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| Laboratory \ Mycobiotic Agar |
Mycobiotic Agar Control Tests
| There have been a number of inquires to Delasco about the availability of a control test for mycobiotic agar that can be performed in the physician’s office. Some CLIA inspectors have apparently required the dermatologist to perform their own “in-house” quality control tests and will not use the manufacturer’s quality assurance testing (included with every box of mycobiotic agar).
Due to a number of biological and hazardous issues, it is not prudent for Delasco to offer a QA test to be performed in the physician’s office. As such, Delasco offers a possible solution to satisfy the in-house QA requirements:
Try to order enough mycobiotic agar to last through much of that shipment's expiration dating. For example, if you call Delasco and find the current batch being shipped has, for example, an expiration date of November 2007. And after checking your records, you determine that your office does about 20 mycobiotic agar tests a month. Assume November 2007 is 11 months away. You might then order 160 bottles or 8 months supply. (Or if the CLIA inspector requires testing some shorter interval as well, then purchase enough for that interval). When you order this amount, specify that you want the whole order from the same manufacturing batch (same lot number).
Also, we suggest ordering a few bottles of DTM as well, and then inoculate in your office with samples from a patient that you have positively identified with a dermatophyte infection. You can then indicate in your record that:
1. Scrapings came from a patient with typical tinea ________. Initial scrapings were evaluated microscopically using a potassium hydroxide preparation, and typical branching hyphae were positively identified. Additional scrapings from this lesion were inoculated on Mycosel media, and growth occurred providing a colony was grossly typical of _____phyton_____. (Take a picture of upper and under sides and include with record).
2. Microscopic examination of culture showed:
branching hyphae with micro and macro conidia of the ________type (or whatever description is appropriate), which is characteristic of _____phyton________. The patient which provided this sample cleared of his/her fungal infection in the appropriate time period after initiation of appropriate fungal treatment.
Such a protocol will establish a known control. You may have to transfer this known culture to fresh DTM at regular intervals to keep it viable (You could establish such an interval on your own, by inoculating fresh DTM at 1 month, 3 months, 6 months, 9 months, and a year (using the original to see how long it will be good - saving the in-between inoculations to be sure that you continue to have viable culture, in case the original dies. Then simply write down or "document" all this for CLIA.) Then you have a known dermatophyte that you can use to "test" your media. |
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