The Department of Health and Human Services (HHS) on July 21 announced an initiative to begin reforming the organ transplant system. The initiative follows a Health Resources and Services Administration (HRSA) investigation that uncovered serious clinical protocol violations during organ procurement.
HRSA found that a federally funded organ procurement organization (OPO) serving Kentucky, southwest Ohio, and parts of West Virginia initiated organ recovery procedures in cases where patients exhibited signs of life. HHS warned the OPO in question that it could face enforcement actions, including decertification, if it fails to demonstrate compliance with the corrective action plan.
The mandated actions include conducting a root cause analysis of its failure to follow internal protocols and developing policies to define donor eligibility criteria. HRSA also instructed the OPO to adopt a formal procedure allowing any staff member to halt a donation process in case of patient safety concerns.
Additionally, HRSA has directed the Organ Procurement and Transplantation Network (OPTN) to improve national safeguards and monitoring. Under HRSA’s directive, data about any safety-related stoppages of organ donation called for by families, hospitals, or OPO staff must be reported to regulators. Additionally, the OPTN must update policies to strengthen organ procurement safety and provide accurate, complete information about the donation process to families and hospitals.
In conjunction with the HHS announcement, the House Oversight and Investigations Subcommittee of the House Committee on Energy and Commerce held a July 22 hearing, Ensuring Patient Safety: Oversight of the U.S. Organ Procurement and Transplant System, to examine systemic failures in organ procurement and explore legislative oversight options.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.
Author