The organ transplant system in the United States is getting a major overhaul, health officials announced Monday.
The Department of Health and Human Services promised to reform the nation’s organ transplant procedures in the aftermath of an investigation by the Health Resources and Services Administration that found disturbing practices, including instances of organ procurement from donors who were still alive.
“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 a statement. “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.”
HRSA officials ordered the nation’s transplant system, the Organ Procurement and Transplantation Network, to reexamine a case involving a patient of a federally-funded organ procurement organization serving Kentucky and parts of Ohio and West Virginia.
A report in March revealed that HRSA examined 351 cases in which organ donation was authorized, but wasn’t ultimately completed. Of those, 103 had concerning details, including 73 patients with “neurological signs incompatible” to organ donation, HHS officials said.
At least 28 patients may not have been deceased when organ procurement efforts began, prompting 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,” HHS officials said.
Patients at smaller and more rural hospitals were most vulnerable, revealing oversight and accountability gaps. Organ procurement organizations, also known as OPOs, must now adopt formal procedures to allow any staff member to stop donation processes if concerns arise.
OPOs must develop clear policies to defining donor eligibility criteria and conduct a “full root cause analysis” of failure to follow existing protocols, including for surgeons to wait five minutes after a patient’s death to stop operating. Any OPO that fails to comply with the corrective actions will be decertified, HHS officials said.
A House committee hearing chaired by Rep. Brett Guthrie, R-Kentucky, and Rep. John Joyce, R-Pennsylvania, will be held Tuesday on the nation’s organ procurement and transplant system.
“Shocking information obtained by the committee has shone a spotlight on ongoing patient safety concerns, lack of transparency, and mismanagement occurring within this system,” Guthrie and Joyce said in a joint statement. “This hearing is an opportunity to build upon previous bipartisan oversight work by this committee and better understand how entities within the organ procurement and transplant system intend to institute reforms. Our members are committed to following the facts wherever they may lead with the goal of improving the organ procurement and transplant system in the United States and restoring faith in the system.”
The reforms announced Monday came a day after a New York Times report featured several patients who endured “rushed or premature” attempts to remove their organs, including a 42-year-old woman who was still alive when a surgeon at a small Alabama hospital cut into her chest in 2024.
HRSA officials also directed OPOs to improve safeguards and monitoring on a national level, mandating that data about safety-related stoppages as requested by families, hospitals or staff to be reported to regulators, according to HHS.
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