Lab supervisors; Lab directors (and/or assistant directors); Lab managers (supervisory and/or non-supervisory); Medical technologists; Point-of-Care coordinators; Pathologists; In-training individuals

Basic

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 challenges associated with evaluating a new method or a new instrument.
  
   

• Moderator: Stacy Kenyon, PhD, DABCC, NRCC, Phoenix Children's Hospital
• David Koch, PhD, DABCC, FADLM, Emory University
• Kornelia Galior, PhD, DABCC, FADLM, Emory University

(5 minutes) Welcome and Intro (Kornelia Galior)

The course will begin with an overview of the agenda, objectives, and table materials. Participants will be oriented to the interactive nature of the course.

(45 minutes) The essence of method evaluation and the wisdom of establishing performance standards (Stacy Kenyon)

Dr. Kenyon will begin with a presentation focused on defining quality goals and explaining why establishing performance standards early is a critical component of method evaluation. Available resources for setting quality goals will be reviewed, along with the advantages and limitations of each approach as they apply to clinical laboratory practice. Audience response polling questions will be used throughout to assess understanding, and small-group discussions will be incorporated to promote active participation and peer learning.

• Defining quality goals in method evaluation and resources
• Resource advantages and limitations
• Polling and small group discussion

(5 min) Break

(50 min) Developing the method evaluation plan and analyzing the data in terms of allowable error (David Koch)

Dr. Koch will present the fundamentals of method evaluation for both FDA approved and non–FDA approved tests, drawing on real examples from the presenter’s institution. This section will guide participants through the full lifecycle of a method evaluation study, including protocol development, data collection, and summarizing results. Participants will actively engage in analyzing data and determining acceptability, with discussion of practical solutions to common challenges encountered during method evaluations. Audience polling will be integrated throughout the presentation to reinforce key concepts and encourage participation.

•  Fundamentals of method evaluations for FDA approved and non-FDA approved tests with case examples
• Proper design for method evaluation studies including protocol, data collection, and summarizing findings
• Practical solutions to common problems
• Polling and audience exercises in analyzing results and decision-making

(5 min) Break

(50 min) Navigating practical challenges during method verification: Experiences from non-academic laboratories (Kornelia Galior)

Dr. Galior will lead an interactive, case-based discussion centered on real-world method verification data from non‑academic laboratory settings. Common challenges will be explored, including method comparisons that fail acceptance criteria, reference interval verification during instrument changes, verification of alternate specimen types, variability between assay manufacturers, and determining appropriate verification requirements for semi‑quantitative and qualitative assays. Audience response questions will be used throughout to stimulate discussion and assess understanding. Two small-group interactive discussions will be incorporated, during which participants will outline method verification experiments and acceptance criteria. These activities are designed to reinforce and apply concepts introduced in the earlier presentations.

• Case-based scenarios and interactive discussion on real-world scenarios
• Practical solutions to common challenges
• Polling, interactive discussions, and small group discussion

(20 min) Closing and Q&A (All)

The course will conclude with a facilitated question-and-answer session and panel discussion. This final segment will provide an opportunity to address outstanding questions, clarify complex topics, and encourage open dialogue between faculty and participants.