The Development And Application Of Inter-laboratory Comparison And Monitor Platform Of Patient Data In Clinical Laboratory

ObjectiveTo study and develop the inter-laboratory comparison and monitor platform of patient data in clinical laboratory which is easy to operate.Laboratories can monitor the long-term stability by applying the two software using the medians and percentiles of patient data,and realize the inter-laboratory comparison by comparing with other laboratories to evaluate performance ultimately.MethodsAccording to the domestic and international literature of quality control and comparison of patient data,the principles of peer-groups comparison in medians and the calculation of moving medians,inter-laboratory comprisons and monitor platform of patient data was designed.Medians of daily patient data in 181 gerenal hospitals nationawide in July 2016 were collected to apply the fuction of acquisition and comparison software in clinical laboratory.Medians of daily screening data of 105 neonatal screening laboratories nationwide in June 2016 were chosen to apply the inter-laboratory comparison platform for neonatal screening.ResultsTwo softwares were developed in this study,which were acquisition and comparison software of patient data in clinical laboratories and inter-laboratory comparison platform for neonatal screening.The percentiles of patient data in each scheme can be collected,compared and long-term monitored by acquisition and comparison software of patient data in clinical laboratories,and inter-laboratory comparison platform for neonatal screening was mainly for data analysis of neonatal screening.Data can be collected by organizers via the two softwares,and the platforms can carry out verious statistic analysis,for instance,original data statistic,grouping statistic,regional statistic,percentage difference statistic,and frequency histogram,scatter plot,box figure,and moving median figures were also provided.The acquisition and comparison software of patient data was applied to compare and monitor the percentiles of patient data for chemistry incluing 21 analytes,and there were 181 clinical laboratories having submitted the results in July 2016.The median of potassium in outpatient department was 4.09 mmol/L,while the median in in-patient department was 4 mmol/L.The median of potassium for 119 laboratories in out-department using ion selective electrode(indirect method)was 4.07 mmol/L,while that using ion selective electrode(direct method)was 4.13 mmol/L.When grouping statistic,the ratio of percentage difference of ALT,AST,y-GT,urea,creatinine,total bilirubin,triglycerides in outpatient department devided by twice health industry standards allowable bias were larger than 2,showing the obvious difference among different measurement systems,the ratio of Na,Ca,Mg,and ALP in outpatient department was lower than 1,indicating the better comparability among various measurement systems.The reference interval of potassium was 3.5?5.3 mmol/L,and P97.5 and P2.5 of laboratories was 3.3?5.02 mmol/L,indicating the current reference interval was suitable.The reference interval of glucose was 3.9?6.1 mmol/L,while P97.5 and P2.5 of laboratories was 4.1?11.42 mmol/L,illustrating population in China may face the problem of higher glucose.Screening data of 105 laboratories in 16 provinces nationawide were adopted.The results of TSH and G6PD were strongly influenced by region,the medians of TSH in Guangdong,Jilin,Gansu,and Yunnan were larger tha 3 ?IU/mL,the medians of G6PD in Guangxi and Yunnan reached 9.14?10.15 U/gHb,and 4?7 U/gHb in other provinces.In group comparison section,the distribution of medians of Phe was 0.5?0.93 mg/dL,median of group Ani labsystems(10.3 U/gHb)of G6PD was higher than other groups(4.26?5.2 U/gHb).For TSH and 17-OHP,the medians of groups using fluorescence enzyme immunoassay(3.91 ?IU/mL,11.23 nmol/L)were relatively higher than groups using time resolved fluoroimmunoassay(1.51?2.0 ?IU/mL,6.37?7.64 nmol/L).The moving median figures showed that medians of Phe in June 2016 of the randomly selected laboratory was 0.7?1.2 mg/dL when n=1,and laboratories should pay attention when the upward or downward trend appeared.ConclusionsThe results of biochemical peer-group comparison showed significant differences existed among various groups in 21 analytes,and comparability still needs to be improved.The comparison between percentile of patient data and reference range can also provide certain basis for the establishment of reference range.Inter-laboratory comparison and monitor platform of patient data in clinical laboratory is a beneficial complement for quality management.It can help laboratories to perform quality control,achieve the inter-laboratory comparison and provide reference for mutual recognition of results.