SACRAMENTO, Calif. (AP) — An analysis of a federal investigation of the UC Davis Medical Center — conducted after the deaths of three brain surgery patients at the facility — found that hospital policies and federal regulations were violated, The Sacramento Bee http://bit.ly/108jwvS ) reported Sunday.
The 92-page report released earlier this month by the Centers for Medicare and Medicaid Services, found that besides the alleged violations, investigators found hospital staff repeatedly failed to intervene or raise questions about the unusual surgeries on the three brain cancer patients, the newspaper said.
"(T)he hospital failed to effectively govern the activities and conduct of the hospital staff to provide safe and quality care to all patients," the report by the watchdog agency said, and described the hospital's problems as "systemic failures."
The three cases involved two neurosurgeons implanting bowel bacteria into patients' brains — work that received so little scrutiny that the agency concluded all UC Davis hospital patients were at increased risk for infections and even death, The Bee said.
The Bee first reported in July that surgeons J. Paul Muizelaar, 65, the former chairman of the neurological surgery department, and Rudolph J. Schrot, 44, had begun working on a procedure to treat brain cancer patients with a novel procedure involving live bacteria.
In 2010 and 2011, three patients with deadly glioblastomas consented to have their skulls opened and intentionally infected with Enterobacter aerogenes, the bacteria commonly found in the gastrointestinal tract, the newspaper said.
Use of experimental drugs or devices in humans is tightly regulated and must undergo a rigorous review process by both the research institution and government agencies, The Bee said.