Fundamentals of Method Evaluation and Validation (Half Day)

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.

Target Audience

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.

Prerequisite Knowledge 

No prerequisite knowledge required. 

What to Bring

A personal laptop or other electronic device to participate in audience polling and slide review (optional). 

Learning Objectives

  • Define quality goals for clinical laboratory methods and why they are relevant during method evaluation.
  • Outline and describe requirements for method validation and verification.
  • Navigate through challenges associated with evaluating a new method or a new instrument.


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

Course Outline

  1. The Essence of Method Evaluation and the Wisdom of Establishing Performance Standards Early in the Process (55 mins.)
    This presentation will focus on defining quality goals, why this step is important in method evaluation, and what resources are available to clinical laboratory professionals for this task. The advantages and limitations for each resource will be discussed. Audience polling will be implemented throughout this section.

  2. Developing the Validation Plan and Evaluating the Data in Terms of Allowable Total Error (55 mins.)
    This presentation will cover the basics of method evaluations for FDA-approved and non-FDA-approved tests and provide examples for each study from the presenter’s institution. The audience will also participate in the analysis of the results and make decisions on the acceptability of the data. During this presentation, we will also discuss studies that are debated among laboratorians, including: what is required/recommended after moving an instrument to a new location, the validation of body fluids, and what experiments are necessary when evaluating CLIA-waived tests. Audience polling will be incorporated throughout to capture common practices among the laboratories.

  3. Navigating Practical Challenges During Method Verification: Experiences From Non-Academic Laboratories (50 mins.)
    This presentation will be a case-based and interactive discussion illustrating practical challenges that a laboratory may experience during method evaluation. Data from both successful and problematic studies will be presented and discussed, with attendees being encouraged to provide feedback and insight via audience response tools. The cases will primarily be examples from non-academic and/or low-volume clinical laboratories.

  4. Q&A (20 mins.)