Health and Human Services Secretary Robert F. Kennedy Jr. announced on Sept. 18 that a Florida organization responsible for coordinating organ donations in the U.S. was being shut down for "unsafe practices," calling the action a historical first.

"For the first time in the history, HHS will de-certify an organ procurement organization mid-cycle," he said. "We are acting because of years of documented patient safety data failures and repeated violations of federal requirements."

Kennedy said he intended this decision to "serve as a clear warning."

He said the organization, Life Alliance Oregon Recovery Agency, based in Miami, has a long "record of deficiencies directly tied to patient harm."

"It had a 65% staffing shortage consistently across the years and may have caused as many as eight missed working recoveries each week. Roughly one life lost each day," said Kennedy.

An investigation uncovered years of "unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors," according to the HHS.

The action is part of a reform initiative announced in July after a federal investigation found at least 28 instances in a Kentucky-based federally funded Organ Protection Organization called the Network of Hope where the process of procuring organs for donation was initiated from people who may not have been dead.

The investigation also found that 73 patients showed neurological signs incompatible with donation at these organizations.

That organization, which is one of 55-federally funded organizations nationwide, is now undergoing an HHS directed "Corrective Action Plan" following a "serious patient safety event."

"The incident was an adverse event that required immediate action. While serious, it does not reflect a pattern of persistent noncompliance," HHS Spokesperson Emily Hillard told USA TODAY.

The plan, Hillard said, requires the organization "to correct deficiencies, strengthen safeguards, and prevent recurrence."

The action reflects HHS’s responsibility to act quickly when patient safety is at risk, while reserving "decertification for the most severe and sustained failures," according to a statement released by the HHS.

The organ donation system, as this decertification shows, is in need of reform and updating, said Arthur Caplan, founding head of the Division of Medical Ethics at NYU Grossman School of Medicine.

But reform should be handled with care, he said.

"Transplantation relies on altruism from both the living and the deceased to obtain life-saving organs and tissues. That altruism in turn requires trust," said Caplan. "In improving organ availability it is vitally important to do nothing that damages trust which is the fuel that provides treatments to those in organ failure."

Nearly 100,000 Americans are currently on transplant waitlists, and an average of 13 patients die each day waiting for an organ even as more than 28,000 donated organs go unmatched each year, according to the HHS.

Swapna Venugopal Ramaswamy is a White House Correspondent for USA TODAY. You can follow her on X @SwapnaVenugopal

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This article originally appeared on USA TODAY: RFK Jr. announces plans to shut down Florida organ transplant group citing safety issues

Reporting by Swapna Venugopal Ramaswamy, USA TODAY / USA TODAY

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