Laboratory Quality Management

Recommended Prerequisites

Mathematics; Statistics.      

Teaching Methods

The problem-solving classes are concerned with the application of theory to the work in a typical clinical laboratory. They are interactive and given in an integrated way with theory classes. The resolution of particular problems, the building of control charts and its interpretation allow the students to reinforce the learned concepts.

Learning Outcomes

The aim of this curricular unit is to provide students with specific knowledge and competencies needed to contribute to a better Quality service given by the clinical laboratory.
At the end, the students will be able:
- To understand the relevance of the implementation of a Laboratory Quality Management System at a Clinical Laboratory;
- To build a control chart and to know the rules underlying the Internal Quality Control (IQC);
- To understand the aim of the External Quality Control (EQC) and to get knowledge about data interpretation and corrective actions;
- To know the ISO Standards for the Clinical Laboratory, their advantages and differences;
- To interpret the technical requirements of an ISO standard and to implement it.

Work Placement(s)

No

Syllabus

1. The Quality Management System in a Clinical Laboratory.
2. Quality assurance, associated services, costs.
3. Internal Quality Control (IQC), in the pre-analytical, analytical and post-analytical phases, and External Quality Control (EQC):
. Pre-analytical phase - sampling conditions, samples transport, handling and preservation
. Analytical phase - laboratory errors, the Levey-Jennings and Westgard rules.
. IQC Charts - basic rules for its preparation and interpretation. Descriptive analysis of data. Probability models. Confidence intervals. Control charts. Imprecision and inaccuracy.
. External Quality Assessment.
. Post-analytical phase - rules for samples preservation and disposal.

Problem-solving
1. National legislation - Handbook of Good Laboratory Practice.
2. ISO Standards for the Clinical Laboratory - NP EN ISO9001: 2000, EN ISO/IEC 17025:2000, ISO/ DIS 15189.2 - contribution to the Laboratory Quality improvement.
3. Building and interpreting control charts.

Head Lecturer(s)

Teresa Carmo Pimenta Dinis Silva

Assessment Methods

Assessment
Exam: 100.0%

Bibliography

Tietz Fundamentals of Clinical Chemistry and Molecular Diagnostics (7th Ed.). Burtis and Bruns,Eds. Elsevier Saunders (2015)
Juran’s Quality Control Handbook, The complete guide to performance excellence (6th Ed.),Juran and De Feo, Eds MacGraw-Hill (2010)
Clinical Chemistry: Theory, Analysis and Correlation. Kaplan, Pesce, and Kazmierczak,Eds,Mosby Inc(2010)
O que é o “Lean Six Sigma”? George M, Rowlands D, Kastle B, Actual Editora (2008)
Westgard JO, Barry P L, Hunt M R and Groth T, A multi-rule Shewhart chart for quality control in clinical chemistry.Clin Chem (1981)27:493-501
Plebani M, Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med (2006), 44:750-759
Manual de Boas Práticas Laboratoriais-Desp. 8835:2001,27 Abril 2001
NP EN ISO 9001:2008 – Sistemas de gestão da qualidade
NP EN ISO 15189:2007 - Requisitos particulares da qualidade e competência
NP EN ISO/IEC 17025:2005, Requisitos gerais de competência em laboratórios de ensaio/calibração