摘要
目的运用Westgard西格玛规则管理血清淀粉酶(AMY)室内质量控制(质控),计算质量目标指数(QGI),找出方法性能不佳的原因及改进方向。方法根据公式σ=(TEa-|bias|)/CV,统计我室参加2017年卫生部临床检验中心室间质评的3次15个血清AMY偏倚结果,并取偏倚绝对值的平均值。采用中华人民共和国卫生行业标准(WS/T)403-2012的允许总误差(TEa),根据实验室2017年全年西门子ADVIA 2400室内质控累积结果,计算不同批号质控品室内质控变异系数(CV)。计算σ值,结合Westgard西格玛规则,选择适合实验室血清AMY项目的质控规则。计算血清AMY的QGI,根据QGI查找分析项目未达到6σ的原因,选择优先改进的方法。结果统计显示,我室质控品批号为1027UN、1093UN时,血清AMY室内质控所得σ分别为3.50、3.10,实验室应选择的质控规则为13s/2-32s/R4s/31S/6x;质控品批号为793UE时,血清AMY室内质控所得σ为4.28,实验室应选择的质控规则为13s/2-32s/R4s/31S。计算得所有批号质控品所得QGI均小于0.8,提示导致方法性能不佳的主要原因为检测结果的不精密度相对较差。结论Westgard西格玛规则可用于检验科选择血清AMY和其他生化项目的室内质控规则以及每批质控个数,也可以寻找方法学性能不佳的原因,以便更好地管理室内质控和有针对性地改进室内质控性能。
Objective To use Westgard sigma rule to manage the indoor quality control of serum amylase(AMY), calculate the quality goal index(QGI) to look for the reason of poor method performance and the direction of improvement. Methods According to the formula σ=(TEa-|bias|)/CV, the results of 15 serum amylase bias in 3 times and the average value of the bias absolute values were evaluated and calculated in the meeting our laboratory joined for quality evaluation in the Ministry of Health Clinical Laboratory Center in 2017. The allowable total error(TEa) of Chinese health industry standard(WS/T) 403-2012 was adopted, according to the accumulated indoor quality control results of Siemens ADVIA 2400 in the whole year of 2017 in the laboratory, the indoor quality control variation coefficients(CV) of quality control products of different batches were calculated. Theσvalue was calculated, and combined with Westgard Sigma rule, the quality control rule suitable for the laboratory’s serum AMY project was selected. Moreover, the serum amylase QGI was calculated. According to the QGI, the reason why the analyzed project did not reach 6σ was looked for, and the preferred improvement method was chosen. Results The statistics showed: when the batch numbers of the quality control products in this room were 1027 UN and 1093 UN, the indoor quality control of serum AMY σ were 3.50 and 3.10, respectively;the quality control rule the laboratory should choose was 13s/2-32s/R4s/31S/6x;when the batch number of the quality control product was 793 UE, the indoor quality control of serum AMY reached σ=4.28, and the quality control rule the laboratory should choose was 13s/2-32s/R4s/31S. The QGIs of all batches of quality control products were calculated to be less than 0.8, suggesting that the main reason for the poor performance of the method was the accuracy of the test results being relatively poor. Conclusions The Westgard sigma rule can be used to select the indoor quality control rules of serum AMY and other biochemical projects in
作者
宋立兴
邓焘
Song Lixing;Deng Tao(Department of Laboratory,the Fourth People's Hospital,Zigong 643000,Sichuan,China;the Southwest Medical University,Luzhou 646000,Sichuan,China)
出处
《实用检验医师杂志》
2018年第4期205-208,共4页
Chinese Journal of Clinical Pathologist
