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.
TopBackground: Iso 15189 ‑ An Overview
The Working Group 1 of the Technical Committee ISO/TC 212, established in 1995, published the first edition of an international standard intended for medical laboratories known as ISO 15189 “Medical laboratories – Requirements for quality and competence” (ISO, 2003). To meet the needs of laboratories in the healthcare sector, ISO 15189 adopted the competency requirements of ISO 9001 and the quality system of ISO/IEC 17025.
ISO/IEC 17025, first issued in 1991, is the main ISO standard adopted and used by calibration and testing laboratories and is titled “General requirements for the competence of testing and calibration laboratories” (Akyar, 2009; ISO, 17025). ISO 9001, published in 1987, is adopted and used by organizations as it identifies requirements for a quality management system (QMS). It ensures that it reliably and consistently provides services and products that meet the expectations and requirements of regulatory bodies and customers (ISO, 1987).
Key Terms in this Chapter
Quality: Quality as it relates to laboratory is defined as accuracy, precision, reliability and acceptable turnaround time of test results.
Medical Laboratory: A medical or clinical laboratory is a place where tests on biological samples are performed in order to obtain information about an individual health’s relating to screening, diagnosis, therapeutic monitoring and disease prevention.
Competence: In relation to medical laboratory it is the capacity to execute activities according to well defined procedures resulting in testing results that are timely and accurate.
Strengthening Laboratory Management Toward Accreditation (SLMTA): A structured task-based laboratory program which train and mentor managers in resource-limiting settings to establish practical quality management systems yielding accurate and reliable results which support optimal patient care.
ISO15189: 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.
Accreditation: Accreditation relating to medical laboratory is a procedure by which there is formal recognition of technical competence to perform particular types of clinical testing, calibration of equipment and measurement thereby creating confidence in results.