The Importance of Medical Laboratory Quality and Its Impact on Patients

Abstract

Patients and clinicians often rely on laboratory tests, but how trustworthy are these results? Quality management is vital for laboratories to ensure reliable outcomes. This review focuses on external quality assessment (EQA) schemes that help laboratories improve their testing quality. It provides an overview of the significance of EQA schemes for clinical laboratories and discusses various types and providers available. Accreditation demonstrates laboratory competence, and in some regions, it is or will be mandatory. It acts as a motivator for maintaining quality systems and improving service standards for patients and physicians. Accreditation, an independent process, formally recognizes a body's ability to perform specific tasks. The ISO 15189 standard is the most recognized accreditation for clinical laboratories in Europe. The 2012 version offers enhanced definitions related to patient safety, structured through processes. Key areas include automated reporting, biological reference intervals, and quality indicators. All lab processes prioritize patient welfare, with clearly defined responsibilities for sample handling and result transfer between laboratories. Identifying risks to patient safety and lab processes is crucial for mitigation. Labs need to establish quantitative quality indicators and review all processes regularly, ensuring confidentiality of information. Continual improvement of the quality management system, including corrective and preventive actions, should focus on high-priority areas identified through risk assessments.