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Tag No.: A0322
Based on interview and record review, the hospital failed to follow its policy and procedure to report to the California Department of Public Health of an unusual occurrence that occurred on 2/8/21 regarding a missing bag of Fentanyl drip (a narcotic pain medication that is addictive). The drip is a mixture of Fentanyl 1000 mcg (micrograms- a unit of measurement) in 100 ml (milliliter, a unit of measurement) of Normal Saline solution. This incident happened on 2/8/21 but pharmacy did not discover the reconciliation and documentation of wastage for this controlled substance (fentanyl) not until 5/26/21. This failure had the potential to result in delayed in diversion investigation.
Findings:
During a concurrent interview and review of the MIDAS (an occurrence reporting system) Event Triage and Ranking (METER), on 7/15/21, at 5:05 PM, with the Director of Risk Management (DRM), the METER, a MIDAS report, dated 5/26/21, was reviewed. The MIDAS report indicated on 5/27/21, a bag of Fentanyl drip was delivered to a patient unit during an emergency. The Fentanyl drip was not administered to the patient or returned to the pharmacy after the emergency situation. The Fentanyl drip was gone. DRM stated an extensive review and internal investigation were conducted on 6/2/21 and the incident was reported to the Critical Review Committee (CRC- a committee comprised of the leadership team whose main goal is to review events, identify the contributing factors, and provide recommendations to prevent future harm). DRM stated the Committee determined the incident was not a reportable event.
During an interview on 7/15/21, at 3:35 PM, with the Emergency Department Clinical Pharmacist (RPHED 1), RPHED 1 stated, "A Code Blue was called for [Patient 75] in 5T...The Code Team was trying to decide what sedation was appropriate for the patient. I recommended Fentanyl so I went to the Pharmacy to pick up the Fentanyl drip solution. I remember handing the drug and the 'pink sheet' (pharmacy proof-of-use sheet to account for the controlled substance) to a nurse on the Code Blue team, but I did not get her to sign the sheet." At 4:15 PM, RPHED 1 stated, there was a delay in the reconciliation and discovery of the pharmacy-proof-of use sheet. The pharmacy recognized there was no disposition documentation of the controlled substance; there was no disposition documentation of waste.
During a review of the facility's policy and procedure (P&P) titled, "Dangerous Drugs: Theft/Loss," dated 3/16/21, the P&P indicated, "Procedure: ll. As per Administrative Policy (AP. 110), the following agencies will be notified in the event of theft/loss of dangerous drugs. . .F. California Department of Public Health-by Risk Management."