Department of Quality Assurance and Laboratory Management, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
Department of Hematology and Immunohematology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
Sci Rep. 2024 Apr 2;14(1):7745. doi: 10.1038/s41598-024-58525-6.
Proficiency testing (PT) is an impartial laboratory performance-evaluating system using an independent body. It is a mandatory accreditation requirement and means for improving the laboratory's performance. The study aimed to evaluate the performance of PT, with a focus on identifying and discussing determinants that influence PT performance at comprehensive specialized hospitals in northwest Ethiopia. A retrospective cross-sectional study was carried out from 2020 to 2022. Using a convenient sampling technique, laboratory tests with recorded PT results in each hospital laboratory were included. A data collection template and customized checklists were used to collect the data. Epi Data Version 3.1 for data entry and STATA Version 14.1 for cleaning and analysis were used. Binary logistic regression analyses were used. Variables with p < 0.05 in the multivariable logistic regression were considered to be statistically significant. Over nine cycles, 3807 PT challenges were distributed. The total failure rate of the laboratories was 32.4%, with a peak failure rate of 40.3% in 2020, after which the failure rate was decline to 20.6% in 2022. Among the five laboratory sections, molecular biology had the lowest failure rate (22.2%), while microbiology had the highest failure rate (56.5%). Multivariate logistic regression revealed that PT results reported without appropriate unit of measurement (AOR 7.5), lack of corrective action for PT nonconformance (AOR 7.1), and reagent unavailability (AOR 6.1) had significant effects on PT performance (p < 0.001). The results of this study showed that the overall performance of the laboratory was lower. Reporting PT results without appropriate units of measurement and not taking corrective action for PT nonconformance were the major aggravating factors for high failure rates.
能力验证(PT)是使用独立机构对实验室进行公正的绩效评估系统。它是强制性认证要求和提高实验室绩效的手段。本研究旨在评估 PT 的性能,重点是确定和讨论影响埃塞俄比亚西北部综合专科医院 PT 性能的决定因素。这是一项回顾性的横断面研究,于 2020 年至 2022 年进行。使用便利抽样技术,纳入了每个医院实验室记录有 PT 结果的实验室检测。使用数据收集模板和定制清单来收集数据。Epi Data 版本 3.1 用于数据录入,STATA 版本 14.1 用于清理和分析。使用二元逻辑回归分析。多变量逻辑回归中 p 值<0.05 的变量被认为具有统计学意义。在九个周期中,分发了 3807 个 PT 挑战。实验室的总失败率为 32.4%,2020 年的峰值失败率为 40.3%,之后失败率下降到 2022 年的 20.6%。在五个实验室部分中,分子生物学的失败率最低(22.2%),而微生物学的失败率最高(56.5%)。多变量逻辑回归显示,PT 结果报告没有适当的测量单位(AOR 7.5)、对 PT 不合格没有采取纠正措施(AOR 7.1)和试剂不可用(AOR 6.1)对 PT 性能有显著影响(p<0.001)。本研究结果表明,实验室的整体性能较低。报告 PT 结果没有适当的测量单位和对 PT 不合格不采取纠正措施是导致高失败率的主要加重因素。