The role of 3 external quality assessment programs in assessment of analytical quality on determination of serum creatinine and urea

Abstract

Objective To describe and compare the roles of 3 external quality assessment programs in assessment of analytical quality of serum creatinine and urea. Methods Research in quality management methods.Sixty-five laboratories those enrolled in the Natonal Center for Clinical Laboratories′ programs of routine chemistry external quality assessment (EQA), trueness verification (TV) for small molecular metabolites and external comparison of internal quality control (IQC) simultaneously in 2013 were selected，the performances of those laboratories of serum creatinine (crea) and urea in terms of total errors(TE), bias and CV were obtained by using the above 3 programs, and these performance were assessed against the criterion listed in the analytical quality specifications for routine analysis in clinical biochemistry (WS/T 403-2012). The failure ratio of 65 laboratories on each performance was calculated, the sensitivity of 3 external quality assessment programs in detection of analytical quality deficiency among clinical laboratories were compared. Results Only 1 laboratory failed in the 1st routine chemistry EQA in terms of TE of creatinine, failure ratio is 1.5%(1/65). Three laboratories failed in the 2nd EQA and caused a failure ratio of 4.6%(3/65). For serum urea, 3 laboratories failed in the 1st routine chemistry EQA with a failure ratio of 4.6%(3/65). Two laboratories failed in the 2nd EQA with a failure ratio of 3.1%(2/65).The failure ratios of creatinine determination in two samples in TV were 41.5%(24/65) and 21.5%(14/65) respectively, and the failure ratio of urea determination were 53.8%(36/65) and 32.3%(21/65) respectively. In the program of external comparison of IQC，the CVs of creatinine and urea determination ranged from 0.7% to 6.2% and from 1.0% to 7.2% respectively, their respective failure ratio range were 15.4%(10/65) and 40.0%(26/65). The failure ratio in routine EQA were much less than those in the other two programs, the laboratories failed in routine EQA program were all failed in trueness verification or/and the comparison of IQC programs, but not vice versa. Conclusions By participating in the programs of routine EQA, TV and comparison of IQC laboratories could assess the performances of inaccuracy, bias and imprecision. Laboratories should participate in different external quality assurance programs to detect their quality issues and get improved.（Chin J Lab Med,2014,37:357-361） Key words: Laboratories, hospital; Quality control; Creatinine; Urea; Uncertainty