Proposal to Align OPTN Policies with the 2013 PHS Guideline for Reducing Transmission of HIV, HBV, and HCV Through Solid Organ Transplantation Ad Hoc Disease Transmission Advisory Committee (DTAC) Spring 2014

 Final Rule requires OPTN policies “consistent with CDC recommendations for testing organ donors and following recipients to prevent the spread of infectious disease.”  New PHS Guideline -- June 2013  Current policies not consistent with new recommendations The Problem

 Modify existing policies/create new policies to align testing requirements with PHS recommendations  Enhance patient safety-related requirements Goal of the Proposal

Joint Working Group formed:  Living Donor Committee  OPO Committee  Operations and Safety Committee  four professional societies (AST, ASTS, AOPO, NATCO) Background

Reviewed 34 specific recommendations  Testing of living and deceased donors  Informed consent  Testing of recipients pre- and post-transplant  Collection and storage of donor and recipient specimens Additional Background

**SEE PAGE 110 FOR ACTUAL POLICY LANGUAGE**  Modify existing policies language:  donors with unknown med-soc are increased risk  Update informed consent requirements  Update post-transplant testing requirements for increased risk donor organs  Create new policies to reflect PHS recommendations  HIV NAT or Ag/Ab combination testing for increased risk donors  HCV NAT for all donors  Living donors HIV/HBV/HCV (NAT and serology) testing as close as possible, but within 28 days of recovery How the Proposal will Achieve its Goal

 Supporting documentation from PHS Guideline  Numerous journal articles  Subject matter expertise within Joint Subcommittee  Unpublished data, including aggregate DTAC statistics from potential transmission events  Testing package inserts Supporting Evidence

 OPOs and Living Donor Recovery Hospital Highlights  Coordinate with labs used for donor testing - is HCV NAT and either HIV Ag/Ab combo test or HIV NAT available?  LD testing for HIV, HBV, HCV (NAT and serology) within 28 days of recovery  Transplant Hospitals Highlights  Review modifications to informed consent policy language  Develop plan for post-transplant testing for recipients of increased risk donor organs What Members will Need to Do

 Implementation timeframe?  Impacts on delay of organ offers and procurement?  Potential loss of organs due to initial positive NAT?  Impacts of positive NAT result received post transplant- legal and ethical considerations?  Subpopulations that should be exempted? Peds?  Dialysis as HCV risk factor? Specific Feedback

 Michael Green, MD, MPH Committee Chair  Name Region # Representative  Shandie Covington Committee Liaison Questions?