United Network for Organ Sharing

1. United Network for Organ Sharing

2. The Problem Demand Supply

3. Waiting List as of Oct. 9, 2009 • 81,884 patients waiting for a kidney transplant. • 15,944 patients waiting for a liver transplant. • 1,496 patients waiting for a pancreas transplant. • 200 patients waiting for a pancreas islet cell. • 2,187 patients waiting for a kidney-pancreas transplant. • 226 patients waiting for an intestine transplant. • 2,888 patients waiting for a heart transplant. • 82 patients waiting for a heart-lung transplant. • 1,867 patients waiting for a lung transplant. • 104,296 TOTAL PATIENTS*

4. Topics • UNOS/OPTN History and Organization • Organ Allocation Principles and Policies • Donor Risk Index

5. UNOS/OPTN Orientation • History • Structure • Contract & Board Responsibilities • Policy Development • Policy Compliance Monitoring & Enforcement

6. History

7. 1984 – Congress Saw Need for a Network Supply enhancement donation recovery usage Supply management efficiency effectiveness equity

8. National Organ Transplant Act of 1984 • Prohibited buying & selling organs • Organ Procurement & Transplantation Network (OPTN) • Private nonprofit entity by contract with HHS • National policy board • National policy and system • Nationwide coordination • Created the modern OPO system

9. OPTN Structure • Secretary of HHS • Health Resources and Services Administration • OPTN/UNOS Board of Directors • UNOS Staff and Committees

10. UNOS Regional Map

11. OPTN Regions

12. OPTN Membership Transplant centers 257 Organ Procurement Organizations 58 Histocompatibility labs 58 Public organizations 10 Medical/Scientific Organizations 23 Business Members 2 Individual Members 12 TOTAL 420

13. OPTN Leadership • Board of Directors • 25% recipients, donors, donor families • 50% transplant doctors • Designated professional representation • HRSA representatives • Committees • 20 national committees • 23 Regional and National Review Boards • 550 volunteer participants • Patients, families, doctors, allied professionals • HRSA representatives

14. Organ Specific Thoracic Liver/Intestine Kidney Pancreas Ethics Finance Histocompatibility Ad Hoc International Relations Living Donation MPSC Minority Affairs OPO Organ Availability Patient Affairs Pediatrics Policy Oversight Transplant Administrators Transplant Coordinators Operations Ad hoc Disease Transmission Advisory Committee OPTN Committees

15. Each OPTN Committee has … • Chair and Vice Chair • Dedicated Volunteers • regional representation • professionals • lay constituents • Government Representative • Staff Liaison

16. OPTN Policies • OPTN Board responsible for developing policies • Equitable allocation of cadaveric organs • Donor testing to prevent spread of infectious diseases • Reduce socio-economic inequities • MD requirements for designated programs • As Secretary directs

17. Allocation Policy Criteria • Organ-specific • Sound medical judgment • Best use of organs • Give programs the right to refuse • Avoid wastage and futile transplants • Promote patient access • Promote efficient organ placement • Not to be based on candidate’s location unless to do otherwise would result in inefficient placement, wasted organs, poor use of organs…

18. Performance Goals • Objective, measurable listing criteria • Ranking by urgency • Taking into account the final rule’s policy criteria and alternative approaches • Distribution over as large an area as feasible in order of decreasing urgency • Reduce inter-program performance indicator variance as reasonable

19. Policy Compliance Monitoring and Enforcement

20. Policy Compliance • UNOS Approach to the OPTN • Collective & interdependent • Collaboration and cooperation • Policies by consensus • Peer-based QA and organ sharing • Participation & representation

21. Approach to Compliance • Peer-to-peer collaboration • Policies by consensus • Day to day interaction • Mutual dependency and obligation • Data for monitoring • Staff analysis and audits

22. Field Audits • Every heart & liver program 3 years • Every OPO every 3 years • Onsite review of medical records • every status 1 listing • random sample of other status codes • Data completeness

23. Policy Enforcement • Board advises HHS of noncompliance and makes recommendations • Recommendations may include • Loss of designation to receive organs • Termination of Medicare participation • Other measures in approved policy • Secretary may take action as appropriate

24. Policy Enforcement • Peer review and due process • assurance of compliance, not punitive • formal process of hearings • Potential adverse actions • Member Not in Good Standing • standards of practice • legal and business risks • reprimand, further audit, probation, suspension • recommend action to HHS Secretary

25. Two Tiered Approach – OPTN Action • OPTN attempts to bring members into compliance and to make performance improvements • Focus on corrective action • Use of sanctions to prompt corrective action when necessary • Conducted as confidential peer review to encourage authentic participation in quality improvement

26. Two Tiered Approach – OPTN Action • OPTN sanctions used to encourage compliance • Letter of warning or reprimand (confidential peer review) • Probation (public notice) • Member Not in Good Standing (public notice)

27. Principles of Organ Allocation

28. Allocation of Organs • At first (1980s) allocation for all organs was based on waiting time. • This was an ethical system but not too efficient. • Different rules for different organs due to cold ischemic tolerance, etc.

29. ALLOCATING IN TIMES OF SHORTAGE • Many ethicists have studied and written about this. • UNOS Principles and Objectives of Equitable Organ Allocation- 1991 • Policies must balance justice and medical utility • These ethical concepts sometimes compete

30. JUSTICE in ALLOCATION • Justice means: evenhanded, impartial, fair, unbiased… • Aristotle defined justice as “equals must be treated equally, and unequals must be treated unequally.” • In times of shortage, justice becomes the equitable distribution of benefits and burdens in society.

31. Even though no two persons are equal in all respects, no person should be treated unequally unless some difference between that person and others is relevant to the treatment at stake.

32. What makes organ allocation so challenging from an ethical standpoint is determining which differences are relevant and should be considered in making organ allocation policies. • Under NOTA and the HRSA contract, it is UNOS/OPTN task to consider and implement such determinations.

33. OPO Service Areas

34. UNOS Regional Map

35. Kidney Policy Elements • Local/regional/national sequence • Priority given for: • Pediatric candidates • High PRA candidates • Zero or one DR mismatch • Candidates with longest wait time • Prior living donors

36. The Kidney Committee is currently conducting an extensive multi-year study to determine whether a kidney allocation policy can be devised that takes into account both medical urgency and net benefit.

37. Liver Policy Elements • MELD/PELD formula: estimates likelihood of short-term death w/o transplant • Provides more consistent ratings of illness • Regional allocation first for most urgent candidates, then local, regional, national. • Exceptions made for HCC, rare conditions • Pediatric donor/candidate priority

38. Lung Policy Elements • Lung Allocation System (LAS) predicts “Net Benefit”. Score combines: • Likelihood of short-term death w/o transplant • Likelihood of longer-term survival • Exceptions made for rare conditions • Different criteria for candidates age 0-11 • Local/zone allocation sequence (concentric circles from donor site)

39. Heart Policy Elements • Urgency priority based on level of intervention • Medications, LVADs • Local/zone allocation sequence (concentric circles from donor site) • Pediatric donor/candidate priority

40. Pancreas Policy Elements • Local/regional/national sequence • Priority given for: • High PRA candidates • Candidates with longest wait time • Islet recovery allowed for qualifying donors if whole organ is not accepted

41. Intestinal Policy Elements • Urgency priority based on liver function, IV feeding access • Local/regional, then national allocation • Priority for pediatric candidates • Liver/intestine or multiorgan combinations usually allocated according to liver urgency, donor suitability

42. Data Update Introduction to Kidney Donor Risk Index (DRI)

43. Donor Risk Index (DRI) • ECD/SCD definition of donor quality is insufficient as many so called “ECD” kidneys are of equal or better quality than some “SCD” kidneys • The SRTR has developed continuous measures that better quantify the risk associated with certain organs and has published these for liver and kidney1,2. • The OPTN/UNOS Kidney Transplantation Committee has been considering ways to introduce the concept of a Donor Risk Index into a new allocation system 1Feng et al., Characteristics associated with liver graft failure: the concept of a donor risk index.Am J Transplant. 2006;6:783-790 2Rao et al., A comprehensive risk quantification score for deceased donor kidneys: the kidney donor risk index. Transplantation 2009;88:231-236

44. Objectives of this Presentation • To illustrate some basic donor recovery information stratified by the DRI rather than just the ECD/SCD/DCD criteria. • To familiarize you with the concept of the DRI and help you to understand how various donor characteristics relate to DRI. • To examine some of the variability in donors recovered by DRI across regions and DSAs.

45. Deceased Donors by Type1998 – 2008U.S.

47. Kidney Donor Risk Index Deceased Donors Recovered 1998 - 2008

48. All Deceased Donors Recovered 2008 Kidney DRI Distribution

49. The following slides show the distribution of the Kidney Donor Risk Index for various donor characteristics

50. All Deceased Donors Recovered 2008 Kidney DRI By Donor Age