Evaluating Laboratory Performance on Point-of-Care Glucose Testing with Six Sigma Metric for 151 Institutions in China.

BACKGROUND: The aim of this study was to use Six Sigma(SM) (Motorola Trademark Holdings, Libertyville, IL) techniques to analyze the quality of point-of-care (POC) glucose testing measurements quantitatively and to provide suggestions for improvement.

MATERIALS AND METHODS: In total, 151 laboratories in China were included in this investigation in 2014. Bias and coefficient of variation were collected from an external quality assessment and an internal quality control program, respectively, for POC glucose testing organized by the National Center for Clinical Laboratories. The σ values and the Quality Goal Index were used to evaluate the performance of POC glucose meters.

RESULTS: There were 27, 30, 57, and 37 participants in the groups using Optium Xceed™ (Abbott Diabetes Care, Alameda, CA), Accu-Chek(®) Performa (Roche, Basel, Switzerland), One Touch Ultra(®) (Abbott), and "other" meters, respectively. The median of the absolute value of percentage difference varied among different lots and different groups. Among all the groups, the Abbott One Touch Ultra group had the smallest median of absolute value of percentage difference except for lot 201411, whereas the "other" group had the largest median in all five lots. More than 85% of participate laboratories satisfied the total allowable error (TEa) requirement in International Organization for Standardization standard 15197:2013, and 85.43% (129/151) of laboratories obtained intralaboratory coefficient of variations less than 1/3TEa. However, Six Sigma techniques suggested that 41.72% (63/151) to 65.56% (99/151) of the laboratories needed to improve their POC glucose testing performance, in either precision, trueness, or both.

CONCLUSIONS: Laboratories should pay more attention on the practice of POC glucose testing and take actions to improve their performance. Only in this way can POC glucose testing really function well in clinical practice.