Lesson 4: What quality is needed for a laboratory test?

In The Need for Standard Processes and Standards of Quality, Dr. Westgard discusses different terms and characteristics that are used to describe quality and provides a systems perspective to show the relationship between these different characteristics. Per Hytloft Petersen provides a review of approaches to setting analytical quality specifications in his discussion of European Approaches to Analytical Goal-Setting. Summary tables are provided for available CLIA analytical total error criteria, clinical decision interval criteria, and European biological goals. (Revised 11/99).


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Objectives:

Learn about the different ways of defining quality requirements. 
Identify three different formats for specifying quality requirements. 
Identify three sources of recommendations for quality requirements. 

Web materials:

Lesson: The Need for Standard Processes and Standards of Quality 
Essay: European Approaches to Analytical Goal-Setting 
Table of analytical quality requirements 
Table of clinical quality requirements 
Table of European biological goals and calculated total allowable errors 

Things to do:

Study the materials. 
Print copies of the quality requirements for your own use. 
Review your laboratory's quality requirements. 

Assessment: View the Answers

What type of quality requirement is used for PT criteria of acceptability? 
What is a clinical decision interval? 
What is the principle used in setting European quality goals? 
For cholesterol, what are the analytical, clinical, and biologic quality requirements? 
What is your laboratory's quality requirement for cholesterol? 
Does your laboratory define quality requirements for each test? 

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