1. Maintaining laboratory quality assurance and safety in a pandemic: Experiences from the KEMRI-Wellcome Trust Research Programme laboratory’s COVID-19 response [version 2; peer review: 2 approved]
- Author
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Shadrack Mutua, Brian Bartilol, Debra Riako, Lydia Nyamako, Angela Karani, Daisy Mugo, Brian Tawa, Michael Opiyo, Wesley Cheruiyot, Metrine Tendwa, Oscar Kai, Caroline Ngetsa, Yiakon Sein, Nelson Ouma, Arnold W. Lambisia, Bonface M. Gichuki, Boniface Karia, John M. Morobe, Shaban Mwangi, Benjamin Tsofa, Philip Bejon, Alfred Mwakubia, Fredrick Mitsanze, Kelly Ominde, Patience Kiyuka, Martin Rono, Johnstone Makale, Agnes Mutiso, Perpetual Wanjiku, Victor Osoti, John N. Gitonga, Alfred Mwanzu, Calleb Odundo, Martin Mutunga, Salim Mwarumba, Donwilliams O. Omuoyo, Amek Nyaguara, Clement Lewa, Elijah Gicheru, Wilson Gumbi, Jennifer Musyoki, Susan Njuguna, Moses Mosobo, Lynette Isabella Ochola-Oyier, Horace Gumba, Wilfred Nyamu, Khadija Said Mohammed, Janet Thoya, Edward Otieno, Domtila Kimani, Jedidah Mwacharo, David Amadi, Charles N. Agoti, Zaydah R. de Laurent, and Robinson Cheruiyot
- Subjects
Quality management system ,laboratory pandemic response ,quality assurance ,coronavirus disease ,COVID-19 testing ,COVID-19 pandemic ,eng ,Medicine ,Science - 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.
- Published
- 2022
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