Maintaining laboratory quality assurance and safety in a pandemic: Experiences from the KEMRI-Wellcome Trust Research Programme laboratory’s COVID-19 response

Laboratory diagnosis plays a critical role in the containment of pandemic. Strong laboratory quality management systems (QMS) are essential for diagnostic services. However, low capacities resource-limited countries has made maintenance assurance, especially during pandemic, daunting task. In this paper, we describe our experience how went about providing testing services SARS-CoV-2 through reorganization, redefining workflow, and training development COVID-19 documented procedures, all while maintaining assurance processes pandemic at Kenya Medical Research Institute (KEMRI) Wellcome Trust Programme (KWTRP) laboratory. The KWTRP managed to respond outbreak by coastal region country, its research standard processes. A team comprising seven sub-teams with assigned specific responsibilities an organizational chart established reporting lines were developed. Additionally, total four sessions conducted county Rapid Response Teams (RRTs) personnel. 11 procedures developed support processes, three pre-analytical phases, analytical phase, one post-analytical phase. With workflow re-organization, appropriate operating training, laboratories can effectively outbreaks QMS procedures.