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https://doi.org/10.11613/BM.2016.022

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

Güzin Aykal ; Central Laboratories, Antalya Education and Research Hospital, Antalya, Turkey
Ayşenur Yegin ; Central Laboratories, Antalya Education and Research Hospital, Antalya, Turkey
Özgür Tekeli ; Central Laboratories, Antalya Education and Research Hospital, Antalya, Turkey
Necat Yilmaz


Puni tekst: engleski pdf 371 Kb

str. 202-209

preuzimanja: 366

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Sažetak

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.
Conclusion: 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.

Ključne riječi

point-of-care testing (POCT); quality management program for glucometers; high-volume clinical setting; ISO 15197

Hrčak ID:

161688

URI

https://hrcak.srce.hr/161688

Datum izdavanja:

15.6.2016.

Posjeta: 956 *