Sutter Health is a not-for-profit integrated health delivery system headquartered in Sacramento, California. It operates 24 acute care hospitals and over 200 clinics in Northern California. Sutter Hospital Association was founded in 1921 as a response to the 1918 flu pandemic. Named for nearby Sutter’s Fort, its first hospital opened in 1923.
The a Report by Becker’s Hospital Review said that California State Board of Pharmacy documented “major deficiencies” related to staff training and knowledge in 2019 at Sutter Coast Hospital’s compounding pharmacy, which was recently placed on a three-year probation. Sutter Coast Hospital is a community-based, not-for-profit hospital serving residents of Del Norte County, California, and Curry County, Oregon.
According to an Accusation made on November 6, 2021 by the Board of Pharmacy, Department of Consumer Affairs,during a routine inspection in January 2019, an investigator noted “major deficiencies” related to compounding training among staff, according to documents on the probation agreement.
The pharmacist in charge and her staff “had not conducted most of the training required prior to commencing compounding,” the investigator found. When asked to demonstrate knowledge of “aseptic hand washing, garbing, cleaning of a controlled environment and the ability to accurately document each documented drug compound,” inspectors found “major deficiencies” in employees’ knowledge of these regulations.
The investigator also found the only sink available was in a restroom, despite pharmacy law requiring a sink with running water is within the “parenteral solution compounding area or adjacent to it.”
During the inspection, the Board investigator observed that compounding staff failed to wear appropriate clothing. Specifically, compounding staff: failed to wear non-shedding gowns, and wore isolation gowns instead; failed to don personal protective equipment immediately outside the segregated compounding area; did not dry hands with a low-lint towel prior to donning a non-shedding gown; and wore visible jewelry.
The facility documented sterile compounding with a system called EPIC and did not ensure the records kept included all the required elements. Specifically, records for completed compounded drug products for vancomycin, ketamine, and Remicade did not contain all ingredients used to compound the products, did not contain the beyond use date of the final compounded products, and did not contain final volumes.
During the inspection, the Board investigator observed unsanitary conditions, including that the Pharmacy did not clean the hoods, all surfaces and floors with a germicidal detergent and sterile water. Respondent Pharmacy’s policies and procedures stated that cleaning must be conducted with a detergent, but the pharmacy only used isopropyl alcohol and water for cleaning.
In May 2023, Sutter Coast Hospital Pharmacy entered into a Stipulated Settlement and admitted all of the accusations made against it. A probation began July 23 for the Crescent City, Calif.-based hospital’s compounding facility. During the probation, the hospital will be subjected to unannounced visits from the pharmacy board and will be required to provide quarterly updates to the state, provide five hours of compounding education for pharmacy technicians and pay an undisclosed fine.
The pharmacy has since worked with the state pharmacy board and violations have been corrected, a spokesperson for Sacramento-based Sutter Health previously told Becker’s.
“We have partnered with the California Board of Pharmacy and have made significant investments at Sutter Coast’s compounding facility,” a spokesperson said. “These recent upgrades exceed all sterile compounding standards for hazardous drugs, which provide protections for employees and patients. Sutter Health remains committed to providing our patients excellent and quality care and supporting overall community health.”