Abstract
BackgroundUse of laboratory evidence-based patient health care in Tanzania remains a complex problem, as with many other countries in sub-Saharan Africa. As at 2010, 39 African countries, including Tanzania, had no clinical laboratories that met the minimum requirements for international laboratory standards (International Organization for Standardization [ISO] 15189).ObjectiveThe aim of this article is to share experience from Bugando Medical Centre laboratory’s milestones in reaching ISO 15189 accreditation.MethodsMentors to address the laboratory management and technical requirements performed a gap analysis using the Southern African Development Community Accreditation system checklist. Several non-conformances were detected. System and technical procedures were developed, approved and communicated. Quality indicators were established to measure laboratory improvement and to identify issues which require immediate and preventive actions.ResultsThe departments’ external quality assessment performance increased after ISO 15189 implementation (e.g. Parasitology from 45% to 100%, Molecular Biology from no records to 100%, Biochemistry 50% to 95%, Tuberculosis Microscopy 60% to 100%, and Microbiology from 48.1% to 100%). There was a reduction in complaints, from eight to two per week. Rejected samples were reduced from 7.2% to 1.2%. Turn-around time was not recorded before implementation but reached 92% (1644/1786) of the defined targets, and the proportion of contamination in blood cultures decreased from 16% to 4%.ConclusionOur experience suggests that the implementation of a quality management system is possible in resource-limited countries like Tanzania. Mentorship is necessary and should be done by professional laboratory mentors trained in quality management systems. Financial resources and motivated staff are key to achieving ISO 15189 accreditation.
Highlights
Use of laboratory evidence-based patient health care in Tanzania remains a complex problem, as with many other countries in sub-Saharan Africa
External quality assessment for the Parasitology section increased from 45% before implementation of International Organization for Standardization (ISO) to 100% after implementation, the Biochemistry section performance increased from 50% to 95%, the Molecular biology section performance increased from no record to 100%, the Tuberculosis Microscopy section increased from 60% to 100%, and the Microbiology section increased from 48.1% to 100% (Table 1)
A customer survey, conducted to measure what clinicians were saying about the laboratory services, revealed that clinicians of the hospital were able to trust and make clinical decisions supported by laboratory results.[10]
Summary
Use of laboratory evidence-based patient health care in Tanzania remains a complex problem, as with many other countries in sub-Saharan Africa. The use of laboratory evidence-based patient healthcare in Tanzania remains a complex problem, as in many other countries in sub-Saharan Africa.[1] Clinicians often believe that laboratory tests are additional health costs, because diagnosis and treatment are often done using empirical clinical judgement. It has been emphasised that healthcare professionals should make clinical decisions based on the best available evidence.[3] Access to unreliable diagnostic services and misdiagnosis causes confusion during patient management, and can result in unnecessary expenditure and in some cases death.[4] There are recent global calls to provide more resources for the diagnosis, treatment and prevention of infectious diseases affecting the African population. Clinicians, financial controllers and public policy makers in resource-limited settings may be unaware of the importance of a laboratory-proven diagnosis for appropriate disease management.[4]
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