Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings:  A Health Program Evaluation Framework Case Study From East Africa.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Zhang, HL; Omondi, MW; Musyoka, AM; Afwamba, IA; Swai, RP; Karia, FP; Muiruri, C; Reddy, EA; Crump, JA; Rubach, MP

Published Date

  • August 2016

Published In

Volume / Issue

  • 146 / 2

Start / End Page

  • 199 - 206

PubMed ID

  • 27473737

Pubmed Central ID

  • PMC6410885

Electronic International Standard Serial Number (EISSN)

  • 1943-7722

Digital Object Identifier (DOI)

  • 10.1093/ajcp/aqw083


  • eng

Conference Location

  • England