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

Timothy Kien 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 2012

Fingerprint

Africa South of the Sahara
Research
National Institutes of Health (U.S.)
Physiologic Monitoring
Patient Safety
Alanine Transaminase
Hematocrit
Albumins
Creatinine
Hemoglobins
Sodium
Observation
Clinical Trials
HIV
Antibodies

Keywords

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

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

Cite this

External quality assurance performance of clinical research laboratories in Sub-Saharan Africa. / Amukele, Timothy Kien; Michael, Kurt; Hanes, Mary; Miller, Robert E; Jackson, J. Brooks.

In: American Journal of Clinical Pathology, Vol. 138, No. 5, 11.2012, p. 720-723.

Research output: Contribution to journalArticle

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