UC Davis doctors' actions spur investigation by accrediting agency
11/10/2012 12:00 AM
10/06/2014 3:01 PM
The controversial activities of two UC Davis neurosurgeons have triggered another investigation into patient safety and care at the university hospital, this time by the independent, nonprofit body that accredits hospitals nationwide, The Bee has learned.
An investigator with the Joint Commission arrived unannounced at the medical center this week to interview staff about the work of Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot.
The Joint Commission, whose accreditation decisions are a critical lifeline for any hospital, is at least the fourth body to investigate the surgeons in the last 18 months.
Muizelaar and Schrot, faculty members in the UC Davis neurological surgery department, were banned by the university last year from performing any further research involving human subjects.
The unusual ban followed a six-month internal probe, which determined the doctors had conducted experimental treatments in 2010 and 2011 on three dying brain cancer patients without proper approval from the university or federal regulators.
Since UC Davis reported the doctors' "serious and continuing noncompliance" to the U.S. Food and Drug Administration – and The Bee reported those findings in July – the university's chancellor and the federal Centers for Medicare and Medicaid Services have initiated investigations.
Bonnie Hyatt, spokeswoman for the UC Davis Health System, said the Joint Commission surveyor closely examined the three neurosurgical patients' cases.
"It was quite rigorous, and we provided everything he needed," she said.
The investigations into the neurosurgeons' activities have evoked concern by some bioethicists. Use of humans to test experimental drugs or procedures is tightly controlled to prevent subjects from being harmed or exploited.
Muizelaar, 65, the former department chairman, and Schrot, 44, obtained consent from three patients with deadly glioblastomas to open their skulls and intentionally infect them with bacteria, according to university documents. The doctors theorized that a postoperative infection might stimulate the immune system and prolong the lives of such patients, who typically survive only about 15 months after diagnosis.
Two of the three patients developed sepsis and died several weeks after their procedures in 2010 and 2011, university documents reveal. A third patient lived for some months but also has since died, Muizelaar told The Bee in July.
Both doctors have said their problems stem from a misunderstanding, and that they believed they had the official go-ahead to perform what they described as "innovative treatment" on their three gravely ill patients.
A spokesman for the Illinois-based Joint Commission said Friday it conducted a "for-cause, on-site survey" this week at the UC Davis Medical Center, based on a complaint received by the organization. Spokesman Bret Coons said that complaints can originate with federal or state agencies, media reports, a patient, the hospital or others, and the source is kept confidential.
Coons said the survey is done in cases where "we have a reason to go in and look at the organization's compliance with our standards."
The Joint Commission, formerly known as the Joint Commission on Accreditation of Healthcare Organizations, accredits and certifies more than 19,000 hospitals and health care programs in the country.
The last time the UC Davis Medical Center underwent a full survey and was awarded accreditation was in June 2010, commission reports show. According to the organization's procedures, UC Davis would have expected its next full accreditation survey within 36 months.
Coons said he could not disclose whether the commission is specifically investigating Muizelaar and Schrot, but the university confirmed that they were the focus.
Based on the findings, the commission could alter or even revoke a hospital's accreditation status.
In addition to this inquiry, the Centers for Medicare and Medicaid Services recently completed its probe. The federal watchdog agency asked the California Department of Public Health this fall to assist in a review of the care provided to Muizelaar's and Schrot's patients. Findings are expected to be released soon.
In July, UC Davis Chancellor Linda P.B. Katehi also ordered a top-level "comprehensive review" of the matter. Findings from that investigation, being led by Ralph J. Hexter, the university's provost and executive vice chancellor, are expected "in the relatively near term," said UC Davis spokesman Barry Shiller.
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