National Webinar to Review Non-Discussion Agenda

1. National Webinar to Review Non-Discussion Agenda Spring 2016 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. Webinar Objectives • Review non-discussion agenda process • Present and discuss proposals on the non-discussion agenda • Review methods to submit feedback to sponsoring committees

3. Regional Meeting Goals • Discuss 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 committee activities and projects • Discuss regional business

4. Regional Meeting Agenda • Discussion Agenda • 6proposals presented, discussed, and voted on during meeting • Non-Discussion Agenda • 3proposals 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 regional meeting date • If the 15% threshold is met, proposal will be presented and discussed during regional meeting

5. Non-Discussion Agenda Proposals • Adding HLA DQA1 Unacceptable Antigen Equivalences Table (Histocompatibility Committee) • List Covered Body Parts Pertaining to Vascularized Composite Allografts (Vascularized Composite Allograft Transplantation Committee) • Modifications to the Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors (Ad Hoc Disease Transmission Advisory Committee)

6. Adding HLA DQA1 Unacceptable Antigen Equivalency Table Histocompatibility Committee Spring 2016

7. What problem will the proposal solve? • Programs can’t automatically exclude donors with HLA DQA1 subtypes by selecting a broad antigen type • Example: Donors with DQA1*03:01, 03:02 etc. are NOT automatically excluded when DQA1*03 is input as an unacceptable antigen • Potential patient safety issue • Inappropriate allocation; unexpected possible crossmatch; potential for organ wastage

8. Entering DQA1 Unacceptable Antigens Selecting broad value as unacceptable Doesn’t exclude donors with a subtype value, and candidates can match with donors if subtypes aren’t selected

9. Members must select broad antigens and subtypes Members must select broad type AND subtypes in order to successfully exclude all donors with DQA1 unacceptable subtype antigens

10. Warnings appear in UNetSM WARNING: For DQA1, select all unacceptable antigens that apply (parent and subtype). For example, if candidate is to be excluded from donors with parent values for DQA1*03, select DQA1*03 (parent) and all subtypes of DQA1*03 (e.g. 03:01, 03:02, etc.). Selecting only value DQA1*03 will NOT exclude donors reported as 03:01, 03:02, etc.

11. What is the goal of the proposal? • Reduce potential patient safety issues • Allow UNetSM users to exclude donors with a DQA1 subtype when a DQA1 broad antigen is selected as an unacceptable for a candidate.

12. How does the proposal address the problem statement? • Solution: Add a DQA1 equivalent antigens table to policy to avoid matching candidates with incompatible donors based on DQA1 subtype antigens.

13. How will members implement this proposal? • Labs, OPOs, and transplant centers need to familiarize themselves with UNetSM changes once UNOS staff has programmed the new DQA1 table. • Members will report DQA1 unacceptable antigens differently once these changes go into effect

14. How does this proposal support the OPTN Strategic Plan? • Goal 4: Promote Living Donor and Transplant Recipient Safety • Reduces risk to patients of matching with donors who have unacceptable subtype antigens. • Reduces risk of an unexpected positive crossmatch • Reduces risk of organ wastage

15. Questions – click hand button

17. List Covered Body Parts Pertaining to Vascularized Composite Allografts (VCAs) VCA Transplantation Committee Spring 2016

18. What problem will the proposal solve? • HRSA notified OPTN of inconsistency between OPTN Bylaws and Policies, and the Final Rule • HRSA requested OPTN and VCA Committee generate list of covered body parts • VCA Committee drafted list of covered body parts, along with associated policy and bylaw changes

19. What is the goal of the proposal? • Not an endorsement of research on a new type of organ transplant • OPTN Bylaws and Policies consistent with the Final Rule • Provide transparency • Define scope of oversight

20. List of Covered Body Parts

21. List of Covered Body Parts

22. How will members implement this proposal? • Members must tell the OPTN the specific type of VCA they will transplant • Key personnel must meet qualifications in effect when they apply for approval • OPOs are highly encouraged to collaborate with VCA programs

23. How does this proposal support the OPTN Strategic Plan? • Strategic Goal – Promote the efficient management of the OPTN • This proposal addresses an inconsistency between the OPTN Final Rule and OPTN Bylaws and Policies.

24. Questions – click hand button

25. Questions? Sue V. McDiarmid, M.D. Committee Chair smcdiarmid@mednet.ucla.edu Christopher L. Wholley, M.S.A. Committee Liaison christopher.wholley@unos.org

26. Modifications to the Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors Ad Hoc Disease Transmission Advisory Committee Spring 2016

27. What problem will the proposal solve? HOPE Act requires the OPTN to review results of research in conjunction with the Secretary HOPE Act variance language does not include: • Specific data submission requirements • Expiration date

28. What is the goal of the proposal? • To provide members participating in the HOPE Act variance with specific data submission requirements • To establish an expiration date for the variance

29. How does the proposal address the problem statement? • Modifies the HOPE Act variance policies to: 1. Require participating members to submit IRB data safety monitoring reports 2. Set an expiration date of January 1, 2018

30. How will members implement this proposal? Approved HOPE Act IRB study participants must: • Give the OPTN a schedule of deadlines for data safety monitoring reports that address HHS research criteria requirements • Submit IRB data safety monitoring reports at each scheduled deadline

31. How does this proposal support the OPTN Strategic Plan? • Strategic Goal – Promote living donor and transplant recipient safety Allows the OPTN to review IRB data safety monitoring reports to identify issues or trends across multiple research studies.

32. Questions – click hand button

33. Questions? Dan Kaul, MD Committee Chair kauld@umich.edu Susan Tlusty Committee Liaison susan.tlusty@unos.org

34. Spring 2016 Public Comment • Opened January 25 • Closes March 25 • Proposals are posted on the OPTN website under “Governance” tab http://optn.transplant.hrsa.gov/governance/public-comment/

35. Providing Feedback • Submit comments on the OPTN website • http://optn.transplant.hrsa.gov/governance/public-comment/ • Communicate with your regional representative • http://optn.transplant.hrsa.gov/converge/members/committees.asp

36. Regional Meeting Information https://www.transplantpro.org

37. Regional Administrators Contacts