External quality assurance performance of clinical research laboratories in Sub-Saharan Africa

Timothy K. Amukele, Kurt Michael, Mary Hanes, Robert E. Miller, J. Brooks Jackson

Research output: Contribution to journalArticle

Abstract

Patient Safety Monitoring in International Laboratories (JHU-SMILE) is a resource at Johns Hopkins University that supports and monitors laboratories in National Institutes of Health-funded international clinical trials. To determine the impact of the JHU-SMILE quality assurance scheme in sub-Saharan African laboratories, we reviewed 40 to 60 months of external quality assurance (EQA) results of the College of American Pathologists (CAP) in these laboratories. We reviewed the performance of 8 analytes: albumin, alanine aminotransferase, creatinine, sodium, WBC, hemoglobin, hematocrit, and the human immunodeficiency virus antibody rapid test. Over the 40- to 60-month observation period, the sub-Saharan laboratories had a 1.63% failure rate, which was 40% lower than the 2011 CAP-wide rate of 2.8%. Seventy-six percent of the observed EQA failures occurred in 4 of the 21 laboratories. These results demonstrate that a system of remote monitoring, feedback, and audits can support quality in low-resource settings, even in places without strong regulatory support for laboratory quality.

Original languageEnglish (US)
Pages (from-to)720-723
Number of pages4
JournalAmerican journal of clinical pathology
Volume138
Issue number5
DOIs
StatePublished - Nov 1 2012

Keywords

  • CAP
  • HIV
  • Laboratory
  • PEPFAR
  • Quality assurance
  • Sub-Saharan Africa

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

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