ISO 15189:2022 – Medical Laboratory Quality & Accreditation
Internal Quality Control: Statistical Analysis and Corrective Actions
SPEA Approved Certificate
Overview
Practical techniques for analyzing internal quality control data, detecting analytical deviations, and implementing corrective actions to improve the accuracy and reliability of laboratory results.
-
This training course develops practical skills in managing Internal Quality Control (IQC) in medical laboratories, statistically analyzing quality control data, and interpreting monitoring results to identify analytical deviations and errors at an early stage.
-
The course covers fundamental IQC principles, calculating the mean, standard deviation, and coefficient of variation, constructing Levey–Jennings charts, applying appropriate Westgard rules, and distinguishing between random and systematic errors.
-
Through practical exercises and case studies, participants learn to evaluate quality control results, investigate out-of-control conditions, identify underlying causes, implement corrective actions, and verify their effectiveness before resuming patient result reporting.
-
The course focuses on statistical applications of internal quality control in accordance with relevant ISO 15189:2022 requirements. Advanced measurement uncertainty estimation and examination method validation and verification are addressed in separate specialist programs.
-
This professional development course does not grant formal laboratory accreditation.
Who Should Attend
- Medical laboratory scientists and technicians.
- Internal quality control officers in medical laboratories.
- Medical laboratory managers and technical supervisors.
- Clinical chemistry, hematology, and laboratory medicine professionals.
- Laboratory quality, technical competence, and accreditation personnel.
- Professionals responsible for reviewing quality control results and monitoring analytical performance
Learning Outcomes
- By the end of the course, participants will be able to: Explain internal quality control principles and their role in ensuring reliable laboratory results.
- Calculate and interpret the mean, standard deviation, and coefficient of variation.
- Construct Levey–Jennings charts and analyze quality control result trends.
- Apply appropriate Westgard rules to identify out-of-control analytical conditions.
- Distinguish between random and systematic errors and investigate analytical deviations.
- Identify, document, and evaluate the effectiveness of appropriate corrective actions.
Course Outline
-
Module 1: Fundamentals of Internal Quality Control
• IQC objectives and relevant ISO 15189:2022 requirements. • Selection of control materials, levels, and acceptance limits. • Random and systematic errors and analytical performance indicators.
-
Module 2: Statistical Analysis and Quality Control Charts
• Calculating the mean, standard deviation, and coefficient of variation. • Constructing and interpreting Levey–Jennings charts. • Analyzing trends and deviations in quality control results.
-
Module 3: Westgard Rules and Corrective Actions
• Applying and interpreting appropriate Westgard rules. • Investigating unacceptable or out-of-control quality control results. • Identifying corrective actions and verifying their effectiveness.
-
Module 4: Practical Applications and Analytical Performance Improvement
• Analyzing actual or simulated quality control datasets. • Interpreting charts and making decisions on analytical run acceptance or rejection. • Documenting corrective actions and developing an analytical performance improvement plan.
Assessment
• Short knowledge checks covering IQC principles. • Calculation exercises involving mean, standard deviation, and coefficient of variation. • Practical application of Levey–Jennings charts and Westgard rules. • Case study on quality control deviations and corrective actions. • Final assessment of the intended learning outcomes.