Lesson 14, QC Planning for Healthcare Laboratories, WesTgard ® Quality Corporation © 1997

Lesson 14: Applications - How do you determine the precision and accuracy needed for a test?

In Quality by Design, Dr. Westgard discusses how to use an OPSpecs chart to establish precision and accuracy "specifications for purchase." In the application QC planning using European biologic goals, this approach is used to compare the maximum allowable CVs for cholesterol and glucose testing processes that are designed to assure the quality required by clinical, analytical, and biological quality requirements.

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Objectives:

Understand the idea of "specifications for purchase" as a way to obtain a method having the necessary analytical performance.
Learn how to use an OPSpecs chart as a user's "quality by design" tool.

Web materials:

Essay: Quality by Design
QC planning applications: European quality requirements

Things to do:

Study the materials.
Identify a new or recent instrument acquisition, review the specifications, and determine how your laboratory sets specifications for method performance.

Assessment: View the Answers

What purchase specifications should be set for a cholesterol method to satisfy the CLIA PT criteria for acceptable performance?
What purchase specifications should be set to satisfy the NCEP clinical quality requirement?
What purchase specifications should be set to satisfy the European biological goals?

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