Enduring Leveraging Lessons from the Past Webinar: Environmental Conditions Risk Assessment of the Clinical Laboratory

Course overview

This webinar will provide an overview of a practical strategy used to support compliance with CAP and CLIA requirements for temperature and humidity control of instruments and equipment used in laboratory testing systems. Participants will review the new CAP COM.30580 humidity checklist requirement, along with related existing standards, and discuss what these requirements mean for clinical laboratories. The presentation will introduce the Environmental Conditions Risk Assessment (ECRA) tool, a resource designed to help laboratories document acceptable temperature and humidity thresholds, assess the risk associated with environmental excursions, and record mitigation strategies when excursions occur. We will also include a demonstration of the ECRA tool and share examples of instrument and equipment entries from multiple laboratories, offering practical approaches that attendees can adapt for their own compliance and quality programs. Learning Objectives: 1. Assess CAP and CLIA standards for environmental conditions in the clinical laboratory. 2. Describe methods of determining upper and lower thresholds for temperature and humidity. 3. Evaluate potential risks associated with operating laboratory instruments and equipment outside of manufacturer-identified environmental conditions. 4. Review an electronic tool designed for laboratories to record environmental thresholds and demonstrate use of the tool.