Lab Med Qual Assur.  2023 Sep;45(3):107-114. 10.15263/jlmqa.2023.45.3.107.

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

• Jo YH
• Choi S
• Lee JJ
• Kim JG
• Lee YW

• KMID: 2546623
• DOI: http://doi.org/10.15263/jlmqa.2023.45.3.107

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.

Keyword

Point-of-care testing; Glucometer; Glucose; Quality assurance; Quality control; Laboratory information system; CLSI POCT12-A3