HHS Announces Organ Transplant System Reform

At least 28 patients may not have been deceased when operations began to harvest their organs, according to a federal review of one federally funded organ procurement organization. In response to the disturbing report, the U.S. Department of Health and Human Services (HHS) has announced an initiative to reform the organ transplant system.

“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” Secretary Robert F. Kennedy Jr. said in a statement Tuesday. “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.”

Kentucky Organ Donor Affiliates, the organ procurement organization in question, serves Kentucky, southwest Ohio, and parts of West Virginia. The organization is now called Network for Hope after merging with another organization. The Health Resources and Services Administration (HRSA) examined more than 350 cases where organ donation was authorized but ultimately not completed and found evidence pointing to poor neurological assessment, lack of coordination with medical teams, questionable consent practices, and misclassification of causes of death, according to a press release from HHS.

“These were not unique. These are horrific reports,” House subcommittee Chair Dr. John Joyce, a Pennsylvania Republican, said in a hearing Tuesday. “It affirms the need for this investigation to occur.”

In response to the findings, HRSA has mandated corrective actions for the organization and system-level changes to safeguard potential organ donors. Kennedy said he will decertify the organization if it fails to comply with the corrective action requirements.

The HRSA will work to earn back the trust of families harmed by the organ transplant system, Raymond Lynch, chief of HRSA’s organ transplant branch, told the House Energy and Commerce Committee Subcommittee on Oversight and Investigations Tuesday.

“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 said.

The agencies began the review after a 33-year-old patient, TJ Hoover, reported waking up on the operating table while medical staff were preparing his body for an organ harvesting operation. A doctor had declared him brain-dead earlier that day after he was hospitalized for a drug overdose.

Network for Hope CEO Barry Massa testified Tuesday that the organization is in the process of reviewing the issues cited in the HRSA report and addressing the agency’s concerns.

“Patient safety is at the forefront of everything that we do,” Massa said. “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 organ procurement organization in Kentucky is one of 55 in the country, and about 170 million people around the U.S. have signed up to donate their organs when they die, according to 2022 data. Lynch said Tuesday that HRSA is undertaking investigations of similar patterns happening in other parts of the country and will have additional investigative reports on patient safety in the organ donation system in the near future.