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159 N 3RD ST

MACCLENNY, FL 32063

PHARMACY ADMINISTRATION

Tag No.: A0491

Based on observation, interview and record review, it was determined the hospital failed to ensure refrigerated medications were stored in accordance with accepted professional principles by failing to ensure temperatures were monitored for 1 of 3 medication refrigerators. (medical surgical unit)

The findings include:

On 9/11/23 at approximately 2:45 PM, a tour of the Emergency Department (ED) was conducted with the Director of Nursing (DON). The ED medication room was observed to contain a Pyxis (secured medication delivery system) refrigerator containing numerous medications. The DON indicated pharmacy staff maintained the refrigerators including the monitoring of appropriate temperatures on the medical surgical unit, the Operating Room (OR) and in the ED. The Director of Pharmacy arrived to the ED at this time and confirmed her staff were responsible for monitoring the Pyxis refrigerator temperatures in the ED, OR, and on the medical surgical unit. The Director of Pharmacy indicated the refrigerators were to be maintained between 36-46 degrees Fahrenheit (F). She offered to provide additional evidence of the hospital's medication refrigerator monitoring practices.

At approximately 3:00 PM in the hospital pharmacy, the Director of Pharmacy indicated the Pharmacy Technicians visually check the three refrigerators in the mornings and evenings when they are delivering medications, and then daily review the continuous temperature database contained in the pharmacy's computer server. The Director of Pharmacy demonstrated the data from the server for May 2023. The temperature data revealed on May 5, 2023 the medication refrigerator on the medical surgical unit was out of range for approximately 2 hours with readings of 50-74 degrees F, however there was no corresponding evidence the pharmacy staff were aware of the discrepancy or responded in any way.

An interview was conducted at this time with staff member C, a Pharmacy Technician, regarding the task of checking the continuous temperature monitoring logs contained in the server. The Pharmacy Technician confirmed she was to check the server logs, but indicated she "tries to check the logs on the server when we have time." An interview with the Director of Pharmacy was conducted at this time and she indicated she was unaware the Pharmacy Technicians were not consistently monitoring the continuous temperature logs in the server and was unaware of the incident on May 5, 2023.

A review of the hospital's policies and procedures for Automated Dispensing Machines/Infection and Inventory #6231 and Drug Storage Monitoring #6215 indicated the medication refrigerators were to be maintained between 36-46 degrees F. The polices revealed that a record of the continuous monitoring of refrigerator temperatures would be maintained and if the temperatures were found to be out of acceptable temperature ranges, pharmacy services would be notified. Neither policy included a requirement for Pharmacy Technicians to monitor the continuous temperature logs maintained on the pharmacy server.

On 9/12/23 at approximately 8:53 AM, an interview was conducted with the Director of Pharmacy. She presented amendments to policies and procedures to ensure proactive review of the continuous temperature server logs twice daily by pharmacy staff Monday through Friday and then twice daily by nursing staff on Saturday and Sundays. The polices revealed the inclusion of accepted professional standards from the Centers for Disease Control (CDC) for medication storage practices.
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