Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory – Mwanza, Tanzania
Background: 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 laborator...
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| Format: | Article |
| Language: | English |
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AOSIS
2018-07-01
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| Series: | African Journal of Laboratory Medicine |
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| Online Access: | https://ajlmonline.org/index.php/ajlm/article/view/657 |
| _version_ | 1828398694334988288 |
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| author | Medard Beyanga Lisa Gerwing-Adima Kahima Jackson Benjamin Majaliwa Henrico Shimba Simon Ezekiel Charles Massambu Dickson Majige Michael Mwasegaka Wilson Mtotela Patrick Mateta Christa Kasang |
| author_facet | Medard Beyanga Lisa Gerwing-Adima Kahima Jackson Benjamin Majaliwa Henrico Shimba Simon Ezekiel Charles Massambu Dickson Majige Michael Mwasegaka Wilson Mtotela Patrick Mateta Christa Kasang |
| author_sort | Medard Beyanga |
| collection | DOAJ |
| description | Background: 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).
Objective: The aim of this article is to share experience from Bugando Medical Centre laboratory’s milestones in reaching ISO 15189 accreditation.
Methods: 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.
Results: 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%.
Conclusion: 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. |
| first_indexed | 2024-12-10T09:05:30Z |
| format | Article |
| id | doaj.art-89b4e5fb1a974bd7812468b44d1abae4 |
| institution | Directory Open Access Journal |
| issn | 2225-2002 2225-2010 |
| language | English |
| last_indexed | 2024-12-10T09:05:30Z |
| publishDate | 2018-07-01 |
| publisher | AOSIS |
| record_format | Article |
| series | African Journal of Laboratory Medicine |
| spelling | doaj.art-89b4e5fb1a974bd7812468b44d1abae42022-12-22T01:55:09ZengAOSISAfrican Journal of Laboratory Medicine2225-20022225-20102018-07-0171e1e610.4102/ajlm.v7i1.657191Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory – Mwanza, TanzaniaMedard Beyanga0Lisa Gerwing-Adima1Kahima Jackson2Benjamin Majaliwa3Henrico Shimba4Simon Ezekiel5Charles Massambu6Dickson Majige7Michael Mwasegaka8Wilson Mtotela9Patrick Mateta10Christa Kasang11Department of Clinical Laboratory Services, Bugando Medical Center, MwanzaDepartment of Clinical Laboratory Services, Bugando Medical Center, MwanzaDepartment of Clinical Laboratory Services, Bugando Medical Center, MwanzaDepartment of Clinical Laboratory Services, Bugando Medical Center, MwanzaDepartment of Clinical Laboratory Services, Bugando Medical Center, MwanzaDepartment of Clinical Laboratory Services, Bugando Medical Center, MwanzaTanzania Ministry of Health Community Development, Gender, Elderly and Children, DodomaTanzania Ministry of Health Community Development, Gender, Elderly and Children, DodomaUS Centers for Disease Control and Prevention, Dar es SalaamClinical and Laboratory Standards Institute, Wayne, New JerseyClinical and Laboratory Standards Institute, Wayne, New JerseyMedical Mission Institute, Wuerzburg, BavariaBackground: 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). Objective: The aim of this article is to share experience from Bugando Medical Centre laboratory’s milestones in reaching ISO 15189 accreditation. Methods: 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. Results: 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%. Conclusion: 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.https://ajlmonline.org/index.php/ajlm/article/view/657LaboratoryqualitymanagementaccreditationTanzaniaAfricaQMS |
| spellingShingle | Medard Beyanga Lisa Gerwing-Adima Kahima Jackson Benjamin Majaliwa Henrico Shimba Simon Ezekiel Charles Massambu Dickson Majige Michael Mwasegaka Wilson Mtotela Patrick Mateta Christa Kasang Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory – Mwanza, Tanzania African Journal of Laboratory Medicine Laboratory quality management accreditation Tanzania Africa QMS |
| title | Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory – Mwanza, Tanzania |
| title_full | Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory – Mwanza, Tanzania |
| title_fullStr | Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory – Mwanza, Tanzania |
| title_full_unstemmed | Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory – Mwanza, Tanzania |
| title_short | Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory – Mwanza, Tanzania |
| title_sort | implementation of the laboratory quality management system iso 15189 experience from bugando medical centre clinical laboratory mwanza tanzania |
| topic | Laboratory quality management accreditation Tanzania Africa QMS |
| url | https://ajlmonline.org/index.php/ajlm/article/view/657 |
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