Volume 2024 | No. 2
SURVEYOR
PHARMACY
n During the facility tour, it was observed that there was no evidence indicating that the fire extinguisher had been checked by a qualified third party. A dated inspection tag, which can serve as evidence of a proper check, was missing. n There was no evidence that the generators were checked at least annually to ensure they would work if needed. n Emergency lights did not turn on when the surveyor showed the manager how to press the test button. All batteries were dead. n Install illuminated exit signs at appropriate locations to facilitate safe evacuation in case of an emergency. Remember that all exit routes must be adequately lighted and visible so that any employee can see the direction of travel to the exit. n Establish a process ensuring that fire extinguishers are inspected by a qualified third party at least annually. Maintain a dated inspection tag attached to each extinguisher, providing clear evidence of compliance with safety standards. n Complete and document annual fire drills with an evaluation. Share the results with personnel. n Document testing of emergency power sources (generator) and items with a battery backup (e.g., exit lights, smoke detectors, server batteries, etc.) at least annually.
n Temperature and humidity levels are monitored but not documented and recorded daily. n No evidence of the monitoring devices used for temperature and humidity are verified for accuracy. n There is no daily monitoring and recording of the temperature for medications stored in a clinic. The clinic is in a large medical building that only provides an alert range when the room temperature is outside the set range of 62 to 75 degrees Fahrenheit. n IV fluids and flushes were in a storage room that is not monitored for the appropriate storage conditions according to USP <659>. n The continuous monitoring system for both the refrigerator and room temperatures had inaccurate alert ranges. The refrigerator temperature was below range for the past two weeks. n The pharmacist in charge could not articulate a designated contingency plan to address temperature excursions. n Retrain staff on policy and procedures associated with cleaning and disinfecting work areas of the pharmacy. n Maintain cleaning logs for the pharmacy that include the cleaning/disinfecting agent(s) used, the area/items cleaned, and who performed the cleaning. The cleaning logs should show documentation of the cleaning of shelves and refrigerators when they occur. n 70% isopropyl alcohol is a good disinfecting agent, but it does not deactivate or decontaminate hazardous drug powder. Before cleaning/sanitizing, use a deactivating decontaminating agent on hazardous drug pill-counting trays and countertops. Select additional cleaning and sanitizing agents or an EPA-registered one-step cleaning and sanitizing agent to use following the deactivating and decontaminating steps for hazardous drug storage areas and equipment used to handle hazardous drugs. n Maintain the appropriate storage conditions as described in USP <659>. Document and monitor temperatures and humidity at least daily or via a continuous monitoring device. n Implement a process for removing any unacceptable drugs (e.g., monthly inspections of drug inventories and documentation of such on the daily log). n Develop written contingency plans to address situations where pharmaceutical storage conditions fall outside of the established range. n Set the drug storage area humidity limit to alarm at >60% per USP or have documentation explaining the reason for and supporting a higher limit (e.g., site issue).
Tips for compliance:
Tips for compliance:
DRX7-9A
Overview of the requirement:
Written policies and procedures address purchasing and onsite storage of pharmaceuticals. Ambulatory Infusion, Infusion Nursing, Infusion Pharmacy with or without Sterile Compounding, Mail Order Pharmacy, Specialty Pharmacy with or without DME Compliance is assessed through direct observation, response to interviews, review of policies and procedures, and review of temperature and cleaning/ disinfecting logs. Most deficiencies related to insufficient cleaning and disinfection practices or temperature and humidity monitoring.
Applicable services:
Comment on deficiencies:
Frequency of citation:
25%
Examples of surveyor findings:
n Written policies and procedures relating to onsite storage of pharmaceuticals did not define cleaning and disinfection processes. n Cleaning and disinfection documentation lacked the cleaning or disinfection agent used. Audit of cleaning logs was performed per the PIC, but errors/ omissions were not corrected nor documented. n Policies and procedures were specific for the decontaminating and cleaning steps when handling/dispensing hazardous drugs, but the documentation was lacking to support the steps performed.
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