학술논문
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]
Document Type
article
Author
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; Robinson Cheruiyot
Source
Wellcome Open Research, Vol 6 (2022)
Subject
Language
English
ISSN
2398-502X
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.