Verichems concentration range does not exactly match my manufacturers stated dynamic range. Do I need to use a calibration verification product that has ranges custom designed for my system?
The patient results of most laboratories rarely covers the entire dynamic range stated by the system manufacturer. Therefore, it is not required by CLIA that you verify the manufacturer’s stated range to an exact degree. You are required by CLIA and other peer agencies to verify or establish the patient reportable range before reporting patient results. CAP abides by the CLIA requirement stating the laboratory must demonstrate that the reportable range is comparable to that established by the manufacturer. The key word of the requirement is comparable. Verichem’s universal ranges are designed to establish the patient reportable range and verify the manufacturer’s stated range of most clinical laboratory systems. Once calibration verification procedures are completed and you have determined your laboratory’s reportable range, then all patient results within that range have been validated. This is true regardless of whether or not your reportable range closely matches the manufacturer’s
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