ISO 15189 Medical laboratories - Requirements for quality and competence is an international standard that stipulates the quality management system particularly the management and technical requirements of clinical laboratories. It is used to assess the competence of medical laboratories by regulating authorities, accreditation bodies and healthcare providers.
Published in Chapter:
Accreditation of Medical Laboratories: Challenges and Opportunities
Donovan McGrowder (Department of Pathology, Faculty of Medical Sciences, The University of the West Indies, Kingston, Jamaica), Dwayne Tucker (Department of Pathology, Faculty of Medical Sciences, The University of the West Indies, Kingston, Jamaica), Fabian G. Miller (Faculty of Education, The Mico University College, Kingston, Jamaica), Melisa Anderson (College of Health Sciences, University of Technology, Jamaica), Kurt Antonio Vaz (Department of Pathology, Faculty of Medical Sciences, The University of the West Indies, Kingston, Jamaica), and Lennox Anderson-Jackson (Department of Pathology, Faculty of Medical Sciences, The University of the West Indies, Kingston, Jamaica)
Copyright: © 2021
|Pages: 17
DOI: 10.4018/978-1-7998-3476-2.ch037
Abstract
Quality test results generated by medical laboratories across the globe are critical for patient diagnosis and treatment. In addition, this is an area of healthcare that requires standardization. Accreditation is the formal recognition by an authoritative body noting that the clinical laboratory has an established quality management system and is competent to carry out specific tasks related to testing. The Strengthening Laboratory Management Toward Accreditation (SLMTA) program was established to strengthen national laboratory systems and to drive improvements that are immediate and measurable in developing countries, particularly those in Sub-Saharan Africa. This review seeks to look at opportunities that can be garnered by accredited medical laboratories and challenges in seeking accreditation during the implementation and operational states of the criteria of ISO 15189:2012. It also examines the progress toward clinical laboratories becoming accredited due to the enactment of the SLMTA in resource-limited settings.