Rules Violated in Hershey Transplant Program

By Walter F. Roche Jr.

The Milton S. Hershey Medical Center suspended its abdominal transplant program in April just weeks before a highly critical report by state inspectors who found numerous violations of transplantation rules including failure to obtain proper informed consent from patients.
The report by state Health Department surveyors found some liver and kidney transplant patients were not told prior to surgery that the organs they were about to receive were classified as high risk for failure.
Citing statements from an unnamed Hershey employee, patients themselves and hospital records, the report states that the programs' informed consent process did not ensure that patients were informed of the condition of the organ offered for transplant.
One patient told state surveyors that it wasn't until after her surgery that she was informed that her donor was considered high risk.
An unnamed Hershey employee told the surveyors he/she was aware of two cases in which the patient wasn't told the organ being donated was "high risk" The report also states that the Hershey transplant program officials failed to report to state and federal officials critical changes in staffing and a series of adverse events including the death of one organ recipient.
"The staff failed to analyze a post operative death," the report states citing a patient death on Jan. 28.
"The transplant program must conduct a thorough analysis of any documentany adverse event," the report concludes.
In a statment issued today Hershey officials stressed that the suspension of liver and kidney transplant programs was voluntary and that some corrective measures have already been put in place.
"After placing the program on hold, we engaged an experienced outside third party to conduct an extensive review of our abdominal transplant program. Both the UNOS (United Network for Organ Sharing)and external reviews determined that while our clinical outcomes have been on par with other transplant programs, we have opportunities for structural and operational improvements that will enhance the program," said Scott Gilbert, a hospital spokesman.
The state Health Department report listed five cases in which patients had to be returned to the operating room after transplants due to a series of complications including a perforated colon and misplacements of the kidneys.
Even Hershey quality control officials were left out of the loop.
"They did not come to me, however they should have," Hershey's chief quality officer told surveyors from the Health Department.
Hospital officials also failed to submit for a qualty review five of the kidney cases requiring a return to the operating room.
As for the staffing changes, the report states that at the time of the inspections one key transplant official had been fired and another was on administrative leave. Additionally another transplant official died and yet another had retired.
Another official told surveyors the termination of the transplant manager was due to multiple "derelictions of duty."
"A transplant program must notify CMS (Center for Medicare and Medicaid Services) immediately of any significant changes related to the program that could affect its compliance," the report states.
It was only a year ago that the Hershey program was cited for failing to follow transplant program rules. Last year Hershey was cited for failing to promptly inform the Organ Procurement and Transplantation Network that patients had been removed from the transplant list.
Gilbert stressed that other hospital programs have not been affected by the suspension of the abdominal transsplant program.
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