Nurses weren't told what was going on in the operating room. Top hospital leaders were kept in the dark, or avoided asking questions. Hospital policies and federal regulations were violated.
These are the stark conclusions of a widening federal probe of the UC Davis Medical Center and the deaths of three patients.
Investigators found hospital staff repeatedly failed to intervene or raise questions about three highly unusual surgeries on brain cancer patients, according to a Bee analysis of the findings, released earlier this month by the Centers for Medicare and Medicaid Services.
In its 92-page report, the federal watchdog agency detailed the secrecy and inaction that enveloped the "non-standard, experimental treatments."
Virtually everyone interviewed at the hospital – from scrub nurses to pharmacists to top leadership – trusted their doctors to follow proper procedures, then failed to step in when they did not, investigators reported.
"I'm not sure what we could have done differently," the operating room manager told investigators during interviews in August, a refrain echoed by others. "We trusted our surgeons."
The three cases, which involved two neurosurgeons implanting bowel bacteria into patients' brains, received so little scrutiny that the agency concluded all UC Davis hospital patients were at increased risk for infections and even death.
"(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 stated, describing the hospital's problems as "systemic failures."
University officials have rejected that sweeping assessment and have offered strong assurances that patient care at the medical center remains "excellent." The university has submitted a corrective plan to federal regulators to avert any loss of federal funding.
The controversy centers around the work of Dr. J. Paul Muizelaar, 65, the former chairman of the neurological surgery department, and his protégé, Dr. Rudolph J. Schrot, 44.
Both maintain their posts at the medical center, although Muizelaar recently took a leave of absence from clinical work while the most recent malpractice claims involving him are reviewed.
As first reported by The Bee in July, Muizelaar and Schrot had embarked on a quest four years ago 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.
Use of experimental drugs or devices in human beings is tightly regulated and must undergo a rigorous review process by both the research institution and government agencies.
The UC Davis neurosurgeons are accused of sidestepping those processes with their "probiotic intracranial therapy," an untested procedure based on their theory that postoperative infections might stimulate patients' immune systems and prolong their lives. The bacteria, though, were not approved for use in humans and had been purchased for the doctors' study involving lab rats, according to university and federal documents.
Only after the third patient was treated in March 2011 – and died 14 days later of sepsis, a severe bodily reaction to infection – did the university order the neurosurgeons to "cease and desist."
The university has not identified the three patients, but The Bee has learned that at least two of the families are pursuing legal action over their loved ones' unsuccessful treatments. Those families have not agreed to speak publicly about their cases.
A hospital in the dark
The patients' unorthodox treatments might have remained an internal matter for the university if not for a complaint received by the Centers for Medicare and Medicaid Services. The agency regulates health care facilities and controls Medicare and other federal funding.
In late August, a team of investigators from the California Department of Public Health descended on the hospital at the request of the federal agency. A team returned to the hospital earlier this month for a survey of the entire hospital operation.
In their Aug. 27-30 review of medical records and interviews with at least 27 doctors, nurses and hospital officials, investigators identified numerous instances of irregularities that should have been reported but were not.
Investigators eventually concluded that "multiple staff and leaders" were unwilling or unable to report the "unsafe care practices" involved in the three patients' cases.
In some cases, investigators determined, key hospital decision-makers were simply kept out of the loop. For instance, the neurosurgery resource nurse – whose job included working with doctors on new procedures – was unaware of the three cases because two of the patients were "add-ons" to the surgery schedule, thus circumventing his involvement. The other patient's surgery information made no mention of the bacteria and escaped his notice, investigators found.
The actions and inactions of hospital staff are spelled out in an unredacted version of the report released to The Bee by federal officials. UC Davis previously had provided a version that had been redacted, shielding some details about the patients and their care.
Among the regulators' findings:
The operating room manager said he did not know about live bacteria in the surgical suite until he was told later by the risk management office. Although "concerned," he said, he did not conduct an internal investigation.
At least four nurses involved with the surgeries said they couldn't recall getting any information about "probiotics" or the wound-contaminating procedures. The chief of nursing services told investigators there was no need for the nurses to question the procedures because "nurses are not 'whistle-blowers.' "
The hospital's infection prevention manager did not know about the three cases until she read about them in the newspaper more than a year later. She told investigators she "hoped" the operating rooms had been appropriately cleaned afterward, and that it was "unlikely we would have approved" the bringing of live bacteria into the hospital.
The pharmacy director told investigators that use of an unapproved bacterial biologic "could conceivably be reported as a (medication) error," but that he had not initiated any investigation into the matter.
Muizelaar said he had "no meaningful data" to support his work, and that his actions "went against all OR (operating room) rules." He told investigators he did not give the nursing staff any instructions regarding disposal of the bacteria at the end of the surgeries.
The hospital attorney said she heard about plans for the first surgery when she was copied into an email seeking feedback on patient consent. "I was asked to weigh in myself, but didn't respond," the top lawyer told investigators.
A culture unchallenged
John R. Griffith, a University of Michigan professor who wrote a definitive textbook on health care management, said the medical staff's apparent unwillingness to question the neurosurgeons is not uncommon.
"These neurosurgeons walk into cases where they know half their patients will die, and they pick up the knife and try to come out the right side," he said. "They obviously command a fair amount of respect.
"So the classic response in almost every situation would be, 'Yes, doctor.' That's maybe not what should be, but that's a realistic picture of what is – and it's not just UC Davis."
Griffith, who teaches at the University of Michigan School of Public Health, said the more serious issue facing the medical center is its alleged failure to adequately monitor the doctors' work – and the outcomes – to head off further harm to patients.
"They could have and should have known about it sooner and done something about it sooner," he said.
The federal agency's harsh report marks another tumultuous chapter for the 619-bed public hospital along Stockton Boulevard.
In November, Dr. Claire Pomeroy, dean of the UC Davis School of Medicine, announced she would be stepping down. Her boss, UC Davis Chancellor Linda P.B. Katehi, made no link between Pomeroy's departure and the investigation into the neurosurgeons, and praised Pomeroy for her "many contributions."
However, the federal watchdog agency came down hard on Pomeroy, stating that she and other top leaders had failed to hold medical staff accountable – and had thus placed all patients at increased risk.
In her interview with investigators, Pomeroy "acknowledged there had been no evaluation of the system that failed," according to the report.
The university banned both doctors last year from performing any research involving human subjects. In October 2011, the university's vice chancellor for research reported the surgeons' "serious and continuing noncompliance" to the U.S. Food and Drug Administration.
Now, more than a year later, medical center officials are adamant that Muizelaar and Schrot never engaged in unapproved research. Instead, the university contends, the surgeons were providing "innovative treatment" to try to save three terminally ill patients, all of whom consented to the procedures.
"While we agree that the surgeons did not obtain appropriate approvals from the Institutional Review Board and/or Medical Staff for the second and third cases, we also believe that all of these surgical cases were physician-driven efforts to prolong the patients' lives," the university said in a response to the report.
UC Davis added that the investigators "did not seem to understand the nature of innovative and compassionate care, which is that it typically involves the use of non-standard, non-approved materials that do not fit the mold of standard, approved therapies."
Stakes for UC Davis
Ann Madden Rice, the medical center's chief executive officer, told The Bee earlier this month that some of the agency's findings were inaccurate – especially its sweeping assessment about overall patient care.
"We're confident we're providing excellent patient care," she said.
But Rice, who was interviewed by investigators in August, also noted, "We think we can always get better."
The stakes are high for UC Davis, as the federal agency has threatened to cut off federal funding if the "serious deficiencies" aren't addressed.
While both sides say that is unlikely, the threat became reality for Martin Luther King Jr./Harbor Hospital in Los Angeles. The hospital was forced to close in 2007 after the federal agency withdrew its funding due to a series of failed inspections.
Last month, UC Davis submitted a 141-page plan of correction for how it plans to address the federal agency's concerns about its hospital.
While the university did not specifically address the futures of Muizelaar and Schrot, investigators found that discipline of the doctors had been spotty and inconsistent, according to the report.
For instance, Muizelaar and Schrot were "reprimanded" in March 2011 after a medical staff peer review committee determined they had "performed a non-standard, experimental treatment on 3 patients after being warned not to," the documents show.
The peer review committee ultimately found that the neurosurgeons had "violated hospital policies and federal safety regulations for use of a non-approved biologic material." However, no formal disciplinary action was taken, and Muizelaar's faculty reappointment and renewal of clinical privileges were approved by a credentials committee in August 2011.
In a one-hour meeting in November 2011, a committee of top leaders reviewed more than 200 patient complaints and competency concerns raised by other medical staff regarding Muizelaar.
"No action plan was documented," the report stated, noting that no plans were made to monitor Muizelaar's and Schrot's activities to "verify compliance."
The California Department of Public Health recently completed a full hospital survey on behalf of the feds, and a new report is expected soon. Federal officials said this more recent floor-by-floor survey was intended to look beyond the three brain cancer patients' cases.
"When we go into a facility, we don't go in with blinders on," said Rufus Arther, the Centers for Medicare and Medicaid Services director of hospital operations for Region 9, based in San Francisco.