全国431家临床实验室常规生化专业室内质量控制现状调查与分析

Research and analysis of status of internal quality control on routine biochemistry in 431 laboratories in China

目的了解全国临床实验室常规生化专业的室内质量控制现状。方法采用网络问卷调查的方式对全国1 952家临床实验室生化专业的室内质量控制的现状进行调查,并对结果进行分析。结果共431家实验室回报了调查结果,大多数医院为三级甲等医院和综合医院,其中使用实验室信息系统(LIS)的实验室为90.9%,使用LIS系统中质控管理模块进行室内质量控制,且从LIS中采集质控数据的实验室有79.4%。对质控品进行调查,使用最多的为2个浓度(71.7%),拥有使用数量最多的质控品厂家为朗道(34.4%)。对于确定中心线(均值)的方法,当刚更换批号时,有88.2%的实验室采用至少20个该批号质控品的测定结果暂定均值;对于长期使用的质控品,有70.0%的实验室采用一段时间长期在控数据计算的均值。调查室内质控方案,有63.2%是凭经验进行设计,有58.8%对不同的检测项目使用相同的质控方案,19.9%所有项目都使用12S/13S/22S/R4S/41S/10x珋规则进行失控判断。结论实验室室内质量控制呈现随意性,需进一步规范操作。

Objective To investigate the status of internal quality control（ IQC） on routine biochemistry in China. Methods Using the manner of questionnaire survey on the Internet to investigate the status of IQC on biochemistry in China,and analyze the results.Results The questionnaires returned from 431 laboratories. Most of them were grade A tertiary hospitals or genaral hospitals. Among them 90. 9% were equipped with laboratory information system（ LIS）. The percentage of laboratories which used management module of LIS and collected the IQC data from LIS was 79. 4%. For control material,71. 7% laboratories used two levels in daily routine practice,and the manufacturer with most users was Randox（ 34. 4%）. For the method of assigning center line,88. 2% adopted at least 20 results of this lot to assign the value momentarily when changing the lot of control matetial. For long-term material,70. 0% used the mean value calculated from data in control for a long time. For choice of the IQC plan,63. 2% of laboratories designed by experience,58. 8% used the same IQC plan for different analytes,and 19. 9% used 12S/13S/22S/ R4S/41S/10x珋rule to determine whether the test results of all analytes were out of control. Conclusion The status of IQC in China presented random,so further standardized operations should be needed.