HHS to reform organ donation system amidst House scrutiny

The Department of Health and Human Services on Monday said it would restructure the system to protect the lives of potential donors. An investigation by the department’s Health Resources and Services Administration determined some hospitals began the organ procurement process even when patients showed signs of life. Organ procurement organizations that receive federal funding and coordinate transplants would be held accountable, DHS Secretary Robert F. Kennedy Jr. said. The HRSA directed the Organ Procurement and Transplantation Network to update its safety policies, provide complete information about the process to families and hospitals, and report any safety-related stoppages of organ donation.

Lawmakers have also called for an overhaul of the system. The House Committee on Energy and Commerce on Tuesday began a hearing about safety lapses in organ donation. Procurement and transplant organizations were set to present ways they plan to improve the system.

What led up to the investigation? Last year, reports circulated about a 2021 case in which a 36-year-old Kentucky man was declared dead but woke up on an operating table just before his organs were set to be removed. The organ procurement organization that operates in Kentucky, Ohio, and West Virginia, called KYDA, denied claims about the case, saying the hospital and its own staff followed protocols to maintain the patient’s safety. Meanwhile, the Association of Organ Procurement Organizations also criticized reports about the case and said the story had resulted in people removing themselves from the organ donation registry.

The Organ Procurement and Transplantation Network’s initial review into the incident closed the case without action, but federal officials earlier this year directed the organization to reopen it. Following a new review, officials directed KYDA to perform a root cause analysis of its failures to adhere to its policies. The organization was also called to develop a clear policy about who is a suitable organ donor candidate, and to allow any individual to stop a donation if they identify a patient safety issue. The organization could be decertified if it fails to comply with the corrective action.

What else did the report find? The investigation examined 351 cases where organ donation was authorized but not completed and determined that 73 patients showed neurological signs that would disqualify them from donation. Officials also determined that 28 patients may not have been deceased when the procurement procedure began. The report also found evidence of inadequate neurological assessments for candidates, not enough coordination with medical teams, and questionable consent practices. KYDA, now called Network for Hope, says it is committed to transparency and is addressing the federal agency’s guidance. The organ procurement organization is one of 55 in the country, and health officials said it had received similar reports at other organizations.

How many people are organ donors? As of 2022, about 170 million people in the United States are registered organ donors, according to Donor Alliance. Last year, doctors completed more than 48,000 transplants, but more than 103,000 were on the national transplant waiting list. The vast majority of patients on the waiting list need a kidney transplant, and more than 40% of patients are in their 50s or 60s.

Dig deeper: Listen to Les Sillars’ report about the dangers of leaving ethics out of organ donation decisions.