Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory – Mwanza, Tanzania

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.

From benchmarking to best practices: Lessons from the laboratory quality improvement programme at the military teaching hospital in Cotonou, Benin

“…Few laboratories are accredited to international quality standards, and most of these internationally accredited laboratories are based in South Africa. 4 Quality assurance, which comprises QMS including the existence of a quality manual, use of internal quality controls (IQC) and participation in external quality assessment (EQA), is poorly implemented and often unavailable in many laboratories in sub-Saharan Africa. 5,6,7 In the absence of quality assurance, there is the risk of laboratory errors, which could adversely impact patient care.…”

An overview of medical diagnostic laboratories in South Africa that meet the international standard of accreditation: ISO 15189

“…Implementation of the QMS starts with management; 21 for example, clause 4.2 states that the laboratory shall establish, document, implement and maintain a QMS. Implementation of an internal audit programme is required by clause 4.14, conducting management reviews by clause 4.15 and implementing improvement plans by clause 4.12.…”

Building resources to meet evolving laboratory medicine challenges in Africa

“…To process laboratory specimens locally, and to the highest standards, it will often be necessary to upgrade or entirely refurbish existing laboratories or plant new ones. While this prospect may be seen as difficult or even daunting, the experiences of others, such as Beyanga et al 11 and Mtisi et al 12 (both this issue) are essential for replicating success and avoiding costly pitfalls. Beyanga et al 11 outline the path of a Tanzanian diagnostic laboratory to accreditation.…”

“…While this prospect may be seen as difficult or even daunting, the experiences of others, such as Beyanga et al 11 and Mtisi et al 12 (both this issue) are essential for replicating success and avoiding costly pitfalls. Beyanga et al 11 outline the path of a Tanzanian diagnostic laboratory to accreditation. In their description of the construction of a specialised pharmacology laboratory capable of performing pharmacokinetic analyses, Mtisi et al 12 outline the process from the stage of initiating public-private international partnerships, through human resource development to preparations for ISO 15189 accreditation.…”