UCSF Autoclave Quality Control Program

Bio Symbol

Policy:

To comply with the California Medical Waste Management Act (MWMA) (Ca. Health and Safety Code Chapter 8, Section 118215 Methods), solid medical waste generators must either:

· Treat the waste using certified facility and equipment to sterilize all biohazardous materials, OR

· Dispose of the waste as medical/infectious by incineration, autoclaving, or other State authorized method performed by a commercial vendor approved by the State for this work.

NO MEDICAL (RED BAG) WASTE MAY EVER BE DISPOSED OF IN REGULAR TRASH, EVEN AFTER AUTOCLAVING ONLY DISPOSE OF THROUGH EH&S

Steam sterilization in certified autoclaves is an acceptable method of medical waste treatment. The MWMA specifies that proper sterilization conditions are achieved when the autoclave environment maintains 121º Centigrade (250º Fahrenheit) for at least 30 minutes. Autoclave records (or charts) indicating the date, time, and temperature must be used during all autoclave runs and must be maintained on file for three years. Note: Sterilization time may vary with the quantity and density of items in the autoclave chamber. The conditions above are minimums.

Standard Operating Procedures (SOPs)

Written standard operating procedures must be developed for each autoclave and kept nearby. The SOP should be developed from the manufacturers instructions supplied with the autoclave, and describe minimum time, temperature, and pressure; the type of waste permitted in the autoclave; type of container and closure on container; pattern of loading in the autoclave; water content of waste container; and maximum load quantity.

Quality control (QC)

To confirm adequate sterilization conditions, a spore test vial of the biological indicator Bacillus stearothermophilus must be placed at the center of a normal waste load and processed under standard operating conditions at least monthly. Sealed spore test vials are available commercially. A quality control program shall be in place that meets the following objectives:

· Test the autoclave monthly by the laboratory using B. stearothermophilus spores.

· Use the Autoclave Quality Control log below to document the date, operator, cycle information, and test results. File and maintain the log in the Autoclave Logbook for three years along with the run chart or printout.

· At least annually, perform maintenance, thermometer calibration and certification by a commercial vendor that will also provide calibration data for their temperature test equipment

· Maintain all records to be readily available for inspection by the Office of Environmental Health and Safety (EH&S) and/or the San Francisco Department of Public Health upon demand. These records must include, at minimum, monthly testing logs, maintenance and repair documents, certification documents, autoclave run data for each load, written SOPs, and any Notice of Violation documents pertaining to that autoclave.

· Confirmatory tests may be performed by EH&S annually.

UCSF AUTOCLAVE QUALITY CONTROL LOG

Principal Investigator: 

Autoclave manufacturer: Model Number:

Autoclave Serial Number:

Autoclave Location:

Building:   Floor:  Room:

1. Every month perform the autoclave QC test

2. Place Bacillus stearothermophilus vial in the center of the bag

3. Process the load using normal operating procedures

4. Incubate B. stearothermophilus at 55-60°C for 24-48 hours

5. Incubate a control vial that has not been autoclaved, media should turn yellow to indicate growth.  If the control vial remains purple, there may be a problem with the batch of indicator vials and the test may not be valid.  Repeat the run, and if the result is the same obtain a new set of test vials. Return the waste to the bin as in step 8 below and re-run with a new batch of vials.

6. If the test vial media is purple after incubating 72 hours, sterilization is successful, there was no growth.

7. If the media turns yellow the bacteria grew, sterilization failed

a. Review the run chart to see if the conditions were met. If they were NOT, discontinue using the autoclave, return the waste to a medical waste bin, and contact the service provider to get the autoclave repaired.

b. If the conditions were met, repeat the run with a new test vial

c. Retest after the repairs are completed

8. Record all results on this page and retain in the Autoclave logbook

Year: 

Date of Test

Operator Name

Cycle Time

Cycle Temp

Results

Comments

Jan.

         

Feb.

         

Mar.

         

Apr.

         

May

         

Jun.

         

Jul.

         

Aug.

         

Sep.

         

Oct.

         

Nov.

         

Dec.

         

Results: OK = no growth, sterilization successful

GROW = growth, media yellow, sterilization failed, describe how corrected

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