UNOS’ updates from the July 22 Energy and Commerce Oversight hearing
UNOS CEO Maureen McBride is testifying July 22 at the House Committee on Energy and Commerce Oversight & Investigations Subcommittee. The hearing is focused on oversight of the organ donation and transplant system, and UNOS is participating because of its role as a contractor that manages the Organ Procurement and Transplantation Network (OPTN).
Here, we highlight statements made during the hearing, with a focus on correcting any inaccurate information presented at the hearing.
1:37 p.m.
Prioritizing patient safety with “No Wrong Door” Patient Safety Reporting
While the OPTN currently has in place a procedure for reporting patient safety issues, it’s not enough.
That’s why UNOS is calling for Congress to call on HRSA and CMS to create a comprehensive “No Wrong Door” patient safety reporting system to ensure that patient safety events are quickly reported by providers, patients, family members, or anyone who has witnessed or learns of a potential safety incident.
The avenues for reporting in the current system include a secure online portal available to OPTN members, an OPTN reporting phone line that anyone can call anonymously, and the option to email [email protected]. OPTN members are required to report certain events in accordance with OPTN policy and many also submit voluntary reports. However, anyone who is not an OPTN member, such as a donor family member or a patient, would have to do research to find options for reporting.
Anyone who has witnessed or experienced poor care should have a clear path for reporting their concerns. Since more than 95 percent of hospitals in the U.S. are not OPTN members, CMS and HRSA must work together to close the reporting gap.
We must have a system that is widely known and publicized to ensure patient safety issues are addressed immediately and appropriately. This system needs to be accessible to the public in a way that does not rely on them understanding the transplantation and donation system’s governance structure, including the difference between OPTN, HRSA, and CMS, much less even knowing that they exist.
1:25 p.m.
UNOS is a private nonprofit organization. UNOS has served the nation’s organ donation and transplant system since 1986 through its OPTN contract with the federal government (HRSA). UNOS is not the OPTN. UNOS is one of several federal government contractors that support the work of the OPTN. UNOS acts as directed by and with oversight from HRSA to support the OPTN’s operations in accordance with NOTA, the Final Rule, OPTN policies, and OPTN bylaws.
Under UNOS’ OPTN contract with HRSA it is responsible for:
- Managing the national transplant waiting list and organ matching system 24/7/365
- Providing support to OPTN volunteers during the policy development and compliance oversight processes. The donation and transplant community and the general public have the opportunity to influence all policies developed by the OPTN.
- Monitoring compliance through data reporting systems and supporting the OPTN volunteers’ investigations of reported patient safety incidents
- Collecting and maintaining OPTN data on behalf of HRSA
Under UNOS’ OPTN contract with HRSA, UNOS is not responsible and cannot:
- Make any clinical decisions, including declaring death. The patient’s physician, the transplant team, and OPO professionals do this.
- Conduct oversight over hospitals. CMS, and HRSA in the case of a transplant hospital, does this.
- Direct OPTN investigations or deciding the outcome of OPTN investigations
- Unilaterally implement changes to the OPTN’s processes or systems without HRSA’s review and approval
12:01 p.m.
Statement: UNOS has obstructed the federal government’s access to data in the system, and demanded compensation for that access
Facts: It is written in UNOS’ OPTN contract with HRSA that the federal government can audit and access the data that’s stored in the OPTN computer system. UNOS has never demanded compensation from the government for OPTN data in its system. The contract even requires UNOS allow the government to inspect the computer system at any time.
In 1999, HRSA included in the OPTN contract a requirement for UNOS to build a contractor-owned, contractor-operated (COCO) computer system to support the OPTN’s functions. The resulting product is UNet, which UNOS has continued to use, in support of the OPTN and as required by the OPTN contract, ever since. UNOS, HRSA, and the OPTN have worked together over the last 25 years to continue to improve and evolve UNet to keep up with the OPTN’s needs. HRSA has always had the option to license UNet from UNOS to continue to use it in support of the OPTN if HRSA so chooses. The price for licensing the system is built into the contract. This is not a ransom, this is a result of a contract negotiated in good faith between the federal government and a private, non-profit organization.
11:45 a.m.
Statement: UNOS, as the OPTN contractor, “elected” to close the investigation into the Kentucky case
Facts: UNOS monitors OPTN members with compliance monitoring plans that are required to be submitted by UNOS to HRSA under the OPTN contract. HRSA can and should direct UNOS to revise them any time HRSA identifies a need. UNOS adheres to these plans at all points throughout an investigation.
UNOS staff acts with integrity, in good faith and in accordance with the information available at the time and in alignment with established processes. If UNOS closes an investigation without the input of the OPTN, it is based on HRSA-reviewed, OPTN processes: “At the conclusion of the investigation, staff present findings to a multi-disciplinary team that determines whether a potential policy or bylaw noncompliance occurred, or if there is an ongoing risk to patient safety or public health. If a potential noncompliance does not exist, there is no threat to patient safety or public health, and the reported event is not a living donor event as defined by OPTN policy, staff close the case and the member(s) receives a closure letter.”
All such closures are retrospectively reported to the MPSC and HRSA in the Report of Investigative Activities.
The OPTN, with oversight and participation from HRSA, conducted two investigations into the Kentucky case from September 2024 through March 2025. As a HRSA contractor supporting the OPTN, UNOS redirected resources and swiftly responded to all requests by HRSA regarding this case. UNOS worked throughout the investigative process as directed by the OPTN volunteers and authorized by HRSA and approved processes.
HRSA was involved in every step of each investigation and had direct oversight of the process. UNOS, at no point, was able to direct or determine the outcome of the investigation. UNOS did not have a decision-making role in the investigation, including the decision to close a review or investigation. As the OPTN Contractor, UNOS did not “elect to close the case” as stated by Dr. Lynch. That decision was made by the OPTN.
11:29 a.m.
Statement UNOS employees were ‘conflicted’ for signing AOPO letter
Facts: On Sept. 27, 2024, more than 1,000 members of the organ donation and transplant community signed on to an open letter expressing concerns about misinformation regarding donation and transplantation. Specifically, the letter took aim at “malicious misinformation and defamatory attacks based on hearsay, creating a false narrative that donation and transplant in the US is untrustworthy and broken.”
It went on to say, “The life-saving work of donation and transplant is too important to be undermined by unsubstantiated accusations as serious as claiming OPOs are hastening death or attempting to recover organs before donors have died – no legitimate evidence has been produced to support these outrageous claims.”
At no point did the letter itself identify specific allegations or specific organizations. The letter’s only reference to UNOS was a link to a published UNOS statement decrying false statements about UNOS, not the investigation. Those statements referred to sworn testimony that UNOS had acted in violation of law, exercising market “monopoly” power and then engaging in criminal whistleblower retaliation. Both these statements were false, unsubstantiated allegations. The linked UNOS statement made no reference to OPOs, or whether allegations against them were true or false. An individual not affiliated with UNOS made those allegations in Congressional testimony, and UNOS has never made a public statement on their accuracy.
The letter was signed by 1,125 people spanning the donation and transplantation community, including 20 members of the UNOS staff. Each UNOS staff member signed in the staff member’s individual capacity, not on behalf of UNOS. The letter provided a space for signers to also identify their employment if they chose, and some signers chose to fill in that blank.
The letter followed allegations raised at a hearing in September 2024 before the House Committee on Energy and Commerce Oversight & Investigations Subcommittee, where testimony indicated that someone in Kentucky being considered for donation after cardiac death nearly had his organs recovered. UNOS immediately notified HRSA about the allegations, as required under the OPTN contract. That notification triggered an investigation into the incident by the MPSC, with the support of UNOS staff.
On Nov. 20, 2024, HRSA sent an email to UNOS and OPTN leadership directing “The OPTN with support from the OPTN contractor [UNOS] should not plan to further investigate the case of the patient identified in the alleged incident. HRSA requests that the plan be revised to focus on the data submitted by KYDA on all other patients with potential to become DCD organ donors.”
In the same email, HRSA took personal aim at the members of UNOS staff who signed the letter, saying, “Unfortunately, the fact that OPTN contractor staff and leadership have signed this letter creates a perception of conflicted interest for these individuals (and perhaps the organization) and compromises the ability of the OPTN contractor to support the OPTN in its investigation.
“HRSA is requesting that the plan be revised to document how the OPTN will manage any potential conflicts of interest in its review of KYDA activities and be revised to include specific activities that the OPTN contractor proposes to take to mitigate perceptions of conflicted interest caused by employee signatures on the letter so that the OPTN contractor can effectively support the OPTN in this investigation.”
UNOS disagrees that signing the letter created a conflict of interest, and disputes that actions to punish UNOS staff for otherwise protected public speech were necessary or warranted. Nonetheless, UNOS followed HRSA’s direction and excluded the staff who had signed from the investigative process regarding OPO activity. Of note, at least two members of the recently elected OPTN board of directors also signed the letter. Among the reasons HRSA cited for the special board election was to “mitigate conflicts of interest.”
Contrary to what HRSA’s Nov. 20 email said, the letter called upon “all those working to improve the donation and transplant system and members of the media who cover it to reject reckless allegations, think critically about what you hear and seek out the actual facts.” The letter’s aim was consistent with UNOS’ role in supporting the OPTN’s patient safety investigations: to investigate, at the direction of HRSA and the OPTN, all allegations to gather as much corroborating evidence as possible to allow the OPTN to deliberate and make informed decisions.
If it is a conflict to “reject reckless allegations” and “think critically about what you hear and seek out the actual facts,” then it is unclear how UNOS could avoid such an alleged “conflict.”
11:16 a.m.
Statement: The governance structure of the OPTN created a potential conflict of interest
Facts: UNOS’ board of directors has been independent from the OPTN board of directors since March 2024. Since the 1980s, the OPTN contract required that UNOS, as an OPTN contractor, have the same board of directors. UNOS led the charge to separate the two boards, which required approval by the then UNOS board. The board separation represented a significant change in governance structure, and it received wide-ranging support – from HRSA, from members, and even from critics of the current OPTN system – as it benefits the entire transplant community. Board separation also is in line with HRSA’s Modernization Initiative. More information, including a timeline detailing UNOS’ efforts to make the two independent can be found here.
11:15 p.m.
Statement: The relationship between the OPTN contractor (UNOS) and HRSA is akin to one where the contractor is an architect, home builder and inspector, and HRSA “lives across the street.”
Facts: The OPTN has always been structured with HRSA providing federal oversight, guided by law and regulation. The contractor organizations contribute subject matter expertise from volunteers, many of whom also work actively in organ donation and transplantation. While certainly drawing upon their acquired expertise, these volunteers are tasked with developing and improving the national system for the benefit of all donors and patients.
UNOS believes that the independence of the OPTN and UNOS Boards, implemented in March 2024, was an improvement for the transplant system to help achieve accountability, transparency and good governance, leading to greater public trust in the national system. However, UNOS’s mission has never conflicted with the goals of the OPTN, and UNOS rejects allegations that UNOS or its employees ever exhibited a “per se” or potential conflict of interests with the OPTN.
11:05 a.m.
Statement: UNOS is a monopoly, and that monopoly has meant that patients don’t receive the care they need.
Facts: While witnesses used the term “monopoly” to characterize UNOS’ contract role, the characterization is false. The fact that there has only ever been a single OPTN contractor is because the law –not UNOS — said there could only be one OPTN contractor. Since the OPTN’s inception, HRSA has issued requests for proposals for a single organization to operate the network. UNOS submitted a bid proposal at each opportunity to compete. HRSA awarded the OPTN contract to UNOS in 1986, 1987, 1990, 1993, 1996, 2000, 2005, and 2018 HRSA, not UNOS, structures the OPTN contract and the bid process. Use of the term “monopoly” suggests that there is (or should be) a “market” for organ donation and transplant in America – a position with which UNOS strongly disagrees.