Federal authorities, in an unprecedented move, are set to terminate the contract of an organization tasked with coordinating organ donations across the United States. Health Secretary Robert F. Kennedy Jr. made the announcement on Thursday, signaling a significant escalation in the government’s ongoing campaign to rectify systemic issues within the national transplant framework, which has been plagued by reports of unsafe and inequitable practices.
The affected entity is the Life Alliance Organ Recovery Agency, a South Florida-based nonprofit that holds one of 55 federal contracts nationwide for organ donation coordination. This decision to sever ties, which will effectively shut down Life Alliance, serves as a stark warning to other procurement organizations: either dramatically improve operations or risk suffering the same outcome, according to Secretary Kennedy.
Furthermore, Secretary Kennedy has mandated that all organ procurement organizations (OPOs) implement critical changes, including the appointment of dedicated patient safety officers. These new roles are intended to enhance donor protection and guarantee impartiality in the distribution of vital organs.
These governmental actions follow extensive reporting that brought to light numerous deficiencies within the broader transplant system.
“We are taking bold and historic action to restore much-needed trust in the organ procurement process,” stated Mr. Kennedy.
He specifically cited a “long record of deficiencies directly tied to patient harms” at the South Florida organization. This group had accumulated multiple citations for critical issues such as chronic understaffing, inadequate training, and significant paperwork inaccuracies.
Life Alliance, currently based at the University of Miami, retains the right to appeal this decision to the Health Department and would continue its operations during the appeal process. Should the appeal fail and the contract be officially revoked, a different procurement organization would be assigned to cover the region.
The South Florida organization did not respond to inquiries regarding these developments.
Many of the persistent issues plaguing the system originate from a growing practice known as donation after circulatory death.
Unlike traditional organ donations, which typically involve individuals declared brain-dead, donation after circulatory death involves potential donors who still exhibit brain function. These patients are usually in a coma on life support with no expectation of recovery. If consent for donation is given, medical professionals will remove life support, allow the patient’s heart to cease beating, and then proceed with organ retrieval.
Previous reports detailed a dozen cases where patients undergoing this process experienced premature or botched attempts at organ retrieval. Hospitals, responsible for the care of potential donors, sometimes made erroneous recovery assessments. Furthermore, some procurement organizations overlooked clear signs of alertness in patients being readied for donation.
One particularly disturbing incident involved the Miami organization. In 2023, two Life Alliance employees reported that doctors at a Florida hospital removed life support from a patient who was visibly distressed, crying and even biting his breathing tube. The patient subsequently died, and his organs were removed. Life Alliance declined to comment on this specific case, citing privacy regulations.
The Association of Organ Procurement Organizations, a national industry body, asserts that such errors are infrequent and that organ donations continue to save thousands of lives annually.
Compounding these issues, procurement organizations have also been found to increasingly violate federal regulations by bypassing sicker patients on transplant waiting lists. Instead, organs were given to less critical recipients who had not waited as long. Reports indicate that last year, OPOs nationwide skipped patients in almost 20 percent of transplants—a sixfold increase compared to just a few years prior.
These “line-skipping” practices were also observed in cases linked to Life Alliance Organ Recovery Agency. Its former executive director admitted a personal dislike for bypassing patients but justified the practice by claiming it was efficient and helped reduce organizational costs.
For many years, officials largely failed to address these “line-skipping” and other systemic problems. While the government once threatened to withhold a contract renewal from a New York City procurement organization in 2018, it ultimately did not follow through. Thursday’s announcement marks the first instance where the agency has actually moved to decertify an organization in the middle of its contract term.
Federal oversight of the system intensified after a House committee heard alarming testimony last year. It described a Kentucky man whose organs were being prepared for retrieval even as he visibly shook his head and pulled his knees to his chest. A subsequent federal investigation confirmed that the Kentucky procurement organization had repeatedly disregarded similar signs of brain activity in dozens of other patients scheduled for donation after circulatory death.
The House committee convened a hearing in July and last week issued a bipartisan request to the agency, seeking further details on patient safety protocols. Concurrently, another committee penned a separate letter specifically expressing grave concerns regarding Life Alliance.
In response, the Health Department mandated reforms for the Kentucky procurement organization and has introduced broader systemic changes. Specialized working groups are currently developing new policies for donation after circulatory death and organ allocation. Additionally, a public website has been launched to monitor how frequently organizations bypass eligible patients, and investigations into other procurement agencies are ongoing.
Secretary Kennedy also revealed on Thursday that this year’s intensified efforts to curb line-skipping have already resulted in organs being successfully directed to an estimated 289 patients who might otherwise have been unfairly overlooked.
He shared a personal anecdote about a nephew who had become an organ donor, emphasizing that these reforms are vital to safeguarding the profound gift of organ donation and maintaining public trust among donor families.
“Should families lose trust in this critical process, fewer will opt for donation,” warned Thomas J. Engels, who leads the division overseeing the transplant system. “That outcome is simply unacceptable, and our mission here is to rectify these issues.”