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Criteria for external assessment of the quality of evaluation of 23 biochemical parameters of the blood, meeting the standards of accuracy determined by the Order No. 45 of Ministry of Health of Russia of February 7, 2000 for intralaboratory quality control have been estimated. According to the data of the Federal System for External Evaluation of the Quality of Clinical Laboratory Studies, the percentage of results of analyses of test sera meeting these criteria has been estimated. Introduction of new criteria for external assessment of the quality of biochemical tests into the practice of the Federal System will not notably modify the currently used criteria with regard to the majority of biochemical parameters, except introduction of more stringent criteria for albumin and magnesium and less stringent for creatine kinase.

The National External Quality Assessment Scheme for analysis of the urine is presented. It includes 9 parameters: protein, glucose, creatinine, urea, uric acid, sodium, potassium, hemoglobin, and pH. Two lyophilized of liquid control samples of urine (normal and abnormal) are distributed to the participating laboratories. An original evaluation protocol for qualitative and semiquantitative methods is proposed in addition to the traditional statistical approach to evaluation of the results of quantitative methods.

Center for External Quality Assessment in Laboratory Medicine has been organized in Russia. The National External Quality Assessment Scheme for 16 common analyses in clinical chemistry was implemented in 1992 under governmental support. A total of 1180 laboratories wished to participate in the program. 636 laboratories presented the results of analyses of 4 control serum pools, 2 with normal and 2 with increased concentrations of the constituents. Each control pool was analyzed twice allowing separate estimation of the accuracy and precision. Accuracy was assessed as the bias from method-dependent means and reference values. Reference methods were implemented for sodium, potassium, total protein, cholesterol, and triglycerides. Analysis of variance demonstrated that the errors are mainly due to the variability of methodologies in different laboratories, this variability being negligible.