Journal Information
Journal ID (publisher-id): BM
Journal ID (nlm-ta): Biochem Med (Zagreb)
Title: Biochemia Medica
Abbreviated Title: Biochem. Med. (Zagreb)
ISSN (print): 1330-0962
ISSN (electronic): 1846-7482
Publisher: Croatian Society of Medical Biochemistry and Laboratory Medicine
Article Information
Copyright statement: Croatian Society of Medical Biochemistry and Laboratory Medicine.
Copyright: 2017, Croatian Society of Medical Biochemistry
License (open-access):
This is an Open Access article distributed under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Date received: 02 December 2017
Date accepted: 24 April 2018
Publication date (print and electronic): 15 June 2018
Volume: 28
Issue: 2
Electronic Location Identifier: 020710
Publisher ID: bm-28-2-020710
DOI: 10.11613/BM.2018.020710
Comprehensive evaluation of the internal and external quality control to redefine analytical quality goals
Introduction
The aim of this work is to design a selection algorithm for total allowable error (TEa) source using a graphic tool that, by integrating internal (IQC) and external (EQC) quality control performances, enables the laboratory to evaluate which TEa source better fits the test analytical performance.
Materials and methods
Two analytical performance indicators (bias and Sigma metrics) were estimated for 23 biochemistry tests during 2016. Bias was estimated on the EQC, and Sigma metrics was calculated through the results obtained in the IQC. The Sigma metrics was charted as a function of the bias (TEa%). Following the proposed algorithm (considering the hierarchy in the Milan 2014 consensus), the TEa was evaluated depending on two areas. One area in the chart was defined as the objective area in which the used TEa is the appropriate one for the analytical performance of the test under evaluation. For any test located outside this area, a performance re-evaluation was required using another source of TEa.
Keywords: total quality management; quality control; bias; laboratory proficiency testing/methods; clinical chemistry test
