San Joaquin General Hospital

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 27000 Based on observation, interview, and record review, the hospital failed to ensure that safe pharmaceutical services had been provided and that these services met the needs of each patient as evidenced by: 1. Droperidol (medication to treat or prevent postoperative nausea and vomiting and agitation) was not administered in accordance with the U.S. Food and Drug Administration (FDA) Boxed Warning or Black Box Warning (BBW, strongest warnings the FDA requires for medications) for three out of three sampled patients (Patients 4, 5, and 6). Patients 4 and 5 received droperidol with QTc interval (corrected QT, measure on an electrocardiogram [ECG, measures the electrical activity of the heart] that shows how long it takes for the heart’s lower chambers to recharge electrically between beats) above 440 (a BBW contraindication - condition advised against in specified cases) milliseconds (msec), and Patient 6 had no baseline ECG and alternatives attempted before being administered droperidol. Additionally, there were no hospital established policy, protocol, or guidelines for droperidol use or monitoring. There was no education provided to the physicians, nursing, and pharmacy related to droperidol use. Furthermore, there was no internal review or medication utilization review (tracking of use and outcomes) per recommendations from the Pharmacy and Therapeutics (P&T) committee (multidisciplinary group of physicians, pharmacists, and healthcare leaders who manage drug formularies and medication policies) and Medical Executive Committee (MEC, primary governing body representing a hospital’s medical staff, responsible for overseeing patient care quality) after droperidol was added to the hospital’s drug formulary in August 2021. The failures had the potential for patients receiving droperidol to develop QT prolongation (electrical disturbance where the heart’s lower chambers take too long to recharge between beats, measured as an extended “QT interval” on an ECG), torsade de pointes (a rare, life-threatening type of ventricular tachycardia [fast heart rhythm] where the heart’s lower chambers beat rapidly, often with a distinct “twisting” pattern on an ECG), and death. (Refer to A-500) 2. The hospital failed to ensure accountability procedures were in place and implemented to control the use of all controlled substances (CS, medications with a high potential for abuse and addiction, and are under strict government control) in accordance with hospital policy and procedures and current accepted professional standards when: a. The pharmacy had a discrepancy of 15 lorazepam (CS medication to treat agitation or seizure) injectable vials during an inventory for five CS medications. b. There was no established process, through practice and policy and procedures, for follow-up on proactive diversion reports (report identifying “high users” of CS medications, with 3 or more standard deviations (set indicator) above their peer) sent weekly by the pharmacy manager. This resulted in no response for eight out of 38 “high users” identified on the December 2025 Proactive Diversion Reports. c. Four CS medications, removed by an anesthesia (the medical specialty associated with the total perioperative care of patients before, during, and after surgery) provider, were not reconciled with patient use to account for the medications. The pharmacist did not follow up on this discrepancy. These failures resulted in the lack of tight control and diligent monitoring and surveillance for CS use in the hospital to prevent or readily identify drug diversion (illegal use of prescription medication or use for purposes not intended by the prescriber) and abuse/misuse of CS medications. (Refer to A-494) 3. Medications requiring light protection were observed not protected from light in the pharmacy; one of two malignant hyperthermia (MH, muscle disorder triggered by certain types of anesthesia that may cause a fast-acting life-threatening crisis) emergency carts was secured with a lock and key instead of a breakable seal, which could delay access during an emergency and allow removal of medications without detection, compromising inventory integrity; monthly pharmacy unit inspections were not conducted for all patient care units as required for five out of six months reviewed; and high-alert medications (those with inherent high risk for adverse drug events) were not labeled with high-alert identifiers in the automated dispensing cabinets (ADCs) for 3 out of 6 ADC machines sampled. These failures had the potential to result in patients receiving expired or ineffective medications, emergency medications not being available when needed, and an increase in adverse events associated with high-alert medications. (Refer to A-491) 4. Two of eight observed emergency carts (cart containing medications and supplies for use in a medical emergency) was observed unlocked; and the adult emergency cart medication trays were not sealed by a pharmacist, as required. These failures had the potential for unauthorized access and removal of emergency medications which could have resulted in delays in the administration of critical medication during emergencies. (Refer to A-502) 5. 1,320 vials of injectable lorazepam and 10 cassettes each containing 100-milliliter of fentanyl (a potent narcotic for pain) were stored in unlocked refrigerators in the pharmacy. This failure had the potential for diversion and unauthorized access to CS medications. (Refer to A-503) 6. Outdated, mislabeled, and unlabeled medications were available for patient use in 3 out of 10 observed storage areas. (Refer to A-505) The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care, in compliance with the Condition of Pharmaceutical Services.”

“PHARMACY ADMINISTRATION CFR(s): 482.25(a) [§482.25 Condition of Participation: Pharmaceutical Services .....The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. This Standard is not met as evidenced by: 52080 Based on observation, interview, and record review, the hospital failed to provide pharmaceutical services in accordance with professional standards and the facility’s policies and procedures (P&P)when: 1. Medications requiring light protection were observed not protected from light in the pharmacy. 2. One of two malignant hyperthermia (MH, muscle disorder triggered by certain types of anesthesia that may cause a fast-acting life-threatening crisis) emergency carts was secured with a lock and key instead of a breakable seal, which could delay access during an emergency and allow removal of medications without detection, compromising inventory integrity. 3. Monthly pharmacy unit inspections were not conducted for all patient care units as required for five out of six months reviewed. 4. High-alert medications (those with inherent high risk for adverse drug events) were not labeled with high-alert identifiers in the automated dispensing cabinets (ADCs) for 3 out of 6 ADC machines sampled. These failures had the potential to result in patients receiving expired or ineffective medications, emergency medications not being available when needed, and an increase in adverse events associated with high-alert medications. Findings: 1a. During a tour of the pharmacy on 2/9/26 at 10:25 a.m. with the Pharmacy Manager (PHM) and the Compliance & Standards Manager (SCM), vials of labetalol (a medication used to treat severe high blood pressure) were observed stored in full bin without light protection. The PHM read the manufacturer’s label stating, “Protect from light” and confirmed the vials were not covered. 1b. On 2/9/26 at 10:55 a.m., eight vials of cefazolin (an antibiotic) 1 gram, mini-bag plus system, were observed on an open shelf exposed to light in the pharmacy. The PHM read the manufacturer’s label that indicated, “Protect from light “ and confirmed the vials were not covered to protect them from light. 1c. On 2/9/26 at 11:20 a.m., during an inspection of the pharmacy refrigerators with the PHM and SCM, 15 vials of lorazepam (injectable sedative) 2 mg/mL were observed loose in clear plastic bag, and three bags of compounded phenylephrine (an intravenous infusion for severe hypotension) were observed stored in a blue bin without light protection. The PHM confirmed the medications were not protected from light. A review of the Prescribing Information (PI- detailed description of a drug’s uses, dosage range, side effects, drug-drug interactions, and contraindications that is available to clinicians) for labetalol vials, updated December 10, 2025 retrieved from DailyMed (internet database operated by the U.S. National Library of Medicine providing labeling for prescription and nonprescription drugs), indicated, “Protect from...light.” A review of the PI for cefazolin 1 gm vials, updated July 25, 2025, retrieved from DailyMed, indicated, “Protect from light...” A review of the PI for lorazepam 2 mg per mL vials, updated April 27, 2021, retrieved from DailyMed, indicated, “PROTECT FROM LIGHT. Use carton to protect contents from light.” A review of the PI for phenylephrine vials, updated July 10, 2020, retrieved from DailyMed, indicated, “Protect from light...” During a review of the facility’s P&P titled, “Storage and Maintenance of Medications in Inpatient Care Areas,” effective date May 2023, the P&P indicated, “Medications are stored under the proper conditions of sanitation, temperature, light, moisture, segregation and security following policy, regulations, and drug product information.” 2. During an inspection and interview on 2/10/26 at 11:30 a.m. in the Labor and Delivery Anesthesia Workroom, with the Assistant Nurse Manage (ANM) and the SCM, the MH cart was observed secured with a lock requiring a key, and without a breakable seal. When asked about the cart’s security, the ANM stated that the key is kept by the charge nurse at the nursing station. In the event of an MH emergency, staff would need to obtain the key to access the medications. The ANM stated that the cart is checked each shift to ensure it is locked, and its medication contents are verified monthly. The ANM also confirmed that anyone with access to the key could remove medications without detection. When asked if the MH cart was considered an emergency cart, the SCM stated, “Yes.” During a review of the Malignant Hyperthermia Association of the United States (MHAUS)-a professional organization whose mission is to reduce mortality and morbidity from MH by providing educational materials, a 24-hour emergency hotline, and resources for healthcare professionals and families-MHAUS defines MH as “a potentially fatal, inherited disorder usually associated with the administration of certain general anesthetics and/or the drug succinylcholine.” The MHAUS website further states that “an MH cart or kit containing the required drugs, equipment, supplies, and forms should be immediately accessible to operating rooms” (MHAUS FAQs, accessed 2/18/26) During a review of the facility’s P&P titled, “Emergency Cart-Maintenance”, effective date March 2023, indicated, “The emergency cart is sealed with break-away locks when not in use. It is the responsibility of unit personnel to verify that the locks are intact, and drawers cannot be opened without breaking the lock(s).” 3. During a concurrent interview and record review on 2/10/26 at 4:40 p.m. with the PHM, she stated that medication unit inspections are conducted monthly by both pharmacists and pharmacy technicians. The PHM explained that technicians check medication and kit expiration dates, while pharmacists inspect crash carts, MH carts, and controlled substances stocked in automated dispensing cabinets. A report of all medication unit inspections completed by pharmacists and technicians, from August 2025 through January 31, 2026, was reviewed with the PHM on 2/10/26 at 4:45 p.m. The report indicated there were 60 locations inspected each month. However, they were not all completed, as follows: · August 2025: Six locations were not completed · September 2025: Nine locations were not completed · October 2025: All locations were completed · November 2025: Two locations were not completed · December 2025: Four locations were not completed · January 2026: Seven locations were not completed The PHM confirmed that pharmacists and pharmacy technicians did not complete monthly unit inspections for all required areas. She acknowledged that the absence of these inspections reflected the survey findings of an expired medication kit, and unsealed emergency crash carts observed during the survey. During a review of the facility’s P&P titled, “Unit Inspections”, effective date April 2021, the P&P indicated, “In accordance with California T22 [Title 22] regulations and the Joint Commission standards, all patient care areas that stock medication will be inspected by a pharmacist and a pharmacy technician each month...” The P&P further indicated: “IV. The pharmacist must perform the following each month... “A. Inventory and expiration date check for all controlled substances... “B. Inspection of the contents of the emergency cart... “V. When the monthly inspection is complete, the pharmacist and the pharmacy technician must complete and sign the ‘Patient Care Area Inspection Report’.” 4a. During an inspection of the Emergency Department (ED) medication room on 2/9/26 at 1: 47 p.m. with PHM and the SCM, staff were asked to remove high-alert medications from the ADC. The following was observed: · Heparin (an anticoagulant used to treat or prevent blood clots): Numerous pre-filled syringes, too many to count, were stored in the ADC pocket. There were no alerts displayed on the ADC screen and no visual alerts or high-alert stickers on the storage bin or the medication. · Enoxaparin (an anticoagulant used to prevent blood clots): o 30 mg syringes (8 observed) were stored in the ADC without screen alerts or visual alerts on the bin or medication. o 40 mg syringes (8 observed) were stored in the ADC without screen alerts or visual alerts on the bin or medication. The PHM confirmed the medications were stored without visual alerts for high-alert medications. 4b. On 2/9/26 at 2:40 p.m., during an inspection of the front Intensive Care Unit (ICU) medication room with the interim ICU Manager (NM5), PHM, and SCM, NM5 was asked to remove heparin syringes from the ADC. The following was observed: · Heparin 5,000 units/0.5 mL (drug concentration): Numerous pre-filled syringes, too many to count, were stored in the ADC. There were no alerts displayed on the ADC screen and no high-alert stickers observed within the storage bin or on the medication. During an inspection of the back ICU medication room with NM5, PHM, and SCM, on 2/9/26 at 3:00 p.m., NM5 was asked to remove a high-alert medication from the ADC. NM5 selected Norepinephrine (an intravenous medication used to treat severe hypotension). The following was observed: · Norepinephrine 8 mg/250 mL pre-mixed infusion bags (8 observed) were stored in the ADC without screen alerts or visual alerts on the bin or medication. NM5 confirmed that both heparin and norepinephrine were stored in the ADC without any visual alerts on the screen, the medication, or the storage bins. During an interview with the PHM on 2/10/26 at 5:06 p.m., she confirmed all high-alert medications should have high-alert stickers in the ADC and on the products to let the staff know they are high-alert medications. During a review of the facility’s P&P titled, “Medication Administration,” effective date, July 2023, the P&P indicated, “A. High-alert Medications are those that have been shown to have a narrow margin of safety, placing patients at risk of significant harm when they are used in error. Enhanced awareness and safety practices are required to reduce the risk of errors with these medications. “B. The following are considered high-alert medications at San Joaquin General Hospital: i. Insulin, all types and routes ii. Parenteral antithrombotic agents (e.g., heparin, enoxaparin... v. Vasoactive medications (e.g., epinephrine, phenylephrine, norepinephrine, dopamine... “H. High-alert medications, when feasible will be marked as such with a visual alert (e.g., high-alert sticker), both on the medication itself and on the storage area, including storage bins or within the Pyxis [ADC] unit.””

“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 observation, interview, and record review, the hospital failed to ensure accountability procedures were in place and implemented to control the use of all controlled substances (CS, medications with a high potential for abuse and addiction, and are under strict government control) in accordance with hospital policy and procedures (P&P) and current accepted professional standards when: 1. The pharmacy had a discrepancy of 15 lorazepam (CS medication to treat agitation or seizure) injectable vials during an inventory for five CS medications. 2. There was no established process, through practice and policy and procedures, for follow-up on proactive diversion reports sent weekly by the Pharmacy Manager. This resulted in no response for 8 out of 38 “high users” identified on the December 2025 Proactive Diversion Reports (PDRs). 3. Four CS medications, removed by an anesthesia provider (the medical specialty associated with the total perioperative care of patients before, during, and after surgery), were not reconciled with patient use to account for appropriate use. The pharmacist did not follow up on this discrepancy. These failures resulted in the lack of tight control and diligent monitoring and surveillance for CS use in the hospital to prevent or readily identify drug diversion (illegal use of prescription medication or use for purposes not intended by the prescriber) and abuse/misuse of CS medications. Findings: 1. During a visit to the pharmacy accompanied by the Pharmacy Manager (PHM) and the Standards and Compliance Manager (SCM), on 2/9/26 at 11:05 a.m., two large medication refrigerators (Ref A and Ref B) were identified, sitting side by side to each other. The bottom shelf of Ref A was observed to have two large plastic bins containing numerous boxes of lorazepam injection 2 milligrams per milliliter (mg/mL) 1-mL vials. On 2/9/26 at 11:22 a.m., the PHM was asked to perform an inventory for lorazepam vials in Ref A. The PHM’s inventory reflected there were 1,320 lorazepam 2 mg/ml 1-mL vials on hand while the Pyxis CII Safe (medication cabinet that stores, tracks, and monitors activities of CS medications within the pharmacy) indicated there should have been 1,305 lorazepam vials (a discrepancy of 15 vials). After a few moments of review, the PHM stated 15 vials were supposed to have gone to the Intensive Care Unit (ICU, specialized hospital department that gives care to people who are critically ill) on 2/6/26 (3 days ago) but they did not. The PHM asked a pharmacy technician (PTech) why the 15 vials did not go to the ICU, to which she responded, “I forgot.” A review of the hospital’s P&P titled “CONTROLLED SUBSTANCES,” reviewed/revised 6/24, indicated: “The Department of Pharmacy will ensure that all controlled substance records are completed accurately...” 2. During a visit to the pharmacy on 2/9/26 at 11:25 a.m., the PHM was asked to describe the CS monitoring and surveillance program in the hospital. She stated she runs the Proactive Diversion Report (PDR) weekly, which she explained, is a report identifying “high users” of CS medications, with 3 or more standard deviations (set indicator) above their peers. She further explained, these weekly reports would be sent to the respective department managers and anesthesia providers for review. When asked whether there was a tracking system or mechanism to ensure the reports were reviewed for appropriate use and responded back to the pharmacy, the PHM stated, “No.” On 2/10/26 at 1:33 p.m. in the presence of the SCM, the PHM was asked to provide the PDR data and number of response the pharmacy received for December 2025. On 2/10/26 at 3:30 p.m., the SCM provided the PDR data for December 2025. Its review with the SCM indicated there were 38 users identified on the report: 32 users were from nursing department and 6 users were from anesthesia department. The report also indicated 9 department managers and 52 assistant department managers (ADMs) received the reports. Of the 61 individuals responsible for reviewing these reports, the pharmacy only received one (1) response from them. The SCM stated the Deputy Director of Nursing (DDN) and the Chief Nursing Officer (CNO) may keep their own tracking system for these PDRs. During an interview with the DDN on 2/11/26 at 11:05 a.m. in the presence of the SCM, the DDN stated the department managers and ADMs receiving pharmacy’s proactive diversion reports are to review the identified user’s activities for appropriateness and respond back to her and the CNO within a week using the Proactive Diversion Audit Tool. When asked if there was a tracking mechanism for complete review and timely response, and of those individuals whose names are repeated on the reports, the DDN said no to both. She was asked to provide response for 32 nursing users identified on the pharmacy’s PDRs for December 2025. The SCM was asked to provide response for the six anesthesia users. During a follow-up interview and review with the DDN and the SCM on 2/11/26 at 3:34 p.m., the DDN provided the diversion report data, and stated she received response for 30 out of 32 users from nursing managers/ADMs for the December 2025 PDRs. She explained two users were from the PACU (post anesthesia care unit, hospital unit where patients recover from anesthesia after surgery), but the PACU manager did not know she needed to respond back after her review of the users’ CS medication use activities. During an interview with the Chief Medical Officer (CMO), on 2/12/26 at 2:59 p.m., regarding the follow-up process on the pharmacy’s PDRs to anesthesia providers, the CMO stated, “Anesthesia use these drugs more than anyone else... They should send a quick note to the pharmacy about what they did and close the case.” During a follow-up interview with the SCM, on 2/12/26 at 3:45 p.m., regarding the six anesthesia users in the December 2025 PDRs, she stated there was no response from anesthesia. She provided an email communication, dated 2/11/26 at 4:31 p.m., indicating weekly PDRs were reviewed and compared with medications removed by the Chair of Anesthesiology (ChAN). The SCM stated the ChAN said he only responded back to pharmacy if there are any concerns. When asked how the pharmacy would ensure that the reports were reviewed weekly without receiving a response, the SCM stated, “We will have a procedure to ensure we get a response back.” During an interview with the CNO on 2/13/26 at 1:52 p.m., she stated the pharmacy sent weekly PDRs to the department managers and ADMs on a weekly basis; and she and the DDN receive the response to those reports after a week. She stated there was “no formal process” for tracking to ensure the reports were reviewed and responded back, and no process for “flagging users whose name appear on the list more than once.” A review of the hospital’s P&P titled “CONTROLLED SUBSTANCES,” reviewed/revised 6/24, indicated: “PURPOSE: To maintain control and documentation for all controlled substances according to state and federal law, as well as accepted standards of pharmacy and nursing practice... Proactive Diversion Report i. A weekly audit of removals by Pyxis users with a standard deviation at 3+ or above as identified on the Pyxis Proactive Diversion Report will be performed by Nursing Leadership ii. Pharmacy will provide Nursing with the names of users and a detailed activity report for said users each week.” The above P&P did not address the response timeline, the process for review or investigation, and a tracking and trending process to ensure the reports were reviewed and responded back to leadership. A review of the “ASHP Guidelines on Preventing Diversion of Controlled Substances,” dated 12/15/22, by the American Society of Health System Pharmacists (ASHP, a national organization advocating and supporting the professional practice of pharmacists in hospitals, health systems, and other settings spanning the full spectrum of medication use) indicated the following: “There are many points in the medication management process where diversion may occur... CSDPPs [CS Diversion Prevention Program], that build in tight control through process checks and balances, diligent surveillance, and prompt interventions are required to prevent, promptly identify, and investigate suspected diversion. Such programs require proactive surveillance and a rapid response by key stakeholders, using established processes and time frames as defined by the organization. Clear policies, procedures, and lines of accountability must be in place for conducting such investigations, reporting findings, and implementing corrective action plans in a timely and thorough manner.... The organization, through its CSDPP committee, should define, review, and audit relevant data that could indicate potential CS diversion and ensure that trends and variances are acted on in a timely manner and that corrective action plans are implemented... Prescribing practices and prescribing trends are evaluated, and significant variation from peers should be reviewed.” 3. During a concurrent interview and record review with the SCM and the Pharmacy Supervisor (PHS) on 2/11/26 at 10:40 a.m., the two staff were asked about the pharmacy’s process for reconciling CS medication pulled from the Pyxis machines by anesthesia providers. They explained CS medications are removed under the patient’s name; any CS removed without a patient name will need to be “assigned” to a patient in order to account for the medication. Any un-assigned CS pull would show up on the “My Items Report.” A review of the newly generated “My Items Report” indicated an anesthesia provider (Anesth MD) removed 4 CS medications on 1/6/26, as follows: a. 1 vial of fentanyl (a potent narcotic for pain) 100 micrograms/2 mL at 7:04 a.m. b. 1 injection syringe of hydromorphone (a potent narcotic for pain) 1 mg/1 mL at 8:50 a.m. c. 1 vial of midazolam (a controlled medication to produce anesthesia during surgery) 2 mg/2 mL at 7:04 a.m. d. 1 vial of midazolam 2 mg/2 mL at 10:20 a.m. During an interview on 2/11/26 at 10:49 a.m., the SCM and the PHS stated these 4 CS transactions were not “assigned” to a patient to account for the medication used. They were asked to see if the Pharmacy Manager (PHM) followed up on the unreconciled “My Items Report.” The PHM was not available for interview. During a follow-up interview with the SCM and PHS on 2/11/26 at 3:28 p.m., the PHS stated the PHM did not follow up on the 4 CS transactions removed by Anesth MD on 1/6/26 (more than a month ago). During an interview with the CMO on 2/12/26 at 3:03 p.m. regarding unreconciled CS removals from anesthesia, she stated it is the responsibility of the provider to ensure correct reconciliation of CS use. During another interview on 2/12/26 at 3:45 p.m., the SCM stated her follow-up with Anesth MD indicated they were used for Patient 30 during a procedure. She stated Anesth MD “forgot to assign” them to Patient 30 in the Pyxis machine to account for the use. A review of the hospital’s P&P titled “PYXIS MEDICATION DISPENSING SYSTEMS, reviewed/revised 5/23, indicated: “Patient information is populated on the Pyxis stations via the electronic health records interface. If the patient is not listed on the station at the time a medication is needed, the user may use the ‘Add Patient’ function to add the patient information to the system... It is the user’s responsibility to edit the Pyxis patient information when the patient’s identity is determined.” A review of the hospital’s P&P titled “CONTROLLED SUBSTANCES,” reviewed/revised 6/24, indicated: “The Hospital Pharmacy Manager, Pharmacy Supervisor, or designee will review all narcotic discrepancy documentation. If the controlled substance discrepancy documentation is not completed timely or if the documentation is incomplete, a CRO [confidential report of occurrence] will be filed.””

“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: 27000 Based on interviews and record review, the hospital failed to ensure safe medication use when droperidol (medication to treat or prevent postoperative nausea and vomiting and agitation) was not administered in accordance with the U.S. Food and Drug Administration (FDA) Boxed Warning or Black Box Warning (BBW, strongest warnings the FDA requires for medications) for three out of three sampled patients (Patients 4, 5, and 6). Patients 4 and 5 received droperidol with QTc interval (corrected QT, measure on an electrocardiogram [ECG, measures the electrical activity of the heart] that shows how long it takes for the heart’s lower chambers to recharge electrically between beats) above 440 (a BBW contraindication - condition advised against in specified cases) milliseconds (msec), and Patient 6 had no baseline ECG and alternatives attempted before being administered droperidol. Additionally, there were no hospital established policy, protocol, or guidelines for droperidol use or monitoring. There was no education provided to the physicians, nursing, and pharmacy related to droperidol use. Furthermore, there was no internal review or medication utilization review (tracking of use and outcomes) per recommendations from the Pharmacy and Therapeutics (P&T) committee (multidisciplinary group of physicians, pharmacists, and healthcare leaders who manage drug formularies and medication policies) and Medical Executive Committee (MEC, primary governing body representing a hospital’s medical staff, responsible for overseeing patient care quality) after droperidol was added to the hospital’s drug formulary in August 2021. The failures had the potential for patients receiving droperidol to develop QT prolongation (electrical disturbance where the heart’s lower chambers take too long to recharge between beats, measured as an extended “QT interval” on an ECG), torsade de pointes (a rare, life-threatening type of ventricular tachycardia [fast heart rhythm] where the heart’s lower chambers beat rapidly, often with a distinct “twisting” pattern on an ECG), and death. Findings: A review of the product information (includes details and directions health care providers need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations and dosage, and how to administer the drug) for droperidol injection, revised 3/23, indicated it had an FDA boxed warning which read, “Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving droperidol at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal [in bold text for emphasis]. “Due to its potential for serious proarrhythmic [ability to cause heart rhythm problems] effects and death, droperidol should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs... Cases of QT prolongation and serious arrhythmias (e.g., torsade de pointes) have been reported in patients treated with droperidol. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of droperidol to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, droperidol should NOT be administered. For patients in whom the potential benefit of droperidol treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2-3 hours after completing treatment to monitor for arrhythmias.... Droperidol is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome... Droperidol should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia [lower heart rhythms], use of a diuretic [medication to remove water and salt from body], cardiac hypertrophy [thickening and enlargement of the heart], hypokalemia [low potassium in the blood], hypomagnesemia [low magnesium in the blood], or administration of other drugs known to increase the QT interval). Other risk factors may include age over 65 years, alcohol abuse... Droperidol should be initiated at a low dose and adjusted upward, with caution, as needed to achieve the desired effect.” During the survey, a list of patients who have received droperidol in the past 30 days was requested from the hospital administration. On 2/10/26, a review of the provided list indicated 40 patients received droperidol from 1/9/26 to 2/8/26. Three patients were selected for review. a. A review of Patient 4’s Emergency Department (ED) clinical record was conducted with the Medication Safety Pharmacist (MSP), clinical pharmacist 1 (RPH1), and two nursing informatics staff on 2/12/26 at 8:35 a.m. Patient 4 arrived in the ED on 1/15/26 at 3:11 p.m. for nausea, vomiting, and diarrhea for 3 days, “unable to keep anything down”, and “Refused [oral] zofran [anti-nauseant medication] en route.” His past medical history included tachycardia (abnormally fast heart rate). The continued review of the ED record with the staff indicated Patient 4 received two doses of: - Droperidol 2.5 milligrams (mg) via IVP (IV push; rapid, direct injection of medication into a vein or intravenous line) on 1/16/26 at 00:53 a.m. (first dose) - Droperidol 2.5 mg IVP on 1/16/26 at 1:16 p.m. (second dose) Prior to receiving the first dose of droperidol, Patient 4 had an EKG conducted on 1/15/26 at 4:47 p.m., which showed the QTc was 470 msec (above the 440 msec, a BBW contraindication). Although the ED record showed Patient 4 was placed on telemetry unit (specialized hospital unit for patients needing constant, remote, electronic, heart and vital sign monitoring), starting at 1/15/26 at 6:42 p.m., the informaticists could not find any documented QTc immediately prior to first droperidol dose. During the interview and record review as above, on 2/12/26 at 8:55 a.m., RPH1 stated droperidol was requested to be added into the hospital drug formulary “recently.” He stated there were updated literature indicating QT prolongation “is not significant at lower doses, less than 5 mg; and it was approved by P&T.” When asked if there were policy and procedures, protocol, or guidelines for droperidol use, the MSP stated, “No.” She also stated there was no restriction or criteria for its use such as restricting it by area (eg. ED only), or for use in patients on heart monitor, or for those who have failed other medications. On 2/12/26, RPH1 provided a document titled, “SJGH [San Joaquin General Hospital] FORMULARY REVIEW droperidol (INAPSINE)”, dated August 23, 2021. Its review indicated it was presented to the P&T committee with information including: “Warnings & Precautions” (same language as in the FDA boxed warning), background information, summary of two studies leading to black box warning, and summary of three studies after black box warning. Under “Warnings & Precautions”, the Formulary Review indicated: “Droperidol is contraindicated in patients with known or suspected QT prolongation (i.e., QTc interval greater than 440 msec for males or 450 msec for females).” Under “CURRENT GUIDELINES RECOMMENDATIONS”, the Formulary Review indicated a position statement by the American Academy of Emergency Medicine (AAEM): “· Uses: droperidol is efficacious for the treatment of agitation, headache, nausea (Class B [meaning recommended or acceptable] Recommendation). “· ECG requirement: there is insufficient evidence to recommend mandatory ECG or telemetry monitoring for droperidol doses [less than or equal to symbol] 2.5 mg administered as intravenous (IV) or intramuscular (IM) injections (Class A [meaning strong] Recommendation). “· Doses of up to 10 mg: droperidol doses [less than or equal to symbol] 10 mg, when administered as an IM injection, appear to be as safe and as effective as other mediations [sic] used for sedation of agitated patients (Class B Recommendation).” Under “FORMULARY RECOMMENDATIONS”, the formulary review indicated: “· Add droperidol to the SJGH formulary “· Recommend starting doses of [less than or equal to symbol] 2.5 mg. Recommend monitoring patients on telemetry if additional or higher doses are required. “· Add a QTc prolonging agent alert to the electronic health record system for droperidol orders. “· Consider a follow-up medication use evaluation in 3 to 6 months.” During a concurrent interview and review of the droperidol formulary review, on 2/12/26 at 9:19 a.m., the MSP and RPH1 stated there was no follow-up review or medication use evaluation (MUE, a structured method used in healthcare to evaluate and improve medication utilization processes - prescribing, dispensing, administering, and monitoring - to optimize patient outcomes) for droperidol since it was added to the formulary in August 2021. b. A review of Patient 5’s ED clinical record, on 2/12/26 starting at 9:31 a.m., with the MSP, RPH1, and two nursing informatics staff indicated he was seen in the ED on 1/12/26 at 7:19 p.m. complaining of vomiting and abdominal pain for 5 days. The ED record indicated Patient 5 “drinks a pint of liquor a day, ...daily marijuana use, ... and tobacco smoking.” The ED record indicated his initial potassium level was low, at 3.1 mEq/L (milliEquivalent/liter; normal values: 3.5 and 5.2 mEq/L). Further review indicated the patient was placed on telemetry (heart monitoring) on 1/12/26 at 8:30 p.m. The continued review with the staff indicated Patient 5 received: droperidol 1.25 mg IVP on 1/12/26 at 11:06 p.m. Prior to the droperidol dose, Patient 5 had an ECG done on 1/12/26 at 9:08 p.m., 2 hours before droperidol administration, which showed his QTc was 522 msec (over the 440 msec for males, a contraindication for droperidol use as the FDA BBW). Review of Patient 5’s ED record showed he was discharged on 1/13/26 at 00:18 a.m. (approximately 1 hour after receiving the droperidol dose). During the review, on 1/12/26 at 9:50 a.m., the MSP and RPH1 confirmed Patient 4 received droperidol with known QTc above 440 msec; and Patient 5, who had concurrent alcohol abuse and low potassium level (special precautions in boxed warning), received droperidol with baseline QTc of 552 msec, and was discharged 1 hour after droperidol dose while the BBW indicated ECG monitoring should be continued for 2-3 hours after completing treatment to monitor for arrhythmias. When asked if there were any absolute contraindication for droperidol use, the MSP stated, “No absolute contraindication on the formulary review.” c. A review of Patient 6’s ED record was conducted with the MSP, RPH1, and the two nursing informatics staff on 1/12/26 at 9:55 a.m. Patient 6 arrived in the ED on 1/10/26 at 5:02 p.m. for “mechanical level fall secondary to alcohol use, ...was heavily intoxicated, and extremely combative.” A review of the medication use in the ED with the staff indicated he received a dose of midazolam (medication to cause sedation) 2 mg intramuscularly on 1/10/26 at 6:27 p.m. and a dose of droperidol 5 mg IM on 1/10/26 at 6:29 p.m. (2 minutes after the midazolam). The review indicated there were no other medications for agitation or combativeness administered or attempted before droperidol administration. Continued review of Patient 6’s ED clinical record indicated Patient 6 was not placed on heart monitoring. There was no baseline ECG done; however, there was one ECG obtained on 1/11/26 at 3:13 a.m. (more than 8 hours after droperidol administration), which showed a QTc of 457 msec. RPH1 stated it would not be reasonable to do an ECG while the patient was combative. During a telephone interview with the Chair of the ED Department (ChED) on 2/12/26 at 10:35 a.m., he stated all ED physicians should screen patients for heart conditions before IV use of droperidol, and he would recommend QT be monitored if multiple doses are used. With regard to Patient 4 and Patient 5 receiving droperidol with known QTc above 440 msec, the ChED stated, “My recommendation is that cardiac monitoring be monitored. It’s a judgment call for physician if the dose is low.” Regarding Patient 6 not having a baseline EKG, he stated it would not be safe for the staff to conduct an EKG while the patient is combative; however, he would recommend an ECG after the patient calmed down. When asked if there had been an internal review or MUE for droperidol use post formulary addition as recommended by the P&T committee, the ChED stated he was not aware of any but education to the physicians was provided. During further interview and review of Patient 6’s ED clinical record on 2/12/26 at 12:05 p.m., RPH1 confirmed there were no alternative medications ordered and administered for Patient 6’s agitation. He confirmed Patient 6 “could use alternatives” instead of droperidol as a first line agent. During an interview with the Chief Medical Officer (CMO) on 2/12/26 starting at 2:30 p.m., she stated she was not aware of any negative outcomes related to droperidol use since its addition to the formulary. She stated it was approved by the P&T committee, which was then forwarded to the MEC for approval. When asked if there are any specific criteria for use, protocol, or policy for droperidol use, the CMO stated, “I don’t think we’ve done guidelines... I agree with you, we are doing policy changes.” The CMO confirmed there had been no internal review or MUE for droperidol. She stated, “When we work with drug with problems, there should be alerts and MUE done.” When asked if there were education provided, the CMO stated, “There may be something from the pharmacy originally” but she was not aware of any education for physician, nursing, or pharmacy. She additionally stated, “The expectation is to get education by the pharmacy.” On 2/12/26 at 2:55 p.m., during an interview regarding droperidol use in Patients, 4, 5, and 6, the CMO stated droperidol should not be used in patients with known QTc of 470 and 522, respectively for Patient 4 and 5. About Patient 6, she stated she understands why a baseline EKG was not done due to his combativeness, but “as soon as he’s quiet, there should be an EKG.” When conveyed that ECG was done more than 7 hours later, she said, “That’s too late.” When asked should other alternatives be tried first for this patient, the CMO stated, “There are other avenues to treatment [of agitation].” During an interview with the Director of Standards and Compliance (DSC) on 2/12/26 at 3:42 p.m., she stated she could not find any droperidol education as mentioned by the ChED. The P&T and MEC meeting minutes were requested for review. During an interview with the MSP and the SCM on 2/13/26 at 8:45 a.m., the MSP confirmed there was no education provided to nursing and physicians on droperidol use. She stated the pharmacy staff discussed it during morning huddle “but we don’t take minutes.” A review of the hospital P&T committee meeting minutes, dated 8/23/21, indicated: “...New safety information was presented. The recommendation was to add droperidol back to the formulary, recommend doses [less than or equal symbol] 2.5 mg, add an alert for QT prolongation to the order comments, and consider a medication utilization evaluation in 3 to 6 months to assess use.” A review of the hospital MEC meeting minutes, dated 11/16/21, indicated, “Formulary Changes - Droperidol was added to the inpatient formulary at the request of the ED physicians with a recommendation not to exceed doses 2.5 mg IV without appropriate monitoring. A follow-up MUE will be conducted in 3-6 months depending on overall utilization.” A review of the hospital’s policy and procedures titled “MEDICATION FORMULARY PROCESS,” dated 3/23, indicated, “All medications on the SJGH Drug Formulary will be submit [sic] to periodic review based on emerging safety and efficacy data published in the medical literature and medication safely literature, as well as an internal review of reported adverse drug reactions.””

“SECURE STORAGE CFR(s): 482.25(b)(2)(i) §482.25(b)(2)(i) - All drugs and biologicals must be kept in a secure area, and locked when appropriate. This Standard is not met as evidenced by: 52080 Based on observation, interview, and record review, the facility failed to ensure emergency medications were stored in a locked or secure manner for 2 out of 8 observed emergency carts (cart containing medications and supplies for use during a medical emergency) when: 1a. The pediatric emergency cart was observed unlocked with two medications boxes (instead of one) in the Emergency Department Trauma Room. 1b. The Malignant Hyperthermia (MH, muscle disorder triggered by certain types of anesthesia that may cause a fast-acting life-threatening crisis) cart was observed unlocked in the Post-Anesthesia Care Unit (PACU). 2. The Intensive Care Unit (ICU) adult emergency cart medication trays were not sealed by a pharmacist, as required. These failures had the potential for unauthorized access and removal of emergency medications which could have resulted in delays in the administration of critical medication during emergencies. Findings: 1a. During an inspection of a Pediatric Emergency Cart on 2/9/26 at 2:22 p.m. with the Pharmacy Manager (PHM) and the Manager of Standards and Compliance (SCM) in the Emergency Trauma Room, a black, portable box labeled “ Pediatric Code Box #4 “ was observed on a stand outside of the cart. Upon further inspection, the grey-colored first drawer of the Pediatric Emergency Cart was not locked or sealed. The drawer was opened, and a second portable black box labeled “ Pediatric Code Kit #13 “ was inside. The PHM confirmed the cart was unlocked and stated the cart should only contain one pediatric emergency box sealed inside the cart. 1b. During an inspection of the MH cart on 2/9/26 at 3:10 p.m. with PHM, SCM and the Manager of Perioperative Services (NM2) in the PACU, the cart was observed to be sealed with a white breakable lock. The first drawer of the cart was labeled “MEDICATIONS. “ Upon further inspection of the cart, the drawer containing the medications was able to be opened without breaking the white seal. NM2 confirmed the MH cart was not locked and stated, “Yes, it should be locked. I didn’t realize [it wasn’t].” During a review of the facility’s policy and procedure (P&P) titled, “Emergency Cart-Maintenance,” effective date March 2023, the P&P indicated, “Supplies and equipment are standardized for each cart... The emergency cart is sealed with break-away locks when not in use. It is the responsibility of unit personnel to verify that the locks are intact, and drawers cannot be opened without breaking the lock(s).” 2. On 2/9/26 at 2:55 p.m. with PMH, SCM and the ICU Nursing Manage (NM5) in the back of the ICU, the sealed Adult Crash Cart was opened for inspection. The white medication tray inside the cart was observed open, allowing all medications to be accessed during the inspection. In other words, the medication tray did not have a sealed lid or covering. On 2/10/26 at 4:40 p.m., during an interview with PHM, she stated, the pharmacy technician fills the emergency medication trays, and the pharmacist checks the contents and signs it off on the contents list. However, the medication tray does not have a sealed lid or covering. She additionally stated the nursing staff notify pharmacy when an emergency cart is opened. If medication is used from the cart, pharmacy sends a new opened medication tray with a pharmacy technician to exchange and lock the cart. If no medication was used, pharmacy sends a breakable lock for nursing to lock the crash cart. The PHM confirmed that without sealing the medication tray or locking the crash cart themself, the pharmacist would not be able to verify the medication contents for correct medications and counts before the crash cart is sealed. During an interview on 2/13/26 at 9:35 a.m., the SCM stated the hospital had 25 adult crash carts. During a review of the facility’s P&P titled, “Medication Trays and Kits,” effective date February 2023, the P&P indicated, “B. Emergency Medication Trays should be inspected by the pharmacist as part of the sign out process. i. All other kits are sealed by the pharmacist at the time they are filled and do not require a final inspection prior to leaving the pharmacy.” During a review of the facility’s P&P titled, “Emergency Cart-Maintenance,” effective date March 2023, indicated, “...Restocking after a Code Blue: The medication tray... is sent to the Pharmacy for replacement.””

“CONTROLLED DRUGS KEPT LOCKED CFR(s): 482.25(b)(2)(ii) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area. This Standard is not met as evidenced by: 27000 Based on observation, interview, and record review, the hospital failed to ensure all controlled substance (CS, those with high potential for abuse and addiction, and are under strict government control) medications were kept locked at all times in accordance with current accepted professional standards when 1,320 vials of injectable lorazepam (a controlled medication to treat agitation or seizure) 2 milligrams (mg, unit of measurement) per milliliter (mL, unit of volume) and 10 cassettes each containing 100-mL of fentanyl (a potent narcotic for pain) 2 micrograms per mL (mcg/mL) were stored in unlocked refrigerators in the pharmacy. This failure had the potential for diversion (illegal use of prescription medication or use for purposes not intended by the prescriber) and unauthorized access to CS medications. Findings: During a visit to the pharmacy accompanied by the Pharmacy Manager (PHM) and the Standards and Compliance Manager (SCM), on 2/9/26 at 11:05 a.m., two large medication refrigerators (Ref A and Ref B) were identified, sitting side by side to each other. Both refrigerators were full of various medications such as antibiotics, insulin, vaccines, surgery medications, compounded medications. The bottom shelf of Ref A was observed to have two large plastic bins containing numerous boxes of lorazepam injection 2 mg/mL 1-mL vials. The bottom shelf of Ref B had a large blue bin containing 10 cassettes, each cassette containing a compounded (mixed) preparation labeled with “FentaNYL 2 mcg/ml; bupivacaine 0.125%, 100 mL EPIDURAL” (combined epidural anesthesia/analgesia preparation for labor pain). Both refrigerators were not locked. During an interview on 2/9/26 at 11:20 a.m., the PHM stated all CS medications in the pharmacy are stored and tracked in the Pyxis CII Safe (medication cabinet that stores, tracks, and monitors activities of CS medications within the pharmacy), but because both lorazepam and epidural fentanyl/bupivacaine require refrigeration, they are stored in the regular refrigerators. The PHM confirmed both refrigerators are not locked. She stated there was no designated refrigerator for CS medications. On 2/9/26 at 11:22 a.m., the PHM was asked to perform an inventory for these two products. The CII Safe medication storage cabinet was observed located in the back of the two refrigerators, its back was against the refrigerators’ back. The PHM was observed signing into the CII Safe machine, left the screen open, walked over to the refrigerator behind the CII Safe cabinet, counted the product, then walked back to the CII Safe, and entered the count into the machine. She did this two different times for both products. The PHM’s inventory reflected there were 1,320 lorazepam 2 mg/ml 1-mL vials, and ten 100-mL fentanyl/bupivacaine epidural cassettes in the unlocked refrigerators. During this observation and interview, on 2/9/26 at 11:25 a.m., the PHM showed the surveyors the camera in the ceiling, which she stated had direct sight over or near the CII Safe for monitoring its activities, but there was no camera above Ref A and Ref B. She confirmed the said camera would not be able to capture activities in the two unlocked refrigerators. During another interview with the PHM on 2/10/26 at 1:50 p.m., she confirmed that all CS medications should be locked. She acknowledged anyone accessing Ref A and Ref B also had access to the lorazepam and the fentanyl/bupivacaine epidural cassettes without accessing the CII Safe; loss of these products would not be detected until someone accessed these products via the CII Safe. She stated the pharmacy is frequented by pharmacists, technicians, and pharmacy students. She stated the hospital has about 5 to 6 pharmacy students per semester, who would come in the pharmacy in the evenings for their learning. During an interview with the Chief Nursing Officer/Chief Operating Officer (CNO) on 2/13/26 at 1:52 p.m., she stated she expected all controlled medications to be locked for security. A review of the hospital’s policy and procedures titled “CONTROLLED SUBSTANCES,” reviewed/revised 6/24, indicated: “PURPOSE: To maintain control and documentation for all controlled substances according to state and federal law, as well as accepted standards of pharmacy and nursing practice... “A. All controlled substances will be stored in, and inventory tracked using the Pyxis CIISafe medication storage cabinet. B. Controlled substances that require refrigerated storage will be stored in a medication refrigerator located in the pharmacy department.” A review of the “ASHP Guidelines on Preventing Diversion of Controlled Substances,” dated 12/15/22, by the American Society of Health System Pharmacists (ASHP, a national organization advocating and supporting the professional practice of pharmacists in hospitals, health systems, and other settings spanning the full spectrum of medication use) indicated, “Storage and security of CS require a coordinated approach that includes facility controls (eg, camera surveillance), physical access controls (eg, locks or biometric access technology), and frequent inventory checks and surveillance to allow discrepancies to be discovered in a timely manner... CS are securely stored in a locked location (ie, ADC [automated dispensing cabinet], safe, locked cabinet/drawer, refrigerator) accessible only to authorized individuals at all times unless in the direct physical control of an authorized individual... Security measures and other physical controls, such as camera surveillance throughout the pharmacy, are imperative in this setting to deter and monitor for suspected theft and provide an avenue for discrepancies to be resolved in a timely manner.””

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 52080 Based on observation, interview, and record review, the facility failed to ensure outdated, mislabeled, and unlabeled medications were not available for patient use in three out of ten observed storage areas, when: 1. Mislabeled insulin vials were stored in both the pharmacy and Emergency Department (ED). 2. Expired medications were stored in the pharmacy refrigerator. 3 . One open single dose vial (SDV) was not discarded in Operating Room (OR), and several opened multiple-dose vials (MDV) were stored without open dates in the ED. 4. One Needle Stick Medication kit expired in the ED. 5. One intravenous large-volume bag was hung on a pole and connected to tubing without a date label in the OR’s Anesthesia Workroom. These failures had the potential for patients to receive ineffective, expired, or contaminated medications placing patients at risk for adverse events. Findings: 1a. During a visit to the pharmcy, on 2/9/26 at 12:25 p.m., with the Pharmacy Manager (PHM), Standards and Compliance Manager (SCM), and Registered Pharmacist (RPH3), RPH3 was observed verifying the preparation of compounded Regular Insulin infusions (100 units in 100 milliliters of Normal Saline). The insulin vial used in preparing the compounds was labeled with 2/9/26 open date and expiration date of 3/12/26 (more than 28 days after opening). RPH3 confirmed the vial was misdated. 1b. On 2/9/26 at 1:47 p.m., during an inspection of the medication refrigerator in the ED with SCM and PHM, a vial of Admelog (insulin lispro, rapid-acting insulin) was labeled dated opened on 3/9/26 and expired date of 4/20/26. The PHM confirmed the vial was misdated. 2. During an inspection of the medication refrigerator and a concurrent interview conducted on 2/9/26 at 11:10 a.m. in the pharmacy, a reconstituted oral liquid suspension bottle of Amoxicillin and Clavulanate (a liquid antibiotic) was observed with a yellow auxiliary sticker indicating “EXP Date: 2/7/26.” Additionally, two bags of compounded Vancomycin (an intravenous antibiotic), 1.5 grams per 250 mL of Normal Saline, had the expiration date of 2/6/26. The PHM confirmed the medications were expired. During a review of the facility’s policy and procedure (P&P) titled, “Storage and Maintenance of Medications in Inpatient Care Areas,” effective date May 2023, the P&P indicated, “Medications are...discarded at the appropriate time” and further indicated, “All expired drugs are returned to the Pharmacy for disposal...” 3a. During an inspection of the medication floor-stock cabinet in the ED Medication Room on 2/9/26 at 1:47 p.m. with PHM and SCM, the following opened, undated medications were observed stored in the cabinet for patient use: · 1 SDV of Bupivacaine (medication used as a local anesthetic) 0.5% (concentration) 10 mL1 MDV of Xylocaine (medication used as a local anesthetic) 1% 20 mL · 1 MDV of Lidocaine 1% with Epinephrine 1:100,000 (medication used as a local anesthetic) 20 mL The PHM confirmed the opened medications were not dated and should have been discarded. 3b. On 2/9/26 at 3:25 p.m., during an inspection of Operating Room (OR) 3 with the PHM and Nursing Perioperative Service Manager (NM2), one opened, undated vial of neostigmine (a medication used to reverse medication-induced paralysis during surgery) was observed in the automated dispensing anesthesia cart. NM2 confirmed the opened, undated vial was in the cart for patient use. A review of the facility’s P&P titled, “Storage and Maintenance of Medications in Inpatient Care Areas,” effective date May 2023, indicated, “ D. Single dose vials and any unused portion are discarded immediately after use. E. All multi-dose vials must have date/time of expiration written legibly on the label 28 days from the date/time of being opened, or less if recommended by the manufacturer.” 4. On 2/9/26 at 2:12 p.m., during an inspection of the ED medication room with PHM and SCM a Needle Stick Medication Kit was observed with an expiration date of 12/13/25. The PHM stated the kit was intended for use if staff were stuck by a needle and confirmed the kit contained medications for post-exposure prophylaxis (PEP). PEP are emergency medications taken within 72 hours of potential HIV exposure to prevent infection. The PHM confirmed the kit had expired. A review of the facility’s P&P titled, “Medication Trays and Kits,” effective date February 2023, indicated, “All medication kits will be inspected monthly to ensure that the contents are still within their expiration dates.” 5. During inspection of the Anesthesia Work Room in the OR with PHM and NM2 on 2/9/26 at 3:28 p.m., one large-volume 1-liter bag of Normal Saline was observed hanging on a pole and connected to IV tubing. The bag and tubing were not labeled. NM2 stated that these bags are prepared in advance for trauma cases. She confirmed the bag was not labeled and once spiked, the bag is only good for 24 hours. A review of the facility’s P&P titled, “Tubing Line and Reconciliation Process, “ review date October 30, 2023, indicated, “Label tubing with date/time hung...””