Wellcome Open Research (Mar 2022)

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]

  • 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

Journal volume & issue
Vol. 6

Abstract

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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.

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