US begins organ-transplant reform as 'signs of life' found before some retrievals
The investigation conducted by the Health Resources and Services Administration (HRSA), a division of HHS, examined 351 cases where organ donation was authorized but not completed. It found 73 patients had shown neurological signs incompatible with organ donation and at least 28 patients may not have been deceased at the time organ procurement was initiated, the HHS said in a statement on Monday.
The probe also found evidence of poor neurologic assessments, questionable consent practices, and misclassification of causes of death in several cases, the agency said.
The HHS has directed the national Organ Procurement and Transplantation Network (OPTN) to report to regulators data concerning safety-related stoppages of organ donation called for by families, hospitals, or staff at organ procurement organizations.
The HRSA has also said it would decertify Network for Hope - a federally funded organ procurement organization (OPO) that serves states including Kentucky, southwest Ohio, and part of West Virginia - if it does not comply with certain corrective actions.
"Network for Hope looks forward to working collaboratively with HHS and HRSA and encourages the development of policies that support the betterment of the organ transplant system as a whole," CEO Barry Massa told Reuters in an email.
The mandated actions include a root cause analysis of its failure to follow internal protocols and to develop policies to define donor eligibility criteria. It has also instructed the OPO to adopt a formal procedure allowing any staff member to halt a donation process in case of patient safety concerns.
OPOs are not-for-profit organizations responsible for recovering organs from deceased donors for transplantation.
The announcement comes after the New York Times on Sunday reported on premature attempts to remove organs from patients who exhibit signs of life.
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