Adventist Health Bakersfield

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 47444 Based on observation, interview and record review, the hospital failed to follow their policy and procedure (P&P) titled, “Point of Care Testing Nova StatStrip Glucose Meter (glucometer - used to test blood sugar level),” when glucose control solutions (GCS -used to ensure glucometer accuracy and reliability of test results) were not labeled with legible discard date and not discarded after 90 days (after opened). These failures had the potential to result in patients having inaccurate blood glucose test results. Findings: During a concurrent observation and interview on 7/7/25 at 10:09 a.m. with Registered Nurse (RN) 1, the glucose testing supply box contained one red topped bottle (level 3 - higher blood glucose level) with discard date of 6/16/25 and one green topped bottle (level 1 - lower blood glucose level) with a discard date that was unable to be read. RN 1 stated the red and green topped bottles contained solutions used daily to test the glucometer to ensure accurate patient blood sugar test results. RN 1 stated the red topped bottle should have been discarded on 6/16/25 (21 days prior). RN 1 stated she was unable to read the outdate on the green topped bottle. During an interview on 7/7/25 at 10:10 a.m. with Emergency Department Manager (EDM), EDM stated the control solutions are good for 90 days after opened. EDM stated when opened the nurse was expected to write the “discard by” date on the front of the solution bottle. EDM stated the nurse who performs the glucometer testing each day was to check the discard dates before use of the control solutions. EDM stated if the solutions were used past the discard date, the glucometer control test results could give a false reading which could affect patient blood glucose testing by producing inaccurate results. During a review of the hospital’s P&P titled, “Point of Care Testing Nova Statstrip Glucose Meter,” dated 10/14/24, the P&P indicated, “2. StatStrip Glucose Control Solutions: Level 1 and 3. . . c. Once opened, the controls are stable for 3 months or until manufacturer’s expiration date, whichever comes first. D. Note expiration date once open.””

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 29618 Based on interview and record review the hospital failed to follow their policy and procedures (P&P) when: 1. One of one Emergency Department crash cart didn’t have expired items discarded. This failure had the potential for outdated supplies to be used on patients. 2. Two of three sampled patients (Patient 13 and Patient 17) had an incomplete “Acute Ischemic Stroke (AIS - occurs when blood clots or narrowed arteries restrict blood flow to the brain) TNKase (tenecteplase- medication to treat AIS by breaking down blood clots) Infusion Order Sheet (AISTIOS).” This failure had the potential to affect the decision to administer TNKase. 3. One of three sampled patients (Patient 13) received more than the maximum dose per P&P of TNKase. This failure had the potential for bleeding in the brain. Findings: 1. During a concurrent observation and interview on 7/7/25 at 9:40 a.m. with Emergency Department Manager (EDM) in the Emergency Department (ED), the crash cart was checked. On the fifth drawer there was a white sticker titled “Crash Cart Item Check.” The sticker indicated on 7/1/25 the first item to expire was 18 gauge needles. On the sixth drawer there was a white sticker titled “Crash Cart Item Check.” The sticker indicated on 7/6/25 the first item to expire was 10 fr (french -unit of measurement for the size of medical tubes) Triflow (suction tubing). During an interview on 7/7/25 at 9:41 a.m. with Emergency Department Director (EDD), EDD stated, “They [staff] should check and call for replacement (of expired supplies).” During a review of the facility’s P&P titled, “Emergency Crash Cart Procedure,” revision date 8/15/22, the P&P indicated, “B. Pharmacy Procedures: 5. The contents of the medication drawer(s) shall be inspected at least every 30 days by Pharmacy personnel to check for outdates and ensure lock integrity. D. Nursing Procedures: 6. b. A visual check to review earliest expiration stickers on all of the locked supply drawers. If any drawers are expiring before the next inspection, the Charge Nurse will be notified to coordinate exchange of the appropriate supply trays. 7. The crash cart checklist will be completed at least once every 24 hours.” 2. During a concurrent interview and record review on 7/8/25 at 9:30 a.m. with Stroke Coordinator (SC), the Electronic Medical Record (EMR) for Patient 13 was reviewed. The following was noted: ED Physician Notes, dated 4/29/25 at 08:04 (8:04 a.m.), indicated “Medical Decision Making: . . .we agreed to give the patient TNK (tenecteplase). . . TNK given at 0800.” AISTIOS, dated 4/29/25 for Patient 13 was not completed. SC confirmed the AISTIOS was incomplete. During a concurrent interview and record review on 7/8/25 at 11:00 a.m. with SC, the EMR for Patient 17 was reviewed. The AISTIOS, dated 6/2/25 for Patient 17 was not completed. SC stated, “It [AISTIOS] should of been completed. There’s only one box marked for if the patient is 18 years.” During an interview on 7/8/25 at 11:22 a.m. with SC, SC stated “The nurses are taught that the form needs to be done. There is a time out for the form before giving the medication [TNK].” During a concurrent interview and record review on 7/8/25 at 1:36 p.m. with Registered Nurse (RN) 2, Patient 17’s AISTIOS was reviewed. RN 2 stated she was the nurse to verify the TNK dose was correct. RN 2 stated, “The bedside nurse is to review it. If it’s not done the nurse should let the doctor know to complete it. Check the boxes.” During a concurrent interview and record review on 7/9/25 at 9:58 a.m. with Registered Nurse Regulatory Specialist (RS), the AISTIOS for Patient 13 and Patient 17 was reviewed. RS stated RN 3 was the administering RN for Patient 13, and RN 4 was the administering RN for Patient 17. During a concurrent interview and record review on 7/9/25 at 10:02 a.m. with EDM, the “ED Boot Camp (EDBC),” sign-in sheet, dated 8/20/24 - 8/23/24 was reviewed. The EDBC indicated RN 3 attended and received training. During a review of the facility training document titled EDBC, dated 8/20/24 thru 8/23/24, the EDBC indicated, “TNK - Inclusion/Exclusion criteria is required.” During a concurrent interview and record review on 7/9/25 at 10:17 a.m. with RS, RN 4’s “AHKC [facility name/county] Stroke Center Orientation (ASCO)” Certificate of Completion and training documents, dated 5/1/25 were reviewed. The ASCO training documents indicated, Slide 34 “Start the inclusion/exclusion criteria. . . .Pull the TNK to the bedside - Do NOT open until you have an order for the TNK and inclusion/exclusion criteria met!” During a concurrent interview and record review on 7/9/25 at 10:45 a.m. with RN 4, the AISTIOS for Patient 17 was reviewed. RN 4 confirmed that out of the 28 check boxes for the Inclusion and Exclusion criteria there was only one box checked. RN 4 stated the form has to be completed prior to the TNK administration. RN 4 stated, “It’s my responsibility to ensure it’s completed, and it’s not.” During an interview on 7/9/25 at 10:47 a.m. with RN 4, RN 4 was asked if she received training on completing the AISTIOS form, and RN 4 stated, “Yes, I did.” During a review of facility training document titled, “Stroke Quality Metrics (SQM),” dated 2025, the SQM indicated, “Before administering TNK, our stroke form must be filled out. . . Key points before TNK administration: Inclusion and exclusion criteria on the stroke form must be filled out by the ED physician . . .but the ED provider and nurse must still review the ENTIRE inclusion and exclusion checklist. Test Question- 4. True of False: It is the telestroke doctor’s responsibility to assure the inclusion and exclusion criteria is done. False: . . . it is the bedside nurse’s and ED physician’s role to go over the complete inclusion and exclusion criteria list.” During a review of the facility’s P&P titled, “Thrombolysis (a medical procedure that breaks down blood clots that are blocking blood flow in veins or arteries) For Acute Ischemic Stroke,” revision date 12/2/22, the P&P indicated, “C. Procedure: 1. Provider and/or Neurologist to assess for inclusion and exclusion criteria for thrombolysis. 2. The inclusion and exclusion criteria form (Attachment A) will be signed, timed, and dated by the ordering provider, or otherwise entered into the medical record indicating the review of the information on this form will be completed prior to ordering thrombolytic (medications that dissolve blood clots).” 3. During a concurrent interview and record review on 7/7/25 at 2:50 p.m. with Quality Assurance Registered Nurse (QRN), Patient 13’s EMR was reviewed. The following was noted: ED MSE (Medical Screening Exam- a procedure to detect health issues in individuals who don’t yet have symptoms, often before they would typically seek medical care), dated 4/29/25 indicated TNK if no bleed. ED Physician Notes, dated 4/29/25 at 08:04 (8:04 a.m.), indicated “Medical Decision Making: . . .we agreed to give the patient TNK (tenecteplase). . . TNK given at 0800.” AISTIOS dated 4/29/25, indicated at the top of box for administration “Dose: 0.25 mg (milligram)/kg (kilograms) (MAX [maximum] DOSE: 25 mg)” The bottom of box for calculation of administration indicated “Total Dose: 30 mg 6.5 ml (milliliter) given at 0800 (8:00 a.m.).” During a concurrent interview and record review on 7/8/25 at 8:35 a.m. with Risk and Regulatory Analyst (RRA), Patient 13’s Physican Order for TNK was reviewed. RRA stated Patient 13 received 30 mg of TNK, and confirmed the order indicated a max dose of 25 mg. During a concurrent interview and record review on 7/8/25 at 9:52 a.m. with SC, the EMR and AISTIOS for Patient 13 was reviewed. SC stated 25 mg was the recommended max dose. SC stated, “The dose was off of the patient weight. The Doctor talked to the wife about patient [Patient 13] getting 30 mg. There should be documentation about the overdose.” SC was unable to find documentation of a note regarding overdose. During an interview on 7/8/25 at 1:38 p.m. with RN 2, RN 2 stated 25 mg of TNK is the max dose, and the two nurses are to check the dose before giving. RN 2 was asked about giving a dose of 30 mg, and RN 2 stated, “You can’t the max is 25 mg.” During an interview on 7/8/25 at 1:47 p.m. with EDD, EDD stated, “There should be some type of documentation for giving more than the max amount.” During a concurrent interview and record review on 7/8/25 at 1:58 p.m. with EDD and SC, Patient 13’s Medication Administration Record and AISTIOS was reviewed. EDD and SC confirmed Patient 13 received 30 mg of TNK. EDD stated “It’s not recommended.” SC stated “There was no note by the Physician. It was a medication error.” During a concurrent interview and record review on 7/9/25 at 10:02 a.m. with EDM, the “ED Boot Camp (EDBC)” sign-in sheet, dated 8/20/24 - 8/23/24 was reviewed. The EDBC indicated RN 3 attended and received training. During a review of the facility training document titled EDBC, dated 8/20/24 thru 8/23/24, the EDBC indicated, “Policies reviewed during this Boot Camp: Acute Ischemic Stroke Management. Nursing & Thrombolysis for Stroke. Policy No. 16017.” During a review of facility training document titled, “SQM,” dated 2025, the SQM indicated, “Key points before TNK administration: Get the patient dose from the TNK dosing chart behind the stroke form. MAX DOSE IS 25 MG = 5 ML.” During a review of the facility’s P&P titled, “Thrombolysis For Acute Ischemic Stroke,” revision date 12/2/22, the P&P indicated, “E. Thrombolytic Administration: iii Calculate dose II. The maximum total dose of Tenecteplase for treatment of AIS is 25 mg.””

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 40516 Based on observation, interview, and record review, the hospital failed to ensure adequate staffing levels for the Emergency Department (ED) South for 19 of 19 sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, Patient 13, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18 and Patient 19). This failure resulted in state mandated staffing ratios not being met and had the potential for unmet care needs. Findings: During an interview on 2/18/25 at 1:50 p.m. with Regulatory Specialist (RS), RS stated the hospital does not have a nurse staffing policy and procedure but follows Title 22 (sets of regulations for health care facilities licensed by the state) for staffing and nurse ratios. During an observation on 2/19/25 at 9:30 a.m. in ED South, multiple recliners in a bay on the east side of ED South were filled with patients, patients were seated in three recliners around the nurse’s station, and three bays on the north side of the department had patients. During an interview on 2/19/25 at 90:35 a.m. with Shift Lead Registered Nurse (SLRN) 1, SLRN 1 stated she is the only RN for twenty patients in beds, recliners, and rooms. SLRN 1 stated there is one Quick Look RN (assesses patients’ acuity when entering the ED to determine how quickly the patient needs to be seen) but she is not assigned patients, and one triage RN who is not assigned patients but can help is she is not busy, and one licensed vocational nurse (LVN). SLRN 1 stated one RN came briefly from ED North but was called back to ED North. SLRN 1 stated her shift started at 7 a.m. and there were 13 patients in ED South at that time. SLRN 1 stated she thinks the nurse-to-patient ratio for the ED is 1:4 (one nurse for four patients). During an interview on 2/19/25 at 9:50 a.m. with Emergency Department Director (EDD), EDD stated, “The census is the ED is fluid” but gave no response as to why the float nurse did not stay in ED south or what other measures were taken. During a concurrent interview and record review on 2/19/25 at 10:12 a.m. with Emergency Department Nurse Manager (EDNM), EDNM stated nurses assigned as the Quick Look nurse are always at the entrance to the ED and the Quick Look nurse is not assigned patients. EDNM stated the ED Triage Nurse’s main duty was to input medical histories of patients and can help with patient related tasks when not busy, but are not assigned patients. Print out of patients in ED South from 7 a.m. to 9:35 a.m. and corresponding “ED Activity Log” reviewed. During an interview on 2/19/25 at 12:15 p.m. with Patient Care Executive (PCE), PCE stated it was her expectation that frontline staff be comfortable in reporting staffing concerns and for managers and directors to help with patient care as needed. During a review of Title 22 Code of Regulation Division 5 §70217 Nursing Service Staff a. (8) “In a hospital providing basic emergency medical services or comprehensive emergency medical services, the licensed nurse-to-patient ratio in an emergency department shall be 1:4 or fewer at all times that patients are receiving treatment. There shall be no fewer than two licensed nurses physically present in the emergency department when a patient is present. At least one of the licensed nurses shall be a registered nurse assigned to triage patients. The registered nurse assigned to triage patients shall be immediately available at all times to triage patients when they arrive in the emergency department. When there are no patients needing triage, the registered nurse may assist by performing other nursing tasks. The registered nurse assigned to triage patients shall not be counted in the licensed nurse-to-patient ratio.””

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 40516 Based on observation, interview, and record review, the hospital failed to ensure adequate staffing levels for the Emergency Department (ED) South for 19 of 19 sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, Patient 13, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18 and Patient 19). This failure resulted in state mandated staffing ratios not being met, and had the potential for unmet care needs. Findings: During an interview on 2/18/25 at 1:50 p.m. with Regulatory Specialist (RS), RS stated the hospital does not have a nurse staffing policy and procedure, but follows Title 22 (sets of regulations for health care facilities licensed by the state) for staffing and nurse ratios. During an observation on 2/19/25 at 9:30 a.m. in ED South, multiple recliners in a bay on the east side of ED South were filled with patients. Patients were seated in three recliners around the nurse’s station, and three bays on the north side of the department had patients. During an interview on 2/19/25 at 90:35 a.m. with Shift Lead Registered Nurse (SLRN) 1, SLRN 1 stated she is the only RN for twenty patients in beds, recliners, and rooms. SLRN 1 stated there is one Quick Look RN (assesses patients’ acuity when entering the ED to determine how quickly the patient needs to be seen) but she is not assigned patients, and one triage RN who is not assigned patients but can help is she is not busy. There is also one licensed vocational nurse (LVN). SLRN 1 stated one RN came briefly from ED North but was called back to ED North. SLRN 1 stated her shift started at 7 a.m. and there were 13 patients in ED South at that time. SLRN 1 stated she thinks the nurse-to-patient ratio for the ED is 1:4 (one nurse for four patients). During an interview on 2/19/25 at 9:50 a.m. with Emergency Department Director (EDD), EDD stated, “The census is the ED is fluid” but gave no response as to why the float nurse did not stay in ED south or what other measures were taken. During a concurrent interview and record review on 2/19/25 at 10:12 a.m. with Emergency Department Nurse Manager (EDNM), EDNM stated nurses assigned as the Quick Look nurse are always at the entrance to the ED. The Quick Look nurse is not assigned patients. EDNM stated the ED Triage Nurse’s duties is to input medical histories of patients and can help with patient related tasks when not busy but are not assigned patients. The print out of patients in ED South from 7 a.m. to 9:35 a.m. and corresponding “ED Activity Log” reviewed. During an interview on 2/19/25 at 12:15 p.m. with Patient Care Executive (PCE), PCE stated it was her expectation that frontline staff be comfortable in reporting staffing concerns and for managers and directors to help with patient care as needed. During a review of Title 22 Code of Regulation Division 5 §70217 Nursing Service Staff a. (8) “In a hospital providing basic emergency medical services or comprehensive emergency medical services, the licensed nurse-to-patient ratio in an emergency department shall be 1:4 or fewer at all times that patients are receiving treatment. There shall be no fewer than two licensed nurses physically present in the emergency department when a patient is present. At least one of the licensed nurses shall be a registered nurse assigned to triage patients. The registered nurse assigned to triage patients shall be immediately available at all times to triage patients when they arrive in the emergency department. When there are no patients needing triage, the registered nurse may assist by performing other nursing tasks. The registered nurse assigned to triage patients shall not be counted in the licensed nurse-to-patient ratio.””

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 42744 The hospital failed to meet the regulatory requirements for the Condition of Participation: CFR 482.23 Nursing Services as evidenced by the following: 1. Based on interview and record review, the facility failed to follow their policy and procedure (P&P) titled, “Facility Policy: Inter-disciplinary Care Planning,” for three of 51 sampled patients (Patient 2, Patient 3, and Patient 12) when comprehensive care plans were not initiated on admission. This failure had the potential to result in unmet care needs. (Refer to A-0396) 2. Based on interview and record review, the facility failed to follow their P&P titled, “Facility Policy: Post Anesthesia Recovery Standards of Care,” for three of five sampled Post Anesthesia Care Unit (PACU) patients (Patient 25, Patient 26, and Patient 29) when: Patients did not receive care in a safe environment. (Patient 25) Patients’ pain was not controlled. (Patient 25, Patient 26) Patients’ vital signs and Aldrete score (a scoring system from 0 to 10 that determines when a patient is ready for discharge from the PACU) were not assessed per P&P. (Patient 26, Patient 29) Family’s discharge education needs were not met. (Patient 25) Patients were discharged prior to meeting criteria for safe discharge. (Patient 26) Traveler (Agency nurses who are contracted for two-month assignments) PACU Registered Nurse (PACURN) was not provided adequate supervision and oversight. These failures resulted in inadequate pain management, unsafe discharge, lack of assessments, fear and anxiety, and unsafe nursing care. (Refer to A-0398) 3. Follow their P&P titled, “Facility Policy: Pain Management Assessment and Reassessment,” for four of 16 sampled patients (Patient 6, Patient 12, Patient 25, and Patient 28) when pain level was not reassessed. This failure had the potential to result in patients not receiving pain management due to lack of reassessment. (Refer to A-0398) 4. Based on interview and record review, the facility failed to follow their policy and procedure (P&P) titled, “Facility Policy: Medication Administration,” for two of four sampled patients (Patient 26 and Patient 27) in the Post Anesthesia Care Unit (PACU) when staff did not follow physician’s orders for administration of pain medication according to pain level. This failure had the potential for patients to receive inadequate pain control. (Refer to A-0405) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure nursing services were provided in a safe manner and patient care needs were being met.”

“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: 13095 The hospital failed to meet the regulatory requirements for the Condition of Participation: CFR 482.25 Pharmaceutical Services as evidenced by the following: 1. Based on observation, interview, and record review, the hospital failed to: a. Follow their policy and procedure (P&P) titled, “Patient Own Medication Storage” for five of six patients (Patient 34, Patient 35, Patient 36, Patient 37, and Patient 38) reviewed. b. Ensure that all overrides (override medications are medications that can be obtained prior to Pharmacy review. These medications are reserved for critical clinical situations) were addressed in a timely manner, for one of five patients’ (Patient 44) override transactions reviewed. c. Follow their P&P regarding maintaining records and providing evidence of drug discrepancy monitoring for the hospital’s Pyxis (Automated medication dispensing cabinet that securely stores and electronically tracks medications) removal transactions for nursing. These failures had the potential to result in diversion/medication loss for patient own medications and the diversion of overridden medications. (Refer to A-0491) d. Follow their policy and procedure (P&P) titled, “Model Policy: Controlled Substance Waste Disposal” when staff in the Surgical Intensive Care Unit (SICU) did not dispose of controlled substances in the proper waste container. This failure had the potential for narcotic medication waste being retrievable by staff and others. (Refer to A-0491) e. Ensure the P&P titled, “Facility Procedure: Medications Brought From Home,” was approved through the committee and board of directors. This failure had the potential to result in pharmacy and nursing staff being unaware of the procedure for handling patient medications brought from home. (Refer to A-0491) f. Ensure a medication storage refrigerator was appropriately equipped to alert staff when temperatures went out of range. This failure had the potential for patients to receive medications with unsafe or reduced potency from improper storage. (Refer to A-0491) 2. Based on Pharmacy staff interviews, and record review, the hospital failed to follow it’s policy and procedure for the administration and monitoring for four of six sampled patients (Patient 39, Patient 40,Patient 41, and Patient 43) who received Droperidol (a medication which is used as an antipsychotic and to reduce the incidence of nausea and vomiting). This failure had the potential of jeopardizing patient safety. (Refer to A-0500) 3. Based on interview and record review, the hospital failed to establish a contractual agreement between the hospital pharmacy and the supplier for a cardioplegia solution (a pharmacological therapy used during cardiac surgery to temporarily stop the heart) used during heart surgery; assign accurate expiration dating to compounded medications; and maintain the compounding equipment and environment in a manner to reduce the risk of contamination of medications. This failure had to potential to result in the hospital obtaining medications that were not prepared according to standards of practice and accepted quality assurance practices, patients receiving medications with unsafe or reduced potency from improper expiration date labeling or contamination. (Refer to A-0501) 4. Based on observation, interview, and record review, the hospital failed to ensure expired refrigerated medications were removed from the pharmacy’s active stock. This failure had the potential for patients to receive medications with unsafe or reduced potency from being used past their expiration date or improper storage. (Refer to A-0505) 5. Based on interview and record review, the hospital failed to develop a system to automatically stop drugs after a reasonable time or number of doses. This failure had the potential to result patients unnecessarily receiving medication and exposure to side effects. (Refer to A-0507) 6. Based on interview with Pharmacy Administrative Staff team and record review of the hospital’s policies and procedures (P&P), the hospital failed to ensure: a. A system to detect drug diversion, with the hospital’s Pyxis (Automated Drug Delivery Device) system. b. To report loss of controlled substances (medication with a high potential for abuse and addiction) in accordance with California State law within 30 days of being made aware of the incident. These failures had the potential for drugs to be removed from the facility without appropriate authorization and resulted in non-compliance with regulatory standards. (Refer to A-0509) 7. Based on interview and record review the hospital failed to: a. Ensure the hospital’s drug formulary did not contain non-drug items on the hospital’s drug specific formulary. b. Follow it’s Hospital Formulary policy and procedure. These failures had the potential of jeopardizing patient safety and ensuring that the facility remained in compliance with the regulations. (Refer to A-0511) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care, in compliance with the Condition of Pharmaceutical Services.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 42744 Based on interview and record review, the facility failed to follow their policy and procedure (P&P) titled, “Facility Policy: Inter-disciplinary Care Planning,” for three of 51 sampled patients (Patient 2, Patient 3, and Patient 12) when comprehensive care plans were not initiated on admission. This failure had the potential to result in unmet care needs. Findings: During a concurrent interview and record review on 10/31/24 at 10:09 a.m. with the 3 South Manager (3SM), Patient 2’s care plans (CPs), dated 10/30/24 were reviewed. 3SM stated Patient 2 was admitted on 10/29/24 at 6:20 p.m. and got to the unit on 10/30/24 at 3:27 p.m. Patient 2’s CPs indicated only one care plan that was initiated by the physical therapist on 10/30/24 at 11:03 a.m. 3SM stated the expectation was the patient’s needs should have been care planned within an hour or two of admission. 3SM stated subsequent nurses should have updated the care plan accordingly. 3SM stated Patient 2’s care plan had not been updated since his admission. 3SM stated Patient 2 should have had the following CPs initiated on admission: high risk for falls, blood glucose management, nutrition, risk for skin breakdown, safety due to confusion, and discharge readiness. During an interview on 10/31/24 at 10:43 a.m. with Registered Nurse (RN) 2, RN 2 stated she was the admitting nurse for Patient 2. RN 2 stated Patient 2 got to the floor about 3:27 p.m. RN 2 stated she had a busy shift and forgot to pass on to the next shift care plans needed to be done. RN 2 stated she should have done them but didn’t. During an interview on 10/31/24 at 10:49 a.m. with 3SM, 3SM stated it was not okay for RN 2 to pass initiating care plans to the next shift. 3SM stated night shift should have also caught that Patient 2 needed care plans. During a concurrent interview and record review on 11/4/24 at 12:20 p.m. with Registered Nurse Supervisor 5 North (RNS), Patient 3’s CPs, dated 10/31/24 were reviewed. Patient 3’s CPs indicated care plans initiated by the physical therapist on 10/31/24, but no comprehensive care plan was done on admission. RNS stated Patient 3 was admitted on 10/30/24 and the expectation was Patient 3 would have care plans addressing his needs within 24 hours of admission. RNS stated this did not happen. During a concurrent interview and record review on 11/4/24 at 3:02 p.m. with RNS, Patient 12 was admitted on 10/31/24. Patient 12’s CPs were reviewed, and indicated no nursing care plans were initiated until 11/2/24. RNS stated Patient 12’s care plans should have been initiated within 24 hours of admission. During a review of the facility’s P&P titled, “Facility Policy: Inter-disciplinary Care Planning,” dated 12/27/23, the P&P indicated, “POLICY SUMMARY/INTENT: The intent of this policy is to outline the elements in providing an individualized/patient-specific integrated plan of care for all patients through the use of an inter-disciplinary approach. . . POLICY COMPLIANCE- KEY ELEMENTS: . . . b. The written plan of care is based on the needs identified by the patient’s assessment, reassessment, results of diagnostic testing, patient’s goals and time frames, setting, and services required to meet the goals. C. The plan of care, goals for care, treatment, and services is dynamic and is revised as the needs of the patient changes. D. Based on the goals established in the patient’s plan of care, staff evaluates the patient’s progress to determine the progress towards the goal achievement and the effectiveness of the care plan. This evaluation takes place at least once every 24 hours. . . E. Within twenty-four hours of admission all patients shall have a plan of care initiated.””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 42744 Based on interview and record review, the facility failed to: 1. Follow their policy and procedure (P&P) titled, “Facility Policy: Post Anesthesia Recovery Standards of Care,” for three of five sampled Post Anesthesia Care Unit (PACU) patients (Patient 25, Patient 26, and Patient 29) when: a. Patients did not receive care in a safe environment. (Patient 25) b. Patients’ pain was not controlled. (Patient 25, Patient 26) c. Patients’ vital signs and Aldrete score (a scoring system from 0 to 10 that determines when a patient is ready for discharge from the PACU) were not assessed per P&P. (Patient 26, Patient 29) d. Family’s discharge education needs were not met. (Patient 25) e. Patients were discharged prior to meeting criteria for safe discharge. (Patient 26) f. Traveler (Agency nurses who are contracted for two-month assignments) Registered Nurse PACU (RN 1) was not provided adequate supervision and oversight. These failures resulted in inadequate pain management, unsafe discharge, lack of vital assessments, fear and anxiety, and unsafe nursing care. 2. Follow their P&) titled, “Facility Policy: Pain Management Assessment and Reassessment,” for four of 16 sampled patients (Patient 6, Patient 12, Patient 25, and Patient 28) when pain level was not reassessed. This failure had the potential to result in patients not receiving pain management due to lack of reassessment. Findings: 1.a. During an interview on 11/6/24 at 10:30 a.m. with Multi-Site Risk Manager (MSR), MSR stated RN 1 was soft spoken, thoughtful, and appropriate, then had a drastic change in behavior. MSR stated on 9/26/24 RN 1 was walking barefoot through the PACU, was swinging a cord around, and pulled the code blue (emergency response button) in a vacant bay. MSR stated RN 1 told them, “She just wanted to know who would come.” During an interview on 11/6/24 at 11:28 a.m. with Patient 25’s Family Member (FM) 1, FM 1 stated there was an issue with Patient 25’s nurse on 9/26/24 while in the PACU. FM 1 stated RN 1 did not let FM 2 come back to the PACU timely after Patient 25’s surgery. FM 1 stated RN 1 was acting bizarre, talking to herself, and acting abrasive towards other nurses. FM 1 stated Patient 25 was afraid to ask for anything because of RN 1’s behavior. During an interview on 11/6/24 at 11:44 a.m. with Patient 25’s FM 2, FM 2 stated RN 1 was rude from the beginning. FM 2 stated RN 1 would not answer her questions but told her “Hold on! He’s fine.” FM 2 stated, “I couldn’t ask her anything else. I didn’t want to upset her.” FM 2 stated it took RN 1 an hour to allow her back to the PACU to be with Patient 25. FM 2 stated, RN 1 told her she was going to get Patient 25 out of bed when she proceeded to pat the bed at the top, middle, bottom, and then make a sign like when airplanes come up to park. FM 2 stated she thought maybe RN 1 had a tick. FM 2 stated RN 1 did not mess with the computer like other nurses. FM 2 stated, “She was nice to us, but I knew there was something up with her because of the way she was acting, She would talk to herself, look at the wall, and then turn back to look at them. She got really aggressive with the nurses asking if they could help her. Once the nurses left, she picked up (Patient 25’s) finger like the birdy.” FM 2 stated she was not going to say anything to RN 1 because she could do anything with the IV (Intravenous access line). FM 2 stated RN 1 had her hold her phone when she went to the nurse’s station. FM 2 stated she was twirling a clear tube (nasal cannula tubing) and kept hitting the walls with it. FM 2 stated when RN 1 took out the IV, she slid it upward with her hand on the needle, which hurt (Patient 25), but “we did not want to piss her off because it could have gotten ugly.” FM 2 stated, “I know she was on something because you can tell. She was taking care of (Patient 25) and I didn’t want anything to happen to him.” During a review of the facility’s “Summary of Timeline and investigation for Suspected Diversion” (STISD), the STISD indicated Post Anesthesia Care Unit Manager (PACUM) received a call from another nurse in the PACU on 9/26/24 at approximately 8:30 p.m. stating RN 1’s behavior was erratic, odd, and she was not making sense. PACUM came to the hospital to investigate and found RN 1 walking around holding two charts, one with what appeared to be an IV catheter that had been removed from a patient attached to it, and two empty vials of medication.” During a review of the facility’s P&P titled, “Facility Policy: Post Anesthesia Recovery Standards of Care,” dated 7/15/2020, the P&P indicated, “Standards of Post Anesthesia Patient Care 1. Safety: Patient can expect to receive care in a safe and therapeutic environment. . . 3. Coping: Patients can expect that their anxiety/stressor(s) will be addressed and/or minimized. 4. Comfort: Patients can expect that their comfort needs will be met. . . 8. Education: If appropriate, the patients educational needs will be addressed. . . 10. Nursing Care: Each patient will receive optimum nursing care.” 1.b. During an interview on 11/5/24 at 3:37 p.m. with Patient 26, Patient 26 stated his pain was not controlled while he was in the PACU on 9/12/24. Patient 26 stated he opened his eyes, and it was the most excruciating pain he had ever felt in his entire life. Patient 26 stated, “I was white knuckling it.” Patient 26 stated RN 1 asked him what his pain level was on the pain scale, and he reported “15,” to which she replied to him, “Oh, Mr. (Patient 26), you’re not dying.” Patient 26 stated he was given medications like Fentanyl and Morphine, but all they did was make him sleepy. Patient 26 stated RN 1 was in a hurry to get him discharged and “the only regard was to get me out of there as fast as possible.” Patient 26 stated RN 1 told him, “If you are falling asleep you can’t be in that much pain.” Patient 26 stated there was no attempt to contact his physician for a change in pain medication and he was discharged home with excruciating pain at a level of 15. During an interview on 11/6/24 at 11:28 a.m. with Patient 25’s FM 1, FM 1 stated Patient 25 was done with surgery around 3 p.m. on 9/26/24 but was not discharged until 8 or 9 p.m. FM 1 stated Patient 25 was in a lot of pain the entire time he was in PACU. FM 1 stated RN 1 was acting bizarre and Patient 25 was afraid to ask for anything. During an interview on 11/6/24 at 12:11 p.m. with RN 4, RN 4 stated patients must have a discharge order, be stable, be easily arousable, and have pain controlled prior to discharge from the PACU. RN 4 stated the nurse should call the physician if a patient’s pain is not controlled. During an interview on 11/6/24 at 12:27 p.m. with Patient 25’s FM 2, FM 2 stated she told RN 1 Patient 25 was in pain. FM 2 stated RN 1 “got her phone and called the pharmacy.” FM 2 stated RN 1 never gave Patient 25 anything for pain. FM 2 stated Patient 25’s pain level was a ten when he was discharged from the PACU. During a concurrent interview and record review on 11/6/24 at 4:04 p.m. with Manager of Quality, Patient Safety, and Accreditation (MQPSA), Patient 25’s Medical Record (MR) was reviewed. Patient 25’s MR indicated Patient 25 was given Hydromorphone 0.5 mg intravenous (in the vein) for pain level of ten on 9/26/24 at 5:35 p.m. During a review of an email to Multi-Site Pharmacy Director (MSPD) from Senior Pharmacist for Controlled Substance Diversion (SCSP), dated 9/30/24 at 12 p.m., the email indicated RN 1 dispensed Fentanyl (a potent pain medication) 100 mcg on 9/26/24 at 4:38 p.m. and Meperidine (medication for the treatment of moderate to severe pain) 25 mg at 5:50 p.m. from the Pyxis (automated medication dispensing machine) for Patient 25. The email indicated RN 1 never documented administration, waste, or return of these medications. During a review of the Department’s “Intake Information,” dated 10/2/24, the Intake Information indicated, “PACU manager indicated two empty vials of Fentanyl and meperidine were found in her hand with no documentation supporting administration of these medications to the patient.” During a review of the facility’s P&P titled, “Facility Policy: Post Anesthesia Recovery Standards of Care,” dated 7/15/2020, the P&P indicated, “C. Standards of Post Anesthesia Nursing Practice . . . 4. Systems Assessment . . . n. Pain Assessment Parameter (Re-assess frequently until pain or discomfort is controlled) i. Functional ability and ability to relax ii. Pain type, location, quality, and frequency (continuous or intermittent) will be assessed utilizing the self-reported pain rating scale . . . iii. Self-report of comfort level utilizing a numerical scale (0 to 10 scale), modified FLACC (Face, Legs, Activity, Cry, Consolability- Behavioral pain assessment scale used for patients who are unable to rate their pain level) or age appropriate pain scale. iv. Physical appearance (e.g. pain/discomfort behaviors: Pain behaviors are highly individual and the absence of any specific behaviors, e.g. facial expression or body movement, does not indicate the absence of pain) . . . vi. Achievement of pain relief/ comfort treatment goals. O. Report promptly to MD (medical doctor): . . . v. Non-relief of pain . . . G. Discharge 1. Patient discharge form the Post Anesthesia Care Unit will be after a final nursing assessment and evaluation have determined it is safe to do so . . .a. Patients may be transferred to Phase II recovery (Outpatients) or to the Nursing Unit (Inpatients) according to physician order and when the following criteria are met: . . . iv. Absence or control of pain . . . b. Patients may be discharged from Phase II or home according to a physician order and when the following criteria are met: . . . x. Patient is free of excessive pain.” 1.c. During a concurrent interview and record review on 11/6/24 at 2:58 p.m. with MQPSA, Patient 26’s MR was reviewed. Patient 26 was in the PACU on 9/12/24. Patient 26’s MR indicated the Aldrete score was “4” on 9/12/24 at 8:59 a.m., “8” at 9:10 a.m., “10” at 10 a.m., and “10” at 10:20 a.m. Patient 26’s MR indicated a baseline pre-op blood pressure (BP- measurement of adequate circulation) of 118/75 at 5:38 a.m., then BPs of 146/95 at 8:59 a.m., 129/110 at 9:10 a.m., 143/81 at 10 a.m., and 165/81 at 10:20 a.m. Patient 26’s MR indicated on the Aldrete score Patient 26’s BPs were +/- 20 mmHg (millimeters of mercury- unit of measurement for BP) of preop BP at 8:59 a.m., 9:10 a.m., 10 a.m., and 10:20 a.m. MQPSA stated Patient 26’s BPs were going up his entire stay in the PACU and BPs were not within +/- 20 mmHg of the baseline BP as indicated in the MR. MQPSA stated the last BP was way over baseline. MQPSA stated RN 1 did the Aldrete score twice ten minutes apart, which also did not follow the P&P. During a review of the facility’s STISD, the STISD indicated RN 1 9/12/24 was her first shift in the PACU. STISD indicated on 9/25/24 Patient 26’s surgeon contacted the Surgery Director (SD) and expressed concern that Patient 26 was discharged with a pain level of 7/10 from the PACU. STISD indicated Patient 26 reported to his surgeon that his pain was not controlled prior to discharge. During a concurrent interview and record review on 11/6/24 at 4:37 p.m. with MQPSA, Patient 29’s MR, dated 9/25/24 was reviewed. Patient 29’s MR indicated the last time an Aldrete score was done was at 2:15 p.m. Patient 29 met discharge criteria from the PACU at 5:12 p.m. even though no more Aldrete scores were documented. MQPSA stated Aldrete score should have been documented per P&P. During a review of the facility’s P&P titled, “Facility Policy: Post Anesthesia Recovery Standards of Care,” dated 7/15/2020, the P&P indicated, “C. STANDARDS OF POST ANESTHESIA NURSING PRACTICE: . . . 4. Systems Assessment . . . m. Vital signs . . . ii. Aldrete/ Return of protective reflexes and motor function: I. On arrival II. 15 minutes x 1 III. Every 30 minutes until discharge from PACU phase 1 iii. PACU 2 Vital Signs- (pertains to outpatients only) I. Every 15 minutes x 2 . . . II. Every 30 minutes x 2 . . . III. Hourly until discharge from the unit.” 1.d. During an interview on 11/6/24 at 11:28 a.m. with Patient 25’s FM 1, FM 1 stated RN 1 handed the family Patient 25’s discharge instructions and told them to “just read the discharge paperwork. I don’t have time to go over it. You have to read it yourself.” During an interview on 11/6/24 at 12:27 p.m. with Patient 25’s FM 2, FM 2 stated RN 1 gave no instructions for discharge, only provided paperwork. FM 2 stated RN 1 provided a lot of band-aids instead of tape in the supplies sent home with Patient 25 for dressing changes. FM 2 stated she used the band-aids provided and Patient 25 got a red rash from using the band-aids. During a review of the facility’s P&P titled, “Facility Policy: Post Anesthesia Recovery Standards of Care,” dated 7/15/2020, the P&P indicated, “Standards of Post Anesthesia Patient Care . . .8. Education: If appropriate, the patients educational needs will be addressed. . . G. Discharge . . . 1.b. Patient may be discharged from Phase II or home according to a physican order and when the following criteria are met. . . viii. Patient/family member verbalizes understanding of discharge instructions.” 1.e. During a concurrent interview and record review on 11/6/24 at 2:58 p.m. with MQPSA, Patient 26’s MR was reviewed. Patient 26 was in the PACU on 9/12/24. Patient 26’s MR indicated a pre-op blood pressure of 118/75. Patient 26’s MR indicated his last vital signs were taken at 10:20 a.m. and his blood pressure was 165/81. Patient 26’s MR indicated his pain level was “7” at discharge. MQPSA stated Patient 26 was discharged at 11:02 a.m. without rechecking his vital signs to ensure he was stable. MQPSA stated Patient 26 did not meet discharge criteria based on policy. During a review of the facility’s STISD, the STISD indicated RN 1 9/12/24 was her first shift in the PACU. STISD indicated on 9/25/24 Patient 26’s surgeon contacted the SD and expressed concern that Patient 26 was discharged with a pain level of 7/10 from the PACU. STISD indicated Patient 26 reported to his surgeon that his pain was not controlled prior to discharge. During a review of the facility’s P&P titled, “Facility Policy: Post Anesthesia Recovery Standards of Care,” dated 7/15/2020, the P&P indicated, “G. Discharge . . . b. Patients may be discharged from Phase II or home according to a physician order and when the following criteria are met: . . . iii. Patients cardiovascular status exhibits regular rate or per pre-op status, blood pressure within 50mmHG of pre-op status. . . viii. Patient/family member verbalizes understanding of discharge instructions . . . x. Patient is free of excessive pain.” 1.f. During a concurrent interview and record review on 11/5/24 at 3:44 p.m. with Network Human Resources Director (NHRD), RN 1’s personnel records (PR) were reviewed. PR indicated the majority of RN 1’s nursing career was as a Traveler, working in one facility for no more than two months. PR indicated RN 1 was not employed from January 2023 to August 2024. During an interview on 11/5/24 at 4:23 p.m. with MQPSA, MQPSA stated, “We don’t typically do evals of travelers, not unless there are questions.” During an interview on 11/6/24 at 8:43 a.m. with PACUM, PACUM stated because Travelers are experienced nurses, they receive training from a preceptor on the PACU’s processes including receiving a patient from the operating room, pain management, how to tell if physician orders look proper, who to call for issues, how to use the medication dispensing unit, how to waste narcotics, and how to chart in the computer, among other things. PACUM stated Travelers are precepted for one day on the unit. PACUM stated she meets personally with the new employees to make sure they are comfortable on the unit and to answer questions. PACUM stated she does not personally do any chart reviews for Travelers. During a review of the facility’s P&P titled, “Facility Policy: Post Anesthesia Recovery Standards of Care,” dated 7/15/2020, the P&P indicated, “A. Responsibility. 1. The Department Director/ Manager/ Unit shift leader is responsible for maintaining safety standards, developing safety rules, supervising and training personnel in department standards.” 2. During a concurrent interview and record review on 11/4/24 at 2:37 p.m. with Registered Nurse Supervisor 5 North (RNS), Patient 12’s Medical Record (MR), dated 11/3/24 was reviewed. Patient 12’s MR indicated one tab of Acetaminophen-Hydrocodone (Norco- a strong pain relief medication for moderate to severe pain) was given on 11/3/24 at 8:25 a.m. for a pain level of “10” (most severe pain level) in the abdomen. The MR indicated there was no reassessment of Patient 12’s pain level after the administration of the Norco. RNS stated Patient 12’s pain should have been reassessed within an hour after giving oral pain medication. During a concurrent interview and record review on 11/4/24 at 4:01 p.m. with Charge Nurse 4 Telemetry (CN), Patient 6’s MR, dated 11/3/24 was reviewed. The MR indicated Patient 6 received Ofirmev (Acetaminophen Intravenous used to treat pain) 1000 mg on 11/3/24 at 3:24 a.m. for head pain at a pain level four. The MR indicated Patient 6’s pain was not reassessed until 7:29 a.m. CN stated Patient 6’s pain should have been reassessed within thirty minutes to an hour after the medication was given. During a concurrent interview and record review on 11/6/24 at 4:04 p.m. with MQPSA, Patient 25’s MR, dated 9/26/24 was reviewed. Patient 25 was admitted to the PACU on 9/26/24 at 10:32 a.m. The MR indicated Patient 25 had a pain level of “10” on 9/26/24 at 5:35 p.m. and was medicated with Hydromorphone (a pain reliever five to ten times stronger than morphine) 0.5 mg intravenously by RN 1. MQPSA stated no pain reassessment was done. During a concurrent interview and record review on 11/6/24 at 4:22 p.m. with MQPSA, Patient 28’s MR, dated 9/13/24 was reviewed. Patient 28 was admitted to the PACU on 9/13/24 at 10:53 a.m. Patient 28’s MR indicated Patient 28 received Fentanyl (a potent opioid pain medication) 25 mcg on 9/13/24 at 11:52 a.m. and 12:02 p.m. by RN 1. MQPSA stated there was no pain reassessment after the second dose of Fentanyl and Patient 28’s blood pressure went up at that time. MQPSA stated Patient 28 should have been reassessed in the PACU, but the reassessment was not done until 1:30 p.m. by the floor nurse. During a review of the facility’s P&P titled, “Facility Policy: Pain Management Assessment and Reassessment,” dated 6/20/24, the P&P indicated, “Policy: Compliance- Key Elements . . . C. Pain Reassessment 1. A pain reassessment shall be performed within one hour after pain intervention.””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 42744 Based on interview and record review, the facility failed to follow their policy and procedure (P&P) titled, “Facility Policy: Medication Administration,” for two of four sampled patients (Patient 26 and Patient 27) in the Post Anesthesia Care Unit (PACU), when staff did not follow physician’s orders for administration of pain medication according to pain level. This failure had the potential for patients to receive inadequate pain control. Findings: During a concurrent interview and record review on 11/6/24 at 2:48 p.m. with Manager of Quality, Patient Safety, and Accreditation (MQPSA), Patient 26’s Medical Record (MR), dated 9/12/24 was reviewed. Patient 26’s MR indicated Morphine 2 mg was given at 9:33 a.m., 9:50 a.m., and 10:20 a.m. for a pain level of 7 (severe pain). Patient 26’s MR indicated Morphine was to be given for a pain level of 4-6 (moderate pain). MQPSA stated Registered Nurse PACU (RN 1) did not follow the physician’s orders for a pain level of 7. During a concurrent interview and record review on 11/6/24 at 3:37 p.m. with MQPSA, Patient 27’s MR, dated 9/25/24 was reviewed. Patient 27’s MR indicated Patient 27 received Fentanyl 25 mcg at 6:25 p.m. for a pain level of 10 and at 6:55 p.m. for a pain level of 5. Patient 27’s MR indicated Fentanyl 25 mcg was to be given for a pain scale of 1-3 (mild pain). MQPSA stated Fentanyl 25 mcg was indicated for a mild pain and RN 1 did not follow physician’s orders. During a review of the facility’s P&P titled, “Facility Policy: Medication Administration,” dated 2/29/24, the P&P indicated, “Policy Compliance- Key Elements A. Administration 1. Medications at [hospital] will be administered only upon the order of physicians, physician’s assistants, nurse practitioners, or clinical pharmacist, who are members of the Medical Staff, or have been granted clinical privileges to write such orders and under the guidelines of their respective scopes of practice.””

“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: 13095 Based on observation, interview, and record review the hospital failed to: 1. Follow their policy and procedure (P&P) titled, “Patient Own Medication Storage” for five of six patients (Patient 34, Patient 35, Patient 36, Patient 37, and Patient 38) reviewed. 2. Ensure that all overrides (Override Medications are medications that can be obtained prior to Pharmacy review. These medications are reserved for critical clinical situations) were addressed in a timely manner, for one of five patients’ (Patient 44) override transactions reviewed. 3. Follow their policy and procedure regarding maintaining records and providing evidence of drug discrepancy monitoring for the hospital’s Pyxis (automated medication dispensing cabinet that securely stores and electronically tracks medications) removal transactions for nursing. These failures had the potential to result in diversion/medication loss for patient own medications and the diversion of overridden medications. 4. Follow their P&P titled, “Model Policy: Controlled Substance Waste Disposal,” when staff in the Surgical Intensive Care Unit (SICU) did not dispose of controlled substances in the proper waste container. This failure had the potential for narcotic medication waste being retrievable by staff and others. 5. Ensure the P&P titled “Facility Procedure: Medications Brought From Home” was approved through the committee and board of directors. This failure had the potential to result in pharmacy and nursing staff being unaware of the procedure for handling patient medications brought from home. 6. Ensure a medication storage refrigerator was appropriately equipped to alert staff when temperatures went out of range. This failure had the potential for patients to receive medications with unsafe or reduced potency from improper storage. Findings: 1. During an observation of the hospital’s “Pharmacy Patient Own Medication Storage Area”, on 10/30/2024 at 11:35 a.m. and review of the Pharmacy policy and procedure (P&P) titled, “Medication Brought From Home”, dated 7/22/2022, the P&P indicated “. . . 3.(e) The Nurse shall be responsible for ensuring delivery of the sealed bag to the pharmacy.” For three patients (Patient 34, Patient 35, and Patient 36) it revealed that their medications were never brought down to the Pharmacy by their Nurses. During a concurrent interview and record review on 10/30/2024 at 11:45 a.m. with the Operations Pharmacy Manager (OPM), the hospital P&P titled, “Medication Brought From Home,” dated 7/22/2022 was reviewed. OPM stated “Nursing staff are not allowed to use the hospital’s Pneumatic Tube System (PTS), to send patient own medications down to the hospital Pharmacy.” On further examination, Patient 36’s medications had been sent down to the Pharmacy using the hospital’s PTS on 10/27/2024 contrary to the hospital’s policy. Review of the Patient’s Own Medication log for Patient 34, revealed that the Pharmacy had no documentation on the log of which Nurse had brought Patient 34’s medications down to the Pharmacy, as requested on the hospital’s Patient Own Medication log. Further interview with Pharmacy Administrative Staff team and review of the Pharmacy’s Patient Own Medications log revealed that Patient 36’s medications had been left in a Pharmacy return bin up on a unit. Pharmacy staff who found the medications on the hospital unit’s return bin, brought these medications down to the hospital’s Pharmacy contrary to the hospital’s policy and procedure. Further review of the hospital’s policy and procedure indicated, “Medications may be disposed of 30 days after discharge if not picked up . . .” Review of the Patient Own medication storage area revealed that Pharmacy did not know or have any record of when these patients had been discharged from the hospital. Some of the logs indicated that someone in the Pharmacy had attempted to get ahold of some of these patients without success as almost all of the logs indicated that the patients had been called and a message had been left for the patients. For Patients 37 and Patient 38, whose medications came into the hospital’s pharmacy on 9/23/2024 and 9/30/2024 respectively, the Pharmacy was unable to locate these patient’s medications and the Pharmacy had no record of what had happened with these patient’s medications. Neither of the documents in the Patient’s Own Medication Storage log had any signatures that these medications had been returned to these patients. During a concurrent interview and record review on 10/30/2024 at 12:15 p.m. with OPM, OPM confirmed that the Pharmacy could not figure out what had happened to the patients’ own medications. Review of the hospital’s P&P titled “Medication Brought From Home,” dated 7/22/2022, the P&P indicated “3. All medications brought in with the patient upon admission will be returned to the patient or patient representative upon discharge as outlined . . .” For six out of seven Patient Own Medication belonging bags, only one of the Patient’s Own Medications had been returned to the patients, contrary to the hospital’s policy and procedure. 2. During a review of the hospital’s “All Device Events Narrative Report (Override),” date range 10/31/24 to 11/5/24, revealed that the hospital’s Pharmacy had been unable to locate a physician’s order for Piperacillin Tazobactam (Zosyn) 4.5 grams which had been removed from the Pyxis using the override function on 10/31/2024, for Patient 44. This override meant that 6 days after the Nurse had taken the Zosyn from the Pyxis without a valid physician’s order, the Pharmacy was still unable to validate that a physician had ordered this medication for Patient 44. During a review of the hospital’s P&P titled, “Pyxis Medstation ES and Medication Management”, undated and unapproved, the P&P indicated “Override Medications are medications that can be obtained prior to Pharmacy review. These medications are reserved for critical clinical situations . . . The RN obtaining the override medication is responsible for ensuring that an order for the medication is generated and transmitted to the Pharmacy as soon as possible. Pharmacy will review all override reports each day to ensure that any override meds (medication) without orders or improper utilization of the override privilege are referred to the designated Clinical Director for follow up . . . Override report of all medications that have been overridden during the previous 24 hours will be analyzed. If not acceptable, education, follow-up and disciplinary action will occur as appropriate. . . The use of override should only be used in cases of legitimate patient emergencies, not convenience. The order, related to an override, must then be scanned and charted appropriately.” During an interview on 11/5/2024 at 2:50 p.m. with the hospital’s Pharmacy Administrative Staff team confirmation was provided that the hospital never addressed or followed up on this override as outlined in the hospital’s P&P. The hospital’s Pharmacy Administrative Staff team also confirmed during this interview that 6 days without being able to locate a medication order for the Zosyn was unacceptable. The hospital’s P&P also failed to address a time frame for which these overrides need to be resolved. 3. During an interview on 11/6/2024 at 9:30 a.m. with the hospital’s Pharmacy Administrative Staff team, Pharmacy Administrative Staff team stated that the hospital had just installed the hospital’s Pyxis (Automated Drug Delivery Devices) in August of this year (2024). OPM stated the Pyxis discrepancy reports are generated automatically by the “system”, every morning at 5:00 a.m. OPM stated that the Pharmacy was not keeping records of these discrepancy reports, so the hospital was unable to provide evidence that they had completed reviews of these reports. OPM stated that the hospital had “thrown away” all of the discrepancy reports that had been generated, since the hospital had started using the Pyxis devices. This meant the hospital had no way of showing that the hospital had been reconciling the Nurses medication discrepancies. During a review of the hospital’s P&P titled, “Pyxis Medstation ES and Medication Management”, undated and unapproved (which had been provided to the surveyors) indicated, “v. Discrepancy reports will be monitored by the Pharmacy on a daily basis to investigate contributing factors to unbalanced machine PAR’s (periodic automatic replenishment- levels help determine inventory levels). Unit Directors will receive feedback regarding employee behavior, which results in inaccurate PAR maintenance for corrective action . . . Pharmacy: Controlled Substance discrepancies will be reviewed by pharmacy management per nursing area via a daily report. 1. Unclear reasons or incorrect resolutions will be returned to the charge nurse or nurse manager to obtain a corrected written statement by the user who created the discrepancy . . .the written statement will be returned to the pharmacy and filed with all of the discrepancy reports that may be reviewed . . .” The hospital failed to follow the policy and procedure which the hospital had provided to the survey team.. 42744 4. During a concurrent observation and interview on 10/29/24 at 2:48 p.m. with Manager of Quality, Patient Safety, and Accreditation (MQPSA) at the medication waste area in the SICU, a black plastic bin with a white lid containing a yellow circular removable cap, labeled “Kendall RCRA Hazardous Waste Container,” and dated 9/10/24 was observed. The yellow cap was opened, and the container had approximately one inch of liquid in it. The liquid was accessible to remove from the open container. MQPSA stated the unit should have a jug to dispose of liquid narcotic waste. During a concurrent observation and interview on 10/29/24 at 2:50 p.m. with Intensive Care Unit Manager (ICUM) at the medication waste area in the SICU, an empty bracket was observed on the wall. ICUM stated the bracket on the wall was for the narcotic waste disposal jug. ICUM stated she thought the waste container disposal company put the black containers on the unit and did not replace the jug in the bracket. During an interview on 10/29/24 at 3:05 p.m. with Registered Nurse (RN) 3 in the SICU, RN 3 stated she did not think the jug was there yesterday. RN 3 stated she was not sure when the jug went away. RN 3 stated maybe it went away in late September when the facility implemented the new Pyxis (medication dispensing cabinet). During a concurrent interview and record review on 10/29/24 at 4:35 p.m. with Multi-Site Director of Pharmacy (MSDP), photos of the plastic black bin with a white lid containing a yellow circular seal, labeled “Kendall RCRA Hazardous Waste Container,” located in the SICU were observed. MSDP stated, “This is not the right one. Deterra (used to destroy and properly dispose of unused, unwanted and expired medications) is the one they should be using.” MSDP stated waste disposal bins for narcotics must deactivate the product. During a review of the hospital’s P&P titled, “Controlled Substance Waste Disposal,” dated 11/30/23, the P&P indicated, “Definitions: 1. Designated controlled substance waste container- A secured container designated to deposit waste of controlled medications rendering them irretrievable. . . Policy: Compliance- Key Elements A. Unused controlled medications are wasted in a designated controlled substance waste container in accordance with established procedure and documentation requirements.” 5. During a concurrent interview and record review on 11/6/24 at 11:39 a.m. with MSDP, the hospital’s policy and procedure (P&P) titled, “Facility Procedure: Medications Brought From Home,” dated 7/11/22 was reviewed. The P&P indicated, “Approval Pathway: None.” MSDP stated she was in the process of revising this P&P (revision 4), so it did not have an approval pathway. MSDP stated the previous revision should have gone through an approval pathway. MSDP stated she would review the online history for this P&P to confirm. During an interview on 11/6/24 at 2:30 p.m. with MSDP, MSDP stated the P&P had not been routed through committees for approval. MSDP stated the P&P should have gone through and been approved by the Nursing Committee, Pharmacy and Therapeutics Committee, Medical Executive Committee, and Clinical Board of Directors, but had not. During a review of the hospital’s P&P titled, “Facility Procedure: Policy Development and Approval Routing,” dated 12/4/23, the P&P indicated, “Policy: Compliance- Key Elements A. Lucidoc [P&P management program.] Administrator (LA) and Director, Risk Management & Accreditation. 1. The LA will review documents submitted for approval routing in Lucidoc and schedule approval routing in Lucidoc . . . . 3. The LA and Director, Risk Management & Accreditation are tasked with: a. Reviewing Policies and Procedures (P&P) and other documents to ensure that they are routed for review to the appropriate committees/individuals . . . D. Approval Routing . . . 2. The recommended flow for approvals is as follows: 3.a. Submitted to the LA for appropriate committee routing. i. First approval goes to all committees affected by the policy/procedure/form. These committees include General Committee Path, Medical Staff Department Committees, Pharmacy & Therapeutics (P&P) Committee Path. ii. If the policy affects the Medical Staff or is physician driven it will then go to the Medical Executive Committee (MEC) for approval. iii. Final policy approvals go to the Clinical Practice (CP) Subcommittee, where upon approval will be made Official. iv. All Clinical Practice Consent Agendas are sent quarterly to Community Board for final approval. . . 4. Lucidoc process: . . . b. Once all committee approvals have been documented, the document will be published official and any previous revisions will be archived.” 43258 6. During a concurrent observation and interview on 10/28/24 at 11:44 a.m. with OPM, the hospital’s Pharmacy Chemo Med (Medication) Refrigerator was inspected. The refrigerator had two thermometers, one that was built into the refrigerator itself and a second digital thermometer that was affixed to the outside with a temperature probe placed inside. OPM confirmed the pharmacy relied on the externally affixed digital thermometer to monitor storage conditions and alert staff of temperature excursions. OPM confirmed the refrigerator’s built-in thermometer indicated the temperature was 3.6 degrees Celsius and was actively fluctuating up and down while the affixed digital thermometer read 4.1 degrees Celsius. OPM stated the digital thermometer was set to send temperature excursion alerts to staff if the temperature went below 2 degrees Celsius or above 8 degrees Celsius. During a concurrent interview and record review on 10/28/24 at 12:27 p.m. with OPM, the Pharmacy Chemo Med Refrigerator Monthly Report dated September 2024 was reviewed. OPM confirmed the report indicated the refrigerator reached a maximum of 14.2 degrees Celsius on 9/21/24. OPM confirmed he did not receive an alert to notify him of the temperature excursion. During an interview on 10/28/24 at 12:36 p.m. with Pharmacy IT Technician (PITT), PITT stated he set up the digital thermometers for medication storage refrigerators to send alerts to himself and pharmacy staff whenever there were temperature excursions. He stated he received reports and alerts to his phone and reviewed the refrigerators that were set up to alert him. PITT confirmed the Chemo Med Refrigerator had not been set up to alert him or pharmacy staff of temperature excursions since it was first put in use, and that it was an oversight. PITT stated the alarm for the thermometer was turned off and confirmed no one was alerted of the temperature excursion on 9/21/24. He stated there was no way for staff to have been alerted if the temperature went out of range. During an interview on 10/28/24 at 1 p.m. with Multi-Site Director of Pharmacy (MSRD), MSRD confirmed the Pharmacy Chemo Med Refrigerator had been in use by the hospital’s pharmacy since October 30, 2023. During a review of the hospital’s P&P titled, “Facility Procedure: Inventory Storage, Handling and Disposal,” dated 8/19/24, the P&P indicated, “Procedure: Compliance- Key Elements . . . B. Pharmacy inventory items (compounded and non-compounded) with an expiration or beyond-use date have a limited shelf life and must be closely monitored to ensure proper usage and shipment to patients . . . E. Storage: 1. Pharmacy inventory items and CSPs must be stored in conditions consistent with USP/NF and manufacturer recommendations as follows: a. Controlled Cold Temperature: 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit . . .” During a review of the hospital’s P&P titled, “Facility Policy: Temperature and Humidity Monitoring in Compounding and Controlled Storage Areas,” dated 11/30/23, the P&P indicated, “Policy: Compliance- Key Elements C. Procedures . . . b. Continuous recording devices are preferred over thermometers because the individual taking the daily reading can review the past 24-hour period to ascertain any deviations from expected . . . D. Documentation 1. Daily temperature readings will be recorded on the Temperature and Humidity Monitoring Log or its electronic equivalent. 2. The log will be used unless there is both an audible alarm for excursion AND a continuous history of temperatures is kept on file for each device . . .” During a review of the hospital P&P titled, “Facility Policy: Storage of Medications (General Statement),” dated 3/8/19, the P&P indicated, “Policy: Compliance- Key Elements ... D. All items requiring refrigeration shall be stored in a refrigerator designated only for storage of medications. All refrigerators will contain thermometer for temperature monitoring. All temperatures will be kept between 36 to 46 degrees Fahrenheit . . . and monitored via computerized electronic temperature sensors. 1. In the even that the temperature is out of range. . . Pharmacy will be notified by the system and steps to solve the issue . . .””

“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: 13095 Based on Pharmacy staff interviews, and record review, the hospital failed to follow it’s policy and procedure for the administration and monitoring for four of six sampled patients (Patient 39, Patient 40,Patient 41, and Patient 43) who received Droperidol (a medication which is used as an antipsychotic and to reduce the incidence of nausea and vomiting). This failure had the potential of jeopardizing patient safety. Findings: During a review of the hospital’s policy and procedure (P&P) titled “Droperidol”, dated 5/8/2024, the P&P indicated “A. Cases of QT prolongation, torsade de pointes (TdP), and death have been reported with Droperidol in a dose-dependent manner with some cases occurring in patients with no know risk factors and doses at or below recommended ...6. A baseline QTc should be obtained (within 48 hours) for all single or cumulative (within 2 hours) doses of = or greater than 2.5 mg, followed by either a 12-lead ECG (a non-invasive test that measures the heart’s electrical activity and is used to diagnose and monitor heart conditions) or continuous telemetry monitoring 2-3 hours post dose.” During a review of the the following four patient (Patient 39, Patient 40,Patient 41, and Patient 43) clinical records, the clinical records did not reveal a baseline or follow up ECG as outlined in the hospital’s policy and procedure above. 1. During a review of the clinical record with hospital staff for Patient 39 on 10/31/2024 at 12 p.m., Patient 39 received 2.5 mg of Droperidol on 8/30/2024 at 11:14 a.m. Only a baseline ECG had been completed, but no ECG was done for this patient post dose administration as outlined in the hospital’s policy and procedure. 2. Review of the clinical record with hospital staff for Patient 40 on 10/31/2024 at 12:05 p.m., Patient 40 received 5 mg of Droperidol on 10/11/2024 at 4:54 p.m. No baseline ECG had been completed prior to the patient receiving the medication as outlined in the hospital’s policy and procedure. 3. Review of the clinical record with hospital staff for Patient 41 on 10/31/2024 at 12:30 p.m., Patient 41 received a 1.25 mg dose of Droperidol on 10/24/2024 at 3:37 p.m., and 5 mg dose of Droperidol on 10/24/2024 at 8:55 p.m. No ECG had been done for this patient post dose administration as outlined in the hospital’s policy and procedure. 4. Review of the clinical record with hospital staff for Patient 43 on 10/31/2024 at 12:45 p.m., Patient 43 received a 5 mg dose of Droperidol on 9/18/2024 at 4:32 p.m. No ECG had been done for this patient post dose administration as outlined in the hospital’s policy and procedure above. The manufacturer of the drug Droperidol published a package insert which has the FDA’s Black Box Warning in bold print and it reads: “WARNING 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. Due to its potential for serious proarrhythmic 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 (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS). 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 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, use of a diuretic, cardiac hypertrophy, hypokalemia, hypomagnesemia, or administration of other drugs known to increase the QT interval). Other risk factors may include age over 65 years, alcohol abuse, and use of agents such as benzodiazepines, volatile anesthetics, and IV opiates. Droperidol should be initiated at a low dose and adjusted upward, with caution, as needed to achieve the desired effect.””

“PHARMACIST SUPERVISION OF SERVICES CFR(s): 482.25(b)(1) §482.25(b)(1) - All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. This Standard is not met as evidenced by: 43258 Based on interview and record review, the hospital failed to establish a contractual agreement between the hospital pharmacy and the supplier for a cardioplegia solution (a pharmacological therapy used during cardiac surgery to temporarily stop the heart) used during heart surgery; assign accurate expiration dating to compounded medications; and maintain the compounding equipment and environment in a manner to reduce the risk of contamination of medications. This failure had to potential to result in the hospital obtaining medications that were not prepared according to standards of practice and accepted quality assurance practices, patients receiving medications with unsafe or reduced potency from improper expiration date labeling or contamination. Findings: During an interview on 10/30/24 at 9:31 a.m. with Multi-Site Risk Manager (MSR) and Multi-Site Director of Pharmacy (MSDP), MSR stated there was no contract that outlined the agreement between the hospital and the supplier who provided Del Nido Cardioplegia Solution (a solution used to protect the heart during cardiac surgery when the heart needs to be stopped) to the pharmacy for inpatient use. During an interview on 10/31/24 at 1:16 p.m. with MSDP, MSDP stated the hospital’s pharmacy had been purchasing cardioplegia from the supplier since 6/12/17 (over 7 years). A review of the hospital’s purchases from the supplier indicated the hospital had purchased a total of 104 units of Del Nido Cardioplegia Solution 1000 mL from 8/14/23 to 10/10/24, an average of nearly nine units per month. During a review of the hospital’s policy and procedure (P&P) titled, “Facility Policy: Scope of Service- Pharmacy,” dated 5/2/24, the P&P indicated, “Policy: Compliance- Key Elements. . . B. The department will provide medications for neonate, infant, pediatric, adolescent, adult, and geriatric patients in accordance with currently accepted State and Federal regulatory standards for pharmaceuticals. . .” During a concurrent observation and interview on 10/30/24 at 12:30 p.m. with Pharmacy Technician (PT), the Segregated Compounding Area (SCA - a designated space for preparing sterile medications that is separate from the rest of a pharmacy) was inspected. A metal cart with human hair wrapped around the wheels was identified. PT confirmed the finding and agreed the hair should have been cleaned from the cart. The hood used for preparing medications was observed with a broken side panel at the base where it attached into a metal bracket to secure it. The broken base had cracks and crevices that were not accessible for cleaning and had visible buildup. PT confirmed the cracked hood needed repair to prevent buildup of contaminants in the space between the metal bracket and the side of the hood. The perimeter of the SCA was observed to have a light black, dusty and gritty buildup on the floor. PT explained the cleaning agent used to clean the floors had a chemical residue that it left behind. She confirmed dust and dirt had accumulated on the build up of residue that should have been cleaned to maintain a clean compounding area. During a concurrent interview and record review on 10/30/24 at approximately 1 p.m. with Lead Pharmacist (LP), pictures of the findings inside the SCA area were reviewed. LP stated they had tried different cleaning agents but dealt with an issue of residue buildup. She confirmed there was potential for better cleaning in the SCA and the hood needed repair to maintain sanitary conditions. During an observation and interview on 10/30/24 at approximately 1:15 p.m. with LP, and intravenous (IV) preparation that had just been compounded in the SCA was observed. The label on the preparation indicated it was prepared on 10/30/24 at 8:53 a.m. and a beyond use date (BUD, an expiration date) of 10/31/24 at 8:55 a.m., 24 hours later. LP stated the IV preparation should have only had a BUD of 12 hours after preparation, not 24 hours. During an interview on 10/30/24 at 2:58 p.m. with Multi-Site Director of Pharmacy (MSDP), MSDP stated the pharmacy followed USP 797 (standards that ensure the safety and quality of compounded sterile medications) for sterile compounding and confirmed observed IV preparation should have only had a 12-hour expiration date. During an interview on 10/31/24 at 2:46 p.m. with MSDP, MSDP stated the hospital’s software for the SCA automatically assigned the 24-hour expiration date for IV preparations and the pharmacists needed to manually cross out the date and assign a 12-hour BUD. She stated the library for compounded formulas was shared across the entire hospital system and the 24-hour BUD was appropriate for other hospital pharmacy compounding areas that were appropriately designed. She stated their SCA was designed to allow for up to 12 hours BUD for IV preparations and confirmed that a medication could leave the pharmacy if the pharmacist overlooked manually changing the BUD. During a review of the hospital’s P&P titled, “Facility Policy: Scope of Service- Pharmacy,” dated 5/2/24, the P&P indicated, “Policy: Compliance- Key Elements. . . B. The department will provide medications. . .in accordance with currently accepted State and Federal regulatory standards for pharmaceuticals ...” During a review of the hospital’s P&P titled, “Facility Policy: Sanitization of the Controlled Sterile Compounding Environments,” dated 8/20/24, the P&P indicated, “Policy Summary/Intent. . . Environmental contact is a major source of microbial contamination of CSPs, therefore scrupulous attention to cleaning and disinfecting of the areas used for sterile compounding is required to reduce and minimize this potential source of CSP contamination. . .” During a review of the hospital’s P&P titled, “CSP (compounded sterile preparations) Stability and Beyond Use Dating,” dated 10/31/22, the P&P indicated, “Policy: Compliance- Key Elements ... A. Beyond use dating is assigned to CSPs based on the default storage periods in of USP <797> and is based on both the chemical stability and microbial sterility of the components as well as the compounding risk level of a given CSP ... 3. BUDs may NOT exceed those based on the storage times published in USP Chapter <797> ... Table 1: Maximum Storage Periods according to Risk Level in the absence of sterility testing ... Storage Temperatures: Controlled Room Temperature. . . Segregated Compounding Area. . . 12 hours. . .””

“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: 43258 Based on observation, interview, and record review, the hospital failed to ensure expired refrigerated medications were removed from the pharmacy’s active stock. This failure had the potential for patients to receive medications with unsafe or reduced potency from being used past their expiration date or improper storage. Findings: During a concurrent interview and tour of the hospital inpatient pharmacy on 10/28/24 at 11:44 a.m. with Operations Pharmacy Manager (OPM), one bottle propylthiouracil (medication to treat thyroid disease) 50 milligrams/milliliter (mg/ml, a unit of measurement) oral solution expired 5/29/24 was identified inside the chemotherapeutics refrigerator. Three bags ganciclovir (medication to treat infection) 300 mg in sodium chloride 0.9% intravenous (IV, into the vein) were also identified, one expired 8/25/24, the second expired 8/26/24, and the third unlabeled with an expiration date. OPM confirmed the identified medications were expired and should have been removed from stock and discarded. During a review of the hospital’s policy and procedure (P&P) titled, “Facility Procedure: Inventory Storage, Handling and Disposal,” dated 8/19/24, the P&P indicated, “Procedure: Compliance- Key Elements. . . B. Pharmacy inventory items (compounded and non-compounded) with an expiration or beyond-use date have a limited shelf life and must be closely monitored to ensure proper usage and shipment to patients. . . E. Storage. . . 6. A restricted or quarantined inventory area must be set up where recalled, damaged, or unusable/sellable products, drugs and/or solutions are stored. This area must be physically segregated from the in-use pharmacy inventory. 7. Pharmacy inventory is best stored in manner that allows for rapid review of lot number and expiration dating. . . 10. All inventories will be checked routinely to ensure product integrity and allow for removal of expired drugs, products and solutions. The pharmacy manager will establish the time interval of the routine checks.””

“STOP-ORDERS FOR DRUGS CFR(s): 482.25(b)(5) §482.25(b)(5) - Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff. This Standard is not met as evidenced by: 43258 Based on interview and record review, the hospital failed to develop a system to automatically stop drugs after a reasonable time or number of doses. This failure had the potential to result patients unnecessarily receiving medication and exposure to side effects. Findings: During a concurrent observation and interview on 11/4/24 at 2:15 p.m. with Multi-Site Director of Pharmacy (MSDP), the hospital’s electronic health record system was reviewed. MSDP selected Protonix (a medication to treat chronic acid reflux) intravenous (IV, into the vein) in the ordering system and confirmed there were no restrictions for indications for use and or automatic stop system to limit duration of treatment or number of doses. During an interview on 11/6/24 at approximately 8 a.m. with Multi-site Risk Manager (MSR), MSR stated the hospital did not have a policy or list of medications that determined and established a reasonable time to automatically stop orders for drugs and biologicals not specifically prescribed as to time or number of doses. A review of the manufacturer’s package insert (MPI) for Protonix, undated, the MPI indicated, “1. Indications and Usage ... PROTONIX I.V. for Injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis. Safety and efficacy of PROTONIX I.V. for Injection as a treatment of patients with GERD and a history of erosive esophagitis for more than 10 days have not been demonstrated.””

“REPORTING ABUSES/LOSSES OF DRUGS CFR(s): 482.25(b)(7) Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate. This Standard is not met as evidenced by: 13095 Based on interview with Pharmacy Administrative Staff team and record review of the hospital’s policies and procedures (P&P), the hospital failed to ensure: 1. A system to detect drug diversion, with the hospital’s Pyxis (Automated Drug Delivery Device) system. This failure had the potential for drugs to be removed from the facility without appropriate authorization. 2. To report loss of controlled substances (medication with a high potential for abuse and addiction) in accordance with California State law within 30 days of being made aware of the incident. This failure resulted in non-compliance with regulatory standards. Findings: During a review of the hospital’s suspected drug diversion report indicated a Travel Nurse (RN 1- Registered Nurse Post Anesthesia Care Unit [PACU]), who had worked in the hospital’s PACU on 9/26/2024, was observed exhibiting strange behavior and found with empty vials of Fentanyl and Meperidine (both controlled narcotics). No patient orders could be found for any of the nurse’s patients at the time that these empty vials were discovered. RN 1 was asked to take a medical screening and a drug test, but refused to take either. Review of the hospital’s policies and procedures revealed that the hospital did not have a policy and procedure which addressed monitoring for controlled drug diversion with the hospital’s Pyxis units. During a Microsoft TEAMS(computer) interview on 10/29/2024 at 9:10 a.m. with the Senior Pharmacist for Controlled Substance Diversion (SCSP), Multi-Site Risk Manager (MSR), Clinical Pharmacy Director (CPD), and Post Anesthesia Care Unit Manager (PACUM), SCSP stated they did not have a way to monitor the hospital’s Anesthesiologists activities because the hospital was still using paper records. SCSP also stated that even though the Pharmacy has a Drug Diversion monitoring system Bluesight, also known as Control Check (can compare Individual Risk Identification Scores [IRIS]). IRIS scores are weighted assessments of the degree of difference between controlled substance users. By using IRIS scores, individual controlled drug transactions can be tracked. SCSP stated during the interview that he was unfamiliar with how to use the IRIS scores to evaluate staffs-controlled drug usage. Both CPD and SCSP stated that the hospital did not have any other Pharmacist, who would be able to provide the same level of controlled drug monitoring if the SCSP had to go out on vacation leave, illness, accident, injury, etc. The hospital had not developed a system to ensure that controlled drug monitoring activity would have been able to continue in his absence. The SCSP also stated that he does not use this feature (IRIS scores) to evaluate the hospital staff as he was unclear about the correct way to analyze these IRIS scores. SCSP, stated that he had not used this IRIS score system for the last two years, even though it was available for use. SCSP and CPD stated that the hospital’s Nurse Managers and Nursing Supervisors had not received any continual training on Bluesight (Control Check). CPD confirmed that Nursing Management and Nursing Supervisors had received minimal training on Bluesight at best. This was confirmed by PACUM, who indicated that she had been in her role for 11 months, but she could not remember receiving any training on how to decipher Bluesight (Control Check). The hospital’s MSR during the TEAMs meeting confirmed that the hospital’s policy and procedure for controlled and regulated substance stewardship did not align with the hospital’s recently developed charter. The hospital was also unable to resolve the following, inconsistencies which had been created by RN 1, as the only source for RN 1 to obtain the following medications was from the hospital’s Pyxis machine. On 9/25/2024 RN 1 removed only one vial of Fentanyl 100 mcg (micrograms) /2 ml (milliliters), yet RN 1 documented in the patient’s medical record that she administered (a total of 150 mcg), 50 mcg on 9/25/2024 at 2:14 p.m., 50 mcg at 2:46 p.m., and 50 mcg at 3:30 p.m. RN 1 could not have administered 150 mcg of Fentanyl from a single 100 mcg vial. On the same day RN 1 documented in a patient’s medical record that she administered Norco (a controlled drug) 10mg-325 mg to a patient, but the Pyxis (Automated Drug Delivery Device). Records indicate that RN 1 never pulled this strength of Norco from the Pyxis machine, so there was no way that this Nurse could have administered this medication to her patient on that day. On 9/17/2024 RN 1 pulled one 2 mg syringe of Morphine (a controlled drug), but RN 1 documented in the patient’s medical record that she had administered three 2 mg doses of Morphine, but the Pyxis report did not indicate that 2 additional doses of Morphine had been pulled from the Pyxis by RN 1. These and other types of “inconsistencies” could have been identified with the hospital’s use of IRIS (Individual Risk Identification Score) if the hospital had employed this portion of their Bluesight (controlled drug diversion system). 43258 2. During an interview on 10/28/24 at 4:22 p.m. with MSR, MSR stated the hospital had been made aware of an incident that involved diversion of controlled substances (medication with a high potential for abuse and addiction) by nursing staff on 9/26/24. During an interview on 10/28/24 at 4:41 p.m. with Multi-Site Director of Pharmacy (MSDP), MSDP stated a report for the loss of controlled substances had not been reported to the California Board of Pharmacy but agreed it should have been. She acknowledged and agreed the report was to have been made within 30 days of having been made aware of the loss. During a review of the California State Board of Pharmacy regulation for reporting drug loss, the regulation indicated, “The owner shall submit. . . to the Board a report. . . no later than thirty (30) days after the date of discovery of the following. . . Any loss of a controlled substance. . .””

“FORMULARY SYSTEM CFR(s): 482.25(b)(9) A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs. This Standard is not met as evidenced by: 13095 Based on interview and record review the hospital failed to: 1. Ensure the hospital’s drug formulary did not contain non-drug items on the hospital’s drug specific formulary. 2. Follow it’s Hospital Formulary policy and procedure. These failures had the potential of jeopardizing patient safety and ensuring that the facility remained in compliance with the regulations. Findings: The following are just a few examples and are not all inclusive of the non-formulary drug which appeared on the hospital’s local drug formulary. 1. During a concurrent interview and record review on 11/4/24 at 2:25 p.m. with the Pharmacy Administrative staff team, the hospital’s specific local drug formulary was reviewed. Pharmacy Administrative staff team revealed the following non-drug item was listed: Baby Powder which is an over-the-counter item which does not require a prescription, as confirmed by Pharmacy Administrative Staff team, who agree that Baby Powder should not be on the hospital’s drug formulary as the hospital has not carried this item since 2007 (17 years ago). Additional review of the hospital’s specific local drug formulary and interview with Pharmacy Administrative staff team revealed the following non-drug item was listed: Emollients moisturizing cream which is also over the counter and has no active drug ingredients, and multiple versions of this product should not have been on the Pharmacy’s Drug Formulary. Fixodent denture adhesive cream which is also over the counter and has no active drug ingredients, as it is not a product that the Pharmacy carriers or dispenses to the hospital’s patients. The Pharmacy Administrative Staff team confirmed these products should not have been on the Pharmacy’s Drug Formulary. The document that was provided to the survey team was just a billing document and the hospital had not developed a true drug formulary which Nursing staff, Pharmacy staff, and Medical staff would be able to review and use as an official hospital drug formulary. 2. During a review of the hospital’s policy and procedure (P&P) titled, “Hospital Formulary,” dated 7/30/2024, the P&P indicated “5. The Hospital also has established an antimicrobial formulary. This formulary shall specify which antibiotics shall be used in the hospital and also includes suggested dosage and frequencies.” Review of the “unofficial” hospital drug formulary was provided, the hospital was unable to provide an antimicrobial drug formulary. Further review of the P&P “Hospital Formulary” indicated “9. A drug information document (Attachment A) will be available to all prescribers and nurses.” The hospital did not provide an “Attachment A” to go with the hospital’s formulary P&P. During an interview on 11/4/2024 at 2:30 p.m. with Pharmacy Administrative Staff team and Hospital Administrative staff, confirmed the hospital did not have a drug information document of the drug formulary as outlined in the hospital’s P&P above. Based on the interview above, the Medical, Nursing, and Pharmacy staff did not have access to the hospital’s drug formulary.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 47095 Based on interview and record review the facility failed to ensure Registered Nurse (RN) care met the professional standards when: 1. A change in condition notification to Medical Doctor (MD) was not done per Policy and Procedure (P&P) titled, “ASSESSMENT AND REASSESSMENT OF PATIENTS” for one of 31 sampled patients (Patient 30). 2. Vitals signs (heart rate, breathing rate, pain, oxygen level, and blood pressure) were not done every 15 minutes for one of 31 sampled patients (Patient 30) during an administration of an intravenous (IV- medication delivery into a vein) medication Norepinephrine (medication to increase blood pressure). 3. The facility’s P&P titled, “STANDARDIZED PROCEDURE: RAPID RESPONSE TEAM RRT MANAGEMENT OF PATIENTS” was not followed for respiratory distress (difficulty breathing) for one of 31 sampled patients (Patient 30). These failures resulted in a disruption in the continuity of quality care nursing services, providers not being updated on patient care changes and outcomes for Patient 30. Findings: 1. During a concurrent interview and record review on 9/26/24 at 9:16 a.m. with Quality Safety Registered Nurse (QSRN), Patient 30’s “Vitals Section (VS),” dated 4/30/24 was reviewed. The VS indicated on, 4/30/24, at 1:34 a.m., Patient 30’s heart rate was 140 (normal heart rate 60 to 100 beats per min[ute]-bpm) and breathing rate was 56 (normal breathing rate 12 to 22) breathes per minute. QSRN stated, Patient 30 was breathing fast, admitted for Sepsis (a life-threatening condition that occurs when the body’s immune system overreacts to an infection or injury, causing organ dysfunction) and was “very sick.” QSRN stated the facility process for change in condition was not followed and MD should have been contacted regarding Patient 30’s increased respiratory rate of 56 and heart rate of 140 bpm. QSRN stated on 4/30/24, at 4:12 a.m., Patient 30’s heart rate was 121 bpm, breathing rate was 30, and pulse oximetry (measurement of oxygen level) was 81% (normal oxygen level greater than or equal to 92%) with supplemental oxygen at 10 liters/minutes delivery via nasal cannula (a tube device used to deliver oxygen through the nose). QSRN stated MD was not notified of Patient 30’s condition for respiratory distress and should have been. During a concurrent interview and record review on 9/26/24 at 9:18 a.m. with QSRN, the facility’s P&P titled, “ASSESSMENT AND REASSESSMENT OF PATIENTS,” dated 11/27/18 was reviewed. The P&P indicated, “A. The following processes will be followed to identify and deliver the proper patient care, treatment, and services. . . H. INTERVENTION- 1. The planning and delivery of patient care shall reflect all elements of the nursing process. . . 4. RNs play the predominant role in the timely communication of the patient’s response or lack of response to treatment to others, such as the physician.” QSRN stated MD should have been notified of Patient 30’s change in condition. During a concurrent interview and record review on 9/26/24 at 1:33 p.m. with MD. Patient 30’s medical record (MR), dated 4/30/24 was reviewed. There was no indication of MD being notified of Patient 30’s respiratory distress condition. MD stated Patient 30’s respiratory distress should have been reported to her. 2. During a concurrent interview and record review on 9/25/24 at 3:32 p.m. with QSRN, Patient 30’s “Physician Order (PO),” dated 4/30/24 was reviewed. The PO indicated, “Norepinephrine drip 8 mg (milligram) + (plus) Sodium Chloride 0.9% premix diluent titrate.” QSRN stated the facility P&P included vitals signs for Norepinephrine were to be obtained and assessed every 15 minutes with an infusion of Norepinephrine. During a concurrent interview and record review on 9/25/24 with QSRN at 3:36 p.m. Patient 30’s “Medication Administration Record (MAR),” dated 4/30/24 was reviewed. The MAR indicated Norepinephrine drip was started on 4/30/24, at 5:37 a.m. QSRN stated there were no vitals prior to the administration or every 15 minutes after being initiated. During a concurrent interview and record review on 9/30/24 at 11:17 a.m. with QSRN, the facility’s P&P titled, “ASSESSMENT AND REASSESSMENT OF PATIENTS,” dated 11/27/18 was reviewed. The P&P indicated, “F. VITAL SIGN ASSESSMENT- 1. Vital signs include the following: Temperature, blood pressure, pulse, respirations, and level of pain. . . 3. The frequency of vital signs throughout a shift is based on clinical area and the patient’s condition. a. Critical Care: Blood pressure, pulse, respiratory rate, and other hemodynamic measurements should be monitored and recorded. . . Frequent VS, e.g., every 15 minutes, may be required according to specific care/treatment guidelines, medications, and interventions.” QSRN stated there were no vitals signs obtained every 15 minutes for Patient 30. QSRN stated the facility’s P&P should have been followed. 3. During a concurrent interview and record review on 9/25/24 at 3:27 p.m. with QSRN, Patient 30’s “Rapid Response Team (RRT) note,” dated 4/30/24 was reviewed. The RRT note indicated on, 4/30/24, at 4:40 a.m., Patient 30 had respiratory distress and a RRT call was placed for a critical care trained nurse evaluation. QSRN stated there was 28 minutes from the time Patient 30 had a drop in his oxygen level to when the RRT was implemented. QSRN stated the facility process is to call a RRT when there is a decrease in oxygenation below 92%, increased respirations, changes in heart rate, and a nurse concern for the patient condition. QSRN stated Patient 30 had physician orders that included to monitor and maintain an oxygen saturation level equal to or greater than 92%. QSRN stated Patient 30 had an oxygen level of 81% with supplemental oxygen in use of 10 liters/minute via nasal cannula with a breathing rate of 30, and that was criteria for a Rapid Response. During a concurrent interview and record review on 9/25/24 at 3:41 p.m., with QSRN, the facility’s P&P titled, “STANDARDIZED PROCEDURE: RAPID RESPONSE TEAM RRT MANAGEMENT OF PATIENTS,” dated 12/29/2020 was reviewed. The P&P indicated, “STANDARDIZED PROCEDURE SUMMARY/INTENT. . . for safe and appropriate management by the Rapid Response Team (RRT) for patients exhibiting signs and symptoms of impending respiratory and/or cardiovascular collapse. . . C. Circumstances under which the RN may perform the function: 1. . . . The RRT may be activated in all situations where rapid patient evaluation is needed including but not limited to the following signs/symptoms. . . a. Circulation: Acute change in. . . heart rate. . . > [greater than] 130 bpm. . . b. Airway: Respiratory distress and/or threatened airway. C. Breathing: Acute change in respiratory rate > 30. . . SpO2 < 90% despite oxygen use. . . f. Staff concern: Nurse or other hospital staff members are worried or concerned about patient. . . failure to respond to treatment, increasing level of care or acuity.” QSRN stated Patient 30’s oxygen saturation was critically low, and a RRT should not have taken 28 minutes to call. During an interview on 9/26/24 at 1:56 p.m. with MD, MD stated, “30 minutes or so is a long time, we cannot put the person [Patient 30] at risk.” MD stated Patient 30 met rapid response criteria.”

“CONTENT OF RECORD: ORDERS,NOTES,REPORTS CFR(s): 482.24(c)(4)(vi) [All records must document the following, as appropriate:] All practitioner’s orders, nursing notes, reports of treatment, medication records, radiology and laboratory reports, and vital signs and other information necessary to monitor the patient’s condition. This Standard is not met as evidenced by: 47095 Based on interview and record review the facility failed to ensure completeness of a medical record (MR) for one of 31 sampled patients (Patient 30) when a heart monitoring tracing strip was not included in the MR for one of 31 sampled patients (Patient 30). This failure resulted in an incomplete medical record for Patient 30. Findings: During a concurrent interview and record review on 9/26/24 at 9:27 a.m. with Quality Safety Registered Nurse (QSRN), Patient 30’s “Telemetry (heart monitoring) Tracings (TR),” dated 4/29/24 to 4/30/24 was reviewed. The TR indicated, on 4/30/24 Patient 30 had no documented telemetry tracing other than the code blue (medical emergency) telemetry tracing. QSRN stated Patient 30 was admitted to a telemetry care area with heart monitoring ordered, and there should be a telemetry tracing rhythm strip in his MR. QSRN stated the facility process included the registered nurse (RN) to review, sign, and have the telemetry tracing rhythm strip scanned into the MR. QSRN stated Patient 30 had no telemetry tracing documentation to provide from the telemetry care area. During a concurrent interview and record review on 9/26/24 at 4:30 p.m. with QSRN, the facility’s P&P titled, “MEDICAL RECORD CONTENT AND COMPLETENESS”, dated 12/28/22 was reviewed. The P&P indicated, “POLICY SUMMARY/INTENT. . . Assure the medical record contains patient specific data and information to . . . support the diagnosis, facilitate patient care, treatment of services. . . support decision analysis, justify treatment. . . to provide a medical record for all patients that is timely, meaningful, an authentic and legible description of the patient’s clinical condition and hospital course. . . define a complete and properly documented patient medical record that supports patient care. . . E. The patient medical record shall include. . . 3. Any findings of assessments and reassessments. . . 9. Any observations relevant to care, treatment, and service.” QSRN stated, “All documentation for Patient 30’s care should be in the MR, and not documented is incomplete and not done.” During a concurrent interview and record review on 9/26/24 at 5:04 p.m. with QSRN, the facility’s P&P titled, “REMOTE CARDIAC TELEMETRY MONITORING & AUTOSTOP PROCEDURE”, dated 2/22/23 was reviewed. The P&P indicated, “C. PROCEDURE. . . 13. Telemetry tracings, trends, and alarm reviews will be reviewed . . . The strips will be placed in the medical record by the RN after reviewing, signing, dating and timing it. . . a. Any significant arrhythmia events observed between routine 12-hour reviews and tracings will be documented by running a strip and documenting in the chart.” During an interview on 9/30/24 at 3:39 p.m. with Chief Medical Officer (CMO), CMO stated Patient 30’s chart had a lack of documentation and “not documented is not done.” CMO stated all staff was to follow policy, and that included complete and accurate documentation of the care provided.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 42148 The hospital failed to meet the regulatory requirements for the Condition of Participation: CFR 482.13 Patient’s Rights as evidenced by the following: 1. Based on interview and record review, the hospital failed to ensure the “CONDITIONS OF REGISTRATION [COR- a legal agreement between the patient and the hospital consenting to treatment, assignment of insurance benefits accepting financial responsibility for their medical services]” policy and procedure (P&P) was followed for two of 32 sampled patients (Patient 3 and Patient 4). This failure resulted in Patient 3 and Patient 4 not being informed of the care agreement for care services and financial obligations during their hospitalization. (Refer to A-0117) 2. Based on interview and record review, the hospital failed to ensure the “Advanced Healthcare Directives, Surrogate Decision Maker” policy and procedure (P&P) was followed for four of 32 sampled patients (Patient 1, Patient 10, Patient 11, and Patient 12). This failure resulted in violation of patient right to make medical care decisions and formulate an advance directive (a written statement of a person’s wishes regarding medical treatment, often including a living will, made to ensure those wishes are carried out should the person be unable to communicate them to a doctor). (Refer to A-0132) 3. Based on observation, interview, and record review, the hospital failed to: Provide personal privacy to one of 32 sampled patients (Patient 2) when Patient 2’s legs and brief were exposed in an area that could be seen by other patients, staff, and visitors. Ensure that Protected Health Information (PHI- also referred to as personal health information like name, date of birth, medical histories, test and laboratory results, mental health conditions, insurance information and other data that a healthcare professional collects to identify an individual) was protected and not accessible by unauthorized persons for five of 32 sampled patients. (Patient 7, Patient 8, Patient 9, Patient 13, and Patient 16). These failures resulted in violation of the right to privacy and dignity for Patient 2 and a violation of confidentiality for Patient 7, Patient 8, Patient 9, Patient 13, and Patient 16. (Refer to A-0143) 4. Based on observation, interview, and record review, the hospital failed to ensure a safe environment for one of 32 sampled patients (Patient 1) when: Patient 1, who was not registered as a patient for treatment, was given access to a secured locked location. Patient 1 accessed laboratory specimen collection supplies and collected her blood with the use of her Port-a-Cath (an implanted device used for blood draws and medications that is placed in front of a patient’s chest). Patient 1 collected her own blood specimen without proper training. These failures had the potential to cause harm, infection, and contribute to adverse patient outcomes. (Refer to A-0144) 5. Based on interview and record review, the hospital failed to follow it’s “STANDARD POLICY: RESTRAINT MANAGEMENT (MECHANICAL, CHEMICAL, SECLUSION) policy and procedure (P&P) for three of five sampled patients (Patient 2, Patient 3, and Patient 4) when nursing restraint ongoing patient assessment, least restrictive measures, alternative planning, and implementation of nursing restraint checks every two hours for Patient 2, Patient 3, and Patient 4 were not completed. This failure had the potential to result in Patient 2, Patient 3, and Patient 4 experiencing adverse health outcomes due to restraint use. (Refer to A-0175) The cumulative effect of these systemic problems resulted in the hospital’s failure to ensure patient rights were protected.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 42148 The hospital failed to meet the regulatory requirements for the Condition of Participation: CFR 482.23 Professional Standards as evidenced by the following: 1. Based on observation, interview, and record review, the hospital failed to ensure Registered Nursing (RN) care met the professional standards when: Critical laboratory results were not reported to a physician for three of 32 sampled patients (Patient 2, Patient 14, and Patient 15). Wound assessment and prevention were not completed for 3 of 3 sampled patients (Patient 4, Patient 5 and Patient 6). These failures resulted in providers not being updated on patient care changes and outcomes for Patient 2, Patient 4, Patient 5, Patient 6, Patient 14, and Patient 15.(Refer to A-0395) 2. Based on interview and record review, the hospital failed to ensure a nursing care plan was developed, implemented, and revised to meet professional standards for three of three sampled patients (Patient 4, Patient 5 and Patient 6). This failure resulted in Patient 4, Patient 5, and Patient 6’s needs not met and had the potential to contribute to an adverse health outcome. (Refer to A-0396) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure nursing services were provided in a safe manner and patient care needs were being met.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 47095 Based on interview and record review, the hospital failed to ensure the “CONDITIONS OF REGISTRATION [COR- a legal agreement between the patient and the hospital consenting to treatment, assignment of insurance benefits accepting financial responsibility for their medical services]” policy and procedure (P&P) was followed for two of 32 sampled patients (Patient 3 and Patient 4). This failure resulted in Patient 3 and Patient 4 not being informed of the agreement for care services and financial obligations during their hospitalization. Findings: During a concurrent interview and record review on 7/26/24 at 9:14 a.m. with Patient Access Manager (PAM) the hospital’s P&P titled, “CONDITIONS OF REGISTRATION,” dated 4/20/20 was reviewed. The P&P indicated, Patients written documented agreement for care services with a signature page for consent. PAM stated the expectation was for the Patient Access Staff (PAS) to follow the Hospital’s P&P. PAM stated when patients were unable to sign, the PAS were expected to document the reason the patient was unable to sign, have their designated representative sign on their behalf, and reattempts to sign the COR. During a concurrent interview and record review on 7/26/24 at 9:17 a.m. with PAM, Patient 3’s COR was reviewed. The COR indicated, a verbal notation for Patient 3’s consent signature. PAM stated the hospital’s COR P&P was not followed. During a concurrent interview and record review on 7/26/24 at 9:20 a.m. with PAM, Patient 4’s COR was reviewed. The COR indicated, a verbal notation for Patient 4’s consent signature. PAM stated, “no it [COR P&P] was not” followed for Patient 4’s consent signature. During a review of the Hospital’s P&P titled, “CONDITIONS OF REGISTRATION,” 4/20/20 indicated, “POLICY SUMMARY/INTENT: It is the policy of the Patient Access Department to have all patients or their legal representative sign the Conditions of Registration at the time of admission given that the every patient has the legal right to agree to refuse medical treatment. . . Conditions of Registration (COR) or formally known as Conditions of Admission (COA): The COR is a legal agreement between the patient and the hospital consenting to treatment, assignment of insurance benefits, and accepting financial responsibility for their medical services. . . AFFECTED DEPARTMENT/SERVICES: 1. Patient Access 2. Patient Financial Services (PFS) 3. Health Information Management (HIM) 4. Risk Management. POLICY: COMPLIANCE - KEY ELEMENTS. . . C. Patients who are unable to sign the COR 1. When a patient is unable to sign due to their medical condition and there is not a legal representative, the Patient Access Associate will document in the COR field in Cerner unsigned and account notes. 2. A follow up label will be placed on the back of the unsigned CORs and they will be placed in the follow up folder in the Patient Access Department. Patient Access staff will attempt once a day to provide the patient or their representative with the COR and obtain signatures and document on the label.””

“PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This Standard is not met as evidenced by: 42148 Based on interview and record review, the hospital failed to ensure the “Advanced Healthcare Directives, Surrogate Decision Maker” policy and procedure (P&P) was followed for four of 32 sampled patients (Patient 1, Patient 10, Patient 11, and Patient 12). This failure resulted in violation of patient rights to make medical care decisions and formulate an advance directive (a written statement of a person’s wishes regarding medical treatment, often including a living will, made to ensure those wishes are carried out should the person be unable to communicate them to a doctor). Findings: During a concurrent interview and record review on 7/24/24 at 2:13 p.m. with Registered Nurse 9 (RN 9), Patient 12’s “Conditions of Registration ED [Emergency Department] [COR- a legal agreement between the patient and the hospital consenting to treatment, assignment of insurance benefits accepting financial responsibility for their medical services],” dated 7/18/24 was reviewed. The COR indicated, section “19. Patient Self Determination Act” was blank with no choices marked by Patient 12. RN 9 stated Patient 12’s COR section 19. Patient Self Determination Act was blank and should have been completed. During a concurrent interview and record review on 7/25/24 at 10:03 a.m. with Emergency Department Manager 2 (EDM) 2, Patient 11’s “COR” dated 7/20/24 was reviewed. The COR indicated, section “Number 19. Patient Self Determination Act” was blank with no choices marked by Patient 11. EDM 2 stated Patient 11’s COR section 19. Patient Self Determination Act was blank and should have been completed. During a concurrent interview and record review on 7/25/24 at 11:36 a.m. with Regulatory Accreditation Registered Nurse (RARN), Patient 10’s “COR” dated 7/3/24 was reviewed. The COR indicated, section “Number 19. Patient Self Determination Act” was blank with no choices marked by the patient. RARN stated Patient 10’s COR Number 19. Patient Self Determination Act was blank and should have been completed. RARN stated the COR informs patients of their right to formulate an advance directive. During a concurrent interview and record review on 7/25/24 at 5:33 p.m. with EDM 2, Patient 1’s “COR,” dated 6/21/24 was reviewed. The COR indicated, section “Number 19. Patient Self Determination Act” was blank with no choices marked by the patient. EDM 2 stated Patient 1’s COR Number 19. Patient Self Determination was blank and should have been completed. During a review of the hospital’s P&P titled, “Advanced Healthcare Directives, Surrogate Decision Maker,” dated 6/17/2020, the P&P indicated, “The intent of this policy is to support a patient’s right to formulate advance directives and to guide [Hospital] staff and LIP’s [licensed independent practitioners] who provide care in complying with these directives. This includes the rights of a patient to make medical care decisions, the right to request or refuse treatment, the right to formulate an advance directive and the right to designate a surrogate decision maker. A. ADVANCE DIRECTIVES 1. [Hospital] shall provide to each adult individual, at the time of his or her admission as an inpatient, written information describing: a. An individual’s right under California statutes and court decisions to accept or refuse medical or surgical treatment, to formulate advance directives; and b. The hospital’s policies regarding these rights to make health care decisions and to formulate advance directives, and regarding the way such decisions and directives will be implemented to the hospital. 2. The hospital shall document in the individual’s medical record whether or not the individual has an advance directive.””

“PATIENT RIGHTS: PERSONAL PRIVACY CFR(s): 482.13(c)(1) The patient has the right to personal privacy. This Standard is not met as evidenced by: 42148 Based on observation, interview, and record review, the hospital failed to: 1. Provide personal privacy to one of 32 sampled patients (Patient 2) when Patient 2’s legs and brief were exposed in an area that could be seen by other patients, staff, and visitors. This failure resulted in a violation of the right to privacy and dignity for Patient 2. 2. Ensure that Protected Health Information (PHI- also referred to as personal health information like name, date of birth, medical histories, test and laboratory results, mental health conditions, insurance information and other data that a healthcare professional collects to identify an individual) was protected and not accessible by unauthorized persons for five of 32 sampled patients. (Patient 7, Patient 8, Patient 9, Patient 13, and Patient 16). This failure resulted in a violation of confidentiality for Patient 7, Patient 8, Patient 9, Patient 13, and Patient 16. Findings: 1. During a concurrent observation and interview on 7/22/24 at 11:18 a.m. with Registered Nurse (RN) 12 in the intensive care unit (ICU-patient care area for critical patients), Patient 2 was lying in her hospital bed sideways without a blanket or privacy curtain pulled. Patient 2’s legs and brief were exposed. RN 12 stated Patient 2 should have been covered with a blanket and had the privacy curtain pulled for more patient privacy. During a review of the Hospital’s P&P titled, “RIGHTS AND RESPONSIBILITIES OF PATIENTS,” dated 3/28/24, the P&P indicated, “POLICY: COMPLIANCE-KEY ELEMENTS . . . B. Patient Rights-The following patient rights . . . 1. Considerate and respectful care, and to be made comfortable. Patient has the right to respect for patient’s cultural, psychosocial, spiritual, and personal values, beliefs, and preferences . . . 11. Have personal privacy respected . . . Privacy curtains will be used . . .” 2a. During a concurrent observation and interview on 7/22/24 at 9:57 a.m. with Emergency Department Manager (EDM) 1, in the ED, Patient 7, Patient 8, Patient 9, and Patient 13’s laboratory specimen labels (attached to specimen container with patient identification like Patient name, Date of birth or Medical record number) were found inside an unlocked lab cart. EDM 1 stated, “the labels should have been shredded, that is the process.” EDM 1 stated healthcare staff are expected to follow protected privacy practices, that did not include leaving the labels in an unsecured lab cart. EDM 1 stated, “they should have been discarded properly, not placed in there [lab cart].” 2b. During a concurrent observation and interview on 7/22/24 at 11:52 a.m. with RN Lead (RNL) and RN Manager (RNM), in the GI Lab (area where gastrointestinal procedures are done), documents containing Patient 16’s PHI was found in the basket of an ultrasound machine that was sitting in the hallway where staff, visitors, and patients walked through. RNL and RNM stated the documents contained confidential information from Patient 16’s chart dated 2023 and should have been shredded per Policy and Procedure (P&P). During a review of the Hospital’s P&P titled, “Confidentiality of Protected Health Information (PHI),” dated 9/7/22, the P&P indicated, “The purpose of this policy is to provide procedures to ensure the confidentiality and integrity of patient information. . . [Hospital] is committed to protecting the privacy and security of protected health information (PHI) and our commitment. . . is an extension of our mission, vision, and values. Definitions: P. Protected Health Information (PHI): Individually identifiable information that is: 1) transmitted by electronic media, 2) maintained in electronic media, or 3) transmitted or maintained in any other form or medium. Policy: Compliance- Key Elements: A. Leaders of [Hospital] have the responsibility of creating and promoting a climate for maintaining the confidentiality of patient information a “culture of confidentiality,” [Hospital] must demonstrate commitment and leadership across the organization to the principles embodies in the HIPAA Privacy rule. It is the policy of [Hospital] to maintain confidentiality for individuals at all times and under all circumstances. This commitment must be supported by working to see: 1. That access to the medical record is restricted based on the minimum amount of PHI necessary to accomplish the intended purpose of any use, disclosure or request. . . B. Protection of PHI: 1. [Hospital] and its subsidiaries may not disclose, share, or otherwise use any individually identifiable health information except for the purposes of treatment, payment, and health care operations unless expressly authorized by the patient or permitted or otherwise required by law. 2. All information contained in patient medical and billing record is confidential regardless of format. These confidentiality protections extend not only to the patient’s medical record, but also to information from the record. This includes, but is not limited to, abstracts of charts, medical record numbers, diagnoses, case histories, and descriptions of medical procedures that include or refer to the patient’s name, social security number or other identifying information. In addition, information orally communicated about a patient must be maintained as confidential PHI. C. 1. All [Hospital] workforce members are responsible for maintaining the security and confidentiality of PHI. This responsibility includes both the physical record and all information contained in, or derived from, the medical record, including information disclosed or transmitted orally. c. Safeguards to Protect PHI: i. In addition to protecting the privacy of a patient’s health information by complying with regulations regarding use and disclosure of PHI, workforce members are responsible to protect PHI with reasonable physical, technical, and administrative safeguards. It is the responsibility of all workforce members to secure PHI that they have access to complete assigned responsibilities. ii. Reasonable safeguards are to be used at all times to ensure that confidential information is not disclosed to individuals who are not authorized to receive the information and to minimize incidental disclosures of PHI. I. Physical Safeguards A. Each workforce member is responsible to protect the physical security of the PHI they are using, accessing or maintaining in their work area, including but not limited to, 1. Ensuring that PHI is not readily visible to visitors or to the public; 2. Maintaining charts in designated secure areas and not leaving charts unattended in areas that the public has access to; 3. Locking areas that contain medical and billing records at the end of the day or when there are no staff in the area.” 47095”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 42148 Based on observation, interview, and record review, the hospital failed to ensure a safe environment for one of 32 sampled patients (Patient 1) when: 1. Patient 1, who was not registered as a patient for treatment, was given access to a secured locked location. 2. Patient 1 accessed laboratory specimen collection supplies and collected her blood with the use of her Port-a-Cath (an implanted device used for blood draws and medications that is placed in front of a patient’s chest). 3. Patient 1 collected her own blood specimen without proper training. These failures had the potential to cause harm, infection, and contribute to adverse patient outcomes. Findings: 1. During a concurrent observation and interview on 7/22/24 at 9:30 a.m. with Emergency Department Manager (EDM) 1 in the emergency room entrance and waiting area. EDM 1 stated, “It is possible for a patient to bypass the start nurse and registrar and have a seat in the lobby without staff knowledgement.” During an interview on 7/22/24 at 4:45 p.m. with Security Manager (SM), SM stated Patient 1 came into the Emergency Department (ED) front entrance on 6/21/24 and provided a text message to Security Guard [SG] 1, who was on duty that evening. SM stated Patient 1 was allowed access to a secure patient area without being registered for treatment and was not a patient visitor. SM stated Patient 1 should not have been allowed into a secure area. SM stated this was a breach of security and safety concern to other patients and staff. During an interview on 7/22/24 at 4:55 p.m. with SG 1, SG 1 stated she was the security guard on duty 6/21/24 during night shift. SG 1 stated Patient 1 showed her a text message that stated “something to the sort that staff told her [Patient 1] that she could go ahead and come back to be seen for an infusion (a method of infusing fluids).” SG 1 stated, “She seemed legit so I led her back and badged her into the back.” SG 1 stated she should have verified her identity and asked her more questions then directed her to the triage nurse. SG 1 stated this was a security and safety breach. During a review of the hospital’s policy and procedure (P&P) titled, “Badge and Building Access Policy,” dated 1/31/24, the P&P indicated,”. . .C. Enforcement: 1. Any employee encountering an unknown person without proper identification in a non-public area should offer assistance. If the employee has any doubt as to the person’s response or demeanor, security should be notified. During a review of the facility’s policy and procedure (P&P) titled, “Patient Identification Policy,” dated 1/25/23, the P&P indicated, “The intent of this policy is to ensure that patients in all area of the hospital are correctly identified prior to any service treatment or procedure, patient identification should reliably identify the individual as the person for whom the service, treatment or procedure is intended. A. 1. Principles of identification: 1. A system for positive identification of all hospital patients fulfills four (4) basic functions; a. Provides positive identification of patients from the time of admittance or acceptance for treatment. b. Provides a positive method of liking patients to their medical records and treatment. c. Minimizes the possibility that identifying date can be lost or transferred from one patient to another. D. Improves the accuracy of patient identification. . . 3. No procedure shall be conducted when the patient’s identity cannot be verified because the imprinted band/label is illegible or missing. . .C. 1. Before any procedure is carried out, the identification of the patient will be verified by the responsible care provider using the two identifiers listed below to ensure that the right patient is involved. the room number will not be used as a patient identifier. 2. During an interview on 7/22/24 at 9:45 a.m. with EDM 1, EDM 1 stated when a patient comes in with a Port-a-Cath, staff are expected to obtain an order from the provider to access a Port-a-Cath for blood specimen collection. During a concurrent observation and interview on 7/22/24 at 9:48 a.m. with EDM 1 in ED nursing station, a lab cart was located in between the nurses station and patient treatment rooms. The lab cart was unlocked and contained lab supplies including needles, laboratory blood specimen tubes, and vacutainers (a double ended needle blood collection device). EDM 1 stated the observed lab cart should be locked and not accessible to unauthorized individuals. EDM 1 stated the observed lab cart was always kept unlocked with a box of normal saline syringes that was “always” on the top of the lab cart. During a concurrent observation and interview on 7/22/24 at 9:55 a.m. with EDM 1 in a procedure room in ED, there was an unlocked “procedure” cart next to the patients bed. The procedure cart had a metal arm that was labeled “lock/unlock.” The metal arm was able to move from lock to unlock without a key or a code. The procedure cart had 4 drawers that contained 18 gauge (g-unit for measurement) needles, scalpels, razors used for hair shaving, skin staplers, suture removal kits, various size sutures (in boxes), laceration (deep cut) trays (providers use for laceration repair), normal saline, sterile water, and betadine (antiseptic used for skin disinfection) bottles. EDM 1 stated, “This presents a safety concern.” EDM 1 stated a patient could open the cart if unattended and access any supplies that are inside. Also in the procedure room, there were unlocked cabinets and drawers that contained normal saline syringes and a bag of IVF’s (Intravenous Fluids-electrolytes administered into a persons vein). EDM 1 stated the cabinets and drawers should be locked and the normal saline syringes and IVF’s should not be inside of the procedure rooms unlocked cabinets and drawers. During a concurrent observation and interview on 7/22/24 at 10:10 a.m. with Quality and Safety Registered Nurse (QSRN) in ED procedure room, unlocked cabinets and drawers had 18g (grams), IV insertion devices inside. QSRN stated, “This should not be stored like this, it is a safety risk concern.” During a concurrent observation and interview on 7/22/24 at 10:12 a.m. with EDM 1 at ED nursing station, a mobile computer on wheels was located next to a patient’s room and contained a compartment connected to the back of the computer cart. There was one saline syringe and three 18g needles. EDM 1 stated, “These items should not be there and a patient could get a hold of them.” During a concurrent observation and interview on 7/22/24 at 10:15 a.m. with EDM 1 at ED nursing station, a second mobile computer on wheels next to “triage chair #4” that had a pediatric patient and a family member next to it, had seven normal saline syringes found in the compartment connected to the cart. EDM 1 stated these should not have been accessible to the patient and family member and is a safety concern. During a concurrent observation and interview on 7/22/24 at 10:28 a.m. with EDM 1 at ED nursing station, a large cart in the hallway where foot traffic was noted was found unlocked. Cart contained scalpels, needles, arterial line kits (used to access arterial lines in patients by providers). EDM 1 stated this is a “Central Line Cart [cart where a catheter often place in a large vein in the neck]” and should not be unlocked. EDM 1 stated it contains supplies that could pose a safety concern to patient’s and visitors. During a concurrent observation and interview on 7/22/24 at 10:30 a.m. with EDM 1 at ED nursing station, an Ultrasound machine (imaging test that uses sound waves to make pictures of the organs) on wheels was observed in the hallway by the nurses station. Long needles used by provides to place a guided intravenous line was found in an attached compartment behind the ultrasound machine. EDM 1 stated these are considered sharps and should not be accessible to patients or visitors. During a concurrent observation and interview on 7/22/24 at 11:05 a.m. with Registered Nurse (RN) 15 in the Intensive Care Unit (ICU- a patient care area for critical patients). Observed multidrawer carts in three different rooms unlocked. The 4th drawer of all the carts contained needles, normal saline syringes, laboratory specimen tubes, various size needles used to start IV’s. RN 15 stated these should be locked and not accessible to patients or visitors and could potentially cause safety concerns. During an interview on 7/22/24 at 11:25 a.m. with Nurse Manager Intensive Care Unit (NMICU), NMICU stated all of the carts in ICU 1 and ICU 2 are “end of life” and don’t lock. NMICU stated the RN’s do keep sharps and normal saline flushes in them so they can be easily accessible to them and stated these carts should be locked. NMICU stated none of the carts lock and stated she has brought this safety concern to her nurse leadership team. NMICU stated there are 20 “end of life” carts in her department that do not lock. NMICU stated patients and visitors could access these carts when left unattended. During an interview on 7/22/24 at 4:15 a.m. with Emergency Department Director (EDD). EDD stated nurses should not initial specimens that they did not draw directly from a patient. EDD stated this is not a standards of practice. EDD stated patients and visitors should not be able to access any sharps, syringes, or normal saline syringes in the ED. EDD stated this poses a safety concern with patients and visitors. During a concurrent interview and record review on 7/23/24 at 10:30 a.m. with LVN 2, Patient 1’s “Nursing Note (NN),” dated 6/19/24 was reviewed. The NN indicated, “[Patient 1] accessed supply cart without approval to do her own labs from PICC line [sic].” LVN 2 stated on 6/19/24 she noticed Patient 1 lying on a stretcher with a syringe full of blood hooked up to her port-a-cath with blood in it. LVN 2 stated Patient 1 should not have been able to access supplies in the ED and should not have been obtain her own blood specimens. LVN 2 stated this is not normal practice and is a safety and infection concern. During an interview on 7/23/24 at 11:15 a.m. with Emergency Department Nurse Practitioner (EDNP), EDNP stated “I heard staff was upset with Patient 1 because she was caught drawing her own blood.” EDNP stated, “I saw her [Patient 1]grabbing the supplies from the white lab cart and was pulling syringes then drawing her blood from her Port-a-Cath.” EDNP stated, “It is absolutely not acceptable for a patient to draw her own blood.” EDNP stated, “I told the patient that if she wasn’t going to follow the rules, that she wasn’t going to take care of her. I don’t think patients should have access to the supplies, I have never witnessed this in 19 years.” During an interview on 7/23/24 at 1:15 p.m. with Emergency Department Medical Director (EDMD). EDMD stated it is unacceptable to find sharps, normal saline flushes, and laboratory specimen tubes unsecured and accessible to patients and/or visitors. EDMD stated it is not standard practice or safe for a patient to access their own Port-a-Cath to collect blood specimens and should be left for the RN’s that are trained to do that procedure. During an interview on 7/23/24 at 3:11 p.m. with Emergency Department Physician’s Assistant (EDPA), EDPA stated on 6/19/24, she witnessed Patient 1 flushing her Port-a-Cath with a normal saline flush syringe. EDPA stated it is not safe for Patient 1 to access her own Port-a-Cath and should not have drawn her own blood. EDPA stated this is a safety concern and also concern for infection preventions. EDPA stated this is not normal practice and patients and visitors should not have access to supplies including syringes, normal saline flushes, or laboratory specimen tubes. During a review of the hospital’s policy and procedure (P&P) titled, “Stop the Line,” dated 5/14/21, the P&P indicated, “All hospital employees, medical staff, students, and volunteers have the responsibility and authority to immediately intervene to protect patients’ rights and safety of a patient, to prevent a patient safety event and subsequent patient harm or patient safety violations. It is the expectation that any person providing patient car will immediately stop and respond to the request to stop for clarification to reassess the patient’s safety. This is a proactive practice to SPEAK UP in advocating for patient safety and is applicable for all patients receiving Hospital services. Compliance-Key Elements A. Any person who observes or becomes aware of an imminently harmful situation in patient care, or witnesses a disruptive behavior has the authority and responsibility to speak up and request the process be stopped; to clarify the patient safety situation. This person needs to say in a firm, clear and respectful manner: “STOP, I am Concerned,” If that request does not produce safety, the person should continue with the CUS statement, “I am Uncomfortable” and finally, if the situation persists, “This is a Safety Issue.” B. Utilizing 3Ws, state: What is the safety observation, What is the concern, and What needs to occur to maintain safety. C. “Stop the line” request needs to be clear and timely to restore patient safety and minimize intrusion into the care process. During a review of the hospital’s policy and procedure (P&P) titled, “Scope of Service-Emergency Dept,” dated 3/2/24, the P&P indicated, “. . .E. The goal of the Emergency Department will be to ensure that all patients treated will receive high quality care in the most expedient and professional manner possible. . .G. All individuals who provide emergency services are licensed or registered and have the appropriate training and competence. Staff include: . .5. Licensed Vocational Nurses. M. Department Objectives: . . 2. To deliver safe, effective, and appropriate care in a cost effective manner. . .7. To provide necessary expertise, technology, instrumentation and equipment for the management of patients. 8. To provide nursing care based on the nursing process. 3. During an interview on 7/22/24 at 2:48 p.m. with Infection Prevention Registered Nurse (IPRN) and Director of Infection Prevention (DIP), IPRN stated, “It is against our policy to have patients access their own implanted devices.” DIP stated, “Only staff that have competency can draw from central lines.” DIP stated patients should not have access to normal saline syringes and laboratory specimen tubes. DIP stated Patient 1 should not have been able to obtain her own blood specimens. DIP stated, “This is a high priority and an infection control risk.” During an interview on 7/24/24 at 4:46 p.m. with LVN 1, LVN 1 stated Patient 1 collected her own laboratory blood specimens in two syringes and handed him (LVN 1) the blood filled syringes. LVN 1 stated he accepted Patient 1’s self collected blood filled syringes and transferred the blood into laboratory specimen tubes. LVN 1 stated he labeled Patient 1’s blood specimen with his initials and sent Patient 1’s blood specimens to the laboratory for processing. LVN 1 stated this is not a normal practice and that he should not have accepted blood he did not collect. LVN 1 stated Patient 1 should not have access to ED supplies, including syringes, laboratory tubes, or normal saline syringes. During an interview on 7/24/24 at 10:11 a.m. with RN 30 and EDM 1, RN 30 stated he saw Patient 1 standing at the nursing station with a syringe full of blood hanging from a lumen of her Port-a-Cath. RN 30 stated patient should not have access to supplies, including laboratory specimen tubes, sharps, needles, and normal saline syringes and is a patient safety concern including a “infection control risk.” During an Interview on 7/25/24 at 8:30 a.m. with Emergency Department Provider (EDP) EDP stated, “This is completely unacceptable, this is a danger for [Patient 1]. [Patient 1] should not be allowed to provide herself care with supplies and drawing her own blood. The house supervisor should have been called. This is not standard of care and should have been escalated to security/law enforcement of theft, stealing supplies. [Patient 1] was a danger to herself and is not a trained professional to access a line. The ball was dropped. Breached the standard of care.” EDP stated all carts with supplies should have been secured. EDP stated “ER should be a safe haven.” During a review of the facility’s policy and procedure (P&P) titled, “CLABSI Prevention-Central Venous Catheter management,” dated 8/15/23, the P&P indicated, “Compliance-Key Elements B. Education, Training and Qualifications; 1. Patient/Family Education: Prior to catheter insertion and as needed, educate patients and their families about central line associated bloodstream infection prevention. Include topics such as rationale for device, expected dwell time and care/maintenance of device. 2. Healthcare Personnel Education and Training: 1. insertion, care and maintenance of CVC will be performed by healthcare personnel who are educated and trained about indications for intravascular catheter use, insertion, maintenance, and appropriate infection prevention measures to prevent intravascular catheter-related infections.” During a review of “Infection Prevention and Control Program Plan (IPCP),” dated 2024, the “IPCP” indicated, “Purpose: The IPC [Infection Program Control] program assists patient care by reducing the risk of infection in patients, visitor, associates and others through education, surveillance, prevention, control, and continuous review and evaluation of infection prevention practices. Policy: It is the policy of [Hospital] to provide safe and effective care for all our patients. The infection prevention and control program will implement and maintain active hospital-wide activities for the prevention, control and investigation of infections and communicable diseases. During a review of the hospital’s policy and procedure (P&P) titled, “Rights and Responsibilities of Patients,” dated 3/38/24, the P&P indicated, “. . .B. Patient Rights- The following patient rights information is provided as supplemental descriptive information to the patient or their representative. It may not contain all of the patient rights on the lists provided to the patient. . .13. Receive care in a safe setting, free from mental physical, sexual or verbal abuse and neglect, exploitation or harassment, the patient has the right to access protective and advocacy services including notifying government agencies of neglect or abuse.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 42148 Based on interview and record review, the hospital failed to follow it’s “POLICY: RESTRAINT MANAGEMENT (MECHANICAL, CHEMICAL, SECLUSION) policy and procedure (P&P) for three of five sampled patients (Patient 2, Patient 3, and Patient 4) when nursing restraint ongoing patient assessment, least restrictive measures, alternative planning, and implementation of nursing restraint checks every two hours for Patient 2, Patient 3, and Patient 4 were not completed. This failure had the potential to result in Patient 2, Patient 3, and Patient 4 experiencing adverse health outcomes due to restraint use. Findings: During a concurrent interview and record review on 7/24/24 at 10:44 a.m. with Quality Safety Registered Nurse (QSRN), Patient 3’s “Restraint Flowsheet (RF)” dated 7/9/24 at 10 p.m. and on 7/10/24 at 12 a.m. was reviewed and incomplete. QSRN stated the restraint checks were expected to be completed every two hours per hospitals P&P. During an interview on 7/24/24 at 10:48 a.m. with QSRN, QSRN stated the expectation for patients that are restrained are assessed “every two hours” and the restraint order is renewed by a doctor every three days. QSRN stated the hospital’s patient care staff were to “follow policy” for restraint use and management. During a concurrent interview and record review on 7/24/24 at 2:41 p.m. with QSRN, Patient 2’s, “RF” dated 7/18/24 was reviewed. The RF indicated, no restraint assessment was done at 6 p.m. QSRN stated the expectation was for Patient 2 to have ongoing restraint assessments every two hours. During a concurrent interview and record review on 7/25/24 at 12:09 p.m. with Registered Nurse (RN) 17, Patient 4’s, “RF” dated 6/30/24 was reviewed. The RF indicated, restraint assessment, monitoring, and least restrictive interventions were not done from “7 a.m. to 7 p.m.” RN 17 stated, “There are gaps and the expectation was for nurses to follow the hospital restraint P&P, which included a restraint for use patient assessment every two hours.” During an interview on 7/26/24 at 1:16 p.m. with Director Critical Care (DCC), DCC stated the hospital process was to perform ongoing assessments for the restrained patient(s) for their needs with a safety goal to discontinue restraints. DCC stated restraint use is a patient safety priority. DCC stated the restraint use process involved nursing communicating with the physician for restraint use and involved “every 2 hours” assessments, least restrictive interventions, hydration, elimination, redirecting and orienting, planning, and work towards discontinuing the restraint use. DCC stated the importance of following the hospital process was to “make sure not causing [patient] harm.” During a review of the hospital’s P&P titled, “Restraint Management (Mechanical, Chemical, Seclusion)” dated 01/20/2021, the P&P indicated, “POLICY SUMMARY/INTENT: A. To outline an organizational approach to restraints that protects the patient health and safety and preserves their dignity, rights and well-being. This includes a description of patient’s health and safety and preserves their dignity, rights and well-being. This includes a description of patients’ basic rights, organizational intent to. . . manage restraint initiation, monitoring, discontinuation, documentation, staff education and reporting. . . B. This organization recognizes that restraint use has the potential to produce serious consequences, such as physical and psychological harm, loss of dignity, violation of patient’s rights and even death. It is our intent to provide an environment that minimizes circumstances that give rise to use of restraint (s). . . and maximizes safety when restraint or seclusion is used. . . E. Licensed Independent Practitioner (LIP): An individual permitted by law and by the organization to provide care, treatment, and services without direction or supervision. A licensed independent practitioner operates within the scope of his or her license. . . A. Applies to all licensed hospital departments, including, but not limited to medical/surgical, critical care. . . and all patients. . . c. Application of handcuffs, manacles, or shackles is performed by non-employed or contracted and/or law enforcement personnel only and will be documented by nursing staff in the medical record accordingly. . . c. RN may authorize /initiate mechanical or seclusion restraints (excluding chemical) in emergency situations without an order but must obtain an order from the LIP during the emergency application of the restraint or seclusion, or immediately (within a few minutes) after the restraint has been applied. D. LIP or clinical psychologist is consulted , as soon as possible, if they did not order the restraint(s) or seclusion. . . 5. Ongoing Monitoring/Documentation a. Documentation of restraint and/or seclusion episodes (s) to include, but not limited to: assessments/re-assessments, interventions, care plan/plan of care modifications, response to interventions, criteria met for discontinuation. i. Ongoing assessments/interventions are documented according to the frequency. . . E. RESTRAINT CONSIDERATION- NON-VIOLENT/NON-SELF-DESTRUCTIVE 1. These types of restraint orders are used to protect the physical safety of non-violent or non-self-destructive patients. 2. Orders will be renewed every 3 days if continued restraints are needed. 3. Assessment and monitoring will be conducted at minimum, every 2 hours. . . iv. Documents in the log the patient’s name, date of birth, date of death, name of LIP responsible for the care of the patient, medical record number, and primary diagnosis.” 47095”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 47095 Based on observation, interview, and record review, the hospital failed to ensure Registered Nursing (RN) care met the professional standards when: 1. Critical laboratory results were not reported to a physician for three of 32 sampled patients (Patient 2, Patient 14, and Patient 15). 2. Wound assessment and prevention were not completed for 3 of 3 sampled patients (Patient 4, Patient 5 and Patient 6). These failures resulted in providers not being updated on patient care changes and outcomes for Patient 2, Patient 4, Patient 5, Patient 6, Patient 14, and Patient 15. Findings: 1. During a concurrent interview and record review on 7/24/24 at 11 a.m. with RN 21, Patient 15’s “Laboratory-MRSA [Methicillin Resistant Staphylococcus Aureus-type of bacteria] results (LR),” dated 7/19/24 was reviewed. The LR indicated, MRSA result was positive. RN 21 stated the process is the lab will notify their department head in charge the day the result comes back and the provider and parent/guardian of patient will be notified. RN 21 stated that the test result was received after Patient 15 was discharged home and was unable to provide documentation that the parent/guardian and provider was notified of the result. During a concurrent interview and record review on 7/24/24 at 4:41 p.m. with Quality Safety Registered Nurse (QSRN), Patient 2’s, “Troponin” (a protein involved in the muscle contraction of the heart) result dated 7/17/24 was reviewed. The Troponin result on 7/17/24 at 11:46 a.m. indicated a critical high value of 4621.2. (between 0- 0.04 ng/ml (nanogram per milliliter-unit of measurement). QSRN stated the facility process was “typically within one-hour critical labs” are reported to the physician. QSRN was unable to provide documentation that Patient 2’s critical Troponin was reported within the hospitals P&P of one hour. During a concurrent interview and record review on 7/25/24 at 3:53 p.m. with Emergency Department Manager (EDM) 2, Patient 14’s “Laboratory-Troponin results (TRW),” dated 6/24/24 was reviewed. The TRW indicated, Troponin result was 141.9 ng/ml and the result was called to Registered Nurse (RN) 20. EDM 2 stated that when the results reach a critical level, the laboratory staff will notify the RN in charge of the patient’s care then it is the responsibility of the RN to notify the provider of the patient with the result and document under “Provider Notification.” EDM 2 stated there is no documentation that RN 20 notified the provider of Patient 14’s critical Troponin level. During a review of the hospital’s policy and procedure (P&P) titled, “Critical Tests and Critical Results Reporting,” dated 3/27/20, the P&P indicated, “Policy Summary/Intent: [Hospital entity] adopts the following systemwide policy to standardize the process when critical results of tests fall significantly outside the normal range and may indicate a life-threatening situation. The objective of this policy is to provide guidelines for management and reporting of critical tests and critical results of test to provide patients with prompt treatment. Applies to all licensed entities [inpatient/outpatient] including but not limited to medical/surgical, critical care, forensic units, emergency department or psychiatric units and all patients, regardless of age who have critical reports or results that need to be reported. . . C. Receiving Results/Reports 1. Registered Nurse for inpatients. . . a. Communicates to ordering provider/designee with 60 minutes and documents the following: . . . i. Provider notified ii. Date/time collected iii. Two patient identifiers confirmed with provider/designee iv. Critical result reported v. Read-back completed vi. Actions taken. . . D. Reporting Time frames: 1. Critical Results of Test measurement Parameters-The maximum length of time between the availability of critical result(s) and reporting of such critical result(s) to the ordering provider/designee should not exceed 60 minutes.” 2. During a review of Patient 4’s “Wound Care Order (WCO),” dated 7/24/24 at 4:19 p.m. The WCO indicated, “. . . 3. Sacrum/Buttocks- clean with warm bath wipes and pat dry, apply Calazime [Skin barrier protective] Cream BID [twice a day] and with any incontinence episode. (NO MEPILEX). 4. Spine-Bony Areas- Cover with Mepilex Change Q3D [every three days].” During a concurrent interview and record review on 7/25/24 at 3:20 p.m. with RN 17, Patient 6’s, “Medical Record (MR),” was reviewed. The MR indicated, Patient 6 was admitted on 7/1/24 and discharged on 7/22/24. RN 17 stated Patient 6 was admitted to the intensive care unit on 7/15/24 for Pneumonia (infection of the lungs) and was intubated (insertion of a breathing tube). RN 17 stated there were wound photos of Patient 6’s right and left buttocks and coccyx photographed wound was “maroon red” and not blanchable (manual pressure applied goes away after pressure is removed). RN 17 stated Patient 6’s right and left buttock coccyx area pressure injury wound’s first photo was taken on 7/15/24. RN 17 stated there was no documentation of the right and left buttock coccyx area pressure injury wound. RN 17 stated Patient 6 was admitted with “no skin issue.” RN 17 stated, “He [Patient 6] didn’t have it [right and left coccyx wound]” on admission. RN 17 stated there was no documentation to provide that Patient 6 was admitted with a wound to the right and left buttocks and coccyx. During a concurrent observation and interview on 7/25/24 at 7:50 p.m., with Director Critical Care (DCC), in Patient 4’s room, Patient 4’s buttock and backside had a Mepilex (a soft silicone dressing for pressure offloading of bony body parts) located on his lower spine area above the buttock area. DCC stated the observed upper right and left buttock area below the spine was a “maroon” color. DCC stated, “that’s [Mepilex dressing] not supposed to be like that.” DCC was observed removing Patient 4’s lower spine Mepilex dressing and reapplied the same Mepilex dressing to cover Patient 4’s upper right and left buttock area below Patient 4’s spine. DCC stated the location that needed to be covered was the “right and left buttock and coccyx [bone at the lower part of the spine]” area. During a concurrent interview and record review on 7/26/24 at 10:26 a.m. with RN 13. Patient 4’s “Turn q (every) 2 hours Flowsheet (T2F),” dated 6/27/24 to 7/24/24”, Patient 5’s “T2F,” dated 7/10/24 to 7/24/24, and Patient’s 6’s “T2F,” dated 7/3/24 to 7/22/24 were reviewed, these T2Fs indicated, there was missing documentation that these patients were turned every two hours. RN 13 stated pressure off-loading measures included repositioning patients every two hours and the expectation was for the intervention to be completed and documented in the patients’ medical record. During a concurrent interview and record review on 7/26/24 at 10:30 a.m. with RN 13, the hospital’s, “Pressure Injury List (PIL),” dated 7/22/24 was reviewed. The PIL indicated, Patient 6 was not on the list provided by the hospital. RN 13 stated the patients listed on the “PIL” had pressure injury wounds. RN 13 stated Patient 6 was not on the list and should have been. RN 13 stated Patient 6 was admitted on 7/1/24, with a Braden score (scaled skin assessment score ) of 19-23 which indicated no risk for impaired skin. RN 13 stated on 7/16/24 Patient 6’s Braden score was 11 which increased to high risk. During a concurrent interview and record review on 7/26/24 at 10:35 a.m. with RN 13, Patient 6’s, “MR” (Braden Scale) was reviewed. The MR indicated, Patient 6’s Braden scale completed on 7/1/24 was 19-23. RN 13 stated on admission a “head to toe” physical assessment was expected to be completed which includes the skin. RN 13 stated she was unable to find documentation for a documented wound on admission. RN 13 stated the only documentation of Patient 6’s right and left buttock coccyx pressure injury wound was on 7/15/24 and there was no prior documentation of the wound. RN 13 reviewed the photos taken on 7/15/24 of Patient 6’s right and left buttocks and coccyx area and stated, “classify as DTI [Deep Tissue Pressure Injury].” RN 13 stated Patient 6’s right and left buttock coccyx area was “purple, maroon” and should have been escalated to wound consult and the doctor for treatment. RN 13 stated there is no documentation to provide that Patient 6 had the DTI on admission and was “unacceptable.” During an interview on 7/26/24 at 11:12 a.m. with RN 13, RN 13 stated the expectation was to ensure that there was not a “rapid progression of the wound.” RN 13 stated nursing interventions included assessing the patient for pressure injury and wounds, escalate concerns to the wound nurse and doctor, perform wound care as ordered, reevaluate the wound, report any changes, and document nursing care provided. During a concurrent interview and record review on 7/26/24 at 12:05 p.m. with RN 13 the hospital’s P&P titled, “MODEL POLICY: PRESSURE INJURY OR SKIN/WOUND CONDITIONS - ASSESSMENT, PREVENTION AND MANAGEMENT,” dated 5/4/22 was reviewed. The P&P indicated, “ To assess and document patient skin risk, develop a plan of care for prevention and /or management of skin condition, wound or pressure injury. . . 4. Deep Tissue Pressure Injury- DTPI: Persistent non-blanchable deep red, maroon or purple discoloration. In/tact or nonintact skin with localized area of persistent non-blanchable deep red, maroon, purple discoloration. . . This injury results from intense and/or prolonged pressure and shear forces at the bone-muscle interface.” RN 13 stated DTPI’s are concerning and nursing care included “pressure off loading [repositioning every 2 hours] and use of Mepilex to cover the boney areas.” RN 13 stated this was a common wound management intervention that “every nurse” assigned to a patient is responsible for. During an interview on 7/26/24 at 1:16 p.m. with Critical Care Director (CCD), CCD stated nursing interventions includes “off load the area” for the prevention of wounds. CCD stated the expectation was for all staff providing patient care services to document their care provided. During an interview on 7/26/24 at 2:15 p.m. with DCC, DCC stated wound care prevention and management was a priority and the nursing process, included assessment, care planning, performing wound care as ordered and updating the patient care plan as needed based on the patients needs. DCC stated this process was expected to be followed by all nursing staff.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 47095 Based on interview and record review, the hospital failed to ensure a nursing care plan was developed, implemented, and revised to meet professional standards for three of three sampled patients (Patient 4, Patient 5 and Patient 6). This failure resulted in Patient 4, Patient 5, and Patient 6’s needs not met, and had the potential to contribute to an adverse health outcome. Findings: 1. During a concurrent interview and record review on 7/25/24 at 9:30 a.m., with Registered Nurse (RN) 17, Patient 5’s, “Care Plan Section (CPS)” was reviewed. The “CPS” indicated, Patient 5 had a pressure injury wound care plan formulated and implemented on 7/23/24. RN 17 stated Patient 5 was admitted on 7/9/24 with a stage 3 (a full thickness skin loss- muscle, bone are not exposed) pressure injury to the left buttock. RN 17 stated the expectation for nurses was to formulate and implement a care plan “on [the]same day” pressure injury wound was noted. RN 17 stated the professional standard was not met and a care plan for Patient 5’s pressure injury wound (Stage 3) should have been “done before the 23 rd.” 2. During a concurrent interview and record review on 7/25/24 at 12:22 p.m. with RN 17, Patient 4’s “CPS” was reviewed. The CPS indicated, a careplan for deep tissue pressure injury (DTPI- persistent non-blanchable deep red, maroon or purple discoloration, Skin intact or not intact resulting from intense or prolonged pressure or shear forces at the bone-muscle interface) to Patient 4’s right and left buttocks coccyx (lower back upper buttock bone) area pressure injury was initiated on 7/25/24. RN 17 stated Patient 4 was admitted with a pressure injury wound on 6/27/24 and should have had a pressure injury wound care plan formulated and implemented prior to 7/25/24. 3. During a concurrent interview and record review on 7/25/24 at 4:21 p.m. with RN 17, Patient 6’s “CPS,” was reviewed. The CPS indicated, Patient 6 was admitted on 7/1/24 and did not have a care plan for his pressure injury wound to provide. RN 17 stated Patient 6 had a pressure injury wound located to his right and left buttocks coccyx area that was photographed on 7/15/24. RN 17 stated the expectation was for Patient 6 to have a pressure injury wound care plan formulated and implemented. RN 17 stated Patient 6 did not have a care plan documented for his right and left buttock coccyx are pressure injury wound. RN 17 stated, “not documented not done.” During an interview on 7/26/24 at 1:55 p.m. with Director of Critical Care (DCC). DCC stated care plans “drive the [nursing] care” and the expectation was for nursing staff to follow the hospital’s P&P while providing patient care. During a review of the hospital’s P&P titled, “FACILITY POLICY:INTER-DISCIPLINARY CARE PLANNING,” dated 12/3/19. The P&P indicated, “The written plan of care is based on the needs identified by the patient’s assessment, results of diagnostic testing, patient’s goals and time frames, settings, and services required to meet goals. C. The plan of care, goals for care, treatment, and services is dynamic and is revised as the needs of the patient changes. D. Based on the goals established in the patient’s plan of care, staff evaluates the patient’s progress to determine the progress towards the goal achievement and the effectiveness of the care plan. This evaluation takes place at least once every 24 hours. . . E. Within twenty-four hours of admission all patients shall have a plan of care initiated.””

“VERBAL ORDERS FOR DRUGS CFR(s): 482.23(c)(3)(i) If verbal orders are used, they are to be used infrequently. This Standard is not met as evidenced by: 47095 Based on interview and record review the hospital failed to ensure physician’s verbal orders were authenticated within 48 hours for two of 32 patients sampled (Patient 3 and Patient 5). This failure had the potential for Patient 3 and Patient 5 receiving medication error and potential for adverse health outcomes. Findings: During a concurrent interview and record review on 7/24/24 at 1:52 p.m. with QSRN, Patient 3’s “MOS” dated 7/11/24 was reviewed. The MOS indicated, on 7/11/24 at 1:01 a.m. a VTO for a continuous IV infusion for Levophed (a critical life sustaining medication that improves blood pressure ) was received. QSRN stated the Levophed infusion was started on 7/11/24 at 1:02 a.m. QSRN stated the physician still hasn’t authenticated the VTO at this time (13 days later). QSRN stated Patient 3’s Levophed continuous IV medication infusion VTO should have been authenticated within 48 hours and had not been completed. During a concurrent interview and record review on 7/24/24 at 3:11 p.m. with Quality Safety Registered Nurse (QSRN), Patient 3’s “Medication Order Section (MOS)” dated 7/11/24, was reviewed. The MOS indicated, on 7/11/24 at 4:23 a.m. a verbal telephone order (VTO) for a continuous intravenous (IV) infusion for Dopamine (a critical life sustaining medication that improves blood pressure and heart function) was received. QSRN stated Patient 3’s Dopamine IV infusion was started on 7/11/24 at 4:31 a.m. The MOS indicated, the physician authenticated the verbal order on 7/17/24 at 11:22 a.m. (six days later). QSRN stated the hospital policy and procedure (P&P) and professional standard for VTO’s was not met when the order was authenticated more than 48 hours. During a concurrent interview on 7/24/24 at 3:14 p.m. with QSRN, the hospital’s P&P, titled “Verbal /telephone orders,”dated 10/03/2018 was reviewed. The P&P indicated, “A. California: within 48 hours. . . 2. Verbal /Telephone orders must be authenticated by either the ordering provider or covering provider responsible for care of the patient and who in accordance with hospital policy; law and regulation; and medical staff bylaws, rules, and regulations, is authorized to write orders.” QSRN stated Patient 3’s continuous critical care medications VTO should have been co-signed and was a patient safety, quality care concern.” QSRN stated, “Absolutely expect [P&P] to be followed.” During a concurrent interview and record review on 7/24/24 at 3:52 p.m. with QSRN, Patient 5’s “MOS” dated 7/17/24 was reviewed. The MOS indicated, on 7/17/24 at 12:32 p.m. a VTO for a continuous IV infusion for Levophed was received. QSRN stated the continuous IV infusion of Levophed was initiated on 7/17/24 at 1 p.m. QSRN stated the physician authenticated the Levophed VTO on 7/22/24 at 12:10 p.m. which was five days later. During a concurrent interview and record review on 7/24/24 at 4 p.m. with QSRN, Patient 5’s “MOS” dated 7/17/24 was reviewed. The MOS indicated, on 7/17/24 at 12:51 p.m. a VTO for Fentanyl (A medication used to treat pain and/or sedate for comfort) was received. QSRN stated the continuous IV infusion for Fentanyl was initiated on 7/17/24 at 1 p.m. QSRN stated the doctor authenticated the Fentanyl VTO on 7/22/24 at 12:10 p.m. (five days later). QSRN stated, “This was past the hospital’s P&P within 48 hour authentication requirement.” During a review of the hospital’s P&P titled, “Verbal /telephone orders” dated 10/03/18. The P&P indicated, “[Hospital] adopts the following systemwide [Hospital] policy to outline the process for giving, receiving and authenticating verbal/telephone orders to reduce or prevent medical errors. . . Authentication: An order is considered authenticated when the ordering provider or covering provider has signed, dated and timed the order. . . Covering Provider: A provider that assumes responsibility for his/her colleague’s patient while the attending provider is absent. . . Licensed or Certified Professional: A person holding a license, registration. . . according to state laws and functioning within their professional scope of practice. . . AFFECTED DEPARTMENTS/SERVICES: All clinical settings where patient care is provided. . . E. Authenticating Inpatient/Outpatient Verbal Orders: 1. Verbal/Telephone orders will route to the provider’s message center for electronic signature. . . Orders must be dated, timed and signed within the established state law authentication timeframe. A. California: within 48 hours. . . 2. Verbal /Telephone orders must be authenticated by either the ordering provider or covering provider responsible for care of the patient and who in accordance with hospital policy; law and regulation; and medical staff bylaws, rules, and regulations, is authorized to write orders.””

“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: 42148 Based on observation, interview, and record review, the hospital failed to ensure medications were stored in a secured and locked area to prevent unauthorized use. This failure had the potential to result in unauthorized individuals tampering or taking medications. Findings: During a concurrent observation and interview on 7/22/24 at 10 a.m. with Emergency Department Manager (EDM) 1, in the emergency department (ED) procedure room, a cabinet drawer was unlocked and inside had four normal saline syringe flushes, 1 Liter normal saline bag, and a full bottle of Tetracaine eyedrops (medication used to numb the eye before surgery, tests, or procedures). EDM 1 stated patients should not have access to normal saline syringe flushes, normal saline bags, and Tetracaine medication. EDM 1 stated this is not a safe practice and these should be locked and secured. During a concurrent observation and interview on 7/22/24 at 10:07 a.m. with QSRN, in ED procedure room, an unlocked cabinet had a container labeled “Dental Box”. Inside the “Dental Box” was Lolicaine (topical numbing medication for the mouth), Benzocaine 20% (topical numbing medication for the mouth). QSRN stated, “These medications should be locked up.” During an interview on 7/22/24 at 10:10 a.m. with Quality Safety Registered Nurse (QSRN), QSRN stated normal saline flushes, normal saline bags, and Tetracaine medication should not be left in an unsecured, unlocked cabinet drawer. QSRN stated, “This [unlocked storage] is a safety concern.” During an interview on 7/22/24 at 11:36 a.m. with Pharmacy Director (PD), PD stated, “Medications and fluids controlled by the Drug Enforcement Agency [DEA] [e.g. saline flush syringes and bags of saline solution] should be locked and not accessible to patients and/or visitors and could cause a safety concern if used.” PD stated Tetracaine, Lollicaine, and Benzocaine medication are controlled by pharmacy and should be locked in an area not accessible to patients. During a review of the hospital’s policy and procedure (P&P) titled, “Medication Access and Authorized Persons,” dated 4/3/19, the P&P indicated, “Definitions: 3. Secure = To be in locked containers (carts, drawers, etc.) in a locked room, or under constant surveillance. Medications are considered secure if non-authorized individuals cannot access them. Policy: Compliance- Key Elements A. 7. Keys to cupboards, cabinets, rooms, etc. where medications are stored will be controlled at all times. Access will be limited to authorized hospital personnel only. Keys must be transferred to appropriate personnel at shift change, or must be secured so that only authorized peronnel may have access to them.” 47095”