Objectives: As part of the ISO 15189:2007 accreditation process, the Aga Khan University Hospital Nairobi laboratory became the first internationally accredited hospital laboratory in sub-Saharan Africa outside South Africa in 2011 through the South Africa National Accreditation System. Methods: Seven preanalytic, 10 analytic, eight postanalytic, and five administrative performance parameters were monitored from 2009 to 2012 to measure the impact of the accreditation process. Results: Most measures in all four categories showed substantial improvement. The seven preanalytic measures all showed major improvement - between a quarter and a half sigma. Real but less dramatic improvement appeared in analytic and postanalytic measures, but greater than one sigma decrease in analytic "procedure violations" and a three-quarter sigma decrease in excessive turnaround time were noted in these categories. Administrative improvements included dramatic decreases in misdirected and missing reports and complaints. Conclusions: This study demonstrates the correlation of the accreditation process with improvement in quality measures in a low-resource region.
- ISO 15189:2007
- Medical laboratory accreditation
- Quality improvement
- South Africa National Accreditation System
- Sub-Saharan Africa
- Three-phased model