Title Page
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Conducted on
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UCLA SMH STERILE PROCESSING DEPARTMENT
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Prepared by
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Personnel
DECONTAMINATION
INSTRUMENT ARRIVAL
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Containment cart/device clearly indicates contaminated items are present
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Are contaminated items properly contained during transport?
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Disposable sharps are NOT present
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Has gross soil been removed from instrumentation
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Instruments arrive moist in decontamination
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PPE is available and used appropriately when removing contaminated items from cart/device
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Time between arrival and decontamination is minimized
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Transport carts/devices are decontaminated between each use
MANUAL CLEANING
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Appropriate PPE is available and donned for pre washing and manual wash
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Sink, sonic and washer cleaning/disinfection chemicals are labeled, diluted properly for use, and within expiration
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All lumens and cannulated instruments are pre-cleanedby brushing and flushing
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Cleaning brushes are maintained in good condition and are cleaned and disinfected on a daily basis
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Explain the process of soaking, rinsing instruments. Best practice is the process of rinsing occurring in a separate sink.
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Water/detergent solutions are used in sink according to manufacturer's instruction for use (IFU)
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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
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Explain the process of changing the water in the ultrasonic cleaner. The process should always coincide with the manufacturer's IFU.
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Explain the process for instruments placed in the ultrasonic cleaner.
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Explain the process for loading the mechanical instrument washers properly
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Explain the process for delicate items that can't go into the instrument washers(Power equipment, micro and eye instruments)
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Ultrasonic cleaners are tested at least weekly, passed and recorded. Ask to review the log
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Mechanical instrument washers are tested at least weekly, passed and recorded. Ask to review the log
ASSEMBLY/INSTRUMENT PREPARATION
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Instruments are inspected for cleanliness and properly functioning.
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Instruments are evenly distributed in trays
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No paper/plastic peel pouches inside instrument sets. Ask the staff to show you medical grade instrument bags
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Hinged instruments are open/disassembled. Delicate instruments are protected with appropriate assessories
PACKAGING PEEL POUCHES
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Are peel pouches used for lightweight instruments only(Maximum two (2) instruments)
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Are the pouches use for the appropriate method of sterilization (Paper/plastic for steam/ETO, Tyvek/plastic for Sterrad) Along with the chemical indicators
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Are the peel pouches sealed smoothly and air removed
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If peel pouches are prepared as double; no folds present in the inner package
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Are labels only on the plastic side
PACKAGING-RIGID CONTAINERS
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Are rigid containers maintained in good working order
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Class 5 Chemical indicators are placed inside each set in the appropriate location according to the manufacturer's recommendations
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Are rigid containers cleaned and decontaminated between each use
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Are the rigid containers used within the manufacturer weight limits
STEAM STERILIZATION-EQUIPMENT CONTROL
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Steam sterilizes are operating following manufacture instructions
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Bowie-Dick test is performed daily before 1st load in Prevac sterilizer cycles
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Biological indicators are used for monitoring sterilizers weekly but preferably daily. Ask the staff to explain the process
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A biological indicator control is processed each day a test biological indicator is run
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All sterilization monitoring devices are used correctly
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Biological incubators are located and used according to the Manufacturer Instructions for use(IFU)
HYDROGEN PEROXIDE PLASMA-EQUIPMENT CONTROL(STERRAD, V-PRO)
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Biological indicators are used for monitoring sterilizers daily but preferably with each load
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A biological control is processed each day a test BI is run
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Appropriate biological indicator is used and positioned according to IFU
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Biological indicators are located and used according to manufacturer Instructions for use (IFU)
RECORDKEEPING
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Sterilization records are organized and easily retrieved
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Sterilization logs contain the lot number, the date of the load, and the load contents(the sterilizer # and cycle sequence#)
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What is the process for handling a positive biological indicator and recall is in place
LOADING THE STERILIZER
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Peel pouches stand on the edge in relation to the sterilizer cart
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Mesh bottom pans/rigid containers are flat on the sterilizer cart shelf
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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
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Cycle printout checked before removing items
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Items allowed to cool before handling
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Distance between sterilized and clean items maintained
STORAGE
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Storage area is clean and organized with no outside shipping containers
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Sterile items are stored in a manner that will not compromise sterility
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Sterile supplies are stored in closed cabinets or open shelving with solid bottom shelves or bottom shelves with liners
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Storage shelving/carts are: 18" from the ceiling, 8-10" above the floor, and at least 2 " from the outside walls
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Sterile supplies are rotated on the "first in, first out" concept
PHYSICAL ENVIRONMENT
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Department size is sufficient for the volume of work activities and to promote good work flow
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Workflow in the department promotes a clear separation of dirty/clean/sterile processes
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Doors and pass-through windows are kept closed when not in use
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Temperature and humidity is monitored and documented. Ask the staff to explain the process and retrieve the log
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Ventilation and airflow are appropriate in the decontamination and clean processing area
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No fans present in the department
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Overhead lighting is sufficient for inspection of surgical instruments during processing
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Magnification available for detail inspection and used
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Work area surfaces are cleaned daily or when soiled. Ask the staff to explain the cleaning process
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All area floors are horizontal surfaces are cleaned on a daily basis and separating each side (decontamination/prep)
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No inappropriate or unnecessary equipment and supplies present in decontamination
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Traffic is restricted to authorized, appropriately attired personnel
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Hand Washing sink in decontamination and prep areas and are only used for that purpose
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Eyewash/shower present in decontamination and prep areas. Tested routinely and recorded.
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Floors, walls, ceilings, and work surfaces are constructed of cleanable materials and are maintained in good condition
IMMEDIATE USE STEAM STERILIZATION(IUSS)
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Pre-cleaning same as SPD routine process and separate from direct patient care area
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Closed container or wrapping validated for IUSS
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Cycle settings in correspondence to container manufacturer's IFU
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What measures are taken to prevent contamination during transfer to sterile field. Ask the staff to explain the process
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IUSS instruments are used immediately and not stored for any amount of time
ROBOTIC/INTUITIVE INSTRUMENTS
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All robotic instruments must coincide with the manufacturer's instructions for use. <br>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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