Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research

Abstract

Good Clinical Laboratory Practice (GCLP) is a standard that Background: helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low-and middle-income countries may face additional challenges.This paper describes implementation of Good Clinical Methods: Laboratory Practice (GCLP) at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations.Following a baseline assessment in March 2017, training, Results: mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in How to cite this article: et al. Implementing a quality management system using good clinical laboratory Wellcome Open Research 2018, practice guidelines at KEMRI-CMR to support medical research [version 1; peer review: 2 approved] 3 :137 ( ) https://doi.org/10.12688/wellcomeopenres.14860.1 31 Oct 2018, :137 ( ) First published: 3 https://doi.org/10.12688/wellcomeopenres.14860.1 PubMed Abstract | Publisher Full Text | Free Full Text Ezzelle J, Rodriguez-Chavez IR, Darden JM, et al.: Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. J Pharm Biomed Anal. 2008; 46(1): 18-29. PubMed Abstract | Publisher Full Text | Free Full Text Gershy-Damet GM, Rotz P, Cross D, et al.: The World Health Organization African region laboratory accreditation process: improving the quality of laboratory systems in the African region. Am J Clin Pathol. 2010; 134(3): 393-400.PubMed Abstract | Publisher Full Text Gostin LO, Waxman HA, Foege W: The president's national security agenda: curtailing Ebola, safeguarding the future. JAMA. 2015; 313(1): 27-8, Publication: Bulletin of the World Health Organization; Type: Research. PubMed Abstract | Publisher Full Text Gumba H: KEMRI-CMR Data collected & analyzed.xls. figshare. Dataset. 2018. Harteloh PP: Understa...

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