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

Background: Good Clinical Laboratory Practice (GCLP) is a standard that 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. Methods: This paper describes implementation of 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. Results: Following a baseline assessment in March 2017, training, 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 May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.

[1]  Marcella Sarzotti-Kelsoe,et al.  Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL) , 2014, Journal of immunological methods.

[2]  Linda R. Andiric,et al.  One laboratory’s progress toward accreditation in Tanzania , 2014, African journal of laboratory medicine.

[3]  P. Harteloh Understanding the quality concept in health care , 2004 .

[4]  L. Gostin,et al.  The president's national security agenda: curtailing Ebola, safeguarding the future. , 2015, JAMA.

[5]  Clement Zeh,et al.  The World Health Organization African region laboratory accreditation process: improving the quality of laboratory systems in the African region. , 2010, American journal of clinical pathology.

[6]  E. Luman,et al.  Using standard and institutional mentorship models to implement SLMTA in Kenya , 2014, African journal of laboratory medicine.

[7]  D. Yach,et al.  Global health security: the wider lessons from the west African Ebola virus disease epidemic , 2015, The Lancet.

[8]  Frank H. Wians,et al.  Clinical Laboratory Tests: Which, Why, and What Do The Results Mean? , 2009 .

[9]  E. Luman,et al.  Progressing beyond SLMTA: Are internal audits and corrective action the key drivers of quality improvement? , 2014, African journal of laboratory medicine.

[10]  T. Hearn,et al.  Implementation of a quality systems approach for laboratory practice in resource-constrained countries , 2005, AIDS.

[11]  Marcella Sarzotti-Kelsoe,et al.  Evaluation and Recommendations on Good Clinical Laboratory Practice Guidelines for Phase I–III Clinical Trials , 2009, PLoS medicine.

[12]  J. Nkengasong A shifting paradigm in strengthening laboratory health systems for global health: acting now, acting collectively, but acting differently. , 2010, American journal of clinical pathology.

[13]  J. Darden,et al.  Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. , 2008, Journal of pharmaceutical and biomedical analysis.

[14]  C. Awasom,et al.  From grass to grace: How SLMTA revolutionised the Bamenda Regional Hospital Laboratory in Cameroon , 2014, African journal of laboratory medicine.