Potential use of Six Sigma metrics in the quality control review of hospital glucose meters.

Background and aim: This study applied Six Sigma metrics to facilitate the quality control (QC) review for hospital glucose meters. Materials and methods: QC data from a period of six months on all hospital glucose meters were extracted from the data management system. Sigma values for each meter at two QC levels were calculated and evaluated each month by combining the imprecision, the absolute bias between the meter mean and all-meter mean, and the standards from ISO 15179:2013. The effectiveness of using Sigma values in identifying meters with possible quality problems for further Levey-Jennings QC chart review was assessed. Results: More than 80 % of the meter's Sigma values within the six months were greater than 4 at either QC level. At the high QC level, twice as many Sigma values were below 4 than the low QC level. Including Sigma values 4, 3.5 or 3 in the criteria for the QC review reduced the number of chart review to 32.8 %, 11.2 % or 3.5 %, respectively. Conclusions: The majority of the glucose meters examined in this study demonstrated optimal Sigma values. The Sigma metrics-based approach could be a valuable tool to guide an effective QC review of glucose meters for quality improvement.