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Preface ix
Acknowledgements
Chapter 1 Introduction
The Business of Diagnostic Testing
Quality Has Improved–Yet Physicians Rely More on Test Results
Lifescan: One Manufacturer’s Problem
University of Washington Medical Center: A Laboratory Problem
Analysis of the Two Problems
Why Problems Occur
Financial Incentives Don’t Favor Allocating Resources to Quality
Industry-supported Studies Favor Low-information-content Reports
Corporate Culture
Inertia
How This Book Can Help
Appendix The Role of Assay Error in Decisions to Approve Assays for Use
Chapter 2 The Diagnostic Assay Development Landscape and the Role of Consultants
The Technical Environment
The Commercial Environment
The Regulatory and Medical Environment
The Management Environment
The Five Stages of Product Development
The Consultant’s Environment–How Consultants Get Their Solutions Implemented
How Statisticians Are Often Perceived and What They Really Do
When Management Resists–Techniques Used by Consultants to Implement Solutions
It’s About Control
The Successful Consulting Cycle
Technology Transfer–The Benefits of a Learning Organization
Training as Part of a Learning Organization
Chapter 3 Stage I: Researching New Opportunities
Why Scientists and Engineers Need to Understand Financial Models
Using Decision-analysis-based Financial Models to Value Opportunities
Decision-analysis Background and Terms
Selecting Decision-analysis Software
Creating the Decision-analysis Team
Preparing an Influence Diagram
Techniques to Solicit Unbiased Data
Performing the Analysis–The Results
The Base Case
Sensitivity Analysis
Distribution Analysis
Techniques to Improve Decision-analysis Models
The Use of Options
Markov Analysis
Methods to Evaluate the Probability of the Technical Success of Opportunities
Different States of Knowledge Require Different Strategies
Results Based on Decision Analysis
Why Management Always Wants the Product Released Sooner
Why Quality Ranks Low in Terms of Financial Rewards
Portfolio Analysis
A Caveat About Using Decision Analysis
Appendix How Expected NPVs Are Calculated
Chapter 4 Stage II: Proving Feasibility
Setting Performance Specifications Using Quantitative Methods
The Importance of Adequate Performance Specifications
Adequate and Less-than-adequate Performance Specifications
Nonexistent Specifications
Nonquantitative Specifications
Unrealistic Specifications
Incorrect Specifications
Specifications Without an Associated Testing and Analysis Method
Characteristics of an Adequate Performance Specification
An Example of a Performance Specification for Blood Gas Analyzer Glucose Imprecision
How Specifications Change Through the Development Process
Different Origins of Performance Specifications
Regulatory
Medical Need
Competitive
How Specifications Are Used Differently by Manufacturers and Customers
Specific Techniques Used to Set Performance Specifications
Focus Groups and Surveys
Conjoint Analysis
Quality Function Deployment
Different Approaches to Demonstrating Feasibility
Beware the Technical Administrator
Chapter 5 Stage III: Scheduled Development
Why Products Are Almost Always Late
Using Design of Experiments Methods to Build Robust Assays
Why Many Scientists Do not Use Design of Experiments (DOE) Methods
Cause-and-effect Diagrams and Process Flow Charts
Factorial and Response-surface Methods
Experiment-planning Checklist
Writing Reports That Convert Data into Information
The Need for Written Reports
Tips for Converting Data into Information
A Suggested Report Format
Symptoms for Problem Reports
Using Reliability Growth Management to Build Reliable Systems
An Overview of Reliability Growth Management
When “Testing in Quality” Is More Efficient Than “Designing in Quality”
A Model of Instrument System Service Calls
Redundancy and Reliability Goals
FRACAS
Data Analysis
Corrective Action
Measuring Progress
Results Achieved with Reliability Growth Management
Chapter 6 Stage IV: Validation
Why Many Published Validation Methods Fall Short in Assessing Assay Quality
Validation Methods Within Companies
Error Modeling Using Simulation
A Block Diagram or Flow Chart of the System
A Cause-and-effect Diagram of Error
How the Error Model Works
The Simulation Software
Total Analytical Error
Multifactor Protocols
Introduction
Multifactor Protocol History
Understanding Multifactor Protocols
Use and Interpretation of Multifactor Protocols
Examples
Implementation
Additional Special Studies
Diagnostic Accuracy
The Detection Limit
Specific Interference Studies
Direct vs. Indirect Methods of Estimation
Estimation of Outliers
Outlier Goals
Estimation of Outlier Rates
External (Customer) Validation Methods
Why Manufacturer Trials Held at Customer Sites Often Fail to Detect Problems
Chapter 7 Stage V: Commercialization
How Claims Differ from Internal Specifications
The Typical Data Claim
The Guaranteed Performance Claim
Obtaining and Analyzing Remote Data
Fault Detection
Data Collection
Data Analysis
The Mean Cumulative Repair Function
Using Process Capability to Compare Performance Across Assays
The Difference Between Quality Control and Process Capability
An Example Set of Assays Compared
Interpretation
Using Complaints to Improve Assays
Index

PREFACE 6
ACKNOWLEDGEMENT 7
1. THE ROLE OF FAULT TREES AND FMECAS IN A HOSPITAL 8
PURPOSE 8
SOME DEFINITIONS (SEE ALSO THE GLOSSARY) 8
TWO TYPES OF PREVENTABLE MEDICAL ERRORS 8
THE HOSPITAL ENVIRONMENT 9
DIFFERENCE BETWEEN JCAHO RECOMMENDED FMEAS AND IFTF 10
DISCUSSION AND RECOMMENDED IMPROVEMENTS 11
A GENERIC FAILURE EVENT SEQUENCE 14
HOW A FAULT TREE / FMECA HELPS TO MANAGE RISK 16
FAULT TREE / FMECAS HELP TO ORGANIZE KNOWLEDGE 16
THE BENEFIT OF AN INTEGRATED FAULT TREE / FMECA 16
SOME LIMITATIONS OF A FAULT TREE / FMECA 17
ACCREDITATION VS. QUALITY 17
MANAGEABLE FAULT TREES 19
THE RELATIONSHIP BETWEEN DESIGN AND ERROR REPORTING TOOLS 19
APPENDIX – THE SPECTRUM OF PREVENTABLE ERRORS 23
2. GETTING STARTED 24
PURPOSE 24
OUTLINE OF THE PROCESS 24
SELECT A PROJECT 24
CREATE A PROCESS FLOWCHART 24
BUILDING A SIMPLE TREE 27
THE PROJECT DATABASE 27
ADDING SOME NODES 27
OR GATES 27
AND GATES 28
BASIC GATES 29
PRINTING THE FAULT TREE 29
AN ANALYSIS PREVIEW 30
REVIEW 31
ADDING FMECA INFORMATION 31
EVENT ATTRIBUTES 31
FAILURE MODE AND CAUSES 31
FAILURE MODE EFFECTS 32
FAULT DETECTION 32
FAULT ISOLATION 32
COMPONENT 32
RECOVERY 32
ACTION TAKEN 32
COMMENTS 33
REVIEW 33
VIEWING FMECA INFORMATION 33
REPORT FEATURES 34
REPORT FILTERS 34
REPORT GROUPING OPTIONS 34
3. UNDERSTANDING FAULT TREES AND FMECAS 36
INTRODUCTION 36
THE SEQUENCE OF POSSIBLE STEPS FOR A FAILURE MODE EVENT 36
IMMEDIATE EFFECTS FOR FAILURE MODE EVENTS 37
THE BRAINSTORMING MEETING FOR BUILDING THE TREE 37
FACILITATING THE MEETING 37
FMEA AS A DESIGN REVIEW 38
BLOCK DIAGRAMS AS A STARTING POINT FOR CONSTRUCTING A FAULT TREE 38
CREATING BLOCK DIAGRAMS AND PROCESS FLOWCHARTS 39
WHEN A DETECTION OR RECOVERY METHOD IS A PROCESS STEP 41
USING PROCESS FLOWCHARTS 42
WHY THE PROCESS FLOW CHART IS NEVER SUFFICIENT 42
USING EXISTING CHECKLISTS 43
FAULT TREE RELATIVES 43
MORE ABOUT SEVERITY 44
MORE ABOUT PROBABILITY 45
FILLING IN THE FMECA EVENTS 46
INTRODUCTION 46
THE FAILURE MODE AND CAUSE FIELD 46
THE FAILURE MODE EFFECTS FIELD 47
THE FAULT DETECTION FIELD 47
THE FAULT ISOLATION FIELD 48
THE COMPONENT FIELD 48
THE RECOVERY FIELD 49
UNDERSTANDING THE ACTION TAKEN FIELD 49
STATE OF KNOWLEDGE 49
HIERARCHY OF ACTIONS TAKEN 49
CORRELATION BETWEEN OF ACTION TAKEN AND STATE OF KNOWLEDGE 50
REVIEW 50
APPENDIX A – HOSPITAL LAB QSES 51
APPENDIX B – HEALTHCARE QSES 53
4. RISK ANALYSIS 55
INTRODUCTION 55
DANGERS IN SOME RISK QUANTIFICATION SCHEMES – BEWARE THE RISK PRIORITY NUMBER (RPN) 55
PARETO VIEWS IN THE VIEW FMECA TAB 56
PARTIAL PARETO 56
FULL PARETO 56
RISK MAP TAB 56
CONTROLLING PROBABILITY OF OCCURRENCE 57
RISK CHART 57
OVER-INTERPRETING THE RISK MAP AND RISK CHART 58
PROBABILITY CAN NEVER BE ZERO 59
EVENT MODELS 59
DECISION ANALYSIS MODELS 60
5. MITIGATION STRATEGIES 61
THE HIERARCHY OF MITIGATION 61
DESIGN CHANGES 61
PREVENTING AN ERROR SOURCE FROM OCCURRING 61
REDUCING THE RATE OF OCCURRENCE OF AN ERROR SOURCE 62
TYPES OF DESIGN CHANGES 62
DETECTION – AUTOMATED VS. MANUAL DETECTION 62
EARLY DETECTION 63
DETECTION VIEWED AS A MEDICAL TEST 63
RECOVERY CHANGES 63
THE COST OF MITIGATIONS 64
THE RISK OF MITIGATIONS CAUSING NEW PROBLEMS 65
DETERMINING THE QUALITY OF A RISK OF MITIGATION 65
MITIGATIONS CAN ALWAYS BE IMPROVED 66
6. IFTF USER’S MANUAL 67
PROGRAM DESCRIPTION 67
HARDWARE REQUIREMENTS 67
SOFTWARE REQUIREMENTS 67
INSTALLATION 67
FILES INSTALLED IN THE IFTF DIRECTORY 68
PROGRAM REMOVAL 68
LICENSE 68
FAULT TREE TAB 70
ADDING A NODE 70
EDITING A NODE 71
DELETING NODE(S) 71
CUT, COPY, AND PASTE 71
EVENT NAME AND IDS 71
PRINTING THE TREE 72
EXITING THE PROGRAM 72
ENTER FMECA TAB 72
MAINTAINING THE “COMPONENT LIST” 73
MAINTAINING THE “FAULT DETECTION LIST” 73
VIEW FMECA TAB 73
FILTERING DATA 74
REPORT TYPES 74
USING THE REPORT TOOLBAR 74
RISK MAP  TAB 75
RISK CHART  TAB 75
THE PROJECTS TAB 75
CHANGING TO A NEW PROJECT 75
ADDING ONE PROJECT (OR PART OF A PROJECT) INTO ANOTHER PROJECT 75
CHANGING THE WORKING DIRECTORY 76
OPTIONS TAB 76
NODE COLOR 76
MAINTAIN RESPONSIBLE LIST 77
THE PROCESS FLOWCHART TAB 77
OPENING AN EXISTING FLOWCHART 77
SAVING A FLOWCHART 77
CLEARING ALL FLOWCHART OBJECTS 77
CREATING A FLOWCHART 77
WORKING WITH SHAPES 77
WORKING WITH LINES 78
COPYING OR DELETING SHAPES AND LINES 78
ADDING A TITLE 78
GROUPING 78
PRINTING THE FLOWCHART 78
ABOUT TAB 79
USER PREFERENCES 79
APPENDIX – DECIDING ON PROGRAM FUNCTIONALITY 80
QUANTIFYING PROBABILITIES 80
SECURITY, USERS, AND AUDIT FUNCTIONS 80
DEFINITIONS OF TERMS – GLOSSARY 81
PROGRAM FAQS (FREQUENTLY ASKED QUESTIONS) 82
ABOUT THE AUTHOR 83

 

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