PREFACE

6

ACKNOWLEDGEMENT

7

1. THE ROLE OF FAULT TREES AND FMECAS IN A HOSPITAL

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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

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A GENERIC FAILURE EVENT SEQUENCE

14

HOW A FAULT TREE / FMECA HELPS TO MANAGE RISK

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FAULT TREE / FMECAS HELP TO ORGANIZE KNOWLEDGE

16

THE BENEFIT OF AN INTEGRATED FAULT TREE / FMECA

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SOME LIMITATIONS OF A FAULT TREE / FMECA

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ACCREDITATION VS. QUALITY

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MANAGEABLE FAULT TREES

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THE RELATIONSHIP BETWEEN DESIGN AND ERROR REPORTING TOOLS

19

APPENDIX – THE SPECTRUM OF PREVENTABLE ERRORS

23

2. GETTING STARTED

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PURPOSE

24

OUTLINE OF THE PROCESS

24

SELECT A PROJECT

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CREATE A PROCESS FLOWCHART

24

BUILDING A SIMPLE TREE

27

THE PROJECT DATABASE

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ADDING SOME NODES

27

OR GATES

27

AND GATES

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BASIC GATES

29

PRINTING THE FAULT TREE

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AN ANALYSIS PREVIEW

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REVIEW

31

ADDING FMECA INFORMATION

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EVENT ATTRIBUTES

31

FAILURE MODE AND CAUSES

31

FAILURE MODE EFFECTS

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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

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REPORT GROUPING OPTIONS

34

3. UNDERSTANDING FAULT TREES AND FMECAS

36

INTRODUCTION

36

THE SEQUENCE OF POSSIBLE STEPS FOR A FAILURE MODE EVENT

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IMMEDIATE EFFECTS FOR FAILURE MODE EVENTS

37

THE BRAINSTORMING MEETING FOR BUILDING THE TREE

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FACILITATING THE MEETING

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FMEA AS A DESIGN REVIEW

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BLOCK DIAGRAMS AS A STARTING POINT FOR CONSTRUCTING A FAULT TREE

38

CREATING BLOCK DIAGRAMS AND PROCESS FLOWCHARTS

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WHEN A DETECTION OR RECOVERY METHOD IS A PROCESS STEP

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USING PROCESS FLOWCHARTS

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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

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THE FAILURE MODE EFFECTS FIELD

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THE FAULT DETECTION FIELD

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THE FAULT ISOLATION FIELD

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THE COMPONENT FIELD

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THE RECOVERY FIELD

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UNDERSTANDING THE ACTION TAKEN FIELD

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STATE OF KNOWLEDGE

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HIERARCHY OF ACTIONS TAKEN

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CORRELATION BETWEEN OF ACTION TAKEN AND STATE OF KNOWLEDGE

50

REVIEW

50

APPENDIX A - HOSPITAL LAB QSES

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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

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PARTIAL PARETO

56

FULL PARETO

56

RISK MAP TAB

56

CONTROLLING PROBABILITY OF OCCURRENCE

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RISK CHART

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OVER-INTERPRETING THE RISK MAP AND RISK CHART

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PROBABILITY CAN NEVER BE ZERO

59

EVENT MODELS

59

DECISION ANALYSIS MODELS

60

5. MITIGATION STRATEGIES

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THE HIERARCHY OF MITIGATION

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DESIGN CHANGES

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PREVENTING AN ERROR SOURCE FROM OCCURRING

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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