Bioethics and Safety Laboratory Quality Assurance

Objectives

1. Introduction to bioethics. Law and ethics. Ethics and research; 
2. Know the principles of informed and informed consent. Recognize the role and 
importance of Health Ethics Committees and the role of CEIC. 
3. Know the principles and general rules of Laboratory Safety: Degree of biohazard. 
Primary barriers: Laminar flow chambers, personal protective equipment, respiratory 
protective equipment. Decontamination, sterilization, disinfection and asepsis.   
4. Know the general principles of Quality Assurance in Microbiology Laboratories: 
Standard NP EN 17025. Human Resources. Facilities: space organization (requirements), 
hygiene, environmental control. Equipment: calibration, performance check, maintenance. 
Reagents and culture media. Method validation. Quality control (internal and external).

General characterization

Code

10123

Credits

2.0

Responsible teacher

Maria de Jesus Fernandes Chasqueira

Hours

Weekly - 1

Total - 12

Teaching language

Português

Prerequisites

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 Laboratory Standards Certification and Accreditation of 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 process, examination and post-examination; Quality warranty. Presentation and issuing findings and Information Management.

Bibliography

- 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.

- 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.

Teaching method

The lectures are taught by teachers of curricular unit, depending on the 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

 Written Exam: 20 Multiple-choice test, lasting 30 minutes

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 Laboratory Standards Certification and Accreditation of 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 process, examination and post-examination; Quality warranty. Presentation and issuing findings and Information Management.

Programs

Programs where the course is taught: