Introduction to risk management frameworks in clinical laboratories

Previous articles on measurement uncertainty, statistical quality control and method comparison studies have had a statistical basis for managing quality in medical laboratories. This next series is going to take these concepts to the next level – demonstrating how they reduce risk of clinical harm to our patients when implemented properly. We start with a gentle introduction to risk management here, then move onto the tools and interpretation of our processes in the context of risk in future articles. 

In medical laboratories, risk management is an essential element for ensuring reliable results and safeguarding patient safety. This has always been the focus for us in the laboratory, but the transition to ISO 15189:2022 has solidified this link, with a focus very much on clinical risk. ISO 15189:2022 and ISO 22367:2020 guide laboratories with systematic approaches to identify, evaluate and control risks throughout the entire testing process. 

ISO 15189:2022 establishes a comprehensive framework for embedding risk management into the operations of medical laboratories. This standard ensures that risk is identified, evaluated and mitigated across all phases of the laboratory testing process, enabling laboratories to deliver reliable results while minimising the potential for harm to patients. ISO 22367 offers the methodology for identifying hazards, assessing their potential impacts, and implementing controls to mitigate risks.