Africa Centres for Disease Control and Prevention, African Union Commission, Roosevelt Street (Old Airport), Addis Ababa, P.O. Box 3243, Addis Ababa, Ethiopia.
Department of Medical Microbiology, Midlands State University Faculty of Medicine, Gweru, Zimbabwe.
Pan Afr Med J. 2022 Jul 14;42:204. doi: 10.11604/pamj.2022.42.204.34040. eCollection 2022.
The Africa Union (AU) Trusted Travel Initiative was introduced in 2021 to support Africa Union member states enhance their current health screening systems. Trusted Travel offers an online digital platform for the verification and authentication of COVID-19 results based on a collaborative effort across a network of participating COVID-19 testing laboratories. In this paper, we describe the certification process of laboratories to qualify for listing on the AU Trusted Travel platform as approved and recognized COVID-19 testing facilities. A checklist prepared from the ISO15189: 2012, ISO15190: 2020 and World Health Organization Laboratory Safety Manual, 4 edition was used to audit laboratories. Approved auditors completed the audit checklist through reviewing laboratory documents and records, observing laboratory operations whilst asking open-ended questions to clarify documentation seen and observations made. A laboratory was recommended for certification after scoring at least 90%. Between May and September 2021, a total of 26 (19%) of the 134 medical laboratories authorized for SARS-CoV-2 testing had been audited for CoLTeP certification in Zimbabwe. The majority 16 (62%) attained 5 stars rating with 10 (38%) attaining 0-4 stars. Performance was highest in the area of test result and data management (mean score 93%, SD 9.1). The least performance of the laboratories was on the laboratory biosafety and biosecurity (mean score 73%, SD 17.0) and Quality Control and Assurance (mean score 71%, SD 15.0). There is need for laboratories to commit their resources to quality assurance programs and training of laboratory personnel in biosafety and biosecurity as part of continuous quality improvement.
非洲联盟(AU)可信旅行倡议于 2021 年推出,旨在支持非洲联盟成员国加强其当前的健康筛查系统。可信旅行提供了一个在线数字平台,用于根据参与 COVID-19 检测实验室网络的合作努力验证和认证 COVID-19 结果。在本文中,我们描述了实验室的认证过程,以符合在 AU 可信旅行平台上列出的条件,成为获得认可的 COVID-19 检测设施。从 ISO15189:2012、ISO15190:2020 和世界卫生组织实验室安全手册,第 4 版准备的检查表用于审核实验室。经过审核的审核员通过审查实验室文件和记录、观察实验室操作并提出开放式问题来澄清所看到的文件和观察结果来完成审核检查表。实验室得分至少为 90%后,即可推荐认证。2021 年 5 月至 9 月期间,在津巴布韦,共有 26 家(19%)获得 SARS-CoV-2 检测授权的 134 家医疗实验室接受了 CoLTeP 认证审核。其中 16 家(62%)获得了 5 星级评级,10 家(38%)获得了 0-4 星级评级。在测试结果和数据管理方面表现最佳(平均得分 93%,SD 9.1)。实验室在实验室生物安全和生物安保(平均得分 73%,SD 17.0)和质量控制和保证(平均得分 71%,SD 15.0)方面的表现最差。实验室有必要将资源投入到质量保证计划和实验室人员的生物安全和生物安保培训中,作为持续质量改进的一部分。