C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER G—STANDARDS AND CERTIFICATION › PART 482—CONDITIONS OF PARTICIPATION FOR HOSPITALS › Subpart C—Basic Hospital Functions

42 C.F.R. § 482.21

Condition of participation: Quality assessment and performance improvement program

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The hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital's governing body must ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS.

(a) Standard: Program scope. (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes and identify and reduce medical errors.

(2) The hospital must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that assess processes of care, hospital service and operations.

(b) Standard: Program data. (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions.

(2) The hospital must use the data collected to—

(i) Monitor the effectiveness and safety of services and quality of care; and

(ii) Identify opportunities for improvement and changes that will lead to improvement.

(3) The frequency and detail of data collection must be specified by the hospital's governing body.

(4) Effective January 1, 2027, for hospitals that offer obstetrical services, the hospital must utilize its quality assessment and performance improvement (QAPI) program to assess and improve health outcomes and disparities among obstetrical patients on an ongoing basis. At a minimum, the hospital must:

(i) Analyze data and quality indicators collected for the QAPI program by diverse subpopulations as identified by the hospital among obstetrical patients.

(ii) Measure, analyze, and track data, measures, and quality indicators on patient outcomes and disparities in processes of care, services and operations among obstetrical patients.

(iii) Analyze and prioritize patient health outcomes and disparities, develop and implement actions to improve patient health outcomes and disparities, measure results, and track performance to ensure improvements are sustained among obstetrical patients.

(iv) Conduct at least one measurable performance improvement project focused on improving health outcomes and disparities among the hospital's population(s) of obstetrical patients annually.

(c) Standard: Program activities. (1) The hospital must set priorities for its performance improvement activities that—

(i) Focus on high-risk, high-volume, or problem-prone areas;

(ii) Consider the incidence, prevalence, and severity of problems in those areas; and

(iii) Affect health outcomes, patient safety, and quality of care.

(2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital.

(3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained.

(d) Standard: Performance improvement projects. As part of its quality assessment and performance improvement program, the hospital must conduct performance improvement projects.

(1) The number and scope of distinct improvement projects conducted annually must be proportional to the scope and complexity of the hospital's services and operations.

(2) A hospital may, as one of its projects, develop and implement an information technology system explicitly designed to improve patient safety and quality of care. This project, in its initial stage of development, does not need to demonstrate measurable improvement in indicators related to health outcomes.

(3) The hospital must document what quality improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects.

(4) A hospital is not required to participate in a QIO cooperative project, but its own projects are required to be of comparable effort.

(e) Standard: Maternal health QAPI activities. Effective January 1, 2027, for hospitals that offer obstetrical services, the following additional QAPI requirements apply:

(1) Obstetrical services leadership must engage in QAPI as specified in this section for obstetrical services, including but not limited to participating in data collection and monitoring as specified in paragraph (b) of this section.

(2) If a maternal mortality review committee (MMRC) is available at the State, Tribal, or local jurisdiction in which the hospital is located, the facility leadership, obstetrical services leadership, or their designate(s) must further have a process for incorporating publicly available MMRC(s) data and recommendations into the hospital QAPI program as specified in paragraph (b) of this section.

(f) Standard: Executive responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following:

(1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained.

(2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety; and that all improvement actions are evaluated.

(3) That clear expectations for safety are established.

(4) That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and reducing risk to patients.

(5) That the determination of the number of distinct improvement projects is conducted annually.

(g) Standard: Unified and integrated QAPI program for multi-hospital systems. If a hospital is part of a hospital system consisting of multiple separately certified hospitals using a system governing body that is legally responsible for the conduct of two or more hospitals, the system governing body can elect to have a unified and integrated QAPI program for all of its member hospitals after determining that such a decision is in accordance with all applicable State and local laws. The system governing body is responsible and accountable for ensuring that each of its separately certified hospitals meets all of the requirements of this section. Each separately certified hospital subject to the system governing body must demonstrate that:

(1) The unified and integrated QAPI program is established in a manner that takes into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; and

(2) The unified and integrated QAPI program establishes and implements policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, are given due consideration, and that the unified and integrated QAPI program has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed.

[68 FR 3454, Jan. 24, 2003, as amended at 84 FR 51818, Sept. 30, 2019; 89 FR 94591, Nov. 27, 2024]
Notes of Decisions
Cited in 13 cases (2 in the last 5 years), 1992–2023 · leading case: Burger v. Lutheran Gen. Hosp., 759 N.E.2d 533 (Ill. 2001).
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Burger v. Lutheran Gen. Hosp., 759 N.E.2d 533 (Ill. 2001). · cites it 2× “, 42 C.F.R. § 482.21 (2001) (Medicare and Medicaid regulations require hospitals to engage in ongoing quality assurance reporting); 21 C.”
Univ. of Kentucky v. Bunnell, 532 S.W.3d 658 (Ky. Ct. App. 2017). · cites it 4× “42 C.F.R. § 482.21 (c)(2), (e)(2). 45 Under a section of the rule entitled “Program data[,]” it is the hospital,' not the government, that specifies “[t]he frequency and detail of data collection.”
Herbert J. Thomas Mem'l Hosp. Assoc. v. Susan Nutter, 795 S.E.2d 530 (W. Va. 2016). “Standard 42 CFR 482.21 (e) (2): Public policy requires that the hospital governing body, medical staff, and administrative officials are responsible and accountable for ensuring that the hospital-wide quality assessment and performance improvement efforts address priorities for…”
Evelyn v. v. Kings Cnty. Hosp. Ctr., 956 F. Supp. 288 (E.D.N.Y 1997). · cites it 3× “12 (Governing Body), 42 C.F.R. § 482.21 (Quality Assurance), 42 C.”
Evelyn v. v. Kings Cnty. Hosp. Ctr., 819 F. Supp. 183 (E.D.N.Y 1993). “7(b)(6), (8) — (11), (14) (1988); and (7) adequate plans for discharge and post-hospital follow-up care, in violation of 42 C.F.R. § 482.21 (b) (1992); and N.Y.Pub.”
Aurora Chi. Lakeshore Hosp. v. Azar, 356 F. Supp. 3d 749 (E.D. Ill. 2018). “The Illinois Department of Human Services completed its investigation on November 21, 2018, finding that Aurora remained non-compliant with the condition of participation concerning patients' rights, was no longer in compliance with the condition of participation governing…”
Johnson v. Nyack Hosp., 964 F.2d 116 (2d Cir. 1992). “” 42 C.F.R. § 482.21 . To comply with these mandates, in 1985, defendant Nyack Hospital (“Nyack”) asked Dr.”
East Texas Med. Ctr. Gilmer v. Birder Porter (Tex. App. 2015). · cites it 7× “Excerpts from the CMS State Operations Manual, Appendix A, Survey Protocol, Regulations and Interpretive Guidelines for Hospitals.”
Montejo v. Martin Mem'l Med. Ctr., Inc., 874 So. 2d 654 (Fla. 4th DCA 2004). “42 C.F.R. § 482.21 (b)(2). 59 Fed. Reg. 64149 .”
Spath v. Cnty. of Santa Clara (N.D. Cal. 2023). · cites it 3× “Failure to provide adequate resources for departmental quality assessment projects 16 under 42 C.F.R. § 482.21 (e)(4) 17 Plaintiffs allege Defendants violated 42 C.”
Herbert J. Thomas Mem'l Hosp. Assoc. v. Susan Nutter (W. Va. 2016). “Standard 42 CFR 482.21 (e) (2): Public policy requires that the hospital governing body, medical staff, and administrative officials are responsible and accountable for ensuring that the hospital-wide quality assessment and performance improvement efforts address priorities for…”
Olicia v. The Methodist Hosp. (S.D. Tex. 2022). “” 42 C.F.R. § 482.21 . The presentation also cites to the Patient Safety and Quality Improvement Act of 2005, which required the federal Agency for Healthcare Research and Quality to develop reporting methods for hospitals to implement such a program.”
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— 42 C.F.R. § 482.21(a)(2) — 1 case
East Texas Med. Ctr. Gilmer v. Birder Porter (Tex. App. 2015). “Excerpts from the CMS State Operations Manual, Appendix A, Survey Protocol, Regulations and Interpretive Guidelines for Hospitals.”
— 42 C.F.R. § 482.21(e)(3) — 1 case
East Texas Med. Ctr. Gilmer v. Birder Porter (Tex. App. 2015). “Excerpts from the CMS State Operations Manual, Appendix A, Survey Protocol, Regulations and Interpretive Guidelines for Hospitals.”
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