Laboratory Quality Control

Base Knowledge

Not applicable.

Teaching Methodologies

Theoretical classes adopt an interactive lecture-based approach, combined with active learning methodologies that promote student engagement, participation and reflection. Interactive digital tools, such as Mentimeter, are used for polls, quizzes and real-time responses. These methodologies are complemented by guiding questions, pair or small-group discussions, analysis of practical cases and collaborative problem-solving, thereby promoting active participation, formative feedback and the consolidation of learning.

Learning Results

The student must acquire knowledge of:
– Quality and its importance;
– Standards and quality indicators;
– Certification and accreditation processes;
– Certification and accreditation standards applicable to clinical laboratory;
– Lean and six sigma methodologies;
The student must acquire skills of:
– control quality in a clinical laboratory, as well as contributing to the implementation of a quality system leading to its certification or accreditation.
The student must acquire competences of:
– Possess a global vision on quality and its importance;
– Identify and know the importance of standards and quality indicators;
– Have a general notion concerning certification and accreditation processes and identify applicable standards;
– Application of lean and six sigma methodologies to the clinical laboratory.

Program

Quality:
– General concepts;
– Origin and evolution;
– Total quality management.
– Quality in public services:
– Public administration of quality;
– Indicators and quality standards.
Quality in health services:
– Concept and quality reasons in health; Certification and accreditation-fundamental concepts;
– Quality management system;
– Steps of implementation of a quality assurance system according to ISO standards;
– Legislation and standards of reference.
– Pre analytical , analytical and post analytical quality in clinical laboratories: Clinical Biochemistry; Clinical Microbiology; Clinic Haematology; Clinic Imunohemoterapia; Histopathology; Cytopathology;
Immunohistochemistry.

Methodologies lean and six sigma.

Curricular Unit Teachers

Armando José Cerejo Caseiro

Grading Methods

Continuous assessment consists of a written examination (50%) and a diverse set of assessment activities carried out throughout the semester (50%), which may include group work, individual activities, the resolution of questions and problems, quizzes, case analysis, and other knowledge-application tasks. For the purposes of continuous assessment, students must complete at least 75% of the proposed activities.

To pass through continuous assessment, students must obtain a minimum mark of 9.5 out of 20 in both the written examination and the overall continuous assessment activities component. Students pass the curricular unit if they achieve a final grade of at least 10 out of 20.

Students may opt for assessment by exame, in accordance with the applicable assessment regulations.


    Internship(s)

    NAO

    Bibliography

    Primary bibliography:

    Westgard, James. Basic Qc Practices : Training in Statistical Quality Control for Medical Laboratories. 4th ed. Madison, WI: Westgard QC, 2016.

    Westgard, James; Westgard, Sten. Basic Quality Management Systems. 1st ed. Madison, WI: Westgard QC, 2014.

    Westgard, James. Six Sigma Risk Analysis. 1st ed. Madison, WI: Westgard QC, 2011.

    Westgard, James O. Six Sigma Quality Design and Control: Desirable Precision and Requisite Qc for Laboratory Measurement Processes. 2nd ed. Madison, WI: Westgard QC. Inc., 2006.

     

    Secondary bibliography:

    Westgard, J.O., N.B. Person, and S.A. Westgard, Basic method validation : training in analytical quality management for healthcare laboratories. 4th edition. ed. Back to basics. Madison, Wisconsin: Westgard QC, 2020.

    Arthur, Jay. Lean Six Sigma for Hospitals : Simple Steps to Fast, Affordable, and Flawless Healthcare. New York: McGraw-Hill, 2011.

    Pimentel, Rui A. Medicina Laboratorial: Qualidade – Da prescrição à interpretação clínica. Vol. 5. Lisboa: Lidel, dez. 2024.