Tests in the point of care – glucose meter as a POCT tool. Implement a quality system control

Abstract

Introduction: Point of care testing (POCT) are tests carried out near to the patient, outside the laboratory. There is a continuing increase interest in POCT, however the issue of quality of those tests rises concerns. Glucose concentration measurements are carried out using glucometers, which makes those analyzers a POCT tool. All devices outside the laboratory should be included in internal quality control system according to ISO 22870, so it is necessary to control glucometers as well.<br>Aim: To perform the quality control of glucometers as a POCT tools in University Hospital in Wroclaw, evaluate the correct use of glucometers, conduct replacement of devices, and implement constant internal quality control.<br>Materials and methods: The approximate count of blood glucose measurements in the hospital was determined on the basis of laboratory data and glucometers strips orders. Quality control was performed using MediSense certified control materials at two concentrations levels. A total of 272 control measurements were used for interpretation, which were made on 25 FreeStyle Optium H glucometers. The results were registered in quality control sheet.<br>Results: Laboratory determinations of glucose concentration represented 24.6% of all glucose measurements, POCT tests 75,4%. Among control measurements 80.88% were within ± 15% error recommended by Polish Diabetology Association and 19.12% exceeded it, 7.35% exceeded ± 20%. However none measurement exceeded the error recommended by glucometer manufacturer.<br>Conclusions: Based on our results several glucometers were replaced and the systematic internal quality control was introduced. Numerous of glucometer training courses for medical staff were conducted.