Cidex OPA Solution Training Checklist and Competency for Semi-Critical Medical Devices

Transcription

1 Name Method of Validation: Direct observation Today s Date: Unit/Department Please have user do the following: 1. Locate Cidex OPA Safety Data Sheet. 2. Verbalize which semi-critical devices are cleaned/disinfected with Cidex OPA. 3. Locate where device instructions approve the use of Cidex OPA for disinfection of instruments. 4. What are the storage requirements for Cidex OPA?: Stored between F (15-30 C) in a well-ventilated, low-traffic area. Confirm Cidex OPA user is documenting following sections in Use Log (Use Cidex OPA Use Log to go through sections outlined below) Original Container: Lot number, date opened, date expires. Test Strips: Lot number, date opened, date expires. Quality Assurance: Positive control, negative, tested by initials. Secondary Container: Lot number (same as original), date poured, date expires. Original Container - 5. How should the Original Container be labeled? Should be labeled with expiration date and initials of person opening container. 6. When does the original solution expire? 75 days after opening/manufacturer expiration whichever is first. Secondary Container 7. How should the Secondary Solution be labeled? Should be labeled with solution name, and date it should be discarded/expiration date. 8. When does the solution poured into the secondary container expire? 14 days after pouring, if test strips fail, or manufacturer expiration whichever is first. Test Strips Bottle 9. How should the Test Strip Bottle be labeled? Should be labeled with expiration date and initials of person opening container. 10. When do the Test Strips expire? 90 days after opening/manufacturer expiration (DO NOT USE 3 MONTHS) whichever is first. Performed Independently Performed with coaching Page 1 of 5

2 11. How should the Test Strips be stored? Bottled should not be opened greater than 30 minutes at a time. Cap should be tightly closed between uses. Must be protected from light and humidity. Bottle must be discarded 90 days after opening or manufacturer s expiration whichever is first. Quality Assurance: New Bottle Test Strips 12. How often should Quality Assurance Testing be performed on Test Strips? Whenever new bottle of strips is opened for use. Test strips can be tested more often if indicated to minimize errors. Test strips can be tested to determine if product has been improperly stored or handled. 13. Explain the appropriate quality assurance procedure for new bottle of test strips. Prepares positive and negative control solutions for testing, verifying that the labeled expiration date for the solution is appropriate. Positive Control: full strength Cidex OPA solution. Negative Control: dilute one part of full-strength Cidex OPA with one part water. Labels each control solution appropriately. Submerges three test strips in each of the freshly prepared solutions above for three seconds each. Compares indication pad on strips to the color chart on test strip bottle for interpretation of results: Positive Control: at 75 seconds test strips should exhibit a complete purple color. Negative Control: at 75 seconds test strips should either remain completely orange or exhibit an incomplete color change to purple. 14. What should be done if the results obtained from using positive and negative controls indicate the test strip is not functioning properly? Discard remaining strips. Device Processing Log should include: Date of processing, test strip results, solution temp prior to use, ID number or name of device, soak start and end time, user initials, and patient identifier 15. When should a new log be initiated? For each new solution or when new test strip bottle is opened. Solution (original or secondary container) or test strips expires. Page 2 of 5

3 Device Processing Procedure: 16. What PPE should be worn & when? Nitrile Gloves: Rinsing/wiping medical devices Testing solution with test strips Gloves, eye/face protection, and plastic gown Disposing of solution Pouring solution into containers Testing 17. How often should test strips be used to check Cidex OPA activity? Prior to each use 18. Explain how to test Cidex OPA activity Completely submerges the pad end of the strip into Cidex OPA solution for 1 second without stirring Removes strip without shaking. Excess solution is removed by standing strip upright on paper towel. Reads results at 90 seconds after removal from solution. Solution is effective: strip is completely purple. Solution is ineffective: any blue remains on the pad (aside from the top line). Record results on log sheet. 19. If solution fails the test-strips what actions should be taken- If test strips are expired? Discard and retest with new strips. o New strips will require QC testing. If test strips are in-date? Discard solution, rinse container, refill with fresh solution, and retest. 20. When should the Cidex OPA solution be discarded? Solution fails the test trips indicating inactivity. Solution is at end of the 14 day activation. Temperature of Solution 21. How often should the Cidex OPA temperature be checked? Prior to each use 22. What is the minimum temperature for use? Minimum of 68 F (20 C) 23. What should be done when temperature is out of range? Demonstrate knowledge of action to be taken when temperature out of range (minimum of 68 F/20 C): Solution cannot be used until temperature is within range. Page 3 of 5

4 24. What should be done with equipment prior to placing it in the Cidex OPA solution? Thoroughly clean Rinse with tap water Dry completely 25. What percentage of the equipment should be immersed in the Cidex OPA solution? 100% - Equipment must be completely immersed (all scope channels should be filled). 26. What is the minimum amount time equipment must remain immersed in Cidex OPA? Minimum contact time of 12 minutes. Container must be completely covered. 27. Explain the equipment rinsing & drying process once removed from Cidex OPA solution Equipment must be thoroughly rinsed by immersing it completely in large volume of water unless otherwise specified by manufacturer s instructions. Equipment is to remain immersed for one minute, unless longer time specified by manufacturer. After one minute, equipment is removed and rinse water is discarded. This process is repeated two more times for a total of three rinses. After rinsing, equipment is dried. Channels of scopes are to be blown out with compressed air. 28. Does any of your equipment require the use of sterile water and sterile technique during rinsing and handling? Indications for sterile water/technique: Devices for use in normally sterile areas of body, devices intended. for use in known or potential immunocompromised patients, and bronchoscopes. 29. What is the process for disposing of Cidex OPA? Cidex OPA solution is deactivated with Glute-out neutralizer, in the container for five minutes prior to disposal. Run water prior to dispensing neutralized solution down drain and for at least three minutes after process is completed. 30. What steps should be taken in the case of a Cidex OPA spill? Describe or follow Cidex OPA Spill response (see binder). 31. Can you locate your Cidex OPA Spill kit? Page 4 of 5

5 Final Rating Independent performs independently (Check One): Not Met - unable to perform even with coaching Action Plan Required Action Plan: I verify I have reviewed the CIDEX OPA procedure and understand how to use this solution safely. Employee Signature I verify the employee demonstrates the appropriate knowledge and steps for safe CIDEX OPA use. Trainer Signature I verify this employee has received training for the CIDEX OPA procedure. Supervisor Signature Page 5 of 5