CMS SOM App. X, Tag X-099

(QAPI)

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.

Guideline §482.96

The transplant program develops its transplant program-specific quality assessment and

performance improvement (QAPI) program either individually or collaboratively with the

transplant hospital QAPI program and functions as a component of the associated hospital QAPI

program required at 42 CFR §482.21. There should be evidence of communication between the

two entities to ensure that both entities are actively involved in QAPI activities which address the

specific requirements of the transplant CoPs. If the transplant program has a separate QAPI

program, it must provide evidence that it is interrelated with the hospital QAPI plan.

A comprehensive transplant QAPI program evaluates and monitors performance of

transplantation services across every aspect of the program from the evaluation of a potential

recipient/donor candidate through his/her discharge from the hospital. A comprehensive QAPI

program approach embraces a broad, multidisciplinary, system-wide perspective. It

encompasses all aspects of clinical care and all relevant hospital services and includes input from

a broad representation of staff at all levels, including individuals with authority to make

decisions about the transplant program’s policies, practices and resources. It continuously

monitors, evaluates and improves all organ transplantation services for transplant candidates,

transplant recipients, donor candidates, and living donors across all phases of transplantation and

living donation, including transplant services provided under contract or arrangement.

A data-driven transplant QAPI program continually uses data to guide quality assessment and

performance improvement activities with respect to all transplantation services. The program

proactively, systematically and at regular specified intervals:

• Identifies, implements, assesses and re-assesses the data to be collected for each measure

and other information needed to monitor and evaluate performance of transplantation

services in all areas;

• Collects, records and reviews the data for accuracy;

• Analyzes the data and uses the data/analyses to assess the program’s performance; and

• Uses the results of its analyses to monitor, evaluate and improve the quality and safety of

all transplantation/donation services on an ongoing basis.