Laboratory Biorisk Management: Biosafety and Biosecurity

Laboratory Biorisk Management: Biosafety and Biosecurity
 
Author:
Reynolds M. Salerno, Jennifer Gaudioso
Published in: CRC Press
Release Year: 2015
ISBN: 978-1466-5-9365-7
Pages: 264
Edition: First edition
File Size: 5 MB
File Type: pdf
Language: English



Description of Laboratory Biorisk Management: Biosafety and Biosecurity


The central premise of this Laboratory Biorisk Management: Biosafety and Biosecurity book are that biological research, clinical, diagnostic, and production/manufacturing communities need to embrace and implement biorisk management systems in their facilities and operations. In most countries, the current system mitigates the risk of accidental infection, accidental release, and intentional misuse of pathogens and toxins based on general, predetermined biosafety levels and/or prescriptive biosecurity regulations. 
Although this approach may have sufficed when the biological life science community was relatively small, and work with particularly dangerous organisms was limited to a few countries and facilities, the life sciences have grown significantly in the last two decades—in both scope and sophistication. 
Much of this growth has extended well beyond North America and Western Europe, and deep into the developing world. Simply, there are more people in more places working with, and even creating, more dangerous pathogens and toxins than ever before—and that trend shows no sign of abating in the future.

Content of Laboratory Biorisk Management: Biosafety and Biosecurity



Chapter 1 Introduction: The Case for Biorisk Management.1
Reynolds M. Salerno and Jennifer Gaudioso
Abstract 1
Laboratory Biosafety and Biosecurity .1
A Short History of Laboratory Biosafety 2
A Short History of Laboratory Biosecurity.6
Recent Biosafety and Biosecurity Incidents 7
A Model of Biorisk Management Begins to Emerge ..9
New Focus on Risks of Bioscience Research 11
Learning Lessons from Other Industries... 12
Union Carbide, Bhopal, 1984  13
Chernobyl Nuclear Power Plant, 1986... 14
Piper Alpha Oil Platform, 1988. 15
Texas City Refinery, 2005. 16
Fukushima Nuclear Power Plant, 2011.. 16
Y-12 Nuclear Facility, 2012 ... 17
Pharmaceutical Industry 18
Food Industry 20
Airline Industry. 21
Biorisk Management ..23
References ..24

Chapter 2 The AMP Model  31
Lisa Astuto Gribble, Edith Sangalang Tria, and Laurie Wallis
Abstract .. 31
Introduction  31
Assessment. 33
When to Perform and Review a Laboratory Risk Assessment. 35
Shared Roles and Responsibilities in Assessing Risk ... 35
Mitigation ...36
Mitigation Control Measures.37
Performance ...39
Laboratory Biorisk Management Guidelines40
Plan-Do-Check-Act 40
Conclusion.. 42
References .. 42

Chapter 3 Risk Assessment. 45
Susan Caskey and Edgar E. Sevilla-Reyes
Abstract .. 45
Definition of Risk... 45
Biosafety Risks..46
Biosecurity Risks...46
Traditional Risk Assessment Approaches for Biorisks.46
Risk Governance and Biorisk Management.. 47
Risk Assessment Methodology .. 47
Biosafety Risk Assessment50
Biosecurity Risk Assessment  53
Ethics of Biorisk/Risk Acceptability. 57
Roles and Responsibilities for Risk Assessment 59
Conclusion.. 62
References .. 62

Chapter 4 Facility Design and Controls..65
William D. Arndt, Mark E. Fitzgerald, and Ross Ferries
Abstract ..65
Introduction 65
Design for Biorisk Management. 67
Risk-Based Design Decisions.69
The Design Process 71
Project Stakeholders...73
Predesign  74
Information Gathering ... 75
Schematic Design... 76
Laboratory Design Best Practices.. 76
Public-Private Separation.. 76
Zone Strategies..77
Flow Analysis 78
Layers of Protection...79
Placement of Primary Containment Devices 81
Facility Design Factors...82
Sustainability.82
Adaptability and Flexibility ..83
Conclusion..84
Key Concepts .85
References ..85

Chapter 5 Rethinking Mitigation Measures87
Jennifer Gaudioso, Susan Boggs, Natasha K. Griffith,
Hazem Haddad, Laura Jones, Ephy Khaemba, Sergio Miguel,
and Cecelia V. Williams
Abstract ..87
Introduction 87
Case Study: Challenges Mitigating Biorisks—Texas A&M
University ...89
Using AMP to Strengthen Mitigations... 91
Primary Engineering Controls.. 91
Standard Operating Procedures 93
Personnel ...94
Eliminating Safety and Security Conflicts95
Case Study: Different Solution Paths to Working with Ebola Virus96
Conclusion..97
References ..97

Chapter 6 Biorisk Management Training.. 101
Lora Grainger and Dinara Turegeldiyeva
Abstract  101
Introduction .. 101
An International and Historical Perspective  102
Using ADDIE for BRM Training. 103
Incorporating Instructional Design . 111
Identifying, Compiling, and Organizing Training Content. 116
Measuring Training Performance and Success... 119
Conclusion 121
References  121

Chapter 7 Operations and Maintenance Concepts 125
William Pinard, Stefan Breitenbaumer, and Daniel Kümin
Abstract  125
Introduction .. 125
Foot-and-Mouth Disease Virus Release..126
Maintenance Strategies 127
Overview . 127
Reactive Maintenance (Event-Oriented Maintenance) ... 128
Preventive Maintenance .. 128
Predictive Maintenance (Conditional Maintenance)... 130
Reliability-Centered Maintenance .. 131
Developing a Tiered Maintenance System... 132
System Layout . 132
Roles and Responsibilities... 133
Maintenance Context... 135
Maintenance Categories.. 137
Implementation. 140
Maintenance Planning. 140
List of Facility Systems... 141
Maintenance Activities 141
Arrangement into Maintenance Categories. 141
Conclusion 142
References  143
Additional References Consulted. 143

Chapter 8 Evaluating Biorisk Management Performance. 145
LouAnn Burnett and Patricia Olinger
Abstract  145
Introduction .. 145
The Importance of Performance to Biorisk Management ... 146
Establishing Biorisk Management Performance Measurements. 149
Step 1: Identify the Key Issues of Concern. 150
Steps 2 and 3: Define Outcome and Activity Indicators and
Metrics. 151
Step 4: Collect Data and Report Indicator Results.. 152
Step 5: Act on Findings from Performance Indicators 153
Step 6: Evaluate and Refine Performance Indicators.. 154
Specific Biorisk Management Examples.. 154
Example A: Setting Biorisk Management Performance
Indicators during the Planning Stage .. 155
Example B: Expanding Biorisk Management Performance
Indicators during the Planning Stage .. 158
Example C: Utilizing Existing Data to Create or Expand
Performance Measurements 162
Example D: Using Biorisk Management Functions
and Performance Indicators Outside of Laboratories.. 164
Conclusion 164
References  166

Chapter 9 Communication for Biorisk Management 169
Money Makvandi and Mika Shigematsu
Abstract  169
A Case Study 169
Background .. 172
Roles and Responsibilities 173
Communicating Biorisk Management Information. 175
Drivers of Public Perception 177
Hazard Communication .. 178
Communication of Risk Assessment Findings 180
Risk Communication in a Risk Governance Framework. 182
Preassessment (Hazard Identification)  182
Risk Assessment.. 183
Tolerability and Acceptance Judgment (Risk Tolerance and
Acceptability) .. 183
Risk Management (Risk Mitigation and Evaluation).. 185
Crisis Communication.. 185
Risk and Crisis Communication during Hurricane Katrina ... 186
Conclusion 187
References  188

Chapter 10 Three Recent Case Studies: The Role of Biorisk Management ... 191
Reynolds M. Salerno
Abstract  191
Introduction .. 191
Case Study 1: Anthrax Mishandling at the CDC. 192
A Role for Biorisk Management?  192
Case Study 2: H5N1 Influenza Mishandling at CDC .. 196
A Role for Biorisk Management?  196
Case Study 3: Mishandling Inventory at the NIH 198
A Role for Biorisk Management?  199
Conclusion 201
References 202

Chapter 11 Future Development of Biorisk Management: Challenges and
Opportunities205
Benjamin Brodsky and Uwe Müeller-Dobies
Abstract 205
Introduction ..205
Challenges and Opportunities..207
Biorisk Assessment..207
Biorisk Mitigation 216
Biorisk Management Performance—Evaluating the
Organizational Benefits from a Matured Biorisk
Management System 221
Conclusion225
References 226
Index..229

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