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KMID : 0985420230450030107
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Laboratory Medicine and Quality Assurance
2023 Volume.45 No. 3 p.107 ~ p.114
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Development of a Systematic Quality Control Program for Point-of-Care Glucose Testing
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Jo Yong-Hun
Choi Soo-In
Lee Jae-Joon
Kim Jeong-Gwon
Lee Yong-Wha
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Abstract
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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.
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KEYWORD
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Point-of-care testing, Glucometer, Glucose, Quality assurance, Quality control, Laboratory information system, CLSI POCT12-A3
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