Berta Dereje Mengesha, Grima Mekonnen, Melku Mulugeta, Adane Tiruneh, Chane Elias, Teketelew Bisrat Birke, Yalew Aregawi
Department of Hematology and Immunohematology University of Gondar Gondar Ethiopia.
Department of Quality Assurance and Laboratory Management, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences University of Gondar Gondar Ethiopia.
Health Sci Rep. 2024 Jan 22;7(1):e1833. doi: 10.1002/hsr2.1833. eCollection 2024 Jan.
Assuring laboratory quality by minimizing the magnitude of errors is essential. Therefore, this study aimed to assess hematology laboratory performance in the total testing process using quality indicators and sigma metrics.
A cross-sectional study was conducted from April to June 2022. The study included a total of 13,546 samples. Data on included variables were collected using a checklist. Descriptive statistics were used to present the overall distribution of errors. Binary logistic regression models were applied. Furthermore, using a Sigma scale, the percentage of errors was converted to defects per million opportunities to assess laboratory performance. Finally, the defect per million opportunities was converted to a sigma value using a sigma calculator.
Of the 13,546 samples and corresponding requests, the overall error rate was 123,296/474,234 (26%): 93,412/47,234 (19.7%) pre-analytical, 2364/474,234 (0.5%) analytical, and 27,520/474,234 (5.8%) post-analytical. Of the overall errors, 93,412/123,296 (75.8%), 2364/123,296 (1.9%), and 27,520/123,296 (22.3%) were pre-analytical, analytical, and post-analytical errors, respectively. The overall sigma value of the laboratory was 2.2. The sigma values of the pre-analytical, analytical, and post-analytical phases were 2.4, 4.1, and 3.1, respectively. The sample from the inpatient department and collected without adherence to the standard operating procedures (SOPs) had a significantly higher ( < 0.05) rejection rate as compared to the outpatient department and collected with adherence to SOPs, respectively. In addition, an association between prolonged turnaround times and manual recording, inpatient departments, and morning work shifts was observed.
The current study found that the overall performance of the laboratory was very poor (less than three sigma). Therefore, the hospital leadership should change the manual system of ordering tests and release of results to a computerized system and give need-based training for all professionals involved in hematology laboratory sample collection and processing.
通过尽量减少误差幅度来确保实验室质量至关重要。因此，本研究旨在使用质量指标和西格玛度量来评估血液学实验室在整个检测过程中的表现。
于2022年4月至6月进行了一项横断面研究。该研究共纳入13546份样本。使用清单收集有关纳入变量的数据。采用描述性统计来呈现误差的总体分布。应用二元逻辑回归模型。此外，使用西格玛量表，将误差百分比转换为每百万机会缺陷数来评估实验室表现。最后，使用西格玛计算器将每百万机会缺陷数转换为西格玛值。
在13546份样本及相应申请中，总体误差率为123296/474234（26%）：分析前93412/47234（19.7%），分析中2364/474234（0.5%），分析后27520/474234（5.8%）。在总体误差中，分析前、分析中、分析后误差分别占93412/123296（75.8%）、2364/123296（1.9%）、27520/123296（22.3%）。实验室的总体西格玛值为2.2。分析前、分析中、分析后阶段的西格玛值分别为2.4、4.1和3.1。与门诊部且按标准操作规程采集的样本相比，住院部且未按标准操作规程采集的样本拒收率显著更高（<0.05）。此外，观察到周转时间延长与手工记录、住院部以及早班之间存在关联。
当前研究发现该实验室的总体表现非常差（低于三个西格玛）。因此，医院领导应将手工的检测申请和结果发布系统改为计算机化系统，并对参与血液学实验室样本采集和处理的所有专业人员进行按需培训。
