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Unit #7-Basic Quality Control for the Clinical Laboratory
Unit #7 - Basic Quality Control for the Clinical Laboratory Cecile Sanders, M.Ed., MT(ASCP), CLS (NCA) Unit #7 - Basic Quality Control for the Clinical Laboratory Introduction The results obtained from laboratory analyses are used to diagnose, prescribe treatment, and/or monitor the health or progress of the patient. Since such importance is placed upon test results, they must be as reliable and accurate as possible. Unit #7 - Basic Quality Control for the Clinical Laboratory Elements of a Total Quality Control Program (may be referred to as QC, QA, or TCM, among others) Current procedure manual Documentation Qualified personnel Fire and safety program Use of appropriate standards and controls External proficiency testing Unit #7 - Basic Quality Control for the Clinical Laboratory Standards and Controls Standard A substance that has an exact known value and that, when accurately weighed or measured, can produce a solution of an exact concentration Also called “reference materials” Not usually used on a daily basis Used to calibrate new instruments, recalibrate instruments after repair, at manufacturer’s recommended intervals, or if a method is out of control Unit #7 - Basic Quality Control for the Clinical Laboratory Control A solution that contains the same constituents as those being analyzed in the patient sample Most are commercially produced from pooled sera The manufacturer has analyzed each lot of serum for a variety of test components and the expected range of assay values for each component is provided to the laboratory when shipped Unit #7 - Basic Quality Control for the Clinical Laboratory Control (cont’d) Controls are analyzed with each patient test or batch of tests and the results are compared with the manufacturer’s range of values For most tests, a “normal” control and an “abnormal” control are analyzed with each patient test or batch of tests Results are plotted on a QC record called a Levey-Jennings Chart Unit #7 - Basic Quality Control for
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