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.
Table of Contents
Introduction: The Case for Biorisk Management
Laboratory Biosafety and Biosecurity
Learning Lessons from Other Industries
The AMP Model
Definition of Risk
Risk Assessment Methodology
Ethics of Biorisk/Risk Acceptability
Roles and Responsibilities for Risk Assessment
Facility Design and Controls
Design for Biorisk Management
Risk-Based Design Decisions
The Design Process
Laboratory Design Best Practices
Facility Design Factors
Rethinking Mitigation Measures
Case Study: Challenges Mitigating Biorisks—Texas A&M University
Using AMP to Strengthen Mitigations
Case Study: Different Solution Paths to Working with Ebola Virus
Biorisk Management Training
An International and Historical Perspective
Using ADDIE for BRM Training
Operations and Maintenance Concepts
Developing a Tiered Maintenance System
Evaluating Biorisk Management Performance
The Importance of Performance to Biorisk Management
Establishing Biorisk Management Performance Measurements
Specific Biorisk Management Examples
Communication for Biorisk Management
A Case Study
Roles and Responsibilities
Communicating Biorisk Management Information
Risk Communication in a Risk Governance Framework
Three Recent Case Studies: The Role of Biorisk Management
Case Study 1: Anthrax Mishandling at the CDC
Case Study 2: H5N1 Influenza Mishandling at CDC
Case Study 3: Mishandling Inventory at the NIH
Future Development of Biorisk Management: Challenges and Opportunities
Challenges and Opportunities
Reynolds M. Salerno is the senior manager for Cooperative Threat Reduction Programs at Sandia National Laboratories in Albuquerque, New Mexico. These programs enhance security by reducing biological, chemical, and nuclear threats worldwide. Reynolds M. Salerno received his PhD from Yale University. Recognized as a leading expert on laboratory biosecurity, Dr. Salerno and his Sandia team have worked extensively in laboratory biosafety, biosecurity, biocontainment, and infectious disease diagnostics and control internationally. As a technical advisor to the World Health Organization (WHO), he was a member of its international team which inspected the Maximum Containment (smallpox) Laboratory at the State Research Center of Virology and Biotechnology VECTOR in Koltsovo, Russia. He recently held the position of vice chairman of the board of directors of the International Federation of Biosafety Associations.
Jennifer Gaudioso leads the International Biological Threat Reduction and International Chemical Threat Reduction programs at Sandia National Laboratories in Albuquerque, New Mexico. These programs enhance US and international security by promoting safe, secure, and responsible use of dangerous biological and chemical agents. The team currently consults in more than 40 countries specifically on biosecurity and chemical security issues. Jennifer Gaudioso earned her PhD in chemistry from Cornell University. Dr. Gaudioso and her Sandia team work with international partners, such as the World Health Organization and the International Federation of Biosafety Associations. Dr. Gaudioso is the author of numerous journal articles and has presented her research at national and international meetings.
"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