Fundamentals of method evaluation and validation
3.0 ACCENT credits / 3.0 CME credits
Sunday, July 27, 2025
Morning course | 9 a.m. – 12 p.m. US Central Time
McCormick Place Chicago
Description
Analytical evaluation of clinical laboratory assays is a useful and required process to ensure high quality patient results. However, method evaluation requirements are open to interpretation and vary based on the classification and type of assay.
This course covers the essential requirements of method validation and verification in the clinical laboratory. The course reviews the importance and approach to setting performance standards for method evaluations, and explains how to define quality goals, how to collect and analyze data, and how to determine the acceptability of the assay. Clinical chemistry and urinalysis cases will be used to illustrate applications and foster discussion about challenges and troubleshooting method evaluation processes. Audience polling and group discussions will be used throughout the course to test knowledge, ask questions, and share commons experiences with method evaluations.
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.
Presentation level
Basic
Prerequisite knowledge
General knowledge in laboratory medicine and familiarity with method evaluation principles will be helpful, but not required.
What to bring
A laptop or personal device for notetaking and audience participation.
Learning objectives
After participating in this course, participants will be able to:
- Define quality goals for clinical laboratory methods and understand 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.
Skills you will gain
- Setting and conducting key steps required in a method evaluation.
- Establishing quality goals for method evaluation experiments.
- Creating a method evaluation plan for FDA-approved tests, including establishing quality goals and evaluating if data meets those goals.
Faculty
Stacy Kenyon, PhD, DABCC, NRCC | Phoenix Children's Hospital
David Koch, PhD, DABCC, FADLM | Emory University/Grady Memorial Hospital
Kornelia Galior, PhD, DABCC | Emory University
Course outline
- (5 min) Welcome and introductions (Stacy Kenyon)
- (45 min) The essence of method evaluation and the wisdom of establishing performance standards (David Koch)
Dr. Koch will define quality goals, discuss their importance in method evaluation, and share practical resources for clinical laboratorians in goal-setting. Participants will learn the about the key advantages and limitations for these resource as well as their applications. Participants will also breakout into group discussions. Audience polling will be used throughout to share and test knowledge.
(5 min) Break
- (50 min) Developing the method evaluation plan and analyzing the data in terms of allowable error (Kornelia Galior)
Dr. Galior will dive into the essentials of method evaluations using real-world examples of FDA approved and non-FDA approved tests to compare and contrast processes. Dr. Galior will teach participants how to properly design method evaluation studies from writing a protocol and collecting the data to writing a summary of findings. Participants will have direct opprtunities to actively participate in the analysis of results and in making decisions on the data acceptability. Practical solutions to the problems commonly encountered during method evaluations will be included. Audience polling will be used throughout to share and test knowledge.
(5 min) Break
- (50 min) Navigating practical challenges during method verification: Experiences from non-academic laboratories (Stacy Kenyon)
Dr. Kenyon will use a case-based approve to lead participants through an interactive discussion and illustrate practical challenges laboratories may experience during method evaluation. Dr. Kenyon will use data from successful and problematic studies in non-academic and/or low volume clinical laboratories to highlight challenges, solutions, and facilitate group discussion. Participants in dive into challenges and cases such as:
• Method comparisons not meeting acceptance criteria
• Addressing reference intervals when changing instruments, and requirements for verifying alternate specimen types
• Variability in results between assay manufacturers and data interpretation impact
• Determining verification requirements and acceptance criteria for semiquantitative assays that lack clear guidance
Dr. Kenyon will also use two interactive discussions to guide small group breakouts that will outline method verification experiments and acceptance criteria (one quantitative assay and one qualitative assay).
- (20 min) Q&A panel and closing
Faculty will review key take-home messages, actionable practice changes, and resources. Faculty will open the room for audience questions that were not already addressed in prior course sections.
