National organ transplant overseer takes hard stance against Penn State Health
The nation’s leading organ transplant oversight organization has declared Penn State Health Milton S. Hershey Medical Center “a member not in good standing,” its most severe action against a hospital in more than 15 years.
The Organ Procurement and Transplantation Network says the purpose of its action is to call public attention to a transplant program “that has committed a serious violation of OPTN policies or bylaws or has demonstrated a serious lapse in patient safety or quality of care.”
The action was triggered by factors including “reports of surgical complications and questions about the currency of surgical expertise, as well as a culture of retaliation for reporting potential problems,” according to OPTN.
It applies to Penn State Health’s kidney and liver transplant program, which were faulted by federal and state agencies in May for a range of problems, but not the hospital’s other organ transplant programs, which include heart and lung transplants.
Penn State Health is technically allowed to continue doing kidney and liver transplants, although it would be subject to special oversight.
However, Penn State Health voluntarily deactivated the kidney and liver transplant program in April. In deactivating the program, Penn State Health had to notify 1,100 patients of the situation, including about 200 on its waiting lists for kidney or liver transplants, and provide any help they needed in transferring to different programs.
Many have transferred to other hospitals, including some who have already received kidney transplants at UPMC Harrisburg Hospital or were put on the waiting list there. Penn State Health said it couldn’t share a timeline for resuming kidney and liver transplants.
Spokeswoman Barbara Schindo said in an email, “We are fully committed to giving people in our region the first-class abdominal transplant program they need, and we are working every day to achieve this goal.”
The OPTN took the action in September and publicly announced it in October. OPTN requires at least a nine-month period for a hospital to address its issues before it will return a program to normal status.
OPTN says Penn State Health is working with OPTN to address the problems; Penn State Heath has said it hired a third-party to help evaluate the program.
“We’ve taken significant steps to implement our action plans, including working to recruit new, worldclass transplant surgeons; making program staffing changes; and improving our quality and compliance processes,” Ms. Schindo said in response to questions from PennLive. “We have undertaken a full program review to assure regulatory compliance at all levels; and we are continuing to focus on building a positive culture within the program.”
Penn State Health’s kidney and liver transplant program was faulted in May by federal and state officials for failing to inform organizations including OPTN and Medicare of personnel changes that could impact quality of transplants. The program was further faulted for failing to analyze five instances of newly transplanted patients having to go back to the operating room or be readmitted to the hospital, and not informing two patients they were receiving high-risk organs.
Some of the problems appear staffing-related, according to publicly available inspection reports. In 2020, the department director and a transplant surgeon retired, and another transplant surgeon died.
Two more transplant surgeons began working in early 2022, with one of them also becoming the chief of the abdominal transplant division. But investigators found problems related to the credentials of the new surgeon who became program chief.
Penn State Health’s policy for granting surgical privileges requires surgeons to “demonstrate recent clinical activity in their primary area of practice during the past year.”
However, investigators said records showed the surgeon had done 29 liver transplants in 2015 and 2016, but none between July 29, 2016, and Oct. 19, 2021. The surgeon logged two more transplants on Oct. 20 and Oct. 21 of 2021. But investigators said it was “uncertain if [the surgeon] performed the two liver transplants or was present and observed them.”
The surgeon acknowledged not doing any transplants between July 2016 and October 2021 because the program where the surgeon had worked “did not have a liver transplant program,” according to the investigation report.
The surgeon told investigators of being told it required completing two liver transplants in order to be considered “current” in liver transplantation.
Based on that, the surgeon contacted a surgeon at another transplant program and arranged a four-day visit in which the surgeon “completed two liver transplants,” according to the investigation report.
Penn State Health declined to answer a question from PennLive about whether the surgeon actually did two transplants in October 2021, and whether it had known the surgeon recently went five years without doing a liver transplant.