The Department of Health and Human Services decertified a Kentucky organ procurement organization on Aug. 5, stripping it of federal authority to recover and allocate donated organs after it failed to meet federal performance standards.
Federal decertification of an organ procurement organization is a rare and severe enforcement action with immediate consequences for transplant access in the affected region, according to HHS.
Transplant patients in Kentucky’s service area will be redirected to other certified organ procurement organizations during the transition period, HHS said. The agency is working to ensure continuity of organ recovery services to minimize disruption to patients on transplant waiting lists.
More than 100,000 Americans are currently on organ transplant waiting lists nationwide, and thousands die each year while waiting for a transplant, according to federal data. Any disruption to organ recovery operations in a service area can directly affect the supply of transplantable organs available to patients whose survival depends on timely transplants.
The action reflects HHS’s ongoing effort to reform the U.S. organ procurement system, which critics have argued fails to maximize organ recovery rates from eligible donors. Studies have found significant performance variation among the nation’s organ procurement organizations, with some recovering far fewer organs than their donor potential suggests.
Decertification is the most severe enforcement tool available to HHS for addressing organ procurement organization failures. The department has historically been reluctant to use the authority, making the Kentucky action notable.
HHS said the decertification was based on documented performance deficiencies and serves as a signal that the federal government will hold organ procurement organizations accountable for meeting established performance metrics.