Transcript Proposal to Align OPTN Policies with the 2013 PHS

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
The Problem
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Final Rule requires OPTN policies “consistent with
CDC recommendations for testing organ donors
and following recipients to prevent the spread of
infectious disease.”
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New PHS Guideline -- June 2013
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Current policies not consistent with new
recommendations
Goal of the Proposal
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Modify existing policies/create new policies to align
testing requirements with PHS recommendations
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Enhance patient safety-related requirements
Background
Joint Working Group formed:
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Living Donor Committee
OPO Committee
Operations and Safety Committee
four professional societies (AST, ASTS, AOPO, NATCO)
Additional Background
Reviewed 34 specific recommendations
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Testing of living and deceased donors
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Informed consent
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Testing of recipients pre- and post-transplant
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Collection and storage of donor and recipient
specimens
Working Groups Consideration
The four working groups were assigned
recommendations for discussion, and asked to
consider the following points for each
recommendation:
1.
Is the PHS recommendation covered by the Final
Rule?
2.
Is there policy already in place to address this? If
so, does it need to be changed?
3.
Should there be policy in place to address this, or
should it remain as a PHS recommendation only?
How the Proposal will Achieve its Goal
**SEE PAGE 110 FOR ACTUAL POLICY LANGUAGE**
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Modify existing policies language:
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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
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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
Supporting Evidence
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Supporting documentation from PHS Guideline
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Numerous journal articles
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Subject matter expertise within Joint Subcommittee
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Unpublished data, including aggregate DTAC
statistics from potential transmission events
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Testing package inserts
What Members will Need to Do

OPOs and Living Donor Recovery Hospital
Highlights
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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
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Review modifications to informed consent policy language
Develop plan for post-transplant testing for recipients of
increased risk donor organs
Specific Feedback
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Implementation timeframe?
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Impacts on delay of organ offers and procurement?
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Potential loss of organs due to initial positive NAT?
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Impacts of positive NAT result received post
transplant- legal and ethical considerations?
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Subpopulations that should be exempted? Peds?
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Dialysis as HCV risk factor?
Questions?
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Michael Green, MD, MPH
Committee Chair
[email protected]
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Name
Region # Representative
Email
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Shandie Covington
Committee Liaison
[email protected]