Audit

I. GENERAL DOCUMENTATION REQUIREMENTS

1. Manufacturers' Instructions for Use (IFUs) are accessible and referred to by staff (for endoscopes, endoscope accessories, and re-processing equipment).

COMMENTS: Look for physical evidence ("show me" and note where found).

2. Policies related to endoscope reprocessing methods are accessible to staff.

COMMENTS: Look for physical evidence and note where found.

3. Safety Data Sheets (SDS) for each chemical utilized in endoscope reprocessing are accessible to staff.

COMMENTS: Look for physical evidence and note where found.

4. Staff have received initial training with verification of competencies for all scopes, accessories and associated equipment (e.g. AER) and have updated competencies (annually).

COMMENTS: Look for physical evidence in personnel files.

5. Logs (electronic or paper) are maintained with full traceability of the scope (e.g. serial #) to the patient, including who processed the scope.

COMMENTS: Look for physical evidence and note electronic or paper ......

II. ENDOSCOPE REPROCESSING ROOM REQUIREMENT

COMMENTS: Summon Facilities for questions or problems with #1-#5 in this section!

1. Endoscope reprocessing room is free of any dividing walls (e.g. curtain, temporary dividers are not allowable).

COMMENTS: Procedural barriers are in place to prevent cross contamination.

2. Decontamination room air pressure is negative to surrounding spaces.

COMMENTS: Door to room must be kept closed to maintain negative pressure.

3. Room air exhausts directly outside (air cannot be reused elsewhere in the building).

4. Minimum # of Air Changes Per Hour: Air is changed a minimum of 10 times per hour and 2 of the 10 air changes are fresh, outside air.

COMMENTS: There are no requirements for relative humidity or temperature. Look for physical evidence.

5. Water quality is tested annually.

COMMENTS: Look for physical evidence.

6. Spill neutralizer is readily available as needed per high level disinfectant manufacturers.

COMMENTS: Look for physical evidence.

7. Endoscope reprocessing room contains the following:

. Sinks to manually clean flexible endoscopes

. Separate hand-washing sink

. Eyewash station present and attached to Clean Sink (may be hand-washing sink)

8. Chemical Handling: High-level Disinfectant:

COMMENTS: Ask the question: How do you mix and dispose of chemicals?

a. When indicated, activates and mixes high-level disinfectant (as needed following manufacturers recommendations) at the beginning of the day or before the endoscopic procedure. Transfers high-level disinfectant into processing bin/AER.

b. Disposes of chemical appropriately per dept processes and the disinfectant manufacturer's IFU.

9. Chemical Documentation
a. Maintains high-level disinfectant logbook with:

COMMENTS: Look at the logbook (paper or electronic) to verify.

. Dates of activation and expiration

. Type and percentage of high-level disinfectant solution

. Each use high-level disinfectant strip results checked (pass/fail), with appropriate follow-up actions if test strip fails

. Validates correct QC strip is being used

. Documents corresponding date with strip in logbook.

. Labels QC strip bottle with expiration date.

. Performs QC, if required by manufacturer, on test strip per guidelines when bottle is first opened and documents results.

b. Soaking bin is labeled with the following information filled in/ checked off:

. Date of activation and expiration

. Type and percentage of high-level disinfectant solution

III. PRE-CLEANING AT THE POINT OF USE

1. Wears personal protective equipment (PPE) including impervious gowns, gloves as recommended by the high level disinfectant manufacturer, chemical goggles, or face shield.

2. Immediately following invasive procedure, and while still in procedure room:

a. Wipes exterior of scope with enzymatic solution according to manufacturer guidelines.

b. Flushes suction channels with enzymatic and air.

3. Transports used scope from procedure room to decontam room in scope bag or covered Bin Marked As Biohazard.

IV. CLEANING (INCLUDING LEAK TESTING)

1. Wears personal protective equipment (PPE) including impervious gowns, gloves as recommended by the high level disinfectant manufacturer, chemical goggles or face shield, and fluid resistant mask.

2. Visually inspects the endoscope, universal cord, and bending section (as applicable) for holes, tears, or other gross damage.

3. Performs leak testing according to manufacturer's instructions.

4. If the endoscope is leaking, calls the manufacturer for repair. Follows manufacturer's recommended procedures for preparation of the endoscope before sending out for repairs.

COMMENTS: Ask what you would do if scope is leaking?

5. Manual Cleaning with an Enzymatic Solution: Detaches all removable parts (as applicable), soaks them and brushes them to remove debris. Rinses parts with water.

6. Immerses endoscope completely in enzymatic solution and thoroughly cleans the exterior of the endoscope.

7. Cleans inside the suction valve, air water valve, biopsy port openings and all other channel openings (as applicable) with a brush or lint free applicator.

a. Chooses correctly sized channel brush.

b. Brushes in the direction of the distal tip from the biopsy port.

c. Brushes the channel between the suction valves.

d. Brushes the channels in the direction of the light guide connector.

e. Uses short choppy strokes with the brush.

f. Cleans the bristles of the brush each time it exits the endoscope before retracting.

g. Repeats brushing until no debris is visible on the brush.

h. With an ERCP endoscope, deflects and cleans around the elevator.

i. Carefully, uses a soft brush to break up any blockage present at the tip of the air/water channel.

8. Attaches cleaning adapters to the endoscope and covers the biopsy port.

9. Immerses the endoscope, suctions in and soaks the endoscope in enzymatic solution for the manufacturer's recommended amount of time.

COMMENTS: Ask how long scope soaks in enzymatic solution.

10. Rinses the endoscope and all removable parts (as applicable) under running water to remove residual enzymatic solution.

11. Flushes all channels with water.

12. Purges all channels with air.

13. Removes excess water from the exterior of the endoscope to prevent dilution of high-level disinfectants used in the next step (using lint free cloth).

NOTE: The endoscope may need to be completely dried at this point if being processed by an AER or other system.

14. Fresh enzymatic solution is used for each scope cleaned.

15. Cleaning implements (brushes) are disposed of or cleaned and high level disinfected (including the sink) after each scope is cleaned.

V. HIGH-LEVEL DISINFECTION

1. For Manual Disinfecting:

COMMENTS: Please note if gluteraldehyde is used.

a. Immerses the endoscope in disinfectant.

b. Using the cleaning adapters fills all channels completely until no bubbles appear.

c. Place all valves, removable parts, and any reusable brushes in disinfectant.

d. Covers basin with tightly fitting lid.

e. Checks instructions for the correct immersion time (Sporox= 30min, gluteraldehyde=20min, Cidex OPA=12min, Metrocyde=40mins.) and sets timer.

f. When immersion is complete, purges channels with air to remove the disinfectant.

g. Check temperature per manufacturer's instructions for use.

2. For Automated Endoscope Reprocessor:

a. Follows the manufacturer's instructions to connect the endoscope to the re-processor.

b. Places the valves and other removable parts including re-usable brushes in the re-processor, if possible (otherwise parts must be manually high-level disinfected).

c. Attaches channel cleaning connectors.

d. For ERCP endoscope, the elevator wire channel must be accessed manually.

e. Follows manufacturer's instructions for high-level disinfectant.

f. Sets the machine for the recommended time and confirm recommended temperature.

g. Log exits to record manual process.

h. Records are available for appropriate annual PM's and/or filter changes.

VI. RINSING

1. With an automated re-processor, ensures that rinsing is performed by machine.

COMMENTS: If yes, 2-4 are N/A.

2. Thoroughly rinses the exterior surface of the endoscope with water according to disinfectant instructions for use.

3. Flushes all channels with water or sterile water.

4. Rinses all valves and other removable parts in water or sterile water.

VII. DRYING

1. Purges all channels with air.

2. Prior to storage, flushes all channels with 70%-90% alcohol to facilitate drying if non-sterile rinse water was used and documents the alcohol flush if not documented on the automated reprocessing printout.

3. Removes all cleaning adapters and devices.

4. Dries the exterior with a soft, dry lint free cloth.

5. Removes personal protective gear and washes hands before leaving reprocessing room.

VIII. STORAGE

1. Hangs flexible endoscopes vertically in a well-ventilated area.

COMMENTS: Cabinet must be closed, ventilated, composed of all wipe able surfaces. Scopes may not touch each other, sides, or bottom.

2. Stores endoscope in a protected manner, but does not store in case.

a. Removes water-resistant cap if used.

b. Attaches venting cap for storage, if needed.

3. Scopes are tagged with date of processing and tech's initials.

COMMENTS: How long are scopes stored between patients before being reprocessed? Should not be more than 30 days.

4. Verbalizes process for routine soaking bin cleaning and storage when not in use.

5. Stores removable parts separately. (i.e., air/water & suction buttons, biopsy caps, water-resistant caps).

IX. MISCELLANEOUS

1. Water bottles and tubing are sterilized daily.

2. Quality Control measures are applied and followed through entire reprocessing cycle.

3. Ask: Where are other scopes stored, if any?

4. What is the process for recalls? (Internal due to outbreak and or external due to manufacturer recall).

5. Ask what process is in place, if any, for differentiating a clean scope from a dirty one, anywhere along the high-level disinfection process, if the process is interrupted for some reason and the scope is laid down.

X. FOLLOW-UP

COMMENTS

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.