The extended internal QC (eIQC): A new practical approach for quality assurance in point-of-care glucose testing using the POCTopus Software - A pilot study

Abstract

Quality assurance (QA) in point-of-care testing (POCT) is an important issue for organizing POCT structures within the healthcare sector. In Germany, only one device needs to participate in an external QA program, if the responsible core laboratory is supervising internal quality controls of all other identical POCT devices. This flexible definition of quality control (QC) testing is in line with the fundamentals of ISO 22870 and the ISO 15189, but can only be regarded as a minimum requirement. We present a pilot study for an inexpensive new approach for additional POCT QC measurement similar to the external QA program within the medical laboratory using capillary glucose measurement as an example. This new system, referred to as "extended internal QC (eIQC)", uses in-house generated QC material from leftover full blood from routine diagnostics. We provide information on calculation of target values and acceptance ranges and preliminary data on stability and comparison between POCT and core laboratory testing (COBAS 8000). Additionally, we simulated the approach using three devices within the laboratory as surrogate for three POCT sites. In this pilot study, measurements of QC material beyond the mandatory QA plan are structured and optimized through the use of the POCTopus Software solution. QC material was easily generated including specification of target values. The software aided in automatized processing of the samples. The software showed limitations in evaluation and monitoring without relevant use of resources. We found a significant bias between measurements on POCT and COBAS 8000 instruments. The presented new approach for additional QAs for POCT enables POCT coordinators to establish an additional safety and QC level. Further software improvements are required. Further studies are needed for validation and comparison measurements between methods. Overall, this approach offers great potential for POCT structures seeking higher quality standards.