Method 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 waved 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

Lecture Presenter

Lauren Pearson, DO, MPH

Lauren Pearson, DO, MPH

Co-Director of Clinical Laboratories
University Hospital
Medical Director: South Jordan Health Center Clinical Laboratory
ARUP Laboratories
Assistant Professor
University of Utah School of Medicine

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.

Objectives

After this presentation, participants will be able to:

  • Identify the difference between method validation and method verification
  • Describe the studies required to document method performance
  • Interpret method performance data and statistical data outcomes

Sponsored by:

University of Utah School of Medicine, Department of Pathology, and ARUP Laboratories