摘要
目的应用临床检验定量测定项目室内质量控制数据监测平台对黑龙江省室内质量控制数据进行实验室室间比对分析。方法使用室内质量控制数据监测平台的用户端软件系统采集黑龙江省某一家实验室的室内质量控制数据，并对其进行纵向总结分析。使用监测平台的后台分析系统对全省的数据进行比对分析，并对该实验室室内质量控制结果进行横向分析。结果根据该实验室的检测性能使用用户端软件系统中的Westgard西格玛规则和操作过程规范图方法为所有项目设计了室内质量控制方案，进行了相应的设置，绘制了每月的质控图，并对连续多月的结果进行了统计分析，血糖项目批号M302023（生理）2014年6月～12月的平均值范围为9．91～10．14mmol／L，标准差范围为0．16～0．28mmol／L，变异系数的范围为1．58％～2．83％，失控率范围为0～6．45％。通过后台分析系统对所有参加实验室的结果进行原始数据统计、分组统计、稳健统计、CV统计、差值统计、SDI和CVI统计等各种形式的统计，并形成相应的报表。该实验室常规化学专业所有项目的SDI范围为-14．3～11．2，CVI范围为0．6～6．4，CV范围为0．8％～7．09％。结论临床检验定量测定项目室内质量控制数据监测平台可帮助实验室管理室内质量控制，帮助临床检验中心统计分析数据，评价实验室的精密度和可比性，实现室内质量控制实验室间比对，为检验结果互认提供依据。
Objective To make inter-laboratory comparison for the internal quality control （IQC） data of Heilongjiang Province with the application of IQC data monitor platform. Methods The IQC data of one laboratory in Heilongjiang Province was collected and analyzed by the client system of IQC data monitor platform. The data of whole province was comparatively analyzed by the analysis system of the platform. Results According to the testing performance of this laboratory,IQC plan of each analyte was designed by Westgard sigma rules and operational process specifications chart of the client system. The IQC chart and data analysis of each month was made. The range of means for blood glucose lot M302023 （physiology） from June to December 2014 was 9.91-10.14 mmol/L,the range of standard deviation was 0.16-0.28 mmol/L,the range of coefficient of variation （CV） was 1.58%-2.83% ,and the range of out of control rate was 0-6.45%. All kinds of statistic analysis such as original data statistics, grouping statistics, robust statistics, CV statistics, deviation statistics, standard deviation index （SDI） statistics and coefficient of variation index （CVI） statistics of all participants were made by the analysis system. The range of SDI for this laboratory was -14. 3-11.2,the range of CVI was 0.6-6.4,and the range of CV was 0. 8%-7. 09%. Conclusion The IQC data monitor platform for quantitative testing in clinical laboratory can help clinical laboratory to manage the IQC process and help clinical laboratory centre to statistic analyze the data. It also can evaluate the precision and comparability for clinical laboratory, make IQC data inter-laboratory comparison and provide the basis for mu tual recongnition of testing results.
出处
《现代检验医学杂志》
CAS
2016年第2期149-156,共8页
Journal of Modern Laboratory Medicine
基金
北京市自然科学基金资助项目(7143182)
关键词
室内质量控制
实验室间比对
质控规则
性能评价
统计分析
internal quality control
inter-laboratory comparison
quality control rules
performance evaluation
statistical analysis
