Abstract
IntroductionAnalytical quality is an essential requirement for best practice in any medical laboratory. Lack of a harmonized approach for sigma calculation is considered an obstacle in the objective comparability of analytical performance among laboratories adopting sigma metrics. It is urgently needed that all laboratory professionals interested in the analytical quality to work hard towards harmonization protocol for sigma calculation in order to properly select their analytical goals. This study aims at harmonization of Sigma metrics calculation in four accredited Egyptian laboratories.Materials and methodsThis observational cross sectional study compared the sigma levels for certain biochemical parameters in the four participating laboratories.ResultsCoefficient of variation (CV) and bias were determined for some biochemical analytes, data assayed by different automated analysers in the four different accredited laboratories. The sigma level for the four medical laboratories was calculated for each biomedical parameter with changed sigma level after total allowable error (Tea) unification among participating laboratories.ConclusionEach laboratory should select the TEa goal based on clear standardized criteria of selection without any subjective preferences as either under or over estimation of Sigma metrics will affect the patient centred care negatively if laboratories use quality control procedures wrongly based on incorrect Sigma metrics calculation with subsequent misleading medical decisions.
Highlights
Analytical quality is an essential requirement for best practice in any medical laboratory
Coefficient of variation (CV) and bias were determined for some biochemical analytes, data assayed by different automated analysers in the four different accredited laboratories
Patientcentred care, the main target of medical laboratories, depends on the key concepts of internal quality control (IQC) which was established by Levey and Jennings followed by the interpretative rules published by Westgard and colleagues and external quality assurance (EQA) programs, which established in the late nineties as a complementary pillar to IQC, provide a tool of peer comparison [1,2,3,4,5]
Summary
Analytical quality is an essential requirement for best practice in any medical laboratory. Lack of a harmonized approach for sigma calculation is considered an obstacle in the objective comparability of analytical performance among laboratories adopting sigma metrics. It is urgently needed that all laboratory professionals interested in the analytical quality to work hard towards harmonization protocol for sigma calculation in order to properly select their analytical goals. This study aims at harmonization of Sigma metrics calculation in four accredited Egyptian laboratories. The minimization of analytical imprecision reflected as random errors via proper IQC plans and minimization of analytical bias seen as systematic errors through EQA programs are considered fundamental tools for any quality management system in laboratory medicine [6]. The first method depends on counting the defects or errors which are expressed as defects per million (DPM); the DPM are subsequently converted to a SM scale of 0 to 6, with 6 being world class (3.4 defects per million) and 3 being the minimum level of performance (about 66,800 defects per million) [9]
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