HHS says it will begin reforms of organ donation system after federal investigation finds ‘horrifying’ problems
By Jen Christensen, CNN
(CNN) — The US Department of Health and Human Services said Monday that it’s undertaking an initiative to reform the country’s organ donation system, after a federal investigation found that one organization in the Kentucky region began the process to take organs from people who may not have been dead.
A House subcommittee held a hearing Tuesday on organ donation safety lapses and how procurement and transplant organizations intend to improve the system, to regain the trust of donors and their families. That trust is essential because the US organ donation system relies on people to volunteer to donate, often when they get a driver’s license.
As of 2022, about 170 million people in the US have signed up to donate their organs when they die, but there is always more demand for organs than what is 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 federal Health Resources and Services Administration, or HRSA.
HHS says the reform initiative was launched after an investigation by HRSA found problems with dozens of cases involving incomplete donations – when an organization started the process to take someone’s organs but, for some reason, the donation never happened.
Dr. Raymond Lynch, chief of HRSA’s Organ Transplant Branch, said at the hearing Tuesday that the report was focused on problems in Kentucky that should not happen going forward.
“I’d like to begin by expressing my apologies for the care that was delivered to your constituents, to the people of Kentucky. It’s unacceptable, and it’s not something that HRSA is going to let stand,” Lynch told the House Energy & Commerce Committee Subcommittee on Oversight and Investigations.
“Trust is earned. It’s not to be expected. It’s earned every day,” he added.
‘These are horrific reports’
According to the report on the federal investigation, as well as a memo prepared ahead of the House hearing, the cases were managed by Kentucky Organ Donor Affiliates, a procurement organization that handles donations in Kentucky and parts of Ohio and West Virginia, which has merged with another group and is now called Network for Hope.
Of the 351 cases in the investigation, more than 100 had “concerning features, including 73 patients with neurological signs incompatible with organ donation,” HHS said in a news release Monday. At least 28 cases involved patients who may not have been deceased at the time the organ procurement process began, raising “serious ethical and legal questions.”
“These were not unique. These are horrific reports,” House subcommittee Chair Dr. John Joyce, a Pennsylvania Republican, said Tuesday. “It affirms the need for this investigation to occur.”
HHS Secretary Robert F. Kennedy Jr. also cited the investigation as the impetus for new oversight of the organ donation process.
“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 Monday’s release. “The organ procurement organizations that coordinate access to transplants will be held accountable. The entire system must be fixed to ensure that every potential donor’s life is treated with the sanctity it deserves.”
Network for Hope did not respond to CNN’s request for comment, but it says on its website that it is “fully committed to transparency” and is in full compliance with all requirements of the Centers for Medicare & Medicaid Services, which regulates organ donation organizations. “Our goal has always been and will remain to meet the highest ethical and medical standards in donation and transplantation.”
CEO Barry Massa testified Tuesday that the organization got the HRSA report only a few days ago and said it is in the process of reviewing the issues cited and is addressing the agency’s concerns.
“It is clear that the report’s allegations and contents are serious and alarming,” Massa said. “Patient safety is at the forefront of everything that we do. I want to assure the subcommittee that Network for Hope will take any appropriate action necessary to continue to implement policies and procedures, to continuously improve, and be better, and most importantly, ensure and promote patient safety.”
The investigation found patterns such as 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 report from HRSA.
The investigation also found that the Kentucky-area organization and the Organ Procurement and Transplantation Network, which oversees the local groups, failed to “adequately recognize and respond to poor patient care and quality practices,” the report says.
The organ procurement organization in Kentucky is one of 55 in the US, and since the federal review, HRSA said, it has received reports of “similar patterns” of high-risk procurement practices at other organizations.
Lynch said Tuesday that the agency was undertaking investigations of cases in other parts of the country and would have an additional investigative report on patient safety in the organ donation system.
The agency is mandating system-level changes to safeguard potential organ donors across the US and said the Kentucky-area organization needed to conduct a “full root cause analysis of its failures to follow internal protocols.” It also said the organization must adopt a formal procedure to halt a donation process if there are safety concerns.
Network for Hope says on its website: “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.”
TJ Hoover’s story
The federal investigation was launched after one case in Kentucky came to light during a congressional hearing in September.
In 2021, 33-year-old TJ Hoover was hospitalized after a drug overdose. He woke up in the operating room to find people shaving his chest, bathing his body in surgical solution and talking about harvesting his organs. Earlier that day, a doctor had declared him brain-dead, according to his medical records, even though he seemed to be reacting to stimuli, making eye contact and shaking his head.
Former staffers of the organ procurement organization who were involved in Hoover’s case raised concerns that he wasn’t brain-dead and should not have been on the operating table. The concerns were 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 Kentucky procurement organization told CNN last fall that it had reviewed the case and “remains confident that accepted practices and approved protocols were followed.”
Hoover now lives with his sister in Richmond, Kentucky, and is undergoing extensive physical therapy and treatment, much of which is shared on TikTok in an effort to inspire others.
Massa, who took his position with Network for Hope after Hoover’s case, testified Tuesday that the organization had followed policy and regulations, but in this case, “communication could have been vastly improved.”
Massa said that Covid had complicated communication between the organ procurement team and the hospital.
Although the process was followed, he added, “there was a lot of unique things that could have been done better.”
Massa said that Network for Hope is doing its own independent investigation of Hoover’s and the other cases mentioned in the HRSA report. The organization has put additional safeguards in place to bring more trust to the system, he said: Nurses and attending physicians now have a checklist so they know what their role is in particular donations, and the organization has created an explanatory video.
HRSA’s Lynch testified that appropriate reevaluation of neurologic status would have prevented many of the errors in the Kentucky cases.
“Building that collaborative relationship and listening to the medical teams and the families would have prevented many of these,” he said.
The agency is also creating a place on its website for people to report any concerns they encounter during any part of the organ donation process.
Donation after circulatory death
Congress has been investigating the nation’s organ donation system for years. Tuesday’s hearing was intended to determine what lessons could be learned from the investigation, what changes are necessary to make the system better and what challenges lie ahead.
One issue involves organs procured from patients who aren’t brain-dead. Although most donations in the US come from people who are brain-dead, there are other circumstances in which a patient may become an organ donor. It’s called donation after circulatory death, or DCD, and it has become much more common in recent years. Some experts question the ethics of the practice.
A donation after brain death is defined by the Organ Procurement and Transplantation Network as “the organ recovery process that may occur following death by irreversible cessation of cerebral and brain stem function; characterized by absence of electrical activity in the brain, blood flow to the brain, and brain function as determined by clinical assessment of responses.”
DCD, by comparison, is when “you’ve got somebody with essentially devastating illness or injury, and their family’s decided to withdraw life support,” Dr. Robert Cannon, an associate professor of surgery and surgical director of the liver transplant program at the University of Alabama at Birmingham, told CNN last year after Hoover’s case came to light.
Cannon was not involved in Hoover’s case but was familiar with it because he testified about lapses in the organ procurement system at the House Energy and Commerce Oversight and Investigations Subcommittee hearing where the case came to light in September.
“Certainly, we have potential DCD donors with lots of reflexes,” Cannon said. “But as long as the family knows this is what’s happening with their loved one, this process is considered ethical and standard.”
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