Federal regulators identified "serious deficiencies" at the UC Davis Medical Center, related to three patient deaths in 2010 and 2011. Among their findings:
The "non-standard, experimental treatments" by two neurosurgeons, Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot, resulted in "medical complications" and may have been responsible for "contributing to or causing the death of at least one patient."
Hospital leadership failed to protect overall patient safety by adequately monitoring medical staff.
Leadership failed to ensure that products obtained for patient care from an outside source were safe and effective.
The hospital did not complete a "comprehensive investigation" of the three related deaths, even though hospital policy required such a review.
Nurses, physicians, pharmacists, therapists, billing staff and others failed to identify and report the "unsafe" or "harmful" practices used by Muizelaar and Schrot to treat the brain cancer patients.
Hospital leadership sanctioned Muizelaar and Schrot but failed to "closely monitor" their subsequent activities.
UC DAVIS RESPONSE
UC Davis does not believe existing oversight and policies "were deficient in any significant respect."
Patients consented to the surgeries, which were sought to "prolong the patients' lives."
Surgeries were not "experimental," but were "innovative care."
Contends a federal finding that hospital "lacks the capacity to render adequate care to patients" is an unreasonable conclusion.
Notes that doctors were issued letters of warning after second and third surgeries.
Notes that "evidence of the effectiveness of the intervention is that to this date, 20 months following Patient 3's procedure, there has been no use of unapproved biologic material at UCDMC."
University created new policy to ensure "unapproved drugs, devices and biologics are used safely and in compliance with UCDMC policies and state and federal regulations."
Source: Findings from "complaint validation survey" conducted Aug. 27-30, 2012, by the California Department of Public Health, as requested by the federal Centers for Medicare and Medicaid Services