Hospital-based Quality Assurance and Performance Improvement Program

(A) Each cardiac catheterization or electrophysiology service shall establish and maintain an effective, ongoing, data-driven, evidence-based quality assessment and performance improvement (QAPI) program for all catheterization procedures, including electrophysiology procedures, if applicable, that focuses on patient outcomes while assessing individual operator clinical proficiency as well as overall laboratory safety and efficiency. (B) The hospital, through its QAPI program, shall: (1) Identify quality measures, based on nationally accepted standards, that capture the quality of care provided and patient safety; (2) Collect and maintain data pertaining to these measures in a systematic manner; (3) Perform statistical analyses of the data for comparison with nationally accepted quality indicator benchmarks and longitudinally within the hospital on a routinely scheduled basis; (4) Analyze comparison results and identify areas for improvement; and (5) Develop, implement and evaluate evidence-based improvement interventions to address the identified areas, and incorporate feedback for catheterization service staff on the effectiveness of the solutions and/or triggers for further opportunities for improvement. (C) The program shall include, but not be limited to, assessments of the following: (1) Appropriate patient selection (according to preestablished selection criteria, consistent with nationally accepted standards); (2) The appropriateness of each cardiac catheterization or electrophysiology service procedure; (3) Technical quality of the catheterization or electrophysiology service studies; (4) Diagnostic accuracy and completeness of studies; (5) All catheterization or electrophysiology procedure-related complications and adverse outcomes (including infections) identified or reported; (6) Number of cases requiring interhospital transfer and the reason for transfer; (7) The number and percent of diagnostic cardiac catheterization procedures determined to be normal (i.e., no disease or physiologically insignificant coronary stenoses); and (8) Patient experience measure data. (D) Each cardiac catheterization service shall participate in a national data registry to help compare results and track complications. (E) Cardiac catheterization or electrophysiology service medical records must include at a minimum the following information: type of procedure performed, indication for procedure, time course of procedural events, time and dose of all medications administered, fluoroscopy time, all catheter sheaths and special guide wires used, pertinent hemodynamic and/or electrophysiologic data, a detailed summary of the procedure, and a description of the angiographic or electrophysiologic findings and clinical recommendations. (F) The hospital shall maintain quarterly written reports of QAPI findings, recommended actions, progress on implementation and supporting data, which shall be available for Department review upon request.