UNOS DonateLife

December 21, 2006

Monitoring Compliance, Safety Key to Transplant System

Historically, the OPTN's primary focus has been the efficient and equitable allocation of the nation's organ supply and the collection of data for analyzing organ donation, organ transplantation and transplant outcomes. UNOS has always considered patient health and safety as a paramount concern in the development and implementation of organ distribution policy and membership standards.

In recent years, especially since the promulgation of the OPTN Final Rule in 2000, increasing emphasis has been placed on the process of monitoring and reviewing OPTN/UNOS member organizations. This is done to ensure compliance with OPTN policies and by-laws, as well as the safety and quality of care provided to transplant candidates, transplant recipients and living organ donors.

Under its contract with the Health Resources and Services Administration (HRSA) for operation of the OPTN, UNOS evaluates OPTN member compliance and patient safety through the UNOS Department of Evaluation and Quality (DEQ), the UNOS Membership Department, and the OPTN/UNOS Membership and Professional Standards Committee (MPSC). The DEQ and Membership Department monitor members and refer any potential violations or compliance issues to the MPSC for review and consideration.

Under the MPSC's oversight and direction, UNOS staff perform or coordinate a number of activities to monitor and assess institutional performance. These include:

• In-house reviews of individual organ allocations to ensure members have followed the OPTN match run
• Review boards, composed of transplant professionals, who ensure that urgent liver, heart and lung candidates have met criteria to justify their priority status
• Onsite reviews of transplant programs and organ procurement organizations to assess accuracy and completeness of data conveyed to UNOS and adherence to policies regarding patient listing, organ donation and transplantation
• Identification of transplant programs whose patient or graft survival rates are significantly lower than expected, based on comparable national data
• Special reviews to address issues of patient safety as directed by HRSA through the OPTN contract.

If any review or analysis of a member institution reveals potential compliance or safety issues, the MPSC further evaluates the situation. Depending on the circumstances of the issue, the MPSC may conduct confidential, peer-review interviews and hearings with members to assess facts relevant to the OPTN's authority.

The MPSC often requests from the member a plan of corrective action.  The OPTN by-laws outline the procedural guidelines for all interviews and hearings, as well as various recommendations or actions the MPSC can take.  If the committee believes additional action by the OPTN/UNOS Board of Directors is warranted, it will offer recommendations to the Board.

The ultimate goal of the MPSC process is to ensure policy compliance and institutional performance within an expected range based on national experience.  However, certain recent issues have resulted in publicly announced designations of either member probation or Member Not in Good Standing.  Members under these designations are subject to enhanced monitoring of activity, and they can have the designation removed only after they demonstrate to the MPSC and Board of Directors that they have thoroughly addressed issues leading to the action. In other instances, transplant programs have chosen to inactivate or close when it is clear that they cannot meet OPTN standards or requirements.

Ensuring compliance and patient safety is a herculean effort that consumes thousands of hours every year of both UNOS staff and committee volunteers. But the result is a compliance-review process that is thorough, consistent and responsive in helping to ensure that members follow established policies and maintain transplant equity. Assuring the integrity of the national transplant system is crucial to building and maintaining the public's trust, which in turn is vital to promoting organ donation and transplantation.