OVERVIEW

The course is structured into modules aimed at introducing students to the professional world.
The Applied Medical Sciences module offers an in-depth focus on the Quality Management System, specifically providing tools for managing organizational systems and promoting an approach centered on the principle of "learning from errors."

The course aims to equip students with both theoretical and practical knowledge of two key analytical technologies: chromatography and flow cytometry. It delivers advanced technical training that is useful for working in clinical analysis laboratories, biomedical research labs, molecular diagnostics centers, and quality control laboratories in the pharmaceutical sector.

The study of information processing systems introduces students to the correct use of hardware and software equipment commonly found in large healthcare facilities.

AIMS AND CONTENT

LEARNING OUTCOMES

Quality Management Systems in Healthcare Services and Laboratories
Understanding the UNI EN ISO reference standards and their application. Clinical risk and error management.

Chromatographic Techniques and Principles of Mass Spectrometry
Topics include liquid gas chromatography – mass spectrometry, method validation in chromatography, and the application of chromatographic methods in biomedical laboratories. Students will gain:

• An understanding of chromatographic separation.
• The ability to assess chromatographic resolution.
• The capacity to distinguish between different chromatographic techniques.
• Knowledge of HPLC technology and its applications.
• The ability to choose and use appropriate detection systems in chromatography.
• Understanding of internal and external standards.
• Practical skills in applying chromatographic techniques.

Fluorochrome Physical-Chemistry and Flow Cytometry
The course provides the theoretical foundation of fluorochrome chemistry and their interaction with light (optical principles). Students will learn to:

• Select and use the appropriate fluorochrome in multiparametric flow cytometry.
• Understand fundamental principles of flow cytometry and apply them to methodological decision-making.
• Prepare samples for flow cytometric analysis from various tissue types.
• Choose proper controls, analyze results, and manage errors in data interpretation.

Information Technology in Healthcare
Students will be introduced to the use of IT systems within large healthcare facilities.
The course prepares future Biomedical Laboratory Technicians to effectively use enterprise-level hardware and software infrastructure, supporting the production, processing, communication, and secure storage of digital health data.

AIMS AND LEARNING OUTCOMES

Provide the theoretical foundations of Chromatography, Chromatographic Techniques, and Detection Systems.
Introduce the principles of Mass Spectrometry, including the fundamentals of Gas Chromatography and Gas Chromatography–Mass Spectrometry (GC-MS).

For Flow Cytometry, the course covers the theoretical basis of the physical-chemistry of fluorochromes and their interaction with light (optical principles).
Additionally, the course addresses the use of data within the Information Technology systems of large healthcare facilities, preparing future Biomedical Laboratory Technicians to effectively operate large-scale institutional IT infrastructures, including the proper use of hardware and software for managing clinical data.

PREREQUISITES

Basic chemistry and physical–chemistry, as well as foundations of immunology, make learning the course modules easier

TEACHING METHODS

Lessons aim for the constant engagement of students. The lesson content is based on the instructor's slides.

Lectures are delivered in the classroom with slide presentations and simulations of practical applications.

SYLLABUS/CONTENT

CHROMATOGRAPHY:

• Basic chemistry concepts: matter, states of matter, solutions, compounds, basic chemical reactions, chemical and physical transformations, changes of state.
• Birth and history of chromatography.
• Chromatographic procedure.
• Mobile phase and stationary phase.
• Chemical interactions between the stationary and mobile phases.
• Separation mechanisms: adsorption, partition, ion exchange, affinity, exclusion.
• Chromatographic resolution.
• Retention: factors influencing chromatographic migration.
• Theoretical plates.
• Chromatogram.
• Physico-chemical conditions that alter the separation of components.
• Classification of chromatographic techniques: based on the mobile phase.
• Classification of chromatographic techniques: based on the stationary phase.
• Theory of gas chromatography and HPLC.

FLOW CYTOMETRY:

• Fluorescence and fluorochromes: principles and function; general knowledge of dyes for nucleic acids and proteins.
• Cytometer anatomy: fluidics, optics, electronics.
• Data acquisition, analysis, and representation.
• Instrument performance procedures: instrument control (calibration, tuning, linearity); setting of analysis threshold, compensation.
• Sample preparation: basic knowledge for preparing samples (fresh, fixed, or frozen); treatment and analysis of solid tissue samples (biopsies), with focus on disaggregation techniques.
• Multiparametric flow cytometry: sample preparation and panel setup; spillover and compensation; autofluorescence, quenching, bleaching; antibody setting (staining index).
• Data management and analysis: main concepts related to the analysis of cytometric files; gating strategies; offline fluorescence compensation; isotypic and isoclonic controls, fluorescence minus one (FMO); criteria for positivity evaluation; main types of cytometric data representation.

QUALITY MANAGEMENT SYSTEM:

• Evolution of Quality: Theorists Deming, Juran, Crosby – Leadership – Customer focus – Understanding and improving processes – Deming Cycle – Teamwork – Cost of Quality.
• The Ligurian model regulating the accreditation of healthcare facilities: Institutional Accreditation – ISO organizational models.
• Key innovations introduced by the UNI EN ISO 9001:2015 standard compared to the previous revision.
• Peculiarities of the September 2015 revision compared to 2008.
• Audits – Audit procedures – Effectiveness check of corrective actions.
• Clinical Risk: error – human behavior – error classification – Event analysis tools: SEA* - RCA** - FMEA*** – Clinical Audit.
  • *SEA: Significant Event Analysis
  • **RCA: Root Cause Analysis
  • ***FMEA: Failure Mode and Effects Analysis
• Role of the Quality Office in a Healthcare Organization.
• Quality System Management in a Clinical Laboratory.

INFORMATION PROCESSING SYSTEMS:

• Introduction to data processing systems and their evolution.
• Hardware components of computers.
• Introduction to software and computer operating systems.
• Network infrastructure in business environments.
• Introduction to healthcare information systems and the LIS (Laboratory Information System).
• Computer and laboratory analyzer interfacing with enterprise networks and systems.
• Access rules to information systems and basic concepts of cybersecurity.
• Introduction to the EU General Data Protection Regulation (GDPR).

TEACHERS AND EXAM BOARD

Exam Board

ADRIANO DESSYPRIS (President)

DANIELA FENOGLIO (President)

MADDALENA MASTROGIACOMO (President)

LESSONS

Class schedule

APPLIED MEDICAL SCIENCE AND CHROMATOGRAPHIC TECHNIQUES

EXAMS

EXAM DESCRIPTION

During the exam, the rules regarding the assessment method of DSA certified students or students with other educational needs indicated by the university will be respected. (e.g.: additional time in the case of written exams, use of concept maps to be viewed for approval by the teachers at least one week before the exam date).

ASSESSMENT METHODS

The assessment focuses on the understanding of the basic concepts presented in the teaching programs. Students are expected to know and define the fundamental elements of Chromatographic Techniques and Detection Systems, Flow Cytometry Techniques, the basic principles of Quality Management Systems, and the accreditation processes of healthcare facilities.

FURTHER INFORMATION

It is advisable for cases with DSA certification, disabilities, or other special educational needs to contact both the Department representative, Prof. Nicola Girtler, and the teacher at the beginning of the lessons to agree on teaching and examination methods that, while respecting the objectives of the teaching, take into account individual learning methods and provide suitable compensatory/exemptive tools recognized by the DSA Student Service of the University.