The U.S. Department of Health and Human Services (HHS) is decertifying organ procurement organization (OPO) Network for Hope, HHS Secretary Robert F. Kennedy Jr. announced in a Wednesday press conference.
Kennedy said the decision was made after “extensive reviews” from the U.S. Centers for Medicare and Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA) “found persistent patient safety failures” after repeated warnings and corrective action plans.
“Federal reviewers found serious deficiencies in nearly 30% of the cases that they examined,” Kennedy said. “We found patients placed on the organ donation pathway who should have never been there. We found cases in which the donation process continued despite signs that patients were not appropriate organ donors. We found repeated failures in clinical judgment, oversight, and patient safety, and we found that these problems continued even after the organization promised to correct them.”
The Network for Hope, a federally funded OPO, serves Kentucky as well as parts of Indiana, Ohio and Virginia.
HRSA Administrator Tom Engels said care will still be offered to patients served by the organization. “We will closely monitor them throughout this process as CMS goes through a process to replace the organizations here,” he added.
Moreover, an Aug. 5 press release said that, in addition to the CMS findings, HRSA reviewed 351 cases in which organ donations were authorized but not completed at the organization. It found 103 cases showed “concerning features” and some potential donors may not have been dead at the time of organ procurement.
In September, the agency announced it would decertify Life Alliance Organ Recovery Agency, a division of the University of Miami Health System.
HHS announced a “major initiative” to overhaul the U.S. organ transplant system last July, following a graphic report that detailed a patient taken off life support and declared dead. The patient’s heart and respiratory systems were found to still be active after surgeons had made an incision to secure her organs for donation.
HRSA directed the OPTN to implement a comprehensive corrective action plan and a monitoring program for Network of Hope after uncovering the patient safety concerns, per the press release.
It built on Congressional and Biden administration-era work on reforming the Organ Procurement and Transplantation Network (OPTN).
Kennedy has also directed all OPOs to appoint an OPTN Patient Safety Officer to oversee patient safety, according to the press release.
Network for Hope CEO Barry Massa told Fierce Healthcare in an emailed statement the organization "strongly disagrees with Secretary Kennedy’s decision" and will appeal it.
"NFH is compliant with all OPTN policies and has implemented a first-of-its-kind “pause in procedure” process," Massa said. "This pause process is now Kentucky law and NFH proudly worked hand-in-hand with legislators and regulators by providing input in the drafting both of the new law and its implementing regulations. Despite this, and despite NFH’s demonstrated dedication to improving organ and tissue donation outcomes across its service area, Secretary Kennedy has acted to decertify our OPO that serves seven million people across four states. Under HRSA's oversight, organ donation went down for the first time in 14 years. As a result, more than 3,000 people waiting for a life-saving organ transplant will be negatively impacted by the decision announced today."