CMS SOM App. Y, Tag Z200

The OPO’s QAPI program must include objective measures to evaluate and

demonstrate improved performance with regard to OPO activities, such as hospital

development, designated requestor training, donor management, timeliness of on-site response to hospital referrals, consent practices, organ recovery and placement,

and organ packaging and transport. The OPO must take actions that result in

performance improvements and track performance to ensure that improvements

are sustained.

Interpretive Guidelines §486.348(a)

The OPO QAPI program must include a comprehensive plan that encompasses each

phase of an organ procurement process (i.e., pre-organ procurement, procurement of the

organ(s), and post-organ procurement).

This plan should include:

a. QAPI Committee or organizational structure (the plan should delineate lines of

communication, committee composition, roles and responsibilities);

b. Objective measures by which the quality-related data will be collected and

analyzed;

c. Established frequencies for review of program performance and reporting to the

QAPI Committee or governance/leadership structure;

d. Designation of person or persons responsible for monitoring the QAPI program

and description of their role(s) and responsibilities;

e. Evidence of systemic approaches that are focused on changes and promote

sustained improvements;

f. Evidence of implementation of recommendations and continuing compliance for

improvement;

g. Evaluation of missed opportunities for donation identified through death record

reviews;

h. Analysis of complaints/investigations;

i. Measurement of the level of compliance with OPTN policies;

j. Evaluation of infectious disease;

k. Staff training requirements (sensitivity and family interactions);

l. Measurement of effectiveness with relationships to tissue banks and eye banks;

m. Measurement of effectiveness with relationships to hospitals;

n. Data collection, analysis, and reporting;

o. Evaluation of potential for Advisory Board, Governing Body conflicts of interest;

p. Evaluation of staff compliance with approved protocols; and

q. Analysis of adverse events reported to the OPO by a transplant center.