Laboratory Biorisk Management: Biosafety and Biosecurity, 1st Edition (Hardback) book cover

Laboratory Biorisk Management

Biosafety and Biosecurity, 1st Edition

Edited by Reynolds M. Salerno, Jennifer Gaudioso

CRC Press

264 pages | 24 B/W Illus.

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Hardback: 9781466593640
pub: 2015-05-08
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Description

Over the past two decades bioscience facilities worldwide have experienced multiple safety and security incidents, including many notable incidents at so-called "sophisticated facilities" in North America and Western Europe. This demonstrates that a system based solely on biosafety levels and security regulations may not be sufficient.

Setting the stage for a substantively different approach for managing the risks of working with biological agents in laboratories, Laboratory Biorisk Management: Biosafety and Biosecurity introduces the concept of biorisk management—a new paradigm that encompasses both laboratory biosafety and biosecurity. The book also provides laboratory managers and directors with the information and technical tools needed for its implementation.

The basis for this new paradigm is a three-pronged, multi-disciplinary model of assessment, mitigation, and performance (the AMP model). The application of the methodologies, criteria, and guidance outlined in the book helps to reduce the risk of laboratories becoming the sources of infectious disease outbreaks.

This is a valuable resource for those seeking to embrace and implement biorisk management systems in their facilities and operations, including the biological research, clinical diagnostic, and production/manufacturing communities.

Reviews

"Wow—what an eye-opening read on the necessity of biosafety risk management and how to successfully implement it and monitor its effectiveness. This is a great addition for any laboratory—clinical, research, other—working with any biological agent that has disproportionately hazardous adverse health effects."

—Valerie L. Ng, PhD MD, Alameda County Medical Center/Highland Hospital, writing in Doody’s Review Service

Table of Contents

Introduction: The Case for Biorisk Management

Laboratory Biosafety and Biosecurity

Learning Lessons from Other Industries

Biorisk Management

The AMP Model

Abstract

Introduction

Assessment

Mitigation

Performance

Plan-Do-Check-Act

Summary

References

Risk Assessment

Abstract

Definition of Risk

Risk Assessment Methodology

Ethics of Biorisk/Risk Acceptability

Roles and Responsibilities for Risk Assessment

Summary

References

Facility Design and Controls

Abstract

Introduction

Design for Biorisk Management

Risk-Based Design Decisions

The Design Process

Project Stakeholders

Predesign

Information Gathering

Schematic Design

Laboratory Design Best Practices

Facility Design Factors

Summary

Key Concepts

References

Rethinking Mitigation Measures

Abstract

Introduction

Case Study: Challenges Mitigating Biorisks—Texas A&M University

Using AMP to Strengthen Mitigations

Case Study: Different Solution Paths to Working with Ebola Virus

Summary

References

Biorisk Management Training

Abstract

Introduction

An International and Historical Perspective

Using ADDIE for BRM Training

Conclusion

References

Operations and Maintenance Concepts

Abstract

Introduction

Maintenance Strategies

Developing a Tiered Maintenance System

Implementation

Conclusion

References

Evaluating Biorisk Management Performance

Abstract

Introduction

The Importance of Performance to Biorisk Management

Establishing Biorisk Management Performance Measurements

Specific Biorisk Management Examples

Conclusion

References

Communication for Biorisk Management

A Case Study

Background

Roles and Responsibilities

Communicating Biorisk Management Information

Risk Communication in a Risk Governance Framework

Crisis Communication

Conclusion

References

Three Recent Case Studies: The Role of Biorisk Management

Abstract

Introduction

Case Study 1: Anthrax Mishandling at the CDC

Case Study 2: H5N1 Influenza Mishandling at CDC

Case Study 3: Mishandling Inventory at the NIH

Conclusion

Future Development of Biorisk Management: Challenges and Opportunities

Abstract

Introduction

Challenges and Opportunities

Conclusion

References

Subject Categories

BISAC Subject Codes/Headings:
MED022090
MEDICAL / Infectious Diseases
MED078000
MEDICAL / Public Health
SCI045000
SCIENCE / Life Sciences / Biology / Microbiology