BIOWATCH AND PUBLIC HEALTH SURVEILLANCE
Evaluating Systems for the Early Detection of Biological Threats
Abbreviated Version
INSTITUTE OF MEDICINE AND
NATIONAL RESEARCH COUNCIL
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
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NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.
This study was supported by Contract No. HSHQDC-08-C-00043 between the National Academy of Sciences and the Department of Homeland Security. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.
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Suggested citation: IOM (Institute of Medicine) and NRC (National Research Council). 2011. BioWatch and public health surveillance: Evaluating systems for the early detection of biological threats. Abbreviated version. Washington, DC: The National Academies Press.
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.
The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.
The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.
COMMITTEE ON EFFECTIVENESS OF NATIONAL BIOSURVEILLANCE SYSTEMS: BIOWATCH AND THE PUBLIC HEALTH SYSTEM
BERNARD D. GOLDSTEIN (Chair), Professor,
Department of Environmental and Occupational Health, University of Pittsburgh Graduate School of Public Health, Pennsylvania
JOSEPH M. DESIMONE (Vice-Chair), Chancellor’s Eminent Professor of Chemistry,
University of North Carolina at Chapel Hill, and
William R. Kenan, Jr. Distinguished Professor of Chemical Engineering,
North Carolina State University
MICHAEL S. ASCHER, Senior Medical Advisor,
California Emergency Management Agency, and
Visiting Researcher,
Department of Medicine and Epidemiology, School of Veterinary Medicine, University of California, Davis
JAMES W. BUEHLER, Research Professor,
Department of Epidemiology, Center for Public Health Preparedness and Research, Rollins School of Public Health, Emory University, Atlanta, Georgia
KAREN S. COOK, Ray Lyman Wilbur Professor of Sociology,
Department of Sociology, Stanford University, California
NORMAN A. CROUCH, Assistant Commissioner,
Health Protection Bureau, Minnesota Department of Health, St. Paul (retired)
FRANCIS J. DOYLE III, Professor, Duncan & Suzanne Mellichamp Endowed Chair in Process Control,
Department of Chemical Engineering, University of California, Santa Barbara
SETH FOLDY, State Health Officer and Administrator,
Division of Public Health, State of Wisconsin
ELIN A. GURSKY, Principal Deputy for Biodefense,
ANSER/Analytic Services, Inc., Arlington, Virginia
SANDRA HOFFMANN, Fellow,
Resources for the Future, Washington, District of Columbia
CALVIN B. JOHNSON, Vice President and Chief Medical Officer,
Temple University Health System, Philadelphia, Pennsylvania
PAUL KEIM, Regents Professor and Cowden Endowed Chair in Microbiology,
Northern Arizona University, and
Director of Pathogen Genomics,
The Translational Genomics Research Institute
ARTHUR L. KELLERMANN, Professor and Associate Dean for Health Policy,
Emory University School of Medicine, Atlanta, Georgia
KENNETH P. KLEINMAN, Associate Professor,
Department of Ambulatory Care and Prevention, Harvard Medical School, Boston, Massachusetts
MARCELLE LAYTON, Assistant Commissioner,
Bureau of Communicable Disease, New York City Department of Health and Mental Hygiene, New York
EVA K. LEE, Associate Professor and Director,
Center for Operations Research in Medicine and Health Care, School of Industrial & Systems Engineering, Georgia Institute of Technology, Atlanta
SHANE D. MAYOR, Research Professor,
Department of Geological and Environmental Sciences, California State University, Chico
TIMOTHY F. MOSHIER, Senior Principal Scientist,
Environmental Science Center, Syracuse Research Corporation, New York
FREDERICK A. MURPHY,
Department of Pathology, The University of Texas Medical Branch at Galveston
ROYCE W. MURRAY, Kenan Professor,
Department of Chemistry, University of North Carolina at Chapel Hill
DOUGLAS K. OWENS, Senior Investigator,
VA Palo Alto Healthcare System, and
Professor of Medicine and of Health Research and Policy,
Center for Primary Care and Outcomes Research and Center for Health Policy, Stanford University, California
STEPHEN M. POLLOCK, Herrick Professor Emeritus of Manufacturing, Professor Emeritus of Industrial and Operations Engineering,
University of Michigan
I. GARY RESNICK, Bioscience Division Leader,
Los Alamos National Laboratory, New Mexico
R. PAUL SCHAUDIES, Chief Executive Officer,
GenArraytion, Inc., Rockville, Maryland
JEROME S. SCHULTZ, Distinguished Professor and Chair,
Department of Bioengineering, University of California, Riverside
Study Staff
LOIS JOELLENBECK, Study Director,
Board on Health Sciences Policy
JANE DURCH, Senior Program Officer,
Board on Health Sciences Policy
MICHAEL MCGEARY, Senior Program Officer,
Board on Health Sciences Policy
KATHRYN HUGHES, Program Officer,
Board on Chemical Sciences and Technology
ERICKA MCGOWAN, Program Officer,
Board on Chemical Sciences and Technology
SUSAN MCCUTCHEN, Senior Program Associate,
Board on Health Sciences Policy
JON Q. SANDERS, Program Associate,
Board on Health Sciences Policy
DONNA RANDALL, Financial Associate,
Board on Health Sciences Policy
JESSICA PULLEN, Administrative Assistant,
Board on Chemical Sciences and Technology
ANDREW POPE, Director,
Board on Health Sciences Policy
FRANCES SHARPLES, Director,
Board on Life Sciences
DOROTHY ZOLANDZ, Director,
Board on Chemical Sciences and Technology
Consultants
JENNIFER BAXTER,
Industrial Economics, Incorporated, Cambridge, Massachusetts
DAVID BUCKERIDGE, Assistant Professor,
McGill University, Montreal, Canada
HENRY ROMAN,
Industrial Economics, Incorporated, Cambridge, Massachusetts
Reviewers
This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:
Damon T. Arnold, Illinois Department of Public Health
Cynthia J. Bruckner-Lea, Pacific Northwest National Laboratory
J. Wiley Davidson, Los Alamos National Laboratory
Richard C. Flagan, California Institute of Technology
Mary J. Gilchrist, Massachusetts Department of Public Health
Thomas V. Inglesby, University of Pittsburgh Medical Center
Peter R. Jutro, U.S. Environmental Protection Agency
Edward H. Kaplan, Yale School of Management
Lisa G. Kaplowitz, Alexandria (Virginia) Health Department
Frances S. Ligler, Naval Research Laboratory
Joseph S. Lombardo, Johns Hopkins University
Donald Prosnitz, RAND Corporation
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Georges C. Benjamin, American Public Health Association, and Chris G. Whipple, ENVIRON. Appointed by the National Research Council and the Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.
Preface
Biological warfare is not a new phenomenon. In North America, the first historically documented use was by Lord Jeffery Amherst, the British commander in North America during the French and Indian War, who proposed spreading smallpox among vulnerable American Indians. Population vulnerability to infectious agents wielded by enemies who wish to destroy and terrorize is of increasing concern to our nation. We also have come to recognize the threats to our health and to our social well-being caused by the natural emergence of infectious diseases, such as HIV and SARS, that can be rapidly spread in our interconnected globe. In response to these concerns, the United States of America, as well as many other countries, has been actively seeking means to improve capabilities to detect and respond to biological threats. Our nation has done so through a mixture of enhancing existing time-honored public health approaches to disease and by developing new approaches to prevention, early detection, and treatment. These new approaches need to be integrated into the overall prevention and response system, and their cost-effectiveness needs to be evaluated in comparison to other investments that could be made to attain the same goals.
As described in the body of this report, the Committee on Effectiveness of National Biosurveillance Systems: BioWatch and the Public Health System has prepared a review and assessment of the effectiveness and costs of surveillance for and detection of disease threats through the Department of Homeland Security’s (DHS’s) BioWatch program and through the public health and health care systems. The report presents the committee’s findings and conclusions concerning the comparative merits of these approaches,
examines costs, and describes promising enhancements to strengthen the nation’s capacity to conduct surveillance for major natural and man-made disease threats. As a result of its review, the committee identified various opportunities to further these enhancements, and it recommends actions that DHS, the Department of Health and Human Services, and others should undertake to help realize them.
The members of the committee have welcomed being participants in the ongoing recalibration of the nation’s response to the threat of major natural and man-made disease outbreaks. Review and recalibration is a continuous process. Changes in technology related both to the threat and to the response will necessitate repeated revisiting of the many issues related to how best to protect the public. We hope that our specific recommendations about technical aspects of detection of disease threats will soon be out of date—replaced by newer methodologies that provide enhanced security to our nation. We also hope that our recommendations related to process will persist, particularly those that call for improved coordination among the disparate governmental bodies: local, state, and national.
The fragmentation of powers related to protecting the health of the public, which is built into our Constitution and in many ways has served us so well, inherently necessitates coordination among governmental organizations to effectively address national issues that require local or regional responses. This is particularly true for the BioWatch program for which the organizations involved in assessing the threat and in determining the technology, configuration, and reporting pathways of this key surveillance approach extend well beyond those traditionally involved in disease surveillance and response. In view of its formation at a time of recognized need for rapid response, and the decision to place the BioWatch program within DHS where it can most effectively coordinate with others involved in the national response to terrorism, as well as the inherent fragmentation of our public health system, it is not surprising that the committee has found that coordination of BioWatch with the public health community is still a work in progress. Fortunately, it is clear that the BioWatch program has recognized this need and is moving toward meeting it.
The breadth of the topic, and the involvement of so many different governmental programs at the federal, state, and local levels which contribute to the overall mission of protecting the public against biothreats, inevitably has limited our ability to probe as deeply as we would like in all of the relevant areas. Not surprisingly, it has been challenging to compare BioWatch, a reasonably well-defined system with a specific budget and hosted in a single federal agency that began just a few years ago, with a diverse public health system that has roots dating back to the middle ages, diverse responsibilities, and a structure that does not readily lend itself to comparative cost accounting of essential cross-cutting activities, such as
surveillance for infectious diseases. Meeting this challenge has been helped by the committee’s recognition that BioWatch should best be considered as part of the nation’s overall surveillance activities. We also recognize that in response to concern about the nation’s public health infrastructure, the National Academy of Sciences (NAS) and other major national organizations in recent years have reviewed and made recommendations about the U.S. public health system that are pertinent to our charge. This recognition has led us to focus on the BioWatch system and how it could be integrated into an enhanced public health surveillance system.
It is also clear that the nation’s public health system is a funnel that collects and sees all types of health situations, natural and otherwise, and in many ways is the ideal place to detect all biological outbreaks, regardless of the disease or the exposure mechanism (air, food, water). It is also a place where small improvements may pay significant dividends to improve its effectiveness.
We have also faced the challenges of needing a relatively large committee (25 members) so as to adequately address the broad range of scientific and technical issues, and of having a relatively short time period (6 months between the first and last of our five meetings) to do so. As leaders of the committee, we want to particularly acknowledge the hard work and collegiality of the committee members. Without their willingness to listen and to learn, and the deep respect they have shown to each other and to the committee staff, this report could not have been completed.
We deeply appreciate the cooperation received from the leadership and staff of the BioWatch program, especially Robert Hooks, Diane Berry, Malcolm Johns, Constantin Langa, and Brian Smith. Also providing especially notable assistance to the committee are Daniel Sosin and many unnamed colleagues at the Centers for Disease Control and Prevention and three consultants to the committee: Jennifer Baxter and Henry Roman of Industrial Economics, Incorporated, and David Buckeridge at McGill University. The committee is also very grateful to numerous other contributors to the committee’s information gathering during meetings held in Washington, DC. These contributors are listed in Appendix A.
We also note that the staffing for this committee cut across three different NAS organizational components: the Board on Health Sciences Policy in the Institute of Medicine (IOM) and the Board on Chemical Sciences and Technology and the Board on Life Sciences in the Division on Earth and Life Studies (DELS). The challenge of coordinating all of these components was ably met by all of the contributing staff: Lois Joellenbeck, IOM (study director); Jane Durch, IOM; Kathryn Hughes, DELS; Susan McCutchen, IOM; Michael McGeary, IOM; Ericka McGowan, DELS; Andrew Pope, IOM; Jessica Pullen, DELS; Donna Randall, IOM; Jon Sanders, IOM; Frances Sharples, DELS; and Dorothy Zolandz, DELS. We
also want to thank other NAS staff members who aided our core staff in important ways: Clyde Behney, Detra Bodrick-Shorter, Greta Gorman, Kevin Hale, Bronwyn Schrecker Jamrok, Abbey Meltzer, Paul Michaels, Machelle Reynolds, Janice Sabuda, Gregory Symmes, Jackie Turner, and Jordan Wyndelts.
Before its public release, and as required under the terms of the contract for this study, the full report was sent to DHS for security classification review. DHS has determined that the full report contains information exempt from public disclosure pursuant to the Freedom of Information Act (FOIA), 5 USC Sections 552(b)(2), 552(b)(7)(E), and 552(b)(7)(F). Therefore, dissemination of the full report is limited to those federal, state, and local governments and their officials, employees, and contractors, as well as non-governmental entities, who have a need to know the information exempt from public disclosure pursuant to the cited FOIA exemptions. Requests for the full report may be directed to the NAS Program Security Office. Requests for the full report may also be directed to DHS. Requests for the full report will be considered on a case-by-case basis.
The NAS reached agreement with DHS that this abbreviated version of the report could be released without restriction. Although certain operational details have been omitted in the public version of the report, the committee’s recommendations remain unchanged from the full report provided to DHS.
Bernard D. Goldstein
Chair
Joseph M. DeSimone
Vice Chair
Committee on Effectiveness of National Biosurveillance Systems: BioWatch and the Public Health System
Tables, Figures, and Boxes
TABLES
S-1 |
Capabilities and Costs of the BioWatch System and Surveillance Through the Public Health and Health Care Systems, |
|||
1-1 |
Federal Funding for Selected Civilian Activities to Defend Against Bioterrorism and Other Significant Biological Threats, Fiscal Years 2007–2010, |
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2-1 |
Features of BioWatch Generations 1, 2, and 3, |
|||
2-2 |
Forecasted Cost of Implementing Alternative BioWatch Scenarios (10-year forecast), |
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3-1 |
Key Features of the BioWatch Generation 2 System and the Proposed Generation 3 System, |
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6-1 |
Steps Necessary for BioWatch to Help Reduce Illness and Loss of Life, |
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6-2 |
Implied Number of Additional Lives That BioWatch Would Have to Save in the Event of an Attack to “Break Even” on Program Costs, |
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6-3 |
Capabilities and Costs of the BioWatch System and Surveillance Through the Public Health and Health Care Systems, |
FIGURES
1-1 |
Schematic illustration of the temporal relation among potential mechanisms for detecting an aerosolized biological threat, |
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2-1 |
Event-to-detection time line for BioWatch Generations 1 and 2, |
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4-1 |
Simplified depiction of information flow in outbreak detection and reporting through the public health and health care systems, |
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4-2 |
A schematic depiction of the relationships between functional components of biosurveillance and the associated flows of information, |
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6-1 |
A schematic illustration of the relation between the BioWatch program and other sources of information needed for infectious disease surveillance in the public health and health care systems, |
BOXES
S-1 |
Statement of Task, |
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1-1 |
Statement of Task, |
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1-2 |
CDC Categories of Potential Bioterrorism Agents and Their Related Diseases, |
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2-1 |
Definitions of Key Terms Related to the Performance of BioWatch, |
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3-1 |
Potential Approaches for Improving Incident Characterization, |
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3-2 |
Possible Elements of an After-Action Report Following a BAR, |
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4-1 |
National Biosurveillance System: Laboratory Response Network, |
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5-1 |
Biosurveillance: A Critical Component of Public Health and Medical Preparedness, |
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5-2 |
The 10 Essential Public Health Services, |
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5-3 |
Pandemic Influenza A (H1N1): Implications for Enhanced Surveillance, |
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6-1 |
Potential Enhancements to Surveillance Through Public Health and Health Care, |
Acronyms and Abbreviations
AAR after-action report
AHIC American Health Information Community
AIDS acquired immune deficiency syndrome
AOAC Association of Analytical Communities
APDS Automated Pathogen Detection System
APHL Association of Public Health Laboratories
ASTHO Association of State and Territorial Health Officials
BAC BioWatch Advisory Committee
BAND Bioagent Autonomous Networked Detector
BAR BioWatch Actionable Result
BASIS Biological Aerosol Sentry and Information System
BDS Biohazard Detection System
BERT Bioagent Event Reconstruction Tool
BRRAT Bioterrorism Rapid Response and Advanced Technology Laboratory
BTAC BioWatch Technical Advisory Committee
BTRA Bioterrorism Risk Assessment
BWIC Biological Warning and Incident Characterization
CBRN chemical, biological, radiological, and nuclear
CDC Centers for Disease Control and Prevention
CIDRAP Center for Infectious Disease Research and Policy
CRS Congressional Research Service
CSTE Council of State and Territorial Epidemiologists
DFU Dry Filter Unit
DHS Department of Homeland Security
DNA deoxyribonucleic acid
DoD Department of Defense
DOE Department of Energy
DSBCC Detection Systems for Biological and Chemical Countermeasures
DT&E developmental testing and evaluation
ED emergency department
EHR electronic health record
ELR electronic laboratory reporting
EMR electronic medical record
EPA Environmental Protection Agency
ESP Electronic Support for Public Health
ESSENCE Electronic Surveillance System for the Early Notification of Community-based Epidemics
FBI Federal Bureau of Investigation
FEMA Federal Emergency Management Agency
FOUO For Official Use Only
FTE full-time equivalent positions
FY fiscal year
GAO Government Accountability Office
GI gastrointestinal
HAN Health Alert Network
HEPA high-efficiency particulate air
HHS Department of Health and Human Services
HIE health information exchange
HITSP Healthcare Information Technology Standards Panel
HPP Hospital Preparedness Program
HSARPA Homeland Security Advanced Research Projects Agency
HSEEP Homeland Security Exercise and Evaluation Program
HSPD Homeland Security Presidential Directive
HVAC heating, ventilation, and air conditioning
ICD-9 International Classification of Diseases, Ninth Revision
ICD-10 International Classification of Diseases, Tenth Revision
IEc Industrial Economics, Incorporated
IMAAC Interagency Modeling and Atmospheric Assessment Center
IOM Institute of Medicine
IT information technology
LACDPH Los Angeles County Department of Public Health
LANL Los Alamos National Laboratory
lidar light detection and ranging
LIMS Laboratory Information Management System
LLNL Lawrence Livermore National Laboratory
LOINC Logical Observation Identifiers Names and Codes
LRN Laboratory Response Network
MDHSS Missouri Department of Health and Senior Services
NACCHO National Association of County and City Health Officials
NAS National Academy of Sciences
NBAS National Biosurveillance Advisory Subcommittee
NBIC National Biosurveillance Integration Center
NBIS National Biosurveillance Integration System
NEDSS National Electronic Disease Surveillance System
NETSS National Electronic Telecommunications System for Surveillance
NIAID National Institute of Allergy and Infectious Diseases
NIH National Institutes of Health
NNDSS National Notifiable Diseases Surveillance System
NPHPSP National Public Health Performance Standards Program
NRC National Research Council
NSF National Science Foundation
O&M operation and maintenance
ODIN Outbreak Detection Information Network
OHA Office of Health Affairs
OMB Office of Management and Budget
ORD operational requirements document
OT&E operational testing and evaluation
PA-OH Pennsylvania-Ohio
PCR polymerase chain reaction
PHEP Public Health Emergency Preparedness
PHRED Public Health Reporting of Electronic Data
PSU Portable Sampling Unit
RHIO regional health information organization
RODS Real-time Outbreak and Disease Surveillance
RT-PCR real-time polymerase chain reaction
S&T Science and Technology Directorate
SARS severe acute respiratory syndrome
SNOMED Systematized Nomenclature of Medicine–Clinical Terms
SPADA Stakeholder Panel on Agents for Detection Assays
STD sexually transmitted disease
T&E testing and evaluation
TCL Target Capabilities List
TEMP Test and Evaluation Master Plan
TFAH Trust for America’s Health
TOPOFF Top Officials
TRL technology readiness level
USAMRIID U.S. Army Medical Research Institute of Infectious Diseases
USPS U.S. Postal Service
UTL Universal Task List
VSL value of a statistical life
WADOH Washington State Department of Health
WHO World Health Organization
WMD weapons of mass destruction