Teshome Mulugeta, Worede Abebaw, Asmelash Daniel
Department of Medical Laboratory, Dessie Comprehensive Specialized Hospital, Dessie, Ethiopia.
Department of Clinical Chemistry, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
J Multidiscip Healthc. 2021 Jan 15;14:125-136. doi: 10.2147/JMDH.S286679. eCollection 2021.
Currently, the use of clinical laboratory tests is growing at a promising rate and about 80% of the clinical decisions made are based on the laboratory test results. Therefore, it is a major task to achieve quality service. This study was conducted to assess the magnitude of errors in the total testing process of Clinical Chemistry Laboratory and to evaluate analytical quality control using sigma metrics.
A cross-sectional study was conducted at Dessie Comprehensive Specialized Hospital Clinical Chemistry Laboratory, Northeast Ethiopia, from 10 February 2020 to 10 June 2020. All Clinical Chemistry Laboratory test requests with their respective samples, external quality control and all daily internal quality control data during the study period were included in the study. Data were collected using a prepared checklist and analyzed using SPSS version 21.
A total of 4719 blood samples with their test requests were included in the study. Out of 145,383 quality indicators, an error rate of 22,301 (15.3%) was identified in the total testing process. Of the total errors, 76.3% were pre-analytical, 2.1% were analytical and 21.6% were post-analytical errors (p<0.0001). Of the total 14 analytes in the sigma metric evaluation, except ALP, all routine clinical chemistry tests were below the standard (<3). In multivariate logistic regression, the location of patients in the inpatient department was significantly associated with the specimen rejection ((AOR=1.837, 95% CI (1.288-2.618), p=0.001).
The study found a higher frequency of errors in the total testing process in the Clinical Chemistry Laboratory and almost all test parameters had an unsatisfactory sigma metric value.
目前，临床实验室检测的使用正以可观的速度增长，约80%的临床决策是基于实验室检测结果做出的。因此，提供优质服务是一项重要任务。本研究旨在评估临床化学实验室总检测过程中的误差程度，并使用西格玛指标评估分析质量控制。
于2020年2月10日至2020年6月10日在埃塞俄比亚东北部德西综合专科医院临床化学实验室进行了一项横断面研究。研究纳入了研究期间所有临床化学实验室检测申请及其相应样本、外部质量控制和所有日常内部质量控制数据。使用预先准备的检查表收集数据，并使用SPSS 21版进行分析。
本研究共纳入了4719份带有检测申请的血样。在145383个质量指标中，总检测过程中识别出22301个（15.3%）错误率。在所有错误中，76.3%为分析前错误，2.1%为分析中错误，21.6%为分析后错误（p<0.0001）。在西格玛指标评估的总共14种分析物中，除碱性磷酸酶外，所有常规临床化学检测均低于标准（<3）。在多因素逻辑回归中，住院部患者的位置与样本拒收显著相关（比值比=1.837，95%置信区间（1.288 - 2.618），p = 0.001）。
该研究发现临床化学实验室总检测过程中的错误频率较高，几乎所有检测参数的西格玛指标值都不令人满意。
