Abstract

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

Highlights

  • Laboratory diagnosis forms an essential component of any disease outbreak (Nkengasong et al, 2018; Perkins et al, 2017; Wilson et al, 2018)

  • Development of COVID-19 testing standard operating procedures To ensure the laboratory maintains the quality assurance within the COVID-19 testing process, we developed and documented various new SOPs; and reviewed the existing ones to support the COVID-19 diagnostic testing

  • The formation of the COVID-19 team with assigned responsibilities and the redistribution of the workload across the SARS-CoV-2 testing process enhanced the maintenance of quality assurance and enabled a high standard of testing

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Summary

Introduction

Laboratory diagnosis forms an essential component of any disease outbreak (Nkengasong et al, 2018; Perkins et al, 2017; Wilson et al, 2018). Studies have shown that weak laboratory diagnostic capacity has contributed to significant delays in the identification of the recent outbreaks of Ebola (Perkins et al, 2017), Yellow Fever (Berkley, 2018), and Zika (Lowe et al, 2018). This, emphasizes the importance of investing in stronger laboratory capacity that can respond to disease outbreaks. This should include elaborate and strong quality management systems (QMS). Weak laboratory quality systems in low- and middle-income countries (LMICs) coupled with the low laboratory capacity, and the technical challenges of developing suitable diagnostic tests for pandemic prevention and containment, has made the implementation of laboratory quality assurance (QA) processes during a pandemic a daunting task (Nkengasong et al, 2018; Olmsted et al, 2010)

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