Consultant Surgeon Andrew Ready and his team conduct a live donor kidney transplant at The Queen Elizabeth Hospital Birmingham on June 9, 2006, in Birmingham, England. / Credit: Christopher Furlong/Getty Images
CNA Staff, Jul 23, 2025 / 18:17 pm (CNA).
The U.S. Department of Health and Human Services (HHS) has announced a sweeping reform initiative of the nation's organ transplant system after a four-year investigation by the Health Resources and Services Administration (HRSA) uncovered systemic ethical and safety violations.
The violations discovered during the investigation, outlined July 21 in an HHS press release, showed "that hospitals allowed the organ procurement process to begin when patients showed signs of life," said HHS Secretary Robert F. Kennedy Jr., who called this "horrifying."
"The organ procurement organizations that coordinate access to transplants will be held accountable," Kennedy continued. "The entire system must be fixed to ensure that every potential donor's life is treated with the sanctity it deserves."
The investigation identified major problems with organ procurement processes, including poor neurologic assessments, inadequate coordination with medical teams, questionable consent practices, and misclassification of causes of death, particularly in overdose cases. Smaller and rural hospitals were found to be especially vulnerable.
Joseph Meaney, former president of the National Catholic Bioethics Center, said on "EWTN News Nightly" on July 22 that these problems are "extremely concerning" and that organ procurement processes have had "persistent flaws."
The Catechism of the Catholic Church teaches that organ donation after death "is a noble and meritorious act and is to be encouraged as an expression of generous solidarity."
The donor or a proxy must consent, however, and organs cannot be removed until there is "moral certitude" a person is dead, Meaney said. "The Uniform Determination of Death Act says there has to be zero functioning in the brain to be able to declare a person brain dead … before any kind of vital organ donation process is initiated."
The HRSA investigation was prompted by the troubling case of Anthony Thomas Hoover II. According to the New York Times, Hoover, now 36, was hospitalized four years ago in Kentucky for a drug overdose.
He was unresponsive for two days, and his family agreed to remove life support so his organs could be harvested.
A federally funded organ procurement organization (OPO) called Network for Hope (formerly known as Kentucky Organ Donor Affiliates) began the process of procuring his organs even though he allegedly seemed to be improving. According to the Times, he was "thrashing on the bed" and subsequently sedated.
Hospital staff became "uncomfortable with the amount of reflexes" the patient was exhibiting, and some began to call his organ procurement procedure "euthanasia," though representatives of the procurement group told them it was not.
A physician refused to withdraw life support and continue with the organ procurement, despite pressure from the procurers. Hoover survived, though he suffers from neurological impairment.
The HRSA's investigation of Network for Hope revealed 351 instances where organ donation was authorized but not completed. The results were alarming: 103 cases (29.3%) showed cause for concern, including 73 patients with neurological signs incompatible with organ donation.
Most disturbingly, at least 28 patients may not have been deceased when organ procurement began.
Network for Hope CEO Barry Massa said in a statement to CNA on July 22 that "patient safety is our top priority. Network for Hope looks forward to working collaboratively with HHS and HRSA and encourages the development of policies that support the betterment of the organ transplant system as a whole."
Every state is served by one or more nonprofit organ procurement organizations (OPOs) that work with hospitals to manage organ donations.
HRSA has directed the implicated OPO to strengthen its patient safeguards and has mandated rigorous corrective actions. These include a root cause analysis of its failure to follow protocols, such as the five-minute observation rule post-death, and the development of clear donor eligibility criteria.
The organ procurement organization must also establish a procedure allowing staff to halt donation if safety concerns arise. Failure to comply risks decertification, a move Kennedy has vowed to enforce.
Father Tad Pacholczyk, a senior ethicist at the NCBC, applauded the new procedure to halt the process due to safety concerns, telling CNA that it is "a very sensible safeguard."
Brain death vs. circulatory death
The HHS investigation revealed that some OPOs actively seek cardiac, or circulatory, death donors rather than brain death ones.
The majority of organ donations come from patients who are determined to have suffered death by neurologic criteria, or brain death, and whose bodies are being sustained mechanically to preserve organ viability. Organ donation following circulatory death, however, has seen significant growth, driven in part by the increased demand for organ transplants and federal pressure on procurement groups.
Unlike brain death, where patients are determined to be in an irreversible state with no brain activity, circulatory death involves patients who are typically comatose and on life support.
These individuals retain some brain function but are deemed unlikely to recover based on medical assessments, which can involve the subjective judgment of the doctors.
Meaney said there are "question marks" surrounding organ donations that result from the determination of circulatory death, or what he called "cardiac determination," telling EWTN there is no uniform time clinicians must wait after the heart stops. Hospitals establish the amount of time that can pass before clinicians can determine someone has circulatory death, generally around five minutes.
In some of these cases, Meaney said "the extraction of the organs is actually the cause of death" for the patient.
About 20,000 organs last year were procured after a patient was said to have undergone circulatory death, representing one-third of all donations in the U.S, according to the New York Times. This figure is three times higher than it was five years ago, reflecting a rising reliance on this method.
When families consent to organ donation, once the transplant teams have arrived, the hospital discontinues life support and monitors the patient in the operating room until his or her heart stops. While hospitals oversee patient care until death, once there is cessation of cardiac activity for a sufficient amount of time, specialized surgical teams affiliated with the OPOs are often brought in to proceed with organ retrieval, which must occur quickly to ensure organs remain suitable for transplantation.
One neurointensivist who spoke to CNA on the condition of anonymity described OPOs as "vultures" who, after they are informed by the hospital that a patient is moribund and may become a potential organ donor, "set up shop" in a hospital.
The HRSA investigation found that OPOs sometimes pressure families and medical staff to expedite the organ retrieval process.
The HRSA's proposed reforms are critical to maintaining public trust in organ donation.
About 170 million Americans are currently listed as organ donors, but the number may go down as trust declines.
Pacholczyk told CNA: "Many of us would like to become organ donors, but we have questions, even doubts, about whether we can 'trust the system.' One of the more widely articulated concerns is whether organs will be taken before patients are properly determined to be deceased, leading many individuals to decide against checking the box on their driver's license."
"Given the significant internal and external pressures to procure organs for transplantation today, and given the fact that our society no longer fully esteems the value of every human life, our organ procurement organizations must be subjected to a process of transparent and independent review," Pacholczyk said.
