HHS moves to shut down major organ donation group in latest steps to reform nation’s transplant system

By Jacqueline Howard, Jen Christensen, CNN

(CNN) — As part of its efforts to strengthen the country’s organ transplant system, the US Department of Health and Human Services says it is moving to decertify a major organ procurement organization – essentially shutting it down and removing it from the nation’s network of organ donation groups.

HHS Secretary Robert F. Kennedy Jr. called the move a “clear warning” to other groups that also work to coordinate organ donations.

HHS officials are moving to close the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, after an investigation uncovered unsafe practices, staffing shortages and paperwork errors, Kennedy said Thursday.

“We are acting because of years of documented Patient Safety Data failures and repeated violations of federal requirements, and we intend this decision to serve as a clear warning,” he said.

The Life Alliance Organ Recovery Agency is one of 55 organ procurement organizations that are federally designated nonprofits responsible for managing the recovery of organs for transplantation in the United States, in which they focus on specific geographic regions and work with hospitals.

The Association of Organ Procurement Organizations (AOPO) said in a statement Thursday that the Life Alliance Organ Recovery Agency serves 7 million people across six counties in South Florida and the Commonwealth of the Bahamas.

“Through this process, AOPO pledges that we and our members will keep saving lives nationwide. We will continue to support the team at Life Alliance to ensure South Florida organ donors, transplant patients and their families have access to organ donation and transplantation services,” AOPO President Jeff Trageser said in a statement, while thanking federal health officials for recognizing the importance of organ donation.

“Because there is only one OPO per donation service area, it’s critical for CMS/HHS to manage the situation carefully and work with Life Alliance, hospitals & the wider donation community to ensure there are no lapses in donation during this process so lives can continue being saved,” he added in an email.

There is a process by which the Life Alliance Organ Recovery Agency could appeal the decertification. Neither the organization nor the University of Miami Health System immediately responded to CNN’s request for comment.

“The Life Alliance Organ Recovery Agency based in Miami, Florida, has a long record of deficiencies directly tied to patient harm,” Kennedy said Thursday.

“Staffing shortfalls alone may have caused – it 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. “Our goal is clear: Every American must trust the nation’s organ procurement system. We will not stop until that goal is met.”

Kennedy also plans to direct organ procurement organizations to appoint full-time patient safety officers to monitor safety practices, report incidents and ensure that corrective actions are implemented, among other responsibilities.

“This officer will be responsible for coordinating responses across clinical operational teams, ensure compliance with federal priorities and take corrective action whenever patients are at risk,” Thomas Engels, administrator of the federal Health Resources and Services Administration, said Thursday.

These moves are part of an ongoing initiative to reform the organ transplant system after a federal investigation earlier this year found what Kennedy called “horrifying” problems, including medical teams beginning the process of harvesting organs before patients were dead.

‘We are sending a tough message’

Each year in the United States, more than 28,000 donated organs go unused and are discarded because of inefficiencies in the system, Centers for Medicare & Medicaid Services Administrator Dr. Mehmet Oz said Thursday.

“We are sending a tough message to all the other nonprofit organ procurement agencies, organizations, so they know we’re serious,” Oz said. “We want them to know there’s a new sheriff in town, and we’re coming for them if they don’t take care of the American people.”

Organ transplant programs are certified under the Centers for Medicare & Medicaid Services, and they must meet certain requirements to be approved by Medicare.

“We’re going to crack down on noncompliance with Medicare requirements,” Oz said, adding that more action could be coming.

“We’re going to be tougher than ever before, because if we lose trust in the organ transplantation system of this country, tens of thousands of people are going to die yearly whose lives could be saved,” he said.

Public trust of the organ donation system is essential since the system relies on people to volunteer to donate their organs when they die. Most sign up when they’re getting their driver’s license.

As of 2022, about 170 million people in the US have signed up to donate their organs, but there is always more demand than there are organs available.

Last year, there were more than 48,000 transplants in the US, but more than 103,000 people were on waiting lists. About 13 people in the United States die every day waiting for a transplant, according to the Health Resources and Services Administration.

Investigations into organ procurement

In July, HHS announced its intention to fix the nation’s organ donation system. The agency directed the Organ Procurement and Transplantation Network, the public-private partnership that runs the complex donation system in the United States, to improve safeguards and monitoring at the national level and to find ways to strengthen safety protocols and transparency.

An investigation by the Health Resources and Services Administration – detailed in a hearing in July and a memo from March – found problems with dozens of transplant cases involving incomplete donations, when an organization started the process to take someone’s organs but for, some reason, the donation never happened.

The cases were managed by a procurement organization that handles donations in Kentucky and parts of Ohio and West Virginia; formerly called Kentucky Organ Donor Affiliates, it has merged with another group and is now called Network for Hope.

Network for Hope said on its website in July, “We are equally committed to addressing the recent guidance from the HRSA and we are already evaluating whether any updates to our current practices are needed.”

Of the 351 cases in the federal investigation, more than 100 had “concerning features, including 73 patients with neurological signs incompatible with organ donation,” HHS said in a July news release.

The investigation was launched after one Kentucky case came to light during a congressional hearing last year. In that case, 33-year-old TJ Hoover woke up in the operating room to find people shaving his chest, bathing his body in surgical solution and talking about harvesting his organs. Staffers had been concerned that he wasn’t brain-dead, but the concerns were initially ignored, according to the federal investigation.

Staff told CNN that the procedure to take Hoover’s organs stopped after a surgeon saw his reaction to stimuli.

The federal investigation found “concerning” issues in multiple cases, including failures to follow professional best practices, to respect family wishes, to collaborate with a patient’s primary medical team and to recognize neurological function, suggesting “organizational dysfunction and poor quality and safety assurance culture” in the Kentucky-area organization, according to a federal report.

Since the federal review, the Health Resources and Services Administration said, it has received reports of “similar patterns” of high-risk procurement practices at other organizations.

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