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, 2016 Aug.
Article
em En
| MEDLINE
| ID: mdl-27473737
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Garantia da Qualidade dos Cuidados de Saúde
/
Avaliação de Programas e Projetos de Saúde
/
Países em Desenvolvimento
/
Serviços de Laboratório Clínico
Tipo de estudo:
Evaluation_studies
Aspecto:
Determinantes_sociais_saude
Limite:
Humans
País/Região como assunto:
Africa
Idioma:
En
Revista:
Am J Clin Pathol
Ano de publicação:
2016
Tipo de documento:
Article