In today’s vastly regulated setting, clinical laboratories must now contend with numerous agencies and organizations. As a result, it can be time-consuming, confusing, and even costly for the laboratory to monitor and conform to all regulations necessary to achieve full concord. When one reviews the clinical chemistry department, probably the most demanding section of a clinical laboratory, one regulatory requirement has emerged which has major consequences on the diagnostic systems responsible for testing – the calibration verification of those systems. One cannot afford to misjudge the need for, and the importance of, calibration verification testing. As a point of reference, lack of conducting required calibration verification testing, or performing incorrect or incomplete testing, is frequently reported as one of the top reasons for a laboratory to be cited with a deficiency during inspection. However, it is important to remember the reason for calibration verification is not to saddle the laboratory with inconsequential testing, but to confirm that the diagnostic system in use is reporting accurate patient test results.
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