The U.S. Department of Health and Human Services said Monday it is implementing initiatives to reform the country’s organ donation system after a federal investigation discovered. One organization in the Kentucky area has begun the process of stripping organs from people who may not be dead.
House subcommittee was held A hearing about the lapse of organ donation safety on Tuesday and how procurement and transplant organizations intend to improve the system to regain the trust of donors and their families. That trust is essential as the US organ donation system often relies on people to volunteer to donate when they obtain their driver’s license.
As of 2022, around 170 million people in the US have signed up to donate organs when they die, but there is always a demand for organs rather than what is available. There were over 48,000 transplants last year. In the US, over 103,000 people were on the waiting list. About 13 people in the United States are awaiting a transplant, according to the Federal Health Services Agency (HRSA).
According to the HHS, after an investigation by the HRSA discovered issues with dozens of cases, including incomplete donations, the organization began the process of taking someone’s organ, but for some reason the donation did not occur.
Dr. Raymond Lynch, chief of HRSA’s organ transplantation division, said at a hearing Tuesday that the report focuses on issues in Kentucky that should not happen any more.
“I want to start by expressing an apology for the care that has been delivered to your members, the people of Kentucky. That’s not acceptable. It’s not something that HRSA is trying to endure.”
“You’ll earn trust. You’re not expected. You’re making money every day,” he added.
According to reports on the federal investigation and memos prepared before the House hearing, the affiliates of Kentucky Organ Donor, a procurement organization that handles donations in Kentucky, Ohio and West Virginia, were managed by a procurement organization that handles parts of Kentucky and West Virginia.
Of the 351 cases under investigation, more than 100 “relevant to functional function, including 73 patients with neurological signs that are incompatible with organ donation,” HHS said in a news release Monday. At least 28 cases were involved in patients who may not have died when the organ procurement process began, raising “serious ethical and legal questions.”
“These were not unique. They are horrifying reports,” Dr. John Joyce, chairman of the House Subcommittee of the Pennsylvania Republican, said Tuesday. “We are confirming the need for this investigation to occur.”
HHS secretary Robert F. Kennedy Jr. also cited the study as a driving force behind new surveillance in the organ donation process.
“Our findings show that the hospital allowed patients to begin organ procurement processes when they show signs of life, which is frightening,” Kennedy said on Monday’s release. “The organ procurement organizations that regulate access to transplants are accountable. The entire system must be fixed so that the lifespan of all potential donors is treated with the sanctity it deserves.”
Network for Hope did not respond to CNN’s request for comment, but its website states it is “fully committed to transparency” and fully complies with all the requirements of the Centers for Medicare and Medicaid Services, which regulate organ donation organizations. “Our goal is and continues to meet the highest ethical and medical standards in donation and transplantation.”
CEO Barry Massa testified on Tuesday that the organization received the HRSA report just a few days ago, saying it is considering the issues cited and is addressing the agency’s concerns.
“It’s clear that the allegations and contents of the report are serious and surprising,” Massa said. “Patient safety is at the forefront of everything we do. I want to assure the Subcommittee that the Network for Hope continues to implement policies and procedures, continually improve, better and most importantly, take the appropriate steps necessary to ensure and promote patient safety.”
The study found patterns of working with key patients’ health teams and following specialized best practices to recognize neural function, respecting family wishes, working with key patients’ health teams, working with key patients’ health teams, and recognizing neural function, as reported by the HRSA.
The study found that Kentucky area organizations and organ procurement and transplant networks that oversee local groups “will not be able to properly recognize and respond to poor patient care and quality practices.”
Kentucky’s organ procurement organization is one of the 55 US organ procurement organizations, since the federal era. According to the HRSA, the review said it received reports of “similar patterns” of high-risk sourcing practices in other organizations.
Lynch said Tuesday that the agency is investigating cases in other parts of the country and has additional investigation reports on patient safety in the organ donation system.
The agency has required system-level changes to protect potential organ donors across the United States, and said Kentucky area organizations should conduct a “full root cause analysis of failure to follow internal protocols.” He also said that if there are safety concerns, organizations must adopt formal procedures to stop the donation process.
Network for Hope said on its website: “We are equally committed to addressing recent guidance from the HRSA and have already assessed whether an update to current practices is necessary.”
A federal investigation began after one Kentucky incident was revealed at a legislative hearing in September.
In 2021, 33-year-old TJ Hoover was hospitalized after a drug overdose. He woke up in the operating room, shaved his breasts, soaked his body with a surgical solution, and found someone talking about organ harvesting. That day, doctors had declared him brain dead, despite the fact that he seemed to respond to the stimuli, make eye contact and shake his head.
Former staff at the organ procurement organization involved in Hoover’s case raised concerns that he was not brain dead and should not be on the operating table. The concerns were ignored, according to the federal government. investigation.
Staff told CNN that the procedure for taking Hoover’s organs has stopped after the surgeon saw the response to the stimulus. The Kentucky Procurement Agency told CNN last fall that it was “confident that accepted practices and approved protocols are being followed.”
Hoover currently lives with her sister in Richmond, Kentucky, and receives extensive physical therapy and treatment.
He took his position on the network for hope after the Hoover incident, but testified on Tuesday that the organization was following policies and regulations, in this case, “communication could have been significantly improved.”
Massa said Covid has complicated communication between the organ procurement team and the hospital.
He followed the process, but he added, “We could have done better, but there were more unique things.”
Massa said Network for Hope is conducting its own independent investigation into Hoover and other cases mentioned in the HRSA report. The organization has introduced additional safeguards to bring more trust to the system, he said: nurses and participating doctors now have a checklist, so they know what their role is, especially in donations, and the organization has created an explanatory video.
HRSA Lynch testified that a proper reassessment of neurological conditions prevents many errors in Kentucky.
“Building that collaborative relationship and listening to the medical team and family would have hindered a lot of these,” he said.
The agency has also created locations on its websites to report concerns encountered during part of the organ donation process.
For years, Congress has been investigating the country’s organ donation system. Tuesday’s hearing was intended to determine lessons that could be learned from the investigation, changes needed to improve the system, and future challenges.
One problem involves organs sourced from patients who are not brain dead. Most donations in the US come from brain dead people, but there are other circumstances in which patients may become organ donors. Called circulatory death or donation after DCD, it has become much more common in recent years. Some experts question the ethics of practice.
Post-brain death donations are defined by organ procurement and transplant networks as “characterised by the process of organ recovery that may occur after death due to irreversible cessation of brain stem function, lack of electrical activity to the brain, blood flow to the brain, and brain function are determined by clinical assessment of responses.”
By comparison, DCD “has had an inherently catastrophic illness or injury that made the family decide to withdraw life support,” Dr. Robert Cannon, director of the University of Alabama’s Liver Transplant Program, told CNN last year after the Hoover incident came to light.
Cannon was not involved in the Hoover incident, but was familiar with it as he testified about the expiration of the organ procurement system at a hearing of House Energy and commercial oversight and investigations at the location where the incident was revealed in September.
“It’s true, we have a potential DCD donor with a lot of reflexes,” Cannon said. “However, as long as the family knows that this is happening with loved ones, this process is considered ethical and standard.”
