National Webinar to Review Non-Discussion Agenda

1. National Webinar to Review Non-Discussion Agenda Fall 2014 Public Comment If you are logged into the webinar, please enter the audio PIN Please put your phone on MUTE and do not place this call on HOLD

2. Objectives of Call • Share Non-Discussion Agenda development process • Present and Discuss Non-Discussion proposals • Review Regional Meeting voting procedures • Methods to submit feedback to the committee

3. Background Regional Meeting Goals • Discuss and comment on proposed policies and bylaws • Collect feedback and provide to sponsoring committees • Advisory to the councillor during Board deliberations • Executive Update on OPTN/UNOS activities • Receive updates on OPTN/UNOS committee activities and projects • Discuss regional business

4. Fall 2014 Regional Meetings • 18 proposals submitted for public comment • 2 VCA proposals • 10 OPTN/UNOS committees with updates • Feedback Sessions

5. Regional Meeting Agenda • Discussion Agenda • Eleven proposals presented, discussed and voted on during meeting • Non-Discussion Agenda • Five proposals presented today • No discussion at the regional meeting • Regional Vote • Process for moving a proposal to the Discussion Agenda • 15% of member institutions within a region submit a request • All requests must be received one week prior to the meeting date • If the15% threshold is met, proposal will be presented and discussed during Regional Meeting

6. Non-Discussion Agenda Proposals • Proposal to Convert KPD Contact Responsibilities and Donor Pre-Select Requirements from the OPTN/UNOS Kidney Paired Donation Pilot Program Operational Guidelines into OPTN Policy (Kidney Committee) • Clarification of Multi-Organ Policies  (Policy Oversight Committee) • Proposal to Automatically Transfer Pediatric Classification for Registered Liver Candidates Turning (Pediatric Committee) • Proposal to Collect Extracorporeal Membrane Oxygenation (ECMO) Data upon Waitlist Removal for Lung Candidates(Thoracic Transplantation Committee) • Proposal to Reduce the Reporting Requirements for the Deceased Donor Registration Form(OPO Committee)

7. Fall 2014 Public Comment Proposals • September 23rd • Draft proposals posted to the OPTN website: http://optn.transplant.hrsa.gov/ContentDocuments/2014-09_Public_Comment.pdf • September 29th • Proposals officially released and posted to the OPTN website and open for comment

8. Proposal to Convert KPD Contact Responsibilities and Donor Pre-Select Requirements from Operational Guidelines into OPTN Policy Kidney Transplantation Committee Mark Aeder, MD

9. The Problem OPTN/UNOS KPD Pilot Program (KPDPP) • still governed by guidelines and policies • processes that help make program run efficiently are in guidelines • guidelines not enforceable, monitorable or transparent

10. Goal of the Proposal • Facilitate efficient operations of OPTN/UNOS KPDPP • Reduce match failures • Reduce time from match offer to match acceptance and transplant

11. How the Proposal will Achieve its Goal • Donor Pre-Select • You may pre-accept or pre-refuse all potential donors for a particular candidate • System will not match candidates with pre-refused donors • CPRA > 90% - donor pre-select is mandatory • potential donors not pre-accepted are treated as pre-refused • KPD Contact responsibilities • Timelines for responses to match offers • Ability to request extensions

12. What Members will Need to Do For donor pre-select: • If CPRA > 90%--pre-accept or pre-refuse all potential donors • If CPRA < 90%--pre-accept or pre-refuse is optional but encouraged Appoint a KPD contact and alternate • Perform post-match offer responsibilities within timeframes defined by policy

13. What Members Will Need to Do

14. Questions – Click hand button

16. Clarification of Multi-Organ Policies Policy Oversight Committee (POC) Mark Aeder, MD

17. The Problem • Plain language rewrite project revealed OPTN multi-organ policies as unclear and inconsistent • Required substantive changes - out of scope of plain language rewrite • Organ-specific committees need to address multi-organ allocation issues

18. Goal of the Proposal • Clarification and better readability of these policies • Improvements in organization • Deletion of duplicated policy language

19. How the Proposal will Achieve its Goal Multi-committee work group: • drafted proposed policy language • provided input to ensure that changes are in-line with clinical practice

20. How the Proposal will Achieve its Goal Changes to policy language: • 2.15.F (Multiple Organ Procurement) – edited for clarity and to explain requirements for organ recovery • 3.4.C (Candidate Registrations) – Moved the multi-organ candidate registration requirements to this section • 5.4.D (Multiple Organ Procurement and Offers) – deleted, since it has the same information as 2.15.F

21. How the Proposal will Achieve its Goal Changes to policy language (cont.): • New sections 5.8.A(Allocation of Heart-Lungs)and 5.8.B (Other Multi-Organ Combinations) clarifies current language and eliminates payback recommendation • Moved Current 6.4.A (Waiting Time for Multi-organ Candidates – Heart, Lung, and Heart/Lung) to 3.7 (Waiting Time Modifications) for better organization

22. What Members will Need to Do • Board review – June 2015 If approved, effective Sept. 1, 2015 • Transplant programs and OPOs - familiarize yourselves with revised policies • Current way of compliance monitoring won’t change

23. Questions – click hand button

24. Questions? • Yolanda Becker, MDChair, Policy Oversight Committee ybecker@surgery.bsd.uchicago.edu • Leigh A. Kades, MA Liaison, Policy Oversight Committee leigh.kades@unos.org

25. Proposal to Automatically Transfer Pediatric Classification for Registered Liver Candidates Turning 18 Pediatric Transplantation Committee Eileen Brewer, MD

26. The Problem Liver inconsistent with most other organ allocation policy for pediatrics: • Pediatric classification not automatically retained when a liver candidate turns 18 • Exception: Status 1A and 1B candidates rogram can apply to RRB for pediatric classification for adult candidates (age 18 and older) to return to the waitlist if ever registered prior rogramsnot aware of this exception process.

27. Goal of the Proposal • Retain pediatric classification for all liver candidates who turn 18 while waiting • Eliminate pediatric classification exception process for adults ever listed before age 18 but since removed and relisted

28. Supporting Evidence • RRBs consistent in decision-making in decision-making • 38 MELD candidates that would qualify for automatic ped classification (as of June 20) • 71% (27) were 15-17 years old at listing • Age 18-33, only 11% (4) older than 25 • Wait time <1-17 years • Most MELD scores <13 (5 with past due re-certifications) • No previous liver transplants • Most had received at least one offer • No prevalent diagnosis Bs consistent in decision-making

29. What Members will Need to Do • If approved by the Board, proposal will be implemented without any action from liver programs • Will require UNetSM programming to fully automate

30. Questions – click hand button

32. Proposal to Collect Extracorporeal Membrane Oxygenation (ECMO) Data When Removing Lung Candidates from Waitlist Thoracic Transplantation Committee Joseph Rogers, MD

33. The Problem • Insufficient data to analyze effect of ECMO on candidates listed for lung transplant • ECMO use currently only reported • at time of registration • at time of transplant

34. Goal of the Proposal • Collect ECMO data from a contemporary cohort of lung transplant candidates • Analyze ECMO data • Determine if ECMO should be a variable in the LAS calculation

35. How the Proposal will Achieve its Goal • Modify candidate removal page in WaitlistSM to include fields for ECMO/mechanical ventilatory support data • Dates of cannulation/intubation and decannulation/extubation • Site of cannulation • Ambulation status • Type of ECMO (VA or VV)

36. Supporting Evidence • Growing use of ECMO as bridge to transplant • Correlation between high LAS at transplant and ECMO use • Conflicting retrospective studies regarding relationship between ECMO use and post-transplant outcomes

37. What Members will Need to Do Transplant Programs must: • Report whether a candidate was supported by invasive mechanical ventilation or ECMO • If yes, report information for additional data fields for each lung candidate you remove from WaitlistSM

38. Questions – click hand button

40. Proposal to Reduce the Reporting Requirements for the Deceased Donor Registration (DDR) Form Organ Procurement Organization Committee Jennifer Prinz and Patti Niles

41. The Problem • Inconsistent data reporting on potential deceased donors that do not proceed to donation • Policy: Host OPO must complete deceased donor registration (DDR) for all deceased donors and authorized but not recovered potential deceased donors • DDR never intended to be used for non-donors • DDR contains basic demographic information and detailed clinical information that only applies to actual donors

42. Goals of the Proposal • Remove policy requirement to complete the DDR for non-donors • Current requirement provides minimal information

43. What Members will Need to Do • Complete the donor feedback form • DDR will not be generated if you check the “no organs were transplanted for the purpose of transplantation” box (currently labeled as “referral only”) • Requirements for completing Death Notification Registration won’t change • Routine monitoring of OPTN members won’t change • UNet data subject to OPTN review-members must provide documentation as requested

45. Questions – click hand button

46. Providing Feedback • Submit comments onthe OPTN website beginning 9/29 • http://optn.transplant.hrsa.gov/governance/public-comment/ • Communicate with your regional representative • Webinar scheduled for October 20th at 2pm ET for members not attending today’s webinar • Registration Link: https://attendee.gotowebinar.com/register/4113117229163803394

47. Regional Meeting Information http://transplantpro.org

48. Regional Administrator Contacts