28 Patients May Have Been Alive When Organ Procurement Was Initiated, HHS Investigation Finds

A Health Resources and Services Administration (HRSA) investigation found at least 28 patients out of 351 cases may not have been deceased at the time organ procurement was initiated. One hundred three cases had “concerning features,” according to the HHS press release. Seventy-three patients had neurological signs that were incompatible with organ donation. The New York Times report states, “In 73 instances, officials should have considered stopping sooner because the patients had high or improving levels of consciousness.”

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

This investigation concerned Kentucky Organ Donor Affiliates (KODA), according to The New York Times. The Organ Procurement and Transplantation Network (OPTN) investigation was closed by the Biden administration. HRSA reopened the investigation and found the company was clearly negligent.

“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,” the press release stated.

Specifically, “donation after circulatory death” occurs when a patient still has some level of brain function, but is on life support. Many times, the patient can be in a coma. If the family agrees to organ donation, the patient is taken off life support and must die within an hour or two for the organs to be viable. The staff with the OPO must wait five minutes to ensure the patient is truly dead before procurement takes place.

Anthony Thomas Hoover II overdosed in 2021, and his family agreed to organ donation after the man was unresponsive for two days. KODA staff moved forward with protocols over the next two days to prepare the man for surgery despite the man’s improved neurological condition. Medical reports state the man was “thrashing on the bed” and was sedated as a result. The hospital staff referred to the actions of the procurement organization to move forward as euthanasia, but the KODA coordinator “assured them it was not,” according to the NY Times report.

Hoover “cried, pulled his knees to his chest, and shook his head” when he was taken into the surgery room for organ procurement. If the doctor hadn’t refused to withdraw life support from the man, the procurement company would have moved forward with the procedure, according to Natasha Miller, a former employee of KODA who was in the room at the time. Hoover later recovered and is still alive today at 36 years old after the organ procurement attempt in 2021.  He has ongoing neurological issues.

The HHS statement said there are “systemic gaps in oversight and accountability” in smaller and rural hospitals. KODA is required to investigate and issue a comprehensive root cause analysis of this failure, along with an assessment of internal protocols. The report must explain why the staff failed to observe the patient for five minutes before attempting to begin the procedure.

The company must develop a formal protocol that allows any staff member to halt a donation process for any safety concern. HHS stated that system-level changes are also being implemented to protect organ donors nationwide. The organization will be decertified if they don’t comply with the stated corrective actions.

HRSA is also directing OPTN to collect data from any organ procurement process that is halted for safety reasons. The OPTN will also update policies to strengthen safety protocols.

“These findings from HHS confirm what the Trump administration has long warned: entrenched bureaucracies, outdated systems, and reckless disregard for human life have failed to protect our most vulnerable citizens,” the HHS press release said.

ABC 7 New York reported on a bonus incentive program for employees of LiveOnNY, an OPO. The 2023 report detailed the 2022 email that promised employees a 5% bonus for meeting organ donation and procurement goals for the year. The outlet confirmed that the company had reached its goal and followed through with a 5% bonus for all staff who were team members by October 2022.

The company confirmed that they transplanted 1,300 organs in 2022 and secured 961 tissue donors, but would not comment about the incentive program. ABC 7 contacted the Center for Medicare and Medicaid Services (CMS). “​​CMS does not encourage employee bonuses, but we do not comment on business practices and processes that are outside of our regulatory authority,” CMS said in a statement.

ABC 7 New York also spoke with several former employees of LiveOnNY, who confirmed that employees felt pressured to increase organ donations to meet company goals. One anonymous man told the outlet he was fired for poor performance.

“The goal is to try to get every patient to be a donor,” the man said. “A lot of times, families are not ready. They’re just hearing about the death sometimes, or they’re processing, and they want us to talk to families right away.”