Volume 2025 | No. 2
SURVEYOR
PHARMACY
SECTION 7: RISK MANAGEMENT: INFECTION AND SAFETY CONTROL DRX7-8F Frequency of the citation: 21% Overview of the requirement: Temperature, humidity, and other storage conditions are managed to maintain the integrity and security of pharmaceuticals, components, and compounded preparations. Comment on deficiencies: Compliance is assessed by direct observation, response to interviews, and by reviewing documentation. Surveyors most often noted failure to use NIST-certified devices, to define required conditions, to monitor temperatures daily, and to define actions when conditions were outside the established range.
Compliance tips continued:
■ Audit personnel files and confirm applicable trainings/competencies are being conducted at the correct frequency for each employee’s role and responsibility. ■ Review the form used to document aseptic technique competency assessments. Are all required data included? Revise if necessary. ■ Confirm all policies and procedures have been updated to comply with USP <797>. ■ Have the designated person assign trainers to assist in the training and competency assessments required for personnel involved in any aspects of compounding. Trainers must ensure compliance with USP <797> and facility policies and procedures. ٝ The aseptic validation competency must include an initial GFT sampling, with three samplings yielding zero colony-forming units (CFUs) on three separate and complete evaluations in a row. ٝ Aseptic technique validation includes zero CFUs post-hand hygiene and garbing, ≤ 3 CFUs post-media fill validation (representing the most challenging and complex compounding process), and a surface sample of the direct compounding area with ≤ 3 CFUs.
Nerd Apprentices (audit for excellence) continued
Nerd Trailblazers (prepare the path for others)
Examples of ACHC Surveyor findings:
■ The organization is not monitoring freezer temperatures. ■ Refrigerator temperatures were monitored, but for three of eight refrigerator sensors no min/max ranges had been set to alert for excursion. Sensor data showed out-of-range readings but without corrective action. Additionally, two of three ambient drug storage areas were not being monitored for temperature/humidity excursions and their locations were not identified in the monitoring system so it was unclear if any data were captured. ■ Per the organization's policy and procedure, the pharmacy temperature must be maintained at or below 68°F. The temperature in the pharmacy on the second day of survey was 72°F and the temperature in the cleanroom was 70-72°F. The staff reported the temperature was trending higher as recorded by daily monitoring but had no contingency plans to address temperature excursion. The pharmacist entered a work order for engineering on the day of survey. ■ Cleaning and disinfecting of the reusable storage containers was not consistent. Items put into containers stored on a desk in the pharmacy were sprayed with SIPA but the container was not cleaned and disinfected before it was introduced into the cleanroom. No evidence of cleaning and disinfecting reusable containers was documented. ■ There was no evidence of regular inspections to remove and dispose of expired pharmaceuticals. Several bottles of expired sterile water and a box of expired Tylenol 650mg unit doses were observed.
■ Confirm that expectations are correct for:
ٝ Documentation of incubation times, lots, expiration dates, etc. ٝ Training on the PECs. ٝ Aseptic technique.
■ Conduct mock survey interviews with staff.
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