School of Biomedical and Laboratory Science, College of Medicine and Health Science, University of Gondar, Gondar, Ethiopia.
Department of Medical Laboratory Sciences, College of Health Science, Addis Ababa University, Addis Ababa, Ethiopia.
Am J Clin Pathol. 2018 Aug 30;150(4):303-309. doi: 10.1093/ajcp/aqy049.
The World Health Organization African Regional Office recommends ISO 15189 standards to improve performance quality in sub-Saharan African laboratories. We specify challenges Ethiopian laboratorians encountered applying ISO 15189 standards.
From a structured survey at 12 Ethiopian government hospitals, 175 laboratory staff replied; all were aware of the ISO standards and 138 had been involved in the ISO 15189 inspection process. In addition, 11 laboratory heads, 10 quality officers, and three medical directors were interviewed in depth.
Half or more respondents identified six challenges obstructing accreditation to a "large" or "very large" degree: (1) low management support, (2) inadequate training, (3) insufficient infrastructure, (4) excessive documentation, (5) little mentorship, and (6) increased accreditation-related workload. Interviewees added (7) poor equipment, (8) unavailable/poor-quality reagents, and (9) high staff turnover.
The survey and interviews specified nine major challenges for Ethiopian government hospital laboratories that seriously obstruct meeting ISO 15189 demands.
世界卫生组织非洲区域办事处建议采用 ISO 15189 标准，以提高撒哈拉以南非洲实验室的性能质量。我们具体说明了埃塞俄比亚实验室人员在应用 ISO 15189 标准时遇到的挑战。
在对 12 家埃塞俄比亚政府医院进行的结构化调查中，有 175 名实验室工作人员做出了回应；所有人都了解 ISO 标准，其中 138 人参与了 ISO 15189 检查过程。此外，还对 11 名实验室主任、10 名质量官员和 3 名医疗主任进行了深入访谈。
半数或更多的受访者认为有六项挑战在很大程度上或非常大程度上阻碍了认证：（1）管理层支持不足，（2）培训不足，（3）基础设施不足，（4）文件过多，（5）指导很少，（6）与认证相关的工作量增加。受访者还补充了（7）设备差，（8）试剂不可用/质量差，（9）员工流动率高。
调查和访谈具体说明了埃塞俄比亚政府医院实验室面临的九个主要挑战，这些挑战严重阻碍了满足 ISO 15189 要求。
