Medical laboratory technology: quality assesment, validation of methods and statistics

The following topics will be presented in lectures to guide laboratory work and groupwork: Quality and sustainability in work processes, quality management of laboratory practices, quality controls, validation of methods, procedures, revision of laboratory practices, reference values, statistical testing and use of statistical functions and tools in Excel.

Central theories/perspectives in the humanities and social sciences with primary focus on sustainability and values in health care.

After completing the course, the student should:

• Know about quality-improving (quality management) and sustainable work processes.
• Know how laboratory operations are quality-assessed through certification systems and accreditation schemes.
• Be familiar with IVDR and risk assessments of laboratory operations.
• Have knowledge of, and be able to reflect upon the use of, quality management systems to ensure reliable analytical results in medical laboratories.
• Know how protocols are developed and revised in accredited medical laboratories.
• Be able to evaluate results from various analysis based on current quality requirements.
• Be able to make professional decisions that promote sustainability and HSE, and strive to choose materials, equipment, and procedures (protocols) that reduce the use of resources without compromising the quality of the results.
• Be able to plan and carry out varied tasks within the field of biomedical laboratory sciences, including those which are carried out over a period of time.
• Be able to document and disseminate knowledge within the field of biomedical laboratory sciences through oral and written presentations.
• Be able to reflect critically on one's own professional practice and values, acquire new knowledge and seek and receive tutoring.

Students' total effort is estimated to be 200 hours, consisting of lectures (30 hours), mandatory laboratory activities (20 hours), practice in statistics (8 hours) and self study (142 hours). There will also be written and oral presentations.