The Department of Health and Human Services, under the direction of Secretary Robert F. Kennedy, Jr., announced an initiative on Monday to begin reforming the organ transplant system after an investigation uncovered “disturbing practices.”
The Health Resources and Services Administration, which is housed under HHS, ordered the Organ Procurement and Transplantation Network to review a transplant case from the Kentucky Organ Donor Affiliates, a federally-funded organ procurement organization that serves Kentucky, southwest Ohio, and part of West Virginia.
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“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” Kennedy said in a press release. “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.”
The review was ordered following claims from a former KYDA employee that “in 2021, a patient had been inaccurately pronounced brain dead and was pursued as an organ donor by KYDA” and the patient displayed “clear signs of life at multiple points, but KYDA senior staff directed that organ recovery proceed,” according to a memorandum from the House Subcommittee on Oversight and Investigations for a hearing scheduled for Tuesday morning. KYDA merged with LifeCenter Organ Donor Network in October 2024 and is now known as Network for Hope.
HRSA’s investigation reviewed KYDA’s conduct and patient care, ultimately discovering “clear negligence,” while a previous review by the OPTN’s board of directors under the Biden administration claimed to find “no major concerns” and previously closed the same case without action.
HRSA reviewed 351 cases where organ donation was authorized, but the procedures weren’t completed. Of these cases, 103 showed “concerning features,” including 73 patients who showed neurological signs “not conducive” to organ procurement, such as “pain or discomfort” during events leading up to organ procurement, HRSA said in its letter to OPTN.
The investigation also found that at least 28 patients had no recorded time of cardiac death, suggesting they were not deceased when the organ procurement process began. These concerning findings can be attributed to “poor neurologic assessments, lack of coordination with medical teams, questionable consent practices, and misclassification of causes of death.”
Smaller hospitals and those in more rural areas were found to be most at risk. The HRSA has instructed OPTN to develop a yearlong plan to address the problems raised by the HRSA review, including improved documentation of patients’ neurologic status, which is due in 30 days.
In the wake of reports of questionable practices at several other OPOs, Kennedy also instructed OPTN to implement “minimum safety standards” for neurologically injured patients being considered for organ donation.
Kennedy also required OPTN to develop new policies that improve safety for potential organ procurement patients and increase the amount of information shared with patients’ families. Kennedy expects the proposal of these new policies within six months.
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“These findings from HHS confirm what the Trump administration has long warned: entrenched bureaucracies, outdated systems, and reckless disregard for human life have failed to protect our most vulnerable citizens,” HHS said in its press release. “These reforms are essential to restoring trust, ensuring informed consent, and protecting the rights and dignity of prospective donors and their families.”
There are currently more than 103,000 people on the national transplant waiting list, including adults and children. More than 48,000 organ transplants were performed in 2024, according to statistics from the HRSA.