Geto Zeleke, Getahun Tigist, Lejisa Tadesse, Tolcha Yosef, Bikila Demirew, Bashea Chala, Meles Mehari, Habtu Wossene, Ashebir Genet, Negasa Bikila, Sileshi Meron, Daniel Yeabkal, Gashu Andargachew, Challa Feyissa
Department of Biomedical Science, College of Medicine and Health Science, Wollo University, Dessie, Wollo Ethiopia.
Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.
Indian J Clin Biochem. 2022 Jul;37(3):285-293. doi: 10.1007/s12291-021-00994-x. Epub 2021 Aug 2.
Clinical laboratories are mandated to deliver accurate, reliable, timely and correctly reported result which, used in decision making for disease screening, diagnosis and monitoring. With aid of six sigma principles and metrics it is possible to assess the quality laboratory process and the quality control that is needed to ensure that the desired quality is achieved. Thus, this study was undertaken to evaluate the performance of biochemical parameters by calculating the sigma metrics of individual parameters using internal quality control (IQC) and Proficiency Testing (PT) results. The sigma metrics of 21 clinical chemistry parameters were calculated from COBAS 6000 analyzer with internal quality control (IQC) materials and external quality assurance scheme (EQAS) performance in national clinical chemistry laboratory for the period of six months. We obtained an excellent performance (≥ 6 sigma) for test parameters amylase pancreatic, amylase total, HDL, magnesium, AST, triglyceride, total bilirubin and ALT in both levels of quality control. Urea, creatinine and chloride were failed to meet the minimal sigma performance for both level 1 and 2. Sigma values of 3-6 were observed for ALP, Direct bilirubin, total protein, albumin, glucose, potassium, and phosphate with both levels of quality control. Though, stringent IQC strategy is not mandatory for analytes that scored sigma value ≥ 6. However, continuous monitoring quality control is required for renal function tests and process improvement will be designed for those with poor sigma values.
临床实验室必须提供准确、可靠、及时且报告正确的结果，这些结果用于疾病筛查、诊断和监测的决策。借助六西格玛原则和指标，可以评估实验室流程的质量以及确保达到期望质量所需的质量控制。因此，本研究旨在通过使用内部质量控制（IQC）和能力验证（PT）结果计算各个参数的西格玛指标，来评估生化参数的性能。在国家临床化学实验室中，使用COBAS 6000分析仪，根据内部质量控制（IQC）材料和外部质量保证计划（EQAS）在六个月期间的性能，计算了21个临床化学参数的西格玛指标。在两个质量控制水平下，我们获得了淀粉酶（胰腺）、总淀粉酶、高密度脂蛋白、镁、天冬氨酸转氨酶、甘油三酯、总胆红素和丙氨酸转氨酶等检测参数的优异性能（≥6西格玛）。尿素、肌酐和氯在1级和2级水平均未达到最低西格玛性能。在两个质量控制水平下，碱性磷酸酶、直接胆红素、总蛋白、白蛋白、葡萄糖、钾和磷酸盐的西格玛值为3至6。不过，对于西格玛值≥6的分析物，严格的IQC策略并非强制要求。然而，对于肾功能测试需要持续监测质量控制，并且将为西格玛值较差的项目设计流程改进措施。
