Shalinder Kaur Hooda* and Rania Medhat Seliem

Hematopathology Division, Department of Laboratory Medicine and Pathology, Dubai Health, United Arab Emirates

*Corresponding Author: Shalinder Kaur Hooda, Hematopathology Division, Department of Laboratory Medicine and Pathology, Dubai Health, United Arab Emirates.

Received: March 20, 2025; Published: March 28, 2025

Abstract

Background: Accurate laboratory results are crucial for patient care, necessitating rigorous performance monitoring. Sigma metrics, a statistical method, can be used for performance evaluation of analytical methods in a diagnostic laboratory.

Objective: This study aimed to evaluate performance and recommend customized quality control design for an automated blood count analyzer by application of Six sigma methodology.

Methods: Internal Quality control and peer group evaluation data were used to calculate average imprecision and bias observed for the analytical instrument under study. CLIA (Clinical Laboratory Improvement Amendments) goals for analytical performance (Total allowable error) were applied to derive the ‘sigma value’ for the key measured parameters- Hemoglobin (Hb), Red Blood Cell count (RBC), Hematocrit (HCT), White Blood Cell count (WBC) and Platelet count to rate the performance based upon sigma scale and recommend tailored quality control strategies for each parameter.

Results: The analyzer showed acceptable performance (above 3 sigma) for all parameters evaluated, with some parameters like Platelets showing beyond world class performance. While the overall analyzer performance was observed to be acceptable, a potential for further optimization was realized, especially for parameters like RBC and Hematocrit.

Conclusion: Six sigma is an invaluable statistical tool available to diagnostic laboratories to ascertain analytical performances of its testing methods and optimize quality control processes, by utilizing readily available internal and external quality assurance data

Keywords: Total Allowable Error; Bias; CV (Coefficient of Variation); Sigma

References

1. Westgard JO and Barry PL. "Beyond quality assurance: committing to quality improvement”. Laboratory Medicine 4 (1989): 241-247.
2. Tefferi A., et al. "How to interpret and pursue an abnormal complete blood cell count in adults”. Mayo Clinic Proceedings7 (2005): 923-936.
3. Westgard JO. “Internal quality control: planning and implementation strategies”. Annals of Clinical Biochemistry (2003).
4. Harry M and Schroeder R. “Six Sigma: The breakthrough management strategy revolutionizing the world’s top corporations”. 1^st New York: Currency (2000).
5. Coskun A. "Six sigma and calculated laboratory tests”. Clinical Chemistry5 (2006): 770-771.
6. Westgard S., et al. "Analytical Sigma metrics: A review of Six Sigma implementation tools for medical laboratories”. Biochemica Medica (Zagreb)2 (2018): 020502.
7. Zhou B., et al. "Practical application of Six Sigma management in analytical biochemistry processes in clinical settings”. Journal of Clinical Laboratory Analysis 1 (2020): e23126.
8. Garg M., et al. "Sigma Metrics Assessment as Quality Improvement Methodology in a Clinical Chemistry Laboratory”. Indian Journal of Medical Biochemistry2 (2023): 23-27.
9. Westgard JO. “2024 CLIA requirements”. (2024).
10. Monica Gupta., et al. “Application of sigma metrics in haematology laboratory”. International Journal of Clinical and Diagnostic Pathology 5.2 (2022): 21-25.
11. Harrison HH and Jones JB. "Using Sigma Quality Control to Verify and Monitor Performance in a Multi-Instrument, Multisite Integrated Health Care Network”. Clinical Laboratory Medicine 2 (2017): 207-241.
12. Luo Y., et al. "Application of Sigma metrics in the quality control strategies of immunology and protein analytes”. Journal of Clinical Laboratory Analysis 11 (2021): e24041.
13. Ozdemir Seyda and Ucar Fatma. "Determination of Sigma metric based on various TEa sources for CBC parameters: the need for Sigma metrics harmonization”. Journal of Laboratory Medicine2 (2022): 133-141.

Citation

Citation: Shalinder Kaur Hooda and Rania Medhat Seliem. “Six Sigma Approach for Performance Analysis of Hematology Analyzers in a Clinical Laboratory".Acta Scientific Medical Sciences 9.4 (2025): 126-133.

Copyright

Copyright: © 2025 Shalinder Kaur Hooda and Rania Medhat Seliem. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.