Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings: A Health Program Evaluation Framework Case Study From East Africa.
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.
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https://hdl.handle.net/10161/13755Published Version (Please cite this version)
10.1093/ajcp/aqw083Publication Info
Zhang, Helen L; Omondi, Michael W; Musyoka, Augustine M; Afwamba, Isaac A; Swai, Remigi
P; Karia, Francis P; ... Rubach, Matthew P (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.
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Show full item recordScholars@Duke
John Andrew Crump
Adjunct Professor in the Department of Medicine
I am based in northern Tanzania where I am Site Leader for Duke University’s
collaborative research program based at Kilimanjaro Christian Medical Centre and Director
of Tanzania Operations for the Duke Global Health Institute. I oversee the design
and implementation of research studies on infectious diseases, particularly febrile
illness, invasive bacterial disease, HIV-associated opportunistic infections, clinical
trials of antiretroviral therapy and prevention of mother-to-child tr
Charles Muiruri
Assistant Professor of Population Health Sciences
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 non
Matthew P. Rubach
Associate Professor of Medicine
Helen Zhang
House Staff
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