Quality Assurance
DaRob shall perform quality assurance testing to demonstrate the capability of the autoclave to achieve the performance standard of a minimum four log10 reduction or a similar alternative offered by the independent testing laboratory of Bacillus Stearothermophilus spores. The quality assurance testing for autoclaves shall be performed monthly, in accordance with the following provisions:

Perform monthly quality assurance testing every calendar month in which the
autoclave is used for the treatment of infectious wastes to ensure the capability of the autoclave to achieve the performance standards of a minimum four log10 reduction of Bacillus Sterothermophilus spores;

Use a challenge population of spores as either spore strips with a population
of at least 1.0 X 10 (4) Bacillus Sterothermophilus spores, ampules containing at least 1.0 X 10 (4) Bacillus Sterothermophilus spores per milliliter or a commercially available steam pack which contains a population of at least 1.0 X 10 (4) Bacillus Sterothermophilus spores or a similar alternative offered by the independent testing laboratory. The owner or operator shall ensure that the Bacillus Sterothermophilus spore testing methodology does not result in the denaturation of the proteins within the inoculating media;

Compose the waste load of containers of both infectious wastes and non-
infectious wastes. The majority of the waste load may consist of infectious wastes. However, at least three test containers shall consist of material such as newspaper, plastic backed absorbent pads, or general refuse placed into either boxes, bags, or sharps containers representative of normal or anticipated use for that autoclave unit. A spore strip or ampule shall be placed in the center of each test container. In the event that the autoclave will not hold three containers of wastes, then each test container shall contain a spore strip or ampule. Alternatively, commercially available steam packs may be placed into the three representative containers instead of the newspaper, plastic backed absorbent pads, or general refuse;

Treat the waste load containing the challenge population of spores in the same manner as the daily operation of the autoclave for the treatment of infectious wastes. This would include the same temperature, pressure, time, and total treatable volume. The quality assurance testing shall be performed at the same combinations of temperature, pressure, and time, as the validation testing;

Record the following information during the monthly quality assurance testing:
Arrow Graphic The date;
Arrow Graphic The time the treatment cycles started, as specified in paragraph (D)(1) of this rule;
Arrow Graphic The time the treatment cycle ended, as specified in paragraph (D)(1) of this rule;
Arrow Graphic The chart or graph of the chamber temperature produced by the permanently connected temperature recording device;
Arrow Graphic The name of the person who loaded the autoclave and the name of the person performing laboratory analysis of the challenge population of spores;
Arrow Graphic A diagram depicting the pattern of infectious waste loading and location of the challenge population of spores during the testing except those units which have rotating treatment chambers are not required to diagram the pattern of waste loading;
Arrow Graphic The total treatable volume of infectious wastes used during the quality assurance testing as defined in paragraph (D)(1) of this rule;
Arrow Graphic The autoclave chamber pressure, as displayed by the permanently connected gauge, during the treatment cycle as specified in paragraph (D)(1) of this rule;
Arrow Graphic The incubation temperature and time (in days) of the challenge population of spores, in accordance with the manufacturer's recommendation for optimal growth; and
Arrow Graphic The results of spore growth during incubation for a period of seven days or for the maximum period of time as specified by the manufacturer of the spore test. The results of spore growth shall be recorded as indicated by the development of turbidity in the growth media. The development of turbidity in the growth media is indicative of growth of the challenge population of spores present unless other morphological or metabolic testing indicates that the growth is due to a contaminating microorganism.

Remove and incubate the challenge population of spores used in the quality
assurance testing for either seven days or for the maximum period of time as specified by the manufacturer of the spore test. If any of the challenge population of spores used to perform the testing is positive for growth at any time during the incubation period, the unit has failed to achieve the performance standard required for treatment. Infectious wastes placed within the unit during and after the spore testing shall not be considered treated and shall be handled as infectious wastes. The autoclave unit shall not be used for further treatment of infectious wastes until the problem has been determined and rectified and another successful quality assurance test performed. The rectification may require the operator to increase the minimum temperature and/or pressure requirements or cycle time; and

Perform the quality assurance testing, upon request by, and in the presence of,
the Kentucky EPA or approved Health Department to verify that the written operating procedures as located in the Facility Management Plan are sufficient to meet the performance standard of a four log10 reduction in Bacillus Sterothermophilus spores. If so directed, the owner or operator shall use twice as many spore tests in the same location in the autoclave and permit the Kentucky EPA or approved Health Department to remove and separately incubate one-half of the spore tests.

Perform daily quality assurance testing with autoclave indicator strips to insure established operating parameters and desired results are being achieved.

 

 

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