Beyanga Medard, Gerwing-Adima Lisa, Jackson Kahima, Majaliwa Benjamin, Shimba Henrico, Ezekiel Simon, Massambu Charles, Majige Dickson, Mwasegaka Michael, Mtotela Wilson, Mateta Patrick, Kasang Christa
Department of Clinical Laboratory Services, Bugando Medical Center, Mwanza, Tanzania.
Tanzania Ministry of Health Community Development, Gender, Elderly and Children, Dodoma, Tanzania.
Afr J Lab Med. 2018 Jul 31;7(1):657. doi: 10.4102/ajlm.v7i1.657. eCollection 2018.
Use 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).
The aim of this article is to share experience from Bugando Medical Centre laboratory's milestones in reaching ISO 15189 accreditation.
Mentors 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.
The 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%.
Our 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.
与撒哈拉以南非洲的许多其他国家一样，在坦桑尼亚使用基于实验室证据的患者医疗保健仍然是一个复杂的问题。截至2010年，包括坦桑尼亚在内的39个非洲国家没有达到国际实验室标准（国际标准化组织[ISO]15189）最低要求的临床实验室。
本文旨在分享布甘多医疗中心实验室在获得ISO 15189认可过程中的里程碑经验。
负责解决实验室管理和技术要求的导师使用南部非洲发展共同体认可系统清单进行了差距分析。发现了几个不符合项。制定、批准并传达了系统和技术程序。建立了质量指标以衡量实验室的改进情况并识别需要立即采取和预防措施的问题。
实施ISO 15189后，各部门的外部质量评估表现有所提高（例如，寄生虫学从45%提高到100%，分子生物学从无记录提高到100%，生物化学从50%提高到95%，结核病显微镜检查从60%提高到100%，微生物学从48.1%提高到100%）。投诉从每周8起减少到2起。拒收样本从7.2%减少到1.2%。周转时间在实施前未记录，但达到了规定目标的92%（1644/1786），血培养中的污染比例从16%降至4%。
我们的经验表明，在坦桑尼亚这样资源有限的国家实施质量管理体系是可行的。指导是必要的，应由接受过质量管理体系培训的专业实验室导师进行。财政资源和积极主动的员工是获得ISO 15189认可的关键。
