Fifth Edition Lab Statistics - Data Innovations

1 Fifth Edition Lab Statistics Fun and Easy By David G. Rhoads A Practical Approach to Method Validation Developing Software for the Quality-Driven Clinical Laboratory Since 1983. Lab Statistics Fun and Easy A Practical Approach to Method Evaluation Fifth Edition by David G. Rhoads David G. Rhoads Associates A data Innovations brand 120 Kimball Ave, Suite 100. South Burlington, VT 05403. (800) 786-2622 and (802) 658-1955. Table of Contents Preface Copyright i i Preface for the Fifth History of Our Clinical Laboratory and Standards Institute chapter 1. Introduction chapter 2.

2 Effects of Bad Lab Results Case of the Disappearing Case of the Congressional Case of the Failed Case of the Mistaken Murder How Lab Error Contributes to Higher Health care Key Role of Clinical Laboratory ..2-4. Why include these cases in a Lab Statistics Manual?..2-4. It's the Culture, Stupid!!..2-5. chapter 3. Relevant Highlights of CLIA 88 Regulations Startup Requirements ..3-2. Periodic Requirements ..3-4. Performance Requirements of Other Deemed chapter 4. Statistics 101. Major Statistical Statistical Terms used in Clinical Table of Contents -1. chapter 5.

3 Understanding Error and Performance Standards Experimental Error ..5-1. Concepts of Performance Standards ( Total Allowable Error)..5-5. QC Error Error Calculation of Allowable Systematic 5-11. Assessing 5-11. chapter 6. Defining Performance Standards Performance Standards Defining PS for Established Comprehensive Approach for Defining Low End Performance 6-11. Limits defined by Performance 6-11. Defining Performance Standards - Case 6-11. chapter 7. Managing Quality Control Target Mean ..7-2. Target SD ..7-3. QC Tips on Managing QC ..7-5. In the Event of QC Average of chapter 8.

4 Performance Validation Experiments Startup Recurring Before You Begin..8-4. -2 Lab Statistics - Fun and Easy chapter 9. Interpreting Method Comparison Experiments Interpretation of Method Comparison Concepts and Types of Method Comparison Interpretation of Case 1: A Good Properties of Good Report for Good Case 2: Effect of Proportional Case 3: Effect of Constant Case 4: Effect of Random Case 5: Non-Linear Case 6: Effect of Case 7: Effect of Extreme Case 8: Effect of Range of Case 9: Effect of Number of Case 10: Effect of Poor Distribution of Method Harmonization chapter 10.

5 Interpreting Linearity Experiments Definition of Some Statistical Linearity ..10-2. Reportable Calibration Case Case 1: A Non-Linear Case 2: Inaccurate Case 3: Failures Due to Inappropriate 10-11. Table of Contents -3. chapter 11. Understanding Proficiency Testing Regulatory 11-1. Theoretical 11-2. 11-3. Calculating the Probability of PT 11-4. 11-7. Strategy to Pass Proficiency 11-9. Proficiency Testing 11-11. chapter 12. Precision Experiments Simple Precision Simple Precision Report (Page 1)..12-3. Complex Precision Complex Precision Report (Page 1)..12-5. Complex Precision Report (Page 2).

6 12-6. chapter 13. Understanding Reference Intervals Key Sources of Medical Decision Verifying vs. Establishing vs. Verifying a Normal Range ..13-3. Establishing a Normal MDP's which are Cast in Stone ..13-7. Accuracy and Precision for Normal Interpreting the Reference Interval Case 1: An Uncomplicated Example ..13-15. Case 2: Skewed Case 3: Effect of Number of Case 4: Partitioning (by Gender, Race, etc.)..13-19. Case 5: Effect of Case 6: Effect of ERI Report showing Effect of Tails (no Truncation)..13-25. ERI Report showing Effect of Tails (with Truncation).

7 13-26. -4 Lab Statistics - Fun and Easy chapter 14. Sensitivity Experiments Sensitivity (Limits of Blank) Experiment ..14-2. Sensitivity (LOB) - Alternate Sensitivity (Limits of Quantitation) Appendix A. Published Performance Standards Medical Appendix B. Technical CLIA 88 Regulations Subpart K - Quality Systems for Nonwaived Testing .. B-1. Selected Interpretative B-17. Appendix C. Glossary AppendixD. Bibliography Appendix E Our Products EP Evaluator , Release E-1. Instrument Manager .. E-5. Table of Contents -5. -6 Lab Statistics - Fun and Easy Preface Copyright Notice This manual is copyrighted 1996 - 2012 by data Innovations , LLC.

8 All rights are reserved worldwide. No part of this book may be reproduced, transmitted, tran- scribed or translated into any language by any means without the express written consent of data Innovations , LLC. For further information, contact: David G. Rhoads Associates A data Innovations brand data Innovations NORTH AMERICA data Innovations EUROPE. Phone: (802) 658-1955 Phone: +32 2 332 24 13. Fax: (802) 658-2782 Fax: +32 2 376 43 84. Email: Email: Email: data Innovations ASIA data Innovations LATIN AMERICA. Phone: +852 2398 3182 Phone: +55 (11) 3801-3283. Fax: +852 2398 8667 Fax: +55 (11) 3871-9592.

9 Email: Email: Preface -i Acknowledgements My wife, Elizabeth Rhoads, has as always, been very helpful in the produc- tion of this book. She remains a tower of support. My colleague, Marilyn Fleming, has been essential to the development of EP. Evaluator . Her background in programming and Statistics coupled with a will- ingness to understand major components of how a laboratory works has been an essential component of the success of our company and our software. In recent years, Marilyn has been presenting several sections of our workshop including one section on Statistics .

10 Her input has been invaluable. Gregory R. Vail and David G. Potter, founders of data Innovations . They deserve recognition both for their vision that quality in clinical laboratories is important, and for their commitment to help laboratories achieve that quality. If you, the reader, have comments or criticism about this book, please share them with us. In that way, we will be able to improve the next version. I take full responsibility for any errors in this book. David G. Rhoads, , DABCC. Kennett Square, PA. October, 2009. Preface for the Fifth Edition There is one notable difference between the Fourth and Fifth editions of Lab Statistices Fun and Easy: the Performance Standard for HbA1c was changed to reflect current requirements (see Table I on page 6-4).