Perhaps you didn't hear the news, but the dastardly pharmaceutical companies of the Bay Area did business dealing with the old Soviet Union's government in Germany, a mysterious region during the cold war otherwise known as the "East Germany". The business deal between the old East German government and the pharmaceutical companies was that there would be made available prisoners in old East Germany for medical testing otherwise illegal in the United States or Western Europe.
But it's ok. the News has been embedded in our Bay Area since time before the Great War of 1898, with the ties that bind between "medical" companies, prisons and universities...
2012-12-11 "Feds inspect UCD Medical Center in probe of questionable neurosurgeries" by Marjie Lundstrom and Sam Stanton from "Sacramento Bee"
A team of eight inspectors arrived unannounced Monday for a floor-by-floor survey of the UC Davis Medical Center, part of a widening probe of the hospital over untested surgical procedures performed by two neurosurgeons on three terminally ill patients who later died.
The team, sent by the federal Centers for Medicare & Medicaid Services, arrived to conduct a "full validation survey" on all 22 conditions the hospital must meet to continue participating in the Medicare and Medicaid programs, according to an internal memo posted Monday to medical staff.
"As always with these kinds of visits, the surveyors will conduct a floor-by-floor inspection of our facilities, examine documents – including medical records, policies and procedures – and interview faculty, staff and patients," said the memo from Ann Madden Rice, the hospital's CEO.
The inspection team from the California Department of Public Health was sent into the 619-bed hospital at the behest of the federal watchdog agency, the second time in four months. Their work is expected to continue at least through the week.
Monday's unannounced visit comes just three days after the public release of a blistering report by the Centers for Medicare & Medicaid Services, or CMS, that questioned whether the medical center had the ability to "render adequate care to patients."
UC Davis officials have rejected some of the report's toughest findings, and Rice said in an interview Friday that the hospital is "providing excellent patient care."
Rice said that the UC Davis Health System receives consistently high marks based on a variety of databases, national benchmarks and other health care indicators.
Just last week, the school announced that UC Davis Medical Center ranked among the Leapfrog Group's list of top hospitals for 2012, according to a university news release about the national survey. The Leapfrog Group, a nonprofit coalition of some of the nation's largest employers and health care purchasers, recognized 89 hospitals for their "exceptional performance in critical areas of patient safety and quality," the announcement stated.
"Our read of our performance is that we're providing high-quality care," Rice told The Bee.
The federal agency's harsh and sweeping assessment stemmed from its August investigation of a complaint regarding the neurosurgeons' untested treatments of three dying brain cancer patients.
The report questioned whether the surgeons – 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."
All three patients, who had deadly glioblastomas, gave their consent in 2010 and 2011 to have Muizelaar and Schrot open their skulls and introduce bacteria into the wounds. The doctors theorized that a postoperative infection might trigger an immune response that could prolong their lives.
Two of the patients developed sepsis and died shortly after their surgeries; the third lived about a year after the operation.
The CMS report labeled the doctors' surgeries as "non-standard, experimental treatments" and found that hospital officials failed to monitor the surgeons' activities.
Investigators said that the bacteria used to contaminate the patients came from "a type of live bowel bacteria" that was brought to the hospital in a Styrofoam cooler from "a university campus animal research laboratory," according to the report.
Hospital managers conceded to investigators that there was no oversight of how the material was brought into the operating room and that the bacteria was "not approved for use in humans."
The university redacted some portions of the report before releasing it to The Bee on Friday. But portions left intact show that investigators had concerns about how the hospital's leadership responded to the surgeries, and that Muizelaar planned on trying his theory out on five more patients before he was halted.
The report also found that a review panel decided in August 2011 that Muizelaar could continue to practice at the hospital despite "more than 200 patient complaints and misconduct and competence concerns by other medical staff members."
Steven Chickering, a CMS official based in San Francisco, said Monday the new unannounced survey is intended to ensure that "all systems are as they should be."
"Most hospitals take this process very seriously, taking the necessary steps and corrective measures to come back into compliance," said Chickering, noting that the federal agency rarely has to follow through on its drastic threat to yank a hospital's Medicare and Medicaid funding.
In fiscal 2012, UC Davis received $275 million in revenue from Medicare, or about 20 percent of its total revenue of $1.3 billion, according to Bonnie Hyatt, spokeswoman for UC Davis Health System.
Muizelaar, once the head of the neurological surgery department, took a leave of absence last week from providing patient care. The dean of the medical school, Dr. Claire Pomeroy, announced her resignation last month.
University officials say that Muizelaar opted to take a leave of absence after a "peer review" was launched into four recent malpractice claims involving his patients. Hyatt explained that university policy requires such an audit when a physician has three or more malpractice claims in a rolling 12-month period.
The four malpractice claims that triggered Muizelaar's review include three lawsuits filed in the last six months in Sacramento Superior Court, plus a fourth "notice of intent" to file suit, according to Hyatt.
All three lawsuits were filed by the same Sacramento law firm, Poswall, White & Cutler. None was filed on behalf of Patients 1, 2 and 3, who have not been identified by the university to protect patient privacy. And, none of the most recent malpractice suits involved bacteria and intentional wound-contamination surgeries.
In one lawsuit filed in September, a woman claims she received an injection from Muizelaar to relieve "significant head pain" from a car accident years earlier and wound up losing her left eye, said her attorney, Jennifer Cutler.
Cutler filed another suit in June involving one of Muizelaar's patients. That lawsuit alleges that Muizelaar performed head surgery on a man that resulted in complications, including "excruciating pain and symptoms." The man required an additional surgery by a different physician that resulted in an infection and the need for a third surgery, according to the lawsuit.
A third lawsuit filed in September claims that Muizelaar performed surgery on a boy that resulted in brain damage, said the attorney, R. Parker White.
Years earlier, White handled two other malpractice cases in which Muizelaar was the surgeon. Those lawsuits resulted in settlements totaling about $500,000, according to White and court documents.