XXI međunarodna konvencija o kvalitetu JUSK ICQ – 29 – 31. maj 2025, Beograd, (201-210 str.)
AUTOR(I) / AUTHOR(S): Mila Kolundžić, Snežana Jovičić 
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DOI: 10.46793/XXIJUSK-ICQ.201K
SAŽETAK / ABSTRACT:
The „Six Sigma“ principle is a method for evaluating quality by identifying and quantifying process defects. It directs analysts to address systematic issues and understand the significance of the problem. If the sigma value is ≥3, the method is applicable in clinical laboratories with an appropriate quality control plan. The aim of this study is quality evaluation of the parameters that are used for diagnosis, monitoring and differentiation of anemia, using the „Six Sigma“ method.
A retrospective analysis of internal and external quality control for hematological, biochemical, and immunochemical parameters was conducted in a clinical laboratory. Sigma values were calculated based on the coefficient of variation, bias, and total allowable error.
Out of 77 calculated sigma values for 16 parameters, 44 had values lower than three, indicating unacceptable performance.
Some controlled parameters showed acceptable sigma values and can reliably be used in laboratory testing for anemia. However, certain parameters had unacceptable performance. Sigma values highly vary based on the data base used for the total allowable error.
KLJUČNE REČI / KEYWORDS:
Six Sigma, quality control, anemia
PROJEKAT / ACKNOWLEDGEMENT:
LITERATURA / REFERENCES:
- Burtis CA, Ashwood ER, Bruns DE, Tietz textbook of clinical chemistry and molecular diagnostics, 5th edition, St. Louis: Elsevier 2012.
- Six Sigma table, Westgard QC [(accessed on 13 March 2024)], available online: https://www.westgard.com/resources/29-resources/416-sixsigtable
- Inal TC, Goruroglu Ozturk O, Kibar F, Cetiner S, Matyar S, Daglioglu G, Yaman A. Lean six sigma methodologies improve clinical laboratory efficiency and reduce turnaround times. J Clin Lab Anal. 32(1): e22180, 2018.
- Marisavljević D, et al. Clinical hematology, Belgrade, Zavod za udžbenike, 2012 (Marisavljević D, i sar, Klinička hematologija , Beograd, Zavod za udžbenike, 2012)
- EFLM Biological Variation Database, EFLM, [(accessed on 23 December 2023)], available online: https://biologicalvariation.eu
- 2024 CLIA Proposed Acceptance Limits for Proficiency Testing, Westgard QC, (accessed on 23. December. 2023), available online: https://www.westgard.com/2024-clia-requirements.htm
- Desirable Biological Variation Database specifications, Westgard QC, (accessed on 23 December 2024), available online: https://www.westgard.com/biodatabase1.htm
- RCPA Allowable Limits of Performance for Biochemistry, Westgard QC, (accessed on 23 December 2023), available online: https://www.westgard.com/rcpa-biochemistry.htm
- Shaikh MS, Moiz B Analytical performance evaluation of a high-volume hematology laboratory utilizing sigma metrics as standard of excellence. Int J Lab Hematol. Apr;38(2):193-7. 2016.
- Nar R, Emekli DI The Evaluation of Analytical Performance of Immunoassay Tests by using Six-sigma Method. J Med Biochem. Oct 28;36(4):301-308. 2017.
- Mao X, Shao J, Zhang B, Wang Y. Evaluating analytical quality in clinical biochemistry laboratory using Six Sigma. Biochem Med (Zagreb). 2018 Jun 15; 28(2): 020904. doi: 10.11613/BM.2018.020904. PMID: 30022890; PMCID: PMC6039163.
- Sandber S, Coskun A, Carobene A, Fernandez-Calle P, Diaz-Garzon J, Bartlett WA, et al. Analytical performance specifications based on biological variation data – considerations, strengths and limitations. Clinical Chemistry and Laboratory Medicine (CCLM), Online ahead of print. 2024.
