MABIO4600 Statistics, Quality Control and Quality Assurance Course description

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

Students must have been admitted to the Master’s Programme in Health and Technology - Specialisation in Biomedicine. The course is also offered as an individual course, with the same admission requirements as for the specialisation.

After completing the course, the student should have the following learning outcomes defined in terms of knowledge, skills and general competence:

Knowledge

The student

• can justify the choice of systems and procedures for quality monitoring and quality assurance of analysis processes
• can describe systems and processes relating to the accreditation and certification of medical laboratories
• can statistically assess and establish a reference area
• can determine and assess the specificity, sensitivity and accuracy of analytical methods
• can explain the concepts predictive value, odds ratio and ROC curves
• can explain the laws and regulations that regulate medical laboratory activities
• can explain how durability tests of sample material are carried out

Skills

The student

• can apply statistical methods and tools, such as table analysis, variance analysis, correlation, and simple and multiple linear and logistic regression
• can carry out and explain hypothesis testing, parametric and non-parametric methods, as well as correlation and regression analysis
• can use one and two-way variance analysis for repeated measurements
• can assess and discuss the significance of pre-analytical, analytical and post-analytical sources of error for the result/quality of the analysis
• can choose and apply statistical methods used to quality assure medical laboratories
• can plan and carry out comparisons of analytical methods and assess measures
• can apply advanced knowledge of analytical variation in terms of repeatability and reproducibility

General competence

The student

• can describe key methods for statistical analysis and make justified choices of statistical methods for use in research and method validation
• can discuss and analyse relevant issues and actively contribute to the execution of advanced work tasks relating to quality control and quality assurance in laboratories

Work and teaching methods include lectures, digital lectures, flipped classroom, seminars, group work and self-study

The following must have been approved in order for the student to take the exam:

• Practical execution of a statistics assignment in groups of 3-4 students. The assignment is carried out with the help of relevant analysis programs used in the course.

Supervised individual written exam, 4 hours.

The paper can be written in English or a Scandinavian language.

A handheld calculator that cannot be used for wireless communication or to perform symbolic calculations. If the calculator’s internal memory can store data, the memory must be deleted before the exam. Random checks may be carried out.

Grade scale A-F.

All answers are assessed by one examiner. An external examiner is used regularly, at a minimum of every third completion of the course. When selecting answers for external evaluation, a minimum of 10 percent of the answers shall be included, with no fewer than 5 answers. The external examiner’s assessment of the selected answers shall benefit all students.

None.