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Understanding Q.A. in Medical Technology: Physician's Expectations, Diagnosis, Therapy, and Technology

Explore the importance of Quality Assurance (Q.A.) in medical technology, including physician's expectations, diagnosis specifics, therapy adjustments, and complex instruments used. Learn about Q.A. processes, control materials, assay conditions, peer reviews, error calculations, and statistical tools like Levey-Jennings Charts and Westgard Rules.

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Understanding Q.A. in Medical Technology: Physician's Expectations, Diagnosis, Therapy, and Technology

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Presentation Transcript

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

  2. Physician’s Expectations

  3. Diagnosis • Specificity –True Positive in Disease • Sensitivity –True Negative

  4. Therapy • Adjustment of Medication

  5. Technology • Complex Instruments • Complex Reagents • Micro Techniques

  6. What is Q.A.? • Samples • Control Material • Assay Conditionsa. Reagentsb. Instruments • Daily Review • Retrospective Peer Review

  7. Controls • Similar to patient samples • Respond like samples • Stability like samples

  8. Daily Review • Decision Rules • Random Error • Systematic Error

  9. Calculations

  10. Gaussian Distribution

  11. Abnormal Distribution

  12. Graphing – Levey-Jennings Charts

  13. Normal

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

  15. 1 – 3s

  16. 2 – 2s

  17. 2 – 2s

  18. R – 4s

  19. 4 – 1s

  20. 10x

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

  22. SDI-Standard Deviation Index

  23. SDI Interpretation • Like Signs • Spread of 1 SDI • Reproducibility

  24. SDI

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

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