US health regulator moves to decertify Network for Hope over patient safety failures
The Department of Health and Human Services has initiated proceedings to revoke the certification of Network for Hope, a move that would effectively shut down the group and trigger a regional reassignment of organ donation coordination.
The US Department of Health and Human Services (HHS) has commenced proceedings to decertify Network for Hope, a Kentucky-based organ procurement organisation, citing persistent patient safety failures identified during federal investigations. The announcement, made on Wednesday, signals a potential shutdown of the organisation, which currently coordinates donations across Kentucky and parts of Indiana, Ohio, and West Virginia. Should the decertification proceed, the HHS will appoint a different entity to manage organ procurement in the region.
The regulatory action follows two separate investigations conducted by the HHS’s Centers for Medicare & Medicaid Services and the Health Resources and Services Administration (HRSA). The HRSA inquiry, which concluded last year, reviewed 351 cases where organ donations were authorised but ultimately cancelled. Investigators identified concerning features in 103 of these cases, including 73 instances where patients exhibited neurological signs that should have rendered them ineligible for donation. The HHS stated that these failures persisted despite extensive oversight and opportunities for the organisation to implement corrective measures.
The scrutiny intensifies against a backdrop of a 2021 incident involving Anthony Thomas Hoover II, a Kentucky man in his 30s who had overdosed and was unresponsive for two days. As Hoover was being wheeled into surgery for organ retrieval, he began showing signs of responsiveness, including crying, pulling his knees to his chest, and shaking his head. Doctors refused to proceed with the retrieval while Hoover was responsive, leading to the cancellation of the surgery. Hoover recovered but sustained lingering neurological injuries. His sister attended the press briefing announcing the HHS decision.
Network for Hope, whose predecessor organisation KODA was involved in the 2021 incident, stated it strongly disagrees with the findings and intends to appeal the decertification. The organisation noted that it has implemented a pause process since the incident, allowing family members or healthcare providers to halt donation plans if concerns arise. This protocol was subsequently codified into Kentucky state law. The HHS maintains, however, that the organisation failed to adequately address the systemic issues highlighted in the federal reviews.
Regulatory attention on organ procurement organisations is increasing due to a rise in donations from individuals with circulatory deaths, where the heart stops, rather than those declared brain-dead. While these organisations are legally barred from declaring a person dead or participating in care decisions such as withdrawing life support, the timing of such decisions remains complex. More than 103,000 people are currently on the US organ transplant waiting list, with over 49,000 transplants performed last year.
