In a scathing review of three experimental surgeries at the UC Davis Medical Center, federal regulators found that deficiencies were so severe the 619-bed hospital "lacks the capacity to render adequate care to patients."
The 92-page report from investigators for the Centers for Medicare and Medicaid Services concluded that hospital administrators repeatedly failed to rein in the activities of two UC Davis neurosurgeons, who performed untested treatments on three critically ill brain cancer patients.
Additionally, medical staff were kept in the dark about the doctors' work or failed to follow hospital policies and professional standards, the report stated.
"These failures put all surgical patients at risk for injury and harm, including death," the report stated.
The federal watchdog agency went so far as to say the neurosurgeons, Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot, may have been responsible for "contributing to or causing the death of at least one patient."
UC Davis officials rejected some of the investigators' harshest findings, responding in their "plan of correction" that the agency's findings were incorrect in some areas and that the medical center already had taken steps to correct problems.
"We're confident we're providing excellent patient care," said Ann Madden Rice, the medical center's chief executive officer.
In an interview Friday, Rice told The Bee that some hospital policies "could have been stronger and could have been clearer" at the time of the controversial surgeries.
As a result, she said, the university has developed a comprehensive new policy regarding "innovative care" to help medical staff "minimize the potential risk to both patients and physicians."
Innovative care is defined as a treatment or medication given to a patient that "departs in a significant way from standard or accepted medical practice," according to the university's correction plan.
Much of the current controversy stems from the fact that some regulators have interpreted the surgeons' acts as unauthorized research on human subjects – an explosive issue in research settings.
In its response, UC Davis rebuts the notion that the surgeries were experimental or constituted research, writing that "all of these surgical cases were physician-driven efforts to prolong the patients' lives."
"The care was innovative and non-standard, not experimental," the university wrote.
But university officials have acknowledged for more than a year now that the neurosurgeons failed to get proper approval for their unusual work. As a result, both doctors were banned last year from performing any research involving human subjects, and the university's vice chancellor for research reported the doctors' "serious and continuing noncompliance" to the U.S. Food and Drug Administration.
The report released Friday is the latest fallout in a scandal that has engulfed both neurosurgeons as well as nursing and operating room staff, lab assistants, fellow doctors and top-level administrators at the medical center.
Muizelaar, the lead physician and former chairman of the neurological surgery department, has taken a leave of absence from providing patient care, the university announced Thursday. The dean of the School of Medicine, Dr. Claire Pomeroy, announced her resignation last month.
Federal investigators have warned that the hospital could lose its Medicare funding if the corrective plan is unacceptable or the medical center fails to make promised changes. However, both sides acknowledge that scenario is unlikely.
"But if there is continuing noncompliance, that certainly is a potential implication," said Rufus Arther, CMS' director of hospital operations for Region 9, based in San Francisco. The investigation was conducted in August by the California Department of Public Health, at the behest of the federal agency.
Investigators focused their attention on the treatments in 2010 and 2011 of three terminally ill patients, who agreed to allow the doctors to open their skulls and intentionally introduce bacteria into the wounds. Muizelaar and Schrot theorized that a postoperative infection might trigger an immune response and prolong their lives.
Two of the patients quickly developed sepsis and died; a third lived about a year after the wound-infection surgery.
The CMS report concluded that the "non-standard, experimental treatments" had resulted in "medical complications and the need for medical interventions," and may have contributed or caused the death of the third patient.
That patient, documents show, was newly diagnosed with a deadly glioblastoma and went directly to the wound-infection surgery in March 2011 without undergoing the standard treatment of chemotherapy and radiation.
All three patients gave their consent for the procedures, although regulators and medical ethicists have questioned whether they were adequately informed or even able to make an informed decision.
The documents show that medical staff had varying degrees of knowledge about the doctors' work. For instance, the report raises questions about whether the nursing teams or the operating room manager even knew that bacteria was being brought in for the surgeries.
"Although he (the operating room manager) was concerned that something was brought into the OR without his knowledge, he did not conduct an internal investigation," the report stated.
Federal investigators determined that for each surgery "a type of live bowel bacteria (biologic material) from a university campus animal research laboratory" was brought to the hospital in a Styrofoam cooler by a research assistant at the request of one of the doctors.
"The original product was labeled for animal use, and was not approved for use in humans," the report stated.
A medical center official later conceded to investigators that "there was no safety oversight for how the biologic material was obtained and brought into the hospital," the report stated.
Officials disputed some findings regarding the bacteria, saying the material was not stored in a lab that conducts animal research and that "the process was safe and in conformance with regulatory and professional standards for microbiologic products."
Many portions of the report involving the patients' treatments were redacted by the university. But the findings show that Muizelaar told investigators "there was no post operative plan to determine the circumstances to rescue each patient from life-threatening, adverse effects of the treatment."
"How did you know how much bacteria to implant?" investigators asked him. "We did not know," Muizelaar responded, according to the report. "(T)he solution had slight smell of feces."
"We told the nursing staff we were going to do this (in the OR), and what it would do. It went against all OR rules," Muizelaar reportedly said.
Muizelaar was told by a hospital official before operating on the first patient that he needed to perform specific tasks, including an ethics consultation and planning with the family for possible complications and payment obligations. The surgeon failed to do so, the report said. After that lapse, he was warned "not to perform the treatment on any other hospital patients" until proper approval was received, the federal report states. Despite that, he went ahead with two other surgeries.
During the third patient's hospitalization, the chief medical officer learned Muizelaar "planned on performing the experimental surgery on an additional five patients," the report found.
At that point, both doctors were ordered to cease and desist and were later reprimanded.
A university leadership committee agreed in August 2011 to allow Muizelaar to continue practicing at the hospital, even after "reviewing more than 200 patient complaints and misconduct and competence concerns by other medical staff members," the federal report found.
Rice said Friday that Muizelaar opted to begin a leave of absence this week while his peers examine four new malpractice cases involving patients under his care.
Rice said the university's correction plan includes numerous reforms, including a tightening of procedures involving the use and handling of biologic agents. Staff communication and training efforts also are being improved, she said.
The next step will be an unannounced visit by investigators to assess the hospital's compliance, said Arther, the CMS official based in San Francisco. Arther said he could not provide a timetable.