Seventy people died and 249 developed diseases after mistakes in the screening of organs they received in transplants, a Senate committee reported Wednesday after an investigation that found widespread deficiencies throughout the U.S. organ transplant system.
Testing errors and overlooked communications allowed the transmission of cancer, a rare bacterial infection and other diseases, the Senate Finance Committee found in its review of hundreds of thousands of pages of subpoenaed documents and other material that formed the basis of the two-and-a-half-year investigation.
The errors included failures to identify disease in donor kidneys, hearts and livers, as well as mix-ups in matching blood types and delays in blood and urine tests that were not completed before transplant surgeries occurred, the investigators concluded in a report obtained by The Washington Post.
The Senate committee partly blamed lax oversight of organ procurement organizations (OPOs), the regional nonprofits responsible for collecting donated organs, by the United Network for Organ Sharing, the Richmond-based contractor that oversees the system. It listed as problems careless treatment of donated organs, organs lost in transit, and technological issues.
In 2020, the investigation found, two healthy kidneys were accidentally thrown in the trash in Indiana. In 2015, an airline temporarily lost a donated kidney that was supposed to be shipped from South Carolina to Florida — causing the transplant surgery to be canceled and the organ discarded. In 2017, another kidney was misplaced and missed a flight from South Carolina to California, leading to another canceled transplant, but the organ was used by a local transplant team.
A UNOS spokesman said the organization could not respond to a report that its officials had not yet seen but provided a copy of testimony by UNOS chief executive Brian Shepard prepared for delivery at a Wednesday afternoon hearing of the committee. Shepard is stepping down in September.
“Ours is a complex system; one that is dedicated to continuously improving, monitoring and adapting; one that involves thousands of people coming together every single day across the country in order to save lives,” the testimony said. “It is a system Congress set in motion nearly forty years ago, and which, thanks to the decisions and expertise of those who laid the foundation, allows us to best serve patients in need of a transplant.”
The Association of Organ Procurement Organizations declined to comment.
The review provides a rarely seen level of detail into the operations of a system with seemingly little regulatory oversight, where strict privacy rules and legal restrictions typically limit the amount of information available to outsiders and whose successes largely have been trumpeted since the first successful transplant in 1954.
The Senate report examined 1,118 complaints filed from 2010 to 2020 with UNOS. The death toll from failed organ screenings — detailed in a 2016 UNOS report handed over to Senate investigators — covered a shorter time period, 2008 to mid-2015.
The deaths and illnesses were a tiny fraction of the 174,338 organs transplanted in that seven-year period. But “this data illustrates the lethality of diseases contracted during a transplantation and the need for exacting scrutiny of such transmissions,” the committee wrote in a 60-page memo prepared for the Wednesday afternoon hearing.
The Senate report is the most recent government study to find serious weaknesses in the transplant system, which is funded primarily by fees charged to patients awaiting transplants. A confidential government report by the United States Digital Service, completed 18 months ago, called for the technology that powers the system to be completely overhauled. It cited aged software, periodic system failures, mistakes in programming and overreliance on manual input of data, The Washington Post reported Sunday.
In February, a study by the prestigious National Academies of Sciences and Medicine found the transplant system to be inequitable, with unexplained performance differences across the system. It also said that 1 in 5 procured kidneys is never transplanted.
An estimated 106,000 people are awaiting transplants in the United States. About 22 die every day awaiting a transplant, according to the National Academies. In 2021, 41,354 organs were transplanted, a record.
The committee criticized UNOS for poor oversight of the 57 OPOs. It found that UNOS staff referred 40% of the 1,118 patient safety complaints they received between 2010 and 2020 to the organization’s oversight panel, the Membership and Professional Standards committee. Of those, one resulted in probation — a public designation, according to UNOS’s website, that a member of the network is under a corrective action plan “for noncompliance or a serious lapse in patient safety or quality of care.”
Three complaints resulted in a “peer visit”; 63 resulted in letters of warning or reprimand; 298 led to notices of noncompliance or uncontested violation; and 68 were closed with no action.
The complaints covered all parts of the network, not just OPOs. Only the government can revoke an OPO’s right to gather organs, but that has never happened in the history of the transplant system, according to the report.
The OPOs are nonprofit organizations overseen by the Centers for Medicare and Medicaid Services, part of the Department of Health and Human Services. Each holds a monopoly to collect organs and human tissue in a specific region of the country, where its employees work with families at hospitals to obtain consent. The OPOs also are responsible for screening organs and, in most cases, arranging to send them to transplant hospitals as quickly as possible.
Kidneys, which make up more than 80% of organs transplanted, usually are transported by plane, under controlled conditions. Surgeons will often retrieve hearts, livers, lungs and other less-common organs themselves. In 2020, 21.3% of procured kidneys were not transplanted, according to the Scientific Registry of Transplant Recipients. The reasons are in dispute, with members of the transplant network often blaming each other.
The Senate committee study recommended that the government create competition for UNOS, which has held the contract to run the transplant network for the entire 36 years of the system’s existence. It also suggested awarding a separate contract for the transplant system’s technology; increasing “transparency and accountability for chain of custody and transportation of organs”; and increasing accountability for lost, damaged and delayed organs.
Among the results of organ mistakes, the documents show, were canceled transplants. In several cases, organs already transplanted had to be removed. Some patients were able to find other organs. The fates of other patients were unknown.
One patient was told in 2020 by a transplant surgeon in Wisconsin that their new heart had come from a donor who had aggressive brain cancer — a diagnosis discovered only after the transplant — so they “likely” would die within the next three years, according to records. The documents do not say what happened to the patient.
In 2018, confusion over one organ donor’s blood type in South Carolina led to four separate transplant surgeries with incompatible recipients, the documents show. The man who received the donor’s lungs died the next day, after his body apparently rejected the organ. Surgeons were forced to remove another patient’s transplanted heart for the same reason. The patient went back on the organ waitlist and soon found another heart. Other patients with the donor’s liver and kidney survived. But another kidney and the pancreas were thrown out once the blood mismatch was uncovered.
Matching a donor’s blood type with the recipient’s is often essential for avoiding organ rejection. It is normally a simple test. But blood typing can be complicated by blood transfusions, which are common in donors killed in car crashes or by gunfire.
The South Carolina case involved a donor who died after a motorcycle accident and had received massive blood transfusions. The transplant of her organs was coordinated by We Are Sharing Hope SC, the OPO responsible for most of South Carolina, records show.
A first test failed to pinpoint a blood type, showing signs of both type O and type A. A second test was also indeterminate. But a third test showed signs of type O. A later investigation by UNOS and the OPO found that the indeterminate results were not fully communicated to surgeons who accepted the donor’s organs.
The mistake wasn’t discovered until about nine hours after the donor’s organs had been removed, documents show. A surgeon at another hospital who had received the donor’s pancreas noted the organ was labeled type O, but a blood test run there showed type A. The surgeon was concerned and canceled the pancreas transplant.
But it was too late for the others. The five other organs had already been transplanted. The OPO did not return requests for comment on the case.
A similar problem occurred in December 2020, when a blood-type mismatch with a single donor in California disrupted four transplants, forcing the rushed removal of three organs — including a heart — after they had been implanted.
The confusion about the donor’s blood type was recognized from the beginning, with a transplant worker with Donor Network West — the San Ramon, Calif.-based OPO that handles organ donations in the San Francisco area — even calling UNOS to discuss doubts about the conflicting results, according to call notes.
The UNOS representative tried to be reassuring, adding, “all you can (do) is disclose everything.” In the end, the donor’s blood type officially was labeled O, but the conflicting results were noted in the computer system that coordinates transplants. All of the intended recipients of the organs had type O blood.
The donor’s blood type, however, eventually was determined to be B — but only after the donor’s liver, heart, kidneys and pancreas has been transplanted. All of the transplanted organs had to be removed, except the liver; doctors there had noted the confusion and took extra steps to reduce the risk of rejection.
Janice Whaley, president of Donor Network West, acknowledged in an interview that her OPO’s employees should have asked more questions before proceeding. The organization has changed its policy to use a more sensitive DNA test now if there are questions over blood type.
Undetected infections can affect multiple patients, the review found. In 2017, a kidney transplant recipient in Nevada died from the rare bacterial infection tularemia just days after receiving a new organ. A patient in California who received a kidney from the same donor also was infected but survived.
Tularemia in humans is rare in the United States, with only a couple hundred cases reported in a typical year. When the Centers for Disease Control and Prevention learned about the outbreak tied to an organ donor, an agency official wrote in an email, “This is obviously a public health emergency” and expressed worry that dozens of health-care workers and transplant patients could be at risk.
Two years later, CDC and university researchers wrote in the journal Emerging Infectious Diseases that two dead rabbits found near the donor’s home contained the bacteria.
Kelley McClellan, director of community development for Nevada Donor Network, declined to discuss the case until she had seen the full report.
Undetected cancer in a donor led to the discovery in 2019 of a mass on the transplanted liver of a recipient undergoing his one-year follow-up appointment. A biopsy showed the cells had originated with testicular cancer, a diagnosis that had been noted in the organ donor’s autopsy report but overlooked by LifeQuest Organ Recovery Services, the Gainesville, Fla.-based group that handles transplants in the Florida Panhandle.
The recipient underwent chemotherapy and survived, according to a follow-up report.
Kathleen Giery, director of donor program development at LifeQuest acknowledged in an email that the OPO had missed the autopsy finding of cancer. After learning of the diagnosis eight months later, the OPO notified another recipient of organs from that donor, conducted an investigation and established new policies to prevent another incident.
They include having “multiple individuals review the autopsies within 24 hours, as well as any other test results,” she wrote.
In another case, a heart transplant recipient learned in 2020 that staff at the OPO Life Connection of Ohio in Maumee, Ohio, had missed a positive brain cancer biopsy result from the organ’s donor, records show. The donor was a woman who had died after a brain bleed at a hospital in Ohio, according to records. There were signs of a potential brain mass before the transplant. But a formal diagnosis of glioblastoma — a fast-moving and often fatal cancer — did not come until several days after the transplant.
The heart transplant patient was told about the cancer diagnosis nine weeks later by a surgeon in Wisconsin. The patient reported the incident to UNOS, noting the surgeon said they “don’t know how they ‘messed up’ and did not catch this prior to (transplant),” records show.
In an email, Matthew Wadsworth, chief executive of Life Connection of Ohio, said results of a CT scan on the donor did not mention a mass in the brain, which means there was no indication for additional testing. The tumor was found during an autopsy, and the OPO notified UNOS and all hospitals that had accepted organs from the donor, he wrote.
“Life Connection followed its processes when evaluating the patient for donor suitability as well as the process for reporting a patient safety event,” Wadsworth wrote.
A June 2020 incident in which two healthy kidneys were accidentally thrown in the trash at an Indiana hospital resulted in UNOS issuing a noncompliance order to the Indiana Donor Network, which procures organs across the state.
According to documents, a liver that had been removed from the donor was quickly packaged for delivery out of state, but the donor’s kidneys were left on a table in the operating room. The three Indiana Donor Network workers responsible for the organs had left the operating room to make sure the liver departed safely.
When they returned, just six minutes later, and started scrubbing in to deal with the kidneys, they discovered hospital workers “aggressively” cleaning the operating room, according to a summary of events. The workers found the kidneys in the trash. “Hospital staff believed all that was remaining was trimmed fat to be discarded,” read an internal report on the incident.
After talking with a surgeon, the transplant coordinators decided the kidneys couldn’t be used.
The Indiana Donor Network had been cited by UNOS previously for errors. In 2019, it was criticized for failing to complete donor blood tests and then for failing to provide an accurate description of a donated kidney in 2018, records show. In November 2017, the group received a violation notice for late reporting of a positive test for parasitic roundworms in a donor.
The trashed kidneys led to UNOS issuing a new notice of noncompliance and requiring the transplant coordinators to craft a plan to avoid repeating the same mistake.
“Three of the citations you reference were the result of circumstances outside our organization’s control and the result of errors made by others unaffiliated with Indiana Donor Network,” said Mark Back, manager of marketing and communication for the OPO. “In each case, we worked quickly and aggressively with our partners to implement new policies and procedures to prevent future errors.”