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

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

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 Background

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

 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 Regional Meeting Agenda

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) Non-Discussion Agenda Proposals

Fall 2014 Public Comment Proposals  September 23 rd  Draft proposals posted to the OPTN website: 09_Public_Comment.pdf 09_Public_Comment.pdf  September 29 th  Proposals officially released and posted to the OPTN website and open for comment

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

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 The Problem

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

 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 How the Proposal will Achieve its Goal

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 What Members will Need to Do

What Members Will Need to Do Upon receipt of a match offer, the following members: Must:Within: Transplant hospital receiving match offer Report preliminary response to the OPTN (in the KPD application) 2 business days of receiving the match offer. Transplant hospital with matched candidate Give the matched donor’s transplant hospital: required contents in the crossmatch kit instructions for the donor address for sending completed blood samples to 2 business days of receiving notification of preliminary offer acceptance. The matched donor transplant hospital Send the completed blood samples to the address specified by the matched candidate’s hospital. 5 business days of receiving the required information (see middle column above) from the transplant hospital with the matched candidate The matched donor transplant hospital Records must include any updated serology and NAT testing results, and must indicate whether the matched donor is increased risk according to the PHS Guidelines. 2 business days of receiving notification of preliminary exchange acceptance. The matched candidate transplant hospital Report the results of the crossmatch to the OPTN (in the KPD application) 13 business days of receiving notification of preliminary exchange acceptance. The matched candidate transplant hospital Review the matched donor’s records and report a final acceptance or refusal of the match to the OPTN Contractor (in the KPD application) 13 business days of notification of preliminary exchange acceptance.

Questions – Click hand button

Questions? Committee ChairRichard Formica, Committee LiaisonGena Boyle, Region 1 RepReginald Gohh, Region 2 RepAlexander Gilbert, edu Region 3 RepNicole Turgeon, Region 4 RepSteven Potter, MD, Region 5 RepJonathan Fisher, MD, Region 6 RepEric Langewisch, Region 7 RepArjang Djamali, Region 8 RepClifford Miles, Region 9 RepLiise Kayler, MD, MS, Region 10 RepDean Kim, Region 11 RepTitte Srinivas,

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

 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 The Problem

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

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

 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 What Members will Need to Do

Questions – click hand button

 Yolanda Becker, MD Chair, Policy Oversight Committee  Leigh A. Kades, MA Liaison, Policy Oversight Committee Questions?

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

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 rograms not aware of this exception process. The Problem

 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 Goal of the Proposal

 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 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 Supporting Evidence

 If approved by the Board, proposal will be implemented without any action from liver programs  Will require UNet SM programming to fully automate What Members will Need to Do

Questions – click hand button

Questions? Committee ChairEileen Brewer, Committee LiaisonChristine Flavin, Region 1 RepNancy Rodig, Region 2 RepKenneth Lieberman, Region 3 RepJayme Locke, MD, Region 4 RepDev Desai, MD, Region 5 RepLinda Book, Region 6 RepPatrick Healey, Region 7 RepSrinath Chinnakotla, MD, MCh Region 8 RepSteven Kindel, Region 9 RepNadia Ovchinsky, Region 10 RepJulia Steinke, Region 11 RepAndrew Savage,

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

 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 The Problem

 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 Goal of the Proposal

 Modify candidate removal page in Waitlist SM 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) How the Proposal will Achieve its Goal

 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 Supporting Evidence

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 Waitlist SM What Members will Need to Do

Questions – click hand button

Questions? Committee ChairJoe Rogers, Committee LiaisonLiz Robbins Region 1 RepTodd Astor, MD, Region 2 RepRyan Davies, Region 3 RepParag Patel, Region 4 RepMark Drazner, MD, Region 5 RepDavid Weill, Region 6 RepErika Lease, Region 7 RepChristopher Wigfield, MD, FRCS, (C/Th) Region 8 RepScott Silvestry, Region 9 RepMaryjane Farr, Region 10 RepThomas Wozniak, Region 11 RepMark Steele,

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

 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 The Problem

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

 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 What Members will Need to Do

Questions? Committee ChairSean Van Committee Liaison Robert Region 1 RepHelen Nelson, RN, BSN, CCTC, CPTC Region 2 RepDebbie Williams, MBA, BSN, Region 3 RepRam Subramanian, Region 4 RepTammie Peterson, MSH/MPH, RN, CPTC 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, CPTC edu Region 10 RepEllen Blair, RN, Region 11 RepPaul

Questions – click hand button

 Submit comments on the OPTN website beginning 9/29  comment/ comment/  Communicate with your regional representative  Webinar scheduled for October 20 th at 2pm ET for members not attending today’s webinar  Registration Link: Providing Feedback

Regional Meeting Information

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