Posted by Sten Westgard, MS
34101 Biological Variation: Improved Interpretation of Lab Results and Reduced False Rejections for QC
08/01/2018 10:30 AM Until 08/01/2018 12:00 PM Product Category: Scientific Session |
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CE Hours: 1.5 Hours
Session Level: Intermediate Session Overview: The biological variation of a laboratory test is a determination of the assay's analytical imprecision, and variances within and between individuals. From these data, the index of individuality, reference change value, homeostatic set points, and establishment of performance goals for quality control can be determined. Needs Assessment: Few laboratorians and even fewer physicians understand the concepts and value of biological variation (BV) studies. Yet, these measurements determine if reference intervals are appropriate for a laboratory test, how serial test can be interpreted, how one can establish a baseline for a test, and how BV data can be used for specify quality control goals . For example, cholesterol has low BV, and an index of individuality, therefore routine monitoring is a useful for prediction of cardiovascular disease risk. Serial rather than single measurements are essential in the rule out of acute myocardial infarction for patients with a mild increase in troponin. Alanine aminotransferase has high BV, therefore QC goals can be relaxed from the +/- 2SD rules to +/-2.5SD or even 3SD, to reduce the number of false QC rejections. A failure to understand BV will result in laboratories performing unnecessary investigations of QC failures. The number of papers published each year on biological variation have more than doubled since 2008. Intended Audience: This session is intended for all individuals who work in clinical laboratory science, from technologists who perform analyses, supervisors who must evaluate quality control data, lab scientists who perform biological variation studies, lab directors who provide clinical interpretation of laboratory data to those who order lab tests, and physicians who make management decisions based on lab test results. Expected Outcome: After this session, participants will be able to 1. design a study to determine the biological variation of a laboratory test 2. calculate from biological variation data, the index of individuality, reference change value and number of samples to establish a homeostatic set point 3. design a quality control system that incorporates the biological variation of a laboratory test as one of the important attributes. Speakers: Alan Wu, PhD, University of California/San Francisco General Hospital
Determining biological variation for clinical lab tests Sten Westgard, MS, Westgard QC, Inc. Biological variation for establishing quality control goals |
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