The Department of Health and Human Services (HHS) said Monday it has launched “a major initiative” to overhaul the nation’s organ transplant system.
The announcement cites an investigation conducted earlier this year by the department’s Health Resources and Services Administration (HRSA) “that revealed disturbing practices by a major organ procurement organization.”
The news also came a day after a New York Times report that vividly described the case of a patient taken off life support and declared dead but whose heart and respiratory systems were found to still be active after surgeons had made an incision into her chest to secure her organs for donation.
That report, citing interviews with 55 medical workers in 19 states who told the paper they “had witnessed at least one disturbing case of donation after circulatory death,” broadly raised questions over whether pressure from the federal government and organ procurement organizations (OPOs) to increase the supply of donor organs has weakened patient safety procedures.
The announcement also comes as the HRSA has been working to reform the Organ Procurement and Transplantation Network (OPTN) and as bipartisan members of Congress maintain their heavy scrutiny of both the update and of persistent whistleblowing over patient safety and mismanagement. The House’s Energy and Commerce Subcommittee on Oversight and Investigations, citing “shocking information obtained by the Committee,” had already scheduled a hearing on the subject for Tuesday morning.
The HHS said its initiative stems from a directive to the OPTN to reopen “a disturbing case involving potentially preventable harm to a neurologically injured patient” and called for an independent review of the relevant OPO. Those actions and the subsequent examination of 351 authorized-but-incomplete organ donations—which found 73 patients for whom the process should have been halted earlier due to the patient’s neurological signs—led the HRSA to mandate “strict corrective actions” for the individual OPO and “system-level changes” affecting donors nationwide, the HHS said.
“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” HHS Secretary Robert F. Kennedy Jr. said in the department’s 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 HHS’ announcement included a heavily redacted copy of the May 28 notice OPTN heads sent the OPO threatening decertification if the corrective actions are not taken.
The New York Times, in June, had published a rundown of the HRSA’s investigation and the case of the Kentucky patient who spurred it based on information it said was provided by the government agency. That report identifies the OPO as Kentucky Organ Donor Affiliates, which is now called Network for Hope following a merger. The organization had previously said the case was misrepresented when discussed during a September 2024 House Committee on Energy and Commerce hearing.
At a national level, the HRSA said it has directed all data related to safety-related organ donation stoppages to be reported to the regulator. It also is requiring the OPTN “to strengthen organ procurement safety and provide accurate, complete information about the donation process to families and hospitals,” the HHS said.
The department’s press release noted that the Kentucky patient’s case had previously been closed without action by the OPTN’s Membership and Professional Standards Committee under the Biden administration.
It also said the HRSA’s reexamination “confirm[s] 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.” The department under RFK Jr. and White House directives have made a similar case when outlining plans to reduce regulatory burdens and when introducing new Medicare and Medicaid policies they say will improve quality and reduce fraud.