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.
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?
Return to the top
View the Participant Q & A |