The agency said that the noncompliance “has caused, or was likely to cause, serious injury or death to patients,” and in all cases constituted an “immediate jeopardy” for patients.
Sutter Lakeside Hospital in Lakeport and St. Helena Hospital Clearlake each received $25,000 penalties, the Department of Public Health reported. It was the first time such penalties were assessed to either facility, which reported the issues to the state.
The situations with the local hospitals both occurred last year, according to Department of Public Health documents.
Representatives from both of the local hospitals – which were notified of the assessments earlier this week – said they've taken action to address the situations that led to the penalties.
Other hospitals receiving penalties were Arrowhead Regional Medical Center, Colton; Children’s Hospital of Orange County, Orange; Enloe Medical Center, Chico; Hoag Memorial Hospital Presbyterian, Newport Beach; Kaiser Foundation Hospital and Rehabilitation Center, Vallejo; Los Angeles County/University of Southern California, Los Angelesy; Mark Twain, St. Joseph Hospital, San Andreas; Mercy San Juan Medical Center, Carmichael; South Coast Medical Center, South Laguna; and Southwest Healthcare Systems, Riverside.
Facilities that are assessed the penalties must immediately implement a plan of correction to prevent future incidents, according to the state.
“It is imperative that hospitals promptly respond to the issues identified by the Department of Public Health,” said Kathleen J. Billingsley, RN, the deputy director or the Department of Public Health's Center for Health Care Quality.
This is the eighth time the Department of Public Health has issued groups of penalties against medical facilities under the auspices of recent state legislation that aims to improve medical procedure compliance, Billingsley said.
In all, they've assessed 98 penalties on 67 different hospitals, for a total amount of $2.45 million. Not all of the penalties have yet been paid, she noted.
Billingsley said after a violation is substantiated, it's required that the facility immediately fix it and create a corrective plan.
The goal, she said, is to improve health care and eliminate surgical and medical errors.
In eight of the 12 cases reported Thursday – including Sutter Lakeside and St. Helena Hospital Clearlake – penalties arose from failure to follow surgical policy and procedures, which resulted in foreign objects, such as surgical sponges or instruments, being left inside patients during surgery.
Other hospitals were cited for failing to safely administer medications or continuously monitor patients, not following procedures for fall prevention or not complying with minimum staffing requirements for nursing care.
Sutter Lakeside case identifies policy issues
In the case of Sutter Lakeside, a female patient was admitted for a paraesophageal hernia repair and graft surgery that took place on May 21, 2008.
Sponges and instruments were counted both before the procedure and prior to closing, but seven days later an imaging report revealed a mini laparotomy sponge had been left in the patient's left upper abdomen. The sponge was surgically removed without difficulty, the report noted.
A review of hospital procedures found that the situation resulted because the sponge count policy had not been properly performed.
Diane Pege, M.D., Sutter Lakeside's vice president of medical affairs, said the state visited the hospital in June of 2008 and issued a report his past March in which it cited Sutter Lakeside for the occurrence.
“Our greatest priority is, and always will be, patient safety,” Pege said. “As such, Sutter Lakeside took immediate and aggressive steps to prevent this from happening in the future. We did not wait for the anticipated state visit, but promptly reviewed and revised our current protocols and procedures.”
The hospital was placed on an “immediate jeopardy” standing which Pege said put into place is a regulatory process to assure that the problem was immediately corrected. She said that, due to the hospital's prompt response, immediate jeopardy was lifted a short time after it was implemented.
Pege noted that the California Department of Public Health, other health care regulatory agencies and hospitals across the United States are giving special attention to the issue of “retention of foreign objects,” which she said is an infrequent occurrence at hospitals such as Sutter Lakeside, but one that requires special protocols and procedures to minimize occurrences.
St. Helena-Clearlake issue also involved procedures, surgery
St. Helena Hospital-Clearlake's case involved leaving part of an instrument in a patient's intestine during surgery.
“St. Helena Hospital Clearlake follows meticulous standards to prevent medical errors,” said spokesman Jeff Davis. “Following this particular incident, which we self-reported to the California Department of Public Health, a thorough investigation was conducted by the hospital, and our findings could not determine if the error was caused by medical personnel or related to the specific surgical device used during the procedure.”
The surgery, which removed the lower part of a male patient's colon, was performed on Oct. 28, 2008, according to the state report.
The physician was using a disposable stapling instrument to join the edges of the remaining portion of colon with surgical staples. The instrument came in two parts – one was placed above the upper cut edge of the remaining colon and the other part was inserted through the anus and placed at the lower cut edge before the instrument was fired.
However, when the instrument was removed, the surgical team didn't notice that one of the parts of the instrument was missing.
Four days later, the patient had a bowel movement and passed the upper portion of the stapling device, but did not experience increased pain or suffer any injury.
The physician, who had performed 50 such procedures, said he had not noticed the instrument was not complete when he handed it off to the circulating nurse. The report found that the hospital had failed to follow surgical policies and procedures regarding the accounting of all surgical equipment.
Chief Medical Officer Marc Shapiro, MD, said the hospital has implemented guidelines developed by the World Health Organization to add an additional layer of safety to all surgical procedures performed at the hospital.
“We are keenly focused on improving patient safety through the use of system improvements, patient-safety checklists, safety-enhancing practices and information technology,” said Davis.
Davis said patient safety and quality care is the hospital's primary focus. “We sincerely regret that this error occurred and are thankful that no harm was caused to our patient.”
Penalties to be used for improving health care
Billingsley said the money from the assessments is kept in a fund to assist in improving health care quality. To use it, the Department of Public Health must have the Legislature's approval.
Recently, the agency met with the California Hospital Association to ask for suggestions on how to reduce adverse events or medical errors, said Billingsley.
The agency will use that information in formulating a quality improvement effort that it can then take to the Legislature for funding approval through the appropriations process, Billingsley said.
She said officials have seen a dramatic improvement as a result of the work they've done through evaluating and assessment facilities. “I am extremely proud of the positive outcome we have had with the administrative penalties,” he said.
Billingsley cautioned, however, “We can't change things overnight.”
The administrative penalties were issued under authority granted by Health and Safety Code section 1280.1 which took effect January 1, 2007.
Facilities that received the penalties currently are in a 10-day appeal period, the Department of Public Health said. If they don't appeal and pay the penalties, they are only required to pay 65 percent of the assessment, or $16,250.
Silva said Sutter Lakeside will not appeal the assessment. Davis did not indicate if St. Helena Hospital Clearlake would appeal.
Going forward, facilities will face a doubling of the current fine amounts.
Officials said Gov. Arnold Schwarzenegger last year legislation to significantly increase the fine for administrative penalties for violations or deficiencies constituting an immediate jeopardy to the health and safety of patients.
The new law, which took effect Jan. 1, increases fines from $25,000 to $50,000 for the first violation.
The cases reported Thursday are not subject to the new fine amounts because they occurred in 2007 and 2008, before the new law took effect, the Department of Public Health stated.
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