Audit

I. Administrative Requirements

1. Manufacturers’ written instructions current, readily available to staff, and followed for:
a. Equipment
b. Instruments
c. Cleaning solution

2. All sterilization and reprocessing policies and procedures readily available for staff

3. Orientation and education performed and documented
a. Demonstrated knowledge of and documented competence
b. Continuing education at regular intervals
c. Training for all new instrumentation, devices, and equipment

4. Equipment maintenance records maintained

5. Sterilization records storage follows the facilities record retention policy

6. Management of loaner instrumentation program in place

7. Consistently adhering to dress code (facial hair covered, facility laundered scrub attire)

8. Hands are washed after removing PPE

9. PPE readily accessible, worn and removed as indicated

II. Point of Use

1. Disposable sharps are separated from reusable items

2. Delicate instruments are kept separated

3. Instruments are kept moist prior to transport and decontamination

4. Instruments are not cleaned in hand sinks or scrub sinks

5. Contaminated items are properly contained during transport

6. Containment devices are appropriately labeled with biohazard warning symbols or identified by color

7. Transport devices are decontaminated between each use

8. Time between use and decontamination is minimized

III. Decontamination Room

1. Are instruments pre-cleaned or soaked soon after use?

2. Clean and dirty areas and processes separate and do not cross over

3. Cleaning brushes are reusable and in good working condition; disinfected daily or cleaning brushes are discarded after use

4. Brushing occurs under water

5. Appropriate cleaning and decontamination solutions:
a. Dilution measuring cups and lines in the sink for accurate measuring
b. Expiration dates labeled
c. Solution labeled with appropriate hazardous warning symbols

6. Instruments are not cleaned in hand sinks or scrub sinks

7. Water quality meets manufacturers requirements

8. Disinfectant concentration is tested per manufacturer’s recommendations

9. Weekly Instrument Washer Tests performed and documented

10. Supplies necessary for cleaning all instruments and devices are easily available, adequately stocked and in good condition

11. Staff can describe all processes related to decontamination

IV. Instrument Preparation

1. Supplies necessary for packaging and wrapping all instruments and devices are easily available, adequately stocked (integrators, packaging, wrapping, tape, protectors, markers, etc.)

2. Hand hygiene dispenser present

3. Items are properly packaged, wrapped, and properly identified

4. Labeling on indicator tape, patient record cards or plastic side of peel packs

5. Instrument set weights not over 25 pounds

6. Peel Packs- double peel packs are not folded, proper size used

7. Internal and external chemical indicators (CI) used for all packages
a. Geometric center of wrapped packages
b. Two opposite corners in rigid containers
c. On all levels

8. Instruments are in good condition

9. Instrument refurbishing plan

10. Instrument tape (if used) is in good condition

11. Tip protectors are validated for use

12. No single-use devices are being reprocessed (needs to be FDA cleared)

13. Instrument tracking system available

V. Sterilization

1. Routine maintenance performed per manufacturer’s guidelines. Cleaning schedule for sterilizers in place

2. Instruments sterilized in open position (e.g., scissors)

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)

4. A process (policy and procedure) in place to ensure proper reprocessing of loaner instruments from vendors or other medical facilities

5. Implants are monitored with a biological indicator (BI) and a class 5 CI

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

7. Biological indicator failure equipment recall process in place and reported to Infection Control Designee. How frequent are recalls?

8. Sterilization monitors
a. Biological indicators run at least weekly or more often per manufactures recommendation
b. The same lot number is used for the control and the processed BI
c. Chemical Indicators are used in every load

9. Every biological record is checked for result and properly recorded

10. IUSS limited to emergent needs

11. IUSS parameters are documented

12. Items are appropriately cleaned prior to IUSS

13. Use of IUSS closed containers

14. Aseptic transportation to point of use

15. All IUSS is traceable to the patient

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

1. Semi-critical equipment is high-level disinfected or sterilized

2. Items are pre-cleaned according to manufacturer’s instructions or evidence-based guidelines prior to high-level disinfection

3. Medical devices and instruments are visually inspected for residual soil and re-cleaned as needed before high-level disinfection

4. High-level disinfection equipment is maintained according to manufacturer instructions

5. Chemicals used for HLD are prepared according to manufacturer instructions

6. Temperature of HLD chemicals are checked and recorded per manufacturer’s instructions

7. Chemicals used for HLD are tested for appropriate concentration according to manufacturer instructions or evidence based guidelines and are replaced before they expire

8. Chemicals used for HLD are documented to have been prepared and replaced according to manufacturer’s instructions or evidence-based guidelines

9. Equipment is HLD according to manufacturer’s instructions or evidence-based guidelines

10. Items are rinsed according to manufacturer’s instructions

11. Items that undergo HLD are dried before re-use

12. HLD logs are in order

13. Test strips are properly dated

14. Control checks on test strips are performed and documented according to manufacturer’s instructions

VII. Sterile Storage

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

2. Bottom storage shelves of supply cart(s) are solid to prevent contamination from floor dust and cleaning

3. Sterilized items are stored and rotated with FIFO process (first in first out) by expiration date

4. Storage area is clean, dry adequate and integrity of packaging maintained

5. Sterile items separate from clean items

6. Staff can describe expiration dates and event related sterile storage

7. Heavy wrapped trays are not stacked

8. No web-edged or corrugated boxes

9. Space proportioned to expected volume

10. Inappropriate or unnecessary equipment and supplies are not present in the area

11. Ceiling flush surface, no shedding materials with recessed and enclosed pipes

12. Equipment maintenance records maintained

13. Functional work flow pattern (dirty to clean)

VIII. Physical Environment

1. Area restricted to authorized personnel only

2. All areas have a functional work flow pattern (dirty to clean)

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

4. Cardboard boxes removed before items are brought to restricted areas

5. Temperature and humidity levels monitored and recorded daily
a. 68-73 degrees F clean areas
b. 60-65 degrees F decontamination areas

6. Humidity
a. 30-60% work areas
b. Less than 70% in sterile storage areas

7. Ventilation
a. Soiled area, negative pressure (10 air exchanges per hour)
b. Clean/sterile areas, positive pressure (10 air exchanges per hour)

8. Housekeeping procedures
All areas cleaned daily (should be the same as in OR)

9. Separate cleaning equipment for decontamination

10. Do processes appear efficient in SP with items/areas tidy and well labeled?

11. Environmental Services support is adequate-environment is clean and orderly

12. Hand Hygiene supplies adequate and conveniently located in all areas (soap, water, lotion, and de-germer)

13. Handwashing stations conveniently located in clean and decontamination areas

14. Eye wash stations located within 10 seconds travel time to areas where hazardous chemical use occurs

IX. Handling and Distribution of Sterile Items

1. Items transported are covered or contained during transport

2. Transport carts, if used, have a solid bottom shelf

3. Carts and transport devices, covers, and containment devices are decontaminated between uses

4. Unused items returned to inventory are inspected for package integrity

Additional Comments or Findings

Any additional comments or 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.