Module 4: Quality Control
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4 purposes of quality control
• systematic monitoring • detect analytical error • prevent reporting of incorrect patient test results • performance monitoring
a definitive procedure that produces a test result
analytical method
4 qualities of an analytical method
accurate relevant effective reproducible
ability of a method to detect small quantities of an analyte
analytical sensitivity
ability of a method to detect only the analyte it is designed to determine
analytical specificity
5 qualities of a control material
• must be insufficient quantity • must last at least a year • aliquoted in stable form • minimal variation between vials • spans clinically important range
what is the stable form of a control material
lyophilized
two levels lf control material
L1 - normal control L2- abnormal control
what values are compared in quality control
determined values expected values
what is being tested in quality control
analytical methods
for highly precise assays, control materials must be analyzed for:
5 days
for less precise assays, control materials should be analyzed for
at least 20 days