A message from the OPTN Board President regarding organ donation process questions

Published on: Thursday, December 26, 2024

Richard Formica, M.D., President of the Organ Procurement and Transplantation Network (OPTN) Board of Directors, sent the following message to OPTN members in light of recent media reports.

We have heard and share in the concern regarding the account presented last month to the House Energy and Commerce Committee’s Oversight Subcommittee alleging that a person showed signs of life during assessment as a potential deceased organ donor. Organ donors and their families provide a sacred and life-saving gift, and the entire organ donation and transplantation process is dependent on their generosity. All individuals evaluated for organ donation deserve the highest standard of care.

The OPTN is cooperating with inquiries from the Health Resources & Services Administration (HRSA) directed towards the OPTN and towards OPTN members, including OPOs. The OPTN has robust and varied compliance monitoring processes in place to proactively and retrospectively evaluate member compliance with all OPTN obligations, including any risk to patient safety or public health.

Details of such investigations may remain confidential, as they often involve protected health information and may be conducted under a medical peer review process.* That said, the OPTN, in coordination with HRSA, will closely examine all details, documents, records, and witness accounts available to us to determine whether there was any impropriety, and to determine whether there are any opportunities for improvement within the OPTN’s purview. *

Given the sensitive and intended confidential nature of these proceedings, the OPTN is limited in what it can share publicly, though it is worth noting that the OPTN Membership and Professional Standards Committee has published recommendations to guide members on issues of safety or quality and will continue to do so.*

I urge you to emphasize the following resource information to peers or members of the public seeking a better understanding of the donation process:

• Organ donation involves a number of responsibilities and meticulous interactions between the hospital where the donation occurs (the donor hospital) and the organ procurement organization (OPO) where the donor hospital is located.
• The donor hospital is responsible for key activities including:
  • providing all clinical care to the patient
  • notifying their assigned OPO that the person potentially is eligible to be an organ donor based on certain clinical indicators
  • declaring the death of the patient according to applicable law and clinical standards
• The OPO, once notified of a potential donor, has responsibilities including:
  • evaluating the individual’s eligibility to be an organ donor and, if so, what organs may be transplantable
  • confirming that the person has consented to be an organ donor and/or obtaining authorization from the patient’s family
  • entering information about the person into the OPTN Computer System to identify organ transplant candidates that may be a clinical match if donation is authorized
  • arranging for the surgical recovery of the donor’s organs, which must occur after the donor hospital declaration of death
  • making organ offers for transplant candidates and arranging for transportation of the donated organs to the transplant hospital(s) where any accepting candidate is located

Please also emphasize that there are two pathways for deceased organ donation. While each involves somewhat different criteria, each also involves the donor hospital pronouncing death before organs are recovered.

• Brain death occurs when the person experiences irreversible cessation of all brain activity. This is the most common way for a patient to become an organ donor. After the pronouncement of death, artificial support of vital functions may continue until medical professionals are ready to recover organs.
• Circulatory death occurs when the patient experiences irreversible cessation of circulatory and respiratory functions. This is a less common way for a patient to become an organ donor. Organ recovery begins several minutes after a physician has declared death due to a permanent loss of circulation.

Thank you for your attention to this issue and the need to provide accurate information to characterize the donation process to all interested parties.

*Language has been updated as of Dec. 26, 2024, to clarify that some HRSA-directed investigations may not be subject to confidential medical peer review.