Bioethics, Laboratory Safety and Quality Assurance

Objectives

- To understand the principles of bioethics;

- To know the main rules of laboratory safety;

- To know the principles of Quality Assurance in microbiology and its main practical applications.

General characterization

Code

21214

Credits

2

Responsible teacher

Prof.ª Doutora Maria de Jesus Chasqueira

Hours

Weekly - Available soon

Total - Available soon

Teaching language

Portuguese

Prerequisites

 

Bibliography

- Stapleton G, Schröder BäckP, Laaser U, Meershoek A, Popa D. Global health ethics: an introduction to prominent theories and relevant topics. Glob Health Action. 2014 13;7:23569- Njoroge SW, Nichols JH. Risk management in the clinical laboratory. Ann Lab Med. 2014 ;34(4):2748.

- Wilson ML. Assuring the quality of clinical microbiology test results. Clin Infect Dis. 2008;47(8):107782.

- ISO 15189. Medical laboratories - Requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization; 2017.

- ISO/IEC 17025. General requirements for the competence of testing and calibration laboratories. Geneva, Switzerland: International Organization for Standardization; 2012.

- OGC001 - Guia para a aplicação da NP EN ISO/IEC 17025 – IPAC, 2018.

- OGC004 - Guia para a aplicação da NP EN ISO 15189 – IPAC, 2017.

Teaching method

Theoretical classes will be taught by the teachers of the course via Zoom, depending on their respective specializations. The form of lecture, in which they will address issues considered essential by providing data to guide students to an individual study.

Evaluation method

Student assessment – Written examination – multiple choice test of 20 questions (duration 30 minutes; face to face).

Minimum attendance of 2/3 of the classes, without any supplementary regimen for students without attendance minimum, except in the situations provided for by law. The student will be excluded if the exam grade is less than 9.5.

Subject matter

Bioethics: Introduction. Law and ethics. Ethics and research.

Laboratory safety: Biosafety in Microbiological laboratory: biohazard Degree; Laboratory Biosafety levels, primary barriers: biological safety cabinets, personal protective equipment.

Secondary barriers: infrastructure; Assessment and risk management. Good Laboratory Practices; Decontamination procedures: disinfection and sterilization.

Quality assurance in Microbiology Laboratories: Certification and Accreditation Standards for testing laboratories: NP EN ISO 9001, NP EN ISO/IEC 17025 and EN ISO 15189. Technical requirements on Microbiology Laboratory: Personnel; Installations and environmental conditions; Equipment, reagents and consumables; Pre examination, examination and post-examination processes; Quality assurance. Reporting and releasing results, and Laboratory Information Management.

Programs

Programs where the course is taught: