Members of the Senate Finance Committee and fellow witnesses roasted the head of the United Network for Organ Sharing (UNOS) during a hearing on Wednesday, over what Committee Chair Ron Wyden (D-Ore.) characterized as “gross mismanagement and incompetence.”
Witnesses described organs delivered in boxes with tire treads or left rotting at airports, and the committee’s 2.5-year investigation uncovered hundreds of organ recipients who contracted diseases because of lax screening.
Around 6,000 Americans die each year waiting for organ transplants, Wyden noted. A good number of those deaths could have been prevented, but UNOS and many of the organ procurement organizations (OPOs) it oversees are not only “failing,” but “uninterested in improving,” he added.
“The bottom line is the failures we uncovered cost lives,” he said.
In November 2020, CMS issued new performance standards for OPOs. More than a third of the 57 entities fell short.
Moreover, the technology that UNOS uses to run their system is “outdated, mismanaged, and insecure,” Wyden said.
A report from the U.S. Digital Service issued last year determined that the network lacks the technical capacity to modernize the system. The report recommended that the contract for the system, worth $248 million, be separate from a contract for policy management, according to The Washington Post.
Sen. Elizabeth Warren (D-Mass.), not one to mince words, told Brian Shepard, CEO of UNOS, “I’ll just be clear. You should lose this contract. You should not be allowed anywhere near the organ transplant system in this country. And if you try to interfere with the process of turning the contract over to someone who can actually do the job, you should be held accountable for that.”
Warren was referring to concerns that UNOS might potentially hold the transplant system hostage, which were raised by Jayme Locke, MD, MPH, director of the division of transplantation at the Heersink School of Medicine at the University of Alabama at Birmingham.
Locke said she was disturbed by a Washington Post article that said that UNOS had “threatened to walk away and continue operating without a contract, despite the fact that it would be illegal.”
“I would lose my medical license for walking away from a patient. If it is true that UNOS has suggested that it might walk away or not cooperate with the transition to new contractors, that would make it an organization that cannot be responsible for taking care of lives,” she said.
UNOS Won the Bid
In the early 1980s, the federal government sought an organization to oversee the first computerized system matching sick patients with organs, the Organ Procurement and Transplantation Network (OPTN), explained Wyden. UNOS won that contract in 1986, and seven other bids since then.
UNOS oversees a network of close to 400 members, including 252 transplant centers and 57 regional OPOs. As Sen. Chuck Grassley (R-Iowa) explained, the network’s responsibilities are three-fold: it manages the policymaking, technology delivery, and oversight of member compliance.
The committee’s review of 100,000 UNOS documents uncovered “shocking” errors in both procurement and transplantation, including 1,100 complaints filed by patients, families, transplant centers, and staff from 2010 to 2020, Wyden said.
In a number of instances, OPOs failed to conduct mandatory tests for blood types, diseases, and infections, which led to approximately 249 recipients becoming sick from transplanted organs from 2008 to 2015, he noted.
“More than a quarter of them died,” he said.
The committee also found 53 complaints related to organ delivery, including couriers missing flights, and organs that were abandoned at airports or never picked up.
Throughout decades of oversight, Wyden noted, UNOS has only ever recommended that one OPO lose its certification.
Shepard argued that the OPTN’s authority allows for “peer monitoring and quality improvement” — a role that is distinct from CMS’s role of regulatory certification and oversight. He also stressed more than once that “all the certification and decertification authority lives at CMS.”
But as Wyden later clarified, UNOS does have the authority, under the OPTN final rule, to refer an OPO to CMS for decertification.
At the close of the hearing, Wyden noted that the investigation would continue and will examine the role of federal agencies, including CMS and the Health Resources and Services Administration.
A Squished Box, and a Kidney Frozen Solid
Of the many errors highlighted, Locke described one kidney that was delivered frozen solid back in 2014, “like an ice cube you can put in your drink,” which had to be thrown in the trash. A few years later, another arrived in a squished box with tire marks on it. Despite the container inside having broken, that one was salvageable.
Over 1 week this past May, she received four kidneys from four different OPOs, all of which had basic errors. One involved a botched biopsy and another involved a nicked artery that could have been fixed if someone had discovered the damage. “Two others arrived to me blue, meaning they hadn’t been flushed,” she said. All were unusable.
It’s errors like these that account for the transplant system’s 25% kidney discard rate, Locke said. That’s roughly 8,000 kidneys lost last year, she noted.
Locke said that one of the things that frustrates her most about the transplant system is its maddening inability to think outside the box.
An organ traveling from California to Birmingham, Alabama at night could be flown from San Francisco to Atlanta and driven 2 hours by courier to Birmingham, she said. But what happens instead is the organ will be sent from San Francisco to Atlanta and put into cargo hold overnight “where it literally is rotting.”
Diane Brockmeier, RN, president and CEO of Mid-America Transplant in St. Louis and a board member of the OPTN from 2018 to 2020, shared similar frustrations.
“When an OPO goes out of sequence to place an organ that would otherwise be thrown away, UNOS requires an explanation. However, when organs are recovered and discarded, UNOS remains silent,” she said.
Brockmeier also recalled how, as a board member, voices calling for reforming the system were squelched. She noted that some members were “kept in the dark about critical matters” and “marginalized” if their views clashed with UNOS’s leadership (OPTN’s board and UNOS’s board are currently the same).
In addition, small group calls were held prior to the board meetings to “explore voting intentions, and if the board member was not aligned with the opinion of UNOS leadership, follow-up calls” would be initiated, she said, adding that fellow board members reported being pressured to align themselves with UNOS leaders.
Brockmeier urged Congress to split the OPTN functions into separate contracts, giving patients a chance “to be served by best-in-class vendors,” and “to immediately separate the boards of the OPTN and OPTN contractors … to ensure that patients are safeguarded through open data from both the OPTN and OPOs.”
Locke noted that “one of the things that we really want to understand [is], why have we not engaged experts in applied mathematics to really optimize our matching algorithms and organ placement? And why haven’t we really engaged experts in logistics around transportation?”
Everyday, thousands of planes fly over the U.S. at the same time, and the Federal Aviation Administration ensures that they don’t crash into each other because they know precisely where each plane is, she said. “We should be able to do the same thing for our transplant system, for our organs.”
UNOS’s contract will likely be rebid in 2023.