Pharmacy Cleaning & Hygiene Audit

This inspection checklist can be used to assess the cleaning and housekeeping, sterile preparation compounding and infection control practices in pharmacies.

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Pharmacy Cleaning & Hygiene Audit



Cleaning & Disinfecting

1. Are all areas of the pharmacy including areas where medications are stored, compounded, dispensed, prepared and administered cleaned and disinfected?


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2. Do the staff use only approved cleaning procedures; cleaning and disinfecting agents?


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3. Is there an adequate number of sinks and sufficient space and materials for cleaning equipment and washing hands?


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4. Are alcohol-based hand rubs appropriately located?


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5. Are cleaning agents and supplies readily available to staff?


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6. Are cleaning and disinfecting agents appropriately labelled and diluted?


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7. Is equipment kept clean and stored in a clean area?


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8. Are drug preparation, packaging, and dispensing devices cleaned after each use and disinfected, if necessary?


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9. Are devices used for crushing or splitting tablets cleaned immediately after use according to manufacturers’ recommendations and instructions?


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10. Are medication carts, drawers, and bins containing individual patient’s medications kept clean?


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11. Are automated dispensing cabinets and bins cleaned according to the manufacturer’s recommendations and instructions?


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Boxes & Storage

1. Are cardboard boxes stored off the floor?


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2. Are shipping containers not stored or opened in any area reserved for pre-packaging medications or compounding sterile preparations?


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3. Is handling and storing of shipping containers (e.g., cardboard boxes) done with minimal air disturbances and dissemination of dust particles?


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4. Are Intravenous (IV) bags and bottles and related supplies removed from cartons and wiped with an approved disinfecting agent prior to placing them in the sterile preparation area?


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Waste

1. Does staff dispose of waste in accordance with the organization’s infection control policies and procedures?


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2. Are waste disposal containers close to the area of use?


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3. Is non-infectious waste disposed separately without mixing with infectious waste?


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Infectious Waste

1. Is infectious waste disposed in accordance with the organization’s infection control policies and procedures?


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2. Are infectious waste disposal containers close to the area of use?


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3. Is infectious waste placed in specially marked containers (e.g., red bags) and disposed of separately from routine trash?


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4. Is it ensured that items used in patient rooms are not returned to the pharmacy?


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Attire

1. Do personnel wear appropriate attire in non-sterile areas?


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2. Do staff wear clean attire with no shedding and contamination as per the organization’s policy and state regulations in the sterile compounding areas?


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3. Do personnel remove jewellery and cosmetics prior to compounding sterile preparations?


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Hygiene

1. Do personnel with rashes, sunburn, weeping sores, conjunctivitis, or active respiratory infection avoid participating in the sterile preparations or sterile areas?


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2. Does fingernail length comply with the organization’s policies and procedures?


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3. Does the use of artificial fingernails comply with the organization’s policies and procedures?


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4. Is routine hand washing performed at the beginning of the shift, after visiting the restroom, before and after eating, and when the hands are obviously soiled?


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5. Does staff use a hand washing technique and cleaning agents approved by the organization?


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Sterile Preparation Compounding

1. Do personnel wash their hands thoroughly prior to compounding sterile preparations?


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2. Do personnel who leave the sterile preparations compounding area rewash their hands prior to resuming compounding?


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3. Do areas for compounding sterile preparations minimize opportunities for particulate and microbial contamination of the preparations?


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4. Are floors in the ante and buffer areas cleaned in accordance with the guidelines?


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5. Are all compounded sterile preparations labelled with expiry dates?


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6. Are compounded sterile preparations quarantined and inspected by a pharmacist prior to release from the pharmacy?


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Primary Engineering Controls (PEC)

1. Are sterile preparations compounded in a properly maintained laminar airflow workbench, biological safety cabinet, compounding aseptic isolator, or compounding aseptic containment isolator?


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2. Are compounding of medium-risk and high-risk preparations, parenteral nutrition, antineoplastic and other hazardous agents, cardioplegia, and other preparations that require specialized knowledge or equipment compounded in the pharmacy by specially trained staff?


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3. Are primary engineering control surfaces cleaned and disinfected frequently, including at the beginning of each work shift, before each batch preparation is started, every 30 minutes during continuous compounding activity, when spills occur, and whenever surface contamination is known or suspected?


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4. Is USP Purified Water used to remove water-soluble residues and are the same surfaces then disinfected with a non-residue generating agent using a lint-free wipe?


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5. Are all items (including syringes, vials, and other extraneous items) removed from the hood before cleaning it?


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6. Is a schedule and technique for cleaning primary engineering controls available?


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7. Are the work surfaces, side panels and other accessible surfaces cleaned starting at the top and rear and working downward and toward the front, unless the manufacturer recommends a different procedure?


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8. Is routine maintenance, such as cleaning or replacing pre-filters, performed regularly and according to manufacturers’ specifications (e.g., monthly or quarterly)?


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9. Are HEPA filters replaced or repaired when recommended by a qualified certifier?


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10. Is environmental monitoring of both non-viable and viable particles performed as required?


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11. Are results of environmental monitoring reported to the management?


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12. Are primary engineering controls checked and certified when they are first placed in service and thereafter at least every 6 months, when maintenance is completed, or they are moved to a new location?


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13. Are checks of operational efficiency of all primary engineering controls, ante areas and buffer areas performed at least once every 6 months by a qualified certifier?


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Aseptic Technique

1. Is a sterile syringe used for each medication withdrawn?


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2. Are syringes used on one patient only and then disposed appropriately?


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3. Are containers for disposal of used needles and other sharp objects available, used properly and not overfilled?


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Single-Use Containers

1. Are single-use containers not reused?


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2. Are single-use containers discarded immediately after use in accordance with the organization’s policies?


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Multiple-Dose Containers

1. Are multiple-dose containers that are reused after the first puncture labelled with an appropriate beyond-use date?


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2. Are multiple-dose containers not used beyond the time specified by the organization’s policies?


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3. Are pharmacy bulk packages of electrolytes and other products used in the pharmacy for no more than 4 hours after the initial entry into the container unless the manufacturers’ product information provides for another time period?


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4. Are any unused portions of bulk packages of electrolytes and other products discarded?


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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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