Lesson 13, QC Planning for Healthcare Laboratories, WesTgard ® Quality Corporation © 1997

Lesson 13: Applications - How do you select acceptability criteria to satisfy CLIA QC guidelines?

In Selecting QC procedures to satisfy CLIA requirements, a detailed step-by-step procedure is described that begins with the definition of quality according to the CLIA proficiency testing criteria for acceptable performance and uses OPSpecs charts for selecting controls rules and numbers of control measurements. Detailed applications are discussed by Dr. Neill Carey in Tips on Managing the Quality of Immunoassays.

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Objectives:

Learn how to use the manual QC planning process to assure the quality required by CLIA proficiency testing criteria for acceptability.
Learn to use automatic QC selection.
Review some practical examples that demonstrate the use of this QC planning process for immunassay methods.

Web materials:

Application: Selecting QC procedures to satisfy CLIA requirements
Essay: Tips on Managing the Quality of Immunoassays

Things to do:

Study the materials.
Run the QC Validator Tutorial C.
Pick a regulated test for which you have information about the method imprecision and inaccuracy, then manually apply the QC planning process using the CLIA PT requirement.
Apply the automatic QC selection process to the earlier examples in Lesson 11.

Assessment: View the Answers

For a glucose method having a CV of 2% and bias of 0.0%, what QC procedure using 2 control materials would be appropriate to assure the quality required by CLIA PT?
For a pCO₂ measurement having an observed imprecision of 2.0% and an observed inaccuracy of 0.0%, if you were analyzing 3 control materials, what would be an appropriate QC procedure to assure the quality required by CLIA PT?
For a leukocyte count, your method has a CV of 3.9% and a bias of 0.0%. When using 3 control materials, what would be an appropriate QC procedure to assure the quality required by CLIA PT?

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