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PT Provider Roundtable

This document summarizes a roundtable discussion held at the College of New Jersey on February 26, 2004, led by Chuck Wibby, focusing on the establishment of acceptance limits in compliance with NELAC standards. Key topics include fixed limits, regression equations centered on assigned values and expected mean recovery, and methods for calculating predicted means and standard deviations. The insights shared during this session are crucial for enhancing quality assurance in laboratory settings. Contact details for follow-up are provided.

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PT Provider Roundtable

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  1. PT Provider Roundtable Chuck Wibby College of New Jersey February 26, 2004

  2. Establishing Acceptance Limits

  3. NELAC Acceptance Limits • Fixed Limits • +15% • Centered on assigned value (100% concentration) • Regression equations • Centered on expected mean recovery • Regression equation SDs • Combinations • Centered on study mean • Regression equation SDs

  4. Regression equations

  5. Regression equations • Y = mx + b • a, b, c, d???? • Predicted mean = (Assigned Value * a) + b • Predicted SD = (Assigned Value * c) + d • WS Acceptance Limits = Pred mean + 2 * Pred SD • WP Acceptance Limits = Pred mean + 3 * Pred SD

  6. Manufacturing

  7. Verification

  8. Homogeneity

  9. Post Study

  10. Stability

  11. Post Study

  12. Thank You! Keith Ward 303-940-0033, ext 202 kward@wibby.com Chuck Wibby 303-940-0033, ext 201 cwibby@wibby.com Ty Garber 303-940-0033, ext 213 tgarber@wibby.com

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