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Based on interview and record review, the facility failed to follow their policy and procedure of reporting an adverse event to the state agency in a timely manner for six patients (Patients 1, 2, 3, 4, 5, and 6), when a sterilization breach occurred.

This failure had the potential to cause further complications to the patient, multiple procedures, and/or death.

Findings:

On July 17, 2025, at 3:23 p.m., the facility reported to the state agency, a sterilization breach that occurred at the facility on April 25, 2025.

On July 28, 2025, at 2:49 p.m., a concurrent interview and record review were conducted with the Chief Nurse Officer (CNO), Clinical Effectiveness Coordinator (CEC) 1, and Scribe (S) 1 (S 1). The CNO stated, "We narrowed it down after conducting an investigation, there were six patients that may have been affected by the breach. The enzymatic cleaning solution, in a multi-step cleaning process, was switched out unintentionally with lubricant, the second enzymatic cleaning cycle was omitted, the instruments used did go through the sterilization process." The CNO further stated Test Object Surgical Instrument (TOSI) passed, all six charts were reviewed, staff and physicians' were interviewed, a root cause analysis (RCA), and improved process improvement measures were in place. The CNO stated disclosure was completed for all six patients, and testing was offered.

On July 31, 2025, at 9:12 a.m., an interview was conducted with the CNO. The CNO stated this was not reported to the state agency because they (the facility) referenced the adverse event list and it did not fall under the category.

A review of the facility Policy and Procedure (P&P) titled, "Event Reporting," dated June 9, 2025, was reviewed. The P&P indicated, "...Occurrence...That which is not consistent with routine care of patient and/or the desired operations of the facility. The results of this event require or could have required (closed call/near miss) unexpected medical intervention, unexpected intensity of care, or causes or had the potential to cause an unexpected physical or mental impairment...Unsafe Condition, could lead to patient safety event; potential for error...Reporting to the State Department of Health Services (if required by state law)...Events will be reported to the State Department of Health as required by state law and regulation..."

A review of the "...California Code of Regulations...Title 22, §70972...Adverse Event Reporting Requirements...Pursuant to Health and Safety Code sections 1279.1 and 1279.3...adverse events shall be reported by the hospital through a secure internet website maintained by the Department pursuant to the following timelines...Adverse events that are ongoing urgent or emergent, threatening the welfare, health, or safety of patients, personnel, or visitors, shall be reported within 24 hours after the adverse event is detected...All other adverse events shall be reported to the Department no later than five (5) calendar days after the adverse event is detected..."

Based on interview and record review, the facility failed to perform a surgical procedure in a timely manner for one of 21 sample patient (Patient 19).

This failure caused a delay in care, extended hospital stay, emotional stress, and potentially worsening medical condition.

Findings:

A review of Patient 19's medical record was conducted on July 29, 2025, at 1:16 p.m., with Scribe (S) 1 and S 2.

A facility document titled, "History and Physical," dated July 19, 2025, at 6:28 p.m., was reviewed. The document indicated, "...History of present illness...past medical history of recently diagnosed cholelithiasis [the presence of one or more calculi (gallstones) in the gallbladder ] a month ago, eclampsia [a pregnancy disorder characterized by high blood pressure and protein in the urine], C-section [cesarean section, surgical procedure where a baby is delivered through incisions in the mother's abdomen and uterus] 10 weeks ago, presenting with right upper quadrant pain...General surgery was consulted, plan possible cholecystectomy [surgical removal of the gallbladder] today or tomorrow...The patient will be admitted for further evaluation and management of possible cholecystitis [inflammation of the gallbladder] and choledocholithiasis [a condition where one or more gallstones are present in the common bile duct]..."

A facility document titled, "Orders," dated July 21, 2025, was reviewed. The document indicated,"...Diet Type...Regular...Diet Parameter...Fat Restriction...Advance as tolerated...Yes...Special Instructions...Low Fat diet..."

A facility document titled, "Intake and Output Print Request," dated July 20, 2025, through July 22, 2025, was reviewed. The document indicated Patient 19's last meal was on July 20, 2025, between 2 p.m. to 2:59 p.m.

A facility document titled, "Progress Note-Physician," dated July 20, 2025, at 11:28 a.m., was reviewed. The document indicated, "...Clinical presentation is consistent with cholelithiasis and acute cholecystitis. Nonemergent laparoscopic cholecystectomy is indicated, however due to ultrasound findings, MRCP [Magnetic Resonance Cholangiopancreatography - medical imaging that takes detailed pictures of the bile and pancreatic ducts] is recommended to rule out further hepatobiliary disease prior to the procedure...She is eager to go home as she has twin sons that she is breast feeding. Surgery following..."

A facility document titled, "Progress Notes-Physician," dated July 21, 2025, at 5:14 a.m., was reviewed. The document indicated, "...MRCP positive. ERCP [endoscopic retrograde cholangiopancreatography, a procedure that examines and treats problems in the bile and pancreatic ducts] pending today..."

A facility document titled, "Progress Notes- Physician," dated July 22, 2025, at 10:48 a.m., was reviewed. The document indicated, "...She underwent EUS [Endoscopic ultrasound - a minimally invasive procedure that combines endoscopy and ultrasound to examine the digestive tract and surrounding organs] yesterday. EUS showed in CBD [common bile duct] and ERCP followed. ERCP demonstrated dominant major papilla with no stone in the CBD and sphincterotomy [a procedure, typically performed during endoscopic retrograde cholangiopancreatography (ERCP), where a small incision is made in the sphincter of Oddi, a muscle at the junction of the bile and pancreatic ducts with the small intestine] was done...scheduled to undergo laparoscopic cholecystectomy on 07/23 [July 23] evening. However, she has 11 week old twins and is lactating mother with the wait for scheduling being a source of frustration...Plan for laparoscopic cholecystectomy pending OR [Operating Room] availability if patient wants to stay...Attending Attestation...Pt upset that there is a delay in scheduling surgery. I had explained that there is short staffing pushing surgeries to very late into the evening, which is generally reserved for emergency procedures. I do not feel it is safe to perform a non-emergent cholecystectomy in the middle of the night with skeleton staffing who have already been working 12+ hours. I am unable to schedule her elective surgery as an outpatient due to her insurance. Alternatively, she is to FU [follow up] at [Name of another facility], should she not want to wait for surgery. They will discuss. Surgery team will continue to follow and offer surgery once OR is available..."

A facility document titled, "[Facility Name] Main OR-Operating Room Schedule," dated July 23, 2025, was reviewed. The document indicated, "...2000[8 p.m.]...Inpatient...[Patient 19] add-on...Yes...Procedure detail...Cholecystectomy Laparoscopic...[Name of MD 2]..."

An interview was conducted on July 29, 2025, at 1:55 p.m., with the Perioperative Director (PD) and Perioperative Manager (PM). The PD stated they use five OR rooms daily for scheduled and add-on (a procedure that is scheduled after the initial operating room schedule has been finalized) surgery cases. The PD further stated the provider (doctor) can call the surgery scheduler to schedule an add-on case 24/7 (24 hour/7 days a week). The PM stated the OR has scheduled on call staff consisting of a Registered Nurse circulator, a surgery technician and an anesthesia (use of medications (called anesthetics) to keep you from feeling pain during procedures or surgery) provider daily beginning at 5 p.m. or 7 p.m. for a 12-hour shift.

A facility document titled, "[Facility Name] Main OR-Operating Room Schedule," dated July 1, 2025, through July 23, 2025, was reviewed. The document indicated add-on surgery cases were added on to the schedule and performed between 7:30 p.m. and 1:05 a.m.

A concurrent interview and record review were conducted on July 29, 2025, at 2:29 p.m., with the PD. The facility document titled, "[Facility Name] Main OR-Operating Room Schedule," dated July 21, 2025, through July 22, 2025, indicated the OR was using two OR rooms on July 21, 2025, and five OR rooms on July 22, 2025, for surgery cases. The PD stated Patient 19 could have been added on to these two rooms after scheduled cases were finished. The PD further stated he verified with the surgery scheduler, the Medical Doctor (MD 1) did not call them to add the patient [Patient 19] to the surgery schedule between July 21, 2025, through July 22, 2025.

A review of the facility untitled document, dated July 19, 2025, through July 22, 2025, was conducted on July 29, 2025, at 2:47 p.m., with the PM. It indicated, "...C= Gen [general] Call...Gen and Heart call starts at 1700 [5 p.m.] - 0630 [6:30 a.m.] (M-F) [Monday - Friday]..."

An interview was conducted on July 29, 2025, at 2:29 p.m., with the PM. The PM stated the document was the OR on-call schedule and they had on-call staff scheduled daily.

An interview was conducted on July 29, 2025, at 2:58 p.m., with MD 1. MD 1 stated there was an anesthesia shortage, the surgery was non emergent and when MD 1 escalated the situation to the Chief of Operation, (COO), Chief of Surgery and the PD, the consensus was it was unnecessary to "bump" a surgery case because "...gallbladder surgery is not a life-threatening emergency. It's urgent but not emergent..."

An interview was conducted on July 29, 2025, at 3:24 p.m., with the COO and the Chief Nurse Officer (CNO). The COO stated he was made aware of Patient 19's situation by MD 1 on July 22, 2025. The COO stated, per MD 1 Patient 19's surgery was not an emergency and will not necessitate to "bump" a scheduled surgery case. The COO further stated, "...we could have potentially done the case earlier because we have the staff (OR staff) and Anesthesia on call..." The CNO stated, "... MD 1 was part of a larger group and could have reached out to her peer group/department or to the chair and find another surgeon to do the surgery..."

An interview and record review were conducted on July 29, 2025, at 3:42 p.m., with the PD. The untitled document dated July 22, 2025, indicated the CRNA (Certified Registered Nurse Anesthetist - registered nurse who has completed advanced education and training to administer anesthesia) work schedule. The PD stated there were Anesthesia provider on-call staff scheduled and available.

An interview and record review were conducted on July 29, 2025, at 3:43 p.m., with the Kaiser Permanente Case Manager (KPCM). The facility document, "Case Management Notes," was reviewed. The record did not indicate documented evidence that KPCM were aware of the delayed surgery. The KPCM stated Patient 19's case should have been discussed with the KP interdisciplinary team and inform them that this patient [Patient 19] was only waiting for surgery and possibly request for a transfer to an appropriate medical center.

An interview was conducted on July 29, 2025, at 3:50 p.m., with the Kaiser Permanente Manager (KPM). The KPM stated the normal length of stay of a patient without serious complications undergoing a Laparoscopic Cholecystectomy was 1 to 2 days. KPM further stated the expectation was to ensure the KPCM team had close contact with the provider for updates on the plan, in this case KPCM should have helped coordinate to find another team or doctor to do the surgery instead of the patient waiting.

A review of the facility's Medical Staff Bylaws, dated April 11, 2022, indicated, "...Responsibilities of Membership...Each member of the Medical Staff must continuously comply with the provisions of these By laws, and Medical Staff Rules and Regulations, and Medical Staff Policies...Members must also: Provide continuous and timely care to all patients for whom the Practitioner maintains responsibility..."

Based on interview and record review, the facility failed to implement their "Informed Consent," policy for one of 21 sample patients (Patient 4), when a consent for surgery and anesthesia were not completed prior to the procedure.

This failure resulted in being Patient 4 having a surgical procedure and anesthesia performed, without written consent.

Findings:

On July 30, 2025, at 9:36 a.m., a review of Patient 4's medical record was conducted with the Clinical Effectiveness Coordinator (CEC) 1 and 2.

A review of the facility document titled, "History and Physical," dated April 24, 2025, at 3:20 p.m., was reviewed. The document indicated, "...history of kidney stones, biliary sludge [particles that precipitate out of bile and can be found in the gallbladder]...who presents...with complaints of acute onset abdominal pain..."

A review of the facility document titled, "Operative Reports," dated April 26, 2025, at 12:24 p.m., was reviewed. The document indicated, "...Indication for surgery....acute cholecystitis [inflammation of the gallbladder] necessitating a cholecystectomy [removal of the gallbladder]...Preoperative Diagnosis...acute cholecystitis...Postoperative Diagnosis...Same..."

A review of the facility undated document titled, "Preprocedure Checklist," was reviewed. The document indicated, "...Procedural Forms...Procedural Consent Signed...Anesthesia Consent Signed...Blood Consent Signed..." all left blank.

There was no documented evidence of a consent for surgery, and anesthesia were completed, signed and placed in Patient 4's medical record.

On July 30, 2025, at 11:01 a.m., an interview was conducted with the Clinical Effectiveness Coordinator (CEC) 1 and 2. CEC 1 and 2 stated the consent for the surgical procedure and anesthesia were not found in Patient 4's medical record.

A review of the facility Policy and Procedure (P&P) titled, "Consents," dated January 13, 2025, was reviewed. The P&P indicated, "...Informed consent is a process of communicating between a treating practitioner and a patient that results in the patient's authorization or agreement to undergo a specific medical intervention...It is the responsibility of the treating provider to apprise the patient of nature, risks and alternate of a medical procedure or treatment before the treatment provider or healthcare professional begins any course...A licensed healthcare professional from the Hospital may witness the patient/legal representative sign the consent...All signed consents forms shall be placed in the medical chart..."