House Committee on Energy and Commerce is Continuing to Investigate Concerning Practices Within Our Nation’s Organ Procurement and Transplant System
WASHINGTON, D.C. – Last month, the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations held a hearing diving deeper into concerning practices within our nation’s organ procurement and transplant system that were identified by a recent Health Resources and Services Administration (HRSA) investigation. During the two-panel hearing titled “Ensuring Patient Safety: Oversight of the U.S. Organ Procurement and Transplant System,” Committee Members heard from the Chief of the Organ Transplant Branch of HRSA regarding the agency’s recently released investigative report outlining shocking revelations about the system’s procedures that put patient safety at risk. The investigation examined an “index case” (KYDA-001) where the organ procurement organization (OPO) that services Kentucky was contacted shortly after the arrival of a patient who was experiencing cardiovascular collapse after an unintentional overdose. After it was determined that further treatment would be futile, the patient’s family made the decision to end life-sustaining treatment and move forward with organ donation via a process known as donation after cardiac (or circulatory) death (DCD). However, despite OPO and hospital staff noting signs of the patient’s improved neurologic function, discomfort, and even expression of fear at multiple points over the multi-day period between when the OPO was first contacted and the patient was brought to the operating room (OR), the decision to pursue organ recovery was not reversed until the physician in the OR became uncomfortable and refused to continue with the process. In addition to the index case, HRSA analyzed 351 unique cases of authorized, not recovered (ANR) patients. This means that the patients were considered for DCD recovery, but no organs were transplanted. The report shows that 103 of these cases, which is nearly 30 percent, “had concerning features.” HRSA’s Organ Transplant Branch Chief, Dr. Raymond Lynch, testified about KYDA’s (Network for Hope) patterns that were identified in the report, which include: A failure to recognize neurologic function inconsistent or unfavorable for DCD organ recovery on initial patient assessment or subsequent follow up; A failure to work collaboratively with patients’ primary medical teams, including instances of potential violation of separation of roles in patient care; A failure to respect family wishes and appropriately safeguard the decision-making authority of legal next of kin; and A failure to follow professional best practices as well as policies and guidelines for collection of patients’ medical data. The second panel included witnesses from “Network for Hope,” the OPO involved in all of the cases that HRSA reviewed; the United Network for Organ Sharing (UNOS); and the current and recent past President of the Organ Procurement and Transplantation Network (OPTN) Board of Directors. Chairman Joyce probed Network for Hope CEO, Mr. Barry Massa, for using the word “unique” to describe the index case, the same case where “...hospital staff [felt] extremely uncomfortable with the amount of reflexes patient is exhibiting,” during the procurement process. Congressman Gary Palmer (AL-06) questioned witnesses about an open letter that was issued after the Subcommittee’s September 2024 hearing and signed by the organ donation and transplant industry and community members, including individuals at UNOS and OPTN Board Members. The open letter, per HRSA’s report, “characterized the ongoing effort to improve patient safety through enhanced oversight as a ‘misinformation campaign,’” noting that “[i]t is time for it to stop.” Specifically, the letter portrayed the previous oversight efforts by this Committee as “[s]preading misinformation based on conspiracy theories and hearsay.” UNOS’s CEO, Dr. Maureen McBride, admitted to signing the letter. The Committee has serious concerns about the message this letter sends both to those conducting oversight of the organ procurement and transplant system and to those who wish to speak up when they wish to report concerns or potential wrongdoing. Oversight of this issue is far from over, and the Committee remains committed to protecting patient safety and maintaining trust in the system to ensure transparency and accountability. As Chairman Guthrie said when recalling his personal experience with our nation’s organ procurement and transplant system, “The conclusion [of this process] is going to come when we have confidence in the system.” ###