561.14 Space
There shall be adequate space provided for pharmaceutical operations, and the storage of drugs
at a satisfactory location with proper lighting. Ventilation and temperature controls shall be in accordance with 49 Pa. Code 27.15 - 27.16 (relating to sanitary standards construction requirements).
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Observations:
Based on review of facility documents, and staff interview (EMP) it was determined the facility failed to ensure medications were stored in a refrigerator that maintained an acceptable temperature range according to facility policy and manufacturer guidelines.
Findings include:
On April 17, 2025, review of facility policy "Medication Refrigerator" effective July 2023, revealed "Policy: A refrigerator is maintained for drug storage purposes. Purpose: To maintain the integrity of medications stored at cooler temperatures. Procedures: Food or drinks are not stored in the medication refrigerator. A sign is posted on the medication refrigerator informing staff of this statement (e.g., Medications only). The medication refrigerator is plugged into a red emergency outlet. A trackable thermometer is kept on a shelf in the refrigerator, and not in the door of the refrigerator. Daily, the medication refrigerator is inspected and the temperature registered on the thermometer is documented on the Medication Refrigerator Log. The acceptable temperature range is 35to 46The guidelines are posted on the log sheet. If the temperature is ever found to be outside the acceptable range: The temperature is adjusted. The temperature is re-checked every 30 minutes until the temperature stabilizes."
Observation on April 17, 2025, at 10:00am the medication refrigerator thermometer read 33.4 degrees.
On April 17, 2025, review of facility document "Medication Refrigerator Log" revealed on:
February 17, 2025, minimum refrigerator temp 32.2 degrees
February 18, 2025, minimum refrigerator temp 33.5 degrees
February 21, 2025, minimum refrigerator temp 32.2 degrees
February 25, 2025, minimum refrigerator temp 32.2 degrees
February 26, 2025, minimum refrigerator temp 33.3 degrees
February 28, 2025, minimum refrigerator temp 33.7 degrees
March 3, 2025, minimum refrigerator temp 33.1 degrees
March 4, 2025, minimum refrigerator temp 33.1 degrees
March 7, 2025, minimum refrigerator temp 33.1 degrees
March 10, 2025, minimum refrigerator temp 33.1 degrees
March 11, 2025, minimum refrigerator temp 33.1 degrees
March 12, 2025, minimum refrigerator temp 33.3 degrees
March 13, 2025, minimum refrigerator temp 32.9 degrees
March 14, 2025, minimum refrigerator temp 33.3 degrees
March 18, 2025, minimum refrigerator temp 33.3 degrees
March 19, 2025, minimum refrigerator temp 33.1 degrees
March 20, 2025, minimum refrigerator temp 33.3 degrees
March 21, 2025, minimum refrigerator temp 33.0 degrees
March 26, 2025, minimum refrigerator temp 32.0 degrees
April 2, 2025, minimum refrigerator temp 33.1 degrees
April 7, 2025, minimum refrigerator temp 32.9 degrees
April 9, 2025, minimum refrigerator temp 33.1 degrees
April 14, 2025, minimum refrigerator temp 33.3 degrees
Medication Stored in the refrigerator included Famotidine (Pepcid), Cardizem, Insulin, and Rocuronium Bromide.
On April 17, 2025, review of manufacturer documentation for storage of Famotidine reveal "Store famotidine at 2? to 4? (36? to 46?).
On April 17, 2025, review of manufacturer documentation for storage of Diltiazem Hydrochloride (Cardizem) reveal "Diltiazem Hydrochloride should be stored 2? to 4? (36? to 46?). DO NOT FREEZE."
On April 17, 2025, review of manufacturer documentation for storage of Insulin reveal "Unopened insulin should be stored in a refrigerator at 36? to 46? (2? to 4?) until its expiration date. ... Insulin should never be frozen and should be kept away direct heat or sunlight. Keep away from freezer section or where it might freeze."
On April 17, 2025, review of manufacturer documentation for storage of Rocuronium Bromide reveal "Rocuronium Bromide should be stored 2? to 4? (36? to 46?). DO NOT FREEZE.
Interview with EMP1 on April 17, 2025, EMP1 confirmed the medication refrigerator readings above were not within range of facility policy and manufacturer guidelines.
Interview with EMP1 on April 18, 2025, EMP1 confirmed the facility Pharmacy Consultant advised medication in the refrigerator be discarded due to freezing temperatures.
| | Plan of Correction - To be completed: 05/16/2025
S6127 561.14 SPACE MEDICATION REFRIGERATOR TEMPERATURE LOG DOCUMENTATION CORRECTIVE ACTIONS / SYSTEMIC CHANGES:
The Center Administrator (CA) verified the medications that were in the refrigerator on 4/17/2025 were disposed of on 4/18/2025 and re-ordered. The CA updated the Medication Refrigerator Policy to reflect the acceptable minimum temperature range to 36°F on 05/05/2025. An all-staff meeting was held 5/6/2025 the CA reviewed the updated policy and re-educated all applicable staff to ensure documentation of the Medication Refrigerator temperature occurs daily and as needed per Center policy. Staff were re-educated to clear minimum and maximum temperatures after they are checked, and to ensure any corrective actions are documented and temperatures are rechecked within 30 minutes per facility policy when applicable. Any staff not in attendance will review the meeting minutes and Medication Refrigerator Policy on their next scheduled day at the Center and will sign the acknowledgement of review once it has been completed. The CA will ensure all review is completed by 05/16/2025.
MONITORING AND SUSTAINING THE PLAN The CA or designee will monitor the Medication Refrigerator Temperature logs daily for 4 weeks beginning 05/05/2025, to ensure the medication refrigerator temperatures are documented per facility policy for 100% compliance. Once the initial monitoring period is over and compliance is met, ongoing monitoring will be performed during monthly Environment of Care Rounds. Any non-compliance will be addressed immediately with re-education and further corrective actions implemented as applicable.
RESPONSIBLE PARTY AND REPORTING
The CA is responsible to implement the changes identified in this POC.
The CA will provide results of this survey, the corrective actions, and results from monitoring to the Quality Assurance Improvement Committee quarterly for review and recommendations.
Recommendations will be submitted to the Governing Board for review and approval.
CORRECTIVE ACTIONS COMPLETED BY: 05/16/2025
MONITORING COMPLETED BY 6/02/2025
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