COVID-19 and solid organ transplant

The U.S. Food and Drug Administration (FDA) has amended emergency usage authorizations to administer an additional dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine for certain immunosuppressed individuals, such as organ transplant recipients. For more information, refer to the FDA statement.

The Centers for Disease Control and Prevention (CDC) has also endorsed the recommendation for an additional dose of vaccine. For more information, read the CDC statement.

Organ recovery teams should be aware of donor hospital vaccine requirements before traveling. Given the spread of the Delta variant, many hospitals now require evidence of COVID vaccination from their employees and other professionals who enter the facility.

Some hospitals are requiring the local OPO to certify that teams are fully vaccinated, so some OPOs are also now requiring teams to show evidence of COVID vaccination.

Carrying a vaccine card or other evidence of vaccination will help recovery teams meet hospital requirements and avoid disruptions to the organ recovery process.

• Lower respiratory testing of all potential lung donors for SARS-CoV-2 to take effect May 27 NEW
• Effective April 1, 20201: COVID-19 data amnesty status for follow-up forms ended; Retrospective forms due July 1
• Emergency actions help members protect patient safety and access to transplant during COVID-19
• COVID-19 offer refusal codes
• Changes to wait time initiation for non-dialysis kidney candidates
• Relaxation of TIEDI data submission requirements
• COVID-19 infectious disease testing in DonorNet
  • Report suspected transplant-related disease transmission

View more on COVID-19 policy actions

The Organ Procurement and Transplantation Network has released a Summary of Evidence on SARS-CoV-2 donor evaluation and testing, as well as organ recovery from donors with a history of COVID-19. Compiled by the OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC), the document includes the latest information known for minimizing the risk of donor-derived COVID-19 transmission while maximizing donor utilization.

View summary

The committee developed the summary in collaboration with colleagues representing AST, ASTS, AOPO, HRSA, and the CDC. This document contains information on the following:

• SARS-CoV-2 deceased donor evaluation and testing
• Recovery of organs from deceased donors with a history of resolved COVID-19
• Recovery of organs from deceased donors with active COVID-19
• SARS-CoV-2 living donor testing and other precautions to minimize the risk of donor-derived COVID-19
• Recovery of organs from living donors with a history of resolved COVID-19

DTAC has committed to reviewing the document quarterly.

• May 27, 2021: SRTR announces monitoring changes for January 2022 reporting cycle in response to COVID-19
• Mar. 16, 2021: SRTR announces monitoring changes for July 2021 reports in response to COVID-19
• Aug. 7, 2020: SRTR modifying evaluation metrics for transplant programs and OPOs
• April 1, 2020: SRTR extends data review period deadline to May 31

On March 25, 2021, the OPTN Membership and Professional Standards Committee agreed to resume monitoring of transplant program functional activity and patient notification requirements, effective July 1, 2021.

All updates to monitoring changes may be found in a supplement to the OPTN member evaluation plan on the OPTN compliance page.

View the updated list of time-limited monitoring changes

This supplemental document serves as a quick-reference guide to all temporary member monitoring changes implemented as a result of the pandemic. Unless new monitoring changes are implemented or effective dates are delayed, it will be retired on July 1, 2021. Any remaining changes as of that date will be published in the OPTN Member Evaluation Plan.

Site surveys updated

Transition back to in-person site surveys postponed. In order to protect the safety of our community and their patients as well as our staff during the current wave of Delta infections, the transition back to in-person site surveys is postponed. Site surveys will continue to be held virtually through September. We will continue to assess the situation and resume travel when it is safe to do so. Please email MQfeedback@unos.org with questions.

Performance monitoring

The MPSC and the Scientific Registry of Transplant Recipients have made adjustments to the July 2021 program-specific reports (PSRs) and OPO-specific reports (OSRs). Evaluation cohorts will continue to exclude transplants and follow-up time beyond March 12, 2020. Find details about the SRTR monitoring changes here.

About MPSC and rationale for COVID-19 updates

The MPSC is a body of peers from within the donation and transplant community. It maintains membership criteria and monitors OPTN member compliance with OPTN membership criteria, OPTN bylaws and policies, and the OPTN Final Rule.

OPTN policies and requirements have not been suspended as a result of COVID-19. However, deviations from OPTN requirements will be evaluated in the context of the circumstances that have arisen due to this national crisis. The MPSC will look for a commitment to patient safety, stewardship of donated organs, and the rationale for the decisions that your transplant program or OPO make.

The OPTN is collecting information about challenges and issues created by the outbreak in order to evaluate further improvements or assistance that HHS, the OPTN and UNOS can provide. Please use the survey tool linked below to report interruptions or issues. Please note that the link works in the Google Chrome browser, but it does not work in Internet Explorer.

Report COVID-19 issues

• Status report available: Follow up data submission requirements new
• Report transplant candidate data
• Report cause of death for transplant candidates and recipients

• System modification to Waitlist^SM allows hospitals to reactivate liver candidates without having to update labs
• Reactivation process for multiple kidney transplant candidates now available
• Making candidates temporarily inactive
• Maintain wait time for inactive candidates
• Temporary COVID-19 precaution inactivation for multiple kidney transplant candidates

Questions about program inactivation due to COVID: Please email MembershipRequests@unos.org or call (833) 577-9469

Third dose of COVID-19 vaccine approved for immunocompromised people

The U.S. Food and Drug Administration (FDA) has amended emergency usage authorizations to administer an additional dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine for certain immunosuppressed individuals, such as organ transplant recipients. For more information, refer to the FDA statement.

The Centers for Disease Control and Prevention (CDC) has also endorsed the recommendation for an additional dose of vaccine. For more information, read the CDC statement.

AST COVID-19 guidance documents

• Joint statement about vaccine efficacy in organ transplant recipients updated

ISHLT

• COVID-19 vaccination in heart and lung transplantation: Recommendations from the International Society of Heart & Lung Transplantation (ISHLT) COVID-19 Task Force

VCU Health

• COVID-19 vaccines and transplant patients: Is vaccination safe?

Find additional patient-focused vaccination resources on the Transplant Living website.

• AJT: “Coronavirus disease 2019: Implications of emerging infections for transplantation”
• AHA: “Challenges in heart transplantation in the era of COVID-19”

To the extent practical, continue to follow the match run. If transportation systems become disrupted and an organ cannot be transported to a hospital on the match run, use the 861 bypass code and proceed to allocate as high on the match run as logistics allow. These decisions should be based on the availability of transportation options, not on DSA or regional boundaries.

• Lower respiratory testing of all potential lung donors for SARS-CoV-2 to take effect May 27
• Lower respiratory tract testing available, resource PDF
• Record donor COVID-19 testing and results data in DonorNet

• COVID-19 Weekly RUM Report now available in the Data Portal
• Refer to the AOPO informational resource addressing donor evaluation and OPO procedures in light of potential COVID-19 infection