Abstract:

Objective To evaluate blood cell analysis projects through using 6 sigma （σ） performance evaluation,to select the individual quality control rules in order to improve the determination quality.Methods By using the function of Unity Real Time software platform 's Westgard Advisor,the information of σ value,σ measurement figure and suggested rules was obtained according to imprecision [coefficient of variation（ CV）],inaccuracy [bias（Bias）] and allowable total error（TEa）. The projects whose σ values did not reach 6 were analyzed,and the main causes of poor method analysis performance were evaluated through quality goal index （QGI）. The project analysis length was identified according to the analysis length of Westgard σ flow chart of Westgard σ rules.Results The performance characteristics and recommended rules of each item of blood cell analysis are not the same. The selection of individual quality control rules for each item was realized by a single rule or multiple rules. To analyze the projects whose σ values did not reach 6,QGI indicated that,except hemoglobin,accuracy improvement was the priority,while the other items indicated precision improvement was the priority. The length of the analysis batch determined by the comprehensive evaluation of system was 200,which was consistent with the daily sample size of system of about 200. Conclusions The Unity Real Time software platform can be applied to perform 6σ performance evaluation for quantitative analysis projects such as blood cell analysis,select individual quality control rules according to performance characteristics,and make continuous improvement according to QGI. According to the flow chart of Westgard σ rules,the appropriate batch length is determined to ensure the quality of patient test results.

Key words: Unity Real Time software, Blood cell analysis, Individuation, Quality control rule, Analysis batch length