Contact

Daria Pašalić
Editor-in-Chief
Department of Medical Chemistry, Biochemistry and Clinical Chemistry
Zagreb University School of Medicine
Šalata ul 2.
10 000 Zagreb, Croatia
Phone +385 (1) 4590 205; +385 (1) 4566 940
E-mail: dariapasalic [at] gmail [dot] com

Useful links

 

Mauro Panteghini. Global harmonization in laboratory medicine. Biochemia Medica 2015;25(Suppl 1):S7.

Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Milan, Italy

 

Harmonization in laboratory testing is more than merely analytical harmonization. It includes all aspects of the total testing process from the “pre-pre-analytical” phase through analysis to the “post-post-analytical” phase. Rapidly available and precise results can indeed be of very limited value if they cannot be compared with each other, are produced on a wrong material or within an inappropriate diagnostic workflow. Harmonizing the pre-analytical phase requires use of standardized operating procedures for correct test selection, sample collection and handling, while standardized test terminology and units and correct implementation of metrological traceability, according to ISO standard 17511, are required to ensure equivalency of measurement results. Use of harmonized reference limits and decision levels will reduce inaccurate clinical interpretation and unnecessary laboratory testing. In the post-analytical phase, harmonized procedures for the management of critical laboratory test results are required to improve service quality and ensure patient safety. Monitoring of the outcomes of harmonization activities is through surveillance by EQAS that use commutable materials and auditing of the “pre-pre-analytical” and “post-post-analytical” phases. Successful implementation of harmonization in laboratory testing requires input by all stakeholders, including the clinical laboratory community, diagnostics industry, clinicians, professional societies, IT providers, consumer advocate groups and governmental bodies. A harmonized context will increase the value of laboratory results facilitating their interpretation and thus improving the patient’s outcome.

 

e-mail: mauro [dot] panteghini [at] unimi [dot] it