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Showing results for tags 'expired panel cells'.
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I just finished listening to an ARC webinar that included accred reps from CAP, AABB, and CLIA. A question regarding use of expired panel cells was brought up and answered by the reps with, what sounded to me like, some hesitation. CLIA added that we are required to add a disclaimer with each test report in which expired panel cells was used. Something along the lines of it not being an FDA approved reagent, yada yada yada...AND that this will be considered an LDT. Yes, the dreaded laboratory developed test. Have any of you ditched the use of expired panel cells altogether? Are you currently validating as an LDT, including using the disclaimer on each test result? I guess this CLIA person threw me for a loop. Christy
