Laboratory Quality Control

Not applicable.

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 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.

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.

NAO

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.