Foreword |
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xi | |
Acknowledgments |
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xv | |
Who Should Read This Book |
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xvii | |
Limitations of Our Advice |
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xix | |
Authors |
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xxi | |
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1 | (4) |
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Chapter 2 Our Root Cause Analysis Process |
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5 | (10) |
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5 | (3) |
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Step 1: Define the Use Error |
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8 | (1) |
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Step 2: Identify Provisional Root Causes |
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9 | (1) |
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Step 3: Analyze Anecdotal Evidence |
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10 | (1) |
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Step 4: Inspect Device for User Interface Design Flaws |
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11 | (1) |
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Step 5: Consider Other Contributing Factors |
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11 | (1) |
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Step 6: Develop a Final Hypothesis |
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12 | (1) |
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Step 7: Report the Results |
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13 | (1) |
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13 | (2) |
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Chapter 3 The Regulatory Imperative to Perform Root Cause Analysis |
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15 | (6) |
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15 | (3) |
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European Union Regulations |
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18 | (1) |
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19 | (2) |
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Chapter 4 Applicable Standards and Guidelines |
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21 | (8) |
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27 | (2) |
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Chapter 5 The Language of Risk and Root Cause Analysis |
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29 | (10) |
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29 | (10) |
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Chapter 6 Types of Use Errors |
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39 | (8) |
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Perception, Cognition, and Action Errors |
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39 | (4) |
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Slips, Lapses, and Mistakes |
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43 | (1) |
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Errors of Commission and Omission |
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44 | (1) |
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Safety-Related and Non-Safety-Related Use Errors |
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45 | (2) |
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Chapter 7 Detecting Use Errors |
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47 | (8) |
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Detecting Use Errors during Usability Tests |
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47 | (3) |
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Detecting Use Errors during Clinical Studies |
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50 | (1) |
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Detecting Use Errors during the Device's Life Cycle |
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51 | (4) |
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Chapter 8 Interviewing Users to Determine Root Causes |
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55 | (6) |
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55 | (2) |
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57 | (1) |
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Interviewing Participants during Formative Usability Tests |
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57 | (1) |
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Interviewing Participants during Summative Usability Tests |
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58 | (2) |
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60 | (1) |
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Chapter 9 Perils of Blaming Users for Use Errors |
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61 | (6) |
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61 | (4) |
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Reporting Test Artifact as a Root Cause of Use Error |
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65 | (2) |
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Chapter 10 User Interface Design Flaws That Can Lead to Use Error |
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67 | (22) |
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67 | (5) |
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General User Interface Design Flaw Examples |
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72 | (1) |
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Inadequate Feedback (or Delayed Feedback) |
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72 | (1) |
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Insufficient User Support |
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72 | (1) |
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72 | (1) |
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Too Many Procedural Steps |
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73 | (1) |
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Hardware User Interface Design Flaw Examples |
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73 | (6) |
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73 | (1) |
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73 | (1) |
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73 | (1) |
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74 | (1) |
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74 | (1) |
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Insufficient Touch Screen Sensitivity |
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75 | (1) |
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Limited Display Viewing Angle |
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75 | (1) |
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75 | (1) |
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Narrow and Shallow Handles |
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75 | (1) |
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76 | (1) |
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76 | (1) |
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77 | (1) |
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77 | (1) |
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77 | (1) |
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Requires Too Much Dexterity |
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77 | (1) |
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77 | (1) |
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78 | (1) |
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Widely Compatible Connectors |
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79 | (1) |
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Software User Interface Design Flaw Examples |
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79 | (3) |
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79 | (1) |
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79 | (1) |
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Insufficient Visual Hierarchy |
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79 | (1) |
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80 | (1) |
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81 | (1) |
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81 | (1) |
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81 | (1) |
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81 | (1) |
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82 | (1) |
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82 | (1) |
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Document User Interface Design Flaw Examples |
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82 | (3) |
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Binding Does Not Facilitate Hands-Free Use |
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82 | (1) |
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Black and White Printing Limits Comprehension |
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82 | (1) |
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No Graphical Reinforcement |
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83 | (1) |
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83 | (1) |
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No Troubleshooting Section |
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83 | (1) |
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83 | (1) |
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Poor Information Placement |
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84 | (1) |
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84 | (1) |
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84 | (1) |
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84 | (1) |
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Packaging User Interface Design Flaw Examples |
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85 | (4) |
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85 | (1) |
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Inconspicuous and Difficult-to-Read Expiration Date |
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86 | (1) |
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86 | (1) |
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87 | (1) |
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87 | (2) |
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Chapter 11 Reporting Root Causes of Medical Device Use Error |
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89 | (10) |
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89 | (6) |
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Distinguishing Facts and Hypotheses |
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95 | (1) |
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96 | (1) |
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Presenting the Results of a Residual Risk Analysis |
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97 | (2) |
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Chapter 12 Root Cause Analysis Examples |
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99 | (108) |
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About the Root Cause Analysis Examples |
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99 | (3) |
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102 | (4) |
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106 | (4) |
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Automated External Defibrillator (AED) |
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110 | (3) |
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113 | (4) |
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117 | (3) |
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120 | (3) |
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Electronic Health Record (EHR) |
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123 | (4) |
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127 | (4) |
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131 | (4) |
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135 | (3) |
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138 | (3) |
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141 | (4) |
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Ventricular Assist Device (VAD) |
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145 | (3) |
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148 | (4) |
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152 | (3) |
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Smartphone Application: Insulin Bolus Calculator |
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155 | (4) |
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159 | (3) |
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162 | (3) |
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165 | (3) |
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168 | (4) |
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172 | (4) |
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176 | (4) |
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180 | (4) |
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Electrosurgical Generator and Handpiece |
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184 | (3) |
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Large Volume Infusion Pump |
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187 | (3) |
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190 | (4) |
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194 | (4) |
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198 | (3) |
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201 | (3) |
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204 | (3) |
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Chapter 13 Guide to Designing an Error-Resistant User Interface |
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207 | (10) |
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207 | (1) |
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208 | (4) |
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208 | (2) |
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210 | (1) |
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210 | (1) |
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211 | (1) |
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212 | (1) |
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212 | (1) |
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212 | (2) |
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212 | (1) |
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213 | (1) |
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213 | (1) |
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214 | (3) |
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214 | (1) |
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215 | (1) |
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215 | (1) |
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Protection against Inadvertent Actuation |
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215 | (1) |
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Instructional Content and Format |
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215 | (1) |
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216 | (1) |
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Chapter 14 Other Root Cause Analysis Methods |
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217 | (16) |
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217 | (1) |
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218 | (1) |
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219 | (1) |
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220 | (3) |
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The Joint Commission's Framework for Conducting a Root Cause Analysis |
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223 | (3) |
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226 | (4) |
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227 | (1) |
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227 | (1) |
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228 | (1) |
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229 | (1) |
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229 | (1) |
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230 | (1) |
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230 | (1) |
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Critical Decision Method (CDM) |
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231 | (1) |
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Systems-Theoretic Accident Model and Processes (STAMP) |
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231 | (1) |
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The Human Factors Analysis and Classification System (HFACS) |
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231 | (1) |
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Event Analysis for Systemic Teamwork (EAST) |
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232 | (1) |
Resources |
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233 | (4) |
Index |
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237 | |