E&C Leaders Send Bipartisan Letter to HRSA Following Oversight Hearing on Concerning Practices in Organ Procurement and Transplant System

WASHINGTON, D.C. - House Committee on Energy and Commerce Chairman Brett Guthrie (KY-02) and Ranking Member Frank Pallone Jr., (NJ-06), along with Energy and Commerce Subcommittee on Oversight and Investigations Chairman John Joyce, MD (PA-13), and Ranking Member Yvette D. Clarke (NY-09), wrote to the Health Resources and Services Administration (HRSA) requesting a briefing on its ongoing oversight of patient safety in our nation's organ procurement and transplant system.

In July, the Committee's Oversight and Investigations Subcommittee held a hearing in response to a HRSA investigative report that found patient safety concerns at Kentucky Organ Donor Affiliates (KYDA) - the organ procurement organization (OPO) serving the state of Kentucky. In the investigative report, HRSA revealed that of the 351 cases reviewed, 103 cases (29.3 percent) showed "concerning features." These concerning features included problems with patient-family interactions, medical assessments and team interactions, recognition of high neurologic function, and recognition and documentation of drugs in records.

In addition, HRSA issued a corrective action plan to address the findings in its report specific to KYDA and directing the Organ Procurement and Transplantation Network (OPTN) Board of Directors to develop certain safety guidelines for the entire OPTN. The corrective action plan raised further questions about the possibility that there may be more systemic issues at OPOs across the country, noting that "[s]ince the review of KYDA was initiated, HRSA has received reports of similar patterns of high risk [donation after circulatory death] procurement practices at other OPOs." Moreover, during the July hearing, HRSA's Organ Transplant Branch Chief, Dr. Raymond Lynch was questioned about the potential failure to adhere to existing protocols by Rep. Erin Houchin (IN-09): "is it a broader systemic issue or is it limited to KYDA?" Dr. Lynch responded that "[u]nfortunately, it is not limited to KYDA. During the course of this investigation we received concerns that were in areas served by other OPOs."

Chairmen Guthrie and Joyce and Ranking Members Pallone and Clarke issued the following joint statement:

"The Committee's examination of the organ procurement and transplant system has demonstrated the need for further oversight. Testimony from the July hearing, HRSA's investigative report and corrective action plan, and continued reports of similar patterns at other OPOs all raise serious concerns. The American people should be able to have full faith and confidence in our organ donor and transplant system, and we will continue to work together to prevent these harmful practices from continuing. Americans' confidence in the system comes when patient safety is protected."

Read the full letter here.

Background:

· During the 118th Congress, the Committee on Energy and Commerce passed the Securing the U.S. Organ Procurement and Transplantation Network Act to both modernize the OPTN and allow HRSA to institute a competitive contracting process to find the best contractors for various OPTN functions. This legislation was signed into law on September 22, 2023.

· On March 20, 2024, the Committee launched an investigation into the organ procurement and transplantation system by sending a letter to United Network for Organ Sharing (UNOS) requesting information related to concerns surrounding data security and operability, patient safety and equity, and conflicts of interest.

· On March 20, 2024, the Committee also sent a letter to HRSA requesting information related to implementation of the Securing the U.S. Organ Procurement and Transplantation Network Act as well as other concerns related to effective oversight and management.

· On September 11, 2024, the Subcommittee on Oversight and Investigations held a hearing that focused on the implementation of reforms at the OPTN, including the need for stronger oversight and accountability as well as ongoing patient safety concerns.

· During the hearing, questions were raised related to allegations of mismanagement and patient safety concerns after patients began exhibiting signs of increased neurologic function after being previously deemed suitable as an organ donation candidate. Several of these allegations, particularly those related to patient safety, were later substantiated through the findings contained in HRSA's March 2025 report.

· On March 24, 2025, HRSA's Division of Transplantation issued a report that summarized the findings of its investigation into KYDA, the OPO now known as Network for Hope, which serves Kentucky and parts of Ohio, West Virgina, and Indiana.

· On May 28, 2025, HRSA issued a CAP to OPTN, which directed the OTPN to take specific actions within a specified period of time, including developing a 12-month OPTN monitoring plan for KYDA to address concerns identified. The corrective action plan also requires the OPTN to propose policies for public comment to improve safeguards for potential donation after circulatory death (DCD) patients in the organ procurement process and increase information shared with patient families regarding DCD organ procurement.

· On July 22, 2025, the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations held a hearing examining concerning practices within our nation's organ procurement and transplant system that were identified by HRSA's investigation.

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