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World J Methodol. Mar 26, 2016; 6(1): 93-100
Published online Mar 26, 2016. doi: 10.5662/wjm.v6.i1.93
Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population
Zlata Flegar-Meštrić, Sonja Perkov, Andrea Radeljak
Zlata Flegar-Meštrić, Sonja Perkov, Andrea Radeljak, Department of Medical Biochemistry and Laboratory Medicine, Reference Centar University Hospital Merkur, 10000 Zagreb, Croatia
Author contributions: All authors equally contributed to analysis and interpretation of data, finding materials, writing and reviewing this paper.
Supported by The Ministry of science and technology, Zagreb, Croatia, No. 55.3-01-143.
Conflict-of-interest statement: No potential conflicts of interest.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Zlata Flegar-Meštrić, PhD, Department of Medical Biochemistry and Laboratory Medicine, Reference Centar University Hospital Merkur, Zajčeva 19, 10000 Zagreb, Croatia. zlata.flegar-mestric@kb-merkur.hr
Telephone: +385-1-2431397 Fax: +385-1-2431397
Received: August 17, 2015
Peer-review started: August 21, 2015
First decision: October 13, 2015
Revised: January 18, 2016
Accepted: February 14, 2016
Article in press: February 16, 2016
Published online: March 26, 2016
Processing time: 213 Days and 12.7 Hours
Abstract

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients’ care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine.

Keywords: Calibration traceability; Applicability of reference intervals; Harmonization and standardisation; External quality assessment; International Federation of Clinical Chemistry enzyme reference methods; Aminotransferase “common” reference intervals; Creatinine enzymatic method

Core tip: The main goal of medical laboratories is to be able to support the clinicians with the best achievable quality in all laboratory results and reports. Ongoing evaluation and improvement processes are essential to ensure performance in compliance with the highest professional and accreditation standards in order to provide optimal health benefit for the patient. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant biochemical constituents which are in accordance with an ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine.