DTM IQCP
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I work in a pediatrics clinic lab and we use the Hardy DTM slants for dermatophyte testing. I really need to get an IQCP in place so that controls don't need to be plated with every patient. I have the literature from CLIA and the CDC/CMS but I am still little confused on what the final document should look like. Looking for tips on writing one and if anyone can share an examples to help me on my journey. Thanks!
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Before our Derm clinics decided to send DTMs to our micro department, the protocol (in agreement with our micro department) was to run controls on each new lot/shipment. I would provide the vials for micro to perform the QC prior to releasing to Derm. All that being said, I am not sure you need to run QC every day or need an IQCP. That being said, it has been a year or two since Derm started sending cultures to micro, so the rules may have changed.
The clinic was cited during our inspection 2 years ago for not running controls each time a patient was set up (which is not necessarily every day). Although the prior inspections were ok just running controls with new shipment/lot/controls. Having an IQCP in place will allow us to go back to those rules and not have us set up 3 controls for every patient.
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