Analytical Performance Evaluation of Hematology Analyzer Using Various TEa Sources and Sigma Metrics

References

• Ahmed El-Neanaey W, Mahmoud AbdEllatif N, Abdel Haleem Abo Elwafa R. Evaluation of sigma metric approach for monitoring the performance of automated analyzers in hematology unit of Alexandria Main University Hospital. Int J Lab Hematol. 2021;43(6):1388–1393. doi:10.1111/ijlh.13660
   PubMed Web of Science ®Google Scholar
• Charuruks N. Sigma metrics across the total testing process. Clin Lab Med. 2017;37(1):97–117. doi:10.1016/j.cll.2016.09.009
   PubMed Web of Science ®Google Scholar
• Chaudhuri S, Das A, Das SK, Saha T. Evaluation of performance in the pre-analytical phase of a clinical biochemistry laboratory in a Tertiary Medical College Hospital. AJMS. 2022;13(6):62–67.
   Google Scholar
• Fuadi R. Using six sigma to evaluate analytical performance of hematology analyzer. Indones J Clin Pathol Med Lab. 2019;25(2):165–169. doi:10.24293/ijcpml.v25i2.1375
   Google Scholar
• Levey S, Jennings ER. The use of control charts in the clinical laboratory. Am J Clin Pathol. 1950;20(11):1059–1066. doi:10.1093/ajcp/20.11_ts.1059
   PubMed Web of Science ®Google Scholar
• Nevalainen D, Berte L, Kraft C, Leigh E, Picaso L, Morgan T. Evaluating laboratory performance on quality indicators with the six sigma scale. Arch Pathol Lab Med. 2020;124(4):516–519. doi:10.5858/2000-124-0516-ELPOQI
   Google Scholar
• Gupta M, Ranapurwala M, Kansara K, Chhatriwala M. Application of sigma metrics in haematology laboratory. Int J Clin Diag Pathol. 2022;5(2):21–25. doi:10.33545/pathol.2022.v5.i2a.467
   Google Scholar
• Westgard S, Westgard Q. Six sigma metric analysis for analytical testing processes. Abott Lab MS. 2019;9(5):4–256.
   Google Scholar
• Sawalakhe P, Desmukh S, Lakhe R. Evaluating performance of testing laboratory using six sigma. Int J Innov Eng Sci. 2016;1(1):13–20.
   Google Scholar
• Coskun A. Six sigma: projects and personal experiences. BOD. 2011;3(6):250 (12–18).
   Google Scholar
• 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. IJAM. 2019;6(5):1.
   Google Scholar
• Turgeon ML. Clinical Hematology: Theory and Procedures. Lippincott Williams & Wilkins; 2005.
   Google Scholar
• Nagaraj RB, Ansari MKA, Shivanna BDM. Evaluation of quality control in clinical hematology laboratory by using six-sigma. Ann Rom Soc Cell Biol. 2021;25:20354–20359.
   Google Scholar
• Hidayati L, Maradhona Y. Six sigma for evaluation of quality control in clinical laboratory. Int J Public Health Sci. 2018;5(4):144–150.
   Google Scholar
• 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):193–197. doi:10.1111/ijlh.12468
   PubMed Web of Science ®Google Scholar
• Moya-Salazar J, Pio-Dávila L. Critical systematic errors in the implementation and follow-up of performance in the hematology area: a prospective study. Med Uni. 2018;20(1):22–34.
   Google Scholar
• Oprea OR, Hutanu A, Pavelea O, Kodori DR, Dobreanu M. Quality control strategy for automated CBC: a laboratory point of view deducted from an internal study organised in an emergency laboratory. RRML. 2020;28(1):19–27.
   Google Scholar
• Ozdemir S, Ucar F. Determination of sigma metric based on various TEa sources for CBC parameters: the need for sigma metrics harmonization. Laboratoriums Medizin. 2022;46(2):133–141.
   Google Scholar
• Rishniw M, Pion PD. Evaluation of performance of veterinary in‐clinic hematology analyzers. VCP. 2016;45(4):604–614.
   PubMed Web of Science ®Google Scholar
• Adane K, Girma M, Deress T. How does ISO 15189 laboratory accreditation support the delivery of healthcare in Ethiopia? A systematic review. Ethiop J Health Sci. 2019;29(2):259–264. doi:10.4314/ejhs.v29i2.13
   PubMed Web of Science ®Google Scholar
• Coşkun A, Carobene A, Kilercik M, et al. Within-subject and between-subject biological variation estimates of 21 hematological parameters in 30 healthy subjects. Clin Chem Lab Med. 2018;56(8):1309–1318. doi:10.1515/cclm-2017-1155
   PubMed Web of Science ®Google Scholar
• EFLM Biological Variation. Available from: https://biologicalvariation.eu/meta_calculations. Accesssed September 7, 2023.
   Google Scholar
• 2016 state of the art hematology performance specifications – Westgard. Available from: https://www.westgard.com/sota-2016-hematology.htm. Accesssed September 7, 2023.
   Google Scholar
• Spanish minimum consensus performance specifications – Westgard. Available from: https://www.westgard.com/minimum-consensus-specifications.htm. Accesssed September 7, 2023.
   Google Scholar
• 2024 CLIA proposed acceptance limits for proficiency testing – Westgard. Available from: https://www.westgard.com/2024-clia-requirements.htm. Accesssed September 7, 2023.
   Google Scholar
• Rilibak - German guidelines for quality – Westgard. Available from: https://www.westgard.com/rilibak.htm. Accesssed September 7, 2023.
   Google Scholar
• Gras JM, Philippe M. Application of the six sigma concept in clinical laboratories: a review. Clin Chem Lab Med. 2017;45(6):789–796.
   Google Scholar
• Westgard J. Westgard Sigma Rules - Westgard 2023. Available from: https://www.westgard.com/westgard-sigma-rules.htm. Accesssed September 7, 2023.
   Google Scholar
• Desirable biological variation database specifications – Westgard. Available from: https://www.westgard.com/biodatabase1.htm. Accesssed September 7, 2023.
   Google Scholar
• Vis J, Huisman A. Verification and quality control of routine hematology analyzers. Int J Lab Hematol. 2016;38:100–109. doi:10.1111/ijlh.12503
   PubMed Web of Science ®Google Scholar
• Berte LM. Quality Management System: A Model for Laboratory Services; Approved Guideline. Clinical and Laboratory Standards Institute; 2011.
   Google Scholar
• Coskun A, Braga F, Carobene A, et al. Systematic review and meta-analysis of within-subject and between-subject biological variation estimates of 20 haematological parameters. Clin Chem Lab Med. 2019;58(1):25–32. doi:10.1515/cclm-2019-0658
   PubMed Web of Science ®Google Scholar
• Westgard QC. Westgard Sigma Rules. Available from: https://www.westgard.com/westgard-sigma-rules.htm Accessed 15 September 2023.
   Google Scholar
• World Health Organization. Guide for the stepwise laboratory quality improvement process towards accreditation (SLIPTA) in the WHO African Region—Revision 2; 2020.
   Google Scholar
• Unalli OS, Ozarda Y. Stability of hematological analytes during 48 hours storage at three temperatures using Cell-Dyn hematology analyzer. J Med Biochem. 2021;40(3):252. doi:10.5937/jomb0-27945
   PubMed Web of Science ®Google Scholar
• BIPM I, IFCC I, ISO I, IUPAP O. Evaluation of measurement data ̶ an introduction to the ‘Guide to the expression of uncertainty in measurement’and related documents. JCGM. 2009;104:1–104.
   Google Scholar
• Mario P, Urrechaga E, Martinez A, Merino M, Muguerza G, Perez I, editors. Sigma metrics for evaluating the performance of complete blood counts. In: Clinica Chimica Acta. RADARWEG 29, 1043 NX AMSTERDAM, NETHERLANDS: Elsevier 51 ; 2022.
   Google Scholar
• Oprea OR, Preda EC, Mănescu IB, Dobreanu M. Setting up an own laboratory performance-based internal quality control plan-a model for complete blood count. Rev Rom Med Lab. 2022;30(4):477–482. doi:10.2478/rrlm-2022-0036
   Web of Science ®Google Scholar
• Westgard S, Westgard Q. Quantitating quality: best practices for estimating the sigma-metric. Abbott Diagn. 2016;1:1–12.
   Google Scholar
• Kashyap A, Sampath S, Tripathi P, Sen A. Sigma metrics: a valuable tool for evaluating the performance of internal quality control in laboratory. J Lab Physicians. 2021;13(04):328–331. doi:10.1055/s-0041-1731145
   PubMed Web of Science ®Google Scholar
• Hens K, Berth M, Armbruster D, Westgard S. Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target. Clin Chem Lab Med. 2014;52(7):973–980. doi:10.1515/cclm-2013-1090
   PubMed Web of Science ®Google Scholar