The Application of the Sigma Measurement Value Combined with the Quality Target Index in Evaluating the Performance of Various Blood Analyser Models
Objective This study aims to evaluate the performance of quantitative testing items in different types of automatic hematology analyzers in a clinical laboratory using the σ measure combined with the quality goal index(QGI).This approach can provide a foundation for assessing and improving the analytical quality of these testing items across four different types of hematology analysis modules in the laboratory.Methods Following the"top-down"approach specified in the CNAS-TRL-001:2012 technical report by the China National Accreditation Service for Conformity Assessment,the indoor datasets were collected from January to December,2023 for four different types of automatic hematology analysers.The weighted average coefficient of variation(CV)was calculated using a weighting method,and combined CVs were determined for two concentrations of whole blood quality control substances at levels 1 and 2.The Bias(Bias％)was calculated using IQA data and the target values for the respective groups,which provided by the National Center for Clinical Laboratories.Allowable total error(TEa)was determined according to the National Health Industry Standard WS/T 406-2012,which was then used to calculate the sigma(σ)measure and QGI for the four different types of automatic hematology analysers.Performance of studied analyser was evaluated using the σ measure,while QGI was employed to identify specific areas and directions for quality improvement.Results The combined evaluation of σ measure and QGI revealed that eight testing items in modules 1 and 2 achieved o measures of 4 or higher,indicating a good or superior analytical quality,with no recommended improvements according to relevant literature.In module 3,the HCT σ measure ranged from 2 to less than 3,indicating a poor analytical quality,with a QGI greater than 1.2 suggesting a need for accuracy improvement.For module 4,the WBC and HCT σ measures ranged from 3 to less than 4,indicating a critical analytical quality.The RBC and MCHC σ measures ranged from 2 to less than 3,indicating a poor analytical quality,while the MCV σ measure less than 2,indicating an unacceptable analytical quality.In this scenario,QGIs less than 0.8 for WBC and HCT indicated a need for precision improvement.The RBC QGI ranging from 0.8 to 1.2 suggested the need for both precision and accuracy improvement.QGIs less than 1.2 for MCV and MCHC indicated a need for accuracy improvement.Conclusion The σ measure objectively assesses the analytical quality of quantitative testing items across different types of hematology analyser modules in clinical laboratories.Additionally,the integrated application of σ measure and QGI can provide more effective guidance for improving quality across various items within clinical laboratories.
Six SigmaAutomatic blood analyzerQuality assessmentQuality improvement
万方数据
维普
