Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings: A Health Program Evaluation Framework Case Study From East Africa.
Date
2016-08
Journal Title
Journal ISSN
Volume Title
Repository Usage Stats
views
downloads
Citation Stats
Abstract
OBJECTIVES: Using a clinical research laboratory as a case study, we sought to characterize barriers to maintaining Good Clinical Laboratory Practice (GCLP) services in a developing world setting. METHODS: Using a US Centers for Disease Control and Prevention framework for program evaluation in public health, we performed an evaluation of the Kilimanjaro Christian Medical Centre-Duke University Health Collaboration clinical research laboratory sections of the Kilimanjaro Clinical Research Institute in Moshi, Tanzania. Laboratory records from November 2012 through October 2014 were reviewed for this analysis. RESULTS: During the 2-year period of study, seven instrument malfunctions suspended testing required for open clinical trials. A median (range) of 9 (1-55) days elapsed between instrument malfunction and biomedical engineer service. Sixteen (76.1%) of 21 suppliers of reagents, controls, and consumables were based outside Tanzania. Test throughput among laboratory sections used a median (range) of 0.6% (0.2%-2.7%) of instrument capacity. Five (55.6%) of nine laboratory technologists left their posts over 2 years. CONCLUSIONS: These findings demonstrate that GCLP laboratory service provision in this setting is hampered by delays in biomedical engineer support, delays and extra costs in commodity procurement, low testing throughput, and high personnel turnover.
Type
Department
Description
Provenance
Citation
Permalink
Published Version (Please cite this version)
Publication Info
Zhang, Helen L, Michael W Omondi, Augustine M Musyoka, Isaac A Afwamba, Remigi P Swai, Francis P Karia, Charles Muiruri, Elizabeth A Reddy, et al. (2016). Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings: A Health Program Evaluation Framework Case Study From East Africa. Am J Clin Pathol, 146(2). pp. 199–206. 10.1093/ajcp/aqw083 Retrieved from https://hdl.handle.net/10161/13755.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
Collections
Scholars@Duke
Charles Muiruri
Dr. Muiruri is a health services researcher, Assistant Professor in the Duke Department of Population Health Sciences, Assistant Research Professor in the Global Health Institute, and Adjunct lecturer at the Kilimanjaro Christian Medical University College, Moshi Tanzania.
Broadly, his research seeks to improve the quality of healthcare and reduce disparities for persons with multiple chronic conditions both in and outside the United States. His current work focuses on prevention of nonAIDS comorbidities among people living with HIV. His current projects funded by NIAID, NHLBI and NIMHD focus on improving the quality of cardiovascular disease prevention and care among people living with HIV in North Carolina and Tanzania.
Areas of Expertise: Mixed methods, Qualitative methods, Applied Econometrics in Health services Research, Preference research, Implementation Science, Global Health, Health Policy
John Andrew Crump
I am an Adjunct Professor of Medicine, Pathology, and Global Health. My work with Duke University is primarily based in northern Tanzania where I am former Site Leader and current Principal Investigator on projects linked to Duke University’s collaborative research program at Kilimanjaro Christian Medical Centre. I oversee the design and implementation of research studies on infectious diseases, particularly febrile illness, invasive bacterial disease, zoonotic infections, and infectious diseases diagnostics. In addition, I am Professor of Medicine, Pathology, and Global Health at the University of Otago and a medical epidemiologist with the US Centers for Disease Control and Prevention (CDC). My CDC work focuses on non-malaria febrile illness.
Matthew P. Rubach
Unless otherwise indicated, scholarly articles published by Duke faculty members are made available here with a CC-BY-NC (Creative Commons Attribution Non-Commercial) license, as enabled by the Duke Open Access Policy. If you wish to use the materials in ways not already permitted under CC-BY-NC, please consult the copyright owner. Other materials are made available here through the author’s grant of a non-exclusive license to make their work openly accessible.