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Based on medical record review, facility document review, and staff interview, it was determined the facility failed to ensure policies and procedures that address the 1) wasting and the documentation of the waste of IV (intravenous) infusions of Controlled Dangerous Substances (CDS); and 2) the monitoring of CDS accountability for IV infusions of CDS, dispensed from the pharmacy department to the patient care units, are developed and implemented.

Findings include:

1. Four of six medical records (MR), MR1, MR4, MR5, and MR 8, that contained documentation of CDS infusion administration, reviewed on 4/17/24 and 4/18/24, lacked documentation that the disposal of partial doses of CDS infusions were completed in a timely manner. During an interview on 4/18/24 at 4:15 PM, S5, the Director of Pharmacy, stated that partial doses of CDS that need to be wasted should be done "promptly." S5 stated that the benchmark for "promptly" would be within 60 minutes of discontinuing the infusion. During an interview on 4/17/24 at 12:30 PM, S16, the ICU (intensive care unit) clinical coordinator, stated that the wasting of partial doses of CDS infusions, such as Dilaudid and Morphine, should be documented on the I&O Flow Sheet found in the medical record, in accordance with facility policy below. The following was identified during medical record review:

On 4/17/24 at 11:45 AM, MR1 was reviewed with S15, the ICU manager, and S16. The Resident Death Exam Note note dated 4/13/24 at 6:11 AM stated, "...Patient was pronounced at 5:52 AM..." The I&O Flow Sheet dated 4/13/24 at 5:50 AM indicates that 43.25 ml (milliliters) of Dilaudid 20 mg (milligrams)/ 100 ml infused. Therefore 56.75 ml of Dilaudid infusion was remaining. The I&O Flow Sheet lacked documentation that the Dilaudid was wasted. This was confirmed with S15 and S16 on 4/17/24 at 12:00PM. On 4/17/24 at 3:29 PM during an interview, S8, an ICU RN (registered nurse), explained that he/she was P1's nurse on 4/13/24. S8 stated that his/her shift started at 7:00 AM and the Dilaudid infusion was still in P1's room because P1's family was present. S8 explained that he/she was going to waste the remaining Dilaudid infusion around 12:30 PM on 4/13/24, approximately six and a half hours after the infusion was discontinued, and discovered that the IV (intravenous) tubing was cut and the Dilaudid was missing. Review of the facility's investigation, and interview with S18, an environmental services staff member, on 4/18/24 at 12:35 PM, confirmed that S18 cut the IV line while cleaning the room, the Dilaudid leaked onto the floor, and CDS diversion did not occur. However, the facility failed to ensure the CDS was wasted in a timely manner and the Dilaudid was available for diversion.

On 4/18/24 at 10:30 AM, MR4 was reviewed with S15. The Resident Death Exam Note dated 4/10/24 at 4:18 PM stated, "...Patient was pronounced at 16:09 (4:09 PM)." S15 confirmed that the Flow Sheet found in MR4 lacked documentation that the Morphine 100 mg/ 100 ml infusion, that was discontinued on 4/10/24, was wasted as required by facility policy. Review of the Pyxis, "Returns and Wastes" report, contained documentation that 85 mg of Morphine dispensed to P4 was wasted on 4/10/24 at 17:24 (5:24 PM). On 4/18/24 at 11:00 AM, S5 confirmed the CDS was wasted more than an hour after is was discontinued.

On 4/18/24 at 11:05 AM, MR5 was reviewed with S15. MR5 contained documentation that P5 was pronounced on 4/10/24 at 23:20 (11:20PM). The I&O Flow Sheet found in MR5 lacked documentation that the remaining Morphine 100 mg/100 ml that was administered to P5 was wasted, as required by facility policy. With further review of MR5, S15 identified a Nurse Progress Note dated 4/11/24 at 2:56 AM that stated, "...Wasted 60 cc (cubic centimeters) of morphine drip with [nurse's name] RN." The note was written approximately three and half hours after the Morphine infusion was stopped. It could not be determined when the Morphine was wasted. This finding was confirmed by S5 and S15 on 4/18/24 at 12:00 PM.

On 4/18/24 at 11:40 AM, MR8 was reviewed with S15. MR8 contained documentation the P8 was pronounced on 3/23/24 at 2:49 AM. The I&O Flow Sheet, dated 3/23/24 at 6:00 AM, indicated the Morphine 100 mg/ 100 ml administered to P8, was wasted. This is approximately three hours and ten minutes after the infusion was discontinued. S15 confirmed the CDS infusion was wasted late on 4/18/24 at 11:47 AM.

Facility policy titled "Medication Administration Record (MAR)" dated 10/23, states, "...Documentation of Large Volume Controlled Substance Waste... The waste is documented on the I&O (in and out) flow sheet for the medication being wasted. The RN (registered nurse) requests a 'Cosign' and enters the 2nd RNs name..."

During an interview conducted in 4/17/24 at 3:15 PM, S9, an ICU RN, explained that CDS infusions should be wasted as soon as they are discontinued and if a patient is deceased, the CDS should be removed from the patient room and wasted before the family members enter the room. S9 confirmed that CDS infusion waste should be documented on the I&O Flow Sheet.

On 4/17/24, the facility policy that addressed the wasting of partial doses of CDS, including CDS infusions, was requested. The facility provided multiple policies including "Pain Management," dated 12/22, "Controlled Substance Procurement, Storage, and Distribution," dated 8/23, and "Continuous Critical Care Intravenous Medication Infusions(s) Titration Protocol," dated 2/24. On 4/17/24 at 4:15PM, these were reviewed with S5, and S5 confirmed the polices do not indicate that the CDS waste should be completed as soon as possible or within a timely manner.

2. During an interview on 4/18/24 at 11:52 AM, the above findings were reviewed with S5, the Director of Pharmacy. It was determined that the software system utilized to monitor CDS administration and waste in the facility, called Bluesight, collected data for CDS removed from the Pyxis, an automated drug cabinet, and reconciled it with data found in the electronic medical records. Bluesight did not collect data for patient specific CDS distributed from the pharmacy directly to the patient care area, such as the Dilaudid infusion. Therefore, CDS infusions distributed directly to patient care areas were not included in the data monitored by Bluesight. When questioned about the processes in place to ensure the accountability of patient specific CDS dispensed directly from the pharmacy, and not stored in the Pyxis, S5 stated "... good question... ." S5 confirmed the facility did not have a process to monitor the CDS infusions distributed from the pharmacy to the patient care area, and that those CDS were not captured in the monitoring conducted by Bluesight on 4/18/24 at 11:56 AM.