When reporting results using reagents that are not FDA cleared, a disclaimer must be added stating this. UNLESS: According to subpart K of good 'ol CLIA, any assay which has been tested in house and proven to be equivalent to an FDA cleared assay may be reported out as if it were itself FDA cleared. There are no specific guidelines for performing this comparison. In the flow lab, other than CD4's, HLA-B27's, and reticulocyte counts, I don't think much else (cytometry related) has been FDA cleared, and thus must all carry a disclaimer. i.e. If there is no FDA cleared equivalent assay, you will always add a disclaimer. In the past, I have used something like: "This assay is not by itself diagnostic and must be used in conjunction with other clinical and laboratory data when evaluating patient status". It states what it must state while not signalling insurance guru's to refuse payment. Then again, that's only my interpretation. I could be wrong. good luck. Keith Bahjat Kbahjat@nwu.edu
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