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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 riskUpdate informed consent requirementsUpdate 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 donorsHCV NAT for all donorsLiving 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Unpublished data, including aggregate DTAC statistics from potential transmission events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 [email protected]
Name Region # Representative Email
Shandie Covington
Committee Liaison [email protected]
Questions?
