Code of Federal Regulations Title 42. Public Health § 42.482.96 Condition of participation:  Quality assessment and performance improvement (QAPI)

(a) Standard:  Components of a QAPI program. The transplant program's QAPI program must use objective measures to evaluate the center's performance with regard to transplantation activities and outcomes. Outcome measures may include, but are not limited to, patient and donor selection criteria, accuracy of the waiting list in accordance with the OPTN waiting list requirements, accuracy of donor and recipient matching, patient and donor management, techniques for organ recovery, consent practices, patient education, patient satisfaction, and patient rights. The transplant program must take actions that result in performance improvements and track performance to ensure that improvements are sustained.

(b) Standard:  Adverse events. A transplant program must establish and implement written policies to address and document adverse events that occur during any phase of an organ transplantation case.