OPTN policies to align with 2020 U.S Public Health Service Guideline
In June 2020, the U.S. Public Health Service (PHS) updated the Guideline for assessing solid organ donors and monitoring transplant recipients for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection due to improved testing and risk assessment methods.
In December 2020, the OPTN Board of Directors approved a set of new and amended policies to align with the PHS guidelines. The majority of these policies will be implemented March 1, 2021; others as noted below will become effective on June 1, 2021.
Policy changes include:
- Refined criteria for determining if a deceased or living donor has risk for acute HIV, HBV, or HCV.
- Removal of increased risk terminology.
- Modified testing requirements and timeframes for deceased donors, living donors, candidates, and recipients.
- Substitution of providing information to potential recipients rather than requiring specific, separate informed consent from them.
Implementation changes include:
- New TransNetSM application version that must be used beginning March 1.
- Changes to transplant recipient follow-up form (TRF) in TIEDI® for all organs to include making the viral detection section available for all organ recipients on the six-month and one-year form.
- DonorNet MobileSM will reflect the removal of the increased risk terminology beginning March 1.
Other changes include:
- Extra vessels labels—both the sterile internal label and the poly plastic label affixed on the outside of the triple sterile barrier—have been modified. New versions must be used starting March 1.
What all members need to do
- Ensure all staff are familiar with upcoming policy and implementation changes.
- Implement changes to donor risk criteria assessment.
- Implement new testing, specimen collection, and storage requirements.
- Utilize OPTN resources to learn about the changes in more detail.
What OPO members need to do
- Download the new version of TransNetSM and start using it March 1. Older versions of the application will no longer print correctly on labels beginning March 1. Further instructions for downloading the new version of TransNetSM will be provided to users by Feb. 1.
- Revise screening questions to assess donor risk criteria. Four risk criteria have been removed and two risk criteria have been changed. Work with electronic medical record vendors to implement changes.
- Do not use term “increased risk donor.” Instead, refer to “risk criteria” present for acute transmission of HIV, HBV, or HCV.
- Inform transplant programs of identified risk criteria. Transplant hospitals are no longer required to obtain separate informed consent to use organs with identified risk criteria, but must inform candidates or their agents.
- Obtain and test specimens from donors within 96 hours prior to organ procurement for:
- HIV: NAT and either anti-HIV or HIV Ab/Ag
- HBV: NAT, total anti-HBc, and HBsAg
- HCV: NAT and anti-HCV
- Obtain donor blood specimen for 10 year storage within 24 hours prior to organ procurement.
- Obtain and use all revised extra vessels labels.
What transplant hospital members need to do
- Familiarize all staff with revised risk criteria. Do not use term “increased risk donor.”
- Inform candidate, or candidate’s agent, if risk criteria are present in the donor. It will no longer be necessary to obtain specific informed consent.
- Obtain pre-transplant specimens and test all candidates after hospital admission for transplant before first anastomosis occurs for:
- HIV: Use Centers for Disease Control and Prevention recommended HIV testing algorithm
- HBV: Total anti-HBc, HBsAg, and HBsAb (anti-HBs)
- HCV: NAT and anti-HCV
- Test all recipients four-to-eight weeks after transplant for HIV, HBV and HCV using NAT.
- Test all liver recipients 11-to-13 months after transplant for HBV using NAT.
- Note: Upon implementation March 1, 2021, expected six-month and one-year TRF forms will display the viral detection section, as well as TRF forms generated on the day of implementation for all recipients. Members will continue to have all response options for these fields, including “Not done.”
- Obtain and use revised extra vessels labels when repackaging extra vessels.
Additional changes for transplant hospitals performing living donor recoveries:
- Be familiar with all changes for transplant hospitals.
- Obtain specimens and test all potential living donors as close as possible, but within 28 days prior to, organ recovery for:
- HIV: NAT and anti-HIV testing
- HBV: NAT, total anti-HBc, and HBsAg testing
- HCV: NAT and anti-HCV testing
- Use revised extra vessels labels when recovering or storing extra vessels from living donors.
*Transplant hospital changes to be implemented at later dates:
- Evaluate all candidates for their need for HBV vaccination. Report vaccination status to the OPTN. If HBV vaccination cannot be started or completed, document in the medical record and report to OPTN. Changes to enable reporting to the OPTN will be implemented in the transplant recipient registration (TRR) form. Implementation of the HBV vaccination data collection will occur following TRR form change and an OPTN notice to members.
- Obtain living donor informed consent as part of overall informed consent requirements to obtain and store blood specimen for ten years only to be used for investigation of potential donor-derived disease. Implementation will occur June 1, 2021.
- Obtain living donor blood specimen within 24 hours of recovery and arrange specimen storage for ten years. Implementation will occur June 1, 2021.
- Read the 2020 PHS Guideline
- Read the policy notice
- Read a crosswalk comparing requirements of the 2020 and 2013 PHS guidelines and associated OPTN policy
- View policy effective dates of OPTN policy changes
- Read a comparison of 2013 and 2020 PHS risk criteria
- Read the Board briefing paper
- Read the public comment proposal and resulting comments
Resources & education
Two educational offerings on this subject are available in UNOS Connect, with course numbers as listed:
- SFT127: PHS Guidelines in OPTN Policy
- SFT128: Talking About Risk Criteria for Disease Transmission
A preview is available of changes to the OPTN Evaluation Plan that will result from the newly added and updated policies.
Additional resources are in development for this policy implementation. Check back for more information as it becomes available.