Master in Laboratory Medicine

4

• Know the type of clinical analysis laboratories and their role in the national health service as well as the corresponding legislation
• Know the organization and the technical operation of clinical laboratories
• Meet the need to produce valid and rapid laboratory results with quality
• Know how to implement and maintain a Laboratory Quality Management System
• Be able to implement an internal quality control system and an external quality assessment of the analytical methods, in the different laboratory valences
• Be able to determine the precision, the accuracy and the overall error of the different laboratory parameters
• Acquire the concepts of biological variation and reference values
• Establish the main differences between Certification and Accreditation of clinical laboratories and meet the applicable ISO standards (15189 and 9001)
• Learn the applicable legislation of medical devices
• Know the point­of­care devices and the corresponding legislation

Lectures:
Types of laboratories: organization and resources
Legislation: Licensing and Best Practices
Pre ­ analytical: Costumer service, collection and products screening
Analytical phase: equipment, technical validation. Analytical interferences.
Post­analytical phase: validation of results; reference values and biological variability
Health and safety measures
Implementation of a Quality Management System
Internal and external quality control, precision and accuracy of the results
Certification: ISO 9001 NP
Accreditation: ISO NP 15189
Quality Audits
Informatics
Marketing
Point of care testing
Legislation of Medical devices
Innovation and clinical analysis

Practical teaching:
Internal Quality Control: construction and analysis of control charts, application of the Westgard rules
External quality assessment: Interpretation of results
Total error calculation and implementation of a six sigma methodology

Laboratory teaching
Collection of biological samples