• Document No.

  • 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 hinged instruments opened prior to use of enzymatic solution?

  • 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?

  • 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.)

Decontamination Area

  • Appropriate flow from dirty to clean

  • PPE appropriately utilized

  • Three sink configuration used for cleaning instruments

  • Water temperature monitored per disinfectant IFUs

  • Low foaming disinfectant utilized per manufacturer recommendation

  • Brushing of instruments takes place under the water

  • Appropriate size brushes are utilized according to the instruments IFU

  • Brushes are in good condition

  • Brushes are washed daily and replaced when needed

  • Ultrasonic quality testing completed and documented daily

  • Ultrasonic water changed per policy

  • Ultrasonic degassed according to IFU

  • Washer in good working condition & serviced according to manufacturer IFU

  • TOSTI test performed on each level of washer daily & documented

  • Washing descaling performed according to manufacturer IFU

  • No trash located in the washer

  • No solid rigid containers utilized in the washer

  • All hinged instruments in open position when placed in the washer

  • Quality testing performed on cart washer according to manufacturer IFU

  • Separate sink available for hand washing

  • Pass through window remains closed then not in use

  • Eye wash station available on a clean sink

  • Eye wash log current

  • Area cleaned daily when department in use

  • Dedicated cart utilized for decontamination area of processing department

  • Decontamination area clean with minimal dust present

  • No Stained ceiling tiles

  • All sprinkler free of dust with escusions present and intact

  • Negative Pressure

Quality Testing & Monitoring

  • 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.

  • Maintenance on sterilizers are completed and documented according to manufacturer IFU

  • Leak test performed on each sterilizer weekly

  • Bowie-Dick performed daily in each sterilizer and documented

  • Biological indicator test completed daily

  • Biological indicator placed with every sterilization load

  • Implants are never released until confirmation of passed biological indicator

  • Instruments sets weigh less than 25Ibs

  • When recommissioning and performance requalification is performed the process is documented and a copy filed in the facility.

Section 2: Packaging and wrapping of items prior to sterilization

  • Appropriate PPE worn while in the department

  • Staff have access to manufacturer IFU

  • Manufacturer IFU are followed for each instrument

  • 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 are not utilized in the prep and pack area

  • Brushes are not utilized in the prep ad pack area

  • Class V indicator placed in the most challenging area

  • 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.

  • Sterilizer 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.

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.

  • Magnification available to assist with visual inspection

  • 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.

EOC Prep & Pack area of SPD

  • Prep & pack area with positive air pressure

  • Humidity within range (30-60%, AAMI)

  • No dirty equipment found in prep & pack area

  • No Food in department

  • Area cleaned Daily with department in use

  • Area clean with minimal dust on horizontal surfaces

  • Floor clean and free of debris

  • No stained ceiling tiles

  • Sprinklers dust free with eschusions in place and in working order

Sterile Storage

  • Sterile Supplies stored at least 2 inches from the outside wall, 18 inches below the ceiling (or level of the sprinkler head), and 8-10 inches above the floor to prevent contamination from floor dust and cleaning.

  • Bottom storage shelves of supply cart are solid to prevent contamination from floor dust and cleaning

  • Is event related sterility assurance policy applied?

  • Storage area is clean, dry adequate and integrity of packaging maintained.

  • Heavy wrapped trays are not stacked

  • Corrugated boxes not present

  • Inappropriate or unnecessary equipment and supplies are not present in the area


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