Volume 2025 | No. 2
SURVEYOR
PHARMACY
Compliance tips for:
DRX7-8P.01 DRX7-8P.02 Frequency of the citation: DRX7-8P.01 19%; DRX7-8P.02 20%
■ The intent of the first standard discussed here is to ensure that CSPs are prepared in appropriately certified areas and that third party certification reports are reviewed with action take for any unacceptable results. ■ The second standard identifies ongoing environmental monitoring and defines requirements for air and surface sampling procedures including: ٝ Sample collection (what, when, how). ٝ Sample size. ٝ Data evaluation. ٝ Corrective actions.
Nerd Newbies (understand the requirement)
Overview of the requirement: Written policies and procedures require certification of classified air environments for CSPs prior to initial use of the spaces and every six months thereafter. Written policies and procedures for environmental monitoring of these classified areas align with current USP <797> requirements. Comment on deficiencies: These closely related standards are evaluated by reviewing written policies and procedures and observing practice. Most of the finding for DRX7-8P.01 noted that after third party testing, there was no review of the report by the designated person and therefore no QA of the testing and no QI in the form of corrective action for unacceptable results.
■ Ensure that the designated person:
Nerd Apprentices (audit for excellence)
ٝ Conducts a review of the certification report. ٝ Signs the report and submits it to the PIC for review and signature. ■ Expand the certification monitoring checklist (mentioned above in standard DRX7-80) to include an executive summary of the findings from the certification report for the designated person to complete when reviewing certification reports. ■ Educate the DP on the environmental monitoring tests, testing requirements, frequency of testing, and what determines passing for the test. For air and surface sampling, ensure the DP understands what the action and alert levels are and what actions to take when an action or alert level is reached. ■ Educate compounding personnel on the environmental monitoring testing requirements, such as: ٝ Dynamic operating conditions. ٝ Frequency of testing. ٝ Surface sampling procedures, alert and action levels, and corrective actions to be taken for alert and action levels. ٝ Documentation requirements.
Nerd Trailblazers (prepare the path for others)
Examples of ACHC Surveyor findings: DRX7-8P.01
■ The most recent written environmental report did not include the activities being performed during the dynamic smoke test. When reviewing the video, the technician was observed sitting still and holding a syringe in a bag, but not actually performing compounding. ■ The organization provided no evidence that certification reports of classified air environments were reviewed by the USP designated person. ■ Cleanroom reports with actionable growth mid-July, retested in two weeks (still actionable), retested in two more weeks (clean). There was no documentation of the corrective actions taken. This scenario was a recurrance from the prior year. DRX7-8P.02 ■ No evidence that monthly surface sampling was completed. ■ Surface sample documentation had issues with incomplete documentation, incorrect incubation time/temperatures and did not indicate that the COA for the agar was reviewed. ■ Corrective action plans only state “retest.”
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