Transplant programs must develop, implement, and maintain a written, comprehensive, data-driven QAPI program designed to monitor and evaluate performance of all transplantation services, including services provided under contract or arrangement.

(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.

(1) The policies must address, at a minimum, the process for the identification, reporting, analysis, and prevention of adverse events.

(2) The transplant program must conduct a thorough analysis of and document any adverse event and must utilize the analysis to effect changes in the transplant program's policies and practices to prevent repeat incidents.

[72 FR 15273, Mar. 30, 2007, as amended at 84 FR 51822, Sept. 30, 2019]