The article is composed in the form of discussion with authors of another article published in the same issue of journal. The publication considers factors impacting analytical quality of results of clinical laboratory analyses. The cases in question are content of normative documents in force, expedience to complete them with more specific requirements to producers of laboratory analysis tools and recommendations for laboratories on implementation of verification of characteristics of techniques and medical tools for diagnostic in vitro. The article also considers requirements to metrologic traceability of control materials and necessity of formation of national reference system for laboratory medicine. The description of projects of methodical documents proposed to be considered by the profile expert commission on clinical laboratory diagnostic of Minzdrav of Russia is presented. These documents include complex of requirements to producers of medical tools for diagnostic in vitro. The proposal is expressed to develop a normative document of top status to establish a unified system of requirements implemented in all executive and methodical documents concerning regulation of access of medical tools for diagnostic in vitro, supporting security of application and quality of clinical laboratory analyses.
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