1 National Webinar to Review Non-Discussion Agenda Fall 2015 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 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 committee activities and projects  Discuss regional business

4 Regional Meeting Agenda  Discussion Agenda  8 proposals presented, discussed, and voted on during meeting  Non-Discussion Agenda  4 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  Proposed Changes to Transplant Program Key Personnel Procurement Requirements (Membership and Professional Standards Committee)  Revising Kidney Paired Donation Pilot Program Priority Points (Kidney Transplantation Committee)  Proposal to Update the Human Leukocyte Antigen (HLA) Equivalency Tables (Histocompatibility Committee)  Proposal to Reduce the Documentation Shipped with Organs (Organ Procurement Organization Committee)

6 Changes to Transplant Program Key Personnel Procurement Requirements Membership and Professional Standards Committee Fall 2015

 Update key personnel procurement Bylaws to:  Correct unexplained inconsistencies  Clearly establish requirements that are currently viewed as optional  Remove unnecessary specificity  Accommodate applications that the MPSC generally believes are acceptable, but that it must reject due to current Bylaws requirements  Thereby,  Simplifying the key personnel application process for members and the MPSC What is the goal of the proposal? 7

 Inconsistent primary surgeon procurement requirements  Solution:  Delete primary kidney transplant surgeon multi-organ procurement requirement  Delete primary liver transplant surgeon donor selection and management requirement What problem will the proposal solve? 8

 The word “should” means Primary transplant physician aren’t required to observe organ procurements  Solution:  Use the word “must” What problem will the proposal solve? 9

 Questionable necessity of specifying primary transplant physicians must observe multi-organ donor procurements  Solution:  Delete primary transplant physician multi-organ procurement observation requirement  Exposure to multi-organ donors will likely occur without an explicit OPTN Bylaws requirement considering:  Proposed change that primary transplant physicians must observe at least three organ procurements  Multiple organs procured from the overwhelming majority of donors What problem will the proposal solve? 10

 Surgeons applying through fellowship pathway sometimes meet all requirements, but didn’t perform the requisite number of procurements during fellowship  Solution:  Allow applying surgeons to cite procurements performed both during their fellowship and 2 years after completion  Otherwise, must apply through clinical experience pathway What problem will the proposal solve? 11

 Proposal stems directly from recommendations developed by a Joint Societies Working Group (JSWG)  Collaborative effort between:  American Society of Transplantation (AST)  American Society of Transplant Surgeons (ASTS)  North American Transplant Coordinators Organization (NATCO)  MPSC Supporting Evidence 12

 No immediate action required of members upon implementation  Membership and key personnel change applications submitted on or after the implementation date will be evaluated based on these requirements  Anticipated board review date – December 2015  Anticipated implementation date – March 2016 How will members implement this proposal? 13

 Promote the efficient management of the OPTN  Proposal addresses key personnel procurement requirements that are:  inconsistent  unnecessarily specific  needing additional flexibility How does this proposal support the OPTN Strategic Plan? 14

15 Questions

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Questions? Committee ChairJonathan Chen, Committee LiaisonChad Region 1 RepDavid Axelrod, MD, Region 2 RepMatthew Cooper, Region 3 RepThomas Pearson, MD, Region 4 RepAdam Bingaman, MD, Region 5 RepLisa Stocks, RN, MSN, Region 6 RepChristian Kuhr, Region 7 RepDavid Cronin II, MD, PhD, Region 8 RepTimothy Schmitt, MD, Region 9 RepLewis Teperman, Region 10 RepTodd Pesavento, Region 11 RepKenneth Brayman, MD, PhD, 17

18 Revising Kidney Paired Donation Pilot Program Priority Points Kidney Transplantation Committee Fall 2015

19 What problem will the proposal solve? OPTN KPD system does not fully consider: Increased difficulty in matching some pairs (i.e. high CPRA and certain blood types) Certain data to identify matches more likely to be accepted Problem 1 Revise optimization algorithm’s priority points to identify matches to optimize the pair pool for “difficult to match” pairs and consider potentially relevant data Solution

20 What problem will the proposal solve? KPD informed consent policies will require programs to inform on remedies for failed exchanges (if one exists) OPTN policy does not provide a remedy for candidates in failed exchanges in the OPTN KPD Problem 2 Award high point value to “orphan candidates” (1,000,000 points) Ensures that NDD chain will end with “orphan candidate” if possible Only applies to candidates “orphaned” in the OPTN KPD Solution

Maintain Base points for all matches (100 pts) Points for prior living donors and pediatric candidates Waiting time Remove Points for same region and same DSA Negative points for “all other antibody specificities” Revise Adopt a sliding scale CPRA Increase points for same hospital matches Reduce points for 0-ABDR mismatches Add Points Categories Candidate and paired donor ABO Previous negative or positive but acceptable crossmatches (with or without desensitization) Orphan candidates How does the proposal address the problem statement? 21

Sensitivity Study Design Re-optimized 136 historical OPTN KPD match runs using 24 scenarios Evaluation # and % of matches by candidate and pair characteristics Match rate Change in total # of matches found Impact of potential changes on equitable access for patients Limitations Focus on # of matches, not transplants Static study Limited ability to evaluate small subpopulations (i.e. living donors) Supporting Evidence 22

 Increased the # of matching opportunities for 99% and 100% CPRA candidates  Prioritizing by pair characteristics increased the # of matching opportunities for hard to match pairs  Blood type O candidates  Candidate’s whose paired donor is non-O Supporting Evidence – Overall Trends 23

 Members participating in KPDPP will need to communicate the changes as a part of informed consent, particularly about the remedy for a failed exchange  Proposal does not require additional data collection  No changes to current routine site surveys  Anticipated Board Date: December 2015  Implementation Date: Pending programming How will members implement this proposal? 24

 Increase the number of transplants  Increase # of matches found  Incentivize transplant hospitals to participate  Use data to improve chance of timely offers to candidates most likely to accept  Improve equity in access to transplants  Addresses increased difficulty in matching certain blood types and CPRA levels  Improves access for candidates in failed exchanges How does this proposal support the OPTN Strategic Plan? 25

26 Questions

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Questions? Committee ChairMark Aeder, Committee LiaisonMelinda Region 1 RepReginald Gohh, Region 2 RepAlexander Gilbert, Region 3 RepTruman Earl, MD, Region 4 RepSteven Potter, MD, Region 5 RepJonathan Fisher, MD, Region 6 RepEric Langewisch, Region 7 RepDidier Mandelbrot, Region 8 RepClifford Miles, Region 9 RepVinay Nair, Region 10 RepJoshua Augustine, Region 11 RepVincent Casingal, 28

29 Proposal to Update the HLA Equivalency Tables Histocompatibility Committee Fall 2015

30 What problems will the proposal solve?  Some equivalences have changed since last update  Proposed solution - update equivalency tables based on:  advances in HLA typing  the frequencies of antigens reported for donors and antigens and unacceptable antigens reported for candidates  Some HLA antigen dropdowns in UNet SM disadvantage candidates with antibodies against some alleles but not all of them  Proposed solution - update dropdowns in UNet  Policy references to HLA DPB, DQA, and DQB are out of date  Proposed solution – change policy references to these loci to DPB1, DQA1, and DQB1

 Increase opportunities for candidates to receive offers  Compatible donors will not be excluded based on outdated or broad HLA typing constraints of prior equivalency tables  Reduce risk of positive crossmatch after shipping kidneys nationally and regionally What is the goal of the proposal? 31

Supporting Evidence 32 Broad antigens reported for deceased donors ( ) * C3 was reported by 33 labs for 264 donors. Note: Labels show the number of labs for each broad antigen.

 Transplant Programs:  Request updated HLA typing using molecular methods for existing candidates who may be affected by the changes to the equivalences tables  Review/modify unacceptable antigens reported for candidates with antibodies against alleles that are being added  Labs:  Assign split (not broad) antigens to candidates How will members implement this proposal? 33

Strategic GoalImpact Increase the number of transplantsImprove efficiency of allocation for sensitized candidates Improve equity in access to transplants Allow members to enter more specific data to ensure candidates are not excluded from donors against whom they don’t have UAs Improve waitlisted patient, living donor, and transplant recipient outcomes Table updates will lead to better compatibility and decrease probability of post-transplant rejection Allocation to candidates less likely to have a positive crossmatch reduces cold ischemia time Promote living donor and transplant recipient safety Reduce risk of organ discards due to futile shipments How does this proposal support the OPTN Strategic Plan? 34

35 Questions

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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, 37

38 Proposal to Reduce the Documentation Shipped with Organs Organ Procurement Organization Committee Fall 2015

39 What problem will the proposal solve?  Current policy requires OPOs to send complete donor record with each organ  Requirement originated before OPOs could upload information into DonorNet ®  During the TransNet sm project, UNOS staff members observed attempts to make copies of documentation, often interrupting donor management

 Free up OPO staff to concentrate on donor management and packaging and shipping quality by eliminating requirements to include documentation they have already provided to transplant centers What is the goal of the proposal? 40

 Reduces the need to copy and ship documentation already provided to transplant programs  Blood type documentation (including subtype if used for allocation) and infectious disease testing results will still be packaged with each organ  Death pronouncement source documentation, authorization for donation source documentation, human leukocyte antigen (HLA) type, donor evaluation and management, donor medical and behavioral history, and organ intraoperative findings will be provided in DonorNet upon receipt  Transplant programs can accurately and completely evaluate donor suitability using information provided in DonorNet How does the proposal address the problem statement? 41

 OPOs must:  Submit deceased donor information to UNOS upon receipt so transplant programs can evaluate donor suitability  Still include source documentation for blood type and infectious disease testing with each organ  Transplant hospitals must:  Be aware that deceased donor information is available in DonorNet and can print copies if necessary  The proposed language will not change the way UNOS conducts its routine site surveys How will members implement this proposal? 42

 Strategic Goal: Promote the efficient management of the OPTN  Allow for more efficient and timely communication of donor information using DonorNet instead of paper documentation that gets packaged and shipped with each organ. How does this proposal support the OPTN Strategic Plan? 43

44 Questions

Questions – click hand button 45

Questions? Committee ChairSean Van Slyck, MPA, HAS, Committee LiaisonRobert Region 1 RepJill Stinebring, Region 2 RepDebbie Williams, MBA, BSN, RN, Region 3 RepGiridhar Vedula, Region 4 RepJanice Whaley, MPH, Region 5 RepSindhu Chandran, Region 6 RepStephen Kula, PhD, Region 7 RepJ. Kevin Cmunt, BS, Region 8 RepDiane Brockmeier, RN, BSN, Region 9 RepRebecca Milczarski, MSN, MBA, Region 10 RepDaniel Lebovitz, Region 11 RepDwayne 46

 Opened August 14  Closes October 14  Proposals are posted on the OPTN website under “Governance” tab Fall 2015 Public Comment 47

 Submit comments on the OPTN website   Communicate with your regional representative  Providing Feedback 48

Regional Meeting Information 49

RegionRegional AdministratorPhone Number 1,4,9Shannon 2,6,8Betsy 3,11Cliff 5,7,10Chrystal Regional Administrators Contacts 50