INTEGRIS Sterile Processing Department Audit

• Document No.

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

Section 1: Cleaning and handling Used Items

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

  Yes

  No

  N/A

• Are hinged instruments opened prior to use of enzymatic solution?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are written procedures for handling of used equipment available?

  Yes

  No

  N/A

• Are all single-use items discarded at point of use?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Decontamination Area

• Appropriate flow from dirty to clean

  Yes

  No

  N/A

• PPE appropriately utilized

  Yes

  No

  N/A

• Three sink configuration used for cleaning instruments

  Yes

  No

  N/A

• Water temperature monitored per disinfectant IFUs

  Yes

  No

  N/A

• Low foaming disinfectant utilized per manufacturer recommendation

  Yes

  No

  N/A

• Brushing of instruments takes place under the water

  Yes

  No

  N/A

• Appropriate size brushes are utilized according to the instruments IFU

  Yes

  No

  N/A

• Brushes are in good condition

  Yes

  No

  N/A

• Brushes are washed daily and replaced when needed

  Yes

  No

  N/A

• Ultrasonic quality testing completed and documented daily

  Yes

  No

  N/A

• Ultrasonic water changed per policy

  Yes

  No

  N/A

• Ultrasonic degassed according to IFU

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Washing descaling performed according to manufacturer IFU

  Yes

  No

  N/A

• No trash located in the washer

  Yes

  No

  N/A

• No solid rigid containers utilized in the washer

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Quality testing performed on cart washer according to manufacturer IFU

  Yes

  No

  N/A

• Separate sink available for hand washing

  Yes

  No

  N/A

• Pass through window remains closed then not in use

  Yes

  No

  N/A

• Eye wash station available on a clean sink

  Yes

  No

  N/A

• Eye wash log current

  Yes

  No

  N/A

• Area cleaned daily when department in use

  Yes

  No

  N/A

• Dedicated cart utilized for decontamination area of processing department

  Yes

  No

  N/A

• Decontamination area clean with minimal dust present

  Yes

  No

  N/A

• No Stained ceiling tiles

  Yes

  No

  N/A

• All sprinkler free of dust with escusions present and intact

  Yes

  No

  N/A

• Negative Pressure

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Leak test performed on each sterilizer weekly

  Yes

  No

  N/A

• Bowie-Dick performed daily in each sterilizer and documented

  Yes

  No

  N/A

• Biological indicator test completed daily

  Yes

  No

  N/A

• Biological indicator placed with every sterilization load

  Yes

  No

  N/A

• Implants are never released until confirmation of passed biological indicator

  Yes

  No

  N/A

• Instruments sets weigh less than 25Ibs

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Section 2: Packaging and wrapping of items prior to sterilization

• Appropriate PPE worn while in the department

  Yes

  No

  N/A

• Staff have access to manufacturer IFU

  Yes

  No

  N/A

• Manufacturer IFU are followed for each instrument

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Cleaning agents are not utilized in the prep and pack area

  Yes

  No

  N/A

• Brushes are not utilized in the prep ad pack area

  Yes

  No

  N/A

• Class V indicator placed in the most challenging area

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Flexible packaging materials are loaded on edge.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

• Manufacturers recommendations are available for processing equipment and instruments.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Magnification available to assist with visual inspection

  Yes

  No

  N/A

• Instrument repairs are only performed by a qualified person.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

EOC Prep & Pack area of SPD

• Prep & pack area with positive air pressure

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• No dirty equipment found in prep & pack area

  Yes

  No

  N/A

• No Food in department

  Yes

  No

  N/A

• Area cleaned Daily with department in use

  Yes

  No

  N/A

• Area clean with minimal dust on horizontal surfaces

  Yes

  No

  N/A

• Floor clean and free of debris

  Yes

  No

  N/A

• No stained ceiling tiles

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Is event related sterility assurance policy applied?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Heavy wrapped trays are not stacked

  Yes

  No

  N/A

• Corrugated boxes not present

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Other

• Yes

  No

  N/A

• Yes

  No

  N/A

• Yes

  No

  N/A