Connect Sign InMethod Validation and Verification
This presentation will provide an understanding of the fundamental concepts of method/assay verification and validation. Which studies are required by CLIA regulations based on waived versus nonwaived test categorization will be defined, as well as best laboratory practices for meeting each of the requirements. Practical application of these concepts will be demonstrated using a recent example of an assay that was implemented at University Hospital laboratory.
Originally published on April 6, 2021.
Dr. Lauren Pearson is the co-director of clinical laboratories at the University Hospital, a medical director of the South Jordan Health Center Clinical Laboratory, and an assistant professor of pathology at the University of Utah School of Medicine. She received a master’s degree in public health and a medical degree from Touro University California. She then completed an anatomic and clinical pathology residency at the University of Vermont College of Medicine, where she also served as chief resident. Dr. Pearson is board certified in anatomic and clinical pathology, and her research interests include community health and quality management and control.
