Information
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Document No.
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Audit Title
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
I. Administrative Requirements
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1. Manufacturers’ written instructions current, readily available to staff, and followed for:<br>a. Equipment<br>b. Instruments<br>c. Cleaning solution
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2. All sterilization and reprocessing policies and procedures readily available for staff
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3. Orientation and education performed and documented<br>a. Demonstrated knowledge of and documented competence<br>b. Continuing education at regular intervals<br>c. Training for all new instrumentation, devices, and equipment
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4. Equipment maintenance records maintained
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5. Sterilization records storage follows the facilities record retention policy
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6. Management of loaner instrumentation program in place
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7. Consistently adhering to dress code (facial hair covered, facility laundered scrub attire)
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8. Hands are washed after removing PPE
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9. PPE readily accessible, worn and removed as indicated
II. Point of Use
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1. Disposable sharps are separated from reusable items
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2. Delicate instruments are kept separated
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3. Instruments are kept moist prior to transport and decontamination
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4. Instruments are not cleaned in hand sinks or scrub sinks
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5. Contaminated items are properly contained during transport
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6. Containment devices are appropriately labeled with biohazard warning symbols or identified by color
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7. Transport devices are decontaminated between each use
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8. Time between use and decontamination is minimized
III. Decontamination Room
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1. Are instruments pre-cleaned or soaked soon after use?
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2. Clean and dirty areas and processes separate and do not cross over
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3. Cleaning brushes are reusable and in good working condition; disinfected daily or cleaning brushes are discarded after use
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4. Brushing occurs under water
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5. Appropriate cleaning and decontamination solutions:<br>a. Dilution measuring cups and lines in the sink for accurate measuring<br>b. Expiration dates labeled <br>c. Solution labeled with appropriate hazardous warning symbols
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6. Instruments are not cleaned in hand sinks or scrub sinks
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7. Water quality meets manufacturers requirements
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8. Disinfectant concentration is tested per manufacturer’s recommendations
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9. Weekly Instrument Washer Tests performed and documented
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10. Supplies necessary for cleaning all instruments and devices are easily available, adequately stocked and in good condition
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11. Staff can describe all processes related to decontamination
IV. Instrument Preparation
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1. Supplies necessary for packaging and wrapping all instruments and devices are easily available, adequately stocked (integrators, packaging, wrapping, tape, protectors, markers, etc.)
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2. Hand hygiene dispenser present
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3. Items are properly packaged, wrapped, and properly identified
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4. Labeling on indicator tape, patient record cards or plastic side of peel packs
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5. Instrument set weights not over 25 pounds
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6. Peel Packs- double peel packs are not folded, proper size used
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7. Internal and external chemical indicators (CI) used for all packages<br>a. Geometric center of wrapped packages<br>b. Two opposite corners in rigid containers<br>c. On all levels
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8. Instruments are in good condition
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9. Instrument refurbishing plan
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10. Instrument tape (if used) is in good condition
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11. Tip protectors are validated for use
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12. No single-use devices are being reprocessed (needs to be FDA cleared)
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13. Instrument tracking system available
V. Sterilization
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1. Routine maintenance performed per manufacturer’s guidelines. Cleaning schedule for sterilizers in place
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2. Instruments sterilized in open position (e.g., scissors)
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3. Sterilization load record consisting of: date, load #, sterilizer #, operator’s name, items, quantity of each item, biological indicator lot # (if needed), biological control lot # (if needed), type of sterilizer and cycle used, verification of sterilization parameters, results of the sterilization process monitors (physical, CI, BI)
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4. A process (policy and procedure) in place to ensure proper reprocessing of loaner instruments from vendors or other medical facilities
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5. Implants are monitored with a biological indicator (BI) and a class 5 CI
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6. Implantable devices are quarantined until BI results are negative; if implants are released early, the incidence is documented on an Implantable/Non-implantable Device Early Release Record
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7. Biological indicator failure equipment recall process in place and reported to Infection Control Designee. How frequent are recalls?
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8. Sterilization monitors <br>a. Biological indicators run at least weekly or more often per manufactures recommendation <br>b. The same lot number is used for the control and the processed BI<br>c. Chemical Indicators are used in every load
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9. Every biological record is checked for result and properly recorded
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10. IUSS limited to emergent needs
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11. IUSS parameters are documented
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12. Items are appropriately cleaned prior to IUSS
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13. Use of IUSS closed containers
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14. Aseptic transportation to point of use
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15. All IUSS is traceable to the patient
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16. Volume of IUSS is tracked to determine need for intervention to reduce- not used as a substitute for insufficient instrument inventory.
VI. High Level Disinfection
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1. Semi-critical equipment is high-level disinfected or sterilized
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2. Items are pre-cleaned according to manufacturer’s instructions or evidence-based guidelines prior to high-level disinfection
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3. Medical devices and instruments are visually inspected for residual soil and re-cleaned as needed before high-level disinfection
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4. High-level disinfection equipment is maintained according to manufacturer instructions
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5. Chemicals used for HLD are prepared according to manufacturer instructions
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6. Temperature of HLD chemicals are checked and recorded per manufacturer’s instructions
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7. Chemicals used for HLD are tested for appropriate concentration according to manufacturer instructions or evidence based guidelines and are replaced before they expire
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8. Chemicals used for HLD are documented to have been prepared and replaced according to manufacturer’s instructions or evidence-based guidelines
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9. Equipment is HLD according to manufacturer’s instructions or evidence-based guidelines
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10. Items are rinsed according to manufacturer’s instructions
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11. Items that undergo HLD are dried before re-use
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12. HLD logs are in order
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13. Test strips are properly dated
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14. Control checks on test strips are performed and documented according to manufacturer’s instructions
VII. Sterile Storage
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1. 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
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2. Bottom storage shelves of supply cart(s) are solid to prevent contamination from floor dust and cleaning
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3. Sterilized items are stored and rotated with FIFO process (first in first out) by expiration date
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4. Storage area is clean, dry adequate and integrity of packaging maintained
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5. Sterile items separate from clean items
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6. Staff can describe expiration dates and event related sterile storage
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7. Heavy wrapped trays are not stacked
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8. No web-edged or corrugated boxes
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9. Space proportioned to expected volume
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10. Inappropriate or unnecessary equipment and supplies are not present in the area
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11. Ceiling flush surface, no shedding materials with recessed and enclosed pipes
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12. Equipment maintenance records maintained
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13. Functional work flow pattern (dirty to clean)
VIII. Physical Environment
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1. Area restricted to authorized personnel only
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2. All areas have a functional work flow pattern (dirty to clean)
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3. Doors and pass-through windows are kept closed when not in use
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4. Cardboard boxes removed before items are brought to restricted areas
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5. Temperature and humidity levels monitored and recorded daily<br>a. 68-73 degrees F clean areas<br>b. 60-65 degrees F decontamination areas
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6. Humidity <br>a. 30-60% work areas<br>b. Less than 70% in sterile storage areas
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7. Ventilation<br>a. Soiled area, negative pressure (10 air exchanges per hour)<br>b. Clean/sterile areas, positive pressure (10 air exchanges per hour)
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8. Housekeeping procedures<br>All areas cleaned daily (should be the same as in OR)
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9. Separate cleaning equipment for decontamination
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10. Do processes appear efficient in SP with items/areas tidy and well labeled?
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11. Environmental Services support is adequate-environment is clean and orderly
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12. Hand Hygiene supplies adequate and conveniently located in all areas (soap, water, lotion, and de-germer)
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13. Handwashing stations conveniently located in clean and decontamination areas
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14. Eye wash stations located within 10 seconds travel time to areas where hazardous chemical use occurs
IX. Handling and Distribution of Sterile Items
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1. Items transported are covered or contained during transport
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2. Transport carts, if used, have a solid bottom shelf
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3. Carts and transport devices, covers, and containment devices are decontaminated between uses
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4. Unused items returned to inventory are inspected for package integrity
Additional Comments or Findings
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Any additional comments or findings?
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Surveyor Signature
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Select date
