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lite.cnn.com - on gopher - inofficial | |
ARTICLE VIEW: | |
HHS moves to shut down major organ donation group in latest steps to | |
reform nation’s transplant system | |
By Jacqueline Howard, Jen Christensen, CNN | |
Updated: | |
5:12 PM EDT, Fri September 19, 2025 | |
Source: 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 , 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) 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 but the organization said in a | |
statement to CNN that it would not do so. | |
“The top priority of the Life Alliance Organ Recovery Agency (LAORA) | |
has always been safe, respectful, and compliant organ donation | |
practices. We are aware of the decision issued today by the Department | |
of Health and Human Services (HHS) and of the agency’s investigations | |
into organ procurement practices across the country. We will cooperate | |
fully with HHS to ensure a smooth transition and will not appeal. We | |
hope that other OPOs follow suit in putting patients first,” it said. | |
Kennedy said Thursday that Life Alliance had a “long record of | |
deficiencies directly tied to patient harm.” | |
“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 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 , 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 have signed up to donate their organs, but there is | |
always more demand than there are organs available. | |
Last year, there were more than in the US, but more than 103,000 people | |
were on waiting lists. 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 , HHS announced its intention to fix the nation’s organ donation | |
system. The agency directed , 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 – 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 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 . | |
The investigation was launched after one Kentucky case came to light | |
during a 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 of high-risk | |
procurement practices at other organizations. | |
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