Method Validation and Verification in Medical Laboratories

Overview

Practical approaches to evaluating examination method performance and verifying fitness for intended use, enhancing result reliability and technical competence in medical laboratories.

• This training course develops the technical knowledge and practical skills of medical laboratory professionals in examination Method Verification and Method Validation, supporting reliable laboratory results and the suitability of examination methods for their intended clinical applications.
• The course explains the distinction between method verification and validation, relevant ISO 15189:2022 requirements, and approaches to evaluating analytical performance characteristics, including precision, repeatability, bias, and measuring range, as well as selecting appropriate acceptance criteria.
• Through calculation exercises, case studies, and practical applications using laboratory datasets, participants learn to develop verification plans, analyze performance results, evaluate compliance with predefined acceptance criteria, and document evidence supporting decisions on the suitability of examination methods for routine laboratory use.
• The course focuses primarily on quantitative laboratory examinations, with recognition that verification and validation requirements vary according to the method and its intended use. Advanced measurement uncertainty estimation and internal quality control statistics are covered in separate specialist programs within the training package.
• This professional development course does not grant formal laboratory accreditation.

Who Should Attend

Learning Outcomes

• By the end of the course, participants will be able to: Distinguish between examination method verification and validation in accordance with ISO 15189:2022.
• Identify relevant analytical performance characteristics and acceptance criteria for the intended use.
• Develop an initial examination method verification or validation plan.
• Analyze repeatability, precision, bias, and measuring range data.
• Evaluate verification results and determine whether an examination method is suitable for its intended use.
• Prepare a concise technical report documenting verification results and evidence supporting method acceptance.

Course Outline

1. Module 1: Fundamentals of Examination Method Verification and Validation

   • Differences between Method Verification and Method Validation. • Relevant ISO 15189:2022 requirements. • Intended use, performance characteristics, and acceptance criteria.

2. Module 2: Planning Verification and Validation Studies

   • Developing verification plans and selecting samples and datasets. • Evaluating repeatability, precision, and bias. • Assessing measuring range and relevant performance characteristics.

3. Module 3: Performance Data Analysis and Evaluation

   • Applying basic statistical calculations to performance data. • Comparing results against predefined acceptance criteria. • Evaluating deviations and making method acceptance decisions.

4. Module 4: Practical Applications and Technical Documentation

   • Case study involving examination method verification. • Preparing verification reports and documenting results. • Reviewing technical evidence and determining fitness for intended use.

Assessment

• Short knowledge checks covering verification and validation principles. • Calculation exercises involving analytical performance characteristics. • Case study on evaluating Method Verification or Method Validation results. • Practical exercise on preparing a verification plan and concise technical report. • Final assessment of the intended learning outcomes.