuring that the correct medication is administered in the correct dose, in accordance with manufacturer’s specifications and with standards of practice, to the correct person via the correct route in the correct dosage form and at the correct time; • Defining the schedules for administering medications to: o Maximize the effectiveness (optimal therapeutic effect) of the medication (for example, antibiotics, antihypertensives, insulin, pain medications, proton pump inhibitors, metered dose inhalers, and medications via enteral feeding tubes); o Prevent potential significant medication interactions such as medication- medication or medication-food interactions; and o Honor resident choices and activities, as much as possible, consistent with the person-centered comprehensive care plan; • Defining general guidelines for specific monitoring related to medications, when ordered or indicated, including specific item(s) to monitor (e.g., blood pressure, pulse, blood sugar, weight), frequency (e.g., weekly, daily), timing (e.g., before or after administering the medication), and parameters for notifying the prescriber; • Defining pertinent techniques and precautions that meet current standards of practice for administering medications through alternate routes such as eye, ear, buccal, injection, intravenous, atomizer/aerosol/ inhalation therapy, or enteral tubes. For example, for enteral feeding tubes, define procedures including but not limited to: o Types of medications that may be safely administered via enteral feeding tube; o Appropriate dosage forms; o Techniques to monitor and verify that the feeding tube is in the right location (e.g., stomach or small intestine, depending on the tube) before administering medications; and o Preparing drugs for enteral administration, administering drugs separately, diluting drugs as appropriate, and flushing the feeding tube before, between, and after drug administration, including the amount of water to be used for the flushing and administration of medications (and obtaining physician/practitioners order to address a resident with fluid restrictions). NOTE: Enteral feeding tube practice recommendations may be found in ASPEN Safe Practices for Enteral Nutrition Therapy, https://aspenjournals.onlinelibrary.wiley.com/doi/full/10.1177/0148607116673053. References to non-CMS sources do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services and were current as of the date of this publication. • Documenting the administration of medications, including: o The administration of routine medication(s), and, if not administered, an explanation of why not; o The administration of “as-needed” (PRN) medications including the justification and response; o The route, if other than oral (intended route may be preprinted on Medication Administration Record (MAR); and o Location of administration sites such as transdermal patches and injections; • Providing accessible current information about medications (e.g., medication information references) and medication-related devices and equipment (e.g., user’s manual) for all staff involved with the medication administration process; • Clarifying any order that is incomplete, illegible, or presents any other concerns, prior to administering the medication; and • Reconciling medication orders including telephone orders, monthly or other periodic recapitulations, and MAR, including who may transcribe prescriber’s orders and enter the orders onto the MAR. Disposition of Medications Examples of procedures addressing the disposition of medications include: • Timely identification and removal (from current medication supply) of medications for disposition; • Identification of storage method for medications awaiting final disposition; • Control and accountability of medications awaiting final disposition consistent with standards of practice; • Documentation of actual disposition of medications to include: resident name, medication name, strength, prescription number (as applicable), quantity, date of https://aspenjournals.onlinelibrary.wiley.com/doi/full/10.1177/0148607116673053 disposition, and involved facility staff, consultant(s) or other applicable individuals; and • Method of disposition (including controlled medications) should prevent diversion and/or accidental exposure and is consistent with applicable state and federal requirements, local ordinances, and standards of practice; Authorized Personnel The facility may permit unlicensed personnel to administer medications if state law permits, but only under the general supervision of a licensed nurse. The facility assures that all persons administering medications are authorized according to state and federal requirements, oriented to the facility’s medication-related procedures, and have access to current information regarding medications being used by the residents, including side effects of medications, contraindications, doses, etc. Examples of procedures addressing authorized personnel include: • How the facility assures ongoing competency of all staff (including temporary, agency, or on-call staff) authorized to administer medications and biologicals; • Training regarding the operation, limitations, monitoring, and precautions associated with medication administration devices or other equipment, if used, such as: o IV pumps or other IV delivery systems including calculating dosage, infusion rates, and compatibility of medications to be added to the IV or enteral feeding pump; o Blood glucose meters, including calibration and cleaning between individual residents; and o Using, maintaining, cleaning, and disposing of the various types of devices for administration including nebulizers, inhalers, syringes, medication cups, spoons, and pill crushers; • Identifying pharmacy personnel in addition to the pharmacist (e.g., pharmacy technicians, pharmacist assistants) who are authorized under state and federal requirements to access medications and biologicals. C. SERVICES OF A LICENSED PHARMACIST The facility is responsible for employing or contracting for the services of a pharmacist to provide consultation on all aspects of pharmaceutical services. The facility may provide for this service through any of several methods (in accordance with state requirements) such as direct employment or contractual agreement with a pharmacist. Whatever the arrangement or method employed, the facility and the pharmacist identify how they will collaborate for effective consultation regarding pharmaceutical services. The pharmacist reviews and evaluates the pharmaceutical services by helping the facility identify, evaluate, and address medication issues that may affect resident care, medical care, and quality of life. The pharmacist is responsible for helping the facility obtain and maintain timely and appropriate pharmaceutical services that support residents’ healthcare needs, goals, and quality of life that are consistent with current standards of practice, and that meet state and federal requirements. This should include, but is not limited to, collaborating with the facility and medical director to: • Develop, implement, evaluate, and revise (as necessary) the procedures for the provision of all aspects of pharmaceutical services, including procedures to support resident quality of life such as those that support safe, individualized medication administration programs; • Coordinate pharmaceutical services if and when multiple pharmaceutical service providers are utilized (e.g., pharmacy, infusion, hospice, prescription drug plans [PDP]) • Develop intravenous (IV) therapy procedures if used within the facility (consistent with state requirements) which may include: determining competency of staff and facility-based IV admixture procedures that address sterile compounding, dosage calculations, IV pump use, and flushing procedures; • Determine (in accordance with or as permitted by state law) the contents of the emergency supply of medications and monitor the use, replacement, and disposition of the supply; • Develop mechanisms for communicating, addressing, and resolving issues related to pharmaceutical services; • Strive to assure that medications are requested, received, and administered in a timely manner as ordered by the authorized prescriber (in accordance with state requirements), including physicians, advanced practice nurses, pharmacists, and physician assistants; • Provide feedback about performance and practices related to medication administration and medication errors. In addition, the pharmacist may collaborate with the facility and medical director on other aspects of pharmaceutical services including, but not limited to: • Developing procedures and guidance regarding when to contact a prescriber about a medication issue and/or adverse effects, including what information to gather before contacting the prescriber; • Developing the process for receiving, transcribing, and recapitulating medication orders; • Recommending the type(s) of medication delivery system(s) to standardize packaging, such as bottles, bubble packs, tear strips, in an effort to minimize medication errors; • Developing and implementing procedures regarding automated medication delivery devices or cabinets, if automated devices or cabinets are used, including: the types or categories of medications, amounts stored, location of supply, personnel authorized to access the supply, record keeping, monitoring for expiration dates, method to ensure accurate removal of medications and the steps for replacing the supply when dosages are used, and monitoring the availability of medications within the system; • Interacting with the quality assessment and assurance committee to develop procedures and evaluate pharmaceutical services including delivery and storage systems within the various locations of the facility in order to prevent, to the degree possible, loss or tampering with the medication supplies, and to define and monitor corrective actions for problems related to pharmaceutical services and medications, including medication errors; • Recommending current resources to help staff identify medications and information on contraindications, side effects and/or adverse effects, dosage levels, and other pertinent information; and • Identifying facility educational and informational needs about medications and providing information from sources such as nationally recognized organizations to the facility staff, practitioners, residents, and families. NOTE: This does not imply that the pharmacist must personally present educational programs. D. CONTROLLED MEDICATIONS Regulations require that the facility have a system to account for controlled medications’ receipt and disposition in sufficient detail to enable an accurate reconciliation, and that the facility conduct a periodic reconciliation. This system should include, but is not limited to: • Record of receipt of all controlled medications with sufficient detail to allow reconciliation (e.g., specifying the name and strength of the medication, the quantity and date received, and the resident’s name). However, in some delivery systems (e.g., single unit package medication delivery system or automated dispensing systems utilizing single-unit packages of medications that are not dispensed pursuant to a specific order), the resident’s name may not be applicable; NOTE: If permitted by, and in accordance with, state requirements, the facility may store some controlled medications in an emergency medication supply. The facility’s policies and procedures must address the reconciliation of this supply, see 42 C.F.R. § 483.45(b)(2) and (3). • Records of personnel access, usage, and disposition of all controlled medications with sufficient detail to allow reconciliation (e.g., the MAR, proof-of-use sheets, or declining inventory sheets), including destruction, wastage, return to the pharmacy/manufacturer, or disposal in accordance with applicable State requirements; • Periodic reconciliation of records of receipt, disposition, usage, and inventory for all controlled medications (as defined by facility procedures or when loss is identified). The reconciliation identifies loss or potential diversion of controlled medications so as to minimize the time between the actual loss or potential diversion and the time of detection and follow-up to determine the extent of loss. Because diversion can occur at any time, periodic reconciliation should accommodate actual facility experience, such that if there is any evidence or even suspicion that diversion may be occurring, then that may dictate conducting the periodic reconciliation as frequently as daily. State or other federal requirements may specify the frequency of reconciliation. o If discrepancies are identified during the reconciliation, the pharmacist and the facility develop and implement recommendations for resolving them, and make referrals to law enforcement agencies as appropriate. o Data from injectable, scheduled drug tracking should be regularly reviewed and discrepancies or unusual access patterns are investigated including whether residents should be screened for exposure to blood borne pathogens. See §483.80 Infection Control, F880. o Liquid controlled medications are often dispensed in multi-dose containers which indicate approximate volume. The containers may also be opaque to protect the medication from light. It should be noted that absolute accuracy in tracking volume and use of liquid controlled medications may not be possible. The actual volume in these containers may be slightly over or under the manufacturer’s stated volume depending on the shape and material of the container and the formulation of the medication such as thick liquid suspensions. The opaque container, measurement markings, manufacturer fill volume variation, and method for recording usage all make detection of diversion for liquid controlled medications more difficult. The general standard of practice for documenting usage of liquid controlled medications is to record the starting volume from the label, record each dose administered, subtract the dose administered from the previously recorded volume, and record the remaining amount. Any observed discrepancy between the recorded amount and what appears to be remaining in the container should be reported according to facility policy. Manufacturer’s instructions may list the estimated volume variance (e.g., 30 mL plus or minus 2.5 mL). For liquid controlled medications, signs of diversion may include: an observable discrepancy between the written balances of remaining medication compared to the remaining amount in the bottle upon visual inspection; changes in the viscosity or color of the medication; reports of spills; and, as with other controlled medications, statements from a resident that the medication is not working. • Disposal methods for controlled medications must involve a secure and safe method to prevent diversion and/or accidental exposure. • Fentanyl transdermal patches present a unique situation given the multiple boxed warnings, and the substantial amount of fentanyl remaining in the patch after removal, creating a potential for abuse, misuse, diversion, or accidental exposure. Due to the life threatening risks associated with exposure to or ingestion of the patch, the Food and Drug Administration (FDA) and manufacturer instructions recommend consumers dispose of used fentanyl patches by folding the patch in half with the sticky sides together and flushing the patch down the sink or toilet, https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e15a7e9b-8025- 49dd-9a6d-bafcccf1959f&type=display. . The Environmental Protection Agency bans flushing of pharmaceuticals if they are considered hazardous waste pharmaceuticals; fentanyl patches are not in this category, https://www.epa.gov/hw/defining-hazardous-waste-listed-characteristic-and-mixed- radiological-wastes#PandU. However, this method of disposal may not always be appropriate in nursing homes, particularly in areas where state or local laws restrict flushing of pharmaceuticals. Therefore, nursing homes may use drug disposal products or systems for fentanyl patches and other controlled medications as long as the facility can show that the product or system minimizes accidental exposure or diversion. Disposal in common areas or resident room trashcans or sharps containers are methods that would not prevent accidental exposure or diversion. Concerns related to fentanyl patch disposal which could lead to accidental exposure should be investigated at F689. NOTE: The pharmacist is not required by these regulations to perform the reconciliation of medications, but rather to evaluate and determine that the facility maintains an accurate account of all controlled medications and completes the reconciliation according to its procedures, consistent with State and federal requirements. PROCEDURES §483.45 Use the Medication Administration Observation and the Medication Storage and Labelling Critical Element Pathway, as appropriate, along with the above interpretive guidelines when determining if the facility meets the requirements for, or investigating concerns related to, the provision of Pharmacy Services. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F755, the surveyor’s investigation will generally show that the facility failed to: • Provide medications and/or biologicals, as ordered by the prescriber, to meet the needs of each resident; or • Ensure that only appropriate personnel administer medications, consistent with applicable state law and regulations; or • Provide pharmaceutical services to meet each resident’s needs which includes: acquiring, receiving, dispensing, accurately administering, or disposing of medications; or https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e15a7e9b-8025-49dd-9a6d-bafcccf1959f&type=display https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e15a7e9b-8025-49dd-9a6d-bafcccf1959f&type=display https://www.epa.gov/hw/defining-hazardous-waste-listed-characteristic-and-mixed-radiological-wastes#PandU https://www.epa.gov/hw/defining-hazardous-waste-listed-characteristic-and-mixed-radiological-wastes#PandU • Provide or arrange for a licensed pharmacist who consults on all aspects of pharmaceutical services; or • Establish systems to accurately reconcile controlled medications using acceptable standards of practice; or • Have safeguards and systems in place to control, account for, and periodically reconcile controlled medications in order to prevent loss, diversion, or accidental exposure. DEFICIENCY CATEGORIZATION In addition to actual or potential physical harm, always consider whether psychosocial harm has occurred when determining severity level. For additional guidance, see also the Psychosocial Outcome Severity Guide at the CMS Nursing Homes Survey Resources website that can be accessed by visiting https://www.cms.gov/files/zip/survey-resources- 10262022.zip. Examples of noncompliance that demonstrate severity at Level 4 may include, but are not limited to: • The facility, in collaboration with the pharmacist, failed to establish effective procedures to meet the needs of the residents, such as: o Assuring that pain medications were available to meet the needs of the resident-- The facility failed to obtain the routine regularly scheduled pain medicine for a resident who was to receive it every six hours. The investigation confirmed that the resident had been without pain medication for 2 days, the equivalent of 8 missed doses. This failure resulted in the resident complaining of excruciating, unrelieved pain (e.g., a pain score of 9 on a 10- point scale). The pain was all-consuming and overwhelming, leading to sleep loss, and a loss in interest and ability to perform activities of daily living. o Assuring that devices used to administer medications (such as IV pumps) were working properly, leading to an adverse consequence at the immediate jeopardy level, in which a resident received an incorrect dose of IV medication. o Provisions to assure that staff were trained or competent to use new medication-related devices (e.g., intravenous pump). This resulted in a resident receiving an inappropriate dose of medication requiring subsequent hospitalization. Examples of Level 3, Actual harm (physical or psychosocial) that are not immediate jeopardy, may include, but are not limited to: • The facility and the pharmacist failed to assure that procedures were developed and implemented so that all medication orders were processed consistently and accurately through the stages of ordering, receiving, and administering medications (including transfer orders, admission orders, telephone orders, order renewals, and the MAR). For example, an ordering error led to an incorrect dose of a medication being administered and the resident experienced spontaneous bruising and frequent nosebleeds requiring medical intervention that was able to be performed in the nursing home. • The facility failed to implement a system to consistently and accurately reconcile controlled medications. As a result, when staff attempted to administer pain medication to a resident, staff found no available medications despite documentation which showed the medications were available. The resident experienced mild to moderate pain that prevented the resident from attending physical therapy. Examples of Level 2, No actual harm with a potential for more than minimal harm that is not immediate jeopardy, may include, but are not limited to: • As a result of failure of licensed staff to supervise medication administration by authorized unlicensed personnel, two residents received their oral antibiotics late on one day, however the residents did not experience any harm. • The facility failed to obtain or provide the services of a pharmacist or to collaborate with the pharmacist to assure that effective policies and procedures were established and implemented including, for example: o A resident did not receive medication for heartburn for two or more days and had difficulty sleeping during that time due to nocturnal heartburn. The level of discomfort did not interfere with the resident’s participating in activities or performing activities of daily living. o As a result of failure to identify medications that should not be crushed for administration, a resident received a newly ordered medication that was crushed, contrary to the manufacturer’s specifications. While the resident did not experience any harm, the potential for harm to the resident was present. Severity Level 1: No Actual Harm with Potential for Minimal Harm Severity Level 1 does not apply for this regulatory requirement because the failure of the facility to provide routine and emergency drugs and biologicals to its residents creates the potential for more than minimal harm. This provision, along with pharmaceutical procedures and services are essential aspects of both process and outcome requirements. Potential Tags for Additional Investigation Examples of some of the related requirements that should be considered when concerns have been identified include the following: • 42 CFR §483.12, F602, Right to be Free from Misappropriation/Exploitation o Determine if the facility diverted a resident’s medication, including, but not limited to, controlled substances for staff use or personal gain. If it is determined that a resident’s medications were diverted, the State Agency must make referrals to appropriate agencies, such as local law enforcement; Drug Enforcement Administration; State Board of Nursing; State Board of Pharmacy; the state Medicaid Fraud Control Unit, and possibly the State licensure board for Nursing Home Administrators. • 42 CFR §483.35, F725, Sufficient Staff and F726, Competent Staff o Determine if the facility had competent staff in sufficient numbers available to provide medications on a 24-hour basis to meet the needs of the residents, based upon the comprehensive assessment and care plan. • 42 CFR §483.45(g) and (h), F761, Labeling and Storage of Drugs and Biologicals o Determine if the facility properly labeled and stored all drugs and biological in accordance with currently accepted professional principles. • 42 CFR §483.70(g), F841, Medical Director o Determine whether the medical director, in collaboration with the facility and the pharmacist, and based on current standards of practice, helped the facility develop procedures for the safe and accurate provision of medications to meet the needs of the residents. • 42 CFR §483.70(h), F842, Medical Records o Determine whether the facility has maintained clinical records, including medication administration, in accordance with accepted professional standards and practices that are complete, accurately documented, and readily accessible. • 42 CFR §483.75(g), F867, Quality Assessment and Assurance o If concerns regarding pharmaceutical services have been identified, determine whether the quality assessment and assurance committee has identified and responded to those concerns, as appropriate, and has developed, implemented, and monitored appropriate plans of action to correct identified quality deficiencies. F756 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.45(c) Drug Regimen Review. §483.45(c)(1) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist. §483.45(c)(2) This review must include a review of the resident’s medical chart. §483.45(c)(4) The pharmacist must report any irregularities to the attending physician and the facility’s medical director and director of nursing, and these reports must be acted upon. (i) Irregularities include, but are not limited to, any drug that meets the criteria set forth in paragraph (d) of this section for an unnecessary drug. (ii) Any irregularities noted by the pharmacist during this review must be documented on a separate, written report that is sent to the attending physician and the facility’s medical director and director of nursing and lists, at a minimum, the resident’s name, the relevant drug, and the irregularity the pharmacist identified. (iii) The attending physician must document in the resident’s medical record that the identified irregularity has been reviewed and what, if any, action has been taken to address it. If there is to be no change in the medication, the attending physician should document his or her rationale in the resident’s medical record. §483.45(c)(5) The facility must develop and maintain policies and procedures for the monthly drug regimen review that include, but are not limited to, time frames for the different steps in the process and steps the pharmacist must take when he or she identifies an irregularity that requires urgent action to protect the resident. INTENT §483.45(c)(1), (2), (4), and (5) The intent of this requirement is that the facility maintains the resident’s highest practicable level of physical, mental and psychosocial well-being and prevents or minimizes adverse consequences related to medication therapy to the extent possible, by providing oversight by a licensed pharmacist, attending physician, medical director, and the director of nursing (DON). NOTE: Although the regulatory language refers to “drug regimen review,” the guidance in this document generally will refer to “medication regimen review,” except in those situations where the term “drug” has become part of an established pharmaceutical term (e.g., adverse drug event, and adverse drug reaction or consequence). DEFINITIONS §483.45(c)(1), (2), (4), and (5) Definitions are provided to clarify terminology related to pharmaceutical services and the management of each resident’s medication regimen for effectiveness and safety. “Adverse consequence” is a broad term referring to unwanted, uncomfortable, or dangerous effects that a drug may have, such as impairment or decline in an individual’s mental or physical condition or functional or psychosocial status. It may include various types of adverse drug reactions and interactions (e.g., medication-medication, medication-food, and medication-disease) (adapted from The Merck Manual Professional Version, http://www.merckmanuals.com/professional/clinical-pharmacology/adverse- drug-reactions/adverse-drug-reactions.) NOTE: Adverse drug reaction (ADR) is a form of adverse consequence. It may be either a secondary effect of a medication that is usually undesirable and different from the therapeutic and helpful effects of the medication or any response to a medication that is noxious and unintended and occurs in doses used for prophylaxis, diagnosis, or therapy. The term “side effect” is often used interchangeably with ADR; however, side effects are but one of five ADR categories. The others are hypersensitivity, idiosyncratic response, toxic reactions, and adverse medication interactions. A side effect is an expected, well- known reaction that occurs with a predictable frequency and may or may not rise to the level of being an adverse consequence. “Clinically significant” means effects, results, or consequences that materially affect or are likely to affect an individual’s mental, physical, or psychosocial well-being either positively by preventing, stabilizing, or improving a condition or reducing a risk, or negatively by exacerbating, causing, or contributing to a symptom, illness, or decline in status. “Dose” is the total amount/strength/concentration of a medication given at one time or over a period of time. The individual dose is the amount/strength/concentration received at each administration. The amount received over a 24-hour period may be referred to as the daily dose. “Irregularity” refers to use of medication that is inconsistent with accepted standards of practice for providing pharmaceutical services, not supported by medical evidence, and/or that impedes or interferes with achieving the intended outcomes of pharmaceutical services. An irregularity also includes, but is not limited to, use of medications without adequate indication, without adequate monitoring, in excessive doses, and/or in the presence of adverse consequences, as well as the identification of conditions that may warrant initiation of medication therapy. (See reference to F757 Unnecessary Drugs which defines unnecessary drugs in opening regulatory language.) “Medication Interaction” is the impact of another substance (such as another medication, herbal product, food or substances used in diagnostic studies) upon a medication. The interactions may alter absorption, distribution, metabolism, or elimination. These interactions may decrease the effectiveness of the medication or increase the potential for adverse consequences. “Medication Regimen Review (MRR)” or Drug Regimen Review is a thorough evaluation of the medication regimen of a resident, with the goal of promoting positive outcomes and minimizing adverse consequences and potential risks associated with medication. The MRR includes review of the medical record in order to prevent, identify, report, and resolve medication-related problems, medication errors, or other irregularities. The MRR also involves collaborating with other members of the IDT, including the resident, their family, and/or resident representative. http://www.merckmanuals.com/professional/clinical-pharmacology/adverse-drug-reactions/adverse-drug-reactions http://www.merckmanuals.com/professional/clinical-pharmacology/adverse-drug-reactions/adverse-drug-reactions GUIDANCE §483.45(c)(1), (2), (4), and (5) A. OVERVIEW Many nursing home residents have been identified as being at high risk for adverse consequences related to medications. Some adverse consequences may mimic symptoms of chronic conditions, the aging process, or a newly emerging condition. This guidance is not intended to imply that all adverse consequences related to medications are preventable, but rather to specify that a system exists to assure that medication usage is evaluated on an ongoing basis, that risks and problems are identified and acted upon, and that medication-related problems must be considered when the resident has a change in condition. This guidance will discuss the following aspects of the facility’s MRR component of the pharmaceutical services systems: • A pharmacist’s review of the resident’s medication regimen and medical record to identify and report irregularities; and • Acting upon identified irregularities in order to minimize or prevent adverse consequences, to the extent possible. NOTE: The surveyor’s review of medication use is not intended to constitute the practice of medicine. However, surveyors are expected to investigate the basis for decisions and interventions affecting residents, including whether or not the resident, resident’s family and/or representative were informed about risks, benefits and treatment options and involved in the decision-making process. The review should take into account resident preferences and provide recommendations that assist facility staff in understanding and communicating to the resident any risks related to their preferences regarding medications or medication administration, as well as modifications that can be made to mitigate those risks. Transitions in care such as a move from home or hospital to the nursing home, or vice versa, increase the risk of medication-related issues. Medications may be added, discontinued, omitted, or changed. It is important, therefore, to review the medications. Currently, safeguards to help identify medication issues around transitions in care and throughout a resident’s stay include: • The pharmacist performing the medication regimen review, which includes a review of the resident’s medical record, at least monthly; • The pharmacist reporting any irregularities in a separate written report to the attending physician, medical director, and director of nursing; and • The attending physician reviewing and acting on any identified irregularities. B. MEDICATION REGIMEN REVIEW (MRR) The MRR is an important component of the overall management and monitoring of a resident’s medication regimen. The pharmacist must review each resident’s medication regimen at least once a month in order to identify irregularities and to identify clinically significant risks and/or actual or potential adverse consequences which may result from or be associated with medications. It may be necessary for the pharmacist to conduct the MRR more frequently, for example weekly, depending on the resident’s condition and the risks for adverse consequences related to current medications. Regulations prohibit the pharmacist from delegating the medication regimen reviews to other staff. The requirement for the MRR applies to all residents (whether short or long-stay) without exceptions. The pharmacist performing the monthly MRR must also review the resident’s medical record to appropriately monitor the medication regimen and ensure that the medications each resident receives are clinically indicated. Certain circumstances which may include residents who have multiple medical conditions, concurrent administration of certain medications, administration of medications which require close monitoring through lab work, and transitions of care may also increase the risk of adverse consequences. Review of the medical record as part of the MRR may prevent errors due to drug-drug interactions, omissions, duplication of therapy, or miscommunication during the transition from one team of care providers to another. Facilities must develop policies and procedures to address the MRR. The policies and procedures must specifically address: • The appropriate time frames for the different steps in the MRR process; and • The steps a pharmacist must follow when he or she identifies an irregularity that requires immediate action to protect the resident and prevent the occurrence of an adverse drug event. MRR policies and procedures should also address, but not be limited to: • MRRs for residents who are anticipated to stay less than 30 days; • MRRs for residents who experience an acute change of condition and for whom an immediate MRR is requested after appropriate staff have notified the resident’s physician, the medical director, and the director of nursing about the acute change. While conducting the MRR in the facility is not required for compliance, important information about indications for use, actual or potential medication irregularities or adverse consequences (such as symptoms of tardive dyskinesia, dizziness, anorexia, or falls) may be attainable only by talking to the staff, reviewing the medical record, and observing and speaking with the resident, the resident’s family and/or representative. However, electronic health and medication records and other available technology may permit the pharmacist to conduct some components of the review outside the facility. Electronic transmission of information may enable facilities to quickly communicate resident-specific information to an off-site pharmacy or pharmacist, however, electronic communication must remain secure to protect individually identifiable information as mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996. With secure electronic communication the pharmacist may promptly identify actual or potential medication-related problems before a medication is initiated or soon afterwards. However, brief communication via secure devices to address or prevent immediate or potential problems does not constitute a complete MRR. All information that is needed to perform an MRR may not be available electronically, for example, flow sheets that monitor a resident’s pain or that document other observations or symptoms. Resources are available to facilitate evaluating medication concerns related to the performance of the MRR, such as: • U.S. Department of Health and Human Services, Food and Drug Administration (FDA) http://www.fda.gov/medwatch/safety.htm. • American Society of Consultant Pharmacists (ASCP) http://ascp.com/; • American Medical Directors Association – The Society for Post-Acute and Long- Term Care Medicine (AMDA) http://www.paltc.org/; • National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) http://www.nccmerp.org; • American Geriatrics Society (AGS) http://www.americangeriatrics.org; and NOTE: References to non-CMS sources or sites on the Internet are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services. CMS is not responsible for the content of pages found at these sites. URL addresses were current as of the date of this publication. Identification of Irregularities An objective of the MRR is to try to minimize or prevent adverse consequences by identifying irregularities including, for example: syndromes potentially related to medication therapy, emerging or existing adverse medication consequences (e.g., drug reactions or medication errors). The resident’s record may contain information regarding possible and/or actual medication irregularities. Possible sources to obtain this information include: the medication administration records (MAR); prescribers’ orders; progress, nursing and consultants’ notes; the Resident Assessment Instrument (RAI); laboratory and diagnostic test results, and other sources of information about documented expressions or indications of distress and/or changes in condition. The pharmacist may also obtain information from the Quality Measures/Quality Indicator reports, the attending physician, facility staff, and (as appropriate) from interviewing, assessing, and/or observing the resident. The pharmacist’s review considers factors such as: http://www.fda.gov/medwatch/safety.htm http://ascp.com/ http://www.paltc.org/ http://www.nccmerp.org/ http://www.americangeriatrics.org/ • Whether the physician and staff have documented objective findings, diagnoses, symptom(s), and/or resident goals and preferences to support indications for use; • Whether the physician and staff have identified and acted upon, or should be notified about, the resident’s allergies and/or potential side effects and significant medication interactions; • Whether the medication dose, frequency, route of administration, and duration are consistent with the resident’s condition, manufacturer’s recommendations, and applicable standards of practice; • Whether the physician and staff have documented progress towards, decline from, or maintenance of the resident’s goal(s) for the medication therapy; • Whether the physician and staff have documented any attempts for gradual dose reduction (GDR) or added any non-pharmacological approaches, in an effort to reduce or discontinue a drug; • Whether the physician and staff have obtained and acted upon laboratory results, diagnostic studies, or other measurements (such as bowel function, intake and output) as applicable; • Whether medication errors exist or circumstances exist that make them likely to occur; and • Whether the physician and staff have noted and acted upon possible medication- related causes of recent or persistent changes in the resident’s condition such as worsening of an existing problem or the emergence of new signs or symptoms. Some examples of changes potentially related to medication use that could occur include: o Anorexia and/or unplanned weight loss, or weight gain; o Expressions or indications of distress, or other changes in a resident’s psychosocial status; o Bowel function changes including constipation, ileus, impaction; o Confusion, cognitive decline, worsening of dementia (including delirium); o Dehydration, fluid/electrolyte imbalance; o Excessive sedation, insomnia, or sleep disturbance; o Falls, dizziness, or evidence of impaired coordination; o Headaches, muscle pain, generalized aching or pain; o Rash, pruritus; o Spontaneous or unexplained bleeding, bruising; and o Urinary retention or incontinence. Upon conducting the MRR, the pharmacist may identify and report irregularities in one or more of the following categories: • The use of a medication without identifiable evidence of adequate indications for use, such as, the use of a medication to treat a clinical condition without identifiable evidence that safer alternatives or more clinically appropriate medications have been considered; • The use of homeopathic or herbal options (e.g., St. John’s Wort) that may interfere with the effectiveness of clinically appropriate medications; • The use of an appropriate medication that is not helping attain the intended treatment or resident’s goals because of timing of administration, dosing intervals, sufficiency of dose, techniques of administration, or other reasons; • The use of a medication in an excessive dose (including duplicate therapy) or for excessive duration, thereby placing the resident at greater risk for adverse consequences or causing existing adverse consequences; • The presence of an adverse consequence associated with the resident’s current medication regimen; • The use of a medication without evidence of adequate monitoring; i.e., either inadequate monitoring of the response to a medication or an inadequate response to the findings; • Presence of medication errors or the risk for such errors; • Presence of a clinical condition that might warrant initiation of medication therapy; and NOTE: The presence of a diagnosis or symptom does not necessarily warrant medication, but often depends on the consideration of many factors simultaneously. • A medication interaction associated with the current medication regimen. NOTE: Concomitant use of certain medication combinations is not necessarily inappropriate. Often, several medications with documented interactions can be given together safely. However, concomitant use of certain medications warrants careful consideration of potential alternatives, possible need to modify doses, and diligent monitoring. Websites for organizations such as AMDA - The Society for Post-Acute and Long-Term Care Medicine (American Medical Directors Association) have made information available regarding problematic medication interactions in the long-term care population: • https://www.amda.com/tools/clinical/m3/topten.cfm; and • https://www.crediblemeds.org/healthcare-providers/drug-drug-interaction, Woosley, RL and Romero, KA, www.Crediblemeds.org, QTdrugs List, [Accessed March6, 2017], AZCERT, Inc. 1822 Innovation Park Dr., Oro Valley, AZ 85755. NOTE: References to non-CMS sources do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services and were current as of the date of this publication. Location and Notification of Medication Regimen Review Findings The pharmacist is expected to document either that no irregularity was identified or the nature of any identified irregularities. The pharmacist is responsible for reporting any identified irregularities to the attending physician, the facility’s medical director, and director of nursing. The timeliness of notification of irregularities depends on factors including the potential for or presence of serious adverse consequences; for example, https://www.amda.com/tools/clinical/m3/topten.cfm https://www.crediblemeds.org/healthcare-providers/drug-drug-interaction http://www.crediblemeds.org/ immediate notification is indicated in cases of bleeding in a resident who is receiving anticoagulants or in cases of possible allergic reactions to antibiotic therapy. The pharmacist must document any identified irregularities in a separate, written report. The report may be in paper or electronic form. If no irregularities were identified during the review, the pharmacist includes a signed and dated statement to that effect. The pharmacist does not need to document a continuing irregularity in the report each month if the attending physician has documented a valid clinical rationale for rejecting the pharmacist’s recommendation unless warranted by a change in the resident’s condition or other circumstances. The pharmacist’s findings are considered part of each resident’s medical record and as such are available to the resident/representative upon request. If documentation of the findings is not in the active record, it is maintained within the facility and is readily available for review. Establishing a consistent location for the pharmacist’s findings and recommendations can facilitate communication with the attending physician, the director of nursing, the remainder of the IDT, the medical director, the resident and his or her legal representative, the ombudsman, and surveyors. Response to Irregularities Identified in the MRR The medical record must show documentation that the attending physician reviewed any irregularities identified by the pharmacist. For those issues that require physician intervention, the attending physician either accepts and acts upon the report and recommendations or rejects all or some of the report and should document his or her rationale of why the recommendation is rejected in the resident’s medical record. It is not acceptable for an attending physician to document only that he/she disagrees with the report, without providing some clinical basis for disagreeing. The facility should have a procedure for how to resolve situations where: • The attending physician does not concur with or take action on identified irregularities, and; • The attending physician is also the medical director. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F756, the surveyor’s investigation will generally show that: • The MRR was not conducted by a licensed pharmacist; or • The pharmacist failed to conduct a complete MRR, at least monthly (or more frequently, as indicated by the resident’s condition) for every resident of the facility; or • The pharmacist’s findings in the MRR did not show evidence that the pharmacist also reviewed the resident’s chart, for example, the pharmacist did not reference the resident response to a particular medication that was cited as an irregularity; or • The pharmacist failed to identify or report the absence of or inadequate indications for use of a medication, or a medication or medication combination with significant potential for adverse consequences or medication interactions; or • The pharmacist failed to identify and/or report medications prescribed or administered in excessive dose (including but not limited to duplicate therapy); or • The pharmacist failed to identify and/or report medications prescribed or administered for excessive duration; or • The pharmacist failed to identify and/or report medications prescribed or administered without adequate monitoring; or • The pharmacist failed to identify or report medications in a resident’s regimen that could (as of the review date) be causing or associated with new, worsening, or progressive signs and symptoms; or • The pharmacist failed to identify and report the absence of any explanation as to why or how the benefit of a medication(s) with potential for clinically significant adverse consequences outweighs the risk; or • The attending physician failed to document that he or she reviewed the pharmacist’s identified irregularities and/or failed to document the action taken or not taken to address the irregularities; or • The facility failed to develop, maintain, and implement policies and procedures which address the time frames for the steps in the MRR process; or • The facility failed to develop and implement policies and procedures which address steps the pharmacist must take when he or she identifies an irregularity that requires urgent action to protect the resident. PROCEDURE Use the Unnecessary Medications, Psychotropic Medications, and Medication Regimen Review Critical Element Pathway, as appropriate, along with the above interpretive guidelines when determining if the facility meets the requirements for, or investigating concerns related to Medication Regimen Review. DEFICIENCY CATEGORIZATION In addition to actual or potential physical harm, always consider whether psychosocial harm has occurred when determining severity level (See Appendix P, Section IV, E, Psychosocial Outcome Severity Guide). Examples of noncompliance that demonstrate severity at Level 4 include, but are not limited to: • Despite identifying irregularities with the potential for serious harm or death in a resident’s medication regimen, the pharmacist did not report the irregularities to the attending physician, DON, and medical director or action was not taken on the irregularities reported. • On the MRR, the pharmacist identified that a resident was prescribed an antipsychotic medication without a clinical indication. This placed the resident at likely risk for harm such as experiencing a fall, mental status changes, or sustained negative psychosocial outcomes. The medical record did not show evidence that the attending physician had reviewed and responded to the identified irregularity. Examples of Level 3, Actual harm (physical or psychosocial) that are not immediate jeopardy, include, but are not limited to: • The pharmacist’s MRR failed to identify the indication for continued use for opioid analgesics that had been prescribed for a resident’s acute pain which had resolved. As a result of prolonged duration of use, the resident continued to be or became more lethargic and/or withdrawn. • The pharmacist’s MRR identified that the staff were crushing medications that should not be crushed. As a result of facility failure to act upon the notification, the resident experienced clinically significant adverse consequences such as hypoglycemia or hypotension that required medical intervention. • The attending physician failed to act in response to the pharmacist’s MRR which identified the indefinite continuation of an antidepressant in a resident who had no history of depression, who had been placed on the antidepressant without an evaluation to confirm presence of depression, and whose function and mood were not monitored while getting the medication for months. The resident experienced clinically significant adverse consequences such as falls without serious injury, constipation, or change in weight. Examples of Level 2, No actual harm with a potential for more than minimal harm that is not immediate jeopardy, may include but are not limited to: • The facility failed to respond to the pharmacist’s notification that the resident was not receiving an over-the-counter (OTC) dietary supplement that had been prescribed. Currently, there was no change in the resident’s condition, such as a weight loss. • The pharmacist’s MRR failed to evaluate and report on the potential adverse consequences of a medication that may increase the possible side effects of another clinically appropriate medication that had been prescribed. The resident had not yet experienced side effects from the combined medications. Severity Level 1 Considerations: No Actual Harm with Potential for Minimal Harm Severity Level 1 does not apply for this regulatory requirement because the failure to perform the MRR according to the regulatory provisions creates the potential for more than minimal harm. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION Examples of some of the related requirements that should be considered when concerns have been identified include the following: • 42 CFR §483.10(g)(14), F580, Notification of Changes o Review whether a member of the IDT contacted the attending physician regarding a significant change in the resident’s condition in relation to a potential adverse consequence of a medication, or a need to alter treatment significantly (i.e., a need to discontinue an existing form of treatment due to adverse consequences, or to commence a different form of treatment). • 42 CFR §483.45(d), F757, Unnecessary Drugs and 42 CFR §483.45(e), F758, Psychotropic Medications o Review whether the resident is receiving any medications without an indication for use, in excessive dose or duration, with inadequate monitoring, or in the presence of any adverse consequences that indicate that the dose should be reduced or discontinued. • 42 CFR §483.30(a), F710, Physician Supervision o Review whether the attending physician supervised the resident’s medical treatment, including assessing the resident’s condition, identifying the need for and continuing use of medication to address the resident’s needs, and identifying and addressing adverse consequences related to medications. • 42 CFR §483.30(b), F711 Physician Visits and 42 CFR §483.30(c), F712, Frequency of Physician Visits o Review whether the attending physician or another designated practitioner reviewed the resident’s total program of care including the beneficial and adverse effects of medications and treatment, and provided a relevant progress note at each visit. • 42 CFR §483.45(a), (b)(1)-(3), F755, Pharmacy Services o Review whether the licensed pharmacist has provided consultation regarding all aspects of pharmaceutical services. • 42 CFR §483.70(g), F841, Medical Director o Review whether the medical director, when requested by the facility, interacted with the attending physician regarding an inadequate response to identified or reported potential medication irregularities and adverse consequences. F757 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.45(d) Unnecessary Drugs—General. Each resident’s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used— §483.45(d)(1) In excessive dose (including duplicate drug therapy); or §483.45(d)(2) For excessive duration; or §483.45(d)(3) Without adequate monitoring; or §483.45(d)(4) Without adequate indications for its use; or §483.45(d)(5) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or §483.45(d)(6) Any combinations of the reasons stated in paragraphs (d)(1) through (5) of this section. F758 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.45(c)(3) A psychotropic drug is any drug that affects brain activities associated with mental processes and behavior. These drugs include, but are not limited to, drugs in the following categories: (i) Anti-psychotic; (ii) Anti-depressant; (iii) Anti-anxiety; and (iv) Hypnotic. §483.45(e) Psychotropic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that-- §483.45(e)(1) Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record; §483.45(e)(2) Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs; §483.45(e)(3) Residents do not receive psychotropic drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record; and §483.45(e)(4) PRN orders for psychotropic drugs are limited to 14 days. Except as provided in §483.45(e)(5), if the attending physician or prescribing practitioner believes that it is appropriate for the PRN order to be extended beyond 14 days, he or she should document their rationale in the resident’s medical record and indicate the duration for the PRN order. §483.45(e)(5) PRN orders for anti-psychotic drugs are limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication. INTENT: (F757) §483.45(d) Unnecessary drugs and (F758) §483.45(c)(3) and (e)Psychotropic Drugs The intent of these requirements is that: • each resident’s entire drug/medication regimen is managed and monitored to promote or maintain the resident’s highest practicable mental, physical, and psychosocial well-being; • the facility implements gradual dose reductions (GDR) and non-pharmacological interventions, unless contraindicated, prior to initiating or instead of continuing psychotropic medication; and • PRN orders for psychotropic medications are only used when the medication is necessary and PRN use is limited. NOTE: For concerns related to unnecessary medications, excluding psychotropic medications, surveyors should assess compliance with §483.45(d), F757. For concerns related to psychotropic medications only, including the unnecessary medication requirements, surveyors should assess compliance with §§483.45(c) and (e), F758. The Guidance for these two tags is combined to avoid unnecessary duplication. Although the regulatory language refers to “drugs,” the guidance in this document generally will refer to “medications,” except in those situations where the term “drug” has become part of an established pharmaceutical term (e.g., adverse drug event, and adverse drug reaction or consequence). For purposes of this guidance, references to “the pharmacist” mean the facility’s licensed pharmacist, whether employed directly by the facility or through arrangement. The surveyor’s review of medication use is not intended to constitute the practice of medicine. However, surveyors are expected to investigate the basis for decisions and interventions affecting residents. DEFINITIONS (F757) §483.45 (d) Unnecessary Drugs and (F758) §483.45(c)(3) and (e) Psychotropic Drugs Definitions are provided to clarify terminology related to medications and to the evaluation and treatment of residents. “Adverse consequence” is a broad term referring to unwanted, uncomfortable, or dangerous effects that a drug may have, such as impairment or decline in an individual’s mental or physical condition or functional or psychosocial status. It may include various types of adverse drug reactions and interactions (e.g., medication-medication, medication-food, and medication-disease) (adapted from The Merck Manual Professional Version, http://www.merckmanuals.com/professional/clinical-pharmacology/adverse- drug-reactions/adverse-drug-reactions.) NOTE: Adverse drug reaction (ADR) is a form of adverse consequences. It may be either a secondary effect of a medication that is usually undesirable and different from the therapeutic effect of the medication or any response to a medication that is noxious and unintended and occurs in doses for prophylaxis, diagnosis, or treatment. The term “side effect” is often used interchangeably with ADR; however, side effects are but one of five ADR categories, the others being hypersensitivity, idiosyncratic response, toxic reactions, and adverse medication interactions. A side effect is an expected, well-known reaction that occurs with a predictable frequency and may or may not constitute an adverse consequence. “Anticholinergic side effect” is an effect of a medication that opposes or inhibits the activity of the parasympathetic (cholinergic) nervous system to the point of causing symptoms such as dry mouth, blurred vision, tachycardia, urinary retention, constipation, confusion, delirium, hallucinations, flushing, and increased blood pressure. Types of medications that may produce anticholinergic side effects include: • Antihistamines, antidepressants, anti-psychotics, antiemetics, muscle relaxants; and • Certain medications used to treat cardiovascular conditions, Parkinson’s disease, urinary incontinence, gastrointestinal issues and vertigo. “Behavioral interventions” are individualized, non-pharmacological approaches to care that are provided as part of a supportive physical and psychosocial environment, directed toward understanding, preventing, relieving, and/or accommodating a resident’s distress or loss of abilities, as well as maintaining or improving a resident’s mental, physical or psychosocial well-being. “Clinically significant” refers to effects, results, or consequences that materially affect or are likely to affect an individual’s mental, physical, or psychosocial well-being either positively by preventing, stabilizing, or improving a condition or reducing a risk, or negatively by exacerbating, causing, or contributing to a symptom, illness, or decline in status. “Dose” is the total amount/strength/concentration of a medication given at one time or over a period of time. The individual dose is the amount/strength/concentration received at each administration. The amount received over a 24-hour period may be referred to as the daily dose. “Duplicate therapy” refers to multiple medications of the same pharmacological class/category or any medication therapy that substantially duplicates a particular effect of another medication that the individual is taking. “Excessive dose” means the total amount of any medication (including duplicate therapy) given at one time or over a period of time that is greater than the amount recommended by the manufacturer’s label, package insert, and accepted standards of practice for a resident’s age and condition. “Expressions or indications of distress” refers to a person’s attempt to communicate unmet needs, discomfort, or thoughts that he or she may not be able to articulate. The expressions may present as crying, apathy, or withdrawal, or as verbal or physical actions such as: pacing, cursing, hitting, kicking, pushing, scratching, tearing things, or grabbing others. “Extrapyramidal symptoms (EPS)” are neurological side effects that can occur at any time from the first few days of treatment with antipsychotic medication to years later. EPS includes various syndromes such as: • Akathisia, which refers to a distressing feeling of internal restlessness that may appear as constant motion, the inability to sit still, fidgeting, pacing, or rocking. • Medication-induced Parkinsonism, which refers to a syndrome of Parkinson-like symptoms including tremors, shuffling gait, slowness of movement, expressionless face, drooling, postural unsteadiness and rigidity of muscles in the limbs, neck and trunk. • Dystonia, which refers to an acute, painful, spastic contraction of muscle groups (commonly the neck, eyes and trunk) that often occurs soon after initiating treatment and is more common in younger individuals. “Gradual Dose Reduction (GDR)” is the stepwise tapering of a dose to determine if symptoms, conditions, or risks can be managed by a lower dose or if the dose or medication can be discontinued. “Indications for use” is the identified, documented clinical rationale for administering a medication that is based upon an assessment of the resident’s condition and therapeutic goals and is consistent with manufacturer’s recommendations and/or clinical practice guidelines, clinical standards of practice, medication references, clinical studies or evidence-based review articles that are published in medical and/or pharmacy journals. “Neuroleptic Malignant Syndrome (NMS)” is a syndrome related to the use of medications, mainly antipsychotics, that typically presents with a sudden onset of diffuse muscle rigidity, high fever, labile blood pressure, tremor, and notable cognitive dysfunction. It is potentially fatal if not treated immediately, including stopping the offending medications. “Psychotropic drug” is defined in the regulations at §483.45(c)(3), as “any drug that affects brain activities associated with mental processes and behavior.” Psychotropic drugs include, but are not limited to the following categories: anti-psychotics, anti- depressants, anti-anxiety, and hypnotics. “Serotonin Syndrome” is a potentially serious clinical condition resulting from overstimulation of serotonin receptors. It is commonly related to the use of multiple serotonin-stimulating medications (e.g., SSRIs, SNRIs, triptans, certain antibiotics). Symptoms may include restlessness, hallucinations, confusion, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea. “Tardive dyskinesia” refers to abnormal, recurrent, involuntary movements that may be irreversible and typically present as lateral movements of the tongue or jaw, tongue thrusting, chewing, frequent blinking, brow arching, grimacing, and lip smacking, although the trunk or other parts of the body may also be affected. GUIDANCE (F757) §483.45(d) Unnecessary Drugs and (F758) §483.45(c)(3) and (e) Psychotropic Drugs Medications are an integral part of the care provided to residents of nursing facilities. They are administered to try to achieve various outcomes, such as curing an illness, arresting or slowing a disease process, reducing or eliminating symptoms, or as part of diagnosing or preventing a disease or symptom. Proper medication selection and prescribing (including dose, duration, and type of medication(s)) may help stabilize or improve a resident’s outcome, quality of life and functional capacity. Any medication or combination of medications—or the use of a medication without adequate indications, in excessive dose, for an excessive duration, or without adequate monitoring—may increase the risk of a broad range of adverse consequences such as medication interactions, depression, confusion, immobility, falls, hip fractures, and death. The Beers Criteria for Potentially Inappropriate Medication Use in Older Adults provides information on safely prescribing medications for older adults, http://www.healthinaging.org/medications-older-adults/. NOTE: References to non-CMS sources do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services and were current as of the date of this publication. Intrinsic factors including physiological changes accompanying the aging process, multiple comorbidities, and certain medical conditions may affect the absorption, http://www.healthinaging.org/medications-older-adults/ distribution, metabolism or elimination of medications from the body and may also increase an individual’s risk of adverse consequences. While assuring that only those medications required to treat the resident’s assessed condition are being used, reducing the need for and maximizing the effectiveness of medications are important considerations for all residents. Therefore, as part of all medication management (especially psychotropic medications), it is important for the IDT to implement non-pharmacological approaches designed to meet the individual needs of each resident. Educating facility staff and providers about the importance of implementing individualized, non-pharmacological approaches to care prior to the use of medications may minimize the need for medications or reduce the dose and duration of those medications. Additional information as well as examples of non-pharmacological interventions may be found in other guidance for regulations at (F741) §483.40, Behavioral Health Services and (F679) §483.24, Quality of Life. The indications for initiating, withdrawing, or withholding medication(s), as well as the use of non-pharmacological approaches, are determined by assessing the resident’s underlying condition, current signs, symptoms, and expressions, and preferences and goals for treatment. This includes, where possible, the identification of the underlying cause(s), since a diagnosis alone may not warrant treatment with medication. Orders from multiple prescribers or providers can increase the resident’s chances of receiving unnecessary medications. Staff and practitioner access to current medication references and pertinent clinical protocols helps to promote safe administration and monitoring of medications. One of the existing mechanisms to warn prescribers about risks associated with medications is the Food and Drug Administration (FDA) requirement that manufacturers include within the medication labeling warnings about adverse reactions and potential safety hazards identified both before and after approval of a medication, and what to do if they occur (Visit: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event- reporting-program or search for “FDA Safety Alerts for Human Medical Products.”. Manufacturers are required to update labels to warn about newly identified safety hazards—regardless of whether causation has been proven and whether the medication is prescribed for a disease or condition that is not included in the “Indications and Usage” section of the labeling (so-called “off-label” or unapproved use). Federal regulations at 21 CFR 201.57 (a)(4) and (c)(1) also require manufacturers to place statements about serious problems or contraindications in a prominently displayed box that appears on the medication labelling and in greater detail in the full prescribing information that accompanies the medication. The boxed warning is reserved for prescription drugs that pose a significant risk of serious or life-threatening adverse effects, based on medical studies. The facility’s pharmacist is a valuable source of information about medications. Listings or descriptions of most significant risks, recommended doses, medication interactions, cautions, etc. can be found in widely available, standard references, and computer software and systems that provide up-to-date information. It is important to note that https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program some of the medication information found in many of these references is not specific to older adults or individuals residing in nursing homes. A list of resources and tools is provided at the end of this guidance. MEDICATION MANAGEMENT Medication management is based in the care process and includes recognition or identification of the problem/need, assessment, diagnosis/cause identification, management/treatment, monitoring, and revising interventions, as warranted as well as documenting medication management steps. The attending physician plays a key leadership role in medication management by developing, monitoring, and modifying the medication regimen in conjunction with residents, their families, and/or representative(s) and other professionals and direct care staff (the IDT). When selecting medications and non-pharmacological approaches, members of the IDT, including the resident, his or her family, and/or representative(s), participate in the care process to identify, assess, address, advocate for, monitor, and communicate the resident’s needs and changes in condition. This guidance is intended to help the surveyor determine whether the facility’s medication management supports and promotes: • Involvement of the resident, his or her family, and/or the resident representative in the medication management process. • Selection of medications(s) based on assessing relative benefits and risks to the individual resident; • Evaluation of a resident’s physical, behavioral, mental, and psychosocial signs and symptoms, in order to identify the underlying cause(s), including adverse consequences of medications; • Selection and use of medications in doses and for the duration appropriate to each resident’s clinical conditions, age, and underlying causes of symptoms and based on assessing relative benefit and risks to, and preferences and goals of, the individual resident; • The use of non-pharmacological approaches, unless contraindicated, to minimize the need for medications, permit use of the lowest possible dose, or allow medications to be discontinued; and • The monitoring of medications for efficacy and adverse consequences. • Resident Choice –If a resident declines treatment, the facility staff and physician should inform the resident about the risks related to the lack of the medication, and discuss appropriate alternatives such as offering the medication at another time or in another dosage form, or offer an alternative medication or non- pharmacological approach. • Advance Directives – A resident’s advance directives may include withdrawing or withholding medications. Whether or not a resident has an advance directive, the facility is responsible for giving treatment, support, and other care that is consistent with the resident’s condition and applicable care instructions, according to the resident’s care plan. If there are concerns regarding Resident Choice or Advance Directives, consider investigating the requirements at §483.10, Resident Rights and §483.21, Care Planning. The resident’s medical record documents and communicates to the entire team the basic elements of the care process and the resident’s goals and preferences. Information about aspects of the care process related to medications may be found in various locations within the record, such as: hospital discharge summaries and transfer notes, progress notes and interdisciplinary notes, history and physical examination, Resident Assessment Instrument (RAI), plan of care, laboratory reports, professional consults, medication orders, Medication Regimen Review (MRR) reports, and Medication Administration Records (MAR). The regulations associated with medication management include consideration of: • Indication and clinical need for medication; • Dose (including duplicate therapy); • Duration; • Adequate monitoring for efficacy and adverse consequences; and • Preventing, identifying, and responding to adverse consequences. With regard to psychotropic medications, the regulations additionally require: • Giving psychotropic medications only when necessary to treat a specific diagnosed and documented condition; • Implementing GDR and other non-pharmacologic interventions for residents who receive psychotropic medications, unless contraindicated; and • Limiting the timeframe for PRN psychotropic medications, which are not antipsychotic medications, to 14 days, unless a longer timeframe is deemed appropriate by the attending physician or the prescribing practitioner. • Limiting PRN psychotropic medications, which are antipsychotic medications, to 14 days and not entering a new order without first evaluating the resident. NOTE: While there may be isolated situations where a pharmacological intervention is required first, these situations do not negate the obligation of the facility to develop and implement non-pharmacological interventions. For additional information related to situations where a non-pharmacological intervention may be contraindicated, refer to §483.40(a)(2), Implementing non-pharmacological interventions. Indication for Use The resident’s medical record must show documentation of adequate indications for a medication’s use and the diagnosed condition for which a medication is prescribed. An evaluation of the resident by the IDT helps to identify his/her needs, goals, comorbid conditions, and prognosis to determine factors (including medications and new or worsening medical conditions) that are affecting signs, symptoms, and test results. This evaluation process is important when selecting initial medications and/or non- pharmacological approaches and when deciding whether to modify or discontinue a current medication. The evaluation also clarifies: • Whether other causes for the symptoms (including expressions or indications of distress that could mimic a psychiatric disorder) have been ruled out; • Whether the physical, mental, behavioral, and/or psychosocial signs, symptoms, or related causes are persistent or clinically significant enough (e.g., causing functional decline) to warrant the initiation or continuation of medication therapy; • Whether non-pharmacological approaches are implemented, unless clinically contraindicated for the resident or declined by the resident; • Whether a particular medication is clinically indicated to manage the symptom or condition; and • Whether the intended or actual benefit is understood by the resident and, if appropriate, his/her family and/or representative(s) and is sufficient to justify the potential risk(s) or adverse consequences associated with the selected medication, dose, and duration. The content and extent of the evaluation may vary with the situation and may employ various assessment instruments and diagnostic tools. Examples of information to be considered and evaluated may include, but are not limited to, the following: • An appropriately detailed evaluation of mental, physical, psychosocial, and functional status, including comorbid conditions and pertinent psychiatric symptoms and diagnoses and a description of resident complaints, symptoms, and signs (including the onset, scope, frequency, intensity, precipitating factors, and other important features); • Each resident’s goals and preferences; • Allergies to medications and foods and potential for medication interactions; • A history of prior and current medications and non-pharmacological interventions (including therapeutic effectiveness and any adverse consequences); • Recognition of the need for end-of-life or palliative care; and • The basis for declining care, medication, and treatment and the identification of pertinent alternatives. • Documentation of indications of distress, delirium, or other changes in functional status. Circumstances that warrant evaluation of the resident and medication(s) include: • Admission or re-admission; • A clinically significant change in condition/status; • A new, persistent, or recurrent clinically significant symptom or problem; • A worsening of an existing problem or condition; • An unexplained decline in function or cognition; • A new medication order or renewal of orders; and • An irregularity identified in the pharmacist’s medication regimen review. See F756 for guidance related to the medication regimen review. • Orders for PRN psychotropic and/or antipsychotic medications which are not prescribed to treat a diagnosed specific condition or do not meet the PRN requirements for psychotropic and antipsychotic medications. Specific considerations related to these circumstances may include the following: • Admission (or Readmission) – Some residents may be admitted on medications for an undocumented chronic condition or without a clear indication as to why a medication was begun or should be continued. It is expected that the attending physician, pharmacist, and staff subsequently determine if continuing the medication is justified by evaluating the resident’s clinical condition, risks, existing medication regimen, preferences, goals, and related factors. • Multiple prescribers – Regardless of who the prescribers are, the continuation of a medication needs to be evaluated to determine if the medication is still warranted in the context of the resident’s other medications and comorbidities. Medications prescribed by a specialist or begun in another care setting, such as the hospital, need to have a clinically pertinent documented rationale in the resident’s medical record. • New medication order as an emergency measure – When a resident is experiencing an acute medical problem or psychiatric emergency (e.g., the resident’s expression or action poses an immediate risk to the resident or others), medications may be required. In these situations, it is important to identify and address the underlying causes of the problem or symptoms. Once the acute phase has stabilized, the staff and prescriber consider whether medications are still relevant. Subsequently, the medication is reduced or discontinued as soon as possible or the clinical rationale for continuing the medication is documented. If the new medication is a psychotropic or antipsychotic medication ordered on a PRN basis, the PRN order(s) must be consistent with the requirements for PRN use of psychotropic and antipsychotic medications at §483.45(e)(3), (4), and (5). When psychopharmacological medications are used as an emergency measure, adjunctive approaches, such as individualized, non-pharmacological approaches and techniques must be implemented. Longer term management options should be discussed with the resident, their family, and/or representative(s). • Psychiatric disorders or expressions and/or indications of distress – As with all symptoms, it is important to seek the underlying cause of the distress. Some examples of potential causes include delirium, pain, psychiatric or neurological illness, environmental or psychological stressors, dementia, or substance intoxication or withdrawal. Non-pharmacologic approaches, unless clinically contraindicated, must be implemented to address expressions or indications of distress. However, medications may be effective when the underlying cause of a resident’s distress has been determined, non-pharmacologic approaches to care have been ineffective, or expressions of distress have worsened. Medications may be unnecessary and are likely to cause harm when given without a clinical indication, at too high of a dose, for too long after the resident’s distress has been resolved, or if the medications are not monitored. All approaches to care, including medications, need to be monitored for efficacy, risks, benefits, and harm and revised as necessary. NOTE: Permission given by or a request made by the resident and/or representative does not serve as a sole justification for the medication itself. Dose Medications are prescribed based on a variety of factors including the resident’s diagnoses, signs and symptoms, current condition, age, coexisting medication regimen, review of lab and other test results, input from the IDT about the resident, including the resident’s preferences and goals, the type of medication(s), and therapeutic goals being considered or used. The route of administration influences a medication’s absorption and ultimately the dose received. Examples of factors that can affect the absorption of medications delivered by transdermal patches include skin temperature and moisture, and the integrity of the patch. Similarly, the flow rate of intravenous solutions affects the amount received at a given time. Duplicate therapy is generally not indicated, unless current clinical standards of practice and documented clinical rationale confirm the benefits of multiple medications from the same class or with similar therapeutic effects. Some examples of potentially problematic duplicate therapy include use of more than one product containing the same medication, concomitant use of drugs within the same class, or medications from different therapeutic categories with similar effects or properties. Additionally, the risk for duplication is particularly high during transitions of care, especially if medications are not tracked closely between locations or within the care settings. Documentation is necessary to clarify the rationale for and benefits of duplicate therapy and the approach to monitoring for benefits and adverse consequences. Duration Periodic re-evaluation of the medication regimen is necessary to determine whether prolonged or indefinite use of a medication is indicated. The clinical rationale for continued use of a medication(s) may have been demonstrated in the clinical record, or the staff and prescriber may present pertinent clinical reasons for the duration of use. Regarding PRN medications, it is important that the medical record include documentation related to the attending physician’s or other prescriber’s evaluation of the resident and of indication(s), specific circumstance(s) for use, and the desired frequency of administration for each medication. As part of the evaluation, gathering and analyzing information helps define clinical indications and provide baseline data for subsequent monitoring. Common considerations for appropriate duration may include: • A medication initiated as a result of a time-limited condition (for example, delirium, pain, infection, nausea and vomiting, cold and cough symptoms, or itching) is then discontinued when the condition has resolved, or there is documentation indicating why continued use is still relevant. Failure to review whether the underlying cause has resolved may lead to excessive duration. • A medication administered beyond the stop date established by the prescriber, without evidence of clinical justification for continued use of the medication, may be considered excessive duration. • A medication, which is prescribed on a PRN basis, is requested by the resident and/ or/administered by staff on a regular basis, indicating a more regular schedule or other change in medication regimen may be needed. Monitoring for Efficacy and Adverse Consequences The information gathered during the initial and ongoing evaluations and through conversations with the resident and, as appropriate, his or her family or representative is essential to: • Verify or differentiate the underlying diagnoses or other underlying causes of signs and symptoms. • Incorporate into a comprehensive care plan that reflects person-centered medication related goals and parameters for monitoring the resident’s condition, including the likely medication effects and potential for adverse consequences. Examples of this information may include the FDA boxed warnings or warnings of adverse consequences that may be rare, but have sudden onset, or that may be irreversible. If the facility has established protocols for monitoring specific medications and the protocols are accessible for staff use, the care plan may refer staff to these protocols; • Optimize the therapeutic benefit of medication therapy and minimize or prevent potential adverse consequences; • Establish parameters for evaluating the ongoing need for the medication; and • Track progress and/or decline towards the therapeutic goal. Sources of information to facilitate defining the monitoring criteria or parameters may include cautions, warnings, and identified adverse consequences from: • Manufacturers’ package inserts and boxed warnings; • Facility policies and procedures; • Pharmacists; • Clinical practice guidelines or clinical standards of practice; • Medication references; and • Clinical studies or evidence-based review articles that are published in medical and/or pharmacy journals. Monitoring and accurate documentation of the resident’s response to any medication(s) is essential to evaluate the ongoing benefits as well as risks of various medications. Monitoring should also include evaluation of the effectiveness of non-pharmacological approaches, such as prior to administering PRN medications. Monitoring involves several steps, including: • Identifying the essential information and how it will be obtained and reported-- It is important to consider who is responsible for obtaining the information, which information should be collected, and how the information will be documented. The information that is collected depends on therapeutic goals, detection of potential or actual adverse consequences, and consideration of risk factors, such as: o Medication-medication, medication-food interactions; o Clinical condition (for example renal disease); o Properties of the medication; o Boxed warnings; and o Resident’s history of adverse consequences related to a similar medication. • Determining the frequency of monitoring-- The frequency and duration of monitoring needed to identify therapeutic effectiveness, achievement of resident goals, and adverse consequences will depend on factors such as clinical standards of practice, facility policies and procedures, manufacturer’s specifications, and the resident’s clinical condition and choices. Monitoring involves three aspects: o Periodic planned evaluation of progress toward the therapeutic goals; o Continued vigilance for adverse consequences; and o Evaluation of identified adverse consequences. • Defining the methods for communicating, analyzing, and acting upon relevant information-- The monitoring process needs to identify who is to communicate with the prescriber, what information is to be conveyed, and when to ask the prescriber to evaluate and consider modifying the medication regimen. • If the therapeutic goals are not being met or the resident is experiencing adverse consequences, it is essential for the prescriber in collaboration with facility staff, the pharmacist, and the resident to consider whether current medications and doses continue to be appropriate or should be reduced, changed, or discontinued. Serum concentration monitoring may be necessary for some medications. Abnormal or toxic serum concentrations must be evaluated for dosage adjustments. If serum concentrations are within normal ranges, each resident should still be evaluated for effectiveness and side effects. • Re-evaluating and updating monitoring approaches-- Modification of monitoring may be necessary when the resident experiences changes, such as: o Acute onset of signs or symptoms or worsening of chronic disease; o Addition or discontinuation of medications and/or non-pharmacological approaches, for example, a resident who takes warfarin regularly starts on a medication that interacts with warfarin, therefore more frequent blood work may be needed; o Addition or discontinuation of care and services such as enteral feedings; and o Significant changes in diet that may affect medication absorption or effectiveness or increase adverse consequences. Additional examples of circumstances that may indicate a need to modify the monitoring include: changes in manufacturer’s specifications, FDA warnings, pertinent clinical practice guidelines, or other literature about how and what to monitor. Adverse consequences related to medications are common enough to warrant serious attention and close monitoring. An HHS Office of the Inspector General (OIG) report released in February 2014 found approximately one in five SNF residents experienced at least one adverse event during their SNF stay. Thirty-seven percent of these events were related to medications and were often preventable. See the full report, “Adverse Events in Skilled Nursing Facilities: National Incidence among Medicare Beneficiaries” at http://oig.hhs.gov/oei/reports/oei-06-11-00370 . Some adverse consequences may be avoided by: • Following relevant clinical guidelines and manufacturer’s specifications for use, dose, administration, duration, and monitoring of the medication; • Defining appropriate indications for use; • Determining that the resident: o Has no known allergies to the medication; o Is not taking other medications, nutritional supplements including herbal products, or foods that would be incompatible with the prescribed medication; and o Has no condition, history, or sensitivities that would preclude use of that medication. • Responding to the resident’s reported experience with medications and treatments they have received. The risk for adverse consequences increases with both the number of medications being taken regularly and with medications from specific pharmacological classes, such as anticoagulants, diuretics, psychotropic medications, anti-infectives, and anticonvulsants.1 Adverse consequences can range from minimal harm to functional decline, hospitalization, permanent injury, and death. Use of a tool, such as the CMS Adverse Drug Event Trigger Tool, may assist in identifying resident risk factors and triggers for http://oig.hhs.gov/oei/reports/oei-06-11-00370 adverse drug events as well as in determining whether a facility has systems and processes in place to minimize risk factors and mitigate harm to residents. The tool is available on the CMS Nursing Home Quality Assurance and Performance Improvement website, https://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/QAPI/Downloads/Adverse-Drug-Event-Trigger-Tool . Additionally, as part of a facility’s QAPI program, a facility may track its use of certain classes of medications, such as antipsychotics, through reports from the long-term care pharmacist which could identify trends and reduce adverse events. One common adverse consequence is delirium, which presents as an alteration in attention and awareness associated with a change in cognition not explained by a current or emerging neurocognitive disorder. Delirium may result from medications as well as other factors including electrolyte imbalances or infections. While delirium is not always preventable, identifying and addressing risk factors may reduce the occurrence. In many facilities, a majority of the residents have dementia. Individuals who have dementia may be more sensitive to medication effects and may be at greater risk for delirium.2 Delirium may go undiagnosed, be misinterpreted as dementia, or misdiagnosed as a psychiatric disorder, such as bipolar disorder. Delirium develops rapidly over a short period of time, such as hours or days, and usually follows a fluctuating course throughout the day. Additionally, the resident may have difficulty paying attention and be less aware of his or her surroundings. Delirium can be characterized as hyperactive (e.g., extreme restlessness, climbing out of bed), hypoactive (e.g., sluggish and lethargic), or mixed (e.g., normal level of activity with lowered awareness). Delirium is particularly common post-hospitalization; signs and symptoms may be subtle and therefore are often missed. Although generally thought to be short lived, delirium can persist for months. Recognizing delirium is critical, as failure to act quickly to identify and treat the underlying causes may result in poor health outcomes or death. Negative psychosocial outcomes can also occur in relation to unnecessary medications, including psychotropic medications. These adverse consequences may include: suicidal ideation, recurrent debilitating anxiety, extreme aggression or agitation, significant decline in former social patterns, social withdrawal, psychomotor agitation or retardation, inability to think or concentrate, and apathy. Psychotropic Medications and Antipsychotic Medications (F758 Only Guidance) In accordance with §483.45(d)(4) and as clarified in the section above on Indication for Use, residents must not receive any medications which are not clinically indicated to treat a specific condition. The medical record must show documentation of the diagnosed condition for which a psychotropic medication is prescribed (§483.45(e)(1)). All medications included in the psychotropic medication definition may affect brain activities associated with mental processes and behavior. Use of psychotropic medications, other than antipsychotics, should not increase when efforts to decrease antipsychotic medications are being implemented. Risks associated with psychotropic medications still exist regardless of the indication for their use (e.g., nausea, insomnia, itching), therefore https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/Downloads/Adverse-Drug-Event-Trigger-Tool https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/Downloads/Adverse-Drug-Event-Trigger-Tool the requirements pertaining to psychotropic medications in §483.45(e) apply to the four categories of drugs (anti-psychotic, anti-depressant, anti-anxiety and hypnotic) listed in §483.45(c)(3) without exception. Other medications not classified as anti-psychotic, anti-depressant, anti-anxiety, or hypnotic medications can also affect brain activity and should not be used as a substitution for another psychotropic medication listed in §483.45(c)(3), unless prescribed with a documented clinical indication consistent with accepted clinical standards of practice and in accordance with §483.45(d)(4). Categories of medications which affect brain activity include antihistamines, anti-cholinergic medications and central nervous system agents used to treat conditions such as seizures, mood disorders, pseuodobulbar affect, and muscle spasms or stiffness. The requirements pertaining to psychotropic medications apply to these types of medications when their documented use appears to be a substitution for another psychotropic medication rather than for the original or approved indication. For example, if a resident is prescribed valproic acid and the medical record shows no history of seizures but there is documentation that the medication is being used to treat agitation or other expressions of distress, then the use of valproic acid should be consistent with the psychotropic medication requirements under §483.45(e). Residents who take these medications must be monitored for any adverse consequences, specifically increased confusion or over-sedation, as required by §483.45(d)(3). Concerns related to the use of the medications noted here would be investigated at F757, Unnecessary Medications, if the medication is being used for its original or approved indication and not primarily as a psychotropic medication. The regulations and guidance concerning psychotropic medications are not intended to supplant the judgment of a physician or prescribing practitioner in consultation with facility staff, the resident and his/her representatives and in accordance with appropriate standards of practice. Rather, the regulations and guidance are intended to ensure psychotropic medications are used only when the medication(s) is appropriate to treat a resident’s specific, diagnosed, and documented condition and the medication(s) is beneficial to the resident, as demonstrated by monitoring and documentation of the resident’s response to the medication(s). Concerns related to inappropriate prescribing of psychotropic medications may require referrals by the facility and/or the survey team to State Medical Boards or Boards of Nursing. Note: CMS is aware of situations where practitioners have potentially misdiagnosed residents with a condition for which antipsychotics are an approved use (e.g., new diagnosis of schizophrenia) which would then exclude the resident from the long-stay antipsychotic quality measure. For these situations, please refer to the following regulations: • §483.21(b)(3)(i), F658, to determine if the practitioner’s diagnostic practices meet professional standards. • §483.20(g), F641 to determine if the facility completed an assessment which accurately reflects the resident’s status. Use of Psychotropic Medications in Specific CircumstancesAcute or Emergency Situations: When a psychotropic medication is being initiated or used to treat an emergency situation (i.e., acute onset or exacerbation of symptoms or immediate threat to health or safety of resident or others) related to a documented condition or diagnosis, a clinician in conjunction with the IDT must evaluate and document the situation to identify and address any contributing and underlying causes of the acute condition and verify the need for a psychotropic medication. Use of psychotropic medication to treat an emergency situation must be consistent with the requirements regarding PRN orders for psychotropic and antipsychotic medications and any continued use must be consistent with the requirements for gradual dose reduction (GDR). Enduring Conditions: Psychotropic medications may be used to treat an enduring (i.e., non-acute; chronic or prolonged) condition. Before initiating or increasing a psychotropic medication for enduring conditions, the resident’s symptoms and therapeutic goals must be clearly and specifically identified and documented. Additionally, the facility should ensure that the resident’s expressions or indications of distress are: • Not due to a medical condition or problem (e.g., pain, fluid or electrolyte imbalance, infection, obstipation, medication side effect or poly-pharmacy) that can be expected to improve or resolve as the underlying condition is treated or the offending medication(s) are discontinued; • Not due to environmental stressors alone (e.g., alteration in the resident’s customary location or daily routine, unfamiliar care provider, hunger or thirst, excessive noise for that individual, inadequate or inappropriate staff response), that can be addressed to improve the symptoms or maintain safety; • Not due to psychological stressors alone (e.g., loneliness, taunting, abuse), anxiety or fear stemming from misunderstanding related to his or her cognitive impairment (e.g., the mistaken belief that this is not where he/she lives or inability to find his or her clothes or glasses, unaddressed sensory deficits) that can be expected to improve or resolve as the situation is addressed; and • Persistent--The medical record must contain clear documentation that the resident’s distress persists and his or her quality of life is negatively affected and, unless contraindicated, that multiple, non-pharmacological approaches have been attempted and evaluated in any attempts to discontinue the psychotropic medication. New Admissions: Many residents are admitted to a SNF/NF already on a psychotropic medication. The medication may have been started in the hospital or the community, which can make it challenging for the IDT to identify the indication for use. However, the attending physician in collaboration with the consultant pharmacist must re- evaluate the use of the psychotropic medication and consider whether or not the medication can be reduced or discontinued upon admission or soon after admission. Additionally, the facility is responsible for: • Preadmission screening for mental illness and intellectual disabilities, see §483.20(k), F645 and F646; and • Obtaining physician’s orders for the resident’s immediate care, see §483.20(a), F635. Monitoring of Psychotropic Medications: When monitoring a resident receiving psychotropic medications, the facility must evaluate the effectiveness of the medications as well as look for potential adverse consequences. After initiating or increasing the dose of a psychotropic medication, the behavioral symptoms must be reevaluated periodically (e.g., at least during quarterly care plan review, if not more often) to determine the potential for reducing or discontinuing the dose based on therapeutic goals and any adverse effects or functional impairment. If the record shows evidence of prescribing multiple psychotropic medications, or switching from one type of psychotropic medication to another category of psychotropic medication, surveyors must review the medical record to determine whether the prescribing practitioner provided a rationale. Potential Adverse Consequences: The facility assures that residents are being adequately monitored for adverse consequences such as: • General: anticholinergic effects which may include flushing, blurred vision, dry mouth, altered mental status, difficulty urinating, falls, excessive sedation, constipation • Cardiovascular: signs and symptoms of cardiac arrhythmias such as irregular heart beat or pulse, palpitations, lightheadedness, shortness of breath, diaphoresis, chest or arm pain, increased blood pressure, orthostatic hypotension • Metabolic: increase in total cholesterol and triglycerides, unstable or poorly controlled blood sugar, weight gain • Neurologic: agitation, distress, EPS, neuroleptic malignant syndrome (NMS), parkinsonism, tardive dyskinesia, cerebrovascular event (e.g., stroke, transient ischemic attack (TIA). If psychotropic medication(s) are identified as possibly causing or contributing to adverse consequences as identified above, the facility and prescriber must determine whether the medication(s) should be continued and document the rationale for the decision. Use of multiple psychotropic medications can increase the risk of adverse consequences and/or confound the effects of individual medications although there may be infrequent times when use of multiple psychotropic medications is indicated, such as to treat multiple symptoms of a condition or to address side effects. Additionally, the medical record should show evidence that the resident, family member or representative is aware of and involved in the decision. In some cases, the benefits of treatment may outweigh the risks or burdens of treatment, so the medication(s) may be continued. Antipsychotic Medications As with all medications, the indication for any prescribed first generation (also referred to as typical or conventional antipsychotic medication) or second generation (also referred to as atypical antipsychotic medication) antipsychotic medication must be thoroughly documented in the medical record. While antipsychotic medication may be prescribed for expressions or indications of distress, the IDT must first identify and address any medical, physical, psychological causes, and/or social/environmental triggers. Any prescribed antipsychotic medication must be administered at the lowest possible dosage for the shortest period of time and is subject to the GDR requirements for psychotropic medications. Antipsychotic medications (both first and second generation) have serious side effects and can be especially dangerous for elderly residents. When antipsychotic medications are used without an adequate rationale, or for the sole purpose of limiting or controlling expressions or indications of distress without first identifying the cause, there is little chance that they will be effective, and they commonly cause complications such as movement disorders, falls with injury, cerebrovascular adverse events (cerebrovascular accidents (CVA, commonly referred to as stroke), and transient ischemic events) and increased risk of death. The FDA Boxed Warning which accompanies second generation anti-psychotics states, “Elderly patients with dementia-related psychosis treated with atypical anti-psychotic drugs are at an increased risk of death,” https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsand Providers/ucm053171.htm. The FDA issued a similar Boxed Warning for first generation antipsychotic drugs, https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsand Providers/ucm124830.htm. . Diagnoses alone do not necessarily warrant the use of an antipsychotic medication. Antipsychotic medications may be indicated if: • behavioral symptoms present a danger to the resident or others; • expressions or indications of distress that are significant distress to the resident; • if not clinically contraindicated, multiple non-pharmacological approaches have been attempted, but did not relieve the symptoms which are presenting a danger or significant distress; and/or 3 • GDR was attempted, but clinical symptoms returned. If antipsychotic medications are prescribed, documentation must clearly show the indication for the antipsychotic medication, the multiple attempts to implement care- planned, non-pharmacological approaches, and ongoing evaluation of the effectiveness of these interventions. Gradual Dose Reduction for Psychotropic Medications https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm053171.htm https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm053171.htm https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124830.htm https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124830.htm The requirements underlying this guidance emphasize the importance of seeking an appropriate dose and duration for each medication and minimizing the risk of adverse consequences. The purpose of the required GDR or tapering of medication is to find an optimal dose or to determine whether continued use of the medication is benefiting the resident. Tapering may be indicated when the resident’s clinical condition has improved or stabilized, the underlying causes of the original target symptoms have resolved, and/or non-pharmacological approaches have been effective in reducing the symptoms. There are various opportunities during the care process to evaluate the effects of medications on a resident’s physical, mental, and psychosocial well-being, and to consider whether the medications should be continued, reduced, discontinued, or otherwise modified. Examples of these opportunities include: • During the monthly medication regimen review, the pharmacist evaluates resident-related information for dose, duration, continued need, and the emergence of adverse consequences for all medications; • When evaluating the resident’s progress, the attending physician or prescribing practitioner reviews the total plan of care, orders, the resident’s response to medication(s), and determines whether to continue, modify, or stop a medication; and • During the quarterly MDS review, the facility evaluates mood, function, behavior, and other domains that may be affected by medications. The time frames and duration of attempts to taper any medication must be consistent with accepted standards of practice and depend on factors including the coexisting medication regimen, the underlying causes of symptoms, individual risk factors, and pharmacologic characteristics of the medications. Some medications (e.g., antidepressants, sedative/hypnotics, opioids) require more gradual tapering so as to minimize or prevent withdrawal symptoms or other adverse consequences. Close monitoring while medications are tapered will enable facility staff to determine whether a resident is experiencing side effects, changes in behavior, or withdrawal symptoms that originally prompted prescribing of the drug. However, some residents with specific, enduring, progressive, or terminal conditions such chronic depression, Parkinson’s disease psychosis, or recurrent seizures may need specific types of psychotropic medications or other medications which affect brain activity indefinitely. NOTE: If the resident’s condition has not responded to treatment or has declined despite treatment, it is important to evaluate both the medication and the dose to determine whether the medication should be discontinued or the dosing should be altered, whether or not the facility has implemented GDR as required, or tapering. Dose reductions should occur in modest increments over adequate periods of time to minimize withdrawal symptoms and to monitor symptom recurrence. Compliance with the requirement to perform a GDR may be met if, for example, within the first year in which a resident is admitted on a psychotropic medication or after the prescribing practitioner has initiated a psychotropic medication, a facility attempts a GDR in two separate quarters (with at least one month between the attempts), unless clinically contraindicated. Additional information related to gradual dose reduction may be found The American Psychiatric Association Practice Guidelines on the use of Antipsychotics to Treat Agitation or Psychosis in Patients with Dementia, 2016, https://psychiatryonline.org/doi/full/10.1176/appi.books.9780890426807.ap02 and at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3119470/, Discontinuing Medications: A Novel Approach for Revising the Prescribing Stage of the Medication-Use Process (2008). For any individual who is receiving a psychotropic medication to treat expressions or indications of distress related to dementia, the GDR may be considered clinically contraindicated for reasons that include, but that are not limited to: • The resident’s target symptoms returned or worsened after the most recent attempt at a GDR within the facility; and • The physician has documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the resident’s function or increase distressed behavior. For any individual who is receiving a psychotropic medication to treat a disorder other than expressions or indications of distress related to dementia (for example, schizophrenia, bipolar mania, depression with psychotic features, or another medical condition, other than dementia, which may cause psychosis), the GDR may be considered clinically contraindicated for reasons that include, but that are not limited to: • The continued use is in accordance with relevant current standards of practice and the physician has documented the clinical rationale for why any attempted dose reduction would be likely to impair the resident’s function or exacerbate an underlying medical or psychiatric disorder; or • The resident’s target symptoms returned or worsened after the most recent attempt at a GDR within the facility and the physician has documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the resident’s function or exacerbate an underlying medical or psychiatric disorder. PRN Orders for Psychotropic and Antipsychotic Medications In certain situations, psychotropic medications may be prescribed on a PRN basis, such as while the dose is adjusted, to address acute or intermittent symptoms, or in an emergency. However, residents must not have PRN orders for psychotropic medications unless the medication is necessary to treat a diagnosed specific condition. The attending physician or prescribing practitioner must document the diagnosed specific condition and indication for the PRN medication in the medical record. (§483.45(e)(3)) The table below explains additional limitations for PRN psychotropic (other than antipsychotic medications) and PRN antipsychotic medications. https://psychiatryonline.org/doi/full/10.1176/appi.books.9780890426807.ap02 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3119470/ Type of PRN order Time Limitation Exception Required Actions PRN orders for psychotropic medications, excluding antipsychotics 14 days Order may be extended beyond 14 days if the attending physician or prescribing practitioner believes it is appropriate to extend the order. Attending physician or prescribing practitioner should document the rationale for the extended time period in the medical record and indicate a specific duration. PRN orders for antipsychotic medications only 14 days None If the attending physician or prescribing practitioner wishes to write a new order for the PRN antipsychotic, the attending physician or prescribing practitioner must first evaluate the resident to determine if the new order for the PRN antipsychotic is appropriate. The required evaluation of a resident before writing a new PRN order for an antipsychotic entails the attending physician or prescribing practitioner directly examining the resident and assessing the resident’s current condition and progress to determine if the PRN antipsychotic medication is still needed. As part of the evaluation, the attending physician or prescribing practitioner should, at a minimum, determine and document the following in the resident’s medical record: • Is the antipsychotic medication still needed on a PRN basis? • What is the benefit of the medication to the resident? • Have the resident’s expressions or indications of distress improved as a result of the PRN medication? NOTE: Report of the resident’s condition from facility staff to the attending physician or prescribing practitioner does not constitute an evaluation. KEY ELEMENTS OF NONCOMPLIANCE If any of the elements the sections below involve psychotropic medications, investigate F758. For all other medications, investigate F757. To cite deficient practice at F757and/or F758, the surveyor’s investigation will generally show: Inadequate Indications for Use • Failure to document a clinical reason or a clinically pertinent rationale, for using medication(s) for a specific resident or for continuing medication(s) that may be causing an adverse consequence; or • Prescribing or administering a medication despite an allergy to that medication, or without clarifying whether a true allergy existed; or • Failure to consider relative risks and benefits or potentially lower risk medications before initiating medication(s) that present clinically significant risks; or • Failure to provide a clinically pertinent explanation for concomitant use of two or more medications in the same pharmacological class; or • Failure to consider other factors that may be causing expressions or indications of distress before initiating a psychotropic medication, such as an underlying medical condition (e.g., urinary tract infection, dehydration, delirium), environmental (lighting, noise) or psychosocial stressors; or • Administering a psychotropic medication(s), which the resident has not previously received, when it is not necessary to treat a specific condition that has been diagnosed and documented in the clinical record; or • Failure to attempt non-pharmacological approaches, unless clinically contraindicated, in efforts to discontinue psychotropic medications. NOTE: For concerns related to a medication that involves an inadequate indication for use and evidence shows the medication is also being used for the purpose of discipline or staff convenience rather than to treat the resident's medical symptoms, surveyors should evaluate whether evidence shows the medication is being used to sedate the resident or restrict the resident’s movement or cognition and assess compliance with §483.10(e)(1) and §483.12(a)(2), F605, Right to Be Free From Chemical Restraints, instead of citing both at F605 and F757 or F758 for the same evidence. NOTE: Instances of prescribing antibiotics unnecessarily should be cited at §483.45(d), F757. The findings may support citing F881 as well, in which case the surveyor must also show that the facility is not implementing part or all of the Antibiotic Stewardship Program (e.g., antibiotic use protocols that utilize an infection assessment tool, monitoring of antibiotic use, or feedback and education to prescribing providers). Inadequate Monitoring – • Failure to monitor the responses to or effects of a medication, or • Failure to respond when monitoring indicates a lack of progress toward the therapeutic goal (e.g., relief of pain or normalization of thyroid function) or the emergence of an adverse consequence; or • Failure to monitor for changes in psychosocial engagement resulting from adverse consequences of medications, (e.g., resident no longer participates in activities because medication causes confusion or lethargy); or • Failure to monitor a medication consistent with the current standard of practice or manufacturer’s guidelines; or • Failure to carry out the monitoring that was ordered or failure to monitor for potential adverse consequences; or • Failure to consider whether the onset or worsening of symptoms, or a change of condition, may be related to a medication; or • Failure to monitor effectiveness of non-pharmacological approaches, unless clinically contraindicated, before prescribing and administering medications. NOTE: Additional information as well as examples of non-pharmacological approaches may be found in other guidance for regulations at §483.40, Behavioral Health Services and §483.25, Quality of Care and Quality of Life. Excessive Dose (including duplicate therapy) – • Giving a total amount of any medication at one time or over a period of time that exceeds the amount prescribed by the prescribing practitioner, the amount recommended by the manufacturer’s recommendations, clinical practice guidelines, evidence-based studies from medical/pharmacy journals, or standards of practice for a resident’s age and condition, without a documented clinically pertinent rationale; or • Failure to consider periodically the continued necessity of the dose or the possibility of tapering a medication; or • Failure to provide and/or document a clinical rationale for using multiple medications from the same pharmacological class. • Failure to consider each resident’s clinical condition as a factor in determining an appropriate dose, as adverse consequences may occur even when medication serum concentration levels are in the therapeutic range. Excessive Duration – • Continuation beyond the manufacturer’s recommended time frames, the stop date or duration indicated on the medication order, facility-established stop order policies, or clinical practice guidelines, evidence-based studies from medical/pharmacy journals, or current standards of practice, without documented clinical justification; or • Continuation of a medication after the desired therapeutic goal has been achieved, without evaluating whether there is a continued need for the medication, for example, use of an antibiotic beyond the recommended clinical guidelines or the facility policy without adequate reassessment and evaluation of the resident. Adverse Consequences • Failure to act upon (i.e., discontinue a medication or reduce the dose or provide clinical justification for why the benefit outweighs the adverse consequences) or report the presence of adverse consequence(s); or • Failure to monitor for the presence of adverse consequences related to the use of medications (e.g., particularly high risk medications, such as warfarin, insulin, opioids, or medications requiring monitoring of blood work); or • Failure to respond to the presence of adverse consequences related to the use of medications (e.g., particularly high risk medications, such as warfarin, insulin, or opioids). Psychotropic Medications • Failure to present to the attending physician or prescribing practitioner the need to attempt GDR in the absence of identified and documented clinical contraindications; or • Use of psychotropic medication(s) without documentation of the need for the medication(s) to treat a specific diagnosed condition; or • PRN psychotropic medication ordered for longer than 14 days, without a documented rationale for continued use; or • Failure to implement person-centered, non-pharmacological approaches in the attempt to reduce or discontinue a psychotropic medication (§§483.40(a)(2) and 483.45(e)(2)); or • Administering a new PRN antipsychotic medication for which the resident had a previous PRN order (for 14 days) but the medical record does not show that the attending physician or prescribing practitioner evaluated the resident for the appropriateness of the new order for the medication. PROCEDURES: §483.45(d) Unnecessary drugs and §§483.45(c)(3) and (e) Psychotropic Drugs Investigating Concerns Related to Medication Regimen Review, Unnecessary Medications, and Psychotropic Medications Use the Unnecessary Medications, Psychotropic Medications, and Medication Regimen Review Critical Element (CE) Pathway along with the interpretive guidelines when determining if the facility meets the requirements for, and when investigating concerns related to, Medication Regimen Review, Unnecessary Medications, and Psychotropic Medications. Review the medications (prescription, over-the-counter medications, and nutritional supplements such as herbal products) currently ordered and/or discontinued by the prescriber at least back to the most recent signed recapitulation of all medications. Obtain a copy of the current orders if necessary. Gather information regarding the resident’s mental, physical, functional, and psychosocial status and the medication- related therapeutic goals identified in the care plan as the basis for further review. Use the table below to guide observations, record review, and interviews with the resident or representative and relevant staff. Symptoms and signs described in the table may also be related to a resident’s condition or disease. The surveyor may seek clarification about the basis of specific signs and symptoms from the attending physician and/or pharmacist. SYMPTOMS, SIGNS, AND CONDITIONS THAT MAY BE ASSOCIATED WITH MEDICATIONS REVIEW FOR HOW THE IDT MANAGED MEDICATIONS FOR THE RESIDENT Determine if the resident has been transferred to acute care since the last survey and/or has recently (e.g., the previous 3 months) experienced a change in condition or currently has signs and symptoms, such as: • Anorexia and/or unplanned weight loss, or weight gain • Apathy • Behavioral changes, unusual patterns (including increased expressions or indications of distress, social isolation or withdrawal) • Bleeding or bruising, spontaneous or unexplained • Bowel dysfunction including diarrhea, constipation and impaction • Dehydration, fluid/electrolyte imbalance • Depression, mood disturbance • Dysphagia, swallowing difficulty • Falls, dizziness, or evidence of impaired coordination • Gastrointestinal bleeding • Headaches, muscle pain, generalized or nonspecific aching or pain • Lethargy • Mental status changes, (e.g., new or worsening confusion, new cognitive decline, worsening of dementia (including delirium), inability to concentrate) • Psychomotor agitation (e.g., restlessness, inability to sit still, pacing, hand-wringing, or pulling or rubbing of the skin, clothing, or other objects). • Psychomotor retardation (e.g., slowed speech, thinking, and body movements) Review the record (including the care plan, comprehensive assessment, and other parts of the record as appropriate) to determine whether it reflects the following elements related to medication management for the resident: • Clinical indications for use of the medication • Implementation of person- centered, non-pharmacological approaches to care • Dose, including excessive dose and duplicate therapy • Duration, including excessive duration • Consideration of potential for tapering/GDR or rationale for clinical contraindication • Monitoring for and reporting of: o Response to medications and progress toward therapeutic goals and resident’s goals o Emergence of medication- related adverse consequences • Adverse consequences, if present and potentially medication-related, note if there was: o Recognition, evaluation, reporting, and management by the IDT o Physician action regarding potential medication-related adverse consequences SYMPTOMS, SIGNS, AND CONDITIONS THAT MAY BE ASSOCIATED WITH MEDICATIONS REVIEW FOR HOW THE IDT MANAGED MEDICATIONS FOR THE RESIDENT • Rash, pruritus • Respiratory difficulty or changes • Sedation (excessive), insomnia, or sleep disturbance • Seizure activity • Urinary retention or incontinence If observations or record review indicate symptoms or changes in condition that may be related to medications, determine whether the facility considered medications as a potential cause of the change or symptom. • The residents goals and preferences for medications and treatments Interview the resident, his or her family, and representative(s) and the IDT, as needed to gather information about use of medications and any possible side effects in the nursing home. Evaluate if the resident may have experienced psychosocial harm related to side effects of medications. Did side effects such as sedation, lethargy, agitation, mental status changes, or behavior changes: • affect a resident’s abilities to perform activities of daily living or to interact with others, • cause the resident to withdraw or decline from usual social patterns, • show the resident has decreased engagement in activities, • cause diminished ability to think or concentrate. For a resident who is unable to communicate psychosocial outcomes related to medication side effects, the surveyor should consider how a reasonable person would experience the changes caused by medication side effects as explained in the Psychosocial Outcome Severity Guide, on the CMS Nursing Homes Survey Resources website. NOTE: This review is not intended to direct medication therapy. However, surveyors are expected to review factors related to the implementation, use, monitoring, and documentation of medications. The surveyor is not expected to prove that an adverse consequence was directly caused by a medication or combination of medications, but rather that there was a failure in the care process related to considering and acting upon such possibilities. If during the course of this review, the surveyor needs to contact the attending physician regarding questions related to the medication regimen, it is recommended that the facility’s staff have the opportunity to provide the necessary information about the resident and the concerns to the physician for his/her review prior to responding to the surveyor’s inquiries. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION Examples of some of the related requirements that may be considered when concerns have been identified include the following: • 42 CFR 483.10(g)(14), F580, Notification of Changes o Review whether the facility contacted the attending physician regarding a significant change in the resident’s condition in relation to a potential adverse consequence of a medication, or if the resident has not responded to medication therapy as anticipated and/or indicated. • 42 CFR 483.10 (c), F552, Planning and Implementing Care o Determine whether the resident was advised of her/his medical condition and therapy and was informed about her/his treatment including medications and the right to refuse treatments. • 42 CFR 483.24(c), F679, Activities o Review whether the facility provides activities that address a resident’s needs and may permit discontinuation or reduction of psychotropic medications. Review also whether adverse consequences of medications interfere with a resident’s ability to participate in activities. • 42 CFR 483.24(a), F676, Activities of Daily Living o Review whether the facility had identified, evaluated, and responded to a new or rapidly progressive decline in function, development or worsening of movement disorders, increased fatigue and activity intolerance that affected the resident’s ADL ability in relation to potential medication adverse consequences. • 42 CFR 483.40, F740, Behavioral Health Services o Review whether the facility had identified, evaluated, and responded to a change in behavior and/or psychosocial changes, including depression or other mood disturbance, distress, restlessness, increasing confusion, or delirium in relation to potential medication adverse consequences. • 42 CFR 483.30(a), F710, Physician Supervision o Review if the attending physician supervised the resident’s medical treatment, including assessing the resident’s condition and medications, identifying the clinical rationale, and monitoring for and addressing adverse consequences. • 42 CFR 483.30(b), F711, Physician Visits and 42 CFR 483.30(c), F712, Frequency of Physician Visits o Review if the attending physician or designee reviewed the resident’s total program of care and wrote, signed, and dated progress notes covering pertinent aspects of the medication regimen and related issues. • 42 CFR 483.70(g), F841, Medical Director o Review whether the medical director, when requested by the facility, interacted with the attending physician regarding a failure to respond or an inadequate response to identified or reported potential medication irregularities and adverse consequences; and whether the medical director collaborated with the facility to help develop, implement, and evaluate policies and procedures for the safe and effective use of medications in the care of residents. • 42 CFR §483.80(a)(3), F881, Antibiotic Stewardship Program o Review whether the facility has developed and implemented their antibiotic stewardship program (e.g., antibiotic use protocols that utilize an infection assessment tool, monitoring of antibiotic use, feedback and education to prescribing providers). DEFICIENCY CATEGORIZATION See also the Psychosocial Outcome Severity Guide on the CMS Nursing Homes Survey Resources website for additional information on evaluating the severity of psychosocial outcomes. Examples of noncompliance that demonstrate severity at Level 4 immediate jeopardy to resident health or safety include, but are not limited to: • Facility failure to take appropriate action (e.g., suspending administration of the anticoagulant) in response to an elevated International Normalized Ratio (INR) for a resident who is receiving warfarin, resulting in either the potential or actual need to transfuse or hospitalize the resident. • Failure to respond appropriately to an INR level that is above or below the target range for treatment of atrial fibrillation, prevention of deep vein thrombosis (DVT) or pulmonary embolus, or other documented indication. • Failure to recognize developing serotonin syndrome (e.g., confusion, motor restlessness, tremor) in a resident receiving a SSRI antidepressant, leading to the addition of medications with additive serotonin effect or medication to suppress the symptoms. • Failure to recognize and respond to signs and symptoms of neuroleptic malignant syndrome (NMS). • In the presence of initial gastrointestinal bleeding, i.e. blood in stool, the failure to recognize medication therapies (such as NSAIDs or COX-2 inhibitors, bisphosphonates) as potentially causing or contributing to the gastrointestinal bleed, resulting in the continued administration of the medication, until the resident required hospitalization for severe bleeding. • Failure to recognize that use of an antipsychotic medication, originally prescribed for agitation, has caused significant changes in the resident’s quality of life. The resident no longer participates in activities that they previously enjoyed, has difficulty concentrating and carrying on conversations, and spends most of the day isolated in his or her room, sleeping in a recliner or in bed. Continued use of the antipsychotic medication without an adequate clinical indication, GDR attempts, and evidence of non-pharmacological approaches resulted in psychosocial harm. • Failure to re-evaluate the appropriateness of continued administration of a PRN antipsychotic medication, originally prescribed for acute delirium, which resulted in the likelihood of significant side effects from the medication. Examples of Level 3, Actual harm (physical or psychosocial) that are not immediate jeopardy, include, but are not limited to: • The facility failed to evaluate a resident’s new medication regimen as the source of a resident’s recent nausea. The prescriber then added a medication to treat the nausea, which caused agitation and insomnia. • Failure to evaluate a resident for a GDR for a psychotropic medication originally prescribed to treat delirium. Delirium symptoms subsided but the resident remained drowsy and inactive. Examples of Level 2, No actual harm with a potential for more than minimal harm that is not immediate jeopardy, may include but are not limited to: • Facility failure to identify and act upon minor symptoms of allergic response to medications, such as a rash with mild itching to the abdomen and no other symptoms, causing minimal discomfort. • Facility failure to monitor for response or for the emergence or presence of adverse consequences for a resident who has not yet experienced an adverse consequence or decline in function, such as by monitoring hydration status and basic metabolic profile for a resident receiving diuretics or ACE inhibitors. Severity Level 1: No Actual Harm with Potential for Minimal Harm Severity Level 1 does not apply for this regulatory requirement because the failure of the facility to provide appropriate care and services to manage the resident’s medication regimen to avoid unnecessary medications and minimize negative outcome places residents at risk for more than minimal harm. RESOURCES AND TOOLS The following resources and tools provide information on medications including box warnings, appropriate dosing, medication categories, drug interactions, and medication safety information. Some of these resources also assist in identifying the correct class of a medication (e.g., identifying whether a medication is an antipsychotic or other category of psychotropic medication). Additionally, the list includes some of the recognized clinical resources available for understanding the overall treatment and management of medical problems, symptoms and medication consequences and precautions. • U.S. Department of Health and Human Services, National Institute of Mental Health Web site, which includes publications and clinical research information www.nimh.nih.gov • MedlinePlus, https://www.nlm.nih.gov/medlineplus/druginformation.html http://www.nimh.nih.gov/ https://www.nlm.nih.gov/medlineplus/druginformation.html • National Library of Medicine Drug Information Portal, http://druginfo.nlm.nih.gov/drugportal/drug/categories (medication class information). • The Food and Drug Administration (FDA) webpage, Medwatch: The FDA Safety Information and Adverse Event Reporting Program, http://www.fda.gov/Safety/MedWatch/default.htm • The University of Maryland Medical Center Drug Interaction Tool, http://umm.edu/health/medical/drug-interaction-tool • American Medical Directors Association, www.amda.com • American Society of Consultant Pharmacists, www.ASCP.com This list is not all-inclusive. CMS is not responsible for the content or accessibility of pages found at these sites. URL addresses were current as of the date of this publication. 1 Handler, S.M., Wright, R.M., Ruby, C.M., Hanlon, J.T. (2006). Epidemiology of medication-related adverse events in nursing homes. The American Journal of Geriatric Pharmacotherapy, 4, pp. 264-272. Retrieved from http://www.sciencedirect.com/science/article/pii/S1543594606000559. 2 Fong, T.G., Davis, D., Growdon, M.E., Albuquerque, A., Inouye, S.K. (2015). The interface between delirium and dementia in elderly adults. The Lancet, 14, pp.823-832. Retrieved from http://thelancet.com/journals/laneur/article/PIIS1474-4422(15)00101-5/fulltext. 3 Steinberg, M., Lyketsos, C.G. (2012). Atypical antipsychotic use in patients with dementia: managing safety concerns. The American Journal of Psychology, 169, pp. 900-906. Retrieved from http://ajp.psychiatryonline.org/doi/full/10.1176/appi.ajp.2012.12030342. http://druginfo.nlm.nih.gov/drugportal/drug/categories http://www.fda.gov/Safety/MedWatch/default.htm http://umm.edu/health/medical/drug-interaction-tool http://www.amda.com/ http://www.ascp.com/ http://www.sciencedirect.com/science/article/pii/S1543594606000559 http://thelancet.com/journals/laneur/article/PIIS1474-4422(15)00101-5/fulltext http://ajp.psychiatryonline.org/doi/full/10.1176/appi.ajp.2012.12030342 F759 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.45(f) Medication Errors. The facility must ensure that its— §483.45(f)(1) Medication error rates are not 5 percent or greater; and F760 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) The facility must ensure that its— §483.45(f)(2) Residents are free of any significant medication errors. DEFINITIONS “Medication Error” means the observed or identified preparation or administration of medications or biologicals which is not in accordance with: 1. The prescriber’s order; 2. Manufacturer’s specifications (not recommendations) regarding the preparation and administration of the medication or biological; or 3. Accepted professional standards and principles which apply to professionals providing services. Accepted professional standards and principles include the various practice regulations in each State, and current commonly accepted health standards established by national organizations, boards, and councils. “Significant medication error” means one which causes the resident discomfort or jeopardizes his or her health and safety. Criteria for judging significant medication errors as well as examples are provided below. Significance may be subjective or relative depending on the individual situation and duration, e.g., constipation that is unrelieved because an ordered laxative is omitted for one day, resulting in a medication error, may cause a resident slight discomfort or perhaps no discomfort at all. However, if this omission leads to constipation that persists for greater than three days, the medication error may be deemed significant since constipation that causes an obstruction or fecal impaction can directly jeopardize the resident’s health and safety. “Medication error rate” is determined by calculating the percentage of medication errors observed during a medication administration observation. The numerator in the ratio is the total number of errors that the survey team observes, both significant and non- significant. The denominator consists of the total number of observations or “opportunities for errors” and includes all the doses the survey team observed being administered plus the doses ordered but not administered. The equation for calculating a medication error rate is as follows: Medication Error Rate = Number of Errors Observed divided by the Opportunities for Errors (doses given plus doses ordered but not given) X 100. The error rate must be 5% or greater in order to cite F759. Rounding up of a lower rate (e.g., 4.6%) to a 5% rate is not permitted. A medication error rate of 5% or greater may indicate that systemic problems exist. The survey team should consider investigating additional potential noncompliance issues, such as F755– Pharmacy Services, related to the facility’s medication distribution system. NOTE: Significant and non-significant medication errors observed at 5% or greater during the Medication Administration Observation task should be cited at F759. However, any significant medication error, whether or not the error rate is 5% or greater, should be cited at F760. Significant and Non-significant Medication Errors Determining Significance The relative significance of medication errors is a matter of professional judgment. Follow three general guidelines in determining whether a medication error is significant or not: • Resident Condition - The resident’s condition is an important factor to take into consideration. For example, a diuretic (fluid pill) erroneously administered to a dehydrated resident may have serious consequences, but if administered to a resident with a normal fluid balance may not. If the resident’s condition requires rigid control, such as with strict intake and output measurement, daily weights, or monitoring of lab values, a single missed or wrong dose can be highly significant; • Drug Category - If the medication is from a category that usually requires the resident to be titrated to a specific blood level, a single medication error could alter that level and precipitate a reoccurrence of symptoms or toxicity. This is especially important with a medication that has a Narrow Therapeutic Index (NTI) (i.e., a medication in which the therapeutic dose is very close to the toxic dose). Examples of medications with NTI include: phenytoin (Dilantin), carbamazepine (Tegretol); warfarin (Coumadin); digoxin (Lanoxin); theophylline (TheoDur); lithium salts (Eskalith, Lithobid); and • Frequency of Error - If an error is occurring repeatedly, there may be more reason to classify the error as significant. For example, if a resident’s medication was omitted several times, it may be appropriate, depending on consideration of resident condition and medication category, to classify that error as significant. (See Dose Reconciliation Technique to the Observation Technique below). Significant medication errors are cited at F760 in the following circumstances: • When the surveyor observes a significant medication error during a medication preparation and/or administration (regardless of whether the overall facility error rate is 5% or greater); • When the surveyor identifies a significant medication error(s) during the course of a resident record review. While observation is the preferred method for citing medication errors, the surveyor may identify medication errors based on evidence from other sources, such as documentation of a change in the resident’s condition determined to be due to medication errors, reports from family members that medication was given incorrectly and investigation supports that a medication error occurred, or discrepancies in the MAR that lead to identification of a medication error. The surveyor must conduct any follow up investigation to obtain corroborating information regarding the error, such as interviews with the nurse, Director of Nursing, or the pharmacist, and review other relevant documents. Surveyors should evaluate whether past non-compliance exists using the survey protocol. Medication errors identified through methods other than observation are not counted in the medication pass observation and not cited at F759, but, any significant medication errors would be cited at F760 if evidence supports the citation. Examples of Significant and Non-Significant Medication Errors Some of the error examples are identified as significant. This designation is based on accepted clinical standards of practice without regard to the status of the resident because these error examples show a high potential for creating problems for the typical long- term care facility resident. Those errors identified as non-significant have also been designated primarily on the basis of the nature of the medication. Resident status, actual or potential resident response to the error, and frequency of error could cause such errors to be classified as significant. Examples of Medication Errors In the following tables, S=Significant; NS=Not Significant. Omissions (Medication ordered but not administered at least once): Medication Order Significance Metoprolol Succinate 100mg daily S Furosemide 40mg twice daily S Trazodone 25mg at bedtime NS Ibuprofen 400mg three times daily NS Artificial tears 2 drops both eyes three times daily NS Fiber supplement one packet twice daily NS Multivitamin one daily NS Calcium Carbonate Chewable 1 tablet three times a day after meals NS Unauthorized Medication (Medications administered without a physician’s order): Medication Order Significance Warfarin 4mg Amoxicillin 500 mg S S Allopurinol 100mg Ferrous Sulfate 325mg S NS Acetaminophen 325 mg NS Wrong Dose: Medication Order Administered Significance Digoxin 0.125mg everyday Morphine Sulfate 20mg/ml 0.25 ml 0.25mg 0.5ml S S Calcium Carbonate 600 mg 500mg NS Wrong Route of Administration: Medication Order Administered Significance Neomycin and Polymyxin B Ear Drops 4 to 5 drops to left ear four times a day Left Eye S Wrong Dosage Form: Medication Order Administered Significance Dilantin Kapseals 100 mg three Kapseals by mouth at bedtime Prompt Phenytoin 100 mg three capsules by mouth at bedtime S* Docusate Sodium Liquid 100mg twice daily Capsule NS * Parke Davis Kapseals have an extended rate of absorption. Prompt phenytoin capsules do not. Wrong Medication: Wrong Time: Medication Order Administered Significance Oxycodone 5mg 2 Tabs 20 min. before painful treatment 2 Tabs given after treatment S Losartan 50mg daily at 8 a.m. At 9:30 am NS Medication Errors Due to Failure to Follow Manufacturers Specifications or Accepted Professional Standards Failure to “Shake Well” or Mix a Suspension The failure to “shake” a medication that is labeled “shake well” may lead to a diluted dose or overly concentrated dose depending on the product and the elapsed time since the last “shake.” Some medications, for example phenytoin, require correct preparation to achieve the desired therapeutic effect. Surveyors may also observe facility staff mixing suspensions that should not be shaken vigorously but instead “rolled.” Any rolling motion used is acceptable as long as the suspension appears uniformly milky and the Medication Order Administered Significance Vibramycin Vancomycin S Tums Oscal NS rolling action has not created bubbles which can affect measurement and administration of the correct dose. Crushing Medications The crushing of tablets or capsules for which the manufacturer instructs to “do not crush” requires further investigation by the surveyor. The Institute for Safe Medication Practices website provides a list of oral dosage forms that should not be crushed which may be helpful. http://www.ismp.org/tools/DoNotCrush . Some exceptions to the “Do Not Crush” instruction include: • If the prescriber orders a medication to be crushed which the manufacturer states should not be crushed, the prescriber or the pharmacist must explain, in the clinical record, why crushing the medication will not adversely affect the resident. Additionally, the pharmacist should inform the facility staff to observe for pertinent adverse effects. • If the facility can provide literature from the medication manufacturer or from a peer-reviewed health journal to justify why modification of the dosage form will not compromise resident care. The standard of practice is that crushed medications should not be combined and given all at once via feeding tube. Crushing and combining medications may result in physical and chemical incompatibilities leading to an altered therapeutic response, or cause feeding tube occlusions when the crushed medications are combined and administered via feeding tube. Flushing the feeding tube between each medication is also standard of practice. A facility is not required to flush the tubing between each medication if there is a physician’s order that specifies a different flush schedule because of a fluid restriction. For a resident who requires fluid regulation, the physician’s order should include the amount of water to be used for the flushing between crushed medications and administration of medications. Before giving medications via feeding tube, the placement of the feeding tube should be confirmed in accordance with the facility’s policy based on current standards of practice. Concerns related to placement and function of the feeding tube should be evaluated under the requirements at §483.25(g)(4)-(5), F693, Enteral Nutrition. Lastly, the administration of enteral nutrition formula and administration of phenytoin (Dilantin) must be separated to minimize interaction, according to drug and enteral formula manufacturer recommendations. The surveyor should consider the simultaneous administration of phenytoin and enteral nutrition formula as a medication error. NOTE: Additional information related to administering medications via feeding tube may be found in ASPEN Safe Practices for Enteral Nutrition Therapy at https://www.ismp.org/tools/articles/ASPEN (2009) and http://pen.sagepub.com/content/early/2016/11/09/0148607116673053.full (2016). References to non-CMS sources do not constitute or imply endorsement of these https://www.ismp.org/tools/articles/ASPEN http://pen.sagepub.com/content/early/2016/11/09/0148607116673053.full organizations or their programs by CMS or the U.S. Department of Health and Human Services and were current as of the date of this publication. Crushing Oral Medications – To address concerns with physical and chemical incompatibility and complete dosaging, best practice would be to separately crush each medication and separately administer each medication with food. However, separating crushed medications may not be appropriate for all residents and is generally not counted as a medication error unless there are instructions not to crush the medication(s). Facilities should use a person-centered, individualized approach to administering all medications. If a surveyor identifies concerns related to crushing and combining oral medications, the surveyor should evaluate whether facility staff have worked with the resident/representative and appropriate clinicians (e.g., the consultant pharmacist, attending physician, medical director) to determine the most appropriate method for administering crushed medications which considers each resident’s safety, needs, medication schedule, preferences, and functional ability. Giving Adequate Fluids with Medications Administering medications without adequate fluid when the manufacturer specifies that adequate fluids be taken with the medication requires further investigation. Taking medications with inadequate fluid may interfere with the medication working properly. Most medications can be taken with water, but there are exceptions, as further explained below. If the resident declines to take adequate fluid, the facility is not at fault so long as they made a good faith effort to offer fluid, and provided any assistance that may be necessary to drink the fluid. Additionally, the surveyor should look for evidence that the IDT considered other medication options or routes of administration for residents who decline to take adequate fluids or who are fluid restricted. For example, the surveyor would count fluids consumed during meals or snacks (such as coffee, juice, milk, soft drinks, etc.) as fluids taken with the medication, as long as they have consumed within a reasonable time of taking the medication (e.g., within approximately 30 minutes). Medications that are recommended to be given with adequate fluid include, but are not limited to: • Bulk laxatives (e.g., Metamucil, Fiberall, Serutan, Konsyl, Citrucel); • Alendronate—should be taken with 6-8 ounces of plain water only. • Potassium supplements (solid or liquid dosage forms) such as: Kaochlor, Klorvess, Kaon, K-Lor, K-Tab, K-Dur, K-Lyte, Slow K, Klotrix, Micro K, or Ten K should be administered with or after meals with a full glass (e.g., approximately 4 - 8 ounces of water or fruit juice). This will minimize the possibility of gastrointestinal irritation and saline cathartic effect. Medications that must be taken with food or antacids The administration of medications without food or antacids when the manufacturer specifies that food or antacids be taken with or before the medication is considered a medication error. The most commonly used medications that should be taken with food or antacids are the Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). There is evidence that older individuals living with multiple diagnoses are at greater risk of gastritis and GI bleeds. Determine if the time of administration takes into account the need to give the medication with food. Nutritional and Dietary Supplements Nutritional supplements are medical foods that are used to complement a resident’s dietary needs. Examples of these are total parenteral products, enteral products, and meal replacement products (e.g., Ensure, Glucerna and Promote.) Herbal and alternative products are considered to be dietary supplements. They are not regulated by the Food and Drug Administration (e.g., they are not reviewed for safety and effectiveness like medications) and their composition is not standardized (e.g., the composition varies among manufacturers). If a dietary supplement is given to a resident between meals and has a vitamin(s) as one or more of its ingredients, it should be documented and evaluated as a dietary supplement, rather than a medication. For clinical purposes, it is important to document a resident’s intake of such substances elsewhere in the clinical record and to monitor their potential effects, as they can interact with other medications. NOTE: Because nutritional and dietary supplements are not considered to be medications for purposes of the medication administration observation, noncompliance with the administration of these products should not be included in the calculation of the facility’s medication error rate. The exception to this would be vitamins and minerals which are generally considered a category of dietary supplements. Medication errors involving vitamins and/or minerals should be documented at F759 and counted towards the error rate calculation. Medication errors involving vitamins and minerals would not be considered to be a significant medication error unless the criteria at F760 were met. It is expected that the facility staff, along with the prescriber and consulting pharmacist, are aware of, review for, and document any potential adverse consequences between medications, nutritional supplements, and dietary supplements that a resident is receiving. Medications Administered into the Eye Facility staff must follow the manufacturer’s product information for administration instructions. Facility staff must verify the eye(s) into which eye medication will be administered. When observing the administration of eye drops, confirm that the medication makes full contact with the lower conjunctival sac, so that the medication is washed over the eye when the resident closes eyelid; the eye drop(s) should not fall onto the cornea and the tip of the eye drop bottle should not touch any portion of the eye. The eye drop must contact the eye for a sufficient period of time before the next eye drop is administered. The time for optimal eye drop absorption is approximately 3 to 5 minutes. Systemic effects of eye medications may be reduced if the nurse or resident presses the tear duct for one minute after eye drop administration or gently closes the eye for approximately three minutes after the administration. For additional information related to administration of eye drops, see http://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Libraries/NEW- WEBSITE-LOGOeyedropinstruction_orig_HI and http://journals.lww.com/nursing/Citation/2007/05000/Administering_eyedrops.14.aspx NOTE: References to non-CMS sources do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services and were current as of the date of this publication. Sublingual Medications If the resident persists in swallowing a sublingual tablet (e.g., nitroglycerin) despite efforts to train otherwise, the facility should endeavor to seek an alternative. Metered Dose Inhalers (MDI) Ensuring that a device is administered correctly is vital to optimizing inhalation therapy. The surveyor would observe the administration of MDIs for the following: • Shake the container well; • Position the inhaler in front of or in the resident’s mouth. Alternatively a spacer or valved holding chamber may be used; • For cognitively impaired residents, many clinicians believe that the closed mouth technique is easier for the resident and more likely to be successful. However, the open mouth technique often results in better and deeper penetration of the medication(s) into the lungs, when this method can be used. • If more than one puff is required (whether the same medication or a different medication), follow the manufacturer’s product information for administration instructions including the acceptable wait time between inhalations. NOTE: If the person administering the medication follows all the procedures outlined above, and there is an isolated failure to administer the medication because the resident is unable to understand the procedure (for example, a resident with dementia), this should not be counted as a medication error. The surveyor would evaluate the facility’s responsibility to assess the resident’s circumstance, and possibly attempt other dosage forms such as oral dosage forms or nebulizers. If the facility staff repeatedly fail to administer the inhaler due to circumstances related to the resident’s condition, then the surveyor would cite a medication error. The surveyor should look for evidence of staff communication with the prescriber and/or the consultant pharmacist to address inability to administer a resident’s medication(s) as prescribed. The surveyor should also investigate appropriate tags related to the circumstances which prevent the administration of an inhaler or other medication(s), such as care of residents with dementia. For concerns related to care of residents with dementia, the surveyor should also consider the requirements at §483.40 Behavioral Health Services. Determining Medication Errors Timing Errors If a medication is prescribed before meals (AC) and administered after meals (PC), always count this as a medication error. Likewise, if a medication is prescribed PC and is given AC, count as a medication error. Count a wrong time error if the medication is http://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Libraries/NEW-WEBSITE-LOGOeyedropinstruction_orig_HI http://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Libraries/NEW-WEBSITE-LOGOeyedropinstruction_orig_HI http://journals.lww.com/nursing/Citation/2007/05000/Administering_eyedrops.14.aspx administered 60 or more minutes earlier or later than its scheduled time of administration, but only if that wrong time error can cause the resident discomfort or jeopardize the resident’s health and safety. Counting a medication with a long half-life (e.g., digoxin) as a wrong time error when it is 15 minutes late is improper because this medication has a long half-life (beyond 24 hours) and 15 minutes has no significant impact on the resident. The same is true for many other wrong time errors (except AC AND PC errors). To determine the scheduled time, examine the facility’s policy relative to dosing schedules. The facility’s policy should dictate when it administers a.m. doses, or when it administers the first dose in a 4-times-a-day dosing schedule. Residents have the right to choose health care schedules consistent with their interests and preferences, and the nursing home should gather this information in order to be proactive in assisting residents to fulfill their choices. The adjustment of medication administration times, to meet the individual needs and preferences of residents, must be considered by the nursing home. However, medication administration scheduling must still consider physician prescription, manufacturer’s guidelines, and the types of medication, including time-critical medications. Some medications require administration within a narrow window of time to ensure resident safety or achieve a therapeutic effect while other medications are not affected by a more flexible schedule. Additionally, a facility may, for example, set up a medication ordered twice a day (BID) on a different schedule for one resident than for another resident, based upon individual preferences. Prescriber’s Orders The latest recapitulation of medication orders is sufficient for determining whether a valid order exists provided the prescriber has signed the “recap.” The signed “recap,” if the facility uses the “recap” system and subsequent orders constitute a legal authorization to administer the medication. Omitted Dose One of the most frequent types of errors is a dose of medication that is ordered but not given (omitted). If a surveyor detects an omitted dose, investigate the omission further through interviews with the responsible person(s) (and/or his/her supervisor) and all relevant individuals if a medication cart is shared. Ask the person administering medications, if possible, to describe the system for administering the medications given. Occasionally, a respiratory therapist may administer inhalers, a designated treatment person may only administer topical treatments, a hospice nurse may administer hospice medications, another person may administer eye drops or as needed medications, etc. INVESTIGATIVE PROCEDURES Use the Medication Administration Observation Facility Task, as appropriate, along with the interpretive guidelines, when determining if the facility meets the requirements for, or investigating concerns related to, Medication Administration and Medication Errors. Medication Administration Observation Methodology The survey team should observe the administration of medications on several different medication “passes” to capture different staff members who administer medications as well as multiple routes and times of administration. However, when observing medication pass for one resident at a specific time, plan to observe all of the medications prescribed to be given at that time for that resident. Following this process will help to identify if omissions have occurred. Record what is observed; and reconcile the record of observation with the prescriber’s medication orders to determine whether or not medication errors have occurred. Paper review may help identify possible errors, however detection of blank spaces on a medication administration record does not alone constitute the occurrence of actual medication errors. The surveyor(s) conducting medication observation will need to follow-up on any observed concerns through additional record review and interviews. Observation Technique The survey team must know what medications, in what strength, dosage forms, and administration route are being administered. This is accomplished prior to medication administration and may be done in a number of ways depending on the medication distribution system used (e.g. unit dose, vial system, punch card). Medication Preparation and Administration Observation 1. Identify the medication by observing the label. When a punch card or unit dose system is used, the survey team can usually observe the label and adequately identify the medication. For multi-medication packet systems, staff identify medications by dose and descriptions provided by the pharmacy. Ask the nurse how medication(s) being administered is identified so the resident receives the correct medication(s). 2. Observe and record the administration of medications (“pass”). Findings at this juncture should be focused on what the surveyor observes, not what the medication administration record states. Follow the person administering medications and observe residents receiving medications (e.g., actually swallowing oral dosage forms). Be neutral and as unobtrusive as possible during this process. • The surveyor should ask appropriate staff to explain the facility policy or system for the identification of residents. • Multiple tablets or capsules required to deliver a dose of a single medication count as one observation and one opportunity for error; • If medications are crushed prior to administration: o Ask staff how they know the medication is permitted to be crushed. o Observe whether the crushed medications are combined for administration via feeding tube and flushed between each medication. If so, the number of errors would equal the number of medications that were combined. For example, if four medications were crushed and combined to be administered all at once via feeding tube, then four errors have occurred before the medications have been administered. • Observe infection prevention practices by staff administering medications, including the procedures used for insulin pens and single dose vial use, in addition to the disinfection of blood glucose monitors (BGMs). If the staff administering medications fail to use appropriate infection prevention and control standards of practice, it should also be evaluated under §483.80, Infection Prevention and Control Program. 3. Reconcile the surveyor’s record of observation with physician or prescribing practitioner orders. • Compare the record of observation with the most current orders for medications. • For each medication on the surveyor’s record of observation, determine if the medication was administered: o According to a valid prescriber’s order(s); o To the correct resident; o At the correct time; o In the correct dose; o By the correct route; and o According to correct accepted standards of practice and manufacturer’s specifications. • For medications not on the surveyor’s list: Examine the record for medication orders that were not administered and should have been. Such circumstances may represent omitted doses, one of the most frequent types of errors. • The surveyor should now have a complete record of what was observed and what should have occurred according to the prescribers’ orders. Determine the number of errors by adding the errors on each resident. Before concluding for certain that an error has occurred, discuss the apparent error, if possible, with the person who administered the medications, as there may be a logical explanation for an apparent error. For example, the surveyor observed that a resident had received Lasix 20 mg, but the order was for 40 mg. This was an apparent error in dosage. But the nurse showed the surveyor another more recent order which discontinued the 40 mg order and replaced it with a 20 mg order. 4. Reporting Errors -- At the exit conference, the survey team describes to facility staff each error that they detected. The survey team is not required to analyze the errors and come to any conclusions on how the facility can correct them. Do not attempt to categorize errors into various classifications (e.g., wrong dose, wrong resident). Stress that an error occurred and that future errors must be avoided. Intervening During Medication Administration -- There may be times when the surveyor should intervene before the person administering the medication makes a suspected medication error. This would occur in the event the surveyor becomes aware of the concern before reconciling the medication administration observations with the physician’s orders. Examples of this may include, but are not limited to, situations where the surveyor understands that the resident is about to receive: • An unusually large dose of medication; • A medication via the wrong route, such as ear drops in the eyes; or • An inaccurate amount of medication (difference in what was seen prepared versus what the staff member stated they were preparing, such as amount of insulin). When the surveyor encounters such a situation, he or she should bring it to the attention of the person about to administer the medication. The timing of this would take place at the point in which that person has committed to administering the medication, such as upon entering the resident’s room or approaching the resident. The surveyor should question the person away from the resident, such as at the medication cart or in the medication room, in a way that is respectful of the person administering medication and will not bring unnecessary alarm to the resident. The intent is to confirm whether a medication error (significant or non-significant) was or was not about to occur. If a surveyor intervened, prior to medication reconciliation, to prevent a medication error from occurring, each potential medication error would be counted toward the facility’s medication error rate. If the error is discovered later by the surveyor during the medication reconciliation, the observation would still be counted toward the facility’s medication error rate. The facility is responsible for ensuring that medication error rates are not 5 percent or greater and that residents are free of any significant medication errors. Dose Reconciliation Technique Supplement to the Observation Technique -- When an omission error has been detected through the observation technique, the dose reconciliation technique can sometimes enable the survey team to learn how frequently an error has occurred in the past. Learning about the frequency of an error can assist in judging the significance of the error. (See Significant and Non-Significant Medication Errors above.) The dose reconciliation technique requires a comparison of the number of doses remaining in a supply of medications with the number of days the medication has been in use and the directions for use. For example, if a medication was in use for 5 days with direction to administer the medication 4 times a day, then 20 doses should have been used. If a count of the supply of that medication shows that only 18 doses were used (i.e., two extra doses exist) and no explanation for the discrepancy exists (e.g., resident declined the dose, or resident was hospitalized), then two omission errors may have occurred. The surveyor should investigate further through interviews and record review to determine if actual medication errors occurred. Use the dose reconciliation technique when the number of medications received, and the date and the specific “pass” when that particular medication was started are captured in the resident’s medical record. Unless this information is available, do not use this technique. If this information is not available, there is no Federal authority under which the survey team may require it, except for controlled drugs. F761 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.45(g) Labeling of Drugs and Biologicals Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable. §483.45(h) Storage of Drugs and Biologicals §483.45(h)(1) In accordance with State and Federal laws, the facility must store all drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys. §483.45(h)(2) The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected. INTENT §483.45(g) Labeling of Drugs and Biologicals and §483.45(h) Storage of Drugs and Biologicals The intent of this requirement is that the facility, in coordination with the licensed pharmacist, provides for: • Accurate labeling to facilitate consideration of precautions and safe administration, of medications; and • Safe and secure storage (including proper temperature controls, appropriate humidity and light controls, limited access, and mechanisms to minimize loss or diversion) of all medication. NOTE: For purposes of this guidance, references to “the pharmacist” mean the licensed pharmacist, whether employed directly by the facility or through arrangement. DEFINITIONS §483.45(g) Labeling of Drugs and Biologicals and §483.45(h) Storage of Drugs and Biologicals “Biologicals” are made from a variety of natural sources––human, animal, or microorganisms. Biologics are used to treat, prevent, or diagnose diseases and medical conditions. They may include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. “Controlled Medications” are substances that have an accepted medical use (medications which fall under US Drug Enforcement Agency (DEA) Schedules II—V), have a potential for abuse, ranging from low to high, and may also lead to physical or psychological dependence. GUIDANCE §483.45(g) Labeling of Drugs and Biologicals and §483.45(h) Storage of Drugs and Biologicals LABELING OF MEDICATIONS AND BIOLOGICALS This section requires facility compliance with currently accepted labeling requirements, even though the pharmacies are responsible for the actual labeling. Labeling of medications and biologicals dispensed by the pharmacy must be consistent with applicable federal and State requirements and currently accepted pharmaceutical principles and practices. Although medication delivery and labeling systems may vary, the medication label at a minimum includes the medication name (generic and/or brand), prescribed dose, strength, the expiration date when applicable, the resident’s name, and route of administration. The medication should also be labelled with or accompanied by appropriate instructions and precautions (such as shake well, take with meals, do not crush, special storage instructions). For medications designed for multiple administrations (e.g., inhalers, eye drops), the label identifies the specific resident for whom it was prescribed. When medications are prepared or compounded for intravenous infusion, the label contains the name and volume of the solution, resident’s name, infusion rate, name and quantity of each additive, date of preparation, initials of compounder, date and time of administration, initials of person administering medication if different than compounder, ancillary precautions as applicable, and date after which the mixture must not be used. The FDA and the Institute for Safe Medication Practices provide labelling guidance and recommendations aimed at preventing errors, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid ances/UCM349009 and https://www.ismp.org/tools/guidelines/labelFormats/comments/default.asp. For over-the-counter (OTC) medications in bulk containers (e.g., in states that permit bulk OTC medications to be stocked in the facility), the label contains the original manufacturer’s or pharmacy-applied label indicating the medication name, strength, quantity, accessory instructions, lot number, and expiration date when applicable. The facility ensures that medication labeling in response to order changes is accurate and consistent with applicable state requirements. Additionally, to minimize contamination, facility staff should date the label of any multi- use vial when the vial is first accessed and access the vial in a dedicated medication preparation area: • If a multi-dose vial has been opened or accessed (e.g., needle-punctured), the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. • If a multi-dose vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer’s expiration date. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM349009 https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM349009 https://www.ismp.org/tools/guidelines/labelFormats/comments/default.asp The Centers for Disease Control and Prevention website provides additional information regarding multi-use vials, http://www.cdc.gov/injectionsafety/providers/provider_faqs_multivials.html. MEDICATION ACCESS AND STORAGE A facility is required to secure all medications in a locked storage area and to limit access to authorized personnel (for example, pharmacy technicians or assistants who have been delegated access to medications by the facility’s pharmacist as a function of their jobs) consistent with state or federal requirements and professional standards of practice. Storage areas may include, but are not limited to, drawers, cabinets, medication rooms, refrigerators, and carts. Depending on how the facility locks and stores medications, access to a medication room may not necessarily provide access to the medications (for example, medications stored in a locked cart, locked cabinets, a locked refrigerator, or locked drawers within the medication room). When medications are not stored in separately locked compartments within a storage area, only appropriately authorized staff may have access to the storage area. Access to medications can be controlled by keys, security codes or cards, or other technology such as fingerprints. Schedule II-V medications must be maintained in separately locked, permanently affixed compartments. The access system (e.g. key, security codes) used to lock Schedule II-V medications and other medications subject to abuse, cannot be the same access system used to obtain the non-scheduled medications. The facility must have a system to limit who has security access and when access is used. Exception: Controlled medications and those medications subject to abuse may be stored with non-controlled medications as part of a single unit package medication distribution system, if the supply of the medication(s) is minimal and a shortage is readily detectable. During a medication pass, medications must be under the direct observation of the person administering the medications or locked in the medication storage area/cart. In addition, the facility should have procedures for the control and safe storage of medications for those residents who can self-administer medications. (See F554, §483.10(c)(7) for guidance related to the right to self-administer medications). Safe medication storage includes the provision of appropriate environmental controls. Because many medications can be altered by exposure to improper temperature, light, or humidity, it is important that the facility implement procedures that address and monitor the safe storage and handling of medications in accordance with manufacturers’ specifications, State requirements and standards of practice (e.g., United States Pharmacopeia (USP) standards). PROCEDURES Use the Medication Administration Observation Facility Task and the Medication Storage and Labeling Critical Element pathway, as appropriate, along with the above interpretive guidelines when determining if the facility meets the requirements for, or investigating concerns related to, Medication Labeling and Storage. http://www.cdc.gov/injectionsafety/providers/provider_faqs_multivials.html KEY ELEMENTS OF NONCOMPLIANCE §483.45(g) Labeling of Drugs and Biologicals and §483.45(h) Storage of Drugs and Biologicals To cite deficient practice at F761, the surveyor’s investigation will generally show that the facility failed to: • Ensure that all drugs and biologicals used in the facility are labeled in accordance with professional standards, including expiration dates and with appropriate accessory and cautionary instructions; or • Store all drugs and biologicals in locked compartments, including the storage of schedule II-V medications in separately locked, permanently affixed compartments, permitting only authorized personnel to have access except when the facility uses single unit medication distribution systems in which the quantity stored is minimal and a missing dose can be readily detected, or • Store medications at proper temperatures and other appropriate environmental controls to preserve their integrity. DEFICIENCY CATEGORIZATION In addition to actual or potential physical harm, always consider whether psychosocial harm has occurred when determining severity level (See Appendix P, Section IV, E, Psychosocial Outcome Severity Guide). Examples of noncompliance that demonstrate severity at Level 4 include, but are not limited to: • The facility failed to assure that medications were secure and inaccessible to unauthorized staff and residents. As a result, a resident accessed and ingested medications that caused clinically significant adverse consequences necessitating hospitalization to stabilize the resident; or • As a result of an incorrect label on the package, staff administered the wrong medication or wrong dose(s) of a medication (e.g., anticonvulsant, antihyperglycemic, benzodiazepine) with a potential for clinically significant adverse consequences, which resulted in, or had the potential for, serious harm or death (e.g., toxic levels of the medication, unresponsiveness, uncontrolled seizures). An example of Level 3, Actual harm (physical or psychosocial) that is not immediate jeopardy, includes, but is not limited to: • Medication labeling was incomplete and lacked instructions that the medication was not to be given with specific foods (e.g., milk or milk-based products) resulting in altered effectiveness of the medication and worsening of the residents’ symptoms, requiring medical intervention. Examples of Level 2, No actual harm with a potential for more than minimal harm that is not immediate jeopardy, may include but are not limited to: • The facility’s medication cart was not kept locked or under direct observation of authorized staff in an area where residents could access it. No medications were taken by residents but the potential for more than minimal harm exists; or • As a result of inaccurate labeling, the resident received the wrong medication or dose or the correct medication by the wrong route and experienced discomfort but did not require any interventions. Severity Level 1 Considerations: No Actual Harm with Potential for Minimal Harm • Severity Level 1 does not apply for this regulatory requirement because the failure of the facility to accurately label and safely secure storage of all medications places residents at risk for more than minimal harm. §483.50 Laboratory, radiology, and other diagnostic services This regulation is intended to ensure that laboratory, radiology, and other diagnostic services meet the needs of residents, that results are reported promptly to the ordering provider to address potential concerns and for disease prevention, provide for resident assessment, diagnosis, and treatment, and that the facility has established policies and procedures, and is responsible for the quality and timeliness of services whether services are provided by the facility or an outside resource. There are clinical and physiological risks when laboratory, radiology, or other diagnostic services are not performed in a timely manner or the results of these services are not reported and acted upon quickly. These delays may adversely affect a resident’s diagnosis, treatment, assessment, and interventions. If a resident has been adversely affected, refer as appropriate, to Quality of Care, Quality of Life, Abuse, or Neglect. Also refer to Physician Services and Nursing Services if test results were not acted upon timely as per the facility’s policies or the prescribing practitioner orders. There is no Tag for this section; refer to other Tags for concerns related to noncompliance. F770 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.50(a) Laboratory Services. §483.50(a)(1) The facility must provide or obtain laboratory services to meet the needs of its residents. The facility is responsible for the quality and timeliness of the services. (i) If the facility provides its own laboratory services, the services must meet the applicable requirements for laboratories specified in part 493 of this chapter. DEFINITIONS §483.50(a)(1)(i) “Laboratory service ” as referenced in §493.2, is any examination of materials derived from the human body for purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings. GUIDANCE §483.50(a)(1)(i) If a facility provides its own laboratory services or performs any laboratory tests directly (e.g., blood glucose monitoring, etc.) the provisions of 42 CFR Part §493 apply and the facility must have a current Clinical Laboratory Improvement Amendment (CLIA) certificate appropriate for the level of testing performed within the facility. Facilities collecting and/or preparing specimens and not performing testing are not considered to be providing laboratory services and do not need to meet the requirements of 42 CFR Part §493. Surveyors should only verify that the facility has a current CLIA certificate and not attempt to determine compliance with the requirements in 42 CFR part 493; rather, refer questions or concerns to CLIA surveyors. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION If noncompliance with §483.50(a)(1)(i) has been identified, the surveyor may have identified concerns with related structure, process, and/or outcome requirements. If an additional concern has been identified, the surveyor must investigate the identified concern. Do not cite any related or associated requirements before first conducting an investigation to determine compliance or non-compliance with the related or associated requirement. Examples include, but are not limited to, the following: • §483.30 - Physician Services • §483.35 - Nursing Services • §483.70(f) - Use of Outside Resources • §483.70(g) - Medical Director • §483.75 - Quality Assessment and Performance Improvement KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F770, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • Have a current CLIA certificate appropriate for the level of testing it performs; OR • Meet the needs of residents with regard to the quality and/or timeliness of providing laboratory services and reporting laboratory results: OR • Provide or obtain laboratory services, to meet the needs of its residents. F771 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.50(a)(1) The facility must provide or obtain laboratory services to meet the needs of its residents. The facility is responsible for the quality and timeliness of the services. (ii) If the facility provides blood bank and transfusion services, it must meet the applicable requirements for laboratories specified in part 493 of this chapter. GUIDANCE §483.50(a)(1)(ii) Transfusion services includes the process of transferring blood or blood components received from one person to another. Blood components include red blood cells, plasma, platelets, clotting factors, immunoglobulins, and white blood cells. Facilities must use processes for transfusion, including positive confirmation of the correct blood or blood components into the intended recipient. Only authorized personnel in accordance with State law, including scope of practice laws, shall verify the correct identification of transfusion recipients and administer blood or blood components. Personnel performing blood and/or blood component transfusions shall have the competencies and training to perform these services and identify and manage adverse events appropriately. For concerns related to staff competencies or training refer to: • Nursing Services §483.35(a)(3); • Administration §483.70(e); • Training §483.95. Recipients of transfusion services must be closely monitored during and after the transfusion for signs of adverse reactions and all transfusion-related activities must be documented in the resident’s medical record. Examples of adverse events/reactions either during or after transfusion include, but may not be limited to: • Increase in temperature or pulse rate • Conjunctival edema • Edema of lips, tongue and uvula • Erythema and edema of the periorbital area • Generalized flushing • Hypotension • Localized angioedema • Maculopapular rash • Pruritus (itching) • Respiratory distress; bronchospasm • Urticaria (hives) The above examples are based on information from the American Association of Blood Banks (AABB) https://www.aabb.org . PROCEDURES https://www.aabb.org/ If a nursing home provides blood transfusions (cross-matched at an outside laboratory), it must hold an appropriate CLIA certificate and must meet all of the requirements of §493.1103 for transfusion services and document all transfusion-related activities as required under §493.1103(d). The facility must have procedures for preventing transfusion reactions and promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory that provided the blood or blood products and as appropriate, to Federal and State authorities. If facility staff failed to properly identify the resident receiving the blood/blood products or failed to monitor the status of the resident during and/or after a transfusion, it should be cited under Quality of Care at F684. Nursing home surveyors should not evaluate compliance with the requirements in 42 CFR part §493. Questions or concerns must be referred to State Agency or Regional Office CLIA surveyors to determine whether or not the nursing home provided transfusion services in accordance with the requirements for specified in part §493. If it is verified by State Agency or Regional Office CLIA surveyors that requirements in part 493 were not met cite a deficiency under this Tag F771. The facility must have procedures for preventing transfusion reactions and promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory that provided the blood or blood products and as appropriate, to Federal and State authorities. If the facility provides transfusion services, determine whether they have policies, procedures, and protocols for: (a) Transfusion processes that include adverse reaction identification and corrective actions to be taken; (b) Investigating all transfusion reactions; and (c) Reporting all transfusion reactions to the appropriate officials and agencies. Review the facility’s procedures to ensure their process includes the positive identification of the blood or blood components to be transfused into the intended recipient. If a facility has not established policies as referenced above do not cite here but cite under §483.70(d) Governing body, F837. Also consider requirements at §483.70(g) Medical director, F841 for the responsibility to implement resident care policies. If a transfusion will be performed during the survey, observe the transfusion preparation process. Observe to determine whether or not a positive recipient verification and a second independent recipient verification were conducted prior to the initiation of the transfusion. If a surveyor has reason to suspect a resident is having an adverse reaction to a transfusion or the transfusion itself is not being properly administered, the surveyor shall immediately notify the facility Director of Nursing and the facility administrator. Assure that blood and blood components are stored in a clean and orderly environment which ensures the integrity of the component. Whole blood, red blood cells, and thawed plasma shall be stored in accordance with §493.1103(c). If there are questions or concerns, consult with CLIA surveyors. If blood and blood components are not stored to ensure the integrity of these components do not cite here, cite under §483.45(h) - Storage of drugs and biologicals. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F 771, the surveyor’s investigation will generally show that the facility failed to: • Provide transfusion services in accordance with the requirements for laboratories specified in part §493 to meet the needs of the residents. §483.50(a)(1) (iii) If the laboratory chooses to refer specimens for testing to another laboratory, the referral laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the requirements of part 493 of this chapter. There is no Tag for §483.50(a)(1)(iii). Nursing home surveyors should not attempt to determine compliance with the requirements in 42 CFR part §493 but should refer questions or concerns to the State Agency or CMS Regional Office for appropriate follow-up by CLIA surveyors. F772 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.50(a)(1) The facility must provide or obtain laboratory services to meet the needs of its residents. The facility is responsible for the quality and timeliness of the services. (iv) If the facility does not provide laboratory services on site, it must have an agreement to obtain these services from a laboratory that meets the applicable requirements of part 493 of this chapter. GUIDANCE §483.50(a)(1)(iv) If the facility does not provide laboratory services on site, it must have a written agreement to provide services from a laboratory which meets the requirements of 42 CFR part §493. Nursing home surveyors should not attempt to determine compliance with the requirements in 42 CFR part §493 but should refer questions or concerns to the State Agency or CMS Regional Office for appropriate follow-up by CLIA surveyors. If verified by CLIA surveyors that requirements in part §493 were not met cite a deficiency under this Tag, F772. F773 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.50(a)(2) The facility must— (i) Provide or obtain laboratory services only when ordered by a physician; physician assistant; nurse practitioner or clinical nurse specialist in accordance with State law, including scope of practice laws. (ii) Promptly notify the ordering physician, physician assistant, nurse practitioner, or clinical nurse specialist of laboratory results that fall outside of clinical reference ranges in accordance with facility policies and procedures for notification of a practitioner or per the ordering physician’s orders. GUIDANCE §483.50(a)(2)(i)(ii) For purposes of this requirement “promptly” means that results shall be relayed with little or no delay to the ordering physician, physician assistant, nurse practitioner, or clinical nurse specialist according to facility policies and procedures for notification and the medical orders. Facility policies and procedures should be developed in consultation with the medical director and follow current standards of practice. Such policies may include defining categories that are considered outside clinical reference ranges for laboratory values, the urgency of reporting values, and a process for monitoring the effectiveness of communication to ensure that communication was received, and delegation by the ordering provider to a qualified on-call individual as appropriate. PROCEDURES When reviewing the resident’s medical record, surveyors would determine that laboratory services were provided only when ordered by a physician, physician assistant, nurse practitioner or clinical nurse specialist in accordance with State law, including scope of practice laws, and facility staff and the ordering provider(s) were promptly notified of the results. If test results were not acted upon in a timely manner by the physician, physician assistant, nurse practitioner, clinical nurse specialist, or by facility staff as ordered, consider additional review for possible deficient practices under Medical Director, Nursing Services, Quality of Care or Quality of Life requirements. Do not cite any related or associated requirements before first conducting an investigation to determine compliance or non-compliance with the related or associated requirement. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F773, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • Obtain or provide laboratory services without an order by a physician, physician assistant. nurse practitioner or clinical nurse specialist in accordance with State law, including scope of practice laws; OR • Promptly notify the ordering physician, physician assistant, nurse practitioner, or clinical nurse specialist of laboratory results according to facility policies and procedures for notification and the medical orders. F774 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.50(a)(2) The facility must— (iii) Assist the resident in making transportation arrangements to and from the source of service, if the resident needs assistance. PROCEDURES During record reviews and interviews with residents, family members or resident representatives, determine if residents were offered and assisted in making transportation arrangements. In order to assist a resident, the facility should consider the resident’s clinical, physical, mental, and financial condition. For example, assisting a resident who has limited funds to be transported by a taxi when other, more inexpensive options are available would not really be assisting the resident. However, this standard is not requiring a facility to defray or cover the costs of transportation. If appointments were cancelled due to difficulties with transportation including the costs of transportation, determine if this was due to the facility’s procedures. If there are concerns regarding charges to the resident for any of these services, refer to §483.10(f)(10) and (11), Resident Rights Self-determination or §483.10(g)(17) and (18), Information and Communication. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F774, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • If required or requested, residents were not assisted in making transportation arrangements to and from the source of service; OR • If any delay in making these arrangements adversely affected resident care or treatment. If so, also refer to Quality of Care or Quality of Life requirements. F775 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.50(a)(2) The facility must— (iv) File in the resident's clinical record laboratory reports that are dated and contain the name and address of the testing laboratory. PROCEDURES Review the resident’s clinical record to determine laboratory reports are included and that the reports are dated and contain the name and address of the testing laboratory. If there are other medical record documentation concerns, refer to §483.70(h) - Medical Records. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F775, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • Have laboratory reports filed in the resident’s clinical record; OR • Laboratory reports were not dated; OR • Laboratory reports did not contain the name and address of the testing laboratory. F776 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.50(b) Radiology and other diagnostic services. §483.50(b)(1) The facility must provide or obtain radiology and other diagnostic services to meet the needs of its residents. The facility is responsible for the quality and timeliness of the services. (i) If the facility provides its own diagnostic services, the services must meet the applicable conditions of participation for hospitals contained in §482.26 of this subchapter. (ii) If the facility does not provide its own diagnostic services, it must have an agreement to obtain these services from a provider or supplier that is approved to provide these services under Medicare. GUIDANCE §483.50(b)(1)(i)(ii) If the facility provides its own radiologic or other diagnostic services, the services must meet the applicable requirements for radiologic services contained at §482.26 – Conditions of Participation for Hospitals- Radiologic Services. If there are questions or concerns refer to State Agency or CMS Regional Office for appropriate discussion and follow-up with surveyors trained in assessing compliance with §482.26 (i.e., hospital surveyors). If the facility does not provide its own radiologic or diagnostic services, it must have a written agreement to obtain these services from a provider or supplier that is approved to provide these services under Medicare. For concerns regarding this agreement, refer to §483.70(f) - Use of Outside Resources. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F776, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • Provide or obtain radiology or other diagnostic services to meet the needs of its residents: OR • Meet the needs of residents with regard to the quality and/or timeliness of providing radiology or other diagnostic services: OR • Have a written agreement to obtain these services from a provider or supplier that is approved to provide these services under Medicare: OR • If the facility provides its own radiologic or other diagnostic services, the services do not meet the applicable requirements at §482.26. F777 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.50(b)(2) The facility must— (i) Provide or obtain radiology and other diagnostic services only when ordered by a physician; physician assistant; nurse practitioner or clinical nurse specialist in accordance with State law, including scope of practice laws. (ii) Promptly notify the ordering physician, physician assistant, nurse practitioner, or clinical nurse specialist of results that fall outside of clinical reference ranges in accordance with facility policies and procedures for notification of a practitioner or per the ordering physician’s orders. GUIDANCE §483.50(b)(2)(i)(ii) For purposes of this requirement “promptly” means that results shall be relayed, with little or no delay to the ordering physician, physician assistant, nurse practitioner, or clinical nurse specialist according to facility policies and procedures for notification and the medical orders. Facility policies and procedures should be developed in consultation with the medical director and follow current standards of practice. Such policies may include defining categories where follow-up is required, the urgency of reporting specific concerns, and a process for monitoring the effectiveness of communication to ensure that communication was received, and delegation by the ordering provider to a qualified on-call individual as appropriate. PROCEDURES When reviewing the resident’s medical record, surveyors would determine that radiology and other diagnostic services were provided only when ordered by a physician, physician assistant, nurse practitioner or clinical nurse specialist in accordance with State law, including scope of practice laws, and facility staff and the ordering provider(s) were promptly notified of the results. If results were not acted upon in a timely manner by the physician; physician assistant; nurse practitioner; clinical nurse specialist; or by facility staff as ordered, consider additional review for possible deficient practices under Medical Director, Nursing Services, Quality of Care or Quality of Life requirements. Do not cite any related or associated requirements before first conducting an investigation to determine compliance or non-compliance with the related or associated requirement. KEY ELEMENTS OF NON-COMPLIANCE To cite deficient practice at F777, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • Provide or obtain radiology or other diagnostic services within the timeframe(s) specified in the medical order(s), or obtained or provided these services without an order by a physician; physician assistant; nurse practitioner or clinical nurse specialist in accordance with State and scope of practice laws; OR • Promptly notify the ordering physician, physician assistant, nurse practitioner, or clinical nurse specialist of results according to facility policies and procedures for notification and the medical orders. F778 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.50(b)(2)(iii) Assist the resident in making transportation arrangements to and from the source of service, if the resident needs assistance. PROCEDURES During record reviews and interviews with residents, family members or resident representatives, determine if residents were offered and assisted in making transportation arrangements. In order to “assist” a resident, the facility should consider the resident’s clinical, physical, mental, and financial condition. For example, assisting a resident who has limited funds to be transported by a taxi or a private car service when other, more inexpensive options are available would not really be “assisting” the resident. However, this standard is not requiring a facility to defray or cover the costs of transportation either. If any appointments were canceled due to difficulties with transportation including the costs of transportation, determine if this was a result of facility procedures. If there are concerns regarding charges to the resident for any of these services, refer to §483.10(f)(10) and (11) - Resident Rights - Self-determination or §483.10(g(17) and (18) – Information and Communication. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F778, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • If required or requested, assist residents in making transportation arrangements to and from the source of service; OR • If any delay by the facility in making these arrangements adversely affected resident care or treatment. If so, also refer to Quality of Care or Quality of Life requirements. F779 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.50(b)(2)(iv) File in the resident's clinical record signed and dated reports of radiologic and other diagnostic services. PROCEDURES Review resident clinical records to determine if reports of radiologic and other diagnostic services reports are filed and that they are signed and dated. If there are other medical record documentation concerns, refer to §483.70(h) - Medical Records. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F779, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • Have reports filed in the resident’s clinical record; OR • Reports were not dated or signed. F790 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.55 Dental services. The facility must assist residents in obtaining routine and 24-hour emergency dental care. §483.55(a) Skilled Nursing Facilities A facility— §483.55(a)(1) Must provide or obtain from an outside resource, in accordance with with §483.70(f) of this part, routine and emergency dental services to meet the needs of each resident; §483.55(a)(2) May charge a Medicare resident an additional amount for routine and emergency dental services; §483.55(a)(3) Must have a policy identifying those circumstances when the loss or damage of dentures is the facility’s responsibility and may not charge a resident for the loss or damage of dentures determined in accordance with facility policy to be the facility's responsibility; §483.55(a)(4) Must if necessary or if requested, assist the resident; (i) In making appointments; and (ii) By arranging for transportation to and from the dental services location; and §483.55(a)(5) Must promptly, within 3 days, refer residents with lost or damaged dentures for dental services. If a referral does not occur within 3 days, the facility must provide documentation of what they did to ensure the resident could still eat and drink adequately while awaiting dental services and the extenuating circumstances that led to the delay. F791 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.55 Dental Services The facility must assist residents in obtaining routine and 24-hour emergency dental care. §483.55(b) Nursing Facilities. The facility— §483.55(b)(1) Must provide or obtain from an outside resource, in accordance with §483.70(f) of this part, the following dental services to meet the needs of each resident: (i) Routine dental services (to the extent covered under the State plan); and (ii) Emergency dental services; §483.55(b)(2) Must, if necessary or if requested, assist the resident— (i) In making appointments; and (ii) By arranging for transportation to and from the dental services locations; §483.55(b)(3) Must promptly, within 3 days, refer residents with lost or damaged dentures for dental services. If a referral does not occur within 3 days, the facility must provide documentation of what they did to ensure the resident could still eat and drink adequately while awaiting dental services and the extenuating circumstances that led to the delay; §483.55(b)(4) Must have a policy identifying those circumstances when the loss or damage of dentures is the facility’s responsibility and may not charge a resident for the loss or damage of dentures determined in accordance with facility policy to be the facility's responsibility; and §483.55(b)(5) Must assist residents who are eligible and wish to participate to apply for reimbursement of dental services as an incurred medical expense under the State plan. INTENT of §483.55(a)[F790] & (b) [F791] To ensure that residents obtain needed dental services, including routine dental services; to ensure the facility provides the assistance needed or requested to obtain these services; to ensure the resident is not inappropriately charged for these services; and if a referral does not occur within three business days, documentation of the facility’s to ensure the resident could still eat and drink adequately while awaiting dental services and the extenuating circumstances that led to the delay. DEFINITIONS for §483.55(a)[F790] & (b) [F791] “Emergency dental services” includes services needed to treat an episode of acute pain in teeth, gums, or palate; broken, or otherwise damaged teeth, or any other problem of the oral cavity that required immediate attention by a dentist. “Promptly” means within 3 business days or less from the time the loss or damage to dentures is identified unless the facility can provide documentation of extenuating circumstances that resulted in the delay. “Routine dental services” means an annual inspection of the oral cavity for signs of disease, diagnosis of dental disease, dental radiographs as needed, dental cleaning, fillings (new and repairs), minor partial or full denture adjustments, smoothing of broken teeth, and limited prosthodontic procedures, e.g., taking impressions for dentures and fitting dentures. GUIDANCE for §483.55(a)[F790] & (b) [F791] A dentist must be available for each resident. The dentist can be directly employed by the facility or the facility can have a written contractual agreement with a dentist. The facility may also choose to have a written agreement for dentist services from a dental clinic, dental school or a dental hygienist all of whom are working within Federal and State laws and under the direct supervision of a dentist. For Medicare and private pay residents, facilities are responsible for having the services available, but may bill an additional charge for the services. For Medicaid residents, the facility must provide all emergency dental services and those routine dental services to the extent covered under the Medicaid state plan. The facility must inform the resident of the deduction for the incurred medical expense available under the Medicaid State plan and must assist the resident in applying for the deduction. If any resident is unable to pay for dental services, the facility should attempt to find alternative funding sources or delivery systems so that the resident may receive the services needed to meet their dental needs and maintain his/her highest practicable level of well-being. This can include finding other providers of dental services, such as a dental school or the provision of dental hygiene services on site at a facility. The facility must assist residents in making arrangements for transportation to their dental appointments when necessary or requested. The facility should attempt to minimize the financial burden on the resident by finding the lowest cost or no cost transportation option to dental health care appointments. The facility must have a policy identifying those instances when the loss or damage of partial or full dentures is the facility’s responsibility, such as when facility staff discards dentures placed on a meal tray. A blanket policy of facility non-responsibility for the loss or damage of dentures or a policy stating the facility is only responsible when the dentures are in actual physical possession of facility staff would not meet the requirement. In addition, the facility is prohibited from requesting or requiring residents or potential residents to waive any potential facility liability for losses of personal property. See §483.15(a)(2)(iii), F620, Admissions Policy. Prompt referral means no later than three (3) business days from the time the partial or full dentures are lost or damaged. Referral does not mean that the resident must see the dentist at that time. It does mean that an earliest possible appointment (referral) is made, or that the facility is aggressively working to have the dentures repaired or replaced if the dentist was contacted timely and determined the dentures could be repaired or replaced without a dental visit. If there is a delay in making the referral, the facility must document the circumstances that led to the delay. The facility must also be able to provide documentation demonstrating what they did to ensure the resident could still adequately eat and drink while waiting for the issue with their dentures to be addressed. If concerns are identified regarding providing ADL assistance for oral hygiene (such as assistance with brushing, flossing, denture cleaning), do not cite here. See guidance under §483.24(a), F677, Activities of Daily Living. Summary of Procedures for §483.55(a)[F790] & (b) [F791] The process to review concerns are outlined in the Dental Care Area Pathway. Record Review Review the resident’s records for identification of the resident’s dental needs and the resident’s responsiveness to dental services. The information found in the resident’s assessment and care plans should be used to guide resident observations, and to determine whether the facility has met or is meeting related regulatory requirements including, but not limited to, person-centered care planning, resident assessment, and dental services. Finally, determine the resident’s payer status (Medicare, Medicaid or private pay) for service eligibility determinations. Observation Observe the resident to determine if his or her dental status is consistent with the comprehensive assessment or if the resident exhibited signs of dental health concerns that may not have been identified. Resident/Resident Representative Interview Interview the resident and/or resident representative to determine if any concerns identified since the last survey were promptly addressed to the resident’s or the resident representative’s satisfaction. This includes determining if the facility provided the assistance to obtain dental services needed or requested by the resident or resident representative and whether the facility assisted the resident with arranging transportation to the dental appointment. If the identified concern is related to missing or damaged dentures, interview the resident and family/resident representative to determine if a referral was promptly (within three business days) made, if an explanation was provided if a referral was not promptly made, and if the facility took measures to ensure the resident was able to continue to eat or drink adequately while awaiting dental services. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice, the surveyor’s investigation will generally show that the facility any of the following: For residents receiving Medicare and private pay residents, F790: • Failed to provide or obtain from an outside resource, in accordance with §483.70(f), routine and emergency dental services to meet the needs of each resident; or • Did not assist the resident as necessary or requested to make appointments for dental services and/or arrange for transportation to and from the dental service location; or • Did not promptly, within three business days, refer a resident with lost or damaged partial or full dentures and/or documented the extenuating circumstances that led to a delay; or • Did not document what the facility did to ensure a resident with missing or damaged dentures could still eat and drink adequately while awaiting dental services; or • Charged a resident for the loss or damage of partial or full dentures determined to by facility policy to be the facility’s responsibility. For residents receiving Medicaid, F791: • Failed to provide or obtain from an outside resource, in accordance with §483.70(f), routine (to the extent covered by the State plan) and emergency dental services for each resident; or • Did not assist the resident as necessary or requested to make appointments for dental services or arrange for transportation to and from dental services locations; or • Did not promptly, within three days, refer a resident with lost or damaged partial or full dentures and/or documented the extenuating circumstances that led to a delay; or • Did not document what the facility did to ensure a resident with missing or damaged partial or full dentures could still eat and drink adequately while awaiting dental services; or • Charged a resident for the loss or damage of partial or full dentures determined to by facility policy to be the facility’s responsibility; or • Failed to assist a resident(s) who are eligible to participate and/or wish to participate to apply for reimbursement of dental services as an incurred medical expense under the State plan; or • Charged a Medicaid resident an added fee for routine dental services covered by the State plan or for emergency dental services. ADDITIONAL TAGS FOR CONSIDERATION MAY INCLUDE, BUT ARE NOT LIMITED TO: • §483.10(g)(14), F580, Notification of Change o Determine whether staff notified all necessary care providers and resident representatives of change in dental/oral condition when required. • §483.20(b)(i), (iii), F636, Comprehensive Assessment o Determine if the facility comprehensively assessed the resident’s risk and/or underlying causes (to the extent possible) of the resident’s dental/oral condition and the impact upon the resident’s function, mood and cognition. • §483.20(g), F641, Accuracy of Assessments o Determine whether the assessment accurately reflected the dental condition of the resident at the time of the assessment. • §483.21(b)(1), F656, Comprehensive Care Plan o Determine if the facility developed a care plan based on the comprehensive assessment to address the resident’s dental/oral condition. • §483.25(g)(1)-(3), F692, Assisted Nutrition and Hydration o Determine if the staff ensured the resident maintained or did not experience an avoidable decline in nutritional status related to the resident’s oral/dental condition. • §483.25(k), F697, Pain Management o Determine whether staff have assessed, care-planned, and provided services to manage a resident’s oral/dental pain. • §483.35(a), F725, Sufficient and Competent Nursing Staff o Determine whether based on the resident’s needs the facility had qualified staff in sufficient numbers and with the required competencies to identify dental concerns and provide necessary routine resident dental care. • §483.40(d), F745, Social Services o Determine whether the facility provided medically-related social services by addressing any unmet needs related to dental/denture or oral care. • §483.45(d), F757, Unnecessary Medications o Determine if the resident is experiencing an adverse dental/oral consequence of a medication which indicated the dose should have been reduced or discontinued, or any combination of the reasons stated in §§483.45(d)(1)-(5). • §483.70(h)(5), F842, Medical Records o Determine whether the resident’s records accurately and completely document the resident’s dental/oral status and the care and services provided in accordance with current professional standards and practices. • §483.70(f), F840, Use of Outside Resources o Determine whether dental services provided met professional standards and principles and the timeliness of those services. • §483.70(g), F841, Medical Director o Determine if the medical director was involved in the development of dental/oral health policies/procedures and the coordination of care both on-site as well as availability of off-site providers and addressed any quality concerns. F800 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.60 Food and nutrition services. The facility must provide each resident with a nourishing, palatable, well-balanced diet that meets his or her daily nutritional and special dietary needs, taking into consideration the preferences of each resident. INTENT §483.60 - To ensure that facility staff support the nutritional well-being of the residents while respecting an individual’s right to make choices about his or her diet. GUIDANCE §483.60 This requirement expects that there is ongoing communication and coordination among and between staff within all departments to ensure that the resident assessment, care plan and actual food and nutrition services meet each resident’s daily nutritional and dietary needs and choices. While it may be challenging to meet every residents’ individual preferences, incorporating a residents’ preferences and dietary needs will ensure residents are offered meaningful choices in meals/diets that are nutritionally adequate and satisfying to the individual. Reasonable efforts to accommodate these choices and preferences must be addressed by facility staff. Also, cite this Tag if there are overall systems issues relating to how the facility manages and executes its food and nutrition services. F801 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.60(a) Staffing The facility must employ sufficient staff with the appropriate competencies and skills sets to carry out the functions of the food and nutrition service, taking into consideration resident assessments, individual plans of care and the number, acuity and diagnoses of the facility’s resident population in accordance with the facility assessment required at §483.71 This includes: §483.60(a)(1) A qualified dietitian or other clinically qualified nutrition professional either full-time, part-time, or on a consultant basis. A qualified dietitian or other clinically qualified nutrition professional is one who— (i) Holds a bachelor’s or higher degree granted by a regionally accredited college or university in the United States (or an equivalent foreign degree) with completion of the academic requirements of a program in nutrition or dietetics accredited by an appropriate national accreditation organization recognized for this purpose. (ii) Has completed at least 900 hours of supervised dietetics practice under the supervision of a registered dietitian or nutrition professional. (iii) Is licensed or certified as a dietitian or nutrition professional by the State in which the services are performed. In a State that does not provide for licensure or certification, the individual will be deemed to have met this requirement if he or she is recognized as a “registered dietitian” by the Commission on Dietetic Registration or its successor organization, or meets the requirements of paragraphs (a)(1)(i) and (ii) of this section. (iv) For dietitians hired or contracted with prior to November 28, 2016, meets these requirements no later than 5 years after November 28, 2016 or as required by state law. §483.60(a)(2) If a qualified dietitian or other clinically qualified nutrition professional is not employed full-time, the facility must designate a person to serve as the director of food and nutrition services. (i) The director of food and nutrition services must at a minimum meet one of the following qualifications— (A) A certified dietary manager; or (B) A certified food service manager; or (C) Has similar national certification for food service management and safety from a national certifying body; or D) Has an associate’s or higher degree in food service management or in hospitality, if the course study includes food service or restaurant management, from an accredited institution of higher learning; or (E) Has 2 or more years of experience in the position of director of food and nutrition services in a nursing facility setting and has completed a course of study in food safety and management, by no later than October 1, 2023, that includes topics integral to managing dietary operations including, but not limited to, foodborne illness, sanitation procedures, and food purchasing/receiving; and (ii) In States that have established standards for food service managers or dietary managers, meets State requirements for food service managers or dietary managers, and (iii) Receives frequently scheduled consultations from a qualified dietitian or other clinically qualified nutrition professional. INTENT §483.60 (a)(1)-(2) - To ensure there is sufficient and qualified staff with the appropriate competencies and skill sets to carry out food and nutrition services. DEFINITIONS §483.60(a)(1)-(2) “Full-time” means working 35 or more hours a week. “Part-time” employees typically work fewer hours in a day or during a work week than full-time employees. The U.S. Department of Labor, Bureau of Statistics uses a definition of 34 or fewer hours a week as part-time work. Part-time workers may also be those who only work during certain parts of the year. “Consultants” means an individual who gives professional advice or services. They are generally not direct employees of the facility and may work either full or part-time. GUIDANCE §483.60(a)(1)-(2) Cite F801 for concerns regarding the qualifications of the dietitian, other clinical nutrition professionals, or the food services director. For concerns regarding support personnel refer to F802, Sufficient Dietary Support Personnel. In addition, cite F801 if staff, specifically the qualified dietitian or other clinically qualified nutrition professional did not carry out the functions of the food and nutrition services. While these functions may be defined by facility management, at a minimum they should include, but are not limited to: • Assessing the nutritional needs of residents; • Developing and evaluating regular and therapeutic diets, including texture of foods and liquids, to meet the specialized needs of residents; • Developing and implementing person centered education programs involving food and nutrition services for all facility staff; • Overseeing the budget and purchasing of food and supplies, and food preparation, service and storage; and, • Participating in the quality assurance and performance improvement (QAPI), as described in §483.75, when food and nutrition services are involved. The qualified dietitian or other clinically qualified nutrition professional can decide to oversee and delegate some of the activities listed above to the director of food and nutrition services. PROBES §483.60(a)(1)-(2) If the survey team finds concerns regarding a resident’s food and/or nutritional status determine: • If the practices of the dietitian, nutrition professional, and/or food services director contributed to the identified concerns. If so how? • How facility management ensures that staff have the appropriate competencies and skills sets to carry out the functions of the food and nutrition service? • If a food services director is employed by the facility, do they have frequent consultations with the dietitian or other nutrition professionals or consultants employed by the facility? POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION §483.60(a)(1)-(2) During the investigation of F801, the surveyor may have identified concerns with additional requirements related to outcome, process, and/or structure requirements. The surveyor is advised to investigate these related requirements before determining whether non-compliance may be present at these other tags. Examples of some of the related requirements that may be considered when non-compliance has been identified include, but are not limited to, the following but are not limited to: • §483.25(b)(1), F686, Pressure Injury o Determine if the facility identified, evaluated, and responded to a change in a resident’s skin integrity. • §483.25(g)(1)-(3), F692, Nutrition/Hydration Status o Determine if the facility identified, evaluated, and responded to a change in nutritional parameters, anorexia, or unplanned weight loss, dysphagia, and/or swallowing disorders in relation to the resident’s ability to eat. • §483.25(g)(4)-(5), F693, Tube Feeding Management o Determine if the facility identified, evaluated, and responded to the use of a naso-gastric and gastrostomy tubes. F802 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.60(a) Staffing The facility must employ sufficient staff with the appropriate competencies and skills sets to carry out the functions of the food and nutrition service, taking into consideration resident assessments, individual plans of care and the number, acuity and diagnoses of the facility’s resident population in accordance with the facility assessment required at §483.71. §483.60(a)(3) Support staff. The facility must provide sufficient support personnel to safely and effectively carry out the functions of the food and nutrition service. §483.60(b) A member of the Food and Nutrition Services staff must participate on the interdisciplinary team as required in § 483.21(b)(2)(ii). DEFINITION §483.60(a)(3)-(b) “Sufficient support personnel” means having enough dietary and food and nutrition staff to safely carry out all of the functions of the food and nutrition services. This does not include staff, such as licensed nurses, nurse aides or paid feeding assistants, involved in assisting residents with eating. PROCEDURES §483.60(a)(3) and (b) • Through observations and interviews determine if there are sufficient support personnel to safely and effectively carry out the meal preparation and other food and nutrition services as defined by facility management. • Observe and interview residents to determine if their needs and preferences are met, if the food is palatable, attractive, served at the proper temperatures and at appropriate times? If concerns are identified, determine if they may be related to insufficient or inadequately trained personnel. • Do observations and/or interviews indicate there are sufficient staff to prepare and serve meals in a timely manner and to maintain food safety and temperature? • Determine who represents food and nutrition services at interdisciplinary team meetings. When evaluating timeliness, factors that should be considered include but may not be limited to: • Meals or nutritional supplements are provided in accordance with a resident’s medication requirements; • Meals intended to be “hot” are served as such and are maintained at the desired temperature when provided to the resident; • Meals or nutritional supplements are provided to residents within 45 minutes of either a residents request or less depending on the facility’s scheduled time for meals. If a concern with having sufficient staff is identified, determine if the staffing levels provided were based on the facility assessment. If a concern with the facility assessment is identified, see §483.71, F838, Facility Assessment. F803 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.60(c) Menus and nutritional adequacy. Menus must- §483.60(c)(1) Meet the nutritional needs of residents in accordance with established national guidelines; §483.60(c)(2) Be prepared in advance; §483.60(c)(3) Be followed; §483.60(c)(4) Reflect, based on a facility’s reasonable efforts, the religious, cultural and ethnic needs of the resident population, as well as input received from residents and resident groups; §483.60(c)(5) Be updated periodically; §483.60(c)(6) Be reviewed by the facility’s dietitian or other clinically qualified nutrition professional for nutritional adequacy; and §483.60(c)(7) Nothing in this paragraph should be construed to limit the resident’s right to make personal dietary choices. INTENT §483.60(c)(1)-(7) - To assure that menus are developed and prepared to meet resident choices including their nutritional, religious, cultural, and ethnic needs while using established national guidelines. DEFINITIONS §483.60(c)(1)-(7) “Reasonable effort” means assessing individual resident needs and preferences and demonstrating actions to meet those needs and preferences, including reviewing availability of procurement sources of such food items, identifying preparation methods and approaches, and determining whether purchasing and serving such items can occur. “Periodically” means that a facility should update its menus to accommodate their changing resident population or resident needs as determined by their facility assessment. See F838. This includes ethnic, cultural, or religious factors that may potentially affect the care provided by the facility, including, but not limited to, activities and food and nutrition services. GUIDANCE §483.60(c)(1-7) The facility must make reasonable efforts to provide food that is appetizing to and culturally appropriate for residents. This means learning the resident’s needs and preferences and responding to them. For residents with dementia or other barriers or challenges to expressing their preferences, facility staff should document the steps taken to learn what those preferences are. It is not required that there be individualized menus for all residents; however, alternatives aligned with individual needs and preferences should be available if the primary menu or immediate selections for a particular meal are not to a resident’s liking. Facilities must make reasonable and good faith efforts to develop a menu based on resident requests and resident groups’ feedback. PROCEDURES §483.60(c)(1-7) If during meal observations, a resident’s dietary intake appears inadequate determine through interviews and record review if facility staff made reasonable efforts to review and/or adjust the menu and/or the individual resident’s food plan to meet the nutritional, religious, cultural, and ethnic needs, and preferences of the resident. If the survey team observes deviation from a resident’s planned menu, review documentation, i.e., diet card, medical record and interview the resident, food service manager or dietitian to support reason(s) for deviation from the planned menu. PROBES §483.60(c)(1-7) Through interviews, observations and record reviews determine if: • Residents are receiving food in the amount, type, consistency and frequency to maintain normal body weight and acceptable nutritional values. • Resident preferences and needs are incorporated into the development of the individual food plan? • A resident chooses not to consume certain foods or food groups such as the resident is a vegetarian or does not eat dairy, how does the facility ensure the resident’s menu and/or the individual resident’s food plan meets his or her nutritional needs? • Menus meet basic nutritional needs by providing meals based on individual nutritional assessment, the individualized plan of care, and established national guidelines and are periodically updated to mitigate the risk of menu fatigue? • Menus are reviewed and revised as needed by a qualified dietitian or other qualified nutrition professional? NOTE: Standard meal planning guides may be used for menu planning and food purchasing. They are not intended to meet the nutritional needs and preferences of residents and must be adjusted to consider individual differences. Some residents will need more due to age, size, gender, physical activity, and state of health. There are many guides , i.e., American Diabetes Association, Academy of Nutrition and Dietetics, American Medical Association, or U.S. Department of Agriculture, that are available and appropriate for use when adjusted to meet each resident’s needs. DEFICIENCY CATEGORIZATION • Examples of Level 4, immediate jeopardy to resident health and safety, include, but are not limited to: o The facility only maintains a one day supply of foods and drink on hand to prepare and serve their planned menus. This supply did not include foods to meet the nutritional needs or choices of residents. Several residents reported that they were often hungry and were told by staff that no snacks or other food was available. o Facility staff failed to follow a menu for a resident on a puree diet. The wrong texture of diet was provided which resulted in a choking incident for this resident. This placed the resident at risk for potential death or brain damage due to lack of oxygen from choking. • An example of Level 3, Actual harm (physical or psychological) that is not immediate jeopardy, includes, but is not limited to: o Based on a resident’s current comprehensive assessment, the resident’s nutritional needs changed; however facility staff did not change or updated a menu to meet the nutritional needs of this resident. As a result this resident experienced significant weight loss. • Examples of Level.2 - No actual harm with a potential for more than minimal harm (physical or psychological) that is not immediate jeopardy, include but are not limited to: o The facility failed to ensure the resident’s menus and/or the individual resident’s food plan met her/his nutritional needs and preferences. o A repetitive menu was provided to the residents resulting in complaints about the lack of variety in food options. • An example of Level 1 - No actual harm with a potential for minimal harm includes but is not limited to: o While no resident complaints were received during survey, it was observed that food items were being substituted with equally nutritious foods, but not noted or updated on the menu and residents were not notified of the change. F804 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.60(d) Food and drink Each resident receives and the facility provides— §483.60(d)(1) Food prepared by methods that conserve nutritive value, flavor, and appearance; §483.60(d)(2) Food and drink that is palatable, attractive, and at a safe and appetizing temperature. INTENT §483.60(d)(1)-(2) - To assure that the nutritive value of food is not compromised and destroyed because of prolonged: (1) Food storage, light, and air exposure; or (2) Cooking of foods in a large volume of water; or (3) Holding on steam table. DEFINITIONS §483.60(d)(1)-(2) “Food attractiveness” refers to the appearance of the food when served to residents. “Food palatability” refers to the taste and/or flavor of the food. “Proper (safe and appetizing) temperature” means both appetizing to the resident and minimizing the risk for scalding and burns. GUIDANCE §483.60(d)(1)-(2) Food should be palatable, attractive, and at an appetizing temperature as determined by the type of food to ensure resident’s satisfaction, while minimizing the risk for scalding and burns. Providing palatable, attractive, and appetizing food and drink to residents can help to encourage residents to increase the amount they eat and drink. Improved nutrition and hydration status can help prevent, or aid in the recovery from, illness or injury. PROCEDURES §483.60(d)(1)-(2) If there are complaints concerning food temperatures, palatability, or attractiveness from residents or through group interviews, observations of food not being eaten, or delay in passing of food trays, request a test tray from the dining area, floor or unit of most concern. In addition; • Review recipes, if needed, to determine if non-compliance exists. • If a test tray was obtained, how did it support resident or observed concerns? PROBES §483.60(d)(1)-(2) • Does food have a distinctly appetizing aroma and appearance, which is varied in color and texture? • Is food generally well-seasoned (use of spices, herbs, etc.) and acceptable to residents? If not, did the facility ensure all ingredients were available to make recipes as instructed for palatability? • Is food prepared in a way to preserve vitamins? Method of storage and preparation should cause minimum loss of nutrients. For example, foods are prepared as directed or not held at hot temperatures for hours prior to meal service because prolonged hot temperatures can result in a loss of vitamins. • Is food served at preferable temperature for the resident (hot foods are served hot and cold foods are served cold and in accordance with resident preferences). (Not to be confused with the proper holding temperature. Refer to §483.60(i) food safety requirements. • Was the facility aware of the resident(s) complaint(s) about the food through resident council, the grievance/complaint process at the facility, or communication directly with staff? What did facility do to address the complaint(s)? F805 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.60(d) Food and drink Each resident receives and the facility provides— §483.60(d)(3) Food prepared in a form designed to meet individual needs. PROCEDURES §483.60(d)(3) • Observe meals and food preparation to assure the food is prepared and appropriate to meet resident’s needs and according to their assessment and care plan. • Are there any observations of residents having difficulty chewing or swallowing their food? • Is the food cut, chopped, ground, or pureed for individual resident’s needs? F806 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.60(d) Food and drink Each resident receives and the facility provides— §483.60(d)(4) Food that accommodates resident allergies, intolerances, and preferences; §483.60(d)(5) Appealing options of similar nutritive value to residents who choose not to eat food that is initially served or who request a different meal choice; and GUIDANCE §483.60 (d)(4)-(5) Facilities should be aware of each resident’s allergies, intolerances, and preferences, and provide an appropriate alternative. A food substitute should be consistent with the usual and/or ordinary food items provided by the facility. For example, the facility may, instead of grapefruit juice, substitute another citrus juice or vitamin C rich juice the resident likes. PROCEDURES §483.60(d)(4)-(5) Observe meal services. If a resident appears to refuse food or drink items, determine if he or she is offered the opportunity to receive substitutes. PROBES §483.60(d)(4)-(5) • Ask residents how the food meets their preferences, allergies and/or intolerances. • If residents who refuse food or drinks, ask them if they are offered substitutes. • Interview residents or staff to determine how alternate food choices are communicated to the residents? • How are food textures, allergies, intolerances, and preferences accommodated per a resident’s assessment, care plan and choice and how is this information communicated to staff? POTENTIAL TAGS FOR FURTHER INVESTIGATION §483.60(d)(4)-(5) During the investigation of F806, the surveyor may have identified concerns with additional requirements related to outcome, process, and/or structure requirements. The surveyor is advised to investigate these related requirements before determining whether non-compliance may be present at these other tags. Examples of some of the related requirements that may be considered when non-compliance has been identified include, but are not limited to, the following: • §483.20(b), F636, Comprehensive Assessments o Determine if the resident’s allergies, intolerances, preferences, or need for a therapeutic diet were comprehensively assessed. • §483.21(b)(1), F656, Comprehensive Care Plans o Determine if a comprehensive care plan was developed to include the resident’s allergies, intolerances, preferences, or need for a therapeutic diet. • §483.21(b)(2), F657, Comprehensive Care Plan Revision o Determine if the care plan was reviewed and revised by appropriate staff, in conjunction with the interdisciplinary team and with input from the resident or his/her legal representative, to try to address any allergies, intolerances, preferences, or need for a therapeutic diet. • §483.21(b)(3)(i), F658, Care provided by Qualified Persons in Accordance with the Plan of Care o Determine whether the care plan for a resident with allergies, intolerance, preferences, or a therapeutic diet is adequately and/or correctly implemented. • §483.25(g)(1)-(3), F692, Nutrition/Hydration o Determine if the facility has managed the resident’s nutritional interventions to meet the resident’s nutritional needs, while accommodating the resident’s allergies, intolerances, preferences, or need for a therapeutic diet. F807 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.60(d) Food and drink Each resident receives and the facility provides— §483.60(d)(6) Drinks, including water and other liquids consistent with resident needs and preferences and sufficient to maintain resident hydration. GUIDANCE §483.60(d)(6) Proper hydration alone is a critical aspect of nutrition among nursing home residents. Individuals who do not receive adequate fluids are more susceptible to urinary tract infections, pneumonia, decubitus ulcers, skin infections, confusion and disorientation. 1, 2, 3 1 Chidester, J.C., and Spangler, A.A, “Fluid Intake in the Institutionalized Elderly,” Journal of the American Dietetic Association 97 (1991):23-30. 2 Feinsod, F., Levenson, S., Rapp, K., Rapp, M., Beechinor, E., Liebmann, L. (2004). “Dehydration in frail, older residents in long-term care facilities.” Journal of the American Medical Directors Association, 5(2 Suppl), S35-S41. 3 Gasper, P.M. “Water Intake of Nursing Home Resident.” Journal of Gerontologic Nursing. 1999; 25(4):22-29. Other food items may also include items that become a liquid at room temperature, such as popsicles and ice cream. If a concern is identified regarding maintaining a resident’s hydration status or about a resident’s fluid restriction, see §483.25(g)(1)-(3), F692, Nutrition/Hydration Status. PROBES §483.60(d)(6) • Are drinks and other fluids provided when the resident requests and consistent with the resident’s care plan, preferences and choices? • Does facility staff provide sufficient drinks that the resident prefers to maintain hydration? • Are other liquids, such as broth, popsicles, or ice cream, offered to the resident to encourage fluid intake? • What action does facility staff take to ensure resident hydration is maintained if a resident refuses the fluids offered? POTENTIAL TAGS FOR FURTHER INVESTIGATION §483.60(d)(6) During the investigation of F807, the surveyor may have identified concerns with additional requirements related to outcome, process, and/or structure requirements. The surveyor is advised to investigate these related requirements before determining whether non-compliance may be present at these other tags. Examples of some of the related requirements that may be considered when non-compliance has been identified include, but are not limited to, the following: • §483.10(c), F552, Right to Make Treatment Decisions o Determine if the facility addressed the resident’s right to refuse treatment, including drinks and thickened fluids. • §483.20(b), F636, Comprehensive Assessments o Determine if the resident’s hydration status was comprehensively assessed. • §483.21(b)(1), F656, Comprehensive Care Plans o Determine if a comprehensive care plan was developed to address a resident’s hydration needs and fluid preferences. • §483.21(b)(2), F657, Comprehensive Care Plan Revision o Determine if the care plan was periodically reviewed and revised by appropriate staff, in conjunction with the practitioner and with input from the resident or his/her legal representative, to address resident hydration needs and preferences. • §483.25(g)(1)-(3), F692, Assisted Nutrition and Hydration o Determine if the facility has managed the resident’s hydration needs. • §483.35(a), F725, Sufficient Staffing o Determine if the concerns related to providing residents with sufficient liquids is related to having sufficient nursing assistant staff to meet these needs. • §483.10(c), F552, Right to Make Treatment Decisions o Determine if the facility addressed the resident’s right to refuse treatment, including drinks and thickened fluids. • §483.20(b), F636, Comprehensive Assessments o Determine if the resident’s hydration status was comprehensively assessed. • §483.21(b)(1), F656, Comprehensive Care Plans o Determine if a comprehensive care plan was developed to address a resident’s hydration needs and fluid preferences. • §483.21(b)(2), F657, Comprehensive Care Plan Revision o Determine if the care plan was periodically reviewed and revised by appropriate staff, in conjunction with the practitioner and with input from the resident or his/her legal representative, to address resident hydration needs and preferences. • §483.25(g)(1)-(3), F692, Assisted Nutrition and Hydration o Determine if the facility has managed the resident’s hydration needs. • §483.35(a), F725, Sufficient Staffing o Determine if the concerns related to providing residents with sufficient liquids is related to having sufficient nursing assistant staff to meet these needs. F808 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.60(e) Therapeutic Diets §483.60(e)(1) Therapeutic diets must be prescribed by the attending physician. §483.60(e)(2) The attending physician may delegate to a registered or licensed dietitian the task of prescribing a resident’s diet, including a therapeutic diet, to the extent allowed by State law. INTENT §483.60(e)(1)-(2) - To assure that residents receive and consume foods in the appropriate form and/or the appropriate nutritive content as prescribed by a physician, and/or assessed by the interdisciplinary team to support the resident’s treatment, plan of care, in accordance with his her goals and preferences. GUIDANCE §483.60(e)(1)-(2) If the residents’ attending physician delegates this task he or she must supervise the dietitian and remains responsible for the resident’s care even if the task is delegated. The physician would be able to modify a diet order with a subsequent order, if necessary. NOTE: The terms “attending physician” or “physician” also includes a non-physician provider (physician assistant, nurse practitioner, or clinical nurse specialist) involved in the management of the resident’s care. DEFINITIONS §483.60(e)(1)-(2) “Therapeutic Diet” means a diet ordered by a physician or delegated registered or licensed dietitian as part of treatment for a disease or clinical condition, or to eliminate or decrease specific nutrients in the diet, (e.g., sodium) or to increase specific nutrients in the diet (e.g., potassium), or to provide food the resident is able to eat (e.g., a mechanically altered diet). “Mechanically altered diet” means one in which the texture of a diet is altered. When the texture is modified, the type of texture modification must be specific and part of the physicians’ or delegated registered or licensed dietitian order. PROBES §483.60(e)(1)-(2) • If a resident is receiving a therapeutic diet, is the diet prescribed by the attending physician or delegated registered or licensed dietitian? • If a registered or licensed dietitian has written the order, is this delegation by the physician allowed by State law? • If a resident has inadequate nutrition or nutritional deficits that manifest into and/or are a product of weight loss or other medical problems, determine if there is a therapeutic diet that is medically prescribed. POTENTIAL TAGS FOR FURTHER INVESTIGATION §483.60(e)(1)-(2) During the investigation of F808, the surveyor may have identified concerns with additional requirements related to outcome, process, and/or structure requirements. The surveyor is advised to investigate these related requirements before determining whether non-compliance may be present at these other tags. Examples of some of the related requirements that may be considered when non-compliance has been identified include, but are not limited to, the following: • §483.30(e)(2), F715, Physician Delegation to Dietitians o Determine if concerns are identified with the physician delegation/supervision of a registered or licensed dietitian • §483.25(g)(1)-(3), F692, Assisted Nutrition and Hydration. o Determine if concerns are identified regarding a resident’s nutritional status F809 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.60(f) Frequency of Meals §483.60(f)(1) Each resident must receive and the facility must provide at least three meals daily, at regular times comparable to normal mealtimes in the community or in accordance with resident needs, preferences, requests, and plan of care. §483.60(f)(2)There must be no more than 14 hours between a substantial evening meal and breakfast the following day, except when a nourishing snack is served at bedtime, up to 16 hours may elapse between a substantial evening meal and breakfast the following day if a resident group agrees to this meal span. §483.60(f)(3) Suitable, nourishing alternative meals and snacks must be provided to residents who want to eat at non-traditional times or outside of scheduled meal service times, consistent with the resident plan of care. DEFINITIONS §483.60(f)(1)-(3) A “Nourishing snack” means items from the basic food groups, either singly or in combination with each other. “Suitable and nourishing alternative meals and snacks” means that when an alternate meal or snack is provided, it is of similar nutritive value as the meal or snack offered at the normally scheduled time and consistent with the resident plan of care. GUIDANCE §483.60(f)(1)-(3) Facility staff must ensure meals and snacks are served at times in accordance with resident’s needs, preferences, and requests. Suitable and nourishing alternative meals and snacks must be provided for residents who want to eat at non-traditional times or outside of scheduled meal times. Adequacy of the “nourishing snack” will be determined both by resident interviews and by evaluation of the overall nutritional status of residents in the facility, (for example: Is the offered snack usually satisfying?) This regulation is not intended to require facilities to provide a 24-hour-a-day full service food operation or an on-site chef. Suitable alternatives may be meals prepared in advance that can be appropriately served by appropriately trained facility staff at non-traditional times. PROCEDURES §483.60(f)(1)-(3) Observe meal times and schedules and determine if they are offered at regular times comparable to normal times found in the community. Interview residents to get their input on meal service schedules to determine if they meet their choices and their input regarding eating at non-traditional times and the availability of snacks throughout the day. PROBES §483.60(f)(1)-(3) • Are three meals offered at regular times? • Are snacks and meals available for residents at non-traditional times or outside of scheduled meal service times, or upon request? • Ask residents if they are offered snacks at bedtime. If snacks are not offered, would they want them? F810 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.60(g) Assistive devices The facility must provide special eating equipment and utensils for residents who need them and appropriate assistance to ensure that the resident can use the assistive devices when consuming meals and snacks. GUIDANCE §483.60(g) The facility must provide appropriate assistive devices to residents who need them to maintain or improve their ability to eat or drink independently, for example, improving poor grasp by enlarging silverware handles with foam padding, aiding residents with impaired coordination or tremor by installing plate guards, or specialized cups. The facility must also provide the appropriate staff assistance to ensure that these residents can use the assistive devices when eating or drinking. For concerns regarding the use of other types of assistive devices, such as postural supports for head, trunk and arms, please see guidance under F676 and F677 for ADL care and services. PROCEDURES §483.60(g) Review sampled residents’ comprehensive assessment and plan of care for their capacity/ability to eat independently: • Determine if recommendations were made for adaptive eating equipment and utensils. If they were, determine if these utensils are available and utilized by residents. • If recommended but not used, determine if this is by resident’s choice. • If eating equipment and utensils are not being utilized, determine when these were recommended and how their use is being monitored by the facility and if the staff is developing alternative recommendations and monitoring ongoing assessments. • Observe whether staff competently assists residents who use assistive devices. F811 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.60(h) Paid feeding assistants- §483.60(h)(1) State approved training course. A facility may use a paid feeding assistant, as defined in § 488.301 of this chapter, if— (i) The feeding assistant has successfully completed a State-approved training course that meets the requirements of §483.160 before feeding residents; and (ii) The use of feeding assistants is consistent with State law. §483.60(h)(2) Supervision. (i) A feeding assistant must work under the supervision of a registered nurse (RN) or licensed practical nurse (LPN). (ii) In an emergency, a feeding assistant must call a supervisory nurse for help. §483.60(h)(3) Resident selection criteria. (i) A facility must ensure that a feeding assistant provides dining assistance only for residents who have no complicated feeding problems. (ii) Complicated feeding problems include, but are not limited to, difficulty swallowing, recurrent lung aspirations, and tube or parenteral/IV feedings. (iii) The facility must base resident selection on the interdisciplinary team’s assessment and the resident’s latest assessment and plan of care. Appropriateness for this program should be reflected in the comprehensive care plan. NOTE: Paid feeding assistants must complete a training program with the following minimum content as specified at §483.160. a. Minimum training course contents. A State-approved training course for paid feeding assistants must include, at a minimum, 8 hours of training in the following: (1) Feeding techniques; (2) Assistance with feeding and hydration; (3) Communication and interpersonal skills; (4) Appropriate responses to resident behavior; (5) Safety and emergency procedures, including the Heimlich maneuver; (6) Infection control; (7) Resident rights; and (8) Recognizing changes in residents that are inconsistent with their normal behavior and the importance of reporting those changes to the supervisory nurse. b. Maintenance of records. A facility must maintain a record of all individuals, used by the facility as feeding assistants, who have successfully completed the training course for paid feeding assistants. INTENT §483.60(h)(1)-(3) - To ensure that residents are assessed for appropriateness for a feeding assistant program, receive services as per their plan of care, and feeding assistants are trained and supervised. The use of paid feeding assistants is intended to supplement certified nurse aides, not substitute for nurse aides or licensed nursing staff. DEFINITIONS §483.60(h)(1)-(3) “Paid feeding assistant” is defined in the regulation at 42 CFR §488.301 as “an individual who meets the requirements specified at 42 CFR §483.60(h)(1)(i) and who is paid by the facility to feed residents, or who is used under an arrangement with another agency or organization.” NOTE: The regulation uses the term “paid feeding assistant.” While we are not using any other term, facilities and States may use whatever term they prefer, such as dining assistant, meal assistant, resident assistant, nutritional aide, etc. in order to convey more respect for the resident. Facilities may identify this position with other titles; however, the facility must be able to identify those employees who meet the requirements under the paid feeding assistant regulation. While the facility is still responsible for ensuring the safety and care of all residents, this regulation does not apply to family members or to volunteers. GUIDANCE §483.60(h)(1)-(3) NOTE: The regulation requires that paid feeding assistants must work under the supervision of an RN or LPN, and they must call the supervisory nurse in case of an emergency. Therefore, a facility that has received a waiver and does not have either an RN or LPN available in the building cannot use paid feeding assistants during those times. Interdisciplinary Team Assessment of Resident Eligibility for Feeding Assistance When determining whether a resident may be assisted by a paid feeding assistant facility staff must base resident selection on the interdisciplinary team’s current assessment of the resident's condition and the resident’s latest comprehensive assessment and plan of care. Appropriateness should be reflected in the resident’s comprehensive care plan. Paid feeding assistants are only permitted to assist residents who have no complicated eating or drinking problems as determined by their comprehensive assessment. Examples of residents that a paid feeding assistant may assist include residents who are independent in eating and/or those who have some degree of minimal dependence, such as needing cueing or partial assistance, as long as they do not have complicated eating or drinking problems. Paid feeding assistants are not permitted to assist residents who have complicated eating problems, such as (but not limited to) difficulty swallowing, recurrent lung aspirations, or who receive nutrition through parenteral or enteral means. Nurses or nurse aides must continue to assist residents who require the assistance of staff with more specialized training to eat or drink. Paid feeding assistants may assist eligible residents to eat and drink at meal times, snack times, or during activities or social events as needed, whenever the facility can provide the necessary supervision. Supervision of Paid Feeding Assistants - Paid feeding assistants must work under the supervision of an RN or LPN. While we are not prescribing the exact means by which facility RNs and LPNs assert their supervisory responsibilities, we expect that facilities will do so in a way that avoids negative outcomes for their residents. If a facility chooses to use paid feeding assistants, it is the facility’s responsibility to ensure that adequate supervisory nursing staff are available to supervise these assistants. Adequate supervision by a supervising nurse does not necessarily mean constant visual contact or being physically present during the meal/snack time, especially if a feeding assistant is assisting a resident to eat in his or her room. However, in the event that an emergency should occur, the feeding assistant must be aware of and know how to access the supervisory nurse immediately and the nurse must be located close enough to the resident that he or she can promptly respond. Should an emergency arise, a paid feeding assistant must immediately call a supervisory nurse for help. Supervisory nurses should monitor the provision of the assistance provided by paid feeding assistants to evaluate on an ongoing basis: • Their use of appropriate feeding techniques; • Whether they are assisting assigned residents according to their care planned eating and drinking needs; • Whether they are providing assistance in recognition of the rights and dignity of the resident; and • Whether they are adhering to safety and infection control practices. Use of Existing Staff as Paid Feeding Assistants - Facilities may use existing staff, i.e., licensed nurses, certified nursing assistants, to assist residents in feeding. However, other employees for example, administrative, clerical, housekeeping, dietary staff, or activity specialists, etc. must have successfully completed a State-approved training course for paid feeding assistants, as required in §483.160. Maintenance of Training Records - The facility must maintain a record of all employees used as paid feeding assistants. The record should include verification that they have successfully completed a State-approved training course as required in §483.160. INVESTIGATIVE PROTOCOL - Use of Paid Feeding Assistants Objectives - To determine if: • Individuals used as paid feeding assistants successfully completed a State- approved training course; • Sampled residents who were selected to receive assistance from paid feeding assistants were assessed and determined to be eligible to receive these services based on the latest assessment and plan of care; • Paid feeding assistants are supervised by an RN or LPN; and, • Paid feeding assistants know how to obtain assistance in emergencies. Use - When through observation, record review, or interview(s) with residents, family, or staff, a surveyor identifies concerns that the facility may not be following the requirements regarding paid feeding assistants, including proper training and supervision, and proper assessment and selection of residents for feeding assistance. Procedures - Review the resident’s comprehensive assessment and interdisciplinary care plan to guide observations and interviews. Observations - If a concern was discovered through resident or family interview(s), observe the resident while he or she is being assisted to eat and drink by a paid feeding assistant. Determine if the assistant is using proper feeding technique and is providing the type of assistance specified in the resident’s care plan. Note the resident’s condition and observe for the presence of complicated feeding problems that may require the assistance of a nurse aide or licensed nursing staff. The use of paid feeding assistants is intended to supplement, not substitute for, nursing staff. Also, during observation note whether: • A paid feeding assistant was observed assisting a resident in a location without a call system available or other means of emergency notification; • A resident who was assessed as ineligible for services due to complicated eating/drinking problems, or a resident who has not been assessed for eligibility, is being assisted by a paid feeding assistant; and, • RN or LPN staff members assigned to supervise paid feeding assistants were observed to be unavailable (for example, not available in case of emergency). If the concern was discovered through observations that were already made, only conduct additional observations if necessary to complete the investigation. Resident and Family Interviews - If a resident is selected for this protocol through surveyor observation that he or she is having difficulties in eating or drinking and he or she is being assisted by a paid feeding assistant, interview the resident if the resident is interviewable. Ask questions to gain information about why the resident is receiving these services and the resident's experience with receiving assistance to eat and drink. If concerns are identified, inquire if the resident has reported these problems to a nurse. If the resident is not interviewable, ask these questions of a family member or the resident’s representative. If the concern was discovered through resident, resident representative or family interviews already conducted, focus any additional interview on questions specific to complete the investigation. Paid Feeding Assistant Interviews - Interview paid feeding assistants assisting the selected resident. Determine whether there are concerns with their training, supervision, or the selection of the resident such as: • What training did you successfully complete in providing feeding assistance? • What information did you receive about this resident's needs for assistance (type of assistance needed, any precautions)? • In what manner and by whom are you supervised while assisting residents? • What issues/problems do you report (such as coughing, choking, changes in the resident’s usual responses, or level of alertness) and to whom do you report? • What would you do if an emergency occurred while you were assisting a resident to eat or drink? Who would you contact and how would you contact them? Interdisciplinary Team Interview - Interview the nurse or other member(s) of the interdisciplinary team responsible for assessing if the resident is eligible and appropriate to receive assistance by a paid feeding assistant. Ask: • How they determined that this resident has no complicated feeding problems and is eligible to be assisted by a paid feeding assistant? • If a resident is appropriate to receive assistance from a paid feeding assistant, how is this resident’s needs reflected in his or her comprehensive care plan? • How they determine that each eligible resident remains free of emergent complicated feeding problems? • Who supervises paid feeding assistants and how is the supervision accomplished? • Describe the processes in place to handle emergencies when a supervisor is not present in the area where paid feeding assistants are assisting residents. Review of Resident Assessment of Eligibility to Receive Assistance from a Paid Feeding Assistant - Determine whether the resident’s assessment regarding his or her ongoing eligibility to be assisted by a paid feeding assistant is based on identification of the current condition of the resident and any additional or new risk factors or condition changes that may impact on the resident's ability to eat or drink. This information may be contained in the RAI or in other supporting documents such as progress notes, etc. The assessment of eligibility to receive assistance from a paid feeding assistant is ongoing and should be reflected in a resident’s comprehensive care plan. Requirements for Training of Paid Feeding Assistants - Determine how the facility identifies that paid feeding assistants have successfully completed a State-approved training course that meets the requirements at 42 CFR §483.160 before they are allowed to assist eligible residents with eating and drinking. If the facility uses temporary (agency) staff as paid feeding assistants, request documentation that these staff have met the minimum training requirements at 42 CFR §483.160. Review facility’s records for all employees used as paid feeding assistants to verify their completion of a State approved training course (it is recommended the survey team coordinator assign one surveyor to obtain and verify these records). NOTE: If the facility has not ensured any paid feeding assistant has completed a State- approved training course, do not cite here. Cite 42 CFR §483.95(h), F948, Required training of feeding assistants. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION §483.60(h)(1)-(3) During the investigation of F811, the surveyor may have identified concerns with additional requirements related to outcome, process, and/or structure requirements. The surveyor is cautioned to investigate these related requirements before determining whether non-compliance may be present at these other tags. Examples of some of the related requirements that may be considered when non-compliance has been identified include, but are not limited to, the following: • §483.10, F550, Resident Rights o Determine if staff are attentive and responsive to the resident’s requests, and if they provide assistance to eat in a manner that respects the resident’s dignity, meets needs in a timely manner, and minimizes potential feelings of embarrassment, humiliation, and/or isolation related to inability to assist themselves with food or fluid intake. • §483.10(c), F552 and F578, Planning and Implementing Care o Determine if the facility addressed the resident’s right to choose or refuse treatment, including receiving assistance to eat or drink by a paid feeding assistant. • §483.20(b), F636, Comprehensive Assessments o Review whether facility staff initially and periodically conducted a comprehensive, accurate assessment of the resident’s ability to eat and drink with or without assistance and/or identified a condition that makes the resident ineligible for this service. • §483.21(b)(1), F656, Comprehensive Care Plans o Review whether facility staff developed or implemented a comprehensive care plan that was based on the assessment of the resident’s conditions, needs, and behaviors, and was consistent with the resident’s goals in order to provide assistance with nutrition and hydration as necessary. • §483.21(b)(2)(iii), F657, Comprehensive Care Plan Revision o Determine if the care plan was reviewed and revised periodically, as necessary, related to eligibility to eat and drink with assistance of a paid feeding assistant. • §483.25(g)(1)-(3), F692, Nutrition/Hydration Status o Review if facility staff had identified, evaluated, and responded to a change in nutritional parameters, anorexia, or unplanned weight loss, dysphagia, and/or swallowing disorders in relation to the resident’s ability to eat. o Review if facility staff had identified, evaluated, and responded to a change in the resident’s ability to swallow liquids. • §483.25 (b)(4), F676, ADL Assistance for Dependent Residents o Determine if staff identified and implemented appropriate measures to provide food and fluids for the resident who cannot perform relevant activities of daily living. • §483.35(a), F725, Sufficient Staff o Determine if the facility has qualified staff in sufficient numbers to provide assistance to eat or drink to those residents who require such assistance. For residents who are not eligible to receive assistance from paid feeding assistants, determine if there are sufficient staff to provide this assistance to these residents in a timely fashion. • §483.70(g), F841, Medical Director o Determine whether the medical director collaborates with the facility to help develop, implement, and evaluate resident care policies and procedures based on current standards of practice, e.g., the use of paid feeding assistants, their supervision, and the criteria for determining which residents are eligible to receive assistance to eat or drink from paid feeding assistants. • §483.95(h), F948, Required training of feeding assistants. o Determine if the facility has ensured the paid feeding assistant(s) has completed a State-approved training course prior to employment. KEY ELEMENTS OF NONCOMPLIANCE: To cite F811, the surveyor’s investigation will generally show the facility failed to do any one or more of the following: • Prohibit an employee who did not complete a State-approved training to assist a resident to eat or drink; or • Ensure all paid feeding assistants (permanent or temporary) are used consistent with State law; or • Maintain documentation of a paid feeding assistant’s successful completion of a State-approved paid feeding training course; or • Ensure paid feeding assistants were supervised by a licensed nurse; or • Ensure a paid feeding assistant called a supervisory nurse in an emergency; or • Ensure paid feeding assistants are assisting only those residents without complicated feeding problems and who have been selected as eligible to receive these services from a paid feeding assistant; or • Ensure the interdisciplinary team assessed the resident’s appropriateness for paid feeding assistance and this need is reflected in the comprehensive care plan. DEFICIENCY CATEGORIZATION • An example of Level 4, immediate jeopardy to resident health and safety, includes, but is not limited to: o A resident is being assisted to eat by a paid feeding assistant and begins to experiencing choking. The assistant was not trained to provide abdominal thrusts or the Heimlich maneuver and the supervising nurse or other qualified staff were not available to assist. • An example of Level 3, Actual harm (physical or psychological) that is not immediate jeopardy, includes, but is not limited to: o A resident who did not have a complicated feeding problem and who was assessed to have the potential to improving his or her eating ability was assisted to eat by a paid feeding assistant. The assistant provided too much food too quickly and the resident was pocketing the food in their cheeks. The assistant did not notice this was happening and as a result the resident experienced coughing and subsequently vomited. • Examples of Level.2 - No actual harm with a potential for more than minimal harm (physical or psychological) that is not immediate jeopardy, includes but are not limited to: o Residents are being assisted to eat by individuals who have not successfully completed a State-approved paid feeding assistant training course and who otherwise by State law would not be allowed to feed residents (note that RNs, LPNs or CNAs are permitted to feed residents), and there were no resident negative outcomes. o Paid feeding assistants are assisting eligible residents; however supervising nurses are not nearby or immediately available to promptly respond to an emergency, but there have been no negative resident outcomes. Level 1 - Severity 1 does not apply for this regulatory requirement. F812 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.60(i) Food safety requirements. The facility must – §483.60(i)(1) - Procure food from sources approved or considered satisfactory by federal, state or local authorities. (i) This may include food items obtained directly from local producers, subject to applicable State and local laws or regulations. (ii) This provision does not prohibit or prevent facilities from using produce grown in facility gardens, subject to compliance with applicable safe growing and food-handling practices. (iii) This provision does not preclude residents from consuming foods not procured by the facility. §483.60(i)(2) - Store, prepare, distribute and serve food in accordance with professional standards for food service safety. INTENT §483.60(i)(1)-(2) - To ensure that the facility: • Obtains food for resident consumption from sources approved or considered satisfactory by Federal, State or local authorities; • Follows proper sanitation and food handling practices to prevent the outbreak of foodborne illness. Safe food handling for the prevention of foodborne illnesses begins when food is received from the vendor and continues throughout the facility’s food handling processes; and, • Ensures food safety is maintained when implementing various culture change initiatives such as when serving buffet style from a portable steam table, or during a potluck. DEFINITIONS §483.60(i)-(2) The following definitions are provided to clarify terms related to professional standards for food service safety, sanitary conditions and the prevention of foodborne illness. Foodborne illness refers to illness caused by the ingestion of contaminated food or beverages. "Critical Control Point" means a specific point, procedure, or step in food preparation and serving process at which control can be exercised to reduce, eliminate, or prevent the possibility of a food safety hazard. “Cross-contamination” means the transfer of harmful substances or disease-causing microorganisms to food by hands, food contact surfaces, sponges, cloth towels, or utensils which are not cleaned after touching raw food, and then touch ready-to-eat foods. http://www.businessdictionary.com/definition/procedure.html http://www.businessdictionary.com/definition/food.html http://www.businessdictionary.com/definition/control.html http://www.businessdictionary.com/definition/safety.html http://www.businessdictionary.com/definition/hazard.html Cross-contamination can also occur when raw food touches or drips onto cooked or ready-to-eat foods.1 “Danger Zone” means temperatures above 41 degrees Fahrenheit (F) and below 135 degrees F that allow the rapid growth of pathogenic microorganisms that can cause foodborne illness. Potentially Hazardous Foods (PHF) or Time/Temperature Control for Safety (TCS) Foods held in the danger zone for more than 4 hours (if being prepared from ingredients at ambient temperature) or 6 hours (if cooked and cooled) may cause a foodborne illness outbreak if consumed. “Dry Storage” means storing/maintaining dry foods (canned goods, flour, sugar, etc.) and supplies (disposable dishware, napkins, and kitchen cleaning supplies). “Food Contamination” means the unintended presence of potentially harmful substances, including, but not limited to microorganisms, chemicals, or physical objects in food. 2 “Food Preparation” means the series of operational processes involved in preparing foods for serving, such as: washing, thawing, mixing ingredients, cutting, slicing, diluting concentrates, cooking, pureeing, blending, cooling, and reheating. “Food Distribution” means the processes involved in getting food to the resident. This may include holding foods hot on the steam table or under refrigeration for cold temperature control, dispensing food portions for individual residents, family style and dining room service, or delivering meals to residents’ rooms or dining areas, etc. When meals are assembled in the kitchen and then delivered to residents’ rooms or dining areas to be distributed, covering foods is appropriate, either individually or in a mobile food cart. “Food Service” means the processes involved in actively serving food to the resident. When actively serving residents in a dining room or outside a resident’s room where trained staff are serving food/beverage choices directly from a mobile food cart or steam table, there is no need for food to be covered. However, food should be covered when traveling a distance (i.e., down a hallway, to a different unit or floor). “Potentially Hazardous Food (PHF)” or “Time/Temperature Control for Safety (TCS) Food” means food that requires time/temperature control for safety to limit the growth of pathogens (i.e., bacterial or viral organisms capable of causing a disease or toxin formation). “Storage” refers to the retention of food (before and after preparation) and associated dry goods. GUIDANCE §483.60(i)(1)-(2) Nursing home residents risk serious complications from foodborne illness as a result of their compromised health status. Unsafe food handling practices represent a potential source of pathogen exposure for residents. Sanitary conditions must be present in health care food service settings to promote safe food handling. CMS recognizes the U.S. Food and Drug Administration’s (FDA) Food Code and the Centers for Disease Control and Prevention’s (CDC) food safety guidance as national standards to procure, store, prepare, distribute, and serve food in long term care facilities in a safe and sanitary manner. Effective food safety systems involve identifying hazards at specific points during food handling and preparation, and identifying how the hazards can be prevented, reduced or eliminated. It is important to focus attention on the risks that are associated with foodborne illness by identifying critical control points (CCPs) in the food preparation processes that, if not controlled, might result in food safety hazards. Some operational steps that are critical to control in facilities to prevent or eliminate food safety hazards are thawing, cooking, cooling, holding, reheating of foods, and employee hygienic practices • Web sites for additional information regarding safe food handling to minimize the potential for foodborne illness include: National Food Safety Information Network’s Gateway to Government Food Safety Information at http://www.FoodSafety.gov; • United States Food & Drug Administration Food Code Web site at https://www.fda.gov/food/fda-food-code/food-code-2017 If there is reason to believe that a potential food borne illness/outbreak has occurred at the facility, surveyors should not attempt to investigate on their own but should consult with their State or local Department of Public Health that handles these types of investigations, i.e., Food & Drug or Infection Control departments. In addition, States or local public health agencies may have requirements for reporting a potential food borne illness/outbreak, facilities must follow these requirements as appropriate. Much of this guidance is referenced from the 2017 Recommendations of the United States Food and Drug Administration Food Code. While we do not expect surveyors to determine compliance with this Food Code we are providing a link for reference and information only. https://www.fda.gov/food/fda-food-code/food-code-2017 Food contaminants fall into 3 general categories: 1. Biological Contamination - are pathogenic bacteria, viruses, toxins, and spores that contaminate food. The two most common types of disease producing organisms are bacteria and viruses. Parasites may also contaminate food, but are less common. http://www.foodsafety.gov/ https://www.fda.gov/food/fda-food-code/food-code-2017 Factors which may influence the growth of bacteria may include but are not limited to: • Hazardous nature of the food. Although almost any food can be contaminated, certain foods are considered more hazardous than others and are called “potentially hazardous foods (PHF) or Time/Temperature Controlled for Safety (TCS)” food. Examples of PHF/TCS foods include ground beef, poultry, chicken, seafood (fish or shellfish), cut melon, unpasteurized eggs, milk, yogurt and cottage cheese; • Acidity (pH) of the food. More acidic food (i.e., pH < 5), such as pineapple, vinegar, and lemon juice, tends to inhibit bacterial growth; • Water percentage of the food. Foods that have a high level of water (e.g., fruits and vegetables) encourage bacterial growth; and • Time and temperature control of the food. Time in conjunction with temperature controls is critical. The longer food remains in the danger zone, the greater the risks for growth of harmful pathogens. Bacteria multiply rapidly in a moist environment in the danger zone. Freezing does not kill bacteria. Rapid death of most bacteria occurs at 165 degrees F or above. NOTE: Some foods may be considered a TCS food needing time/temperature control for safety to limit pathogenic microorganism growth or toxin formation. Examples include foods held for later service (e.g., cooked rice, beans, grilled sautéed onions, or baked potatoes). 2. Chemical Contamination - The most common chemicals that can be found in a food system are cleaning agents (such as glass cleaners, soaps, and oven cleaners) and insecticides. Chemicals used by the facility staff, in the course of their duties, may contaminate food (e.g., if a spray cleaner is used on a worktable surface while food is being prepared it becomes exposed to a chemical). An inadequately identified chemical may be mistaken for an ingredient used in food preparation. For example, incorrectly stored (e.g., dishwashing liquid stored in a syrup bottle) or unlabeled (e.g., white granulated cleaner that looks like salt) cleaning products may be inadvertently added to food and cause illness. Chemical products and supplies, must be clearly marked as such and stored separately from food items. 3. Physical Contamination - Physical contaminants are foreign objects that may inadvertently enter the food. Examples include, but are not limited to, staples, fingernails, jewelry, hair, glass, metal shavings from can openers, and pieces or fragments of bones from fish or chicken for example. Potential Factors Implicated in Foodborne Illnesses - Many influences may contribute to foodborne outbreaks, such as: • Poor Personal Hygiene - Employees, residents, family or visitor’s health and hygiene are significant factors in preventing foodborne illness. "Infectious” individuals (persons capable of transmitting an infection or communicable disease) are a source of contaminants such as Norovirus, Influenza, etc. Proper hand washing techniques and exclusion of infectious individuals from handling food are critical for prevention of foodborne illness. • Inadequate Cooking and Improper Holding Temperatures - Poorly cooked food or food that is not held at appropriate temperatures may promote the growth of pathogens that cause foodborne illness. • Contaminated Equipment - Equipment can become contaminated in various ways including, but not limited to: o Poor personal hygiene; o Improper sanitation; and o Contact with raw food (e.g., poultry, eggs, seafood, and meat). • Unsafe Food Sources - If surveyors have concerns or questions regarding the origin or processing of meat or other food products served to the facility residents, the surveyor should request that the facility provide documents which indicate the food product is from an approved or satisfactory source, as required by §483.60(i)(1) (F812). NOTE: The food procurement requirements for facilities are not intended to restrict resident choice. All residents have the right to accept food brought to them by family or visitor(s). Strategies for Control of Potential Foodborne Illness - The table below illustrates the more commonly identified ingestible food items and sources of contamination which have been associated with food borne illness and possible strategies to prevent illness. Source of Contamination Primary Agents of Concern Primary Control Strategies A. Hazards that are likely to occur - strategies that must be in place to prevent foodborne illness. Eggs - unpasteurized or raw • Salmonella • PHF/TCS • Cook until all parts of the egg are completely firm • Prevention of cross-contamination to foods Poultry, raw • Campylobacter • Salmonella • PHF/TCS • Cook to proper temperature • Prevention of cross-contamination to other foods • Clostridium perfringens • PHF/TCS • Cook to proper temperature Meat, raw • E. coli 0157:H7 • Salmonella • Campylobacter • PHF/TCS • Cook to proper temperature • Prevention of cross-contamination to foods • Clostridium perfringens • PHF/TCS • Cook to proper temperature Infectious food workers • Norovirus • Hepatitis A virus • Shigella • Salmonella • Exclusion of infectious food workers • Proper hand-washing procedures • Avoid bare-hand contact with any foods • Staphylococcus aureus • Proper hand-washing procedures • Avoid bare-hand contact with foods B. Hazards that may occur as a result of food products being adulterated, and for which good food handling practices are needed to minimize the potential for foodborne illness transmission. The US Food & Drug Administration (FDA) considers food adulteration as the act of intentionally debasing the quality of food offered for sale either by the admixture or substitution of inferior substances or by the removal of some valuable ingredient. Fruits and vegetables, fresh • E. coli O157:H7 • Salmonella • Norovirus • Hepatitis A virus • Shigella • Wash by facility staff prior to use • Keep cut and raw fruits and vegetables refrigerated Ready-to-eat meat and poultry products • Listeria monocytogenes • Proper refrigeration during storage Pasteurized dairy products • Listeria monocytogenes • Proper refrigeration during storage Ice • Norovirus • Cleaning and sanitizing the internal components of the ice machine and utensils according to manufacturers’ guidelines Employee Health - Employees who handle food must be free of communicable diseases and infected skin lesions. (See the requirement at 42 CFR §483.80(a)(2)(v), F880, Infection Control, requiring a facility to have an infection prevention and control program that specifies policies for, among other things, the circumstances under which a facility must prohibit an employee from direct contact with residents or their food). Hand Washing, Gloves, and Antimicrobial Gel - Employees should never use bare hand contact with any foods, ready to eat or otherwise. Since the skin carries microorganisms, it is critical that staff involved in food preparation, distribution and serving consistently utilize good hygienic practices and techniques. Staff should have access to proper hand washing facilities with available soap (regular or anti-microbial), hot water, and disposable towels and/or heat/air drying methods. The appropriate use of items such as gloves, tongs, deli paper, and spatulas is essential in minimizing the risk of foodborne illness. Gloved hands are considered a food contact surface that can get contaminated or soiled. Disposable gloves are a single use item and should be discarded between and after each use. The use of disposable gloves is not a substitute for proper hand washing. Hands must be washed before putting on gloves and after removing gloves. Failure to change gloves and wash hands between tasks, such as medical treatments or contact with residents, between handling raw meats and ready to eat foods or between handling soiled and clean dishes, can contribute to cross-contamination. Hair Restraints/Jewelry/Nail Polish – According to the current standards of practice such as the Food Code of the FDA, food service staff must wear hair restraints (e.g., hairnet, hat, and/or beard restraint) to prevent hair from contacting food. According to the Food Code, food service staff must wear hairnets when cooking, preparing, or assembling food, such as stirring pots or assembling the ingredients of a salad. However, staff do not need to wear hairnets when distributing foods to residents at the dining table(s) or when assisting residents to dine. Staff should maintain nails that are clean and neat, and wearing intact disposable gloves in good condition that are changed appropriately to reduce the spread of infection. Since jewelry can harbor microorganisms, it is recommended that staff keep jewelry to a minimum and cover hand or wrist jewelry with gloves when handling food. According to the Food Code, gloves are necessary when directly touching ready-to-eat food. Additionally, per infection control guidance, gloves are necessary when serving residents who are on transmission-based precautions (See F880 for additional information on transmission-based precautions). However, staff do not need to wear gloves when distributing foods to residents at the dining table(s) or when assisting residents to dine, unless touching ready-to-eat food. Food Receiving and Storage - When food, food products or beverages are delivered to the nursing home, facility staff must inspect these items for safe transport and quality upon receipt and ensure their proper storage, keeping track of when to discard perishable foods and covering, labeling, and dating all PHF/TCS foods stored in the refrigerator or freezer as indicated. When food is brought into the facility from an off-site kitchen (any kitchen that is not proximate to the facility), this kitchen must be approved and inspected by the appropriate Federal, State, or local authorities. This does not include food brought to residents from their family or visitors. Obtain a copy of the last approved inspection of the off-site kitchen to verify it has been approved and inspected by the appropriate Federal, State or local authorities. Do not visit the off-site kitchen. Continue to inspect the facility for safe food handling, storage, and food quality after receiving the food delivery. Food handling risks associated with food stored on the units may include but are not limited to: • Food left on trays or countertops beyond safe time and/or temperature requirements; • Food left in refrigerators beyond safe "use by” dates (including, but not limited to foods that have been opened but were not labeled, etc.); • Food stored in a manner (open containers, without covers, spillage from one food item onto another, etc.) that allows cross-contamination; and • Failure to maintain refrigerated food temperatures at safe levels; Personal Refrigerators – The specific food storage requirements at F812 are for the nursing home food storage and do not apply to residents’ personal refrigerators. However, the nursing home must ensure, under Life Safety Code regulations, that the resident room has an adequate electrical system, such as proper outlets, to allow the connection of a refrigerator without overloading the electrical system. Please see F813 related to nursing facility requirements to have a policy regarding personal food items. • Dry Food Storage - Dry storage may be in a room or area designated for the storage of dry goods, such as single service items, canned goods, and packaged or containerized bulk food that is not PHF/TCS. The focus of protection for dry storage is to keep non-refrigerated foods, disposable dishware, and napkins in a clean, dry area, which is free from contaminants. Controlling temperature, humidity, and rodent and insect infestation helps prevent deterioration or contamination of the food. Dry foods and goods should be handled and stored in a manner that maintains the integrity of the packaging until they are ready to use. It is recommended that foods stored in bins (e.g., flour or sugar) be removed from their original packaging. Food and food products should always be kept off the floor and clear of ceiling sprinklers, sewer/waste disposal pipes, and vents to maintain food quality and prevent contamination. Desirable practices include managing the receipt and storage of dry food, removing foods not safe for consumption, keeping dry food products in closed containers, and rotating supplies. • Refrigerated Storage - PHF/TCS foods must be maintained at or below 41 degrees F, unless otherwise specified by law. Frozen foods must be maintained at a temperature to keep the food frozen solid. Refrigeration prevents food from becoming a hazard by significantly slowing the growth of most microorganisms. Inadequate temperature control during refrigeration can promote bacterial growth. Adequate circulation of air around refrigerated products is essential to maintain appropriate food temperatures. Foods in a walk-in unit should be stored off the floor. Practices to maintain safe refrigerated storage include: o Monitoring food temperatures and functioning of the refrigeration equipment daily and at routine intervals during all hours of operation; o Placing hot food in containers (e.g., shallow pans) that permit the food to cool rapidly; o Separating raw foods (e.g., beef, fish, lamb, pork, and poultry) from each other and storing raw meats on shelves below fruits, vegetables or other ready-to-eat foods so that meat juices do not drip onto these foods; and o Labeling, dating, and monitoring refrigerated food, including, but not limited to leftovers, so it is used by its use-by date, or frozen (where applicable) or discarded. Safe Food Preparation - Many steps in safe food preparation must be controlled and monitored to prevent foodborne illness. Identification of potential hazards in the food preparation process and adhering to critical control points can reduce the risk of food contamination and thereby minimize the risk of foodborne illness. When verifying food temperatures, staff should use a thermometer which is both clean, sanitized, and calibrated to ensure accuracy. • Cross-Contamination - Cross-contamination can occur when harmful substances, i.e., chemical or disease-causing microorganisms are transferred to food by hands (including gloved hands), food contact surfaces, sponges, cloth towels, or utensils that are not adequately cleaned. Cross-contamination can also occur when raw food touches or drips onto cooked or ready-to-eat foods. Examples of ways to reduce cross-contamination include, but are not limited to: o Store raw meat (e.g., beef, pork, lamb, poultry, and seafood) separately and in drip-proof containers and in a manner that prevents cross-contamination of other food in the refrigerator; o Between uses, store towels/cloths used for wiping surfaces during the kitchen’s daily operation in containers filled with sanitizing solution at the appropriate concentration per manufacturer’s specifications. Assure that these sanitizing solutions are safe and do not have a risk of chemical contamination when preparing foods. Periodically testing the sanitizing solution helps assure that it maintains the correct concentration. o Clean and sanitize work surfaces, including cutting boards and food-contact equipment (e.g., food processors, blenders, preparation tables, knife blades, can openers, and slicers), between uses and consistent with applicable code. • Thawing - Thawing some foods at room temperature may not be acceptable because it may be within the danger zone for rapid bacterial proliferation. Recommended methods to safely thaw frozen foods include: o Thawing in the refrigerator, in a drip-proof container, and in a manner that prevents cross-contamination; o Completely submerging the item under cold water (at a temperature of 70 degrees F or below) that is running fast enough to agitate and float off loose ice particles; o Thawing the item in a microwave oven, then cooking and serving it immediately afterward; or o Thawing as part of a continuous cooking process. • Final Cooking Temperatures - Temperatures are critical in preventing foodborne illness. Cooking food to the temperature and for the time specified below will either kill dangerous organisms or inactivate them sufficiently so that there is little risk to the resident if the food is eaten promptly after cooking. Monitoring the food’s internal temperature is important and will help ensure n microorganisms can no longer survive and food is safe for consumption. Foods should reach the following internal temperatures in these situations: o Poultry and stuffed foods, i.e., turkeys, pork chops, chickens, etc. - 165 degrees F; o Ground meat (e.g., ground beef, ground pork), ground fish, and eggs held for service - at least 155 degrees F; o Fish and other non-ground meats - 145 degrees F; o If the facility is using unpasteurized eggs these eggs must be cooked until all parts of the egg are completely firm, regardless of a resident’s request for such things as “sunny side up”. To accommodate residents choice for items such as “sunny side up” the facility must use pasteurized eggs only; o When cooking raw foods in the microwave, they should be rotated and stirred during the cooking process so that all parts are heated to a temperature of at least 165 degrees F, and allowed to stand covered for at least 2 minutes after cooking to obtain temperature equilibrium. NOTE: Fresh, frozen, or canned fruits and vegetables that are cooked do not require the same level of microorganism destruction as raw meats/foods. Cooking to a hot holding temperature (135 degrees F) prevents the growth of pathogenic bacteria that may be present in or on these foods. • Reheating Foods - Reheated cooked foods present a risk because they have passed through the danger zone multiple times during cooking, cooling, and reheating. The PHF/TCS food that is cooked and cooled must be reheated so that all parts of the food reach an internal temperature of 165 degrees F for at least 15 seconds before holding for hot service. Ready-to-eat foods that require heating before consumption are best taken directly from a sealed container (secured against the entry of microorganisms) or an intact package from an approved food processing source and heated to at least 135 degrees F for holding for hot service. Although proper reheating will kill most organisms of concern, some toxins, such as that produced by Staphylococcus aureus, cannot be inactivated by reheating food. NOTE: Using a steam table to reheat food is unacceptable since it does not bring the food to the proper temperature within acceptable timeframes. • Cooling - Improper cooling is a major factor in causing foodborne illness. Taking too long to chill PHF/TCS foods has been consistently identified as one factor contributing to foodborne illness. Foods that have been cooked and held at improper temperatures promote the growth of disease-causing microorganisms that may have survived the cooking process (e.g., spore-formers). Cooled food items can be re-contaminated by unsanitary handling practices or cross- contaminated from other food products, utensils, and equipment. Large or dense food items, such as roasts, turkeys, soups, stews, legumes, and chili may require interventions (e.g., placing foods in shallow pans, cutting roasts into smaller portions, utilizing ice water baths, and stirring periodically) in order to be chilled safely within an allowed time period. These foods take a long time to cool because of their volume and density. If the hot food container is tightly covered, the cooling rate may be slowed further, leading to longer cooling times during which the food remains in the danger zone. Cooked potentially hazardous foods that are subject to time and temperature control for safety are best cooled rapidly within 2 hours, from 135 to 70 degrees F, and within 4 more hours to the temperature of approximately 41 degrees F. The total time for cooling from 135 to 41 degrees F should not exceed 6 hours. • Modified Consistency - Residents who require a modified consistency diet may be at risk for developing foodborne illness because of the increased number of food handling steps required when preparing pureed and other modified consistency foods. When hot pureed, ground, or diced food drop into the danger zone (below 135 degrees F), the mechanically altered food must be reheated to 165 degrees F for 15 seconds if holding for hot service. • Eggs – o Pooled eggs are raw eggs that have been cracked and combined together. The facility should crack only enough eggs for immediate service in response to a resident’s requests or as an ingredient immediately before baking. o Unpasteurized Eggs- Salmonella infections may be prevented by substituting unpasteurized eggs with pasteurized eggs in the preparation of foods that will not be thoroughly cooked, such as, but not limited to, Caesar dressing, Hollandaise or Béarnaise sauce, egg fortified beverages, ice cream, and French toast. o Raw eggs with damaged shells are also unsafe because of the potential for contamination. Food Distribution - Various systems are available for distributing food items to residents. These include but are not limited to tray lines, portable steam tables transported to dining areas, or mobile food carts that maintain food in the proper temperature and out of the Danger Zone. The purpose of these systems is to provide safe holding and transport of the food to the resident’s location. Food safety requires consistent temperature control from the time food leaves the kitchen, to transport and distribution to prevent contamination (e.g., covering food items). Timely distribution is essential to ensure food and beverages are served at the proper temperature. Dining locations include any area where one or more residents eat their meals. These can be located adjacent to the kitchen or a distance from the kitchen, such as residents’ rooms and dining rooms on other floors or areas of the building. Food Service - Meal service may include, but is not limited to, the steam table where hot prepared foods are held and served, and the chilled area where cold foods are held and served. A resident’s meal may consist of a combination of foods that require different temperatures. Food preparation or service area problems/risks to avoid include, but are not limited to: • Holding foods in danger zone temperatures which are between 41 degrees F and 135 degrees F; • Using the steam table to heat food; • Serving meals on soiled dishware and with soiled utensils; • Handling food with bare hands or improperly handling equipment and utensils; • Staff distributing meals without first properly washing their hands; and • Serving food to residents after collecting soiled plates and food waste, without proper hand washing. The temperature of PHF/TCS foods should be periodically monitored throughout the meal service to ensure proper hot or cold holding temperatures are maintained. If time is being used in place of temperature as a means of ensuring food safety, the facility must have a system in place to track the amount of time a PHF/TCS is held out of temperature control and dispose of it accordingly. Snacks - Snacks refer to foods served between meals or at bed time. Temperature control and freedom from contamination are also important when ready-to-eat or prepared food items for snacks are sent to the unit and are held for delivery, stored at the nursing station in a unit refrigerator or unit cupboards, or stored in personal refrigerators in resident rooms. Special Events - Facility-sponsored special events, such as cookouts and picnics where food may not be prepared in the facility’s kitchen and is served outdoors or in other locations, require the same food safety considerations. Potluck Events – Are generally events where families, volunteers or other non-facility staff may organize to provide enjoyment to nursing home residents and support a person- centered, homelike environment. These are different from a facility’s special event. Regarding food brought into a nursing home prepared by others, please remember the nursing home is responsible for: • Storing visitor food in such a way to clearly distinguish it from food used by or prepared by the facility. • Ensuring safe food handling once the food is brought to the facility, including safe reheating and hot/cold holding, and handling of leftovers. • Preventing contamination of nursing home food, if nursing home equipment and facilities are used to prepare or reheat visitor food. • Clearly identifying what food has been brought in by visitors for residents and guests when served. Should a foodborne illness occur as a result of a potluck held at the facility, the nursing home could be held responsible. For example, the facility could be held responsible if the facility failed to ensure the food was protected from contamination while being stored in the refrigerator and became contaminated from raw meat juices or failed to ensure staff involved in food service used appropriate hand hygiene and a foodborne illness resulted. Nursing Home Gardens – Nursing homes that have their own gardens such as, vegetable, fruit or herbs may be compliant with the food procurement requirements as long as the facility has and follows policies and procedures for maintaining and harvesting the gardens, including ensuring manufacturer’s instructions are followed if any pesticide(s), fertilizer, or other topical or root-based plant preparations are applied. NOTE: Facilities must be in compliance with any State or local requirements that may exist pertaining to food grown on facility grounds for resident consumption. Transported Foods - If residents take prepared foods with them out of the facility (e.g., bag lunches for residents attending dialysis, clinics, sporting events, or day treatment programs), the foods must be handled and prepared for them with the same safe and sanitary approaches used during primary food preparation in the facility. Appropriate food transport equipment or another approach to maintaining safe temperatures for food at special events can help minimize the risk of foodborne illness. Ice - Appropriate ice and water handling practices prevent contamination and the potential for waterborne illness. Ice must be made from potable water. Ice that is used to cool food items (e.g., ice in a pan used to cool milk cartons) is not to be used for consumption. Keeping the ice machine clean and sanitary will help prevent contamination of the ice. Contamination risks associated with ice and water handling practices may include, but are not limited to: • Staff, residents, visitors, etc., who fail to wash their hands adequately and use the scoop in an ice machine, or handle ice with their bare hands, are not following appropriate infection control practices when dispensing ice; and • Unclean equipment, including the internal components of ice machines that are not drained, cleaned, and sanitized as needed and according to manufacturer’s specifications. • Ice chests or coolers used to store and transport ice should be cleaned regularly, especially prior to use and when contaminated or visibly soiled. Refrigeration - The facility’s refrigerators and/or freezers must be in good working condition to keep foods at or below 41 degrees F and the freezer must keep frozen foods frozen solid. The following are methods to determine the proper working order of the refrigerators and freezers: • Document the temperature of external and internal refrigerator gauges as well as the temperature inside the refrigerator. Measure whether the temperature of a PHF/TCS food is 41 degrees or less; • To make sure the cooling process is effective, measure the temperature of a PHF/TCS that has a prolonged cooling time (e.g., one in a large, deep, tightly covered container). Determine if it is in the danger zone; • Check for situations where potential for cross-contamination is high (e.g., raw meat stored over ready-to-eat items); • Check the firmness of frozen food and inspect the wrapper to determine if it is intact enough to protect the food; and • Interview food service personnel regarding the operation of the refrigerator and the freezer. Temperature control and freedom from contamination is also important when food or snacks are sent to a unit and held at the nursing station in a unit refrigerator or unit cupboards, or stored in personal refrigerators in resident rooms. Food handling risks associated with food stored on the units may include but are not limited to: • Food left on trays or countertops beyond safe time and/or temperature requirements; • Food left in refrigerators beyond safe "use by” dates (including, but not limited to foods that have been opened but were not labeled, etc.); • Food stored in a manner (open containers, without covers, spillage from one food item onto another, etc.) that allows cross-contamination; and • Failure to maintain refrigerated food temperatures at safe levels; Personal Refrigerators – The specific food storage requirements at F812 are for the nursing home food storage and do not apply to residents’ personal refrigerators. However, the nursing home must ensure, under Life Safety Code regulations, that the resident room has an adequate electrical system, such as proper outlets, to allow the connection of a refrigerator without overloading the electrical system. Please see F813 related to nursing facility requirements to have a policy regarding personal food items. Equipment and Utensil Cleaning and Sanitization - A potential cause of foodborne outbreaks is improper cleaning (washing and sanitizing) of equipment and protecting equipment from contamination via splash, dust, grease, etc. Machine Washing and Sanitizing - Dishwashing machines use either heat or chemical sanitization methods. Manufacturer’s instructions must always be followed. The following are general recommendations according to the U.S. Department of Health and Human Services, Public Health Services, Food and Drug Administration Food Code for each method. High Temperature Dishwasher (heat sanitization): • Wash - 150-165 degrees F; • Final Rinse - 180 degrees F; (160 degrees F at the rack level/dish surface reflects 180 degrees F at the manifold, which is the area just before the final rinse nozzle where the temperature of the dish machine is measured); or 165 degrees F for a stationary rack, single temperature machine. Low Temperature Dishwasher (chemical sanitization): • Wash - 120 degrees F; and • Final Rinse - 50 ppm (parts per million) hypochlorite (chlorine) on dish surface in final rinse. The chemical solution must be maintained at the correct concentration, based on periodic testing, at least once per shift, and for the effective contact time according to manufacturer’s guidelines. Manual Washing and Sanitizing - A 3-step process is used to manually wash, rinse, and sanitize dishware correctly. The first step is thorough washing using hot water and detergent after food particles have been scraped off. The second is rinsing with hot water to remove all soap residues. The third step is sanitizing with either hot water or a chemical solution maintained at the correct concentration, based on periodic testing, at least when initially filled and as needed, such as with extended use, and for the effective contact time according to manufacturer’s guidelines. Facilities must have appropriate and adequate testing equipment, such as test strips and thermometers, to ensure adequate washing and sufficient concentration of sanitizing solution is present to effectively clean and sanitize dishware and kitchen equipment. After washing and rinsing, dishes and utensils are sanitized by immersion in either: • Hot water (at least 171 degrees F) for 30 seconds; or • A chemical sanitizing solution used according to manufacturer’s instructions. Chemical sanitization requires greater controls than hot water sanitization. Manufacturer’s instructions must always be followed. A high concentration of sanitation solutions may be potentially hazardous (see manufacturer’s instructions) and may be a chemical contaminant of food. Improper test strips yield inaccurate results when testing for chemical sanitation. Drying food preparation equipment and utensils with a towel or cloth may increase risks for cross contamination. Cleaning Fixed Equipment - When cleaning fixed equipment (e.g., mixers, slicers, and other equipment that cannot readily be immersed in water), the removable parts must be washed and sanitized and non-removable parts cleaned with detergent and hot water, rinsed, air-dried and sprayed with a sanitizing solution (at the effective concentration). Finally, the equipment is reassembled and any food contact surfaces that may have been contaminated during the process are re-sanitized (according to the manufacturer’s instructions). Service area wiping cloths are cleaned and dried or placed in a chemical sanitizing solution of appropriate concentration. PROCEDURES §483.60(i)(1)-(2) Through observation, interviews, and record review, determine: • If the facility obtained food safe for consumption from approved sources; If the facility stores, prepares, distributes, and serves food in a sanitary manner to prevent foodborne illness; • If the facility has systems (e.g., policies, procedures, training, and monitoring) in place to prevent the spread of foodborne illness and minimize food storage, preparation and handling practices that could cause food contamination and could compromise food safety; and • If the facility utilizes safe food handling from the time the food is received from the vendor and throughout the food handling processes in the facility. Adhere to sanitary requirements (e.g., proper washing hands when entering the kitchen and between tasks, use of hair restraints) when assessing the kitchen and meal service throughout the survey process. Observations - Complete the initial brief kitchen tour upon arrival at the facility, with observations focused on practices that might indicate potential for foodborne illness. Make additional observations throughout the survey process during times when food is being stored, prepared, cooked, plated, distributed, and served to determine if safe food handling practices are being followed. Corroborate observations through interview, record review, and other appropriate documentation. Food Procurement Procedures: Determine whether food meets safe and sanitary conditions related to when, where, and how the food was received for residents’ consumption. If a concern is identified, check invoices from food vendors when necessary to verify the source of food acquisition and the date of delivery. Storage of Food: • Observe for food storage practices that may place the food, including ice, at risk for biological, chemical, or physical contamination. • Check dry storage areas for canned goods that have a compromised seal (e.g., punctures); • Check all facility refrigerators, including those on resident units, to ensure foods are held at appropriate temperatures and PHF/TCS foods for labeling and dates (e.g., use by dates); • Check freezers to ensure foods are frozen solid; • Look for evidence of pests, rodents and droppings and other sources of contamination in food storage areas; and • Check resident rooms for safe food storage practices. Food Preparation Procedures: • Observe staff food handling practices, such as proper hand washing, the appropriate use of utensils, gloves, and hairnets; • Observe food handling practices that have potential for cross-contamination (e.g., use of food contact surfaces and equipment to prepare various uncooked and ready-to-eat foods); • Have staff demonstrate the calibration technique to ensure the temperature readings on the thermometers are reliable; • Determine if the dietary staff are ensuring PHF/TCS foods are at approved cold holding, hot holding, and final cook temperatures; • Determine if the dietary staff follow approved cooling and reheating procedures for PHF/TCS foods; • Observe staff preparing modified consistency (e.g., pureed, mechanical soft) PHF/TCS foods to determine whether food safety was compromised; • If the staff is preparing resident requests for undercooked eggs (i.e. sunny side up, soft scrambled, soft boiled), determine if pasteurized shell eggs or liquid pasteurized eggs were used to prevent foodborne illness; and • During meal service, observe whether the staff measure the temperature of all hot and cold menu items. Service after Meal Times: • Observe whether facility personnel are operating the dish washing machine according to the manufacturer’s specifications. • Check whether the facility has the appropriate equipment and supplies to verify the safe operation of the dish washing machine and the washing of pots and pans. • Check the sanitizing method used (high temperature or chemical) in dishwashing and for storing sanitizing cloths is adequate for sanitizing of dishware, utensils, pots/pans, and equipment. • Observe stored dishes, utensils, pots/pans, and equipment for evidence of soiling. These items should be stored in a clean dry location and not exposed to splash, dust or other contamination; and • Evaluate whether proper hand washing is occurring between handling soiled and clean dishes to prevent cross-contamination of the clean dishes. Interviews - During the course of the survey, interview the staff who performs the task about the procedures they follow to procure, store, prepare, distribute, and serve food to residents. In addition to food safety practices, determine: • What is the facility’s practice for dealing with employees who come to work with symptoms of contagious illness (e.g., coughing, sneezing, diarrhea, vomiting) or open wounds; • Whether the facility has, and follows, a cleaning schedule for the kitchen and food service equipment; and • If there is a problem with equipment, how staff informs maintenance and follows up to see if the problem is corrected. Record Review - In order to investigate identified food safety concerns, review supporting data, as necessary, including but not limited to: • Any facility documentation, such as dietary policies and procedures, related to compliance with food sanitation and safety, including but not limited to policies addressing facility food service, potluck events, food from visitors, facility gardens; • Determine if the food service employees have received training related to such compliance; • Monitoring records, such as temperature logs from the tray line, refrigerators, and freezers, and dishwasher temperature and sanitizing records; • Maintenance records, such as work orders and manufacturer’s specifications, related to equipment used to store, prepare, and serve food. Review of Facility Practices - Review of facility practices may include, but is not limited to, review of policies and procedures for sufficient staffing, staff training, and following manufacturer’s recommendations as indicated. In order to establish if the facility has a process in place to prevent the spread of foodborne illness, interview the staff to determine how they: • Monitor whether the facility appropriately procures, stores, prepares, distributes, and serves food; • Identify and analyze pertinent issues and underlying causes of a food safety concern; • Implement interventions that are pertinent and timely in relation to the urgency and severity of a concern; and • Monitor the implementation of interventions and determine if additional modification is needed. DEFICIENCY CATEGORIZATION • Examples of Level 4, immediate jeopardy to resident health and safety, include, but are not limited to: o A 10-quart covered stock pot with 8 quarts of cooked beans was in the refrigerator. The internal temperature of the beans at the time of survey was measured at 68 degrees F. The cook stated these beans had been cooked the day before and were going to be served at the next meal, unaware they had been improperly cooled. Improperly cooled beans are at risk for growing toxin producing bacteria that are not destroyed in the reheating process. o A roast (raw meat) thawing on a plate in the refrigerator had bloody juices overflowing and dripping onto uncovered salad greens on the shelf below. The contaminated salad greens were used to make salad for the noon meal; o The facility had a recent outbreak of Norovirus after the facility allowed a food worker who was experiencing vomiting and diarrhea to continue preparing food. • An example of Level 3, Actual harm (physical or psychological) that is not immediate jeopardy, includes, but is not limited to: o The facility failed to properly cool leftover turkey. The turkey was served to the residents, which resulted in an outbreak of foodborne illness, which, based on the facility population, did not result in or have the potential for causing serious harm to any resident. • Examples of Level.2 - No actual harm with a potential for more than minimal harm (physical or psychological) that is not immediate jeopardy, include but are not limited to: o Food service workers sliced roast pork on the meat slicer. The meat slicer was not washed, rinsed, and sanitized after use; o During the initial tour of the kitchen, two food service workers were observed on the loading dock. One was smoking and the other employee was emptying trash. Upon returning to the kitchen, they proceeded to prepare food without washing their hands; o Upon inquiry by the surveyor, the food service workers tested the sanitizer of the dish machine, the chemical rinse of the pot-and-pan sink, and a stationary bucket used for wiping cloths. The facility used chlorine as the sanitizer. The sanitizer tested less than 50 ppm in all three locations. Staff interviewed stated they were unaware of the amount of sanitizer to use and the manufacturer’s recommendations to maintain the appropriate ppm of available sanitizer. Level 1 - Severity 1 does not apply for this regulatory requirement. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION §483.60(i)(1)-(2) During the investigation of F812, the surveyor may have identified concerns with additional requirements related to outcome, process, and/or structure requirements. The surveyor is advised to investigate these related requirements before determining whether non-compliance may be present at these other tags. Examples of some of the related requirements that may be considered when non-compliance has been identified include, but are not limited to, the following: • §483.25(g)(1)-(5), F692, Nutrition/Hydration Status and F693, Tube Feeding o Determine if residents have experienced nausea, vomiting, diarrhea, or other gastrointestinal symptoms as a result of the failure to store, handle, administer, or remove and discard tube feeding solutions in a safe and sanitary manner. • §483.35(a), F725 Sufficient Staffing o Determine if the facility has sufficient staffing to meet the needs of the residents. • §483.60(a)(1)(2), F801, Dietary Services - Staffing o Determine if the facility employs or consults with a qualified dietitian. If not employed full-time, determine if the director of food service receives scheduled consultation from the dietitian concerning storage, preparation, distribution and service of food under sanitary conditions. • §483.60(a)(3), F802 Standard Sufficient Staff o Determine if the facility employs sufficient support personnel competent to carry out the functions of the dietary service. • §483.60(h), F811, Paid Feeding Assistants o Determine if the Paid Feeding Assistant(s) has/have successfully completed a State-approved training course that meets Federal requirements and that the Feeding Assistant(s) is/are utilizing proper techniques to prevent foodborne illness. • §483.80, F880, Infection Control o Determine if the facility’s infection control program includes investigation, control, and prevention of foodborne illness. o Determine if the facility has practices in place to prevent the spread of infection, including proper hand washing techniques. • §483.90(c)(2), F908, Maintain All Essential Equipment o Determine if the equipment in the kitchen, such as refrigerators, mobile food carts, tray line equipment, freezers, dishwashers, ovens, stoves, and ranges etc. is maintained in safe operating condition and according to manufacturers’ specifications. • §483.90(i)(4), F925, Effective Pest Control Program o Determine if the facility has maintained an effective pest control program so that it remains free of pests and rodents. Determine whether there is evidence of insect larvae, roaches, ants, flies, mice, etc. in food storage, preparation and service areas. • §483.75(d),(e),and (g)(1)-(2), F867, F868, Quality Assessment and Assurance o Determine whether the quality assessment and assurance committee seeks and reviews concerns related to foodborne illness, and food safety and sanitation to develop and implement appropriate actions to correct identified quality deficiencies when indicated. KEY ELEMENTS OF NONCOMPLIANCE: To cite F812, the surveyor’s investigation will generally show the facility failed to do any one or more of the following: • Procure, store, handle, prepare, distribute, and serve food in accordance with the standards summarized in this guidance; or • Maintain PHF/TCS foods at safe temperatures, at or below 41 degrees F (for cold foods) or at or above 135 degrees F (for hot foods) except during preparation, cooking, or cooling, and ensure that PHF/TCS food plated for transport was not out of temperature control for more than four hours from the time it is plated; or • Store raw foods (e.g., meats, fish) in a manner to reduce the risk of contamination of cooked or ready-to-eat foods; or • Cook food to the appropriate temperature to kill pathogenic microorganisms that may cause foodborne illness; or • Cool food in a manner that prevents the growth of pathogenic microorganisms; or • Utilize proper personal hygiene practices (e.g., proper hand washing and the appropriate use of gloves) to prevent contamination of food; and • Use and maintain equipment and food contact surfaces (e.g., cutting boards, dishes, and utensils) to prevent cross-contamination. 1 Partnership for Food Safety Education. (n.d.). Retrieved from http://www.fightbac.org. 2 Partnership for Food Safety Education. (n.d.). Retrieved from http://www.fightbac.org. F813 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.60(i) Food Safety Requirements The facility must – §483.60(i)(3) Have a policy regarding use and storage of foods brought to residents by family and other visitors to ensure safe and sanitary storage, handling, and consumption. GUIDANCE §483.60(i)(3) The facility must have a policy regarding food brought to residents by family and other visitors. The policy must also include ensuring facility staff assists the resident in accessing and consuming the food, if the resident is not able to do so on his or her own. The facility also is responsible for storing food brought in by family or visitors in a way that is either separate or easily distinguishable from facility food. The facility has a responsibility to help family and visitors understand safe food handling practices (such as safe cooling/reheating processes, hot/cold holding temperatures, preventing cross contamination, hand hygiene, etc.). If the facility is assisting family or visitors with reheating or other preparation activities, facility staff must use safe food handling practices. PROBES §483.60(i)(3) Interview family and/or visitors who bring food in to a resident to determine: • If he or she was provided the policy about the use and storage of foods brought in by family or visitors. • If the policy was provided in a language he or she could understand. • If safe food handling practices were explained to him or her. Interview facility staff to determine: • If they are aware of the facility policy addressing food brought in by residents, family, or visitors and how to apply it. • Who is responsible for sharing the facility policy with residents, families, and visitors? • How the facility ensures the resident, family, and/or visitors understand the policy. • If they are assisting with reheating, preparation, or storage of the food, if they understand safe food handling practices. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION §483.60(i)(3) During the investigation of F813, the surveyor may have identified concerns with additional requirements related to outcome, process, and/or structure requirements. The surveyor is advised to investigate these related requirements before determining whether non-compliance may be present at these other tags. Examples of some of the related requirements that may be considered when non-compliance has been identified include, but are not limited to, the following: • §483.10(f), F561, Self-determination. o Determine if the facility allowed residents to choose to accept food from any friends, family, visitors, or other guests. • §483.10(g)(16), F581, Notice of Rights, Rules, and Services. o Determine if the policy is not provided orally and in writing and in a manner the resident can understand. • §483.60(i)(1)-(2), F812, Food safety requirements o Determine if concerns are identified with the safe storage, handling, or service of food. F814 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.60(i) Food Safety Requirements The facility must – §483.60(i)(4)- Dispose of garbage and refuse properly. PROBES §483.60(i)(4) • Are garbage and refuse containers in good condition (no leaks) and is waste properly contained in dumpsters or compactors with lids or otherwise covered? • Are areas such as loading docks, hallways, and elevators used for both garbage disposal and clean food transport kept clean, free of debris and free of foul odors and waste fat? • Is the garbage storage area maintained in a sanitary condition to prevent the harborage and feeding of pests? • Are garbage receptacles covered when being removed from the kitchen area to the dumpster? F825 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.65 Specialized rehabilitative services. §483.65(a) Provision of services. If specialized rehabilitative services such as but not limited to physical therapy, speech-language pathology, occupational therapy, respiratory therapy, and rehabilitative services for mental illness and intellectual disability or services of a lesser intensity as set forth at §483.120(c), are required in the resident’s comprehensive plan of care, the facility must— §483.65(a)(1) Provide the required services; or §483.65(a)(2) In accordance with §483.70(f), obtain the required services from an outside resource that is a provider of specialized rehabilitative services and is not excluded from participating in any federal or state health care programs pursuant to section 1128 and 1156 of the Act. INTENT §483.65(a)(1)-(2) The intent of this regulation is to ensure that every resident receives specialized rehabilitative services as determined by their comprehensive plan of care to assist them to attain, maintain or restore their highest practicable level of physical, mental, functional and psycho-social well-being. The intent is also to ensure that residents with a Mental Disorder (MD), Intellectual Disability (ID) or a related condition receive services as determined by their Preadmission Screening and Resident Review (PASARR). GUIDANCE §483.65(a)(1)-(2) Regulations governing PASARR are found at 42 CFR §483.100-138. For any questions or concerns regarding PASARR do not cite here but refer to §483.20(e) and (k), F644, F645 and/or F646. “Specialized Rehabilitative Services” includes but is not limited to physical therapy, speech-language pathology, occupational therapy, or respiratory therapy and are provided or arranged for by the nursing home. They are “specialized” in that they are provided based on each resident’s individual assessed rehabilitative needs based on their comprehensive plan of care and can only be performed by or under the supervision of qualified personnel. These services must be provided by the facility or an outside resource and delivered by qualified personnel as defined below in the guidance under tag F826 and who are acting within the State’s scope of practice laws and regulations. The facility must provide or arrange for the provision of specialized rehabilitative services to all residents that require these services for the appropriate length of time as assessed in their comprehensive plan of care. These services are considered a facility service provided to all residents who need them based on their comprehensive plan of care and are included within the scope of facility services. Care provided by all facility staff must be coordinated and consistent with the specialized rehabilitative services provided by qualified personnel, which is defined under tag F826. Restorative services are not considered Specialized Rehabilitative Service - As referenced in Section O of the MDS/RAI manual - Restorative services refers to nursing interventions that promote the resident’s ability to adapt and adjust to living as independently and safely as possible. This concept actively focuses on achieving and maintaining optimal physical, mental, and psychosocial functioning. A resident may be started on a restorative nursing program when he or she is admitted to the facility with restorative needs, but is not a candidate for formalized rehabilitation therapy, or when restorative needs arise during the course of a longer-term stay, or in conjunction with formalized rehabilitation therapy. Generally, restorative nursing programs are initiated when a resident is discharged from formalized physical, occupational, or speech rehabilitation therapy. PROBES §483.65(a)(1)-(2) Physical and occupational therapy: • How did these services maintain, improve, or restore the individual’s muscle strength, balance, range of motion, functional mobility or prevent or slow decline or deterioration in the individual’s muscle strength? • How are these services maintaining, improving or restoring the amount of activity the individual could do to maintain, improve or restore their independence? • Do these services assist an individual in minimizing pain to enhance function and independence? • How are these services maintaining, increasing or decreasing the amount of assistance needed by the individual to perform a task? • How are these services maintaining, improving or restoring gross and fine motor coordination, including sensory awareness, visual-spatial awareness, and body integration? • Do these services assist to maintain, improve or restore memory, problem solving, attention span, and the ability to recognize safety hazards? Speech-language pathology: • How are these services maintaining, improving or restoring auditory comprehension such as understanding common functional words, concepts of time and place, and conversation? • How are these services maintaining, improving or restoring the functional abilities of individuals with moderate to severe hearing loss? For example, is the individual instructed how to effectively and independently use environmental controls to compensate for hearing loss such as eye contact, preferential seating, and use of the better ear or hearing aid? • How are individuals who cannot speak or hear assessed for devices such as a communication board or an alternate means of communication? • How are these services maintaining, improving or restoring the functional abilities of individuals with swallowing disorders? For example, are muscle re-education, swallowing, positioning, or food consistency modification techniques being employed to restore, improve, or maintain safe swallowing function? • How are these services maintaining, improving or restoring the functional abilities of individuals with speech disorders? For example, are muscle re-education, positioning, breathing, or other techniques being employed to maintain, improve or restore the individual’s ability to communicate verbally? Respiratory Therapy: • How are residents assessed to determine which factor or factors may be involved in their underlying causes for ventilator dependence? • How does the clinical team design and implement an individualized comprehensive pulmonary rehabilitation program to include resident assessment, exercise training, education, and psychosocial support? • Are qualified personnel caring for mechanically ventilated residents aware of risk factors for ventilator-associated pneumonia (VAP) (e.g., nebulizer therapy, manual ventilation, and patient transport) and how do they practice prevention for these factors? • How do facility staff implement practices to prevent VAP and other potential infections for residents on ventilator care? Refer to §483.80 (Infection Control). • What precautions do facility staff take to avoid accidental drainage of condensate into the resident’s airway and to avoid contamination of caregivers during ventilator disconnection or during disposal of condensate? Refer to §483.80 (Infection Control). • If the conditions that warranted placing the resident on the ventilator stabilize and begin to resolve, does the clinical team determine the patient’s readiness for subsequent discontinuation of ventilator support and, ultimately, extubation? Is a gradual process implemented according to the physician’s orders to wean the resident from the ventilator? • How and to whom do facility staff report ventilator malfunction? Does the facility have a system in place to provide ventilator services for residents in the event of a malfunction of equipment? • Does the facility have back-up power to assure ventilators and other respiratory devices are operable in the event of a power failure? Refer to §483.90 (Physical environment). PROCEDURES §483.65(a)(1)-(2) For each of the services noted above, surveyors should determine through information obtained by observations, interviews and record reviews, that the facility not only delivered these services, but that the services and interventions: (1) Were monitored for their effectiveness; and (2) Assisted residents to attain or maintain their highest practicable level of physical, mental, functional and psycho-social well-being or to prevent or slow a decline in condition. If the facility did not provide or obtain the required services, cite that here under tag F825. However, if the services provided were not appropriately assessed or delivered in accordance with a resident’s plan of care, do not cite here but refer to the section below, Potential Requirements for Additional Investigation. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION §483.65(a)(1)-(2) For residents with MI or ID, their assessment and comprehensive plan of care must be coordinated with their PASARR. If this coordination is not done, or where it is clear that the resident needs a service according to their comprehensive plan of care and facility staff failed to adequately assess the resident or has failed to care plan for the service, do not cite here but refer to §483.20 Resident Assessment and §483.21 Comprehensive person-centered care planning. Regulations governing PASARR are found at 42 CFR §483.100-138. For any questions or concerns regarding PASARR do not cite here but refer to §483.20(e) and (k), F644, F645 and/or F646. If noncompliance with F825, has been identified, the surveyor may have identified concerns with related structure, process, and/or outcome requirements. If an additional concerns have been identified, the surveyor must investigate the identified concern. Do not cite any related or associated requirements before first conducting an investigation to determine compliance or non-compliance with the related or associated requirement. Other Potential Tags • Use of Outside Resources,§483.70(f); • Self-determination, §483.10; • Quality of Life, §483.24; • Quality of Care, §483.25; • Resident Rights, §483.10 (for example if there are concerns regarding charges to the resident for any of these services refer to §483.10(f)(11)); • If an assistive device is needed for food and nutrition, refer to §483.60; • Behavioral Health Services,§483.40; • Infection Control,§483.80; • Physical Environmental, §483.90 KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F825, the surveyor's investigation will generally show that the facility failed to do any one or more of the following: • Provide specialized rehabilitative services based on a resident’s comprehensive plan of care; OR • Obtain specialized rehabilitative services from an outside resource that is a provider of specialized rehabilitation services that is NOT excluded from participating in any federal or state health care programs pursuant to section 1128 and 1156 of the Social Security Act. F826 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.65(b) Qualifications Specialized rehabilitative services must be provided under the written order of a physician by qualified personnel. DEFINITIONS §483.65(b) “Qualified Personnel” means a physical therapist, occupational therapist, respiratory therapist, speech-language pathologist, physician, nurse practitioner, clinical nurse specialist, or physician’s assistant, who is licensed or certified by the state to furnish therapy services. Qualified personnel may also include a physical therapist assistant (PTA), or an occupational therapy assistant (OTA) when furnishing services under the supervision of a qualified therapist. GUIDANCE §483.65(b) The facility must employ either directly or contract with an outside resource the appropriate qualified personnel as defined above, and additional support staff to ensure the needs of the residents are met in accordance with their comprehensive plan of care. In addition to meeting the specific competency requirements as part of their license and certification requirements defined under State law or regulations, these personnel must have the training, competencies and skill sets to care for residents as identified through resident assessments, and described in the plan of care. NOTE: For residents receiving physical therapy (PT), occupational therapy (OT) and/or speech-language pathology (SLP) services under the Medicare Part B benefit, an order is not required An order from a physician may substitute for the required plan of care (although orders from therapists are not recognized). Although §483.30(e)(3) allows a resident’s attending physician to delegate the task of writing therapy orders to a qualified therapist, Medicare Part B does not currently recognize an order written by a therapist. Under current Part B requirements, when a therapy order is written by a qualified therapist, for that therapy to be covered and paid under the Part B benefit, a physician or recognized non-physician practitioner including a nurse practitioner, clinical nurse specialist or physician assistant – not a therapist − must sign and date the PT, OT, or SLP plan of care which may be established by the therapist. In situations where there are differences between federal and state supervision requirements, the requirement with the greater level of supervision will apply. Only physical therapists may supervise physical therapy assistants, and only occupational therapists may supervise occupational therapy assistants. All speech-language pathology services must be provided by a licensed speech-language pathologist, or by a physician, nurse practitioner, clinical nurse specialist, or physician’s assistant, who is licensed or certified by the state to furnish therapy services. PROCEDURES §483.65(b) During the record review, determine that these services are provided under the written order of a physician (or therapist as delegated by the physician in accordance with §483.30(e)(3)) and provided by qualified personnel. If individuals providing specialized rehabilitative services, i.e., physical, occupational, speech or respiratory therapy are not qualified cite here. If a problem in a resident’s care or services is related to the qualifications, competencies or training, of personnel (i.e., facility staff, contractors, temporary staff, etc.), also refer to: • Nursing services not related to behavioral health care or dementia care, tag F725 or 726, §483.35(a),(c); • Any staff caring for residents with dementia or a history of trauma and/or post- traumatic stress disorder, tag F741, §483.40; • Administration, tag F839, §483.70(e). If there are any problems in quality of care related to restoring, maintaining or improving a resident’s functional abilities, determine if these problems are attributable in part to the qualifications, competencies or training of specialized rehabilitative services staff. Also refer to §483.25 (Quality of Care) and §483.24 (Quality of Life). KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F826, the surveyor's investigation will generally show that the facility failed to do any one or more of the following: • Obtain a written order from a physician (or therapist as delegated by the physician in accordance with §483.30(e)(3)), except as otherwise permitted with regard to residents receiving these services under the Medicare Part B benefit (as explained above); OR, • Ensure that services were provided by qualified personnel. F835 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.70 Administration. A facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident. GUIDANCE §483.70 Resources include but are not limited to a facility’s operating budget, staff, supplies, or other services necessary to provide for the needs of residents. PROCEDURES §483.70 Cite this tag if the actions, inactions, or decisions in administering the facility contributed to deficient practice(s). The facility’s administration is not limited to the administrator and may also include the facility’s governing body, management company, and/or others identified by the facility as part of the facility administration. The investigation must demonstrate how the administration knew or should have known of the deficient practice and how the lack of administration involvement contributed to the deficient practice found. When citing this F835, it is not acceptable to simply reiterate the non-compliance from any other associated tags and then refer to this tag. Surveyors must document how the administration knew or should have known of the deficient practice and taken action(s) as appropriate. F836 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.70(a) Licensure. A facility must be licensed under applicable State and local law. §483.70(b) Compliance with Federal, State, and Local Laws and Professional Standards. The facility must operate and provide services in compliance with all applicable Federal, State, and local laws, regulations, and codes, and with accepted professional standards and principles that apply to professionals providing services in such a facility. §483.70(c) Relationship to Other HHS Regulations. In addition to compliance with the regulations set forth in this subpart, facilities are obliged to meet the applicable provisions of other HHS regulations, including but not limited to those pertaining to nondiscrimination on the basis of race, color, or national origin (45 CFR part 80); nondiscrimination on the basis of disability (45 CFR part 84); nondiscrimination on the basis of age (45 CFR part 91); nondiscrimination on the basis of race, color, national origin, sex, age, or disability (45 CFR part 92); protection of human subjects of research (45 CFR part 46); and fraud and abuse (42 CFR part 455) and protection of individually identifiable health information (45 CFR parts 160 and 164). Violations of such other provisions may result in a finding of non-compliance with this paragraph. DEFINITIONS §483.70(a)-(c) “Accepted professional standards and principles” means Federal, State and local laws or professional licensure standards. An “authority having jurisdiction” is the public agency, i.e., Federal, State or local, or official(s) having the authority to make a determination of noncompliance, and is responsible for providing and signing official correspondence notifying the facility or professional of their final adverse action. GUIDANCE §483.70(a)-(c) This regulation and guidance only applies to actions taken under State licensure authority or other Federal HHS agencies as defined in the regulation, it does NOT include any federal CMS enforcement actions as required at 42 CFR Part §488. PROCEDURES: §483.70(a)-(c) Facility licenses, permits, and approvals must be provided upon request if necessary to determine compliance with these requirements. Surveyors may not interpret or enforce another agency’s requirements. If surveyors identify a situation indicating that the facility or any professional providing services may not be in compliance with a State or local law, regulation, Code and/or standard, refer that information to the authority having jurisdiction for their follow-up action. The Centers for Medicare & Medicaid Services (CMS), Regional Office (RO) will assist you to contact the appropriate Federal agency to refer your concerns. Do not delay a survey waiting for confirmation of receipt from another agency or authority having jurisdiction. If surveyors determined and received confirmation from the authority having jurisdiction that a final adverse action has been taken, then the facility could be found to not meet the requirements at §483.70(b) or (c) and a deficiency may be cited here. A final adverse action includes an action imposed by the authority having jurisdiction and is not under appeal or litigation by the facility or the professional providing services in the facility. Do not cite this tag: • When the authority having jurisdiction has not taken a final adverse action; • To simply cite non-compliance with State or local licensure requirements unless final adverse action from the authority having jurisdiction has been confirmed; or • As past non-compliance if, at the time of the current survey, the facility or professional is in compliance with the Federal, State or local law, regulation, code and /or standard but was found not to be in compliance with those requirements during a time before the current survey. If there is a question, confirm the facility’s current compliance status with the authority having jurisdiction. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F836, the surveyor’s investigation will generally show that the facility failed to do any one of the following: • Hold a current license from the State or other applicable authority to operate as a nursing home and this information has been verified with the appropriate authority; or • Provide services in compliance with all applicable Federal, State, and local laws, regulations, and codes, and with accepted professional standards and principles that apply to any professional providing services in the facility, whether temporary or permanent. F837 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(d) Governing body. §483.70(d)(1) The facility must have a governing body, or designated persons functioning as a governing body, that is legally responsible for establishing and implementing policies regarding the management and operation of the facility; and §483.70(d)(2) The governing body appoints the administrator who is— (i) Licensed by the State, where licensing is required; (ii) Responsible for management of the facility; and (iii) Reports to and is accountable to the governing body. §483.70(d)(3) The governing body is responsible and accountable for the QAPI program, in accordance with §483.75(f). INTENT §483.70(d) This regulation is intended to ensure that the facility has an active (engaged and involved) governing body that is responsible for establishing and implementing policies regarding the management of the facility. DEFINITIONS §483.70(d) “Governing body” refers to individuals such as facility owner(s), Chief Executive Officer(s), or other individuals who are legally responsible to establish and implement policies regarding the management and operations of the facility. GUIDANCE §483.70(d) The facility must determine: • A process and frequency by which the administrator reports to the governing body, the method of communication between the administrator and the governing body including, how the governing body responds back to the administrator and what specific types of problems and information (i.e., survey results, allegations of abuse or neglect, complaints, etc.) are reported or not reported directly to the governing body; • How the administrator is held accountable and reports information about the facility’s management and operation (i.e., audits, budgets, staffing, supplies, etc.).; and • How the administrator and the governing body are involved with the facility wide assessment in §483.71 Facility assessment at F838. PROCEDURES §483.70(d) Request the names and contact information of the members of the governing body at the Entrance Conference. If there are concerns, conduct an interview with the administrator and if possible with one or more members of the governing body or designated person(s) functioning as the governing body. F838 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.71 Facility assessment. The facility must conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day- to-day operations (including nights and weekends) and emergencies. The facility must review and update that assessment, as necessary, and at least annually. The facility must also review and update this assessment whenever there is, or the facility plans for, any change that would require a substantial modification to any part of this assessment. §483.71(a) The facility assessment must address or include the following: §483.71(a)(1) The facility’s resident population, including, but not limited to: (i) Both the number of residents and the facility’s resident capacity; (ii) The care required by the resident population, using evidence-based, data- driven methods that consider the types of diseases, conditions, physical and behavioral health needs, cognitive disabilities, overall acuity, and other pertinent facts that are present within that population, consistent with and informed by individual resident assessments as required under § 483.20 ; (iii) The staff competencies and skill sets that are necessary to provide the level and types of care needed for the resident population; (iv)The physical environment, equipment, services, and other physical plant considerations that are necessary to care for this population; and (v) Any ethnic, cultural, or religious factors that may potentially affect the care provided by the facility, including, but not limited to, activities and food and nutrition services. §483.71(a)(2) The facility’s resources, including but not limited to the following: (i) All buildings and/or other physical structures and vehicles; (ii) Equipment (medical and non- medical); (iii) Services provided, such as physical therapy, pharmacy, behavioral health, and specific rehabilitation therapies; (iv) All personnel, including managers, nursing and other direct care staff (both employees and those who provide services under contract), and volunteers, as well as their education and/or training and any competencies related to resident care; (v) Contracts, memorandums of understanding, or other agreements with third parties to provide services or equipment to the facility during both normal operations and emergencies; and (vi) Health information technology resources, such as systems for electronically managing patient records and electronically sharing information with other organizations. §483.71(a)(3) A facility-based and community-based risk assessment, utilizing an all-hazards approach as required in §483.73(a)(1). § 483.71(b) In conducting the facility assessment, the facility must ensure: § 483.71(b)(1) Active involvement of the following participants in the process: (i) Nursing home leadership and management, including but not limited to, a member of the governing body, the medical director, an administrator, and the director of nursing; and (ii) Direct care staff, including but not limited to, RNs, LPNs/LVNs, NAs, and representatives of the direct care staff, if applicable. (iii) The facility must also solicit and consider input received from residents, resident representatives, and family members. §483.71(c) The facility must use this facility assessment to: §483.71(c)(1) Inform staffing decisions to ensure that there are a sufficient number of staff with the appropriate competencies and skill sets necessary to care for its residents' needs as identified through resident assessments and plans of care as required in § 483.35(a)(3). §483.71(c)(2) Consider specific staffing needs for each resident unit in the facility and adjust as necessary based on changes to its resident population. §483.71(c)(3) Consider specific staffing needs for each shift, such as day, evening, night, and adjust as necessary based on any changes to its resident population. §483.71(c)(4) Develop and maintain a plan to maximize recruitment and retention of direct care staff. §483.71(c)(5) Inform contingency planning for events that do not require activation of the facility's emergency plan, but do have the potential to affect resident care, such as, but not limited to, the availability of direct care nurse staffing or other resources needed for resident care. INTENT The intent of the facility assessment is for the facility to evaluate its resident population and identify the resources needed to provide the necessary care and services the residents require during both day-to-day operations (including nights and weekends) and emergencies. DEFINITIONS “Competency” refers to a measurable pattern of knowledge, skills, abilities, behaviors, and other characteristics in performing that an individual needs to perform work roles or occupational functions successfully. “Representative of direct care employees” is an employee of the facility or a third party authorized by direct care employees at the facility to provide expertise and input on behalf of the employees for the purposes of informing a facility assessment. GUIDANCE A facility assessment may be similar to common business practices for strategic and capital budget planning. Strategic planning is an organization's process of defining its strategy, or direction, and making decisions on allocating its resources to pursue this strategy. However, while a facility may include input from its corporate organization, the facility assessment must be conducted at the facility level. The facility assessment will enable each nursing home to thoroughly assess the needs of its resident population and the required resources to provide the care and services the residents need using evidence-based, data-driven methods. It should serve as a record for staff and management to understand the reasoning for decisions made regarding staffing and other resources, and may include the operating budget necessary to carry out facility functions. To ensure the required thoroughness, individuals actively involved in the facility assessment process must include, but are not limited to, the facility’s leadership (including a member of the governing body and the medical director), management (including the administrator and the director of nursing), and direct care staff (including RNs, LPNs/LVNs, and NAs). The environmental operations manager, and other department heads (for example, the dietary manager, director of rehabilitation services, or other individuals) should be involved as needed. Additionally, the facility must solicit and consider input from residents, their representative(s), family members, and representatives of direct care staff when formulating their assessment. We note there are a variety of ways facilities can solicit this input, such as by distributing a questionnaire related to staffing to residents/families, placing convenient suggestion boxes throughout the facility for anonymous input, or providing annual notices for soliciting input to residents and families prior to conducting the annual review and update of the facility assessment. An assessment of the resident population is the foundation of the facility assessment. Therefore, the assessment must address the resident population including both the number of residents and the facility’s resident capacity. In addition, it must include an evaluation of diseases, conditions, physical and behavioral health needs, cognitive status, acuity of the resident population, and any other pertinent information consistent with resident assessments that may affect and plan for the services the facility must provide (e.g., MDS data). Examples of other pertinent information about the resident population the facility serves may include race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, preferred language, health literacy or other factors that affect access to care and health outcomes related to health equity. The assessment of the resident population will also contribute to identifying the physical environment, equipment (medical and non-medical), assisted technology, individual communication devices, or other material resources that are needed to provide the required care and services to residents. The regulation outlines that the individualized approach of the facility assessment is the foundation to determine staffing levels and competencies. Therefore, the facility assessment must include an evaluation of the overall number of facility staff needed to ensure sufficient number of qualified staff are available to meet each resident’s needs as identified through resident assessments and care plans. Furthermore, the assessment must include a competency-based approach to determine the knowledge and skills required among staff (including both employees and those who provide services under contract) and volunteers, to ensure residents are able to maintain or attain their highest practicable physical, functional, mental, and psychosocial well-being and meet current professional standards of practice. This also includes any ethnic, cultural, or religious factors that may need to be considered to meet resident needs, such as activities, food preferences, nutrition services, and any other aspect of care identified. Finally, the assessment should consider a review of individual staff assignments and systems for coordination and continuity of care for residents within and across these staff assignments. Also refer to F553, §483.10 Resident Rights for more information and guidance on cultural competence. The facility must review and update this assessment as necessary, and at least annually or whenever there is, or the facility plans for, any change that would require a modification to any part of this assessment. For example, if the facility decides to admit residents with care needs who were previously not admitted, such as residents on ventilators or dialysis, the facility assessment must be reviewed and updated to address how the facility staff, resources, physical environment, etc., meet the needs of those residents and any areas requiring attention, such as any training or supplies required to provide care. Additionally, the facility must consider specific staffing needs for each shift (e.g., day, evening, night, weekend shifts) and for each resident unit in the facility based on changes to resident population. The assessment must include or address an evaluation of the facility’s training program to ensure any training needs are met for all new and existing staff including managers, nursing and other direct care staff, individuals providing services under a contractual arrangement, and volunteers, consistent with their expected roles. The assessment should also include an evaluation of what policies and procedures may be required in the provision of care and that these meet current professional standards of practice. If there are any concerns regarding training refer to §483.95 Training. The facility assessment must be used to develop and maintain a plan to maximize direct care staff recruitment and retention. The facility assessment must include an evaluation of any contracts, memorandums of understanding including third party agreements for the provision of goods, services or equipment to the facility during both normal operations and emergencies. The facility assessment must address their process for overseeing these services and how those services will meet resident needs and regulatory, operational, maintenance, and staff training requirements. For example, if the facility contracts for language translation, the assessment must address how those contractors will ensure services are provided both during normal operational hours and during emergencies. The facility assessment must consider health information technology resources, such as managing resident records and electronically sharing information with other organizations. For example, the assessment should address how the facility will securely transfer health information to a hospital, home health agency, or other providers for any resident transferred or discharged from the facility. The facility assessment must include an evaluation of the physical environment necessary to meet the needs of the residents. This must include an evaluation of how the facility needs to be equipped and maintained to protect and promote the health and safety of residents. This should also include an evaluation of building maintenance capital improvements, or structures, vehicles, or medical and non-medical equipment and supplies. The facility assessment must be used to create a contingency plan for events that do not require the activation of the facility emergency plan but have the potential to impact resident care, such as the availability of direct care nurse staffing or other resources needed for care of residents. For example, the use of contract licensed nurses to cover several shifts during a holiday. The facility based and community-based risk assessment, utilizing an all-hazards approach must evaluate the facility’s ability to maintain continuity of operations and its ability to secure required supplies and resources during an emergency or natural disaster. For example, if the facility is located in a flood zone, the risk assessment must include an evaluation of how residents will be kept safe and needs met during a flood affecting the facility. Facility staff should consider involving their local/county Office of Emergency Preparedness when conducting this community based risk assessment. The facility’s emergency preparedness plans as required under §483.73 (a)(1) should be integrated and compatible with the facility assessment. As one is updated, so should the other. Risk Assessment is general terminology that is within the emergency preparedness regulations and preamble to the Final Rule (81 Fed. Reg. 63860, Sept. 16, 2016) which describes a process facilities are to use to assess and document potential hazards within their areas and the vulnerabilities and challenges which may impact the facility. Additional terms currently used by the industry are all-hazards risk assessments, also referred to as Hazard Vulnerability Assessments (HVAs), or all-hazards self-assessments. For the purposes of these guidelines, we are using the term “risk assessment,” which may include a variety of current industry practices used to assess and document potential hazards and their impacts. Hazard Vulnerability Assessments (HVAs) are systematic approaches to identifying hazards or risks that are most likely to have an impact on a healthcare facility and the surrounding community. The HVA describes the process by which a provider or supplier will assess and identify potential gaps in its emergency plan(s). Potential loss scenarios should be identified first during the risk assessment. Once a risk assessment has been conducted and a facility has identified the potential hazards/risks they may face, the organization can use those hazards/risks to conduct a Business Impact Analysis. This guidance is not specifying which type of generally accepted emergency preparedness risk assessment facilities should have, as the language used in defining risk assessment activities is meant to be easily understood by all providers and suppliers that are affected by this final rule and is aligned with the national preparedness system and terminology (81 Fed. Reg. 63860, at 63875). However, facilities are expected to conduct a full assessment of hazards based on geographical location and the individual facility dynamics, such as patient population. INVESTIGATIVE PROCEDURES Surveyors determine whether a facility assessment contains the required components under the regulation. However, they should not evaluate the quality of the assessment. If systemic care concerns are identified that are related to the facility’s planning, review the facility assessment to determine if these concerns were considered as part of the facility’s assessment process. For example, if a facility recently started accepting bariatric residents, and concerns are identified related to providing bariatric services, did facility staff update its assessment before accepting residents with these needs to identify the necessary equipment, staffing, etc., needed to provide care that is effective and safe for the residents and staff? Questions surveyors should consider include, but are not limited to, the following: • Does the facility assessment include an evaluation of the resident population, and its needs (e.g., acuity) based on evidence-based, data-driven methods? Does this reflect the population observed? Does it address the facility’s resident capacity? • Does the facility assessment include information on the staffing level(s) needed for specific shifts, such as day, evening, and night and adjusted as necessary based on changes to resident population? • Does the facility assessment address what skills and competencies are required by those providing care? • Was the facility assessment conducted with input from the individuals stated in the regulation (483.71(b))? • Does the facility assessment indicate what resources, including but not limited to, equipment, supplies, services, personnel, health information technology, and physical environment are required to meet all resident needs? • Does the facility have a plan for maximizing recruitment and retention of direct care staff? • Does the facility assessment include a contingency plan that is informed by the facility assessment? KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F838, the surveyor’s investigation will generally show that the facility failed to do any one of the following: • Annually and as necessary, conduct, document, review and update a facility-wide assessment; or • Address or include in the facility assessment the minimum requirements as described in sections § 483.71(a), (b), and (c). POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION If the survey investigation reveals that there are not sufficient or competent staff refer to: • F639, §483.21(b)(3), Comprehensive Person-Centered Care Planning; • F725 or 726, §483.35(a),(c) for any nursing services not related to behavioral health care or dementia care; • F741, §483.40 for any staff caring for residents with dementia or a history of trauma and/or post-traumatic stress disorder; • F801, §483.60(a) for Food and Nutrition staff; • F826, §483.65(b), Specialized rehabilitative services; • F839, §483.70(e), Staff qualifications; • F837, §483.70(d), Governing Body • F865, §483.75, QAPI/QA&A DEFICIENCY EXAMPLES • One of the sampled residents had experienced a fall while staff were transferring them from the bed to a chair as a result of a faulty mechanical lift. The resident’s care plan indicates requiring a two-person assist using a mechanical lift. After the fall, the resident was evaluated and although he did not suffer any physical harm, upon interview he did express psychological harm and stated he was afraid of using these lifts and would prefer to remain in bed. Interviews with direct care staff indicated that many of the lifts are old, in frequent need of repair, and often malfunction when used. A review of the current Facility Assessment did not include or address equipment necessary to provide for the needs of residents and did not have active involvement of direct care staff in the process. • The facility recently admitted several individuals, some that follow a vegan diet and others that follow the Judaism faith, both of which include dietary restrictions. These individuals did not previously reside in the facility and represents a substantial change in the resident population. The residents expressed concerns that they are not always able to choose foods that are consistent with their cultural beliefs. Upon review of the facility assessment, the facility did not review and update their assessment based on this change in their resident population. As a result, the facility did not adjust the menus for these newly admitted residents. When reviewing the Facility Assessment, the survey team identified that while the assessment included all the required components, it had not been reviewed for any potential updates in the last 15 months. Facilities are required to review and update the assessment as necessary and at least annually. Even though there were no changes to resident needs, staffing, or other resources, the facility’s failure to review the assessment within 12 months may result in the facility failing to identify a factor that would require a change to the assessment, thereby potentially placing the residents at risk for at least minimal harm. F839 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(e) Staff qualifications. §483.70(e)(1) The facility must employ on a full-time, part-time or consultant basis those professionals necessary to carry out the provisions of these requirements. §483.70(e)(2) Professional staff must be licensed, certified, or registered in accordance with applicable State laws. DEFINITIONS §483.70(e) “Licensed health professional” as defined at §483.5 is a physician; physician assistant; nurse practitioner; physical, speech, or occupational therapist; physical or occupational therapy assistant; registered professional nurse; licensed practical nurse; or licensed or certified social worker; or registered respiratory therapist or certified respiratory therapy technician. PROCEDURES §483.70(e) If there is reason to doubt the qualifications or competencies of any personnel, including temporary, agency and contracted individuals, verify qualifications with the appropriate State registry or practitioner professional licensing body. If the survey investigation reveals that there are concerns with the qualifications or competencies of: • Activities professionals refer to F679, §483.24(c)(2); • Nursing Staff refer to F726, §483.35; • Any staff caring for residents with dementia or a history of trauma and/or post- traumatic stress disorder refer to F741, §483.40; • Food and Nutrition staff refer to F801, §483.60(a); • Individuals providing Specialized rehabilitative services refer to F826, §483.65(b),; • Social Workers refer to F850, §483.70(o); NOTE: Only cite F839 for any staff not referenced above or if any professional staff is not licensed, certified, or registered in accordance with applicable State laws. This includes any physician or practitioner including the Medical director that does not hold a valid license to practice in the State where the Nursing Home is located. If a facility has not designated a physician to serve as a Medical Director refer that citation under F841. F840 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(f) Use of outside resources. §483.70(f)(1) If the facility does not employ a qualified professional person to furnish a specific service to be provided by the facility, the facility must have that service furnished to residents by a person or agency outside the facility under an arrangement described in section 1861(w) of the Act or (with respect to services furnished to NF residents and dental services furnished to SNF residents) an agreement described in paragraph (g)(2) of this section. §483.70(f)(2) Arrangements as described in section 1861(w) of the Act or agreements pertaining to services furnished by outside resources must specify in writing that the facility assumes responsibility for— (i) Obtaining services that meet professional standards and principles that apply to professionals providing services in such a facility; and (ii) The timeliness of the services. DEFINITIONS §483.70(f) “Timeliness” means that services are completed and results are provided within the timeframe(s) specified in accordance with facility policies and procedures, the medical orders, or professional standards of practice; and that facility staff notifies the resident’s physician, dentist, physician assistant, nurse practitioner or clinical nurse specialist as directed in the medical order. F841 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(g) Medical director. §483.70(g)(1) The facility must designate a physician to serve as medical director. §483.70(g)(2) The medical director is responsible for— (i) Implementation of resident care policies; and (ii) The coordination of medical care in the facility. DEFINITIONS §483.70(g) “Medical director” means a physician who oversees the medical care and other designated care and services in a health care organization or facility. Under these regulations, the medical director is responsible for coordinating medical care and helping to implement and evaluate resident care policies that reflect current professional standards of practice. “Physician/practitioner” (physician assistant, nurse practitioner, clinical nurse specialist) means the individual who has responsibility for the medical care of a resident. “Current professional standards of practice” refers to approaches to care, procedures, techniques, treatments, etc., that are based on research and/or expert consensus and that are contained in current manuals, textbooks, or publications, or that are accepted, adopted or promulgated by recognized professional organizations or national accrediting bodies. “Resident care policies” refers to the facility’s overall goals, directives, and governing statements that direct the delivery of care and services to residents consistent with current professional standards of practice. GUIDANCE §483.70(g) If the medical director does not hold a valid license to practice in the State where the nursing home is located refer to F839 - §483.70(e) Staff qualifications. The facility must designate a physician to serve as medical director (unless waived per §488.56(b) by CMS). The facility must identify how the medical director will fulfill his/her responsibilities to effectively implement resident care policies and coordinate medical care for residents in the facility. This may be included in the medical director’s job description or through a separate facility policy. Facilities and medical directors have flexibility on how all the duties will be performed. However, the facility must ensure all responsibilities of the medical director are effectively performed, regardless of how the task is accomplished or the technology used, to ensure residents attain or maintain their highest practicable physical, mental, and psychosocial well-being. For example, some, but not all, duties may be conducted remotely using various technologies (e.g., phone, email, fax, telehealth, etc., that is compliant with all confidentiality and privacy requirements). It is important that the medical director’s responsibilities require that he/she be knowledgeable about current professional standards of practice in caring for long term care residents, and about how to coordinate and oversee other practitioners. If the medical director is also an attending physician, there should be a process to ensure there are no concerns with the individual’s performance as a physician (i.e., otherwise, the medical director is monitoring his/her own performance). If there are concerns regarding his/her performance, the facility’s administration should have a process for how to address these situations. While medical directors who work for multi-facility organizations, such as corporate or regional offices, may be involved in policy development, the facility’s individual policies must be based on the facility’s unique environment and its resident’s needs, and not based on a broad, multi-facility structure. Although the medical director is not required to sign policies, the facility must be able to show that the development, review, and approval of resident care policies included his/her input. Medical director responsibilities must include their participation in: • Administrative decisions including recommending, developing and approving facility policies related to residents care. Resident care includes the resident’s physical, mental and psychosocial well-being; • Issues related to the coordination of medical care identified through the facility’s quality assessment and assurance committee and other activities related to the coordination of care; • Organizing and coordinating physician services and services provided by other professionals as they relate to resident care; • Participate in the Quality Assessment and Assurance (QAA) committee or assign a designee to represent him/her. (Refer to F865). NOTE: Having a designee does not change or absolve the Medical Director’s responsibility to fulfill his or her role as a member of the QAA committee, or his or her responsibility for overall medical care in the facility. In addition, the medical director responsibilities should include, but are not limited to: • Ensuring the appropriateness and quality of medical care and medically related care; • Assisting in the development of educational programs for facility staff and other professionals; • Working with the facility’s clinical team to provide surveillance and develop policies to prevent the potential infection of residents. Refer to Infection Control requirement at §483.80; • Cooperating with facility staff to establish policies for assuring that the rights of individuals (residents, staff members, and community members) are respected; • Supporting and promoting person-directed care such as the formation of advance directives, end-of-life care, and provisions that enhance resident decision making, including choice regarding medical care options; • Identifying performance expectations and facilitating feedback to physicians and other health care practitioners regarding their performance and practices; • Discussing and intervening (as appropriate) with a health care practitioner regarding medical care that is inconsistent with current standards of care; and • Assisting in developing systems to monitor the performance of the health care practitioners including mechanisms for communicating and resolving issues related to medical care and ensuring that other licensed practitioners (e.g., nurse practitioners) who may perform physician-delegated tasks act within the regulatory requirements and within the scope of practice as defined by State law. PROCEDURES §483.70(g) If a deficiency has been identified regarding a resident’s care, also determine if the medical director had knowledge or should have had knowledge of a problem with care, or physician services, or lack of resident care policies and practices that meet current professional standards of practice and failed: • To get involved or to intercede with other physicians or practitioners in order to facilitate and/or coordinate medical care; and/or • To provide guidance for resident care policies. Interview the medical director about his/her: • Involvement in assisting facility staff with resident care policies, medical care, and physician issues; • Understanding of his/her roles, responsibilities and functions and the extent to which he/she receives support from facility management for these roles and functions; • Process for providing feedback to physicians and other health care practitioners regarding their performance and practices, including discussing and intervening (as appropriate) with a health care practitioner regarding medical care that is inconsistent with current professional standards of care; • Input into the facility’s scope of services including the capacity to care for residents with complex or special care needs, such as dialysis, hospice or end-of- life care, respiratory support with ventilators, intravenous medications/fluids, dementia and/or related conditions, or problematic behaviors or complex mood disorders; • His/her participation or involvement in conducting the Facility Assessment and the Quality Assessment and Assurance (QAA) Committee. Interview facility leadership (e.g., Administrator, Director of Nursing, and others as appropriate) about how they interact with the medical director related to the coordination of medical care, the facility’s clinical practices and concerns or issues with other physicians or practitioners. Also, refer to §483.30 Physician Services for more information. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F841, the surveyor’s investigation will generally show that the facility failed to do any of the following: • Designate a physician to serve as medical director; or • Ensure the medical director fulfilled his/her responsibility for the implementation of resident care policies or the coordination of medical care in the facility. DEFICIENCY CATEGORIZATION • An example of Level 4, immediate jeopardy to resident health and safety, includes, but is not limited to: o The facility’s medical director was aware of and did not intervene when a health care practitioner continued over several months to provide inappropriate medical care for infection prevention to a resident that was inconsistent with current professional standards of care. As a result this resident’s health continued to decline, and was hospitalized with a severe infection. • An example of Level 3, Actual harm (physical or psychological) that is not immediate jeopardy, includes, but is not limited to: o The Director of Nursing repeatedly requested the medical director’s assistance in coordinating medical care with attending physicians for residents receiving psychotropic medications. In particular there were several physicians who had a known history of failing to provide justification for continued use of these medications and not attempting a gradual dose reduction for the residents under his/her care. As a result of the medical director’s failure to intervene, several residents continued to receive these medications without medical/clinical justification. Based on record review and interviews with residents, their representative’s and staff, there was no supporting evidence to indicate that an Immediate Jeopardy situation existed. However, due to the continuation of the use of these psychotropic medications, the residents withdrew from activities and from eating in the dining room. This caused decreased appetite and substantial weight loss for several residents. Actual harm, both physical and psychosocial was indicated. Unnecessary Medications, was also cited for not ensuring the residents were receiving the lowest dose possible. • An example of Level 2 - No actual harm with a potential for more than minimal harm that is not immediate jeopardy, includes but is not limited to: o The administrator had made multiple requests for the medical director to meet with physicians to ensure that they were familiar with the facility’s resident care policies. At the time of the survey the medical director was interviewed and stated that she had not yet had an opportunity to introduce herself to or meet with physicians. Although no actual harm occurred, due the medical director’s failure to ensure implementation of resident care policies, the potential for more than minimal harm existed. Level 1 - Severity 1 does not apply for this regulatory requirement F842 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.20(f)(5) Resident-identifiable information. (i) A facility may not release information that is resident-identifiable to the public. (ii) The facility may release information that is resident-identifiable to an agent only in accordance with a contract under which the agent agrees not to use or disclose the information except to the extent the facility itself is permitted to do so. §483.70(h) Medical records. §483.70(h)(1) In accordance with accepted professional standards and practices, the facility must maintain medical records on each resident that are— (i) Complete; (ii) Accurately documented; (iii) Readily accessible; and (iv) Systematically organized §483.70(h)(2) The facility must keep confidential all information contained in the resident’s records, regardless of the form or storage method of the records, except when release is— (i) To the individual, or their resident representative where permitted by applicable law; (ii) Required by Law; (iii) For treatment, payment, or health care operations, as permitted by and in compliance with 45 CFR 164.506; (iv) For public health activities, reporting of abuse, neglect, or domestic violence, health oversight activities, judicial and administrative proceedings, law enforcement purposes, organ donation purposes, research purposes, or to coroners, medical examiners, funeral directors, and to avert a serious threat to health or safety as permitted by and in compliance with 45 CFR 164.512. §483.70(h)(3) The facility must safeguard medical record information against loss, destruction, or unauthorized use. §483.70(h)(4) Medical records must be retained for— (i) The period of time required by State law; or (ii) Five years from the date of discharge when there is no requirement in State law; or (iii) For a minor, 3 years after a resident reaches legal age under State law. §483.70(h)(5) The medical record must contain— (i) Sufficient information to identify the resident; (ii) A record of the resident’s assessments; (iii) The comprehensive plan of care and services provided; (iv) The results of any preadmission screening and resident review evaluations and determinations conducted by the State; (v) Physician, nurse, and other licensed professionals progress notes; and (vi) Laboratory, radiology and other diagnostic services reports as required under §483.50. GUIDANCE §483.70(h) The medical record shall reflect a resident’s progress toward achieving their person- centered plan of care objectives and goals and the improvement and maintenance of their clinical, functional, mental and psychosocial status. Staff must document a resident’s medical and non-medical status when any positive or negative condition change occurs, at a periodic reassessment and during the annual comprehensive assessment. The medical record must also reflect the resident’s condition and the care and services provided across all disciplines to ensure information is available to facilitate communication among the interdisciplinary team. The medical record must contain an accurate representation of the actual experiences of the resident and include enough information to provide a picture of the resident’s progress, including his/her response to treatments and/or services, and changes in his/her condition, plan of care goals, objectives and/or interventions. Except for the annual comprehensive assessment, periodic reassessments when a significant change in status occurs, and quarterly monitoring assessments, regulations do not define the documentation frequency of a resident’s progress. Professional standards of practice however suggests documentation include a resident’s care plan implementation progress. Resident Assessment Instrument (RAI) data is part of a resident’s medical record and is protected from improper disclosure by facilities under current Federal law. Facilities are required by §§1819(c)(1)(A)(iv) and 1919(c)(1)(A)(iv) of the Act and §483.70(h)(2) and (h)(3) to keep confidential all information contained in the resident’s medical record and to maintain safeguards against the unauthorized use of a resident’s information, regardless of the storage method of the records. At §483.20(f)(5), Resident-identifiable information, it requires that a facility may not release information that is resident-identifiable to the public and that the facility may release information that is resident-identifiable to an agent only in accordance with a contract under which the agent agrees not to use or disclose the information except to the extent the facility itself is permitted to do so. If a deficiency is identified related to this regulation cite the deficient practice here at F842. Electronic Health Records (EHR) - Facilities using an electronic format for medical or other resident documentation (for example, documenting progress notes, medication administration, electronic claims filing, etc.) must comply with the Health Insurance Portability and Accountability Act (HIPAA) privacy and security rules 45 CFR Parts 160 and 164. Surveyors are not responsible for assessing compliance with these rules. The Department of Health and Human Services’ Office for Civil Rights has primary responsibility for enforcing the HIPAA Privacy and Security Rules. The surveyors’ responsibility is to assess compliance with the regulatory requirement for maintaining the content and confidentiality of the medical record. If there are concerns that the facility’s practice may constitute violations of the HIPAA privacy or security rules, refer these concerns to HHS’ Office for Civil Rights. The facility is responsible for ensuring the backup of data and security of information. CMS encourages the development of systems that permit appropriate sharing of clinical information across providers, if the development of such systems is fully consistent with the requirement for protecting the confidentiality of the medical record. Surveyors should not evaluate the features of the EHR system. Instead focus on how the EHR system is being used in the facility. Use of Electronic Signatures – Electronic signatures are acceptable whether or not the record is entirely electronic. If a facility uses these signatures, they must have policies that identify those individuals who are authorized to sign electronically and describe the security safeguards to prevent unauthorized use of these signatures. Such security safeguards include, but are not limited to, the following: • Built-in safeguards to minimize the possibility of fraud; • That each staff responsible for an attestation has an individualized identifier; • The date and time is recorded from the computer’s internal clock at the time of entry; • An entry is not to be changed after it has been recorded, and; • The computer program controls what sections/areas any individual can access or enter data, based on the individual’s personal identifier (and, therefore his/her level of professional qualifications). When rubber stamp signatures are authorized by the facility’s management, the individual whose signature the stamp represents shall place in the administrative offices of the facility a signed statement to the effect that he/she is the only one who has the stamp and uses it. A list of computer codes and written signatures must be readily available and maintained under adequate safeguards. Refer to §483.30(b) Physician Visits, for additional guidance. INVESTIGATIVE PROCEDURES §483.70(h) When reviewing a resident’s medical record, determine if the record, including any archived information, is accessible to and provides sufficient information for appropriate staff to respond to the changing status and needs of the resident. For example: • Does the medical record provide sufficient information for staff to respond to the changing status and needs of the resident? • How does the facility ensure medical records are accessible to staff? • How does the facility handle the archiving of documentation? Interview facility staff to determine the facility’s policies and practice for maintaining confidentiality of resident’s records. Concerns regarding medical record confidentially, storage (including archiving) should be reviewed under this tag. Determine through observations, record review and interviews: • How facility staff ensure confidentiality of resident records? • If there is a problem with confidentiality, is it systematic, that is, does the problem lie in the recordkeeping system, or with a staff person’s use of records, e.g., leaving records in a place easily accessible to residents, visitors, or other unauthorized persons? • Are computer screens showing information left unattended and readily observable or accessible by others not authorized to view this information? • Are there documents publicly posted such as passwords or other information, which could be evidence of noncompliance with confidentiality? Use of Electronic Records in the Survey Process There are no requirements for the use of Electronic Health Record (EHR) systems, however if a facility uses an EHR system, it must grant access to the survey team timely (i.e., before the end of the first day of the survey). If access to an EHR is required by the surveyor, the facility will: (a) Provide the surveyor with instructions, guidance, or information on how to use its EHR system; and, (b) Designate an individual who will, when requested by the surveyor, access the system, respond to any questions or assist the surveyor as needed in a timely fashion. The facility must make available to surveyors upon their request, a printout of any record or part of a record. Surveyors should only request printed copies when needed to support a potential deficient practice or if additional information is needed that is not contained in the EHR. If facility staff impedes the survey process by purposefully and/or unnecessarily delaying or restricting access to records this may lead to noncompliance and potential enforcement actions. If this situation occurs surveyors should contact their supervisors and if needed they would then contact the CMS Regional Office for assistance. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F842, the surveyor’s investigation will generally show that the facility failed to do any of the following: • Ensure resident-identifiable information was not released to the public or any unauthorized entity as stated in §483.20(f)(5)(ii); or • Ensure that any resident-identifiable information released to an agent, was to an agent in accordance with a contract under which the agent agreed not to disclose any information the facility would not also be able to release publicly; or • Maintain medical records on each resident in accordance with accepted professional standards and practices that are: o Complete; o Accurately documented; o Readily accessible; and o Systematically organized. • Keep all information in the resident’s records confidential, except when release is: o To the resident, or resident representative where permitted by applicable law; or o Required by law; or o For treatment, payment, or health care operations permitted and in compliance with 45 CFR §164.512; or o Allowed under the conditions of §483.70(h)(2)(iv). • Safeguard medical record information against loss, destruction, or unauthorized use; or • Retain medical records for: o The period of time required by State law; or o Five years from the date of discharge when there is no requirement in State law; or o Three years after a minor resident reaches legal age under State law; or • Ensure the medical record contained: o Sufficient information to identify the resident; o A record of the resident’s assessments; o The comprehensive plan of care and services provided; o The results of the pre admission PASARR Level 1 screening and subsequent evaluations and determinations; o Physicians, nurses, and other licensed professionals progress notes; or o Laboratory, radiology, and other diagnostic service reports. F843 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(i) Transfer agreement. §483.70(i)(1) In accordance with section 1861(l) of the Act, the facility (other than a nursing facility which is located in a State on an Indian reservation) must have in effect a written transfer agreement with one or more hospitals approved for participation under the Medicare and Medicaid programs that reasonably assures that— (i) Residents will be transferred from the facility to the hospital, and ensured of timely admission to the hospital when transfer is medically appropriate as determined by the attending physician or, in an emergency situation, by another practitioner in accordance with facility policy and consistent with State law; and (ii) Medical and other information needed for care and treatment of residents and, when the transferring facility deems it appropriate, for determining whether such residents can receive appropriate services or receive services in a less restrictive setting than either the facility or the hospital, or reintegrated into the community will be exchanged between the providers, including but not limited to the information required under §483.15(c)(2)(iii). §483.70(i)(2) The facility is considered to have a transfer agreement in effect if the facility has attempted in good faith to enter into an agreement with a hospital sufficiently close to the facility to make transfer feasible. GUIDANCE §483.70(i) A facility must demonstrate its good faith effort to secure a transfer agreement with a hospital. If a hospital that the facility reached out to refuses to accept a transfer agreement, determine if the facility reached out to any other hospitals. A good faith effort is considered to have been made if the nursing home has exhausted all reasonable means and taken every necessary and appropriate step to enter into an agreement with a hospital sufficiently close to the facility to make the transfer of residents safe and orderly. Also refer to §483.15 - Admission, transfer and discharge rights. Information in the transfer agreement should support the requirements in §483.15(c), F622 and the facility’s efforts to ensure safe and orderly transfers. In addition, the agreement should include the information in §483.15(c)(2)(iii), and consider other information that may be necessary for the safe and orderly transfer of the resident, and care and treatment of the resident at the receiving setting. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F843, the surveyor’s investigation will generally show that the facility failed to do any one of the following: • Have a written transfer agreement in effect with one or more hospitals approved for participation in Medicare/Medicaid programs; or • Ensure the transfer agreement(s) reasonably assured: o Residents will be transferred for timely admission to the hospital when medically appropriate; or o Medical or other information will be exchanged between the facility and the hospital:  Including, but not limited to the information required under §483.15(c)(2)(iii); or  Information needed for resident care/treatment; or  To determine whether the resident can be cared for in a less restrictive setting than either the facility or the hospital; or • Attempt good faith efforts to enter into an agreement with a hospital sufficiently close to the facility to make the transfer safely and orderly. F844 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(j) Disclosure of ownership. §483.70(j)(1) The facility must comply with the disclosure requirements of §420.206 and 455.104 of this chapter. §483.70(j)(2) The facility must provide written notice to the State Agency responsible for licensing the facility at the time of change, if a change occurs in— (i) Persons with an ownership or control interest, as defined in §§420.201 and 455.101 of this chapter; (ii) The officers, directors, agents, or managing employees; (iii) The corporation, association, or other company responsible for the management of the facility; or (iv) The facility's administrator or director of nursing. §483.70(j)(3) The notice specified in paragraph (j)(2) of this section must include the identity of each new individual or company. The following hyperlinks are included for surveyor reference only. 42 CFR §420.201 Disclosure of Ownership and Control: Definitions 42 CFR §420.206 Disclosure of Persons Having Ownership, Financial, or Control Interest 42 CFR §455.101 Disclosure of Information by Providers and Fiscal Agents: Definitions 42 CFR §455.104 Disclosure by Medicaid Providers and Fiscal Agents: Information on Ownership and Control F845 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(k) Facility closure-Administrator. Any individual who is the administrator of the facility must: §483.70(k)(1) Submit to the State Survey Agency, the State LTC ombudsman, residents of the facility, and the legal representatives of such residents or other responsible parties, written notification of an impending closure: (i) At least 60 days prior to the date of closure; or (ii) In the case of a facility where the Secretary or a State terminates the facility's participation in the Medicare and/or Medicaid programs, not later than the date that the Secretary determines appropriate; §483.70(k)(2) Ensure that the facility does not admit any new residents on or after the date on which such written notification is submitted; and §483.70(k)(3) Include in the notice the plan, that has been approved by the State, for the transfer and adequate relocation of the residents of the facility by a date that would be specified by the State prior to closure, including assurances that the residents would be transferred to the most appropriate facility or other setting in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of each resident. GUIDANCE §483.70(k) The closure plan is developed when a facility knows it is closing or upon involuntary termination of the Medicare/Medicaid provider agreement. The closure plan should be based on policies and procedures as required by §483.70(l). An individual serving as the administrator of a skilled nursing facility (SNF), nursing facility (NF) or dually participating facility (SNF/NF) must provide written notification of an impending closure of a facility which also includes the plan for relocation of residents at least 60 days prior to the impending closure; or, if the Secretary terminates the facility’s participation in Medicare or Medicaid, not later than the date the Secretary determines appropriate. Notice must be provided to the State Survey Agency, the State Long Term Care Ombudsman (State LTC), all the residents of the facility, and the legal representatives of residents or other responsible parties. An impending closure does not http://www.ecfr.gov/cgi-bin/text-idx?SID=43e79478c9df1e1218d4637bdc81be0f&mc=true&node=se42.3.420_1201&rgn=div8 http://www.ecfr.gov/cgi-bin/text-idx?SID=43e79478c9df1e1218d4637bdc81be0f&mc=true&node=se42.3.420_1206&rgn=div8 http://www.ecfr.gov/cgi-bin/text-idx?SID=43e79478c9df1e1218d4637bdc81be0f&mc=true&node=se42.3.420_1206&rgn=div8 http://www.ecfr.gov/cgi-bin/text-idx?SID=43e79478c9df1e1218d4637bdc81be0f&mc=true&node=se42.4.455_1101&rgn=div8 http://www.ecfr.gov/cgi-bin/text-idx?SID=43e79478c9df1e1218d4637bdc81be0f&mc=true&node=se42.4.455_1104&rgn=div8 http://www.ecfr.gov/cgi-bin/text-idx?SID=43e79478c9df1e1218d4637bdc81be0f&mc=true&node=se42.4.455_1104&rgn=div8 include events that may result in a temporary closure resulting from a local, regional, State or national emergency situation such as a fire, hurricane, or tornado. In some cases, an administrator may not have direct control over an impending closure and implementing the facility’s written notice and closure plans and procedures. For example, an administrator may be hired to oversee the facility’s impending closure and he/she was not present when the decision was made to close the facility, or the administrator was employed less than 60 days prior to impending closure. However, this does not relieve the current administrator from implementing or developing the plans, procedures, and providing notifications as required. In this example, the administrator must provide the closure notice and plan as soon as possible and begin implementing the plans for closure working with the State Survey Agency for the orderly and safe transfer, discharge and relocation of all residents. The new administrator or other temporary manager hired to assist with the facility closure must develop and/or implement the closure plans and work closely with the State Survey Agency and CMS Regional Office (CMS RO) to ensure that appropriate procedures are implemented. In a situation in which notice requirements were not met by the previous or current administrator, the State Survey Agency and the CMS RO may take action against the administrator as permitted under §488.446. Refer to Chapter 7 of the State Operations Manual for more information on enforcement actions in these situations. For all impending closures, the facility needs to submit its closure plan to the State Survey Agency for review and approval. The closure plan must contain the information necessary to identify the steps for a safe and orderly facility closure, including the transfer, discharge or relocation of all residents and identify the individual(s) responsible for ensuring the plans and procedures are successfully carried out. If CMS or the State Medicaid Agency involuntarily terminates the facility’s participation in the Medicare and/or Medicaid programs, the facility’s notifications must be no later than the date specified by CMS or the State Medicaid Agency. Notice must still be given if the facility remains open but CMS or the State Medicaid Agency involuntarily terminates the facility’s participation in the Medicare and/or Medicaid programs. In addition, the administrator or someone acting on behalf of the administrator should notify in writing, prior to the impending closure of the facility, the: • Facility’s Medical Director; • Residents’ primary physician; • CMS Regional Office (RO ); and • State Medicaid Agency. Although not required, facilities are encouraged to provide notice to other entities that are impacted, such as employees, union representatives, vendors, community partners, hospitals, home health agencies, dialysis facilities and other providers as early as possible. The facility’s notifications should be developed with input from the facility’s medical director and other management staff, and include details from the closure plan for the safe and orderly transfer, discharge or adequate relocation of all residents. In addition to written notification, facility staff should discuss this information with residents, their families and/or legal representatives in order to provide a better understanding of the closure and their rights. Notice of facility closure to residents and their legal or other responsible parties must be provided in a language and manner they understand. Facility staff should make every possible effort to lessen transfer trauma for residents, which may include: • Reviewing the resident’s care routines, needs, and preferences with staff at the receiving facility who will be caring for the resident, and • Assisting residents and or their representatives with obtaining information required to make an informed decision about facility relocation. Also refer to §483.15(c) Transfer and discharge requirements. The notice must include: • The name, address, and telephone number of the State LTC ombudsman; • For residents with developmental disabilities, the mailing address and telephone number of the agency responsible for the protection and advocacy of developmentally disabled individuals established under Part C of the Developmental Disabilities Assistance and Bill of Rights Act; and • For residents with mental illness, the mailing address and telephone number of the agency responsible for the protection and advocacy of individuals with mental illness established under the Protection and Advocacy for Mentally Ill Individuals Act. In addition, the notice should include contact information for the primary facility contact(s) responsible for the daily operation and management of the facility during the facility’s closure process. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F845, the surveyor’s investigation will generally show that the facility failed to do any one of the following: • Provide prior notice of an impending closure to the appropriate parties as required; or • Ensure no new residents continued to be admitted to the facility on or after the date of the notice of impending closure was submitted; or • Ensure residents were transferred, discharged or relocated to the most appropriate and available facility or other setting in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of each resident. F846 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(l) Facility closure. The facility must have in place policies and procedures to ensure that the administrator’s duties and responsibilities involve providing the appropriate notices in the event of a facility closure, as required at paragraph (l) of this section. GUIDANCE §483.70(l) Policies and procedures must be in place at all times in order to be used in the case of a facility closure or in case of termination of a facility’s Medicare and/or Medicaid Provider Agreement, in order to meet the requirements of §483.70(k) The policies and procedures must address: • The administrator’s duties and responsibilities as required per §483.70(k) for submitting a closure plan and providing timely written notice to the State Survey Agency, the State LTC Ombudsman, residents of the facility, and the legal representatives of residents or other responsible parties, including the CMS Regional Office (RO), the State Medicaid Agency, and staff responsible for providing care and services to residents; • How facility staff will identify available settings in terms of quality, services, and location, by taking into consideration each resident’s individual needs, choices, and best interests. The facility may not close until all residents are transferred, relocated or discharged in a safe and orderly manner to the most appropriate setting; and • Assurance that no new residents will be admitted to the facility on or after the date that the written notice of impending closure was provided to the State Survey Agency; To ensure resident safety during a facility closure or termination of a facility’s Medicare and/or Medicaid Provider Agreement, the policies and procedures should also address: • How facility staff will ensure that all pertinent information about each resident is communicated to the receiving provider in accordance with §483.15(c)(2)(iii), and each resident’s complete medical record information including archived files, Minimum Data Set (MDS) assessments, and all orders, recommendations or guidelines from the resident’s attending physician; • In addition to the administrator, the primary contact(s) responsible for the daily operation and management of the facility during the facility’s closure process; • The roles and responsibilities of the facility’s owners, administrator, or their replacement(s) or temporary managers/monitors during the closure process, and their contact information; • Provisions for ongoing operations and management of the facility and its residents and staff during the closure process that include: o Payment of salaries and expenses to staff, vendors, contractors, etc.; o Continuation of appropriate staffing and resources to meet the needs of each resident, including the provision of medications, services, supplies, and treatments as ordered by the resident’s physician/practitioner; o Ongoing accounting, maintenance, and reporting of resident personal funds; and o Labeling, safekeeping and appropriate transfer of resident’s personal belongings, such as clothing, medications, furnishings, etc. at the time of transfer or relocation, including contact information for missing items after the facility has closed. The facility’s policies and procedures should also consider certain provisions to prepare residents to ensure a safe and orderly transfer from the facility. These provisions include, but are not limited to: • Interviewing residents and their legal or other responsible parties, to determine each resident’s goals, preferences, and needs in planning for the services, location, and setting to which they will be moved; • Offering each resident (in a manner and language understood by the resident) the opportunity to obtain information regarding their community options, including setting and location; • Providing residents with information or access to information pertaining to the quality of the providers and/or services they are considering; psychological preparation or counseling of each resident as necessary; and • Making every reasonable effort to accommodate each resident’s goals, preferences and needs regarding receipt of services, location, and setting. PROCEDURES §483.70(l) Once notified of a facility’s impending closure, if a copy of the facility’s plan for the transfer and relocation of the residents was not included with the notice, the State Survey Agency should immediately request a copy of the facility’s closure plan for their review and approval. In addition, the State Survey Agency should request the facility’s admissions records to verify that no new residents have been admitted on or after the date that the notice of closure was provided. A resident who had been temporarily transferred to an acute care setting, is on bed hold, or is on a temporary leave would not be considered to be a new admission upon return to the facility. However, each of these situations may need to be evaluated on a case by case basis in order to determine if the clinical care or social needs of the resident may continue to be met by the facility if transferred back to the facility in closure. If it is determined that the clinical care or social needs of the resident cannot be met by the closing facility and the resident is not transferred back to the closing facility, the same notice requirements specified above apply to the resident and the resident’s legal representatives, other responsible parties, and other parties as if the resident was still living in the facility. Interview the administrator and other individual(s) responsible for managing, overseeing, coordinating and implementing the plan to evaluate how each component of the plan is being operationalized. NOTE: The review of certain components such as an evaluation of the facility’s closure plan, policies and procedures may be conducted off-site by the State Survey Agency and may include assistance from the State LTC Ombudsman as the State Survey Agency deems suitable and necessary. When conducting an onsite survey prior to the impending closure, tour the facility and interview staff including the medical director, residents, and family. Determine their involvement in and/or knowledge of the facility closure plans and the resident transfer procedures. Determine through observation, interview, and record review, as applicable: • That the delivery of resident care and services are continuing to be provided, monitored and supervised based upon the assessed needs and choices of each resident. If problems are noted it may be necessary to further investigate and review other quality of care regulations as appropriate. Do not cite quality of care issues under the Facility Closure regulations; • Whether written notices were provided timely and that the notice included the expected date of the resident’s transfer to another facility or other setting; and • How the facility involved the resident, his/her legal representative or other responsible party, and the resident’s primary physician to determine the resident’s goals, preferences and needs in planning for the services, location and setting to which they will be moved. NOTE: Refer to §483.15 for guidance for the post-discharge plan of care for an anticipated discharge which applies to a resident whom the facility discharges to a private residence or other home and community based setting, to another nursing home, or to another type of residential facility such as a board and care home or an intermediate care facility for individuals with intellectual disabilities or mental illness. NOTE: §488.426(a)(1) and(2) - Transfer of residents, or closure of the facility and transfer of residents, gives authority to the State for temporary facility closure in emergency situations. If the State Survey Agency approves a facility’s temporary relocation of residents during an emergency with the expectation that the residents will return to the facility, this would not be regarded as a facility closure under these requirements and the notification requirements would not be applicable. However, if a facility ultimately closes permanently due to an emergency, the administrator is required to provide proper notifications and follow the procedures outlined in this guidance. F847 Entering Into Binding Arbitration Agreements (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(m) Binding Arbitration Agreements If a facility chooses to ask a resident or his or her representative to enter into an agreement for binding arbitration, the facility must comply with all of the requirements in this section. §483.70(m)(1) The facility must not require any resident or his or her representative to sign an agreement for binding arbitration as a condition of admission to, or as a requirement to continue to receive care at, the facility and must explicitly inform the resident or his or her representative of his or her right not to sign the agreement as a condition of admission to, or as a requirement to continue to receive care at, the facility. §483.70(m)(2) The facility must ensure that: (i) The agreement is explained to the resident and his or her representative in a form and manner that he or she understands, including in a language the resident and his or her representative understands; (ii) The resident or his or her representative acknowledges that he or she understands the agreement… §483.70(m)(3) The agreement must explicitly grant the resident or his or her representative the right to rescind the agreement within 30 calendar days of signing it. §483.70(m)(4) The agreement must explicitly state that neither the resident nor his or her representative is required to sign an agreement for binding arbitration as a condition of admission to, or as a requirement to continue to receive care at, the facility. §483.70(m)(5) The agreement may not contain any language that prohibits or discourages the resident or anyone else from communicating with federal, state, or local officials, including but not limited to, federal and state surveyors, other federal or state health department employees, and representative of the Office of the State Long-Term Care Ombudsman, in accordance with §483.10(k). . . NOTE: The requirements at 483.70(m) went into effect on September 16, 2019. This guidance is intended for the review of arbitration agreements entered into on or after September 16, 2019. INTENT To ensure that long-term care facilities inform residents or their representatives of the nature and implications of any proposed binding arbitration agreement, to inform their decision on whether or not to enter into such agreements. The requirements at F847emphasize the residents’ or their representatives’ right to make informed decisions and choices about important aspects of residents’ health, safety and welfare. Facilities may present residents or their representatives the opportunity to utilize a binding arbitration agreement to resolve disputes at any time during a resident’s stay as long as the agreement complies with the regulations at §483.70(m)(1)-(5). DEFINITIONS Arbitration: a private process where disputing parties agree that one or several other individuals can make a decision about the dispute after receiving evidence and hearing arguments. 1 Binding Arbitration Agreement (Arbitration Agreement or Agreement): a binding agreement by the parties to submit to arbitration all or certain disputes which have arisen or may arise between them in respect of a defined legal relationship, whether contractual or not. The decision is final, can be enforced by a court, and can only be appealed on very narrow grounds. 2 Pre-dispute binding arbitration agreement (pre-dispute arbitration agreement or pre-dispute agreement): A binding agreement to resolve a future unknown dispute with an arbitrator prior to any issue or dispute arising. Post-dispute binding arbitration agreement (post-dispute arbitration agreement, or post-dispute agreement): A binding agreement signed after the circumstances of the dispute have occurred to resolve the dispute with an arbitrator. Dispute: A disagreement, controversy, or claim amongst parties where one party claims to have been harmed. Judicial Proceedings: any action by a judge (i.e., trials, hearings, petitions, or other matters) formally before the court. GUIDANCE §483.70(m)(1)(2)(i)(ii)(3)-(5) Over the years, long-term care facilities and residents have used arbitration to resolve many disputes. Parties subject to arbitration give up their right to have some or all claims heard in court (The arbitration epidemic: Mandatory arbitration deprives workers and consumers of their rights, https://www.epi.org/publication/the-arbitration-epidemic/, Accessed 1/6/2021). The results of arbitration decisions are typically not disclosed to the public and arbitrators’ decisions are generally final and binding with little or no opportunity to initiate judicial proceedings that challenge unfavorable decisions. https://www.epi.org/publication/the-arbitration-epidemic/ Concerns have been raised about the fairness and transparency related to both the means by which these agreements are created and the fairness of the arbitration processes themselves in the specific context of long-term care facilities. For example, an individual is often admitted to a long-term care facility directly from the hospital after a decline in their health. These individuals are often quite ill and are not in a position to engage in meaningful negotiations over the terms of an arbitration agreement or to coordinate care at another facility. As a result, this is quite often an extremely stressful situation with limited time to review documents before signing them. During this time, long-term care facilities have often required individuals to sign pre-dispute arbitration agreements to obtain health care. These factors, among others, impede individuals’ ability to obtain care and simultaneously make it extremely difficult for residents or their representatives to make an informed decision about arbitration. Therefore, asking individuals to commit to binding arbitration agreement in these situations may not represent the best option in terms of advancing the health care of residents. Use of a binding arbitration agreement must be voluntary and must be clearly communicated to the residents or their representatives as optional and not required as a condition of admission or to continue to receive care at the facility. The agreement must be explained so that the resident or his or her representative understands the terms of the agreement. This should include an explanation that the resident may be giving up his or her right to have a dispute decided in a court proceeding. And residents and their representatives must be provided 30 days after signing to fully review and potentially rescind any agreement that was not understood at the time of admission. Pre- and Post-dispute Arbitration Agreements: Binding arbitration agreements may be offered either before (pre-dispute) or after (post-dispute) a dispute arises. A pre-dispute binding arbitration agreement is an agreement to resolve an unspecified future dispute(s) through arbitration. Disputes may vary from a non-life threatening situation such as a financial disagreement, up to and including significant concerns such as abuse, neglect, and/or wrongful injury or death of a resident. By entering into a pre-dispute binding arbitration agreement, the parties are not settling an existing dispute but deciding, in advance, the forum in which any future disputes would be resolved. For example, if a resident enters into a pre-dispute arbitration agreement when admitted to a facility, and a few months later the facility is alleged to have wrongfully caused a type of harm covered by the agreement, such as abuse, the resident cannot seek legal action through the traditional court system. Rather, they must resolve the dispute through the agreed-upon arbitration proceeding. Facilities wishing to utilize pre-dispute binding arbitration agreements will generally offer these arrangements prior to, or early in the admission process. Facilities must not require residents or their representatives to enter into a binding pre-dispute arbitration agreement as a condition of being admitted to the facility or as a requirement for continued care. Post-dispute arbitration agreements involve the use of the arbitration process after a dispute occurs, which would otherwise be resolved in a court proceeding. In such cases, following an issue which gives rise to a dispute, the facility may propose using an arbitrator to resolve the dispute, rather than engage in litigation in court. When the facility wishes to use a post- dispute binding arbitration agreement, existing legal authorities generally provide that the facility must not compel, pressure, or coerce a resident or his or her representative to enter into a binding arbitration agreement, and the regulation provides that the facility must not require arbitration as a condition of receiving continued care at the facility. Requirements for Arbitration Agreements - Transparency in the Arbitration Process: The requirements at §483.70(m)(2)(i) specify that the arbitration “agreement is explained to the resident and his or her representative in a form and manner that he or she understands, including in a language the resident and his or her representative understands.” It is important that the arbitration process is transparent. This means that facilities should take every step to meet the resident’s needs or special accommodations (e.g. literacy level, font size, format, language, etc.) when explaining the arbitration agreement. When explaining the agreement, facilities must identify and use the resident’s or their representative’s preferred communication method, including language, to ensure understanding of the arbitration agreement. The terms and conditions of arbitration agreements must be clearly explained to the resident or his or her representative. The requirement at §483.70(m)(2)(ii) specifies that “the resident or his or her representative acknowledges that he or she understands the agreement.” After the arbitration agreement is explained in a manner and form the resident or their representative understands, the facility must ensure there is evidence that the resident or their representative has acknowledged understanding of the agreement. In some cases, the binding arbitration agreement may specify that the resident or his or her representative acknowledges understanding by signing the document. When a signature is used to acknowledge understanding, additional evidence may be needed to establish that in fact the resident or their representative understood what he or she was signing. It may not be sufficient that the resident or their representative signed the document. It is also important that facilities clarify when a signature is used to acknowledge understanding, when it indicates consent to enter into an agreement, or is used for both purposes. Surveyors should determine how the facility ensures residents or their representatives understood the terms of the binding arbitration agreement, and how this understanding is acknowledged. Surveyors must verify through interview and record review, that the resident or their representative understood what they were signing. In situations where the resident may have cognitive impairment, surveyors should refer to the medical record to identify the resident’s health care decision-making capacity at the time the agreement was offered, explained, and entered into. Arbitration Agreements Embedded within other Contracts or Agreements: Binding arbitration agreements may not necessarily be a stand-alone document. Facilities may choose to offer pre-dispute arbitration agreements at the time of admission. Some facilities may embed the arbitration agreement within the admission agreement, contract, or other documents. In these cases, all of the requirements related to arbitration agreements still apply. For example, the facility must explain that the admissions agreement includes a binding arbitration agreement, and inform the resident of all of their rights related to this agreement in a form and manner that they understand. Additionally, the facility should clearly distinguish the arbitration agreement from the admission agreement, so that, residents or their representatives have a clear understanding of each agreement, and are able to enter into or decline the arbitration agreement. In other words, residents must be allowed to sign an admissions agreement without consenting to the facility’s arbitration agreement. Surveyors should determine how the facility ensures residents or their representatives are made aware of arbitration agreements which are embedded within another document. Surveyors should also obtain copies of any documents or agreements that include information about arbitration. For example, if a facility’s admission agreement has a paragraph referencing arbitration, but also has a separate arbitration agreement, the surveyor will need to examine both documents to ensure compliance. Requirements for Arbitration Agreements – Language: The requirements at §483.70(m)(1), (3)-(5) identify specific terms and conditions which must be “explicitly” stated in any arbitration agreement between a resident or their representative, and a Medicare and/or Medicaid certified facility. Explicitly means clearly and without any vagueness or ambiguity. Thus, these terms and conditions must be disclosed in the agreement in a clear and detailed manner, leaving no room for confusion. For further arbitration agreement language to be included, refer to F848, specifically §483.70(m)(2)(iii), (iv). §483.70(m)(1): The arbitration agreement “…must explicitly inform the resident or his or her representative of his or her right not to sign the agreement as a condition of admission to, or as a requirement to continue to receive care at, the facility.” This means that the agreement must clearly explain that the resident or their representative has the right to refuse to enter into the arbitration agreement without fear of: • Not being admitted; or • Being transferred or discharged as a result of refusing to enter into an arbitration agreement. Facilities cannot refuse to admit any resident who has, or whose representative has, declined to enter into an arbitration agreement. Additionally, facilities must not discharge any resident for failure to use arbitration to settle a dispute. NOTE: Surveyors should thoroughly investigate the basis for transfer or discharge for any resident who has refused to enter into a binding arbitration agreement, and has been, or will be subsequently transferred or discharged. For additional information, refer to the guidance at §483.15(c) - F622, Transfer and Discharge Requirements. §483.70(m)(3): The arbitration “agreement must explicitly grant the resident or his or her representative the right to rescind this agreement within 30 calendar days of signing it.” This means the agreement must clearly explain that the resident or his or her representative has 30 calendar days to withdraw from or terminate the agreement, should he or she change their mind. This ensures that residents or their representatives have time to reconsider the decision to use arbitration to settle a dispute with the facility. This also allows time for them to seek legal advice, if he or she chooses to do so. Facilities should have a process, that is also explained to the resident or their representative, which ensures timely communication to the appropriate facility staff of a resident’s or resident representative’s desire to withdraw from, or terminate the arbitration agreement. Otherwise, miscommunications or delays could deny the resident or representative the right to withdraw from the agreement within the 30-day period. §483.70(m)(4): The arbitration agreement “must explicitly state neither the resident nor his or her representative is required to sign this agreement as a condition of admission to, or as a requirement to continue to receive care at the facility.” This means the agreement itself must contain clear language that neither the resident nor the representative are required to enter into the agreement as a condition of admission or to continue to reside at the facility. As stated above at §483.70(m)(1), this must be clearly conveyed without any ambiguity, thereby ensuring that no resident or his or her representative will have to choose between signing an arbitration agreement and receiving care at the facility. §483.70(m)(5): The arbitration “agreement may not contain any language that prohibits or discourages the resident or anyone else from communicating with federal, state, or local officials, including but not limited to, federal and state surveyors, other federal or state health department employees, and representative of the Office of the State Long-Term Care Ombudsman, in accordance with §483.10(k).” Residents or their representatives have the right to unrestricted communication with officials from federal agencies, as well as with state and local officials, including representatives from the State Survey Agency, State Health department, and representatives from the Office of the State Long-Term Care Ombudsman. In addition to prohibition of language in the agreement which discourages such contact or communication, this also means that there should be no attempt by facility staff to discourage this communication verbally. Surveyors should verify through interview that the resident or his or her representative were not discouraged in any way from contacting federal, state, or local officials, which includes and is not limited to surveyors and ombudsmen, when entering into a binding arbitration agreement. For additional information, refer to the guidance at §483.10(k) - F586, Contact with External Entities. PROCEDURES AND PROBES §483.70(m)(1)(2)(i)(ii)(3)-(5) Surveyors should verify with the facility whether arbitration agreements are used to resolve disputes. If so, determine compliance with F847 through interview of sampled residents, resident representatives, resident council/family council (if one exists), Long-Term Care Ombudsman, facility staff; and record review, which includes reviewing the agreement and other relevant documentation. For facilities that offer arbitration agreements, the following are interview questions that may assist Surveyors in their investigation. Surveyors are not required to ask all of the below interview questions, but instead use these example questions as a guide during interviews. Note: These provisions are not intended to, “supersede or interfere with state laws or other state contract and consumer protection laws . . . except to the extent any such laws are actually in conflict with this regulation.” 84 Fed. Reg. 34718, 34721 (July 18, 2019). Interviews a. Resident and/or his or her Representative: For residents who have arbitration agreements, determine the extent to which the arbitration agreement was explained to the resident or representative by asking: • What is your understanding of the arbitration process when a dispute arises? • Do you understand that you are giving up your right to litigation in a court proceeding? • Were you told that the facility could not require you to enter into an arbitration agreement in order to be admitted, or in order to remain in the facility? • Were you told that you had the right to terminate or withdraw from the agreement within 30 days of signing? If yes, were you told how to do so? • Did you feel you were obligated, required, forced or pressured to sign the binding arbitration agreement? If yes, how so? • Have you filed any complaint(s) or grievance(s) with the facility and/or state survey agency about the arbitration agreement? • Is there anything you would have liked to have known before signing the arbitration agreement? • Was the arbitration agreement explained in a way that you understood? • If the arbitration agreement was included within another document, were you told first that you had the right to decline the agreement; and second, how to exercise this right (crossing out, etc.)? b. Resident Council/ Family Council: For facilities having resident and/or family councils, and that have elected to utilize arbitration agreements, determine if there are general concerns with arbitration agreements. If concerns are identified, surveyors should arrange to meet individually with the resident to discuss their personal/private concerns related to arbitration agreements (for individual interview probes, see resident/representative interview questions above). Ask the following: • Has the Resident’s Council ever voiced any concerns to the facility about arbitration agreements, such as the way they are explained, pressure or being forced into signing them, or concerns with the process for withdrawing or terminating an agreement? • Do you know if residents feel forced (coerced) to sign the arbitration agreement? If yes, how so? • Whom from the facility discusses or reviews the binding arbitration agreement with residents or their representatives? c. Facility staff: Interview facility staff responsible for explaining the arbitration agreement to residents or their representatives. Determine how the facility staff ensure the resident or his or her representative understands the agreement by asking: • When, and under what circumstances, do you request that a resident or his or her representative agree to an arbitration agreement? • How do you ensure the resident or representative understands the terms of the arbitration agreement? • How do you ensure the arbitration agreement is explained in a form and manner that accommodates the resident or his or her representative’s needs? • How do you make sure the resident understands their rights with regard to the arbitration agreement, such as their right to refuse to enter into it, and their right to rescind it within 30 days? • What is the process in your facility for allowing residents or their representatives to terminate, or withdraw from an arbitration agreement in the first 30 days? • Do you know any resident(s) whom your facility refused admission to, or discharged due to refusal to sign a binding arbitration agreement? • Have any residents filed a complaint or grievances with the facility regarding the use of an arbitration agreement? • How do you determine if the resident’s physical condition and his/her cognitive status may be contributing factors in understanding of the binding arbitration agreement, including their ability to make an informed and appropriate decision? d. State Long-Term Care Ombudsman (if available): • Did any resident or his or her representative report that he/she felt forced or pressured into signing the binding arbitration agreements as a condition of admission or as a requirement to continue receiving care at the facility? • Do you know any resident whom the facility may have refused admission to, or who was discharged, due to refusal to sign a binding arbitration agreement? • Are you aware of any issues that have been raised regarding binding arbitration agreements? • Are you aware of any residents or representatives who sought to rescind a binding arbitration agreement? If yes, how did the facility respond to the rescission request? Record Review: Review the resident record, as well as the arbitration agreement to ensure: • The binding arbitration agreement clearly states that the resident or his or her representative is not required to enter into the agreement as a condition of admission to the facility, or as a requirement to continue to receive care. • The binding arbitration agreement does not include language, which prohibits or discourages the resident or representative from communicating with federal, state, or local officials. • There is evidence the binding arbitration agreement was explained in a form, manner and language that the resident or his or her representative understands. • There is evidence that the resident had the cognitive ability to understand the terms of the agreement, and evidence the resident acknowledged this understanding. • The binding arbitration agreement gives the resident or his or her representative the right to rescind the agreement within 30 calendar days of signing it. • For residents who have a representative, there is evidence the representative has the legal authority to sign the binding arbitration agreement. POTENTIAL TAGS FOR ADDITIONAL CONSIDERATION If there are concerns regarding communication with external entities such as federal and state surveyors, other federal or state health department employees, and representative of the Office of the State Long-Term Care Ombudsman, surveyors should further investigate and review regulatory requirements at §483.10(k), F586, Contact with External Entities. If there are concerns regarding admission agreement, surveyors should further investigate and review regulatory requirement at §483.15(a), F620, Admissions Policy. If there are concerns regarding the basis for transfer and discharge for any resident who has refused to enter into a binding arbitration agreement and has been, or will be subsequently transferred or discharged, surveyors should further investigate and review regulatory requirements at §483.15(c), F622 Transfer and Discharge. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F847, the surveyors’ investigation will generally show: The facility failed to: • Explain the terms of the agreement to the resident or his or her representative in a form and manner (including language) that he or she understands; and/or • Inform the resident or his or her representative they are not required to enter into a binding arbitration agreement as a condition of admission, or as a condition to continue to receive care at the facility; or • Inform the resident or representative they have the right to rescind or terminate the agreement within 30 calendar days of signing. The agreement itself: • Contains language that prohibits or discourages the resident or his or her representative from communicating with federal, state, or local officials, including: o Federal and state surveyors, and/or o Other federal or state health department employees, and/or o Representative of the Office of the State Long-Term Care Ombudsman; or • Fails to contain language which clearly informs the resident or their representative they are not required to sign the agreement as a condition of admission to, or as a requirement to continue to receive care at the facility. Guidance on Identifying Noncompliance at F847: In some cases, a resident or his or her representative may not be able to recall the specifics of a conversation explaining arbitration agreements held during admission or at some point previous to the survey. It is not uncommon for an individual to not remember all the technical details of something they signed in the past (e.g., six months ago). If a resident or their representative cannot recall the conversation explaining arbitration agreements, or details of the terms of the agreement, this alone may not necessarily indicate noncompliance. However, if several residents do not recall being advised of their rights related to arbitration agreements, the surveyor should conduct further investigation. Conversely, if a resident or his or her representative actively asserts or complains that they remember the admissions conversation, and can affirm that the facility staff member did not inform them of their rights related to arbitration, this may indicate noncompliance. In either case, surveyors are expected to verify noncompliance through further investigation with the resident or representative, as well as other residents, staff members, and resident council. Guidance on Determining Severity of Noncompliance at F847: When determining the severity of noncompliance at F847, surveyors must always consider what impact the identified noncompliance had on the affected resident(s). However, unlike noncompliance at other tags, such as Abuse or Quality of Care, which may result in physical, mental, and/or psychosocial outcomes, noncompliance at F847 will almost exclusively have a psychosocial impact or outcome. Surveyors must gather sufficient evidence through interviews, record review and observation to demonstrate what the psychosocial impact was to the resident. In some cases, the surveyor may have to use the reasonable person concept to determine severity. Refer to the Psychosocial Severity Outcome Guide for further information. The failure of the facility to meet the requirements at F847 is more than minimal harm. Therefore, Severity Level 1 does not apply for this regulatory requirement. Absent evidence of actual harm, noncompliance at F847 would likely be cited at severity level 2, No Actual Harm with Potential for More than Minimal Harm that is not Immediate Jeopardy. However, if the surveyor identifies that noncompliance at F847 has caused psychosocial harm to the resident (per the Psychosocial Severity Outcome Guide), this should be cited at severity level 3, Actual Harm that is not Immediate Jeopardy. In order to cite Immediate Jeopardy, the surveyor’s investigation would have to show that noncompliance resulted in the likelihood for serious psychosocial injury or harm, or caused actual serious psychosocial injury or harm, and required immediate action to prevent further serious psychosocial injury or harm from occurring or recurring. Refer to Appendix Q for further information. Guidance on Correcting Noncompliance at F847: When noncompliance exists at F847, the Plan of Correction (POC) is expected to include the required elements as identified at State Operations Manual, Chapter 7, §7317 – Acceptable Plan of Correction. These include: • Address how corrective action will be accomplished for those residents found to have been affected by the deficient practice; • Address how the facility will identify other residents having the potential to be affected by the same deficient practice; • Address what measures will be put into place or systemic changes made to ensure that the deficient practice will not recur; • Indicate how the facility plans to monitor its performance to make sure that solutions are sustained; and • Include dates when corrective action will be completed. When the surveyor’s investigation shows systemic noncompliance, indicating a complete disregard or unawareness of the requirements, such as the standard use of arbitration agreements containing language which violates the requirements at F847, evidence that the facility has made no attempt to explain arbitration agreements, or evidence of overt attempts to conceal arbitration agreements within other documents, in addition to the requirements for POCs listed above, CMS has the following expectations with regard to the accepted POC: • The POC must ensure that any new or revised arbitration agreements in use in the facility complies with the requirements at F847 – Surveyors must review the revised agreements and confirm that they comply with F847; • If a resident or their representative has signed a non-compliant agreement, the facility must ensure that the resident or their representative is promptly notified that the agreement does not comply with §483.70(m), and it must promptly offer the resident or their representative a compliant agreement; • The facility must explain the terms of the new agreement to the residents or their representatives, and do so in terms the residents or their representatives can understand; and • All other requirements at F847 are met. 1 Adapted from American Bar Association. “Dispute Resolution Processes: Arbitration.” Americanbar.org, Accessed 1/6/2021) 2 Adapted from American Bar Association. “Dispute Resolution Processes: Arbitration.” Americanbar.org, Accessed 1/6/2021) F848 Arbitrator/Venue Selection and Retention of Agreements (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(m) Binding Arbitration Agreements. If a facility chooses to ask a resident or his or her representative to enter into an agreement for binding arbitration, the facility must comply with all of the requirements in this section. . . §483.70(m)(2) The facility must ensure that . . . (iii) The agreement provides for the selection of a neutral arbitrator agreed upon by both parties; and (iv)The agreement provides for the selection of a venue that is convenient to both parties. . . §483.70(m)(6) When the facility and a resident resolve a dispute through arbitration, a copy of the signed agreement for binding arbitration and the arbitrator's final decision must be retained by the facility for 5 years after the resolution of that dispute on and be available for inspection upon request by CMS or its designee. NOTE: The requirements at 483.70(m) went into effect on September 16, 2019. This guidance is intended for the review of arbitration agreements entered into on or after September 16, 2019. INTENT To provide a neutral and fair arbitration process by ensuring both the resident or his or her representative, and the facility agree on the selection of a neutral arbitrator, and that the venue is convenient to both parties. In addition, the requirement to retain a copy of the signed agreement for binding arbitration and the arbitrator's final decision enables CMS to ensure that CMS can fully evaluate quality of care complaints that are addressed in arbitration and assess the overall impact of these agreements on the safety and quality of care provided in long-term care facilities. DEFINITIONS Arbitrator: A third party who resolves a dispute between others by arbitration and pursuant to an arbitration agreement. Arbitrators are decision makers, with procedures set by the arbitration agreement and state law, except they may not be required to follow federal or state rules of evidence and their decisions may not be reviewable by a court absent extraordinary circumstances. Convenient Venue: A location in which to carry out arbitration proceedings which should be agreed upon and suitable to both parties. Neutral Arbitrator: An impartial, or unbiased third-party decision maker, contracted with, and agreed to by both parties to resolve their dispute. GUIDANCE The requirement at §483.70(m)(2)(iii) states “the facility must ensure that the agreement provides for the selection of a neutral arbitrator agreed upon by both parties.” Facilities wishing to utilize binding arbitration agreements should make reasonable efforts to ensure that any arbitration agreement entered into with a resident or his or her representative provides for the selection of an arbitrator who is impartial, unbiased, and without the appearance of a conflict of interest. This ensures the integrity of the arbitration process, and also ensures that residents who choose this alternative dispute resolution are treated with the same fairness they would have if they chose to litigate. Facilities may put forward suggestions for the use of specific arbitrators for residents (or their representatives) to select. The resident or his or her representative is not obligated to use the arbitrator (either an arbitration services company or an individual arbitrator) suggested by the facility, and may suggest an alternative arbitrator of their choosing. Facilities are expected to make a reasonable attempt to come to agreement with the resident or resident’s representative on the selection of a neutral arbitrator and provide a fair process for selecting an arbitrator or arbitration services company. To ensure a neutral arbitrator is selected, the facility should avoid even the appearance of bias, partiality, or a conflict of interest, and should promptly disclose to the resident or his or her representative the extent of any relationship which exists with an arbitrator or arbitration services company, including how often the facility has contracted with the arbitrator or arbitration service, and when the arbitrator or arbitration service has ruled for or against the facility. The requirement at §483.70(m)(2)(iv) states “the facility must ensure the agreement provides for the selection of a venue that is convenient to both parties.” The binding arbitration agreement must allow for the selection of a venue that is suitable in meeting the needs of both the resident or his or her representative, and the facility. The venue should be agreed upon by both parties. The venue is the geographical location of the arbitration proceeding that may be chosen, in part, on the basis of convenience. Convenience for the resident or resident’s representative may be determined by his or her needs in terms of ability to get to the venue. The requirements at §483.70(m)(6) state that “when the facility and a resident resolve a dispute through arbitration, a copy of the signed agreement for binding arbitration and the arbitrator's final decision must be retained by the facility for 5 years after the resolution of that dispute on and be available for inspection upon request by CMS or its designee.” When a dispute is resolved through arbitration, facilities are accountable and responsible for retaining a copy of the signed binding arbitration agreement and final decision for a period of 5 years following resolution of the arbitrated dispute. These records must be made available for review to surveyors upon request. NOTE: It is important for surveyors to focus on the record retention requirement, not the content of the arbitration agreement or final decision(s) in determining compliance with this requirement. PROCEDURES AND PROBES §483.70(m)(2)(iii) & (iv) Surveyors should verify with the facility whether arbitration agreements are used to resolve disputes. If so, determine compliance with F848 through interview of sampled residents, resident representatives, resident council/family council (if one exists), Long-Term Care Ombudsman, facility staff; and record review, which includes reviewing the agreement and other relevant documentation. For facilities that offer arbitration agreements, the following are interview questions that may assist Surveyors in their investigation. Surveyors are not required to ask all of the below interview questions, but instead use these example questions as a guide during interviews. Note: These provisions are not intended to, “supersede or interfere with state laws or other state contract and consumer protection laws . . . except to the extent any such laws are actually in conflict with this regulation.” 84 Fed. Reg. 34718, 34721 (July 18, 2019). Interviews a. Resident or Representative(s): Interview the resident or their representative to determine the process for selecting a neutral arbitrator and convenient venue. Ask: • How were you included in selecting the arbitrator? • Were you given a choice in arbitrator? • Were you given an opportunity to suggest an arbitrator? • Do you agree with the arbitrator that was selected? • Was more than one arbitrator suggested? • Was a list of arbitrators to select from provided or alternatively were you made aware of how to search for arbitration companies? • What did the facility tell you about the arbitrator or arbitration services company? • Are you aware of any relationship or association between the facility and the arbitrator? • How were you included in selecting the venue? • Were you given a choice in venue? • Was the agreed upon venue convenient to you and/or your representative? • When were the arbitrator and venue selected? Under what circumstances? • Did the facility reject any of your preferred arbitrators or venues? Why? • Are you aware whether or not the facility used the same arbitrator or company in the past? b. Resident Council/Family Council: For facilities having resident and/or family councils and have elected to utilize arbitration agreements, determine if there are general concerns with arbitration agreements. If concerns are identified, surveyors should arrange to meet individually with the resident to discuss their personal/private concerns related to arbitration agreements (for individual interview probes, see resident/representative interview questions above). Ask the following: • Are you aware of any concerns about the selection of a neutral arbitrator and/or the selection of a convenient venue? (Remind residents not to share personal, private information in the group setting.) c. Facility Staff: Interview the facility staff responsible for facilitating the selection of a neutral arbitrator and convenient venue. Ask: • How do you ensure that the resident or his or her representative has an equal role in selecting a neutral arbitrator? • What is your process for selecting a neutral arbitrator? • How do you ensure that the resident or his or her representative has an equal role in selecting a convenient venue? • What is your process for selecting a convenient venue? • When a resident or his or her representative do not agree with the arbitrator and/or venue, what are the next steps? • How does the agreement provide for the selection of the arbitrator is agreed upon by both parties? What is the facility’s policy on retention of the signed binding arbitration agreements and the final dispute documentation? • When, and under what circumstances, do you approach residents or their representatives about selecting an arbitrator or venue? • Are there any active complaints or grievances regarding the selection of an arbitrator or venue? How are you addressing these concerns? • What information do you provide residents or their representatives regarding specific arbitrators or arbitration services companies (i.e., regarding parent corporation/owners using specific arbitration company)? • Have you used more than one arbitrator/arbitration services company in the past few years? How many times have you contracted with the same company? d. State Long Term Care Ombudsmen (if available): Interview the representative of the State Long-Term Care Ombudsman who serves resident of the facility. Ask: • Did any resident or his or her representative ask your assistance to select an arbitrator or venue? • Did any resident or his or her representative complain to you that he/she was forced or pressured to select a particular arbitrator/arbitration company or venue? • Did any resident or his or her representative report that an arbitrator and/or venue was pre-selected (i.e., the resident or his or her representative did not have an opportunity to agree to an arbitrator and/or venue)? • Did any resident or his or her representative complain the venue was inconvenient to them? Record Review: Review the binding arbitration agreement, any other pertinent information relevant to the selection of the arbitrator and venue as well as the arbitrator's final decision after resolution of a dispute (if applicable) to identify the following: • Is there evidence that the resident or his or her representative were provided with the opportunity to select a neutral arbitrator? • Is there evidence that the resident or his or her representative were provided with the opportunity to select a convenient venue? • Is there evidence the facility retained a copy of the signed agreement for binding arbitration and the arbitrator's final decision, after the resolution of a dispute through arbitration for five (5) years? KEY ELEMENTS OF NON-COMPLIANCE To cite deficient practice at F848, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • Ensure that the arbitration agreement specifically provides for the selection of a neutral arbitrator; or • Ensure that the arbitration agreement specifically provides for the selection of a venue that is convenient; or For disputes resolved by arbitration, the facility failed to: • Retain a copy of the signed agreement for binding arbitration and the arbitrator's final decision (for disputes resolved by arbitration) after the facility and a resident or their representative resolve a dispute through arbitration for five (5) years; or • Refuse to make the signed agreement or final decision available for inspections upon request by CMS or its designee. Guidance on Identifying Noncompliance at F848: In some cases, a resident or his or her representative may not be able to recall all the specifics about the selection of a neutral arbitrator or convenient venue. If a resident or their representative cannot recall the details of the selection of a neutral arbitrator or a convenient venue, this alone may not necessarily indicate noncompliance. However, if several residents do not recall the process of selecting a neutral arbitrator, or a convenient venue, the surveyor should conduct further investigation. Conversely, if a resident or his or her representative actively asserts or complains that there is no process for the selection of a neutral arbitrator or a convenient venue to both parties, this likely constitutes noncompliance. In either case, surveyors are expected to verify noncompliance through further investigation with the resident or representative, as well as other residents, staff members, and resident council. Guidance on Determining Severity of Noncompliance at F848: When determining the severity of noncompliance at F848, surveyors must always consider what impact the identified noncompliance had on the affected resident(s). However, unlike noncompliance at other tags, such as Abuse or Quality of Care, which may result in physical, mental, and/or psychosocial outcomes, noncompliance at F848 will almost exclusively have a psychosocial impact or outcome. Surveyors must gather sufficient evidence through interviews, record review and observation to demonstrate what the psychosocial impact was to the resident. In some cases, the surveyor may have to use the reasonable person concept to determine severity. Refer to the Psychosocial Severity Outcome Guide for further information. If the surveyor identifies noncompliance at F848 for the failure to retain signed arbitration agreements and/or the arbitrator’s final decision for residents that have resolved a dispute through arbitration for 5 years, Severity Level 1 may be the appropriate severity level for this regulatory requirement. In other cases, noncompliance at the other requirements at F848 (failure for the agreement to provide for the selection of a neutral arbitrator or convenient location) would likely be cited at severity level 2, No Actual Harm with Potential for More than Minimal Harm that is not Immediate Jeopardy. If the surveyor identifies that noncompliance at F848 has caused psychosocial harm to the resident (per the Psychosocial Severity Outcome Guide), this should be cited at severity level 3, Actual Harm that is not Immediate Jeopardy. In order to cite Immediate Jeopardy, the surveyor’s investigation would have to show that noncompliance resulted in the likelihood for serious psychosocial injury or harm, or caused actual serious psychosocial injury or harm, and required immediate action to prevent further serious psychosocial injury or harm from occurring or recurring. Refer to State Operations Manual (SOM) Appendix Q for further information. Guidance on Correcting Noncompliance at F848: When noncompliance exists at F848, the Plan of Correction (POC) is expected to include the required elements as identified in the SOM, Chapter 7, at 7317 – Acceptable Plan of Correction. These include: • Address how corrective action will be accomplished for those residents found to have been affected by the deficient practice; • Address how the facility will identify other residents having the potential to be affected by the same deficient practice; • Address what measures will be put into place or systemic changes made to ensure that the deficient practice will not recur; • Indicate how the facility plans to monitor its performance to make sure that solutions are sustained; and • Include dates when corrective action will be completed. When the surveyor’s investigation shows systemic noncompliance with F848, indicating a complete disregard or unawareness of the requirements, such as agreements, which make no provision for the selection of a neutral arbitrator or convenient venue, CMS has the following expectations (in addition to the requirements for POCs listed above) with regard to the accepted POC: • The POC must ensure that all arbitration agreements allow for the selection of a neutral arbitrator and convenient venue; and • There must be a process to ensure records are retained for 5 years. F849 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(n) Hospice services. §483.70(n)(1) A long-term care (LTC) facility may do either of the following: (i) Arrange for the provision of hospice services through an agreement with one or more Medicare-certified hospices. (ii) Not arrange for the provision of hospice services at the facility through an agreement with a Medicare-certified hospice and assist the resident in transferring to a facility that will arrange for the provision of hospice services when a resident requests a transfer. §483.70(n)(2) If hospice care is furnished in an LTC facility through an agreement as specified in paragraph (o)(1)(i) of this section with a hospice, the LTC facility must meet the following requirements: (i) Ensure that the hospice services meet professional standards and principles that apply to individuals providing services in the facility, and to the timeliness of the services. (ii) Have a written agreement with the hospice that is signed by an authorized representative of the hospice and an authorized representative of the LTC facility before hospice care is furnished to any resident. The written agreement must set out at least the following: (A) The services the hospice will provide. (B) The hospice’s responsibilities for determining the appropriate hospice plan of care as specified in §418.112 (d) of this chapter. (C) The services the LTC facility will continue to provide based on each resident’s plan of care. (D) A communication process, including how the communication will be documented between the LTC facility and the hospice provider, to ensure that the needs of the resident are addressed and met 24 hours per day. (E) A provision that the LTC facility immediately notifies the hospice about the following: (1) A significant change in the resident’s physical, mental, social, or emotional status. (2) Clinical complications that suggest a need to alter the plan of care. (3) A need to transfer the resident from the facility for any condition. (4) The resident’s death. (F) A provision stating that the hospice assumes responsibility for determining the appropriate course of hospice care, including the determination to change the level of services provided. (G) An agreement that it is the LTC facility’s responsibility to furnish 24- hour room and board care, meet the resident’s personal care and nursing needs in coordination with the hospice representative, and ensure that the level of care provided is appropriately based on the individual resident’s needs. (H) A delineation of the hospice’s responsibilities, including but not limited to, providing medical direction and management of the patient; nursing; counseling (including spiritual, dietary, and bereavement); social work; providing medical supplies, durable medical equipment, and drugs necessary for the palliation of pain and symptoms associated with the terminal illness and related conditions; and all other hospice services that are necessary for the care of the resident’s terminal illness and related conditions. (I) A provision that when the LTC facility personnel are responsible for the administration of prescribed therapies, including those therapies determined appropriate by the hospice and delineated in the hospice plan of care, the LTC facility personnel may administer the therapies where permitted by State law and as specified by the LTC facility. (J) A provision stating that the LTC facility must report all alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property by hospice personnel, to the hospice administrator immediately when the LTC facility becomes aware of the alleged violation. (K) A delineation of the responsibilities of the hospice and the LTC facility to provide bereavement services to LTC facility staff. §483.70(n)(3) Each LTC facility arranging for the provision of hospice care under a written agreement must designate a member of the facility’s interdisciplinary team who is responsible for working with hospice representatives to coordinate care to the resident provided by the LTC facility staff and hospice staff. The interdisciplinary team member must have a clinical background, function within their State scope of practice act, and have the ability to assess the resident or have access to someone that has the skills and capabilities to assess the resident. The designated interdisciplinary team member is responsible for the following: (i) Collaborating with hospice representatives and coordinating LTC facility staff participation in the hospice care planning process for those residents receiving these services. (ii) Communicating with hospice representatives and other healthcare providers participating in the provision of care for the terminal illness, related conditions, and other conditions, to ensure quality of care for the patient and family. (iii) Ensuring that the LTC facility communicates with the hospice medical director, the patient’s attending physician, and other practitioners participating in the provision of care to the patient as needed to coordinate the hospice care with the medical care provided by other physicians. (iv) Obtaining the following information from the hospice: (A) The most recent hospice plan of care specific to each patient. (B) Hospice election form. (C) Physician certification and recertification of the terminal illness specific to each patient. (D) Names and contact information for hospice personnel involved in hospice care of each patient. (E) Instructions on how to access the hospice’s 24-hour on-call system. (F) Hospice medication information specific to each patient. (G) Hospice physician and attending physician (if any) orders specific to each patient. (v) Ensuring that the LTC facility staff provides orientation in the policies and procedures of the facility, including patient rights, appropriate forms, and record keeping requirements, to hospice staff furnishing care to LTC residents. §483.70(n)(4) Each LTC facility providing hospice care under a written agreement must ensure that each resident's written plan of care includes both the most recent hospice plan of care and a description of the services furnished by the LTC facility to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being, as required at §483.24. DEFINITIONS §483.70(n) “Hospice care” means a comprehensive set of services described in Section 1861(dd)(1) of the Social Security Act, identified and coordinated by an interdisciplinary group (IDG) to provide for the physical, psychosocial, spiritual, and emotional needs of a terminally ill patient and/or family members, as delineated in a specific patient plan of care. (42 CFR §418.3) NOTE: These services are provided by a Medicare-certified hospice. “Hospice Attending Physician” - This clarifies that a doctor of medicine, osteopathy or nurse practitioner, if meeting the listed requirements, may function as the “attending physician” in a hospice. The hospice regulations do not provide for a physician assistant to function as the hospice attending physician. §418.3 Definitions. For the purposes of this part — “Attending physician” means a — (1)(i) Doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he or she performs that function or action; or (ii) Nurse practitioner who meets the training, education, and experience requirements as described in §410.75 (b) of this chapter. (2) Is identified by the individual, at the time he or she elects to receive hospice care, as having the most significant role in the determination and delivery of the individual's medical care. In a nursing home, a physician’s assistant may not act as the hospice attending physician, however, the resident’s attending physician at the nursing home may delegate tasks to a physician’s assistant per F714 - §483.30(e)(1). “Palliative care” - means patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and to facilitate patient autonomy, access to information, and choice. (§418.3) “Terminally ill” - means that the individual has a medical prognosis that his or her life expectancy is 6 months or less if the illness runs its normal course. (§418.3) “Bereavement counseling” - means emotional, psychosocial, and spiritual support and services provided before and after the death of the patient to assist with issues related to grief, loss, and adjustment. (§418.3) GUIDANCE §483.70(n) Provision of Hospice Services In A Nursing Home As described in §483.70(n)(1)(i),(ii), there is no requirement that a nursing home allow a hospice to provide hospice care and services in the facility. If a nursing home has made arrangements with one or more hospices to provide services in the nursing home, there must be a written agreement describing the responsibilities between each hospice and the nursing home prior to the hospice initiating care for a resident who has elected the hospice benefit. The written agreement applies to the provision of all hospice services for any nursing home resident receiving services from the specific hospice and does not need to be rewritten for each resident. If the nursing home has a written agreement(s) with one or more hospice provider(s), it must, in accordance with F581-§483.10(g)(16), inform each resident before, or at the time of admission, and periodically during the resident’s stay, of hospice, among other services, available in the nursing home. If the nursing home has an agreement with more than one hospice, this information must be provided to the resident/designated representative in order to allow choice of the hospice provider he/she prefers. If a resident chooses a hospice that does not have an agreement with the nursing home: • The nursing home may establish a written agreement with the hospice and allow the hospice provider to provide hospice services in the nursing home; or • The nursing home must assist the resident, when the resident requests, in transferring to a nursing home of his/her choice that has an agreement or will arrange for the provision of hospice services with a hospice; or in relocating to a non-nursing home setting (e.g. inpatient hospice unit, private home, or residential/assisted living facility) that uses the hospice of his/her choice; or • The resident may choose not to elect the hospice benefit and continue to reside in the nursing home with the attending physician/practitioner of their choice and receive nursing home care and services. If the nursing home or the hospice terminates the written agreement, the nursing home: • Must provide assistance to affected residents in contacting or selecting another hospice provider(s) with which the nursing home has or will enter into a written agreement; or • When the resident requests, assist the resident in transferring to a nursing home of his/her choice that has an agreement or will enter into an agreement for the provision of hospice services; or in relocating to a non-nursing home setting (e.g. inpatient hospice unit, private home, or residential/assisted living facility) that uses the hospice of his/her choice; or • The resident may choose to revoke the hospice benefit and continue to reside in the nursing home with the attending physician/practitioner of their choice and receive nursing home care and services. NOTE: When a resident/designated representative requests and/or initiates a discharge to another facility or location, the nursing home is not required to provide a notice of discharge and/or transfer as it is not a nursing home initiated transfer/discharge. This applies in the situation, in which there is no written agreement for hospice services, and/or the resident chooses a hospice with which the nursing home does not have a written agreement, and the nursing home chooses not to establish such an agreement. Nursing Home Ensures Professional Standards and Timeliness of Services As described in §483.70(n)(2)(i) the nursing home must ensure that services provided by the hospice (including the individuals providing the services) meet professional standards and principles, that the services and care meet the assessed needs of each resident, and that the hospice is certified for participation in the Medicare program. (Refer to F675 and F658.) The nursing home and hospice must assure that all physician/practitioners meet State licensure requirements and are working within their scope of practice and professional State licensure requirements. The nursing home staff must monitor the delivery of care in order to assure that the hospice provides services to the resident in a way that meets his/her needs in a timely manner including: • Observation of interactions and care provided by the hospice staff sufficient to assure that the hospice services meet the professional standards of care; • Interviews with the resident/designated representative regarding hospice care and services; and • Review of the resident’s record for pertinent documentation regarding the delivery of hospice care. For example, if a resident has an increase in pain that is not being managed by the current interventions, or if current interventions may be causing adverse consequences that are distressing to the resident, the requirement that the nursing home ensure the provision of timely hospice services would include notifying the hospice of the resident’s change in condition so that the hospice, in consultation with the nursing home and the resident’s attending physician/practitioner, can reassess the resident and with input from the resident/designated representative, change the plan of care, as indicated, to assure the resident receives the treatment necessary to achieve his/her optimal comfort level. Signed Written Agreement with Hospice Prior to Provision of Care As described in §483.70(n)(2)(ii)(A), the written agreement must be signed by authorized representatives of the hospice and the nursing home prior to the provision of hospice services. The hospice retains primary responsibility for the provision of hospice care and services, based upon the resident’s assessments and choices. According to hospice regulations at §418.100(c)(2) - “Nursing services, physician services, and drugs and biologicals (as specified in §418.106) must be made routinely available on a 24-hour basis, 7 days a week. Other covered services must be available on a 24-hour basis when reasonable and necessary to meet the needs of the patient and family.” Other covered services include counseling (including spiritual, dietary and bereavement), social work, hospice aide, volunteer, and homemaker services, physical therapy, occupational therapy, and speech- language pathology services, short-term inpatient care, drugs, biologicals, and medical appliances related to the palliation and management of the terminal illness and related conditions. (§418.112(c)(6) Hospice Plan of Care As described in §483.70(n)(2)(ii)(B), when a hospice patient is a resident of a nursing home, the hospice must establish the hospice plan of care in coordination with the nursing home, the resident’s nursing home attending physician/practitioner, and to the extent possible, the resident/designated representative. In order to provide continuity of care, the hospice and the nursing home must collaborate in the development of a coordinated plan of care for each resident receiving hospice services. The structure of the plan of care is established by the nursing home and the hospice. The coordinated plan of care must identify the provider responsible for performing each or any specific services/functions that have been agreed upon. The plan of care may be divided into two portions, one maintained by the nursing home and the other maintained by the hospice. The nursing home and the hospice must be aware of the location and content of the coordinated plan of care (which includes the nursing home portion and the hospice portion) and the plan must be current and internally consistent in order to assure that the needs of the resident for both hospice care and nursing home care are met at all times. The nursing home must designate a member of the nursing home’s interdisciplinary team who is responsible for working with hospice to coordinate care for the resident. (See §483.70(n)(3)(i) below.) In addition, different nursing home staff, who are knowledgeable regarding the resident’s care, may also work with hospice staff in the development of the plan of care. The hospice coordinator must provide ongoing coordination and collaboration with the nursing home coordinator, the resident’s attending physician/practitioner and the resident/designated representative regarding changes to the resident’s plan(s) of care. Based on the shared communication between the hospice and the nursing home, the coordinated plan(s) of care should reflect the identification of: • Diagnoses; • A common problem list; • Palliative interventions; • Palliative goals/objectives; • Responsible discipline(s); • Responsible provider(s); and • Resident/designated representative choices regarding care and goals. Nursing Home Responsibilities As described in §483.70(n)(2)(ii)(C), the nursing home retains primary responsibility for implementing those aspects of care that are not related to the duties of the hospice. The nursing home’s services must be consistent with the plan of care developed in coordination with the hospice, and the nursing home must offer the same services to its residents who have elected the hospice benefit as it furnishes to its residents who have not elected the hospice benefit. Therefore, the hospice patient residing in a nursing home should not experience any lack of services or personal care because of his or her status as a hospice patient. This includes what would normally be provided to a resident in the nursing home, including but not limited to the following: conducting the comprehensive assessments which includes the Resident Assessment Instrument (RAI), providing personal care, activities, medication administration, required physician visits, monthly medication regimen review, support for activities of daily living, social services as appropriate, nutritional support and services, and monitoring the condition of the resident. The nursing home must maintain an environment in which there are no inappropriate signs posted in residents’ rooms or in staff work areas visible by other residents and/or visitors that include confidential clinical or personal information, such as information about hospice services. (Refer to F550, Dignity.) Communication Process between Nursing Home and Hospice As described in §483.70(n)(2)(ii)(D), the written agreement must specify a process for communicating necessary information regarding the resident’s care between the nursing home and the hospice 24-hours a day, 7-days a week including how these communications will be documented. Both the hospice and the nursing home may document physician orders in the resident’s nursing home record. Orders are to be dated and signed in accordance with Federal requirements (Refer to F711 – physician orders) and any applicable State laws. There is no Federal regulation that prohibits nursing home staff from taking orders for care from the hospice physician. Any changes to orders initiated by the hospice should be communicated to the resident’s attending physician/practitioner in a timely manner. The nursing home must communicate with the hospice regarding orders provided by the resident’s attending physician/practitioner in the nursing home, if he/she is not the resident’s designated physician on the hospice team. Prior to plan of care or order changes the hospice physician and the resident’s attending physician/practitioner may need to collaborate to address an emergent change in the resident’s condition and to assure the resident’s needs are met. If there is a conflict between orders given by hospice and the resident’s attending physician/practitioner, there must be communication between the nursing home and the hospice regarding the issue. This communication should include the nursing home medical director and the hospice medical director as well as other pertinent staff as needed. Notifying Hospice Regarding Clinical Changes As described in §483.70(n)(2)(ii)(E), the written agreement must include a provision that the nursing home will immediately contact and communicate with the hospice staff regarding any significant changes in the resident’s status, clinical complications or emergent situations. Situations include, but are not limited to, changes in cognition or sudden unexpected decline in condition, a fall with a suspected fracture or adverse consequences related to a medication or therapy, or other situations requiring a revision to the plan of care. The immediate notification to hospice does not change the requirement that a nursing home must also immediately notify the resident’s attending physician/practitioner. Prior to plan of care or order changes, the hospice and the resident’s attending physician/practitioner may need to collaborate to address this change and to assure that the resident’s immediate and ongoing treatment and care needs are met in accordance with the resident’s decisions and advance directives regarding end of life care are met, including situations which could require a potential transfer to an acute care setting. This decision making must be consistent with the resident’s wishes and most current version of advance directive, if any. (Refer to F578) If there is a conflict between the nursing home and the hospice regarding the course of hospice care or level of service, there must be communication between the nursing home and the hospice regarding the issue. This communication should include the nursing home medical director and the hospice medical director as well as other pertinent staff, as needed. Hospice Determines Level of Hospice Services As described in §483.70(n)(2)(ii)(F), the written agreement must state that the hospice assumes responsibility for professional management of the resident's hospice services provided, in accordance with the hospice plan of care and the hospice conditions of participation, and make any arrangements necessary for hospice-related inpatient care in a participating Medicare/Medicaid facility (§418.112(b)). The agreement must also include language that the hospice assumes the responsibility for determining the level of hospice services. Any substantive changes in the level of hospice services must be developed by the hospice and these changes must be reflected in the coordinated plan of care. These changes should be made in collaboration with the resident/designated representative, the resident’s attending physician/practitioner, and nursing home staff. Nursing Home Responsibilities for Personal Care and Nursing Needs in Coordination with Hospice As described in §483.70(n)(2)(ii)(G), the provisions of the written agreement must delineate how the care and needs will be provided based upon the resident’s identified needs. It is the nursing home’s responsibility to continue to furnish 24-hour room and board care, meeting the resident’s personal care and nursing needs. Services provided must be consistent with the plan of care developed in coordination with the hospice Interdisciplinary Group (IDG). Delineation of Hospice Responsibilities As described in §483.70(n)(2)(ii)(H), to comply with this requirement, the written agreement must contain a clear statement that the hospice assumes responsibility for determining the appropriate course of hospice care to be provided and delineate the services that the hospice is required to provide to the resident (not already covered by the nursing home through the provision of room and board and services to meet the resident’s personal care and nursing needs as required by §483.70(n)(2)(ii)(G). When the resident elects the hospice benefit, the resident may choose to specify his/her nursing home attending physician/practitioner as the hospice attending physician. If the resident does not choose his/her nursing home attending physician, he/she may select another physician/practitioner as the hospice attending physician. The hospice IDG in collaboration with the resident’s nursing home attending physician/practitioner is responsible for the palliation and management of specified aspects of care, based on the agreement. The agreement identifies the process for developing the plan of care in collaboration with the resident’s attending physician/practitioner and includes the process to be followed to reconcile disagreements between the resident’s attending physician/practitioner and hospice physician. NOTE: The nursing home regulations at F710 - Physician Supervision), requires that “The facility must ensure that another physician supervises the medical care of residents when their attending physician is unavailable.” According to the hospice CoPs at §418.64(a) and (a)(3) - Standard: Physician services, “The hospice medical director, physician employees, and contracted physician(s) of the hospice, in conjunction with the patient's attending physician, are responsible for the palliation and management of the terminal illness and conditions related to the terminal illness…(3) If the attending physician is unavailable, the medical director, contracted physician, and/or hospice physician employee is responsible for meeting the medical needs of the patient.” The written agreement must identify how the nursing home will obtain information regarding the provision of medical care including medication information from the hospice, and should include the identification of hospice non-physician practitioners who, according to State law, may provide orders for medical care of the resident. Nursing Home Responsibilities for Administration of Prescribed Therapies As described in §483.70(n)(2)(ii)(I), the written agreement must include the provision that the LTC facility personnel may administer therapies where permitted by State law and as specified by the LTC facility as noted in the coordinated plan of care. Report to Hospice any Alleged Violations of Mistreatment, Neglect, Verbal, Mental, Sexual, and Physical Abuse Including Injuries of Unknown Source and/or Misappropriation of Property by Hospice Personnel As described in §483.70(n)(2)(ii)(J), the nursing home must follow all of the requirements within §483.12(a)(b) and (c), Free From Abuse…(F600-610) for the prevention, identification, protection, reporting and investigation of allegations of abuse, neglect, verbal, mental, sexual abuse, mistreatment and injuries of unknown source. This also includes prohibiting taking and/or posting photos or recordings that are demeaning and or humiliating to a nursing home resident or the use of an authorized photo or recording in a demeaning/humiliating manner. The privacy and confidentiality of the resident’s care and records must be maintained. (Refer to F583 - Privacy and Confidentiality). The nursing home must also notify the hospice administrator of any such allegations involving hospice employees and contractors and anyone else providing services on behalf of the hospice and the outcome of its investigation. NOTE: The hospice must follow the requirements as indicated in the Federal regulations at §418.52(b)(4)(i-iv) for reporting, investigating and taking appropriate corrective actions. Responsibilities for Bereavement Services for Nursing Home Staff As described in §483.70(n)(2)(ii)(K), the death of the resident may have a direct impact on identified nursing home staff. The written agreement should specify when the nursing home should provide information to the hospice regarding nursing home staff that may benefit from bereavement services. The written agreement between the hospice and the nursing home should specify how bereavement services will be coordinated and operationalized by the hospice provider for nursing home staff. The written agreement must include a description of the nursing home’s role in providing such services. These services should be individualized based on the resident involved and the staff involvement in their care. In the case of several hospices offering services in a nursing home, each hospice’s written agreement must include the provision regarding bereavement services for staff as noted above. NOTE: According to the hospice CoPs at §418.64(d) - Counseling services must include, but are not limited to, the following: (1) - Bereavement counseling. The hospice must: (ii) “Make bereavement services available to the family and other individuals in the bereavement plan of care up to 1 year following the death of the patient. Bereavement counseling also extends to residents of a SNF/NF or ICF/MR when appropriate and identified in the bereavement plan of care.” Nursing Home Designee(s) Responsibilities As described in §483.70(n)(3)(i)-(v), the nursing home must identify and designate, in writing, an employee of the nursing home to assume the responsibilities for collaborating and coordinating activities between the nursing home and the hospice. The nursing home employee must have a clinical background, function within their State scope of practice act, and have the ability to assess the resident or have access to someone that has the skills and capabilities to assess the resident. The designated nursing home coordinator should be familiar with hospice philosophy and practices. The nursing home should provide the name of the designated nursing home staff member to the resident/representative for ongoing communication regarding care or concerns. If the designated employee is not available, the nursing home may delegate this function to another nursing home employee who meets the requirements identified above. It should be noted that in nursing homes contracting with more than one hospice, the nursing home may designate more than one/different employees to serve as coordinator with the respective hospice(s). Due to the complex clinical needs of a resident who is in the terminal stages of life, the interdisciplinary team member must have the ability to assess the resident or have access to someone who has the ability to assess the resident. The communication process established should include a system for the designated interdisciplinary team member to obtain the information as identified at §483.70(n)(3) (iv) A-G. The resident’s nursing home record must have evidence of this information. The designated employee is responsible for assuring that orientation is provided to hospice staff. This orientation is meant to address the overall facility environment including policies, rights, record keeping and forms requirements. It is important for the nursing home to document and have available information regarding hospice staff orientation. NOTE: Refer to §418.112(f). In addition to the orientation that nursing homes must provide to hospice staff, hospices must provide orientation to nursing home staff providing care for hospice patients. The orientation requirements while separate regulations for both the nursing home and hospice, should be a collaborative effort to assure that the hospice employees provide services and care effectively in the nursing home and that the hospice ensures that the nursing home staff understands the basic philosophy and principles of hospice care. If a nursing home has written agreements with multiple hospice providers, the nursing home should collaborate with each hospice to assure that the nursing home staff are familiar with specific policies and procedures for each individual hospice. It may not be necessary for each hospice to provide information to nursing home staff regarding the hospice philosophy and principles of care if the nursing home staff has received this information and are aware of the philosophy and principles of care. Provision of Current, Coordinated Plan of Care As described in §483.70(n)(4), the intent of this regulation is to ensure coordination of care between the nursing home and the hospice in order to assure that the most current plans of care for each resident have been coordinated, individualized and identify what each entity will provide. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F849, the surveyor’s investigation will generally show that the facility failed to do any one of the following: • Develop a written agreement with the Medicare-certified hospice prior to hospice services being provided to a resident; or • Establish a communication process, including how the communication will be documented between the LTC facility and the hospice provider, to ensure that the needs of the resident are addressed and met 24 hours per day; or • In accordance with the written agreement to immediately notify the hospice about a significant change in the resident’s condition, or the presence of clinical complications that suggest a need to alter the plan of care, or a need to transfer the resident from the facility or of the resident's death; or • To designate a member of the facility's interdisciplinary team who is responsible for working with hospice representatives to coordinate care to the resident provided by the LTC facility staff and hospice staff; or • Ensure that each resident's written plan of care includes both the most recent hospice plan of care and a description of the services furnished by the LTC facility to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being; or • Delineate the responsibilities of the hospice and the LTC facility to provide bereavement services to LTC facility staff. If there are concerns with the implementation of care or services by the hospice provider, then the survey team must refer the complaint to the State agency responsible for oversight of hospice, identifying the specific resident(s) involved and the concerns identified. INVESTIGATIVE SUMMARY Use the Hospice and End of Life Care and Services Critical Element (CE) Pathway, along with the interpretive guidelines when determining if the facility meets the requirements for providing care and services for a resident receiving hospice services, in accordance with professional standards of practice, the coordinated person-centered care plan. In addition, the services must be and based upon the requirements included in the written agreement between the nursing home and hospice. Summary of Investigative Procedure Briefly review the most recent comprehensive assessments, coordinated care plan and orders to identify whether the facility has recognized, assessed, provided interventions and implemented care and services according to professional standards of practice, in order to meet the resident’s hospice care needs. This information will guide observations and interviews to be made in order to corroborate concerns identified. In addition, investigate to assure that there are sufficient numbers of trained, qualified and competent staff to provide the interventions identified for a resident receiving hospice care and services. If concerns are identified, review the appropriate sections of the written agreement above. If the resident has been in the facility for less than 14 days (before completion of all the Resident Assessment Instrument (RAI) is required), review the baseline care plan which must be completed within 48 hours to determine if the facility is providing appropriate care and services based on information available at the time of admission. In addition, review to determine whether the comprehensive care plan is evaluated and revised based on the resident’s response to interventions. NOTE: Always observe for visual cues of psychosocial distress and harm (see Appendix P, Guidance on Severity and Scope Levels and Psychosocial Outcome Severity Guide). If a concern is identified during the survey regarding hospice care and/or the timeliness of the hospice services, the survey team should review how the nursing home’s QAA committee is monitoring the provision of hospice services, such as monitoring the response by the hospice for the timely provision of care, including onsite visits by hospice staff during a crisis or change in the resident’s condition. If noncompliance is identified related to the written agreement, cite at F849. If noncompliance is identified related to quality of care, cite at F685, Quality of Care. DEFICIENCY CATEGORIZATION • Examples of Level 4, immediate jeopardy to resident health and safety, include, but are not limited to: o The failure of the facility to assure that the resident received hospice care and services based upon a written agreement with a Medicare-certified hospice. For example, a deficiency was cited at Severity Level 4, at F697, when the resident has severe uncontrolled pain, or F675, acute respiratory distress and at F849, the facility fails to contact and consult with the hospice as per the written agreement for a change in condition. o The facility failed to establish a written agreement with a Medicare-certified hospice that was allowed to provide hospice services in the nursing home. In this example, a deficiency was cited at Severity Level 4, at F697, when the resident was administered medication for pain management by the hospice, and due to lack of coordination, the nursing home, unaware of the administration of the medication, also administered pain medication resulting in an overdose of opioids and hospitalization due to acute respiratory failure, and at F849, the facility failed to establish a written agreement with a Medicare-certified hospice that was allowed to provide hospice services in the nursing home, resulting in the lack of coordination. • Examples of Level 3 - Actual harm (physical or psychological) that is not immediate jeopardy include but are not limited to: o The failure of the facility to assure that the resident received hospice care and services based upon a written agreement with a Medicare-certified hospice. For example, a deficiency was cited at Severity Level 3, at F697, when the resident has experienced pain that compromised his/her function (physical and/or psychosocial) and/or ability to reach his/her highest practicable well- being as a result of the facility’s failure to recognize or address the situation, or failure to develop, implement, monitor, or modify a pain management plan to try to meet the resident’s needs. For example, the pain was intense enough that the resident experienced recurrent insomnia, or reduced ability to move and perform ADLs, or a decline in mood or reduced ability to communicate/socialize with family and/ or participation in activities; and at F849, the facility failed to contact and consult with the hospice as per the written agreement for reviewing the resident’s care plan for pain management. o At F849, the facility failed to establish a written agreement with a Medicare- certified hospice that was allowed to provide hospice services in the nursing home. In addition, the facility failed to contact and consult with the hospice for concerns related to significant changes in the resident’s physical condition or need to alter the plan of care which is a component of the written agreement regulation. For example, a deficiency was cited at Severity Level 3, at F697, when a resident experienced significant episodic pain (that was not all-consuming or overwhelming but was greater than minimal discomfort to the resident) related to care/treatment such as prior to wound care, exercise or physical therapy. The facility failed to involve the hospice and failed to develop, implement, monitor, or modify pain management interventions. • Examples of Level 2 - No actual harm with a potential for more than minimal harm that is not immediate jeopardy include but are not limited to: o The failure of the facility to assure that the resident received hospice care and services based upon a written agreement with a Medicare-certified hospice. For example, a deficiency was cited at Severity Level 2, at F697, when the resident was on a pain management program utilizing opioids. The resident was experiencing episodic minimal discomfort and the facility failed to consult with the hospice regarding the bowel management plan as identified in the coordinated plan of care. The facility was cited at F849 for failure to contact and consult with the hospice as per the written agreement for communicating with the hospice for review and possible revision of the resident’s care plan. o At F849, the facility failed to establish a written agreement with a Medicare- certified hospice that was allowed to provide hospice services in the nursing home. In addition, the facility failed to contact and consult with the hospice for concerns related to a need to alter the plan of care which is a component of the written agreement regulation. For example, a deficiency was cited at Severity Level 2, at F697, when a resident experienced daily or less than daily discomfort with no compromise in physical, mental, or psychosocial functioning as a result of the facility’s failure to adequately recognize or address the pain management. The resident was able to participate in ADL’s and/or activities of choice. The facility failed to involve the hospice in developing, implementing, monitoring, or modifying pain management interventions. o The facility failed to assure that the written agreement met one or more of the regulatory specifications resulting in the potential for negative resident outcomes. • An example of Level 1 - No actual harm with a potential for minimal harm includes but is not limited to: o There are components of the written agreement that were not met but they may have minimal impact to the resident. Failure to meet these elements will be cited at severity level 1. For example: The facility failed to implement provisions of the agreement regarding bereavement services for the LTC. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION §483.70(n) - Hospice Services If an additional concern has been identified, the surveyor must investigate the identified concern. Do not cite any related or associated requirements before first conducting an investigation to determine compliance or non-compliance with the related or associated requirement. Some examples include, but are not limited to, the following: • 42 CFR §483.21(b)(1), F656, Comprehensive Care Plans; • 42 CFR §483.21(b)(2), F657, Comprehensive Care Plan Revision; • 42 CFR §483.25, F685, Quality of Care; • 42 CFR §483.40(d), F745, Medically Related Social Services; • 42 CFR §483.70(g), F841, Medical Director; • 42 CFR §483.70(h)(5), F842, Resident Records; and • 42 CFR §483.75(c)(h)(i), F866, §483.75(d)(e)(g)(2)(ii)-(iii) F867 Quality Assessment and Assurance. F850 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(o) Social worker. Any facility with more than 120 beds must employ a qualified social worker on a full-time basis. A qualified social worker is: §483.70(o)(1) An individual with a minimum of a bachelor’s degree in social work or a bachelor’s degree in a human services field including, but not limited to, sociology, gerontology, special education, rehabilitation counseling, and psychology; and §483.70(o)(2) One year of supervised social work experience in a health care setting working directly with individuals. GUIDANCE §483.70(o) The regulations do not require a Social Worker when a facility has equal to or less than 120 beds. If the facility has more than 120 beds and its full-time social worker does not provide on- site coverage on a full-time basis determine how these services are provided to meet the individual needs of the resident whenever needed. If social services deficiencies are identified refer to §483.40(d), F745, regardless of the number of beds. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F850, the surveyor’s investigation will generally show that the facility failed to do any one of the following: • A facility with more than 120 beds did not employ a qualified social worker on a full-time basis; or • The individual functioning as the social worker did not meet the qualifications specified in this regulation. F851 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.70(p) Mandatory submission of staffing information based on payroll data in a uniform format. Long-term care facilities must electronically submit to CMS complete and accurate direct care staffing information, including information for agency and contract staff, based on payroll and other verifiable and auditable data in a uniform format according to specifications established by CMS. §483.70(p)(1) Direct Care Staff. Direct Care Staff are those individuals who, through interpersonal contact with residents or resident care management, provide care and services to allow residents to attain or maintain the highest practicable physical, mental, and psychosocial well- being. Direct care staff does not include individuals whose primary duty is maintaining the physical environment of the long term care facility (for example, housekeeping). §483.70(p)(2) Submission requirements. The facility must electronically submit to CMS complete and accurate direct care staffing information, including the following: (i) The category of work for each person on direct care staff (including, but not limited to, whether the individual is a registered nurse, licensed practical nurse, licensed vocational nurse, certified nursing assistant, therapist, or other type of medical personnel as specified by CMS); (ii) Resident census data; and (iii) Information on direct care staff turnover and tenure, and on the hours of care provided by each category of staff per resident per day (including, but not limited to, start date, end date (as applicable), and hours worked for each individual). §483.70(p)(3) Distinguishing employee from agency and contract staff. When reporting information about direct care staff, the facility must specify whether the individual is an employee of the facility, or is engaged by the facility under contract or through an agency. §483.70(p)(4) Data format. The facility must submit direct care staffing information in the uniform format specified by CMS. §483.70(p)(5) Submission schedule. The facility must submit direct care staffing information on the schedule specified by CMS, but no less frequently than quarterly. INTENT §483.70(p) To ensure that long-term care facilities are electronically submitting direct care staffing information (including agency and contract staff) per day, based on payroll and other verifiable and auditable data. The staffing hours, when combined with census information, can then be used to not only report on the level of staff in each nursing home, but also to report on employee turnover and tenure. GUIDANCE §483.70(p) The facility is responsible for ensuring all staffing data entered in the Payroll-Based Journal (PBJ) system is auditable and able to be verified through either payroll, invoices, and/or tied back to a contract. The surveyors can obtain PBJ data from the Certification And Survey Provider Enhanced Reports (CASPER) report to determine if the facility submitted the required staffing information based on payroll data in a uniform format. The facility’s failure to submit PBJ data as required will be reflected on their CASPER report and result in a deficiency citation. If concerns were identified based on the CASPER report, or from any other source, refer to the critical element pathway “Sufficient and Competent Staffing.” Refer to the CMS Electronic Staffing Data Submission Payroll-Based Journal Policy Manual for submission guidelines. Please see the following link for more information: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment- Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ.html For questions related to F851, surveyors, providers, or other stakeholders should email NHStaffing@cms.hhs.gov. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F851, the surveyor’s investigation will generally show that the facility failed to do any one of the following: • Complete data for the entire reporting period, such as hours paid for all required staff, each day; or • Provide accurate data; or • Provide data by the required deadline; or, https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ.html https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ.html • Submit the required staffing information based on payroll data in a uniform format. Noncompliance at F851 focuses on the submission of staffing data. If the surveyor identifies concerns related to sufficient staffing, surveyors would investigate these concerns using the Sufficient and Competent Staff Critical Element Pathway, and guidance at §483.35 Nursing Services (F725 & F727). F865 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.75(a) Quality assurance and performance improvement (QAPI) program. Each LTC facility, including a facility that is part of a multiunit chain, must develop, implement, and maintain an effective, comprehensive, data-driven QAPI program that focuses on indicators of the outcomes of care and quality of life. The facility must: §483.75(a)(1) Maintain documentation and demonstrate evidence of its ongoing QAPI program that meets the requirements of this section. This may include but is not limited to systems and reports demonstrating systematic identification, reporting, investigation, analysis, and prevention of adverse events; and documentation demonstrating the development, implementation, and evaluation of corrective actions or performance improvement activities; §483.75(a)(2) Present its QAPI plan to the State Survey Agency no later than 1 year after the promulgation of this regulation; §483.75(a)(3) Present its QAPI plan to a State Survey Agency or Federal surveyor at each annual recertification survey and upon request during any other survey and to CMS upon request; and §483.75(a)(4) Present documentation and evidence of its ongoing QAPI program's implementation and the facility's compliance with requirements to a State Survey Agency, Federal surveyor or CMS upon request. §483.75(b) Program design and scope. A facility must design its QAPI program to be ongoing, comprehensive, and to address the full range of care and services provided by the facility. It must: §483.75(b)(1) Address all systems of care and management practices; §483.75(b)(2) Include clinical care, quality of life, and resident choice; §483.75(b)(3) Utilize the best available evidence to define and measure indicators of quality and facility goals that reflect processes of care and facility operations that have been shown to be predictive of desired outcomes for residents of a SNF or NF. §483.75(b) (4) Reflect the complexities, unique care, and services that the facility provides. §483.75(f) Governance and leadership. The governing body and/or executive leadership (or organized group or individual who assumes full legal authority and responsibility for operation of the facility) is responsible and accountable for ensuring that: §483.75(f)(1) An ongoing QAPI program is defined, implemented, and maintained and addresses identified priorities. §483.75(f)(2) The QAPI program is sustained during transitions in leadership and staffing; §483.75(f)(3) The QAPI program is adequately resourced, including ensuring staff time, equipment, and technical training as needed; §483.75(f)(4) The QAPI program identifies and prioritizes problems and opportunities that reflect organizational process, functions, and services provided to residents based on performance indicator data, and resident and staff input, and other information. §483.75(f)(5) Corrective actions address gaps in systems, and are evaluated for effectiveness; and §483.75(f)(6) Clear expectations are set around safety, quality, rights, choice, and respect. §483.75(h) Disclosure of information. A State or the Secretary may not require disclosure of the records of such committee except in so far as such disclosure is related to the compliance of such committee with the requirements of this section. §483.75(i) Sanctions. Good faith attempts by the committee to identify and correct quality deficiencies will not be used as a basis for sanctions. INTENT These requirements are intended to ensure that long-term care facilities (including multi-unit chains) implement a comprehensive QAPI program which addresses all the care and unique services a facility provides. DEFINITIONS “Governing body” refers to individuals such as facility owner(s), Chief Executive Officer(s), or other individuals who are legally responsible to establish and implement policies regarding the management and operations of the facility. “Indicators” are measurement(s) of performance related to a particular care area or service. “Quality Assurance and Performance Improvement (QAPI)” is the coordinated application of two mutually-reinforcing aspects of a quality management system: Quality Assurance (QA) and Performance Improvement (PI). QAPI takes a systematic, interdisciplinary, comprehensive, and data-driven approach to maintaining and improving safety and quality in nursing homes while involving residents and families in practical and creative problem solving. “Quality Assurance (QA)” is the specification of standards for quality of service and outcomes, and systems throughout the organization for assuring that care is maintained at acceptable levels in relation to those standards. QA is on-going, both anticipatory and retrospective in its efforts to identify how the organization is performing, including where and why facility performance is at risk or has failed to meet standards. “Performance Improvement (PI)” (also called Quality Improvement - QI) is the continuous study and improvement of processes with the intent to improve services or outcomes, and prevent or decrease the likelihood of problems, by identifying areas of opportunity and testing new approaches to fix underlying causes of persistent/systemic problems or barriers to improvement. PI in nursing homes aims to improve processes involved in health care delivery and resident quality of life. PI can make good quality even better. GUIDANCE QAPI is a type of quality management program which takes a systematic, interdisciplinary, comprehensive, and data-driven approach to maintaining and improving safety and quality. An interdisciplinary approach encompasses all managerial, and clinical, services, which includes care and services provided by outside (contracted or arranged) providers and suppliers. The purpose of a QAPI program is to ensure continuous evaluation of facility systems with the objectives of: • Ensuring care delivery systems function consistently, accurately, and incorporate current and evidence-based practice standards where available; • Preventing deviation from care processes, to the extent possible; • Identifying issues and concerns with facility systems, as well as identifying opportunities for improvement; and • Developing and implementing plans to correct and/or improve identified areas. Program and Documentation Each facility must develop, implement, and maintain an effective, comprehensive, data- driven QAPI program that focuses on indicators of the outcomes of care and quality of life. The facility must maintain and be able to provide documentation and evidence of its ongoing QAPI program, which meets the requirements of §483.75. Demonstration of compliance includes, but is not limited to: • Evidence of systems and reports demonstrating identification, reporting, investigation, analysis and prevention of adverse events; • Data collection and analysis at regular intervals; and • Documentation demonstrating development, implementation and evaluation of corrective actions or performance improvement activities. Upon the request of a State Survey Agency, Federal surveyor or CMS, the facility must present evidence, including documentation, of its ongoing QAPI program’s implementation and the facility’s compliance with requirements. QAPI Plan A QAPI plan is the written plan containing the process that will guide the nursing home’s efforts in assuring care and services are maintained at acceptable levels of performance and continually improved. The plan describes how the facility will conduct its required QAPI and QAA committee functions. The facility is required to develop a QAPI plan and present its plan to federal and state surveyors at each annual recertification survey and upon request during any other survey, and to CMS upon request. The QAPI plan should describe the scope of the QAA committee’s responsibilities and activities, and the process addressing how the committee will conduct the activities necessary to identify and correct quality deficiencies. Each nursing home, including facilities which are a part of a multi-chain organization, should tailor its QAPI plan to reflect the specific units, programs, departments, and unique population it serves, as identified in its facility assessment. The QAPI plan should describe how the facility will ensure care and services delivered meet accepted standards of quality, identify problems and opportunities for improvement, and ensure progress toward correction or improvement is achieved and sustained. The QAPI plan should describe the process for identifying and correcting quality deficiencies. Key components of the process include: • Tracking and measuring performance; • Establishing goals and thresholds for performance measurement; • Identifying and prioritizing quality deficiencies; • Systematically analyzing underlying causes of systemic quality deficiencies; • Developing and implementing corrective action or performance improvement activities; and • Monitoring or evaluating the effectiveness of corrective action/performance improvement activities, and revising as needed. Program Design and Scope Each facility must have a QAPI program that is ongoing, comprehensive and capable of addressing the full range of care and services it provides. At a minimum, the program must: • Address all systems of care and management practices; • Include clinical care, quality of life and resident choice; • Utilize the best available evidence to define measure indicators of quality and facility goals that reflect processes of care and facility operations that have been shown to be predictive of desired outcomes for residents; and • Reflect the complexities, unique care and services that the facility provides. Effective QAPI programs address systems of care and management practices. Systems of care (or care delivery systems) are the processes in place to achieve an expected clinical outcome. Nursing homes have many systems of care which intersect and involve multiple disciplines and departments. For example, the system for prevention of pressure ulcers also involves the system for ensuring adequate nutrition, as well as the systems for identification of changes in condition and infection prevention. In order to ensure all aspects of these systems of care occur consistently, accurately, timely, and with the intended outcome, an effective program includes methods for monitoring the systems. In addition to systems of care, the facility should monitor important management practices such as resident finances and personal funds, admission and discharge practices, and other services that impact quality of life and resident rights. The QAPI program should address quality of life and resident choice by identifying the unique needs and preferences of the varying demographics of residents residing in the facility (i.e., young and/or culturally diverse residents) and seeking ongoing input and feedback from their residents. Governance and Leadership The Governing Body and/or executive leadership (or organized group or an individual who assumes full legal authority and responsibility for operation of the facility), must ensure the QAPI Program: • Is defined, implemented and ongoing; • Addresses identified priorities; • Is sustained through transitions in leadership and staffing; • Has adequate resources, including staff time, equipment, and technical training as needed; • Uses performance indicator data, resident and staff input, and other information to identify and prioritize problems and opportunities; • Implements corrective actions to address gaps in systems and evaluates actions for effectiveness; and • Establishes clear expectations around safety, quality, rights, choice and respect. Disclosure of Information The survey process is intended to be an objective assessment of facility compliance with the requirements of participation. This assessment is guided by facility performance and outcomes as reported by Quality Measures (QMs) and Minimum Data Set (MDS) data, as well as complaints and surveyor observations, interviews, and record reviews. The surveyor task to review QAPI/QAA is intended to occur at the end of the survey, after completion of investigation into all other requirements to ensure that concerns are identified by the survey team independent of the QAPI/QAA review. Surveyors must use critical thinking and investigatory skills to identify noncompliance, rather than using information provided during the QAPI/QAA review as a source to identify deficiencies. Surveyors may only require a facility to disclose QAA committee records if they are used to determine the extent to which the facility is compliant with the provisions for QAPI/QAA. Protection from disclosure is generally afforded documents generated by the QAA committee, such as minutes, internal papers, or conclusions. However, if those documents contain the evidence necessary to determine compliance with QAPI/QAA regulations, the facility must allow the surveyor to review and copy them. The key point is that the facility must provide satisfactory evidence that it has, through its QAA committee, identified its own high risk, high volume, and problem-prone quality deficiencies, and is making a “good faith attempt” to correct them. Examples of when disclosure may be necessary to determine compliance: • If the facility’s infection control data indicates that staff may not have responded in a timely and effective manner to address an outbreak of a communicable disease, the facility must allow the surveyor to review and copy QAA committee minutes and related documentation so that the surveyor is capable of evaluating the facility’s QAPI/QAA compliance. • If the surveyor’s staff interviews and record reviews reveal the facility has a past history of failing to follow care instructions and recommendations from clinical specialists when residents obtain specialty care outside the facility, the facility must allow the surveyor to review and copy QAPI/QAA documentation. Under these circumstances, review of the QAPI/QAA documentation is necessary to evaluate whether the QAA Committee identified a problem with failure to follow care instructions and recommendations from outside specialists and, if it did, whether the QAA Committee adequately addressed the problem. NOTE: Prior to conducting the QAPI/QAA review, the survey team must conduct a thorough investigation of all issues identified, including expanding the sample as necessary to determine the scope of the issue. Reports and Logs Incident and accident reports, wound logs, infection control logs, or other reports or records used to track adverse events are not protected from disclosure. Surveyors may request these documents as part of their normal investigation of other areas of concern throughout the survey to support their findings. Surveyor Access to QAPI/QAA Material and Confidentiality of Patient Safety Work Products CMS supports and encourages nursing homes to work on a confidential basis with an Agency for Healthcare Research and Quality (AHRQ) approved Patient Safety Organization (PSO) to obtain technical assistance in identifying, analyzing and preventing quality deficiencies and adverse events. The Federal Patient Safety and Quality Improvement Act of 2005 (PSQIA), Public Law 109-41, established a voluntary reporting system designed to enhance the data available to assess and resolve patient safety and health care quality issues. PSQIA has afforded privileged and confidential status to “patient safety work product” (PSWP). PSWP includes data, reports, records, memoranda, analysis, or written and oral statements assembled and developed for reporting to a PSO and have been submitted to a PSO approved and listed by the Department of Health and Human Services (HHS), AHRQ. PSQIA and the Patient Safety Rule only limit the disclosure of PSWP. Neither PSQIA nor the Patient Safety Rule limit the disclosure of non-PSWP, including its disclosure to a Federal, state or local government for public health surveillance, investigation or health oversight. The preamble to the final Patient Safety Rule states: “Information is not patient safety work product if it is collected to comply with external reporting, such as…certification or licensing records for compliance with health oversight agency requirements;…complying with required disclosures by particular providers or suppliers pursuant to Medicare’s Conditions of participation or conditions of coverage…” (73 FR 70742-70743, November 21, 2008). Ultimately, it is the nursing home’s final decision as to whether to enter into a relationship with a PSO and to create a patient safety evaluation system (PSES) which is the collection, management, or analysis of information for reporting to or by a PSO. Additionally, the nursing home should determine what information to place within the PSES, considering a number of factors, including how they will demonstrate compliance with the Long-term Care Requirements for Participation, in particular, the QAPI/QAA requirements. A nursing home must be prepared to meet its obligation to provide surveyors access to QAPI/QAA program information to demonstrate compliance without disclosing PSWP as that term is defined in 42 CFR Part 3, the regulation implementing the Federal PSQIA. There is no barrier under the PSQIA for nursing homes to maintain duplicate systems, one consisting of patient safety work product within a protected patient safety evaluation system, and another to demonstrate compliance with local, State or Federal requirements. Surveyors should consider the following key points: • Surveyors assessing QAPI/QAA compliance must ask nursing homes to provide evidence of QAPI/QAA compliance. • Surveyors must never ask or demand that a nursing home show them “patient safety work product.” If a nursing home states that all relevant QAPI/QAA material has been placed in its PSES, or is protected PSWP, surveyors must ask to see the agreement the nursing home has with an AHRQ-approved PSO, to confirm that it has an approved protected PSES. • If a nursing home has placed all evidence related to QAPI/QAA compliance in its PSES as patient safety work product and does not also maintain a separate non-confidential system to provide evidence of compliance, or is unable to remove evidence of such compliance from its PSES, it may not be able to demonstrate its compliance to the surveyor. Sanctions and Good Faith Attempts If the facility, through its QAA committee, has identified and made a good faith attempt to correct the same issue identified by the survey team during the survey, the facility will not be cited for QAA (it may however, still be cited with deficiencies related to actual or potential issues at other tags). To establish that the facility’s QAA committee has made a good faith attempt to correct an identified quality deficiency, a facility must do more than just subjectively assert it has made a good faith attempt; rather, the facility’s actions, taken as a whole, must evidence a good faith attempt to identify and correct quality deficiencies. To evaluate good faith attempts, surveyors will have to determine if the facility became aware of the issue as soon as it should have and where the facility is within the correction process. Additional areas of inquiry include, but are not limited to, the following: was the issue a high-risk, high-volume, or problem-prone issue the facility should have been tracking? Was there a negative outcome to a resident which should have alerted the facility to the issue? What steps did the facility take when it became aware of the issue? Has there been enough time to implement changes and to evaluate the effectiveness of those changes? Do the facility’s efforts demonstrate diligence and a genuine attempt to correct the issue? Identifying and correcting problems requires the facility to: • Collect data from various sources related to high risk, high volume, and problem-prone issues such as medical errors and adverse events; • Analyze the data collected to identify performance indicators signaling deviation from expected performance; • Study the issue to determine underlying causes and contributing factors; • Develop and implement corrective actions; and • Monitor data related to the issue to determine if they are sustaining corrections, or if revisions are necessary. If the survey team has identified a current issue which will be cited at S/S level of E or above, or has identified substandard quality of care, the surveyor conducting the QAPI/QAA Review should consider if the facility’s monitoring systems should also have identified the same issue. The surveyor must take into consideration whether the QAA committee has had sufficient time through its monitoring systems to identify the issue, if it was a high risk, problem-prone issue they should have been monitoring, and whether there has been a reasonable amount of time to respond to the issue. Issues which are likely to cause serious harm, impairment, or death must be responded to immediately. If the facility has identified the issue through its QAA committee, the surveyor must then evaluate the extent to which their actions or plans to correct the issue demonstrate a “good faith attempt.” Surveyors must not use documentation provided by the facility during the QAPI/QAA review to identify additional concerns not previously identified by the survey team during the current survey, nor can they expand the scope or the severity of the problem based on information gleaned from this disclosure. Facility Refusal to Provide Evidence of Compliance To the extent a facility’s QAPI/QAA information is necessary to demonstrate the facility’s compliance with the requirements of 42 CFR § 483.75, a facility is required under 42 CFR § 483.75(h) to disclose this information to the State Agency and/or CMS. Refusal by a facility to produce evidence of compliance with QAPI/QAA will lead to citation of noncompliance with F865, requiring a plan of correction, and possible imposition of enforcement remedies up to and including termination of the facility’s provider agreement (per 42 CFR §489.53). In the event of a facility refusal to produce evidence of compliance, the team coordinator should contact their State Agency supervisor. INVESTIGATIVE PROCEDURE Use the Facility Task Pathway for Quality Assurance and Performance Improvement (QAPI) and Quality Assessment and Assurance (QAA) Review, along with the above interpretive guidelines when determining if the facility meets the requirements for, or when investigating concerns related to QAPI/QAA. Surveyors should refer to the following when investigating concerns and citing non- compliance related to QAPI: • F865: For concerns related to whether a facility has implemented and maintains a comprehensive QAPI program and plan, disclosure of records and governance and leadership. • F867: For concerns related to how the facility obtains feedback, collects data, monitors adverse events, identifies areas for improvement, prioritizes improvement activities, implements corrective and preventive actions, and conducts performance improvement projects. • F868: For concerns related to the composition of the QAA committee, frequency of meetings and reporting to the governing body. KEY ELEMENTS OF NON-COMPLIANCE To cite deficient practice at F865, the surveyor’s investigation will generally show that the facility failed to do any one of the following: • Maintain documentation and evidence of its ongoing QAPI program; or • Present its QAPI plan to the Federal and/or State surveyors during recertification survey or upon request; or • Present QAPI evidence necessary to demonstrate compliance with these requirements; or • Develop, implement and maintain an effective, comprehensive QAPI program, that addresses the full range of services the facility provides; or • Ensure governing body oversight of the facility’s QAPI program and activities. F866 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) Note: Regulatory requirements §483.75(c) and §483.75(c)(1)-(4) have been relocated to F867. F867 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.75(c) Program feedback, data systems and monitoring. A facility must establish and implement written policies and procedures for feedback, data collections systems, and monitoring, including adverse event monitoring. The policies and procedures must include, at a minimum, the following: §483.75(c)(1) Facility maintenance of effective systems to obtain and use of feedback and input from direct care staff, other staff, residents, and resident representatives, including how such information will be used to identify problems that are high risk, high volume, or problem-prone, and opportunities for improvement. §483.75(c)(2) Facility maintenance of effective systems to identify, collect, and use data and information from all departments, including but not limited to the facility assessment required at §483.71 and including how such information will be used to develop and monitor performance indicators. §483.75(c)(3) Facility development, monitoring, and evaluation of performance indicators, including the methodology and frequency for such development, monitoring, and evaluation. §483.75(c)(4) Facility adverse event monitoring, including the methods by which the facility will systematically identify, report, track, investigate, analyze and use data and information relating to adverse events in the facility, including how the facility will use the data to develop activities to prevent adverse events. §483.75(d) Program systematic analysis and systemic action. §483.75(d)(1) The facility must take actions aimed at performance improvement and, after implementing those actions, measure its success, and track performance to ensure that improvements are realized and sustained. §483.75(d)(2) The facility will develop and implement policies addressing: (i) How they will use a systematic approach to determine underlying causes of problems impacting larger systems; (ii) How they will develop corrective actions that will be designed to effect change at the systems level to prevent quality of care, quality of life, or safety problems; and (iii) How the facility will monitor the effectiveness of its performance improvement activities to ensure that improvements are sustained. §483.75(e) Program activities. §483.75(e)(1) The facility must set priorities for its performance improvement activities that focus on high-risk, high-volume, or problem-prone areas; consider the incidence, prevalence, and severity of problems in those areas; and affect health outcomes, resident safety, resident autonomy, resident choice, and quality of care. §483.75(e)(2) Performance improvement activities must track medical errors and adverse resident events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the facility. §483.75(e)(3) As part of their performance improvement activities, the facility must conduct distinct performance improvement projects. The number and frequency of improvement projects conducted by the facility must reflect the scope and complexity of the facility's services and available resources, as reflected in the facility assessment required at §483.71. Improvement projects must include at least annually a project that focuses on high risk or problem-prone areas identified through the data collection and analysis described in paragraphs (c) and (d) of this section. §483.75(g) Quality assessment and assurance. §483.75(g)(2) The quality assessment and assurance committee reports to the facility's governing body, or designated person(s) functioning as a governing body regarding its activities, including implementation of the QAPI program required under paragraphs (a) through (e) of this section. The committee must: (ii) Develop and implement appropriate plans of action to correct identified quality deficiencies; (iii) Regularly review and analyze data, including data collected under the QAPI program and data resulting from drug regimen reviews, and act on available data to make improvements. INTENT These provisions are intended to ensure facilities obtain feedback, use data, and take action to conduct structured, systematic investigations and analysis of underlying causes or contributing factors of problems affecting facility-wide processes that impact quality of care, quality of life, and resident safety. DEFINITIONS “Adverse Event” is defined in §483.5 as an untoward, undesirable, and usually unanticipated event that causes death or serious injury, or the risk thereof. “Corrective Action”: A written and implemented plan of action for correcting or improving performance in response to an identified quality deficiency. Use of the term corrective action in this guidance is not synonymous with a Plan of Correction (formal response to cited deficiencies). This is also separate from the written QAPI plan. “High-risk areas”: Refers to care or service areas associated with significant risk to the health or safety of residents. Errors in these care areas have the potential to cause adverse events resulting in pain, suffering, and/or death. Examples include tracheostomy care; pressure injury prevention; administration of high-risk medications such as anticoagulants, insulin, and opioids. “High-volume areas”: Refers to care or service areas performed frequently or affecting a large population, thus increasing the scope of the problem, e.g., transcription of orders; medication administration; laboratory testing. “Incidence”: is a measure of the number of new cases of a characteristic that develop in a population in a specified time period. National Institute of Mental Health (NIMH) (https://www.nimh.nih.gov/health/statistics/what-is-prevalence.shtml, accessed 12/21/2020). https://www.nimh.nih.gov/health/statistics/what-is-prevalence.shtml “Indicator”: measurement of performance related to a particular care area or service delivered. Used to evaluate the success of a particular activity in achieving goals or thresholds. “Medical Error”: is a deviation from the process of care, which may or may not cause harm to the resident. “Near Miss”: is a serious error or mishap that has the potential to cause an adverse event but fails to do so because of chance or because it is intercepted. It is also called a potential adverse event. “Prevalence”: is the proportion of a population who have a specific characteristic in a given time period. NIMH (https://www.nimh.nih.gov/health/statistics/what-is- prevalence.shtml, accessed 12/21/2020). “Problem-prone areas”: Refers to care or service areas that have historically had repeated problems, e.g., call bell response times; staff turnover; lost laundry. “Quality Assurance and Performance Improvement (QAPI)”: Nursing home QAPI is the coordinated application of two mutually-reinforcing aspects of a quality management system: Quality Assurance (QA) and Performance Improvement (PI). QAPI takes a systematic, interdisciplinary, comprehensive, and data-driven approach to maintaining and improving safety and quality in nursing homes while involving residents and families, and all nursing home caregivers in practical and creative problem solving. • Quality Assurance (QA): QA is the specification of standards for quality of care, service and outcomes, and systems throughout the facility for assuring that care is maintained at acceptable levels in relation to those standards. QA is on-going and both anticipatory and retrospective in its efforts to identify how the organization is performing, including where and why facility performance is at risk or has failed to meet standards. • Performance Improvement (PI): PI (also called Quality Improvement - QI) is the continuous study and improvement of processes with the intent to improve services or outcomes, and prevent or decrease the likelihood of problems, by identifying opportunities for improvement, and testing new approaches to fix underlying causes of persistent/systemic problems or barriers to improvement. PI in nursing homes aims to improve facility processes involved in care delivery and enhanced resident quality of life. PI can make good quality even better. “Quality Deficiency (or Opportunity for Improvement)”: A deviation in performance resulting in an actual or potential undesirable outcome, or an opportunity for improvement. A quality deficiency is anything the facility considers to be in need of further investigation and correction or improvement. Examples include problems such as medical errors and accidents, as well as improvement opportunities such as responses to questionnaires showing decreased satisfaction. This term is not necessarily synonymous with a noncompliance deficiency cited by surveyors, but may include issues related to https://www.nimh.nih.gov/health/statistics/what-is-prevalence.shtml https://www.nimh.nih.gov/health/statistics/what-is-prevalence.shtml deficiencies cited on annual or complaint surveys. “Systematic”: describes a step by step process that is structured, so that it can be replicated. “Systemic”: embedded within, and affecting a system or process. GUIDANCE As required in §483.75(a) (F865), the facility must develop and implement systems that ensure the care and services it delivers meet acceptable standards of quality in accordance with recognized standards of practice. This is accomplished, in part, by identifying, collecting, analyzing and monitoring data which reflects the functions of each department and outcomes to residents. Feedback Feedback is one of many data sources which provide valuable information the facility must incorporate into an effective QAPI program. Each facility must establish and implement written policies and procedures for feedback. Feedback must be obtained from direct care staff, other staff, residents and resident representatives, as well as other sources, and be used to identify problems that are high- risk, high-volume, and/or problem-prone, as well as opportunities for improvement. Feedback from residents is necessary to understand what quality concerns are important to them, their perspectives, values and priorities, as well as the impact of the facility’s daily routines on their physical, mental, and psychosocial well-being. Staff can also provide valuable input into understanding care and service delivery processes. A facility should choose the best mechanism for feedback to support their QAPI program. Examples of mechanisms for obtaining resident and staff feedback may include, but are not limited to: • Satisfaction surveys and questionnaires; • Routine meetings, e.g., care plan meetings, resident council, safety team, town hall; and • Suggestion or comment boxes Effective feedback systems in a QAPI program also include methods for providing feedback to direct care staff, other staff, residents and representatives. This may involve including these individuals in problem solving, various meetings or providing updates and communicating facility system changes. Data Collection Systems and Monitoring In order to ensure care and services are carried out consistently, accurately, timely and according to recognized standards of quality, the facility must collect and monitor data reflecting its performance, including adverse events. Facility policies and procedures must address how data will be identified, and the frequency and methodology for collecting and using data from all departments. The facility determines what data it will collect to represent its care areas considered to be associated with high-risk, high-volume, and/or problem-prone issues. Data collection can be done using several methods, such as audit tools (purchased or developed by the facility), direct observation, interview, or testing. Sources for data may include the Minimum Data Set (MDS) and Quality Measures, electronic and paper medical records, survey results, incident reports, complaints, suggestions and staffing data. CMS expects the data collection methodology to be consistent, reproducible and accurate to produce data that are valid and reliable, and support all departments and the facility assessment (§483.71). It is not necessary to collect all data at the same frequency. The facility may develop a schedule for routine data collection. For example, data related to high-risk or problem- prone issues will generally be collected more frequently (e.g. daily, weekly, or monthly) until performance is at a satisfactory level, then collected less frequently (e.g. quarterly or every six months). Performance Indicators The facility must have policies and procedures in place for developing, monitoring and evaluating performance indicators. The policies and procedures must also describe how and with what frequency the facility develops, monitors and evaluates its performance indicators. A performance indicator is a measurement of from the data collected, which represents performance in a specific care or service area. Performance indicators enable the facility QAA Committee to establish performance thresholds and goals, identify deviations in performance and evaluate progress. An example of monitoring includes comparing results of facility performance over time, as well as to state or national benchmarks. Systematic Analysis and Action As part of its’ QAPI program, each facility is responsible for having systems in place and implementing actions intended to improve performance. This includes implementation of corrective actions, measuring success, and tracking performance, to ensure improvements are achieved and sustained. The facility must develop and implement policies and procedures which address: • How it will use systematic approaches (such as root cause analysis, reverse tracker methodology, or health-care failure and effects analysis) to assist in determining underlying causes of problems impacting larger systems. • How they will develop corrective actions that will be designed to effect change at the systems level to prevent quality of care, quality of life, or safety problems; and • How the facility will monitor the effectiveness of its performance improvement activities to ensure that improvements are sustained. Establishing Priorities The facility must establish priorities for performance improvement activities that focus on resident safety, health outcomes, autonomy, choice and quality of care, as well as high-risk, high-volume, and/or problem-prone areas. When determining priorities, the facility must also consider the incidence, prevalence and severity of problems or potential problems identified. If systemic concerns, especially repeat survey deficiencies, have not been identified or prioritized by the facility’s QAA committee, this may be an indication that the committee is not performing its required functions effectively. Medical Errors and Adverse Events In addition to self-identified improvement activities, the facility must also track medical errors and adverse resident events. When medical errors or adverse resident events are identified, the facility must analyze the cause of the error/event, implement corrective actions to prevent future events, and conduct monitoring to ensure desired outcomes are achieved and sustained. Nursing homes must develop and implement written policies and procedures that enable the facility to systematically identify and investigate for medical errors and adverse events, including how the facility will analyze and use data relating to errors/events to develop activities to prevent future occurrences. In 2014, the Department of Health and Human Services, Office of Inspector General (OIG) released its report “Adverse Events in Skilled Nursing Facilities (SNFs): National Incidence Among Medicare Beneficiaries,” which found that one in three Medicare beneficiaries were harmed by an adverse event or temporary harm event within their first 35 days while residing in a SNF. The OIG determined that nearly sixty percent of the events were potentially preventable. The OIG classified the events into three categories: medication, care, and infection related adverse events. CMS collaborated with the Agency for Healthcare Research and Quality (AHRQ) to develop a listing of common potentially preventable events that occur in nursing homes – this list is not all-inclusive of potentially preventable events. This list is subject to change as technology and research redefine what is preventable. Potentially Preventable Events Related to: Medication Care Infection Change in mental Falls, abrasions/skin tears, Respiratory infections: http://oig.hhs.gov/oei/reports/oei-06-11-00370 http://oig.hhs.gov/oei/reports/oei-06-11-00370 Potentially Preventable Events Related to: status/delirium related to use of opiates and psychotropic medication or other trauma related to care • Pneumonia • Influenza Hypoglycemia related to use of antidiabetic medication Electrolyte imbalance (including dehydration and acute kidney injury/insufficiency) associated with inadequate fluid maintenance Skin and wound infections: • Surgical Site Infections (SSIs) • Soft tissue and non-surgical wound infections Ketoacidosis related to use of antidiabetic medication Thromboembolic events related to inadequate resident monitoring and provision of care Urinary tract infections (UTIs) • Catheter Associated UTIs (CAUTIs) • UTIs (non-catheter associated) Bleeding related to use of antithrombotic medication Respiratory distress related to inadequate monitoring and provision of tracheostomy/ventilator care Infectious diarrhea • Clostridium difficile • Norovirus Thromboembolism related to use of antithrombotic medication Exacerbations of preexisting conditions related to inadequate or omitted care Prolonged constipation/ileus/ impaction related to use of opiates Feeding tube complications (aspiration, leakage, displacement) related to inadequate monitoring and provision of care Electrolyte imbalance (including dehydration and acute kidney injury ) related to use of diuretic medication In-house acquired/worsened stage pressure injuries, and unstageable/suspected deep tissue injuries Drug toxicities including: acetaminophen, digoxin; levothyroxine; ACE inhibitors; phenytoin; lithium; valproic acid; antibiotics Elopement Potentially Preventable Events Related to: Altered cardiac output related to use of cardiac/blood pressure medication Instances of abuse, neglect, and misappropriation of resident property and exploitation (see §483.5) According to the OIG report, preventable adverse events were generally caused by: • Appropriate treatment provided in a substandard way (56%) • Resident’s progress not adequately monitored (37%) • Necessary treatment not provided (25%) • Inadequate resident assessment and care planning (22%) As part of the facility’s performance improvement activities to reduce medical errors and adverse events, feedback and learning must be provided throughout the facility (483.75(e)(2)). Educating staff, residents, resident representatives and family members on medical errors and adverse events, such as what to look for and preventive measures, are important factors in reducing and preventing medical errors and adverse resident events. For additional information regarding QAPI training requirements see §483.95(d), (F944). Identifying Quality Deficiencies and Corrective Actions The QAA committee’s responsibility to identify quality deficiencies requires facilities to have a system for monitoring departmental performance data routinely in order to identify deviations in performance and adverse events. Adverse events, such as the elopement of a cognitively-impaired resident, should be considered a high risk problem for which corrective action is required. Once a quality deficiency is identified, the QAA committee has a responsibility to oversee development of an appropriate corrective action. An appropriate corrective action is one that addresses the underlying cause of the issue comprehensively, at the systems level. There are many different methodologies available to facilities for developing corrective action. CMS has not prescribed a particular method that must be used. Corrective action generally involves a written plan that includes: • A definition of the problem – which includes determining contributing causes of the problem; • Measurable goals; • Step-by-step interventions to correct the problem and achieve established goals; and • A description of how the QAA committee will monitor to ensure changes yield the expected results. Corrective actions may take the form of one or more tests of change, or Plan-Do-Study- Act (PDSA) cycles until the desired performance goals have been met, or the facility may conduct a Performance Improvement Project. Performance Improvement Projects (PIPs) The facility must conduct distinct performance improvement projects, based on the scope and complexity of facility services and available resources, identified as a result of the facility assessment required at §483.71. While the number and frequency of improvement projects may vary, each facility must conduct at least one improvement project annually that focuses on high-risk or problem-prone areas, identified by the facility through data collection and analysis. PIPs are a process that generally involves a team making a concentrated effort over time to improve a systemic problem or improve quality in absence of a problem. PIPs often require a systematic investigation, such as a Root Cause Analysis (RCA) to identify underlying causes or factors which have contributed to, or caused the problem and the development of a corrective action plan. Interventions are designed to address the underlying causes, and once implemented, the team closely monitors results to determine if changes are yielding the expected improvement or if the interventions should be revised. The facility’s action plans to address quality deficiencies and improve performance may be implemented in a variety of ways, including: staff training and deployment of changes to procedures; monitoring and feedback mechanisms; and processes to revise plans that are not achieving or sustaining desired outcomes. The committee may delegate the implementation of action plans to various facility staff and/or outside consultants. Quality assessment and assurance Functioning under the facility’s governing body, the QAA committee is responsible for: • Developing and implementing appropriate plans of action to correct identified deficiencies; • Regularly reviewing and analyzing data, including data collected under the QAPI program and data resulting from drug regimen reviews; and • Acting on available data to make improvements. For concerns related to governance and leadership and the governing body and/or executive leadership, see §483.75(f), (F865). INVESTIGATIVE PROCEDURE Use the Facility Task Pathway for Quality Assurance and Performance Improvement (QAPI) and Quality Assessment and Assurance (QAA) Review, along with the above interpretive guidelines when determining if the facility meets the requirements for, or investigating concerns related to QAPI/QAA. Surveyors should refer to the following when investigating concerns and citing non- compliance related to QAPI: • F865: For concerns related to whether a facility has implemented and maintains a comprehensive QAPI program and plan, disclosure of records and governance and leadership. • F867: For concerns related to how the facility obtains feedback, collects data, monitors adverse events, identifies areas for improvement, prioritizes improvement activities, implements corrective and preventive actions, and conducts performance improvement projects. • F868: For concerns related to the composition of the QAA committee, frequency of meetings and reporting to the governing body. KEY ELEMENTS OF NON-COMPLIANCE To cite deficient practice at F867, the surveyor's investigation must generally show that the facility failed to do any one of the following: • Include in its policies and procedures how it obtains and uses feedback from residents, resident representatives, and staff to identify high-risk, high-volume, or problem prone issues as well as opportunities for improvement; or • Develop and implement policies and procedures which include how it ensures data is collected, used and monitored for all departments; or • Develop and implement policies and procedures for how the facility develops, monitors and evaluates performance indicators and the frequency for these activities; or • Develop policies and procedures for how it will identify, report, and track, adverse events, and high risk, high volume, and/or problem-prone concerns; or • Establish priorities for its improvement activities, that focus on high-risk, high- volume or problem-prone areas, as well as resident safety, choice, autonomy, and quality of care; or • Ensure the QAA Committee developed and implemented action plans to correct identified quality deficiencies; or • Measure the success of actions implemented and track performance to ensure improvements are realized and sustained; or • Track medical errors and adverse events, analyze their causes, and implement preventive actions and mechanisms; or • Conduct at least one PIP annually that focuses on high-risk or problem prone areas, identified by the facility, through data collection and analysis; or • Ensure the QAA Committee regularly reviews and analyzes data collected under the QAPI program and resulting from drug regimen reviews, and act on the data to make improvements. DEFICIENCY CATEGORIZATION Examples of Level 4, immediate jeopardy to resident health or safety include, but are not limited to: • Evidence showing one or more residents received third degree burns from hot water temperatures in the month prior to the survey. QAPI review showed the facility failed to use (e.g. review or analyze) the data they collected for routine monitoring of hot water temperatures throughout the facility. The failure of the facility to use the data it collected, resulted in lack of action to correct the systemic, high-risk issue, which created a situation where some residents were likely to experience serious injury, harm, impairment, or death. • Evidence showing the facility failed to monitor their system for communicating each residents’ code status. This resulted in staff having inaccurate and inconsistent information to use in emergency situations. QAPI review showed the QAA committee was not aware of this high-risk, systemic issue, and was not monitoring facility practices related to accurate and consistent communication of residents’ advance directives and code status. Examples of Level 3, actual harm that is not immediate jeopardy include, but are not limited to: • Evidence showing the facility had repeat deficiencies for the past two surveys related to their failure to ensure residents’ post discharge needs were care planned and met upon discharge. During the current survey it was determined that a resident was discharged with no education about how to manage his new onset diabetes, resulting in his rehospitalization. The QAPI review showed the QAA committee was not aware of the issue, and was not monitoring practices around discharge. An example of Level 2, no actual harm with potential for more than minimal harm that is not immediate jeopardy includes, but is not limited to: • Facility failed to correct and monitor a quality deficiency identified on the previous survey, involving inaccurate weight measurement. This issue has the potential to cause more than minimal harm. An example of Level 1, no actual harm with potential for minimal harm includes, but is not limited to: • Facility failed to ensure that monitoring occurred as planned for an identified quality deficiency. On interview it was determined that the facility’s corrective action involved monitoring monthly for three months to ensure the issue was corrected, however, documentation showed that for the second month, there was no evidence that monitoring had occurred. F868 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.75(g) Quality assessment and assurance. §483.75(g) Quality assessment and assurance. §483.75(g)(1) A facility must maintain a quality assessment and assurance committee consisting at a minimum of: (i) The director of nursing services; (ii) The Medical Director or his/her designee; (iii) At least three other members of the facility's staff, at least one of who must be the administrator, owner, a board member or other individual in a leadership role; and (iv) The infection preventionist. §483.75(g)(2) The quality assessment and assurance committee reports to the facility's governing body, or designated person(s) functioning as a governing body regarding its activities, including implementation of the QAPI program required under paragraphs (a) through (e) of this section. The committee must: (i) Meet at least quarterly and as needed to coordinate and evaluate activities under the QAPI program, such as identifying issues with respect to which quality assessment and assurance activities, including performance improvement projects required under the QAPI program, are necessary. §483.80(c) Infection Preventionist participation on quality assessment and assurance committee. The individual designated as the IP, or at least one of the individuals if there is more than one IP, must be a member of the facility’s quality assessment and assurance committee and report to the committee on the IPCP on a regular basis. DEFINITIONS “Infection Preventionist (IP)”: Term used for the person(s) designated by the facility to be responsible for the infection prevention and control program. (Please refer to F882 for further information on the IP.) “Non-physician practitioner (NPP)”: A nurse practitioner (NP), clinical nurse specialist (CNS), or physician assistant (PA). “Regular basis”: for the purpose of the infection preventionist reporting requirement, reporting should occur at the same frequency as the QAA committee meetings. GUIDANCE QAA Committee QAA committee responsibilities include identifying and responding to quality deficiencies throughout the facility, and oversight of the QAPI program when fully implemented. Additionally, the committee must develop and implement corrective action, and monitor to ensure performance goals or targets are achieved, and revising corrective action when necessary. The committee should be composed of staff who understand the characteristics and complexities of the care and services delivered by each unit, and/or department. The QAA Committee must be composed of, at a minimum: • The director of nursing (DON), • The Medical Director or his/her designee, • The Infection Preventionist (IP), and • At least three other staff, one of whom must be the facility’s administrator, owner, board member, or other individual in a leadership role who has knowledge of facility systems and the authority to change those systems. The facility may have a larger committee than required by the regulation. Residents and families may provide a valuable perspective to committee efforts, although their participation is not required. Representation by staff with responsibility for direct care and services provides perspectives that are valuable in identifying, analyzing and correcting problems in resident care areas. Additionally, departments such as maintenance, housekeeping, laundry services, and other service areas such as the business office should be provided opportunities to participate in the committee, when relevant performance data is discussed. Consideration should be given as to how committee information is provided to and from staff who may not be members of the committee, but whose responsibilities include oversight of departments or services. As noted above, the Medical Director is a required member of the QAA committee. This requirement stems from the Medical Director’s responsibility for the overall medical care provided and the implementation of all resident care policies in the facility. There should be evidence of meaningful participation by the Medical Director in the QAPI program, such as reporting on trends identified during oversight and review of reports such as the report of irregularities from the medication regimen review, and other oversight activities. For additional guidance related to the Medical Director‘s role, see §483.70(g), Medical Director, F841. The Medical Director’s designee must not be another required member, such as the DON, but may be an NPP. The designee must have knowledge of the facility’s policies, procedures and practices so that he/she can fully participate and can add value to the QAA committee comparable to the medical director. Having a designee for the QAA committee, does not change or absolve the Medical Director’s responsibility to fulfill his or her role as a member of the QAA committee, or his or her responsibility for overall medical care in the facility. In addition, there must be evidence of communication of the content of the meeting to the Medical Director, with his/her acknowledgement of this information. The Medical Director, in conjunction with the QAA committee, may arrange for real-time alternative methods of participation, such as videoconferencing and teleconference calls. For additional guidance related to the Medical Director’s responsibilities, see §483.70(g) Medical Director, F841. Infection Preventionist Participation on Quality Assessment and Assurance (QAA) Committee: The IP must be a participant on the facility’s QAA committee and report on the IPCP and on incidents (e.g., healthcare-associated infections (HAIs)) identified under the program on a regular basis. Reporting may include, but is not limited to, facility process and outcome surveillance, outbreaks (ongoing and any since the last meeting) and control measures, occupational health communicable disease illnesses (e.g., TB, influenza) and the Antibiotic Stewardship Program (ASP) related to antibiotic use and resistance data. In order to be considered an active participant, the IP should attend each QAA meeting. If the IP cannot attend, another staff member should report on the IP’s behalf but this does not change or absolve the IP’s responsibility to fulfill the role of QAA committee member or reporting on the IPCP. NOTE: Refer to §483.80(b), F882 for information on the infection preventionist's responsibilities and qualifications. QAA Committee and the Governing Body Functioning under the facility’s governing body, the QAA committee is responsible for reporting its’ activities, including the implementation of the QAPI program, to the governing body or designated person(s) functioning as the governing body. Note: Small facilities might not have a Governing Body; there may only be an administrator who is already a required member of the QAA committee, and therefore, already apprised of QAPI activities. Frequency of Meetings QAA committee meetings must be held at least quarterly or more often as necessary to fulfill the committee’s responsibilities to identify and correct quality deficiencies effectively. The QAA committee determines what performance data will be monitored and the schedule or frequency for monitoring this data. There is no expectation that all performance data will be monitored at each committee meeting, however, the data must be reviewed with enough frequency to enable the committee to know if improvement is needed or if improvement is occurring (for current corrective actions). INVESTIGATIVE PROCEDURE Use the Facility Task Pathway for Quality Assurance and Performance Improvement (QAPI) and Quality Assessment and Assurance (QAA) Review, along with the above interpretive guidelines when determining if the facility meets the requirements for, or investigating concerns related to the QAA Committee. Surveyors should refer to the following when investigating concerns and citing non- compliance related to QAPI: • F865: For concerns related to whether a facility has implemented and maintains a comprehensive QAPI program and plan, disclosure of records and governance and leadership. • F867: For concerns related to how the facility obtains feedback, collects data, monitors adverse events, identifies areas for improvement, prioritizes improvement activities, implements corrective and preventive actions, and conducts performance improvement projects. • F868: For concerns related to the composition of the QAA committee, frequency of meetings and reporting to the governing body. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F868, the surveyor's investigation must generally show that the facility failed to meet any one of the following: • Establish and maintain a QAA committee; • Ensure the QAA committee is composed of the required committee members; • Ensure the QAA Committee reports its activities to the governing body; and/or • Meet at least quarterly, and with enough frequency to conduct required QAPI activities. F880 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.80 Infection Control The facility must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections. §483.80(a) Infection prevention and control program. The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements: §483.80(a)(1) A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to §483.71 and following accepted national standards; §483.80(a)(2) Written standards, policies, and procedures for the program, which must include, but are not limited to: (i) A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility; (ii) When and to whom possible incidents of communicable disease or infections should be reported; (iii) Standard and transmission-based precautions to be followed to prevent spread of infections; (iv) When and how isolation should be used for a resident; including but not limited to: (A) The type and duration of the isolation, depending upon the infectious agent or organism involved, and (B) A requirement that the isolation should be the least restrictive possible for the resident under the circumstances. (v) The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and (vi) The hand hygiene procedures to be followed by staff involved in direct resident contact. §483.80(a)(4) A system for recording incidents identified under the facility’s IPCP and the corrective actions taken by the facility. §483.80(e) Linens. Personnel must handle, store, process, and transport linens so as to prevent the spread of infection. §483.80(f) Annual review. The facility will conduct an annual review of its IPCP and update their program, as necessary. INTENT §483.80(a)(1), (a)(2), (a)(4), (e) and (f) The intent of this regulation is to ensure that the facility: • Develops and implements an ongoing infection prevention and control program (IPCP) to prevent, recognize, and control the onset and spread of infection to the extent possible and reviews and updates the IPCP annually and as necessary. This would include revision of the IPCP as national standards change; • Establishes facility-wide systems for the prevention, identification, reporting, investigation and control of infections and communicable diseases of residents, staff, and visitors. It must include an ongoing system of surveillance designed to identify possible communicable diseases and infections before they can spread to other persons in the facility and procedures for reporting possible incidents of communicable disease or infections. NOTE: For purposes of this guidance, “staff” includes all facility staff (direct and indirect care functions), contracted staff, consultants, volunteers, others who provide care and services to residents on behalf of the facility, and students in the facility’s nurse aide training programs or from affiliated academic institutions. • Develops and implements written policies and procedures for infection control that, at a minimum: o Define standard precautions to prevent the spread of infection and explain their application during resident care activities; o Define transmission-based precautions and explain how and when they should be utilized, including but not limited to, the type and duration of precautions for particular infections or organisms involved and that the precautions should be the least restrictive possible for the resident given the circumstances and the resident’s ability to follow the precautions; o Prohibit staff with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and o Require staff to follow hand hygiene practices consistent with accepted standards of practice. • Requires staff to handle, store, process, and transport all linens and laundry in accordance with accepted national standards in order to produce hygienically clean laundry and prevent the spread of infection to the extent possible. DEFINITIONS • “Airborne precautions” refer to actions taken to prevent or minimize the transmission of infectious agents/organisms that remain infectious over long distances when suspended in the air. These infectious particles can remain suspended in the air for prolonged periods of time and can be carried on normal air currents in a room or beyond, to adjacent spaces or areas receiving exhaust air.1 • “Alcohol-based hand rub (ABHR)” refers to a 60-95 percent ethanol or isopropyl alcohol-containing preparation base designed for application to the hands to reduce the number of viable microorganisms. • “C. difficile infection (CDI)” refers to an infection from a bacterium that causes colitis, an inflammation of the colon, causing diarrhea. • “Cleaning” refers to removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and is normally accomplished manually or mechanically using water with detergents or enzymatic products. • “Cohorting” refers to the practice of grouping residents infected or colonized with the same infectious agent together to confine their care to one area and prevent contact with susceptible residents (cohorting residents).2 During outbreaks, healthcare staff may be assigned to a specific cohort of residents to further limit opportunities for transmission (cohorting staff). The term “cohort” or “cohorting” is standardized language used in the practice of infection prevention and control; the use of this terminology is not intended to offend residents or staff. • “Colonization” refers to the presence of microorganisms on or within body sites without detectable host immune response, cellular damage, or clinical expression. 3 • “Communicable disease (also known as (a.k.a.) “contagious disease”)” refers to an infection transmissible (e.g., from person-to-person) by direct contact with an affected individual or the individual's body fluids or by indirect means (e.g., contaminated object). • “Community-acquired infections (a.k.a. ‘present on admission’)” refer to infections that are present or incubating at the time of admission and which generally develop within 72 hours of admission. • “Contact precautions” refer to measures that are intended to prevent transmission of infectious agents which are spread by direct or indirect contact with the resident or the resident’s environment.4 • “Contaminated laundry” refers to laundry which has been soiled with blood/body fluids or other potentially infectious materials or may contain sharps. • “Decontamination” refers to the use of physical or chemical means to remove, inactivate, or destroy pathogenic organisms on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal. • “Disinfectant” refers to usually a chemical agent (but sometimes a physical agent) that destroys disease-causing pathogens or other harmful microorganisms but might not kill bacterial spores. It refers to substances applied to inanimate objects.5 • “Disinfection” refers to thermal or chemical destruction of pathogenic and other types of microorganisms. Disinfection is less lethal than sterilization because it destroys most recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores). 6 • “Droplet precautions” refer to actions designed to reduce/prevent the transmission of pathogens spread through close respiratory or mucous membrane contact with respiratory secretions. • “Hand hygiene” refers to a general term that applies to hand washing, antiseptic handwash, and alcohol-based hand rub.7 • “Hand washing” refers to washing hands with soap and water.8 • “Healthcare-associated infection (HAI)” refers to an infection that residents acquire, that is associated with a medical or surgical intervention (e.g., podiatry, wound care debridement) within a nursing home and was not present or incubating at the time of admission. • “Hygienically clean” refers to being free of pathogens in sufficient numbers to cause human illness.9 • “Infection” refers to the establishment of an infective agent in or on a suitable host, producing clinical signs and symptoms (e.g., fever, redness, heat, purulent exudates, etc.). • “Infection preventionist” refers to the person(s) designated by the facility to be responsible for the infection prevention and control program as specified in §483.80(b) (F882). • “Legionellosis” refers to two clinically and epidemiologically distinct illnesses: Legionnaires’ disease, which is typically characterized by fever, myalgia, cough, and clinical or radiographic pneumonia; and Pontiac fever, a milder illness without pneumonia (e.g., fever and muscle aches). Legionellosis is caused by Legionella bacteria. • “Multidrug-resistant organisms (MDROs)” refer to microorganisms, predominantly bacteria that are resistant to one or more classes of antimicrobial agents. Although the names of certain MDROs describe resistance to only one agent, these pathogens are frequently resistant to most available antimicrobial agents. • “Personal protective equipment (PPE)” refers to protective items or garments worn to protect the body or clothing from hazards that can cause injury and to protect residents from cross-transmission. • “Standard precautions” refer to the infection prevention practices that apply to all residents, regardless of suspected or confirmed diagnosis or presumed infection status. Standard precautions is based on the principle that all blood, body fluids, secretions, excretions except sweat, regardless of whether they contain visible blood, non-intact skin, and mucous membranes may contain transmissible infectious agents. Furthermore, equipment or items in the resident’s environment likely to have been contaminated with infectious body fluids must be handled in a manner to prevent transmission of infectious agents. Standard precautions include hand hygiene, proper selection and use of personal protective equipment, safe injection practices, respiratory hygiene/cough etiquette, environmental cleaning and disinfection, and reprocessing of reusable resident medical equipment.10, 11 • “Transmission-based precautions (a.k.a. “Isolation Precautions”)” refer to actions (precautions) implemented in addition to standard precautions that are based upon the means of transmission (airborne, contact, and droplet) in order to prevent or control infections. NOTE: Although the regulatory language refers to “isolation,” the nomenclature widely accepted by the healthcare community and used in this guidance will refer to “transmission-based precautions” instead of “isolation” as these terms can be used interchangeably. NOTE: References to non-CMS sources are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services. CMS is not responsible for the content of pages found at these sites. URL addresses and referenced documents were current as of the date of this publication. Guidelines change, and facilities are responsible for following the most current standards. GUIDANCE §§483.80(a)(1), (a)(2), (a)(4), (e), and (f) Infection Prevention and Control Program Healthcare-associated infections (HAIs) can cause significant pain and discomfort for residents in nursing homes and can have significant adverse consequences. The facility must establish and maintain an IPCP designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections. This program must include, at a minimum, a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, and visitors. The IPCP must follow accepted national standards and guidelines. We expect facilities to tailor the emphasis of their IPCP for visitors and to work to prevent transmission of infection to the resident from the visitor using reasonable precautions and national standards.12 For example, “screening may be passive through the use of signs to alert family members and visitors with signs and symptoms of communicable diseases not to enter. More active screening may include the completion of a screening tool or questionnaire which elicits information related to recent exposures or current symptoms. That information is reviewed by the facility staff and the visitor is either permitted to visit or is excluded.”13 The Infection Prevention and Control Program must include, at a minimum, the following parts: • A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases that: o Covers all residents, staff, contractors, consultants, volunteers, visitors, others who provide care and services to residents on behalf of the facility, and students in the facility’s nurse aide training programs or from affiliated academic institutions; o Is based on the individual facility assessment conducted under §483.71; and o Follows accepted national standards. • Written standards, policies and procedures in accordance with §483.80(a)(2); • A system for recording incidents identified under the IPCP and corrective actions taken by the facility; and • An antibiotic stewardship program (ASP) pursuant to §483.80(a)(3) (for more information on ASP requirements, see F881). Facility Assessment Pursuant to §483.71 (F838), the facility must conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies. The facility must review and update that assessment, as necessary, and at least annually. The facility must also review and update this assessment whenever there is, or the facility plans for, any change that would require a substantial modification to any part of this assessment. The facility assessment must address or include, among other things, a facility-based and community-based risk assessment, utilizing an all-hazards approach. See §483.71 (F838) for guidance on the facility assessment. The results of the facility assessment must be used, in part, to establish and update the IPCP, its policies and/or protocols to include a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for residents, staff, and visitors. NOTE: A community-based risk assessment should include review for risk of infections (e.g., multidrug-resistant organisms/MDROs) and communicable diseases such as tuberculosis and influenza. Appropriate resident tuberculosis screening should be performed based on state requirements. NOTE: While not required for compliance, a sample tool of an infection control risk assessment is available for adaptation.14 Infection Control Policies and Procedures The facility must develop and implement written policies and procedures for the provision of infection prevention and control. The facility administration and medical director should ensure that current infection control standards of practice based on recognized guidelines and facility assessment are incorporated in the resident care policies and procedures. These IPCP policies and procedures must include, at a minimum, the following: • As necessary, and at least annually, review and revision of the IPCP based upon the facility assessment (according to 483.71) which includes any facility and community risk; • An ongoing system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility; • When and to whom possible incidents of communicable disease or infections should be reported within the facility; • Which communicable diseases are reportable to local/state public health authorities; • Define and explain standard precautions and their application during resident care activities. Define transmission-based precautions (i.e., contact precautions, droplet precautions, airborne precautions) and explain how and when they should be utilized, as consistent with accepted national standards. The areas listed below are examples of standard and/or transmission-based precautions15 which are further described under their respective sections: o Hand hygiene (HH) (e.g., hand washing and/or ABHR): consistent with accepted standards of practice such as the preferential use of ABHR instead of soap and water in most clinical situations except when hands are visibly soiled16 (e.g., blood, body fluids), or after caring for a resident with known or suspected C. difficile or norovirus infection during an outbreak, or if rates of C. difficile infection (CDI) are high; in these circumstances, soap and water should be used;17 NOTE: According to the Centers for Disease Control and Prevention (CDC), strict adherence to glove use is the most effective means of preventing hand contamination with C. difficile spores as these spores are not killed by ABHR and may be difficult to remove even with thorough hand washing. Additional information on appropriate hand hygiene practices may be found in CDC’s Hand Hygiene in Healthcare Settings website at http://www.cdc.gov/handhygiene/providers/index.html; o The selection and use of PPE (e.g., indications, donning/doffing procedures) and the clinical conditions for which specific PPE should be used (e.g., CDI, influenza); o Addressing the provision of facemasks for residents with new respiratory symptoms; o Addressing resident room assignment (e.g. single/private room/cohorted) as appropriate and/or available, based on a case by case analysis of the presence of risk factors for increased likelihood of transmission (e.g., uncontained drainage, stool incontinence);18 o The process to manage a resident on transmission-based precautions when a single/private room is not available; o Limiting the movement of a resident who is on transmission-based precautions to medically necessary purposes only;19 o Respiratory Hygiene/Cough Etiquette: implementing policies and procedures would include providing resources and instructions for performing HH in or near lobby areas or entrances in accordance with accepted national standards. During times of increased prevalence of respiratory infections in the community, facilities should have facemasks available and offer them to visitors and others entering the facility. In addition, the facility should post signs with instructions on visitation restrictions for those with symptoms of respiratory infection or other communicable diseases;20 and o Environmental cleaning and disinfection:  Routine cleaning and disinfection of frequently touched or visibly soiled surfaces in common areas, resident rooms, and at the time of discharge; and NOTE: Privacy curtains should be changed when visibly dirty and should be laundered or disinfected with an Environmental Protection Agency (EPA)-registered disinfectant per the curtain and disinfectant manufacturer’s instructions. https://www.cdc.gov/handhygiene/index.html http://www.cdc.gov/handhygiene/providers/index.html; http://www.cdc.gov/handhygiene/providers/index.html;  Routine cleaning and disinfection of resident care equipment including equipment shared among residents (e.g., blood pressure cuffs, rehabilitation therapy equipment, blood glucose meters, etc.). • Written occupational health policies that should address: o Reporting of staff illnesses and following work restrictions per nationally recognized standards and guidelines;21, 22 o Prohibiting contact with residents or their food when staff have potentially communicable diseases or infected skin lesions; o Assessing risks for tuberculosis (TB) based on exposure or cases of TB in the facility. Then screen staff for TB to the extent permitted under applicable federal guidelines23 and state law; o Monitoring and evaluating for clusters or outbreaks of illness among staff; and o Implementing an exposure control plan in order to address potential hazards posed by blood and body fluids (e.g., from dialysis, glucose monitoring or any other point of care testing). • Facilities must ensure staff follow the IPCP’s standards, policies and procedures. Knowledge and skills pertaining to the IPCP’s standards, policies and procedures are needed by all staff in order to follow proper infection control practices (e.g., hand hygiene and appropriate use of PPE) while other needs are specific to particular roles, responsibilities, and situations (e.g., injection safety and point of care testing); and • Residents and their representatives should receive education on the facility’s IPCP as it relates to them (e.g., hand hygiene, cough etiquette) and to the degree possible/consistent with the resident’s capacity. For example, residents should be advised of the IPCP’s standards, policies and procedures regarding hand hygiene before eating and after using the restroom. Surveillance The facility must establish a system for surveillance based upon national standards of practice and the facility assessment, including the resident population and the services and care provided. The facility must establish routine, ongoing, and systematic collection, analysis, interpretation, and dissemination of surveillance data to identify infections (i.e., HAI and community-acquired), infection risks, communicable disease outbreaks, and to maintain or improve resident health status. As part of the system of surveillance, the facility should determine how it will track the extent to which staff are following the facility’s IPCP policies and procedures, and facilities should address any areas that need corrective action. The facility’s surveillance system must include a data collection tool and the use of nationally-recognized surveillance criteria, such as but not limited to, the CDC’s National Healthcare Safety Network (NHSN) Long Term Care Criteria to define infections or updated McGeer criteria.24 Furthermore, the facility must know when and to whom to report communicable diseases, healthcare-associated infections (as appropriate), and potential outbreaks (e.g., list of communicable diseases which are reportable to local/state public health authorities). The facility must document follow-up activity in response to important surveillance findings (e.g., outbreaks). In addition, the facility must establish and implement a system, including who to notify (e.g., infection preventionist), for early detection and management of a potentially infectious, symptomatic resident at the time of admission. This includes the identification and use of appropriate transmission-based precautions.25 This is important to incorporate into the resident’s baseline care plan that must be developed within 48 hours of admission and include the minimum healthcare information necessary to properly care for a resident, including physician orders (e.g., medication orders). See §483.21, Comprehensive Person-Centered Care Planning for further information. Furthermore, the facility must have a process for communicating information at the time of transfer (e.g., CDC, state, or other standardized inter-facility infection transfer form) when a resident has an infection or is colonized.26 When a resident is transferred, the information provided to the receiving provider must include special instructions or precautions (e.g., transmission-based precautions, if applicable) for ongoing care and other necessary information including a discharge summary (if discharged). When a resident is discharged, the discharge summary must include the resident’s disease diagnoses and health conditions, course of illness/treatment or therapy, medications, and pertinent lab, radiology, consultation results, and instructions or precautions for ongoing care. See §483.21(c)(2), Discharge Summary (F661) and §483.15(c)(2)(iii), Transfer and Discharge (F622) for further information on these requirements. Additionally, as part of the overall IPCP for surveillance, the facility shall establish process and outcome surveillance. Process Surveillance Process surveillance is the review of practices by staff directly related to resident care.27 The purpose is to identify whether staff implement and comply with the facility’s IPCP policies and procedures. Some areas that facilities may want to consider for process surveillance are the following: • Hand hygiene; • Appropriate use of personal protective equipment (e.g., gowns, gloves, facemask); • Injection safety; • Point-of-care testing (e.g., during assisted blood glucose monitoring); • Implementation of infection control practices for resident care such as but not limited to urinary catheter care, wound care, injection/IV care, fecal/urinary incontinence care, skin care, respiratory care, dialysis care, and other invasive treatments; • Managing a bloodborne pathogen exposure. NOTE: This may not lend itself to monitoring and feedback; • Cleaning and disinfection products and procedures for environmental surfaces and equipment (e.g., objective methods for evaluation may include direct practice observation, fluorescent markers, adenosine triphosphate (ATP) bioluminescence (a method for quantifying the concentration of environmental microorganisms), or swab cultures used primarily for outbreak investigation28); • Appropriate use of transmission-based precautions; and • Handling, storing, processing, and transporting linens so as to prevent the spread of infection. Outcome Surveillance Another component of a system of identification is outcome surveillance. For example, this addresses the criteria that staff would use to identify and report evidence of a suspected or confirmed HAI or communicable disease. This process consists of collecting/documenting data on individual resident cases and comparing the collected data to standard written definitions (criteria) of infections. NOTE: Additional information related to examples of nationally accepted surveillance definitions may be found at the “CDC/SHEA Position Statement: Surveillance Definitions of Infections in Long-Term Care Facilities: Revisiting the McGeer Criteria29” or NHSN at https://www.cdc.gov/nhsn/. The following are some sources of data that can be utilized in outcome surveillance for infections, and antibiotic use and susceptibility: • Monitoring a resident(s) with fever or other signs or symptoms suspicious for infection; • Laboratory cultures or other diagnostic test results consistent with potential infections to detect clusters, trends, or susceptibility patterns; • Antibiotic orders; • Medication regimen review reports; • Documentation from the clinical record of residents with suspicion of an infection such as physician orders/progress notes; and/or • Transfer/discharge summaries for new or readmitted residents for infections.30 System of Surveillance: Data Analysis, Documentation and Reporting The facility’s policies and procedures for a system of surveillance must include data to properly identify possible communicable diseases or infections before they spread. Therefore, the policies and procedures would include identifying: • Data to be collected, including how often and the type of data to be documented, including: o The infection site (i.e., type of infection), pathogen (if available), signs and symptoms, and resident location, including summary and analysis of the number of residents (and staff, if applicable) who developed infections; o Observations of staff including the identification of ineffective practices (e.g., not practicing hand hygiene and/or using PPE when indicated as well as https://www.cdc.gov/nhsn/ practices that do not follow the facility’s IPCP policies and procedures), if any; and o The identification of unusual or unexpected outcomes (e.g. foodborne outbreak), infection trends and patterns. • How the data will be used and shared with appropriate individuals (e.g., staff, medical director, director of nursing, quality assessment and assurance committee- QAA), when applicable, to ensure that staff minimize spread of the infection or disease (e.g., require revision of staff education and competency assessment). The facility must identify how reports will be provided to staff and/or prescribing practitioners in order to revise interventions/approaches and/or re-evaluate medical interventions related to the infection rates and outcomes. Recognizing, Containing and Reporting Communicable Disease Outbreaks The facility must know how to recognize and contain infectious disease outbreaks. An outbreak is the occurrence of more cases of disease than expected in a given area or among a specific group of people over a particular period of time.31 If a condition is rare or has serious health implications, an outbreak may involve only one case. While a single case of a rare infectious condition or one that has serious health implications may or may not constitute an outbreak, facilities should not wait for the definition of an outbreak to act. For example, one case of laboratory confirmed influenza in a resident should alert the facility to begin an outbreak investigation. If an outbreak is identified, the facility must: • Take the appropriate steps to diagnose and manage cases, implement appropriate precautions, and prevent further transmission of the disease as well as documentation of follow-up activity in response; and • Comply with state and local public health authority requirements for identification, reporting, and containing communicable diseases and outbreaks. NOTE: Some states have specific regulations regarding responding to and reporting outbreaks that must be included in the IPCP. NOTE: If there are concerns that actions taken by the facility are not addressing public health authority instructions to contain and remedy the outbreak, the SA must notify the appropriate local/state public health authority. If surveyors cite this tag for an outbreak, utilize the guidelines in Appendix Q to determine if immediate jeopardy exists. Water Management The bacterium Legionella can cause a serious type of pneumonia called Legionnaires’ Disease in persons at risk, such as those who are at least 50 years old, smokers, or with underlying medical conditions such as chronic lung disease or immunosuppression. Legionella can grow in parts of building water systems that are continually wet (e.g., pipes, faucets, water storage tanks, decorative fountains), and certain devices can spread contaminated water droplets via aerosolization. Legionellosis outbreaks are generally linked to locations where water is held or accumulates and pathogens can reproduce, including those found in long-term care facilities. Transmission from these water systems to humans occurs when the water is aerosolized (i.e., converted into a spray/mist in the air). Legionella is less commonly spread by aspiration of drinking water or ice. Facilities must be able to demonstrate its measures to minimize the risk of Legionella and other opportunistic pathogens in building water systems such as by having a documented water management program. Water management must be based on nationally accepted standards (e.g., ASHRAE (formerly the American Society of Heating, Refrigerating, and Air Conditioning Engineers), CDC, U.S. Environmental Protection Agency or EPA) and include: • An assessment to identify where Legionella and other opportunistic waterborne pathogens (e.g., Pseudomonas, Acinetobacter) could grow and spread; and • Measures to prevent the growth of opportunistic waterborne pathogens (also known as control measures), and how to monitor them. Examples of an assessment include a description of the building water systems using text and flow diagrams for identification. Additionally, control measures may include visible inspections, use of disinfectant, and temperature (that may require mixing valves to prevent scalding). Monitoring such controls include testing protocols for control measures, acceptable ranges, and documenting the results of testing. Water management should also include established ways to intervene when control limits are not met. An industry standard calling for the development and implementation of water management programs in large or complex building water systems to reduce the risk of legionellosis was published by ASHRAE. The CDC and its partners developed a toolkit to facilitate implementation of this ASHRAE Standard. Resources are available to develop and implement a water management program, such as: • “The ASHRAE Standard 188- Legionellosis: Risk Management for Building Water Systems” https://www.ashrae.org; • The CDC toolkit to facilitate implementation of the ASHRAE Standard titled “Developing a Water Management Program to Reduce Legionella Growth & Spread in Buildings: A Practical Guide to Implementing Industry Standards” https://www.cdc.gov/legionella/wmp/toolkit/index.html; and • The EPA's “Technologies for Legionella Control in Premise Plumbing Systems: Scientific Literature Review” is available at https://www.epa.gov/ground-water- and-drinking-water/technologies-legionella-control-premise-plumbing-systems. https://www.ashrae.org/ https://www.cdc.gov/legionella/wmp/toolkit/index.html https://www.epa.gov/ground-water-and-drinking-water/technologies-legionella-control-premise-plumbing-systems https://www.epa.gov/ground-water-and-drinking-water/technologies-legionella-control-premise-plumbing-systems At this time, CMS does not require water cultures for Legionella or other opportunistic waterborne pathogens as part of routine program validation, although there may be instances when it is needed (e.g., a case of healthcare-associated legionellosis or a potential outbreak of legionellosis in the facility). The facility should contact the local/state public health authority if there is a case of healthcare-associated legionellosis or an outbreak of an opportunistic waterborne pathogen causing disease. The facility must follow public health authority recommendations which may include, but is not limited to, remediating the pathogen reservoir and adjusting control measures as necessary. The SA should work with local/state public health authorities, if possible, to determine if the water management program was inadequate to prevent the growth of Legionella or other opportunistic waterborne pathogens and whether the facility implemented adequate prevention and control measures once the issue was identified. Prevention and Control of Transmission of Infection Infectious organisms (e.g., bacteria, viruses, or parasites) may be transmitted by direct contact (e.g., skin-to-skin) or indirect contact (e.g., inanimate objects). Healthcare staff and resident care equipment often move from resident to resident and therefore may serve as a vehicle for transferring infectious organisms. Direct Contact Transmission (Person-to-Person) occurs when microorganisms such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), carbapenem-resistant Enterobacteriaceae (CRE), influenza, or mites from a scabies-infected resident are transferred from an infected or colonized person to another person. In nursing homes, resident-to-resident direct contact transmission may occur in common areas of the facility such as the recreation room, rehabilitation area, and/or dining room. Indirect Contact Transmission involves the transfer of an infectious agent through a contaminated inanimate object or person. The following are examples of opportunities for indirect contact transmission: • Clothing, uniforms, laboratory coats, or isolation gowns used as PPE may become contaminated with potential pathogens after care of a resident colonized or infected with an infectious agent, (e.g., MRSA, VRE, and C. difficile); and • Contamination of high touch environmental surfaces (e.g., bedside table, bed rails, toilets, sinks, and handrails), contributes to transmission of pathogens including C. difficile and norovirus. Certain pathogens may contaminate and survive on equipment and environmental surfaces for long periods of time. Examples include, but are not limited to: • C. difficile spores can live on inanimate surfaces for up to 5 months;32 • The hepatitis B virus can last up to a week on inanimate surfaces;33 and • The influenza virus can survive on fomites (e.g., any inanimate object or substance capable of carrying infectious organisms and transferring them from one individual to another) for up to 8 hours.34 Mechanisms to prevent and control transmission of infectious organisms through direct and indirect contact include standard and transmission-based precautions and are described in their subsequent sections. Standard Precautions Standard precautions represent the infection prevention measures that apply to all resident care, regardless of suspected or confirmed infection status of the resident, in any setting where healthcare is being delivered. These evidence-based practices are designed to protect healthcare staff and residents by preventing the spread of infections among residents, staff, and visitors, and ensuring staff do not carry infectious pathogens on their hands or via equipment during resident care. As mentioned above in the definitions section, standard precautions include hand hygiene, selection and use of PPE (e.g., gloves, gowns, facemasks, respirators, eye protection), respiratory hygiene and cough etiquette, safe injection practices, environmental cleaning and disinfection, and reprocessing of reusable resident medical equipment. 35, 36 In order to perform hand hygiene appropriately, soap, water, ABHR, and a sink should be readily accessible in appropriate locations including, but not limited to, resident care areas and food and medication preparation areas. Staff involved in direct resident contact must perform hand hygiene (even if gloves are used). Hand hygiene is performed37: • Before and after contact with the resident; • Before performing an aseptic task; • After contact with blood, body fluids, visibly contaminated surfaces or after contact with objects in the resident’s room; • After removing personal protective equipment (e.g., gloves, gown, facemask); • After using the restroom; and • Before meals. If residents need assistance with hand hygiene, staff should assist with washing hands after toileting, before meals, and use of ABHR or soap and water at other times when indicated. Certain PPE may be required when working in the facility, such as use of facemasks or eye protection during a respiratory virus pandemic. Additionally, the use of PPE during resident care is determined by the nature of staff interaction and the extent of anticipated blood, body fluid, or pathogen exposure to include contamination of environmental surfaces. Furthermore, appropriate use of PPE includes, but is not limited to, the following: • Gloves worn before and removed after contact with blood or body fluid, mucous membranes, or non-intact skin; • Gloves changed and hand hygiene performed before moving from a contaminated-body site to a clean-body site during resident care; • Gown worn for direct resident contact if the resident has uncontained secretions or excretions or with contaminated or potentially contaminated items; • Appropriate mouth, nose, and eye protection (e.g., facemasks, face shield) is worn for resident care or procedures that are likely to contaminate mucous membranes, or generate splashes or sprays of blood, body fluids, secretions or excretions; • PPE appropriately discarded after resident care prior to leaving room followed by hand hygiene; and • Supplies necessary for adherence to proper PPE use (e.g., gloves, gowns, masks) are readily accessible in resident care areas (i.e., nursing units, therapy rooms) although, equipment supply carts should not be brought into the resident’s room. The facility must prevent infections through indirect contact transmission. This requires the decontamination (i.e., cleaning and/or disinfecting an object to render it safe for handling) of resident equipment, medical devices, and the environment. Alternatively, the facility may also consider using single-use disposable devices or designating reusable equipment for only an individual resident. NOTE: Additional information related to environmental cleaning may be found in CDC and the Healthcare Infection Control Practices Advisory Committee’s (HICPAC) “Guidelines for Environmental Infection Control in Health-Care Facilities (2003)”at https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html. Equipment or items in the resident environment likely to have been contaminated with infectious fluids or other potentially infectious matter must be handled in a manner so as to prevent transmission of infectious agents (e.g., wear gloves for handling soiled equipment and properly clean and disinfect or sterilize reusable equipment before use on another resident).38 The CDC has adopted the Spaulding classification system that identifies three risk levels associated with medical and surgical instruments: critical, semi-critical, and noncritical items. • Critical items (e.g., needles, intravenous catheters, indwelling urinary catheters) enter sterile tissue or the vascular system. These items or equipment must be sterile when used, based on one of several accepted sterilization procedures. Sterilization destroys all viable microorganisms to prevent disease transmission associated with the use of that item. Most of the items in this category should be purchased as sterile or be sterilized; • Semi-critical items (e.g., dental, podiatry equipment, electric razors) contact mucous membranes or non-intact skin. Such items require meticulous cleaning followed by high-level disinfection treatment using an FDA-approved high-level chemical disinfectant, or they may be sterilized. High-level disinfection is https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html traditionally defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores. Refer to the specific disinfectant label claim to determine effectiveness; and • Non-critical items are those that come in contact with intact skin but not mucous membranes. Noncritical items are divided into noncritical resident care items (e.g., blood pressure cuffs, stethoscopes, wheelchairs, therapy equipment) and noncritical environmental surfaces (e.g., bed rails, bedside tables). Non-critical items require cleaning followed by either low- or intermediate-level disinfection following manufacturers’ instructions. Disinfection should be performed with an EPA-registered disinfectant labeled for use in healthcare settings. All applicable label instructions on EPA-registered disinfectant products must be followed (e.g., use-dilution, shelf life, storage, material compatibility, safe use and disposal). 39 • Low-level disinfection is traditionally defined as the destruction of all vegetative bacteria (except tubercle bacilli) and most viruses, some fungi, but not bacterial spores. Examples of low-level disinfectants include EPA- registered hospital disinfectants with an HBV and HIV label claim. Low-level disinfection is generally appropriate for most non-critical equipment. • Intermediate-level disinfection is traditionally defined as destruction of all vegetative bacteria, including tubercle bacilli, lipid and some nonlipid viruses, and fungi, but not bacterial spores. EPA-registered hospital disinfectants with a tuberculocidal claim are intermediate-level disinfectants. Given the broader spectrum of activity, intermediate-level disinfection should be considered for non-critical equipment that is visibly contaminated with blood. However, a low-level disinfectant with a label claim against HBV and HIV could also be used.40,41 Single-use disposable equipment is an alternative to reprocessing reusable medical instruments. Single-use devices must be discarded after use and are never used for more than one resident. Nursing homes may purchase reprocessed single-use devices when these devices are reprocessed by an entity or a third party reprocessor that is registered with the FDA. The nursing home must have documentation from the third party reprocessor that indicates that it has been cleared by the FDA to reprocess the specific device in question. NOTE: Additional information related to disinfection and sterilization may be found in CDC’s “Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)” at https://www.cdc.gov/infectioncontrol/guidelines/Disinfection/index.html. Transmission-based Precautions There are three categories of transmission-based precautions: contact precautions, droplet precautions, and airborne precautions. Transmission-based precautions are used when the route(s) of transmission is (are) not completely interrupted using standard precautions alone. For some diseases that have multiple routes of transmission, more than one https://www.cdc.gov/infectioncontrol/guidelines/Disinfection/index.html https://www.cdc.gov/infectioncontrol/guidelines/Disinfection/index.html transmission-based precautions category may be required. Whether used singly or in combination, they must always be used in addition to standard precautions. The type of PPE and precautions used depends on the potential for exposure, route of transmission, and infectious organism/pathogen (or clinical syndrome if an organism is not yet identified). The diagnosis of many infections is based on clinical signs and symptoms, but often requires laboratory confirmation. However, since laboratory tests (especially those that depend on culture techniques) may require two or more days to complete, transmission- based precautions may need to be implemented while test results are pending, based on the clinical presentation and the likely category of pathogens.42,43 The facility should initiate transmission-based precautions for a constellation of new symptoms consistent with a communicable disease. Empirically initiated transmission- based precautions may be adjusted or discontinued when additional clinical information becomes available (e.g., confirmatory laboratory results). Facility policies must identify the type (i.e., contact, droplet, airborne) and duration of the transmission-based precautions required, depending upon the infectious pathogen involved. Residents on transmission-based precautions should remain in their rooms except for medically necessary care.44 Furthermore, transmission-based precautions should be the least restrictive possible for the resident based on his/her clinical situation and used for the least amount of time. When used appropriately, transmission-based precautions is not to be considered involuntary seclusion. However, once the resident is no longer a risk for transmitting the pathogen (e.g., duration of the illness and/or can contain secretions), removing transmission-based precautions is required in order to avoid unnecessary involuntary seclusion. Facility staff should take measures to reduce or minimize any potential psychosocial negative effects of isolation for whom transmission-based precautions are being used. Boredom, anger, withdrawal or depression are just some of the mood changes that could occur. The facility must pro-actively ensure that individualized needs (e.g., activities) are met. Implementation of Transmission-Based Precautions When implementing transmission-based precautions, consideration should be given to the following: • The identification of resident risk factors that increase the likelihood of transmission (such as uncontained secretions or excretions, non-compliance, cognition deficits, incontinence, etc.); • The provision of a private room as available/appropriate; • Cohorting residents with the same pathogen; and • Sharing a room with a roommate with limited risk factors (e.g., without indwelling or invasive devices, without open wounds, and not immunocompromised) as appropriate based on the pathogen and method of transmission.45 When a resident is placed on transmission-based precautions, facility staff should implement the following: • Clearly identify the type of precautions and the appropriate PPE to be used; • Place signage that includes instructions for use of specific PPE in a conspicuous location outside the resident’s room (e.g., on the door or on the wall next to the doorway), wing, or facility-wide. Additionally, either the CDC category of transmission-based precautions (e.g., contact, droplet, or airborne) or instructions to see the nurse before entering should be included in signage. Ensure that signage also complies with residents’ rights to confidentiality and privacy; • Make PPE readily available near the entrance to the resident’s room; • Don appropriate PPE before or upon entry into the environment (e.g., room or cubicle) of a resident on transmission-based precautions (e.g., contact precautions); • Use disposable or dedicated noncritical resident-care equipment (e.g., blood pressure cuff, bedside commode). If noncritical equipment is shared between residents, it will be cleaned and disinfected following manufacturer’s instructions with an EPA-registered disinfectant after use; 46 • Clean and disinfect objects and environmental surfaces that are touched frequently (e.g., bed rails, over-bed table, bedside commode, lavatory surfaces in resident bathrooms) with an EPA-registered disinfectant for healthcare use at least daily and when visibly soiled; 47 and • Provide education to residents (to the degree possible/consistent with the resident’s capacity) and their representatives or visitors on the use of transmission-based precautions. Resources are available for current recommendations on standard and transmission-based precautions, such as: • “Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007)” https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html; and • “Management of Multidrug-resistant Organisms In Healthcare Settings (2006)” https://www.cdc.gov/infectioncontrol/guidelines/mdro/index.html. Contact Precautions Contact precautions are intended to prevent transmission of pathogens that are spread by direct (e.g., person-to-person) or indirect contact with the resident or environment (e.g., C. difficile, norovirus, scabies), and requires the use of appropriate PPE, including a gown and gloves before or upon entering (i.e., before making contact with the resident or resident’s environment) the room or cubicle. Prior to leaving the resident’s room or cubicle, the PPE is removed and hand hygiene is performed. https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html https://www.cdc.gov/infectioncontrol/guidelines/mdro/index.html Contact precautions should also be used in situations when a resident is experiencing wound drainage, fecal incontinence or diarrhea, or other discharges from the body that cannot be contained and suggest an increased potential for extensive environmental contamination and risk of transmission of a pathogen, even before a specific organism has been identified. MDRO Colonization and Infection Contact precautions are used for residents infected or colonized with MDROs in the following situations: • When a resident has wounds, secretions, or excretions that are unable to be covered or contained; and • On units or in facilities where, despite attempts to control the spread of the MDRO, ongoing transmission is occurring. These strategies may differ depending on the prevalence or incidence of the MDRO in the facility and region. For example, additional usage of PPE can be used for residents who do not meet criteria for contact precautions but are infected or colonized with MDROs (or have risk factors for MDRO acquisition). Staff can use gloves and gowns in order to prevent contamination of hands and clothing while performing high-contact resident care activities that pose the highest risk for MDRO transmission. These high- contact activities include dressing, bathing or providing hygiene, transferring, changing briefs or assisting with toileting, changing linens, or providing any type of device or wound care. Use of additional PPE during resident care would not restrict a resident’s ambulation, socialization, and use of common areas and participation in group activities. NOTE: Additional information related to MDROs may be found in CDC’s “Implementation of Personal Protective Equipment in Nursing Homes to Prevent Spread of Novel or Targeted Multidrug-resistant Organisms (MDROs)” at https://www.cdc.gov/hai/containment/PPE-Nursing-Homes.html. Droplet Precautions The use of droplet precautions applies when respiratory droplets contain pathogens which may be spread to another susceptible individual. Respiratory pathogens can enter the body via the nasal mucosa, conjunctivae and less frequently the mouth.48 Examples of droplet-borne organisms that may cause infections include, but are not limited to Mycoplasma pneumoniae, influenza, and other respiratory viruses. Respiratory droplets are generated when an infected person coughs, sneezes, talks, or during procedures such as suctioning, endotracheal intubation, cough induction by chest physiotherapy, and cardiopulmonary resuscitation.49 The maximum distance for droplet transmission is currently unresolved, but the area of defined risk based on epidemiological findings is approximately 3-10 feet.50 In contrast to airborne pathogens, https://www.cdc.gov/hai/containment/PPE-Nursing-Homes.html droplet-borne pathogens are generally not transmitted through the air over long distances. Facemasks should be used upon entry into a resident’s room or cubicle with respiratory droplet precautions.51 Based upon the pathogen or clinical syndrome, if there is risk of exposure of mucous membranes or substantial spraying of respiratory secretions is anticipated, gloves and gown as well as goggles (or face shield in place of goggles) should be worn.52 The preference for a resident on droplet precautions would be to place the resident in a private room.53 If a private room is not available, the resident could be cohorted with a resident with the same infectious agent. If it becomes necessary for a resident who requires droplet precautions to share a room with a resident who does not have the same infection, the facility should make decisions regarding resident placement on a case-by-case basis after considering infection risks to other residents in the room and available alternatives.54 Spatial separation and drawing the curtain between resident beds is especially important for residents in multi-bed rooms with infections transmitted by the droplet route.55 A resident who is on droplet precautions for the duration of the illness (e.g., influenza), should wear a facemask (e.g., surgical or procedure facemask) when leaving his/her room. Airborne Precautions Airborne transmission occurs when pathogens are so small that they can be easily dispersed in the air, and because of this, there is a risk of transmitting the disease through inhalation. These small particles containing infectious agents may be dispersed over long distances by air currents and may be inhaled by individuals who have not had face-to- face contact with (or been in the same room with) the infectious individual. Staff caring for residents on airborne precautions should wear a fit-tested N95 or higher level respirator that is donned prior to room entry.56 NOTE: According to the CDC, preventing the spread of pathogens that are transmitted by the airborne route requires the use of special air handling and ventilation systems such as an airborne infection isolation room (AIIR) to contain and then safely remove the infectious agent.57 Residents with infections requiring an AIIR must be transported to an acute care setting unless the facility can place the resident in a private AIIR room with the door closed. In cases when AIIR is required, such as for a resident with TB, it is important for the facility to have a plan (e.g., public health notification and exposure workup) in place to effectively manage a situation involving a resident with suspected or active TB while awaiting the resident’s transfer to an acute care setting.58 Medical Device Safety Medical devices may be used for administration of medications, point-of-care testing, or for other medical uses. Point-of-Care Testing Point-of-care testing is diagnostic testing that is performed at or near the site of resident care. This may be accomplished through use of portable, handheld instruments such as blood glucose meters or prothrombin time meters. This testing may involve obtaining a blood specimen from the resident using a fingerstick device. The guidance regarding fingerstick devices and blood glucose meters is applicable to other point-of-care devices where a blood specimen is obtained (e.g., prothrombin time meters). Fingerstick Devices CDC recommends the use of single-use, auto-disabling fingerstick devices in settings where assisted blood glucose monitoring is performed. This practice prevents inadvertent reuse of fingerstick devices for more than one person. Additionally, the use of single- use, auto-disabling fingerstick devices protects healthcare staff from needlestick injuries. If reusable fingerstick devices are used for assisted monitoring of blood glucose, then they must never be used for more than one resident. Although the package instructions for some fingerstick devices may indicate or imply the potential for multiple resident use, CMS guidance, based upon nationally recognized standards of practice from the CDC and FDA, prohibits the use of fingerstick devices for more than one resident. NOTE: If fingerstick devices are used on more than one resident, surveyors must cite at this tag and utilize the guidelines in Appendix Q for immediate jeopardy. Furthermore, the SA must notify the appropriate local/state public health authority of the deficient practice. Resources are available on fingerstick safety, such as: • “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” https://www.cdc.gov/injectionsafety/fingerstick-devicesbgm.html; and • CDC’s Frequently Asked Questions (FAQs) regarding Assisted Blood Glucose Monitoring and Insulin Administration https://www.cdc.gov/injectionsafety/providers/blood-glucose- monitoring_faqs.html. Blood Glucose Meters Blood glucose meters can become contaminated with blood and, if used for multiple residents, must be cleaned and disinfected after each use according to manufacturer’s instructions for multi-patient use. Additionally, staff must not carry blood glucose meters in pockets. The FDA has released guidance for manufacturers regarding appropriate products and procedures for cleaning and disinfection of blood glucose meters. FDA’s “Letter to Manufacturers of Blood Glucose Monitoring Systems Listed With the FDA” can be found at: https://www.cdc.gov/injectionsafety/fingerstick-devicesbgm.html https://www.cdc.gov/injectionsafety/fingerstick-devicesbgm.html https://www.cdc.gov/injectionsafety/providers/blood-glucose-monitoring_faqs.html https://www.cdc.gov/injectionsafety/providers/blood-glucose-monitoring_faqs.html http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ ucm227935.htm. An excerpt from this guidance reads: “The disinfection solvent you choose should be effective against HIV, Hepatitis C, and Hepatitis B virus. Outbreak episodes have been largely due to transmission of Hepatitis B and C viruses. However, of the two, Hepatitis B virus is the most difficult to kill. Please note that 70% ethanol solutions are not effective against viral bloodborne pathogens and the use of 10% bleach solutions may lead to physical degradation of your device.” A list of Environmental Protection Agency (EPA) registered disinfectants can be found at the following website: https://www.epa.gov/pesticide-registration/selected-epa-registered-disinfectants. Furthermore, “healthcare personnel should consult the manufacturers of blood glucose meters in use at their facilities to determine what products, meeting the criteria specified by the FDA, are compatible with their meter prior to using any EPA-registered disinfectant for disinfection purposes. If manufacturers are unable to provide this information then the meter should not be used for multiple patients.”59 Blood glucose meters dedicated for single-resident use should be stored in a manner that will protect against inadvertent use of the device for additional residents and also cross- contamination via contact with other meters or equipment. NOTE: If the facility failed to clean and disinfect blood glucose meters per device and disinfectant manufacturer’s instructions for use, they are used for more than one resident, and there is a resident with a known bloodborne pathogen in the facility, surveyors must cite noncompliance under this tag and utilize the guidelines in Appendix Q for determining immediate jeopardy. Furthermore, the SA must notify the appropriate local/state public health authority of this practice. Other instances of deficiencies may meet the definition of immediate jeopardy; utilize guidelines in Appendix Q to make this determination. NOTE: Additional information related to point-of-care testing may be found in CDC’s Infection Prevention during Blood Glucose Monitoring and Insulin Administration website at https://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html. Safe Medication Administration All injectable medications must be prepared and administered in accordance with safe injection practices, which include but are not limited to the following: • Injections are prepared using aseptic technique in a clean area, free from potential sources of contamination (e.g., blood, body fluids, contaminated equipment); • Needles and syringes are used for only one resident (this includes manufactured prefilled syringes and cartridge devices such as insulin pens). http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm227935.htm http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm227935.htm https://www.epa.gov/pesticide-registration/selected-epa-registered-disinfectants https://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html NOTE: If it is identified that needles or syringes are used for more than one resident, surveyors must cite noncompliance at this tag and utilize the guidelines in Appendix Q for determining immediate jeopardy. The SA must notify the appropriate local/state public health authority of the deficient practice; • Medication containers are entered with a new needle and a new syringe, even when obtaining additional doses for the same resident. If noncompliance is found, further investigation is warranted. NOTE: If the medication container is used for more than one resident, a new needle and/or syringe was not used with each access, and the container was then used for another resident, surveyors must cite noncompliance at this tag and utilize the guidelines in Appendix Q for determining immediate jeopardy. The SA must notify the appropriate local/state public health authority of the deficient practice; • Single dose (single-use) medication vials, ampules, and bags or bottles of intravenous solution are used for only one resident; • Medication administration tubing and connectors are used for only one resident. NOTE: Surveyors must cite at this tag if noncompliance is identified and utilize the guidelines in Appendix Q for determining immediate jeopardy. The SA must notify the appropriate local/state public health authority of the deficient practice; and • Multi-dose vials to be used for more than one resident are kept in a centralized medication area (e.g., medication room or cart) and do not enter the immediate resident treatment area (e.g., resident room). If multi-dose vials enter the immediate resident treatment area, they should be discarded immediately after use. NOTE: Additional information related to multi-dose vials may be found in CDC’s Questions about Multi-dose vials website at https://www.cdc.gov/injectionsafety/providers/provider_faqs_multivials.html. Insulin pens are pen-shaped injector devices that contain a reservoir for insulin or an insulin cartridge. These devices are designed to permit self-injection and are intended for single-person use, using a new needle for each injection. Insulin pens are designed to be used multiple times by a single resident only and must never be shared. Facility staff must follow manufacturer’s instructions for administration. Regurgitation of blood into the insulin cartridge after injection will create a risk of bloodborne pathogen transmission if the pen is used for more than one resident, even when the needle is changed. The FDA makes the following recommendations to prevent transmission of bloodborne infections in residents who require insulin pens: • Insulin pens containing multiple doses of insulin are meant for single-resident use only, and must never be used for more than one person, even when the needle is changed; • Insulin pens must be clearly labeled with the resident’s name and other identifiers to verify that the correct pen is used on the correct resident; and • Facilities should review their policies and procedures and educate their staff https://www.cdc.gov/injectionsafety/providers/provider_faqs_multivials.html regarding safe use of insulin pens. NOTE: Sharing insulin pens, or similar devices, between residents is similar to reusing needles or syringes for more than one resident. If noncompliance is found, surveyors must cite at this tag and utilize the guidelines in Appendix Q for determining immediate jeopardy. The SA must notify the appropriate local/state public health authority of the finding. NOTE: Additional information related to insulin pens may be found in FDA’s “Drug Safety Communication: FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients” at https://www.fda.gov/drugs/drugsafety/ucm435271.htm. Accessing Vascular Devices Vascular access devices, especially central venous catheters (CVC), increase the risk for local and systemic infections as well as additional complications such as septic thrombophlebitis. Intravascular access devices such as implanted ports may be accessed multiple times per day, for hemodynamic measurements or to obtain samples for laboratory analysis, thus increasing the risk of contamination and subsequent clinical infection. Limiting access to CVCs for only the primary purpose may help reduce the risk of infection. Resources are available for current standards of practice for the care of CVCs, such as: • CDC’s “Basic Infection Control and Prevention Plan for Outpatient Oncology Settings” https://www.cdc.gov/hai/settings/outpatient/basic-infection-control- prevention-plan-2011/index.html; • CDC’s “Hemodialysis Central Venous Catheter Scrub-the-Hub Protocol” http://www.cdc.gov/dialysis/PDFs/collaborative/Hemodialysis-Central-Venous- Catheter-STH-Protocol ; • CDC’s “Audit Tool: Catheter Exit Site Care Observations” http://www.cdc.gov/dialysis/PDFs/collaborative/Catheter-Exit-Site-Care- Observations ; and • CDC’s “Guidelines for the Prevention of Intravascular Catheter-Related Infections (2011)” https://www.cdc.gov/infectioncontrol/guidelines/index.html/bsi-guidelines- 2011 . System of Recording IPCP Incidents A facility must develop and implement a system for recording incidents identified under the facility’s IPCP and the corrective actions taken by the facility based on the investigation of the incidents in accordance with §483.80(a)(4). A facility-identified incident (e.g., HAI) may include the spread of disease due to errors in infection prevention and control. The facility’s system should include defining, identifying, analyzing, and reporting incidents related to failures in infection control practices to the https://www.fda.gov/drugs/drugsafety/ucm435271.htm https://www.cdc.gov/hai/settings/outpatient/basic-infection-control-prevention-plan-2011/index.html https://www.cdc.gov/hai/settings/outpatient/basic-infection-control-prevention-plan-2011/index.html http://www.cdc.gov/dialysis/PDFs/collaborative/Hemodialysis-Central-Venous-Catheter-STH-Protocol http://www.cdc.gov/dialysis/PDFs/collaborative/Hemodialysis-Central-Venous-Catheter-STH-Protocol http://www.cdc.gov/dialysis/PDFs/collaborative/Catheter-Exit-Site-Care-Observations http://www.cdc.gov/dialysis/PDFs/collaborative/Catheter-Exit-Site-Care-Observations https://www.cdc.gov/infectioncontrol/guidelines/index.html/bsi-guidelines-2011 https://www.cdc.gov/infectioncontrol/guidelines/index.html/bsi-guidelines-2011 director of nursing, medical director, and the QAA committee. These may include but are not limited to the following: • Identification of methods by which the facility would obtain information on incidents from residents, family, and direct care/direct access staff; • A description of how the facility addresses and investigates the incident(s); • Measures to be implemented for the prevention of incidents or potential incidents as they relate to infection prevention and control; • Development and implementation of corrective actions; • Monitoring for the effectiveness of its implemented changes; and • Methods for feedback to appropriate individuals involved in the failed practices. Linens Laundry Services Under §483.80(e), the facility must develop and follow practices on handling, storing, processing, and transporting laundry so as to prevent the spread of infection. The facility must monitor to ensure that the laundry practices are implemented, any deviations from practices must be identified, and corrective actions are put in place. Laundry includes resident’s personal clothing, linens, (i.e., sheets, blankets, pillows), towels, washcloths, and items from departments such as nursing, dietary, rehabilitative services, beauty shops, and environmental services. Laundry services may be provided onsite or the facility may have a written agreement in place for offsite laundry services. Regardless of the location where the laundry is processed, the facility must ensure that all laundry is handled, stored, processed and transported in a safe and sanitary manner. Handling Laundry The facility staff should handle all used laundry as potentially contaminated and use standard precautions (e.g., gloves, gowns when sorting and rinsing). The facility should use the following practices60: • Contaminated laundry is bagged or contained at the point of collection (i.e., location where it was used); • Leak-resistant containers or bags are used for linens or textiles contaminated with blood or body substances; • Sorting and rinsing of contaminated laundry at the point of use, hallways, or other open resident care spaces is prohibited; and • Staff should handle soiled textiles/linens with minimum agitation to avoid the contamination of air, surfaces, and persons. Transport of Laundry The facility practices must include how staff will handle and transport the laundry with appropriate measures to prevent cross-contamination. This includes, but is not limited to, the following: • Contaminated linen and laundry bags are not held close to the body when transporting; • No special precautions (e.g., double bagging, melting bags) or categorizing (e.g. biohazard, color-coded) for linen originating in transmission-based precaution rooms is necessary;61 • Double bagging of linen is only recommended if the outside of the bag is visibly contaminated or is observed to be wet through to the outside of the bag;62 • Contaminated linen carts must be cleaned and disinfected whenever visibly soiled and according to a schedule developed by the facility; • Separate carts must be used for transporting clean and contaminated linen. If this is not possible, the contaminated linen cart should be thoroughly cleaned and disinfected per facility protocol before being used to move clean linens; and63 • Clean linens must be transported by methods that ensure cleanliness and protect from dust and soil during intra or inter-facility loading, transport, and unloading.64 Linen Storage Facility practices must address linen storage, and should include but are not limited to: • Covers are not needed on contaminated textile hampers in resident care areas (unless state licensing rules require them);65 and • Clean linen must always be kept separate from contaminated linen. The use of separate rooms, closets, or other designated spaces with a closing door provides the most secure methods for reducing the risk of accidental contamination. Processing Laundry Including the Use of Laundry Equipment and Detergents in the Facility The facility must have a process to clean laundry. Detergent and water physically remove many microorganisms from the linen through dilution during the wash cycle. Advances in laundry equipment technology allow modern-day detergents to be much more effective in removing soil and reducing the presence of microbes than those used in the past when much of the research on laundry processing was first conducted. Washing/drying processes includes the use of manufacturer’s instructions for use (IFU) for laundry additives and equipment maintenance. The facility staff must prevent contamination of laundry in processing areas. The facility has laundry practices that include but are not limited to the following66: • Availability and use of hand hygiene products, as well as appropriate PPE (i.e., gloves and gowns) while sorting and handling contaminated linens; • The receiving area for contaminated textiles is clearly separated from clean laundry areas. Workflow should prevent cross-contamination; • If using fans in laundry processing areas, prevent cross-contamination of clean linens from air blowing from soiled processing areas (i.e., the ventilation should not flow from soiled processing areas to clean laundry areas); • Laundry equipment (e.g., washing machines, dryers) is used and maintained according to the manufacturer’s IFU to prevent microbial contamination of the system; • Damp laundry is not left in machines overnight; • Laundry detergents, rinse aids or other additives are used according to the manufacturer’s IFU. NOTE: Facilities should communicate information regarding allergies that may impact how an individual resident’s laundry is processed; • Ozone cleaning systems are acceptable for processing laundry; • If laundry chutes are used, they are designed and maintained so as to minimize dispersion of aerosols from contaminated laundry (e.g., no loose items in the chute and bags are closed before tossing into the chute); and • The facility should be using the fabric manufacturer’s recommended laundry cycles, water temperatures and chemical detergent products: o Recommendations for laundry processed in hot water temperatures is 160ºF (71ºC) for 25 minutes; and o For laundry that is not hot water compatible, low temperature washing at 71 to 77 ºF (22-25 ºC) plus chlorine or oxygen-activated bleach can reduce microbial contamination. NOTE: The facility is not required to monitor water temperatures during laundry processing cycles, unless specified by state rules. A chlorine bleach rinse is not required for all laundry items processed in low temperature washing environments due to the availability of modern laundry detergents that are able to produce hygienically clean laundry without the presence of chlorine bleach. The facility should refer to the manufacturer’s recommendations for the use of the detergent and items being laundered. Offsite Professional Laundry Services If linen is sent off-site to a professional laundry, the facility has practices that address how the service will be provided, including how linen is processed and handled to prevent contamination from dust and dirt during loading and transport. The facility should assure that this laundry service meets healthcare industry laundry standards. Mattresses and Pillows Standard permeable mattresses and pillows can become contaminated with body substances during resident care if the integrity of the covers of these items is compromised. A mattress cover is generally a fitted, protective material, the purpose of which is to prevent the mattress from becoming contaminated with body fluids and substances. A linen sheet placed on the mattress is not considered a mattress cover. Patches for tears and holes in mattress covers do not provide an impermeable surface over the mattress. NOTE: Bed and bath linens must be maintained in good condition (Refer to §483.10(i) Safe environment, F584, for further information). The facility must have practices that address the methods for cleaning and disinfecting items that are to be used for another resident after an individual resident’s use. Such practices67 include, but are not limited to, the following: • Mattress covers with tears or holes are replaced; • Moisture resistant mattress covers are cleaned and disinfected between use for different residents with an EPA-approved germicidal detergent to help prevent the spread of infections; • Fabric mattress covers are laundered between use for different residents; • Pillow covers and washable pillows are laundered in a hot water laundry cycle between use for different residents or when they become contaminated with body substances; and • Mattresses are discarded if bodily fluids have penetrated into the mattress fabric. Annual Review of IPCP Under §483.80(f), the facility’s IPCP and its standards, policies and procedures must be reviewed at least annually to ensure effectiveness and that they are in accordance with current standards of practice for preventing and controlling infections; the IPCP must be updated as necessary. In addition, the facility population and characteristics may change over time, and the facility assessment may identify components of the IPCP that must be changed accordingly. INVESTIGATIVE PROCEDURES Use the Infection Prevention, Control & Immunizations Facility Task, along with the above interpretive guidance, when determining if the facility meets the requirements for, or when investigating concerns related to, infection prevention and control. One surveyor should coordinate the review of the facility’s overall IPCP, however, each member of the survey team should assess for compliance throughout the entire survey when observing his/her assigned areas and tasks. The IPCP must be facility-wide and include all departments and contracted services. If potential non-compliance is identified, the surveyor should corroborate those concerns through observations, interviews, and record and/or document review. Observations Specific observations for the provision of infection prevention and control practices such as following standard precautions (e.g., hand hygiene and the appropriate use of PPE) should be made by all team members throughout the survey. Observe care of residents on transmission-based precautions, if any, to determine if implemented appropriately based on precaution type (i.e., contact, droplet, airborne). If concerns are identified, expand the sample to include more residents on transmission-based precautions. Observe laundry services throughout the survey (e.g., resident and laundry rooms) to determine whether staff handle, store, process, and transport linens appropriately. Interviews Surveyors should interview appropriate facility staff regarding the IPCP. In addition, any potential concerns should be followed up with interviews and record reviews as needed. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION • F945: for concerns related to staff training on the standards, policies, and procedures of the infection prevention and control program; • F726: for staff competency concerns related to Nursing Services; • F741: for staff competency concerns related to Behavioral Health staff caring for residents with dementia or a history of trauma and/or post-traumatic stress disorder; • F801: for staff competency concerns related to Food and Nutrition staff; • F839: for staff competency concerns related to Administration for any other staff not referenced above; • F550 and F675: for concerns related to 1) the overuse of transmission-based (“isolation”) precautions, 2) the inappropriate transferring of rooms unnecessarily; or 3) the inappropriate use of PPE such as gloves when used unnecessarily, where residents indicate they are “untouchable,” dirty or unclean; • F603: for concerns related to possible involuntary seclusion; • F755: for concerns related to reconciliation of data from injectable, scheduled drug tracking; • F867: for concerns related to the QAA committee’s responsibility to identify or correct quality deficiencies, which may include systemic infection control concerns; • F841: for concerns related to the medical director’s role in responsibility for care; • F684: for concerns related to the provision of wound care; • F686: for concerns related to the provision of pressure ulcer care; • F690: for concerns related to the provision of urinary catheter care; • F694: for concerns related to the administration of parenteral fluids; and • F695: for concerns related to the provision of respiratory care. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F880, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • Establish and maintain an IPCP designed to provide a safe, sanitary, and comfortable environment and to help prevent development and transmission of disease and infection; or • The IPCP must be reviewed at least annually and updated as necessary; or • Implement a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement, based on the facility assessment [see §483.71] and follows accepted national standards; or • Develop and implement written IPCP standards, policies, and procedures that are current and based on national standards. These must include: o When and to whom possible incidents of communicable diseases should be reported; or o Developing and implementing a system of surveillance to identify infections or communicable diseases; or o How to use standard precautions (to include appropriate hand hygiene) and how and when to use transmission-based precautions (i.e., “isolation precautions”); or o Prohibiting staff with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit disease; or • Assure that staff handle, store, process and transport laundry to prevent the spread of infection; or • Maintain a system for recording identified incidents, and taking appropriate corrective actions. DEFICIENCY CATEGORIZATION Examples of Level 4 immediate jeopardy to resident health and safety include, but are not limited to: • The facility failed to follow standard precautions during the performance of routine testing of blood glucose. The facility reused fingerstick devices for more than one resident. This practice of reusing fingerstick devices for more than one resident created an immediate jeopardy to resident health by potentially exposing residents who required blood glucose testing to the spread of bloodborne infections in the facility. • The facility failed to investigate, document surveillance of, and implement preventative measures to address an outbreak of gastrointestinal illness among residents in one unit of the facility. As a result, several residents in an adjoining unit became seriously ill with diarrheal illnesses resulting in dehydration. • The facility failed to provide a safe and sanitary environment. Staff failed to handle linens so as to prevent the spread of infection. Staff rinsed contaminated linens in the resident’s sink instead of in the facility’s dedicated area. Furthermore, the staff did not clean and disinfect the bathroom sink after rinsing soiled clothing and linens in the shared bathroom sink. A resident was observed to have an acute onset of vomiting and diarrhea resulting in soiled clothing and linens. The nursing staff removed the soiled/contaminated clothing and linens, rinsed them out in the bathroom sink, and placed the wet/soiled linen onto the floor. The bathroom was shared with a roommate who utilized the sink for oral hygiene purposes and stored his/her toothbrush and glass on the sink. The roommate, subsequently developed vomiting and diarrhea, with the development of severe dehydration, resulting in hospitalization. • The facility failed to ensure that its staff demonstrated the proper use of gloves with hand hygiene between residents to prevent the spread of infection. The registered nurse (RN) was observed wearing gloves while providing direct care to a resident who was on contact precautions for an infection with a multidrug- resistant organism. The RN left the room after removing the gloves but did not conduct hand hygiene, went to a second resident and started providing direct care. As a result, the second resident was likely exposed through indirect contact transmission to the MDRO, creating the likelihood of serious injury, serious harm, serious impairment, or death. Examples of Level 3, actual harm that is not immediate jeopardy include, but are not limited to: • The facility failed to identify and prevent the spread of infestation when a case of scabies (i.e., a highly contagious skin condition caused by the itch mite Sarcoptes scabiei) was not diagnosed or adequately treated, and the resident was not placed on transmission-based precautions. Resident A was admitted with an undiagnosed, reddened, itchy pin-point rash which spread, became infected, and disrupted the resident's sleep. A month later, multiple residents developed a red, pin-point rash with severe itching, which was not present prior to resident A being admitted. The facility failed to identify through assessment and therefore, implement control measures to prevent the transmission of scabies among multiple residents in the facility, causing the residents physical harm. In addition to the physical harm, the residents experienced psychosocial harm due to anxiety and loss of sleep from severe itching and lack of timely diagnosis. • The facility failed to ensure that linens were handled and processed in a manner to prevent the spread of pediculosis (i.e., head lice) after a resident (resident A) in a semi private room was diagnosed with pediculosis. Staff were aware of the presence of pediculosis, but did not handle the resident’s linens or clothing appropriately, removing bed linens and placing them on the roommate’s chairs and other furnishings. The resident’s roommate (resident B) became infested with pediculosis. The resident’s roommate was non-verbal and unable to express that he had intense itching and began to scratch himself. Examples of Level 2, no actual harm with potential for more than minimal harm that is not immediate jeopardy include, but are not limited to: • The facility failed to ensure that its staff demonstrates proper use of gloves with hand hygiene between residents to prevent the spread of infections. The nurse administered medications to a resident via a gastric tube and while wearing the same gloves proceeded to administer oral medications to another resident. The nurse did not remove the used gloves nor perform hand hygiene between the two residents. • The facility failed to implement appropriate measures for the transport of contaminated linens. As a result, the potential exists for transmission of organisms from contaminated uniforms to residents during the delivery of care. A nursing assistant was observed removing bed linens contaminated with urine and fecal material without the use of gloves and gown, and carrying the contaminated linens against his/her uniform to the laundry bin. The nursing assistant proceeded to assist the resident’s roommate with transferring to his/her chair, and his/her uniform made contact with the resident’s skin and clothing. • The facility failed to ensure that a staff member implemented appropriate processes related to handling and storing wound care supplies. As a result, the potential existed for transmission of organisms between residents who received dressing changes. A staff member who was providing wound care, was observed to place dressing supplies on one resident’s bedding and after completing the dressing change, placed the supplies, which are used for other residents, in the unit’s dressing cart. An example of Level 1, no actual harm with potential for minimal harm includes, but is not limited to: • The facility failed to ensure that the IPCP program was reviewed annually. The survey was conducted and it was determined that the facility last reviewed the IPCP at 14 months instead of annually (i.e., 12 months). There were no infection control findings outside of annual review and documentation. 1 Siegel, J.D., Rhinehart, E., Jackson, M., Chiarello, L., & the Healthcare Infection Control Practices Advisory Committee. “Guideline for isolation precautions: Preventing transmission of infectious agents in healthcare settings (2007).” Accessed on February 27, 2021 from https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html 2 See endnote 1 3 See endnote 1 4 See endnote 1 5 Centers for Disease Control and Prevention. “Guideline for disinfection and sterilization in healthcare facilities (2008).” Accessed on February 27, 2021 from https://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008 6 See endnote 5 7 Centers for Disease Control and Prevention. (2002, October 25). “Guideline for hand hygiene in health- care settings: Recommendations of The Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force.” MMWR; 51(No.RR-16). Accessed on February 27, 2021 from http://www.cdc.gov/mmwr/PDF/rr/rr5116 8 Centers for Disease Control and Prevention. “Hand Hygiene in Healthcare Settings.” www.cdc.gov. Accessed on February 27, 2021 from https://www.cdc.gov/handhygiene/providers/index.html. (reference was updated from SOM Rev. 173) 9 Association for the Advancement of Medical Instrumentation (AAMI). (2009). ANSI/AAMI ST65:2008/(R)2013. Processing of reusable surgical textiles for use in health care facilities, 2008. Arlington, VA. 10 See endnote 1 11 Healthcare Infection Control Practices Advisory Committee (HICPAC). (2017). “Core infection prevention and control practices for safe healthcare delivery in all settings–recommendations of the https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html https://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008 http://www.cdc.gov/mmwr/PDF/rr/rr5116 http://www.cdc.gov/ https://www.cdc.gov/handhygiene/providers/index.html HICPAC.” www.cdc.gov. Accessed on February 27, 2021 from https://www.cdc.gov/hicpac/recommendations/core-practices.html. 12 See endnote 1 13 See endnote 1 14 Association for Professionals in Infection Control and Epidemiology. “IC risk assessment tool form” and “IC risk assessment analysis.” Accessed on February 27, 2021 from http://community.apic.org/sierra/resources/overview 15 See endnote 1 16 See endnote 11 17 Dubberke, E.R., & Gerding, D.N. “Rationale for hand hygiene recommendations after caring for a patient with Clostridium difficile infection. A compendium of strategies to prevent healthcare-associated infections in acute care hospitals: A fall 2011 update.” https://www.shea-online.org/ Accessed on February 27, 2021 from https://www.shea-online.org/images/patients/CDI-hand-hygiene-Update 18 See endnote 1 19 See endnote 1 20 See endnote 1 21 Bolyard, E.A., Tablan, O.C., Williams, W.W., Pearson, M.L., Shapiro, C.N., Deitchman, S.D., & The Healthcare Infection Control Practices Advisory Committee. “Guideline for infection control in health care personnel, 1998.” www.cdc.gov Accessed on February 27, 2021 from https://www.cdc.gov/hicpac/pdf/InfectControl98 22 Kuhar, D.T., Carrico, R., Cox, K., de Perio, M.A., Irwin, K.L., Lundstrom, T. & the Healthcare Infection Control Practices Advisory Committee. (2019). “Infection Control in Healthcare Personnel: Infrastructure and Routine Practices for Occupational Infection Prevention and Control Services.” www.cdc.gov Accessed on February 27, 2021 from https://www.cdc.gov/infectioncontrol/guidelines/healthcare-personnel/index.html 23 Sosa, L.E., Njie, G.J., Lobato, M.N., Morris, S.B., Buchta, W., & Casey, M.L. “Tuberculosis screening, testing, and treatment of U.S. health care personnel: Recommendations from the National Tuberculosis Controllers Association and CDC, 2019.” MMWR; 68:439–443. Accessed on February 27, 2021 from https://www.cdc.gov/tb/publications/guidelines/infectioncontrol.htm 24 Stone, N.D., Ashraf, M.S., Calder, J., Crnich, C. J., Crossley, K., Drinka, P.J., …Bradley, S.F. (2012). “Surveillance definitions of infections in long-term care facilities: Revisiting the McGeer criteria.” Infect Control Hosp Epidemiology. 33(10), 965-977. 25 See endnote 1 26 Siegel, J.D., Rhinehart, E., Jackson, M., and Chiarello, L. “Management of multidrug-resistant organisms in healthcare settings (2006).” www.cdc.gov. Accessed on February 27, 2021 from https://www.cdc.gov/hicpac/pdf/mdro/mdroguideline2006 27 Smith, P.W., Bennett, G., Bradley, S., Drinka, P., Lautenbach, E., Marx, J.... Stevenson, K. (2008). “SHEA/APIC Guideline: infection prevention and control in the long-term care facility.” Infect Control Hosp Epidemiology. 29(9), 785-814. 28 Guh, A., Carling, P, and Environmental Evaluation Workgroup. (2010). “Options for Evaluating Environmental Cleaning.” www.cdc.gov. Accessed on February 27, 2021 from https://www.cdc.gov/hai/toolkits/evaluating-environmental-cleaning.html 29 See endnote 24 30 See endnote 27 31 Centers for Disease Control and Prevention. “Epidemiology glossary.” www.cdc.gov. Accessed on February 27, 2021 from http://www.cdc.gov/reproductivehealth/data_stats/glossary.html#O 32 Kim, K.H., Fekety, R., Batts, D.H.,Brown, D., Cudmore , M., Silva, J. Jr., & Waters, D. (1981, January 1). “Isolation of Clostridium difficile from the environment and contacts of residents with antibiotic- associated colitis.” Journal of Infectious Disease. 143(1), 42-50. 33 Centers for Disease Control and Prevention. “Hepatitis B questions and answers for health professionals.” www.cdc.gov. Accessed on February 27, 2021 from http://www.cdc.gov/hepatitis/HBV/HBVfaq.htm 34 Centers for Disease Control and Prevention (CDC). “H1N1 Flu: General Info.” www.cdc.gov. Accessed on February 27, 2021 from https://www.cdc.gov/h1n1flu/qa.htm 35 See endnote 1 http://www.cdc.gov/ https://www.cdc.gov/hicpac/recommendations/core-practices.html http://community.apic.org/sierra/resources/overview https://www.shea-online.org/ https://www.shea-online.org/images/patients/CDI-hand-hygiene-Update http://www.cdc.gov/ https://www.cdc.gov/hicpac/pdf/InfectControl98 http://www.cdc.gov/ https://www.cdc.gov/tb/publications/guidelines/infectioncontrol.htm http://www.cdc.gov/ https://www.cdc.gov/hicpac/pdf/mdro/mdroguideline2006 http://www.cdc.gov/ https://www.cdc.gov/hai/toolkits/evaluating-environmental-cleaning.html http://www.cdc.gov/ http://www.cdc.gov/reproductivehealth/data_stats/glossary.html#O http://www.cdc.gov/ http://www.cdc.gov/hepatitis/HBV/HBVfaq.htm http://www.cdc.gov/ https://www.cdc.gov/h1n1flu/qa.htm 36 See endnote 11 37 See endnote 11 38 See endnote 1 39 See endnote 5 40 See endnote 5 41 Sehulster, L.M., Chinn, R.Y., Arduino, M.J., Carpenter, J., Donlan, R., Ashford, D., … Cleveland, J. (2003, Updated July 2019). “Guidelines for environmental infection control in health-care facilities (2003).” www.cdc.gov. Accessed on February 27, 2021 from https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html 42 See endnote 1 43 See endnote 26 44 See endnote 1 45 See endnote 1 46 See endnote 1 47 See endnote 1 48 Hall, C.B., Douglas, Jr., R.G., Schnabal, K.C., and Geiman, J.M. (1981, September). Infectivity of respiratory syncytial virus by various routes of inoculation. Infection and Immunity. 33(3), 779-783. 49 See endnote 1 50 See endnote 1 51 See endnote 1 52 See endnote 1 53 See endnote 1 54 See endnote 1 55 See endnote 1 56 See endnote 1 57 See endnote 1 58 See endnote 1 59 Centers for Disease Control and Prevention. “Frequently asked questions (FAQs) regarding assisted blood glucose monitoring and insulin administration.” www.cdc.gov. Accessed on February 27, 2021 from https://www.cdc.gov/injectionsafety/providers/blood-glucose-monitoring_faqs.html 60 See endnote 41 61 See endnote 41 62 Occupational Safety and Health Administration. “Title 29 Part 1910.1030. Bloodborne pathogens.” Accessed on February 27, 2021 from http://www.ecfr.gov/cgi-bin/text- idx?SID=4e5245f66094d270bc2bd93105f6a92d&mc=true&node=se29.6.1910_11030&rgn=div8 63 See endnote 41 64 See endnote 41 65 See endnote 41 66 See endnote 41 67 See endnote 41 F881 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.80(a) Infection prevention and control program. The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements: §483.80(a)(3) An antibiotic stewardship program that includes antibiotic use protocols and a system to monitor antibiotic use. http://www.cdc.gov/ https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html http://www.cdc.gov/ https://www.cdc.gov/injectionsafety/providers/blood-glucose-monitoring_faqs.html http://www.ecfr.gov/cgi-bin/text-idx?SID=4e5245f66094d270bc2bd93105f6a92d&mc=true&node=se29.6.1910_11030&rgn=div8 http://www.ecfr.gov/cgi-bin/text-idx?SID=4e5245f66094d270bc2bd93105f6a92d&mc=true&node=se29.6.1910_11030&rgn=div8 INTENT The intent of this regulation is to ensure that the facility: • Develops and implements protocols to optimize the treatment of infections by ensuring that residents who require an antibiotic, are prescribed the appropriate antibiotic; • Reduces the risk of adverse events, including the development of antibiotic- resistant organisms, from unnecessary or inappropriate antibiotic use; and • Develops, promotes, and implements a facility-wide system to monitor the use of antibiotics. DEFINITIONS • “Antibiotic” refers to a medication used to treat bacterial infections. They are not effective for infections caused by viruses (e.g., influenza or most cases of bronchitis). • “Antibiotic Stewardship” refers to a set of commitments and actions designed to optimize the treatment of infections while reducing the adverse events associated with antibiotic use.1 This can be accomplished through improving antibiotic prescribing, administration, and management practices thus reducing inappropriate use to ensure that residents receive the right antibiotic for the right indication, dose, and duration.2 • “Methicillin-resistant Staphylococcus aureus (MRSA) (a.k.a. Oxacillin- resistant Staphylococcus aureus)” refers to Staphylococcus aureus bacteria that are resistant to treatment with one of the semi-synthetic penicillins (e.g., Oxacillin/Nafcillin/Methicillin). • “Vancomycin-resistant Enterococcus (VRE)” refers to a species of enterococcus which have developed resistance to the antibiotic, vancomycin. GUIDANCE Antibiotic Stewardship As part of their IPCP programs, facilities must develop an antibiotic stewardship program that promotes the appropriate use of antibiotics and includes a system of monitoring to improve resident outcomes and reduce antibiotic resistance. 3, 4, 5 This means that the antibiotic is prescribed for the correct indication, dose, and duration to appropriately treat the resident while also attempting to reduce the development of antibiotic-resistant organisms. Nursing home residents are at risk for adverse outcomes associated with the inappropriate use of antibiotics that may include but are not limited to the following: • Increased adverse drug events and drug interactions (e.g., allergic rash, anaphylaxis or death); • Serious diarrheal infections from C. difficile; • Disruption of normal flora (e.g., this can result in overgrowth of Candida such as oral thrush); and/or • Colonization and/or infection with antibiotic-resistant organisms such as MRSA, VRE, and multidrug-resistant gram negative bacteria. Resources are available to identify core actions to prevent antibiotic resistance within the control of the nursing home, such as: • The Centers for Disease Control and Prevention’s (CDC) “The Core Elements of Antibiotic Stewardship for Nursing Homes” http://www.cdc.gov/longtermcare/pdfs/core-elements-antibiotic-stewardship- appendix-a ; and • The Agency for Healthcare Research and Quality’s “Nursing Home Antimicrobial Stewardship Guide” http://www.ahrq.gov/nhguide/index.html for examples of antibiotic use protocols, policies and practices. NOTE: References to non-CMS sources are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS or the U. S. Department of Health and Human Services (HHS). CMS is not responsible for the content of pages found at these sites. URL addresses and referenced documents were current as of the date of this publication. Guidelines change, and facilities are responsible for following the most current standards. Antibiotic Stewardship Program (ASP) As summarized by the CDC, the core elements for antibiotic stewardship in nursing homes include: • Facility leadership commitment to safe and appropriate antibiotic use; • Appropriate facility staff accountable for promoting and overseeing antibiotic stewardship; • Accessing pharmacists and others with experience or training in antibiotic stewardship; • Implement policy(ies) or practice to improve antibiotic use; • Track measures of antibiotic use in the facility (i.e., one process and one outcome measure); • Regular reporting on antibiotic use and resistance to relevant staff such as prescribing clinicians and nursing staff; and • Educate staff and residents about antibiotic stewardship.6 The facility must develop an antibiotic stewardship program which includes the development of protocols and a system to monitor antibiotic use. This development should include leadership support and accountability via the participation of the medical director, consulting pharmacist, nursing and administrative leadership, and individual with designated responsibility for the infection control program (i.e., infection preventionist).7 http://www.cdc.gov/longtermcare/pdfs/core-elements-antibiotic-stewardship-appendix-a http://www.cdc.gov/longtermcare/pdfs/core-elements-antibiotic-stewardship-appendix-a http://www.ahrq.gov/nhguide/index.html The antibiotic stewardship program protocols shall describe how the program will be implemented and antibiotic use will be monitored; consequently, protocols should: • Be incorporated in the overall infection prevention and control program; • Be reviewed on an annual basis and as needed; • Contain a system of reports related to monitoring antibiotic usage and resistance data. Examples may include the following: o Summarizing antibiotic use from pharmacy data or electronic health records, such as the rate of new starts, types of antibiotics prescribed, or days of antibiotic treatment per 1,000 resident days; o Summarizing antibiotic resistance (e.g., antibiogram) based on laboratory data from, for example, the last 18 months; and/or o Tracking measures of outcome surveillance related to antibiotic use (e.g., C. difficile, MRSA, and/or CRE).8 • Incorporate monitoring of antibiotic use, including the frequency of monitoring/review. Monitor/review response to antibiotics, and laboratory results when available, to determine if the antibiotic is still indicated or adjustments should be made (e.g., antibiotic time-out); when the resident is new to the facility; when a prior resident returns or is transferred from a hospital or other facility9; during each monthly medication regimen review when the resident has been prescribed or is taking an antibiotic, or any antibiotic regimen review as requested by the QAA committee. Facilities should provide feedback (e.g., verbal, written note in record) to prescribing practitioners regarding antibiotic resistance data, their antibiotic use and their compliance with facility antibiotic use protocols to improve prescribing practices and resident outcomes. 10 Feedback on prescribing practices and compliance with facility antibiotic use protocols may include information from medical record reviews for new antibiotic starts to determine whether the resident had signs or symptoms of an infection; laboratory tests ordered and the results; order documentation including the indication for use (i.e., whether or not an infection or communicable disease has been documented), dosage and duration; and clinical justification for the use of an antibiotic beyond the initial duration ordered such as a review of laboratory reports/cultures in order to determine if the antibiotic remains indicated or if adjustments to therapy should be made (e.g., more narrow spectrum antibiotic); • Assess residents for any infection using standardized tools and criteria 11 (e.g., SBAR tool for urinary tract infection (UTI) assessment12, Loeb minimum criteria for initiation of antibiotics13); • Include the mode (e.g., verbal, written, online) and frequency (as determined by the facility) of education for prescribing practitioners and nursing staff on antibiotic use (stewardship) and the facility’s antibiotic use protocols. NOTE: Prescribing practitioners can include attending physicians and non-physician practitioners (NPP) (i.e., nurse practitioners, clinical nurse specialists, and physician assistants); and • Require antibiotic orders to include the indication, dose, and duration. The Antibiotic Stewardship Program in Relation to Pharmacy Services The assessment, monitoring, and communication of antibiotic use shall occur by a licensed pharmacist in accordance with §483.45(c), F756, Drug Regimen Review. A pharmacist must perform a medication regimen review (MRR) at least monthly, including review of the medical record and identify any irregularities, including unnecessary drugs. INVESTIGATIVE PROCEDURES Use the Infection Prevention, Control & Immunizations Facility Task, along with the above interpretive guidance, when determining if the facility meets the requirements for, or when investigating concerns related to, the antibiotic stewardship program. Determine whether the facility’s antibiotic stewardship program includes antibiotic use protocol(s) addressing antibiotic prescribing practices (i.e., documentation of the indication, dose, and duration of the antibiotic; review of laboratory reports to determine if the antibiotic is indicated or needs to be adjusted; an infection assessment tool or management algorithm is used when prescribing) and a system to monitor antibiotic use (i.e., antibiotic use reports, antibiotic resistance reports). If there are concerns with the ASP, surveyors must include at least one resident on an antibiotic in the resident sample to assess whether the resident(s) is being prescribed an antibiotic(s) unnecessarily and whether there were any negative outcomes such as an adverse drug event. Instances of prescribing antibiotics unnecessarily should be cited at §483.45(d), F757. These findings may support citing §483.80(a)(3), F881, as well, in which case the surveyor must also show that the facility does not have or is not implementing an ASP. It may also be necessary to interview the appropriate person, (e.g., director of nursing, medical director, consulting pharmacist, administrator, or infection preventionist) to verify how antibiotic use is monitored in the facility and confirm with findings from review of the antibiotic stewardship program or resident records. Furthermore, review records including evidence of actions taken by the QAA committee related to antibiotic use and stewardship. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION • F756: for concerns related to the failure of the pharmacist to review and report any unnecessary antibiotic irregularity; • F757: for concerns related to unnecessary antibiotic use; and • F552: for concerns related to the right to be fully informed in advance about care and treatment. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F881, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • Develop and implement antibiotic use protocols to address the treatment of infections by ensuring that residents who require antibiotics are prescribed the appropriate antibiotics; or • Develop and implement antibiotic use protocols that address unnecessary or inappropriate antibiotic use thereby reducing the risk of adverse events, including the development of antibiotic-resistant organisms; or • Develop, promote and implement a facility-wide system to monitor the use of antibiotics. DEFICIENCY CATEGORIZATION An example of Level 4, immediate jeopardy to resident health and safety includes, but is not limited to: • The facility failed to develop and implement an antibiotic use protocol which included reporting results of laboratory data to the ordering practitioner. Medical record review indicated the prescribing practitioner had ordered a culture and sensitivity for a resident and prescribed an antibiotic for treatment of pneumonia prior to receipt of the results of the lab test. The facility received the results of the lab test which indicated that the bacteria was resistant to the antibiotic prescribed, however, they did not provide this information to the practitioner. As a result, the antibiotic was not adjusted accordingly and the resident was hospitalized for complications related to the pneumonia. An example of Level 3, actual harm that is not immediate jeopardy includes, but is not limited to: • The facility did not develop a program for antibiotic stewardship, and did not develop or implement a system to monitor antibiotic use. Based on record review, one resident was currently being treated with antibiotics without an appropriate indication for use. The resident had an indwelling urinary catheter and was asymptomatic for an UTI. There was no established criteria for use in the facility for when to treat a catheter-associated urinary tract infection. As a result of the antibiotic therapy, the resident developed nausea and diarrhea that caused avoidable dehydration and prevented the resident from participating in activities and appropriate sleep. The medical record revealed that the antibiotic was stopped and the resident did not have any further adverse effects. The resident was treated via oral rehydration but did not require hospitalization and fully recovered. An example of Level 2, no actual harm with potential for more than minimal harm that is not immediate jeopardy includes, but is not limited to: • The facility failed to implement its protocol for antibiotic use and failed to monitor actual antibiotic use. Record review indicated that the facility developed a protocol which indicated “residents with MDROs are not to be treated with antibiotics for colonization”. However, record review revealed one resident colonized with an MDRO receiving an antibiotic to eliminate colonization. As a result, the potential exists for the resident to develop an adverse drug event, antibiotic resistance, and/ or CDI. An example of Level 1, no actual harm with potential for minimal harm includes, but is not limited to: • The facility failed to implement their protocol to monitor the rate of antibiotic uses. On review, the monitoring was not completed for 6 weeks. There were no findings of increased MDROs or CDI in the facility. 1 Centers for Disease Control and Prevention. “Core elements of hospital antibiotic stewardship programs.” www.cdc.gov. Accessed on February 27, 2021 from https://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html 2 Centers for Disease Control and Prevention. “The core elements of antibiotic stewardship for nursing homes.” www.cdc.gov. Accessed on February 27, 2021 from https://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html 3 Centers for Disease Control and Prevention. “Antibiotic resistance threats in the United States, 2013.” www.cdc.gov. Accessed on February 27, 2021 from http://www.cdc.gov/drugresistance/threat-report- 2013/pdf/ar-threats-2013-508 4 Spellberg, B., Bartlett, J.G., & Gilbert, D. N. (January 24, 2013). “The future of antibiotics and resistance.” The New England Journal of Medicine, 368, 299-302. 5 The White House. (2014). “National Strategy for Combating Antibiotic Resistant Bacteria.” Accessed on February 27, 2021 from https://obamawhitehouse.archives.gov/sites/default/files/docs/carb_national_strategy 6 See endnote 2 7 See endnote 2 8 See endnote 2 9 See endnote 2 10 See endnote 2 11 See endnote 2 12 Agency for Healthcare Research and Quality. “Toolkit 3. Minimum criteria for common infections.” Accessed on February 27, 2021 from http://www.ahrq.gov/nhguide/toolkits/determine-whether-to- treat/toolkit3-minimum-criteria.html 13 Loeb, M., Brazil, K., Lohfeld, L., McGeer, A., Simor, A., Stevenson, K., Zoutman, D…..Walter, S.D. (2005). “Effect of a multifaceted intervention on number of antimicrobial prescriptions for suspected urinary tract infections in residents of nursing homes: Cluster randomised controlled trial.” BMJ, 331, 669. Accessed on February 27, 2021, from http://www.bmj.com/content/bmj/early/2004/12/31/bmj.38602.586343.55.full http://www.cdc.gov/ https://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html http://www.cdc.gov/ https://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html http://www.cdc.gov/ http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508 http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508 https://obamawhitehouse.archives.gov/sites/default/files/docs/carb_national_strategy http://www.ahrq.gov/nhguide/toolkits/determine-whether-to-treat/toolkit3-minimum-criteria.html http://www.ahrq.gov/nhguide/toolkits/determine-whether-to-treat/toolkit3-minimum-criteria.html http://www.bmj.com/content/bmj/early/2004/12/31/bmj.38602.586343.55.full F882 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.80(b) Infection preventionist The facility must designate one or more individual(s) as the infection preventionist(s) (IP)(s) who are responsible for the facility’s IPCP. The IP must: §483.80(b)(1) Have primary professional training in nursing, medical technology, microbiology, epidemiology, or other related field; §483.80(b)(2) Be qualified by education, training, experience or certification; §483.80(b)(3) Work at least part-time at the facility; and §483.80(b)(4) Have completed specialized training in infection prevention and control. INTENT §483.80(b) The intent of this regulation is to ensure that the facility designates a qualified individual(s) onsite, who is responsible for implementing programs and activities to prevent and control infections. GUIDANCE Responsibility for the Infection Prevention and Control Program (including the Antibiotic Stewardship Program) The facility must designate one or more individuals as the infection preventionist (IP) who is responsible for assessing, developing, implementing, monitoring, and managing the IPCP. The IPCP includes content required in §§483.80(a)(1)-(4), (F880, Infection Prevention and Control and at F881, Antibiotic Stewardship Program (ASP)). While the IP is responsible for the IPCP, other staff play important roles in infection prevention and control as well as antibiotic stewardship. For example, staff must appropriately implement standard precautions such as hand hygiene and transmission-based precautions. Furthermore, ASP development should include leadership support and accountability via the participation of the medical director, consulting pharmacist, nursing and administrative leadership and therefore, the IP should utilize and work collaboratively with these team members to also implement the ASP. While an ASP is a team effort, the IP is responsible for ensuring the program meets the requirements for ASPs (at §483.80(a)(3), F881). The IP should review and approve infection prevention and control training topics and content, as well as ensure facility staff are trained on the IPCP (for further information, see §483.95(e), F945, Infection Control Training). However, the IP is not required to perform the IPCP training, since some facilities may have designated staff development personnel. Primary Professional Training The IP must be professionally-trained in nursing, medical technology, microbiology, epidemiology, or other related field. A professionally-trained nurse must have earned a certificate/diploma or degree in nursing. A professionally-trained medical technologist (also known as clinical laboratory scientist) must have earned at least an associate's degree in medical technology or clinical laboratory science. A professionally-trained microbiologist must have earned at least a bachelor's degree in microbiology. A professionally-trained epidemiologist must have earned at least a bachelor's degree in epidemiology. Examples of other related fields of training that are appropriate for the role of an IP include physicians, pharmacists, and physician's assistants. Qualifications The IP must be qualified by education, training, experience or certification. The IP must have the knowledge to perform the role. The IP should remain current with infection prevention and control issues and be aware of national organizations' guidelines as well as those from national/state/local public health authorities (e.g., emerging pathogens). The facility should ensure the individual selected as the IP has the background and ability to fully carry out the requirements of the IP based on the needs of the resident population, such as interpreting clinical and laboratory data. Examples of experience in infection prevention and control may include, but are not limited to, identification of infectious disease processes, surveillance and epidemiologic investigation, and preventing and controlling the transmission of infectious agents. An example of certification is the Certification in Infection Prevention and Control (CIC®) which is conducted by the Certification Board of Infection Control and Epidemiology, Inc. (CBIC®) and accredited by the National Commission for Certifying Agencies (NCCA). IP Hours of Work Designated IP hours per week can vary based on the facility and its resident population. Therefore, the amount of time required to fulfill the role must be at least part-time and should be determined by the facility assessment, conducted according to §483.71, to determine the resources it needs for its IPCP, and ensure that those resources are provided for the IPCP to be effective. Based upon the assessment, facilities should determine if the individual functioning as the IP should be dedicated solely to the IPCP. A facility should consider resident census as well as resident characteristics, types of units such as respiratory care units, memory care, skilled nursing and the complexity of the healthcare services it offers as well as outbreaks and seasonality of infections such as influenza in determining the amount of IP hours needed. The IP must have the time necessary to properly assess, develop, implement, monitor, and manage the IPCP for the facility, address training requirements, and participate in required committees such as QAA. The IP must physically work onsite in the facility. He/she cannot be an off-site consultant or perform the IP work at a separate location such as a corporate office or affiliated short term acute care facility. Specialized Training in Infection Prevention and Control Infection prevention and control (IPC) training must be sufficient to perform the role of the IP. Specialized training in IPC may include care for residents with invasive medical devices, resident care equipment (e.g., ventilators), and treatment such as dialysis as well as high- acuity conditions. If a facility's resident population changes, the IP should re-evaluate his/her knowledge and skills, and may need to obtain additional training for the change in the facility’s scope of care. An IP must have obtained specialized IPC training beyond initial professional training or education prior to assuming the role. Training can occur through more than one course, but the IP must provide evidence of training through a certificate(s) of completion or equivalent documentation. CMS recommends specialized training include the following topics: • Infection prevention and control program overview, • The infection preventionist’s role, • Infection surveillance, • Outbreaks, • Principles of standard precautions (e.g., content on hand hygiene, personal protective equipment, injection safety, respiratory hygiene and cough etiquette, environmental cleaning and disinfection, and reprocessing reusable resident care equipment), • Principles of transmission-based precautions, • Resident care activities (e.g., use and care of indwelling urinary and central venous catheters, wound management, and point-of-care blood testing), • Water management, • Linen management, • Preventing respiratory infections (e.g., influenza, pneumonia), • Tuberculosis prevention, • Occupational health considerations (e.g., employee vaccinations, exposure control plan, and work exclusions), • Quality assurance and performance improvement, • Antibiotic stewardship, and • Care transitions. A free online training is available and was developed by a collaboration between CMS and the Centers for Disease Control and Prevention (CDC). The "Nursing Home Infection Preventionist Training Course" is located on CDC's TRAIN website (https://www.train.org/cdctrain/training_plan/3814). Other trainings may be available from entities such as associations, state public health, and universities. https://www.cdc.gov/infectioncontrol/guidelines/mdro/index.html INVESTIGATIVE PROCEDURES Use the Infection Prevention, Control & Immunizations Facility Task, along with the above interpretive guidance, when determining if the facility meets the requirements for, or when investigating concerns related to, compliance with the infection preventionist requirement at §§483.80(b)(1)-(4) (i.e., role, qualifications, training, and allowed time for the position). Instances of the facility not implementing transmission-based precautions when indicated should be cited at F880. These findings may support citing F882 as well, in which case the surveyor must also show that the facility did not ensure requirements at §483.80(b) were met. For example, F882 should be cited if the IP was not available to assist staff on multiple occasions with their questions on when transmission-based precautions should be initiated for a resident due to lack of sufficient time to perform the IP role, and this led to noncompliance with F880. The facility may be cited at an infection control tag such as F880, but not at F882. For example, F882 should not be cited if all requirements at §483.80(b) are met, but a staff member did not clean and disinfect reusable resident care equipment (e.g., blood pressure cuff, thermometer) after use on a resident on transmission-based precautions and it was then used on the next resident, despite proper policies and procedures, staff training, and process surveillance of staff practices addressing this concern. Conversely, the facility can be cited at F882 although not at F880, F881, or F945 in cases where a surveyor's investigation began with an infection control concern leading to a review of the IP, but in the end did not result in evidence of noncompliance at another infection control tag (e.g., F880, F881) or F945. For example, during the investigation, the surveyor found through record review that the IP did not have specialized training. Surveyors should utilize the Quality Assessment and Assurance (QAA) and Quality Assurance and Performance Improvement (QAPI) Plan Review Facility Task to determine compliance with §483.80(c), IP participation on QAA committee. KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F882, the surveyor’s investigation will generally show that the facility failed to ensure that the IPCP was overseen by a qualified individual, who: • Meets the requirement for professional training; or • Adequately assesses, develops, implements, monitors, and manages the IPCP; or • Has the appropriate knowledge and skills to care for the IPC needs of the facility's resident population and to be responsible for the IPCP; or • Has time to perform IP responsibilities; or • Performs IP duties in the facility; or • Completed specialized training in IPC. DEFICIENCY CATEGORIZATION An example of Level 4, immediate jeopardy to resident health and safety includes, but is not limited to: • The facility failed to ensure the IP was qualified by education, training, experience or certification to identify a gastrointestinal outbreak in the facility and implement appropriate control measures. Surveyors identified that the IP did not ensure that appropriate control measures (e.g., transmission-based precautions, environmental cleaning and disinfection) and reporting to public health occurred. As a result, several residents became seriously ill with diarrheal illnesses resulting in dehydration. An example of Level 3, actual harm that is not immediate jeopardy includes, but is not limited to: • The facility failed to ensure the IP implemented the IPCP appropriately for a case of pediculosis (i.e., head lice) and the resident's roommate also became infested. Per the IPCP and CDC recommendations, the resident should have been placed on contact precautions until 24 hours after the application of an effective treatment. The IP participated in an interview and confirmed that she was aware of the diagnosis but did not ensure contact precautions were initiated. An example of Level 2, no actual harm with potential for more than minimal harm, that is not immediate jeopardy includes, but is not limited to: • The facility failed to ensure the IP was performing the duties of the position and was qualified to perform the role. The IP did not ensure the facility had an antibiotic stewardship program. Based on record review, the facility could not provide documentation for an antibiotic stewardship program. During the interview, the IP demonstrated a lack of understanding of an effective program and how to implement an antibiotic stewardship program. Additionally, during the interview, the IP confirmed that she did not have training in antibiotic stewardship. An example of Level 1, no actual harm with potential for minimal harm includes, but is not limited to: • The facility failed to ensure the IP had appropriate time to perform IP responsibilities. Record review and interview(s) revealed that the IP failed to ensure that the IPCP was reviewed annually. The IP verified that she did not have enough time onsite to update the IPCP by its annual deadline and two months had passed since an update was required. There were no infection control findings outside of annual review and documentation. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION • F838: for concerns related to the facility assessment; • F867: for concerns related to the QAA committee’s responsibility to identify or correct quality deficiencies, which may include systemic infection control concerns; • F868: for concerns related to the QAA committee to include the IP's participation; • F880: for concerns related to infection prevention and control; • F881: for concerns related to the antibiotic stewardship program; and • F945: for concerns related to staff training on the standards, policies, and procedures of the infection prevention and control program. F883 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.80(d) Influenza and pneumococcal immunizations §483.80(d)(1) Influenza. The facility must develop policies and procedures to ensure that- (i) Before offering the influenza immunization, each resident or the resident’s representative receives education regarding the benefits and potential side effects of the immunization; (ii) Each resident is offered an influenza immunization October 1 through March 31 annually, unless the immunization is medically contraindicated or the resident has already been immunized during this time period; (iii) The resident or the resident’s representative has the opportunity to refuse immunization; and (iv) The resident’s medical record includes documentation that indicates, at a minimum, the following: (A) That the resident or resident’s representative was provided education regarding the benefits and potential side effects of influenza immunization; and (B) That the resident either received the influenza immunization or did not receive the influenza immunization due to medical contraindications or refusal. §483.80(d)(2) Pneumococcal disease. The facility must develop policies and procedures to ensure that- (i) Before offering the pneumococcal immunization, each resident or the resident’s representative receives education regarding the benefits and potential side effects of the immunization; (ii) Each resident is offered a pneumococcal immunization, unless the immunization is medically contraindicated or the resident has already been immunized; (iii) The resident or the resident’s representative has the opportunity to refuse immunization; and (iv) The resident’s medical record includes documentation that indicates, at a minimum, the following: (A) That the resident or resident’s representative was provided education regarding the benefits and potential side effects of pneumococcal immunization; and (B) That the resident either received the pneumococcal immunization or did not receive the pneumococcal immunization due to medical contraindication or refusal. INTENT The intent of this regulation is to: • Minimize the risk of residents acquiring, transmitting, or experiencing complications from influenza and pneumococcal disease by ensuring that each resident: o Is informed about the benefits and risks of immunizations; and o Has the opportunity to receive the influenza and pneumococcal vaccine(s), unless medically contraindicated, refused or was already immunized. • Ensure documentation in the resident’s medical record of the information/education provided regarding the benefits and risks of immunization and the administration or the refusal of or medical contraindications to the vaccine(s). DEFINITIONS • “The Advisory Committee on Immunization Practices (ACIP)” refers to a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States. ACIP’s recommendations stand as public health advice that will lead to a reduction in the incidence of vaccine preventable diseases and an increase in the safe use of vaccines and related biological products. See http://www.cdc.gov/vaccines/acip/index.html for further information. • “Medical contraindication” refers to a condition or risk that precludes the administration of a treatment or intervention because of the substantial probability that harm to the individual may occur. • “Precaution” refers to a condition in a potential recipient that might increase the risk for a serious adverse reaction or that might compromise the vaccine’s induction of immunity. For example, as a result of the resident’s condition, complications could result, or a person might experience a more severe reaction to the vaccine than would have otherwise been expected. However, the risk for this happening is less than expected with medical contraindications. GUIDANCE Overview Receipt of vaccinations is essential to the health and well-being of long-term care residents. Establishing an immunization program against influenza and pneumococcal disease facilitates achievement of this objective. Influenza outbreaks place both the residents and staff at risk of infection. In addition, pneumococcal disease carries serious http://www.cdc.gov/vaccines/acip/index.html morbidity and mortality due to its major clinical syndromes of pneumonia, bacteremia, and meningitis. People 65 years or older are two to three times more likely than the younger population to get pneumococcal infections. An effective immunization program involves collaborating with the medical director to develop resident care policies for immunization(s) that reflect current standards of practice and that include: • Physician approved policies for orders of influenza and pneumococcal vaccines (administration must be based on an assessment of each resident for possible medical contraindications – see 483.30(b)(3), F711, for physician orders for vaccinations); • Review of the resident’s record of vaccination and immunization status, including assessment for potential medical contraindications; • How pertinent information and education will be provided to residents or their representatives. The facility may wish to use educational resources such as those provided by the U. S. Centers for Disease Control and Prevention (CDC)1; and • The vaccination schedule including mechanisms for recording and monitoring for administration of both influenza and pneumococcal vaccines in accordance with national recommendations. 2 NOTE: Review facility policies regarding the provision of vaccines in order to determine if the policies reflect current standards of practice. Refer to §483.21(b)(3)(i)- the services provided or arranged by the facility must meet professional standards of quality (F658). Also, refer to F880 for concerns with infection prevention and control. Provision of Immunizations In order for a resident to exercise his or her right to make informed choices, it is important for the facility to provide the resident or resident representative with education regarding the benefits and potential side effects of immunizations. Facilities are required to document the provision of this education and the administration, refusal of the immunization or the medical contraindication of the immunization. There may be clinical indications or other reasons that a resident may not have received immunizations. The resident’s record should show vaccination administration unless it contains documentation as to why the vaccine was not administered, including but not limited to the following: • A decision may have been made to delay vaccination for a resident because a precaution is present. According to the CDC, “in general, vaccinations should be deferred when a precaution is present. However, a vaccination might be indicated in the presence of a precaution because the benefit of protection from the vaccine outweighs the risk for an adverse reaction…The presence of a moderate or severe acute illness with or without a fever is a precaution to administration of all vaccines”.3 The benefits and risks of receiving the vaccine should be discussed with the resident or resident representative if a resident has a precaution to a vaccine. The vaccine can be administered if the benefit of the vaccine outweighs the risk, the resident or resident representative provides consent, and the resident’s physician approves (refer to §483.30 Physician Services for further information on physician supervision); • A resident may be in the end stages of a terminal illness and receiving care that is limited to comfort or palliative measures only and although eligible, the resident or representative has refused the vaccination(s); • A resident may have a medical contraindication to receiving an influenza or pneumococcal vaccine such as severe allergic reaction to a vaccine component or following prior dose of vaccine; • The resident or representative refused the vaccine; or • The resident has already been immunized. NOTE: Additional information related to current vaccine recommendations including scheduling and contraindications may be found in CDC’s “Epidemiology and Prevention of Vaccine-Preventable Diseases” otherwise known as “The Pink Book” at http://www.cdc.gov/vaccines/acip/index.html or https://www.cdc.gov/vaccines/pubs/pinkbook/chapters.html. NOTE: References to non-CMS sources are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services (HHS). CMS is not responsible for the content of pages found at these sites. URL addresses and referenced documents were current as of the date of this publication. Guidelines change, and facilities are responsible for following the most current standards. NOTE: A nursing home may encounter residents who do not have adequate documentation of vaccinations. With the exception of influenza vaccine and pneumococcal polysaccharide vaccine (PPSV), providers should only accept written, dated records as evidence of vaccination. Self-reported doses of influenza vaccine and PPSV are acceptable. A resident representative can report on behalf of the resident if he/she is unable to self-report and the representative has knowledge of the resident’s medical care. State laws may have more stringent requirements related to documentation. Influenza Immunization The influenza vaccine is given seasonally. The CDC indicates that administering the vaccine when it becomes available each season, rather than date specific, (i.e., “October 1”) is most effective. Facilities should administer the influenza vaccine when it becomes available to the facility. Residents admitted late in the influenza season (typically February or March) should be offered the influenza vaccine as late season outbreaks do occur. If a resident was admitted outside the influenza season, the facility is not expected to offer the influenza vaccine to the resident, but it may, at its discretion. http://www.cdc.gov/vaccines/acip/index.html https://www.cdc.gov/vaccines/pubs/pinkbook/chapters.html NOTE: Flu seasons are unpredictable in a number of ways. They can vary in different parts of the country and from season to season. While flu spreads every year, the timing, severity, and length of the season varies from one year to another. If there is a national shortage of influenza vaccine or other issue with availability leading to an inability to implement the influenza vaccine program, ask the facility to demonstrate that: • The vaccine has been ordered and the facility received either the vaccine or a confirmation of the order indicating that the vaccine has been shipped or that the product is not available but will be shipped when the supply is available; • Plans are developed on how and when the vaccines are to be administered; • Residents have been screened to determine how many and which residents are eligible and wish to receive the vaccine; and • Education regarding immunizations has been implemented. Pneumococcal Immunizations The regulation requires that each resident is offered pneumococcal immunization, unless the immunization is medically contraindicated or the resident has already been immunized. There should be documentation in the medical record if there is reason to believe that pneumococcal vaccine(s) was given previously, but the date cannot be verified, and this had an impact upon the decision regarding administration of the vaccine(s). Facilities should follow the CDC and ACIP recommendations for vaccines. For up-to-date information on indications and timing of pneumococcal vaccines, please refer to CDC’s ACIP Vaccine Recommendations and Guidelines website located at http://www.cdc.gov/vaccines/hcp/acip-recs/index.html, https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing and https://www.cdc.gov/vaccines/schedules/hcp/index.html. INVESTIGATIVE PROCEDURES Use the Infection Prevention, Control & Immunizations Facility Task, along with the above interpretive guidance, when determining if the facility meets requirements for, or when investigating concerns related to, influenza and pneumococcal immunizations. Sampling Procedure Select five residents in the sample to review for the provision of influenza and pneumococcal immunizations. Record Review Review sampled residents’ records for education on and provision, refusal, or documentation of medical contraindications for influenza and pneumococcal immunizations. As necessary, determine if the facility developed influenza and pneumococcal vaccine policies and procedures. KEY ELEMENTS OF NONCOMPLIANCE http://www.cdc.gov/vaccines/hcp/acip-recs/index.html https://www.cdc.gov/vaccines/schedules/hcp/index.html To cite deficient practice at F883, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • Develop, maintain, or follow policies and procedures for immunization of residents against influenza and pneumococcal disease in accordance with national standards of practice; or • Vaccinate an eligible resident with the influenza and/or the pneumococcal vaccine(s), unless the resident had previously received the vaccine, refused, or had a medical contraindication present; or • Allow a resident or a resident’s representative to refuse either the influenza and/or the pneumococcal vaccine(s); or • Provide and/or document the provision of pertinent information regarding the immunizations to the resident or the resident’s representative such as the benefits and potential side effects of the influenza and, as applicable, the pneumococcal immunization(s); or • Document that the resident either received the pneumococcal and influenza vaccine(s) or did not receive the vaccine(s) due to medical contraindications, previous vaccination, or refusal. DEFICIENCY CATEGORIZATION Examples of Level 4, immediate jeopardy to resident health and safety include, but are not limited to: • The facility failed to ensure that medical contraindications were identified for the influenza or pneumococcal vaccine, and administered the vaccine to a resident with identified allergies/contraindications. As a result, the resident experienced a life- threatening reaction of anaphylactic shock requiring immediate treatment and admission to the hospital. • The facility failed to ensure that eligible residents received the influenza vaccine, because it did not have a program for vaccinating residents. As a result, several unvaccinated residents in one unit developed influenza, with elevated temperatures, coughing, labored breathing, and required hospitalization for respiratory compromise and dehydration. Examples of Level 3, actual harm that is not immediate jeopardy includes, but are not limited to: • A resident who was not eligible to receive the influenza vaccine due to medical contraindications received the vaccine and experienced a reaction that was not serious or life-threatening (i.e., hives and dizziness). The reaction resulted in fear and anxiety that was not to the level of panic and immobilization, but required treatment. • The facility failed to administer the influenza vaccine for several weeks, despite its availability. The facility failed to offer influenza immunization to three residents who were eligible to receive the vaccine. Record review and staff interview revealed that the three residents had been admitted in the past two months, but their names were not included in the facility’s monitoring log for residents who had not received the vaccine and when they had last received one. During interviews, two of the three residents stated that they had not taken “a flu shot in over a year”, and one stated that he had never taken a flu shot, but all three stated they would have taken one if offered. Based on record review, two of the three residents were diagnosed with influenza with symptoms of fever, chills, body aches, and had received treatment with an antiviral in the facility. The two residents were unable to participate in activities or leave their rooms due to the acute illness. Record review corroborated the interview information and when interviewed, staff stated they had overlooked the three residents. Examples of Level 2, no actual harm, with potential for more than minimal harm, that is not immediate jeopardy include, but are not limited to: • An eligible resident did not receive the vaccine, but did not develop symptoms of influenza. • An eligible resident received two doses of the same pneumococcal vaccine. The facility could have determined the resident already received the vaccine had it documented in the medical record when it was previously given by the facility. The resident did not experience any untoward reactions from the second immunization. • The staff did not assess a resident for medical contraindications prior to providing the vaccines, but there were no reactions to the vaccines. An Example of Level 1, no actual harm with potential for minimal harm includes, but is not limited to: The facility failed to document that the resident was provided education on the influenza vaccine prior to administration. When interviewed, the resident stated he had received a copy of the information on influenza risks and benefits and provided the copy to the surveyor. However, the medical record did not reflect receipt of the information. 1 Centers for Disease Control and Prevention. “Vaccine information statements.” www.cdc.gov. Accessed on February 27, 2021 from https://www.cdc.gov/vaccines/hcp/vis/index.html 2 Kroger AT, Duchin J, Vázquez M. “General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP).” www.cdc.gov. Accessed on February 27, 2021 from https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html 3 See endnote 2 http://www.cdc.gov/ https://www.cdc.gov/vaccines/hcp/vis/index.html http://www.cdc.gov/ https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html F895 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) 483.85 Compliance and ethics program. §483.85(a) Definitions. For purposes of this section, the following definitions apply: Compliance and ethics program means, with respect to a facility, a program of the operating organization that— §483.85(a)(1) Has been reasonably designed, implemented, and enforced so that it is likely to be effective in preventing and detecting criminal, civil, and administrative violations under the Act and in promoting quality of care; and §483.85(a)(2) Includes, at a minimum, the required components specified in paragraph (c) of this section. High-level personnel means individual(s) who have substantial control over the operating organization or who have a substantial role in the making of policy within the operating organization. Operating organization means the individual(s) or entity that operates a facility. §483.85(b) General rule. Beginning November 28, 2019, the operating organization for each facility must have in operation a compliance and ethics program (as defined in paragraph (a) of this section) that meets the requirements of this section. §483.85(c) Required components for all facilities. The operating organization for each facility must develop, implement, and maintain an effective compliance and ethics program that contains, at a minimum, the following components: §483.85(c)(1) Established written compliance and ethics standards, policies, and procedures to follow that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations under the Act. and promote quality of care, which include, but are not limited to, the designation of an appropriate compliance and ethics program contact to which individuals may report suspected violations, as well as an alternate method of reporting suspected violations anonymously without fear of retribution; and disciplinary standards that set out the consequences for committing violations for the operating organization's entire staff; individuals providing services under a contractual arrangement; and volunteers, consistent with the volunteers' expected roles. §483.85(c)(2) Assignment of specific individuals within the high-level personnel of the operating organization with the overall responsibility to oversee compliance with the operating organization's compliance and ethics program's standards, policies, and procedures, such as, but not limited to, the chief executive officer (CEO), members of the board of directors, or directors of major divisions in the operating organization. §483.85(c)(3) Sufficient resources and authority to the specific individuals designated in paragraph (c)(2) of this section to reasonably assure compliance with such standards, policies, and procedures. §483.85(c)(4) Due care not to delegate substantial discretionary authority to individuals who the operating organization knew, or should have known through the exercise of due diligence, had a propensity to engage in criminal, civil, and administrative violations under the Social Security Act. §483.85(c)(5) The facility takes steps to effectively communicate the standards, policies, and procedures in the operating organization's compliance and ethics program to the operating organization's entire staff; individuals providing services under a contractual arrangement; and volunteers, consistent with the volunteers' expected roles. Requirements include, but are not limited to, mandatory participation in training as set forth at §483.95(f) or orientation programs, or disseminating information that explains in a practical manner what is required under the program. §483.85(c)(6) The facility takes reasonable steps to achieve compliance with the program's standards, policies, and procedures. Such steps include, but are not limited to, utilizing monitoring and auditing systems reasonably designed to detect criminal, civil, and administrative violations under the Act by any of the operating organization's staff, individuals providing services under a contractual arrangement, or volunteers, having in place and publicizing a reporting system whereby any of these individuals could report violations by others anonymously within the operating organization without fear of retribution, and having a process for ensuring the integrity of any reported data. §483.85(c)(7) Consistent enforcement of the operating organization's standards, policies, and procedures through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect and report a violation to the compliance and ethics program contact identified in the operating organization's compliance and ethics program. §483.85(c)(8) After a violation is detected, the operating organization must ensure that all reasonable steps identified in its program are taken to respond appropriately to the violation and to prevent further similar violations, including any necessary modification to the operating organization's program to prevent and detect criminal, civil, and administrative violations under the Act. §483.85(d) Additional required components for operating organizations with five or more facilities. In addition to all of the other requirements in paragraphs (a), (b), (c), and (e) of this section, operating organizations that operate five or more facilities must also include, at a minimum, the following components in their compliance and ethics program: §483.85(d)(1) A mandatory annual training program on the operating organization's compliance and ethics program that meets the requirements set forth in §483.95(f). §483.85(d)(2) A designated compliance officer for whom the operating organization's compliance and ethics program is a major responsibility. This individual must report directly to the operating organization's governing body and not be subordinate to the general counsel, chief financial officer or chief operating officer. §483.85(d)(3) Designated compliance liaisons located at each of the operating organization's facilities. §483.85(e) Annual review. The operating organization for each facility must review its compliance and ethics program annually and revise its program as needed to reflect changes in all applicable laws or regulations and within the operating organization and its facilities to improve its performance in deterring, reducing, and detecting violations under the Act and in promoting quality of care. INTENT To ensure that facilities have in operation an effective compliance and ethics program that uses internal controls to more efficiently monitor adherence to applicable statutes, regulations and program requirements to deter criminal, civil and administrative violations under the Act and promote quality of care for nursing home residents. DEFINITIONS “Due care” generally means the care that a reasonable person would use under the same or similar circumstances.1 "Entire staff" includes all staff employed by the facility or operating organization, individuals providing services under a contractual arrangement, and volunteers, consistent with the volunteers’ expected roles.2 GUIDANCE Background On March 16, 2000, the Department of Health and Human Services Office of the Inspector General (OIG) issued their Compliance Program Guidance for Nursing Facilities to promote “a higher level of ethical and lawful conduct throughout the entire health care industry” (65 FR 14289). The OIG previously issued guidance for other segments of the health care industry based on the belief that “a health care provider can use internal controls to more efficiently monitor adherence to applicable statutes, regulations, and program requirements.” This guidance also provided the basis for Section 6102(b)(1) of the Patient Protection and Affordable Care Act of 2010 which amended the Act to add section 1128I(b) of the Social Security Act (the Act) requiring Medicare skilled nursing facilities and Medicaid nursing facilities to have a compliance and ethics program. The OIG guidance from 2000 recommended seven elements which should be included in an effective, comprehensive compliance and ethics program that are: 1. Implementing written policies, procedures and standards of conduct 2. Designation of a compliance officer and compliance committee 3. Conducting effective training and education 4. Developing effective lines of communication 5. Enforcing standards through well-publicized disciplinary guidelines 6. Conducting internal monitoring and auditing 7. Responding promptly to detected violations and corrective action For further information, see the OIG publications regarding compliance and ethics programs in nursing facilities: • Publication of the OIG Compliance and Ethics Program Guidance for Nursing Facilities (2000): https://oig.hhs.gov/compliance/compliance-guidance/index.asp. • OIG Supplemental Compliance Program Guidance for Nursing Facilities (2008): https://oig.hhs.gov/compliance/compliance-guidance/index.asp Common risk areas are mostly associated with the delivery of health care to nursing facility residents, including sufficient staffing, comprehensive care plans, medication management, infection prevention, appropriate use of psychotropic medications and resident abuse, neglect and safety. Additional risk areas include, but are not limited to, resident rights, fraud prevention, billing and cost reporting, employee screening, resident assessment accuracy, creation and retention of records, falsification and modification of documentation, conflicts of interest, kickbacks, inducements and self-referrals. The above background information and associated documents are provided as resources. REQUIREMENTS FOR ALL FACILITIES Compliance and Ethics Program The operating organization of each facility must have a compliance and ethics program that has been reasonably designed, implemented, maintained and enforced, so that it is https://oig.hhs.gov/compliance/compliance-guidance/index.asp likely to be effective in preventing and detecting criminal, civil, and administrative violations under the Act and in promoting quality of care. It is important for the facility to consider their facility assessment developed according to §483.71 in identifying risk areas, developing and maintaining their compliance and ethics program, and determining resources needed for the program. Written standards, policies and procedures The operating organization must have written standards, policies and procedures for its compliance and ethics program, which include at a minimum: • Designation of an appropriate compliance and ethics program contact to whom an individual can report suspected violations; • An alternate method of reporting suspected violations anonymously without fear of retribution; • Disciplinary standards that describe the consequences for committing violations for the entire staff. High-level Personnel Oversight The operating organization must assign specific individuals within the high-level personnel of the organization with the overall responsibility of overseeing adherence to the compliance and ethics program’s standards, policies, and procedures. High-level personnel means individuals who have substantial control over the operating organization or who have a substantial role in the making of policy within the operating organization. The individuals considered ‘‘high-level personnel’’ will differ according to each operating organization’s structure. Some examples include, but are not limited to, a director; executive officers including the chief executive officer (CEO); members of the board of directors; an individual in charge of a major business or functional unit of the operating organization; or an individual with a substantial ownership interest in the operating organization, as defined in section 1124(a)(3) of the Act. Sufficient Resources and Authority The program must include provisions ensuring that the specific individual(s) designated with oversight responsibility have sufficient resources and authority to assure compliance with program standards, policies, and procedures. The resources devoted should include both human and financial resources. Delegation of Substantial Discretionary Authority Organizations must exercise the care that a reasonable person would use under the same circumstances (due care) when delegating substantial discretionary authority to individuals, to ensure that the delegation is not made to an individual who the operating organization knew, or should have known, through the exercise of due diligence, had engaged in or had the predisposition to engage in unethical acts, or potential criminal, civil and/or administrative violations of the Act. Effectively Communicating Program Standards, Policies and Procedures The facility is required to effectively communicate to the entire staff, the standards, policies and procedures of the compliance and ethics program. Requirements include, but are not limited to, mandatory participation in training, as set forth in §483.95(f), orientation programs, and/or dissemination of information that explains what is required under the program, in a practical manner. For information on compliance and ethics training requirements, see §483.95(f), (F946). Reasonable Steps to Achieve Program Compliance The facility must take reasonable steps to achieve compliance with the program’s standards, policies and procedures. These steps include, but are not limited to: 1. Utilizing monitoring and auditing systems to detect criminal, civil, and administrative violations under the Act, by any of the facility’s entire staff. 2. Publicizing a reporting system whereby any of the organization’s entire staff could report violations anonymously within the operating organization without fear of retaliation. 3. Having a process for ensuring the integrity of any reported data. Consistent Enforcement through Disciplinary Mechanisms The compliance and ethics program must establish appropriate disciplinary mechanisms and effectively communicate those mechanisms, so that the operating organization’s entire staff is clearly aware of the consequences of program violations. The operating organization is required to consistently enforce its standards, policies, and procedures through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for failing to detect and report a violation to the appropriate party identified in the organization’s compliance and ethics program. Response to Detected Violations After an operating organization detects a violation, it must ensure that all reasonable steps identified in its program are taken to respond appropriately to the violation and to prevent further similar violations. This includes any necessary modification to the organization’s program to prevent and detect criminal, civil, and administrative violations under the Act. The reasonable steps that should be taken when a violation is detected should be clearly identified in the operating organization’s program. Such steps may include a corrective action plan, the return of overpayments, a report to the government and/or or a referral to criminal and/or civil law enforcement authorities. The steps will differ depending upon the size of the operating organization, the position of the individual reporting the violation, and the type of violation. For example, an operating organization’s program may state that a staff member should immediately notify their immediate superior when he or she detects a violation. However, if it is the immediate superior or the operating organization’s management whom the staff member believes is committing the violation, the staff member should have an alternative process to report the violation, such as, an executive officer of the organization, the Office of the State Long-Term Care Ombudsman or other appropriate agency or law enforcement authority. Facilities should integrate the information and data they collect or which arises out of their compliance and ethics programs into their Quality Assurance and Performance Improvement (QAPI) program, see §483.75(g)(2)(iii), F868. The QAPI committee should work with the compliance officer to determine if there are trends or patterns of systemic problems. Annual review As an operating organization becomes aware of changes in laws and/or requirements, it should modify its program to ensure it is current with requirements. The operating organization's performance in prior years should also be used to improve its program. As an operating organization revises its program, it should ensure that those changes are communicated to its entire staff. ADDITIONAL REQUIREMENTS FOR OPERATING ORGANIZATIONS WITH FIVE OR MORE FACILITIES Mandatory Annual Training For operating organizations with five or more facilities, the organization must have a mandatory annual training program. The annual training should be delivered in a practical manner based on its resources, the complexity of the operating organization and its facilities and in accordance with compliance and ethics training requirements in §483.95(f), (F946). Designated Compliance Officer Operating organizations that operate five or more facilities must designate a compliance officer for whom the compliance and ethics program is a major responsibility. The operating organization should ensure that the assigned compliance officer has sufficient time and other resources to fulfill all of his or her responsibilities under the operating organization's compliance and ethics program. The compliance officer should be able to communicate with the governing body without being subject to any coercion or intimidation. This is to ensure that the compliance officer is not unduly influenced by other managers or executive officers, such as the general counsel, chief financial officer or chief operating officer. Designated Compliance Liaison A designated compliance liaison must be located at each of the operating organization’s facilities. At a minimum, the facility-based liaison should be responsible for assisting the compliance officer with his or her duties under the operating organization’s program at their individual facilities. INVESTIGATIVE PROCEDURES When concerns regarding the compliance and ethics program are identified, use the applicable probes below to assist with investigating and determining compliance. PROBES • Does the operating organization have written standards, policies and procedures for the compliance and ethics program that are reasonably capable of reducing the possibility of criminal, civil and administrative violations under the Act? • Interview high-level personnel designated to oversee the organization’s compliance and ethics program about their involvement in the program. Determine: o how the facility uses monitoring and auditing systems to detect criminal, civil, and administrative violations by staff; o if they are aware of the potential violation under investigation and what was their response. • Ask staff if: o they are aware of the facility’s compliance and ethics program; o there is a method for staff to anonymously report suspected violations; o they are confident in reporting compliance matters without fear of retaliation. • When reports or reasonable suspicions of violations are identified, did the organization take prompt action to respond to the violation and prevent future occurrences, including enforcement of program standards, policies and procedures through disciplinary mechanisms, if appropriate? • Did the operating organization delegate substantial discretionary authority to an individual it knew or should have known through due diligence, had a propensity to engage in criminal, civil and/or administrative violations? • Does the operating organization review the program annually and as needed, in response to organization, facility and/or regulatory changes? • If the operating organization has five or more facilities, have a compliance officer and a facility-based compliance liaison been designated and is mandatory annual training conducted? POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION If a negative or potentially negative resident outcome is determined to be related to the facility’s failure to meet compliance and ethics requirements it should also be investigated under the appropriate quality of care or other relevant requirement. For concerns related to systems of care and management practices, written policies and procedures for feedback, data collections systems, monitoring, analyzing and acting on available data to make improvements, see Quality Assurance and Performance Improvement (QAPI) requirements in §483.75. 1 http://thelawdictionary.org/due-care/ (accessed on April 17, 2015). 2 Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities [CMS–3260– F], 81 FR 68688, at page 68814 (Oct. 4, 2016). http://thelawdictionary.org/due-care/ §483.90 Physical Environment. The facility must be designed, constructed, equipped, and maintained to protect the health and safety of residents, personnel and the public. §483.90(a) Life safety from fire. §483.90(a)(1) Except as otherwise provided in this section – §483.90(a)(1)(i) The LTC facility must meet the applicable provisions and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.) §483.90(a)(1)(ii) Notwithstanding paragraph (a)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors. §483.90(a)(1)(iii) If a facility is Medicare- or Medicaid-certified before July 5, 2016 and the facility has previously used the Fire Safety Evaluation System for compliance, the facility may use the scoring values in the following Mandatory Values Chart: Mandatory Values—Nursing Homes Containment (Sa) Extinguishment (Sb) People Movement (Sc) Zone Location New Exist. New Exist. New Exist. 1st story 11 5 15(12)* 4 8(5)* 1 2nd or 3rd story 15 9 17(14)* 6 10(7)* 3 4th story or higher 18 9 19(16)* 6 11(8)* 3 * Use ( ) in zones that do not contain patient sleeping rooms. §483.90(a)(2) In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon a long-term care facility, but only if the waiver will not adversely affect the health and safety of the patients. §483.90(a)(3) The provisions of the Life safety Code do not apply in a State where CMS finds, in accordance with applicable provisions of sections 1819(d)(2)(B)(ii) and 1919(d)(2)(B)(ii) of the Act, that a fire and safety code imposed by State law adequately protects patients, residents and personnel in long term care facilities. §483.90(a)(4) A long-term care facility may install alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access. §483.90(a)(5) A long term care facility must: §483.90(a)(5)(i) Install, at least, battery-operated single station smoke alarms in accordance with the manufacturer's recommendations in resident sleeping rooms and common areas. §483.90(a)(5)(ii) Have a program for inspection, testing, maintenance, and battery replacement that conforms to the manufacturer's recommendations and that verifies correct operation of the smoke alarms. §483.90(a)(5)(iii) Exception: §483.90(a)(5)(iii)(A) The facility has system-based smoke detectors in patient rooms and common areas that are installed, tested, and maintained in accordance with NFPA 72, National Fire Alarm Code, for system-based smoke detectors; or §483.90(a)(5)(iii)(B) The facility is fully sprinklered in accordance with NFPA 13, Standard for the Installation of Sprinkler Systems. §483.90(a)(6) A long term care facility must: §483.90(a)(6)(i) Install an approved, supervised automatic sprinkler system in accordance with the 1999 edition of NFPA 13, Standard for the Installation of Sprinkler Systems, as incorporated by reference, throughout the building by August 13, 2013. The Director of the Office of the Federal Register has approved the NFPA 13 1999 edition of the Standard for the Installation of Sprinkler Systems, issued July 22, 1999 for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations. html. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. §483.90(a)(6)(ii) Test, inspect, and maintain an approved, supervised automatic sprinkler system in accordance with the 1998 edition of NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems, as incorporated by reference. The Director of the Office of the Federal Register has approved the NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems, 1998 edition, issued January 16, 1998 for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations. html. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. §483.90(a)(6)(iii) Subject to approval by CMS, a long term care facility may be granted an extension of the sprinkler installation deadline for a time period not to exceed 2 years from August 13, 2013, if the facility meets all of the following conditions: §483.90(a)(6)(iii)(A) It is in the process of replacing its current building, or undergoing major modifications to improve the living conditions for residents in all unsprinklered living areas that requires the movement of corridor, room, partition, or structural walls or supports, in addition to the installation of a sprinkler system; or, has had its planned sprinkler installation so impaired by a disaster or emergency, as indicated by a declaration under section 319 of the Public Health Service Act, that CMS finds it would be impractical to meet the sprinkler installation due date. §483.90(a)(6)(iii)(B) It demonstrates that it has made the necessary financial commitments to complete the building replacement or modification; or pursuant to a declared disaster or emergency, CMS finds it impractical to make reasonable and necessary financial commitments. §483.90(a)(6)(iii)(C) Before applying for the deadline extension, it has submitted plans to State and local authorities that are necessary for approval of the replacement building or major modification that includes the required sprinkler installation, and has received approval of the plans from State and local authorities. §483.90(a)(6)(iii)(D) It agrees to complete interim steps to improve fire safety, as determined by CMS. §483.90(a)(6)(iv) An extension granted under paragraph (a)(8)(iii) of this section may be renewed once, for an additional period not to exceed 1 year, if the following conditions are met: §483.90(a)(6)(iv)(A) CMS finds that extenuating circumstances beyond the control of the facility will prevent full compliance with the provisions in paragraph (a)(8)(i) of this section by the end of the first waiver period. §483.90(a)(6)(iv)(B) All other conditions of paragraph (a)(8)(iii) of this section are met. §483.90(a)(8) When a sprinkler system is shut down for more than 10 hours, the LTC facility must: §483.90(a)(8)(i) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or §483.90(a)(8)(ii) Establish a fire watch until the system is back in service. GUIDANCE: §483.90(a) For additional guidance on life safety from fire and the survey procedures for these regulatory requirements, reference Appendix I in the SOM. Concerns regarding the above regulatory provisions would be addressed through the Life Safety Code survey (K- Tags). §483.90(b) Standard: Building safety. Except as otherwise provided in this section, the LTC facility must meet the applicable provisions and must proceed in accordance with the Health Care Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and TIA 12-6). §483.90(b)(1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities Code do not apply to an LTC facility. §483.90(b)(2) If application of the Health Care Facilities Code required under paragraph (b) of this section would result in unreasonable hardship for the LTC facility, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of residents. GUIDANCE: §483.90(b) For additional guidance and procedures on building safety reference Appendix I in the SOM. F906 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(c) Emergency Power. §483.90(c)(1) An emergency electrical power system must supply power adequate at least for lighting all entrances and exits; equipment to maintain the fire detection, alarm, and extinguishing systems; and life support systems in the event the normal electrical supply is interrupted. §483.90(c)(2) When life support systems are used, the facility must provide emergency electrical power with an emergency generator (as defined in NFPA 99, Health Care Facilities) that is located on the premises. Guidance: §483.90(c)(1) and (c)(2) “Emergency electrical power system” includes, at a minimum, a generator or battery-operated power system for the lighting for all entrances and exits, fire detection and alarm systems, and extinguishing systems. Life support systems are required to be powered by an emergency generator that is located on the premises, see 483.90(c)(2). An “exit” is defined as a means of egress which is lighted and has three components: an exit access (corridor leading to the exit), an exit (a door), and an exit discharge (door to the street or public way). We define an entrance as any door through which people enter the facility. Furthermore, when an entrance also serves as an exit, its components (exit access, exit, and exit discharge) must be lighted. A waiver of lighting required for both exits and entrances is not permitted. “Life support systems” is defined as one or more items of electrically powered equipment whose operation is necessary to maintain a patient or resident’s life. For example, ventilators, suction machines if necessary to maintain an open airway, etc.. The determination of whether a piece of equipment is life support is a medical determination dependent upon the condition of the individual residents of the facility e.g. suction machine maybe required “life support equipment” in a facility, depending on the needs of its residents. “Essential Electrical System” is defined as a system of alternate sources of power and all commercial distribution systems and ancillary equipment, designed to ensure continuity of electrical power to designated areas and functions of a health care facility during disruption of normal power sources, and also to minimize disruption within the internal wiring system. Procedures: §483.90(c)(1) and (c)(2) Review results of inspections by the designated State fire safety authority that the emergency power system has been tested periodically and is functioning in accordance with the Life Safety Code, NFPA 99 and NFPA 110. Check placement of lighting system to ensure proper coverage of the listed areas. Review records of monthly and annual tests to ensure that emergency lighting system for, at least, lighting all entrances and exits is operational. If life support systems are used determine if there is a working emergency generator at the facility. A generator is not required if a facility does not use life support systems. Check that the emergency generator starts and transfers power under load conditions within 10 seconds after interruption of normal power. Where residents are on life support equipment, do not test transfer switches by shutting off the power unless there is an uninterruptible power supply available. A type I Essential Electrical System is required to be installed if the facility uses life support systems and residents are on life support equipment such as a ventilator to assist in breathing. Probes: §483.90(c)(1) and (c)(2) Is emergency electrical service adequate? Additional guidance is available in the National Fire Protection Association’s Life Safety Code NFPA 101 and NFPA 99, Health Care Facilities Code, sections 18.5.1.2, 18.5.1.3 and 18.2.9.2 and 18.2.20.5 which are surveyed in Tags K292 and K915 of the Life Safety code survey. Is there a working generator if the facility is using life support systems and is it maintained in accordance with the manufacturer’s recommendations and NFPA 99 and NFPA 110? Does the facility have a type I electrical system installed throughout the facility or at least to building areas where required in accordance with NFPA 72 and NFPA 99? If applicable, is the generator and emergency electrical system tested and maintained in accordance with NFPA 99 and NFPA 110 and are records of such maintained? F907 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(d) Space and Equipment The facility must-- §483.90(d)(1) Provide sufficient space and equipment in dining, health services, recreation, and program areas to enable staff to provide residents with needed services as required by these standards and as identified in each resident’s assessment and plan of care; and INTENT: §483.90(d)(1) The intent of this regulation is to ensure that dining, health services, recreation, activities and programs areas are large enough to comfortably accommodate the needs of the residents who usually occupy this space. Dining, health services, recreation, and program areas should be large enough to comfortably accommodate the persons who usually occupy that space, including the wheelchairs, walkers, and other ambulating aids used by the many residents who require more than standard movement spaces. “Sufficient space” means the resident can access the area, it is not functionally off-limits, and the resident’s functioning is not restricted once access to the space is gained. Program areas where resident groups engage in activities focused on manipulative skills and hand-eye coordination should have sufficient space for storage of their supplies and “works in progress.” Program areas where residents receive physical therapy should have sufficient space and equipment to meet the needs of the resident’s therapy requirement. “Recreation/activities area” means any area where residents can participate in those activities identified in their plan of care. PROCEDURES: §483.90(d)(1) In the use of space, consider if available space and equipment is sufficient in dining, health services, recreation, and program areas to allow residents to pursue activities and receive health services and programs as identified in their assessment and care plan. Is there sufficient space for storing and utilizing mobility devices, assistive technology, physical therapy or adaptive equipment as identified in the resident assessment or plan of care? F908 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(d)(2) Maintain all mechanical, electrical, and patient care equipment in safe operating condition. PROCEDURES/PROBES: §483.90(d)(2) How does the facility assure all mechanical, electrical and patient care equipment is maintained in safe operating condition? Is essential equipment (e.g., boiler room equipment, nursing unit/medication room refrigerators, kitchen refrigerator/freezer and laundry equipment) in safe operating condition? Inspect the bed control panel covering for signs of damage where liquids could leak in. Inspect the bed’s power cord, cord plug and wall plug in for damage if electrically powered bed. Is equipment maintained according to manufacturer’s recommendations? F909 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(d)(3) Conduct Regular inspection of all bed frames, mattresses, and bed rails, if any, as part of a regular maintenance program to identify areas of possible entrapment. When bed rails and mattresses are used and purchased separately from the bed frame, the facility must ensure that the bed rails, mattress, and bed frame are compatible. GUIDANCE: §483.90(d)(3) For concerns related to the inspection or compatibility of bed frames, mattresses and bed rails, cite those here. For additional guidance on the assessment of individual’s needs, including the potential risks and benefits of the use of bed rails, refer to F700 Bed Rails located in Quality of Care at §483.25(n). PROCEDURES: §483.90(d)(3) When investigating F909, surveyors may reference Food and Drug Administration (FDA) documents entitled “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment” dated March 10. 2006, “Practice Hospital Bed Safety” dated February 2013, and “Guide to Bed Safety Rails in Hospitals, Nursing Homes and Home Health Care: The Facts” as to the proper dimensions and distances apart of various parts of the bed such as distance between bed frames and mattresses, bed rails and mattress etc. to prevent entrapment by users of the bed. PROBES: §483.90(d)(3) How does the facility assure the inspection of all bed frames, mattresses and bed rails, if any, as part of their regular maintenance program? Is equipment inspected and maintained according to manufacturer’s recommendations and requirements and timeframes? Does the mattress fit the bed frame properly limiting entrapment zones? Is the bed rail securely and properly installed according to manufacturer’s requirements to limit entrapment zones? F910 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(e) Resident Rooms Resident rooms must be designed and equipped for adequate nursing care, comfort, and privacy of residents. F911 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90 (e)(1) Bedrooms must §483.90(e)(1)(i) Accommodate no more than four residents. For facilities that receive approval of construction or reconstruction plans by State and local authorities or are newly certified after November 28, 2016, bedrooms must accommodate no more than two residents. GUIDANCE: §483.90(e)(1)(i) As residents are transferred or discharged from rooms with more than four residents, beds should be removed from the variance until the number of residents occupying the room does not exceed four. See §483.90(e)(3) regarding variances. “Reconstruction” means the facility undergoes reconfiguration of the space such that the space is not permitted to be occupied, or the entire building or an entire occupancy within the building, such as a wing of the building, is modified. The requirement applies to the reconstructed area, so that where reconstruction involves a limited area within a building, we would not expect the entire building to upgrade to the new requirements of no more than two residents per room. When a facility undergoes a change of ownership under §489.18 and the new owner does not accept assignment of the existing provider agreement and requires a “new initial certification” for a new provider agreement that would be effective after November 28, 2016, the facility would be expected to be upgraded to meet these new requirements of each bedroom accommodating not more than two residents. This would also apply when the provider agreement was terminated by CMS and another provider is working to reopen the facility. In the case of a natural disaster where the Secretary has declared a public health emergency, a waiver of certain requirements under section 1135 of the Act may be available under certain conditions. The waiving of specific requirements under section 1135 for affected facilities would depend on the many factors, including the extent of damage to the facility. New construction or Reconstruction of facilities affected by a declared disaster should be discussed with the appropriate CMS Regional Office. For facilities that receive approval of construction or reconstruction plans from State and local authorities or are newly certified after November 28, 2016 each resident room must meet the new requirements of no more than two residents per room. PROBES: §483.90(e)(1)(i) Unless a variance has been applied for and approved under §483.90(e)(3), do the residents’ bedrooms accommodate no more than four residents? For resident bedrooms constructed in a certified facility or in a facility certified after November 28, 2016, are there a maximum of two beds per bedroom? F912 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(e)(1)(ii) Measure at least 80 square feet per resident in multiple resident bedrooms, and at least 100 square feet in single resident rooms; GUIDANCE: §483.90(e)(1)(ii) See §483.90(e)(3) regarding variations. The measurement of the square footage should be based upon the useable living space of the room. Therefore, the minimum square footage in resident rooms should be measured based upon the floor’s measurements exclusive of toilets and bath areas, closets, lockers, wardrobes, alcoves, or vestibules. However, if the height of the alcoves or vestibules reasonably provides useful living area, then the corresponding floor area may be included in the calculation. The space occupied by movable wardrobes should be excluded from the useable square footage in a room unless it is an item of the resident’s own choice and it is in addition to the individual closet space in the resident’s room. Non-permanent items of the resident’s own choice should have no effect in the calculation of useable living space. Protrusions such as columns, radiators, ventilation systems for heating and/or cooling should be ignored in computing the useable square footage of the room if the area involved is minimal (e.g., a baseboard heating or air conditioning system or ductwork that does not protrude more than 6 to 8 inches from the wall, or a column that is not more than 6 to 8 inches on each side) and does not have an adverse effect on the resident’s health and safety or does not impede the ability of any resident in that room to attain his or her highest practicable well-being. If these protrusions are not minimal they would be deducted from useable square footage computed in determining compliance with this requirement. The swing or arc of any door which opens directly into the resident’s room should not be excluded from the calculations of useable square footage in a room. PROCEDURES: §483.90(e)(1)(ii) The facility layout may give square footage measurements. Carry a tape measure and take measurements if the room appears small. PROBES: §483.90(e)(1)(ii) Unless a variation has been applied for and approved under §483.90(e)(3), are there at least 80 square feet per resident in multiple resident rooms and at least 100 square feet for single resident rooms? F913 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(e)(1)(iii) Have direct access to an exit corridor; GUIDANCE: §483.90(e)(1)(iii) Each resident bedroom shall be individually accessible from the corridor without passing through another room. There is no authority under current regulations to approve a variance to this requirement. Additional guidance is available in the National Fire Protection Association’s Life Safety Code 101 (NFPA 101, 2012 ed.), 18/19.2.5.1, which is Tag K254 of the Life Safety Code Survey F914 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(e)(1)(iv) Be designed or equipped to assure full visual privacy for each resident; §483.90(e)(1)(v) In facilities initially certified after March 31, 1992, except in private rooms, each bed must have ceiling suspended curtains, which extend around the bed to provide total visual privacy in combination with adjacent walls and curtains. GUIDANCE: §483.90(e)(1)(iv) and (e)(1)(v) “Full visual privacy” means that residents have a means of completely withdrawing from public view, without staff assistance, while occupying their bed (e.g., curtain, moveable screens, private room). The guidelines do not intend to limit the provisions of privacy to solely one or more curtains, movable screens or a private room. Facility operators are free to use other means to provide full visual privacy, with those means varying according to the needs and requests of residents. However, the requirement explicitly states that bedrooms must “be designed or equipped to assure full visual privacy for each resident.” For example, a resident with a bed by the window cannot be required to remain out of his or her room while his/her roommate is having a dressing change. Room design or equipment must provide privacy. The term “initially certified” is defined as all newly certified nursing facilities (NFs) or SNFs as well as NFs and SNFs which re-enter the Medicare or Medicaid programs, whether they voluntarily or involuntarily left the program after March 31, 1992. It is not necessary for the bed to be accessible from both sides when the privacy curtain in pulled. Additional guidance is available in the National Fire Protection Association’s Life Safety Code 101 (NFPA 101, 2012 ed.), 18/19.7.5.1, 18/19.3.5.11, which is Tag K751 of the Life Safety Code Survey. PROCEDURES: §483.90(e)(1)(iv) and (e)(1)(v) There are no provisions for physician statements to be used as a basis for variance of the requirements for full visual privacy. PROBES: §483.90(e)(1)(iv) and (e)(1)(v) Observe whether each resident selected for a comprehensive or focused review has a means to achieve full visual privacy. F915 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(a)(7) Buildings must have an outside window or outside door in every sleeping room, and for any building constructed after July 5, 2016 the sill height must not exceed 36 inches above the floor. Windows in atrium walls are considered outside windows for the purposes of this requirement. §483.90(e)(1)(vi) - Resident Rooms Bedrooms must -- §483.90(e)(1)(vi) - Have at least one window to the outside; and GUIDANCE: §483.90(a)(7) and §483.90(e)(1)(vi) Every resident/patient sleeping room shall have an outside window. A facility with resident room windows, as defined by K381, or that open to an outside atrium such as a courtyard in accordance with Life Safety Code, can meet this requirement for a window to the outside. Windows facing an interior atrium, skylights, etc., do not meet this requirement. In addition to conforming to the Life Safety Code, this requirement was included to assist the resident’s orientation to day and night, weather, and general awareness of space outside the facility. The facility is required to provide for a “safe, clean, comfortable and homelike environment” by deemphasizing the institutional character of the setting, to the extent possible. Windows are an important aspect in assuring the homelike environment of a facility. In buildings constructed after July 5, 2016 or for facilities certified after July 5, 2016, the maximum allowable sill height is 36 inches above the floor. The window may be operable. PROBES: §483.90(a)(7) and §483.90(e)(1)(vi) Is there at least one window to the outside? If the building was constructed or certified as a provider after July 5, 2016, confirm the outside window sill is 36 inches or less above the floor. F916 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(e)(1)(vii) Have a floor at or above grade level. GUIDANCE: §483.90(e)(1)(vii) “At or above grade level” means a room in which the room floor is at or above the surrounding exterior ground level. No resident rooms in basements or below ground level are allowed. PROBES: §483.90(e)(1)(vii) Are the bedrooms at or above ground level? F917 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.10(i)(4) Private closet space in each resident room, as specified in §483.90 (e)(2)(iv) §483.90(e)(2) -The facility must provide each resident with-- (i) A separate bed of proper size and height for the safety and convenience of the resident; (ii) A clean, comfortable mattress; (iii) Bedding, appropriate to the weather and climate; and (iv) Functional furniture appropriate to the resident’s needs, and individual closet space in the resident’s bedroom with clothes racks and shelves accessible to the resident. §483.90(e)(3) CMS, or in the case of a nursing facility the survey agency, may permit variations in requirements specified in paragraphs (e)(1) (i) and (ii) of this section relating to rooms in individual cases when the facility demonstrates in writing that the variations (i) Are in accordance with the special needs of the residents; and (ii) Will not adversely affect residents’ health and safety. GUIDANCE: §483.90(e)(2)(i), (e)(2)(ii), (e)(2)(iii), (e)(2)(iv), §483.10(i)(4), §483.90(e)(3), (e)(3)(i), and (e)(3)(ii) “Functional furniture appropriate to the resident’s needs” means that the furniture in each resident’s room contributes to the resident attaining or maintaining his or her highest practicable level of independence and well-being. In general, furnishings include a place to put clothing away in an organized manner that will let it remain clean, free of wrinkles, and accessible to the resident while protecting it from casual access by others; a place to put personal effects such as pictures and a bedside clock, and furniture suitable for the comfort of the resident and visitors (e.g., a chair). For issues with arrangement of room furniture according to resident needs and preferences, see §483.10(e), Accommodation of Needs, Tag F558. “Clothes racks and shelves accessible to the resident” means that residents can get to and reach their hanging clothing whenever they choose. “Private closet space” means that each resident’s clothing is kept separate from clothing of roommate(s). The term “closet space” is not necessarily limited to a space installed into the wall. For some facilities without such installed closets, compliance may be attained through the use of storage furniture such as wardrobes. Out-of-season items may be stored in alternate locations outside the resident’s room. A variation must be in accordance with the special needs of the residents and must not adversely affect the health or safety of residents. Facility hardship is not part of the basis for granting a variation. Since the special needs of residents may change periodically, or different residents may be transferred into a room that has been granted a variation, variations must be reviewed and considered for renewal whenever the facility is certified. If the needs of the residents within the room have not changed since the last annual inspection, the variance should continue if the facility so desires. PROBES: §483.90(e)(2)(i), (e)(2)(ii), (e)(2)(iii), (e)(2)(iv), §483.10(i)(4), §483.90(e)(3), (e)(3)(i), and (e)(3)(ii) Are mattresses clean and comfortable? Is bedding appropriate to weather and climate? If a resident uses a wheelchair, is the bed positioned at a height that allows the resident to safely transfer to the bed if he or she is able? See requirements at §483.90(d)(3) concerning the regular inspection of all bed frames, mattresses, and bed rails to identify areas of possible entrapment. Functional furniture: Is there functional furniture, appropriate to resident’s needs? Closet space: Is there individual closet space with accessible clothes racks and shelves? If the resident is able to use a closet, can the resident get to and reach her/his hanging clothing as well as items from shelves in the closet? If a resident is unable to use a closet, does the facility provide the resident with adequate assistance for accessing their clothing, or alternative storage space that the resident is able to access? If a resident uses a wheelchair, are dressers or shelves available at a height that the resident can access them and reach them. F918 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(f) Bathroom Facilities Each resident room must be equipped with or located near toilet and bathing facilities. For facilities that receive approval of construction plans from State and local authorities or are newly certified after November 28, 2016, each residential room must have its own bathroom equipped with at least a commode and sink. GUIDANCE: §483.90(f) “Bathing Facilities” is defined as a space that contains either a shower(s) or a tub(s) for resident use. See definition of “toilet facilities” for definition of “located near.” “Toilet facilities” is defined as a space that contains a lavatory and a toilet/commode. CMS is also using the term “commode” to mean the same as a “toilet” when referring to a plumbing fixture. If the resident’s room is not equipped with an adjoining toilet facility, then “located near” means residents who are independent in the use of a toilet/commode, including chair bound residents, can routinely use a toilet/commode in the unit that they can access quickly. When a facility undergoes a change of ownership under §489.18 and the new owner does not accept assignment of the existing provider agreement and requires a “new initial certification” for a new provider agreement that would be effective after November 28, 2016, the facility would be expected to be upgraded to meet these new requirements of each resident bedroom to have its own bathroom consisting of at least a sink and commode/toilet. This would also apply when the provider agreement was terminated by CMS and another provider is working to reopen the facility. In the case of a natural disaster where the Secretary has declared a public health emergency, a waiver of certain requirements under section 1135 of the Act may be available under certain conditions. The waiving of specific requirements under section 1135 for affected facilities would depend on the many factors, including the extent of damage to the facility. New construction or Reconstruction of facilities affected by a declared disaster should be discussed with the appropriate CMS Regional Office. Each resident room must be equipped with or located near toilet/commode and bathing facilities. For facilities that receive approval of construction plans from State and local authorities or are newly certified after November 28, 2016, each resident room must have its own bathroom equipped with at least a commode, and sink. PROCEDURES: §483.90(f) Are resident rooms equipped with or located near toilet and bathing facilities? Does each resident room have its own bathroom equipped with at least a commode and sink for facilities that receive approval of construction from State and local authorities or are newly certified after November 28, 2016? F919 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.90(g) Resident Call System The facility must be adequately equipped to allow residents to call for staff assistance through a communication system which relays the call directly to a staff member or to a centralized staff work area from– §483.90(g)(1) Each resident’s bedside; and §483.90(g)(2) Toilet and bathing facilities. INTENT: §483.90(g)(1) and (g)(2) The intent of this requirement is that residents, when in their rooms and toilet and bathing areas, have a means of directly contacting caregivers. In the case of an existing centralized nursing station, this communication may be through audible or visual signals and may include “wireless systems.” In those cases, in which a facility has moved to decentralized nurse/care team work areas, the intent may be met through other electronic systems that provide direct communication from the resident to the caregivers. GUIDANCE: §483.90(g)(1) and (g)(2) This requirement is met only if all portions of the system are functioning (e.g., system is not turned off at the nurses’ station, the volume too low to be heard, the light above a room or rooms is not working, no staff at nurses’ station), and calls are being answered. For wireless systems, compliance is met only if staff who answer resident calls have functioning devices in their possession and are answering resident calls. The call system must be accessible to residents while in their bed or other sleeping accommodations within the resident’s room. The call system must be accessible to the resident at each toilet and bath or shower facility. The call system should be accessible to a resident lying on the floor. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION Issues related to the timeliness of calls being answered should be referred to and examined for sufficient staffing under §483.35 Nursing Services. PROBES: §483.90(g)(1) and (g)(2) Is there a functioning communication system from rooms, at the bedside, toilets, and bathing facilities in which resident calls are received and answered by staff? Is the call system accessible if the resident were lying on the floor? If a resident has disabilities that make use of the facility’s communication system inaccessible, are alternatives, auxiliary aids, or services available to meet this requirement and to meet the resident’s needs as identified in the resident’s assessment or plan of care? Residents and their representatives should be interviewed about whether calls are being answered. • Has the call system been in need of repair recently? If yes, ask: o What did the facility do if the call system was not working? o How many times was the call system non-functional/not operating? o Were any needed repairs made timely? o How long was the call system non-functional/not operating? Does the facility have process to routinely ensure the call system for residents is operational? During a loss of power, will the resident call system be operational or is an alternate means of communicating with the staff put into place? F920 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(h) Dining and Resident Activities The facility must provide one or more rooms designated for resident dining and activities. These rooms must-- §483.90(h)(1) Be well lighted; §483.90(h)(2) Be well ventilated; §483.90(h)(3) Be adequately furnished; and §483.90(h)(4) Have sufficient space to accommodate all activities. GUIDANCE: §483.90(h)(1), (h)(2), (h)(3) and (h)(4) “Well lighted” is defined as levels of illumination that are suitable to tasks performed by a resident. “Well ventilated” is defined as good air circulation, avoidance of drafts at floor level, and adequate smoke and odor exhaust removal. Reference ASHRAE Standard 179 for ventilation requirements in nursing homes activity and dining areas. An “adequately furnished” dining area accommodates different residents’ physical and social needs. An adequately furnished organized activities area accommodates the needs, interests and preferences of its residents. “Sufficient space to accommodate all activities” means that there is enough space available and it is adaptable to a variety of uses and residents’ needs. PROBES: §483.90(h)(1), (h)(2), (h)(3) and (h)(4) Are there adequate and comfortable lighting levels? Are illumination levels appropriate to tasks with little glare? Does lighting support maintenance of independent functioning and task performance? Is the space well ventilated, providing for good air circulation and adequate smoke exhaust removal? Ask residents if furnishings are adequate for their needs? Are furnishings structurally sound and functional (e.g., chairs of varying sizes to meet varying needs of residents, wheelchairs can fit under the dining room table)? Is space sufficient for all resident activities? Are spaces adaptable for all intended uses? Is resident access to space limited? Do residents and staff have maximum flexibility in arranging furniture to accommodate residents who use walkers, wheelchairs, and other mobility aids, including space for empty wheelchairs if a resident prefers to sit in a regular chair? Is there resident crowding? F921 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(i) Other Environmental Conditions The facility must provide a safe, functional, sanitary, and comfortable environment for residents, staff and the public. F922 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) The facility must-- §483.90(i)(1) Establish procedures to ensure that water is available to essential areas when there is a loss of normal water supply; GUIDANCE: §483.90(i)(1) The facility should have a written procedure which defines the source of water when there is a loss of normal water supply, including provisions for storing the water, both potable and nonpotable, a method for distributing the water and a method for estimating the volume of water required. PROCEDURES: §483.90(i)(1) During the entrance conference, ask the administrator the facility’s procedure to ensure water availability. F923 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(i)(2) Have adequate outside ventilation by means of windows, or mechanical ventilation, or a combination of the two. PROBES: §483.90(i)(2) Is the space ventilated by means of windows, or mechanical ventilation, or a combination of the two? Is there good air circulation? F924 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(i)(3) Equip corridors with firmly secured handrails on each side. GUIDANCE §483.90(i)(3) “Secured handrails” means handrails that are firmly affixed to the wall. PROBES: §483.90(i)(3) Do all corridors have handrails and are the handrails firmly secured and affixed to the corridor walls? F925 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(i)(4) Maintain an effective pest control program so that the facility is free of pests and rodents. GUIDANCE: §483.90(i)(4) An “effective pest control program” is defined as measures to eradicate and contain common household pests (e.g., bed bugs, lice, roaches, ants, mosquitoes, flies, mice, and rats). PROCEDURES: §483.90(i)(4) As part of the overall review of the facility, look for signs of vermin. Evidence of pest infestation in a particular space is an indicator of noncompliance. PROBES: §483.90(i)(4) Ask staff, residents and their representatives if they have observed any pests/vermin? F926 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.90(i)(5) Establish policies, in accordance with applicable Federal, State, and local laws and regulations, regarding smoking, smoking areas, and smoking safety that also take into account nonsmoking residents. GUIDANCE: §483.90(i)(5) The use of oxygen in smoking areas and while smoking is forbidden. PROCEDURES: §483.90(i)(5) Review F689 guidance concerning smoking in the facility. As part of the overall review of the facility, look for signs of smoking by residents, staff, visitors, guests, and non-staff. Look for smoking areas both inside and outside of the facility. Review policies to determine if they have been developed and are being implemented in accordance with Federal, State and local laws and regulations in regards to smoking, smoking areas and smoking safety for both smoking and non-smoking residents. PROBES: §483.90(i)(5) Ask residents who smoke how the facility permits them to smoke. Does the facility allow smoking and how is it managed? §483.90(j) The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may inspect a copy at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations. html. If any changes in this edition of the Code are incorporated by reference, CMS will publish a document in the Federal Register to announce the changes. §483.90(j)(1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org, 1.617.770.3000. (i) NFPA 99, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011. (ii) TIA 12-2 to NFPA 99, issued August 11, 2011. (iii) TIA 12-3 to NFPA 99, issued August 9, 2012. (iv) TIA 12-4 to NFPA 99, issued March 7, 2013. (v) TIA 12-5 to NFPA 99, issued August 1, 2013. (vi) TIA 12-6 to NFPA 99, issued March 3, 2014. (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011; (viii) TIA 12-1 to NFPA 101, issued August 11, 2011. (ix) TIA 12-2 to NFPA 101, issued October 30, 2012. (x) TIA 12-3 to NFPA 101, issued October 22, 2013. (xi) TIA 12-4 to NFPA 101, issued October 22, 2013. §483.95 Training Requirements NOTE: As published in the Federal Register (Vol. 81, No. 192, 68688, 68698, October 4, 2016), this entire section (§483.95) will be implemented in Phase 3 with the following exceptions, which will be implemented in Phase 1: (c) Abuse, neglect, and exploitation training; (g)(1) Regarding in-service training, (g)(2) dementia management & abuse prevention training, (g)(4) care of the cognitively impaired; and (h) Training of feeding assistants. F940 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.95 Training Requirements A facility must develop, implement, and maintain an effective training program for all new and existing staff; individuals providing services under a contractual arrangement; and volunteers, consistent with their expected roles. A facility must determine the amount and types of training necessary based on a facility assessment as specified at § 483.71. Training topics must include but are not limited to— INTENT Facilities are required to develop, implement, and maintain an effective training program for all staff. Appropriately trained staff can improve resident safety, create a more person-centered environment, and reduce the number of adverse events or other resident complications. CMS recognizes that training needs are likely to change over time. Therefore, it is necessary for facilities to have the flexibility to determine training needs based on its facility assessment. Competencies and skill sets for all new and existing staff, individuals providing services under a contractual arrangement, and volunteers must be consistent with their expected roles. All facility staff needs to be trained to be able to interact in a manner that enhances the resident’s quality of life and quality of care and that they can demonstrate competency in the topic areas of the training program. The facility is also expected to keep a record of these trainings. Training requirements should be met prior to staff and volunteers independently providing services to residents, annually, and as necessary based on the facility assessment. See §483.71(a) (2)(iv). CMS does not propose a specific training mechanism to meet the Training Requirements regulation, and the regulation does not specify that a member of the facility must conduct the training activities. Facilities have the flexibility to work with outside entities to provide facilitated training, computer-based training, self-directed learning, mentoring and/or coaching. CMS encourages facilities to leverage community resources to assist with developing training programs, identifying qualified instructors, identifying training materials, and implementing facility training programs. Based upon the outcome of a facility assessment, suggestions for additional training topics may include, but are not limited to, advance care planning, cultural competence, end-of-life care, geriatrics and gerontology (i.e., understanding of how human beings change as they grow older), substance abuse, working with young and middle-aged adults, grief and loss, interdisciplinary collaboration, person centered care, specialized rehabilitative therapy, trauma informed care, intellectual disability, mental disorder and quality of life and care. There are various free online training tools and resources that facilities can use to assist them in complying with this requirement. For example, the Agency for Healthcare Research and Quality (AHRQ) released a set of training modules to help educate LTC facility staff on key patient safety concepts to improve the safety of LTC facility residents. (See http://www.ahrq.gov/professionals/systems/long-term- care/resources/facilities/ptsafety/). Long Term Care Ombudsman can provide in-service trainings to facility staff on a variety of topics. In addition to the web based materials, instructor and student handbooks can be sent to facilities at no additional cost. For the purposes of this training requirement, staff includes all facility staff, (direct and indirect care functions), contracted staff, and volunteers (training topics as appropriate to role). NOTE: References to non-U. S. Department of Health and Human Services (HHS) sources or sites on the internet are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS. CMS is not responsible for the content of pages found at these sites. URL addresses were current as of the date of this publication. Surveyors need to consider the facilities compliance for all training requirements at §483.95. F940 would be cited as a result of the facility’s failure to implement trainings for multiple training topics included at §483.95. F941 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.95 Training Requirements. Training topics must include but are not limited to— http://www.ahrq.gov/professionals/systems/long-term-care/resources/facilities/ptsafety/ http://www.ahrq.gov/professionals/systems/long-term-care/resources/facilities/ptsafety/ §483.95(a) Communication. A facility must include effective communications as mandatory training for direct care staff. DEFINITIONS “Communications” include services such as Teletypewriter (TTY) and Telecommunications Device for the Deaf (TDD), use of devices such as cellular telephones, and accessibility such as reasonable access and privacy for electronic communications like email or internet-based interpersonal video communications. See 483.10(g)(6)(7). “Direct care staff” are those individuals who, through interpersonal contact with residents or resident care management, provide care and services to allow residents to attain or maintain the highest practicable physical, mental, and psychosocial well-being. “Effective communications” describe a process of dialogue between individuals. The skills include speaking to others in a way they can understand and active listening and observation of verbal and non-verbal cues. Understanding what the resident is trying to communicate is essential to giving a response. Additionally, effective communication ensures that information provided to the resident is provided in a form and manner that the resident can access and understand, including in a language that the resident can understand. See 483.10(g)3). INTENT We did not propose to require a specific amount of time, specific communications topics, or specific training mechanisms to meet this requirement. The topics for training should reflect the needs of the resident population and the needs of staff. These needs should correspond with the Facility Assessment. We expect training activities will encourage participation and allow for open dialogue among participants in order to be productive. Facilities must inform residents in a language they can understand of their total health status and to provide notice of rights and services both orally and in writing in a language the resident understands (see §483.10, Resident Rights). For the purposes of this training requirement, staff includes all staff providing direct care services (training topics as appropriate to role). GUIDANCE Recommended methods of effective communication, include, but are not limited to, the following: 1. Identify yourself and use the resident’s name each time you speak with them. 2. Use the proper names for people, places, and objects; avoid saying he, she, it, or they so that the resident can understand. 3. Allow extra time. Many nursing home residents have conditions which require longer information processing time. 4. Avoid distractions, and maintain eye contact, if culturally appropriate. Focus on the resident, make each interaction quality time. 5. Listen carefully to the resident’s responses and directly respond to the questions and concerns. Give residents an opportunity to ask questions and express themselves. 6. Sit face to face, residents may have vision and hearing loss, and reading your lips may be crucial. Even if the resident uses a hearing aid, it can be difficult for the resident to understand you because a hearing aid amplifies all sounds, including background noise. 7. Speak slowly, clearly and in a normal tone, and use short, simple words (no medical or slang jargon) 8. Maintain a positive attitude, including a pleasant tone of voice and facial expression. Residents with dementia respond to the feelings you convey more than the actual words. 9. If the communication form is written, simplify the questions, and stick to one topic at a time. Frequently summarize the most important points. 10. Be aware of a resident’s body language communications. 11. Eliminate assumptions, make adjustments to the communication method as required during a conversation. 12. Visual aids may be required as communication methods. 13. Repeat back what the person has said to make sure that you understand. Ask for clarification if you aren’t sure what the person means. Training Resource • Getting the Facts: Effective Communication with Elders Support Materials https://pogoe.org/sites/default/files/Commun-Support-Mat • Mental Illness: https://www.mentalhealth.gov/talk https://www.nami.org/Find-Support/Family-Members-and-Caregivers/Maintaining-a- Healthy-Relationship NOTE: References to non-U. S. Department of Health and Human Services (HHS) sources or sites on the internet are provided as a service and do not constitute or imply endorsement of these organizations or their programs by CMS. CMS is not responsible for the content of pages found at these sites. URL addresses were current as of the date of this publication. PROBES If there is a concern about effective communication utilize interviews and review of training records to determine the following: https://pogoe.org/sites/default/files/Commun-Support-Mat https://www.mentalhealth.gov/talk https://www.nami.org/Find-Support/Family-Members-and-Caregivers/Maintaining-a-Healthy-Relationship https://www.nami.org/Find-Support/Family-Members-and-Caregivers/Maintaining-a-Healthy-Relationship • Does the facility provide on-going in-service training, as necessary, for permanent, temporary and volunteer direct care staff to improve their ability to communicate effectively? • Does the facility admit and care for residents that do not use the English language? • How does the facility assessment reflect the need for direct care staff training related to communication with residents who do not speak English? What communication tools are provided and how are staff educated about using those tools? • Does the facility have alternative means of communication for residents in need who require them and how are staff educated about using them (e.g. communication boards)? • How are ethnic and cultural differences reflected in communications? • How well do permanent and temporary direct care staff and volunteers communicate with residents? • Does the facility have a process in place to communicate with residents including those with a language/communication barriers during an emergency? • How does the facility train direct care staff on identifying resident non-verbal communication? • How does the facility train direct care staff on identifying and understanding their own non-verbal communication? F942 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.95 Training Requirements. Training topics must include but are not limited to §483.95(b) Resident's rights and facility responsibilities. A facility must ensure that staff members are educated on the rights of the resident and the responsibilities of a facility to properly care for its residents as set forth at §483.10, respectively. INTENT To ensure all facility staff understand and foster the rights of every nursing home resident. For the purposes of this training requirement, staff includes all facility staff, (direct and indirect care functions), contracted staff, and volunteers (training topics as appropriate to role). GUIDANCE §483.95(b) Facilities must develop and implement an ongoing education program on all resident rights and facility responsibilities for caring of residents as outlined in §483.10. The education program should support current scope and standards of practice through curricula which incorporate learning objectives, performance standards, and evaluation criteria. Staff performance assessments should evaluate the ability to integrate knowledge and skills specific to the requirements at §483.10. There should be a process in place to validate that training was completed, whether in a group setting or on an individual basis. If concerns with staff knowledge and understanding of resident rights and facility responsibilities are identified by the survey team, the following probes should be utilized in interview, observation and record review to help determine compliance with F942: • Interview staff to determine if they’ve received training regarding the rights of residents and facility responsibilities. • Observe staff interactions with residents. • Review training documentation provided by the facility related to resident rights and facility responsibilities. • Interview staff from various departments and disciplines about their knowledge of resident rights and facility responsibilities. F943 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.95(c) Abuse, neglect, and exploitation. In addition to the freedom from abuse, neglect, and exploitation requirements in § 483.12, facilities must also provide training to their staff that at a minimum educates staff on— §483.95(c)(1) Activities that constitute abuse, neglect, exploitation, and misappropriation of resident property as set forth at § 483.12. §483.95(c)(2) Procedures for reporting incidents of abuse, neglect, exploitation, or the misappropriation of resident property. §483.95(c)(3) Dementia management and resident abuse prevention. DEFINITION §483.95(c) Staff includes for the purposes of the training guidance, all facility staff, (direct and indirect care and auxiliary functions) contractors, and volunteers. GUIDANCE §483.95(c) All facilities must develop, implement and permanently maintain an effective training program for all staff, which includes, at a minimum, training on abuse, neglect, exploitation, misappropriation of resident property, and dementia management, that is appropriate and effective, as determined by staff need and the facility assessment (as specified at §483.71). Changes to the facility’s resident population, staff turnover, the facility’s physical environment, and modifications to the facility assessment may necessitate ongoing revisions to the facility’s training program. There are a variety of methods that could be used to provide training. For example, staff training may be facilitated through any combination of in-person instruction, webinars and/or supervised practical training hours. Supervised practical training means training in a setting in which instruction and oversight are provided by a person who has relevant education and/or experience specific to the subject of the training being provided. All training should support current scope and standards of practice through curricula which detail learning objectives, performance standards and evaluation criteria, and addresses potential risks to residents, staff and volunteers if procedures are not followed. There should be a process in place to track staff participation in the required trainings. The facility must provide staff orientation and training on the prohibition of all forms of abuse, neglect, and exploitation prohibition. The training must address forms of abuse, neglect, misappropriation of resident property, exploitation and dementia management. Such training would include, but is not limited to: • Identifying how person-centered thinking, planning, and practice skills contribute to a facility culture of prevention and identification of abuse, neglect, and exploitation • Identifying and preventing behavior constituting abuse (including injuries from an unknown source), neglect, exploitation, and misappropriation of resident property; • Identifying physical or psychosocial indicators of abuse (including injuries from an unknown source), neglect, exploitation, and misappropriation of resident property from situations which include, but are not limited to: o Verbal, mental, sexual or physical abuse; o Taking or using photographs or recordings of residents in a demeaning or humiliating manner and sharing them in any manner, including through the use of technology or social media; o Theft of a resident’s personal belongings; o Involuntary seclusion of a resident; o Exploitation of a resident; and o Neglect of a resident as demonstrated by a pattern of willfully failing to provide care to a resident(s). • Facility procedures and Federal and State requirements for reporting abuse, neglect, exploitation, and misappropriation of resident property, including injuries of unknown sources, timeframes for reporting, and to whom staff and others must report their knowledge related to any alleged violation without fear of retaliation; • Reporting reasonable suspicion of a crime against a resident; • Educating staff on factors related to dementia care and abuse prevention, such as understanding that expressions or indications of distress of residents with dementia are often attempts to communicate an unmet need, discomfort or thoughts that they can no longer articulate with words. However, they may be perceived as challenging behaviors to staff and could increase the risk of resident abuse and neglect. Expressions or indications of distress can include, but are not limited to: o Aggressiveness; o Wandering or elopement; o Agitation; o Yelling out; or o Delusions. • Conflict resolution and anger management skills, including resolving conflicts between staff and residents, visitor and resident, and resident-to-resident conflicts; and • Identifying and addressing factors that may precipitate abuse/neglect/exploitation, including, but not limited to: o Signs of staff burnout, frustration, and stress; o Staff prejudices to age, culture, race, religion, and sexual orientation; o Gender differences; and o Negative attitudes toward working with individuals with disabilities. While not required, sources of training materials that facilities may want to consider include: • National Center on Elder Abuse. [On-Line]. Available: https://ncea.acl.gov • University of Southern California. Training Resources on Elder Abuse. Available: http://trea.usc.edu/ References to non-CMS, non-governmental sources do not constitute or imply endorsement of these organizations or their programs by CMS or the U.S. Department of Health and Human Services and were current as of the date of this publication. PROBES §483.95(c) If there is a concern that a resident was abused, neglected, or exploited, interview staff and review training records to determine the following: • Was staff observed working with residents in a manner that indicates a training need? https://ncea.acl.gov/ http://trea.usc.edu/ • Did interviews with residents and/or resident representatives indicate any areas where training was needed? • What type of training do the staff report receiving about the concern identified by the surveyor? • What process does the facility have to encourage staff to express concerns and request training in challenging situations? How does the facility respond to staff’s concerns and requests? • Review the training coursework to determine if the content meets professional standards/guidelines and covers relevant facility policy and procedures. • How does the facility’s abuse, neglect, and exploitation training program ensure staff are instructed to meet the requirements of §483.12(b) Develop/Implement Abuse/Neglect, etc. Policies, tag F607? • How does the facility’s policies reflect staff training is in compliance with §483.12 and §483.12(a)(1) Freedom from abuse, neglect, and exploitation, tag F600? • Verify that the facility has a mandatory requirement that all facility staff participate in an abuse, neglect, and exploitation prevention and dementia management training program, with a process in place to track attendance. • How does the facility determine when training content requires updating to be consistent with current professional standards and Federal and State regulations? • How does the facility assess staff to determine if the training has been effective? POTENTIAL ADDITIONAL TAGS FOR INVESTIGATION For concerns related to the development and implementation of written policies and procedures, that includes training related to abuse, neglect, exploitation, and misappropriation of resident property, see 42 CFR §483.12(b)(3) Develop/Implement Abuse/Neglect, etc. Policies, tag F607. For concerns related to the reporting of a crime, see 42 CFR §483.12(b)(5), Reporting of Reasonable Suspicion of a Crime, tag F609. F944 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.95(d) Quality assurance and performance improvement. A facility must include as part of its QAPI program mandatory training that outlines and informs staff of the elements and goals of the facility's QAPI program as set forth at § 483.75. DEFINITIONS “Quality Assurance and Performance Improvement (QAPI)” is the coordinated application of two mutually-reinforcing aspects of a quality management system: Quality Assurance (QA) and Performance Improvement (PI). QAPI takes a systematic, interdisciplinary, comprehensive, and data-driven approach to maintaining and improving safety and quality in nursing homes while involving residents and families in practical and creative problem solving (https://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/QAPI/qapidefinition, accessed 12/18/2020). GUIDANCE For the purpose of this guidance, the term “staff” includes all new and existing facility staff (with direct and indirect care functions); individuals providing services under a contractual arrangement; and volunteers, consistent with the volunteers’ expected roles (see requirements in §483.95). Facilities must conduct mandatory training, for all staff, on the facility’s QAPI Program, that includes the goals and various elements of the program. It should also include how the facility intends to implement the program. The training should also include the staff’s role in the facility’s QAPI program and how to communicate concerns, problems or opportunities for improvement to the facility’s QAA Committee. As updates are made to the facility's QAPI program or goals, the facility's training should also be updated and staff trained on the updates, as appropriate. All training should support current scope and standards of practice through curricula which detail learning objectives, performance standards, and evaluation criteria. There should be a process in place to track staff participation in the required trainings. PROBES • Verify that the facility has a mandatory requirement that all staff receive QAPI training. • Does the facility have a method for verifying staff attendance at the mandatory QAPI training? If so, do these records confirm that staff attended the mandatory QAPI training? • Does the facility’s training program inform staff of the current elements and goals of the facility’s QAPI program? • Are staff aware of what the facility’s QAPI program entails and how the facility intends to implement and monitor their program? • Are staff aware of how to bring ideas or concerns to the attention of the QAA committee? • How does the facility determine when training content requires updating to be consistent with current professional standards and guidelines? It is not required to have an outcome deficiency cited for this tag to be cited for deficient staff training. If QAPI deficiencies are identified, refer to §483.75 for citation authority. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION • F865-F868: for concerns related to the facility’s QAPI program. F945 https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/qapidefinition https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/qapidefinition (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.95(e) Infection control. A facility must include as part of its infection prevention and control program mandatory training that includes the written standards, policies, and procedures for the program as described at §483.80(a)(2). GUIDANCE §483.95(e) All facilities must develop, implement and permanently maintain an effective training program for all staff, which includes, training on the standards, policies, and procedures for the infection prevention and control program as described at §483.80(a)(2), that is appropriate and effective, and as determined by staff need. For the purposes of this training requirement, staff includes all facility staff (direct and indirect care functions), contracted staff, and volunteers (training topics as appropriate to role). Changes to the facility’s resident population, community infection risk, national standards, staff turnover, the facility’s physical environment, or facility assessment may necessitate ongoing revisions to the facility’s training program for infection prevention and control. All training should support current scope and standards of practice through curricula which detail learning objectives, performance standards, evaluation criteria, and addresses potential risks to residents, staff, and volunteers if procedures are not followed. There should be a process in place to track staff participation in and understanding of the required training. Such infection control training must, at a minimum, include the following areas (as described in §483.80(a)(2)): • The facility’s surveillance system designed to identify possible communicable diseases or infections before they can spread to other persons in the facility; • When and to whom possible incidents of communicable disease or infections in the facility should be reported; • How and when to use standard precautions, including proper hand hygiene practices and environmental cleaning and disinfection practices; • How and when to use transmission-based precautions for a resident, including but not limited to, the type and its duration of use depending upon the infectious agent or organism involved; • Occupational health policies, including the circumstances under which the facility must enforce work restrictions and when to self-report illness or exposures to potentially infectious materials (See 483.80(a)(2)(v)); and • Proper infection prevention and control practices when performing resident care activities as it pertains to particular staff roles, responsibilities, and situations. Please refer to F880 for a detailed description of these topics. PROBES §483.95(e) If there is a concern about infection prevention and control practices or healthcare- associated infections in the facility (F880), interview staff and review training records to determine the following: • Did staff observations or did interviews with residents and/or resident representatives indicate a training need? Did staff report not receiving training about the concern identified by the surveyor? • What process does the facility have to encourage staff to express concerns and request training in challenging situations? Does the facility respond to staff’s concerns and requests for training? • Review the training coursework to determine if the content meets professional standards/guidelines and covers facility policy and procedures for infection prevention and control. • Does the facility implement the training program and ensure staff are instructed to meet the requirements of §483.80(a)(2), Infection Control, F880? • Verify that the facility has a mandatory requirement that all facility staff participate in infection prevention and control training, with a process in place to track such participation. POTENTIAL ADDITIONAL TAGS FOR INVESTIGATION For concerns related to infection prevention and control practices, see 42 CFR §483.80, Infection Control, tag F880. F946 (Rev. 211; Issued: 02-03-23; Effective: 10-21-22; Implementation: 10-24-22) §483.95(f) Compliance and ethics. The operating organization for each facility must include as part of its compliance and ethics program, as set forth at §483.85— §483.95(f)(1) An effective way to communicate the program's standards, policies, and procedures through a training program or in another practical manner which explains the requirements under the program. §483.95(f)(2) Annual training if the operating organization operates five or more facilities. DEFINITION: For the purpose of this guidance, the term “Staff” includes all new and existing staff (direct and indirect care functions); individuals providing services under a contractual arrangement; and volunteers, consistent with the volunteers’ expected roles (see requirements in §483.95). GUIDANCE §483.95(f) The operating organization (the individual or entity that operates a facility) must provide a training program or another practical manner to effectively communicate the standards, policies, and procedures of the compliance and ethics program to its entire staff. For the operating organizations that operate five or more facilities, annual training for staff on the compliance and ethic program must be conducted. All training should support current scope and standards of practice through curricula which detail learning objectives, performance standards, and evaluation criteria. There should be a process in place to track staff participation in the required trainings. PROBES §483.95(f) • Does the facility provide training or effectively communicate, in some manner, the facility’s standards, policies and procedures of the compliance and ethics program? • Does the facility have a system in place to track staff attendance at required trainings? • For organizations with five or more facilities, determine if annual compliance and ethics training is provided. F947 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.95 Training Requirements. Training topics must include but are not limited to— §483.95(g) Required in-service training for nurse aides. In-service training must— §483.95(g)(1) Be sufficient to ensure the continuing competence of nurse aides, but must be no less than 12 hours per year. §483.95(g)(2) Include dementia management training and resident abuse prevention training. §483.95(g)(3) Address areas of weakness as determined in nurse aides' performance reviews and facility assessment at §483.71 and may address the special needs of residents as determined by the facility staff. §483.95(g)(4) For nurse aides providing services to individuals with cognitive impairments, also address the care of the cognitively impaired. DEFINITIONS A “nurse aide” is defined in §483.5 as any individual providing nursing or nursing-related services to residents in a facility. This term may also include an individual who provides these services through an agency or under a contract with the facility, but is not a licensed health professional, a registered dietitian, or someone who volunteers to provide such services without pay. Nurse aides do not include those individuals who furnish services to residents only as paid feeding assistants as defined in §488.301. Private duty nurse aides who are not employed or utilized by the facility on a contract, per diem, leased, or other basis, do not come under the nurse aide training provision and therefore are not required to take the training. Performance Reviews: The process used to evaluate the performance of staff on a periodic basis, which may be annually. NOTE: See Tag F730-§483.35(d)(7) related to the conduct of performance reviews for every nurse aide at least once every 12 months. GUIDANCE §483.95(g) All facilities must develop, implement and permanently maintain an in-service training program for nurse aides that is appropriate and effective, as determined by nurse aide performance reviews [see §483.35(d)(7)] and the facility assessment as specified at §483.71. Changes to the facility’s resident population, the facility’s physical environment, staff turnover, and modifications to the facility assessment may necessitate ongoing revisions to the facility’s training program. There are a variety of methods that could be used to provide training. For example, nurse aide training may be facilitated through any combination of in-person instruction, webinars (though, should not be webinars alone) and/or supervised practical training hours and should be reflective of nurse aides’ performance reviews in order to address identified weaknesses. When able, each nurse aide should be evaluated based on individual performance, and the facility should develop training that can be utilized and beneficial to all nurse aide staff when applicable. Supervised practical training means training in a setting in which instruction and oversight are provided by a person who has relevant education and/or experience specific to the subject of the training being provided. All training should support current scope and standards of practice through curricula which detail learning objectives, performance standards and evaluation criteria, and addresses potential risks to residents, staff and volunteers if procedures are not followed. There should be a process in place to track nurse aide participation in the required trainings. The adequacy of the in-service education program may be measured not only by documentation of hours of completed in-service education, but also by demonstrated competencies of nurse aide staff through written exam and/or in consistently applying the interventions necessary to meet residents’ needs as identified in the facility assessment. Observations of nurse aides that indicate deficiencies in their nurse aide skills may be the result of an inadequate training program and/or inadequate performance review. A minimum of 12 hours of nurse aide training per year is required under §483.95(g)(1). The training must be sufficient to ensure the continuing competence of the nurse aides, which may require more than 12 hours of training per year to meet identified staff or resident needs. The survey team does not need to find a negative outcome to cite a deficiency at F947. PROCEDURES AND PROBES §483.95(g) If there have been deficient care practices identified during the survey, review as appropriate training received by nurse aides in that corresponding subject area. If there is a concern about required in-service training for nurse aides, interview staff and review training records to determine the following: • Were nurse aides observed working with residents in a manner that indicates a training need? • Did interviews with residents and/or resident representatives indicate any areas where training was needed? • What type of training do the nurse aides report receiving about the concern identified by the surveyor? • Verify the mandatory nurse aide in-service program is no less than 12 hours per year. • Review facility training records which supports mandatory nurse aide attendance. • How has in-service education addressed any areas of weakness identified in performance reviews, and any special resident needs, or needs of residents with cognitive impairments? • How does the facility evaluate nurse aide performance to determine what topics must be included in in-service training to address areas of weakness? • How does the facility determine when training content must be updated (e.g., in order to remain consistent with current professional standards and guidelines)? • What process does the facility have to encourage nurse aides to express concerns and request training in challenging situations? How does the facility respond to nurse aide’s concerns and requests? • Does the facility’s training address nurse aide training needs to ensure residents attain or maintain the highest practicable physical, mental, and psychosocial well-being as determined by resident assessments and individual plans of care? • How does the facility assess nurse aides to determine if the training has been effective? POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION For concerns related to nurse aides not demonstrating competent care of a resident that is independent of or related to the training program, see 42 CFR §483.35(c) Proficiency of Nurse Aides tag F726 for guidance. F948 (Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17) §483.95(h) Required training of feeding assistants. A facility must not use any individual working in the facility as a paid feeding assistant unless that individual has successfully completed a State-approved training program for feeding assistants, as specified in §483.160. DEFINITION §483.95(h) Paid feeding assistant is defined in the regulation at 42 CFR 488.301 as “an individual who meets the requirements specified in §483.60(h)(1) of this chapter and who is paid to feed residents by a facility, or who is used under an arrangement with another agency or organization.” GUIDANCE §483.95(h) A State-approved training course for paid feeding assistants must include, at a minimum, 8 hours of training in the following: • Feeding techniques. • Assistance with feeding and hydration. • Communication and interpersonal skills. • Appropriate responses to resident behavior. • Safety and emergency procedures, including the Heimlich maneuver. • Infection control. • Resident rights. • Recognizing changes in residents that are inconsistent with their normal behavior and the importance of reporting those changes to the supervisory nurse. A facility must maintain a record of all individuals, used by the facility as feeding assistants, who have successfully completed the training course for paid feeding assistants. PROBES §483.95(h) • Were paid feeding assistants observed working with residents in a manner that indicates a training need? • Did interviews with residents and/or resident representatives indicate any areas where training was needed? • What type of training do the paid feeding assistants report receiving about the concern or deficient practice identified by the surveyor? https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=0d5647c5d7ec9422788fd6658511aa68&term_occur=1&term_src=Title:42:Chapter:IV:Subchapter:G:Part:483:Subpart:D:483.160 https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=a747821bda156b5fed8947a4b7538024&term_occur=1&term_src=Title:42:Chapter:IV:Subchapter:G:Part:483:Subpart:D:483.160 https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=a0add8f0f5369ecf358b93838206d7a3&term_occur=1&term_src=Title:42:Chapter:IV:Subchapter:G:Part:483:Subpart:D:483.160 https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=a747821bda156b5fed8947a4b7538024&term_occur=2&term_src=Title:42:Chapter:IV:Subchapter:G:Part:483:Subpart:D:483.160 https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=a747821bda156b5fed8947a4b7538024&term_occur=3&term_src=Title:42:Chapter:IV:Subchapter:G:Part:483:Subpart:D:483.160 • If the facility is using paid feeding assistants and the residents requiring assistance with eating are determined to have avoidable negative nutritional outcomes, request proof that the paid feeding assistants successfully completed a State- approved training program. Tag 948 is only to be cited if it is determined the paid feeding assistant(s) has not completed a State-approved training program as specified in §483.160. It is not required to have an outcome deficiency cited for this tag to be cited related to staff training. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION If concerns related to the performance of the paid feeding assistant are identified, see 42 CFR §483.60(h) Paid Feeding Assistants, tag F811, for guidance. F949 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.95 Training Requirements. Training topics must include but are not limited to— §483.95(i) Behavioral health. A facility must provide behavioral health training consistent with the requirements at §483.40 and as determined by the facility assessment at §483.71. GUIDANCE §483.95(i) All facilities must develop, implement, and maintain an effective training program for all staff, which includes, at a minimum, training on behavioral health care and services (consistent with §483.40) that is appropriate and effective, as determined by staff need and the facility assessment (as specified at §483.71). For the purposes of this training requirement, staff includes all facility staff, (direct and indirect care functions), contracted staff, and volunteers (training topics as appropriate to role). Changes to the facility’s resident population, staff turnover, the facility’s physical environment, and modifications to the facility assessment may require ongoing revisions to the facility’s training program. There are a variety of available methods to provide training, including in-person instruction, webinars, and/or supervised practical training. Supervised practical training means training in a setting in which instruction and oversight are provided by a person who has relevant education and/or experience specific to the subject of the training being provided. All training should support current scope and standards of practice through curricula which detail learning objectives, performance standards, and evaluation criteria. There should be a process in place to track staff participation in the required trainings. A behavioral health training course as determined by the facility assessment should include, at a minimum, the competencies and skills necessary to provide the following: • Person-centered care and services that reflect the resident’s goals for care; • Interpersonal communication that promotes mental and psychosocial well-being; • Meaningful activities which promote engagement and positive meaningful relationships; • An environment and atmosphere that is conducive to mental and psychosocial well-being; • Individualized, non-pharmacological approaches to care; • Care specific to the individual needs of residents that are diagnosed with a mental, psychosocial, or substance use disorder, a history of trauma and/or post-traumatic stress disorder, or other behavioral health condition; and • Care specific to the individual needs of residents that are diagnosed with dementia (CMS Hand in Hand: A Training Series for Nursing Homes is an example of training that addresses this area). PROBES §483.95(i) If there is a concern that the behavioral health needs of residents are not being met, utilize observations, interviews and review of training records to determine the following: • Does staff demonstrate the skills needed to promote the highest practicable level of functioning for residents with identified behavioral health care needs? • Can staff explain concepts learned in training? • How does the facility assure that all staff interacting with residents are trained as required? This may include nursing, therapy, activity, housekeeping, dietary staff, and others, as needed. • How does the facility assure that all facility staff, contractors, and volunteers are trained to interact with those residents with specific behavioral health care needs? • Is the training program designed to address the residents’ specific behavioral health care needs? • How does the facility keep track of staff participation in required training? • How does the facility monitor the effectiveness of the training program? • How are changes implemented to the training program if desired outcomes are not achieved? • Is the training curriculum based on the results of the facility assessment required at 483.71 https://surveyortraining.cms.hhs.gov/pubs/ClassInformation.aspx?cid=0CMSHIH_ONL Transmittals Issued for this Appendix Rev # Issue Date Subject Impl Date CR# R211SOM 02/03/2023 Revisions to State Operations Manual (SOM), Appendix PP 10/24/2022 N/A R208SOM 10/21/2022 Revisions to State Operation Manual (SOM), Appendix PP Guidance to Surveyors for Long Term Care Facilities 10/24/2022 N/A R207SOM 09/30/2022 Revisions to State Operation Manual (SOM), Appendix PP Guidance to Surveyors for Long Term Care Facilities 10/01/2022 N/A R173SOM 11/22/2017 Revisions to State Operation Manual (SOM), Appendix PP Guidance to Surveyors for Long Term Care Facilities 11/28/2017 N/A R168SOM 03/08/2017 Revision to State Operations Manual (SOM) Appendix PP - Incorporate revised Requirements of Participation for Medicare and Medicaid certified nursing facilities 03/08/2017 N/A R167SOM 02/10/2017 Revision to State Operations Manual (SOM) Appendix PP - Incorporate revised Requirements of Participation for Medicare and Medicaid certified nursing facilities – Rescinded and replaced by Transmittal 168 02/10/2017 N/A R157SOM 06/10/2016 Revisions to the State Operations Manual (SOM) - Appendix PP – Guidance to Surveyors for Long Term Care Facilities 06/10/2016 N/A R149SOM 10/09/2015 State Operations Manual (SOM) for All Types of Providers and Suppliers Subject to Certification 10/09/2015 N/A R133SOM 02/06/2015 Revisions to State Operations Manual (SOM), Appendix PP – “Guidance to Surveyors for Long Term Care Facilities” 02/06/2015 N/A R130SOM 12/12/2014 Revisions to State Operations Manual (SOM), Appendix PP – “Guidance to Surveyors for Long Term Care Facilities” 12/12/2014 N/A R127SOM 11/26/2014 Revisions to State Operations Manual (SOM), Appendix PP – “Guidance to Surveyors for Long Term Care Facilities” 11/26/2014 N/A R107SOM 04/04/2014 State Operations Manual (SOM) Appendix PP LTCF revisions for Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) 04/04/2014 N/A https://www.cms.gov/files/document/r211SOMA https://www.cms.gov/files/document/r208SOMA https://www.cms.gov/files/document/r207SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R173SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R168SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R167SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R157SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R149SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R133SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R130SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R127SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R107SOMA R70SOM 01/07/2011 Revisions to Appendix PP, State Operations Manual (SOM):Guidance to Surveyors for Long-Term Care Facilities (LTC) for Minimum Data Set (MDS) Implementation October 1, 2010 – Rescinded and replaced by Transmittal 70 10/01/2010 N/A R66SOM 10/01/2010 Revisions to Appendix PP, State Operations Manual (SOM):Guidance to Surveyors for Long-Term Care Facilities (LTC) for Minimum Data Set (MDS) Implementation October 1, 2010 – Rescinded and replaced by Transmittal 70 10/01/2010 N/A R55SOM 12/02/2009 Revisions to Appendix PP, - “Guidelines for Long-Term Care Facilities”, Tag F441 09/30/2009 N/A R54SOM 11/30/2009 Revisions to Appendix PP, - “Guidelines for Long-Term Care Facilities”, Tag F441 – Rescinded and replaced by Transmittal 55 09/30/2009 N/A R52SOM 09/25/2009 Revisions to Appendix PP, - “Guidelines for Long-Term Care Facilities”, Tag F441 – Rescinded and replaced by Transmittal 54 09/30/2009 N/A R51SOM 07/20/2009 Revisions to Appendix PP, - “Guidelines for Long-Term Care Facilities”, Tag F441 – Rescinded and replaced by Transmittal 52 09/30/2009 N/A R48SOM 06/12/2009 Revisions to Appendix PP, - “Guidelines for Long-Term Care Facilities” 06/12/2009 N/A R41SOM 04/10/2009 Revisions to Appendices P and PP 04/10/2009 N/A R36SOM 08/01/2008 Revisions to Appendix PP - Interpretive Guidelines for Long-Term Care Facilities, Tags F325 and F371 09/01/2008 N/A R26SOM 08/17/2007 Revised Appendix P and Appendix PP-New Tag F373 08/17/2007 N/A R22SOM 12/15/2006 Revisions to Appendix P and PP 12/18/2006 N/A R21SOM 10/20/2006 Revised Appendix P &Appendix PP-New Tag F334 10/15/2006 N/A R19SOM 06/01/2006 Revisions to Appendix PP 06/01/2006 N/A R15SOM 11/28/2005 Medical Director Guidance 11/25/2005 N/A R14SOM 11/25/2005 Medical Director Guidance – Replaced by Transmittal 15 11/25/2005 N/A R12SOM 10/14/2005 Appendix PP Technical Corrections 10/14/2005 N/A R08SOM 06/28/2008 Revision of Appendix PP-Section 483.25(d)- Urinary Incontinence, Tags F315 and F316 06/27/2005 N/A https://www.cms.gov/Regulations-and-Guidance/Guidance/transmittals/downloads/R70SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/transmittals/downloads/R66SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R55SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R54SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R52SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/transmittals/downloads/R51SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/transmittals/downloads/R48SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R41SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R36SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R26SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/transmittals/downloads/R22SOM https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R21SOM https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R19SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R15SOM https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R14SOM https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R12SOM https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R8SOM R07SOM 06/27/2005 Revision of Appendix PP-Section 483.25(d)- Urinary Incontinence, Tags F315 and F316 – Replaced by Transmittal 8 06/28/2005 N/A R05SOM 11/19/2004 Revisions to Appendix P and Appendix PP 11/19/2004 N/A R04SOM 11/12/2004 Guidance to Surveyors for Long Term Care Facilities 11/12/2004 N/A R01SOM 05/21/2004 Initial Release of Pub 100-07 N/A N/A https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R7SOM https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R5SOM https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R4SOMA https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R1SOM DEFINITIONS §483.12(a)(1) GUIDANCE §483.12(a)(1) ABUSE Staff to Resident Abuse of Any Type Resident to Resident Abuse of Any Type Visitor to Resident Abuse of Any Type TYPES OF ABUSE Physical Abuse Deprivation of Goods and Services by Staff Mental and Verbal Abuse Sexual Abuse Non-Sexual Physical Contact with Residents Capacity and Consent Residents with Designated or Legally Appointed Representatives Indicators of Potential Sexual Abuse Allegations of Sexual Abuse Allegations of Staff to Resident Sexual Abuse Allegations of Resident To Resident Sexual Abuse Allegations of Visitor to Resident Sexual Abuse Response to Alleged Violations of Sexual Abuse Determination of Findings and Potential to Foresee Abuse Determination of Past Non-Compliance The Link between Noncompliance at Resident’s Rights/Quality of Care/Quality of Life and Neglect of Goods and Services Identifying Neglect Identification of Goods and Services Required by Residents INVESTIGATIVE SUMMARY FOR ABUSE AND NEGLECT INVESTIGATION OF ALLEGATIONS OF ABUSE Summary of Procedures INVESTIGATION FOR ALLEGATIONS OF NEGLECT Use Summary of Procedures KEY ELEMENTS OF NONCOMPLIANCE FOR ABUSE AND NEGLECT §483.12(a)(1) POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION DEFICIENCY CATEGORIZATION §483.12(a)(1) Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident Health or Safety include, but are not limited to: Examples of Severity Level 3 Noncompliance Actual Harm that is not Immediate Jeopardy include, but are not limited to: Examples of Severity Level 2 Considerations Noncompliance No Actual Harm with Potential for More Than Minimal Harm that is Not Immediate Jeopardy include, but are not limited to: DEFINITIONS §483.12 GUIDANCE §483.12 INVESTIGATIVE PROTOCOL FOR MISAPPROPRIATION OF RESIDENT PROPERTY AND EXPLOITATION §483.12 USE PROCEDURES §483.12 ONSITE SURVEY ACTIVITIES OBSERVATION Interview: Staff Interview Alleged Perpetrator Interview: Record Review Reports from Other Investigatory Agencies Interview with Person Responsible for Quality Assurance Administrator Interview Additional Investigatory Activities Related to Allegations of Drug Diversion KEY ELEMENTS OF NONCOMPLIANCE §483.12 POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION DEFICIENCY CATEGORIZATION §483.12 Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident Health or Safety include, but are not limited to: Examples of Severity Level 3 Noncompliance Actual Harm that is not Immediate Jeopardy include, but are not limited to: Examples of Severity Level 2 Noncompliance No Actual Harm with Potential for More Than Minimal Harm that is Not Immediate Jeopardy include, but are not limited to: Severity Level 1: No Actual Harm with Potential for Minimal Harm DEFINITIONS §483.12(a)(1) GUIDANCE §483.12(a)(1) Considerations Involving Secured/Locked Areas Transmission Based Precautions INVESTIGATIVE PROTOCOL FOR INVOLUNTARY SECLUSION USE §483.12(a)(1) Review of Facility Policies and Procedures Observations Interview: Staff Interview Alleged Perpetrator Interview: Other Health Care Professionals Interview Record Review-Resident Record Review-Alleged Perpetrator’s Personnel File Review, if Staff Additional Activities for Investigating Possible Involuntary Seclusion for Residents in Secured/Locked Areas Facility Investigator Interview Administrator Interview Interview with Person Responsible for Quality Assurance KEY ELEMENTS OF NONCOMPLIANCE §483.12(a)(1) POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION DEFICIENCY CATEGORIZATION §483.12(a)(1) Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident Health or Safety include, but is not limited to: Examples of Severity Level 3 Noncompliance Actual Harm that is not Immediate Jeopardy include, but is not limited to: Examples of Severity Level 2 Noncompliance No Actual Harm with Potential for More Than Minimal Harm that is Not Immediate Jeopardy include, but is not limited to: Severity Level 1: No Actual Harm with Potential for Minimal Harm DEFINITIONS GUIDANCE Physical Risks and Psychosocial Impacts Related to Use of Restraints Assessment, Care Planning, and Documentation for the Use of a Physical Restraint Convenience and/or Discipline Determination of Use of Restraints for a Period of Imminent Danger to the Safety and Well- Being of the Resident Determination of Use of Bed Rails as a Restraint Determination of the Use of Position Change Alarms as Restraints PROCEDURES §483.12 and (a)(2)-Physical Restraints KEY ELEMENTS OF NONCOMPLIANCE POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION DEFICIENCY CATEGORIZATION Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident Health or Safety include, but are not limited to: Examples of Severity Level 3 Noncompliance Actual Harm that is not Immediate Jeopardy include, but are not limited to: Examples of Severity Level 2 Noncompliance No Actual Harm with Potential for More Than Minimal Harm that is Not Immediate Jeopardy include, but are not limited to: DEFINITIONS GUIDANCE Determination of Medical Symptoms Determination of Indication for Medication Use Risks and Psychosocial Impacts Related to Use of Chemical Restraints INVESTIGATIVE PROTOCOL FOR CHEMICAL RESTRAINTS USE PROCEDURES Observation Interviews Record Review Facility Review KEY ELEMENTS OF NONCOMPLIANCE POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION DEFICIENCY CATEGORIZATION Examples of Severity Level 4 Noncompliance Immediate Jeopardy to Resident Health or Safety includes, but is not limited to: Examples of Severity Level 3 Noncompliance Actual Harm that is not Immediate Jeopardy include, but is not limited to: Examples of Severity Level 2 Noncompliance No Actual Harm with Potential for More Than Minimal Harm that is Not Immediate Jeopardy include, but are not limited to: Severity Level 1: No Actual Harm with Potential for Minimal Harm  Report the results of all investigations within 5 working days to the administrator or his/her designated representative and to other officials in accordance with State law (including to the State survey and certification agency. GUIDANCE Nonpayment as Basis for Discharge Emergency Transfers to Acute Care §483.15(c)(1)(ii) Discharge pending appeal §483.15(c)(2) Required Documentation Information Conveyed to Receiving Provider INVESTIGATIVE PROTOCOL Summary of Investigative Procedure Deficiency Categorization In addition to actual or potential physical harm, always consider whether psychosocial harm has occurred when determining severity level (See Psychosocial Outcome Severity Guide, https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/Guida... Examples of Severity Level 4 Non-compliance: Immediate Jeopardy to Resident Health or Safety include, but are not limited to:  Facility initiated a discharge on the basis that the resident’s health had improved, however, the resident and her family disagreed and filed an appeal. The facility did not allow the resident to remain in the facility while the appeal was pending ...  A facility initiated a discharge based on the facility’s inability to meet a resident’s needs. However, upon complaint investigation, it was determined by interview and record review that, while the resident was depressed and had challenging behavi... Examples of Severity Level 3 Noncompliance: Actual Harm that is not Immediate Jeopardy include, but are not limited to:  The facility failed to allow a resident to remain in the facility after his skilled rehabilitation ended and while his application for Medical Assistance was pending. The resident consequently was discharged to another facility that was located fur...  A facility initiated a resident’s discharge after the resident attempted to hit a staff member during morning care over several days. The facility discharged the resident claiming the resident was a danger to others. Upon investigation of a complain... An example of Severity Level 2 Noncompliance: No Actual Harm with Potential for More Than Minimal Harm that is Not Immediate Jeopardy includes, but is not limited to:  A facility transferred a resident to the hospital emergently due to a change in condition. The facility failed to provide the hospital with contact information for the practitioner responsible for the resident’s care leading to a delay in admitting... An example of Severity Level 1 noncompliance: The failure to permit the resident to remain in the facility, document the resident’s transfer or discharge, and communicate necessary information to the receiving provider places the resident at risk for ... GUIDANCE Notice of Transfer or Discharge and Ombudsman Notification Facility-Initiated Transfers and Discharges Resident-Initiated Transfers and Discharges Contents of the Notice Timing of the Notice Changes to the Notice Notice in Advance of Facility Closure: GUIDANCE PROCEDURES DEFINITIONS GUIDANCE §483.15(e) Not Permitting Residents to Return Composite Distinct Part INVESTIGATIVE PROTOCOL Summary of Investigative Procedure DEFICIENCY CATEGORIZATION Examples of Severity Level 4 Non-compliance: Immediate Jeopardy to Resident Health or Safety include, but are not limited to: Examples of Severity Level 3 Noncompliance: Actual Harm that is not Immediate Jeopardy include, but are not limited to: An example of Severity Level 2 Noncompliance: No Actual Harm with Potential for More Than Minimal Harm that is Not Immediate Jeopardy includes, but is not limited to: An example of Severity Level 1 noncompliance: No actual harm with potential for minimal harm includes, but is not limited to:  Resident’s decision-making ability has changed;  Presence of a resident mood item not previously reported by the resident or staff and/or an increase in the symptom frequency, e.g., increase in the number of areas where behavioral symptoms are coded as being present and/or the frequency of a sympt...  Changes in frequency or severity of behavioral symptoms of dementia that indicate progression of the disease process since last assessment;  Any decline in an ADL physical functioning area (at least 1) where a resident is newly coded as Extensive assistance, Total dependence, or Activity did not occur since last assessment and does not reflect normal fluctuations in that individual’s fun...  Resident’s incontinence pattern changes or there was placement of an indwelling catheter;  Emergence of unplanned weight loss problem (5% change in 30 days or 10% change in 180 days).  Emergence of a new pressure ulcer at Stage 2 or higher, a new unstageable pressure ulcer/injury, a new deep tissue injury or worsening in pressure ulcer status;  Resident begins to use a restraint of any type, when it was not used before;  Emergence of a condition/disease in which a resident is judged to be unstable. Examples of Improvement include, but are not limited to:  Any improvement in ADL physical functioning area (at least 1) where a resident is newly coded as Independent, Supervision, or Limited assistance since last assessment and does not reflect normal fluctuations in that individual’s functioning;  Decrease in the number of areas where behavioral symptoms are coded as being present and/or the frequency of a symptom decreases;  Resident’s decision making ability improves;  Resident’s incontinence pattern improves; If there is only one change, the resident may still benefit from a SCSA as determined by the IDT or as initiated by the resident based on changes in the care plan. It is important to remember that each resident’s situation is unique. The facility mu... DEFINITIONS §483.24(c) GUIDANCE §483.24(c) Activity Approaches for Residents with Dementia Assessment Risk Factors Although the requirements do not mandate the use of any specific assessment tool (other than the RAI), many validated instruments are available to aid in assessing the risk for developing PU/PIs. It is important to keep in mind that research has shown... Pressure Points and Tissue Tolerance Pressure Injuries at End of Life RISKS AND ENVIRONMENTAL HAZARDS Assistive Devices/Equipment Hazards INTENT §483.25(g) DEFINITIONS §483.25(g) Severity Level 1: No Actual Harm with Potential for Minimal Harm The interdisciplinary team, with support and guidance from the physician, is responsible for assuring the ongoing review, evaluation and decision-making regarding the continuation or discontinuation of all treatments, devices or approaches implemented... PROCEDURES §483.25(g)(4)-(5) KEY ELEMENTS OF NONCOMPLIANCE An example of Severity Level 3 Considerations: Actual Harm that is Not Immediate Jeopardy includes, but is not limited to: Examples of Severity Level 2 Noncompliance: No Actual Harm with Potential for More than Minimal Harm that is Not Immediate Jeopardy includes, but is not limited to: Severity Level 1: No Actual Harm with Potential for Minimal Harm INVESTIGATIVE SUMMARY GUIDANCE §483.30(c) PROBES §483.30(c) POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION DEFICIENCY CATEGORIZATION An example of level 3, actual harm that is not immediate jeopardy, includes, but is not limited to: Examples of Level 2, no actual harm, with potential for than more than minimal harm, that is not immediate jeopardy, includes, but is not limited to: An example of Level 1, no actual harm with potential for no more than a minor negative impact on the resident, includes, but is not limited to: DEFINITIONS §483.40(d) GUIDANCE §483.40(d)  Making arrangements for obtaining items, such as clothing and personal items;  Making referrals and obtaining needed services from outside entities (e.g., talking books, absentee ballots, community wheelchair transportation);  Encouraging staff to maintain or enhance each resident’s dignity in recognition of each resident’s individuality;  Need for emotional support. Examples of some of the related requirements that should be considered when concerns have been identified include the following: Examples of some of the related requirements that should be considered when concerns have been identified include the following: Dose §483.60(d) Food and drink §483.60(d) Food and drink §483.60(d) Food and drink INTENT §483.60(i)(1)-(2) - To ensure that the facility: DEFINITIONS §483.60(i)-(2) GUIDANCE §483.60(i)(1)-(2) 1. Biological Contamination - are pathogenic bacteria, viruses, toxins, and spores that contaminate food. The two most common types of disease producing organisms are bacteria and viruses. Parasites may also contaminate food, but are less common. 2. Chemical Contamination - The most common chemicals that can be found in a food system are cleaning agents (such as glass cleaners, soaps, and oven cleaners) and insecticides. Chemicals used by the facility staff, in the course of their duties, may... 3. Physical Contamination - Physical contaminants are foreign objects that may inadvertently enter the food. Examples include, but are not limited to, staples, fingernails, jewelry, hair, glass, metal shavings from can openers, and pieces or fragment... Potential Factors Implicated in Foodborne Illnesses - Many influences may contribute to foodborne outbreaks, such as: Employee Health - Employees who handle food must be free of communicable diseases and infected skin lesions. (See the requirement at 42 CFR §483.80(a)(2)(v), F880, Infection Control, requiring a facility to have an infection prevention and control pro... Hair Restraints/Jewelry/Nail Polish – According to the current standards of practice such as the Food Code of the FDA, food service staff must wear hair restraints (e.g., hairnet, hat, and/or beard restraint) to prevent hair from contacting food. According to the Food Code, food service staff must wear hairnets when cooking, preparing, or assembling food, such as stirring pots or assembling the ingredients of a salad. However, staff do not need to wear hairnets when distributing foods to resi... Food Receiving and Storage - When food, food products or beverages are delivered to the nursing home, facility staff must inspect these items for safe transport and quality upon receipt and ensure their proper storage, keeping track of when to discard... Safe Food Preparation - Many steps in safe food preparation must be controlled and monitored to prevent foodborne illness. Identification of potential hazards in the food preparation process and adhering to critical control points can reduce the risk ... Equipment and Utensil Cleaning and Sanitization - A potential cause of foodborne outbreaks is improper cleaning (washing and sanitizing) of equipment and protecting equipment from contamination via splash, dust, grease, etc. Machine Washing and Sanitizing - Dishwashing machines use either heat or chemical sanitization methods. Manufacturer’s instructions must always be followed. The following are general recommendations according to the U.S. Department of Health and Huma... PROCEDURES §483.60(i)(1)-(2) Through observation, interviews, and record review, determine: Observations - Complete the initial brief kitchen tour upon arrival at the facility, with observations focused on practices that might indicate potential for foodborne illness. Make additional observations throughout the survey process during times wh... Storage of Food: Service after Meal Times: Interviews - During the course of the survey, interview the staff who performs the task about the procedures they follow to procure, store, prepare, distribute, and serve food to residents. In addition to food safety practices, determine: Record Review - In order to investigate identified food safety concerns, review supporting data, as necessary, including but not limited to: Review of Facility Practices - Review of facility practices may include, but is not limited to, review of policies and procedures for sufficient staffing, staff training, and following manufacturer’s recommendations as indicated. In order to establis... DEFICIENCY CATEGORIZATION POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION §483.60(i)(1)-(2) “Competency” refers to a measurable pattern of knowledge, skills, abilities, behaviors, and other characteristics in performing that an individual needs to perform work roles or occupational functions successfully. DEFICIENCY EXAMPLES When rubber stamp signatures are authorized by the facility’s management, the individual whose signature the stamp represents shall place in the administrative offices of the facility a signed statement to the effect that he/she is the only one who ha... Reports and Logs Surveyor Access to QAPI/QAA Material and Confidentiality of Patient Safety Work Products Surveyors should consider the following key points: Sanctions and Good Faith Attempts Facility Refusal to Provide Evidence of Compliance INVESTIGATIVE PROCEDURE Infection Prevention and Control Program Facility Assessment Pursuant to §483.71 (F838), the facility must conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies. The facility must review ... NOTE: While not required for compliance, a sample tool of an infection control risk assessment is available for adaptation.53F Infection Control Policies and Procedures Surveillance In addition, the facility must establish and implement a system, including who to notify (e.g., infection preventionist), for early detection and management of a potentially infectious, symptomatic resident at the time of admission. This includes the... Process Surveillance System of Surveillance: Data Analysis, Documentation and Reporting Recognizing, Containing and Reporting Communicable Disease Outbreaks The facility must know how to recognize and contain infectious disease outbreaks. An outbreak is the occurrence of more cases of disease than expected in a given area or among a specific group of people over a particular period of time.70F If a con... Water Management Prevention and Control of Transmission of Infection Direct Contact Transmission (Person-to-Person) occurs when microorganisms such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), carbapenem-resistant Enterobacteriaceae (CRE), influenza, or mites from a sca... Standard Precautions NOTE: Additional information related to disinfection and sterilization may be found in CDC’s “Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)” at https://www.cdc.gov/infectioncontrol/guidelines/Disinfection/index.html. Transmission-based Precautions  The identification of resident risk factors that increase the likelihood of transmission (such as uncontained secretions or excretions, non-compliance, cognition deficits, incontinence, etc.);  The provision of a private room as available/appropriate;  Sharing a room with a roommate with limited risk factors (e.g., without indwelling or invasive devices, without open wounds, and not immunocompromised) as appropriate based on the pathogen and method of transmission.84F  Clearly identify the type of precautions and the appropriate PPE to be used;  Place signage that includes instructions for use of specific PPE in a conspicuous location outside the resident’s room (e.g., on the door or on the wall next to the doorway), wing, or facility-wide. Additionally, either the CDC category of transmiss...  Make PPE readily available near the entrance to the resident’s room;  Don appropriate PPE before or upon entry into the environment (e.g., room or cubicle) of a resident on transmission-based precautions (e.g., contact precautions);  Use disposable or dedicated noncritical resident-care equipment (e.g., blood pressure cuff, bedside commode). If noncritical equipment is shared between residents, it will be cleaned and disinfected following manufacturer’s instructions with an EPA...  Clean and disinfect objects and environmental surfaces that are touched frequently (e.g., bed rails, over-bed table, bedside commode, lavatory surfaces in resident bathrooms) with an EPA-registered disinfectant for healthcare use at least daily and ...  Provide education to residents (to the degree possible/consistent with the resident’s capacity) and their representatives or visitors on the use of transmission-based precautions. Contact Precautions Droplet Precautions Medical Device Safety Medical devices may be used for administration of medications, point-of-care testing, or for other medical uses. Point-of-Care Testing Point-of-care testing is diagnostic testing that is performed at or near the site of resident care. This may be accomplished through use of portable, handheld instruments such as blood glucose meters or prothrombin time meters. This testing may involv... Fingerstick Devices Resources are available on fingerstick safety, such as:  “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” https://www.cdc.gov/injectionsafety/fingerstick-devicesbgm.html; and  CDC’s Frequently Asked Questions (FAQs) regarding Assisted Blood Glucose Monitoring and Insulin Administration https://www.cdc.gov/injectionsafety/providers/blood-glucose-monitoring_faqs.html. Blood Glucose Meters Blood glucose meters can become contaminated with blood and, if used for multiple residents, must be cleaned and disinfected after each use according to manufacturer’s instructions for multi-patient use. Additionally, staff must not carry blood glucos... NOTE: If the facility failed to clean and disinfect blood glucose meters per device and disinfectant manufacturer’s instructions for use, they are used for more than one resident, and there is a resident with a known bloodborne pathogen in the facili... NOTE: Additional information related to point-of-care testing may be found in CDC’s Infection Prevention during Blood Glucose Monitoring and Insulin Administration website at https://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html. Examples of Level 3, actual harm that is not immediate jeopardy include, but are not limited to: Examples of Level 2, no actual harm with potential for more than minimal harm that is not immediate jeopardy include, but are not limited to: An example of Level 1, no actual harm with potential for minimal harm includes, but is not limited to: Antibiotic Stewardship Program (ASP) Deficiency Categorization An example of Level 4, immediate jeopardy to resident health and safety includes, but is not limited to: An example of Level 3, actual harm that is not immediate jeopardy includes, but is not limited to:  The facility did not develop a program for antibiotic stewardship, and did not develop or implement a system to monitor antibiotic use. Based on record review, one resident was currently being treated with antibiotics without an appropriate indicat... An example of Level 2, no actual harm with potential for more than minimal harm that is not immediate jeopardy includes, but is not limited to:  The facility failed to implement its protocol for antibiotic use and failed to monitor actual antibiotic use. Record review indicated that the facility developed a protocol which indicated “residents with MDROs are not to be treated with antibiotic... An example of Level 3, actual harm that is not immediate jeopardy includes, but is not limited to: An example of Level 2, no actual harm with potential for more than minimal harm, that is not immediate jeopardy includes, but is not limited to: An example of Level 1, no actual harm with potential for minimal harm includes, but is not limited to: 483.85 Compliance and ethics program. §483.90(c) Emergency Power. Does each resident room have its own bathroom equipped with at least a commode and sink for facilities that receive approval of construction from State and local authorities or are newly certified after November 28, 2016? GUIDANCE Recommended methods of effective communication, include, but are not limited to, the following: 1. Identify yourself and use the resident’s name each time you speak with them.

Turn in your highest-quality paper
Get a qualified writer to help you with

“ Powerpoint Presentation ”

Get high-quality paper

Guarantee! All work is written by expert writers!

Still stressed from student homework?

Get quality assistance from academic writers!

Order now