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501 SOUTH BUENA VISTA STREET

BURBANK, CA 91505

SUPERVISION OF CONTRACT STAFF

Tag No.: A0398

Based on observation, interview, and record review, the facility failed to ensure licensed staffs adhere to facility's policy and procedure for Management of Pharmaceutical Waste by failing to:

1. Properly waste and dispose a vial of diazepam medication (Valium, used to treat anxiety, relieves muscle spasm, and provides sedation) for one (1) of thirty-seven (37) patients (Patient 1).
2. Ensure nursing staff visually witnessed the wasting of a controlled substance (include narcotics, sedatives, hypnotics, and other substances having a high potential for abuse), diazepam medication on two occasions for one (1) of thirty-seven (37) sampled patients (Patient 1).

These deficient practices resulted in a vial of diazepam medication, containing approximately 5 milligrams [mg]) being found in the staff break room ("Zen Den") and accessible to anyone who entered the room. The deficient practice had the potential for diversion (using a controlled substance from the individual for whom it was prescribed to another person for any illicit [forbidden by law] use).

Findings:

1. During an observation in the intensive care unit (ICU, a unit in a hospital providing intensive care for critical ill patients), on 1/23/2023 at 2:27 p.m., with the Nurse Manager for the ICU (NMICU), a room named "Zen Den" was observed with two reclining massage chairs, plastic flowers, an oil diffuser, two yoga mats, blankets, and a music playing sounds of a rainforest. The NMICU stated the room was used by ICU staff during breaks.

During an interview, on 1/25/2023 at 3:29 p.m., the NMICU stated she was notified by the Charge Nurse 1 (CN 1) of the ICU that an open half-full vial (approximately 5 mg) of diazepam was found on a massage chair in the "Zen Den," on 7/21/2022 at 4 a.m. The NMICU stated she arrived at the unit on 7/21/2022 at 6:45 a.m. and saw the diazepam vial. NMICU stated the diazepam vial contained approximately 5 mg of diazepam medication. The NMICU stated she investigated the incident. The NMICU state the investigation finding indicated only one Registered Nurse 1 (RN 1) wasted 5 mg of diazepam medication twice during that night shift (7 p.m. to 7 a.m.) on 7/20/2022 to 7/21/2022. The NMICU stated RN 1 was interviewed, and RN 1 admitted to using the "Zen Den" that night. The NMICU stated the diazepam medication was a controlled substance. The NMICU stated the entire substance (diazepam medication) should have been withdrawn from the vial during wasting.

During an interview, on 1/26/2023 at 9:02 a.m., RN 1 stated he medicated Patient 1 with diazepam, on 7/20/2022 and 7/21/2022. RN 1 stated wasting 5 mg of diazepam medication each time. RN 1 stated he placed the vial of diazepam in his pocket, to scan in Patient 1's room, then donned his personal protective equipment (PPE, gloves, gown, face shield), because Patient 1 had COVID - 19 (coronavirus, an infectious respiratory disease). RN 1 stated upon entering Patient 1's room, Patient 1 was uncooperative, delusional, and trying to kick and punch him. RN 1 stated the vial of diazepam was in his pocket and since he had the PPE on, he was unable to retrieve the vial from his pocket. RN 1 stated he just gave the medication and left the room quickly for safety reasons. RN 1 stated that he was able to take a couple of breaks in the "Zen Den" that night (7/20/2022 to 7/21/2022) and the vial (diazepam medication vial) must have been fallen out of his pocket while he sat on the massage chair. RN 1 stated he was notified by NMICU about the vial of diazepam found in the "Zen Den". RN 1 stated after looking at all the facts presented, he concluded that vial must have been his (the vial from his pocket). RN 1 stated he should have withdrawn all the entire contents of the vial during the wasting of the medication and disposed of the it (the diazepam medication) in the bin (disposal container) used for narcotic wasting. RN 1 stated diazepam was a narcotic, and any staff could have accessed the vial. RN 1 stated there was a potential for diversion.

A review of the facility's policy and procedure titled, "Management of Pharmaceutical Waste", dated 12/2022, indicated the witnessed waste amount is disposed in the controlled Substance(CsRx) waste bin. Solid or liquid controlled substances shall be removed from the original container for disposal. Partially used injectable vials shall be drawn out in an unlabeled syringe and be discarded with a witness in the CsRx waste bin. Empty vials are placed in regular waste / trash container.

2. A review of Patient 1's History & Physical (H&P), dated 7/19/2022 at 7:28 p.m., indicated Patient 1 was admitted to the facility, on 7/19/2022, for an intentional drug overdose and reported suicide (taking one's own life) attempt.

A review of a pharmacy report indicated the following.
1. On 7/20/2022 at 8:46 p.m., RN 1 removed a vial containing 10 mg of diazepam medication (5 mg/1 milliliter [ml, unit of measurement]) from the Pyxis (automated medication dispensing machine) hen at 8:47 p.m., 5 mg of diazepam medication were wasted and witnessed with RN 2.
2. On 7/21/2022 at 4:15 a.m., RN 1 removed a vial containing 10 mg of diazepam from the Pyxis then at 4:17 a.m., 5 mgs of diazepam were wasted and witnessed with RN 3.

A review of Patient 1's medication administration record (MAR) indicated RN 1 administered the following:
1. On 7/20/2022 at 8:58 p.m., Patient 1 received diazepam 10 mg, intravenously (in the vein).
2. On 7/21/2022 at 4:20 a.m., Patient 1 received diazepam 10 mg, intravenously.

During an interview, on 1/26/2023 at 10:23 a.m., the NMICU stated after she was notified that a vial containing approximately 5 mg of diazepam medication was found in the "Zen Den," an investigation was conducted to determine who wasted diazepam medication the night of 7/20/2021 to 7/21/2022. The NMICU stated RN 1 wasted 5 mg of diazepam twice during that night shift. The NMICU stated she interviewed RN 1. The NMICU stated, during the interview with RN 1, RN 1 stated he was not sure if RN 2 and RN 3 visually witnessed the wasting of the diazepam (observed the removal of the diazepam medication from the vial and observed the disposal in a proper disposal container). The NMICU stated she also interviewed RN 2 and RN 3 regarding the wasting of the 5 mg of diazepam, and both RN 2 and RN 3 stated signing off (documenting of being a witness of the wasting) in the Pyxis. The NMICU stated they (RN 2 and RN 3) witnessed (signed off) the wasting of the diazepam, however, they (RN 2 and RN 3) did not actually visually witness the wasting of the medication.

During an interview, on 1/26/2023 at 8:45 am, RN 3 stated on the night of 7/20/2022 to 7/21/2022, RN 1 asked him (RN 3) to witness the wasting of a 5 mg of diazepam for Patient 1. RN 3 stated he (RN 3) observed RN 1 insert the needle into the vial but did not visualize the withdrawal or the wasting of the medication. RN 3 stated he should have visualized the actual withdrawal of the entire contents of the vial, and the actual wasting of the medication in the bin used for narcotic wasting.

During an interview, on 1/26/2023 at 9:02 am, RN 1 stated he medicated Patient 1 with diazepam on the night of 7/20/2022 at 8:58 p.m., and 7/21/2022 at 4:20 a.m., RN 1 stated the first time he removed the diazepam from the Pyxis, on 7/20/2022 , he asked RN 2 to witness the wasting of 5 mg of diazepam. RN 1 stated it (the shift) was a busy night, and he did not remember if RN 2 actually visualized the wasting of the diazepam. RN 1 stated the second time he removed the diazepam from the Pyxis, on 7/21/2022, he asked RN 3 to witness the wasting of 5 mg of the diazepam and could not remember if RN 3 actually visualized the wasting of the diazepam medication. RN 1 stated he should have removed the entire contents of the vial when he wasted the medication. RN 1 also acknowledged that he had given Patient 1, 5 mg of diazepam, instead of 10 mg, as ordered, he realized his mistake after the second dose had been given.

During an interview, on 1/26/2023 at 10:52 a.m., RN 2 stated RN 1 asked her to witness the wasting of a diazepam, on 7/20/2022 at 8:58 p.m., RN 2 stated she could not recall if she actively witnessed the wasting of diazepam. RN 2 stated she should have diligently watched the withdrawal and wasting of the medication in the bin for narcotic wasting. RN 2 that consequences of not visualizing the wasting of the medication could lead to diversion.

A review of the facility's policy and procedure titled, "Management of Pharmaceutical Waste," dated 12/2022, indicated disposition and wasting of controlled substances shall be done in the presence of two licensed staff members that are authorized to handle controlled drugs. The witness must visually witness the actual disposal of the controlled substance prior to signing the waste document.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on interview and record review, the facility failed to administer the correct dose of diazepam (Valium, used to treat anxiety, relieves muscle spasm, and provides sedation) for one (1) of thirty-seven (37) sampled patients (Patient 1) as ordered by Patient 1's physician.

This deficient practice had the potential for Patient 1 to be under-medicated and not have the desired effects of the medication.

Findings:

A review of Patient 1's History & Physical (H&P), dated 7/19/2022 at 7:28 p.m., indicated Patient 1 was admitted to the facility, on 7/19/2022 for an intentional drug overdose and reported suicide (taking one's own life) attempt.

A review of a pharmacy report indicated the following.
1. On 7/20/2022 at 8:46 p.m., RN 1 removed a vial containing 10 mg of diazepam medication (5 mg/ 1 milliliter [ml, unit of measurement]) from the Pyxis (automated medication dispensing machine) then at 8:47 p.m., 5 mgs of diazepam medication were wasted and witnessed with RN 2.
2. On 7/21/2022 at 4:15 a.m., RN 1 removed a vial containing 10 mg of diazepam from the Pyxis, then at 4:17 a.m., 5 mgs of diazepam were wasted and witnessed with RN 3.

A review of Patient 1's medication administration record (MAR) indicated RN 1 administered the following:
1. On 7/20/2022 at 8:58 p.m., Patient 1 received diazepam 10 milligrams (mg, unit of measurement), intravenously (in the vein).
2. On 7/21/2022 at 4:20 a.m., Patient 1 received diazepam 10 mg, intravenously.

During a concurrent interview and record review of Patient 1's medical records, on 1/24/2023 at 4:08 p.m., the Pharmacy Automation Specialist (Pharm 3) stated Patient 1 was admitted to the intensive care unit (ICU, a unit in a hospital providing intensive care for critical ill patients), on 7/19/2022, for a drug overdose (taking too much). Pharm 3 stated Patient 1 had a physician's order, dated 7/20/2022 at 10:58 a.m., for diazepam 10 mg, as needed, every six (6) hours for anticholinergic symptoms (drugs that block the action of acetylcholine that is a chemical messenger affecting the body functions such as causing dry mouth, dilated pupils, blurred vision, increased heart rate and decreased sweating, urinary retention). Pharm 3 stated the Registered Nurse 1 (RN 1) removed 2 ml vial of diazepam containing 10 mg (5 mg / 1 ml) from the Pyxis on 7/20/2022 at 8:46 p.m. and wasted 5 mg at 8:47 p.m. with RN 2. Pharm 3 reviewed the medication administration record (MAR) and stated the documentation showed that Patient 1 received 10 mg of diazepam at 8:58 p.m., however, RN 1 wasted 5 mg of the diazepam, and it (MAR) appeared as if Patient 1 received 5 mg of diazepam instead of 10 mg. Pharm 3 stated that on 7/21/2022 at 4:15 a.m., RN 1 removed 1 vial of diazepam 10 mg, then wasted 5 mg at 4:17 a.m. Pharm 3 reviewed the MAR and stated that the documentation indicated Patient 1 received 10 mg of diazepam, on 7/21/2022 at 4:20 a.m., however, 5 mg had been wasted, so it looked like Patient 1 received 5 mg instead of 10 mg. Pharm 3 stated this was considered a medication error.

During an interview, on 1/26/2023 at 9:02 a.m., RN 1 stated he cared for Patient 1 on two consecutive nights, on 7/19/2022 to 7/20/2022 (7 p.m. to 7 a.m. shift) and on 7/20/2022 to 7/21/2022 (7 p.m. to 7 a.m. shift). RN 1 stated on the first night (7/19/2022 to 7/20/2022 [7 p.m. to 7 a.m. shift]), he gave five (5) mg of diazepam per the physician's order to Patient 1. RN 1 stated that on the second night, on 7/20/2022 to 7/21/2022 (7 p.m. to 7 a.m. shift), he gave five (5) mg of diazepam to Patient 1, because he (RN 1) assumed the previous order had not changed. RN 1 stated he did not check the physician's order or Pyxis for the correct dose to be given on 7/20/2022 to 7/21/2022 (7 p.m. to 7 a.m. shift). RN 1 stated he wasted 5 mg of diazepam on 7/20/2023 at 8:46 p.m., and 7/21/2023 at 4:15 a.m., then documented in the MAR that he had administered 10 mg of diazepam to Patient 1. RN 1 stated, on 7/20/22 at 4:20 a.m., after the second dose of diazepam had been given, he (RN 1) realized the wrong dose was given, but by that time it (diazepam medication administration) was too late. RN 1 stated it (diazepam medication administration) was a medication error, and he should have checked the physician's order to verify the correct dose.

A review of the facility's policy and procedure titled, "Medication Management", dated 12/2021, indicated the following: 3. Medication Administration.
A. Before administering the medication:...
5. Verify the medication is administered at the proper time, correct dose, and correct route.

PHARMACY DRUG RECORDS

Tag No.: A0494

Based on observation, interview, and record review, the facility failed to perform weekly narcotic (a substance or drug that reduces pain, induces sleep, and may alter mood or behavior) counts on three (3) of four (4) units according to facility's policy and procedure.

This deficient practice had the potential for delayed identification of missing narcotics, any narcotic medication count discrepancies, and possible occurrence of narcotic medication diversion (the illegal distribution or abuse of prescription drugs).

Findings:

During a concurrent interview with the Nurse Manager 1 (NM 1) and an observation of the medication (med) room in the Main (2 North [2N]) intensive care unit, on 1/23/2023 at 1:46 p.m., a document titled, "Weekly Pyxis (automated medication dispensing machine) Narcotic Inventory log," dated 2023 was posted in the medication (med) room. The log included all 12 months of the year (2023). The log allowed for the dates of the weekly narcotic count performed to be documented. Week 3 of January 2023 was missing the date of the narcotic counts. The log indicated that it (the narcotic count) was the responsibility of the Nurse/Department manager to ensure the weekly Pyxis Narcotic inventory was performed. NM 1 verified that week 3 was missing from the log and stated she did not verify to see if the narcotic count had been done and had no way of checking in the Pyxis.

During a concurrent interview with Assistant Nurse Manager (ANM) and an observation of a medication room in the Medical-Surgical (M/S) Bariatric (focuses on treatment of obesity) Unit (7 North East [ 7 NE]), on 1/24/2023 at 10:41 a.m., the ANM stated there were two Pyxis on the unit. The ANM reviewed the "Weekly Pyxis Narcotic Inventory Logs," for both Pyxis and stated Week 2 of January 2023 was missing documentation that the narcotic inventory had been performed. The ANM stated the weekly narcotic count should be performed every Sunday night by the charge nurse and another nurse. The ANM stated the nurse manager of the unit should check on Monday morning of each week to ensure that the narcotic count has been done. The ANM stated if not done, the narcotic count should be done immediately to ensure the narcotic counts were correct and to check for any discrepancies. The ANM stated it (weekly narcotic count) was important to conduct weekly to ensure there was no diversion.

During a concurrent interview and review of pharmacy reports of the weekly narcotic counts for December 2022 and January 2023, on 1/25/2023 at 2:38 p.m., the Director of Pharmacy (DOP) stated narcotic counts must be done weekly. The DOP stated the nurse manager for each unit had to make sure it (weekly narcotic county) was done. The DOP stated the count needed to be performed weekly to ensure the count of controlled substances was correct, to resolve any discrepancies, and to identify any potential for diversion. The DOP verified the Labor and Delivery (L&D) unit did not perform any weekly narcotic counts for December 2022 and missed the weekly count for the third (3rd) week of January 2023. The DOP verified that the medical surgical bariatric (M/S- 7 NE) unit had two Pyxis on the unit. Pyxis # 1 was missing the count for the fourth (4th) week of December 2022 and the second (2nd) week of January 2023. Pyxis # 2 was missing the count for the fourth (4th) of December 2022. The DOP verified that the ICU NE, had not performed a weekly count on the third (3rd) and fourth (4th) week of December 2022 and on the first (1st) week of January 2023.

A review of a pharmacy weekly narcotic counts for the L&D unit for 12/2022, the document indicated no narcotic counts were documented for 12/2022.

A review of a Weekly Pyxis Narcotic Inventory Log, Year 2023, for ICU / North A Station, indicated no narcotic counts were documented for week 3 of January 2023.

A review of a Weekly Pyxis Narcotic Inventory Log, Year 2023, for ICU / North C Station, indicated no narcotic counts were documented for week 3 of January 2023.

A review of a Weekly Pyxis Narcotic Inventory Log, Year 2023, for M/S - 7 NE Pyxis # 1 Pyxis, indicated no narcotic counts were documented for week 2 of January 2023.

A review of a Weekly Pyxis Narcotic Inventory Log, Year 2023, for M/S - 7 NE Pyxis # 2, indicated no narcotic counts were documented for week 2 of January 2023.

A review of a Weekly Pyxis Narcotic Inventory Log, Year 2023, for L&D unit, indicated no narcotic counts were documented for week 4 of January 2023.

A review of the facility's policy and procedure titled, "Pyxis Medstation Profile and Non-Profile Automated Medication Dispensing System", dated 2/2021, indicated an inventory count of all controlled substances was performed at least weekly.