Development of a Systematic Quality Control Program for Point-of-Care Glucose Testing

Abstract

Background: While glucose point-of-care testing (POCT) is widely utilized, it is often carried out by clinical staff who may lack specific test-related training, potentially leading to inadequate quality control (QC) procedures. This study aimed to establish a comprehensive quality management system for glucose POCT. Methods: We implemented a systematic approach encompassing quality assurance, equipment maintenance, operator training, and competency assessment in alignment with the Clinical and Laboratory Standards Institute guidelines POCT12-A3. To facilitate structured internal QC, the results of glucose POCT were automatically analyzed within the laboratory information system (LIS). An adjusted acceptable range was defined as mean±2 standard deviations (SD) based on 1 month of QC result analysis operator performance was enhanced through a tailored training program, and proficiency tests were conducted on all glucometers to assess competency. Results: Leveraging the LIS allowed the application of quality control rules to glucose POCT, enabling swift error identification and response. Analysis of one month's QC results revealed that for high-concentration samples, the warning rate using the adjusted range was significantly higher than that using the provided range (1.1% vs. 2.7%, P<0.01). A maintenance schedule was established, encompassing monthly upkeep for glucometers and collective replacement of all QC materials every 3 months. Operator training was facilitated through both face-to-face education and instructional videos. During proficiency testing, four devices initially exhibited deviations beyond 3SD, which were subsequently rectified upon re-examination. Conclusions:The implementation of a systematic and efficient quality control system, as demonstrated in this study, holds the potential to yield accurate and dependable glucose POCT results.