UNOS DonateLife

January 19, 2007

OPTN/UNOS Member Compliance and Quality Review Initiatives

MEMORANDUM

TO:	UNOS Representatives and Alternate Representatives, Transplant Center CEOs, Transplant Program Directors, Transplant Program Administrators/Managers, OPO Executive Directors
FROM:	Sue McDiarmid, M.D., President, OPTN/UNOS
SUBJECT:	OPTN/UNOS Member Compliance and Quality Review Initiatives
DATE:	January 12, 2007

Dear Colleagues,

As we begin this new year, I wish to remind you of the continuing atention the OPTN and UNOS devote to issues of institutional member compliance with policies and by-laws, as well as the safety and quality of outcomes for transplant candidates, recipients and living donors. As many of you know, in the last year the oversight of transplantation, including our role, has been an area of intense media scrutiny.

Evaluating compliance is not a new issue for us. Indeed, since the implementation of the OPTN Final Rule in 2000, UNOS has increased its staffing and developed more sophisticated monitoring tools to identify potential policy violations or deviation from expected performance standards. The OPTN and UNOS actively employ continuous process improvement, both in the data analysis and onsite audits performed by staff and in the peer review process of the OPTN/UNOS Membership and Professional Standards Committee (MPSC).Key areas of review and monitoring include:

• Education, training and clinical experience of key personnel identified by each member institution.
• Waitlisting of transplant candidates and verification of key clinical data
• Center and OPO performance metrics
• Potential transplant program inactivity
• Allocation of each donated organ
• Patient and graft survival rates of each transplant program in relation to volume of transplants
• Peer review of alleged violations of OPTN policies and bylaws

Where reviews have indicated a need for corrective action, our continuing emphasis is to protect patients' interests and encourage the member to come back into compliance and/or an acceptable range of performance. In many instances, this process has resulted in voluntary action by the member. Since the year 2000, 106 transplant programs have voluntarily closed due to an inability to meet OPTN standards or policies.

Yet in 2005 and 2006, issues and events at several member institutions led to an unprecedented scope of action by the OPTN/UNOS Board of Directors. The designation of "Member Not in Good Standing," originally adopted in 1997, had never been applied until 2006; the Board ultimately applied this designation to two transplant centers last year. Three other centers were placed on probation in 2005 and 2006; since November 2005, this designation also includes public notice. In addition, the U.S. Department of Health and Human Services withdrew federal designation for two of the transplant programs cited by the OPTN/UNOS Board; this too was unprecedented before 2006. Other member reviews have resulted in letters of warning or reprimand from the MPSC; four such letters were issued from 2005 through 2006.

We have learned a great deal from the issues that have come before the MPSC in the last two years, some of which had never before been considered in depth. As a result, the OPTN and UNOS are in the process of instituting new measures and processes to continue to improve our monitoring and review. At its most recent meeting in December, the Board adopted a procedure for categorizing potential policy violations and expediting the review for any issues posing an imminent or continuing threat to patient safety. Early in 2007 we expect to seek public comment on new standards for onsite physician and surgeon coverage at transplant programs, as well as how best to monitor key staff who relocate from an institution that has had a significant policy violation or lapse in patient safety or quality of care. During this year you also will be asked to comment on new organ specific metrics under development that would assess each program's risk adjusted organ acceptance rates. We ask for your expertise and support as we develop new standards and policies to ensure our mandates are met properly.

In general, members comply very well with OPTN policies and by-laws and maintain a high quality of care for patients and living donors. Yet we are uniquely bound to high expectations. We depend upon public trust and goodwill in transplantation, as without it we cannot rely on the public to support organ donation. It is in our shared interest to set our standards to their utmost and live up to them in practice. I look forward to your input and cooperation in this new year to ensure that we do so.