Evaluation of Hematology Analysis Efficiency Using the Sigma Metrics System for Quality Control and Performance in Medical Technology Laboratory, Khon Kaen Rajanagarindra Psychiatric Hospital
Keywords:
Quality control, Six Sigma, Laboratory Competency AssessmentAbstract
This retrospective study aimed to evaluate the analytical performance and to plan the quality control (QC) for hematological analysis, using sigma metrics in the Medical Technology Laboratory at Khon Kaen Rajanagarindra Psychiatric Hospital. The study utilized data from Internal Quality Control (IQC) and Peer Group External Quality Control for five clinical hematology parameters: White Blood Cell (WBC), Red Blood Cell (RBC), Hemoglobin (HGB), Mean Corpuscular Volume (MCV), and Platelet (PLT). Data were collected from January 2023 to December 2023.
The results revealed high precision and accuracy in the measurements, as the coefficient of variation (%CV) did not exceed 0.33% of the Total Error Allowable (TEa), while the %bias was also within 0.33% of the TEa. The performance evaluation of the Beckman Coulter Unicel DxH 800 automated analyzer showed that the lowest Sigma metric values for HGB, RBC, WBC, MCV, and PLT were 4.04, 5.44, 7.97, 9.27, and 10.74, respectively. For quality control planning, the single rule 13s (N = 3, R = 1) can be applied to the WBC, MCV, and PLT parameters. For the RBC parameter, the rules 13s /2 of 32s/R4s (N = 3, R = 1) can be utilized, while for the HGB parameter, the 13s /2 of 32s/R4s /31s (N = 3, R = 2) rules can be applied.
The outcome from this study shows that accurate and precise analysis allows for the selection of appropriate quality control rules tailored to each test parameter. Using simple, straightforward rules helps reduce costs on control materials, minimizes the need for retests, and eases operational workload for laboratory personnel. Continuous monitoring, evaluation, and improvement of quality control techniques are essential for the laboratory.
References
Berta, D. M., Melku, M., Adane, T., Girma, M., Mulatie, Z., Chane, E., & Birke Teketelew, B. (2023). Analytical performance evaluation of hematology analyzer using various TEa sources and sigma metrics. Pathology and Laboratory Medicine International, 15, 65–75. doi.org/10.2147/PLMI.S414693
Cakmak, O. (2018). Evaluation of analytical performance specifications of routine clinical biochemistry tests with biological variation-based total allowable error (Tea) criteria. International Journal of Medical Biochemistry. International Journal of Medical Biochemistry, 1(3), 2-18. doi.org/10.14744/ijmb.2018.39974
El-Neanaey, A., AbdEllatif, N. M., & Abo Elwafa, R. H. (2021). Evaluation of sigma metric approach for monitoring the performance of automated analyzers in Hematology Unit of Alexandria Main University Hospital. International Journal of Laboratory Hematology, 43(6), 1388–1393. doi.org/10.1111/ijlh.13660
Katar, M., Deveci, K., & Ozmen, Z. C. (2021). Evaluation of the total quality performance of our clinical laboratory with six-sigma method. Journal of Contemporary Medicine, 11(1), 34-40. doi.org/10.16899/jcm.770304
Koutras, M. V., & Triantafyllou, I. S. (2020). Recent advances on univariate distribution-free Shewhart-type control charts. Distribution-free methods for statistical process monitoring and control, Springer International Publishing 1-56. doi.org/10.1007/978-3-030-25081-2_1
Li, M., Li, X., Lu, X., Zhong, M., Wang, L., Song, M., & Xue, F. (2023). Sigma metric used to evaluate the performance of haematology analysers: choosing an internal reference analyser for the laboratory. Hematology, 28(1), 2-3. doi.org/10.1080/16078454.2023.2277498
Llopis, M. A., Trujillo, G., Llovet, M. I., Tares, E., Ibarz, M., Bionca, C., et al. (2011). Quality indicators and specifications for key analytical-extrametrical processes in the clinical laboratory. Five years’ experience using the Six Sigma concept. Clinical Chemistry and Laboratory Medicine, 9(3), 463-470. doi.org/10.1515/cclm.2011.067
Sirithansakul, T. (2018) Assessment of hematology and clinical chemistry laboratory performance by six sigma metric; department of medical technology, Trang hospital. Technical Journal Medicine, 46(1), 6349–6374. (in Thai)
Velioglu, Y. & Yuksel, A. (2019). Complete blood count parameters in peripheral arterial disease. The Aging Male, 22(3), 187–191. doi.org/10.1080/13685538.2019.1588873
Westgard, J. O. (2017). Six sigma quality management system and design of risk-based statistical quality control. Clinics in Laboratory Medicine, 37(1), 85-96. doi.org/10.1016/j.cll.2016.09.008
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