Quality beyond compliance: leveraging six sigma for clinical laboratory improvement

Authors

  • D. V. Krishna Veni Department of Biochemistry, Apollo Institute of Medical Sciences and Research, Hyderabad, India

DOI:

https://doi.org/10.18203/2320-6012.ijrms20263572

Keywords:

Quality control, Six Sigma, Clinical laboratoty

Abstract

Clinical laboratories are the backbone of modern healthcare, providing crucial diagnostic services that guide patient management and treatment decisions. Accuracy and precision are vital factors for quality control in clinical laboratories. Six Sigma is a powerful quality management tool which enables laboratories to reduce process variability, minimize errors and evaluate analytical performance. This review highlights the various aspects of quality control, application of Six Sigma metrics in clinical laboratory practice. Sigma metrics helps in identification of analytical processes requiring improvement, risk-based quality control planning and implementing effective of internal quality control (IQC) protocols and improves operational efficiency.

References

Forsman RW. Why is the laboratory an afterthought for managed care organizations? Clin Chem. 1996;42: 813-6.

Aggarwal K, Patra S, Acharya V, Agrawal M, Mahapatra SK. Application of six sigma metrics and method decision charts in improvising clinical Chemistry laboratory performance enhancement. Int J Adv Med. 2019;6(5):1524-30.

Kaur v, Kare PK,Madaan H. Quality Control in a Clinical Laboratory. In: Advances in Biochemistry & Applications in Medicine. USA: Open Access; 2018.

Shah S, Saini R, Singh SB, Aggarwal O, Goel AK. Six Sigma Metrics and Quality Control in Clinical Laboratory. Int J Med Res Rev. 2014;2(2):140-9.

Lewis SM. The WHO International External Quality Assessment Scheme for Haematology. Bull World Health Organ. 1988;66:283-290.

UNAIDS/WHO Working Group on Global HIV/AIDS and STI Surveillance. Guidelines for using HIV testing technologies in surveillance: selection, evaluation and implementation–2009 update. Geneva: World Health Organization; 2009. Available from: https://www.ncbi.nlm.nih.gov/books/NBK305270/ Accessed on 06 June 2026.

Bhutta RA. Quality control (QC) of the clinical laboratory Available from: https://labpedia.net/quality-control-of-the-clinical-laboratory/. Accessed on 06 June 2026.

Kearney E. Internal quality control. Methods Mol Biol. 2013;1065:277-89.

Kinns H, Pitkin S, Housley D, Freedman DB. Internal quality control: best practice. J Clin Pathol. 2013;66(12):1027-32.

Parvin CA, Robbins S. Evaluation of the Performance of Randomized versus Fixed Time Schedules for Quality Control Procedures. Clin Chem. 2007;53(4):575-80.

National Accreditation Board for Testing and Calibration Laboratories. Specific criteria for accreditation of medical laboratories. Issue No. 03, amendment No. 03 [Internet]. New Delhi: NABL; 2008 [amended 2012 Oct 16; cited 2026 Jun 06]. Available from: https://nabl-india.org/nabl/file_download1.php?filename=201210170522-NABL-112-doc.pdf. Accessed on 06 June 2026.

James O. Westgard. Statistical quality control procedures. Clin Lab Med. 2013 Mar;33(1):111-24.

Westgard JO, Westgard SA. Basic QC practices: training in statistical quality control for healthcare laboratories. 3rd ed. Madison (WI): Westgard QC; 2010

Ashwood ER., Kroll M. The Role of Six Sigma in Improving Laboratory Quality. Clin Lab Mgmt Rev. 2008; 22(2), 23-30.

Zhou B, Wu Y, He H, Li C, Tan L, Cao Y. Practical application of Six Sigma management in analytical biochemistry processes in clinical settings. J Clin Lab Anal. 2020; 34:e23126.

Harry M, Schroeder R. Six Sigma: the breakthrough management strategy revolutionizing the world's top corporations. New York (NY): Currency; 2005.

Gras JM, Philippe M. Application of the Six Sigma concept in clinical laboratories: a review. Clin Chem Lab Med. 2007;45(6):789-96.

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Published

2026-09-29

How to Cite

Veni, D. V. K. (2026). Quality beyond compliance: leveraging six sigma for clinical laboratory improvement . International Journal of Research in Medical Sciences, 14(10), 4890–4894. https://doi.org/10.18203/2320-6012.ijrms20263572

Issue

Section

Review Articles