Section 416.43 - Conditions for coverage-Quality assessment and performance improvementThe ASC must develop, implement and maintain an ongoing, data-driven quality assessment and performance improvement (QAPI) program.
(a)Standard: Program scope.(1) The program must include, but not be limited to, an ongoing program that demonstrates measurable improvement in patient health outcomes, and improves patient safety by using quality indicators or performance measures associated with improved health outcomes and by the identification and reduction of medical errors.(2) The ASC must measure, analyze, and track quality indicators, adverse patient events, infection control and other aspects of performance that includes care and services furnished in the ASC.(b)Standard: Program data.(1) The program must incorporate quality indicator data, including patient care and other relevant data regarding services furnished in the ASC.(2) The ASC must use the data collected to- (i) Monitor the effectiveness and safety of its services, and quality of its care.(ii) Identify opportunities that could lead to improvements and changes in its patient care.(c)Standard: Program activities.(1) The ASC must set priorities for its performance improvement activities that- (i) Focus on high risk, high volume, and problem-prone areas.(ii) Consider incidence, prevalence, and severity of problems in those areas.(iii) Affect health outcomes, patient safety, and quality of care.(2) Performance improvement activities must track adverse patient events, examine their causes, implement improvements, and ensure that improvements are sustained over time.(3) The ASC must implement preventive strategies throughout the facility targeting adverse patient events and ensure that all staff are familiar with these strategies.(d)Standard: Performance improvement projects.(1) The number and scope of distinct improvement projects conducted annually must reflect the scope and complexity of the ASC's services and operations.(2) The ASC must document the projects that are being conducted. The documentation, at a minimum, must include the reason(s) for implementing the project, and a description of the project's results.(e)Standard: Governing body responsibilities. The governing body must ensure that the QAPI program-(1) Is defined, implemented, and maintained by the ASC.(2) Addresses the ASC's priorities and that all improvements are evaluated for effectiveness.(3) Specifies data collection methods, frequency, and details.(4) Clearly establishes its expectations for safety.(5) Adequately allocates sufficient staff, time, information systems and training to implement the QAPI program. 73 FR 68812 , Nov. 18, 2008