Board addresses compliance and quality monitoring

Published on: Friday, November 18, 2005

Reston, VA -- The OPTN/UNOS Board of Directors, at its meeting Nov. 17-18, voted to expand and improve monitoring and public notice of OPTN/UNOS member institutions for compliance with OPTN/UNOS by-laws and policies and quality outcomes for transplant candidates and recipients.

"Organ transplantation is already accountable to the public to a higher degree than any other form of patient care," said OPTN/UNOS President Francis Delmonico, M.D. "In general, we find an extremely high level of quality and compliance with the standards the transplant community has established. But where additional scrutiny of a member institution is needed to ensure future compliance, we will improve our review and inform the public of the status of the review. This is necessary to maintain public trust in the transplant system, both for those awaiting transplants and those who meet their needs through organ donation."

The OPTN reviews compliance with by-laws and policies addressing how transplant candidates are listed for deceased donor transplantation and matched with available donor organs. OPTN policies also address submission of detailed data about donors and transplant recipients. In addition, the OPTN monitors performance of transplant institutions on key measures such as transplant program activity and outcomes within a statistically expected range.

"We have a peer review process that is focused on improvement and quality," said Dr. Delmonico. "Many issues are readily addressed by the institution early in our review process. But if there are issues that affect patient safety, as determined by the OPTN/UNOS Board, we will make these findings known while we continue to seek quality improvements."

The Board directed the OPTN/UNOS Membership and Professional Standards Committee to study additional means of identifying potential non-compliance or issues of transplant performance. These issues include onsite surgeon and physician coverage at transplant programs; wait list deaths; patterns of organ offer refusals; and actions taken by regulatory or healthcare  organizations that may affect performance. The Committee was asked to present recommendations at the next OPTN/UNOS Board meeting in March 2006.

In other news, the Board approved a modification to the sequence of heart allocation. Because donated hearts remain viable for transplantation only a few hours outside the body, they are offered to compatible candidates based primarily on medical urgency and geographic distance from the donor. Under the revised policy, hearts will be offered to candidates in the two highest levels of medical urgency (Status 1A and Status 1B) up to a distance of 500 miles from the donor location before any local candidates of lower urgency (Status 2) would receive organ offers. Analysis of transplant data indicates the new policy should decrease pre-transplant deaths by about seven percent. The policy is also anticipated to increase transplants of pediatric candidates by about six percent.

UNOS manages the nation's Organ Procurement and Transplantation Network (OPTN) under contract with the U.S. Department of Health and Human Services, Health Resources and Services Administration, Division of Transplantation. The OPTN brings together medical professionals, transplant recipients and donor families to develop organ transplantation policy.