Ad Hoc Disease Transmission Advisory Committee (DTAC) Spring 2014

1. 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

2. The Problem • 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

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

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

5. Additional 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

6. Working Groups Consideration The four working groups were assigned recommendations for discussion, and asked to consider the following points for each recommendation: • Is the PHS recommendation covered by the Final Rule? • Is there policy already in place to address this? If so, does it need to be changed? • Should there be policy in place to address this, or should it remain as a PHS recommendation only?

7. How the Proposal will Achieve its Goal **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

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documentation from PHS Guideline • Numerous journal articles • Subject matter expertise within Joint Subcommittee • Unpublished data, including aggregate DTAC statistics from potential transmission events • Testing package inserts

9. What Members will Need to Do • 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

10. Specific Feedback • 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?

11. Questions? • Michael Green, MD, MPH Committee Chair Michael.Green@chp.edu • Name Region # Representative Email • Shandie Covington Committee Liaison Shandie.Covington@unos.org