关键词: 结果互认, 飞行检查, 常规化学

Abstract: Objective　To analyze the on-spotinspection results of routine clinical chemistry items in Shanghai clinical laboratoriesfrom 2010 to 2011，and to provide the reference for resultinter-accreditation of clinical laboratory tests in Shanghai.   Methods　Shanghai Center for Clinical Laboratory organized 2 on-spotinspectionsfrom 2010 to 2011，which required above Level 2 Grade A hospitals to participate. The results of routine clinical chemistry items were collected and analyzed statistically. The passing rates were calculated，and the coefficients of variation of 20 routine clinical chemistry items were compared in the whole participating laboratories，Level 3 hospitals，Level 2 Grade A hospitals and accredited laboratories. The calculation was based on allowable error and analytical variation of its biological variation. Results　The coefficients of variation among above Level 2 Grade A hospitals were asfollows：3 electrolyte items [potassium（K），sodium（Na） and chlorine（Cl）] and uric acid（UA） were both ＜3.0%，and Na was ≤1.6%；albumin（Alb），calcium（Ca），creatinine（Cr），total cholesterol（TC），glucose（Glu） and total protein（TP） were all ＜5.0%；phosphonium（P），triglyceride（TG），urea and alanine aminotransferase（ALT） were ≤17.9%；aspartate aminotransferase（AST），gamma-glutamyltransferase（GGT），lactic dehydrogenase（LDH），creatine kinase（CK） and total bilirubin（TBil） were ≤11.4%；high-density lipoprotein cholesterol（HDL-C） was 17.9%.The results were better in the accredited laboratories than the others with respectto Alb，ALT，AST，Ca，TC，TG，TP and CK. The means had no significantdifference among the whole participating laboratories，Level 3 hospitals，Level 2 Grade A hospitals and accredited laboratories. ALT，CK and TG met the relatively high quality requirementin the 20 routine clinical chemistry items. Thefollows were AST，K，TBil，UA and urea，and Alb，Ca，Cr，Glu，P，TC and TP. Na，Cl，HDL-C，LDH and GGTmet the minimum required quality goal. Conclusions　The comprehensive quality management，Establishment of reference systems and research based on Chinese population can promote quality control，getresultinter-accreditation gradually andfinally provide diagnostic referencefor clinical application.

Key words: Resultinter-accreditation, On-spotinspection, Routine clinical chemistry