D.7_Appendix F_Competency Assessment_Cleaning and Disinfection.pdf
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- Sterile Compounding Services
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- 36C25727Q0032
About this file
This file is an appendix containing a competency assessment checklist for cleaning and disinfection procedures in a pharmacy controlled environment.
The assessment is organized into three main sections: non-hazardous buffer room/SCA and anteroom daily cleaning, hazardous buffer room/C-SCA daily cleaning, and monthly cleaning. For daily cleaning in non-hazardous areas, employees must demonstrate competency in identifying appropriate germicidal cleaners (TB1-3300 and Peridox), selecting proper cleaning equipment, following USP 797 hand hygiene and garbing protocols, cleaning laminar airflow workbenches with specified dwell times, wiping surfaces with lint-free materials, cleaning pass-throughs and work surfaces, mopping floors with designated equipment, and documenting actions on daily cleaning logs. Hazardous buffer room daily cleaning requires similar competencies but uses Peridox as the primary disinfectant, follows USP 797/800 protocols, cleans biological safety cabinets with a 3-minute dwell time, and observes additional safety requirements specific to hazardous materials. Monthly cleaning activities include initiating cleaning on designated days, identifying sporicidal cleaners, cleaning all surfaces including ceilings and walls, performing deep cleaning of equipment with 3-minute Peridox dwell times, cleaning carts from top to bottom including undersides of shelves, removing disinfectant residue with sterile 70% IPA, and maintaining comprehensive documentation. The assessment format requires a qualified pharmacy staff evaluator to initial each criterion upon successful demonstration, with space provided for additional comments.
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?.## APPENDIX F_COMPETENCY ASSESSMENT_CLEANING AND DISINFECTION
Appendix F
Competency Assessment: Cleaning and Disinfection
Employee: _______________________________ Position:
Evaluator: ________________________________ Initials: _____ Observations and subsequent evaluation must be made by qualified pharmacy staff. Using the space designated next to each criterion, the evaluator will initial to signify that the criterion has been satisfied.
Non-hazardous buffer room/SCA and anteroom daily cleaning
Skill Initials Comments
Identifies TB1-3300 and Peridox as the appropriate germicidal cleaner/disinfectants for non-hazardous cleanroom use and where they are located.
Identifies appropriate cleaning equipment for cleanroom use and where they are located. Uses appropriate mop/wipe for the type of surface to be cleaned (floors, bins, etc.)
Follows hand hygiene and garbing process per USP 797 and pharmacy policy.
Properly cleans LAFW with TB1-3300 (dwell time of 1 minute is observed) and allows area to dry completely.
Use sterile 70% IPA for removal of residue.
Uses a lint free wipe saturated with TB1-3300 (dwell time of 1 minute is observed) and allows area to dry completely. Use sterile 70% IPA for removal of residue.
Cleans all pass throughs, counters, sinks, and easily cleanable work surfaces (i.e., the top of carts, top of stools).
Mops floors using designated floor mop and Peridox starting on the wall opposite the room entry door using even strokes toward the operator.
Moves carts and rolling shelving to ensure that the entire floor surface is cleaned. Ensure wheels are cleaned.
Documents actions on the Daily Cleaning Log for Controlled Environments.
Hazardous buffer room/C-SCA daily cleaning
Identifies Peridox as the appropriate germicidal cleaner/disinfectant for cleanroom use and where it is located.
Identifies appropriate cleaning equipment for cleanroom use and where they are located. Uses appropriate mop/wipe for the type of surface to be cleaned (floors, bins, etc.)
Follows hand hygiene and garbing process per USP 797/800 and pharmacy policy.
Properly cleans BSC with Peridox (dwell time of 3 minutes is observed) and allows area to dry completely before compounding. Use sterile 70% IPA for removal of residue.
Uses a lint free wipe saturated with Peridox (dwell time of 3 minutes is observed) and allows area to dry completely before compounding. Use sterile 70% IPA for removal of residue.
Cleans all pass throughs, counters, sinks, and easily cleanable work surfaces (i.e., the top of carts, top of stools).
Mops floors using designated floor mop and Peridox starting on the wall opposite the room entry door using even strokes toward the operator.
Moves carts and rolling shelving to ensure that the entire floor surface is cleaned. Ensure wheels are cleaned.
Documents actions on the Daily Cleaning Log for Controlled Environments.
Monthly Cleaning
Initiates and performs monthly cleaning on the designated day.
Identifies appropriate sporicidal cleaner/disinfectant for monthly cleanroom use and where it is located.
Identifies appropriate cleaning equipment for cleanroom use and where they are located. Uses appropriate mop/wipe for the type of surface to be cleaned (floors, walls, ceilings, bins, etc.)
Properly cleans LAFW or BSC with Peridox (dwell time of 3 minutes is observed) and allows area to dry completely before compounding. Use sterile 70% IPA for removal of residue. This includes the area beneath the work surface.
Performs all daily cleaning activities above using Peridox for monthly cleaning activities.
Cleans buffer area and anteroom ceiling and walls with Peridox using designated mop.
Uses mop and mop handles appropriate to the area being cleaned such as labeled mop and mop handle for “ceiling/walls” and “floor.”
Cleans all buffer area carts with Peridox beginning with the top and working down to the wheels. Cleans all vertical and horizontal surfaces including underside of shelves using a new wipe for each cart.
Wipes same cart surfaces using lint-free towels wetted with sterile 70% IPA to remove disinfectant residue.
Allows carts to dry before replacing items on shelves.
Cleans buffer area chairs, the interior and exterior of trash bins, as well as all other items that may be in the buffer area.
Uses new wipes as needed throughout the cleaning process.
Documents actions on the Monthly Cleaning Log for Controlled Environments
Additional Comments:
File details come from the government source that posted it. Updated .