Dispute threatens to disrupt flow of organs to transplant hospitals
The flow of lifesaving organs to 63 U.S. transplant centers could be disrupted as soon as Wednesday by a dispute over the use of data, another potential blow to the troubled transplant system the government has promised to overhaul.
The United Network for Organ Sharing, the nonprofit that runs the system, is threatening to revoke an organ-screening company's access to the complex computer network that sends kidneys, livers, hearts, lungs and other organs throughout the country. It has set a Wednesday deadline for the company, Buckeye Transplant Services, to comply with its demands over the use of transplant data.
If no deal is reached, 63 transplant centers that depend on Buckeye to initially evaluate the size, condition and compatibility of organs for patients would find themselves without its services. Buckeye would effectively be out of business for as long as it is disconnected from the nationwide system used to offer and accept organs from deceased donors, known as DonorNet.
"People would die," the president of Buffalo-based Buckeye, Jared Ackley, said of critically ill patients waiting for hearts, livers and lungs. "Transplant centers do not have the bandwidth to, at the flip of a switch, take all this back in. It may sound sensational, but people would likely die."
At the heart of the dispute is UNOS's contention that an automated tool Buckeye has developed retrieves data from UNOS computers that the company is not entitled to. UNOS maintains that once that happens, the nonprofit cannot control whether the information is secure or is being used appropriately.
Buckeye said it is doing nothing wrong, and that other organizations across the transplant system act similarly.
In response, Buckeye sued Richmond-based UNOS in federal court in Virginia on Monday, seeking an injunction that would prohibit UNOS from cutting off its access to the computer network that coordinates the movement of transplant organs. Buckeye alleged that UNOS and Buckeye are competitors offering transplant centers the same data, and that UNOS's efforts already have cost the company money.
The impact on patients at transplant hospitals such as Stanford, Duke, the University of California at San Francisco and others is a matter of debate among transplant professionals as UNOS's deadline approaches. Hospitals would have to take over the 24-hour-a-day task of organ screening, arranging hurried flights and setting up operating rooms, or quickly find another company to do it.
UNOS's general counsel, Jason Livingston, stressed that cutting off Buckeye is a last resort in a negotiation that has been underway for two months. He acknowledged the move could strain hospital staff and cause delays.
"We certainly hope not, but I can't make any guarantees," he said.
At UCSF, where Buckeye evaluates donor hearts for the transplant program, surgical director Jason Smith said a disruption "would be painful for us, for the practitioners," who would have to take over Buckeye's responsibilities. "I wouldn't say it would be catastrophic for the patients," he said, adding that the program would devote the resources necessary to ensure transplants continued, including the possibility of hiring another company to replace Buckeye.
He added that UNOS "would be stabbing the [transplant] programs in the back to get at Buckeye. That would be an incredibly shortsighted maneuver."
Elana Ross, a spokeswoman for the federal Health Resources and Services Administration, which oversees the transplant network, said the dispute is between UNOS and Buckeye, though federal officials have been part of the talks. Ross said HRSA would step in if disruptions to transplant surgeries occur to "hold UNOS accountable to its contractual obligations."
In March, HRSA announced plans to overhaul the beleaguered U.S. transplant system, in part by breaking up the 37-year monopoly UNOS has held as operator of the network. For years, the system has been criticized as inadequate; nearly 104,000 people are on the waiting list for organs, and 22 die each day. Too many organs are discarded, damaged in transit or simply not collected; faulty technology sometimes jeopardizes transplants; and poor performers face little accountability.
Buckeye may be interested in bidding for a part of the contract UNOS holds, if it can supply the required technology, Ackley said. Buckeye's lawsuit contends UNOS "has monopolistic intent to squash the development of technology that could eventually supplant UNOS' system."
As new policies have allowed transplant centers to reach farther away for organs, and the technology to preserve them in transit has improved, the number of organ offers has increased in recent years, placing added burdens on screeners.
A 2022 study in the American Journal of Transplantation found that the number of offers at one Dallas transplant center rose by 140 percent over two years while the number of transplants remained the same. That is an example of how a transplant center now has to sift through a growing number of offers before it identifies the small number of organs it would like to accept for its patients. The process can be time-consuming and labor-intensive.
Buckeye, which says it is the largest organ-screening company in the United States, with 180 employees nationally, has been in business since 2008. Buckeye evaluated 280,000 organ offers in 2022 and was involved in 5,900 organ transplants, Ackley said. In 2022, the roughly 250 U.S. transplant hospitals performed nearly 43,000 transplants, a record, according to UNOS.
The company also collects data on organ offers, acceptances and other matters that it sends to transplant center clients so they can review the decision-making process and possibly alter their criteria for accepting organs.
The way it does that is part of what landed the company in trouble with UNOS in May. After a pair of conference calls and a demonstration of Buckeye's computer equipment, UNOS remained convinced that Buckeye programs were accessing UNOS system data to which it is not entitled. In a June 21 letter, it said the company is violating "terms of use" for the system's data.
"Certain features of Buckeye's electronic systems are capable of and have collected from UNOS systems various large volumes of patient-specific and facility-specific information related to transplant services," a UNOS attorney wrote to Buckeye on June 21.
Livingston, the UNOS general counsel, said in an interview that the data belongs to the Organ Procurement and Transplantation Network, which UNOS runs, and that transplant centers are able to obtain it from the organization if they want it. But Buckeye is not allowed to collect it in bulk and sell it to its customers. He said if Buckeye retrieves and "scrapes" the data, UNOS does not know how well it is secured, whether it is being "misused or mishandled" and how it is being stored. He also said Buckeye could create an alternate database with the information.
"This is data on vulnerable patients and donors, and there's a ton of data," Livingston said. He said no other organization in the sprawling transplant network uses an automated tool to do what Buckeye is doing.
Ackley and a Buckeye attorney disputed those assertions and asserted that the company is being singled out for something that is common practice by researchers, organ-procurement organizations and others across the transplant industry.
"There are at least three other vendors that are in our space that do exactly what we do," Ackley said. "They provide their centers with reports."
Kristy Edwards, chief executive of All Call Nursing, a smaller competitor, said she sends reports to her 27 clients but only from each day's activity in DonorNet, not stored data, to avoid running afoul of UNOS rules.
Nevertheless, a Buckeye attorney asserted in a June 22 letter to UNOS that "choosing to enforce new interpretations of the UNOS terms of use solely against Buckeye is a clear indication that UNOS is intending to harm Buckeye's relationships with its transplant center clients."
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