University of Miami organ bank fails to meet regulatory requirements

A national board that oversees policies and practices for organ transplants has declared South Florida’s only organ bank a “Member Not in Good Standing,” meaning the organ bank has committed a serious violation of policies or a serious lapse in patient safety or quality of care.

The Life Alliance Organ Recovery Agency, owned and operated by the University of Miami, now must take corrective actions, including monthly reports to regulatory officials and unannounced visits, according to people familiar with the organ bank.

Federal regulators said the designation was the result of a peer review process that identified concerns including management practices, staff training and collaboration with transplant hospitals in South Florida.

The organ bank known as LAORA is the only organization federally licensed to procure and distribute solid organs for transplantation in a six-county South Florida area and the Bahamas. Its role is to recover organs from donor patients at South Florida hospitals and to distribute the organs throughout the country for potentially life-saving transplant surgeries.

Alghidak “Sam” Salama, a physician and interim executive director of LAORA, issued a written statement that downplayed the designation as a “recommendation.”

“The leadership of the Life Alliance Organ Recovery Agency (LAORA) is committed to saving lives through organ donation and transplantation,” Salama wrote. “LAORA appreciates the recommendations... and will continue to work with donor hospitals and transplant centers throughout the designated service area to provide the gift of life to as many people as possible.”

While the designation is not the result of a patient death or other so-called “sentinel event,” it is more than a recommendation, according to the United Network for Organ Sharing, or UNOS, a nonprofit organization that coordinates organ donation under a contract with the federal government.

UNOS oversees the Organ Procurement and Transplantation Network, a panel of medical professionals, transplant recipients and donor families that develop national organ transplantation policy, and which recommended the action against the South Florida organ bank.

According to UNOS, the designation means the organ bank “failed to meet key expectations for compliance... It could also apply to a member with a current situation that could pose a risk to the health and safety of transplant patients, living donors or other members of the public.”

UNOS could not provide a more detailed explanation because the organization does not divulge facts and circumstances from confidential medical peer reviews, said Joel Newman, a UNOS spokesman.

But in an announcement on UNOS’ website, the group says the change in designation came after an on-site visit by federal regulators in June.

The designation comes during a period when LAORA has been the subject of lawsuits by former employees alleging a hostile work environment and repeated visits from federal healthcare officials.

Most recently, the organ bank’s executive director stepped down over differences with university administrators — days before federal regulators conducted an unannounced inspection.

Michael Goldstein, a surgeon hired in February 2014 to lead the kidney transplant program at the Miami Transplant Institute and to serve as director of the Life Alliance Organ Recovery Agency, left the university Sept. 25.

Goldstein stepped down despite overseeing a dramatic increase in the numbers of solid organs recovered from local hospitals and distributed throughout the country for potentially life-saving transplant surgeries.

But doctors and nurses at some of the 81 South Florida hospitals where LAORA recovers organs have complained of the agency’s aggressive procurement methods under Goldstein’s tenure, including allegations that the agency’s staff pressured family members to consent to donations, according to internal reports obtained by the Herald.

An attorney representing Goldstein issued a written statement on Friday expressing his support for the organ bank and stating, in part, “I believe they will continue to make improvements to further their mission and provide outstanding community service.”

This story was originally published December 4, 2015 at 12:48 PM with the headline "University of Miami organ bank fails to meet regulatory requirements."