Journal Information
Journal ID (publisher-id): BM
Journal ID (nlm-ta): Biochem Med
Title: Biochemia Medica
Abbreviated Title: Biochem. Med.
ISSN (print): 1330-0962
ISSN (electronic): 1846-7482
Publisher: Croatian Society of Medical Biochemistry and Laboratory Medicine
Article Information
Copyright: 2016, Croatian Society of Medical Biochemistry
Date received: 17 November 2015
Date accepted: 06 March 2016
Publication date (print and electronic): 10 June 2016
Volume: 26
Issue: 2
Pages: 202-209
Publisher ID: bm-26-202
DOI: 10.11613/BM.2016.022
A model for managing and monitoring the quality of glucometers used in a high-volume clinical setting
Author notes:
Corresponding author: guzinaykal@yahoo.com
Introduction
The aim of this study is to present a model for assuring the quality of a large number of glucometers being used in a high-volume hospital clinical setting.
Materials and methods
Internal quality-control samples and blood samples from two patients were used to determine the accuracy of 83 glucometers used at our hospital. On each glucometer three levels of control were used for glucose concentrations determination. In addition, the difference between the results from patient samples obtained with the glucometers and the hexokinase reference method were compared. The differences were assessed based on the International Organization for Standardization (ISO 15197) standards.
Results
The glucose concentrations were as follows: 2.51 ± 0.34 mmol/L for the hypo-control samples; 5.12 ± 0.32 mmol/L for the low-control samples; and 16.11 ± 1.03 mmol/L for high-control samples. All results were within the expected ranges. For Patient I, the result with the first group of 52 glucometers was 11.56 ± 0.5 mmol/L, while the result for Patient II with the second group of 31 glucometers was 10.52 ± 0.62 mmol/L. All data points of the study complied with the requirements of the Clarke error grid.
Keywords: point-of-care testing (POCT); quality management program for glucometers; high-volume clinical setting; ISO 15197
