August 3, 2022
As is ready for delivery
The last place anyone wants to hear about mismanagement and incompetence is in the business of saving lives. This is precisely and unfortunately what the Finance Committee is meeting to discuss today.
This morning’s hearing is an update to an investigation that Senator Grassley and I, along with Senator Cardin and Senator Young, have been conducting for more than two and a half years. It examines the network of dozens of organizations that manage organ transplants and, in particular, the group that oversees and coordinates them, the United Network for Organ Sharing, or UNOS. We reviewed 100,000 UNOS documents totaling more than half a million pages.
Before I get to specific conclusions, I want to frame what we’ve learned as simply as possible. Too many Americans are dying needlessly because UNOS and many of the transplant organizations it oversees are failing and seem uninterested in improving.
These questions involve an alphabet soup of acronyms and organizations, so I’ll start with a little background. A 1984 law created the first computerized system to match sick patients with the organs they needed. It was named the Organ Procurement and Transplantation Network. Someone needed to manage this system for the entire country, so the government looked to hire an organization to run it. UNOS was the sole bidder for this first contract in 1986. The contract has been tendered seven more times. UNOS has won all seven.
Today the network overseen by UNOS consists of nearly 400 members, including 252 transplant centers and 57 regional organizations known as organ procurement organizations or OPOs. Each OPO has a defined geographic service area. A family sitting in a hospital room thinking about donating a loved one’s organ has no OPO option.
Here are the important terms to remember. When a kidney donated in Corvallis needs to reach a patient in Portland, that’s where an OPO steps in. UNOS supervises the OPOs.
As our research shows, UNOS does very poorly.
Serious errors in the procurement and transplant system are surprisingly common. Between 2010 and 2020, more than 1,100 complaints were filed by patients and families, staff, transplant centers and others. The nature of these complaints runs the gamut. For example, in several cases, OPOs had not completed critical and mandatory tests for things like blood types, diseases, and infections.
Our investigation found that one patient died after being transplanted with lungs that a South Carolina OPO labeled with the wrong blood type. Similar blood type errors occurred elsewhere and patients developed serious illnesses. Some had to have organs removed after transplant.
Another patient was told he would likely die within 3 years after an Ohio OPO provided him with a heart from a donor who had died of a malignant brain tumor. UNOS did not take any disciplinary action.
In one Florida case, another patient contracted cancer from transplanted organs, and the OPO sat on the evidence for months.
In total, our research found that between 2008 and 2015, 249 transplant recipients developed a disease from transplanted organs. More than a quarter of them died.
Organ donation has been another source of life-threatening errors. We found 53 such complaints between 2010 and 2020, as well as evidence that they were only the tip of the iceberg. In some cases, couriers missed a flight. In others, the organs were abandoned at airports. Some organs were never harvested. Many of these failures resulted in the organs being discarded.
It is reasonable to assume that many more errors go unreported. Because? Because filing official complaints with UNOS seems to achieve zero productive oversight or reform. Organ transplant professionals repeatedly told the Finance Committee that the UNOS complaint process was a “black hole”. Complaints poured in, UNOS fell silent.
In interviews with the committee, UNOS leaders have dragged their feet, dodged tough questions and shifted responsibility to others. Investigations and disciplinary action are rarely more than a slap on the wrist. Only once, only once, has UNOS recommended that an OPO lose certification.
The bottom line is that the failures we’ve discovered cost lives. Thousands of organs donated each year end up being discarded, including one in four kidneys. However, according to federal data, approximately 6,000 Americans die each year while waiting for an organ transplant.
This type of mismanagement has a disproportionate impact on minority Americans. African Americans, for example, have a greater need for kidney transplants than other demographic groups.
The Centers for Medicare and Medicaid Services recently released new standards for OPO performance, and more than one-third of OPOs are not meeting them. Fixing what’s broken could substantially increase the supply of life-saving organs available for transplant.
Finally, another area of the committee’s investigation has examined the IT used by UNOS to operate the transplant network. This system is outdated, poorly managed and insecure. Using such decrepit technology to run the transplant network puts lives at risk and puts sensitive data at risk, and there is no apparent solution in sight. In a report released last year titled “Lives Are At Stake,” the US Digital Service concluded flatly that UNOS lacked the technical capacity to modernize the system.
I’ll close on this. If you were to look at the staff at UNOS and many of the nation’s OPOs, I’d bet the vast majority are hardworking people doing everything they can to save lives. The glaring problems uncovered in our research stem from leadership failures.
Our investigation is ongoing. It is clear that this system needs major reform. We will continue to investigate issues at UNOS and OPOs, as well as policies that need to be changed at the federal level. This is not a partisan issue. Everyone wants this system to work with as few errors as possible. Senators Grassley, Cardin, Young and I will continue to do so.