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HOPE Act

On November 19 and 21, 2015, we made OPTN policy and system changes to implement the HIV Organ Policy Equity (HOPE) Act, which will allow for research into transplanting organs from HIV-positive donors into HIV-positive recipients.

Participating Transplant Hospitals

  • Duke University Hospital; Durham, NC
    Liver (deceased and living donor) and kidney (deceased and living donor) programs
  • Montefiore Medical Center; Bronx, NY
    Kidney (deceased)program
  • VCU Medical Center; Richmond, VA
    Kidney (deceased)program
  • University of Minnesota; Minneapolis, MN
    Liver (deceased and living)programs and Kidney (deceased)
  • NY Presbyterian Hospital/Columbia University Medical Center; New York, NY
    Liver (deceased donor) and kidney (deceased donor) programs
  • Johns Hopkins Hospital; Baltimore, MD
    Liver and kidney programs
  • Hahnemann University Hospital; Philadelphia, PA
    Liver and kidney programs
  • Mount Sinai Medical Center liver and kidney programs; New York, NY
    Liver and kidney programs
  • University of California San Francisco Medical Center; San Francisco, CA
    Liver (deceased and living donor) and kidney (deceased donor) programs 
  • University of Alabama Hospital; Birmingham, AL
    Kidney (deceased donor) program 
  • Yale New Haven Hospital; New Haven, CT
    Kidney (deceased donor) program
  • Emory University Hospital; Atlanta, GA
    Kidney (deceased donor) program
  • Indiana University Health; Indianapolis, IN
    Kidney (deceased donor) program 
  • Georgetown University Medical Center; Washington DC
    Kidney (deceased donor) program
  • Rush University Medical Center; Chicago, IL
    Kidney (deceased donor) program
  • Massachusetts General Hospital; Boston, MA
    Liver and Kidney (deceased donor) program
  • Methodist Dallas Medical Center; Dallas, TX
    Liver and Kidney (deceased donor) program
  • University of Maryland Medical System; Baltimore, MD
    Liver and Kidney (deceased donor) program

Policy and System Changes

OPTN policy 15: Identification of transmissible diseases

Policy notice (July 2015)

Kidney and liver programs seeking HOPE Act IRB approval[Exit disclaimer]

Policy changes requiring OPOs to re-execute the match run[Exit disclaimer]

HOPE Act variance request form

Complete the form and email it to HOPEAct.VarianceRequest@unos.org.

Instruction

Re-executing the match run[Exit disclaimer]

Re-executing the match run (text only)

Frequently Asked Questions

Frequently asked questions: HOPE Act

What is the HIV Organ Policy Equity Act?

The HIV Organ Policy Equity Act was enacted on November 21, 2013. It calls for the development and publication of research criteria relating to transplantation of HIV positive organs into HIV positive individuals. The HOPE Act requires the following deliverables be met by November 21, 2015:

  • The Secretary of HHS must revise the section of the OPTN Final Rule (42 CFR 121.6) that requires the OPTN to adopt and use standards to prevent the recovery of HIV positive organs.
  • The OPTN must revise standards of quality (i.e. policies) for the recovery and transplantation of organs from HIV positive donors in accordance with the criteria developed by the Secretary.
  • The Secretary of HHS must develop and publish criteria for research relating to transplantation of organs from donors infected with HIV into individuals who are infected with HIV before receiving such organs.

Are the new OPTN policies in effect?

Yes. The OPTN policies became effective on November 21, 2015.

Are the research criteria available?

Yes. The final research criteria were published on November 23, 2015. The research criteria are referenced in the OPTN Final Rule as follows:

§121.6 Organ procurement.
(b) HIV. (1) Organs from individuals infected with human immunodeficiency virus (HIV) may be transplanted only into individuals who—
(i) Are infected with HIV before receiving such organ(s); and
(ii)(A) Are participating in clinical research approved by an institutional review board, as defined in 45 CFR part 46, under the research criteria published by the Secretary under subsection (a) of section 377E of the Public Health Service Act, as amended; or
(B) The Secretary has published, through appropriate procedures, a determination under section 377E(c) of the Public Health Service Act, as amended, that participation in such clinical research, as a requirement for transplants of organs from individuals infected with HIV, is no longer warranted.
(2) Except as provided in paragraph (b)(3) of this section, the OPTN shall adopt and use standards of quality with respect to organs from individuals infected with HIV to the extent the Secretary determines necessary to allow the conduct of research in accordance with the criteria described in paragraph (b)(1)(ii)(A) of this section.
(3) If the Secretary has determined under paragraph (b)(1)(ii)(B) of this section that participation in clinical research is no longer warranted as a requirement for transplants of organs from individuals infected with HIV, the OPTN shall adopt and use standards of quality with respect to organs from individuals infected with HIV as directed by the Secretary, consistent with 42 U.S.C. 274, and in a way that ensures the changes will not reduce the safety of organ transplantation.

Why did the OPTN create an open variance?

Transplants performed under the National Institutes of Health (NIH) research criteria will be evaluated, as outlined in the HOPE Act, by the Secretary of HHS in conjunction with the OPTN. This evaluation will help determine whether the OPTN policies should be revised and whether continuing to require that HIV positive to HIV positive transplants be conducted as clinical research consistent with the NIH research criteria is warranted.

The OPTN created an open variance to evaluate this effort in a specific timeframe as outlined in Policy 1.3 (Variances). The Executive Committee approved an expiration date of January 1, 2018 for Policy 15.6 (Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors). When the Board of Directors meets in December 2017, they will decide if the variance should be extended, amended, or terminated.

What do transplant programs need to do to receive organs as part of the HOPE Act research study?

Transplant hospitals must notify the OPTN Contractor in writing that they intend to participate in an institutional review board (IRB) approved research protocol that meets the criteria published by the Secretary under subsection (a) of section 377E of the Public Health Service Act. The transplant hospital must submit:

  1. A request to join the open variance for the recovery and transplantation of organs from HIV positive donors using the request form created by the OPTN Contractor. Complete the form and send it to HOPEAct.VarianceRequest@unos.org.
  2. A detailed schedule of required deadlines for IRB data safety monitoring reports and a list of data elements that will be included that address the requirements in the HHS research criteria. This must include the actual dates when DSMB reports will be submitted to the OPTN contractor. If a central DSMB is used as part of a multi-center trial, this must be indicated in the request. 

Transplant programs will be required to submit IRB data safety monitoring reports at each deadline in their IRB approved data safety monitoring schedule.

The OPTN Contractor will track when an active kidney or liver transplant program has IRB approval to conduct a research study that is consistent with requirements of the HOPE Act following submission of the required documentation. The transplant programs will then be able to indicate in Waitlist, the HIV status and willingness of each candidate to accept an HIV positive kidney or liver. A second user must verify in Waitlist the HIV status and willingness of the candidate to accept an HIV positive kidney or liver as outlined in Policy 15.6.

A program’s approval to participate in the open variance will expire with the expiration of their IRB approval. In order to continue to participate, the program will need to send in a new IRB approval letter before the expiration date. Programs who lose IRB approval before the expiration date must notify the OPTN.

What do OPOs need to do to participate in an IRB approved HOPE Act research study?

There are no specific requirements in OPTN policy that OPOs must follow prior to allocating HIV positive livers or kidneys to transplant hospitals participating in a research study. However, the research criteria published by the Secretary of HHS contain specific OPO responsibilities, and OPOs must adhere to those requirements. OPOs must accurately report donor HIV test results. If the results are positive, the OPO will only be able to run kidney and liver matches. The match runs will only show the candidates at hospitals that are participating in the research study and whose HIV status and willingness to accept an HIV positive organ has been verified by a second user.

Are living donors eligible to participate in an IRB approved HOPE Act research study?

Yes. As of November 21, 2015, the change to living donor policies (located in Table 14-9: Living Donor Exclusion Criteria) allow for an exception to the HIV exclusionary criteria if qualifying under the research study. Living donor transplant hospitals must meet all the requirements outlined in Policy 15.6: Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors and the research criteria as referenced in the Final Rule §121.6(b)(ii)(A). The research criteria developed by the NIH under the authority of the Secretary of HHS contain additional requirements for living donors participating in a HOPE Act research study.

Why are only livers and kidneys being allocated from HIV positive donors?

Under federal law, HIV positive organs can only be transplanted as part of the NIH research protocol. The research criteria being developed by the NIH “focuses on liver and kidney transplantation, as it is only in liver and kidney transplantation that there is substantial experience with transplantation from HIV negative donors to HIV positive recipients. The intent is not to exclude the possibility of HIV positive to HIV positive transplantation of other organs such as heart or lung in the future; however, transplant teams should gain experience with HIV negative to HIV positive transplantation of a specific organ before taking on the more complex and less well-defined issues of HIV positive to HIV positive transplantation of that organ.”

How will the OPTN evaluate the research study results?

The HOPE Act states that “not later than 4 years after the date of enactment and annually thereafter, the Secretary shall review the results of scientific research in conjunction with the OPTN to determine whether the results warrant revision of the standards of quality.” The OPTN/UNOS Executive Committee approved a modification to the variance requirements in October 2015 that requires members participating in a HOPE Act research study to provide periodic reports from their data safety monitoring boards to the OPTN. This will allow the OPTN Contractor to identify issues or trends across multiple research studies and proactively address potential problems. The OPTN Contractor is developing the process for reviewing the data safety monitoring board reports.

What are the OPTN member obligations related to the HOPE Act?

All HIV positive to HIV positive transplants must be conducted as part of an IRB approved research study that is consistent with the research criteria published by the Secretary of Health and Human Services. OPTN members failing to comply with the research criteria may be subject to OPTN sanctions.

Frequently asked questions: Re-executing a match run

Background Information

The proposal to require another match run based on change in infectious disease test results was approved by the BOD in June 2015. Policy requires that OPOs re-execute a match when infectious disease test results for hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV) or cytomegalovirus (CMV) are changed to positive. The CMV change applies to intestine matches only.

When did the policy go into effect?

The policy went into effect on November 19, 2015.

What happens if infectious disease results that impact the match run are changed to positive?

Scenario 1: An OPO executes a match run and discovers that the donor tests positive for HBV, HCV, or CMV (intestine only). Before the test results are avialble, the deceased donor organ is accepted for a potential transplant recipient. The OPO must:

  • Stop allocation from the original match run.
  • Enter the updated donor test result in DonorNetSM.
  • Report the new test result to the first transplant hospital that accepted the organ as soon as possible, but within one hour of receiving this new test information.
  • If the transplant hospital accepts the organ for the primary potential transplant recipient despite the new donor test result, allocation is complete. The match run does not need to be re-executed.
  • If the transplant hospital refuses the organ based upon this new information, the OPO must re-execute the match run. The OPO cannot offer the organ from the original match run to other potential recipients, even if they have accepted back up offers.

Scenario 2: An OPO executes a match run and discovers that the donor tests positive for HBV, HCV, or CMV (intestine only). No one has accepted the organ offer. The OPO must:

  • Stop allocation from the original match run.
  • Report the updated donor test result in DonorNet.
  • Re-execute the match run.
  • Resume allocation using the new match run.

Scenario 3: An OPO executes a match run and discovers that the donor is HIV positive. Because of the federal HOPE Act (effective November 21, 2015), transplant centers that have HOPE Act IRB approval may transplant HIV positive donor organs into candidates that are HIV positive and have agreed to accept an HIV positive organ. The OPO must:

  • Stop allocation from the original match run.
  • Enter the positive HIV result in DonorNet.
  • Withdraw any pending offers, regardless of whether the transplant hospital has accepted an offer. •Re-execute the match run. (UNet will only run matches for livers and kidneys.)

Does an OPO have to re-execute the match run for all organ types if they receive a positive test result for CMV?

No. Only the intestine match must be re-executed when the CMV test result is changed to positive.

Does an OPO have to re-execute the kidney match runs if both the right and left kidneys have been provisionally accepted and the offer for either the right or left kidney is declined after learning of the change in infectious disease test results to positive?

Yes. When infectious disease test results are changed to positive after a kidney match has been run, the OPO must contact both the transplant hospitals that accepted the right and left kidneys. If one of the potential transplant recipients is not willing to accept the organ (right or left kidney) after being informed of the change in infectious disease test results, the match run must be re-executed to allocate the kidney that was refused. This also applies to lung and split liver placement where organs have been accepted for two primary potential transplant recipients.

What does it mean when a match run is “locked”?

A “locked” match status means that electronic notifications have been disabled for that particular match because of a change in an infectious disease test result to positive. OPOs must continue to comply with existing policy to submit PTR (Potential Transplant Recipient) information within 30 days after the match run date for each deceased donor organ that is offered.

Why can OPOs only run kidney and liver matches for an HIV positive donor?

As a result of the HOPE Act law being enacted, Policy 15.6 (Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors) was changed to allow for the transplantation of kidneys and livers from HIV positive donors into candidates that are HIV positive/have agreed to accept an HIV positive organ and are listed at transplant centers that have HOPE Act IRB approval. If a donor is HIV positive, only kidney and liver matches can be run for the donor.

Does an OPO have to re-execute the match run if they already have one HIV positive result and then receive a second HIV positive result?

No. If any positive HIV test result has already been indicated in DonorNet and a subsequent positive HIV test result is received, the OPO does not have to re-execute the match. DonorNet should reflect the most up to date HIV test results.

Re-execute a match run: Effective practices and process steps

OPTN policy requires members to re-execute a match run when there is a change in infectious disease test results to positive.

When kidney and liver matches are re-executed after HIV test results change to positive, only candidates from centers that have HOPE Act IRB-approved kidney and liver programs will be included in the match results.

Effective Practices

Rapid screen testing for HIV, HBC, HCV

  • Blood for serologies testing drawn as early as possible at the start of a case
  • Results typically in 20-40 minutes
  • If rapid screening results are positive, a match run can be delayed until serology results are available
  • If results are negative, a match could be run sooner

In-house laboratory

  • Serology results typically available within 4-6 hours
  • Automated platform expedites process

Multiple verifications

  • Multiple staff members verify test results before generating match run
  • Verifiers include supervisor on-call

When these effective practices are not an option and it is necessary to re-execute a match run, review the following process steps, as they outline appropriate decision-making points to comply with policy.

The transplant hospital (TH) must obtain informed consent before transplanting organs with positive HIV, HBV, HCV, CMV* test results, per OPTN policy.

Process steps

When OPO gets new positive donor HIV test results:

  • OPO stops allocation process.
  • OPO enters positive test results in DonorNet®.
  • OPO withdraws any pending offers.
  • OPO re-executes match run for kidney and liver only.
  • OPO allocates organ.

When OPO gets new positive donor HBV, HCV, CMV* test results

  • OPO stops allocation process.
  • OPO enters positive test results in DonorNet.
  • Organ accepted before positive test results?
    • If yes:
      • OPO notifies TH of updated test results.
      • TH accepts organ on behalf of primary potential transplant recipient.
      • Within 1 hour of notification, TH informs OPO of decision.
        • If TH accepts, OPO allocates the organ.
        • If TH declines, OPO re-executes the match run and allocates the organ.
    • If no:
      • OPO re-executes the match run and allocates the organ.

*CMV test is for intestine only

Organ Procurement & Transplantation Network

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