title: Promoting good clinical laboratory practices and laboratory accreditation to support clinical trials in sub-Saharan Africa.
abstract: Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices.
authors.affiliation: Mali International Center for Excellence in Research, Faculty of Medicine, Pharmacy and Odonto-Stomatology, University of Bamako, Mali. agnes@icermali.org
authors.forename: Merepen A
authors.initials: MA
authors.lastname: Guindo
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Shott
authors.forename: Renion
authors.initials: R
authors.lastname: Saye
authors.forename: Moussa L
authors.initials: ML
authors.lastname: Diakité
authors.forename: Sintry
authors.initials: S
authors.lastname: Sanogo
authors.forename: Moussa B
authors.initials: MB
authors.lastname: Dembele
authors.forename: Sekouba
authors.initials: S
authors.lastname: Keita
authors.forename: Mary C
authors.initials: MC
authors.lastname: Nagel
authors.forename: Ruth D
authors.initials: RD
authors.lastname: Ellis
authors.forename: Joan A
authors.initials: JA
authors.lastname: Aebig
authors.forename: Dapa A
authors.initials: DA
authors.lastname: Diallo
authors.forename: Ogobara K
authors.initials: OK
authors.lastname: Doumbo
mesh_terms: D000068:Accreditation; D017954:Africa South of the Sahara; D035843:Biomedical Research; D019411:Clinical Laboratory Techniques / Q000592:standards*; D002986:Clinical Trials as Topic; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D007753:Laboratories / Q000458:organization & administration / Q000592:standards*; D008302:Mali; D015203:Reproducibility of Results; D017749:Total Quality Management / Q000379:methods