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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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