| ObjectiveTo develop a set of internal quality control (IQC) data monitor platform for quantitative testing in clinical laboratory which is easy to handle and fully-functional. So as to manage the IQC process for clinical laboratory, monitor and analyze the IQC data for clinical laboratory centre, and implement IQC inter-laboratory comparison ultimately.MethodThe principles of IQC method designing, quality control chart drawing, quality control rule judgment method, and data collection were used to develop the client system of IQC data monitor platform. The principles of data statistic analysis and IQC inter-laboratory comparison were adopted to design the analysis system of the platform. The transmission pathway of IQC data was designed according to the principles of data collection and transmission. The IQC data of Heilongjiang province and Zhejiang province were chosen to apply the function of this platform.ResultAn integrated and practical set of IQC data monitor platform was developed. There were 5 methods in the client system to design IQC which were power function graph, critical error chart, method selection and design table, operational process specifications chart and Westgard sigma rules. After reporting data by handwork or automatic mode, the system could draw IQC chart and judge whether the IQC data were out of control or not. What’s more, it could statistic analyze the testing results and precision vertically, and make inter-laboratory comparison by uploading the data to analysis system. Accordingly, the IQC data and charts of clinical laboratories could be checked in real time by the analysis system of IQC data monitor platform, as well as all kinds of statistic analysis such as original data statistics, grouping statistics, robust statistics, coefficient of variation (CV) statistics, deviation statistics, standard deviation index (SDI) statistics and coefficient of variation index (CVI) statistics. It could also analyze the precision and comparability of clinical laboratories horizontally, and provide comparison reports with scatter diagram, chart of frequency distribution and box plot. The client system was used to design reasonable quality control method and draw quality control chart for routine chemistry including 21analytes of one clinical laboratory in Heilongjiang province. The result of retrospective analysis showed that the out-of control ratio in May 2014 was highest (9.68%), and the mean shifted in cumulative result statistical analysis. The analysis system was applied to monitor and analyze the IQC inter-laboratory comparison scheme for routine chemistry including 21analytes in Heilongjiang province and Zhejiang province. Heilongjiang province used uniform quality control material, and there were 150 clinical laboratories having reported their IQC data. The mean of kalium lot M302022 (physiology) which removed data beyond the mean plus and minus three times the standard deviation was 4.53mmol/L, the standard deviation was 0.49 mmol/L and CV was 10.82%. When robust analyzing, the robust mean of this lot of kalium was 4.46 mmol/L, robust standard deviation was 0.23 mmol/L and robust CV was 5.09%. The mean of this lot of kalium for ion selective electrode (direct method) was 4.54 mmol/L, standard deviation was 0.63 mmol/L and CV was 13.88%. While analyzing CV, the mean of CV for kalium was 2.57% and the ratio of laboratories which CV was less than allowable CV (2.5%) was 58.82%. Zhejiang province didn’t use uniform quality control material, so we just analyzed CV. There were 284 laboratories having reported their kalium results in July 2014, and the median of CV was 1.22%. The ratio of laboratories which CV of kalium was less than allowable CV for ion selective electrode (direct method) was 87.21%. One laboratory in Heilongjiang province had CV of 0.7%～3.13%, and the CV of K, Ca, Na and Cl were bigger than allowable CV. The range of SDI was-12.28～5.12, and CVI was 0.33～2.00. The SDI of method and all laboratories for kalium were 0.14 and 0.06, and CVI were 2.00 and 1.56. That mean that the comparability of kalium for this laboratory was good and the precision was poor.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 mutual recongnition of testing results.. |
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