$25,000 PENALTY FOR KAISER'S DRUG ERROR By Barbara Feder Ostrov  
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Kaiser-Santa Clara hospital fined after baby's death

$25,000 PENALTY FOR KAISER'S DRUG ERROR
By Barbara Feder Ostrov
Mercury News
San Jose Mercury News

Kaiser-Santa Clara hospital was fined $25,000 Thursday by state health officials after a medication error killed a severely ill baby, in a disturbing replay of two similar incidents since 2004.

The baby boy, born with a genetic disorder that caused a dangerous buildup of ammonia in his body, received two medications that had been improperly packaged. One medication, a nutritional supplement, was given at about 25 times the prescribed dose; the other drug was given at about nine times the prescribed dose.
The infant died on Feb. 24 at 7 weeks old.

Kaiser Permanente's hospital in Santa Clara was one of nine hospitals
sanctioned Thursday by the California Department of Public Health.   It was the only Bay Area hospital included.
The fines are the first under a new state law that went into effect in January which gives the state agency the authority to fine hospitals for violating licensing requirements in a manner that could cause serious injury or death.
"This is important information for the public to know," said Kathleen Billingsley, deputy director for the Center for Healthcare Quality at the Department of Public Health, adding that the state agency similarly publicizes fines against nursing homes.

Fine sends a signal

The $25,000 fine is small in comparison to Kaiser's revenues, but it signals that medication errors may still plague the HMO giant after the 2005 deaths of two patients at its Santa Clara hospital.

On Thursday, a Kaiser official admitted the mistake and said the HMO has taken new steps to prevent medication errors.
"The safety of our patients is our first and foremost concern," said Mary Ann Barnes, senior vice president and area manager of Kaiser-Santa Clara hospital. "Unfortunately, individual human error does occur, as it did in the case the California Department of Public Health is referencing. We are deeply sorry for the family that experienced this sad event."

She said the hospital would appeal the sanction, noting that the hospital had taken corrective actions which had been reviewed and approved by several regulating agencies. The hospital is in compliance with all regulations, including those of the California Department of Health, Barnes said.
The baby was born with carbamoyl phosphate synthetase deficiency, an inherited disorder involving a missing enzyme that causes ammonia to build up in the blood, leading to neurological problems. The disease can vary from mild to severe. Symptoms include lethargy, low appetite, breathing problems, seizures or even coma, and the disease can lead to mental retardation or other developmental delays. The baby had also been treated for the disease at Stanford's Lucile Packard Children's Hospital and was transferred back to Kaiser-Santa Clara in preparation for going home.

Kaiser doctors ordered two prescriptions, the nutritional supplement L-citrulline and the drug phenylbutyrate, to reduce the baby's ammonia levels. But pharmacy staff did not account for the weight of the containers in packaging the two drugs, so too much medication was given, according to a CDPH investigation report. The baby experienced acute liver failure and was taken back to Packard, where he died 11 days later.

Although both a pharmacy technician and pharmacist were responsible for checking the baby's medication before it was delivered, the error went unnoticed.

And five weeks after the error was discovered, pharmacy technicians still had not been retrained on how to weigh medications, violating the hospital's own correction plan, according to the report.

Previous deaths
The baby's death followed those of two other patients at Kaiser-Santa Clara in 2004 and 2005: A 64-year old man died in 2004 after he was given an overdose of a stroke drug. In July 2005, a 12-year-old girl died after a nurse gave her a double dose of epinephrine, which speeds up the heart rate.

At that time, Kaiser officials said they had "added additional safeguards to our pharmacy and medication practices."

IF YOU'RE INTERESTED
More information on the investigation and the penalty are at http://www.cdph.ca.gov/
or read the report below:
Contact Barbara Feder Ostrov at bfeder@mercurynews.com or (408) 920-5064.
CALIFORNIA DEPARTMENT OF PUBLIC HEALTH ISSUES ADMINISTRATIVE PENALTIES TO NINE HOSPITALS
NUMBER:  07-53

DATE:  October 25, 2007

CONTACT:  Suanne Buggy or Lea Brooks, (916) 440-7259

SACRAMENTO –The California Department of Public Health (CDPH) announced today that nine California hospitals have been assessed administrative penalties from the state of California after a determination that the facilities’ noncompliance with requirements of licensure has caused, or was likely to cause, serious injury or death to patients.

The administrative penalties are the first to be issued by CDPH under new authority granted by Health and Safety Code section 1280.1 (Senate Bill 1312, Statutes of 2006, Chapter 895), which was signed by Governor Arnold Schwarzenegger last year and took effect Jan. 1, 2007.  The law allows CDPH to impose administrative penalties with a maximum fine of $25,000 per violation that constitutes immediate jeopardy to a patient’s health and safety.

“Working in partnership with hospitals throughout California, we are committed to ensuring all Californians receive quality patient care,” said Kathleen Billingsley, Deputy Director of the Center for Healthcare Quality at the California Department of Public Health.  “These penalties are an important enforcement tool for ensuring that quality care is provided to all patients in California.”

The following hospitals received penalties:

Enloe Medical Center (Chico, Butte County)

The hospital failed to develop and implement policies and procedures for the safe and effective administration of medications known to cause cardiac arrhythmias.

Feather River Hospital (Paradise, Butte County)

The hospital failed to develop and implement policies and procedures to ensure safe food handling practices as evidenced by the pooling of non-pasteurized shell eggs for extended periods of time, which may result in the potential of exposing patients to the risk of food borne illness such as salmonella; and the lack of cool down monitoring for potentially hazardous foods.

Feather River Hospital (Paradise, Butte County)

The hospital failed to provide pharmaceutical services that would meet the needs of the all patients by failing to develop and implement policies and procedures related to the use of pre-printed medication order forms that would ensure for safe and effective use of medications.

Garden Grove Hospital &  Medical Center (Garden Grove, Orange County)

The hospital failed to develop and implement written policies and procedures to ensure the safe and effective use of medications with black box warnings were developed and implemented. A black box warning shows that medical studies indicate that the drug carries a significant risk of serious or even life threatening adverse effects. Facility staff were unaware of the manufacturer’s warning and confirmed that patients were not monitored.

Glendale Memorial Hospital and Health Center (Glendale, Los Angeles County)

The hospital failed to ensure that medications dispensed for patient care were administered as ordered and in accordance with facility approved protocols.  In addition, the hospital failed to clarify an incomplete medication order and failed to follow facility approved policies and procedures for the safe administration of a medication. 

Hanford Community Hospital (Hanford, Kings County)

The hospital failed to have written policies and procedures for the establishment of a safe and effective system for the distribution, dispensing, and use for patient care of biologicals (products produced by living processes, i.e., insulin, vaccines, etc.).  The hospital failed to ensure that staff could accurately and quickly calculate a dose for emergency medications for pediatric use.

Kaiser Foundation Hospital Santa Clara (Santa Clara, Santa Clara County)

The hospital failed to provide patient safety by ensuring that written policies and procedures for the distribution of all drugs were developed and implemented to ensure the safe use of medications. 

Martin Luther King-Harbor Hospital (Los Angeles. Los Angeles County)

The hospital failed to ensure specialty consultation by a physician, ongoing medical evaluation, medically stabilizing treatment and physician intervention to ensure prompt transfer to a higher level of care for a patient who presented to the emergency department.

Martin Luther King-Harbor Hospital (Los Angeles, Los Angeles County)

The hospital failed to ensure prompt nursing assessments and medical care for a patient who presented to the emergency room.  The hospital failed to ensure the availability of competent and appropriate nurse staffing resources so that patients could receive prompt treatment.

Saint Agnes Medical Center (Fresno, Fresno County)

The hospital failed to have the proper policies and procedures for the administration of medications, and failed to ensure that registered nurses were appropriately trained.  The nurses’ knowledge was inconsistent regarding the administration of intravenous medication boluses.  There was a lack of uniformity in the responses regarding the administration of potentially dangerous intravenous medication boluses in the Intensive Care Unit setting.

Universal Health Services of Rancho Springs (Southwest Healthcare Systems) (Murietta, Riverside County)

The facility failed to provide adequate on-call physician coverage to meet the needs of patients receiving emergency care in the Emergency Department.  The facility failed to maintain an effective call system to provide care to patients in the Intensive Care Unit.

Facilities can appeal the administrative penalties by requesting a hearing within 10 calendar days of notification.  If a hearing is requested, the penalties are to be paid if upheld following appeal.   In addition to the penalties, the facility is required to implement a plan of correction to prevent future incidents. 

All hospitals in California are required to be in compliance with applicable state and federal laws and regulations governing general acute care hospitals.  The hospitals are required to comply with these standards to ensure quality of care.

The California Department of Public Health’s Licensing and Certification Division has the statutory authority to assess penalties against hospitals it licenses as part of enforcement remedies for violations of licensing requirements that cause immediate jeopardy to patients. 

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