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

10. Accuracy How close a measurement is to the true value Implies freedom from error
Precision Reproducibility Expressed in terms of SD or CV Implies freedom from variation Does not imply accuracy
Imprecision Large scatter about the mean and increase in SD