RICHMOND, Va. (WRIC) — Richmond-based nonprofit, the United Network for Organ Sharing (UNOS), is under fire from the U.S. Senate Finance Committee, following a more than two-and-half-year investigation into alleged mismanagement.

CEO Brian Shepard appeared before the committee in Washington, D.C., on Wednesday, Aug. 3, accompanied by panelists in the healthcare industry from across the country.

“In my role, I’ve seen up-close the power of organ donation and transplant, lifting and sustaining the families of organ donors, and restoring and inspiring transplant recipients,” he said.

Sen. Ron Wyden (D-OR), leading the hearing, began his testimony by sharing information about alleged failures by UNOS in the context of organ sharing throughout the U.S.

“Far too many Americans are dying needlessly because UNOS and many of the transplant organizations it oversees are failing and seem uninterested in improving,” Wyden said. “In 1984, law created the first computerized system to match sick patients with the organs they need. It was named the Organ Procurement and Transplantation Network [OPTN]. Someone needed to manage that system for the whole country. So government sought to contract an organization to run it. UNOS was the only bidder for that first contract in 1986.”

Photo credit: Paul Nevadomski / 8News

Shepard told 8News on Thursday that the contract is now worth about $64 million a year, with roughly 10% of that coming from the federal government, and the majority paid out by the hospitals and Organ Procurement Organizations (OPOs) with which they work.

“There’s certainly lots of opportunities for all of us to improve the donation and transplant system, and that’s what UNOS’ mission is and what we do every day,” Shepard said, speaking one-on-one with 8News. “That doesn’t give us an unlimited authority or unlimited ability to manage everyone in the field.”

During Wednesday’s hearing, Sen. Wyden stated that their investigation found that, between 2008 and 2015, 249 transplant recipients developed disease from transplanted organs, and more than a quarter of them died.

“Delivering organs has been another source of life-threatening errors,” he said. “We found 53 such complaints between 2010 and 2020, as well as evidence that this was just the tip of the iceberg. In some cases, couriers missed a flight. In others, the organs were abandoned at airports. Some organs were never picked up. Many of these failures resulted in organs being discarded.”

Dr. Jayme Locke, the director of the Heersink School of Medicine’s Division of Transplantation at the University of Alabama at Birmingham, echoed Wyden’s statements.

“There is very little in healthcare that has the immediate life and death stakes as organ transplantation,” she said. “Please realize that every day that passes with these failing systems in place means more of our neighbors will die.”

Locke noted that, in 2014, she received a kidney that arrived frozen. She said it was hard as a rock, and that the intended recipient was highly sensitized, meaning difficult to match.

“The only thing we could do was tell the waiting patient that, due to the lack of safeguards regarding transportation of organs, the kidney had to be thrown in the trash — the final, generous act of a donor in Maryland,” Locke wrote in her testimony. “In 2017, I received a kidney that arrived in a box with tire marks on it. The box was squished, and the container inside had been ruptured.”

Tire marks were seen on the box containing a kidney. Photo contributed by the Senate Finance Committee

Speaking with 8News on Thursday, Shepard noted that there is always room for improvement, and that any discarded organ is unacceptable, but that the U.S. government has regulatory responsibilities, as well.

“We were designed to do a specific kind of quality improvement, which is through using confidential peer review to get a full and frank conversation with folks to come up with better solutions, better processes, things that protect patient safety,” he said. “There is a government agency that does regulation and certification, and the kind of enforcement that the Senate was asking about happens at that government agency.”

8News also spoke with Shepard about the technology issues that were raised during Wednesday’s hearing. Diane Brockmeier, President and CEO of Mid-America Transplant in Missouri, said that OPOs are required to use UNOS’ technology, DonorNet, which she said was in need of updating.

“DonorNet is outdated, difficult to use, and often slow to function, when every minute counts,” she said. “Manual entry subjects it to error, and OPO and transplant center staff are not empowered with the right information when time is critical.”

But Shepard disputed those claims.

“We disagree strongly with what appears to be a leaked draft report from the USDS [United States Digital Service]. When we heard that such a report existed, we asked for it, and have not been provided that,” he said. “We were told that the USDS report says, for example, that we don’t use the cloud when, in fact, we do. All of the algorithm exists in the cloud, and not on hardware here in our building. They said that we don’t use electronic data transfer when, in fact, we do, at more than 200 hospitals and OPOs in the United States.”

Data shows that nearly 106,000 men, women and children are on the national transplant waiting list, most of them needing a kidney donor. Seventeen people die each day waiting for an organ transplant.

But Shepard also pointed out that in 2021, a record number of transplants were performed — more than 41,000.

“The oversight system is fundamentally in the right place, and having one organization that does coaching and improvement, and one organization that does regulation and rules, I think that’s the right model,” he said. “That’s what the Institute of Medicine called for 20 years ago when they kicked off this environment of healthcare quality improvement that we’re in right now. So I think that structure is sound.”

Shepard said there was, though, a need to build better connections among the improvement partners in the organ-sharing space to maximize coordination and joint efforts.

But witnesses appearing before the Senate Finance Committee called for more staunch action.

“We need to urgently address patient safety. Each organ lost due to a system or provider failure has a consequence to the thousands of patients waiting for a transplant. Furthermore, a discarded organ fails to honor the heroic gift from selfless donors and compounds the family’s sense of loss,” Brockmeier said. “UNOS lacks urgency and accountability around identifying and remediating this loss of organs, and they are not required to publicly report adverse events when patients are harmed, organs are lost, or the quality of patient care is deemed unsafe.”

Photo contributed by the Senate Finance Committee

Panelists went on to propose that powers in the organ donation and transplant space in the U.S. be separated.

“We ask that you ensure that the federal government make the fast-approaching contracting cycle competitive for the first time since the original OPTN contract was awarded in 1986, and we implore you to ensure that UNOS does not hold patients hostage in the process,” OPTN Patient Affairs Committee Representative and lung transplant survivor Calvin Henry said. “Across the board, the numbers for kidney failure for Black Americans, Hispanic Americans and Native Americans are far worse than white Americans, yet we also know Black people and people of color are less likely to receive transplants.”

When asked whether he was surprised by any of the information and evidence revealed during Wednesday’s Senate Finance Committee hearing, Shepard told 8News that he was aware of many of the issues raised, and the UNOS had already worked with the organizations that were named to address errors and help develop new practices. But he also maintained that UNOS had been a catalyst for positive change in the industry over the decades.

“I was surprised by the overlap between what our mission is and what CMS [Centers for Medicare & Medicaid Services], the federal agency’s responsibilities are, and I think that it’s going to be our obligation to continue to help explain the differences and why our peer review improvement process is so important,” Shepard said. “When we see an event, or even a near-miss, a hospital can confidently come to us and discuss a near-miss that happened in a way that helps us educate the broader community before it becomes an event, and that sort of confidential process of discussing the actual event leads to very public and widespread education and improvement.”

At the end of June, UNOS announced that Shepard would be stepping down in September from his role as CEO after nine years in that position and more than a decade with the company. The announcement noted that his current contract ends in September.

“As UNOS CEO, Brian was a constant and courageous advocate for increasing equity in our national donation and transplantation system,” UNOS Board of Directors Vice President Dr. Jerry McCauley said at the time. “His leadership has resulted in marked improvements in access to transplants for patients of color and those who have been historically marginalized. I am proud to have worked alongside Brian as a member of the UNOS board and am excited to build upon the foundation he has laid to further advance our mission and save even more lives.”

However, leadership was yet another issue raised during Wednesday’s Senate Finance Committee hearing.

“If you looked at the staff at UNOS and many of the nation’s OPOs, I would wager the vast majority are hard-working, good people, doing their best to save lives,” Wyden said. “The glaring issues uncovered in our investigation stem from failures at the top, leadership failures.”

Wyden added that their investigation is ongoing and that there would be bipartisan pushes for reform in the organ donation and transplantation space.

“Any opportunity for a donation that doesn’t come to fruition really is a tragedy, and our work every day is to reduce those occurrences and make sure that we are transplanting as many as possible,” Shepard said. “We don’t provide or arrange transportation for organs, so we are working with OPOs and transplant hospitals, and also some transportation, to understand their practices, to help them improve their practices, and to reduce events like that in the future.”