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Chapter 14.2 : Quality Control
Category: Clinical Microbiology
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QC programs ensure that information generated by a laboratory is accurate, reliable, and reproducible. This is accomplished by assessing the quality of the specimens; monitoring the performance of test procedures, reagents, media, instruments, and personnel; reviewing test results; and documenting the validity of the test methods.
Fishbone diagram for identification of potential failure modes. Redrawn from CLSI EP23-A ( 1 ) with permission of the publisher.
Process to develop and continually improve a QCP. The terms corrective and preventive action and continual improvement are referred to as CAPA and CI, respectively, in risk management literature.
Performance standards for bacteriological media
Performance standards for mycobacterial media and tests
Performance standards for mycologic media
Performance standards for stains
Performance standards for reagents used for bacteria
Format for a positive-negative diagnostic test
Effects of sensitivity, specificity, and disease prevalence on test parameters
Determination of CI a