External Quality Assurance Performance of Clinical Research Laboratories in Sub-Saharan Africa

• Published in: American journal of clinical pathology Vol. 138; no. 5; pp. 720 - 723
• Main Authors: AMUKELE, Timothy K, MICHAEL, Kurt, HANES, Mary, MILLER, Robert E, BROOKS JACKSON, J
• Format: Journal Article
• Language: English
• Published: Chicago, IL American Society of Clinical Pathologists 01.11.2012; Oxford University Press
• Subjects: Africa South of the Sahara; Biological and medical sciences; Biomedical Research - standards; Human viral diseases; Humans; Immunodeficiencies; Immunodeficiencies. Immunoglobulinopathies; Immunopathology; Infectious diseases; Investigative techniques, diagnostic techniques (general aspects); Laboratories - standards; Medical sciences; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques; Patient Safety - standards; Quality Assurance, Health Care - standards; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Sub-Saharan Africa; Africa; Africa South of the Sahara; Performance evaluation; Immunopathology; Retroviridae; Clinical research; AIDS; PEPFAR; Laboratory; Immune deficiency; Lentivirus; Sub-Saharan Africa; Infection; Virus; Anatomic pathology; Quality assurance; CAP; HIV; Viral disease; External; Human immunodeficiency virus; Performance
• ISSN: 0002-9173; 1943-7722
• DOI: 10.1309/AJCP8PCM4JVLEEQR

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.