Conditions of Participation · 42 CFR Part 484
§484.65 Condition of participation: Quality assessment and performance improvement (QAPI).
The regulation text and CMS’s interpretive guidelines for every survey tag under this condition, quoted from the State Operations Manual, Appendix B (Rev. 245).
§484.65 Condition of participation: Quality assessment and performance improvement (QAPI).
On the 2567: Quality Assessment/Performance Improvement
The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA’s governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS.
CMS’s guidance for this tag
Interpretive Guidelines § 484.65
The manner and degree of noncompliance identified in relation to the standard level tags for §484.65 may result in substantial noncompliance with this CoP, requiring citation at the condition level.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.65(a) Standard: Program scope.
On the 2567: Program Scope
(1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care.
(2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations.
CMS’s guidance for this tag
Interpretive Guidelines §484.65(a)
The HHA selects the indicators that it will utilize in its QAPI program based upon identified adverse or negative patient outcomes or agency processes that the HHA wishes to monitor and measure. Each indicator must be measurable through data to evaluate any HHA change in procedure, policy or intervention.
The HHA QAPI program must include procedures for measurement and analysis of indicators and address the frequency with which such measurement and analysis will occur.
Per §484.70(b) the HHA must maintain a coordinated agency-wide program for the surveillance, investigation, identification, prevention, control and investigation of infectious and communicable diseases as an integral part of the QAPI program.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.65(b) Standard: Program data.
On the 2567: Program Data
(1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program.
(2) The HHA must use the data collected to-
(i) Monitor the effectiveness and safety of services and quality of care; and
(ii) Identify opportunities for improvement.
(3) The frequency and detail of the data collection must be approved by the HHA’s governing body.
CMS’s guidance for this tag
Interpretive Guidelines §484.65(b)(1)-(3)
HHAs seeking initial enrollment in the Medicare program are unlikely to have collected extensive data for their QAPI program indicators, since they likely have been in operation for a relatively brief time. Nevertheless, these initial applicants must have a QAPI program in place, and must be able to describe how the program functions, including which indicators/measures are being tracked, at what intervals, and how the information will be used by the HHA to improve quality and safety.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.65(c) Standard: Program activities.
On the 2567: Program Activities
(1) The HHA’s performance improvement activities must—
(i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients.
CMS’s guidance for this tag
Interpretive Guidelines §484.65(c)(1)
“High risk” areas may include global concerns such as a type of service (e.g., pediatrics), geographic concerns (e.g., safety of a neighborhood served); or specific patient care services (e.g., administration of intravenous medications or tracheostomy care). All factors would be associated with significant risk to the health or safety of patients.
“High volume” areas refers to care or service areas that are frequently provided by the HHA to a large patient population, thus possibly increasing the scope of the problem (e.g. laboratory testing, physical therapy, infusion therapy, diabetes management).
“Problem-prone” areas refer to care or service areas that have the potential for negative outcomes and that are associated with a diagnosis or condition for a particular patient group or a particular component of the HHA operation or historical problem areas.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.65(c)(2)
On the 2567: Track Adverse Patient Events
§484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions.
CMS’s guidance for this tag
Interpretive Guidelines §484.65(c)(2)
“Adverse patient events” are those patient events that are negative and unexpected, impact a patient’s HHA plan of care, and have the potential to cause a decline in a patient’s condition.
HHAs must track all adverse patient events, to determine through subsequent analysis whether they were the result of errors that should have been preventable, to reduce the likelihood of such events in the future. HHAs should also consider a way to identify errors that result in near misses, since such errors have the potential to cause future adverse events.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.65(c)(3)
On the 2567: Improvements Are Sustained
§484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.65(d) Standard: Performance improvement projects.
On the 2567: Performance Improvement Projects
Beginning January 13, 2018 HHAs must conduct performance improvement projects.
(1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations.
(2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects.
- The CFR reads: “Beginning July 13, 2018 HHAs must conduct performance improvement projects”
Logicly’s note, not CMS text
the manual prints January 13, 2018; the CFR prints July 13, 2018
CMS’s guidance for this tag
Interpretive Guidelines §484.65(d)
The HHA should have at least one performance improvement project either in development, on-going or completed each calendar year.
The HHA decides, based on the QAPI program activities and data, what projects are indicated and the priority of the projects.
Survey Procedures §484.65(d)
• Ask the HHA to show you documentation for performance improvement projects currently underway, as well as those completed in the prior year.
• Does the HHA’s documentation indicate the rationale for undertaking each project? Does the HHA have data indicating it had a problem in the area targeted for improvement, or could the HHA point to recommendations from a nationally recognized expert organization suggesting the activities?
• Does the documentation for the completed project(s) include the project’s results? If a project was unsuccessful, ask the HHA what actions it took because of that information. If the project was successful, ask the HHA how it is sustaining the improvement.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.65(e) Standard: Executive responsibilities.
On the 2567: Executive Responsibilities For Qapi
The HHA’s governing body is responsible for ensuring the following:
(1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained;
(2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness;
(3) That clear expectations for patient safety are established, implemented, and maintained; and
(4) That any findings of fraud or waste are appropriately addressed.
CMS’s guidance for this tag
Interpretive Guidelines §484.65(e)(1)-(4)
The governing body must assume overall responsibility for ensuring that the QAPI program reflects the complexity of the HHA and its services, involves all services (including those provided under contract or arrangement), focuses on indicators related to improved outcomes, and takes actions that address the HHA's performance across the spectrum of care. Additionally, the HHA’s governing body must appropriately address any findings of fraud or waste in order to assure that resources are appropriately used for patient care activities and that patients are receiving the right care to meet their needs (82 FR 4504, 4510, 4561 (Jan. 13, 2017)). If the HHA identifies or otherwise learns of an action by an HHA employee, contractor or responsible or relevant physician or allowed practitioner that may be illegal, the HHA should report the action to the appropriate authorities in accordance with applicable law.
Survey Procedures §484.65(e)(1)-(4)
• Ask the HHA for information about its governing body. If there are questions about who constitutes the HHA’s governing body, it may help to review the information the HHA reported on its CMS Form 855A application, identifying those individuals with ownership interest or managing control of the HHA.
• Ask to see meeting minutes or other evidence of how the governing body exercises ongoing oversight of and accountability for the HHA’s QAPI program.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
Current CFR text, 42 CFR 484.65 as revised 2025-10-01 (govinfo)
§ 484.65 Condition of participation: Quality assessment and performance improvement (QAPI).
The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS.
(a) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care.
(2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations.
(b) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program.
(2) The HHA must use the data collected to—
(i) Monitor the effectiveness and safety of services and quality of care; and
(ii) Identify opportunities for improvement.
(3) The frequency and detail of the data collection must be approved by the HHA's governing body.
(c) Standard: Program activities. (1) The HHA's performance improvement activities must—
(i) Focus on high risk, high volume, or problem-prone areas;
(ii) Consider incidence, prevalence, and severity of problems in those areas; and
(iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients.
(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions.
(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained.
(d) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects.
(1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations.
(2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects.
(e) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following:
(1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained;
(2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness;
(3) That clear expectations for patient safety are established, implemented, and maintained; and
(4) That any findings of fraud or waste are appropriately addressed.
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Source: State Operations Manual, Appendix B - Guidance to Surveyors: Home Health Agencies (Rev. 245, issued 08-05-26), text extracted from the PDF with pdftotext, retrieved 2026-10-09, and 42 CFR Part 484, annual edition revised as of October 1, 2025 (govinfo XML granules). Works of the US Government are in the public domain.
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