Information
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Document No.
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Audit Title
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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 2: Cleaning and handling Used Items
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Is gross residual soil removed as close to the point of use prior to return to CSSD
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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 in all areas? ( including treatment rooms )
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Are all single items discarded at point of use?
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Are there separate procedures for the collection of used items and delivery of sterile stock?
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Are collection containers puncture resistant, leak proof and lidded?
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Is the container / trolley 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 specialised equipment?
Section 3: Packaging and wrapping of items prior to sterilisation
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Combinations of hollowware, instruments, dressings, drapes or tubing are not incorporated into a single pack
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Packs have been validated to ensure efficiency of air elimination so that the sterilising agent can penetrate the load.
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All packs are labelled prior to sterilisation
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Each package labelled with batch control information: steriliser identification number / date of sterilisation / cycle or load number.
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Instruments with hinges or ratchets remain open or unlocked during sterilisation
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Multi part instruments are disassembled prior to packaging to permit effective sterilisation
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Hollowware sets are packed so all openings face the same direction
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The colour change of the sterilising 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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Material Safety Data Sheets have been obtained and read prior to introduction of chemicals
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Common household detergents are not used as they have high foaming properties and are difficult to rinse free of residue
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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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Ultra sonic is fitted with a lid and is always operated with the lid closed.
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The ultrasonic is emptied and cleaned at least daily or more frequently depending on use.
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Cleaning equipment is thermally disinfected or sterilised at the end of each session. It is stored dry and clean.
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The functions of the washer disinfector and the detergent dispenser are checked daily and documented.
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Is the batch washer final rinse between 80c and 90c?
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Do cycles that require thermal disinfection meet the time - temperature combinations
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Is there a process to ensure that the internal cleanliness of the washer is maintained I.e descaling, routine self disinfection cycles
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All anaesthetic equipment is placed into drying cabinet after cleaning, other equipment dried with low lint towels<br>
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Tubing and other items with lumens are placed over appropriate connectors in drying cabinets to ensure hot air dries all surfaces
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The drying cabinet operates between 65c and 75c.
Section 5: Loading of Sterilisers
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Hollowware is 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 drapes 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 loading trolley so that they do not touch the chamber walls or fall off the trolley.
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Flexible packaging materials are loaded on edge with paper to laminate or flat with paper surface downward..
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Hollowware in flexible packaging is packed with the opening against the paper not the laminate or plastic
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Loading trolleys are loosely loaded to capacity with only a single layer of packs placed on each tray.
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The department has clear written procedures on the loading of sterilisers and all staff performing this task have had the formal training to do so.
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If 'flash steriliser' is used the items are placed onto a perforated mesh tray or flash pack and placed flat on the steriliser shelf to allow for easy access.
Section 6: Unloading of Sterilisers
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On completion the load is immediately removed from the steriliser and visually inspected to ensure it is dry and that sterilising indicators have made the required colour change
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On removal of the load from the steriliser 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 trolleys containing cooling items are kept away from high activity areas.
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Cooling items are not force cooled by fans or boosted air conditioning n
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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 dirty surface, torn, broken seals or wet are considered non sterile and reprocessed.
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There is a documented procedure for unloading of any items processed 'unwrapped'
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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 sterilising.
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If dust covers are used they are labelled 'dust cover only'
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Theatre staff wear surgical face mask and sterile attire when transferring 'flash sterilised items' to point of use
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Procedures for unloading each type of steriliser at the facility are documented and ongoing compliance with these procedures are monitored.
Section 7: Purchasing, Validation, Monitoring and Maintenance of Sterilisers and Associated Equipment.
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The cleaning process is developed, documented and monitored to ensure that the items can be sterilised.
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The inspection process is developed, documented and monitored to ensure that the items can be sterilised.
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The assembly process is developed, documented and monitored to ensure that the items can be sterilised.
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The packaging process is developed, documented and monitored to ensure that the items can be sterilised.
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The loading process is developed, documented and monitored to ensure that the items can be sterilised.
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The steriliser cycle process is developed, documented and monitored to ensure that the items can be sterilised.
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The calibration, routine monitoring and recording process is developed, documented and monitored to ensure that the items can be sterilised.
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The unloading process is developed, documented and monitored to ensure that the items can be sterilised.
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The storage process is developed, documented and monitored to ensure that the items can be sterilised.
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The distribution process is developed, documented and monitored to ensure that the items can be sterilised.
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The validation process is developed, documented and monitored to ensure that the items can be sterilised.
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Daily the floor of the steriliser is checked and free of debris, chamber drain and filters are clearness, recording devices are functioning correctly and the door gasket is undamaged.
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The loading trolley and external surfaces of the steriliser are cleaned daily.
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The steriliser chamber is cleaned weekly when it is cold and the cleaning documented.
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On Pre vacuum sterilisers there is a daily leak rate test or this is done weekly if there is an air detector is fitted.
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On Pre vacuum sterilisers their 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 sterilisation parameters.
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A comprehensive and documented preventative maintenance program is established.
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On Pre vacuum sterilisers air detector function and performance testing is done at decommissioning and performance requalification.
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Calibration of measuring devices is performed 3/6/12 monthly depending upon history and on IQ, OQ and PQ.
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Filters on sterilisers are checked and this is recorded every 6 months.
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When recommissioning and performance requalification is performed the process is documented and a copy filed in the processing facility.
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Performance requalification is performed at least annually and whenever there is a change made to steriliser load configuration.
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Responsibility for determining the necessity and extent of repeating parts of performance requalification is assigned to the designated person who is trained in this specialty.
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All associated equipment used to process sterile items has established, documented and validated processes in place.
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There is a contract with a trained, competent maintenance contractor, equipment manufacturer or trained organisation staff for preventative maintenance of associated equipment.
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Drying cabinets have a documented daily visual temperature check, check of door seals and filters and a daily surface clean.
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Drying cabinets are on a preventative maintenance schedule at least quarterly
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Drying cabinets are calibrated at least annually and following repair. They also have an annual thermocouple temperature check.
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Batch washers have calibration checks at least annually and following repair.
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Batch washers have quarterly thermocouple temperature checks.
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Batch washers have preventative maintenance scheduled at least quarterly
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There is a process which checks daily and documents jets, filters, door gaskets, external surfaces, detergent and rinse dispensers on batch washers
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Batch washers have documented time at temperature records and cycles which require thermal disinfection are checked.
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Biological indicator incubators are checked annually for temperature
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Rapid attest auto readers have flours globes changed 6/12 monthly and records are kept.
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Ultrasonic washers have documented daily performance testing.
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Ultrasonic washers have annual electrical safety checks performed and documented.
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Daily the ultrasonic tanks are emptied ( more frequently if necessary), external surfaces are wiped and filters and base plates are checked.
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Heat sealers have external surfaces wiped daily, and continuous checks for correct functioning of switches and gauges.
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Heat sealers have documented check of seal integrity pre and post sterilisation daily.
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Heat sealers have maintenance at least quarterly.
Section 8: Quality Management
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1.The person in charge of the processing facility has specific qualifications and experience in sterilising technology.
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2. The person in charge has the authority to implement the requirements of the standard
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3. There are documented policies and procedures for all activities involved in the processing of items
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4. Records are maintained in a designated storage area for a period of time not less than defined by regulatory authorities.
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5. There are written job descriptions for each category of staff in the facility.
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6. There is formal orientation program as set out in 8.4.
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7. There are protocols for stock control to manage stock levels.
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8. Sterile supplies are handled and stored in a manner that maintains integrity and prevents contamination from any source.
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9. Each item intended for use as a sterile item has a label with batch control identification which indicates steriliser, date of sterilisation and cycle or load number.
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10. All sterilising records are maintained and include date of cycle, steriliser number, cycle number, exposure time temperature and pressure, identification of the loading operator, identification of the person authorising release of the load,the specific contents of the load and the results of physical, chemical and biological tests used.
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11. All sterilisers have automatic parameters recorders.
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12. A record of all mechanical testing, repairs and preventative maintenance is kept for each steriliser.
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13. Maintenance records are stored in a designated area with other records.
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14. The is a procedure established and documented for review of deviation reports, quality indicators and procedural problems.
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15. There is a policy and procedure for recall as per 8.5.5
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16. Monitoring of physical parameters include time, temperature and pressure.
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17. The operator examines the record chart to verify that correct cycle parameters were met and sign to allow identification of who released the load.
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18. The chemical indicator 'sterilising tape' are examined after sterilisation to ensure colour change indicating items have been exposed to a sterilisation process.
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19. All items to be processed have external chemical indicators on them.
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20. Internal chemical indicators are retrieved and interpreted by the user of the sterile item at the time of use.
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21. Chemical indicators are used with each unwrapped load, during operational qualification, performance qualification, recommissioning and performance requalification.
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22. If the chemical indicator suggests inadequate processing the contents of the package is not used22.
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23. 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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24. Biological indicators are used during performance and operational qualification, for loads not previously validated, as part of recommissioning and performance requalification and weekly for Sterrad and Steris systems.
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25. Each day biological indicators are used, an additional unexposed indicator from the same batch is incubated to verify pre sterilisation viability of test spores.
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26. When using a pre vacuum steriliser leak rate tests are performed daily prior to Bowie Dick test. Leak test performed weekly if a air detector is fitted.
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27. On pre vacuum sterilisers a daily Bowie Dick testis performed. It is also done on operational qualification, calibration and recommissioning.
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29. There are documented results of commissioning of sterilisers, which forms part of the validation process
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30. Performance qualification has been documented to form part of the validation process.
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31. The person responsible for releasing loads has full knowledge of the validated process and is satisfied that the monitoring and control of the entire process has met specifications.
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32. A full validation process has been undertaken regardless of parametric release or non parametric release policy at the facility.
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33. All released loads are documented with identification of process cycles, the time of release and the name of the person authorising the release.
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34. All packaging is monitored following sterilisation as per 8.9
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35. Staff are immunised as per immunisation guidelines and records are kept including refusals
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36. All staff accidents are recorded and reported.
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37. Staff wear clean attire for the duration of the shift.
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38. All hair is secured and covered whilst preparing items for sterilisation
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39. Plastic aprons, fluid repellent masks , gloves and eye protection are worn when handling used / soiled items
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40. All staff have duration on hand hygiene and follow Hand Hygiene Australia 5 moments
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41. Staff do not wear hand creams while on duty.
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42. The working environment is maintained in a hygienic state at all times.
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43. Attention is given to minimising lint production to prevent contamination of clean instruments.
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44. Regular audits are conducted to evaluate procedures and processes.
Section 9: Storage and Handling of Sterile Stock
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1. The facility has documented policies and procedures for storage, handling and issuing of sterile stock.
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2. Critical medical items, which are stored unwrapped are subjected to the full cleaning process and sterilised before being used.
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3. Critical medical items stored unwrapped are cleaned and re sterilised immediately prior to use.
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4. There is a dedicated sterile storage area, which is controlled to prevent contamination.
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5. The storage area is free of dust, insects and vermin.
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6. All items are stored above floor level by at least 250mm
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7. All items are stored at least 440 mm from ceiling
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8. All stock is protected by direct sunlight.
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9. Storage containers, trolleys and cupboards are clean, dry and in good condition.
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10. Commercial dispenser boxes are not topped up or reused.
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11. All surfaces including walls, floors and ceiling lights are easy to clean, non porous and smooth.
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12. The light fittings in the sterile store are flush with the ceiling.
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13. Temperatures in the storage area are maintained from 18-22 C.
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14. Access to the sterile store is restricted to those who have been trained in handling of sterile items, do not have any skin disorders and have applied hand hygiene on entry
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15. Items are placed in plastic dust covers immediately they are cooled.
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16. Dust covers are sealed.
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17. All batch information is on the sterilised package and not on the dust cover.
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18. Sterile items intended for distribution outside the health facility are securely packed and protected against damage and contamination during transportation.
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19. All transport equipment is maintained in a clean and dry state and in good working order.
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20. When commercially prepared items are delivered dust is wiped from the store pack prior to being opened. Sterile items are removed from the store pack before being bought into the clean area.
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21. Sterile items from external suppliers are inspected for cleanliness and damage prior to being accepted.
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22. The facility has a system of stock rotation based on the date of sterilisation.
Section 11: Cleaning of the Sterilising Process Facility
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1. There is a documented cleaning procedure and good cleaning practices to ensure the environment is clean.
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2. There is a policy which documents the areas and equipment to be cleaned, the method and frequency and who is responsible.
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3. Cleaning activities are documented and records kept.
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4. Surfaces that could be soiled by blood and body fluids are impervious and intact to allow for effective cleaning.
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5: waste generated is placed into appropriate containers.
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6. Sharps containers, which comply with Australian Standards are available for use if necessary.
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7. Sharps are placed into sharps containers by the users at the point of generation and not sent to CSSD.
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8. All waste is removed from sterilising facility via designated disposal exits.
Section 12: Selection and Care of Instruments
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1. The person in charge of the processing facility responsible for reproving of reusable instruments and equipment is involved in the selection process prior to the purchase of the instruments.
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2. Where manufacturers have made claims or recommendations for processing of their equipment you have written details from them.
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3. All staff working in the processing facility has had education and training on the correct handling of instruments.
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4. Instrument repairs are only performed by a qualified trades person.
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5. Colour coding tapes are not used.
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6. During procedures in the operating room, the removal of soils from instruments is continuous using a sponge with sterile water.
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7. Cannulated instruments are not allowed to become dry
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8. Light and delicate instruments are kept separate from heavy instruments that could cause damage.
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9. Instruments which can be disassembled are taken apart prior to terminal cleaning.
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10. Any instrument that appears defective is n cleaned, dried and sterilised prior to being sent for repairs.
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11. All instruments are free from soil, dust and lint.
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12. Lumens, groves and articulation a are free of debris and stylets are passed through lumens.
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13. Joints are free of debris and move smoothly
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14. All instrument surfaces are smooth, well finished, unfitted and free of burrs.
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15. The tips of instruments do not have hooks or snags and approximate accurately
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16. Any instrument with worn areas in jaw serrations are sent for repair.
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17. Stiff or loose instruments are sent for repair ..
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18. All instruments with citing edges are sharp or sent for sharpening.
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19. Any valves move freely and are left in the on position. For processing.
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20. Instruments are tested to ensure they are functioning prior to processing.
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21. Fine instruments and their tips are protected in a manner that does not inhibit the sterilisation process.
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22. Microsurgical instruments are not placed on top of one another during sorting, cleaning or any other part of the packaging and sterilisation process.
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23. Insulated instruments are tested to ensure the integrity of insulations.
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24. All loan sets and instruments undergo complete routine c<br>Earning and processing prior to sterilisation. Perceived Lack of time does not permit the cleaning process to be bypassed.
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25. If soil or debris is found on loan equipment on receipt this is reported to the supplier.
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26. Following use all loan equipment is subjected to the full cleaning proces and sterilised prior to be returned to the source.
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27. Handpieces are cleaned and sterilised after each use.
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28. Sterilisation of hand pieces is done in a steam steriliser.
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29. Sheaths and sleeves for instruments and equipment are not used as a substitute for cleaning, disinfection or sterilisation purposes.
