A model for managing and monitoring the quality of glucometers used in a high-volume clinical setting

• Published in: Biochemia Medica 2016-01, Vol.26 (2), p.202-209
• Main Authors: Aykal, Güzin, Yegin, Ayşenur, Tekeli, Özgür, Yilmaz, Necat
• Format: Article
• Language: English
• Subjects: Blood Glucose - analysis; Equipment and Supplies - standards; high-volume clinical setting; Humans; ISO 15197; point-of-care testing (POCT); Quality Control; quality management program for glucometers
• ISSN: 1330-0962; 1846-7482; 1846-7482
• DOI: 10.11613/BM.2016.022

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. 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. 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. All quality-control and comparison assay results were appropriate for evaluating glucometers used in a high-volume hospital setting. The method used in this study can be suggested as a model for laboratory managers, especially in similar high-volume hospitals.