HospitalInspections.org

Based on observation, interview, and record review, the hospital failed to ensure:

1. Sensorcaine-MPF with Epinephrine was protected from light as specified by the manufacturer.

2. Outdated biological was removed and not available in stock for patient's use.

These failures had the potential for patients to receive decreased potency or efficacy of the medication and/or biological resulting in poor/adverse outcomes.

Findings:

Review of the hospital's P&P titled Medication Labeling, Storage and Security last review 7/6/23, showed storage areas shall be free of expired medications.

Review of Sensorcaine-MPF with Epinephrine manufacturer's package insert showed it should be protected from light.

1. On 11/5/24 at 0930 hours, during an observation and concurrent interview in the main hospital pharmacy medication storage areas in the presence of the Chief Pharmacy Services, Pharmacy Operation Manager, Pharmacy Clinical Manager, and Medication Safety Pharmacist, three 30 ml vials of Sensorcaine-MPF 0.75% (bupivacaine hydrochloride and epinephrine 1:200,000 as bitartrate) used for local or regional anesthesia or analgesia for surgery, were observed on the shelf exposed to light. The Pharmacy Operation Manager stated different manufacturers had different storage conditions. On examining the Sensorcaine-MPF with Epinephrine vial, the Pharmacy Operation Manager verified the vials were labeled to be protected from light.

2. On 11/5/24 at 1000 hours, during an observation and concurrent interview in the main hospital pharmacy in the presence of the Chief Pharmacy Services, Pharmacy Operation Manager, Pharmacy Clinical Manager, and Medication Safety Pharmacist, a vial of ChiRhoStim (a hormone used for the stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction) with expiration date of 2/17 was observed in the medication/biological freezer. The Pharmacy Operation Manager stated ChiRhoStim was not a Pharmacy bought product, it was a clinical trial product stored in the pharmacy freezer. The Pharmacy Operation Manager verified the vial was expired.