Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings: A Health Program Evaluation Framework Case Study From East Africa.
Repository Usage Stats
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.
Published Version (Please cite this version)10.1093/ajcp/aqw083
Publication InfoAfwamba, IA; Crump, John Andrew; Karia, Francis; Muiruri, Charles; Musyoka, AM; Omondi, MW; ... Zhang, HL (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.
More InfoShow full item record
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
Medical Instructor in the Department of Population Health Sciences
Dr. Muiruri is a health services researcher, Medical Instructor 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. Prior to joining Duke faculty, Charles worked in various Global Health operations and leadership roles within the Duke for over 10 years.Broadly, his research seeks to improve the quality of healthcare and reduce dispa
Alphabetical list of authors with Scholars@Duke profiles.