Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Mar 19:25:e00215.
doi: 10.1016/j.plabm.2021.e00215. eCollection 2021 May.

Six Sigma performance of quality indicators in total testing process of point-of-care glucose measurement: A two-year review

Anne Vincent  1 , Donnah Pocius  1 , Yun Huang  1   2
Affiliations

Six Sigma performance of quality indicators in total testing process of point-of-care glucose measurement: A two-year review

Anne Vincent et al. Pract Lab Med. .

Abstract

Objectives: The error rate in the total testing process (TTP) of point-of-care (POC) glucose measurement remains high although a total quality management system has been applied. Quality indicators (QIs) in the TTP of glucose meter were established via risk assessment. Their two-year Six Sigma values were reviewed for quality improvement.

Design: The TTP of POC glucose measurement was mapped to identify risks in key steps. The risks were assessed for their frequency and severity of impact on patient safety. Whenever possible, measurable data from the data management system and other sources was collected to establish QIs for risk monitoring. Average Six Sigma value of each QI in the last two years was calculated for acceptance and for determining corrective action.

Results: 29 risks were identified in eight key steps of the TTP. Eight QIs were established for monitoring six risks and three QIs for two accepted risks were established for improving operator testing skill. The QIs had a good coverage to key steps. Two, five and four QIs showed Six Sigma values <3, 3-4 and >4 respectively. Six Sigma values of two QIs related to quality control (QC) testing were improved by using meters with accurate QC sample loading.

Conclusions: The establishment of QIs for glucose measurement by risk assessment with measurable data from the data management system and on Six sigma scale was effective, efficient, and manageable. Most of QIs' Six Sigma values were between 3 and 5, which could be improved by using upgraded meters.

Keywords: Glucose meter; Point-of-care testing; Quality indicator; Risk assessment; Six sigma.

PubMed Disclaimer

Conflict of interest statement

There are no known conflicts of interest associated with this publication.

Figures

Fig. 1
Fig. 1
Total testing process of POC glucose measurement.
Fig. 2
Fig. 2
The improvement of Six Sigma value of two QIs by using upgraded glucose meters.
See this image and copyright information in PMC

References

    1. Nichols J.H. Blood glucose testing in the hospital: error sources and risk management. J. Diabetes. Sci. Technol. 2011;5:173–177. - PMC - PubMed
    1. Plebani M. Does POCT reduce the risk of error in laboratory testing? Clin. Chim. Acta. 2009;404:59–64. - PubMed
    1. O’Kane M.J., McManus P., McGowan N., Lynch P.L. Quality error rates in point-of-care testing. Clin. Chem. 2011;57:1267–1271. - PubMed
    1. Nichols J.H. Risk management for point-of-care testing. EJIFCC. 2014;25:154–161. - PMC - PubMed
    1. International Organization for Standardization, ISO 14971:2019 Medical Devices - Application of Risk Management to Medical Devices.

LinkOut - more resources