Audit

DECONTAMINATION
INSTRUMENT ARRIVAL

Containment cart/device clearly indicates contaminated items are present

Are contaminated items properly contained during transport?

Disposable sharps are NOT present

Has gross soil been removed from instrumentation

Instruments arrive moist in decontamination

PPE is available and used appropriately when removing contaminated items from cart/device

Time between arrival and decontamination is minimized

Transport carts/devices are decontaminated between each use

MANUAL CLEANING

Appropriate PPE is available and donned for pre washing and manual wash

Sink, sonic and washer cleaning/disinfection chemicals are labeled, diluted properly for use, and within expiration

All lumens and cannulated instruments are pre-cleanedby brushing and flushing

Cleaning brushes are maintained in good condition and are cleaned and disinfected on a daily basis

Explain the process of soaking, rinsing instruments. Best practice is the process of rinsing occurring in a separate sink.

Water/detergent solutions are used in sink according to manufacturer's instruction for use (IFU)

Explain the process of changing the water at the instrument sink. The process Should always coincide with the manufacturer's instructions for use (IFU)

MECHANICAL EQUIPMENT

Explain the process of changing the water in the ultrasonic cleaner. The process should always coincide with the manufacturer's IFU.

Explain the process for instruments placed in the ultrasonic cleaner.

Explain the process for loading the mechanical instrument washers properly

Explain the process for delicate items that can't go into the instrument washers(Power equipment, micro and eye instruments)

Ultrasonic cleaners are tested at least weekly, passed and recorded. Ask to review the log

Mechanical instrument washers are tested at least weekly, passed and recorded. Ask to review the log

ASSEMBLY/INSTRUMENT PREPARATION

Instruments are inspected for cleanliness and properly functioning.

Instruments are evenly distributed in trays

No paper/plastic peel pouches inside instrument sets. Ask the staff to show you medical grade instrument bags

Hinged instruments are open/disassembled. Delicate instruments are protected with appropriate assessories

PACKAGING PEEL POUCHES

Are peel pouches used for lightweight instruments only(Maximum two (2) instruments)

Are the pouches use for the appropriate method of sterilization (Paper/plastic for steam/ETO, Tyvek/plastic for Sterrad) Along with the chemical indicators

Are the peel pouches sealed smoothly and air removed

If peel pouches are prepared as double; no folds present in the inner package

Are labels only on the plastic side

PACKAGING-RIGID CONTAINERS

Are rigid containers maintained in good working order

Class 5 Chemical indicators are placed inside each set in the appropriate location according to the manufacturer's recommendations

Are rigid containers cleaned and decontaminated between each use

Are the rigid containers used within the manufacturer weight limits

STEAM STERILIZATION-EQUIPMENT CONTROL

Steam sterilizes are operating following manufacture instructions

Bowie-Dick test is performed daily before 1st load in Prevac sterilizer cycles

Biological indicators are used for monitoring sterilizers weekly but preferably daily. Ask the staff to explain the process

A biological indicator control is processed each day a test biological indicator is run

All sterilization monitoring devices are used correctly

Biological incubators are located and used according to the Manufacturer Instructions for use(IFU)

HYDROGEN PEROXIDE PLASMA-EQUIPMENT CONTROL(STERRAD, V-PRO)

Biological indicators are used for monitoring sterilizers daily but preferably with each load

A biological control is processed each day a test BI is run

Appropriate biological indicator is used and positioned according to IFU

Biological indicators are located and used according to manufacturer Instructions for use (IFU)

RECORDKEEPING

Sterilization records are organized and easily retrieved

Sterilization logs contain the lot number, the date of the load, and the load contents(the sterilizer # and cycle sequence#)

What is the process for handling a positive biological indicator and recall is in place

LOADING THE STERILIZER

Peel pouches stand on the edge in relation to the sterilizer cart

Mesh bottom pans/rigid containers are flat on the sterilizer cart shelf

If shelf liners are used; you may use them in multiple cycles but the staff must check the integrity of the liner prior to each load

UNLOADING THE STERILIZERS

Cycle printout checked before removing items

Items allowed to cool before handling

Distance between sterilized and clean items maintained

STORAGE

Storage area is clean and organized with no outside shipping containers

Sterile items are stored in a manner that will not compromise sterility

Sterile supplies are stored in closed cabinets or open shelving with solid bottom shelves or bottom shelves with liners

Storage shelving/carts are: 18" from the ceiling, 8-10" above the floor, and at least 2 " from the outside walls

Sterile supplies are rotated on the "first in, first out" concept

PHYSICAL ENVIRONMENT

Department size is sufficient for the volume of work activities and to promote good work flow

Workflow in the department promotes a clear separation of dirty/clean/sterile processes

Doors and pass-through windows are kept closed when not in use

Temperature and humidity is monitored and documented. Ask the staff to explain the process and retrieve the log

Ventilation and airflow are appropriate in the decontamination and clean processing area

No fans present in the department

Overhead lighting is sufficient for inspection of surgical instruments during processing

Magnification available for detail inspection and used

Work area surfaces are cleaned daily or when soiled. Ask the staff to explain the cleaning process

All area floors are horizontal surfaces are cleaned on a daily basis and separating each side (decontamination/prep)

No inappropriate or unnecessary equipment and supplies present in decontamination

Traffic is restricted to authorized, appropriately attired personnel

Hand Washing sink in decontamination and prep areas and are only used for that purpose

Eyewash/shower present in decontamination and prep areas. Tested routinely and recorded.

Floors, walls, ceilings, and work surfaces are constructed of cleanable materials and are maintained in good condition

IMMEDIATE USE STEAM STERILIZATION(IUSS)

Pre-cleaning same as SPD routine process and separate from direct patient care area

Closed container or wrapping validated for IUSS

Cycle settings in correspondence to container manufacturer's IFU

What measures are taken to prevent contamination during transfer to sterile field. Ask the staff to explain the process

IUSS instruments are used immediately and not stored for any amount of time

ROBOTIC/INTUITIVE INSTRUMENTS

All robotic instruments must coincide with the manufacturer's instructions for use.
The manufacturer recommend 15 minutes in the ultrasonic cleaner to flush the ports on the instruments. Ask to staff to articulate the process along with the IP.

OTHER FINDINGS
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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.