Lesson 9: QC Planning Tools - What are Quality Planning Models?

The theoretical and conceptual basis of the QC planning process and the QC planning tools are based on the expected relationship between a quality requirement and the factors that contribute to the variability of a test result. In this lesson on Quality Planning Models, Dr. Westgard uses the concept of an error budget to describe the relationships between analytical total error criteria with analytical factors and clinical decision criteria with preanalytical and analytical factors. Participants should review the two cholesterol examples that represent applications of these analytical and clinical error budgets (Cholesterol with Analytical Quality Requirement, Cholesterol with Clinical Quality Requirement).
View the Outline    View the Syllabus   View the Archives   View the Reference List   View the Glossary

Objectives:

Understand the analytical total error model for stable performance. 
Learn how the analytical quality planning model expands for unstable performance. 
Learn how the clinical model further expands for preanalytical factors. 
Understand the mathematical basis of the OPSpecs chart. 

Web materials:

Lesson: Quality planning models 
Part 2: Mathematical Description of Laboratory Error Budgets 

Things to do:

Study the materials. 
Assess the performance of the QC procedure for the cholesterol method in your lab. 

Assessment: View the Answers

Use the QC Validator program to assess QC performance for a cholesterol method having TEa of 10%, Dint of 20%, swsub of 6.5%, CV of 3.0%, a bias of 0.0%, and expected instability of <2%. Assume you are choosing control rules for 2 control materials. 
For the CLIA PT criterion for acceptable performance, prepare an analytical OPSpecs chart for this cholesterol method. 
For the NCEP clinical requirement for interpretation of a cholesterol screening test, prepare a clinical OPSpecs chart for this same cholesterol method. 
What QC procedure is appropriate for this cholesterol method? 

Return to the top 
View the Participant Q & A

Questions, comments,  suggestions, and feedback are encouraged!
Use feedback form on this website Or e-mail westgard@westgard.com.
This website is best viewed by Internet Explorer or Netscape 2.0 or better.
Copyright © 1998. All rights reserved.
WesTgard® Quality Corporation, 7614 Gray Fox Trail, Madison WI 53717
Call 608-833-4718 or e-mail westgard@westgard.com
 
A Message from JOW
QC Lesson of the Month | QC Application of the Month | Question of the Month | Multirule
CLIA Requirements | What's new with WQC | WQC Catalog | Demo Download
Home  | Glossary | WQC Archives| Links | Feedback