Audit

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.

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

Other

Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things, workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to determine if the use of such checklist is permissible in your workplace or jurisdiction.