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Risk, error and uncertainty : laboratory quality management in the age of metrology

Author: David Armbruster; James O Westgard; Sten A Westgard
Publisher: Philadelphia, Pennsylvania : Elsevier, 2017. ©2017
Series: Clinics review articles.; Clinics in laboratory medicine, v. 37, no. 1.
Edition/Format:   eBook : Document : EnglishView all editions and formats
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Genre/Form: Electronic books
Additional Physical Format: (OCoLC)958355201
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: David Armbruster; James O Westgard; Sten A Westgard
ISBN: 032347764X 9780323477642
OCLC Number: 975026606
Description: 1 online resource (314 pages) : illustrations (some color).
Contents: Title page; Table of Contents; Copyright; Contributors; Forthcoming Issues; Preface; Measuring Analytical Quality: Total Analytical Error Versus Measurement Uncertainty; Key points; Introduction; Background; Reality of bias; Some specific issues and answers; Discussion; Uncertainty in Measurement and Total Error: Tools for Coping with Diagnostic Uncertainty; Key points; Introduction; Measurement error and uncertainty; Uncertainty methods; Error methods; The best may become an enemy of the good; Diagnostic uncertainty in laboratory medicine Estimated glomerular filtration rate: an example of a clinically important measurandSummary; Rhetoric Versus Reality? Laboratory Surveys Show Actual Practice Differs Considerably from Proposed Models and Mandated Calculations; Key points; Materials and methods; Limitations; The real state of analytical goal setting; The real state of measurement uncertainty; The real state of individualized quality control plan implementation; Discussion; Summary; Biologic Variation Approach to Daily Laboratory; Key points; Introduction; Uses of biological variation; Summary Understanding the Use of Sigma Metrics in Hemoglobin A1c AnalysisKey points; Introduction; Methods; Statistics; Results; Discussion; State-of-the-art Approach to Goal Setting; Key points; Introduction; Material and methods; Results; Discussion; Six Sigma Quality Management System and Design of Risk-based Statistical Quality Control; Key points; Introduction; Traditional error model is the foundation for Six Sigma Quality Management System; Sigma-metric is a process capability index; Simple calculation of sigma-metrics at medical decision concentrations is adequate Sigma-metric is a predictor of risk and the needed statistical quality controlStatistical quality control analytical run, or frequency of quality control, can be related to error detection; Summary; Sigma Metrics Across the Total Testing Process; Key points; Introduction; Discussion; Summary; Metrological Traceability of Assays and Comparability of Patient Test Results; Key points; Introduction; Harmonization and standardization; Metrological traceability; The pillars of harmonization; Challenges to harmonization; In vitro diagnostics manufacturers and harmonization; Summary A Total Quality-Control Plan with Right-Sized Statistical Quality-ControlKey points; Introduction; Understanding individualized quality control plan; Guidance for developing a quality control plan; Developing a total quality control plan; General approach; Step-by-step procedure; Right-sizing statistical quality control; Assembling a total quality control plan; Summary; Accreditation of Individualized Quality Control Plans by the College of American Pathologists; Key points; Background; The validation conundrum; The individualized quality control plan development group; Checklist language
Series Title: Clinics review articles.; Clinics in laboratory medicine, v. 37, no. 1.
Responsibility: editors, James O. Westgard, David Armbruster, Sten A. Westgard.

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