Report: ‘Vast restructuring’ needed for organ transplant system

The system for getting donated kidneys, livers and hearts to desperately ill patients relies on outdated technology that has crashed for hours at a time and has never been audited by federal officials for security weaknesses, according to a confidential government review obtained by the Washington Post.

The mechanics of the entire transplant system must be overhauled, the review concluded, citing aged software, system failures, mistakes in programming and reliance on manual input of data.

In its review, completed 18 months ago, the White House's U.S. Digital Service recommended that the government "break up the current monopoly" that the United Network for Organ Sharing — the nonprofit agency that operates the transplant system — has held for 36 years. It pushed for separating the contract for technology that powers the network from UNOS's policy responsibilities, such as deciding how to weigh considerations for transplant eligibility.

About 106,000 people are on the waiting list for organs, the vast majority of them seeking kidneys, according to UNOS. An average of 22 people die each day waiting for organs.

In 2021, 41,354 organs were transplanted nationwide, a record. In Iowa during the same period, 128 people donated a total of 365 organs, according to the Iowa Donor Network — over a triple-digit increase from the year before. The University of Iowa Hospitals alone performed 111 kidney transplants, 26 lung transplants, 19 liver transplants and 11 heart transplants, among other transplant procedures, in 2021, the UI said.

UNOS is overseen by the Health Resources and Services Administration, but that agency has little authority to regulate transplant activity. Its attempts to reform the transplant system have been rejected by UNOS, the report found. Yet the agency continues to pay UNOS about $6.5 million toward its annual operating costs of about $64 million, mostly from patient fees.

"In order to properly and equitably support the critical needs of these patients, the ecosystem needs to be vastly restructured," a team of engineers from the Digital Service wrote in the Jan. 5, 2021, report for the agency, which is part of the U.S. Department of Health and Human Services.

UNOS considers its millions of lines of computer code to be a trade secret and has said the government would have to buy it for $55 million if it ever gave the contract to someone else, the report said.

Transplant doctors have complained for years about archaic aspects of the technology for sharing data and getting organs to the right place as quickly as possible.

"When nearly 100 percent of hospitals use electronic records, the notion that we rely on human beings to enter data into databases is crazy. It should be 85 to 95 percent automatic," said University of California at San Francisco surgery vice chair Ryutaro Hirose, a former chair of the UNOS liver transplant policy committee.

Hirose said he had been forced to turn to travel sites such as Expedia to make plans for transporting organs. "With DoorDash, I know where my food is. That should at least be the case for a life-saving organ," he said.

In an interview, UNOS Chief Executive Brian Shepard said the nonprofit was improving tracking and had a travel-planning app in development. He said the Digital Service report "reads more like an op-ed" opinion piece than a paper based on thorough research. He said the transplant system is secure and effective.

Yet leaders of the Senate Finance Committee, which has scheduled a hearing on the system for Wednesday, grew so alarmed during a closed-door briefing earlier this year that they warned officials at the Department of Homeland Security and intelligence agencies in a letter seen by the Post that they had "no confidence" in the security of the transplant network. They asked the White House to intervene to protect it from hackers.

"We request you take immediate steps to secure the national Organ Procurement and Transplantation Network system from cyberattacks," the committee chair, Sen. Ron Wyden, D-Ore., and Sen. Chuck Grassley, R-Iowa, wrote in February.

The senators wrote that "no one working for the federal government has ever examined the security of this system" and the government "has not imposed any cybersecurity requirements on UNOS."

Shepard, who is stepping down in September, said his organization is audited yearly by government. He said that if officials visit the UNOS office, they can review specific chunks of the source code.

"The code is extremely large," Shepard said. "They can come in and ask for specific pieces."

UNOS said in a statement that its refusal to turn over the full code is part of "an important balance: providing HRSA and other auditors the access they need to ensure the system's security while limiting wider access in order to safeguard patient data and protect UNOS' intellectual property."

UNOS oversees what is formally known as the Organ Procurement and Transplant Network, a complex collection of about 250 transplant-performing hospitals; 57 government-chartered nonprofits that collect organs in their regions; labs that test organs for compatibility and disease; and other auxiliary services.

Located in Richmond, Va., UNOS sits at the center of the system. It is the only organization to ever hold the 36-year-old contract to run the operation, currently worth more than $200 million, funded mainly by fees patients pay to be listed for transplants.

UNOS oversees controversial policies that determine which patients have priority for life-saving kidneys, hearts, livers and other organs. It reviews mistakes by members of the network and maintains the waiting list for organs. And it runs the complex technology that connects the entire enterprise.

Part of UNOS's job is to monitor the performance of organ procurement organizations and hospitals where transplants are performed. When either is reported to have needlessly wasted an organ or endangered safety, UNOS is supposed to look into it.

Critics have long said UNOS does little with many of these complaints, leaving the problems that caused them unresolved. Its findings and the work of its investigators are not made public.

More than 20 percent — 1 in 5 — of all kidneys procured for transplant in the United States are not used, according to data from the Scientific Registry of Transplant Recipients. That rate reached a new high in 2020, when 21.3 percent of procured kidneys were not transplanted, a registry report found. The reasons are in dispute, with members of the network often blaming each other.

European countries report much lower "discard rates" for kidneys, according to various studies. France, for example, had a kidney discard rate of 9.1 percent from 2004-2014, a 2019 study found.