Learning Outcomes:
- Discuss the relevance of a quality system to the laboratory
- Describe the essential components of a quality system
- Describe the quality standards, models, and programs available to Canadian medical laboratories
Module 1
- Describe the attributes of quality health care service
- Define ‘quality system’
- Describe the quality hierarchy
- List the potential benefits of a quality system
- Describe the activities that contribute to the total cost of quality
- Explain risk in the laboratory
- Describe the risk management process
- Explain common risk management tools
Module 2
- List the essential components of a quality system
- Explain three types of quality system documentation
- Describe the contents of a quality manual
- Explain document control
- Describe key management activities in a quality system
- Explain the concept of a healthy workplace
- Describe crucial activities related to management of personnel within a quality system
- Explain the management of equipment within a quality system
- Explain purchasing and inventory activities within a quality system
- Describe process analysis
- Describe the laboratory path of workflow, and give examples of activities within each step of the laboratory path of workflow
- Explain process validation
- Describe three process control tools
- Describe components of information management in the laboratory
- Describe the federal Personal Information Protection and Electronic Documents Act and how it relates to information management in the laboratory
- Discuss occurrence management
- Describe how internal and external assessments contribute to a quality system
- Describe the quality improvement process
- Describe three continuous improvement methodologies or tools
- Explain activities that allow an organization to assess the satisfaction of its customers
- Describe facilities and safety within a quality system
Module 3
- Outline the various Accreditation programs employed across Canada
- Explain ISO 15189:2012 certification
- Describe Accreditation Canada’s QMentum program
- Explain the Ontario Laboratory Accreditation (OLA) 15189Plus program
- Describe the College of American Pathologists (CAP) laboratory accreditation program
- Explain the Clinical Laboratory Standards Institute (CLSI) quality model
Instructor: Joanne Isber, MLT
Author: Sue Bradley, ART, B.Sc., MBA
Version Date: June 2013
PEP hours: 48
CPS credits: 3.0
*Note: PEP hours and/or CPS credits will only be awarded upon successful completion of course requirements.
See attached Course Guide for more information.
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