Sutter Santa Rosa Regional Hospital

“DIRECTOR OF RESPIRATORY SERVICES CFR(s): 482.57(a)(1) There must be a director of respiratory care services who is a doctor of medicine or osteopathy with the knowledge, experience and capabilities to supervise and administer the service properly. The director may serve on either a full-time or part-time basis. This Standard is not met as evidenced by: 51811 Based on interviews and record review, the facility failed to ensure there was a documented, full-time or part-time director of Respiratory Care Services (RCS) who is a Doctor of Medicine (MD) or Osteopathy (DO), with authority and delegated responsibility for operations of RCS. This failure resulted in the facility not establishing an MD or DO on the Medical Staff Organizational Chart who had a fixed line of authority and responsibility for RCS which could preclude patients from safe and effective care provided by the hospital. Findings: During an interview with the Lead Respiratory Therapy (LRT) on 4/7/26 at 11:30 a.m., LRT indicated, LRT directly reports to the Registered Nurse Manager (RNM). The RNM was responsible for the Intensive-Care Unit (ICU) as well as RCS. During an interview with RNM and LRT on 4/8/26 at 2:25 p.m., LRT indicated, any policy or medical treatment changes for RCS would be escalated to RNM who would then discuss changes with Registered Nurse Director (RND). RNM indicated, the RND would bring request for changes to the Monthly Intensive Care Committee (ICC) for review. During an interview with Director of Nursing (DON) on 4/8/26 at 3:30 p.m., DON stated the current process for policy or medical procedural changes within RCS is brought to the Medical Executive Committee (MEC) meetings by the Director of Critical Care (DCC), an MD, for final approval. The DCC oversees the ICU and RCS. During a concurrent interview and review on 4/8/26 at 3:40 p.m., with the DON, the Sutter Santa Rosa Regional Hospital document labeled, “ Sutter Santa Rosa Regional Hospital -Medical Staff Organizational Chart”, was reviewed and the DON confirmed under Medical Directors the chart shows the DCC but does not list an MD as Director of RCS. During an interview on 4/9/26 at 11:30 am. with the Medical Executive Chief (MEC) ,the MEC reviewed the “Medical Staff Organizational Chart” and acknowledged the missing documentation of a delegated Medical Director for RCS.”

“PHARMACY DRUG RECORDS CFR(s): 482.25(a)(3) Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. This Standard is not met as evidenced by: 27000 Based on interview and record review, the hospital failed to ensure the accurate movement of a scheduled drug (those with high potential for abuse or addiction and are under strict government control) when 1 out of 4 pharmacy staff (Tech 2) did not follow the hospital process and policy and procedures (P&P) during the restocking of scheduled drugs on the patient care units. This failure resulted in the movement of scheduled drugs without a pharmacist’s check, made it difficult to trace, and the potential for undetected drug diversion. Findings: During the survey, a list of scheduled drug outdates, from 8/15/25 to 8/31/25, was requested for review. On 9/16/25 at 4:10 p.m., an interview and review of the scheduled drug outdates was conducted with the Director of Pharmacy (DOP) and the Pharmacy Supervisor (PHS). The review indicated a pharmacy technician (Tech 2) used the “outdate” function in the automated dispensing cabinet (ADC, where medications are stored and electronically tracked) to remove three 2-milliliters (mL, unit of measurement) vials of fentanyl (a potent scheduled drug for pain) 50 micrograms (mcg) per 1 mL from an ADC in the Cath Lab 2 (a specialized area for diagnostic tests and procedures) on 8/24/25 at 8:14 p.m. Approximately 2 hours later, on 8/24/25 at 10:04 p.m., the same 3 vials were put back (refilled) into the same ADC (CathLab2). The DOP stated she did not know why they were removed as “outdates” and then later put back. She stated any outdated scheduled drugs are to be brought back to the pharmacy and put into the narcotic vault called the CII Safe, where scheduled drugs are stored, dispensed from, and returned. During a follow-up interview and review, on 9/17/25 at 9:05 a.m., with the DOP, the PHS, and the Ethics and Compliance Director (DIR 4), the DOP stated her investigation showed that Tech 2 did a “stock exchange” rather than a “true” outdating of the medication. The DOP and DIR 4 explained that, on 8/24/25, Tech 2 removed 3 fentanyl vials from the CathLab 2 ADC because they had an expiration date of 8/31/25 (about to expire). Then, instead of returning them to the pharmacy, he moved them into “high use” areas so they could be used before they expired: one was placed in Operating Room (OR) 6 ADC, one vial in OR3 ADC, and one in Endo 3 (an endoscopy unit; area where medical procedures are performed using scopes). In other words, Tech 2 refilled the ADCs in the “high use” areas with stock from CathLab 2, not from the pharmacy. The Tech 2 then went back and refilled the ADC in CathLab2 with 3 fentanyl vials, which he had obtained from the pharmacy earlier. During the review, the DOP stated, “I wasn’t aware [Tech 2] was doing this.” She stated the correct process is to return the nearing outdated vials from CathLab 2 to the CII-Safe and sign them back out to the floors. The DOP and staff present acknowledged this “stock exchange” on the floors did not have the pharmacist’s verification (for correct medication and count) as medications that came from the pharmacy had the pharmacist’s check before they leave the pharmacy. A review of the hospital’s P&P titled “Automated Dispensing Cabinets,” last revised on 8/17/23, indicated, “To Refill a medication: when stock of any medication is depleted, the pocket can be refilled by any Pharmacy staff with ADC privileges. 1. Obtain needed medication from Pharmacy.” Under REVIEWING REPORTS, the P&P indicated, “A pharmacist must double check the technicians pulled refill items. This report can also be used to validate/reconcile loading of controls into the ADC.””

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 52080 Based on observation, interview, and record review, the hospital failed to ensure its policies and procedures (P&P) were followed when: 1. Fentanyl patches (a strong narcotic with life-threatening risks) were available for administration through an override (process where the nursing staff removes the medication for patient administration before the pharmacist reviews the order for appropriateness) and when it was not on the hospital’s approved override list. This had the potential for fentanyl patches to be administered to the patient before pharmacist review, which had the potential for the patient to suffer from side effects such as respiratory (breathing) depression and; 2. Two out of five crash carts (cart containing medications and supplies for use in medical emergencies) did not have a list of contents posted outside. This failure had the potential to preclude clinicians from quickly finding needed medications and supplies during emergencies and the risk of delays or errors in receiving emergency care. Findings: 1. A review of the full prescribing information for fentanyl patch, dated 3/2021, indicated fentanyl transdermal patch is a potent narcotic applied to the skin, to treat moderate to severe pain. It is designed to release the drug in a slow, steady manner over 72 hours and is contraindicated for use in non-opioid tolerant patients (those who had not used opioids previously in sufficient quantities to develop a tolerance to opioid effects). A review of the hospital policy and procedures (P&P) titled, “Fentanyl Patch Prescribing and Use”, revision date 1/8/2024, indicated the following risks, indications and safeguards: “A. The FDA black box warning [FDA’s highest warning of significant risk of serious or life-threatening side effects] is concerned with the associated risk of respiratory depression in patients who are not tolerant to the dose of the patch prescribed, therefore the following criteria MUST be met/demonstrated prior to initiation of fentanyl patch use... “1. Indications: FentaNYL patches are indicated for the management of persistent, moderate to severe chronic pain that requires continuous opioid administration for an extended period (weeks or longer)... 3. Pharmacists role a. Review fentanyl order and validate patient opioid tolerance by Inpatient... - Review of home meds in EHR (electronic health record) - Interview patient for pain management history and/or, - Review analgesic usage during the time period the patient was hospitalized. b ...if the physician is unable to verify that the patient is opioid tolerant, the pharmacists will inform the physician that the FentaNYL patch order may only be filled for opioid tolerant patients.” During a visit to the pharmacy on 9/15/25 at 11:20 a.m., the Director of Pharmacy (DOP) stated fentanyl patches were not available by override in the Automated Dispensing Cabinet (ADC). The DOP said the pharmacist had to review the fentanyl patch order first to ensure the patient met all the prescribing criteria before it could be approved and available for the nurse to administer. On 9/15/25 at 1:30 p.m., during a visit to the Emergency Department (ED) with the DOP and ED Manager (MGR 1), an ED nurse (RN 5) was asked to override a fentanyl patch for one of the patients. She was able to withdraw a fentanyl 12 micrograms (a unit of measure)/hour patch by override without any difficulty, bypassing the pharmacist validation process. MGR 1 was asked if she was aware of any criteria the patient must meet before the fentanyl patch use, MGR 1 stated she did not know. During an interview on 9/15/25 at 3:35 p.m., the DOP stated she ran a report which showed there had been no nursing overrides for fentanyl patches within the past 6 months. She also stated, “It was an oversight by the pharmacy. Fentanyl patches should not be overridable.” On 9/16/25, a review of the hospital approved override list revealed it did not contain fentanyl patches as an overridable medication. A review of the hospital’s P&P titled “Automated Dispensing Cabinets,” revision date 8/17/2023, indicated “Drugs with a delayed onset of action” should not be considered for override. The P&P further indicated, “The Pharmacy & Therapeutics Committee will approve the list of override drugs based on... criteria.” 2. During a visit to the Post-Anesthesia Care Unit (PACU, hospital unit where patients recover from anesthesia after surgery) with the DOP and Registered Nurse (RN 6) on 10/15/25, at 2:20 p.m., one adult and one pediatric crash cart were identified. There was no list of contents on the outside of the pediatric crash cart. RN 6 acknowledged this finding. During a visit to the Operating Room (OR) with the DOP and the Perioperative Director (DIR 5) on 9/15/25 at 2:40 p.m., an adult crash cart was identified in the OR hallway. There was no list of contents on the outside of the cart. After searching the cart, DIR 5 said the list of contents was not there. A review of the hospital’s “Emergency and Special Procedure Cart, Exchange and Check System” P&P, revision date 6/6/2025, indicated, “A content list including list of emergency medications and equipment will be posted on the outside of the cart.””