Abstract The 2022 revision of ISO 15189 places strong emphasis on risk management as the foundation of safe and reliable clinical laboratory practice. In this context, the effective handling of critical values requires not only accurate analytical processes but also systematic methods to identify potential failures, establish reliable communication pathways, and implement technologies that support rapid and traceable actions. This review integrates current knowledge and practical reports essential for strengthening patient safety: risk-based approaches, communication strategies, and automation technologies. Risk-based approaches, including risk identification systems and stratification of critical values based on clinical risk, allow institutions to prioritize corrective measures and reduce preventable errors. Communication strategies – such as multidisciplinary collaboration and patient-centered communication – address long-standing challenges related to delayed or incomplete reporting of life-threatening results. Automation technologies, including autoverification, closed-loop notification platforms, and decision support systems, contribute to faster responses and improved documentation while reducing operator-dependent variability. Integrating these three components within a unified quality management framework enables laboratories to achieve more consistent, timely, and clinically meaningful management of critical values, ultimately supporting safer care for patients in high-risk settings.
Miura et al. (Mon,) studied this question.