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Align OPTN Policies with the
2013 PHS Guideline for Reducing
Transmission of HIV, HBV, and
HCV Through Solid Organ
Transplantation
(Resolution 13)
Ad Hoc Disease Transmission Advisory
Committee (DTAC) Committee
November 12-13, 2014
The Problem

June 2013- US Public Health Service released new
PHS Guideline that now include Hepatitis B (HBV)
and Hepatitis C (HCV) in addition to HIV

The Final Rule, §121.4 (OPTN policies: Secretarial
review and appeals.) notes that the OPTN Board is
responsible for developing policies consistent with
recommendations of the CDC to test potential organ
donors and follow transplant recipients to prevent the
spread of infectious disease.

Current policies are not consistent with new PHS
Guideline
Strategic Plan
#4- Promote
Transplant
Patient Safety
• Improve communication
between OPOs and tx
hospitals
• Increase capacity to
identify patient safety
issues
#5- Promote
Living Donor
Safety
• Develop policy for
medical/social evaluation
Goal of the Proposal

Align OPTN policy with 2013 PHS Guideline to
meet Final Rule requirements

Enhance transplant recipient and living donor
safety through updates to donor and recipient
testing, informed consent, and vessel storage
How Proposal Achieves its Goals
OPOs
Tx Hospitals
LD Recovery Programs
Store samples Develop and implement
for serology and written protocol for
NAT for 10 yrs
post-tx testing for
HIV/HBV/HCV (unless
+ pre-tx)
Complete testing for the
HIV/HBV/HCV as close to
organ recovery as possible but
<28 days
No donor
med/soc =
increased risk
Clarify informed
consent policies - 15.3
HIV NAT or Ag/Ab combo for
increased risk donors
HIV NAT or
Ag/Ab combo
for increased
risk donors
Cannot store HCV Ab
or NAT pos or HBsAg
or NAT pos extra
vessels
HCV NAT for ALL donors
HCV NAT for
ALL donors
Programming Includes:


HIV, HBV, and HCV NAT data collection fields in
DonorNet® for deceased organ donors

Fields must display on DonorNet® and DonorNet® mobile

Serologies tab where they will reside renamed “Viral Detection”
HBV and HCV NAT screening criteria all organ match
runs for all organs for deceased and living donors

Adds fields to the Waiting List for candidates

HIV, HBV, and HCV NAT data collection fields in Tiedi
(Transplant Recipient Registration)

Additional NAT fields on LDR/DDR already being
implemented as part of OMB project
Joint Subcommittee Composition
OPTN
Committees
DTAC
Living Donor
OPO
Operations &
Safety
Professional
Societies
AOPO
AST
ASTS
NATCO
Government
Ex Officio
HRSA
FDA
SRTR invited, but did not participate. Representatives
received all emails and open invite to attend as desired.
Proposal Development

Joint Subcommittee completing comprehensive
review of Guideline’s 34 recommendations to
determine:



Is the PHS recommendation covered by the Final Rule?
Is there policy already in place to address this? Does it
need to be changed?
Should there be policy in place to address this, or should it
remain a PHS recommendations?
Proposal Development

Strong agreement on addressing the 34 PHS
recommendations and subsections within joint
subcommittee and DTAC with one exception

Split vote on this topic from both groups…
HCV nucleic acid testing (NAT)
for ALL organ donors

Committee unanimously supported HIV and HCV
NAT for increased risk donors, but could not come
to agreement on universal HCV NAT
Why is this an issue?

The Final Rule, §121.4, notes that the OPTN Board
of Directors is responsible for developing policies
that are consistent with recommendations of the
Centers for Disease Control and Prevention (CDC)
to test potential organ donors and following
transplant recipients to prevent the spread of
infectious disease.
Public Comment Feedback
Public Comment Response Tally
Type of
Response
Response
Total
Individual
29
Regional
11
Committee
19
In
Favor
22
(76%)
10
(91%)
6
(32%)
No Vote/
In Favor as
No
Amended Opposed Comment/
Did Not
Consider
0
5
(17%)
2
1
(9%)
0
0
0
1
(5%)
12
Professional Society Feedback
ASTS
AST
NATCO
• Oppose due
to universal
HCV NAT
requirement
• Oppose due
to universal
HCV NAT
requirement
• Supports
policy as
written
Comment Themes
Several themes arose in reviewing feedback, and
are outlined in detail on page 45 of the briefing
paper, Exhibit A ,in the DTAC’s board report.
NAT Concerns
Issues Raised
DTAC Comments
Desire for standardization • Challenging, but outside
of NAT across platforms
of OPTN purview.
Guidance on how to
proceed with initial
positive (e.g. Triplex)
•
Thresholds for pos test
results are set by
industry and FDA.
How to proceed with
possible false positive
tests
•
OPOs and tx centers
should work closely with
their labs and carefully
review FDA guidance,
testing package inserts
NAT Concerns
Issues Raised
DTAC Comments
Concerns related to
access to NAT in
some donor service
areas.
• Most OPOs have
capacity to perform
NAT
• A variety of process
issues could result in
delayed or lost donors
Could a NAT
requirement lead to
delayed donation or
lost donors?
OPO NAT Survey Results
OPOs performing NAT for screening of potential
deceased organ donors
Year
2008
HIV NAT
44/58 (76%)
HBV NAT
20/58 (34%)
HCV NAT
40/58 (69%)
2010
56/57 (98%)
43/57 (75%)
55/57 (97%)
OPOs performing NAT for screening of all
potential deceased organ donor, regardless of
risk status
Year
2008
2010
HIV NAT
30/58 (52%)
39/57 (68%)
HBV NAT
14/58 (24%)
30/57 (53%)
HCV NAT
28/58 (48%)
39/57 (68%)
NAT Concerns
Issues Raised
DTAC Comments
OPO Committee supported
Increased false
universal HCV NAT, suggesting:
positives in low
• danger in assuming that a
prevalence population
sub-group of potential donors
with organ wastage
be assumed as “no increased
risk” and allow for exemption
(e.g. pediatric donors)
from testing requirements.
Final Rule does not allow for the
exclusion of any specific group
False positive NAT results




Proportion of false positives depends on incidence in
population
Further testing to clarify initial results rarely practical
in deceased donors
Labs and test package inserts report an extremely low
incidence of false positive rates.
9179 NAT (HIV/HCV) runs in organ or tissue donors
 0.9% initially reactive but not repeatable
 0.04% reactive but not discriminated
 0.001% inhibitors and could not be amplified
 3 (0.03%) NAT reactive and seronegative for HIV-1,
HCV
Personal communication, Marek Nowicki, Nat Institute of Transplantation
HCV donor-derived infection Jan 2008 to
October 2013
DTAC Experience with Donor Hepatitis C Testing; WTC 2014
Additional Comment Themes

Timeline for implementation: OPOs and transplant
hospitals need time to develop new internal
procedures and testing protocols.

Hemodialysis as an increased risk factor for HCV
only

Education materials for patients considering
increased risk organs

How to handle recipient consent if potential living
donor meets increased risk criteria
Overall Project Impact
Product
Policy
Programming
Related education
Target
Population
Impact:
Deceased and Living Donors
Transplant Candidates and Recipients
Total IT
4,500/10,680
Implementation
Hours
Total Overall
4,950/17,885
Implementation
Hours
4500
0
1000
2000
3000
4000
5000
4950
0
2000
4000
6000
Post-Public Comment
Modifications



Added clarification that HIV NAT is not required
when dialysis is only risk factor
 For living and deceased donors
Modifications to nomenclature for viruses to be
consistent between living and deceased donor
language
Addition to include appropriate living donor
reference since it applies to living and deceased
donors
Proposed Amendment to Language
(lines 90 and 97, page 24 of book)
2.9
Required Deceased Donor Infectious Disease Testing
e. Hepatitis C ribonucleic acid (RNA) by donor screening or
diagnostic nucleic acid test (NAT)
If a deceased donor is identified as being at increased risk for
HIV, HBV, and HCV transmission according to the U.S. Public
Health Services (PHS) Guideline, testing must also include HIV
ribonucleic acid (RNA) by donor screening or diagnostic NAT
or HIV antigen/antibody (Ag/Ab) combination test. This does not
apply to donors whose only increased risk factor is receiving
hemodialysis within the preceding 12 months, as they are at risk
only for HCV according to the U.S. Public Health Services (PHS)
Guideline.
Resolution 13 (page 22)

RESOLVED, that additions and modifications to Policies
2.2 (OPO Responsibilities), 2.4 (Deceased Donor
Medical and Behavioral History), 2.7.B (Informing
Personnel), Table 14-2 (Requirements for Living Kidney
Donor Medical Evaluations) with the exception of NATrelated requirements, 15.3 (Informed Consent of
Transmissible Disease Risk), 15.3.A (Deceased Donors
with Additional Risk Identified Pre-transplant), 15.3.B
(Deceased Donor at Increased Risk for Transmission of
Blood-borne Pathogens), and 16.7.B (Vessel Storage) as
set forth in Exhibit A, are hereby approved, effective
February 1, 2015.
and…
Resolution 13 (page 22)

FURTHER RESOLVED, that additions and
modifications related to donor nucleic acid
testing (NAT) requirements in Policy 2.9
(Required Deceased Donor Infectious Disease
Testing) and Table 14-2 (Requirements for
Living Kidney Donor Medical Evaluations) as
set forth in Exhibit A, are hereby approved,
effective pending programming and notice to
the OPTN membership.
Questions?
Thank you!
Daniel Kaul, MD, Committee Chair
[email protected]
Shandie Covington, Committee Liaison
[email protected]