An analytical method needs to be properly calibrated to give valid results. The College of American Pathologists (CAP) requires that calibration be verified according to specific criteria, in accordance with the requirements of the Clinical Laboratory Improvement Act (CLIA).
Criteria for calibration:
(1) initially, when introducing a new method
(2) if quality control (QC) fails to meet established criteria (and not fixed by opening new reagents or controls)
(3) after major maintenance or service
(4) as recommended by the manufacturer
(5) at changes of reagent lots for chemically or physically active or critical reagents.
Exception: The laboratory can demonstrate that the use of different lots does not affect the accuracy of patient test results and the range used to report patient test data.
(6) at least every 6 months
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