Federal Investigation Reveals Serious Failures in Organ Donation System

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More than 48,000 organ transplants occur in the United States annually. Over 103,000 people remain on the waiting list, and around 13 die each day still hoping for a match. Organ donation is often seen as a final act of generosity — it’s the ultimate gift, the gift of life. Being an organ donor saves as many as eight people — and enhances the lives of over 75 more.1

But beneath this noble act, there’s something sinister going on — widespread safety failures, negligence, and oversight that not only disregard the sanctity of the donor, but also put living patients in harm’s way. This is what a federal investigation sought to uncover. Their findings reveal the disturbing practices behind the organ donation system, and expose just how deep the systemic problems run.

The Catalyst — The ‘Brain-Dead’ Organ Donor Who Woke Up on the Table

A sweeping federal investigation into organ procurement misconduct is now being conducted in the U.S., particularly focused on a now-defunct organization in Kentucky. The investigation began after a single, shocking case caught national attention — A brain-dead patient waking up on the operating table just as his organs were about to be harvested.2,3

How it started — On October 25, 2021, Anthony “TJ” Hoover was rushed to the Baptist Health hospital in Richmond, Kentucky because of a drug overdose.

While the doctors did everything they could, the outcome seemed bleak — the 33-year-old, who turned to prescription medications and illicit drugs to cope with his anxiety, depression, and post-traumatic stress disorder (PTSD), had severe brain damage, emptiness in his eyes, and lack of reflexes. The medical staff declared him brain-dead, and his family had agreed to take him off life support.

TJ was on the organ donor registry — An organization called Kentucky Organ Donor Affiliates (KODA) spoke to his loved ones. Being young and relatively healthy, TJ was a good candidate for organ donation, as his organs were viable. KODA (now known as Network for Hope after merging with another group) is the organ procurement organization (OPO) that operates in Kentucky, as well as some parts of Ohio and West Virginia.4

KODA told TJ’s family that his sacrifice would end up saving many lives, which encouraged them to fulfill TJ’s wish, allowing the hospital to harvest his organs. “If I lost my brother and eight people could live, then I felt like my brother wouldn’t die in vain,” Donna Rhorer, TJ’s sister, said.

Miracle or malpractice? Four days after he was hospitalized, TJ was taken off life support and brought to the OR for the procedure. He was even graced with the “honor walk,” with hospital staff and his family lining the corridor toward the OR, as a way to thank him and say their final goodbyes.

But two hours later, a staff member informed TJ’s family that the patient had “woken up,” and that the procedure would not proceed. His family considered it a “miracle.”

But for TJ, the experience was terrifying — He woke up in the OR as medical staff were preparing him for organ harvesting, shaving his chest and bathing his body in surgical solution. Apparently, he was reacting to stimuli — Eye witnesses reported that he was shaking his head, making eye contact, and moving around on the table. Natasha Miller, a former organ perfusionist (one who packages and secures the organs during the procedure) with KODA, was one of them.

“He was moving around — kind of thrashing. Like, moving, thrashing around on the bed. And then when we went over there, you could see he had tears coming down. He was crying visibly,” she recounted.5

Natasha and her fellow staff members raised these concerns — however, their protests were ignored. It was only when the procuring surgeon refused to participate in the organ recovery process was the procedure completely halted, saving TJ’s life.6

TJ’s story brought to light the disastrous and dangerous system behind organ donation. He has long been discharged, and while he is still undergoing extensive physical therapy and treatment, which his family shared on social media in an effort to educate others about the dangers of using illicit drugs, his story served as a catalyst for a much wider investigation into the failings behind this area of healthcare.

Further Investigation Revealed Disturbing Details Regarding Organ Donations

When the Health Resources and Services Administration (HRSA), which is under the U.S. Department of Health and Human Services (HHS), launched a formal investigation into KODA, as well as the Organ Procurement and Transplantation Network (OPTN), they discovered severe systemic failures. According to CNN:

“The investigation found patterns such as failures to follow professional best practices, to respect family wishes, to collaborate with a patient’s primary medical team and to recognize neurological function, suggesting ‘organizational dysfunction and poor quality and safety assurance culture’ in the Kentucky-area organization.”7

The investigation focused on 351 organ donation cases — These were cases wherein organ donation was approved, but was not completed. Among the organ procurement organizations, these cases were called “authorized not recovered” or ANR.

Nearly one-third of the ANR cases were found to have “concerning features” — According to the report, 103 cases or 29% had these features. In fact, of this number, 73 patients had neurological features that were “not conducive to DCD [donation after circulatory death] procurement.”8 To put it simply, their brains were still functioning, indicating that they are not legally or clinically dead. According to CNN, experts have previously questioned the ethics of this practice.9

Here’s what’s even more disturbing — At least 28 patients were not dead when their organ procurement was initiated. According to the report, “At least 28 (8.0%) patients had no cardiac time of death (CTOD) noted, with discharge to hospice, rehabilitation facility or home noted in some cases.”

Smaller hospitals and rural areas seem to have more cases of oversight — These settings tend to have limited management capacities and the coordination between medical teams and procurement staff is often weaker. “Cumulatively, these trends suggest that patients may experience variable care from [KODA] depending on the hospital in which they are seen,” the HRSA reported.

Similar patterns have been observed in other OPOs — KODA is one of the 55 organ procurement organizations all around the U.S., and according to the HRSA, when their federal review was released, high-risk procurement patterns also emerged in other organizations.10

The HHS Announces Plans to Reform the Organ Transplant System

Once these issues came to light — and were found to be more alarming and awful than previously thought — the government announced that there would be major initiatives to reform the system. In a press release, the HHS, led by Secretary Robert F. Kennedy Jr., outlines its plans to help bring back the integrity and transparency of the organ procurement and transplant system:11

The HRSA has set strict corrective actions for the OPO — One of the key requirements by the HHS is for the organ procurement agency to provide a full root cause analysis on why it has failed to comply with its own policies. This aims to safeguard potential organ donors all over the country, preserving their dignity.

KODA failed to follow the “Five Minute Observation Rule” — According to the report, this is one of the major protocols that the agency did not adhere to. This is a mandatory rule wherein a donor is given a full five minutes after their heart has stopped beating before their organs are retrieved.12 This exists to ensure no signs of life reappear before the removal of vital organs begins.

The OPO will also have to develop clear, enforceable policies to define the eligibility of an organ donor, based on certain criteria — In addition, there will be a formal procedure that will authorize any staff member — from nurses to techs — to halt a donation process, if they note that the circumstances are unsafe, or if any other concerns arise.

New national requirements are now in place as well — The HHS has ordered the OPTN to collect and report any instance where the donation process is stopped due to safety concerns — whether it’s a family member, nurse, or doctor raising the red flag. These reports need to be delivered to federal regulators for review.

This move removes the power from the hands of internal committees that, until now, had often dismissed concerns without consequence. It also forces hospitals and OPOs to provide complete and transparent information about organ donation to patients and families — before consent is given.

Organ procurement practices that violate human rights will no longer be tolerated — According to RFK Jr., he will decertify any OPO that will fail to comply with these new safety rules.

“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” he 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.”13

While Network for Hope did not directly comment to media outlets like CNN on this issue, its website states that it “looks forward to working collaboratively” with the HHS and HRSA. In a statement, its CEO, Barry Massa, said:

“We hold ourselves to the highest standards and are committed to ongoing improvement as we carry out the sacred responsibility of honoring each individual’s decision to become an organ donor. We remain focused on our mission and dedicated to earning and maintaining the public’s trust in the donation and transplant system.”

Protect Yourself and Your Loved Ones from Dangerous Organ Donation Practices

Organ donation is said to be the gift of life — it is a profound way to honor the body that you were given and to share a part of yourself with others in need. So being aware of these controversies, and what happens behind closed operating room doors, could cause you to lose faith in the system.

Fortunately, these initiatives by RFK Jr. — all part of the “Make America Healthy Again” (MAHA) campaign — are in the works. “These reforms are essential to restoring trust, ensuring informed consent, and protecting the rights and dignity of prospective donors and their families,” the HHS press release said. If you’ve ever registered as an organ donor, here are steps I recommend you take starting today:

1. Put clear limits on your donor consent — Take the extra step to define your wishes more specifically. Do this by creating a written, signed directive that states under what circumstances you’re willing to donate.

For example, you might state that donation will not proceed unless brain death is confirmed by two independent neurologists — not just one. Keep a copy with your personal documents, and give one to a family member. This makes your voice louder than a checkbox on a government form.

2. Talk with your family about your preferences in detail — Whether you’re young, elderly, healthy, or chronically ill, it’s important your family knows exactly what you want. Explain to them that if something happens to you — especially in a hospital where pressure from organ procurement teams might exist — you expect them to advocate for time, clarity, and full transparency before any donation decisions are made.

Tell them to ask questions, demand documentation, and never feel rushed. Your family’s clarity protects your life.

3. Get familiar with the brain death criteria in your state — Each state defines brain death a bit differently, and some allow hospital teams to skip critical steps in assessment. I recommend you look up your state’s brain death declaration policy and highlight anything that seems vague. Knowledge is your defense — especially when you’re not the one conscious to speak up.

4. Ask your local hospital about their organ donation protocols — If you or a loved one is ever in critical care, don’t wait for a crisis to ask questions. You have every right to know how that hospital handles organ donation evaluations.

Questions you can ask include, “How does this hospital confirm brain death?” and “Who is responsible for calling time of death?” You can also ask, “Can the family pause the donation process if they feel uncomfortable?” Bringing them up shows you’re informed, alert, and not easily manipulated.

Your safety isn’t guaranteed by the system — it’s secured by what you do, ask, and prepare for. These steps will help ensure that you stay in control, that your life and wishes are respected, and that no one rushes you or your family into a decision that cannot be undone.

Frequently Asked Questions (FAQs) About Failures in the Organ Donation System

Q: What triggered the federal investigation into organ donation practices?

A: The investigation began after a shocking case in Kentucky where a man, declared brain-dead, regained consciousness just moments before his organs were to be harvested. This incident led federal health officials to uncover widespread safety failures and negligence within one of the nation’s organ procurement organizations.

Q: How many patients were affected by unsafe organ donation practices?

A: Out of 351 reviewed cases, 103 were flagged as having “concerning features,” and at least 28 patients were found to be alive when organ removal procedures began. These failures exposed serious flaws in how death was determined and documented.

Q: What is “donation after circulatory death” and why is it controversial?

A: Donation after circulatory death (DCD) refers to organ procurement that occurs after a patient’s heart stops — but before brain death is confirmed. The controversy arises because some patients may still exhibit brain activity or reflexes, meaning they are not legally or clinically dead.

Q: What reforms have been announced to fix the system?

A: The Health Resources and Services Administration (HRSA) has introduced strict corrective actions, including requiring enforceable death determination policies, mandatory observation periods, and formal reporting of any halted donation due to safety concerns. Organ procurement organizations (OPOs) that fail to follow these rules may be decertified.

Q: What steps can I take to protect myself or my family?

A: You can write a detailed donor directive, talk with your family about your donation preferences, learn your state’s brain death laws, and ask hospitals about their donation protocols. These steps help ensure your rights and life are respected.

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