MABIO4600 Statistics, Quality Control and Quality Assurance Course description

The course deals with statistical tools used in biomedical research, method development and method validation at medical laboratories. The course also comprises quality assurance systems for such laboratories.

The student must have been admitted to the study programme. The course is also offered as an individual course.

After completing the course, the student is expected to have achieved the following learning outcomes defined in terms of knowledge, skills and competence:

Knowledge

The student

• has advanced knowledge of the selection and use of statistical methods in research and method validation
• has in-depth knowledge of systems and procedures for monitoring quality and quality assurance of analysis processes
• is capable of describing systems and processes related to the accreditation and certification of medical laboratories
• has advanced knowledge of the assessments that form the basis for the establishment of a reference area
• has advanced knowledge of how analysis methods’ specificity, sensitivity and test accuracy are decided and evaluated
• is capable of explaining the concepts predictive value, odds ratio, and ROC curves
• is capable of explaining the laws and regulations that regulate medical laboratory activities
• has advanced knowledge of how to carry out durability tests of sample material
• has advanced knowledge of analytical variation in terms of repeatability and reproducibility

Skills

The student is capable of

• applying statistical methods and tools, such as table analysis, variance analysis, correlation, and simple and multiple, linear and logistic regression
• carrying out and explaining hypothesis testing, parametric and non-parametric methods, as well as correlation and regression analysis
• using one and two-way variance analysis for repeated measurements
• assessing and discussing the importance of pre-analytical, analytical, and post-analytical sources of error related to the result/quality of the analysis
• choosing and applying statistical methods used to quality assure medical laboratories
• planning and carrying out comparisons of analysis methods and assessing measures

Competence

The student is capable of

• discussing and analysing relevant issues and actively contribute to the execution of advanced work tasks related to quality control and quality assurance in laboratories

Work and teaching methods include lectures, seminars, group work and self-study.

The following required coursework must be approved before the student can take the exam:

• presentation of an assignment in groups of 3-5 students

Exam content: The learning outcomes

Exam form: Individual written exam, 4 hours

None

Grade scale A-F

An external and internal examiner will assess all exams