Align OPTN Policies with the 2013 PHS Guideline for Reducing Transmission of HIV, HBV, - PowerPoint Presentation

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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

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June 2013- US Public Health Service released new PHS Guideline that now include Hepatitis B (HBV) and Hepatitis C (HCV) in addition to HIVThe 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

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Strategic

Plan

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Align OPTN policy with 2013 PHS Guideline to meet Final Rule requirementsEnhance transplant recipient and living donor safety through updates to donor and recipient testing, informed consent, and vessel storage

Goal of the Proposal

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OPOs

Tx

HospitalsLD 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 daysNo donor med/soc = increased riskClarify informed consent policies - 15.3HIV NAT or Ag/Ab combo for increased risk donorsHIV NAT or Ag/Ab combo for increased risk donorsCannot store HCV Ab or NAT pos or HBsAg or NAT pos extra vesselsHCV NAT for ALL donorsHCV NAT for ALL donors

How Proposal Achieves its Goals

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HIV, HBV, and HCV NAT data collection fields in DonorNet® for deceased organ donors

Fields must display on

DonorNet® and DonorNet® mobileSerologies 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 donorsAdds fields to the Waiting List for candidatesHIV, 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:

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OPTN Committees

Professional Societies

Government Ex OfficioDTACAOPOHRSA

Living Donor

AST

FDA

OPO

ASTS

Operations & SafetyNATCOJoint Subcommittee CompositionSRTR invited, but did not participate. Representatives received all emails and open invite to attend as desired.

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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

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Strong agreement on addressing the 34 PHS recommendations and subsections within joint subcommittee and DTAC with one exceptionSplit vote on this topic from both groups…

HCV nucleic acid testing (NAT)

for ALL organ donorsCommittee unanimously supported HIV and HCV NAT for increased risk donors, but could not come to agreement on

universal

HCV NAT

Proposal Development

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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?

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Public Comment Response Tally

Type of Response

Response Total

In Favor

In

Favor as Amended

Opposed

No Vote/

No Comment/ Did Not ConsiderIndividual29

22 (76%)

0

5

(17%)

2

Regional

11

10 (91%)

1

(9%)

0

0

Committee196 (32%)01 (5%)12

Public Comment Feedback

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Professional Society Feedback

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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

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Issues

Raised

DTAC CommentsDesire for standardization of NAT across platformsGuidance 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 insertsNAT Concerns

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Issues

Raised

DTAC CommentsConcerns 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 NATA variety of process issues could result in delayed or lost donors

NAT Concerns

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YearHIV NAT

HBV NAT

HCV NAT200844/58 (76%)20/58 (34%)40/58 (69%)201056/57 (98%)43/57 (75%)55/57 (97%)OPO NAT Survey ResultsOPOs performing NAT for screening of potential deceased organ donors

OPOs performing NAT for screening of

all

potential deceased organ donor, regardless of risk status

Year

HIV NAT

HBV NATHCV NAT200830/58 (52%)14/58 (24%)28/58 (48%)201039/57 (68%)30/57 (53%)39/57 (68%)

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Issues

Raised

DTAC CommentsIncreased 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

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Proportion of false positives depends on incidence in populationFurther 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 donors0.9% initially reactive but not repeatable0.04% reactive but not discriminated0.001% inhibitors and could not be amplified3 (0.03%) NAT reactive and seronegative

for HIV-1, HCV

False positive NAT results

Personal communication, Marek

Nowicki

, Nat Institute of Transplantation

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HCV donor-derived infection Jan 2008 to October 2013

DTAC Experience with Donor Hepatitis C Testing; WTC 2014

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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 criteriaAdditional Comment Themes

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Overall Project Impact

4,950/17,885

4,500/10,680

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Added clarification that HIV NAT is not required when dialysis is only

risk factor

For living and deceased donorsModifications to nomenclature for viruses to be consistent between living and deceased donor languageAddition to include appropriate living donor reference since it applies to living and deceased donorsPost-Public Comment Modifications

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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)

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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)

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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)

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Thank you!

Daniel Kaul, MD, Committee Chair

kauld@med.umich.eduShandie Covington, Committee Liaisonshandie.covington@unos.org

Questions?