MMH ENDOSCOPE REPROCESSING TRACER

• Audit Title

• Prepared by

• Conducted on

  Date
• Location
  Address

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).

  Yes

  No

  N/A

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

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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).

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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).

  Yes

  No

  N/A

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

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

  Yes

  No

  N/A

• 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).

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

• 5. Water quality is tested annually.

  Yes

  No

  N/A

• COMMENTS: Look for physical evidence.

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

  Yes

  No

  N/A

• COMMENTS: Look for physical evidence.

• 7. Endoscope reprocessing room contains the following:

  Yes

  No

  N/A

• . Sinks to manually clean flexible endoscopes

  Yes

  No

  N/A

• . Separate hand-washing sink

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 8. Chemical Handling: High-level Disinfectant:

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 9. Chemical Documentation<br> a. Maintains high-level disinfectant logbook with:

  Yes

  No

  N/A

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

• . Dates of activation and expiration

  Yes

  No

  N/A

• . Type and percentage of high-level disinfectant solution

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• . Validates correct QC strip is being used

  Yes

  No

  N/A

• . Documents corresponding date with strip in logbook.

  Yes

  No

  N/A

• . Labels QC strip bottle with expiration date.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• . Date of activation and expiration

  Yes

  No

  N/A

• . Type and percentage of high-level disinfectant solution

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• b. Flushes suction channels with enzymatic and air.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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. <br>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• a. Chooses correctly sized channel brush.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• c. Brushes the channel between the suction valves.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• e. Uses short choppy strokes with the brush.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 11. Flushes all channels with water.

  Yes

  No

  N/A

• 12. Purges all channels with air.

  Yes

  No

  N/A

• 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).

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

V. HIGH-LEVEL DISINFECTION

• 1. For Manual Disinfecting:

  Yes

  No

  N/A

• COMMENTS: Please note if gluteraldehyde is used.

• a. Immerses the endoscope in disinfectant.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• d. Covers basin with tightly fitting lid.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 2. For Automated Endoscope Reprocessor:

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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).

  Yes

  No

  N/A

• c. Attaches channel cleaning connectors.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• g. Log exits to record manual process.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

VI. RINSING

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 3. Flushes all channels with water or sterile water.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

VII. DRYING

• 1. Purges all channels with air.

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 3. Removes all cleaning adapters and devices.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

VIII. STORAGE

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• a. Removes water-resistant cap if used.

  Yes

  No

  N/A

• b. Attaches venting cap for storage, if needed.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

IX. MISCELLANEOUS

• 1. Water bottles and tubing are sterilized daily.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

X. FOLLOW-UP

• COMMENTS