2. Why do Q.A.? Physician’s Expectations Diagnosis Therapy Technology Physician’s Expectations Diagnosis Therapy Technology

3. Physician’s Expectations

4. Diagnosis Specificity – True Positive in Disease Sensitivity – True Negative Specificity – True Positive in Disease Sensitivity – True Negative

5. Therapy Adjustment of Medication

6. Technology Complex Instruments Complex Reagents Micro Techniques Complex Instruments Complex Reagents Micro Techniques

7. What is Q.A.? Samples Control Material Assay Conditions a. Reagents b. Instruments Daily Review Retrospective Peer Review Samples Control Material Assay Conditions a. Reagents b. Instruments Daily Review Retrospective Peer Review

8. Controls Similar to patient samples Respond like samples Stability like samples Similar to patient samples Respond like samples Stability like samples

9. Daily Review Decision Rules Random Error Systematic Error Decision Rules Random Error Systematic Error

10. Calculations

11. Gaussian Distribution

12. Abnormal Distribution

13. Graphing – Levey-Jennings Charts

14. Normal

15. Westgard Rules 1 – 3s 2 – 2s R – 4s 4 – 1s 10x 1 – 3s 2 – 2s R – 4s 4 – 1s 10x

16. 1 – 3s

17. 2 – 2s

19. R – 4s

20. 4 – 1s

21. 10x

22. Retrospective Peer Review Measurement of Peer Precision Method Comparisons Proficiency Surveys and Routine Q.C. Measurement of Peer Precision Method Comparisons Proficiency Surveys and Routine Q.C.

23. SDI-Standard Deviation Index

24. SDI Interpretation Like Signs Spread of 1 SDI Reproducibility Like Signs Spread of 1 SDI Reproducibility

25. SDI

26. E = mc Excellence = Methods x Controls x Calculations Excellence = Methods x Controls x Calculations 2 2