The Final Rule requires the OPTN to set policy for the equitable allocation of deceased donor organs among potential recipients and to set up mechanisms to enforce the Final Rule and OPTN policies. UNOS as the OPTN contractor has processes in place to analyze each case of deceased donor organ allocation that occurs in the United States. Instances of possible egregious deviation from policy requirements are referred to the Membership and Professional Standards Committee (MPSC) for formal review and possible action. We have historically performed this allocation analysis on a case-by-case basis.
Changes in Progress
The MPSC is currently improving the process for compliance review of OPTN member organ allocation activities. The improved process entails a more consistent and efficient way of summarizing and presenting organ allocation information to the Committee. The new process allows for the examination of patterns and trends across time at the member level and also at the OPTN level, as opposed to the historic case by case analysis.
An MPSC sub-group has refined triggers that would signal the possibility of a problematic organ allocation (i.e., organ allocations that do not proceed according to OPTN policy requirements). These triggers will help the MPSC prioritize which allocation-related cases require further review and action. The sub-group also defined additional case information needed to ensure a consistent, accurate, thorough review and they mapped out the process the MPSC would use to work through this trend analysis review.
Priority cases for MPSC review include allocations that involve:
- Allocation to a recipient not on the match run.
- Allocation made out of sequence of the match run.
- Organ re-directed to recipient other than intended recipient (per match run).
The Way it Was
Each year, UNOS staff retrospectively reviews data on every one of the over 20,000 deceased donor organ allocations that result in transplant in the U.S. Of those allocations reviewed, two percent of them contain information or data that signal a potential violation of OPTN allocation policy. This resulted in over 400 individual organ allocation events potentially needing further investigation and MPSC review. A systematic method to screen and prioritize such events, and assure consistency in the review of these events was needed. These improvements have been accomplished.
What can you expect now?
The MPSC will be systematically reviewing those types of deviations listed above. Even if you have provided an explanation for an allocation decision, you need to know that the MPSC may still formally review your response to a written inquiry from UNOS staff. Answering the questions in this inquiry will help the MPSC understand why your organization made specific organ allocation decisions and why you took a particular action. If your program has multiple deviations between scheduled review periods, the MPSC will also now formally look for possible non-compliant practice patterns in organ allocation and determine if any action is necessary. You will continue to be notified in writing if one of your organ allocations is going to be formally reviewed by the MPSC.