HHS to reform organ donation system after finding ‘systemic disregard for sanctity of life’ in transplant system

In a release, HHS said that an investigation by the agency had "revealed disturbing practices by a major organ procurement organization."

“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” said Kennedy. “The organ procurement organizations that coordinate access to transplants will be held accountable. The entire system must be fixed to ensure that every potential donor’s life is treated with the sanctity it deserves.”

HHS cites the disturbing case of a Kentucky man who had been declared brain dead and then woke up on the operating table in 2021 as surgeons were about to take his organs for donations. A non-profit that works to procure organs for those who need them had pushed hospital workers to go and try to take the man's organs while he was still in need of them, it was discovered.

In light of that revelation, the Health Resources and Services Administration "directed the Organ Procurement and Transplantation Network (OPTN) to reopen a disturbing case involving potentially preventable harm to a neurologically injured patient by the federally-funded organ procurement organization (OPO) serving Kentucky, southwest Ohio, and part of West Virginia. Under the Biden administration, the OPTN’s Membership and Professional Standards Committee closed the same case without action."

As part of their investigation, HRSA found that in 351 cases where organ donation was authorized, but ultimately not completed:

• 103 cases (29.3%) showed concerning features, including 73 patients with neurological signs incompatible with organ donation.
• At least 28 patients may not have been deceased at the time organ procurement was initiated—raising serious ethical and legal questions.
• Evidence pointed to poor neurologic assessments, lack of coordination with medical teams, questionable consent practices, and misclassification of causes of death, particularly in overdose cases.

Strict, corrective actions have been required by the organ procurement organization, as well as "system-level changes to safeguard potential organ donors nationally."

That OPO "must conduct a full root cause analysis of its failure to follow internal protocols—including noncompliance with the five-minute observation rule after the patient’s death—and develop clear, enforceable policies to define donor eligibility criteria. Additionally, it must adopt a formal procedure allowing any staff member to halt a donation process if patient safety concerns arise."

The Department of HHS said in 2020 that it would begin grading OPOs on how many transplants they coordinated. If procurement groups didn't meet the threshold, their contracts would be terminated.