SLMTA dataset 2023.

IntroductionThe increase in demand of laboratory services and recent advancements in laboratory technologies underscore the importance of quality laboratory services in delivering accurate, reliable, and timely test results. As a strategy to ensure quality laboratory services in the country, Tanzania started to implement Strengthening Laboratory Management Towards Accreditation (SLMTA) program in 2010. We describe the revolutions made in laboratory quality management system across the 13 years of SLMTA implementation highlighting the impact and achievements attained following the modification of the generic SLMTA approach.MethodologyWe evaluated, described and summarized the 13 years of SLMTA implementation in Tanzania and the quality performance of medical laboratories enrolled into the program. The quality performance was evaluated based on the increase in number of SLMTA laboratories accredited under ISO 15189 by comparing the laboratories enrolled during the generic versus modified SLMTA program.ResultsOut of 138 SLMTA laboratories assessed by 2023 using the SLIPTA checklist, 81 (58.7%) scored 3 stars and above were enrolled in the accreditation process. Of the 81 enrolled laboratories, 50 (61.7%) achieved ISO 15189 accreditation status by 2023. There was a significant increase in number of accredited laboratories during the five years (2018–2023) of modified SLMTA compared to the eight years (2010–2018) of generic SLMTA (47/64 vs. 3/17, p = 0.021). In the context of level of healthcare delivery, most of the accredited laboratories (n = 47/50, 94%), belonged to the district level and above.ConclusionTo the best of our knowledge, this is the first report of the modified SLMTA approach with remarkable results. The modified SLMTA program significantly improved the status and number of accredited laboratories in Tanzania. While the attained milestone demonstrates the SLMTA program’s effectiveness in strengthening quality of laboratory services, the significant achievements underscore the essence of monitoring, evaluation and learning of the implemented programs, and most importantly the need for strategies that contextualize and tailor the program for sustainability.引言 实验室服务需求的持续增长与实验室技术的新近迭代，凸显了优质实验室服务在提供准确、可靠且及时的检测结果中的核心价值。为保障本国实验室服务质量，坦桑尼亚于2010年启动了加强实验室管理以实现认证（Strengthening Laboratory Management Towards Accreditation, SLMTA）项目。本研究梳理了SLMTA项目实施13年来实验室质量管理体系的变革历程，重点阐述了通用型SLMTA方案优化后所产生的实践成效与影响力。 研究方法 本研究对坦桑尼亚SLMTA项目13年的实施历程，以及参与该项目的医学实验室的质量表现进行了评估、梳理与总结。质量表现的评估维度为获得ISO 15189认证的SLMTA实验室数量增长情况，通过对比参与通用型SLMTA项目与优化型SLMTA项目的实验室数据完成评估。 结果 截至2023年，共有138家SLMTA实验室通过实验室绩效改进工具检查表（SLIPTA checklist）完成评估，其中81家（58.7%）获得3星及以上评分的实验室进入认证流程。在这81家进入认证流程的实验室中，有50家（61.7%）于2023年成功获得ISO 15189认证资质。与2010-2018年通用型SLMTA阶段的8年相比，2018-2023年优化型SLMTA阶段的5年内，获得认证的实验室数量实现了显著增长（47/64 vs. 3/17，p=0.021）。从医疗服务层级来看，获得认证的实验室中绝大多数（n=47/50，94%）属于区级及以上层级。 结论 据我们所知，本研究是首个报道优化型SLMTA项目取得显著成效的研究。优化型SLMTA项目显著提升了坦桑尼亚获得认证的实验室数量与资质等级。尽管本次取得的阶段性成果证明了SLMTA项目在强化实验室服务质量方面的有效性，但本次显著成就也凸显了对已实施项目进行监测、评估与学习的核心意义，更重要的是，亟需制定适配本土场景、定制化的方案以保障项目可持续性。