Sunday, July 28, 2024 1:30 PM – 4:30 PM US Central Time McCormick Place Chicago
Analytical evaluation of clinical laboratory assays is both a regulatory requirement and a useful process to ensure the quality of patient results. Guidelines around method performance evaluation requirements are open to interpretation and vary based on the classification and type of assay. This session will cover the basic requirements of method validation and verification. The session will also review the importance of setting performance standards for method evaluations, explain how to define quality goals, how to collect and analyze data, and how to determine the acceptability of the assay using a total analytical error calculation and sigma metric approach. Cases will be used to illustrate the application of these principles and will also be used to foster discussion about challenges during the method evaluation process. Audience polling will be used throughout the course, encouraging attendees to participate in discussions, ask questions, and provide their experience with method evaluation processes.
This activity is designed for lab supervisors, lab directors (and/or assistant directors), lab managers (supervisory and/or non-supervisory), medical technologists, point-of-care coordinators, pathologists, and in-training individuals.
No prerequisite knowledge required.
A personal laptop or other electronic device to participate in audience polling and slide review (optional).
Stacy Kenyon, PhD, DABCC, NRCC | Phoenix Children's
David Koch, PhD, DABCC, FADLM | Emory University/Grady Memorial Hospital
Kornelia Galior, PhD, DABCC | Emory University/Grady Memorial Hospital
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