河北省18家三级甲等医院21项生化常规项目室内质控参数调查分析

Investigation of internal quality control parameters of routine biochemical tests in 18 third-grade class A hospitals of Hebei Province

目的探讨不同实验室问不同检测系统实现统一的生化常规项目室内不精密度范围的可行性。方法经统一培训的生化专业人员实地走访河北省18家三级甲等医院实验室，调阅其微机系统中的生化常规项目的室内质控信息，根据被调查实验室室内参数设定依据进行分类；记录从2010年4至9月间21项常规项目的累积均值、标准差和变异系数等，以美国CLIA’88规定的可接受范嗣各项目的允许总误差（TEa）的1／3、1／4和生物学变异导出的允许变异系数（以下简称“允许CVb％”）进行比较。结果18家实验室中，以半年均值作为靶值的有5家，占27．8％；以初始20d均值作为靶值的有5家，占27．8％；以厂家质控品赋值作为靶值的有8家，占44．4％。以6个月累计数据确定标准差的有6家，占了调查总数的33．3％，以最初20d检测数值确定标准差后固定的有8家，占44．4％，以厂家给定的标准差画质控图的有4家，占22．3％。18家医院实验室21项生化常规项目的CV差别很大，LDH的CV相差6．79倍，CK的CV相差76．79倍；累积变异系数满足小于1／3TEa评价要求的，各项目占比从35．5％～94．1％不等，满足小于1／4TEa评价要求的，各项目占比从0．0％～91．7％不等，满足小于允许CVb％评价要求的，各项目所占比从0．0％～94．1％不等，21项中有16项CV能满足小于1／3TEa，占检测项目的76．2％。未满足小于1／3TEa生化常规项目中，出现的频率排在前5位的有Na、Urea、TBIL、ALT、GLU。结论河北省生化实验室室内质量控制参数的设定标准尚不统一，75％点位作为我省三级甲等医院室内不精密度标准参考，试行一段时问并改进后，设立全省统一的生化常规项目室内不精密度范围，为实现我国室内质控标准统一提供参考依据。

Objective To explore the feasibility of canoeing out the common imprecision range among different biochemical systems in different laboratories. Methods Biochemical professionals visited 18 third-grade class A hospitals in Hebei Province, investigated the internal quality control data of 21 biochemical tests and made classification according to certain parameter criterias. Data were collected from April to September, 2010 and calculated for cumulative mean. standard deviation （s） and CV. Data were compared according to 1/3, 1/4 of TEa established by CLIA＇88 and allowable CVb% derived from biological variants. Results Among 18 hospitals, 5 （27.8%） set their target value by mean value of 6 months, 5 （27.8%） by continuous 20 days and 8 （44. 4% ） by the giverJ value of the supplier. CVs of 21biochemical tests were quite different among 18 biochemistry laboratories, in which LDH was 6. 79 times and CK was 76. 79 times different from one another. 35.5% -94. 1% biochemical tests met the requirement of CV 〈 1/ 3TEa and 0. 0% - 91.7% met the requirement of CV 〈 1/4TEa . 0. 0% - 94. 1% of tests were below allowable CVb% 16/21 （76. 2% ） tests could satisfy the requirement of CV 〈 1/3TEa. The top five tests which didn＇t meet the requirements were Na, Urea, TBIL, ALT and Glu. Conclusions The internal quality control among biochemistry laboratories in Hebei Province has not been standardized yet. According to the survey data, biochemistry laboratories of third-grade class A hospitals may set 75% point of imprecision as a reference. After a period of improvement, we will set common imprecision range among biochemistry laborotories in Hebei Province and even in China.