HHS Targets Transplant System Amid Reports of Donors Showing 'Signs of Life'

 HHS on Monday announced "a major initiative to begin reforming the organ transplant system"

opens in a new tab or window after an investigationopens in a new tab or window by the Health Resources and Services Administration (HRSA) found "disturbing practices" by Kentucky Organ Donor Affiliates (KYDA), an organ procurement organization serving Kentucky, southwest Ohio, and parts of West Virginia.

"Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying," HHS Secretary Robert F. Kennedy Jr. said in the release. "The organ procurement organizations (OPOs) 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."

Specifically, HRSA asked the Organ Procurement and Transplantation Network (OPTN), which oversees KYDA, to reopen a case in which harm was done to a neurologically injured patient by KYDA. The OPTN had previously closed the same case during the Biden administration without taking any action. But now HRSA's investigation "revealed clear negligence after the previous OPTN board of directors claimed to find no major concerns in their internal review," the release said.

In total, the agency analyzed 351 cases in which donation was authorized but not completed. Among its findings were 73 patients with neurological signs incompatible with organ donation, and at least 28 patients who "may not have been deceased at the time organ procurement was initiated -- raising serious ethical and legal questions," HHS said. In addition, "evidence pointed to poor neurologic assessments, lack of coordination with medical teams, questionable consent practices, and misclassification of causes of death, particularly in overdose cases."

HRSA ordered KYDA to conduct "a full root cause analysis of its failure to follow internal protocols -- including noncompliance with the 5-minute observation rule after the patient's death -- and develop clear, enforceable policies to define donor eligibility criteria," according to HHS. "Additionally, it must adopt a formal procedure allowing any staff member to halt a donation process if patient safety concerns arise."

In an 8-page letteropens in a new tab or window to KYDA, HRSA Associate Administrator Suma Nair, PhD, also directed the OPTN to take several corrective actions, including developing a monitoring plan for KYDA that must include improved oversight of patients' neurologic status. If the OPTN fails to follow the corrective action plan, it will "prompt review by the secretary for further actions to protect patient safety and public health," Nair wrote.

The HHS announcement came the day before Tuesday's hearingopens in a new tab or window held by the House Energy & Commerce Subcommittee on Oversight and Investigations to discuss oversight of the organ procurement and transplant system. "HRSA's report contains shocking new information about practices and procedures that may put patients at risk of preventable harm in the organ procurement and transplant system," Reps. Brett Guthrie (R-Ky.), chairman of the full Energy & Commerce Committee, and John Joyce, MD (R-Pa.), chairman of the Oversight and Investigations Subcommittee, said in a joint statementopens in a new tab or window.

"The 'index case,' and others examined by HRSA in the report, are troubling example[s] of threats to patient safety, and what has transpired within these cases cannot go without further analysis and investigation. Oversight and transparency are critical to both improving the system and maintaining public trust," Guthrie and Joyce said. "This committee will continue to engage in open discussions surrounding these systemic issues to protect patients and their families and restore faith in our nation's organ procurement and transplant system."

This is not the first time in recent years that a presidential administration and Congress have scrutinized the transplant system. In September 2023, President Biden signed the Securing the U.S. Organ Procurement and Transplantation Network Actopens in a new tab or window into law; that measure was designed to end the monopoly that the United Network for Organ Sharing (UNOS) currently has as the nation's sole OPTN operator.

In his opening remarks at the hearing, Guthrie noted some of the transportation issues that have arisen with donor organs under UNOS's stewardship. "In 2018, there was a human heart left behind on a commercial plane," he said. "Another mind-boggling story was in 2020 when a kidney was accidentally thrown in the trash by an OPO staff [member], causing it to be unusable."

"I am hopeful that we are moving in the right direction to help mitigate the failures of our current organ transplant system, but more must be done," Guthrie added. "Congress will be watching to ensure this new law is implemented effectively and we do not face the same mistakes again."

https://www.medpagetoday.com/transplantation/transplantation/116620