ISO 15189:2022 – Medical Laboratory Quality & Accreditation
Estimation of Measurement Uncertainty in Medical Laboratories
SPEA Approved Certificate
Overview
Practical approaches to estimating measurement uncertainty, analyzing its sources, and interpreting results to enhance examination reliability and technical competence in medical laboratories.
- This training course develops medical laboratory professionals’ knowledge and practical skills in estimating Measurement Uncertainty (MU), understanding its role in evaluating examination result quality and reliability, and supporting clinical decision-making.
- The course introduces fundamental measurement uncertainty concepts, distinguishes uncertainty from error and bias, identifies uncertainty sources in analytical processes, and explores practical approaches to estimating uncertainty using internal quality control and analytical performance data.
- It also covers the calculation of standard, combined, and expanded uncertainty, result interpretation, documentation, and review in accordance with relevant ISO 15189:2022 requirements.
- Through calculation exercises, case studies, and practical applications, participants learn to develop simplified measurement uncertainty estimates using laboratory data and interpret their limitations and implications for result reliability.
- The course focuses on measurement uncertainty in quantitative examinations. Advanced internal quality control statistics and examination method validation and verification are addressed in separate specialist programs within the training package.
- This professional development course does not grant formal laboratory accreditation.
Who Should Attend
- Medical laboratory scientists and technicians.
- Laboratory quality, technical competence, and accreditation personnel.
- Clinical chemistry and quantitative laboratory examination professionals.
- Medical laboratory managers and technical supervisors.
- Professionals involved in analytical performance evaluation and result review.
- Personnel responsible for examination method verification and measurement reliability assessment
Learning Outcomes
- By the end of the course, participants will be able to: Explain measurement uncertainty concepts and their importance in medical laboratories.
- Distinguish measurement uncertainty from error, bias, and measurement variability.
- Identify sources of measurement uncertainty and select appropriate estimation data.
- Calculate standard, combined, and expanded uncertainty using laboratory examples.
- Interpret uncertainty estimates and evaluate their suitability for the intended use.
- Document and review measurement uncertainty estimates in accordance with relevant ISO 15189:2022 requirements.
Course Outline
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Module 1: Fundamentals of Measurement Uncertainty
• Fundamental concepts and relevant ISO 15189:2022 requirements. • Differences between uncertainty, error, and bias. • Importance of uncertainty in interpreting quantitative examination results.
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Module 2: Uncertainty Sources and Estimation Data
• Identifying uncertainty sources in analytical processes. • Using internal quality control and repeatability data. • Selecting appropriate estimation methods and data.
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Module 3: Uncertainty Calculation and Result Interpretation
• Estimating standard and combined uncertainty. • Calculating expanded uncertainty and applying coverage factors. • Interpreting estimates against analytical performance requirements.
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Module 4: Practical Applications and Documentation
• Calculation exercises using laboratory datasets. • Preparing a simplified measurement uncertainty report. • Reviewing, updating, and documenting uncertainty estimates.
Assessment
• Short knowledge checks covering measurement uncertainty concepts. • Calculation exercises using quantitative laboratory examination data. • Case study on interpreting uncertainty estimates and evaluating their suitability. • Final assessment of the intended learning outcomes.