Information
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Document No.
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CMHS Sterile Processing Audit - DNV-ISO
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
Section 1: Cleaning and handling Used Items
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Is gross tissue removed and is enzymatic solution applied at point of use?
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Are Standard Precautions used at all stages of handling used items? (PPE is used)
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Are written procedures for handling of used equipment available?
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Are all single-use items discarded at point of use? Were disposable items sent to SPD?
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Are there policies/ procedures for the collection of used items and delivery of sterile items?
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Are collection containers puncture resistant, leak proof and lidded?
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Is the container / cart cleaned at the end of each collection round?
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Are all instruments that have been unwrapped for use considered contaminated whether used or not and subjected to full cleaning process?
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Are there written procedures for handling specialized equipment? (Power, delicate, etc.)
Section 2: Packaging and wrapping of items prior to sterilization
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Instruments with hinges or ratchets remain open or unlocked during sterilization.
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Multi part instruments are disassembled prior to packaging to permit effective sterilization.
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Basin sets are packed so all openings face the same direction.
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The color change of the sterilizing indicator tape following exposure is distinct and uniform and markedly different to the unprocessed tape.
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Cleaning agents or other chemicals are not allowed to come in direct contact with personnel.
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Abrasive cleaners, steel wool, powders and paste are not used.
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Safety Data Sheets information has been reviewed with staff.
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Ultrasonic is degassed after each fill before instruments are reprocessed.
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Ultrasonic is tested daily to establish efficiency of transducers. This is documented.
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The ultrasonic is emptied and cleaned at least daily or more frequently depending on use.
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Cleaning brushes are disinfected at the end of each day.
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The functions of the washer disinfector and the detergent dispenser are checked daily.
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Is there a process to ensure that the internal cleanliness of the washer is maintained ie: descaling?
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Staff is able to state the acceptable temperature setting for drying cabinet and actions taken if out of range.
Section 3: Loading of Sterilizers
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Bowls/basins are tilted on edge in a draining position so that only minimal resistance to removal of air, the passage of steam and condensate will be met.
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Packs of towels are loaded in vertical layers to allow air to be removed rapidly from packs.
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Items are loaded within boundaries of the sterilizer cart so that they do not touch the chamber walls or fall from the cart.
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Flexible packaging materials are loaded on edge.
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Sterilizer carts are loosely loaded to capacity with only a single layer of wrapped packs placed on each shelf.
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The department has clear written procedures on the loading of sterilizers and all staff performing this task have had the formal training to do so.
Section 4: Unloading of Sterilizers
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On completion the load is visually inspected to ensure it is dry and that sterilizing indicators have made the required color change.
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When removing of the load from the sterilizer the operator checks printouts and signs that the parameters have been met.
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The load is quarantined and the supervisor is notified immediately if any deviation from the parameters is detected.
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Steriliser carts containing cooling items are kept away from high activity areas.
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Cooling items are never placed onto solid surfaces as condensation may result. <br>
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Items that have been dropped on the floor, placed onto a dirty surface, have torn wrap or broken seals, or are wet are considered non sterile and reprocessed.
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When plastic dust covers are used the items are cool before placing into the cover.
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Dust covers are placed onto cooled items within 2 hours of sterilizing.
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If dust covers are used they are labelled 'dust cover only'.
Section 5: Purchasing, Validation, Monitoring and Maintenance of Sterilizers and Associated Equipment.
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Daily the floor of the sterilizer is checked and free of debris, chamber drain and filters are clear, recording devices are functioning correctly and the door gasket is undamaged.
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The sterilizer chamber is cleaned routinely and the cleaning documented.
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On Pre vacuum sterilizers there is a daily Bowie Dick test performed.
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Every package has an external chemical indicator.
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Every cycle has an electric printout of sterilization parameters.
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A comprehensive and documented preventative maintenance program is established including calibration.
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On Pre vacuum sterilizers Bowie Dick testing is done after return to service.
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Filters on sterilizers are checked and recorded by engineering dept. every 6 months.
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When recommissioning and performance requalification is performed the process is documented and a copy filed in the facility.
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Staff competency is completed annually and as needed for individual training/ retraining.
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There is a contract with a trained, competent maintenance contractor, equipment manufacturer or trained organization staff for preventative maintenance of sterilizer equipment.
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Drying cabinets have a daily visual temperature check.
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Drying cabinets are calibrated routinely.
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Biological indicator incubators are checked for temperature accuracy.
Section 6: Quality Management
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The person in charge of the processing facility has specific qualifications and experience in sterilizing technology.
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There are documented policies and procedures for all activities involved in the processing of items
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Records are maintained in a designated storage area for a period of time not less than defined by regulatory authorities.
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There are written job descriptions for each category of staff in the facility.
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There is formal orientation program.
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Each item intended for use as a sterile item has a label with batch control identification which indicates sterilizer, date of sterilization and cycle or load number.
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All sterilizing records are maintained and include date of cycle, sterilizer number, cycle number, exposure time temperature and pressure, identification of the loading operator, the specific contents of the load and the results of physical, chemical and biological tests used.
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All sterilizers have automatic parameters recorders.
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A record of all mechanical testing, repairs and preventative maintenance is kept for each sterilizer.
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There is a policy and procedure for recall.
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All items to be processed have external chemical indicators on them.
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There is written information from the biological/enzymatic indicator supplier on the storage, handling, use, microbial testing and correct incubation processes.
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Each day biological indicators are used, an additional unexposed indicator from the same batch is incubated to verify pre sterilization viability of test spores.
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Staff wear clean, hospital laundered attire.
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All hair is secured and covered while preparing items for sterilization.
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Plastic aprons, fluid repellent masks, gloves and eye protection are worn when handling used / soiled items.
Section 7: Storage and Handling of Sterile Items
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The facility has documented policies and procedures for storage, handling and issuing of sterile stock.
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All items are stored above floor level by at least 8 inches.
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All items are stored at least 18 inches from ceiling.
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Storage containers, carts and cupboards are clean, dry and in good condition.
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All surfaces including walls, floors and ceiling lights are easy to clean, non porous and smooth.
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All batch information is on the sterilized package and not on the dust cover.
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Sterile items intended for distribution outside the health facility are securely packed and protected against damage and contamination during transportation.
Section 8: Cleaning of the Sterile Processing Department
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Surfaces that could be soiled by blood and body fluids are impervious and intact to allow for effective cleaning.
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Waste is placed into appropriate containers.
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Sharps containers are available for use if necessary and are exchanged when 3/4 full.
Section 9: Selection and Care of Instruments
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The person in charge of the sterile processing department is responsible / involved in the selection process prior to the purchase of instruments.
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Manufacturers recommendations are available for processing equipment and instruments.
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All staff working in the sterile processing department has had education and training on the correct handling of instruments.
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Instrument repairs are only performed by a qualified person.
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Any instrument that appears defective is cleaned, dried and sterilized prior to being sent for repairs.
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Lumens, grooves and articulations are free of debris and stylets are passed through lumens.
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The tips of instruments do not have hooks or snags and approximate accurately.
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All instruments with dull edges are sent for sharpening.
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Any stopcocks move freely and are left in the open position for processing.
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Fine instruments and their tips are protected in a manner that does not inhibit the sterilization process.
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Microsurgical instruments are not placed on top of one another during sorting, cleaning or any other part of the packaging and sterilization process.
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Insulated instruments are tested to ensure the integrity of insulations.
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All loaner sets and instruments undergo complete routine cleaning and processing prior to sterilization. Perceived lack of time does not permit the cleaning process to be bypassed.
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Following use all loan equipment is subjected to the full cleaning process and decontaminated prior to return.
