Rogue Docs Prove Costly To UC Davis

UC Davis Medical Center received an administrative penalty and a $50,000 fine last week from state regulators stemming from unapproved experimental surgeries two neurosurgeons performed on three patients.

Two of the patients died of massive infections shortly after receiving dosages of intestinal bacteria in their brains in order to treat globlastoma multiforme, a particularly aggressive form of brain cancer. A third patient survived the initial treatment, but required nursing home care and multiple surgeries in the weeks after, and eventually died. The treatments took place in 2010 and 2011, records show.

Although Paul Muizelaar, M.D., and Rudolph Schrott, M.D., had obtained consent from the patients, an investigation by the California Department of Public Health concluded both had ignored orders from superiors and two hospital committees to conduct further research before performing the procedure on patients. The bacteria, which is classified as a biologic, was also not approved for use by the U.S Food and Drug Administration.

Both not only ignored the warnings, but went so far as to conceal the use of the bacteria from surgical staff by referring to it as a probiotic, according to records. As a result, hospital staff was also at risk of exposure to the bacteria, according to the CDPH investigation. The hospital's safety and quality manager only became aware of the incident by reading about it in a local newspaper.

The penalty levied against UC Davis was the first involving physicians purposely disregarding hospital and other protocols when providing care, according to Debby Rogers, deputy director for the CDPH's Center for Healthcare Quality.

Muizelaar, a native of the Netherlands, practiced in California through a special waiver for foreign physicians who are academically distinguished in their home country. He resigned from the UC Davis hospital staff and university faculty on June 27, according to Davis spokesperson Bonnie Hyatt. His medical license has also been canceled, according to records from the California Medical Board. He had been on leave from UC Davis since late 2012.

Schrott will resign from the Davis medical center staff effective at the end of this month, although he will retain his faculty position with the university, Hyatt said.

Inserting bacteria into the patients' brains – intended to trigger a reaction that would cause the body's immune system to attack the patients’ tumors – drew an emergency audit by the Centers for Medicare & Medicaid Services in late 2012. 

The CMS briefly threatened to terminate UC Davis' participation in the Medicare program, but withdrew that threat after corrective actions were undertaken.

A peer review of both physicians conducted last year had discovered no issues other than a "communications problem." 

The administrative penalty and fine is the first for UC Davis, one of 10 announced by the CDPH against hospitals late last week involving incidents that placed patients in immediately jeopardy of harm or death. They were accompanied by fines totaling $675,000. The Davis penalty is among the few ever levied against a hospital for an incident involving multiple patients and deaths.

This round of penalties involved seven patient deaths, an unusually high number. Rogers said it was coincidence, and that the agency is not focusing on more severe cases.

Since the CDPH began citing hospitals for medical errors in 2007, it has levied 287 penalties, accompanied by fines totaling $11.9 million, although total collections amount to $9.5 million. Rogers said 39 penalties are currently under appeal, and hospitals do not have to pay fines before the process is completed.

The amount of fines the CDPH may levy against hospitals is expected to rise to $125,000 before the end of the year, Rogers said, when new regulations governing penalties are set to go into effect.

The other penalties and fines issued include:

• St. Jude Medical Center in Fullerton received its fifth administrative penalty and a $100,000 fine for a 2012 incident where a renal cancer patient had his healthy kidney removed by mistake.

• Marin General Hospital received its fourth administrative penalty and a $100,000 fine after a 2011 incident where a respiratory therapist and three nurses failed to adequately monitor a respirator attached to a 52-year-old patient, leading to her death.

• Memorial Medical Center in Modesto received its third penalty and a $100,000 fine for a 2011 incident where a physician was not informed of low sugar levels in a newborn. The child suffered hypoglycemic seizures as a result.

• Sharp Memorial Hospital in San Diego received its third penalty and a $75,000 fine for a 2011 incident that led to the wrong testicle nearly being removed from a patient undergoing an orchiectomy. Although the procedure was completed correctly, the patient suffered an unnecessary incision.

• Hollywood Presbyterian Medical Center received its second penalty and a $50,000 fine for an incident that occurred last year involving a 72-year-old patient who was fed solid food despite not being able to properly cough or swallow. She developed aspiration pneumonia as a result and died.

• Alta Bates Medical Center in Berkeley received its second penalty and a $50,000 fine for a 2011 incident where a cancer patient inadvertently received a nutritional supplement in a peripherally inserted central catheter line rather than her abdominal tube. The error led to her death.

• Desert Valley Hospital in Victorville received its first penalty and a $50,000 fine when an unidentified cardiologist authorized three corrective cardiac catheterizations in 2010 and 2011. The hospital was only licensed to perform such procedures diagnostically. One patient died and another required emergency open heart surgery as a result of those procedures, while a third appeared to have recovered without incident, records show. Rogers noted that the hospital has since been licensed to insert stents and perform other corrective procedures.

• Ronald Reagan UCLA Medical Center received its first penalty and a $50,000 fine stemming from a 2009 incident where a lap sponge was left in a surgical patient. The sponge was removed as part of a second surgical procedure.

• Barlow Respiratory Hospital in Los Angeles received its first penalty and a $50,000 fine when physicians were not alerted to a patient admitted last year with an irregular heart rhythm. The patient died as a result.