Application of the Requirement of Biological Variation Determination in the Quality Management of Blood Cell Analyzer / 现代检验医学杂志

ABSTRACT

Objective To study application of the quality management of Blood Cell Analyzer according to the requirement of biological variation determination.Methods Collected the indoor imprecision value(CV％) from 8 items detected by blood cell analyzer during from April to Nov.of 2016,and the bias (Bias％) of 8 items of two EQA (external quality assessment) from the ministry of health in 2016.Then according to the 3 levels of the minium,appropriate and optimal quality specifications derived from the biological variability the rates of imprecision and bias were culculated.The pass rate of the imprecision and bias was calculated.By using mean bias and mean imprecision and biological variation 3 levels of total error (TEa) crite rion,and to calculate the corresponding σ and QGI value,so as to evaluate the performance of whole blood cell analyzer.Then improved the quality.Results For the imprecision value of 8 items,except the MCHC average value,all others were all 100 ％ meeting the appropriate level of quality requirements.For the bias value (Bias ％) from 8 items,except MCH,all others were over 80 ％ meeting the appropriate level of quality requirements.While for the calculated σ value,based on the best level of quality requirements,except the σ value of WBC was 4.6,the σ value of all other items were all＜3.Based on the appropriate level of quality requirements,except the σvalue of MCHC was 1.9,the value of σ of all other items were all＞ 3,and based on the minimal requirements,the σ value of all 8 items were all ＞3.After analysis,this blood cell analyzer,except that MCHC should use the minimal quality standard requirements,all other examination items could used the proper quality standard requirements,and the calculated QGI were all ＜0.8.Conclusion Based on the biological variation determination requirement and calculated σ and QGI value,this method could be used to more accurate quality evaluation of blood cell ana lyzer.Which is a higher levelof quality management,will be more conducive to quality improvement and better serve the clinical.