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Based on observation, interviews, and record review, the facility failed to establish an appropriate temperature range within the pharmacy refrigerator monitoring system to ensure medications were stored under proper conditions. This practice had the potential to delay the detection of temperature excursions, placing temperature-sensitive medications, including vaccines, for 39 of 39 patients in the facility, at risk for degradation.

During a concurrent observation and interview on 10/21/25 at 2:08 p.m. with the Pharmacist-in-Charge (PIC) in the main hospital pharmacy, the medication refrigerator containing vaccines such as hepatitis B vaccine, a type of vaccine that protects against hepatitis B virus (HBV) infection, which can lead to chronic liver disease, liver cancer, and death, was observed to have a temperature monitoring alert system incorrectly set at 36° F (degrees Fahrenheit, unit of measure) to 53° F. The PIC stated that an email notification is sent when the temperature is out of range. The acceptable temperature range should be set between 36° F and 46° F, as specified by drug manufacturers. The PIC acknowledged that storing medications outside the required temperature range could compromise drug potency and efficacy.

During a review of the hepatitis B manufacturer's label in the pharmacy, the manufacture label on the box indicated, "Store in a refrigerator at 36° F to 46° F."

According to the Centers for Disease Control and Prevention (CDC), refrigerated vaccines must be stored between 36° F and 46° F at all times to maintain their potency and effectiveness. The CDC's Vaccine Storage and Handling Toolkit emphasizes that failure to maintain proper storage temperatures can result in reduced vaccine efficacy and potential patient harm.

Review of the facility policy and procedure titled, "Storage of Medications", last reviewed 12/24, indicated, "Medications will be stored at appropriate temperatures. Refrigerator temperatures, everywhere medications are stored will be maintained between 36o F and 46o F."

Based on observation, interview, and record review, the facility failed to ensure consistent implementation of its policies and procedures (P&P) regarding high-risk and high-alert medications (those that bear a heightened risk of causing significant patient harm if used in error). The high risk and high alert medications for 39 of 39 patients were stored throughout the pharmacy shelves without any distinct labeling to indicate their classification as high-risk or high-alert.

This failure had the potential to increase the risk of medication errors associated with these medications.

Findings:

During an inspection of the main hospital pharmacy on 10/21/25 at 2:20 p.m., high-risk and high-alert medications were observed to be stored throughout the pharmacy shelves without any distinct labeling to indicate their classification as high-risk and high-alert medications.

During an interview on 10/21/25 at 2:25 p.m. with the Pharmacist in charge (PIC), the PIC stated, the pharmacy shelves did not have any labels to identify the high-risk and high-alert medications.

During an interview on 10/23/25 at 11:20 a.m. with the PIC, the facility's P&P were reviewed. The PIC stated, according to the P&P, the high-risk and high-alert medications needed to be identified for the pharmacy staff to prevent medication errors.

During a review of the facility's P&P titled, "High Risk/High Alert Medications," last reviewed 12/2023, the P&P indicated, "II. Strategies will be developed to mitigate risk for each of the high alert medications and will be included on the hospital's list of high-risk medications. III. Medications that appear on the list will be identified in the pharmacy as such on the front of the medication storage bins. IV. Medications from the list that are stocked in the pharmacy will be stored in medication bins of color to distinguish them from other medications."

During a review of the facility's P&P titled, "Storage of Medications," last reviewed 12/2024, the P&P indicated, "Medications designated on the "look-alike/sound-alike" or "high-alert" lists will be stored separately from other medications and/or appropriately labeled with cautionary statements."

According to the Institute for Safe Medication Practices (ISMP), a nonprofit organization in the United States devoted to the prevention of medication errors, for each medication on a facility's high-alert medication list, organizations should outline a robust set of processes for managing risk, impacting as many steps of the medication-use process as feasible. This includes strategies such as distinct labeling, segregation, and visual identification to ensure these medications are easily recognized and handled with appropriate caution.

Based on observation, interview, and record review, the facility failed to ensure a pharmaceutical product available for 39 of 39 patients was stored properly according to the facility's policies and procedures or manufactures' specifications and requirements when an injectable vial of pantoprazole, a medication used to treat stomach ulcers or acid reflux, was not protected from light in accordance with manufacturer's storage requirements. This failure had the potential for medication degradation and administration of potentially ineffective medication.

Findings:

During an inspection of the pharmacy on 10/21/25 at 2:25 p.m., a vial of pantoprazole 40 mg (milligram, unit of measure) per vial was observed stored outside of the manufacture's box, placed on a shelf in the main pharmacy room and exposed to light.

During an interview on 10/21/25 at 2:30 p.m. with the Pharmacist in Charge (PIC), the PIC stated, "the vial should be protected from light to prevent drug degradation [deterioration leaving the medication less effective]."

During a review of the pantoprazole manufacturer's label in the pharmacy, the manufacture label on the vial indicated, "Protect from light."

During a review of the facility's policy and procedure (P&P) titled, "Storage of Medications," last reviewed 12/2024, the P&P indicated, "Medications must be stored under proper conditions of sanitation, light, humidity, ventilation, segregation, and security as determined by the USP/NF compendia and/or manufacturer's labeling, as well as in compliance with applicable federal and state laws/regulations and accreditation standards."