重点专科检验科常规生化项目检测性能现状研究

Study on the Current Performance Characteristics of Biochemistry in Key Specialty Laboratories

目的 评价＂国家临床重点专科建设项目＂检验科常规生化项目的 检测性能.方法 采集19家＂国家临床重点专科建设项目＂检验科2012年第2次全国常规化学室间质评和2011年5月室内质控数据,根据基于生物学变异的质量规范,采用SPSS13.0对K,Na,Cl,Ca等20个检测项目的 室间质评和累计在控变异系数的及格率进行统计分析,并计算各个项目的 实验室间变异,与2012年CAP常规化学调查总结进行比较.结果 室间质评数据表明K,P,Glu等16个项目的 3个批号的质控品基本能保证80%以上的实验室满足适当的质量规范.室内质控数据表明只有Urea,UA,TG,TBil等7个项目的 累积在控变异系数能基本保证80%以上的实验室满足适当的质量规范,很多项目如Na,Cl,Ca,Mg甚至无法达到最低的质量规范.各项目实验室间变异系数与CAP调查结果水平相当,但其参考区间来源与上下限还需进一步统一.结论 ＂国家临床重点专科建设项目＂检验科常规生化项目检测总误差基本能满足适当的质量规范,实验室间一致性较好,但室内质量控制和参考区间还需进一步改进,以提供更好的医疗服务质量.

Objective To study the current performance characteristics of biochemistry in Laboratories of National Clinical Key Specialty Construction Project. Methods Collected the data of external quality assessment （EQA） and internal quality control （IQC） from the 19 laboratories, including K, Na, Ca, Cl, P, Glu, Urea, UA, Crea, TP, Alb, TC, TG, TBil, ALT, AST, ALP,CK,LDH, and Mg. Quality specifications based on biological intra- and inter-individual variability were calculated and used to evaluate the performance characteristics of laboratory. Moreover, the coefficient of variation （CV） among laboratories was calculated and compared with the results of the College of American Pathologists （CAP） survey summary in 2012. Re- suits For EQA,More than 80% of the laboratories could achieve the desirable specification in 16 analysts. For CV, only 7 analysts could assure that more than 80% of the laboratories achieved the desirable specification. The CV of inter-laboratory was comparable to which of the CAP survey. However,the origin of the reference intervals and the low and high limits were different in the 19 laboratories. Conclusion The total error of the 19 Laboratories of National Clinical Key Specialty Con- struction Project could approximately achieve the desirable quality specifications developed from the biological intra-and in- ter-individual variability and the CV among laboratories was acceptable. But to improve the quality of the medical service, the laboratory should make more efforts on internal quality control and the reference intervals.