The University of Miami is searching for a new leader for South Florida’s only organ bank after the 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 “to pursue other opportunities,” according to a UM spokesman.
UM officials wouldn’t say why Goldstein left. He oversaw a dramatic increase in the numbers of solid organs recovered from local hospitals and distributed throughout the country for potentially life-saving transplant surgeries.
Dan Gelber, an attorney and former state legislator acting as a UM spokesman, issued a statement that read, in part, “Dr. Goldstein and the university have different visions for the future direction” of the agency. It is the only group licensed to recover organs in a six-county South Florida area, plus the Bahamas.
Three days after Goldstein stepped down, federal healthcare inspectors with the Centers for Medicare and Medicaid Services, or CMS, which regulates the organ bank, arrived in Miami.
CMS has made unannounced inspections of the organ bank in the past — most recently in March 2014, when the agency found that some employees were not properly trained and certified, and that UM’s medical advisory board exerted little to no oversight of operations.
Gelber wouldn’t comment on the most recent inspection from CMS. A CMS spokesperson acknowledged the visit in response to questions from The Miami Herald about leadership changes at the organ bank, which is known as an Organ Procurement Organization or OPO.
“The OPO informed the CMS team upon arrival on Monday [Sept. 28] of the change in the executive officer, effective on the Friday evening of 9/25/15,” the CMS spokesperson said in a written statement.
CMS would not divulge the reason for the inspection or any results. The South Florida organ bank, commonly referred to by its acronym, LAORA, is required by law to notify state and federal regulators of any changes in control, ownership or service area.
UM, which owns and operates LAORA, has appointed Alghidak “Sam” Salama, a physician who was previously the organ bank’s medical director, the acting executive director, Gelber said.
Goldstein’s departure is the latest in a series of key personnel changes in recent years. The agency’s former director of clinical operations was fired in August 2013, and the former medical director was asked not to return in August 2014 because — after 17 years with UM — her contract would not be renewed.
The women filed separate lawsuits in Miami-Dade circuit court alleging that a male supervisor physically struck them during a 2013 staff meeting in an attempt to silence their complaints. The lawsuits have yet to be resolved.
The former employees alleged the attacks occurred as UM administrators stepped up pressure to harvest more organs. Under Goldstein's leadership, LAORA recovered and distributed more organs for transplant surgeries than ever before.
Goldstein’s methods have drawn complaints in the past. While he was medical director for the New York Organ Donor Network, in southeastern New York, he was named in a 2012 lawsuit filed by a former employee. The suit accused Goldstein and the organ bank’s leaders of pressuring staff to aggressively pursue brain death determinations for hospital patients in order to increase donations.
Alan Livingstone, past chairman of UM’s surgery department and member of LAORA’s board of directors, said in February that the organ bank had allocated 504 organs for transplantation during Goldstein’s first year.
“It is the highest number that the OPO has ever allocated for transplantation since its inception in the 1970s,” Livingstone said at the time.
He said the organization was able to achieve that goal in part by emphasizing organ procurement by using one of two accepted standards of death: donation after cardiac death, or DCD.
“This year we’ve recovered organs from more DCD donors than ever before,” Livingstone said.
Most organs are recovered from patients declared brain dead by an attending physician not affiliated with the organ bank in order to avoid a conflict of interest.
“That’s the most common determination,” said James Bernat, a physician and brain death expert at Dartmouth University’s Geisel School of Medicine.
But a growing number of hospitals around the country are providing organs from patients who have experienced cardiac death — when their heartbeat and circulatory functions have ceased after withdrawal of life support, Bernat said.
“This is a growing percentage,” he said. “Every year it gets more.”
Bernat cautioned that the decision to withdraw life support from a patient should never force doctors and nurses into a conflicted position of either doing what’s best for the patient or potentially saving another life with that patient’s organs.
“You don’t ever want the organ donation to drive the decision to stop treatment,’’ he said. “That would be wrong.”
Yet 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.
Called reports of variance, they are LAORA’s internal system for addressing concerns and fixing errors. The reports can be triggered by a complaint from hospital staff or donor families, an error in processing an organ, or a communication problem.
The reports show that LAORA medical staff has trained some South Florida hospitals on the most effective method to withdraw life support from a potential donor in order to induce cardiac death in a manner that allows surgeons to recover more organs.
Some hospital physicians have complained about the amount of time it has taken for patients to die after withdrawal of life support, according to the reports.
Danielle Cornell, executive director of LifeQuest Organ Recovery Services, the organ bank serving North Florida, said her organization has been working with cardiac death donations since 1993 and does not train hospitals on the most effective way to withdraw life support.
“I don’t talk to critical care doctors and tell them how to pronounce death and give comfort measures,” she said. “I ask them: what do you do?”
Goldstein did not respond to repeated requests for an interview following his departure from UM. But when he spoke with the Herald in February, Goldstein denied that his staff pressured families into donation and said physicians at local hospitals could choose whether or not to participate in cardiac death cases. “We don’t want to involve anyone in the DCD process if they feel uncomfortable,” he said.
Under his leadership, Goldstein said, the rate of donations by cardiac death among South Florida hospitals had increased nine-fold — from 1 percent in 2013 to 10.4 percent as of February 2015.
At the time, Goldstein described his vision for LAORA: “Every donor, every organ, every time,” he said. “That’s how we pursue donation, that’s what CMS expects, and that’s the expectation of our donor families and recipients awaiting a lifesaving organ.”
Under his leadership, Goldstein said, the organ bank “achieved milestones” in the rate of consent for donations, registrations of potential donors, numbers of organ donors, numbers of organs transplanted and donations after cardiac death.
He characterized LAORA’s process as “consistent with the expectations of our regulatory agencies as well as higher performing OPOs around the country.”
Still, during 2014, LAORA staff members filed at least 57 reports of variance, many following complaints by hospital officials about the organ bank’s methods and behavior. Others regard errors in the documentation and packaging of organs, and a handful involve damage to organs.
UM’s Livingstone said in February that the relatively small number of variances — 57 out of 34,300 donor referrals — as well as the fact that these complaints were being reported are evidence that Goldstein fostered a culture of transparency and accountability at LAORA.