title: Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings:  A Health Program Evaluation Framework Case Study From East Africa.
abstract: OBJECTIVE
  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.
authors.affiliation: From the Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Durham, NC.
authors.forename: Helen L
authors.initials: HL
authors.lastname: Zhang
authors.affiliation: Duke Global Health Institute, Duke University, Durham, NC.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Omondi
authors.affiliation: Kilimanjaro Christian Medical Centre, Moshi, Tanzania Kilimanjaro Christian Medical University College, Moshi, Tanzania.
authors.forename: Augustine M
authors.initials: AM
authors.lastname: Musyoka
authors.affiliation: Kilimanjaro Christian Medical Centre, Moshi, Tanzania.
authors.forename: Isaac A
authors.initials: IA
authors.lastname: Afwamba
authors.affiliation: Kilimanjaro Christian Medical Centre, Moshi, Tanzania.
authors.forename: Remigi P
authors.initials: RP
authors.lastname: Swai
authors.affiliation: Kilimanjaro Christian Medical Centre, Moshi, Tanzania Kilimanjaro Christian Medical University College, Moshi, Tanzania.
authors.forename: Francis P
authors.initials: FP
authors.lastname: Karia
authors.affiliation: Duke Global Health Institute, Duke University, Durham, NC.
authors.forename: Charles
authors.initials: C
authors.lastname: Muiruri
authors.affiliation: Division of Infectious Diseases, Department of Medicine, State University of New York Upstate, Syracuse, NY.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Reddy
authors.affiliation: From the Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Durham, NC Kilimanjaro Christian Medical University College, Moshi, Tanzania Centre for International Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
authors.forename: John A
authors.initials: JA
authors.lastname: Crump
authors.affiliation: From the Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Durham, NC.
authors.forename: Matthew P
authors.initials: MP
authors.lastname: Rubach
mesh_terms: D064790:Clinical Laboratory Services / Q000592:standards*; D003906:Developing Countries; D004868:Equipment Failure / Q000706:statistics & numerical data; D006801:Humans; D015397:Program Evaluation; D011785:Quality Assurance, Health Care; D013636:Tanzania
keywords: Africa; Good Clinical Laboratory Practice; Laboratory medicine; Quality assurance