For the first time ever, federal officials are moving to fire an organization that coordinates organ donations in the United States.
Robert F. Kennedy Jr., Secretary of the U.S. Department of Health and Human Services (HHS[1]), just announced plans to decertify the Life Alliance Organ Recovery Agency[2], a University of Miami-based organ procurement organization.
The move comes, he said, after investigators found years of unsafe practices, poor training, understaffing and paperwork errors that endangered patients and undermined public trust.
“We are taking bold action and historic action to restore trust in the organ procurement process,” Kennedy said Thursday[3] about the decision by the Donald Trump administration. “We are acting because of years of undocumented patient safety data failures and repeated violations of federal requirements, and we intend this decision to serve as a clear warning.”
Kennedy added that Life Alliance has “a long record of deficiencies directly tied to patient harm.”
“There was a 65% staffing shortage, consistently, across the years and may have caused as many as eight missed organ recoveries each week, roughly one life lost each day,” he said. “Unlike the Biden administration, which ignored these problems and failed to act, the Trump administration is setting a new standard (where) patient safety comes first.”
Life Alliance is one of 55 nonprofits under federal contract to arrange transplants. If its decertification is finalized, another organ procurement organization would assume its responsibilities in South Florida.
Life Alliance has the right to appeal. It did not immediately respond to requests for comment.
The decision by HHS follows New York Times reporting that uncovered repeated errors across the national transplant system[4], including cases in which patients may not have been legally dead before organ recovery began.
In one 2023 case involving Life Alliance, hospital staff removed a patient’s organs after withdrawing life support, even though the man reportedly cried and bit his breathing tube.
Problems also included “line skipping,” where patients lower on the waitlist were chosen over sicker or longer-waiting patients. According to federal officials, organ procurement organizations nationwide bypassed patients in nearly 20% of transplants last year — six times the rate from only a few years ago.
A former Life Alliance executive told the Times[5] he disliked the practice but acknowledged it saved money.
HHS said nearly 100,000 Americans are currently on organ waitlists. About 13 die each day waiting.
At the same time, more than 28,000 donated organs go unmatched each year.
“If families lose trust, fewer will choose donation,” said Thomas Engels, head of the HHS division that oversees the transplant system. “That is simply unacceptable, and we are here to fix it.”
Deputy Secretary Jim O’Neill said the former President Joe Biden’s administration had “turned a blind eye” to such failures.
“That neglect not only cost patients their chance at life, but it stalled the innovation our system so desperately needed. Today, we are correcting those failures by restoring transparency and embracing forward-looking solutions,” he said.
Dr. Mehmet Oz, Administrator of the Centers for Medicare and Medicaid Services[6], stressed that the agency has a duty to hold organ procurement organizations accountable.
“For too long, patients and families have suffered from systemic failures,” he said. “We are enforcing rigorous standards and modernizing the system with better data, stronger oversight, and innovative tools.”
Kennedy said all organ procurement organizations will now be required to appoint patient safety officers to monitor adverse events, investigate problems and serve as a point of contact for families and hospitals.
Reforms coming soon or already in motion, he said, include safeguards against line skipping, a new transparency tool to track allocations and an independent governing board for the Organ Procurement and Transplant Network[7], the national system that manages organ donation and transplantation in the U.S.
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References
- ^ HHS (www.hhs.gov)
- ^ Life Alliance Organ Recovery Agency (www.laora.org)
- ^ said Thursday (x.com)
- ^ repeated errors across the national transplant system (www.nytimes.com)
- ^ told the Times (www.nytimes.com)
- ^ Centers for Medicare and Medicaid Services (www.cms.gov)
- ^ Organ Procurement and Transplant Network (optn.transplant.hrsa.gov)