Open AccessMaintaining laboratory quality assurance and safety in a pandemic: Experiences from the KEMRI-Wellcome Trust Research Programme laboratory’s COVID-19 response
Author(s) -
Horace Gumba,
Michael Opiyo,
Jennifer Musyoki,
Martin Mutunga,
Caroline Ngetsa,
Salim Mwarumba,
Moses Mosobo,
Susan Njuguna,
Oscar Kai,
Arnold W. Lambisia,
Domtila Kimani,
Robinson Cheruiyot,
Patience Kerubo Kiyuka,
Clement Lewa,
Elijah Gicheru,
Metrine Tendwa,
Khadija Said Mohammed,
Victor Osoti,
Johnstone Makale,
Brian Tawa,
Calleb Odundo,
Wesley Cheruiyot,
Wilfred Nyamu,
Wilson Gumbi,
Jedidah Mwacharo,
Lydia Nyamako,
Edward Otieno,
David Amadi,
Nelson Ouma,
Boniface Karia,
Janet Thoya,
Angela Karani,
Daisy Mugo,
Bonface M. Gichuki,
Debra Riako,
Shadrack Mutua,
John N. Gitonga,
Kelly Ominde,
Perpetual Wanjiku,
Agnes Mutiso,
Alfred Mwanzu,
Yiakon Sein,
Brian Bartilol,
Shaban Mwangi,
Donwilliams O. Omuoyo,
John Mwita Morobe,
Zaydah R. de Laurent,
Fredrick Mitsanze,
Alfred Mwakubia,
Martin K. Rono,
Amek Nyaguara,
Benjamin Tsofa,
Philip Bejon,
Charles N. Agoti,
Lynette Isabella OcholaOyier
Publication year - 2021
Publication title -
wellcome open research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.298
H-Index - 21
ISSN - 2398-502X
DOI - 10.12688/wellcomeopenres.16704.1
Subject(s) - quality assurance , workflow , pandemic , standard operating procedure , medical laboratory , quality (philosophy) , good laboratory practice , medicine , covid-19 , business , operations management , engineering , nursing , computer science , pathology , external quality assessment , philosophy , disease , epistemology , database , infectious disease (medical specialty)
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.