California regulators found that Los Robles Regional Medical Center used contaminated surgical instruments on patients in three procedures and did not report a related adverse event to the state as required.
The findings come from a California Department of Public Health complaint validation survey of the Thousand Oaks, Calif.-based hospital, part of Nashville, Tenn.-based HCA Healthcare. Becker’s reviewed the report, which CDPH completed in May.
The survey was triggered by 11 federal complaints alleging the hospital did not meet Medicare standards. Investigators substantiated seven and cited the hospital for deficiencies in infection control, governing body oversight, patient safety and surgical services.
Beyond the three surgeries in which contaminated instruments were used, investigators said two additional patients were placed under anesthesia for procedures that were then canceled because of compromised equipment.
One case involved a craniotomy, a procedure in which part of the skull is removed. When the instrument tray was opened, staff found false eyelashes and, in a separate account, rust and debris in the tray, according to the report. The physician declined to wait for a replacement tray and proceeded, and the hospital did not report the case to the state.
A hospital patient safety director told investigators the event was not initially reported because it was not considered serious, the report said. Under California’s Health and Safety Code, hospitals must report an adverse event within five days of detection, or within 24 hours if it poses an ongoing threat.
Investigators also found that all three sampled steam sterilizers were not cleaned according to the manufacturer’s instructions on both campuses, that reusable instruments were not properly cleaned, and that decontamination sinks were lined with worn and soiled adhesive tape. A May inspection of five surgical trays found issues with four, including white residue, water stains, scratches and, in one tray, a plastic flake.
The report also faulted the hospital’s board of directors, saying it fell short in setting policy and providing oversight.
The findings follow a roughly five-day pause in surgeries at Los Robles in February, when the hospital diverted ambulances and halted procedures over what CEO Phil Buttell described at the time as an equipment issue affecting presurgical sterilization. In February, an HCA regional spokesperson disputed union claims that unsterilized instruments had been used, saying no patient was harmed or put in danger.
In a written statement to the Ventura County Star, hospital spokesperson Megan Merino said CDPH and CMS conducted a follow-up survey in August and “identified no major deficiencies,” confirming the hospital’s monitoring of presurgical processes “is effective.” She said the hospital has not been fined or penalized and remains focused on patient safety.
Officials with SEIU Local 121RN, which is in contract negotiations with HCA, told the Star the findings revealed a “shocking disregard for patient safety.” The report contradicted the hospital’s earlier claim that no contaminated instruments reached patients, Executive Director Rosanna Mendez said in a statement.
Los Robles Health System told Becker’s:
“At all times, Los Robles Health System is committed to maintaining the trust of the patients and communities we serve. The hospital proactively paused surgical cases earlier this year as we investigated an equipment issue that affected pre-surgical processes.
“Since the onset of the sterile processing findings, Los Robles Health System has been working closely with the California Department of Public Health and Centers for Medicare and Medicaid Services to assess and ensure that all our processes and procedures are aligned with state and federal standards.
“Most recently, CDPH and CMS conducted a validation survey where they identified no major deficiencies and confirmed that our monitoring of pre-surgical processes and instrumentation is effective. We remain focused on sustaining these improvements and maintaining the highest standards of patient safety.”
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