The U.S. Department of Health terminated a contract with one of the organizations that coordinate organ donations, moving to fully confront concerns over safety and fairness. It is the first time the government has ended a contract with an organ transplant group midterm, a move expected to accelerate pressure for systemic reform across the U.S. transplant system.
According to the New York Times (NYT) on the 18th (local time), Minister Robert F. Kennedy Jr. of the Department of Health announced the termination of the contract of Life Alliance Organ Recovery Agency, headquartered in South Florida. Minister Kennedy said the agency has long repeated problems directly linked to patient harm, including staffing shortages, inadequate training, and paperwork errors, and noted, "We cannot continue to work with an organization that cannot ensure patient safety and the fairness of organ distribution." He also said the action would serve as a warning to other procurement organizations and proposed strengthening internal controls, including appointing a patient safety officer.
According to the NYT, vulnerabilities in the U.S. transplant system surfaced most acutely in the donation process after circulatory death (a determination of death made after the heart stops and blood circulation fully ceases). Reports described cases where organ recovery moved ahead hastily even though potential donors still had brain function or a possibility of recovery. In 2023, a shocking case at a Florida hospital came to light in which organs were recovered after life support was withdrawn while the patient was crying and biting a breathing tube. There were also numerous cases in which a patient's condition was misjudged during donation preparation, or the determination that a patient would not recover was wrong.
There were also more cases in which, citing expense reduction and efficiency, patients on the waiting list were skipped and organs were provided to recipients in less critical condition. A federal investigation found this approach accounted for 20% of all transplants, six times higher than a few years ago. Life Alliance, an organ donation and transplant coordination agency, was also cited for repeatedly engaging in such practices. The agency's former chief acknowledged, "We knew it was not desirable, but it helped with efficiency and expense reduction."
The federal government recently tightened oversight after securing testimony at a House hearing that a Kentucky procurement agency removed organs from circulatory death donors while ignoring their brain activity. The agency received a reform order, and additional investigations are underway into agencies in other regions. The Department of Health said this year's crackdown on skipping the waiting list enabled about 289 patients to receive organs legitimately.
Minister Kennedy warned, "Organ donation is a sacred gift, and once families lose trust, the number of people choosing to donate can decline." Thomas J. Engels, the head of the Health Resources and Services Administration (HRSA) at the Department of Health, which oversees the transplant system, also said, "A collapse of trust is unacceptable and must be corrected."
Observers say the move, intertwined with political pressure for transplant system reform, is likely to ripple across the entire framework. Experts assessed, "The Department of Health's decision will be a watershed for restoring trust in the U.S. organ transplant system, going beyond a mere contract termination."