Sterile Processing Checklist

Date_______________________ Audit Conducted by: _________________________________________________________

Sterilization Standards Audit Checklist
Facility design Yes No
1. Are functional work areas physically separated by walls or partitions?
2. Are doors and pass-through windows kept closed when not in use?
3. Are floors level and constructed of materials that will withstand daily or more frequent cleaning?
4. Are ceilings and wall surfaces constructed of nonshedding materials to limit condensation and dust accumulation?
5. Are temperature and humidity levels monitored and recorded daily?
6. Are the temperature and humidity levels within the acceptable ranges?
T = 68-73 F Clean areas 60-65 F decontamination H= 30-60% in work areas Not over 70% in sterile storage areas
7. Are appropriate devices used to maintain temperature and humidity levels?
8. Are areas cleaned daily and kept free of shipping boxes?
• separate cleaning equipment for decontamination
9. Are processing areas kept free of food or drink?
10. Eyewash stations located within 10 seconds travel time?
11. Equipment maintenance records maintained?
12. Functional workflow pattern - Dirty to clean?
13. Ventilation - Soiled area, negative - 10 air exchanges per hour?
Clean/sterile area, positive - 10 air exchanges per hour
Decontamination Yes No
1. Appropriate decontam PPE available? Hands washed after removing PPE?
• Hands washed after removing PPE?
2. Manufacturers recommendations available and followed
• Equipment
• Instruments
• Cleaning solutions
3. Appropriate cleaning and decontamination solutions?
• Dilution - measuring cups and lines in the sink for accurate measuring
• Expiration dates
• Solution containers labeled
3. Appropriate cleaning processes used?
• Sharps and delicates separate
• No use of saline on instruments
• Cleaning happens as soon as possible
• Instruments kept moist until cleaned
• Not cleaned in hand sinks or scrub sinks
• Brushing occurs under water
• Brushes are disposable or decontaminated daily
Personnel training Yes No
1. Are processing areas restricted to authorized personnel only?
2. Are hand washing facilities conveniently located?
3. Are personnel using and removing personnel protective equipment properly?
4. Are personnel consistently adhering to dress code:
• all jewelry is removed?
• hair covers are worn consistently and no hair is visible?
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• facility scrub attire is donned upon arrival at the facility and is not worn out of the facility?
5. Are personnel provided with necessary education regarding sterilization policies and procedures?
6. Is this education documented?

Packaging Yes No
1. Labeling on indicator tape, patient record cards or plastic side of peel packs?
2. Instrument set weights not over 25 pounds?
3. Peel packs - double peel packs are not folded, proper size used?
4. Internal and external chemical indicators (CI) used for all packages?
• Geometric center of wrapped packages
• Two opposite corners in rigid containers
• On all levels
5. Instruments in good condition
6. Instrument refurbishing plan
7. Instrument tape (if used) is in good condition
8. Tip protectors validated for use?
9. Any single use devices reprocessed (need to be FDA cleared)
10. Instrument tracking system available?

Sterilization Yes No
1. Loading and unloading practices
• Peel packs lighter items on top shelf
• Peel packs and linen packs are on edge (not horizontal)
• No stacking of pans (without manufacturers recommendations)
2. Documentation of each load
• Sterilizer identification
• Type of sterilizer and cycle used
• Lot control number
• Load contents
• Critical parameters for specific sterilization method
• Operators name, and
• Results of the sterilization process monitors (physical, CI, BI)
3. Sterilization monitors
• BI - run daily in steam and peracetic acid
• BI- run in every load for ethylene oxide, gas plasma or ozone
• The same lot number is used for the contorl and the processed BI
4. Sterilization records storage follows the facilities record retention policy
5. Manufacturer recommendations readily available and followed
6. Extended cycles run per manufacturers recommendations
7. Implants
• monitored with BI and a Class 5 CI
• Not released until results of BI available
8. Management of loaner instrumentation in place
9. All sterilized items are traceable to the patient
10. recall process in place and reported to Infection Prevention

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11. Flash sterilization practices

• items are appropriately cleaned
• Use of closed flash containers
• All parameters documented
• Aseptic transportation to point of use
• Implants
• BI & CI run with all implants
• Not released until results of BI available
• Traceable to patient
• Not used as substitute for sufficient instrument inventory

Sterile storage Yes No

1. Storage conditions
• Cleanable surfaces
• Bottom shelves are solid
2. All items are
• 18" below the ceiling (or level of sprinkler head)
• 8 - 10" above the floor
• 2" from outside walls
3. Sterile Items separate from clean items
4. Heavy wrapped trays are not stacked
5. Shelf life/event related - stock rotation
6. Controlled area (appropriately attired persons only)
7. Handwashing facilities readily available
9. No web-edged or corrugated cardboard boxes
Policies and Procedures Yes No
1. Current according to best practices
• Dress code
• care and handling of instruments
• Packaging systems - selection and use
• Sterilization recall
• Sterilizer identification
• Sterile storage
• Chemical disinfectant (including high-level disinfecting)
• Shelf life (event related)
• PM for equipment
• Steam shutdown
• Sterilization - steam and low temp
• Endoscopes - cleaning and processing
• Environmental cleaning
• Creutzfeld - Jakob disease (CJD)
• Single use devices
2. Available to staff
3. Followed and monitored

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