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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.

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."

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."

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."

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.

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 . . ."

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."

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. . ."

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."

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."

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).


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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. . ."

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.