Analysis of survey for implementation of professional standards of reference intervals in routine biochemistry laboratories / 临床检验杂志

ABSTRACT

Objective To investigate the implementation of professional standards for reference intervals in routine biochemistry laboratories.Methods The relevant data of reference intervals from different laboratories including upper and lower limits,sources of reference intervals,verification and grouping rules,etc was submitted by using the software of interval quality assessment (EQA) via WEB application.The background monitor saved all the data as Microsoft Excel 2007 documents.The implementation of reference intervals of professional standards for decreed 18 routine biochemical tests was analyzed.Results The proportion of laboratories in which the reference intervals were derived from professional standards increased largely in 2016 compared with those in 2014.The data of 2016 showed that the reference intervals derived from professional standards were verified in 58.9％ to 67.5％ of laboratories before they were used in clinical diagnosis.The grouping rules for reference intervals in most laboratories (59.1％ to 83.3％) were in accordance with professional standards,except for individual items,including urea (43.4％),creatinine (40.1％) and alkaline phosphatase (35.8％).There were significant differences for the upper and lower limits of the most items between the laboratories using professional standards and those without using professional standards (P ＜ 0.05),except for some items,including lower limit value of kalium,upper limit of phosphorus,upper limit of amylase,upper limit of aspartate aminotransferase and lower limit of ferrum.There was no significant difference in most items between the the upper and lower limits of the reference intervals in the laboratories using professional standards and the reference intervals defined by professional standards,except for individual items,including upper limit of total protein,lower and upper limit of creatine kinase,upper limit of urea and upper limit of creatinine (P ＜ 0.05).Conclusion The implementation of reference intervals from professional standards in most routine biochemistry laboratories could not be satisfactory.Only a small part of laboratories used the professional standards,and the reference intervals of professional standards,were not verified before use in quite a part of laboratories.