title: Experience in implementing a quality management system in a tuberculosis laboratory, Kisumu, Kenya.
abstract: We implemented a quality management system (QMS) and documented our improvements in a tuberculosis (TB) laboratory in Kisumu, Kenya. After implementation of the QMS, a sustained reduction in culture contamination rates for solid (from 15.4% to 5.3%) and liquid media (from 15.2% to 9.3%) was observed, and waste from product expiry was reduced significantly. External quality assurance (EQA) results were satisfactory before and after QMS implementation, and a client survey after implementation revealed 98% satisfaction. The laboratory attained ISO 15189 accreditation in October 2013. The implementation of QMS facilitated the attainment of target quality indicators, reduced waste due to expiry and led to high client satisfaction.
authors.affiliation: Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
authors.forename: S
authors.initials: S
authors.lastname: Musau
authors.affiliation: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.
authors.forename: K
authors.initials: K
authors.lastname: McCarthy
authors.affiliation: Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
authors.forename: A
authors.initials: A
authors.lastname: Okumu
authors.affiliation: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.
authors.forename: T
authors.initials: T
authors.lastname: Shinnick
authors.affiliation: Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.
authors.forename: S
authors.initials: S
authors.lastname: Wandiga
authors.affiliation: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.
authors.forename: J
authors.initials: J
authors.lastname: Williamson
authors.affiliation: Division of Tuberculosis Elimination, US Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA; CDC, Kisumu, Kenya.
authors.forename: K
authors.initials: K
authors.lastname: Cain
mesh_terms: D000068:Accreditation / Q000592:standards; D001431:Bacteriological Techniques / Q000592:standards*; D064790:Clinical Laboratory Services / Q000592:standards*; D003258:Consumer Behavior; D019538:Health Care Surveys; D006801:Humans; D007630:Kenya; D011237:Predictive Value of Tests; D015397:Program Evaluation; D011785:Quality Assurance, Health Care / Q000592:standards*; D011786:Quality Control; D058996:Quality Improvement / Q000592:standards*; D019984:Quality Indicators, Health Care / Q000592:standards*; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D014376:Tuberculosis / Q000175:diagnosis* / Q000382:microbiology