Yıl: 2022 Cilt: 5 Sayı: 2 Sayfa Aralığı: 120 - 124 Metin Dili: İngilizce DOI: 10.14744/ijmb.2022.81300 İndeks Tarihi: 18-06-2022

Sigma metric evaluation with different TEa targets in clinical biochemistry

Öz:
Objectives: The aim of this study was to evaluate the analytical performances of various clinical biochemistry analytes by the sigma metrics method according to different total allowable error (TEa) targets and to determine the causes of errors that lead to low sigma score by using Quality Goal Index (QGI). Methods: The study was carried out in the Central Laboratory of Bursa Karacabey State Hospital. Twelve analytes that were studied on the Roche Cobas c 501 autoanalyzer were included in the study. Internal (level 1 and 2) and external quality control data for the period March–August 2020 were obtained retrospectively. The TEa targets were obtained from the Clinical Laboratory Improvement of 2019 (CLIA 2019), biological variation database (BVD), Rili-BAEK, and Turkish data. QGI was calculated for analytes with sigma score <3 according to CLIA. Results: According to the TEa goals of four different guides, different sigma scores were obtained. Three parameters with sigma scores <3 were determined according to TEa targets of CLIA, 8 according to BVD, and 6 according to Rili- BAEK, while there were no parameters with sigma score <3 according to the TEa targets of Turkey. Number of parameters with sigma scores >6 were 7, 10, 6, and 18 according to TEa targets of CLIA, BVD, Rili-BAEK, and Turkey, respectively. When QGI was calculated, it was found that there was inaccuracy problem for albumin and chlorine L1 and imprecision for chlorine L2. Conclusion: Laboratories should determine the appropriate TEa targets and use the sigma metrics method and QGI as a quality improvement tool. In the light of the obtained data, necessary quality improvements should be made, and the reliability of the results should be increased.
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  • 1. International Organization for Standardization (ISO). ISO/IEC 17025. General requirements for the competence of testing and calibration of laboratories, 2005.
  • 2. Burtis CA, Bruns DE. Tietz fundamentals of clinical chemistry and molecular diagnostics. In: Klee GG, Westgard JO, editors. Quality Management. 7th ed. USA: Elsevier Inc; 2015. p. 97–102.
  • 3. Burtis CA, Bruns DE. Tietz fundamentals of clinical chemistry and molecular diagnostics. In: Linnet K, Boyd JC, editors. Selection and analytical evaluation of methods-with statistical techniques. 7th ed. USA: Elsevier Inc; 2015. p. 12.
  • 4. Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med 2006;44(6):750–9.
  • 5. Zhang C, Zhao H, Wang J, Zeng J, Wang Z. The application of six sigma techniques in the evaluation of enzyme measurement procedures in China. Clin Lab 2015;61:461–5.
  • 6. Clinical and Laboratory Standards Institute. EP21A. Estimation of total analytical error for clinical laboratory methods. Wayne, PA: 2003.
  • 7. Coskun A, Inal T, Unsal I, Serteser M. Six sigma as a quality management tool: evaluation of performance in laboratory medicine quality management and six sigma. InTechOpen: Rijeka, Croatia; 2010. p. 248–61.
  • 8. Nevalainen D, Berte L, Kraft C, Leigh E, Picaso L, Morgan T, et al. Evaluating laboratory performance on quality indicators with the six sigma scale. Arch Pathol Lab Med 2000;124(4):516–9.
  • 9. Harry M, Schroeder R, Six Sigma: The breakthrough strategy revolutionizing the world’s top corporation. New York, NY: Random House, Doubleday; 2000.
  • 10. Shaikh MS, Moiz B. Analytical performance evaluation of a high-volume hematology laboratory utilizing sigma metrics as standard of excellence. Int J Lab Hematol 2016;38(2):193–7.
  • 11. Westgard JO, Westgard SA. An assessment of σ metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance. J Vet Diagn Invest 2008;20:536–44.
  • 12. Westgard JO, Westgard SA. The quality of laboratory testing today: an assessment of sigma metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance. Am J Clin Pathol 2006;125(3):343–54.
  • 13. Federal Register. clinical laboratory improvement amendments of 1988 (CLIA) proficiency testing regulations related to analytes and acceptable performance. Federal Register; 2019. p. 1536–67.
  • 14. Westgard JO. WestgardQC, Quality requirements. Available at: https://www.westgard.com/biodatabase1.htm. Accessed Apr 12, 2022.
  • 15. Revision of the “Guideline of the German Medical Association on quality assurance in medical laboratory examinations – Rili-BAEK” (unauthorized translation). LaboratoriumsMedizin 2015;39(1):26–69.
  • 16. T.C. Sağlık Bakanlığı. İzin verilen toplam hata sınırları. Genelge 2016/18. Available at: https://shgmtetkikdb.saglik.gov.tr/Eklenti/ 2581/0/genelge-201618izin-verilen-toplam-hata-sinirlaripdf. pdf. Accessed Apr 12, 2022.
  • 17. Tran MT, Hoang K, Greaves RF. Practical application of biological variation and Sigma metrics quality models to evaluate 20 chemistry analytes on the Beckman Coulter AU680. Clin Biochem 2016;49(16–17):1259–66.
  • 18. Goel P, Malik G, Prasad S, Rani I, Manhas S, Goel K. Analysis of performance of clinical biochemistry laboratory using Sigma metrics and Quality Goal Index. Pract Lab Med 2020;23:e00195.
  • 19. Erçin U. Sigma values according to different %TEa standards and evaluation of the analytical phase. Türk Klinik Biyokimya Derg 2021;19(2):99–107.
  • 20. Xia J, Chen SF, Xu F, Zhou YL. Quality specifications of routine clinical chemistry methods based on sigma metrics in performance evaluation. J Clin Lab Anal 2018;32(3):e22284.
  • 21. Cakmak O, Altun Z, Ayan NN. Evaluation of analytical performance specifications of routine clinical biochemistry tests with biological variation-based total allowable error criteria. Int J Med Biochem 2018;1(3):91–8.
  • 22. Oktay SB, Ayyıldız SN. Assessment of analytical process performance using the Six Sigma method: A comparison of two biochemistry analyzers. Int J Med Biochem 2021;4(2):97–103.
APA Korkmaz Ş (2022). Sigma metric evaluation with different TEa targets in clinical biochemistry. , 120 - 124. 10.14744/ijmb.2022.81300
Chicago Korkmaz Şeniz Sigma metric evaluation with different TEa targets in clinical biochemistry. (2022): 120 - 124. 10.14744/ijmb.2022.81300
MLA Korkmaz Şeniz Sigma metric evaluation with different TEa targets in clinical biochemistry. , 2022, ss.120 - 124. 10.14744/ijmb.2022.81300
AMA Korkmaz Ş Sigma metric evaluation with different TEa targets in clinical biochemistry. . 2022; 120 - 124. 10.14744/ijmb.2022.81300
Vancouver Korkmaz Ş Sigma metric evaluation with different TEa targets in clinical biochemistry. . 2022; 120 - 124. 10.14744/ijmb.2022.81300
IEEE Korkmaz Ş "Sigma metric evaluation with different TEa targets in clinical biochemistry." , ss.120 - 124, 2022. 10.14744/ijmb.2022.81300
ISNAD Korkmaz, Şeniz. "Sigma metric evaluation with different TEa targets in clinical biochemistry". (2022), 120-124. https://doi.org/10.14744/ijmb.2022.81300
APA Korkmaz Ş (2022). Sigma metric evaluation with different TEa targets in clinical biochemistry. International Journal of Medical Biochemistry, 5(2), 120 - 124. 10.14744/ijmb.2022.81300
Chicago Korkmaz Şeniz Sigma metric evaluation with different TEa targets in clinical biochemistry. International Journal of Medical Biochemistry 5, no.2 (2022): 120 - 124. 10.14744/ijmb.2022.81300
MLA Korkmaz Şeniz Sigma metric evaluation with different TEa targets in clinical biochemistry. International Journal of Medical Biochemistry, vol.5, no.2, 2022, ss.120 - 124. 10.14744/ijmb.2022.81300
AMA Korkmaz Ş Sigma metric evaluation with different TEa targets in clinical biochemistry. International Journal of Medical Biochemistry. 2022; 5(2): 120 - 124. 10.14744/ijmb.2022.81300
Vancouver Korkmaz Ş Sigma metric evaluation with different TEa targets in clinical biochemistry. International Journal of Medical Biochemistry. 2022; 5(2): 120 - 124. 10.14744/ijmb.2022.81300
IEEE Korkmaz Ş "Sigma metric evaluation with different TEa targets in clinical biochemistry." International Journal of Medical Biochemistry, 5, ss.120 - 124, 2022. 10.14744/ijmb.2022.81300
ISNAD Korkmaz, Şeniz. "Sigma metric evaluation with different TEa targets in clinical biochemistry". International Journal of Medical Biochemistry 5/2 (2022), 120-124. https://doi.org/10.14744/ijmb.2022.81300