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  6 proposals presented, discussed, and voted on during meeting  Non-Discussion Agenda  3 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 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

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

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

Warnings appear in UNet SM 10 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.

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

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

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

 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 How does this proposal support the OPTN Strategic Plan? 14

Questions – click hand button 15

Questions? Committee ChairDolly Tyan, Committee LiaisonGeoffrey Region 1 RepIndira Guleria, Region 2 RepJulie Houp, Region 3 RepGabriella Wheeler, Region 4 RepChantale Lacelle, Region 5 RepDolly Tyan, Region 6 RepDiane Kumashiro, MS, CHS, Region 7 RepManish Gandhi, Region 8 RepBrian Freed, PhD, Region 9 RepAllen Norin, Region 10 RepSam Ho, PhD, Region 11 RepPeter Lalli, PhD, 16

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

 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 What problem will the proposal solve? 18

 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 What is the goal of the proposal? 19

List of Covered Body Parts 20 Upper limb Including, but not limited to, any group of body parts from the upper limb, or radial forearm flap Head and neck Including, but not limited to, face including underlying skeleton and muscle, scalp, larynx, trachea, thyroid, or parathyroid gland Abdominal wall Including, but not limited to, symphysis pubis and other vascularized pelvic elements Genitourinary organs Including, but not limited to, uterus, internal/external male and female genitalia, or urinary bladder

Lower limb Including, but not limited to, pelvic structures that are attached to the lower limb and transplanted intact, gluteal region, vascularized bone transfers from the lower extremity, anterior lateral thigh flaps, or toe transfers Adrenal gland Spleen Musculoskeletal composite graft segment Including, but not limited to, latissimus dorsi, spine axis, or any other vascularized muscle, bone, nerve, or skin flap List of Covered Body Parts 21

 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 How will members implement this proposal? 22

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

Questions – click hand button 24

Sue V. McDiarmid, M.D. Committee Chair Christopher L. Wholley, M.S.A. Committee Liaison Questions? 25

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

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

 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 How does the proposal address the problem statement? 29

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 How will members implement this proposal? 30

 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. How does this proposal support the OPTN Strategic Plan? 31

Questions – click hand button 32

Dan Kaul, MD Committee Chair Susan Tlusty Committee Liaison Questions? 33

 Opened January 25  Closes March 25  Proposals are posted on the OPTN website under “Governance” tab Spring 2016 Public Comment 34

 Submit comments on the OPTN website   Communicate with your regional representative  Providing Feedback 35

Regional Meeting Information 36

RegionRegional AdministratorPhone Number 1,4,9Shannon 2,6,8Betsy 3,5,7,10,11Cliff Regional Administrators Contacts 37