• Document No.

  • CMHS Sterile Processing Audit - DNV-ISO

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

Section 1: Cleaning and handling Used Items

  • Is gross tissue removed and is enzymatic solution applied at point of use?

  • Are Standard Precautions used at all stages of handling used items? (PPE is used)

  • Are written procedures for handling of used equipment available?

  • Are all single-use items discarded at point of use? Were disposable items sent to SPD?

  • Are there policies/ procedures for the collection of used items and delivery of sterile items?

  • Are collection containers puncture resistant, leak proof and lidded?

  • Is the container / cart cleaned at the end of each collection round?

  • Are all instruments that have been unwrapped for use considered contaminated whether used or not and subjected to full cleaning process?

  • Are there written procedures for handling specialized equipment? (Power, delicate, etc.)

Section 2: Packaging and wrapping of items prior to sterilization

  • Instruments with hinges or ratchets remain open or unlocked during sterilization.

  • Multi part instruments are disassembled prior to packaging to permit effective sterilization.

  • Basin sets are packed so all openings face the same direction.

  • The color change of the sterilizing indicator tape following exposure is distinct and uniform and markedly different to the unprocessed tape.

  • Cleaning agents or other chemicals are not allowed to come in direct contact with personnel.

  • Abrasive cleaners, steel wool, powders and paste are not used.

  • Safety Data Sheets information has been reviewed with staff.

  • Ultrasonic is degassed after each fill before instruments are reprocessed.

  • Ultrasonic is tested daily to establish efficiency of transducers. This is documented.

  • The ultrasonic is emptied and cleaned at least daily or more frequently depending on use.

  • Cleaning brushes are disinfected at the end of each day.

  • The functions of the washer disinfector and the detergent dispenser are checked daily.

  • Is there a process to ensure that the internal cleanliness of the washer is maintained ie: descaling?

  • Staff is able to state the acceptable temperature setting for drying cabinet and actions taken if out of range.

Section 3: Loading of Sterilizers

  • 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.

  • Packs of towels are loaded in vertical layers to allow air to be removed rapidly from packs.

  • Items are loaded within boundaries of the sterilizer cart so that they do not touch the chamber walls or fall from the cart.

  • Flexible packaging materials are loaded on edge.

  • Sterilizer carts are loosely loaded to capacity with only a single layer of wrapped packs placed on each shelf.

  • 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

  • On completion the load is visually inspected to ensure it is dry and that sterilizing indicators have made the required color change.

  • When removing of the load from the sterilizer the operator checks printouts and signs that the parameters have been met.

  • The load is quarantined and the supervisor is notified immediately if any deviation from the parameters is detected.

  • Steriliser carts containing cooling items are kept away from high activity areas.

  • Cooling items are never placed onto solid surfaces as condensation may result. <br>

  • 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.

  • When plastic dust covers are used the items are cool before placing into the cover.

  • Dust covers are placed onto cooled items within 2 hours of sterilizing.

  • If dust covers are used they are labelled 'dust cover only'.

Section 5: Selection and Care of Instruments

  • The person in charge of the sterile processing department is responsible / involved in the selection process prior to the purchase of instruments.

  • Manufacturers recommendations are available for processing equipment and instruments.

  • All staff working in the sterile processing department has had education and training on the correct handling of instruments.

  • Instrument repairs are only performed by a qualified person.

  • Any instrument that appears defective is cleaned, dried and sterilized prior to being sent for repairs.

  • Lumens, grooves and articulations are free of debris and stylets are passed through lumens.

  • The tips of instruments do not have hooks or snags and approximate accurately.

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