内分泌项目性能评价中的标准化西格玛性能验证图应用

Application of standardized Sigma performance verification diagram in performance evaluation of endocrine testing

目的应用西格玛(sigma,σ)性能验证对内分泌项目进行性能评价,结合质量目标指数(quality goal index,QGI)查找导致部分项目性能不佳的原因,为提升内分泌项目的质量提供整改方向。方法选取山西医科大学第二医院实验室参加2016年卫计委临床检验中心内分泌室间质量评价(external quality assessment,EQA)的9个项目作为评价对象,将实验室高低两个水平室内质控累积在控变异系数(coefficient of variation,CV)分别作为估计值,内分泌EQA的百分差值作为实验室的偏倚估计,采用卫生部室间质评标准内分泌项目可接受范围作为允许总误差(total error allowance,TEa),计算各内分泌项目的性能评价指标σ值和QGI。根据σ水平统计9项内分泌项目的σ值分布情况,评价质量水平。统计<6σ水平的内分泌项目的QGI分布情况,分析各项目需要采取的改进措施。结果低水平室内质控:4≤σ<5的项目睾酮(testosterone,T)、叶酸(Folate),占22.22%;3≤σ<4的项目游离甲状腺素(free thyroxine,FT4)、促卵泡生成激素(follicle stimulating hormone,FSH)、黄体生成素(luteinizing hormone,LH)、维生素B12(vitamin B12,Vit B12),占44.44%;σ<3的项目游离三碘甲状腺原氨酸(free triiodothyronine,FT3)、促甲状腺激素(thyroid stimulating hormone,TSH)、孕酮(progesterone,Prog),占33.33%。高水平室内质控:σ≥6的项目T,占11.11%;5≤σ<6的项目Folate,占11.11%;4≤σ<5的项目LH,占11.11%;3≤σ<4的项目FT3、FT4、FSH、Prog、Vit B12,占55.56%;σ<3的项目TSH,占11.11%。在<6σ水平的内分泌项目中,QGI<0.8的项目有FT3、FT4、FSH、LH、Prog、Folate、Vit B12;QGI>1.2的项目有TSH、T。故需改进精密度的项目有FT3、FT4、FSH、LH、Prog、Folate、Vit B12;需改进正确度的项目TSH、T。结论西格玛性能验证可对实验室检测的9项内分泌项目的性能进行较为客观评价,结合QGI可查找项目性能不佳的原因,为实验室质量改进作出指导。

Objective To evaluate the analytical performance of endocrine testing using six sigma（g）, and find the cause of dissatisfied performance for some projects combined with the quality goal index （QGI）, so that provide rectification direction for the improvement of the endocrine projects quality. Methods Nine endocrine items which participated in the clinical laboratory external quality assessment （EQA） of the Ministry of Health in 2016 was selected in this study. The two levels of laboratory internal quality control were accumulated in coefficient fo varivation （CV）, respectively, as the estimation value. By adopting the quality evaluation standard of the Ministy of public healty the acceptable range of endocrine items was measured as the total allowah error （TEa）. CV and Bias with the data of internal quality control （IQC） and EQA was evaluated. The sigma metrics based on the TEa from the National Center for Clinical Laboratory were in accord with the formula σ=（TEa-｜Bias｜）/CV for each endocrine test. Quality goal index（QGI） was also calculated to investigate the reason for dissatisfied performance as follows： QGI=Bias/（1.5＊CV）. Evaluate the quality levels of nine endocrine tests with a statistics. Analyze which improvement measures were needed for each project with QGI. Results In low level of IQC, the rates of endocrine items for 4 ≤σ ~ 5a,3 ≤σ 〈 4, σ 〈 3 were 22.22%, 44.44%, 33.33%, respectively. In high level IQC, the rates of endocrine items for σ≥ 6, 5 ≤ σ 〈 6, 4 ≤ σ 〈 5, 3 ≤σ 〈 4,σ 〈 3 were 11.11%, 11.11%, 11.11%, 55.56% and 11.11%, respectively.In the dissatisfied performance of the endocrine tests, which the QGI〈0.8 include FT3, FT4, FSH, LH, Prog, Folate, VitB12, which the QGI〉1.2 include TSH, T. Conclusions Sigma performance verification can be used to evaluate the performance of laboratory testing projects. The sigma and QGI can be used for investigation of the reason for dissatisfied perfarmance of the project, and guiding the improvement of clinical laboratory quality.