Establishing a sustainable quality management system in a public clinical laboratory: The case of Mbagathi Hospital Laboratory in Kenya

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Background: Between 2021 and 2023, the Association of Public Health Laboratories, in collaboration with the US Centers for Disease Control and Prevention in Kenya, initiated a laboratory improvement programme at the Mbagathi Hospital Laboratory by establishing a molecular assay to respond to the SAR-CoV-2 outbreak in the country and a quality management system (QMS) to improve the quality of laboratory services and processes. Intervention: Interventions were implemented through the procurement of molecular equipment, supplies, and staff capacity development through training and mentorship. Baseline, midterm, and end-term assessments were conducted, and data were collected using the World Health Organization Regional Office for Africa, Stepwise Laboratory Improvement Program Towards Accreditation tool, version 2015. Data were collected, analysed, and presented in graphs and tables. Lessons learnt: Transitioning to a self-sustaining model requires both financial autonomy and decentralised leadership. Empowering section heads, as quality leads, ensured operational continuity, even during high-pressure outbreaks. However, significant constraints included intermittent reagent stock-outs due to global supply chain disruptions and high personnel workload during peak pandemic waves. These were mitigated through standardised clinic-laboratory communication and prioritised local service contracts for equipment maintenance. Recommendations: To achieve resilient accreditation, public health facilities should move towards integrated financial models that leverage locally generated revenue. Institutionalising QMS within core hospital governance, rather than as a donor-dependent project, is essential for long-term sustainability in resource-constrained settings. What this study adds: While previous literature has established that QMS improves service delivery, our manuscript is unique in providing a documented roadmap for turning a diagnostic laboratory into a revenue-generating entity that ensures its own supply chain stability. Mbagathi Hospital now serves as a national benchmark, with other county hospitals seeking to emulate its model of efficient resource utilisation.

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