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QC/QA

QC/QA. Phases of Quality Assurance. Preanalytical Analytical Postanalytical. Preanalytical. Everything that pre cedes actual test performance Test ordering, patient prep & ID, specimen collection, transport and processing. Analytical. Everything related to actual testing

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QC/QA

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  1. QC/QA

  2. Phases of Quality Assurance • Preanalytical • Analytical • Postanalytical

  3. Preanalytical • Everything that precedes actual test performance • Test ordering, patient prep & ID, specimen collection, transport and processing

  4. Analytical • Everything related to actual testing • Test analysis, QC, reagents, calibration and preventive maintenance

  5. Postanalytical • Everything that comes after test analysis • Check of calculations, reference ranges, result reporting,test interpretation, follow up patient care

  6. Miscellaneous QC • Balances verify accuracy using Class S weights • Diluters, Dispensers, Micropipets verify accuracy and precision upon receipt, after service or repair, and on a regular schedule gravimetric or potassium dicromate • Temp Controlled (water baths, heat blocks, refrigerators, freezers) using NIST certified thermometer or calibrated thermometer +/-1 C • Thermometers 6 – 12 months +/- 1 C • Water resistivity, microbiologic contenet, pH, soluble silica

  7. Calibrator Substance with an assigned value by the manufacturer established by using a reference method or reference material traceable to primary standards.Used to set value on instrument • Control Substance similar to specimens chemically and physically used to monitor the precision of a test. Controls should be run at all levels of clinical importance at least every 24 hours or with each batch. • Standard Contains a known amount of an analyte used to calibrate a method or check calibration of method

  8. QA vs QC • QA Process by which a laboratory ensures quality results by closely monitoring the preanalytic, analytical and postanalytical stages of testing • QC Part of the ANALYTICAL stage of QA, process of monitoring results from control samples to verify quality of patient results.

  9. Sensitivity Ability to detect slight differences in concentration Few False negatives Desirable for screening tests • SpecificityAbility tomeasure solely the compound it is supposed to measure Few false positives Good confirmatory test

  10. AccuracyHow close a measurement is to the true valueImplies freedom from error • PrecisionReproducibilityExpressed in terms of SD or CVImplies freedom from variationDoes not imply accuracy • ImprecisionLarge scatter about the mean and increase in SD

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