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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
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
The Problem
#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
Strategic Plan
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
Goal of the Proposal
OPOs Tx Hospitals LD Recovery ProgramsStore samples for serology and NAT for 10 yrs
Develop and implement written protocol for 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
How Proposal Achieves its Goals
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
Programming Includes:
OPTN Committees
Professional Societies
Government Ex Officio
DTAC AOPO HRSA
Living Donor AST FDA
OPO ASTS
Operations & Safety
NATCO
Joint Subcommittee Composition
SRTR invited, but did not participate. Representatives received all emails and open invite to attend as desired.
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
Proposal Development
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.
Why is this an issue?
Public Comment Response Tally
Type of Response
Response Total
In Favor
In Favor as
AmendedOpposed
No Vote/No
Comment/ Did Not
Consider
Individual 29 22 (76%) 0 5
(17%) 2
Regional 11 10 (91%)
1 (9%) 0 0
Committee 19 6 (32%) 0 1
(5%) 12
Public Comment Feedback
ASTS• Oppose due to
universal HCV NAT requirement
AST• Oppose due to
universal HCV NAT requirement
NATCO• Supports policy as
written
Professional Society Feedback
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.
Comment Themes
Issues Raised DTAC Comments
Desire for standardization of NAT across platforms
Guidance on how to proceed with initial positive (e.g. Triplex)
How to proceed with possible false positive tests
• Challenging, but outside of OPTN purview.
• Thresholds for pos test results are set by industry and FDA.
• 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.
Could a NAT requirement lead to delayed donation or lost donors?
• Most OPOs have capacity to perform NAT
• A variety of process issues could result in delayed or lost donors
NAT Concerns
Year HIV NAT HBV NAT HCV NAT2008 44/58 (76%) 20/58 (34%) 40/58 (69%)2010 56/57 (98%) 43/57 (75%) 55/57 (97%)
OPO NAT Survey Results
OPOs performing NAT for screening of potential deceased organ donors
OPOs performing NAT for screening of all potential deceased organ donor, regardless of risk statusYear HIV NAT HBV NAT HCV NAT2008 30/58 (52%) 14/58 (24%) 28/58 (48%)2010 39/57 (68%) 30/57 (53%) 39/57 (68%)
Issues Raised DTAC Comments
Increased false positives in low prevalence population with organ wastage (e.g. pediatric donors)
OPO Committee supported universal HCV NAT, suggesting:• danger in assuming that a
sub-group of potential donors be assumed as “no increased risk” and allow for exemption from testing requirements.
Final Rule does not allow for the exclusion of any specific
group
NAT Concerns
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
False positive NAT results
Personal communication, Marek Nowicki, Nat Institute of Transplantation
8 donors transmitted hepatitis C
3 human error 4 window period
3 detectable by NAT
One “eclipse”
period
1 false neg serology
Likely detectable by NAT
HCV donor-derived infection Jan 2008 to October 2013
DTAC Experience with Donor Hepatitis C Testing; WTC 2014
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
Additional Comment Themes
Product PolicyProgrammingRelated education
Target Population Impact: Deceased and Living DonorsTransplant Candidates and Recipients
Total IT Implementation Hours
Total Overall Implementation Hours
Overall Project Impact
4,950/17,885
4,500/10,680
0 1000 2000 3000 4000 5000
Se-ries1
0 1000 2000 3000 4000 5000 6000
Se-ries1
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
Post-Public Comment Modifications
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.
Proposed Amendment to Language (lines 90 and 97, page 24 of book)
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 NAT-related 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.
Resolution 13 (page 22)
Thank you!Daniel Kaul, MD, Committee Chair
Shandie Covington, Committee [email protected]
Questions?
