Harmony Healthcare International (HHI) Blog

Requirements Of Participation 3: Revised Guidance 6.29.2022



On June 29, 2022, CMS sent a memo to the State Survey Agency Directors providing revisions, clarifications and new guidance on the Requirements of Participation (RoP) that is effective October 24, 2022.
These communications provide information critical to the surveyor’s investigative approach and offer details of CMS’s expectations of the 2016 Requirements of Participation (RoP) for Long-Term Care (LTC) Facilities.
This is a 20/80 moment. Meaning, 20% of your efforts yield 80% of your results. Focus on these areas as they will impact 80% of your clinical and operational outcomes.
The below table is HHI’s attempt to distill and synthesize the highlights of the regulatory changes recently revised by CMS.


The HHI blog Requirements of Participation (RoP) Phase 3 Revised Guidance 6.29.2022 has been made into a PDF for you to download.

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Freedom from Abuse, Neglect, and Exploitation: Psychosocial Outcome Severity Guide



F600 – Free from Abuse, Neglect,



F607 - Investigative Protocol.


F607 – Retaliation Investigation.


F607 - Policies and Procedures.


F607 - Establish Coordination with the QAPI Program.


F608 - Relocated to F607.


F608 – Relocated to F609.


F609 - Reporting of Alleged Violations

Psychosocial Outcome Severity Guide.


F610 - Investigate Allegations.


Changes to Guidance


·      Abuse.


·      Determination of Past Noncompliance.


·      Neglect.


·      Investigative Summary for Abuse and Neglect Investigation of Allegations of Abuse.


·      Deficiency Categorization.


·      Clarifies:


o   Compliance.


o   Abuse reporting.


·      Bodily Injury report within 2 hours.


·      Non-Bodily Injury, report within 24 hours.


·      Includes sample reporting templates.


·      Provides examples of abuse that, because of the action itself, would be assigned to certain severity levels.

Abuse: F600


The resident has the right to be free from abuse, neglect, misappropriation of resident property, and exploitation.


“Although a resident-to-resident altercation should be reviewed as a potential situation of abuse, surveyors should not assume every resident-to-resident altercation result in abuse.”


“Infrequent arguments or disagreements that occurred during normal social interactions would not constitute abuse.”


“Allegations of sexual abuse specifies the facility must:


·      Develop and implement written policies and procedures that ensure reporting of crimes.

·      Meet all required timeframes for such reporting.

·      Have evidence that all alleged violations are thoroughly investigated.

·      Provide the results of the investigation to the administrator or a designated representative and other officials in accordance with state law including the state survey agency within five working days of the incident.

·      Take corrective action if appropriate.”



·      “When a facility has identified abuse, the facility must immediately take all appropriate steps to remediate the non-compliance and protect the resident from additional abuse. This includes:


o   Preventing future potential abuse.


o   Educate all staff prior to working next shift.


o   Reporting the alleged violation and investigation within the required time frames.


o   Conducting a thorough investigation of the alleged violation.


o   Taking appropriate corrective action.


o   Revising the resident’s care plan preferences because of an incident of abuse i.e., only certain gender care givers, option to change room, give the resident accommodations to feel safe and have control over environment.”


Simultaneously refer to:


F607 – Investigative Protocol for 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.





Surveyors are expected to refer 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.


HHI Note: If you have an alleged abuse, treat as an abuse. HHI involved in case in which the resident alleged assault. The facility vehemently denied the assault occurred. Ultimately, the facility was found to be innocent in the case. However, as part of the Plan of Correction, the facility trained all staff on trauma informed care, modified the resident’s care plan, applied accommodations.


The resident was found to have been assaulted in the hospital.


“If you open a barn door and you see a snake, your nervous system goes into fight or flight. Moments later, you realize it is not a snake, but merely a rolled-up piece of rope.”


Think of the resident’s emotions as if the rope were a snake and treat as such. Do not disregard the communicated feelings of a resident.


Neglect: F600 and F607


The definition of “Neglect” (§ 483.5) is expanded and includes physical harm, pain, mental anguish, and emotional distress all of which are the types of damages alleged by Plaintiff’s attorneys in nursing home lawsuits.


A neglect citation requires 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 continue to fail to take action necessary to avoid the potential for harm or actual harm to the resident.”


Neglect occurs when the facility is aware of or should have been aware of, goods or services that are resident requires but the facility fails to revive them to the resident that has resulted in or may result in physical harm pain mental anguish or emotional distress. Neglect includes cases where the facilities indifference or disregard for resident care comfort or safety resulted in or could have resulted in physical harm pain mental anguish or emotional distress.


F607 guidelines are complicated and comprised of several components, all of which need to be present to successfully meet the intent of the regulation. F607 governs the foundational obligations required for a person-centered care facility.


Neglect will be cited if the facility fails to implement an effective communication system across all shifts for communicating necessary care and information between staff practitioners and resident representatives.


“However, when a nursing home resident is treated in any manner that does not uphold resident 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.”


Policies and Procedures: F607


The facility must have Policies and Procedures for reporting crimes.


·      Screening

·      Training

·      Prevention

·      Identification

·      Investigation

·      Protection

·      Reporting/Response


Development and Implementation of Policies for the Prevention, Identification and Training on Abuse and Neglect of Residents.


This regulation not only enforces the need for regulatory compliance, but it also outlines guiding principles for providing remarkable person-centered care.


While citations for F607 identify those facilities requiring initial and ongoing education of staff, the term “staff” refers not only to care-giving staff but also medical directors, consultants, contractors, volunteers, students in nurse aide training programs or students from other disciplines who may be fulfilling course requirements in the facility.


Policies and Procedures

Screening: F607


Polices must exist for screening employees for any history of abuse, neglect, exploitation or misappropriation of resident property to prohibit these actions from occurring in the future. Procedures for this process must be clearly defined and applied with each potential employee.


Residents must also be screened prior to admission to ensure that the current staffing patterns and staff expertise are suitable to provide the necessary care the prospective resident requires, without the possibility of acts of abuse and neglect towards other residents.

Policies and Procedures

Training: F607


Facility policies must clearly define the process by which new and existing staff are trained on identifying and preventing all forms of abuse and neglect.


In addition, training must exist for staff to understand behavioral symptoms which may intensify to potential episodes of abuse towards others.

Behavioral symptoms may include:


·      Wandering.

·      Aggressive reactions.

·      Resisting care.

·      Verbal outbursts.

·      Difficulty adjusting to new routines.


Ongoing training, documentation and supervision of staff is critical to attain compliance with the training segment of the regulation.


Policies and Procedures

Prevention: F607


Policies that are required to meet this portion of the regulation include items such as:


·      Establishing a safe environment for residents.

·      Identifying, correcting and intervening in situations where abuse and neglect are more prevalent.

·      Ensuring that residents are free from abuse and neglect as evidenced through the facility assessment which identifies essential resources to preserve an abuse free environment.


The care planning process is required to include ongoing interventions for residents that may have behaviors with a proclivity to spur conflict, such as:


·      Verbal, physical or sexual aggression.

·      Removal or disturbing other’s property.

·      History of self-injury.

·      Communication disorders.

·      Speak alternate languages.

·      Require extensive nursing care.


Additionally, each resident must be provided health and safety from visitors, including family members, if they so choose and visitors must be made aware of the process in place to voice concerns without fear of retribution to themselves or the resident.


Policies and Procedures

Identification: F607


This would include but not be limited to:


·      Suspicious injuries.

·      Sudden changes in behavior like activities.

·      Fear or feelings of guilt or shame.


Staff members must feel free to report these suspicions without fear of retaliation. Facility policy must provide staff members with the procedures to identify actions classified as abusive or of property misappropriations.


Policies and Procedures

Investigation: F607


“In response to allegations of abuse, neglect, exploitation, or mistreatment, the facility must:


·       Have evidence that all alleged violations are thoroughly investigated.


·       Prevent further potential abuse, neglect, exploitation, or mistreatment while the investigation is in progress.


·       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, and if the alleged violation is verified appropriate corrective action must be taken.”


This is an area that requires special consideration by the facility due to the potential sensitive nature of a complaint or incident. Facility policies must include the staff responsible for any investigations, as well as the careful handling of evidence which could ultimately be used in a criminal investigation.


Policies must also cover investigation of different types of alleged violations, including how to interview all persons involved or who have knowledge of the incident.


The policy must identify how documentation of the incident will occur. Documentation must be concise, but thorough.


Policies and Procedures

Protection: F607


Within the policy, the facility must have clearly written procedures on how to protect, not only the resident(s) identified, but all residents within the facility, from an identified offender and/or current or future incident(s).


This includes:


·      Immediate response to the incident.


·      Preserving the integrity of the investigation.


·      Examination of the victim.


·      Increased supervision of the victim(s).


·      Room or staffing changes needed for protection.


·      Protection from retaliation.


·      Provision of emotional support and/or counseling to the resident(s) as needed.


Policies and Procedures

Reporting/Response: F607


“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.”


Facility policy must include direction on immediate reporting to the administrator, state agencies, protective services and any other required agencies such as law enforcement within required timelines.


Reporters must also be afforded the opportunity to be free from retaliation.


Facilities must also include an analysis of occurrence(s) and determine an underlying root cause of the incident(s).


Facilities must also define how care delivery will change considering the incident(s), training of staff on any changes made and competency of staff’s understanding of the changes.


There must be identification of the staff responsible for implementation and monitoring, and the expected date of implementation of changes.


Psychosocial Outcome Severity Guide: F609


The guidance emphasizes the importance of applying the reasonable person concept in determining the psychosocial outcome or potential outcome that an event may have had on a reasonable person in the residence position.


“Psychosocial” refers to the combined influence of psychological factors and the surrounding

social environment on physical, emotional, and/or mental wellness.


The “reasonable person concept” refers to a tool to assist the survey team’s assessment of the severity level of negative, or potentially negative, psychosocial outcome the deficiency may have had on a reasonable person in the resident’s position.


The reasonable person concept described in the guide is merely a tool to assist the survey team’s assessment of the severity level of negative psychosocial outcomes.


The survey team is provided with three examples (not limited to) to consider when determining the psychosocial impact of an event on a resident.


1.     The resident may consider the facility to be their “home” where there is an expectation that he or she is safe, has privacy, and will be treated with respect and dignity.


2.     The resident trusts and relies on facility staff to meet his or her needs.


3.     The resident may be frail and vulnerable.


Severity Levels

Negative Psychosocial Outcomes.


·      Severity Level 1

No Actual Harm with Potential for Minimal Harm.


·      Severity Level 2

Considerations Noncompliance No Actual Harm with Potential for More Than Minimal Harm that is Not Immediate Jeopardy.


·      Severity Level 3

Noncompliance Actual Harm that is not Immediate Jeopardy.


·      Severity Level 4

Noncompliance Immediate Jeopardy to Resident Health or Safety.


Investigate Allegations: F610


In response to allegations of abuse, neglect, exploitation, or mistreatment, the facility must:


“Thoroughly investigate the alleged violation.”


Prevent further abuse, neglect, exploitation and mistreatment from occurring while the investigation is in progress,”


“Take appropriate corrective action, because of investigation findings.”


·      Have evidence that all alleged violations are thoroughly investigated.


·      Prevent further potential abuse, neglect, exploitation, or mistreatment while the investigation is in progress.


·      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.


·      Reference F609 for the requirement to report the findings of the investigation within 5 working days.


·      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.


·      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.


·      Depending upon the type of allegation received, it is expected that the investigation would include, but is not limited to:


o   Conducting observations of the alleged victim, including identification of any injuries as appropriate.


o   The location where the alleged situation occurred.


o   Interactions and relationships between staff and the alleged victim and/or other residents, Interactions/relationships between resident to other residents.


o   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.


o   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.


·      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 and Protection: F610


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.


·      The facility conducts an inadequate investigation and ceases temporary resident protection measures that were implemented because of the alleged violation.


Examples of measures where the facility succeeded 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 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.


·      Whether administrative staff, including the administrator, were informed and involved as necessary in the investigation.

Admission, Transfer, and Discharge



F622 - Transfer and Discharge.


·       Clarifies requirements related to facility-initiated discharges. Specifically, you cannot kick a resident out when Medicare Benefit ends.


·       Addresses what to do if you cannot meet the needs of the resident.


·       Areas for surveyors to focus on include:


o   Resident signs out of the facility.

o   Resident leaves against medical advice.

o   Resident communicates they are not ready to leave the facility following the completion of therapy.


·      Once a resident is admitted, residents have the right to remain the facility unless the discharge or transfer meets one of the specified exceptions and discharging outside of these limited circumstances is a violation.


·      A resident cannot be discharged for nonpayment while determining the residence Medicaid eligibility is pending.


·      Emergency transfers to acute care defines the scenario as a facility-initiated transfer, not a discharge. The resident must be permitted to return to facility unless the facility initiates the discharge when the resident is in the hospital following the emergency transfer, then the facility must have evidence that the resident status at the time the resident seeks to return to the facility meets the required criteria.


·      The resident also has the right to return to the facility pending an appeal of any facility-initiated discharge unless the return endangers 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.


·      Care setting for routine treatment or planned procedures must also be allowed to return to the facility.


Food and Nutrition



F812 - Food Procurement, Storage, Preparation, Serve-Sanitary.



Food Procurement, Storage, Preparation, Serve-Sanitary: F812


·      CMS revised information on foodborne illnesses’ risks, causes and impact of unsafe food handling practices.


·      CMS outlined how to identify ineffective and unsafe food systems.


·      CMS outlined how to identify hazards in the food service department.


·      Hairnets must be worn:


o   Cooking.


o   Preparing.


o   Assembling.


o   Stirring pots.


o   Assembling ingredients of a salad.


·      Gloves must be worn:


o   Directly touching ready to eat food.

o   Serving residents on transmission-based precautions.


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 residence rooms and dining rooms and other floors for areas of the building.


CMS listed food related focus areas for surveyors to include:


·      Food preparation without staff properly washing their hands.


·      Meal distribution without staff properly washing their hands.


·      Serving food to residents after collecting soiled plates without staff properly washing their hands.


·      Serving food to residents after collecting food waste without staff properly washing their hands.


Mental Health

Substance Use Disorder (SUD)




F689 - Accidents.


F740 - Behavioral Health Services.


F741 - Sufficient/Competent Staff.


F741 - Staff-Behavioral Health.

Addresses rights and behavioral health services for individuals with mental health needs and Substance Use Disorder (SUD): F689, F740, F741


In efforts to improve guidance related to meeting the unique health needs of residents with mental health needs and Substance Abuse Disorder (SUD), CMS clarified that when facilities care for residents with these conditions, policies and practices must not conflict with resident rights or other requirements of participation.


CMS clarified that facility staff should have knowledge of signs and symptoms of possible substance use, and be prepared to address emergencies (e.g., an overdose) by increasing monitoring, administering naloxone, initiating cardiopulmonary resuscitation (CPR) as appropriate, and contacting emergency medical services.


CMS provided resources and non-pharmacological interventions, specific to residents living with mental disorders or substance use disorders, to assist providers in identifying alternative approaches to care to support this population.


CMS updated guidance related to substance use disorder in the following regulations:


Accidents: F689


Safety for residents with Substance Abuse Disorder (SUD) (related to elopement or overdose potential).

Behavioral Health Services: F740


Added to definition of Substance Abuse Disorder (SUD) and included that Substance Abuse Disorder (SUD) should be part of the facility assessment.


Also, included activities for residents living with mental health and Substance Abuse Disorder (SUD) may different based on needs, care plans must address needs of residents with Substance Abuse Disorder (SUD) and outlined areas a behavioral contract may address.


Sufficient/Competent Staff-Behavioral Health: F741


Added SUD to the intent, defined “Substance Use Disorder,” included SUD in guidance related to the need for sufficient staff and skills and competency of staff.


Also, included in the list of non-pharmacological interventions for Substance Abuse Disorder (SUD) is assisting with access to counseling.


Nurse Service Staffing

(Payroll-Based Journal)



F725 - Sufficient Staff.




Sufficient Staff: F725


CMS provides clarification on sufficient staff relative to the state minimum staffing requirements and the use of PBJ data to identify concerns with staffing.


·      Uses payroll-based staffing data to trigger deeper investigations of sufficient staffing and added examples of noncompliance.


·      Compliance with state staffing standards is not necessarily determinative of compliance with federal staffing standards which require enough staff to meet all the residents’ basic and individualized care needs.


·      In other words, the facility may meet the state's minimum staffing requirement but still need additional staff to meet the needs of its residents.


·      The facility is required to provide licensed nursing staff 24 hours per day seven days per week.


·      Surveyors will access the PBJ Staffing Data Report via the Casper reporting system to identify areas of concern with staffing.


Resident Rights



F61 - Self Determination.


F557 - Respect and Dignity.


F563 - Right to Receive Visitors.


F582 - Medicare, Medicaid Coverage, Liability Notices.

·      Substance Abuse.

·      Illicit Drug Usage.


Self-Determination: F61


·      If a facility changes its policy to prohibit smoking it should allow current residents who smoke to continue to smoke in an area that maintains the quality of life for those residents and considers non-smoking residents.


·      The smoking area maybe an outside area provided that residents remain safe. Residents admitted after the facility changes its policy must be informed of this policy at admission.

Respect and Dignity: F557


“A facility should not act as an arm of law enforcement and cases may warrant a referral to local law enforcement if they determine illegal substance has been brought into the facility by a visitor.”


“Facility staff cannot search a residence body or personal possessions without the residents or if applicable the resident’s representatives’ consent and reiterated that a facility should not act as an arm of law enforcement and cases may warrant referral to the local law enforcement.”


Right to Receive Visitors: F563


Addresses visitation rights secondary to unintended results of COVID-19. Provides clarity and technical corrections.


“The resident has a right to receive visitors of his or her choosing at the time of his or her choosing, subject to the residents right to delay deny visitation when applicable, and in a manner that does not impose on the rights of another resident.”


·      Deferring visitation for visitors with signs and symptoms of transmissible infections.

·      Adhering to the core principles of infection prevention to reduce the risk of transmission during visits.

·      Modify visitation practices during communicable disease outbreaks.


Medicare, Medicaid Coverage, Liability Notices: F582


Expanded details regarding beneficiary notices:


·      Notice of Medicare Non-Coverage (NOMNC).

·      Skilled Nursing Facility Advance Beneficiary Notice (SNF ABN).


To include information on the forms, circumstance of whether to initiate the forms or not and when they should be given to the resident.

Comprehensive Person-Centered Care Plan



Potential Inaccurate Diagnosis and/or Assessment


F641– Accuracy of Assessment.


F658 - Comprehensive Care Plan. Misdiagnosed.


F659 - Comprehensive Care Plan. In accordance with plan of care.


F758 - Free from Unnecessary Psychotropic Medications / PRN Usage.

Potential Inaccurate Diagnosis and/or Assessment: F641


·      CMS supplemented guidelines for accurate care planning. Specifically, reporting practitioners not adhering to professional standards of quality of care via incorrectly diagnosing and or coding a resident with new schizophrenia and antipsychotic usage to exclude the resident from the long stay antipsychotic measure.

·      If found, CMS to refer the findings to the professional State Medical Boards, Board of Nursing, etc.

·      This comes down to accurate MDS Coding and resident assessment instrument system refinement.

·      Language added in this area that services must be provided or arranged “in accordance with the resident’s plan of care.”






F755 - Controlled Medications.


F757 - Unnecessary Drugs.


·      Psychotropic Drugs.

·      Fentanyl Patch Disposal.


Controlled Medications: F755


Addresses unnecessary use of non-psychotropic drugs in addition to antipsychotics, and gradual dose reduction.


CMS provides a list of other medication classifications that affect brain activity and indicate that they fall under psychotropic requirements when the documented use appears to be a substitution for another psychotropic medication rather than for the original or approved indication.


CMS provides guidance regarding dose reductions for psychotropic medications to minimize withdrawal end addresses how to meet compliance with the Gradual Dose Reduction (GDR) requirements.




Fentanyl Patch Disposal: F755


·      CMS revised guidance on the disposal of used fentanyl patches.

·      CMS references the Food and Drug administration and manufacture instructions that recommend consumers “dispose of use fentanyl patches by folding the patch in half with the sticky sides together and flushing the patch down the sink or the toilet.”

·      “In geographical areas where state or local laws restrict flushing of pharmaceuticals, nursing homes may use drug disposal products or systems for fentanyl patches and other controlled medications; or if the facility can show that the product or system minimizes accidental exposure or diversion.


Unnecessary Drugs: F757


·      CMS added definitions for:


o   Dose.


o   Duplicate Therapy.


o   Excessive Dose.


·      “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.”


·      “The medical record must show documentation of the diagnosed condition for which psychotropic medication is prescribed.”


·      CMS outlines risks associated with the use of psychotropic medication.

·      CMS indicates that the requirements pertaining to psychotropic medications apply to the four categories of drugs:


1.   Antipsychotic

2.   Antidepressant

3.   Anti-Anxiety

4.   Hypnotic


CMS added a statement that 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.


CMS updated guidance to reflect the medical record must show documentation of the diagnosed condition for which a psychotropic medication is prescribed.



Infection Control



F880 - Infection Prevention and Control.


F881 - Infection Prevention and Control Program (IPCP) and Antibiotic Stewardship.


F882 - Infection Preventionist Role and Qualifications


·      Infection prevention and control program and antibiotic stewardship program.


·      Infection prevention list qualifications and role of the position.


·      PPE – Mask Changes Coming.

Infection Prevention and Control Program (IPCP) Antibiotic Stewardship: F881


Antibiotic Stewardship: F881


·      Requires facilities to have at a minimum, a part-time Infection Preventionist. However, CMS underscores the importance that the Infection Preventionist must meet the needs of the facility.

·      The Infection Preventionist must physically work onsite and cannot be an off-site consultant or work at a separate location.

·      Infection Preventionist role is critical to mitigating infectious diseases through an effective infection prevention and control program.

·      Infection Preventionist requires specialized training.



Infection Prevention and Control Program (IPCP): F880


CMS added a section on staff that 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.


Define standard precautions to prevent the spread of infection and explain their application during resident care activities.


Define transmission-based precautions. C. Difficile, Legionellosis and MDROs definitions added.


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 excluded.


At a minimum, the Infection Prevention and Control Program (IPCP) must include a system for:


·       Preventing.

·       Identifying.

·       Reporting.

·       Investigating.

·       Controlling.


Infections and communicable diseases that 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.



Infection Control Policies and Procedures: F880

Infection Prevention and Control


·      Define and explain standard precautions and their application during resident care activities.


·      Define transmission-based precautions:


o   Contact Precautions.

o   Droplet Precautions.

o   Airborne Precautions.


·      Explain how and when they should be utilized, as consistent with accepted national standards.


·      Define environmental cleaning and disinfection procedures for:


o   Routine cleaning and disinfection of frequently touched or visibly soiled surfaces in communal areas, resident rooms, and


o   At the time of discharge and routine cleaning and disinfection of resident care equipment including equipment shared among residents.


§  Blood pressure cuffs.


§  Rehabilitation therapy equipment.


§  Blood glucose meters.


Water Management: F880

Infection Prevention and Control


·      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.


·      An assessment to identify where Legionella and other opportunistic waterborne pathogens could grow and spread, and measures to prevent the growth of opportunistic waterborne pathogens, and how to monitor them. Control measures may include visible inspections, use of disinfectant, and temperature.


Monitoring controls include:


·      Testing protocols for control measures


·      Acceptable ranges.


·      Documenting results of testing.


·      Water management should include established ways to intervene when control limits are not met.


·      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.


·      If there is a case of healthcare-associated legionellosis or an outbreak of an opportunistic waterborne pathogen causing disease, the facility should contact the local/state public health authority and follow their recommendations.





Multi-Drug-Resistant Organisms (MDRO)

Colonization and Infection: F880

Infection Prevention and Control


Contact precautions are used for resident infected or

colonized with MDROs when a resident has:


·      Wounds.

·      Secretions.

·      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.


Droplet Precautions: F880

Infection Prevention and Control


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.


A resident who is on droplet precautions for the duration of the illness (e.g., influenza), should wear a facemask (surgical or procedure facemask) when leaving their room.


Blood Glucose Monitors: F880

Infection Prevention and Control


If the facility:


·      Failed to clean and disinfect blood glucose meters per device.

·      Failed to disinfect per manufacturer’s instructions for use.

·      Used one machine for more than one resident.

·      There is a resident with a known bloodborne pathogen in the facility the surveyor must cite noncompliance under this tag and using Appendix Q determine immediate jeopardy.


The survey agency must notify appropriate local and state public health authorities of this practice.


Administration - Arbitration Agreements




F847 - Entering Binding Arbitration.


F848 - Arbitrator/Venue Selection and Retention of Agreements.


F851- Mandatory submission of staffing information based on payroll data in a uniform format.


Binding Arbitration Agreements: F847 and F851


Clarifies requirements to settle disputes.


·      Entering Binding Arbitration

·      Arbitrator/Venue Selection and Retention of Agreements


On September 16th, 2019, CMS implemented revised regulations on the usage of arbitration agreements by facilities. The guidance clarified existing requirements for when arbitration agreements are used by nursing homes to settle disputes

This applies to any agreements entered on or after September 16th, 2019.


Entering Binding Arbitration: F847


·      Prevents making entry into an arbitration agreement a condition of admission or continued residency.

·      Requires a facility to explain the agreement to a resident or their representative.

·      Requires a facility to obtain and acknowledgement of such understanding by the resident or they are representative.

·      Requires the agreement to provide a 30 day right of rescission.

·      Prevents the facility to include any language that denies or discourages the resident or anyone else from communicating with government officials.


This new tag elaborates on how facilities should ensure that they properly communicate at the literacy level and language proficiency of the resident.


Arbitrator/Venue Selection and Retention of Agreements: F848


CMS implements requirements that arbitration agreements provide for the selection of a neutral arbitrator and a convenient venue.


“The facility should promptly be disclosed to the resident or his or her representative the extent of any relationship which exists within 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.”


Mandatory Submission of Staffing in a Unform Format


The facilities failure to submit PBJ data will be reflected on their cast for report and result in a deficiency citation.


Training Requirements



F940 - Training Requirements General.


F941 - Communication Training.


F944 - QAPI Training.


F945 - Infection Control Training.


F946 - Compliance and Ethics Training.


F949 - Behavioral Health Training.


Communication Training: F941


A facility must include effective communications as a mandatory training for direct cares staff.


“Communication includes:


·      Teletypewriters.


·      Telecommunications device for the deaf.


·      Cellular phones.


·      Accessibility such as reasonable access and privacy for electronic communications like email or internet-based interpersonal video communication.”

Topics for training should:


·      Meet the needs of the resident population.

·      Meet the needs of staff.

·      Correspond with facility assessment.


Facilities must (in a language they can understand):


·      Inform residents of their total health status

·      Provide notice of rights and services

o   both orally and in writing

o   in language the resident understands.


“Staff” includes all staff providing direct care services (training topics as appropriate to role).


If there is a concern by surveyors about effective communication, they will:


·      Utilize interviews.

·      Review training records to determine ongoing in-service training,

·      Admission of non-English speaking residents.

·      How the facility assessment reflects needs of direct care staff training of non-English speaking residents.

·      Alternative means of communication.

·      Ethnic and cultural differences reflected in communications.

·      How well staff communicate with residents.

·      Processes in place to communicate with residents with language/communication barriers during emergencies.

·      Facility training of direct care staff on non-verbal communication or residents.

·      Training of direct care staff on identifying and understanding their own non-verbal communication.




QAPI Training: F944


·      Facility must conduct mandatory training, for all staff, on the facility’s QAPI program, that includes goals and various elements of the program, including how the facility intends to implement the program. Training should 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 QAPI program, the facilities training should also be updated, and staff trained on updates. Training should support current scope and standards of practice through the curricula which detail learning objectives, performance standards, and evaluation criteria, including a process for tracking staff participation in the required training.


·      Probing questions from state surveyors may include:


o   Verification that the facility has a mandatory requirement that all staff receive QAPI training,

o   Method for verifying attendance at mandatory QAPI training,

o   Did all staff attend mandatory training?

o   Does training program inform staff of current elements and goals of QAPI program?

o   Are staff aware of what the QAPI program entails?

o   How the facility intends to implement and monitor the QAPI program.

o   Are staff aware of how-to bring ideas or concerns to the attention of the QAA committee?

o   How does the facility determine when training content requires updating to be consistent with current professional standards and guidelines?



Infection Control Training: F945


Facilities must develop, implement, and permanently maintain an effective training program for all staff that includes training on:


·      Standards.

·      Policies.

·      Procedures.


The infection prevention and control program is appropriate, effective and determined by staff need.


Staff includes:

·      All facility staff (direct and indirect care functions).

·      Contracted staff.

·      Volunteers (training topics as appropriate to role).


Ensure the Infection Control Training are current with changes to the facility:


·      Resident population.


·      Community infection risk.


·      National standards.


·      Staff turnover.


·      Facility’s physical environment.


·      Facility assessment may necessitate ongoing revisions to the facility’s training program.


·      Training should support current scope and standards of practice through curricula that includes learning objectives, performance standards, evaluation criteria, and address potential risks to staff, residents, and volunteers if procedures are not followed.

Infection Control Training, at a minimum, must include:


·      The surveillance system designed to identify possible communicable disease or infection before they can spread to others, when and to whom possible incidents of communicable disease or infection 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 type and its duration of use depending upon the infection agent or organism, occupational health policies including circumstances under which the facility must enforce work restrictions and when to self-report illness or exposures to potentially infectious materials, and proper infection prevention and control practices when performing resident care activities as it pertains to staff roles responsibilities and situations.


Probing questions for surveyors include:


·      Did observations or interviews with staff indicate a training need?

·      Did staff report not receiving training?

·      What process does the facility have to engage staff to express concerns and request training?

·      Does the facility respond to staff concerns and requests for training, review training coursework to determine if content meets professional standards/guidelines and covers facility policy and procedures for infection prevention and control?

·      Does facility implement the training program and ensure staff are instructed to meet requirements of infection control, verification that all staff participate in infection prevention and control training with a process in place to track participation?

Compliance and Ethics Training: F946


Training for all facility staff (direct and indirect care functions), contractual services, volunteers consistent with expected roles.


Operating organization must provide training program or another practical manner to effectively communicate the


·      standards,


·      policies, and


·      procedures


of the compliance and ethics program to entire staff.


For operating organizations that operate five or more facilities, annual training for staff must be conducted.


Training should support current scope and standards of practice through curricula that includes:


·       Learning objectives.

·       Performance standards.

·       Evaluation criteria with a process to track staff participation in training.


Probing questions from surveyors may include:


·      Does the facility provide training or effectively communicate the standards policies and procedures of the compliance and ethics program?


·      Does facility have system for tracking staff attendance at trainings.


·      Is annual compliance and ethics training provided? (For organizations with five or more facilities.)

Behavioral Health Training: F949


Develop, implement, and maintain effective training program for all staff that includes at a minimum training on behavioral health care and services that is appropriate and effective as determined by staff need and facility assessment that includes:


·      All staff (direct and indirect care functions).

·      Contracted staff.

·      Volunteers (training topics as appropriate to role).

·      Changes to resident population.

·      Staff turnover.

·      Facility physical environment.

·      Modifications to facility assessment may require ongoing revisions to training program.


Training should support current scope and standards of practice through curricula that details learning objectives, performance standards, and evaluation criteria with processes in place to track staff participation at trainings.


Training should include at minimum person-centered care

and services that reflect the:


·       Resident’s goals for care.

·       Interpersonal communication that promotes mental and psychosocial well-being.

·       Meaningful activities that promote engagement and positive meaningful relationships.

·       Environment and atmosphere conducive to mental and psychosocial well-being.

·       Individualized non-pharmacological approaches to care.

·       Care specific to individual needs of resident that are diagnosed with dementia, mental psychosocial, or substance use disorder or history of trauma and/or post-traumatic stress disorder or other behavioral health conditions.

Probing Behavioral Health Training questions from surveyors may include:


·      Does staff demonstrate skills needed to promote highest practicable level of function for residents with identified behavioral health care needs?

·      Can staff explain concepts learned in training?

·      How does facility assure all staff interacting with residents are trained?

·      How does facility assure that all staff including contractors and volunteers are training to interact with residents with specific behavioral health care needs?

·      Is training program designed to address residents’ specific behavioral health care needs?

·      Does facility track staff participation in training?

·      Does facility monitor effectiveness of training?

·      How are changes implemented to training program if desired outcomes are not achieved?

·      Is training curriculum based on results of facility assessment?


Resident’s Rights and Facility Responsibilities


Facility staff understand and foster the rights of all residents. Staff includes all facility staff (direct and indirect care functions), contracted staff, volunteers (training topics as appropriate to role).


Facilities must develop and implement an ongoing education program on all resident rights and facility responsibilities for care of residents as outlined in §483.10.


Education programs should 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.


Process for validating that the training was completed, whether in a group setting or an individual basis. Probing questions from surveyors may include interview of staff to determine if they received training regarding the rights of residents and facility responsibilities, observe staff interactions with residents, review training documentation provided by facility related to resident rights and facility responsibilities, and interview staff from various departments and disciplines about their knowledge of resident rights and facility responsibilities.



Physical Environment



F910 - Resident Rooms.


F919 - Resident Call Systems.

Resident Rooms/Bedrooms: F910


·      CMS is highlighting the benefits of reducing the number of residents in each room given the lessons learned during the COVID-19 pandemic for preventing infections and the importance of residents’ rights to privacy and homelike environment.


CMS is urging providers to consider making changes to their physical environment to allow for a maximum of double occupancy in each room and explore ways to allow for single occupancy rooms as outlined in QSO-22-19-NH.


CMS outlines the advantages to limiting rooms to double or single occupancy, including:


1.     Allowing for more resident privacy for daily activities such as dressing and visiting with friends and family (§483.10(h)).


2.     Encourages a homelike environment (§483.10(i)).


3.     Improving infection control and prevention by reducing the risks associated with multiple residents in the same room and making it easier to isolate or quarantine residents who are infectious.


Resident Call Systems: F919


Additions were made to specify that 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.

·      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.

Quality of Care



F699 - Trauma Informed Care.


Trauma Informed Care: F699


This guidance defines culture, cultural competence, trauma, and trauma-informed care.


Principles pertaining to trauma informed care adapted from SAMHSA including safety, trustworthiness and transparency, peer support and mutual self-help, collaboration, empowerment, voice and choice.


Facilities to provide a comprehensive assessment to identify a history of trauma and cultural preferences.


·      Inquire about resident’s specific triggers or stresses that may prompt a recall of prior traumatic events.


·      Utilize screening and assessment tools, admission assessment, history and physical, social history and utilize feedback from family and other health care professionals.


·      The facility must identify triggers which may re-traumatize residents with history of trauma. The mere fact a resident is transitioning into an institutional setting inherently enhances the potential for re-traumatization.


Example of common triggers:


·      Loud noises.


·      Bight flashing lights.


·      Lack of privacy.


·      Confinement in crowded areas.


·      Confinement in small spaces.


·      Certain sounds.


·      Certain smells.


·      Physical touch.




Increasing changing demographics has led to need to provide culturally competent care that includes racial and ethnic diversity, religious preferences, sexual orientation, and gender identity.


The facility must provide culturally competent care.


·      Racial diversity.

·      Ethnic diversity.

·      Religious preferences.

·      Sexual orientation.

·      Gender identity.



Non-Compliance will be cited if the surveyors find the facility:


·      Failed to identify cultural preferences of resident who is a trauma survivor.

·      Failed to identify a resident’s history of trauma.

·      Failed to identify triggers which may cause re-traumatization.

·      Failed to consistently apply approaches that are culturally competent, and trauma informed.


Cultural Competencies


Help staff communicate effectively with residents/families and provide care that is appropriate to culture and individual.


Care Planning to Address Cultural Preferences


When admitting a resident, facility has determined that it can provide care and services that resident requires.


Create and sustain an environment that humanizes and promotes resident’s well-being and feeling of self-worth and self-esteem. Staff must understand the cultural preferences of individuals and how it impacts the delivery of care.


Staff must demonstrate proficiency in communicating with residents to ensure critical information can be conveyed and must include sufficient guidance for staff, including temporary staff, on how to communicate and deliver care to residents.


Monitoring Delivery of Care and Services


Must monitor effects of their approaches to ensure they are implemented as intended and have the desired effect to achieve measurable objectives and resident’s goals for care.




Care Planning to Address Past Trauma


Facility should collaborate with resident trauma survivors, resident’s family, friends, other healthcare professionals (as appropriate) to develop and implement individualized interventions.


Consider establishing support group run by qualified professional(s) or allowing the support group to meet in a facility.


When trauma survivors are reluctant to share history, the facility is still responsible to try to identify triggers which may cause re-traumatization and develop care plan interventions which minimize or eliminate the effect of the trigger.


Examples of triggers and interventions to minimize are shared in guidance.


Trauma-specific interventions should recognize the interrelation between trauma and symptoms of trauma such as


·      substance abuse,

·      eating disorders,

·      depression, and

·      anxiety.


Interventions generally recognize survivors’ need to be:


·      respected,

·      informed,

·      connected, and

·      hopeful,


regarding their own recovery and may need access to support groups either in facility or in community if appropriate and feasible.



Quality Assurance and Performance Improvement



F865 - QAPI Systems.


F867 - QAPI Policies and Procedures.


F687 - Additional Requirements:



F687 - Additional Requirements:

Data Collection.


F687 - Additional Requirements: Performance Indicators.


F687 - Additional Requirements: Systematic Analysis.


F687 - Additional Requirements:



F687 - Additional Requirements:

Medical Errors and Adverse Events.


F687 - Additional Requirements: Performance Improvement Projects.


F687 - Additional Requirements:

Quality Assessment and Assurance (QAA).


F868 - QAPI Fail to Report.


CMS defines “The Purpose of QAPI” as:


·      Ensuring care delivery systems function consistently, accurately, and incorporate current and evidence-based practice standards where available.

·      Preventing deviation from care process to the extent possible.

·      Identifying issues and concerns with facility systems, as well as identifying opportunities for improvement.

·      Developing and implementing plans to correct and or improve identified areas.”


Additional Requirements: F687


Feedback: F687


Each facility must establish and implement written policies and procedures for feedback.  


Feedback must be collected from:


·      direct care staff,

·      other staff,

·      residents,

·      resident representatives and

·      other sources.


Feedback should be collected:


·      for both problem areas as well as

·      opportunities for improvement.


Feedback should include the provision of feedback from direct care staff, other staff, resident and resident representatives.





Data Collection System and Monitoring: F687


·      Facilities must collect and monitor data reflecting its performance and adverse events.


·      Facilities must have policies and procedures that describe how data will be identified, frequency collected and the methodology for collecting said data.


Performance Indicators: F687


·      Facilities must have policies and procedures in place for monitoring and evaluating performance indicators.


·      These policies and procedures must include what frequency the facility develops, monitors, and evaluates its performance indicators.


Systematic Analysis and Action: F687


·      Facilities must have policies and procedures with address how it will use systematic approaches to determine underlying problems and how corrective actions will be designed to impact change at a systems level.


·      The policies and procedures must also address how the facility will monitor the effectiveness of its performance improvement activities and ensure sustainability of improvements.


Establishing Priorities: F687


·       Facilities must establish priorities for their performance improvement activities.





Medical Errors and Adverse Events: F687


·      Facilities must establish policies and procedures that allow for systematically identifying and investigating medical errors and adverse events.

·      These policies and procedures must include how the facility will analyze and use data to develop activities to prevent further medial errors and adverse events.

·      Instances of abuse, neglect, and misappropriation of resident property and exploitation were added to the list of potentially preventable events related to care.

·      Education must be provided to staff, residents, resident representatives, and family members on medical errors and adverse events.


Performance Improvement Project: F687


·      Facilities must conduct performance improvement projects, with a minimum of one annually.

·      Regulatory requirements of §483.75(c) and §483.75(c)(1)-(4) have been relocated from F866 to F867.


A facility will be cited under F865 if they:


·      Fail to maintain documentation and evidence of its ongoing QAPI program.

·      Fail to present the facility QAPI plan to the Federal and/or State surveyors during recertification survey or upon request.

·      Fail to present QAPI evidence necessary to demonstrate compliance with these requirements.

·      Fail to develop, implement and maintain an effective, comprehensive QAPI program, which addresses the full range of services the facility provides.

·      Fail to ensure governing body oversight of the facility’s QAPI program and activities.



A facility will be cited under F867 if they:


·      Fail to 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.

·      Fail to develop and implement policies and procedures which include how it ensures data is collected, used and monitored for all departments.

·      Fail to develop and implement policies and procedures for how the facility develops, monitors and evaluates performance indicators and the frequency for these activities.

·      Fail to develop policies and procedures for how it will identify, report, and track, adverse events, and high risk, high volume, and/or problem-prone concerns.

·      Fail to establish priorities for its improvement activities, which focus on high-risk, high-volume or problem-prone areas, as well as resident safety, choice, autonomy, and quality of care.

·      Fail to ensure the QAA Committee developed and implemented action plans to correct identified quality deficiencies.

·      Fail to measure the success of actions implemented and track performance to ensure improvements are realized and sustained.

·      Fail to track medical errors and adverse events, analyze their causes, and implement preventive actions and mechanisms.

·      Fail to conduct at least one PIP annually that focuses on high-risk or problem prone areas, identified by the facility, through data collection and analysis.

·      Fail to 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 improvement.


Quality Assessment and Assurance (QAA): F868


A facility will be cited under F868 if QAA Committee:


·      Fails to report updates to the governing body.


QAA Committee


Long term care facilities are required to develop written policies and procedures that define how staff will communicate and coordinate situations of abuse neglect misappropriation of resident property and exploit dictation with the QAPI program.


The QAA committee functions under the facilities governing body and is responsible for:


·      Develop appropriate plans of actions to correct deficiencies identified.


·      Implement appropriate plans of actions to correct deficiencies identified.


·      Regularly review and analyze data under QAPI


·      Regularly review and analyze data and drug regimen review.


·      Act on available data to make improvements.


Quality Assessment and Assurance (QAA) – Infection Preventionist


·      Infection Preventionist (IP) participation on the quality assessment and assurance committee and must report to the committee on the infection prevention and control updates on a regular basis.


·      Infection prevention and control reporting should occur at the same frequency as the QAA committee meetings.


·      Infection prevention and control reporting at QAA meetings may include:


o   Facility process.


o   Outcome surveillance.


o   Outbreaks.


o   Control measures.


o   Occupational health communicable disease illness.


o   Antibiotic stewardship program related to:


§  Antibiotic Usage.

§  Resistance Data.


For the Infection Preventionist (IP) to be considered an active participant of the QAPI process, the Infection Preventionist (IP) should:


·      Attend each QAA meeting.


·      If the Infection Preventionist (IP) cannot attend, then another staff member should report on the Infection Preventionist’s (IP’s) behalf.


·      This representation does not change or absolve the Infection Preventionist’s (IP’s) responsibility to fulfill the role of QAA committee member or reporting on the Infection Prevention and Control Program (IPCP).




State Operations Manual Chapter 5

State Investigations of Complaint Allegations




































Exhibit 23 ASPEN Complaints-Incidents Tracking System (ACTS) 7.26.2022



·      ASPEN Complaints/Incidents Tracking System (ACTS) is a Windows-based program designed to help you process and track complaints and incidents involving health care providers regulated by the Centers for Medicare and Medicaid Services (CMS).


·      Use ACTS to create, update, and upload complaint/incident records


State Operations Manual Chapter 5


CMS to assess the State Agencies (SA) backlog and establish a target implementation date for meeting the new investigation timelines as established with this revision of Chapter 5 of the SOM later, depending on the status of the PHE, and/or unique circumstances occurring in the State Agencies (SA).


·      Revised timeframes.


·      Clarifies


o   timeliness of state investigations, and

o   communication to complainants


to improve consistency across states.


·      CMS indicated that the revised guidance in Chapter 5 will


o   strengthen the oversight of nursing home complaints and Facility Reported Incidents (FRIs) and aims to


o   improve consistency across the State Agencies (SA) in their communication to complainants.


·      The revised guidance includes the following:


·      Ensures that State Agencies (SA) have policies and procedures that are consistent with Federal requirements.


·      Revises timeframes for investigation, to ensure that serious threats to residents’ health and safety are investigated immediately.


·      Requires that allegations of abuse, neglect, and exploitation be tracked in CMS’ system.



·      Requires that the State Agencies (SA):


o   Report all suspected crimes to law enforcement if it has not yet been reported.


o   Removes the term “substantiate” from the SOM and instructs surveyors to specify whether non-compliance was identified during a complaint investigation.


o   Exhibit 23 ASPEN Complaints-Incidents Tracking System (ACTS) 7.26.2022was revised to conform to the changes in Chapter 5. See left column.


o   Exhibits 358 and Exhibit 359 provide sample templates that may be used for Facility Reported Incidents (FRIs).


o   These templates ensure State Agencies (SA) have the information needed to review and prioritize the incident for investigation.


o   Downloads at the end of the blog.




Contact Kris
Kris Mastrangelo OTR/L, MBA, LNHA, President and CEO
Harmony Healthcare International, Inc. (HHI)

Cell: 617.595.6032

Office: 1.800.530.4413




About the Author

Kris Mastrangelo, OTRL/L, LNHA, MBA

Kris Mastrangelo, OTRL/L, LNHA, MBA
President and CEO

Kris is a nationally recognized keynote speaker with more than 32 years of experience in the Health Care industry with a specialty in the Long Term Post-Acute Care Setting. An Occupational Therapist degree from Tufts University followed by a Master's in Business Administration from Salem State University coupled with a Nursing Home Administrator's License, affords Kris an in-depth perspective into the clinical, financial, and operational components critical for business success. Initially providing direct care as an Occupational Therapist, Kris became familiar with the Medicare, Medicaid, and multiple other reimbursement systems.


Kris is the founder, owner, President and CEO of Harmony Healthcare International, Inc (HHI) an internationally recognized, premier Healthcare Consulting firm. Kris started the company in 2001. Harmony Healthcare International, Inc. (HHI) is a recognized consulting firm that uses a systematic approach in addressing the C.A.R.E.S. platform which is trademarked and created by HHI and stands for Compliance, Analysis, Audit, Regulatory, Rehabilitation, Reimbursement, Education, Efficiency and Survey.


Kris speaks on an array of subject matters including Leadership, Compliance, Auditing and Monitoring, QAPI, Analysis, Reimbursement (PDPM, Case Mix, Medicare, Medicaid, HMOs) Regulatory, Survey (Process, IIDR, IIDR, Appeals), Five-Star Quality Rating, Rehabilitation, Program Development, MDS, Facility Assessment, Quality Measures, Value-Based Purchasing, Infection Control, COVID-19, Team Building, Staff Retention, Staff Recruitment and Revenue Cycle Management to name a few.


Kris proclaims that:

"HHI’s on-site and off-site medical record review process is the nucleus for C.A.R.E.S.
optimization and ongoing systems improvement."




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  • HHI Blog 7.27.2022 Requirements of Participation (RoP) Phase 3 Revised Guidance 6.29.2022

    Click here to download this blog as a PDF

  • Appendix PP - Guidance for Surveyors -State Operations Manual - June 2022
  • Exhibit 23 ASPEN Complaints-Incidents Tracking System (ACTS) 7.26.2022
  • Exhibit 358 - Sample Form Facility Reported Incidents 7.26.2022
  • Exhibit 359 - Follow-Up Investigation Report
  • F-Tag Crosswalk 7.26.2022
  • Psychosocial Severity Guide - Appendix P Section IV E 7.26.2022
  • QSO Memo Guidance - Requirements of Participation (RoP) Phase 3 Dated 6.29.2022
  • State Operations Manual (SOM) Chapter 5 - June 2022

    Download the Exhibits, Guidance and Manuals


Topics: CMS, Requirements of Participation, Regulatory Change, Regulatory

Kris Mastrangelo, OTR/L, LNHA, MBA


Kris Mastrangelo, OTR/L, LNHA, MBA

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