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This guide by Mr. Shashikant Mahadik, Scientific Officer in Hematopathology at TMH Mumbai, outlines the implementation and monitoring of Levey-Jennings charts using Westgard rules for quality control in coagulation testing. It includes methodologies for calculating the coefficient of variance (CV) for both commercial and in-house control materials. This resource emphasizes the importance of accuracy, precision, calibration, and the identification of laboratory errors stemming from inadequate management and quality control practices, aligning with ISO 15189 standards and the legacy of Dr. Walter Shewhart.
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Mr.Shashikant Mahadik Scientific Officer Hematopathology,TMH,Mumbai
-Plotting of Levey-Jennings chart- Application of Westgard Rules- Calculation of coefficient of variance
Control Material Commercial / In-house (for coagulation) Tri-levels 1st or 3rd party controlsMonitoring of control L-J charts, Westgard rules and %CV
Accuracy : Closeness of a result to the true valuePrecision : refers to the reproducibility of a resultYou cannot have accuracy without precision, but can have precision without accuracy
Calibration : is done to standardize the instrument for accuracyCalibrator : is a certified reference material used calibrate a measurement on analyzer
Whydolaboratoryerrorsoccur? Inadequate Attention ToDetail Poor Quality Management Non-validated Tests Understaffed & Underequipped Poor Workload Management Time Pressures Poor SampleControl PoorResults Verification Inadequate InternalQuality Control(IQC)& Assessment(EQAS)
TheLevey-Jennings Chart'sInventors In1931,Dr.WalterShewhart,a scientistattheBellTelephone Laboratories,proposedapplying statisticalbasedcontrolchartsto interpretindustrialmanufacturing processes. In1950,S.LeveyandE.R. Jenningssuggestedtheuseof Dr.Shewhart’scontrolchartinthe clinicallaboratory. Fatherofstatisticalqualitycontrol