# Course Content

## 8 - Putting TEa into Quality

### Overview

**Purpose**

To control quality, one must first determine what quality is needed for a test. In this activity, participants will explore what information the fourth key number must provide to define the quality required. Additionally, participants will use a laboratory scenario to assess if the method remains acceptable for the intended clinical use of the test result.

**Key Message**

- TE
_{A}defines the quality specifications specific to the analyte being tested to make the analytical result clinically meaningful. - QC statistics can effectively reflect method performance if acceptable performance limits are defined and applied.
- For clinically meaningful results, the TE should be less than the TE
_{A}for that analyte.

**Self Assessment**

Can you:

- Identify the four key numbers needed for quality?
- Calculate error limits if given the Target Value and TE
_{A}? - Compare TE to TE
_{A}to determine if the method still performs within acceptable limits?

### Resources

- Handout Our QC Journey 8 Putting TEa into qual NEW.docx
- Job Aid 1_ Using TEA (813).pptx
- Job Aid 2_Sample TEA calculations (814).pptx
- Worksheet 1_Intended Use (805).docx
- Worksheet 2A_Intended Use (806).docx
- Worksheet 2B_Intended Use (807).docx
- Worksheet 3A_Intended Use (808).docx
- Worksheet 3B_Intended Use (809).docx
- Worksheet 4_Intended Use (810).docx
- Worksheet 5_Calculating TEA Error Limits (811) NEW.docx
- Worksheet 6_Reagent Lot Number Change (812) NEW.docx