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The head of an organ procurement group told a House panel Tuesday he would be "disturbed" if he had witnessed a 2021 case in which a Kentucky man was prepared for organ retrieval even while shaking his head "no" and bringing his knees up to his chest.
"Seeing someone like that myself, personally, yes, I think I would be disturbed," said Barry Massa, CEO of Network for Hope, a group under scrutiny by federal officials for allowing more than 70 potential donors to be prepared for organ removal even as they showed neurological signs that should have ruled out procurement.
Massa and other officials who coordinate the retrieval and transport of human organs for transplant faced heated questions from an oversight subcommittee of the House Energy and Commerce Committee. The hearing focused on serious mistakes in the process of removing kidneys, livers, lungs and other organs from patients, detailed in a March federal report made public this week.
Lawmakers repeatedly pressed Massa to explain how the Kentucky man, whose case was detailed in the report, could have been moved toward surgery even as he was crying and moving around.
"This seems to be a story more fitting for a horror movie than a congressional hearing, frankly," said Rep. Neal Dunn (R-Florida).
Massa, whose federally chartered nonprofit organization oversees organ procurement in Kentucky and parts of West Virginia and Ohio, said the coronavirus pandemic had affected communication between his workers and hospital staff, but did not explain how. But he insisted policies and regulations were followed throughout the incident.
"I think in that case, the communication could have been vastly improved," Massa told lawmakers.
Massa's group, one of 56 that operate across the U.S., must submit a report to the Department of Health and Human Services by the end of the month on how it aims to avoid repeating dozens of cases in which patients were prepared for donation even while showing signs of life.
Health and Human Services Secretary Robert F. Kennedy Jr. threatened Monday to decertify Network for Hope if it fails to follow protocols that regulate when an organ can be taken from a donor. He also announced changes to the nation's organ transplant system to address systemic problems with the organ donation process and restore public trust in it.
The HHS investigation found Network for Hope's workers pressured doctors to start procuring organs from patients even as they showed signs of life. Of 351 cases in which organ donation was authorized but not completed, HHS found 103 cases with "concerning features, including 73 patients with neurological signs incompatible with organ donation," according to Kennedy's statement. At least 28 patients may not have been deceased when organ procurement was initiated, the statement said.
HHS also said it found evidence of "poor neurological assessments, lack of coordination with medical teams, questionable consent practices and misclassification of causes of death."
On Sunday, a report by the New York Times about such patients included one who was presumed to be dead but whose heart was discovered to be beating after a surgeon made an incision in her chest for procurement surgery.
"Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying," Kennedy said in a statement.
Raymond Lynch, chief of the organ transplant branch of the Health Resources and Services Administration, told lawmakers his agency has received additional reports of similar mistakes in other parts of the country served by other OPOs.
"Unfortunately it is not limited to [Network for Hope]," Lynch said.
The Association of Organ Procurement Organizations, a trade group, said it is "treating the concerns raised in the HHS announcement very seriously."
The controversy around organ donation partly stems from a change in which patients are considered eligible for donation. Historically, the majority of donations have come from brain-dead patients. But now, roughly half of all donations are from patients who have experienced "circulatory death."
Such patients may still show brain activity, but doctors have determined they are near death and will not recover. With family consent, life support can be withdrawn, and doctors then wait for the heart to stop beating.
The number of donations from patients with circulatory death doubled from 2021 to 2024, according to the Organ Procurement and Transplant Network, the organ transplant system. There are now 23 percent more organ transplants performed annually than in 2020, which, in part, reflects an increased supply from this practice.
Still, about 105,000 people are on the waiting list for a transplant and an average of 13 people die every day awaiting organs.
The New York Times also reported that in some cases OPOs have pressured doctors to move quickly to procure organs in the short time frame required, even as patients showed signs of consciousness.
One 50-year-old man detailed in the HHS report woke up while lying on an operating table, prepped for surgery. Even after he was able to follow commands, he wasn't immediately taken back to the Intensive Care Unit.
It created a "very uncomfortable situation for the nurse involved, because the patient had no idea what was going on but was becoming more aware by the minute," according to the report.
HHS launched its investigation after a House committee hearing in September, during which a former employee of the Kentucky OPO revealed that she, a surgeon and other workers refused to procure organs from a patient who was being prepared for surgery but was shaking his head and crying.
Kennedy said OPOs must adopt a formal process that allows any staff member to halt a donation process if patient safety concerns arise. They also must review any failures to follow protocol - including a requirement to wait five minutes after a patient is dead before making an incision - and develop clear policies around who is eligible for organ donation.
Massa told lawmakers that Network for Hope has set up a number of reforms in response to the findings, including checklists for nurses and attending physicians to help them follow protocols in determining when a patient is ready for organ removal surgery. It has produced a 10-minute video that explains the process from beginning to end.
"I think, going forward, we will never have a case like that again," he said, referring to the Kentucky man, who has since recovered.
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