Today, the Organ Procurement and Transplantation Network (OPTN) Board of Directors approved two policies designed to strengthen patient safety, protect patients who may become deceased organ donors and patients who may receive organ transplants, and improve the donation experience for donor families.
Normothermic Regional Perfusion (NRP) Policy
The Board approved the Normothermic Regional Perfusion (NRP) Policy through an emergency action (PDF - 1 MB) (part E.7 in the OPTN Management and Membership Policies) to begin implementation promptly in the interest of public safety. This action allows the OPTN to move forward with immediate patient safeguards while preserving an opportunity for public comment and subsequent policy updates if warranted by that feedback.
The policy follows a September 2024 directive (PDF - 170 KB) from the Health Resources and Services Administration (HRSA) to investigate potential OPTN policy violations, along with subsequent directives to develop NRP standards of practice that protect patients and address donor families’ experiences. The Board received a preview of the proposed policy at its September 2026 meeting.
The policy strengthens safeguards for patient safety, authorization and disclosure, communication, and accountability. It:
- Clarifies and reorganizes required steps for organ procurement organizations (OPOs) to better reflect the stages of the organ donation and procurement process.
- Strengthens the information that must be disclosed to donors or their agents.
- Establishes requirements for using NRP in controlled donation after circulatory death (DCD).
- Adds reporting requirements for NRP procedure details and any potential patient safety events.
Phased implementation
Implementation will begin immediately, with requirements taking effect in phases to prioritize urgent safety protections and allow time for the operational changes needed to support additional requirements.
- Phase 1 (tentatively 30 days after Board approval): Urgent requirements addressing surgical safeguards, documentation of NRP recoveries and attempted recoveries, and reporting of specified patient safety events.
- Phase 2 (tentatively 3-6 months after public comment): Requirements addressing authorization and disclosure, along with team communication and coordination before withdrawal of life-sustaining treatment and organ recovery. Additionally, requirements for a documented plan to transfer patient care back to the hospital healthcare team if concerns arise during the NRP process.
The OPTN will provide implementation notices, guidance, and educational resources on the NRP policy web page to help members meet the requirements as each phase takes effect.
Public comment
The policy will be open for public comment beginning on Nov. 13, 2026. Implementation of the safeguards will proceed during this period to address patient safety concerns without delay. Public input will inform the Board’s review, and the policy may be updated if the feedback warrants changes.
Rabies Screening Policy
The Rabies Screening Policy responds to HRSA’s April 2025 directive to reduce the risk of donor-derived rabies transmission. A 30-day public comment period showed broad support for the proposal. No changes were made to the proposed policy language or data collection requirements following public comment. The Ad Hoc Disease Transmission Committee, in its review of comments from the public, noted the importance of strong implementation and education materials to ensure members are supported in complying with new policy requirements.
The approved policy:
- Establishes screening criteria for high-risk rabies exposures in deceased and living donor populations, and standardize data collection of the criteria;
- Requires organ procurement organizations (OPOs) and Living Donor transplant programs to contact the CDC for additional risk assessment and evaluation when screening criteria are identified in a donor; and
- Requires transplant programs to inform potential recipients when screening criteria are identified, and provide appropriate clinical monitoring after transplant, including monitoring specific to the receipt of rabies post-exposure prophylaxis (PEP).
The OPTN will publish guidance and supporting materials on the Rabies Screening policy web page in mid-December 2026.