The Design And Application Of Statistical Analysis System For External Quality Assessment Data Of Quality Indicators In Total Testing Process

ObjectiveThis study aimed to design a fully functional and simple operating statistical analysis system for external quality assessment(EQA)data of quality indicators(QIs)in total testing process(TTP),for use by National Center for Clinical Laboratories and other provincial centers for clinical laboratories.A comprehensive and systematic analysis of the 2018 national QIs EQA data was carried out by applying the designed system to explore the factors affecting QIs performance.MethodsThis study identified the QIs that eventually included in the 2018 EQA program by referring to the mature QIs system abroad and combining with the opinions collected from clinical laboratories nationwide.A statistical analysis system for EQA data of QIs in TTP was designed by referring to monitoring platform and analysis model of QIs at home and abroad,using statistical principles,and combining with the specific needs of the EQA program of QIs in China.National center for clinical laboratories(NCCL)and provincial clinical laboratory centers jointly carried out the 2018 EQA program of QIs,and by using the user interface,they sent questionnaires to participating laboratories and collect original data.This study conducted an in-depth analysis of 2018 QIs EQA data by applying the background statistical analysis system to show the specific functions of the system one by one.ResultsThis study designed a statistical analysis system for EQA data of QIs in TTP with twenty function modules and meanwhile improved the user interface of QIs EQA.Through the user interface,EQA organizers could send questionnaires and report forms to participating laboratories,and participants could fill in the questionnaires,check and modify the uploaded data.Through the background statistical analysis system,EQA organizers could collect and download original data and ratios,match the QIs data among years,check the list of participating laboratories from different province and establish databases of QIs from different types of laboratories.The statistical functions of the system mainly included could fully meet the needs of EQA organizers,including statistical analysis of basic information of hospitals and laboratories;summary analysis of basic statistics of QIs;grouping analysis of QIs based on years,provinces,disciplines,attributes of institutions,hospital grades,hospital types,number of hospital beds and information construction levels;classification analysis of QIs based on different analytical phases and different types of QIs;comprehensive analysis of quality in laboratory medicine based on the TOPSIS method;formulation of preliminary quality specifications and so on.There were totally 47 QIs included in the 2018 EQA of QIs and the total response rate was 69%.The results of grouping analysis for 15 QIs issued by National Health Commission of the People’s Republic of China were shown below.Only "Tests covered by IQC","Critical values notification" and "Timely critical values notification" had no significant difference among different years.The other 12 QIs all had statistical differences among years and the performances had improved from 2015 to 2018 in general.There were 9 QIs submitted data by different disciplines and all showed statistic differences among different disciplines.The defect percentages of QIs in immunology were the lowest and those in microbiology was the largest;the turnaround time(TAT)of three routine tests was the shortest and TAT of automatic immunoassay was the longest.Different types of laboratories have different QIs performance,and the QIs performance of laboratories approved by ISO 15189 was generally higher than that of laboratories not approved.There were 11 QIs effected by hospital grade and the performance improved with the increase of hospital grade in general.There were 8 QIs effected by hospital type and the overall performance of general hospitals was better than specialized hospitals.There were 12 QIs effected by the number of hospital beds and the performance improved with the increase of the number of hospital beds.There were only 4 QIs effected by information construction level.In pre-analytical phase,the defect percentages of "Incorrect sample type" were the lowest and those of "Blood culture contamination"was the largest but the performance level all exceeded 4σ.In analytical phase,the performance of "Tests covered by an EQA-PT control" and "Unacceptable performances in EQA-PT schemes" reached 6σ;however,the performance of "Tests covered by IQC"and "Tests covered by inter-laboratory comparison" was far less than 3σ.The defect percentages of QIs in post-analytical phase were very low and all reached the optimum performance level.In addition,the comprehensive evaluation results of TOPSIS method showed that the overall quality level in laboratory medicine of China had gradually improved from 2015 to 2018.ConclusionsThe statistical analysis system for EQA data of QIs in TTP not only provided a QIs monitoring and analysis platform for the EQA organizers to promote the long-term development of QIs EQA program,collect submitted information,analyze QIs data and to fully master the application situation of QIs in clinical laboratories of China,but also helped the participating laboratories make full use of QIs data to improve quality in TTP.