California's latest round of penalties for hospital blunders that resulted in patient harm or death includes a wrong-site surgery, feeding errors, a retained surgical object, and a number of unnecessary "emergency" coronary interventions.
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An unapproved fecal transplant research experiment in end-stage brain cancer patients in Davis, a 'time out' lapse resulting in an incision to the wrong testicle in San Diego, and a failure to connect a ventilator in Greenbrae are among the latest round of immediate jeopardy penalties for 10 California hospitals.
"In issuing these administrative penalties, our goal… is to improve the quality of healthcare in all California hospitals," Debby Rogers, deputy director for the state Department of Public Health's Center for Healthcare Quality, said at a news briefing to announce the fines last week.
"Information on incidents that led to the penalties will be used to determine how violations and deficiencies can decrease and be eliminated over time."
The department issues penalties to hospitals about four times a year. The fines are $50,000, $75,000, or $100,000 per incident, depending on whether the penalty is the hospital's first, second, or third within the last three years.
The errors, which resulted in death or other forms of harm to hospitalized patients, are as follows:
1. At the University of California Davis Medical Center, Davis, in Sacramento County, two neurosurgeons harmed three patients diagnosed with end stage glioblastoma multiforme, an aggressive brain tumor, when they experimentally implanted fecal bacteria into their brains without approvals.
According to state documents, the hospital staff and physicians failed to verify staff compliance with research safety and approval protocols, failed to follow acceptable standards of pre, intra, and post-operative surgical care, and failed to comprehensively investigate the infections that resulted from the implants, although the incidents "met the hospital's written criteria for adverse and sentinel events."
The implantation of gastrointestinal tract bacteria into the brain was intended to "create a wound infection that would attack tumor cells," the report said. But the material "had never been tested in humans" nor had the experiment received required approvals from the U.S. Food and Drug Administration or an Institutional Review Board.
The neurosurgeons and hospital staff also didn't inform the hospital's investigational pharmacy of their plans and did not properly label the material before it was taken into the operating room.
The hospital's chief patient care services officer (CPCSO) told state and federal investigators that the incidents were "not a quality of care issue" and "it is clear to me it is a research medical staff issue." The officer added "We only conduct investigations if something is wrong and there was nothing wrong."
According to the report, the fecal material caused one patient to develop encephalitis, became septic and died. A second patient required 11 months of nursing home care and additional surgeries because of increased pressure on the brain and chronic damage because of the infection. And a third patient developed seizures and sepsis, and died due to brain swelling caused by the implanted bacteria.
The hospital's chief medical officer told investigators that he had given the neurosurgeons permission to go forward with the first experiment only if they received appropriate approvals. When the doctors performed the first procedure without those approvals, issued a cease and desist order, but the surgeons went ahead anyway.
"The cumulative effect of the failures identified in this document caused, or was likely to cause, serious injury or death to the patients," the state report said.
The penalty is $50,000. This is the hospital's first administrative penalty.
2. At Memorial Medical Center, Modesto, Stanislaus County, the hospital staff's failure to notify doctors immediately when a newborn has a very low blood glucose levels resulted in a newborn suffering a tonic-clonic seizures for nearly three days after birth without appropriate care, and possibly affecting brain development.
One physician told investigators that nurses should have immediately called a doctor. "The infant probably would not have had seizures if treatment had started right away. The delay could result in the baby having long-term (e)ffects."
The penalty is $100,000. This is the hospital's third administrative penalty.
3. At Marin General Hospital, Greenbrae, in Marin County, a 52-year-old woman diagnosed with respiratory failure due to pneumonia died after staff failed to properly connect her ventilator with her endotracheal tube.
When the patient's cardiac monitor alarm sounded, alerting a nurse and a physician who "ran to the room and noted the ventilator monitor screen read, 'Waiting to be connected to patient,' which meant the ventilator was on 'stand-by' mode and was not providing breaths" to the patient. Resuscitation was unsuccessful.
State investigators faulted the hospital violating its own regulations that require reassessment and continued ongoing assessments for respiratory care, including the intubation procedure and the patient's response to those treatments.
The penalty is $100,000. This is the hospital's fourth administrative penalty.
4. At St. Jude Medical Center, Fullerton, in Orange County, a patient was admitted for cancer surgery on the right kidney when the neoplasm affected the left kidney. The error was discovered by a pathologist who notified the physician that the surgically removed kidney "was normal."
State investigators said that when the physician checked with another hospital, where the diagnostic studies were performed, a CAT scan showed a left mass consistent with renal cell carcinoma.
"This report was not a part of the patient's medical record at St. Jude medical Center, where the surgery was performed. At the time of the surgery, MD 1 (the surgeon) had the reports at his office."
According to the state report, the essential step of checking with the patient failed to prevent a wrong-side surgery. "MD 2 stated he asked the patient and the patient said the right side."
The penalty is $100,000. This is the hospital's fifth administrative penalty.
5. At Sharp Memorial Hospital, San Diego, San Diego County, surgeons
came close to removing a patient's healthy right testicle instead of the unhealthy left one, resulting in an unnecessary incision to the patient's right groin. The error was stopped when a pre-op nurse said, "Wait, it's left side."
According to the report, the surgeon stated the incision was superficial about a couple inches in length, so he closed it with a surgical adhesive bond.
"The surgeon acknowledged that, 'it was our job to concentrate at that moment and we didn't. Everybody heard, but didn't listen.' "
The report said that the hospital's surgical team failed to follow its own policies, which say that patients "may not be transferred to an operating room or given anesthesia until the planned site/side has been verified and initialed by the surgeon," that "the anesthesiologist, scrub person and circulating RN will verbally and visually confirm patient identity, correct procedure, correct surgical site and review consent."
The team also failed to perform an appropriate 'Time Out,' during which "the entire team must pause and focus their attention to verify the correct patient, the correct procedure and the correct side/site is initialed," according to the state report.
The penalty is $75,000. This is the hospital's third administrative penalty.
6. At Hollywood Presbyterian Medical Center, Los Angeles, Los Angeles
County, staff failed to implement its policies to refrain from feeding a stroke patient who was not able to cough on command and lacked swallowing reflex.
The patient, a 72-year-old female, came to the emergency room unable to talk or move, and a physician's exam determined she had "spasticity [stiffness/tightness] of the left side of her body, hemiparalysis [paralysis on one side of body] of the right side of the body."
According to the state report, a physician documented that despite the patient's inability to swallow, "Apparently, the patient was being fed and became hypoxic, respiratory failure and needed to be intubated last night." The patient had respiratory failure…most likely aspiration pneumonia..."
An interim chief nursing officer relayed to investigators that an employee "had fed the patient… (and) should not have fed the patient base on the facility's policy on swallowing screen assessment." The patient died.
The penalty is $50,000. This is the hospital's second administrative penalty.
7. At Desert Valley Hospital, Victorville, San Bernardino County, interventional cardiologists performed "emergency" coronary interventions such as stent placement and carotid angiograms, on patients contrary to the hospital's license, which requires that only patients with acute myocardial infarction or with hemodynamic instability or chest pain could undergo such procedures.
"According to the medical record, Patient 2, Patient 1, and Patient 3 did not present with a acute MI or hemodynamic instability or chest pain refractory [not responding] to medical treatment prior to having an intervention in the cardiac cath lab," the state report said.
For one of the three, a patient who had come to the hospital for an outpatient coronary angiogram and did not have pain, doctors placed a stent in the left anterior descending artery. "Subsequently, at 3:29 pm, patient 3 complained of chest pain, had a decrease in heart rate, then became hypotensive and was the subject of a code blue…Staff was unable to resuscitate the patient, who expired," state investigators said.
The penalty is $50,000. This is the hospital's first administrative penalty.
8. At Alta Bates Summit Medical Center, Oakland, in Alameda County, a patient died from a pulmonary embolus after a nurse mistakenly administered a feeding formula (Glucerna) into the patient's peripherally inserted central catheter (PICC) instead of the instead of a TPN (total parenteral nutrition) mixture.
According to the state report, a code blue was called. Afterwards, another nurse asked the administering nurse "what fluids she administered into Patient 1's PICC prior to the Code Blue and (the first nurse) responded, 'Just the TPN.' "
The inquiring nurse told investigators that the administering nurse "got a 'deer in the headlights look' when she told (the nurse) that the solution was not TPN but an enteral feeding formula [Glucerna]. She stated that (the nurse) 'immediately took the bottle of feeding formula [Glucerna] and the tubing off the pump and threw it in the trash. ' "
The penalty is $50,000. This is the hospital's second administrative penalty.
9. At Barlow Respiratory Hospital, Los Angeles, in Los Angeles County, a patient died after staff failed to notify physicians that he was having repeated episodes of abnormal cardiac electrical signals.
"When a patient experiences runs of VTACH [ventricular tachycardia], the patient should be assessed and the patient's physician should be notified."
A nurse "stated she entered the room and found the patient 'scratching on his chest' and 'became unresponsive.' According to (another nurse), she was not told of any arrhythmias or runs of VTAC? prior to the incident where she went into the patient's room." Despite medications, defibrillator shocks, and CPR, the patient was pronounced dead.
The penalty is $50,000. This is the hospital's first administrative penalty.
10. At Ronald Reagan UCLA Medical Center, Los Angeles, in Los Angeles County, a patient who underwent surgery to remove the gall bladder and pancreatic tumor resection had to undergo a second surgery to remove a forgotten lap sponge.
According to state investigators, the operating room record indicated that
sponge counts were correct.
"However, according to the discharge summary, on the fourth post-operative day, a Gastrogaffin study [swallowing of contrast followed by an x-ray] was done to assess for duodenal leak…, which did not show any leak. Instead, the study showed the ribbon-like structures in the left lower abdominal."
The penalty is $50,000. This is the hospital's first administrative penalty.
Higher Fines Pending
New regulations in the works will raise the maximum penalty to $125,000, says Debby Rogers of California's Department of Public Health's Center for Healthcare Quality. Since the penalties began in 2007, the state has issued 286 penalties to155 of the state's 450 acute care facilities.