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Based on observations, record reviews and interviews, the facility failed to ensure the pharmacy and/or drug storage area was administered in accordance with accepted principles in that:

1. The facility failed to ensure prompt disposition of controlled expired drugs.
2. The facility failed to ensure expired medications were not stored together with other drugs.

This failure placed the facility at increased risk of drug diversions and/or adverse patient outcomes.

Findings included:

Observation on 12/03/18 at 09:25 AM in the facility Pharmacy revealed returned/expired, controlled, intravenous medication (IV) bags stored in a drawer together with bulk, non-expired, controlled medications.

The following medications were observed in the storage drawer: (milligrams/ milliliter)
- Morphine Sulfate 10 mg/250 mls with a prep date of 09/18/18;
- Morphine Sulfate 10 mg/250 mls with a prep date of 10/27/18;
- 3 Fentanyl 1000 mcg/20 mls (one dated 11/15/18 and two with no date);
- 3 Morphine Sulfate 250 mg /250 mls with expire date of 07/01/18;
- Morphine sulfate 10 mg/mls with prep date of 11/22/18; and
- Versed/Midazolam 50 mg/mls with a prep date of 11/16/18.

Observation on 12/03/18 at 1:30 PM revealed a reconstituted, opened, undated bottle of Daptomycin/Cubicin 500 mg per vial in the facility Pharmacy refrigerator.

Interview with facility Personnel #1 on 12/03/18 at 9:25 AM confirmed the expired and partially used IV bags of controlled medication in the pharmacy drawers, stored together with other unexpired medications. Personnel #1 said it was his responsibility to destroy/waste the medications and document the waste. Personnel #1 said, "I don't know why it was not wasted." Personnel #1 reported the returned medications should not have been kept together with clean, bulk, stored medications. Personnel #1 said, "it's an infection control issue, keeping dirty with clean." Personnel #1 reported two pharmacists were supposed to waste and witness the wasting of the controlled IV medication bags. Personnel #1 said prompt disposition of the medication was necessary to prevent the risk of drug diversion. Personnel #1 confirmed the reconstituted, opened and undated Daptomycin vial found in the refrigerator, the excess should have been wasted, not used for other medication prep, and not stored with other medications.

Review of the facility's 02/01/14, revised, "Dispensing" policy stated, "Drugs returned to the pharmacy shall not be placed in active stock or dispensed..."

Based on observation, record review and interviews, the facility failed to ensure outdated, mislabeled or otherwise unusable drugs were not available for patient use in the facility Pharmacy, in that:

Single use intravenous (IV) medication was available after it had been used previously.

This failure placed patient's health at risk by not preventing inadvertent contamination of the vial and infection transmission.

Findings included:

Daptomycin (500 mg/vial) medication was observed on 12/03/18 at 1:30 PM in the pharmacy refrigerator. The medication was undated and had been reconstituted. The medication was labeled "Single use vial - Discard unused portion."

Interview with Personnel #1 on 12/03/18 at 1:35 PM revealed he was not able to tell when the medication had been opened/used. Personnel #1 reported he used the single dose medication vials multiple times and would only discarded it at the end of the day or when all the medication in the vial was used. Personnel #1 could not explain how a single use medication could be used multiples times.

Interview with Personnel # 2 on 12/03/18 at 1:40 PM revealed she had not prepared any Daptomycin medication that day. Personnel #2 said that Personnel #1 instructed/wanted the medication to be used multiple times until all was finished (emitted).

The Facility did not have a policy on single use intravenous medications as per Personnel #1.

https://www.cdc.gov/migration/injectionsafety/providers/references.html#ref

Centers for Disease Control (CDC): recommends not to combine (pool) leftover contents of single-dose or single-use vials or store single-dose or single-use vials for later use. Single-dose or single-use vials are intended for use on a single patient for a single case/procedure. There have been outbreaks resulting from pooling of contents of single-dose or single-use vials and/or storage of contents for future use.

A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case/procedure/injection. Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative.