Laboratory Quality Control

Teaching Methodologies

The theoretical classes are aimed at the detailed presentation of the program contents, using an expository-active
methodology, appealing the direct intervention of the students. The evaluation will include a written assessment
and presentation of a group project on a topic covered in the program contents.

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.

Internship(s)

NAO

Bibliography

Arthur, Jay. Lean Six Sigma for Hospitals : Simple Steps to Fast, Affordable, and Flawless Healthcare. New York:
McGraw-Hill, 2011.
Cohen, Frank. Lean Six Sigma for the Medical Practice : Improving Profitability by Improving Processes. Phoenix,
MD.: Greenbranch Pub., 2010. McPherson, Richard A., Matthew R. Pincus, and John Bernard Henry. Henry’s Clinical Diagnosis and Management
by Laboratory Methods. 21st ed. Philadelphia: Saunders Elsevier, 2007.
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.
Westgard, James O., and Patricia L. Barry. Basic Method Validation. 3rd ed. Madison, WI: Westgard QC, 2008.
Westgard, James O. Basic Qc Practices : Training in Statistical Quality Control for Medical Laboratories. 3rd ed.
Madison, WI: Westgard QC, 2010.