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

Publication ,  Journal Article
Zhang, HL; Omondi, MW; Musyoka, AM; Afwamba, IA; Swai, RP; Karia, FP; Muiruri, C; Reddy, EA; Crump, JA; Rubach, MP
Published in: Am J Clin Pathol
August 2016

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.

Duke Scholars

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Published In

Am J Clin Pathol

DOI

EISSN

1943-7722

Publication Date

August 2016

Volume

146

Issue

2

Start / End Page

199 / 206

Location

England

Related Subject Headings

  • Tanzania
  • Quality Assurance, Health Care
  • Program Evaluation
  • Pathology
  • Humans
  • Equipment Failure
  • Developing Countries
  • Clinical Laboratory Services
  • 3202 Clinical sciences
  • 11 Medical and Health Sciences
 

Citation

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Zhang, H. L., Omondi, M. W., Musyoka, A. M., Afwamba, I. A., Swai, R. P., Karia, F. P., … Rubach, M. 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), 199–206. https://doi.org/10.1093/ajcp/aqw083
Zhang, Helen L., Michael W. Omondi, Augustine M. Musyoka, Isaac A. Afwamba, Remigi P. Swai, Francis P. Karia, Charles Muiruri, Elizabeth A. Reddy, John A. Crump, and Matthew P. Rubach. “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, no. 2 (August 2016): 199–206. https://doi.org/10.1093/ajcp/aqw083.
Zhang HL, Omondi MW, Musyoka AM, Afwamba IA, Swai RP, Karia FP, et al. 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. 2016 Aug;146(2):199–206.
Zhang, Helen L., et al. “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, vol. 146, no. 2, Aug. 2016, pp. 199–206. Pubmed, doi:10.1093/ajcp/aqw083.
Zhang HL, Omondi MW, Musyoka AM, Afwamba IA, Swai RP, Karia FP, Muiruri C, Reddy EA, Crump JA, Rubach MP. 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. 2016 Aug;146(2):199–206.
Journal cover image

Published In

Am J Clin Pathol

DOI

EISSN

1943-7722

Publication Date

August 2016

Volume

146

Issue

2

Start / End Page

199 / 206

Location

England

Related Subject Headings

  • Tanzania
  • Quality Assurance, Health Care
  • Program Evaluation
  • Pathology
  • Humans
  • Equipment Failure
  • Developing Countries
  • Clinical Laboratory Services
  • 3202 Clinical sciences
  • 11 Medical and Health Sciences