Ewha Med J.  2020 Jul;43(3):43-48. 10.12771/emj.2020.43.3.43.

Application of Six Sigma Metrics to Improve Quality Control for Point-of-care Glucose Testing

Affiliations
  • 1Department of Laboratory Medicine, Ewha Womans University College of Medicine, Seoul, Korea
  • 2St. Mary’s Hospital, Pyeongtaek, Korea

Abstract


Objectives
Six sigma is a quality management system for the assessment of precisionand accuracy. We aim to apply the six sigma rule to quality control (QC) of point-of-care(POC) glucose meters in a tertiary hospital.
Methods
Thirty POC glucose meters installed at Ewha Womans University MokdongHospital were monitored between January 2013 and March 2014. The QC data fromthe POC glucose meters at low and high levels were collected. The monthly mean, standarddeviation, bias, coefficient of variation, and mean sigma metrics were calculated.The correlation between accuracy and precision was assessed based on the percentagebias and coefficient of variation. Comprehensive instructions on the QC and maintenanceof the devices were provided in the departments with poor sigma scores. Afollow-up assessment was performed after the intervention.
Results
The mean sigma values for the low and high controls were 3.29 and 3.71, respectively.At the low and high controls, 36.6% and 10% of the glucose meters showeda sigma value <3. The causes of low sigma values included the use of expired controlmaterials, prolonged air exposure of the sample strip, lack of user training, and errors indevice maintenance. On follow-up monitoring for 3 months following QC intervention,23.3% (low control) and 6.6% (high control) of the glucose meters scored a sigma value<3, indicating improved QC.
Conclusion
Sigma metrics-based QC can successfully improve accuracy and precisionof POC glucose meters in an objective and quantitative manner and can be usedfor follow up after QC intervention.

Keyword

Total quality management; Quality control; Sigma metrics; Point-of-care glucose meter
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