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

Autor: Horace Gumba, Perpetual Wanjiku, S J Mwangi, Clement Lewa, Agnes Mutiso, O Kai, W Gumbi, S Njuguna, John N. Gitonga, Donwilliams O. Omuoyo, Patience K. Kiyuka, Charles N. Agoti, D Riako, F Mitsanze, Salim Mwarumba, Amek Nyaguara, K Said Mohammed, Y Sein, Domtila Kimani, Z R de Laurent, Daisy Mugo, Edward Otieno, Lydia Nyamako, Lynette Isabella Ochola-Oyier, Jennifer N. Musyoki, B M Gichuki, Victor Osoti, A Mwakubia, B Tawa, A Mwanzu, Elijah Gicheru, M Rono, W Cheruiyot, Angela Karani, Metrine Tendwa, K Ominde, Johnstone Makale, Caroline Ngetsa, Boniface Karia, John M. Morobe, M Opiyo, M Mosobo, David Amadi, Martin Mutunga, W Nyamu, Benjamin Tsofa, N Ouma, Philip Bejon, Arnold W. Lambisia, Jedidah Mwacharo, Shadrack Mutua, Robinson Cheruiyot, Calleb Odundo, B Bartilol, J Thoya
Rok vydání: 2021
Předmět:
Zdroj: Wellcome Open Research. 6:205
ISSN: 2398-502X
DOI: 10.12688/wellcomeopenres.16704.1
Popis: 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.
Databáze: OpenAIRE