Normothermic Regional Perfusion Policy

Background

Normothermic regional perfusion (NRP) is a technique that restores warm, oxygen-rich blood flow to selected organs after death has been declared to help preserve them for transplantation.

In September 2024, HRSA directed the OPTN to investigate potential policy violations related to NRP and develop standards to protect patients and improve donor families’ experiences.

The OPTN Board of Directors approved the NRP Policy through an emergency action so urgent safety safeguards could take effect immediately, with additional requirements implemented in phases. The policy will still undergo public comment and may be updated based on feedback.

Sponsoring Committee: OPTN Board of Directors 
Public Comment Period: Nov. 13 - Dec. 28, 2026 
Board Approved: TBD
Effective Date: Phased implementation as outlined below

Summary of policy changes

The Board-approved policy establishes new and enhanced 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 begins immediately, with requirements taking effect in phases to prioritize urgent safety protections and allow time for operational changes needed to support additional requirements.

Phase 1 (tentatively 30 days after Board approval)

Surgical techniques

  • NRP must not begin until after 5 minutes have elapsed after pulselessness and the donor is pronounced dead by the hospital patient care team
  • The NRP team must take all necessary steps to prevent blood flow to the brain (secure, transect, and vent blood vessels at risk of perfusing the brain)
  • Paralytic agents must not be used in the context of NRP

Routine documentation

  • For all actual/attempted recoveries using NRP, OPO must upload DCD flowsheet and operative note within 24 hours (requirement expands to include documentation of pre-withdrawal huddle when this is implemented)

Reporting requirements for patient safety events

  • Reportable events: (1) Pre-mortem cannulation is performed and the patient’s death does not occur within the expected time frame; (2) An unplanned pause is requested due to concern that perfusion may have been restored to the brain.
  • Reportable events: There is withdrawal of life-sustaining support prior to the pre-recovery huddle

Phase 2 (tentatively 3-6 months after public comment)

Communication requirements

  • Pre-departure huddle:
    • Includes OPO representative and lead surgeons from procurement and NRP teams
    • Participants review surgical approach and verify surgical team members who will be present
  • Prior to withdrawal of life sustaining therapy (WLST) huddle:
    • Includes OPO staff, donor hospital operating room staff, surgical procurement team, and NRP team
    • Participants (1) review how to raise concerns, how to initiate an unplanned pause, surgical approach; and (2) confirm plan for how patient care will be transferred back to the hospital healthcare team if a concern is raised

Authorization requirements

  • Pre-mortem procedures (e.g., cannulation) require consent of the donor or donor’s agent
  • OPOs may have a separate authorization form for NRP or include NRP authorization in their standard authorization form for organ donation
  • Disclosures regarding NRP must include the following information:
    • NRP is performed to increase the likelihood that the organs will be utilized for transplant
    • NRP restores perfusion to certain organs, and those organs are expected to resume function
    • There is a potential risk of restoring blood flow to the donor’s brain; the team will make every effort to prevent this from happening

Documentation of plan to return donor to the care of the hospital

  • OPOs must have a documented plan for how patient care will be transferred back to the hospital healthcare team if concerns arise for cerebral perfusion or other physical responses during the NRP process

The OPTN will provide implementation notices, guidance, and educational resources to help members meet the requirements as each phase takes effect.

Resources

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