The QAPI revisions in the advanced copy of Appendix PP include three F-tags including F865, F866, F867, and F868. Revisions are summarized below:

F865:

Reviewing the previous intent of this regulation, it described the QAPI plan, the revision language for the intent describes that the provider is now required to “implement” instead of developing a plan.

Definitions were added in the surveyor guidance including governing body, indicators, QAPI, Quality Assurance, and performance improvement. It will be important for providers to incorporate these definitions into your policy and procedure.

Quite a bit of the surveyor guidance under this F-tag was revised. The information in the surveyor guidance describes how a provider is expected to implement the QAPI plan including:

• Utilizing a systematic, interdisciplinary, comprehensive, and data-driven approach to maintaining and improving safety and quality.
  • Interdisciplinary encompasses all managerial, and clinical services, which includes care and services provided by outside (such as contracted or arranged) providers and suppliers.
  • The purpose of the QAPI program is to ensure continuous evaluation of the providers 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 provider systems, as well as identifying opportunities for improvement; and
    • Developing and implementing plans to correct and/or improve identified areas.

Program and Documentation

Each provider is expected to develop, implement, and maintain an effective, comprehensive, data-driven QAPI program that focuses on indicators of the outcomes of care and quality of life. It is required that providers are able to provide documentation and evidence of its ongoing QAPI program.

An example of a recent trend in deficient practice that was noted while reviewing survey trends:

• During multiple resident council meetings, the residents report that call lights are taking longer than 15-minutes for staff to respond to and address their needs. Upon surveyor review of the resident council concerns (or grievance) forms, the management staff indicated that call light audits would be completed. However, upon review of the provider’s QAPI documentation there wasn’t evidence that the provider completed audits of the call light response times.

In this example, providers should audit (whether your call light system has the capability to print reports or if it is direct observation of call light response times) and document data-driven evidence of whether the call light response times are a concern. In your QAPI documentation, surveyors should be able to view (if allowed based on the QAPI privilege) evidence that a management individual (or someone else that was delegated) that call light response times were reviewed. An example may be that staff C observed 20 call lights from the hours of 6 p.m. to 9 p.m. with 2 call lights that exceeded 15 minutes for response.

In addition to monitoring for compliance, providers should also have documentation of:

• Investigation, analysis, and prevention of adverse events;
• Data collection and analysis at regular intervals;
• Development, implementation, and evaluation of corrective actions or performance improvement activities.

CMS also revised the surveyor guidance to include infection control logs as a required report and log that must be incorporated into the QAPI/QAA program.

Putting this into practice:

Since call lights are frequently a concern identified by residents, it would be recommended that call light response times are routinely monitored (for example on a monthly basis) as a part of your QAPI plan. Based on the information in the example of call light monitors above, the QAPI team should investigate and determine what the root cause of the call lights exceeding 15 minutes is. Based on the root cause identified, providers should develop a plan of action to correct the concern, with increased monitoring to ensure the plan of action corrected the identified concern.

The surveyor guidance also notes that upon the request of surveyors (including State Survey Agencies, Federal Surveyors, or CMS, the provider must present evidence, including documentation, of ongoing QAPI program implementation and compliance with requirements.

Program Design and Scope

The QAPI program should be ongoing, comprehensive, and capable of addressing a full range of care and services it provides. At a minimum, the QAPI 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 provider goals, that reflect processes of care and operations that have been shown to be predictive of desired outcomes for residents; and
• Reflects the complexities of unique care and service the provider provides to residents.

Effective QAPI programs address systems of care and management practices. Systems of care (or care delivery systems) are the process in place to achieve an expected clinical outcome. The surveyor guidance describes the system of care for prevention (or treatment) or pressure ulcers. Providers should have systems in place related to pressure ulcers including, but not limited to:

• Identifying pressure ulcers on admission/readmission
• Assessing for risk of pressure ulcers (on admit/readmit and quarterly)
• Implementation of prevention measures based on risk scores (such as cushions, air mattresses, routine repositioning, incontinence cares, etc.)
• A system for CNAs to observe resident’s skin on a routine basis (such as with cares and bathing) and reporting concerns identified to the nurse.
• Upon identification of a skin concern the physician and family should be notified, a treatment should be implemented, additional measures should be implemented to assist with healing the pressure ulcer (such as additional pressure reduction techniques based on where the area is located), consultation with a dietitian and potentially wound clinic
• Care planning all of the above (including when an actual pressure ulcer is identified including the treatment for the pressure ulcer)

Providers should establish routine monitoring of these care delivery systems in their QAPI program. This could include routine monitoring of assessing risk (monitoring all residents records to ensure that assessment of risk is completed on admission and quarterly) or ensuring that systems are implemented upon identification of a pressure ulcer (such as ensuring that skin assessments are completed on a weekly basis after identification, physician and family have been notified, dietitian consultation with implementation of additional nutrition interventions as appropriate, etc.).

In addition to care delivery systems, providers should routinely monitor resident’s quality of life aspects including the right of resident’s preferences. This could be done by routinely interviewing random residents as a part of the QAPI program and identifying if staff are following their preferences such as if they’re able to sleep in until they desire, or go to bed when they desire.

Ideally, all processes regarding resident care and services should be routinely monitoring in the QAPI program.  This will ensure that each step of the system is effectively and timely carried out as required in the RoPs.

Governance and Leadership

The governing body and/or executive leadership (note in the definitions, this is an individual or group that assumes full legal authority and responsibility for operation of the organization) must ensure that the QAPI program:

• Is defined, implemented and ongoing
• Addresses identified priorities
• Is sustained through transitions of 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
• Establishes clear expectations around safety, quality, rights, choice, and respect

QAPI Privilege

According to the surveyor guidance, the QAPI/QAA task must be completed at the end of the survey process, after completion of investigation into other requirements to ensure that concerns are identified by the survey team independent of the QAPI/QAA review. Surveyors may only require that a provide disclose QAA records if they are used to determine the extent to which the provider is compliance with QAPI/QAA provisions.

CMS revised this section to include examples of when disclosure may be necessary to determine compliance:

• If the provider’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 provider must allow the surveyor to review and copy QAA committee minutes and related documentation so that the surveyor is capable of evaluating the provider’s QAPI/QAA compliance.
• If the surveyor’s staff interviews and record reviews reveal the provider has a past history of failing to follow care instructions and recommendations from clinical specialists when residents obtain specialty care outside the building, the provider 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: In addition to the above examples, in the last few months of survey trends deficiencies with QAPI/QAA regulations have been increasing based on recurring deficiencies on multiple surveys. For example, if a provider was cited for F880 related to hand hygiene during perineal cares and the provider indicated in their plan of correction that hand hygiene during perineal cares would be monitored in the QAPI meetings, however, during this survey the surveyors again identified concerns with hand hygiene during perineal cares. The surveyors will want to review the QAPI/QAA documentation to ensure that the plan of correction was followed and what steps the QAPI/QAA committee took to identify ongoing concerns with this same deficient practice. If there is no evidence that the concern was monitored on an ongoing basis, the surveyor may write a deficiency for F865.

Good Faith Attempts

CMS notes that a provider must do more than subjectively assert that it has made a good faith attempt to comply with QAPI/QAA and other regulatory requirements. Surveyors must determine if the provider’s actions, taken as a whole, is evidence of a good faith attempt to identify and correct quality deficiencies. The surveyor should review where the provider is in the correction process to identify whether a good faith attempt was made.

For example, in the example of hand hygiene, upon being cited for a deficiency during the last survey, the provider is showing a good faith attempt to comply if they routinely monitored staff practices related to hand hygiene during perineal cares including implementing corrective action when concerns were identified, with additional monitoring for correction. If the provider lacks documentation of efforts to monitor and implement additional plans of correction, the provider may be cited under F865 for this, in addition to the other relevant deficiency F-tag.

F866:

The regulatory requirements under F866 were relocated to F867.

F867:

The regulatory language from F866 was included in the regulatory language from F867. Reviewing the regulatory language from F866 and F867 there were no changes to the regulatory language.

An intent was added to F867 which states “These provisions are intended to ensure facilities obtain feedback, use data, and take action to conduct structured, systematic investigations and analysis of underlying causes of contributing factors of problems affecting facility-wide processes that impact quality of care, quality of lift, and resident safety.

A few of the definitions in F867 were revised:

• The phrase “which includes near misses” was removed from “Adverse event” and was separated into its own definition and was revised.
• High Risk was changed to “high-risk areas” and a statement added that states “Errors in these care areas have the potential to cause adverse events resulting in pain, suffering and/or death. Examples include (added anticoagulants to the list of medication)”.
• The definition of incidence, indicator, medical error, prevalence, systematic, and systemic were added to this regulation.

There were several additions to the surveyor guidance in F867:

Feedback:

Feedback is one of the many data sources that providers must incorporate into their effective QAPI program. A written policy must be implemented related to how the provider gathers feedback for decisions related to care provided to the resident. Feedback sources include:

• Direct care staff
• Other staff
• Residents and Representatives

Feedback is 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 daily routines on their physical, mental, and psychosocial well-being.

Providers should choose the best mechanism to gather feedback to support their QAPI program including but not limited to:

• Satisfaction surveys and questionnaires
• Routine meetings (including care planning meetings, resident council, safety teams, town halls)
• Suggestion or Comment boxes.

Data Collection Systems and Monitoring:

The policy and procedure must address how data will be identified, and the frequency and methodology for collecting and using data from all departments. The provider determines what data it will collect to represent the 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 auditing tools, direct observations, interviews, testing, MDS and QMs, electronic and paper record reviews, 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 is valid and reliable and support all departments and the facility assessment.

Data collection is not expected to be collected all on the same frequency. Areas that are high-risk or high-volume may be gathered more frequently (such as daily or weekly) where other data collection may occur less frequently (such as quarterly or annually).

Performance Indicators:

The policy and procedure must incorporate developing, monitoring, and evaluating performance indicators. In addition, the policy must describe what frequency the provider develops, monitors, and evaluates its performance indicators. The QAA Committee should establish performance thresholds and goals, identify deviations in performance and evaluate progress.

Systematic Analysis and Action:

The provider is responsible for having systems in place and implementing actions intended to improve performance which includes corrective actions, measuring success, and tracking performance to ensure improvements are achieved and sustained.

The policy and procedure must address:

• How it will use systematic approaches (including RCA, reverse tracking methodology, or health-care failure and effects analysis) to assist in determining underlying causes of problems impacting larger systems.
• How it 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 provider will monitor the effectiveness of performance improvement activities to ensure that improvements are sustained.

Medical Errors and Adverse Events:

In addition to self-identified improvement activities, the provider must also track medical errors and adverse resident events. When medical errors or adverse resident events are identified, the provider must analyze the root cause of the error/event, implement corrective actions to prevent future events, and conduct monitoring to ensure desired outcomes are achieved and sustained.

The policy and procedure must enable the provider to systematically identify and investigate for medical errors and adverse events, including how the provider will analyze and use data relating to errors/events to develop activities to prevent future occurrences.

Performance Improvement Projects (PIPs):

The provider must conduct distinct PIPs, based on the scope and complexity of the services and available resources identified as a result of the facility assessment. While the number and frequency of improvement projects may vary, each provider must conduct at least one PIP annually that focuses on high-risk or problem-prone areas, identified through data collection and analysis. PIPs are a process that involve a team making a concentrated effort over time to improve a systematic problem or improve quality in absence of a problem which require systematic investigation (such as RCA) and the development of corrective action plans.

The action plans are intended to address quality deficiencies and improve performance and may be implemented in a variety of ways including staffing training, deployment of changes to procedures, monitoring and feedback mechanisms, and processes to revise plans that are not achieving or sustaining desired outcomes.

F868:

The regulatory language in F868 was updated to include the Infection Preventionist participation on the QAA committee on a regular basis. The definition section was updated to include the definition of the Infection Preventionist (IP) and regular basis.

In addition, the surveyor guidance was updated to include information on the Infection Preventionists role in the QAA including a report on the Infection Prevention and Control Program (IPCP) and incidents such as healthcare associated infections (HAI). Reporting may include, but is not limited to, the process and outcome surveillance of the provider, outbreaks, control measures, occupational health communicable disease illness (such as TB and Influenza) and the Antibiotic Stewardship Program (ASP). The IP must be an active participant which includes actively attending the meetings, or delegating another staff member to report on the IP’s behalf.

The surveyor guidance also includes the role of the governing body in the QAA committee. The QAA committee is responsible for reporting activities, including the implementation of the QAPI program to the governing body or designated person(s) functioning as the governing body. A note was also included in the surveyor guidance indicating that smaller providers may not have a governing body and may be the administrator, who is already a required member of the QAA committee and therefore already apprised of the QAPI activities.