Editor’s Note: Thomas Engels is the U.S. Department of Health and Human Services Management Administrator.
Organ donation can be the last gift of life. They think about the future that grandchildren will inherit, especially when it becomes urgent and deeply personal, like organ donations and transplants. If he or someone he loves needs an organ transplant, I want him to know that the system is worthy of, fair and worthy of his trust.
Sadly, a U.S. Department of Health and Human Services investigation of the organ transplant system revealed the worst nightmare for everyone: a systematic neglect of life’s sanctity. We have discovered many cases of healthcare providers starting the organ donation process for living patients. In response, we threatened to shut down large organ procurement organizations unless we implement corrective action requirements. It also imposed strict reporting protocols for organ transplant systems, requiring families and hospitals to receive clear and complete information about the donation process.
How could the organ transplant system fail to protect some of our most vulnerable Americans? It worked behind closed doors for decades, controlled by a single private contractor. Too many patients were not waiting for answers, and when such atrocities occurred, there was no family member who had been pursued by the organs of their loved ones while still alive. Only the disease system prioritizes profits over patients.
It was over thanks to leaders of President Donald Trump and HHS secretary Robert F. Kennedy Jr.
The Health Resources and Services Administration (HRSA) is conducting a drastic overhaul of the Organ Procurement and Transplant Network (OPTN), an entity legally responsible for managing organ weight lists and allocations across the country. Our reforms are rooted in two basic truths. Patient safety is not an option, and all life is sacred.
For too long, patients, hospital staff, or grieving families have been forced to report serious safety concerns and misconduct to the contractors who manage the system. This made the family unprecedented, irritated, and even silenced. Those days are over.
Now, under our new reforms, these concerns can come directly to the regulatory authorities HRSA. We have brought federal oversight to the heart of the process and made it clear that we will not compromise on safety and accountability.
They also proposed new data requirements for organ procurement organizations (OPOS) that require complete documentation of every step of the donation process, from contacting hospitals to interacting with donor families. These reforms are more than just performance tracking. They are to restore the safety and dignity of the system that has lost sight of both.
And when the horrific failure becomes clear, we act quickly, like a shocking case in which organ procurement was nearly performed on patients who showed almost a sign of life. HRSA has issued a corrective action plan to the OPO for the first time, but is not reluctant to try again. Americans don’t have to wonder if their lives will be treated with respect in hospitals.
Systematic obstacles were not merely motion, they were structural. For almost 40 years, OPTN was managed by a single private entity, the United Network for Organ Sharing (UNOS). We have ended our monopoly that curtails innovation, enables conflicts of interest, and delays reform.
HRSA held historic national elections to establish an independent OPTN board of directors. This new board will include transplant surgeons, living donors, organ recipients and advocates, bringing a range of expertise and experience to the forefront of reform.
It also modernizes porting systems by expanding its pool of best-in-class vendors to increase system capabilities and performance. With bipartisan support, HRSA currently has the authority to collect OPTN registration fees directly from transplant hospitals, maintain long-term reforms and reduce reliance on single contractors.
Our work is informed by conversations with transplant surgeons, patients, donor families, advocates and hospital staff. These voices made one thing rich and clear. Change cannot wait.
Secretary Kennedy has called for accountability across the HHS, and President Trump has demonstrated an unwavering commitment to ending the satisfaction level of a system that costs money on life. The old system worked closed room. I opened them.
We build a system that is ethical, transparent and centers around the sacred holiness of life. There’s more to do, but like the rest of the Trump administration, we’re making progress quickly. We will not rest until all registered organ donors, patients and families have confidence in our country’s transplant system. Because that is what Americans deserve and what life demands.
