Richmond-based UNOS CEO speaks during Congressional hearing following negligent Kentucky organ sharing incident

RICHMOND, Va. (WRIC) -- Following an incident when a Kentucky organization tried to harvest organs from a patient who was still alive, the CEO for Richmond-based nonprofit United Network for Organ Sharing (UNOS), which is federally contracted to oversee organ transplantation in the U.S., spoke at a Congressional hearing.

Background

In 2023, the Health Resources and Services Administration (HRSA), the federal agency that oversees organ transplantation, began an investigation into an incident involving the Network For Hope -- renamed following the merger of Kentucky Organ Donor Affiliates, Inc. and LifeCenter Organ Donor Network.

The federal government also directed the Organ Procurement and Transplantation Network (OPTN), which oversees 251 hospitals, along with its contractor, Richmond-based UNOS, to investigate the incident.

Network For Hope is a federally funded organ procurement organization that serves Kentucky, parts of Ohio, West Virginia and Indiana. Investigations into the organization began after an incident in which the group allegedly pressured a hospital in 2021 to proceed with organ donation for a man who showed signs of potentially waking up from his drug overdose.

The man reportedly moved and made sounds while being taken to the operating room, which a surgeon noticed, and surgery was canceled. The man survived and was discharged.

Investigative findings

Officials said the investigation found that Network For Hope continued to prepare some patients for organ donation after they showed signs of life on a wider scale than just the alleged incident.

The HRSA's investigation noted numerous instances where patients showed neurological signs that should have prevented medical staff from proceeding with organ donation.

In addition, the HRSA investigation found that dozens of patients who were not dead when organ harvesting was initiated, along with evidence of "poor neurologic assessments, lack of coordination with medical teams, questionable consent practices, and misclassification of causes of death, particularly in overdose cases."

Requirements

In response to these findings, HRSA has required Network for Hope to carry out a full analysis of why it failed to follow internal protocols -- including noncompliance with the five-minute observation rule after the patient’s death -- and make clear, enforceable policies to define donor eligibility criteria.

Secretary Robert F. Kennedy, Jr., who oversees the U.S. Department of Health and Human Services (HHS), will reportedly strip Network for Hope of its certification if the organization does not comply with the requirements.

Additionally, Network for Hope has to adopt a formal procedure allowing any staff member to stop a donation process if patient safety concerns arise.

Further, HRSA directed the OPTN to improve safeguards and monitoring on the national level.

Data about any time organ donation is stopped due to safety concerns, which is called for by families, hospitals or organ procurement organization staff, must be reported to regulators, and the OPTN must update policies to strengthen organ procurement safety and give accurate, complete information about the donation process to families and hospitals.

Congressional hearing and Richmond-based UNOS' connection

During a House Committee on Energy and Commerce, and Oversight and Investigations Subcommittee hearing on July 22, a federal official slammed the OPTN for "poor patient care and quality practices" exposed during HRSA's investigation.

Also during the hearing, UNOS CEO Maureen McBride confirmed that the nonprofit's board previously served as the OPTN's board until March 30, 2024.

HRSA established an independent board for the OPTN in July 2024, and with the federal contract not having changed yet, McBride said UNOS continues to support the board and the OPTN in other ways.

Despite this, UNOS' website said it "does not create or approve policies for the OPTN."

In the hearing, McBride urged Congress to work with UNOS, HRSA, the Centers for Medicare and Medicaid Services (CMS) and the organ donation and transplant community to improve the system for patients and donors.

McBride specifically called on Congress to require CMS and HRSA to work together and establish a patient safety reporting system, as well as recommending the implementation of automated referrals for donors who have died, mandating a national tracking system for donor organs and migrating the network's computer system to the cloud.

McBride also said that different aspects of the system being overseen by two entities -- HRSA and CMS -- has led to confusion and "inconsistent accountability," adding that the nonprofit supports efforts to consolidate the system under one agency.

According to UNOS' website, the nonprofit does not have a "direct role" in patient care, it does not direct operations at hospitals, it does not work with families to secure organ donations, it does not influence patient care protocols and it does not determine deaths or direct medical decisions.

UNOS' background

UNOS has previously come under fire for numerous issues, including a "configuration error" that may have shared some patients' personal and medical information, allegations of mismanagement and its nearly 40-year-long monopoly on organ transplants.