Harmonization, standardization, metrologic, succession in 2014. Principles, importance and data.
Authors:
B. Friedecký 1,2; J. Kratochvíla 1
Authors place of work:
SEKK spol. s r o. Pardubice
1; ÚKBD, Fakultní nemocnice, Hradec Králové
2
Published in the journal:
Klin. Biochem. Metab., 22 (43), 2014, No. 4, p. 177-183
Summary
Harmonization of laboratory results is necessary for approaching the clinical and economical effectiveness in laboratory examinations and also to reduction of patients risk in diagnostic and therapeutic processess due to measurement errors. Harmonization of results in clinical laboratories is based on the standardization of measurement methods and standardization is realized by traceability chains from reference procedures and certified reference materials to calibration of routine methods. The main goal of harmonization is establishment of commonly valid values of reference intervals and/or diagnostic decision limit, values independent on the used measurement nethods and location of laboratories. Communication introduces describing data on the harmonization, produced namely by IFCC, JCTLM, NIST, IRMM-EU. We also deal with Stockholm quality declaration, with the narrow spectrum of harmonized methods, and with the lack of suitable level of working documentation provided by producers of diagnostics.
Keywords:
Standardization, traceability, standardization, reference procedures, reference materials, producers of diagnostics.
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Štítky
Clinical biochemistry Nuclear medicine Nutritive therapistČlánok vyšiel v časopise
Clinical Biochemistry and Metabolism
2014 Číslo 4
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- Harmonization, standardization, metrologic, succession in 2014. Principles, importance and data.