Kenya Medical Research Institute, Mbagathi Road Off Mbagathi Way, Nairobi, Kenya.
Pan Afr Med J. 2023 Oct 17;46:60. doi: 10.11604/pamj.2023.46.60.39549. eCollection 2023.
accreditation is the most effective approach to ensure the quality of services. Laboratory performance can be evaluated using the World Health Organization (WHO)-SLIPTA checklist, which checks a laboratory´s compliance with ISO 15189 on a five-star score scale and improved using the SLMTA approach. Compliance is assessed by an external body and can result in accreditation. In this paper, we describe the steps taken by the Kenya Medical Research Institute (KEMRI) HIV Laboratory, Alupe, a resource-limited public entity, towards accreditation, and discuss the lessons learned.
the laboratory adopted a SLMTA-SLIPTA approach that included targeted mentorship, on-site workshops, and training. Mentorship-based interventions were used to establish a robust quality management system. Targeted mentorship, on-site workshops, and training were conducted between September 2015 and July 2016. Audits used the SLIPTA checklist to detect gaps in 12 quality system essentials. Performance indicators including turnaround time, external quality assurance, sample rejection rates, and corrective actions were tracked. An external assessment by the national accreditation body was conducted between September 2016 and November 2016.
training and mentorship-based interventions were successfully conducted. Quality management systems aligned with ISO 15189 were established. Baseline, midterm, and exit audits yielded scores of 47%, 75%, and 94% respectively. Early infant diagnosis external quality assurance scores were 100% in 2014-2016, while average viral load scores were at 60%, 70% and 90% during the same period. Turnaround time from September 2015 surpassed the 80% target. Accreditation was awarded in March 2017.
the SLMTA-SLIPTA approach is suitable for quality improvement in resource-limited laboratories.
认证是确保服务质量的最有效方法。可以使用世界卫生组织（WHO）-SLIPTA 清单来评估实验室的性能，该清单通过五星级评分来检查实验室对 ISO 15189 的合规性，并通过 SLMTA 方法进行改进。合规性由外部机构进行评估，并可能导致认证。在本文中，我们描述了肯尼亚医学研究所（KEMRI）HIV 实验室（Alupe）作为一个资源有限的公共实体，在认证方面所采取的步骤，并讨论了所获得的经验教训。
该实验室采用了 SLMTA-SLIPTA 方法，其中包括有针对性的指导、现场研讨会和培训。基于指导的干预措施用于建立强大的质量管理体系。针对性指导、现场研讨会和培训于 2015 年 9 月至 2016 年 7 月进行。使用 SLIPTA 清单进行审核，以发现 12 个质量体系要素中的差距。跟踪了包括周转时间、外部质量保证、样本拒收率和纠正措施在内的绩效指标。国家认证机构于 2016 年 9 月至 11 月进行了外部评估。
培训和基于指导的干预措施成功进行。建立了符合 ISO 15189 的质量管理体系。基线、中期和期末审核的得分分别为 47%、75%和 94%。2014-2016 年，早期婴儿诊断外部质量保证得分均为 100%，而同期病毒载量平均得分分别为 60%、70%和 90%。2015 年 9 月以来，周转时间超过了 80%的目标。2017 年 3 月获得认证。
SLMTA-SLIPTA 方法适合资源有限的实验室的质量改进。
