Bioterrorism: Information Technology Strategy Could Strengthen
Federal Agencies' Abilities to Respond to Public Health
Emergencies (30-MAY-03, GAO-03-139).
The October 2001 anthrax attacks, the recent outbreak of the
virulent Severe Acute Respiratory Syndrome (SARS), and increased
awareness that terrorist groups may be capable of releasing
life-threatening biological agents have prompted efforts to
improve our nation's preparedness for, and response to, public
health emergencies--including bioterrorism. GAO was asked, among
other things, to identify federal agencies information technology
(IT) initiatives to support our nation's readiness to deal with
bioterrorism. Specifically, we compiled an inventory of such
activities, determined the range of these coordination activities
with other agencies, and identified the use of health care
standards in these efforts.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-03-139
ACCNO: A07046
TITLE: Bioterrorism: Information Technology Strategy Could
Strengthen Federal Agencies' Abilities to Respond to Public
Health Emergencies
DATE: 05/30/2003
SUBJECT: Biological warfare
Public health research
Strategic planning
Information technology
National preparedness
Emergency preparedness
Terrorism
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GAO-03-139
a
GAO United States General Accounting Office
Report to Congressional Requesters
May 2003 BIOTERRORISM Information Technology Strategy Could Strengthen
Federal Agencies* Abilities to Respond to Public Health Emergencies
GAO- 03- 139
The six key federal agencies involved in bioterrorism preparedness and
response identified about 70 planned and operational information systems
in several IT categories associated with supporting a public health
emergency. These encompass detection (systems that collect and identify
potential biological agents from environmental samples), surveillance
(systems that facilitate ongoing data collection, analysis, and
interpretation of diseaserelated data), communications (systems that
facilitate the secure and timely delivery of information to the relevant
responders and decision makers), and supporting technologies (tools or
systems that provide information for the other categories of systems)* see
table below. For example, the Centers for Disease Control and Prevention
(CDC) is currently implementing its Health Alert Network, an early warning
and response system intended to provide federal, state, and local agencies
with better communications during public health emergencies, and the
Department of Defense is using its Electronic Surveillance System for the
Early Notification of Community- based Epidemics to support early
identification of infectious disease outbreaks in the military by
comparing analyses of data collected daily with historical trends. The
extent of coordination or interaction of these systems among agencies
covered a wide range* from an absence of coordination, to awareness among
the agencies with no formal coordination, to formal coordination, to joint
development of initiatives. Summary of the Systems Inventory by Agency
IT Categories HHS Defense Energy Agriculture EPA VA Total Detection 0 4 6
0 0 0 10
Surveillance 18 7 2 6 0 1 34
Communications 5 2 0 3 0 0 10
Supporting Tech 5 1 6 1 5 0 18 Total 28 14 14 10 5 1 72
Source: GAO. IT can more effectively facilitate emergency response if
standards are developed and implemented that allow systems to be
interoperable. The need for common, agreed- upon standards is widely
acknowledged in the health community, and activities to strengthen and
increase the use of applicable standards are ongoing. For example, CDC has
defined a public health information architecture, which identifies data,
communication, and security standards needed to ensure the
interoperability of related systems. Despite these ongoing efforts to
address IT standards, many issues remain to be worked out, including
coordinating the various standards- setting
initiatives and monitoring the implementation of standards for health care
delivery and public health. An underlying challenge for establishing and
implementing such standards is the lack of an overall strategy guiding IT
development and initiatives. Without such a strategy to address the
development and implementation of standards, agencies may not be well
positioned to take advantage of IT that could facilitate better
preparation for and response to public health emergencies* including
bioterrorism. The October 2001 anthrax attacks, the recent outbreak of the
virulent
Severe Acute Respiratory Syndrome (SARS), and increased awareness that
terrorist groups may be capable of releasing lifethreatening biological
agents have prompted efforts to improve our
nation*s preparedness for, and response to, public health emergencies*
including bioterrorism. GAO was asked, among other things, to identify
federal agencies* information technology (IT) initiatives to support our
nation*s readiness to deal with bioterrorism. Specifically, we compiled an
inventory of such activities, determined the range of these coordination
activities with other agencies, and identified the use of health care
standards in these efforts.
In order to enhance American preparedness for public health emergencies*
especially those involving bioterrorism* GAO recommends that the Secretary
of Health and Human Services (HHS), in coordination with other key
stakeholders, develop a strategy that includes setting priorities for IT
initiatives and coordinating the development of IT standards for the
health care industry.
In commenting on a draft of this report, agencies concurred with our
results but did not comment on the recommendations. Technical
comments were incorporated as appropriate.
www. gao. gov/ cgi- bin/ getrpt? GAO- 03- 139. To view the full report,
including the scope and methodology, click on the link above. For more
information, contact David A. Powner at (202) 512- 9286 or pownerd@ gao.
gov. Highlights of GAO- 03- 139, a report to
Congressional Requesters
May 2003
BIOTERRORISM
Information Technology Strategy Could Strengthen Federal Agencies*
Abilities to Respond to Public Health Emergencies
Page i GAO- 03- 139 Federal Bioterrorism IT Letter 1 Results in Brief 3
Background 5 About 70 Bioterrorism- Related Information Technology
Activities Identified at Six Federal Agencies 17 Health Care Sector Making
Progress on Defining Standards, but
Implementation Challenges Remain for Effective Information Sharing 21
Emerging Information Technologies Could Enhance Agencies*
Abilities to Prepare for and Respond to Public Health Emergencies 26
Conclusions 29 Recommendations 30 Agency Comments and Our Evaluation 31
Appendix I Objectives, Scope, and Methodology 34
Appendix II CDC Biological Diseases/ Agents List 37
Appendix III Categories of Information Technology for Bioterrorism-
Related Systems 39
Detection 39 Surveillance 41 Diagnostic and Clinical Management 45
Communications 46 Supporting Technology 48 Other Clinical Systems 50
Appendix IV Department of Agriculture*s Systems Inventory 51
Appendix V Department of Defense*s Systems Inventory 56
Appendix VI Department of Energy*s Systems Inventory 62 Contents
Page ii GAO- 03- 139 Federal Bioterrorism IT Appendix VII Department of
Health and Human Services* Systems Inventory 68
Appendix VIII Department of Veterans Affairs* Systems Inventory 79
Appendix IX Environmental Protection Agency*s Systems Inventory 80
Appendix X Federal Agencies* Information Technology Initiatives 83
Appendix XI List of Selected Health Care Standards 87
Appendix XII Comments from the Department of Defense 88
Appendix XIII Comments from the Department of Energy 89
Appendix XIV Comments from the Department of Health and Human Services 90
Appendix XV Comments from the Department of Veterans Affairs 95
Appendix XVI: GAO Contacts and Acknowledgments 96 GAO Contacts 96
Acknowledgments 96
Page iii GAO- 03- 139 Federal Bioterrorism IT Tables
Table 1: Summary of the Systems Inventory by Agency 18 Table 2: Summary of
Detection Systems by Agency 40 Table 3: Summary of Surveillance Systems by
Agency 44 Table 4: Summary of Communications Systems by Agency 47 Table 5:
Summary of Supporting Technologies by Agency 50 Figures
Figure 1: Local, State, and Federal Agencies Involved in Response to the
Release of a Biological Agent 6 Figure 2: IT Needs during a Public Health
Emergency 17
Page iv GAO- 03- 139 Federal Bioterrorism IT Abbreviations
AHRQ Agency for Healthcare Research and Quality BASIS Biological Aerosol
Sentry and Information System CDC Centers for Disease Control and
Prevention DHS Department of Homeland Security DOD Department of Defense
DOE Department of Energy EPA Environmental Protection Agency ESSENCE
Electronic Surveillance System for Early Notification
of Community- based Epidemics FDA Food and Drug Administration HAN Health
Alert Network HHS Department of Health and Human Services HIPAA Health
Insurance Portability and Accountability
Act of 1996 IOM Institute of Medicine IT information technology NCVHS
National Committee on Vital and Health Statistics NEDSS National
Electronic Disease Surveillance System NHII National Health Information
Infrastructure SARS Severe Acute Respiratory Syndrome USDA United States
Department of Agriculture VA Department of Veterans Affairs WHO World
Health Organization
This is a work of the U. S. Government and is not subject to copyright
protection in the United States. It may be reproduced and distributed in
its entirety without further permission from GAO. It may contain
copyrighted graphics, images or other materials. Permission from the
copyright holder may be necessary should you wish to reproduce copyrighted
materials separately from GAO*s product.
Page 1 GAO- 03- 139 Federal Bioterrorism IT May 30, 2003 Congressional
Requesters: The October 2001 anthrax attacks highlighted long- standing
weaknesses in the current public health infrastructure 1 and prompted
efforts to improve
our nation*s preparedness for and response to public health emergencies,
including bioterrorism. 2 More recent events have further heightened
awareness of and anxiety related to the consequences of potential
bioterrorism or other public health emergencies. For example, on March 15,
2003, the World Health Organization issued an emergency travel advisory
due to an unknown form of pneumonia now known as Severe Acute Respiratory
Syndrome (SARS). Originating in China, it has infected over 7,900 people
and caused at least 662 deaths worldwide* with 67 probable cases reported
in the United States as of May 20, 2003. Further, terrorist organizations,
such as al Qaeda, may be capable of releasing lifethreatening biological
agents through covert or overt attacks. These events and possibilities
illustrate not only the increased chances that harmful
biological agents could be intentionally released into the environment,
but also the rapid and widespread effects of naturally occurring
infectious diseases.
Many of the activities under way to prepare for and respond to public
health emergencies* including bioterrorism* are supported by information
technology (IT), which can better enable public health agencies to
identify naturally occurring or intentionally caused disease outbreaks and
can support communications related to public health. Recent events, such
as those mentioned, have led to increased action and funding for
undertakings related to bioterrorism throughout the federal government. In
these undertakings, it is important that the IT
1 The public health infrastructure is the foundation that supports the
planning, delivery, and evaluation of public health activities and is
comprised of a well- trained workforce, effective program and policy
evaluation, sufficient epidemiology and surveillance capability to detect
outbreaks and monitor incidence of diseases, appropriate response capacity
for public health emergencies, effective laboratories, secure information
systems, and advanced communications systems.
2 Bioterrorism is the threat or intentional release of biological agents
(viruses, bacteria, or their toxins) for the purpose of influencing the
conduct of government, or intimidating or coercing a civilian population.
United States General Accounting Office Washington, DC 20548
Page 2 GAO- 03- 139 Federal Bioterrorism IT responsibilities and
activities of federal public health entities be well planned and
coordinated to effectively address the response to
bioterrorism, reducing the risk of duplicating efforts and creating
incompatible systems.
You asked us to review federal agencies* IT efforts to support
bioterrorism preparedness and response. Specifically, our objectives were
to compile an inventory of federal agencies* current and planned IT
systems and initiatives related to bioterrorism, and to identify the range
of coordination activities;
identify and describe the development and use of health care IT
standards for bioterrorism- related systems; and
review the potential use of emerging information technologies to support
bioterrorism preparedness and response.
We focused our review on six key federal agencies that are responsible for
supporting the response to bioterrorism and other public health
emergencies using IT: the Department of Agriculture (USDA), the Department
of Defense (DOD), the Department of Energy (DOE), the Department of Health
and Human Services (HHS), the Department of Veterans Affairs (VA), and the
Environmental Protection Agency (EPA). Further details about our
objectives, scope, and methodology are provided in appendix I.
We performed our work at USDA, DOD, HHS, VA, and EPA offices in
Washington, DC; the Centers for Disease Control and Prevention (CDC) in
Atlanta, GA; DeKalb County Board of Health in Decatur, GA; Lawrence
Livermore and Sandia National Laboratories in Livermore, CA; Sandia
National Laboratory in Albuquerque, NM; Los Alamos National Laboratory in
Los Alamos, NM; Denver County Department of Health in Denver, CO; and
Monroe County Department of Health in Rochester, NY, from June 2002
through March 2003, in accordance with generally accepted government
auditing standards.
Page 3 GAO- 03- 139 Federal Bioterrorism IT The six key federal agencies
involved in bioterrorism preparedness and response have a large number of
existing and planned bioterrorism- related
information systems. Specifically, these agencies identified 72
information systems and supporting technologies, as well as 12 other IT
initiatives. Of the 72 systems, 34 are surveillance systems, 18 are
supporting technologies, 10 are communications systems, and 10 are
detection systems. 3 For example, CDC is currently implementing its Health
Alert Network, an early warning and response system intended to provide
federal, state, and local agencies with better communications during
public health emergencies. DOD is using its Electronic Surveillance System
for the Early Notification of Community- based Epidemics to support early
identification of infectious disease outbreaks in the military by
comparing analyses of data collected daily with historical trends. In
planning or operating each of these information systems and IT
initiatives, the extent of coordination or interaction between the lead
agency and other related government agencies covered a wide range. Such
coordination ranged from an absence of contact with other agencies, to
awareness among the agencies, to formal coordination, to joint development
of initiatives. For example, about 30 percent of the systems and
initiatives are formally coordinated or jointly developed with other
agencies.
The identification and implementation of health care data, communications,
and security standards* which are necessary to support the compatibility
and interoperability of agencies* various IT systems* remain incomplete
across the health care sector. However, efforts in the federal government
are under way to strengthen and increase the use of applicable standards
throughout the nation*s health information infrastructure. For example,
CDC has defined a public health information architecture, which identifies
public health data, communications, and security standards that are needed
to ensure the interoperability of related systems. At the same time, this
architecture is still evolving, and many
issues* such as coordination of the various efforts to ensure consensus on
standards, establishment of milestones, and implementation
3 Surveillance systems facilitate the performance of ongoing collection,
analysis, and interpretation of disease- related data. Supporting
technologies are tools or systems that provide information for the other
categories of systems. Communications systems facilitate the secure and
timely delivery of information to the relevant responders and decision
makers. Detection systems consist of devices for the collection and
identification of potential biological agents from environmental samples
that include an IT component that facilitates the collection of data for
surveillance. Results in Brief
Page 4 GAO- 03- 139 Federal Bioterrorism IT mechanisms* remain to be
worked out. Consequently, federal agencies and others associated with the
public health infrastructure cannot ensure
their systems* abilities to exchange data with other systems when needed
and cannot ensure effective preparation for and response to bioterrorism
and other public health emergencies. For example, according to CDC
officials, one of the IT challenges encountered by public health officials
responding to the anthrax events of October 2001 was the issue of
exchanging data between the many participants involved in the response*
clinical sites, local health departments, emergency responders, state
health departments, public health laboratories, and federal agencies.
During this event, participants accumulated dissimilar data and
principally
exchanged it manually. An underlying challenge for establishing and
implementing standards is that no overall strategy guides IT development
and initiatives.
The use of emerging information technologies to support the public health
infrastructure could help to improve federal agencies* abilities to
prepare for and respond to public health emergencies. Agencies have taken
steps to adopt such emerging technologies. For example, Los Alamos
National Laboratory is working on a Web- based system called the Forensics
Internet Research Exchange, which supports the sharing of biothreat
information among research and government agencies and uses public
networks to securely transport private intra- agency and interagency
information. However, barriers exist, such as the lack of a mechanism for
identifying and prioritizing appropriate emerging information technologies
for their transition into the public health community.
We are making recommendations to the Secretary of Health and Human
Services, in coordination with other key stakeholders, to develop a
strategy for public health preparedness and response that includes setting
priorities for IT initiatives and coordinating the development of IT
standards for the health care industry. We received written comments on a
draft of this report from the Deputy Assistant Secretary of Defense for
Chemical/ Biological Defense at DOD, the Acting Associate Administrator
for Management and Administration at DOE, the Acting Principal Deputy
Inspector General at HHS, and the Secretary of Veterans Affairs. These
four agencies generally concurred with our results but did not comment
specifically on the recommendations. Technical comments were incorporated
in this report as appropriate. USDA and EPA officials provided oral
comments, which were also technical in nature and have been incorporated
as appropriate. While DHS was not included as one of the agencies in our
review because
Page 5 GAO- 03- 139 Federal Bioterrorism IT it did not exist until the end
of this engagement, we provided DHS officials with the opportunity to
comment on the draft of this report, which they
declined. In their comments, HHS officials stated that the focus of this
report on IT overemphasized its role and does not address other components
of the public health infrastructure and may simplify a complex issue. As
we describe in the background section of this report, IT is a tool that
enables personnel to fulfill their mission. We recognize that there are
other important issues about the public health infrastructure that merit
attention, such as workforce capacity and training, capacity of the public
health laboratories, and variation in state public health laws, among
others.
Harmful biological agents can be released by way of the air, food, water,
or insects. Their release may not be recognized for several days, during
which time a communicable disease* such as smallpox* can spread to others
who were not initially exposed. Some biological agents* such as anthrax
and plague* produce symptoms that can easily be confused with influenza or
other, less virulent illnesses, leading to a delay in diagnosis or
identification. For example, the recent outbreak of the new infectious
disease, SARS, whose onset includes common symptoms such as high fever,
coughing, and difficulty in breathing, was not recognized until about 4
months after the first known case.
Initial response to a public health emergency, including an act of
bioterrorism, is generally a local responsibility that could involve
multiple jurisdictions in a region, with states providing additional
support when needed. Since clinicians at the local level are most likely
to be the first ones to detect an incident, they and local public health
officials are expected to report incidents or symptoms of suspicious
illness to the state health department and other designated parties.
States can provide supporting personnel, financial resources, laboratory
capacity, and other assistance to local responders. Because of the many
participants involved, the identification and management of bioterrorism
and other public health emergencies call for effective communication and
collaboration across all levels of government and the private sector.
Figure 1 presents the probable series of responses to the release of a
biological agent by the various
players. 4 4 U. S. General Accounting Office, Bioterrorism: Preparedness
Varied Across State and Local Jurisdictions, GAO- 03- 373 (Washington, D.
C.: April 7, 2003). Background
Page 6 GAO- 03- 139 Federal Bioterrorism IT Figure 1: Local, State, and
Federal Agencies Involved in Response to the Release of a Biological Agent
Page 7 GAO- 03- 139 Federal Bioterrorism IT a Health care providers can
also contact state entities directly. b Federal departments and agencies
can also respond directly to local and state entities.
c The Strategic National Stockpile, formerly the National Pharmaceutical
Stockpile, is a repository of pharmaceuticals, antidotes, and medical
supplies that can be delivered to the site of a biological (or other)
attack.
Page 8 GAO- 03- 139 Federal Bioterrorism IT Prior to the anthrax incidents
in October 2001, a number of threats and hoaxes involving biological
agents, and at least one successful bioterrorist
act, had occurred domestically. 5 Since that time, health care and public
health officials at the federal, state, tribal, local, and international
levels, as well as the private sector* part of a complex network of
people, systems, and organizations* have examined their readiness to
respond to acts of bioterrorism and have found weaknesses. Among others,
these
weaknesses include (1) vulnerable and outdated health information systems
and technologies, (2) lack of real- time surveillance and epidemiological
systems, (3) ineffective and fragmented communications networks, (4)
incomplete domestic preparedness and emergency response capability, and
(5) communities without access to essential public health services. 6
These reported deficiencies at local, state, and federal levels may
hinder the effective detection and identification of a potentially harmful
biological agent.
The broad scope of bioterrorism activities brings together different
professional communities with very diverse areas of expertise* the public
health and medical community, the scientific community, and the
intelligence and law enforcement community. The public health and medical
community* consisting of public health officials, clinicians, traditional
first responders, and veterinary and agricultural communities* is
responsible for protecting the health of people, animals, and agricultural
products. The scientific community* consisting of human, microbial,
animal, plant, and environmental researchers, among others* characterizes,
develops detection systems for, and creates vaccines and treatments for
diseases caused by biological agents. The intelligence and law enforcement
community* consisting of intelligence analysts, law enforcement officers,
diplomatic officials, and military officers* monitor and deter terrorist
movement and activity. 7 In addition, other professions, such as drug
store pharmacists and school administrators, are being identified as new
players in bioterrorism preparedness and response.
5 In 1984 a group intentionally contaminated salad bars in local
restaurants in Oregon with salmonella bacteria to prevent people from
voting in a local election. 6 Institute of Medicine of the National
Academies, The Future of the Public*s Health in the 21st Century
(Washington, D. C.: November 11, 2002). 7 RAND Science and Technology
Policy Institute, Summit on Information Technology Infrastructure for
Bioterrorism (Arlington, VA).
Page 9 GAO- 03- 139 Federal Bioterrorism IT Public health and private
laboratories are another vital part of the surveillance network because
only laboratory results can definitively
identify pathogens. 8 Every state has at least one public health
laboratory to support its disease surveillance activities and other public
health programs. State laboratories conduct testing for routine
surveillance or as part of special clinical or epidemiological studies.
Independent commercial and hospital laboratories may also share with
public health agencies information they have gathered through their
private surveillance
efforts, such as studies of patterns of antibiotic resistance or of the
spread of diseases within a hospital. In addition, commercial and hospital
laboratories may be required by state law or regulation to report certain
findings for public health surveillance.
Federal agencies have key responsibilities for bioterrorism preparedness
and response. HHS has primary responsibility for coordinating the nation*s
response to public health emergencies, including bioterrorism. HHS
divisions responsible for bioterrorism preparedness and response, and
their primary responsibilities include:
The Office of the Assistant Secretary for Public Health Emergency
Preparedness coordinates the department*s work to oversee and protect
public health, including cooperative agreements with states and local
governments. States and local governments can apply for funding to upgrade
public health infrastructure and health care systems to better prepare for
and respond to bioterrorism and other public health emergencies. On May 9,
2003, HHS announced that guidelines have
been released for the use of $1.4 billion allocated for bioterrorism
cooperative agreements. It maintains a recently built command center,
where it can coordinate the response to public health emergencies from one
centralized location. This center is equipped with satellite
teleconferencing capacity, broadband Internet hookups, and analysis and
tracking software.
CDC has primary responsibility for nationwide disease surveillance for
specific biological agents, and it also provides an array of scientific
and financial support for state infectious disease surveillance,
prevention, and control. For example, CDC administers cooperative
agreements for
public health preparedness totaling $870 million for fiscal year 2003. CDC
has been addressing bioterrorism preparedness and response
8 Pathogens are bacteria, viruses, parasites, or fungi that have the
capability to cause disease in humans.
Page 10 GAO- 03- 139 Federal Bioterrorism IT explicitly since 1998. In
April 2003, CDC opened a new emergency operations center to organize and
manage all emergency operations at CDC, allowing for immediate
communication between CDC, HHS, DHS,
as well as federal intelligence and emergency response officials, and
state and local public health officials. CDC also provides testing
services and consultation that are not available at the state level;
training on infectious diseases and laboratory topics, such as testing
methods and outbreak investigations; and grants to help states conduct
disease surveillance. In addition, CDC provides state and local health
departments with a wide range of technical, financial, and staff
resources to help maintain or improve their ability to detect and respond
to disease threats.
CDC laboratories provide highly specialized tests that are not always
available in state public health or commercial laboratories, and they
assist states with testing during outbreaks. These laboratories help
diagnose life- threatening, unusual, or exotic infectious diseases,
including those that may be caused by bioterrorist attacks, such as
smallpox. CDC also conducts research to develop improved diagnostic
methods, and it trains laboratory staff to use them.
The Agency for Healthcare Research and Quality (AHRQ) is responsible for
supporting research designed to improve the outcomes and quality of health
care, reduce its costs, address safety and medical errors, and broaden
access to effective services, including antibioterrorism research. AHRQ
has initiated several major projects and activities designed to assess and
enhance the linkages between the clinical care delivery system and the
public health infrastructure. AHRQ- supported research focuses on
emergency preparedness of hospitals and health care systems for
bioterrorism and other public health events; technologies and methods to
improve the linkages between the personal health care system, emergency
response networks, and public health agencies; and training and
information needed to prepare clinicians to recognize the symptoms of
bioterrorist agents and manage patients appropriately.
The Food and Drug Administration (FDA) is responsible for safeguarding
the food supply, ensuring that new vaccines and drugs are safe and
effective, and conducting research on diagnostic tools and treatment of
disease outbreaks. It is increasing its food safety responsibilities by
improving its laboratory preparedness and food monitoring inspections in
accordance with the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002.
Page 11 GAO- 03- 139 Federal Bioterrorism IT The National Institutes of
Health (NIH) is responsible for conducting medical research in its own
laboratories and for supporting the
research of nonfederal scientists in universities, medical schools,
hospitals, and research institutions throughout the United States and
abroad. Its National Institute of Allergy and Infectious Diseases has a
program to support research related to organisms that are likely to be
used as biological weapons. NIH is planning to implement a strategic plan
for research on CDC*s category A, B, and C biological agents. 9 A complete
list of these agents is included in appendix II.
The Health Resources Services Administration (HRSA) is responsible for
improving the nation*s health by ensuring equal access to comprehensive,
culturally competent, quality health care. Its Bioterrorism Hospital
Preparedness program administers cooperative agreements, totaling $498
million, to state and local governments to support hospitals* efforts
toward bioterrorism preparedness and response.
Besides HHS, other federal departments and agencies are involved in
bioterrorism preparedness and response efforts, including the following:
DOD, while primarily responsible for the health and protection of its
service members on the battlefield, conducts research on bioterrorism
preparedness and response through agencies such as the Defense Advanced
Research Projects Agency. This research supports force protection and is
shared with other agencies when it may benefit the civilian population. It
also has civil support responsibilities through the Joint Task Force for
Civil Support, the National Guard, and the Army.
DOE*s national laboratories are developing new capabilities for
countering chemical and biological threats, including biological
detection, modeling, and prediction. EPA is responsible for protecting
the nation*s water supply from
terrorist attack. In January 2003, it established a new homeland 9
Category A agents include organisms that pose a risk to national security
because they can be easily disseminated or transmitted from person to
person; result in high mortality rates and have the potential for major
public health impact; and require special action for public health
preparedness. Category B agents include those that are moderately easy to
disseminate and result in moderate morbidity rates and low mortality
rates. Category C agents include emerging pathogens that could be
engineered for mass dissemination in the future because of availability,
ease of production and dissemination, and potential for high
morbidity and mortality rates and major health impact.
Page 12 GAO- 03- 139 Federal Bioterrorism IT security research center. The
center is assessing threat management for the water supply and
environmental detectors for potential use in
protecting the water supply. USDA has become involved in bioterrorism
preparedness and response
because of the increasing realization that the food supply may become a
vehicle for a biological attack. Biological attacks on the health of
animals and plants are important because animals and plants can spread
diseases and toxins that may be harmful to humans.
VA manages one of the nation*s largest health care systems and is the
nation*s largest drug purchaser. The department purchases pharmaceuticals
and medical supplies for the Strategic National Stockpile and the National
Medical Response Team stockpile. The Department of Veterans Affairs
Emergency Preparedness Act of 2002 10 recently directed VA to establish at
least four medical emergency
preparedness centers to (1) carry out research and develop methods of
detection, diagnosis, prevention, and treatment for biological and other
public health and safety threats; (2) provide education, training, and
advice to health care professionals inside and outside VA; and (3) provide
laboratory and other assistance to local health care authorities in the
event of a national emergency. At least one of VA*s new centers is to
focus on biological threats.
On June 12, 2002, Congress passed the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002. 11 The legislation
requires specific activities related to bioterrorism preparedness and
response. For example, it calls for steps to improve the nation*s
preparedness for bioterrorism and other public health emergencies by
increasing coordination and planning for such events; developing priority
countermeasures, such as the Strategic National Stockpile; and improving
state, local, and hospital preparedness for and response to bioterrorism
and other public health emergencies. It also requires HHS and USDA to
enhance controls on dangerous biological agents and toxins to protect the
safety of food, drugs, and drinking water.
On November 25, 2002, Congress enacted legislation creating the new
Department of Homeland Security (DHS). 12 Consolidating the functions of
10 Public Law 107- 287 (November 7, 2002).
11 Public Law 107- 188 (June 12, 2002). 12 Public Law 107- 296 (November
25, 2002).
Page 13 GAO- 03- 139 Federal Bioterrorism IT 22 federal agencies, DHS*s
primary missions include (1) preventing terrorist attacks in the United
States, (2) reducing America*s vulnerability
to terrorism, and (3) minimizing the damage from potential attacks and
natural disasters. DHS was established on January 24, 2003; most of the
agencies were transferred effective March 1, 2003. According to DHS, the
Secretary has until January 2004 to bring all 22 agencies into the new
organization. The new department is responsible for assisting all levels
of government in
meeting their responsibilities in domestic emergencies and other
challenges* especially in dealing with incidents that are chemical or
biological in nature* through planning, mitigation, preparedness,
response, and recovery activities. DHS is to develop and deploy
countermeasures to current and emerging terrorist threats. In conjunction
with HHS, it is to coordinate the nation*s preparedness and response to
bioterrorism. Two of DHS*s five divisions are to address preparedness and
response to bioterrorism. The Emergency Preparedness and Response
Division*s mission includes assisting all levels of government, and
others, in responding to domestic emergencies; the Science and Technology
program*s mission includes developing and deploying countermeasures to
current and emerging terrorist threats, including bioterrorism. For fiscal
year 2004, the President*s budget requested $365 million to develop and
implement integrated systems to reduce the probability and consequences of
a biological attack on the nation*s civilian population and agricultural
system. DHS has inherited programs from other departments that have a
bioterrorism role, such as USDA*s Agricultural Research Service and Animal
and Plant Health Inspection Service.
We have designated the implementation and transformation of DHS as high
risk and have added it to our 2003 high risk list. This designation is
based on three factors. First, the implementation and transformation of
DHS is an enormous undertaking that will take time to achieve in an
effective and efficient manner. Second, DHS*s prospective components
already face a wide array of existing management and operational
challenges. Finally, failure to effectively carry out DHS*s mission would
expose the nation to potentially very serious consequences. 13 13 U. S.
General Accounting Office, Major Management Challenges and Program Risks:
Department of Homeland Security, GAO- 03- 102 (Washington, D. C.: January
1, 2003).
Page 14 GAO- 03- 139 Federal Bioterrorism IT IT can play an essential role
in supporting federal, state, local, and tribal governments in
bioterrorism readiness efforts. Development of IT builds upon the existing
systems capabilities of local and state public health
agencies, not only to provide routine public health functions but also to
support public health emergencies, including bioterrorism. For public
health emergencies in particular, the ability to quickly exchange data
from provider to public health agency* or from provider to provider* is
crucial in detecting and responding to naturally occurring or intentional
disease outbreaks. It allows physicians to share individually identifiable
information with public health agencies for use in performing public
health activities. In March 2001, CDC*s Public Health*s Infrastructure: A
Status Report acknowledged several IT limitations in the public health
infrastructure. For example, basic capability for disease surveillance
systems to detect and analyze disease outbreaks is lacking for several
reasons. First, health care providers have traditionally used paper- or
telephone- based systems to report disease outbreaks to approximately
3,000 public health agencies. This is a labor- intensive, burdensome
process for local health care providers and public health officials, often
resulting in incomplete and untimely data. Second, not all public health
agencies have access to the
Internet or to secure channels for electronically transmitting sensitive
data.
Several categories of IT can play vital roles during the course of an
event. These categories are described in a technology assessment for AHRQ
that was completed by the University of California San Francisco- Stanford
Evidence- based Practice Center. 14 These categories of IT serve different
but related functions and include the following: Detection* systems that
consist of devices for the collection and
identification of potential biological agents from environmental samples,
which make use of IT to record and send data to a network.
Surveillance* systems that facilitate the performance of ongoing
collection, analysis, and interpretation of disease- related data to plan,
implement, and evaluate public health actions.
14 University of California San Francisco- Stanford Evidence- based
Practice Center,
Bioterrorism Preparedness and Response: Use of Information Technologies
and Decision Support Systems (Stanford, CA: June 2002). A copy of the
report can be downloaded at www. ahrq. gov/ clinic/ evrptfiles. htm# bio-
it. Role of Information Technology for
Bioterrorism Preparedness and Response
Page 15 GAO- 03- 139 Federal Bioterrorism IT Diagnostic and clinical
management* systems with potential utility for enhancing the likelihood
that clinicians will consider the possibility
of bioterrorism- related illness. These systems are generally designed to
assist clinicians in developing a differential diagnosis for a patient who
has an unusual clinical presentation. Communications* systems that
facilitate the secure and timely
delivery of information to the relevant responders and decision makers so
that appropriate action can be taken.
Supporting technologies* tools or systems that provide information for
the other categories of systems (e. g., detection, surveillance, etc.). 15
Recognizing the importance of IT to strengthening the public health
infrastructure, RAND*s Science and Technology Policy Institute held a
series of workshops between November 2001 and April 2002. The workshops
brought together a diverse set of stakeholders to begin the process of
developing an IT infrastructure that could support bioterrorism
preparedness efforts across the country. 16 During these workshops,
consensus was reached on the need for an overarching IT infrastructure to
prepare for and respond to bioterrorism and other public health
emergencies. RAND described the different phases of a bioterrorism event
and the intensity of need for IT during each phase, and it proposed that a
bioterrorism event could consist of the following phases: Prevention and
preparedness* includes reducing the possibility of a
biological event by methods such as developing vaccines, conducting
desktop exercises, and heightening alert status.
Event recognition* includes monitoring and detecting the release of a
biological agent or identifying the first case of an illness, by methods
such as using detection devices and surveillance systems and diagnosing
the first case of smallpox.
Early and sustained response* includes initiating the response to the
initial event and then continuing the measures required to address the
longer- term impact of the exposure, such as deploying resources to
15 Categorized to take into consideration research and development
projects that may offer promising techniques; not part of UCSF- Stanford
Technology Assessment. 16 RAND Science and Technology Policy Institute,
Summit on Information Technology Infrastructure for Bioterrorism
(Arlington, VA).
Page 16 GAO- 03- 139 Federal Bioterrorism IT contain a biological agent,
identifying the source, replenishing medical supplies, ensuring surge
capacity for the treatment of victims, and
monitoring exposed individuals. Recovery* includes recovering after the
biological threat is under
control, by measures such as providing mental health support, restocking
vaccine and drug reserves, and identifying lessons learned to improve
future responses.
According to RAND, during the course of a bioterrorism event, IT should be
capable of addressing all phases of the event. Because of the dynamic and
unpredictable nature of public health emergencies, various types of IT are
needed during the course of an event. These systems and the intensity of
their need for IT may vary from event to event, depending on the
circumstances. In addition, IT components that are required for one phase
may also be critical for other phases, but the intensity of need for them
may vary. These needs include consideration of the phase being
supported, required capabilities for each phase, and the data required at
various points in time. Figure 2 illustrates the probable intensity of
need for each category of IT across the different phases.
Page 17 GAO- 03- 139 Federal Bioterrorism IT Figure 2: IT Needs during a
Public Health Emergency
The six key federal agencies involved in bioterrorism preparedness and
response have a large number of existing and planned bioterrorism- related
information systems. Specifically, these agencies identified 72
information systems and supporting technologies, as well as 12 other IT
initiatives. Of the 72 information systems, 34 are surveillance systems,
18 are supporting technologies, 10 are communications systems, and 10 are
detection systems. Additionally, in planning or operating each of these
systems and IT initiatives, the extent of coordination or interaction
performed by the lead agency with other related government agencies
covered a wide range of activity. Coordination varied by system and IT
initiative, ranging from absence of coordination, to awareness without
coordination, to formal coordination, to joint development of initiatives.
For example, about 30 percent of the information systems and IT
initiatives are being either formally coordinated or jointly developed
with another agency. About 70
Bioterrorism- Related Information Technology Activities Identified at Six
Federal Agencies
Page 18 GAO- 03- 139 Federal Bioterrorism IT The six federal agencies with
key roles in bioterrorism preparedness and response identified 72 existing
or planned information systems and
supporting technologies, as well as 12 other IT initiatives. 17 About 74
percent of these systems and IT initiatives are currently operational. The
estimated costs reported for these systems exceed $63 million for fiscal
year 2003. 18 Of the 72 information systems identified, 34 are
surveillance systems, 18 are supporting technologies, 10 are
communications systems, and 10 are detection systems. Of the 12 IT
initiatives, HHS identified 4, DOD and DOE identified 3 each, and USDA
identified 2. Table 1 summarizes the number of systems by agency and IT
category.
Table 1: Summary of the Systems Inventory by Agency IT categories HHS DOD
DOE USDA EPA VA Total
Detection 0 4 b 6 0 0 0 10
Surveillance 18 a 7 2 a 6 0 1 34
Diagnostic and clinical management 0 0 0 0 0 0 0
Communications 5 2 0 3 0 0 10
Supporting technology 5 1 6 1 5 0 18 Total 28 14 14 10 5 1 72
Source: GAO. a Includes integrated surveillance/ communications systems. b
Includes an integrated detection/ communication system.
Agencies identified a variety of information systems and IT initiatives,
such as the following:
HHS*s 28 systems are largely in operation and are used for surveillance
of diseases and illnesses, as well as for communications. As the lead
federal agency for protecting the health and safety of the public, CDC is
responsible for most of the systems included in the HHS inventory. For
17 The NEDSS Base System is included in the systems inventory and the
NEDSS architecture is included as an IT initiative. 18 We did not validate
cost information reported by the agencies. Additionally, cost information
was not reported for all the systems included in our review. Bioterrorism-
Related
Systems and Initiatives Identified at Six Federal Agencies
Page 19 GAO- 03- 139 Federal Bioterrorism IT example, CDC is currently
implementing the Health Alert Network (HAN), an early warning and response
system that is intended to
provide federal, state, and local health agencies with better
communications during public health emergencies; additional details are
provided in appendix III.
DOD, while primarily responsible for the health of its service members
on the battlefield, conducts research on bioterrorism preparedness and
response for force protection and shares that research with other agencies
when it may benefit the civilian population. Because of the broad nature
of DOD*s responsibilities, it identified 14 systems in all categories. One
example of a DOD system is the Electronic Surveillance System for the
Early Notification of Community- based Epidemics (ESSENCE), which supports
early identification of infectious disease outbreaks in the military by
comparing analyses of data collected daily with historical trends;
additional details are provided in appendix III.
DOE* specifically its national laboratories* has identified 14 research
and development efforts for technologies to support detection systems,
among others. An example is the Biological Aerosol Sentry and Information
System (BASIS), a portable system of networked airsampling units that are
capable of detecting airborne biological incidents at large gatherings
such as political conventions and major indoor and outdoor sporting
events; additional details are provided in appendix III.
USDA*s Food Safety and Inspection Service is using IT to support methods
of inspection to better protect the public from foodborne illness.
EPA has five systems defined as supporting technologies* two that could
potentially support surveillance activities on the safety of drinking
water and three modeling and simulation tools that are used
to simulate the dispersions of contaminants in water and indoor air. 19
VA has one information system that was developed for surveillance within
its health care facilities.
19 EPA relies largely on local water authorities to monitor the safety of
water supplies and report the information to them.
Page 20 GAO- 03- 139 Federal Bioterrorism IT Appendix III provides a
detailed description of the IT categories and additional information on
each, while appendixes IV through IX contain
detailed descriptions of the information systems and supporting
technologies by agency. Appendix X contains detailed descriptions of the
IT initiatives.
In planning or operating each of these information systems and IT
initiatives, the extent of coordination or interaction among the lead
agency and other related government agencies covered a wide range. Such
coordination ranged from a lack of contact with other agencies, to
awareness, to formal coordination, to joint development of initiatives.
According to CDC officials, while collaboration has improved, there are
still organizational difficulties related to combining resources from
multiple sources to meet common goals. It is typical for staff or
contractual resources funded through one mechanism to be kept separate
from those funded through another mechanism.
Agencies reported that about 30 percent of systems and initiatives are
being either formally coordinated or jointly developed with another
agency. Of the six agencies in our review, CDC and DOE*s national
laboratories accounted for the majority of information systems and IT
initiatives that identified formally coordinated or jointly developed
initiatives. One example of a jointly developed information system is
FDA*s eLEXNET system. It is a secure Web- based database for sharing
laboratory data on food safety among FDA, USDA, DOD, state agriculture,
and state and local health laboratories. FDA also shares data with other
HHS operating divisions, as well as with Customs (now part of DHS) and the
Federal Bureau of Investigations (FBI). This joint effort, which is
currently in the planning stage, could improve these agencies* abilities
to address foodborne illnesses. In addition, CDC has several IT
initiatives in coordination with state and local public health agencies.
Coordination Mixed
Among the Information Systems and Initiatives Identified
Page 21 GAO- 03- 139 Federal Bioterrorism IT To support the compatibility,
interoperability, and security of federal agencies* many planned and
operational IT systems, the identification and
implementation of data, communications, and security standards for health
care delivery and public health are essential. Although federal efforts
are now under way to strengthen and increase the use of these standards,
the identification and implementation of these standards remain
incomplete. Several implementation challenges remain, including
coordination of the various efforts to ensure consensus on standards, and
establishment of milestones. Until these challenges are addressed, federal
agencies cannot ensure their systems* abilities to exchange data with
other
systems when needed. A major consequence of not implementing such
standards is the promulgation of piecemeal systems, which results in
disparate systems that cannot exchange data. An underlying challenge for
establishing and implementing standards is that no overall strategy guides
IT development and initiatives.
IT standards, including data standards, enable the interoperability and
portability of systems within and across organizations. 20 As we have
reported in the past, many different standards are required to develop
interoperable health information systems, which reflect the complex nature
of health care delivery in the United States. 21 Vocabulary standards,
which provide common definitions and codes for
medical terms and determine how information will be documented for
diagnoses and procedures, are one type of data standard. Vocabulary
standards are intended to lead to consistent descriptions of a patient*s
medical condition by all practitioners. The use of common terminology
helps in the clinical care delivery process, enables consistent data
analysis from organization to organization, and facilitates transmission
of
information. Without such standards, the terms used to describe the same
diagnoses and procedures sometimes vary. For example, the condition known
as hepatitis may also be described as a liver inflammation. The use
20 Interoperability is the ability of two or more systems or components to
exchange information and to use the information that has been exchanged.
Portability is the degree to which a computer program can be transferred
from one hardware configuration or software environment to another.
21 U. S. General Accounting Office, Automated Medical Records: Leadership
Needed to Expedite Standards Development, GAO/ IMTEC- 93- 17 (Washington,
D. C.: April 30, 1993). Health Care Sector
Making Progress on Defining Standards, but Implementation Challenges
Remain for Effective Information Sharing
Key Standards for Health Care
Page 22 GAO- 03- 139 Federal Bioterrorism IT of different terms to
indicate the same condition or treatment complicates retrieval and reduces
the reliability and consistency of data. In addition to vocabulary
standards, messaging standards are also
important because they provide for the uniform and predictable electronic
exchange of data by establishing the order and sequence of data during
transmission. Medical messaging standards dictate the segments in a
specific medical transmission. For example, they might require the first
segment to include the patient* s name, hospital number, and birth date. A
series of subsequent segments might transmit the results of a complete
blood count, one result (e. g., iron content) per segment. Messaging
standards can be adopted to enable intelligible communication between
organizations via the Internet or some other communications pathway.
Without these standards, the interoperability of federal agencies* systems
may be limited and may limit the exchange of data that are available for
information sharing. In addition to vocabulary and messaging standards,
there is also the need for a high degree of security and confidentiality
to protect medical information from unauthorized disclosure. More detail
on these and other key standards is provided in appendix XI.
The need for health care data standards has been recognized for a number
of years and progress has been made in defining these standards. Yet,
despite these efforts, the identification and implementation of these
standards remains incomplete. CDC acknowledged the need for standards
specific to public health systems, and in 1995 it established the National
Electronic Disease Surveillance System (NEDSS) initiative to address the
limitations of current surveillance systems. These limitations included
(1) the multiplicity of program- specific information systems, (2)
incomplete and untimely data, (3) the unacceptable burden on health care
system respondents, (4) the overwhelming volume of data to be managed by
state and local health departments, and (5) the lack of state- of- the-
art
IT. As part of the NEDSS initiative, CDC, in collaboration with others,
agreed to encourage the use of data, communications, and security
standards that are required for building interoperable public health
systems. CDC expects that the implementation of NEDSS will improve the
reporting of disease outbreaks from the states by increasing the
timeliness, accuracy, and completeness of data. According to CDC, once
fully implemented, these standards are to provide the ability to merge
data from laboratories with epidemiological data, in addition to providing
the ability to obtain information on cross- jurisdictional outbreaks. Need
for Standards Has Been Recognized and
Federal Actions are Under Way to Define and Implement Them
Page 23 GAO- 03- 139 Federal Bioterrorism IT In August 1996, Congress also
recognized the need for standards to improve the Medicare and Medicaid
programs in particular and the
efficiency and effectiveness of the health care system in general. It
passed the Health Insurance Portability and Accountability Act of 1996
(HIPAA), 22 which calls for the industry to control the distribution and
exchange of health care data and begin to adopt electronic data exchange
standards to uniformly and securely exchange patient information.
According to the National Committee on Vital and Health Statistics
(NCVHS), 23 significant progress has occurred on several HIPAA standards,
however, the full economic benefits of administrative simplification will
be realized only when all of the standards are in place. 24 In July 2000,
the NCVHS again reported on the need for standards, this
time highlighting the need for uniform standards for patient medical
record information. They found that major impediments to electronic
exchange of patient medical information were the limited interoperability
of health information systems; the limited comparability of data exchanged
among providers; and the need for better data quality, accountability, and
integrity. 25 In November 2001, NCVHS issued another report outlining a
strategy, which includes developing and using standards. According to
NCVHS, the public health infrastructure could be strengthened through more
rapid identification and implementation of
existing standards and other new standards. The Institute of Medicine
(IOM) and others are also reporting on the lack of national standards for
the coding and classification of clinical and other health care data, and
for the secure transmission and sharing of such data.
Complementary to the work of NEDSS on identifying standards for public
health systems, in 2001 the Office of Management and Budget created the
Consolidated Health Informatics (CHI) initiative as one of its egovernment
projects to facilitate the adoption of data standards, among others, for
health care systems within the federal government. The CHI
22 Public Law 104- 191 (August 21, 1996). 23 A public advisory committee
statutorily authorized to advise the Secretary of HHS on national health
information policy. 24 National Committee on Vital and Health Statistics,
Fifth Annual Report to Congress on the Implementation of the
Administrative Simplification Provisions of the Health
Insurance Portability and Accountability Act (Washington, D. C.: November
12, 2002). 25 National Committee on Vital and Health Statistics, Report on
Uniform Patient Medical Records Information (Washington, D. C.: July 6,
2000).
Page 24 GAO- 03- 139 Federal Bioterrorism IT initiative is an interagency
work group led by HHS and composed of representatives from DOD, VA, and
other agencies. Recognizing the need
for standards to be incorporated across federal health care systems, HHS,
DOD, and VA recently announced its first set of standards (e. g., HL7,
LOINC) for the electronic exchange of health information to be implemented
across the federal government. Once federal agencies adopt the recommended
standards, they are expected to include the standards in their
architectures and to build systems accordingly. This commitment is to
apply to all new systems acquisition and development projects. The CHI
initiative plans to announce additional standards for federal systems as
the working group agrees upon them, but does not have time frames
established for making these announcements.
Despite progress in defining health care IT standards, several
implementation challenges* such as coordination of the various initiatives
to achieve consensus on the use of standards, establishment of milestones,
and development of implementation mechanisms* remain to be worked out.
Currently, there are no activities or mechanisms defined to ensure
coordination and consensus between these initiatives at the national
level. HHS officials agree that leadership and direction are still needed
to coordinate the various standards- setting initiatives and to ensure
consistent implementation of standards for health care delivery and public
health. Coordination of these initiatives is essential to ensure that the
completion of standards development is accelerated and that consensus is
obtained from all stakeholders. According to NCVHS, the process of
developing health care data standards involves many diverse entities, such
as individual and group practices, software developers, domain- specific
professional associations, and allied health services. This fragmentation
has slowed the dissemination and adoption of standards by making it
difficult to convene all of the relevant stakeholders and subject matter
experts in standards development meetings and to reach consensus within a
reasonable period of time.
Another challenge is that not all of the federal government*s
standardssetting initiatives have milestones associated with efforts to
define and implement standards. For example, while the CHI initiative* the
primary federal initiative to establish standards* has announced such
initial standards and implementation requirements for health care
information exchange, it has not yet established milestones for future
announcements. Accordingly, it is not clear when these announcements will
occur. Several Standards
Implementation Challenges Remain
Page 25 GAO- 03- 139 Federal Bioterrorism IT Another challenge is that
there is no mechanism to monitor the implementation of standards
throughout the health care industry. In
November 2001, NCVHS reported a need for a mechanism, such as compliance
testing, to ensure that health care standards are uniformly adopted as
part of a national strategy. NCVHS added that without an implementation
mechanism and leadership at the national level, problems associated with
systems* incompatibility and lack of interoperability will persist
throughout the different levels of government and the private sector and,
consequently, throughout the health care sector. Since that time, however,
no national monitoring mechanism has yet been
established. A major consequence of not implementing such standards is the
promulgation of piecemeal systems, which result in disparate systems that
cannot exchange data. This leads to information gaps, hindering the prompt
and accurate identification of emerging biological threats* consequently,
timely detection of major public health threats is limited. For example,
according to CDC officials, one of the IT challenges encountered by public
health officials responding to the anthrax events of October 2001 was the
issue of exchanging data among the many
participants involved in the response* clinical sites, local health
departments, emergency responders, state health departments, public health
laboratories, and federal agencies. During this event, participants
accumulated dissimilar data and principally exchanged it manually.
An underlying challenge for establishing and implementing such standards
is that no overall strategy guides IT development and initiatives. With no
overall strategy that addresses the development and implementation of
standards and associated milestones, federal agencies cannot ensure their
systems* abilities to exchange data with other systems when needed and
cannot ensure effective preparation for and response to bioterrorism and
other public health emergencies.
Page 26 GAO- 03- 139 Federal Bioterrorism IT Within the public health
sector, the implementation of emerging information technologies could help
to strengthen agencies* technological
capabilities to support the nation*s ability to prepare for and respond to
bioterrorism and other public health emergencies. Agencies identified
several activities to research, develop, and implement emerging
technologies, which were generally initiated to meet agencies* specific
needs. However, barriers exist that may hinder the public health community
from benefiting from the implementation of emerging information
technologies.
An emerging technology is one in which research has progressed far enough
to indicate a high probability of technical success for new products and
applications that might have substantial markets within approximately 10
years. Agencies identified several IT applications that incorporate the
use of emerging technologies. They include commercial IT and
communications solutions, along with IT that was developed specifically
for the health care sector. Examples of emerging information technologies
for use in public health applications include the following:
Geographic information system (GIS): 26 GIS is being used by federal
agencies to support disease and outbreak surveillance. CDC uses GIS to
track the spread of infection through a community, to identify geographic
areas of particular health concern, and to identify susceptible
populations. The resulting information can be used in support of
surveillance systems to help identify spatial clustering of abnormal
events as the data are collected. GIS was used in 2001 to map data related
to CDC*s emergency response to the anthrax bioterrorism event, and it was
used in 2002 to aid the FBI*s investigation of the anthrax attack in
Florida. FDA is currently using GIS technology in its food safety system,
eLEXNET.
Web- based images for diagnosis: Several of CDC*s systems use the
Internet to enhance reporting and communications capabilities. For
26 GIS is a computer application for capturing, storing, checking,
integrating, manipulating, analyzing, and displaying data related to
positions on the earth*s surface. Typically, a GIS is used for handling
maps of one kind or another. These might be represented as several
different layers where each layer holds data about a particular kind of
feature (e. g., roads). Each feature is linked to a position on the
graphical image of a map. Emerging Information
Technologies Could Enhance Agencies* Abilities to Prepare for and Respond
to Public Health Emergencies
Examples of Public Health*s Use of Emerging Information Technology
Page 27 GAO- 03- 139 Federal Bioterrorism IT example, its DPDx system uses
the Internet to strengthen the capabilities of laboratories to diagnose
parasitic diseases. The function also enables users to obtain diagnostic
assistance over the Internet by
allowing laboratories to transmit images to CDC and obtain answers to
inquiries, sometimes within minutes. The system increases the interaction
between CDC and public health laboratories.
Data mining: 27 DOD*s ESSENCE system uses data mining technology to
support early detection of infectious disease outbreaks or bioterrorism
events. This system enhances public health officials* decision- making
capabilities regarding events, which may be public health emergencies.
Grid computing: 28 DOD*s Army Medical Research Institute of Infectious
Diseases is sponsoring a project with the support of several partner
organizations to use grid- computing techniques to help find a treatment
for smallpox after infection. The system will run simulated tests of
molecules representing some 35 million potential drugs to see how they
interact with the smallpox virus.
Computer- aided DNA signature development: DOE*s Lawrence Livermore
National Laboratory is developing software called KPATH, which is a
computer- aided DNA signature development tool. It analyzes pathogen DNA
to identify unique signatures. Once identified, these signatures can be
used to assist in the process of detecting biological incidents. The
results of such development efforts support an enhanced capacity for rapid
identification of biological agents.
Virtual private network (VPN): DOE*s Los Alamos National Laboratory is
working on an Internet- based system called the Forensics Internet
Research Exchange, which supports the sharing of biothreat information
among research and government agencies. This system is secured through the
use of a VPN. A VPN is a communication system that uses public networks to
securely transport private
intraorganizational and interorganizational information. While industry 27
Data mining is the extraction of information from databases to discover
hidden facts. Data mining finds patterns and relationships in data and
infers rules that allow the prediction of future results. 28 Grid
computing ties together geographically disparate and distributed computers
to create a single massive computing resource, taking advantage of their
processing power.
Page 28 GAO- 03- 139 Federal Bioterrorism IT use of VPNs is common, only
four of the systems included in our inventory use VPNs for public health-
specific applications.
Public key infrastructure (PKI): CDC has begun using PKI for secure
communications between public health officials using NEDSS. PKI is a
system of hardware, software, policies, and people that, when fully
implemented, can provide a suite of information security assurances that
are important in protecting sensitive communications and transactions. 29
Portable biological detection unit: DOE*s Sandia National
Laboratory has made progress toward developing a small sampling and
analysis instrument that is portable and does not require a chemist*s
expertise to operate. This system, u ChemLab, is the first that reduces
the size of large instruments to the extent that they can be taken into
the field and used by first responders, such as firefighters. The device
utilizes embedded software algorithms that indicate the level of threat
present in the environment in which the instrument is deployed.
While the public health community may benefit by implementing emerging
information technologies, several factors introduce barriers and risks to
their successful implementation. One barrier is that emerging technologies
likely have not been in use long enough for the developers to identify all
areas for standardization, or for the technologies to have evolved to the
point that they are interoperable with other already- existing
technologies within public health.
Another barrier, according to Gartner, Inc., a leading private research
firm, is that the use of emerging information technologies may likely
change an organization*s existing business model. Therefore their
implementation may introduce a significant level of risk. For these
reasons, the introduction of an emerging information technology may be
disruptive to existing business processes.
A third possible barrier is the lack of a clearly defined mechanism for
continuing research and development for emerging technologies once the
results are turned over to the public health sector. For example,
according
29 U. S. General Accounting Office, Information Security: Advances and
Remaining Challenges to Adoption of Public Key Infrastructure Technology,
GAO- 01- 277 (Washington, D. C.: February 26, 2001). Barriers to Better
Use of
Emerging Technologies
Page 29 GAO- 03- 139 Federal Bioterrorism IT to a CDC official, there is
no mechanism to develop demonstration projects to identify and prove the
usefulness and applicability of emerging
technologies within the public health sector at the federal, state, and
local levels. At the time of our review, funds for two research and
development efforts that were initially identified as promising were
discontinued without consideration of the project*s value to the public
health infrastructure.
Lastly, we observed that activities related to the use of emerging
technologies are often the result of independent efforts for specific
purposes. Consequently agencies may not be able to share successes or
lessons learned. Effectively addressing each of these barriers will be
essential if the health care industry is to take full advantage of
emerging information technologies.
As concerns about the possibility of bioterrorism have been elevated,
federal, state, and local public health agencies have been increasing
efforts to prepare for and respond to public health emergencies. Federal
agencies identified over 70 existing information systems, supporting
technologies, and IT initiatives that may better support the public health
infrastructure. The extent of coordination or interaction among the lead
agency and other related government agencies ranged from a lack of
coordination, to awareness, to formal coordination, to jointly developed
initiatives. As these and future systems are pursued, leadership will be
essential to set priorities for information systems, supporting
technologies, and other IT initiatives to enhance the effective
preparation for and response to bioterrorism and other public health
emergencies.
Although a number of efforts are under way, no comprehensive set of
standards has been implemented sufficiently to fully support the public
health infrastructure. Leadership and an overall IT strategy are important
for ensuring that standards development organizations and federal agencies
address remaining implementation challenges: (1) coordination of the
various efforts and consensus on the use of standards,
(2) establishment of milestones for defining and implementing standards,
and (3) mechanisms for monitoring implementation of standards. Without a
strategy to ensure coordinated efforts and consistent application of
standards, federal agencies cannot ensure that their systems are
compatible or interoperable and, therefore, cannot effectively support
actions to manage public health emergencies through the timely and
accurate exchange of information. Conclusions
Page 30 GAO- 03- 139 Federal Bioterrorism IT Finally, federal agencies
have begun to implement emerging technologies to strengthen the public
health infrastructure. While some emerging
technologies have been implemented, and others are being researched and
developed, agencies cannot take full advantage of these technologies
because several barriers exist. Effectively addressing each of these
barriers will be essential if the health care industry is to fully
leverage these emerging information technologies. Leadership will be
essential to address these barriers and also to establish mechanisms for
identifying and prioritizing uses of emerging technologies to better
support the nation*s ability to prepare for and respond to public health
emergencies.
We recommend that the Secretary of Health and Human Services, in
coordination with other key stakeholders* such as the Secretaries of
Defense, Homeland Security, and Veterans Affairs* establish a national IT
strategy for public health preparedness and response. This IT strategy
should identify steps toward improving the nation*s ability to use IT in
support of the public health infrastructure. More specifically, it should
identify all federal agencies* IT initiatives, using the results of our
inventory as a starting point;
set priorities for information systems, supporting technologies, and
other IT initiatives;
define activities for ensuring that the various standards- setting
organizations coordinate their efforts and reach further consensus on the
definition and use of standards;
establish milestones for defining and implementing all standards;
create a mechanism* consistent with HIPAA requirements* to
monitor the implementation of standards throughout the health care
industry; and
address existing barriers and establish mechanisms for identifying and
prioritizing uses of emerging technologies that are appropriate for
ensuring continued improvements to the nation*s ability to prepare for and
respond to public health emergencies. Recommendations
Page 31 GAO- 03- 139 Federal Bioterrorism IT We received written comments
on a draft of this report from the Deputy Assistant Secretary of Defense
for Chemical/ Biological Defense at DOD,
Acting Associate Administrator for Management and Administration at DOE,
the Acting Principal Deputy Inspector General at HHS, and the Secretary of
Veterans Affairs. These four agencies generally concurred with our
results, but they did not comment specifically on the recommendations.
They provided technical comments, which we have incorporated in this
report as appropriate. USDA and EPA concurred with our results in their
oral comments, which were primarily technical comments and incorporated as
appropriate. Technical comments were generally limited to additional
information or correction of information on the description of their
systems included in the appendixes. While DHS was not included as one of
the agencies in our review because they did not exist until the end of
this engagement, we provided DHS officials with the opportunity to comment
on the draft of this report, which they declined. Written comments from
DOD, DOE, HHS, and VA are reproduced in appendixes XII to XV.
Among its comments, HHS officials stated that the focus of this report on
IT overemphasized its role and does not address other components of the
public health infrastructure. As we describe in the background section of
the report, IT is a tool that enables personnel to fulfill their mission.
We recognize that the United States health care and public health
infrastructure is a complex network of people, systems, and organizations,
with participation at all levels* federal, state, tribal, local,
international, and the private sector. We also recognize that there are
other important issues about the public health infrastructure that merit
attention, such as workforce capacity and training, capacity of the public
health laboratories, variation in state public health laws, capacity of
the health care delivery systems, and communication strategies for
addressing the public.
As agreed with your offices, unless you publicly announce its contents
earlier, we plan no further distribution of this report until 30 days from
the date on the report. At that time, we will send copies of the report to
other congressional committees. We will also send copies of this report to
the Secretaries of Agriculture, Defense, Energy, Health and Human
Services, Homeland Security, and Veterans Affairs, and to the
Administrator of the Environmental Protection Agency. Copies will also be
made available at no charge on our Web site at www. gao. gov. Agency
Comments
and Our Evaluation
Page 32 GAO- 03- 139 Federal Bioterrorism IT If you have any questions on
matters discussed in this report, please contact me at (202) 512- 9286 or
M. Yvonne Sanchez, Assistant Director, at
(202) 512- 6274. We can also be reached by E- mail at pownerd@ gao. gov
and sanchezm@ gao. gov, respectively. Other contacts and key contributors
to this report are listed in appendix XVI. David A. Powner
Director (Acting), Information Technology Management Issues
Page 33 GAO- 03- 139 Federal Bioterrorism IT List of Requesters
Tom Davis Chairman, Committee on Government Reform, House of
Representatives
Christopher Shays Chairman, Subcommittee on National Security, Emerging
Threats, and
International Relations, Committee on Government Reform, House of
Representatives
Mary Bono Member, House of Representatives
Jane Harman Member, House of Representatives
Charles Norwood Member, House of Representatives
Charles Pickering Member, House of Representatives
Mac Thornberry Member, House of Representatives
Edolphus Towns Member, House of Representatives
Jim Turner Member, House of Representatives Edward Whitfield Member, House
of Representatives
Appendix I: Objectives, Scope, and Methodology
Page 34 GAO- 03- 139 Federal Bioterrorism IT The objectives of our review
were to compile an inventory of current and planned bioterrorism
information
technology (IT) initiatives at selected federal agencies and identify the
range of coordination efforts,
identify and describe the development and use of health care IT
standards for bioterrorism- related systems, and
review the potential use of emerging information technologies for
bioterrorism preparedness and response.
To address these objectives, we conducted our audit work at six selected
federal agencies* United States Department of Agriculture (USDA),
Department of Defense (DOD), Department of Energy (DOE), Department of
Health and Human Services (HHS), Department of Veterans Affairs (VA), and
the Environmental Protection Agency (EPA)* that we previously reported
were involved with supporting public health and bioterrorism preparedness
and response, which included the use of IT. 1 We excluded federal agencies
that are responsible only for law
enforcement and consequence management related to other types of
terrorism.
To compile the inventory of current and planned IT initiatives related to
bioterrorism, we met with agency officials and identified the categories
of systems (e. g., detection, surveillance, diagnostic and clinical
management,
communications, and supporting technologies) to be included in the
inventory and the data to be collected about each system. The inventory
includes information systems with applications related to both public
health and bioterrorism, since most systems were developed for routine
public health purposes but are potentially useful during a bioterrorism
event. We also created a database for collecting and analyzing the data
from the selected agencies. Next we collected and compiled the inventory
data and validated the consistency of the data with each agency. We also
included systems that were not necessarily designed for public health
purposes, but might be adapted for that function. We included other
technologies, such as detection devices that include an IT component that
facilitates the collection of data for surveillance systems or otherwise
1 U. S. General Accounting Office, Bioterrorism: Federal Research and
Preparedness Activities, GAO- 01- 915 (Washington, D. C.: September 28,
2001). Appendix I: Objectives, Scope, and
Methodology
Appendix I: Objectives, Scope, and Methodology
Page 35 GAO- 03- 139 Federal Bioterrorism IT enable IT to perform
diagnosis, management, prevention, surveillance, reporting, and
communication functions. Our inventory includes
information systems that support detection, surveillance, diagnostic and
clinical management, communications, and supporting technologies.
The inventory specifically excludes the following types of IT: law
enforcement and intelligence systems, classified systems,
international initiatives, military systems with no applicability to
civilian populations (e. g.,
combat- specific systems), distance learning and other training systems,
disease- specific surveillance systems with no potential to support
bioterrorism preparedness and response, systems designed to track
agricultural terrorism, and consequence management systems for
traditional first responders (e. g.,
police and firefighters). We met with and obtained documentation from
representatives of several nonprofit, research, and public health
professional organizations, such as the RAND Corporation, the University
of California at San FranciscoStanford Evidence- based Practice Center,
and the National Association of County and City Health Officials. Based on
our research and the information provided by those parties, we identified
categories of IT that support public health and bioterrorism preparedness
and response. To illustrate the role of different categories of IT, we
also collected more detailed information about selected systems efforts.
During our discussions with agency officials about the results of their
inventory data, we asked about an agency*s interaction and involvement
with information systems and IT initiatives being led by other federal
agencies. We also collected data as part of the systems inventory about
jointly developed projects that included a partner outside their agency.
Appendix I: Objectives, Scope, and Methodology
Page 36 GAO- 03- 139 Federal Bioterrorism IT To identify and describe the
development, use, and progress of health care data, communications, and
security standards, we identified ongoing
federal efforts and public/ private collaborations to implement standards
for IT systems that could be used to support the public health
infrastructure. In addition, we met with HHS officials to discuss ongoing
activities and progress being made to implement the National Committee on
Vital and Health Statistics* recommendations on the National Health
Information Infrastructure and other standards- related initiatives. We
also met with other experts from the Centers for Disease Control and
Prevention and Stanford University and discussed with them the use and
applicability of health care standards within the public health
infrastructure.
To review the potential use of emerging information technologies for
bioterrorism preparedness and response, we used research from the
Department of Commerce and private- sector consultants to define the term
*emerging technologies* as it pertains to information technology. During
discussions with agency officials, we asked about their uses and
experiences with emerging information technologies, as well as barriers to
their implementation. Then, we reviewed the selected agencies* use of and
plans for applications specific to public health that were included in the
systems inventory.
Appendix II: CDC Biological Diseases/ Agents List
Page 37 GAO- 03- 139 Federal Bioterrorism IT According to CDC, the United
States public health system and primary health care providers must be
prepared to address various biological
agents, including pathogens that are rarely seen in the United States. CDC
defines three categories of biological diseases or agents based upon the
public health impact and the level of risk to the nation*s security that
the transmission of these agents may introduce. The categories and the
associated agents are described below:
Category A Diseases/ Agents: High- priority agents include organisms that
pose a risk to national security because they can be easily disseminated
or transmitted from person to person, result in high mortality rates and
have the potential for major public health impact, might cause public
panic and social disruption, and require special action for public health
preparedness.
Anthrax (Bacillus anthracis) Botulism (Clostridium botulinum toxin)
Plague (Yersinia pestis) Smallpox (Variola major) Tularemia
(Francisella tularensis) Viral hemorrhagic fevers (filoviruses [e. g.,
Ebola, Marburg] and
arenaviruses [e. g., Lassa, Machupo])
Category B Diseases/ Agents: Second highet priority agents include those
that are moderately easy to disseminate, result in moderate morbidity
rates and low mortality rates, and require specific enhancements of CDC*s
diagnostic capacity and enhanced disease surveillance.
Brucellosis (Brucella species) Epsilon toxin of Clostridium
perfringens Food safety threats (e. g., Salmonella species, Escherichia
coli O157: H7,
Shigella) Glanders (Burkholderia mallei) Appendix II: CDC Biological
Diseases/ Agents
List
Appendix II: CDC Biological Diseases/ Agents List
Page 38 GAO- 03- 139 Federal Bioterrorism IT Melioidosis (Burkholderia
pseudomallei) Psittacosis (Chlamydia psittaci)
Q fever (Coxiella burnetii) Ricin toxin from Ricinus communis (castor
beans) Staphylococcal enterotoxin B
Typhus fever (Rickettsia prowazekii) Viral encephalitis (alphaviruses
[e. g., Venezuelan equine encephalitis,
eastern equine encephalitis, western equine encephalitis]) Water safety
threats (e. g., Vibrio cholerae, Cryptosporidium parvum)
Category C Diseases/ Agents: Third highest priority agents include
emerging pathogens that could be engineered for mass dissemination in the
future because of availability, ease of production and dissemination, and
potential for high morbidity and mortality rates and major health impact.
Emerging infectious disease threats such as Nipah virus and hantavirus
Appendix III: Categories of Information Technology for Bioterrorism-
Related Systems Page 39 GAO- 03- 139 Federal Bioterrorism IT In addition
to the phases of an event (i. e., prevention and preparedness,
event recognition, early and sustained response, and recovery) there are
corresponding categories of IT, which play a vital role as the event
progresses. These categories of IT serve different but related functions.
For the purposes of this report, we categorized systems according to their
primary purposes, as defined in a technology assessment for the Agency
for Healthcare Research and Quality that was completed by the University
of California San Francisco- Stanford Evidence- based Practice Center. 1
While not all detectors include IT components, detection systems collect
and identify potential biological agents in environmental samples,
regardless of whether anyone has been exposed to a harmful level of a
contaminant. Components of a detection system can include collection
systems, particulate counters or biomass indicators, rapid identification
systems, and integrated collection and identification systems. In general,
detection systems have three parts: (1) a sampler or collector to
concentrate the aerosol and preserve samples for further analysis, (2) a
trigger component (often a particulate counter or a biomass indicator)
that can identify the presence of a potentially harmful biological agent,
and (3) an identifier to provide specific identification of the biological
agent.
Biological detection technologies are in a much less mature stage of
development than chemical detectors. According to a February 2001 report
by the North American Technology and Industrial Base Organization
(NATIBO), no single sensor detects or identifies all biological agents of
interest. 2 Several different technologies may be needed as components of
a layered detection network. It is difficult to distinguish specific
biological agents from naturally occurring background materials. Real-
time detection and measurement of biological agents in the environment is
challenging because of the number of potential agents to be identified,
the complex nature of the agents themselves, the countless number of
similar micro- organisms that are a constant presence in the environment,
and the minute quantities of pathogen that can initiate
1 University of California San Francisco- Stanford Evidence- based
Practice Center,
Bioterrorism Preparedness and Response: Use of Information Technologies
and Decision Support Systems, (Stanford, CA, June 2002).
2 North American Technology and Industrial Base Organization, A Primer on
Biological Detection Technologies, (Fairfax, VA: February 2001). Appendix
III: Categories of Information
Technology for Bioterrorism- Related Systems Detection
Appendix III: Categories of Information Technology for Bioterrorism-
Related Systems Page 40 GAO- 03- 139 Federal Bioterrorism IT infection.
Most available systems are point detection systems that are
either in the field- testing stage or still in the laboratory. The NATIBO
assessment also reported that current systems for detecting biological
agents are large, complex, expensive, and subject to false results.
The 10 detection systems identified in the inventory include IT
components. These systems make use of IT to record and send data to a
network. Table 2 shows systems included in the inventory that were
developed and operated by DOE and DOD for use in both military and
civilian settings.
Table 2: Summary of Detection Systems by Agency Type of detector Agency
Number of
systems Status Curent/ proposed
monitored populations
Collector N/ A 0 N/ A N/ A Identifier DOE 1 Pilot Local and event-
specific Trigger DOE 1 In development Not available Integrated collector,
identifier, and trigger DOE 4 In development Local, environment, and
large- scale civilian events
DOD 4 2 * Operational 2 * Pilot Military facilities and personnel
Source: GAO. Note: N/ A means not applicable. One example of a detection
system is the Biological Aerosol Sentry and Information System (BASIS).
This is a portable system of networked air sampling units that is capable
of detecting airborne biological incidents at large gatherings such as
political conventions and major indoor and outdoor sporting events. In the
mid- 1990s, DOE*s national laboratories began work to detect and prevent
bioterrorism under the ChemicalBiological National Security Program. As
part of that work, Lawrence Livermore and Los Alamos laboratories
developed BASIS, which has been used during the Olympics and other events
to collect air samples and
provide information on the time, duration, amount, and types of biological
releases. It uses barcodes to maintain data that link samples to filters
taken from specific sampling units. These data are analyzed at field
laboratories and tracked with BASIS. If a biological agent is detected, it
will provide information about the type of agent as well as where and when
it was collected. BASIS also estimates exposure levels and durations
Appendix III: Categories of Information Technology for Bioterrorism-
Related Systems Page 41 GAO- 03- 139 Federal Bioterrorism IT to assist
public health officials in identifying the population that requires
treatment. It was adapted to process samples from the BioWatch program
beginning in February 2003.
Surveillance is the ongoing collection, analysis, and interpretation of
disease- related data to plan, implement, and evaluate public health
actions. Surveillance systems differ from detection systems in that they
monitor the actual incidence of disease or illness. Without an adequate
surveillance system, officials cannot know the true scope of existing
health problems and may not recognize new diseases until many people have
been affected. The surveillance network relies on the participation of
health care providers, laboratories, state and local health departments,
and other nontraditional data sources across the nation. Surveillance
systems monitor and track abnormal situations that require epidemiological
actions and that direct preventive measures by guiding resource allocation
and assessing interventions. The most important aspect of a surveillance
system is its ability to detect an outbreak at a stage when intervention
may affect the expected course of events. It is the public health
officials* most important tool for detecting and monitoring both existing
and emerging infectious diseases.
Surveillance activities may be either active or passive. Passive
surveillance relies on physicians, laboratory and hospital staff, and
others to take the initiative in reporting data to health departments.
Passive systems may be inadequate to identify a rapidly spreading outbreak
in its earliest and most manageable stage because there is a chronic
history of underreporting and a time lag between diagnosis of a condition
and the health department*s
receipt of a report. Active surveillance relies on public health officials
to take the initiative to periodically contact laboratory officials to
gather data. Active surveillance produces more complete information than
passive, but is more costly to use for data collection activities.
Timely and reliable data are essential components of public health
assessment, policy development, and assurance at all levels of government;
however, the current capacity of public health surveillance is weakened by
gaps and fragmentation. Fragmentation has developed in surveillance
systems in part because states and localities have not
developed uniform data collection procedures, storage, and transmission.
In February 1999, we reported on gaps in the nation*s public health
surveillance network for important emerging infectious diseases; and we
recommended that CDC, in collaboration with state, local, and other public
health officials, reach consensus on the core capabilities needed at
Surveillance
Appendix III: Categories of Information Technology for Bioterrorism-
Related Systems Page 42 GAO- 03- 139 Federal Bioterrorism IT each level of
government, including IT capabilities. 3 Another key factor
shaping the development of surveillance systems is that, historically,
investment in these systems has been targeted to specific programs (e. g.,
tuberculosis, sexually transmitted diseases, etc.), resulting in a
patchwork of surveillance efforts across the spectrum of infectious
disease threats and other programs.
Most surveillance systems are identified by the type of data they collect;
there are eight categories of surveillance:
1. Foodborne illness surveillance* systems that collect, process, and
disseminate information on foodborne pathogens or illness. In September
2001, we reported weaknesses in several of CDC*s surveillance systems for
foodborne illness; we reported that these systems had limited usefulness
because there were gaps in the data and because CDC did not release the
data in a timely manner. 4 2. Hospital- based surveillance* systems that
collect data on hospitalacquired
infections for hospital infection control officers. Their primary purpose
is to track hospital acquired infections, not to identify undiagnosed
infections from the community. However, hospital- based surveillance
systems could play two roles in the early detection of emerging
infections: the identification of a cluster of recently admitted patients,
which might suggest a community- based outbreak, and the identification of
a cluster of cases within the hospital that may suggest inpatients with an
unrecognized communicable disease.
3. Influenza surveillance* systems that collect data on influenza- like
illness. These systems are relevant to bioterrorism surveillance because
many bioterrorism- related illnesses present with flu- like symptoms.
Influenza surveillance could also serve as a model because these systems
integrate clinical and laboratory data for the detection of influenza
outbreaks and are coordinated global efforts; they fulfill needs similar
to those of surveillance for bioterrorism.
3 U. S. General Accounting Office, Emerging Infectious Diseases: Consensus
on Needed Laboratory Capacity Could Strengthen Surveillance, HEHS- 99- 26
(Washington D. C.: February 5, 1999). 4 U. S. General Accounting Office,
Food Safety: CDC Is Working to Address Limitations in Several of Its
Foodborne Disease Surveillance Systems, GAO- 01- 973 (Washington, D. C.:
September 7, 2001).
Appendix III: Categories of Information Technology for Bioterrorism-
Related Systems Page 43 GAO- 03- 139 Federal Bioterrorism IT 4. Laboratory
and antimicrobial resistance 5 surveillance* systems
that facilitate the collection, analysis, and reporting of notifiable
pathogens and of antimicrobial resistance data that could potentially
facilitate the rapid detection of a biological agent. Laboratory
surveillance systems are an essential component of any system for the
detection of a covert bioterrorism event, both for the detection of
uncommon organisms (e. g., smallpox, anthrax, and Ebola) and common
organisms with unusual patterns of antimicrobial resistance.
5. Network of clinical reports* systems that collect and analyze clinical
reports from individual clinicians and sentinel networks. 6 The growth of
such networks has generated a demand for information systems capable of
automating data collection, analysis, reporting, and communication.
6. Syndromal surveillance* systems that collect data on the earliest signs
and symptoms caused by most biological agents. 7 Therefore, patients with
these syndromes are the targets of syndromal surveillance programs. These
systems are still considered experimental, and there is no widely accepted
definition for any of these syndromes. As a result, syndromal surveillance
systems are widely heterogeneous with respect to the syndromes under
surveillance and how each syndrome is defined.
7. Zoonotic and animal disease surveillance* systems that collect,
process, and disseminate information on zoonotic and animal diseases.
There are concerns that a bioterrorist attack could involve the
dissemination of a zoonotic illness among animal populations with the
intention of infecting humans or livestock and causing economic and
political/ economic chaos. Early detection of such an event requires
effective rapid detection systems for use by farm workers, meat
inspectors, and veterinarians, with real- time reporting capabilities to
public health officials.
5 Antimicrobial resistance is the result of microbes changing in ways that
reduce or eliminate the effectiveness of drugs, chemicals, or other agents
to cure or prevent infections.
6 A sentinel network is a disease surveillance program that involves the
collection of health data on a routine basis by clinicians with some
training in reporting communicable disease. 7 Symptoms include flu- like
illness, acute respiratory distress, gastrointestinal symptoms, febrile
hemorrhagic syndromes, and febrile illnesses with either dermatological or
neurological findings.
Appendix III: Categories of Information Technology for Bioterrorism-
Related Systems Page 44 GAO- 03- 139 Federal Bioterrorism IT 8. Other*-
systems that collect sufficiently different surveillance data
that they do not fit into the described categories. These systems could be
valuable additions to surveillance networks that integrate data from
clinicians, hospitals, and laboratories.
Our inventory identifies 34 surveillance systems, which monitor and track
specific categories of illness and disease. Some of CDC*s surveillance
systems have been used for several years and only consist of a database,
while others, such as NEDSS, are more comprehensive. As table 3 indicates,
4 systems are in development, 2 are currently being evaluated as pilots, 1
is being planned, and 27 are operational. Table 3: Summary of Surveillance
Systems by Agency
Type of surveillance system Agency Number of systems Status Current/
proposed monitored
populations
Foodborne illnesses HHS 4 Operational Local populations USDA 3 Operational
Slaughter, food processing, retail, and
import establishments Hospital- based surveillance 0 Influenza HHS 1
Operational People with reported cases of influenza- like illness
Laboratory and antimicrobial resistance HHS 4 Operational Local and
national
VA 1 Operational VA hospital population USDA 1 Planning National
population Networks of clinical reports DOD 1 Operational Navy enlisted
personnel
HHS 3 2 * Operational 1 * Pilot
Local, national, and international populations
Syndromal DOD 6 2 * In development 3 * Operational 1 * Pilot
Military personnel and national populations
DOE 1 Operational Local, state, and regional populations HHS 3 1 * In
development
2 * Operational Individuals crossing US- Mexico border
Zoonotic diseases USDA 2 Operational Participating disease control
programs or slaughter test subjects
HHS 1 Operational National population
Appendix III: Categories of Information Technology for Bioterrorism-
Related Systems Page 45 GAO- 03- 139 Federal Bioterrorism IT Type of
surveillance system Agency Number of
systems Status Current/ proposed monitored populations
Other DOE 1 In development Local populations HHS 2 Operational Local
populations Source: GAO. One example of a surveillance system is DOD*s
Electronic Surveillance
System for the Early Notification of Community- based Epidemics (ESSENCE).
ESSENCE was developed to support early identification of infectious
disease outbreaks in the military, and to provide epidemiological tools
for improved investigation. ESSENCE uses ambulatory data that are
collected from its military hospitals and clinics and transmitted daily to
a central database. By comparing the daily analyses to historical trends,
it can identify patterns that suggest an infectious disease outbreak.
ESSENCE uses geo- spatial data 8 to cluster syndromic groupings based on
the locations of occurrences. By getting daily reports and automatic
alerts, epidemiologists can track, in near real-
time, the syndromes that are being reported in a given region. It
incorporates privacy algorithms and supports agent- based response using
artificial intelligence software, reasoning, data mining, and
visualization tools. DOD*s use of electronic medical records enhances its
ability to quickly collect data for syndromic surveillance. In the future,
the department plans to find, analyze, and add new data sources to the
system.
For the purposes of this report, we defined these as systems with
potential utility for enhancing the likelihood that clinicians consider
the possibility of bioterrorism- related illness and treat patients
accordingly.
Diagnostic systems are generally designed to assist clinicians in
developing a differential diagnosis for a patient who has an unusual
clinical presentation and consist of three different types: general
diagnostic decision support systems (DSS), radiology interpretation
systems, and natural language processing techniques. 9 General diagnostic
8 Geo- spatial data is information that identifies the geographic location
and characteristics of natural or constructed features and boundaries on
the earth. This information may be derived from, among other things,
remote sensing, mapping, and surveying technologies. 9 Radiology
interpretation systems are those technologies that could be used to
automate the interpretation of radiological images. Natural language
processing is the process of converting information expressed in spoken
and written human languages into computer
input via specialized software. Diagnostic and
Clinical Management
Appendix III: Categories of Information Technology for Bioterrorism-
Related Systems Page 46 GAO- 03- 139 Federal Bioterrorism IT DSS are those
designed to assist clinicians in developing a specific
diagnosis for a patient who has unusual signs and symptoms. For these
systems to be useful in the event of a covert bioterrorist attack, they
should prompt clinicians to consider the possibility of bioterrorism-
related
illness as a potential cause of the symptoms, thereby increasing the
probability that the clinician will perform appropriate diagnostic
testing. In addition, since many biothreat agents can cause pulmonary
disease, xrays or other radiological tests would be a common diagnostic
procedure performed on patients who might benefit from either the use of
radiology interpretation systems that can increase the diagnostic accuracy
of radiology reports, or the use of natural language processing techniques
to automate the identification of disease concepts in the free text found
in diagnostic reports.
Clinical management systems can also make recommendations to clinicians by
abstracting clinical information from electronic medical records, applying
a set of rules, and generating patient- specific management and prevention
recommendations. In general, these systems are limited to institutions
with electronic medical records and robust medical informatics programs.
There are no known systems specifically designed to provide
recommendations to clinicians or public health
officials for management of a bioterrorism event. Of the systems that are
known to exist, they provide recommendations at the point of care,
typically when the clinician enters the electronic medical record of the
patient in question.
These diagnostic and clinical management systems are similar in that they
both use clinical information about a patient, apply information from a
knowledge base, and generate a list of possible diagnoses or a list of
management recommendations. Based on this similarity, we have included
them in the same category of IT.
Of the federal agencies included in our review that utilize other
diagnostic and clinical management systems for their health care delivery
operations* DOD, VA, and HHS*s Indian Health Services* none has
implemented these particular applications as defined above. The purpose of
communications and reporting systems is to facilitate the
secure and timely delivery of information in the midst of a public health
emergency to the relevant responders and decision makers, so that
appropriate action can be undertaken. During a public health emergency,
clinicians must be able to communicate rapidly with their patients; public
Communications
Appendix III: Categories of Information Technology for Bioterrorism-
Related Systems Page 47 GAO- 03- 139 Federal Bioterrorism IT health
officials must be able to communicate with other local, state, and federal
officials, and laboratories must be able to communicate diagnostic
test results. Robust security measures that ensure patient confidentiality
and resist cyber attacks are also a necessary component of any
healthrelated communication system.
Our systems inventory contains 10 communications systems. While
communications within the public health community still depend largely on
telephone- and paper- based systems, they are moving to Web- based and
electronic data transmission. CDC is responsible for many of the
communications systems under development in HHS; however, some of the
systems are not yet fully implemented at the state or local levels, and
this could negatively affect communication of health information to the
public. As table 4 shows, all 10 of these systems are operational.
Table 4: Summary of Communications Systems by Agency Agency Number of
systems Targeted users Status Frequency of data exchange
Method of data capture and exchange
DOD 2 Navy and Marine medical officials Operational 1 * Monthly 1 * As
needed Electronic
HHS 5 Public health officials, epidemiologists, and veterinarians
Operational 2 * Continuous 1 * Every 10 minutes
2 * Daily Predominantly Web- based
USDA 3 USDA officials and state/ federal animal health agencies
Operational 3 * Continuous Web- based, paper,
and electronic Source: GAO. The Health Alert Network (HAN) is one example
of a nationwide
communications system that is currently being developed by CDC. HAN is to
serve as a platform for (1) distribution of health alerts, (2)
dissemination of prevention guidelines and other information, (3) distance
learning, (4) national disease surveillance, (5) electronic laboratory
reporting, and (6) communication of bioterrorism- related initiatives to
strengthen preparedness at the local and state levels. HAN is intended to
strengthen the capacity of state and local health departments by serving
as an early warning and response system for bioterrorism and other health
events. HAN provides the capacity to send urgent health alerts to local
agencies via broadcast technologies, such as fax services and autodialing.
HHS has awarded grants to all 50 states, 3 large cities, 3 counties, 8
territories, and the District of Columbia for HAN implementation. When
Appendix III: Categories of Information Technology for Bioterrorism-
Related Systems Page 48 GAO- 03- 139 Federal Bioterrorism IT completed,
HAN is to provide high- speed, secure Internet connections for
local health officials; on- line, Internet- and satellite- based distance
learning systems; and early warning broadcast alert systems. HAN currently
provides secure Internet access to two- thirds of the nation*s counties,
and at least 13 states have high- speed Internet access to all of their
counties. State and local governments may also use CDC funding to expand
HAN to community partners such as health organizations and
major hospital networks. In addition to enhancing state and local
communications, at the time of our review, CDC had provided grants to
three local centers for public health preparedness. The centers are
considered models of integrated communications and information systems
across multiple sectors, advanced operational readiness assessment, and
comprehensive training and evaluation. New York*s Monroe County Center
uses its own health alert network to link hospitals, insurers, and county
health care agencies to doctors, pharmacies, and clinics for emergency and
routine
communications. Monroe County also developed a unified platform for the
community to view and track the status of their emergency departments and
the number of available beds for a specialty unit within a hospital. In
addition to working on syndromic surveillance, Colorado*s Denver County
Center has developed a bi- directional alert communication and
notification system for its public health partners and has explored the
use
of redundant response system tools for rapidly notifying key local public
health partners in the event that traditional phone service is lost.
Supporting technologies are tools or systems that provide information for
the other categories of systems (e. g., detection, surveillance, etc.).
During our discussions with federal officials, we found that many projects
still in applied research and development are intended to support a
particular component associated with a type of system, such as detection
devices. These projects offer promising techniques that are not currently
in use.
For example, DOE*s national laboratories conduct research into new
detection and surveillance techniques that, when developed, may be fully
deployed into the public health infrastructure. DOE*s Los Alamos National
Laboratory (LANL) is conducting the Enabling Analytical and Modeling Tools
for Enhanced Disease Surveillance research project. Its objective is to
develop analytical tools to support public health officials in quickly
identifying emerging threats so they can respond accordingly. Subsets of
this research are incorporated into ongoing projects. The Forensics
Internet Research Exchange is another LANL research project that is
intended to connect a network of laboratories and government agencies
Supporting
Technology
Appendix III: Categories of Information Technology for Bioterrorism-
Related Systems Page 49 GAO- 03- 139 Federal Bioterrorism IT through a
secure virtual private network (VPN) so that they can share
genetic sequencing data for identifying strains of biological organisms.
In addition, the Defense Advanced Research Projects Agency*s Bio- ALIRT
program is a research project to further enable early detection of
biological events from artificial or natural causes. Its objective is to
scientifically determine which nontraditional data sources (e. g., human
behavior) are useful in enabling early detection of potential biological
attacks. More detailed descriptions of these projects are included in
appendixes IV through X. Simulation and computational modeling is another
important* and still developing* technology for supporting bioterrorism
preparedness and response. With the increase of computational power
available in today*s technology, and the increasing availability of data,
we may soon be able to predict the course of emerging infectious diseases.
LANL is piloting the Bioreactor Simulation Tools project, which models and
analyzes biological systems in order to create models for predicting the
spread of a biological agent. The DOD Chemical and Biological Defense
program*s Joint Effects Model incorporates simulation tools (used to
create a hazard prediction model) that are expected to predict
environmental effects. Another DOD project, the Joint Operational Effects
Federation, is leveraging existing simulation capabilities to support the
prediction of chemical and biological effects at various levels of
operation. DOD*s simulation tools were developed for military purposes.
Our inventory includes 18 systems that are identified as supporting
technologies. Twelve of these systems are operational, 3 are in
development and 3 are being evaluated as pilots.
Appendix III: Categories of Information Technology for Bioterrorism-
Related Systems Page 50 GAO- 03- 139 Federal Bioterrorism IT Table 5:
Summary of Supporting Technologies by Agency
Agency Number of systems Status
USDA 1 Operational DOD 1 In development DOE 6
1 * Operational 2 * In development 3 * Pilot
HHS 5 Operational EPA 5 Operational Source: GAO. While they are not
included within the scope of our systems inventory,
there are other systems that will facilitate health care delivery during
an act of bioterrorism or other public health emergency. These systems*
such as electronic medical records* were excluded from the scope of this
review because they are neither public health systems nor were they
primarily developed for biodefense. Both DOD and VA have electronic
medical information systems (i. e., Composite Health Care System and
Veterans Health Information Systems and Technology Architecture), which
enhance their ability to automate the collection of surveillance data for
systems such as ESSENCE. Automated medical information systems can play an
important role for clinicians during their response to a medical
emergency, in documenting the treatment of illness and its outcome, and in
collecting and sharing diagnostic test results. Electronic medical records
can play a role during routine surveillance by serving as important data
sources for public health surveillance. The use of electronic medical
records could reduce the burdensome and costly use of paper- based
processes, facilitating rapid access to data critical for near real- time
public health surveillance. Other Clinical Systems
Appendix IV: Department of Agriculture*s Systems Inventory
Page 51 GAO- 03- 139 Federal Bioterrorism IT USDA became involved in
activities concerning bioterrorism because of the increasing realization
that the food supply may become a vehicle for a
biological attack against the civilian population. Biological attacks on
the health of animals and plants are also important to recognize because
there are a number of diseases and toxins harmful to humans that can be
spread by animals and plants. USDA*s Homeland Security staff within the
Office of the Secretary is responsible for coordinating activities on
terrorism across USDA. In addition, three of USDA*s services have been
involved in bioterrorism research and preparedness: 1 Agricultural
Research Service (ARS),
Animal and Plant Health Inspection Service (APHIS), and Food Safety
Inspection Service (FSIS). ARS has conducted research to improve onsite
rapid detection of biological agents in animals, plants, and food and has
improved its detection capacity for diseases and toxins that could affect
animals and humans. APHIS has a role in responding to biological agents
that are zoonotic (i. e., capable of affecting both animals and humans).
APHIS has veterinary epidemiologists to trace the source of animal
exposures to diseases. FSIS provides emergency preparedness for foodborne
incidents, including bioterrorism.
USDA identified 10 information systems and supporting technologies. 1
Portions of ARS and APHIS are now part of DHS. Appendix IV: Department of
Agriculture*s
Systems Inventory
Appendix IV: Department of Agriculture*s Systems Inventory
Page 52 GAO- 03- 139 Federal Bioterrorism IT Department of Agriculture
Animal and Plant Health Inspection Service
Emergency Response Management System (EMRS) Type of system:
Surveillance EMRS is used to manage and investigate outbreaks of animal
diseases in the United States. This Web- based task management system was
designed to automate many of the tasks that are routinely associated with
disease outbreaks and animal emergencies. EMRS is used for routine
reporting of foreign investigations of animal disease, state- specific
disease outbreaks or control programs, classic national responses, or
natural disasters involving animals. EMRS also has a mapping feature,
which allows for real- time identification of outbreaks to enable
responders to respond more quickly by providing high- resolution maps to
decision makers,
government agencies, and the public. The system interfaces with state and
federal diagnostic laboratories for reporting test results. External
collaborating partner: None System is operational Used primarily by state
and federal animal health agencies
FY 2002 IT cost:
$565,000 Est. FY 2003 IT cost:
$615,000
Future plans: Integrate with U. S. Forest Service*s ROSS system.
Generic Disease Data Base (GDB) Type of system: Surveillance GDB monitors
progress in disease control programs, such as the brucellosis and
tuberculosis programs. GDB is a core national database for animal health
information. Each state has its own local GDB that is limited to its own
data, unless it has obtained permission from other states to access their
GDB data. There is also a national GDB at Ft. Collins, CO, which is used
for the National Scrapie program. GDB is used for both domestic disease
control programs and foreign animal disease investigations.
External collaborating partner: None
System is operational Used primarily by state and federal animal health
agencies
FY 2002 IT cost: $550,000
Est. FY 2003 IT cost: $700,000
Future plans: Improvements to make GDB more user- friendly to better serve
APHIS*s needs.
Appendix IV: Department of Agriculture*s Systems Inventory
Page 53 GAO- 03- 139 Federal Bioterrorism IT Food Safety Inspection
Service Automated Import Information System (AIIS) Type of system:
Supporting technology AIIS assigns reinspection tasks to import inspectors
who are stationed at ports of entry. Reinspection of imported goods is
based upon foreign product, plant, and country compliance histories.
Restrictions on imported products ensure that various species and products
do not enter the United States food supply.
External collaborating partner: None System is operational Used primarily
by
import inspectors at ports of entry and circuit supervisors
FY 2002 IT cost:
Not available
Est. FY 2003 IT cost:
Not available
Future plans: Subsequent enhancements to AIIS will include an Intranet
application for reports and systems administration, a replicated database
view to support future reporting requirements, and incorporation of
additional business requirements when they are defined. USDA should
complete these enhancements by the end of fiscal year 2003. Consumer
Complaint Monitoring System (CCMS) Type of system:
Surveillance CCMS is a database used to record, evaluate, and track all
consumer complaints reported to the agency. This includes consumer
complaints reported by a state or local health departments or other
federal agencies. It also includes complaints that involve imported
products recalled from the market. Several program areas have access to
CCMS and are responsible for entering any
consumer complaints that they receive into the system, including those
from district offices and compliance officers, as well as the Food Safety
Education and Communication staff.
External collaborating partner: None System is operational Used primarily
by USDA
officials FY 2002 IT cost:
Not available Est. FY 2003 IT cost:
Not available
Future plans: Enhancing CCMS so that it will be able to exchange
electronic data with state and local public health agencies in a secure
manner using the Internet. This enhancement is expected to decrease the
amount of time it takes to identify and respond to possible bioterrorism
attacks and to other foodborne outbreaks. Syndromic surveillance
capability will be programmed into CCMS for common foodborne illnesses and
for possible bioterrorism attacks. Fast Antimicrobial Screen Test (FAST)
Type of system: Surveillance
FAST stores information on tested samples and provides information on
antimicrobial residues in animal tissues. Test results are used for risk
assessment and decision support purposes, early detection of problem
products, active food safety surveillance, and evaluation of potential
threats to the American food supply.
External collaborating partner: None
System is operational Used primarily by USDA officials FY 2002 IT cost:
Not Available Est. FY 2003 IT cost: Not available
Future plans: FAST will be replaced by the implementation of eSample, a
system for direct data entry by inspection personnel, and by a corporate
database system.
Appendix IV: Department of Agriculture*s Systems Inventory
Page 54 GAO- 03- 139 Federal Bioterrorism IT Meat and Poultry Hotline
(HOTLINE) Type of system: Communications The purpose of the HOTLINE
database is to collect, store, and report data on consumer food safety
information requests and
complaints. Information for the system is obtained from the consumer via
telephone. Administrators of the Consumer Complaint Monitoring System
periodically poll the HOTLINE database and extract data about issues of
concern.
External collaborating partner: None
System is operational Used primarily by meat and poultry hotline technical
information specialists
FY 2002 IT cost:
Not available Est. FY 2003 IT cost: Not available
Future plans: The possible integration of a call distribution system with
the database. The upgrade could take 5 to 10 years. Laboratory Electronic
Application for Results Notification (LEARN) Type of system:
Communications LEARN transmits laboratory test results that detect the
presence of pathogens and residues of drugs, pesticides, and other
chemicals on specimens taken from meat, poultry, and egg products. The
system facilitates and expedites the reporting of food product
contamination to agency personnel and the industry, reducing the chances
of public consumption. Products are randomly sampled or collected based
upon suspected health hazards, and results are reported through the LEARN
system.
External collaborating partner: None
System is operational Used primarily by USDA officials FY 2002 IT cost:
Not available Est. FY 2003 IT cost: $92,185
Future plans: Continued enhancements to the existing application to
improve user- friendliness and to add information and reports that are not
currently included in the application. Plans also include integration of
the system with a new laboratory information system and a new headquarters
sample information system. Microbiological and Residue Computer
Information System (MARCIS) Type of system: Surveillance
MARCIS contains sample identification information and results for analyses
submitted by inspection personnel to laboratories. These samples consist
of meat, poultry, and egg products; and they are analyzed to ensure that
they are safe, wholesome, unadulterated, and properly labeled. The samples
are tested because they bear or contain residues of drugs, pesticides,
other chemicals, and microbiological pathogens. Test results are used to
alert agency personnel and the industry of contaminations and threats to
consumer health and the need for protective actions such as product
recalls. MARCIS is also used for risk assessment and decision support
purposes, improving early detection of problem products, enabling active
food safety surveillance, and
evaluating potential threats to the food supply. External collaborating
partner: None
System is operational Used primarily by USDA, FDA, and EPA officials
FY 2002 IT cost:
Not available
Est. FY 2003 IT cost: Not available
Future plans: Replacement of MARCIS with the Laboratory Information
Management System. This replacement system will serve an analytical
purpose and will populate a corporate sampling database with laboratory
information.
Appendix IV: Department of Agriculture*s Systems Inventory
Page 55 GAO- 03- 139 Federal Bioterrorism IT Pathogen Reduction
Enforcement Program (PREP) Type of system: Communications PREP schedules
tests, tracks samples, and generates a series of reports concerning
testing eligibility and the status of test results.
It collects and stores establishment address and product information as
well as establishment food safety performance. It uses the information for
scheduling and requesting the collection of food samples for
microbiological pathogen testing. Test results are used to alert agency
personnel and the industry of contaminations and threats to consumer
health and the need for protective actions, such as product recalls. PREP
is also used for risk assessment and decision support purposes, improving
early detection of problem products, enabling active food safety
surveillance, and evaluating potential threats to the American food
supply.
External collaborating partner: None
System is operational Used primarily by USDA officials FY 2002 IT cost:
Not Available Est. FY 2003 IT cost: Not available
Future plans: Complete testing of new modules (e. g., eggs, retail, and
special surveys). National Animal Health Laboratory Network (NAHLN) Type
of system:
Surveillance NAHLN is to link federal and state diagnostic labs for the
reporting of cases with certain clinical signs or definite diagnosis. The
types of case reported will be coordinated with CDC and include the use of
data messaging and transfer standards.
External collaborating partner: HHS/ CDC
System is in planning To be used primarily by diagnostic laboratories, and
CDC and USDA officials
FY 2002 IT cost:
$0 Est. FY 2003 IT cost: $250,000
Future plans: Continue development of the database for 13 laboratories in
fiscal year 2003, then further development for other diagnostic
laboratories in fiscal years 2004 and 2005.
Source: GAO analysis of USDA data.
Appendix V: Department of Defense*s Systems Inventory Page 56 GAO- 03- 139
Federal Bioterrorism IT Although DOD is primarily responsible for service
members in the battlefield, the department often shares its research with
other agencies to
benefit the civilian population. DOD*s Defense Advanced Research Projects
Agency has been the central research and development organization for DOD,
managing and directing basic and applied research and development projects
for the department. In addition, the United States Army Medical Research
Institute of Infectious Diseases (USAMRIID) conducts biological research
dealing with militarily relevant infectious diseases and biological
agents. USAMRIID provides professional
expertise on issues related to technologies and other tools to support
readiness for a bioterrorist incident, and also confirms diagnostic
laboratory results for CDC*s Laboratory Response Network. Some of DOD*s
systems, particularly those developed by the Joint Program Office, are
shared between the services.
DOD identified 14 information systems and supporting technologies.
Department of Defense Air Force Global Expeditionary Medical System (GEMS)
Type of system: Surveillance GEMS provides an integrated biohazard
surveillance system that is capable of maintaining a global watch over Air
Force personnel.
It incorporates an electronic medical record as a basis for real- time
data analysis. GEMS establishes records of medical encounters and rapid
identification and notification of clinical events, and it integrates the
symptom level surveillance that is critical for early detection of disease
outbreaks and illnesses. With ongoing site and regional data review,
population- specific analysis picks up disease trends to provide early
warning of disease outbreaks or biological attacks. GEMS serves as the
foundation for an Air Forcewide, integrated medical surveillance and
command and control network. GEMS has four modules: patient encounter,
theater occupational, public health deployed, and theater epidemiology.
External collaborating partner: None
System is operational Used primarily by military health care providers,
public health, and command and control
FY 2002 IT cost:
$500,000 Est. FY 2003 IT cost: Not available
Future plans: Complete infrastructure development.
Appendix V: Department of Defense*s Systems Inventory
Appendix V: Department of Defense*s Systems Inventory Page 57 GAO- 03- 139
Federal Bioterrorism IT Lightweight Epidemiology Advanced, Detection and
Emergency Response System (LEADERS) Type of system: Surveillance LEADERS
is expected to improve the ability to identify and confirm covert
biological warfare incidents or significant natural disease
outbreaks. LEADERS is to be a comprehensive system that supports joint
military and civilian medical surveillance initiatives.
External collaborating partner: None
System is in development
Used primarily by military health care providers, public health, and
command and control
FY 2002 IT cost:
Not available
Est. FY 2003 IT cost: $3,000,000
Future plans: To complete infrastructure development and to attain funding
for clinical interface. The next phase will focus on development of
medical surveillance algorithms for specified diseases representing the
most serious bioterrorism threats. Army
Airbase/ Port Detector System (Portal Shield) Type of system: Detection
The Portal Shield sensor system was developed to provide early and
definitive warning of biological threats for high- value, fixed- site
assets, such as air bases and port facilities. Portal Shield can detect
and identify up to eight biological warfare agents simultaneously, within
25 minutes. Portal Shield uses a "smart logic" algorithm to help reduce
false positives and consumables. The
network can operate in a surveillance mode as well as a random or manual
sample mode. In addition to the biological detection hardware, each sensor
is equipped with its own meteorological station and global positioning
system.
External collaborating partner: None
System is operational Used primarily by military personnel at fixed asset
sites (e. g., air bases and port facilities)
FY 2002 IT cost:
$150,000
Est. FY 2003 IT cost: $0
Future plans: Not available. Biological Integrated Detection System (BIDS)
Type of system: Detection BIDS provides early warning and identification
capability in response to a large area biological warfare attack. It is a
detection suite in a shelter that is mounted on a dedicated vehicle with
an independent power supply. Other BIDS elements include collective
protection, environmental control, and storage for supplies such as a
global positioning system and radios. BIDS was designed to utilize
multiple biological detection technologies in a layered, complementary
manner to maximize detection and presumptive identification capabilities.
BIDS is used for warning and for confirming that a biological attack has
occurred. It provides presumptive identification of the biological agent
being used and produces a sample for laboratory analysis.
External collaborating partner: None
System is operational Used primarily by Army reserve and active chemical
companies
FY 2002 IT cost:
$425,000
Est. FY 2003 IT cost: $0
Future plans: Replacement by JBPDS in fiscal year 2004 and full automation
of real- time detection and identification of the full range of biological
agents.
Appendix V: Department of Defense*s Systems Inventory Page 58 GAO- 03- 139
Federal Bioterrorism IT Early Warning Outbreak and Response System (EWORS)
Type of system: Surveillance EWORS aids in the collection of standardized
medical data, particularly for making area- specific and regional
comparisons for trend
analysis of the data in order to target early warning outbreak recognition
of infectious diseases. EWORS provides for timely and accurate
dissemination of outbreak information, leading to effective intervention
measures, including investigative and containment activities. It
establishes baseline measures for trend analysis that is used to
differentiate outbreak from non- outbreak disease occurrence; employs a
syndromic approach in contrast to disease- specific reporting
classifications; and disseminates real- time information and key- function
data analysis for instant and programmed interpretation. EWORS integrates
public health and hospital networks and was designed as a complementary
system for conventional surveillance methodologies.
External collaborating partner: Indonesia*s Ministry of Health
System is operational Used primarily by national outbreak response
agencies
FY 2002 IT cost:
$200,000 Est. FY 2003 IT cost: $300,000
Future plans: Establishment of the system in the Americas and continued
expansion in Southeast Asia. Electronic Surveillance System for the Early
Notification of Communitybased Epidemics (ESSENCE) Type of system:
Surveillance ESSENCE is used in the early detection of infectious disease
outbreaks and it provides epidemiological tools for improved
investigation. It collects ambulatory data from hospitals and clinics in a
central database on a daily basis. Epidemiologists can track* in near
real- time* the syndromes being reported in a region through a daily feed
of reported data. ESSENCE uses the daily data downloads, along with
traditional epidemiological analyses that using historical data for
baseline comparisons and more cutting edge analytic methods such as
geographic information system. Analysts have implemented an alerting
algorithm methodology to detect localized outbreaks and purely temporal
methods for low- level, scattered threats. DOD public health professionals
use information from ESSENCE to make crucial decisions about potential
health emergencies, based on verified and current data.
External collaborating partner: None
System is operational Used primarily by military health officials FY 2002
IT cost:
$400,000
Est. FY 2003 IT cost: $500,000
Future plans: To improve the interface and find, analyze, and add new data
sources. ESSENCE is being upgraded to incorporate the use of
nontraditional civilian data sources; it is currently operational in the
greater Washington, D. C. area. This expanded capability integrates both
military and civilian health data with daily records of pharmacy sales,
school absenteeism, and other sources, to allow for early warning of
emerging infections. Embedded Common Technical Architecture (ECTA) Type of
system: Supporting technology
ECTA will provide military personnel with sensor connectivity, analysis,
and warning and reporting capability for Joint Service combat platforms,
command and control centers, and fixed sites.
External collaborating partner: None
System is in development Used primarily by defense
nuclear, biological, and chemical specialists
FY 2002 IT cost:
Not available Est. FY 2003 IT cost: Not available
Future plans: ECTA will merge the current capabilities of the Multipurpose
Integrated Chemical Agent Alarm and the JWARN system and provide
additional data processing, production of reports, and access to specific
data to improve the efficiency of limited personnel assets. It will
consist of the hardware and software required to provide sensor
connectivity and analysis between detectors and service- specific systems.
The JWARN- ECTA will transfer data automatically from and to the actual
detector and will provide commanders, units, and systems with analyzed
data for disseminating warnings down to the lowest level of the
battlefield.
Appendix V: Department of Defense*s Systems Inventory Page 59 GAO- 03- 139
Federal Bioterrorism IT Joint Biological Point Detection System (JBPDS)
Type of system: Detection JBPDS detects, identifies, samples, collects,
and communicates the presence of biological warfare agents in order to
enhance the
survivability of U. S. forces. It consists of complementary trigger,
sampler, detector and identification technologies that allow it to rapidly
and automatically detect and identify biological threat agents. Its suite
of tools will be capable of identifying biological warfare agents in less
than 15 minutes. JBPDS is in low- rate initial production and limited
procurement through fiscal year 2006.
External collaborating partner: None
System is operational Used by military health officials and other service
personnel
FY 2002 IT cost:
$489,000 Est. FY 2003 IT cost: $560,000
Future plans: JBPDS is scheduled to begin full production in fiscal year
2007. The next stage will focus on reducing size, weight, and power
consumption while increasing system reliability. JBPDS will also identify
up to 26 agents simultaneously and will interface with JWARN. Joint
Warning and Reporting Network (JWARN) Type of system: Detection/
Communication
JWARN employs warning technology to collect, analyze, identify, locate,
report, and disseminate information related to threats and potentially
contaminated areas. It gathers information from detectors and uses this
information to compute toxic corridors and attacks and to display near
real- time results to onsite commanders. JWARN will be employed in making
decisions about warning dissemination down to the lowest level on the
battlefield and linked to a global command and control system. External
collaborating
partner: Military forces System is being piloted Used primarily by
defense specialists and other designated personnel located at
command and control centers
FY 2002 IT cost:
Not available
Est. FY 2003 IT cost: Not available
Future plans: Fielding of JWARN will begin in fiscal year 2004. Plans
include using the full JWARN capability to provide commanders with
automatic data from sensors and detectors. Navy
Epidemiological Interactive System (EPISYS) Type of system:
Surveillance EPISYS is a program that enables rapid assessment of disease
trends in order to focus research efforts of epidemiologists. It was
developed to integrate Navy inpatient hospitalization data with career
history and demographic data to form a single system with a flexible
interface. It is capable of detecting and flagging diagnostic categories
that show rates in excess of their historical threshold values. This
surveillance capability allows for the early detection of increased
illness rates so that intervention can be started early. Using EPISYS,
users can rapidly answer basic epidemiological questions regarding disease
and injury rates.
External collaborating partner: None
System is operational Used primarily by Navy health researchers FY 2002 IT
cost:
Not available
Est. FY 2003 IT cost: Not available
Future plans: Not available.
Appendix V: Department of Defense*s Systems Inventory Page 60 GAO- 03- 139
Federal Bioterrorism IT Epidemiology Wizard (EPIWIZ) Type of system:
Communications EPIWIZ is a research tool that was developed to organize
SAMS data for further analysis of shipboard illness and injury data.
EPIWIZ is expected to enhance the Navy's medical readiness by converting
SAMS medical encounter data into surveillance information. It will provide
Navy medical personnel easy access to shipboard sick- call information so
they can monitor trends, prevent injuries and diseases, facilitate
reporting, and enhance medical outcomes. EPIWIZ allows the user to display
SAMS medical encounter data in a spreadsheet format to facilitate data
analysis. This improved data analysis results in closing the gap between
medical occurrence and preventative intervention.
External collaborating partner: None System is operational Used primarily
by Navy
health researchers FY 2002 IT cost:
Not available Est. FY 2003 IT cost:
Not available Future plans: Not available. Field Medical Surveillance
System (FMSS) Type of system:
Surveillance FMSS is designed to help detect emerging health problems that
might occur during foreign deployments or conflicts. FMSS can help field
staff to determine incidence rates; project short- term trends; profile
the characteristics of the affected population by person, time, and place;
track the mode of disease transmission; and generate various graphs and
reports. Once data are entered for a patient, the input is processed, and
compatible diagnoses are presented in order of probability, with
biological weapons agents highlighted. FMSS also provides on- line access
to medical reference data and an interface to the GIDEON database* a well-
known knowledge database designed to help diagnose most of the world's
infectious diseases based on the patient*s signs, symptoms, and
laboratory findings. Many FMSS features have now transitioned over to the
Navy*s Medical Data Surveillance System and to other development projects.
External collaborating partner: None System is
operational Used primarily by military
health officials FY 2002 IT cost:
Not available
Est. FY 2003 IT cost:
Not available
Future plans: Not available. Medical Data Surveillance System (MDSS) Type
of system: Surveillance MDSS is an interactive Web application for
collecting data and identifying changes in rates of naturally occurring
injuries and illnesses found within routinely collected clinical data on
active duty personnel. It compiles routine reports on disease and non-
battle injury rates and generates special reports to assist medical staff
to investigate the onset of disease and to evaluate the effectiveness of
preventive measures. By applying advanced analytic techniques, MDSS can
detect shifts in disease trends and outbreaks with minimal historical
information on illness patterns characteristic of the area of interest,
thereby making it particularly suitable for theater operations. These
techniques also facilitate ad hoc analysis. MDSS is being configured to
meet certification requirements so it can be deployed aboard Navy ships.
MDSS is being pilot tested in the 18 th Medical Command in Korea and in
Navy hospitals is Yokosuka, Japan and San Diego, California. External
collaborating
partner: None System is being piloted Used primarily by
military health officials FY 2002 IT cost:
$750,000 Est. FY 2003 IT cost: $1,200,000
Future plans: Continued research and development at an advanced research
level and testing in a deployed environment at fixed facilities and
operational units.
Appendix V: Department of Defense*s Systems Inventory Page 61 GAO- 03- 139
Federal Bioterrorism IT Navy Disease Reporting System (NDRS) Type of
system: Communications NDRS provides for expedient and efficient
submissions of reportable events. It may also be used to track and report
disease and
non- battle injuries. Its main purpose is to improve the compliance,
timeliness, and reliability of disease reporting. Functions have been
included to assist local command with state reporting, prevention
programs, and contract tracing. NDRS enables users to determine what
diseases are present in a particular country, how many outbreaks have
occurred, and what treatments were used. NDRS streamlines reporting and
provides ready access to epidemiological data. NDRS data are used to
conduct trend analysis and to pool findings with data from other services.
External collaborating
partner: None System is operational Used primarily by Navy
health officials FY 2002 IT cost:
$500,000 Est. FY 2003 IT cost: $500,000
Future plans: Integration into the Navy*s database for tracking medical
encounters, known as the Shipboard Non- Tactical Automated Data Processing
Automated Medical System (SAMS). Source: GAO analysis of DOD data
Appendix VI: Department of Energy*s Systems Inventory
Page 62 GAO- 03- 139 Federal Bioterrorism IT DOE is developing new
capabilities to counter chemical and biological threats. DOE expects the
results of its research to be public and possibly
lead to the development of commercial products in the domestic market.
DOE*s Chemical and Biological National Security Program has conducted
research on biological detection, modeling and prediction, and biological
foundations to support efforts in advanced detection, attribution, and
medical countermeasures. Several of DOE*s national research laboratories
(e. g., Lawrence Livermore, Los Alamos, Oak Ridge, and Sandia) have
conducted biological and environmental research related to bioterrorism
preparedness and response.
DOE identified 14 information systems and supporting technologies.
Department of Energy Lawrence Livermore National Laboratory (LLNL)
Autonomous Pathogen Detection System (APDS) Type of system: Detection
APDS is an automated, podium- sized system that monitors the air for all
three biological threat agents (bacteria, viruses, and toxins). The system
has been developed to protect people in critical or high- traffic
facilities and at special events. The system performs continuous aerosol
collection, sample preparation, and multiplexed biological tests using
advanced immunoassays to detect bacteria, viruses, and toxins. More than
ten agents are assayed at once. Current research and development work is
incorporating polymerase chain- reaction (PCR) techniques for detecting
DNA. Single units can be operated to monitor a local space or a central
conduit like an air- supply duct. In a more powerful application, a
network of APDS units can be integrated with central command and control
to protect larger areas. The APDS units can also be networked and
integrated with other sensing and analysis systems to provide multifaceted
detection and response capabilities.
External collaborating partner: None
System is in development
Used primarily for special events of high value and potential fixed
targets
FY 2002 IT cost:
Not available
Est. FY 2003 IT cost: Not available
Future plans: APDS will move into redesign and piloting in fiscal year
2004. There will be a significant effort in communications and IT for
networked instruments in field- testing and beyond. Appendix VI:
Department of Energy*s Systems Inventory
Appendix VI: Department of Energy*s Systems Inventory
Page 63 GAO- 03- 139 Federal Bioterrorism IT Biological Aerosol Sentry and
Information System (BASIS) Type of system: Detection BASIS is a large-
area aerosol pathogen detection system. BASIS will provide early detection
of biological incidents for special events, such as large assemblies and
major sporting events. Planned for civilian use, it will detect a
biological incident within a few
hours of attack, early enough to allow public health officials to mount an
effective medical response. BASIS was developed in close cooperation with
federal, state, and local public health agencies to ensure support for
real world operational needs. This system was adapted to process samples
from the BioWatch a program, beginning in February 2003. External
collaborating
partner: None System is operational Used primarily for
special events of high value and potential fixed targets
FY 2002 IT cost:
$800,000 Est. FY 2003 IT cost: $350,000
Future plans: BASIS funding ended in fiscal year 2002. The fate of BASIS
for fiscal year 2003 was unknown. Given the likelihood of additional armed
conflicts, LLNL anticipates seeing BASIS simultaneously deployed at
multiple sites, such as cities. Computational Design of Pathogen Detection
Assays (KPATH) Type of system: Supporting technology
KPATH is an automated system that analyzes pathogen DNA signatures to
build and maintain unique polymerase chain reaction (PCR) detection
signatures. Signatures are requested by collaborators and are used in
BASIS. DNA signatures developed by KPATH are now in use in the BioWatch
program.
External collaborating partner: HHS/ CDC and FDA, USDA, and DOD/ USAMRIID
System is being piloted Used primarily by federal agencies (e. g., HHS,
USDA, and DOD)
FY 2002 IT cost:
$2,201,200 Est. FY 2003 IT cost: $1,000,000
Future plans: KPATH will be LLNL*s lead system for PCR diagnostic
signature design. LLNL will continue enhancements to KPATH*s DNA signature
capabilities and will work on its ability to computationally predict
protein signatures. a BioWatch is a multiagency program that involves air
filter sampling to detect agents in
certain cities. It is led by the Dept of Homeland Security and is
supported by DOE, EPA, and HHS.
Appendix VI: Department of Energy*s Systems Inventory
Page 64 GAO- 03- 139 Federal Bioterrorism IT Los Alamos National
Laboratory (LANL) Biological Aerosol Sentry and Information System (BASIS)
Type of system: Detection
See BASIS under Lawrence Livermore National Laboratory.
External collaborating partner: None
System is operational Used by cities and special events FY 2002 IT cost:
$3,000,000
Est. FY 2003 IT cost: $3,000,000
Future plans: See LLNL. Bioreactor Simulation Tools Type of system:
Supporting technology Bioreactor Simulation Tools model and analyze
biological systems (i. e., genetic networks, metabolic networks, and
signal transduction networks).
External collaborating partner: None
System is being piloted Used primarily by molecular biologists and
epidemiologists
FY 2002 IT cost:
$600,000 Est. FY 2003 IT cost: $600,000
Future plans: Development of a forward- looking capability to create
detailed models for fundamental processes in molecular biology. Bio-
Surveillance Analysis Feedback Evaluation and Response
(B- SAFER) Type of system:
Surveillance B- SAFER is a medical surveillance system using data from
emergency departments, clinical laboratories, and nontraditional sources
(e. g., RN hotline, drug information calls, ambulance services). B- SAFER
recognizes an anomaly, either naturally occurring or caused by human
intervention. B- SAFER is compliant with HIPAA and NEDSS.
External collaborating partner: DOD
System is in development Used primarily by the
state and local homeland security community
FY 2002 IT cost:
Not available Est. FY 2003 IT cost: Not available
Future plans: To project potential outcomes of an outbreak and the
potential benefit of intervention techniques.
Appendix VI: Department of Energy*s Systems Inventory
Page 65 GAO- 03- 139 Federal Bioterrorism IT Flow Cytometry Type of
system:
Supporting technology Flow cytometry is used in the detection and
identification of pathogens. It is a device comprised of lenses, lasers,
computers and other high- tech equipment. They allow researchers to
analyze, characterize, and sort thousands of biological cells, chromosomes
or molecules in minutes.
External collaborating partner: HHS/ NIH
System is being piloted Used primarily by public health officials, and
diagnostic and research laboratory personnel
FY 2002 IT cost:
$300,000
Est. FY 2003 IT cost: $100,000
Future plans: Database and data analysis tool development.
OpenEMed Type of system:
Supporting technology OpenEMed is a distributed, open architecture, open
source system that supports image, audio, and graphical data, creating a
virtual patient record. OpenEMed has been used with B- SAFER and New
Mexico*s NEDSS integrated data repository. OpenEMed includes standard
service components for person lookup and identity management, dictionary
queries, a clinical data repository, and HIPAA- compliant access control.
This software is available for use by the public.
External collaborating partner: HHS System is
operational Used primarily by public health officials and health
care providers FY 2002 IT cost:
$0
Est. FY 2003 IT cost: $0
Future plans: Not available. Reagentless Pathogen Biosensor Type of
system: Detection This project will develop a point sensor for the
detection of pathogens. This biosensor is being developed for the rapid
detection of disease markers to aid in early diagnosis and could also be
used for environmental and medical surveillance for homeland security.
External collaborating partner: HHS/ NIH, and World Health Organization
(WHO)
System is in development
Used primarily by medical personnel and first responders FY 2002 IT cost:
$2,000,000
Est. FY 2003 IT cost: $1,800,000
Future plans: This biosensor is being adapted for early diagnosis of
common infectious diseases including respiratory viruses and tuberculosis.
There is a proposal pending to adapt it to medical surveillance for the
Department of Homeland Security.
Appendix VI: Department of Energy*s Systems Inventory
Page 66 GAO- 03- 139 Federal Bioterrorism IT Oak Ridge National Laboratory
(ORNL) LandScan USA Type of system:
Supporting technology LandScan USA is expected to be a high- resolution
population distribution model that will provide timely and more spatially
precise population and demographic information to support geographic
analyses anywhere in the United States. In addition to its application for
emergency planning in case of an attack or natural disaster, it has
potential uses for socioenvironmental studies, including exposure and
health risk assessment, and urban sprawl estimates. It can support
improved development of emergency response plans in case of an attack or
natural disaster, homeland security, environmental justice analyses,
exposure/ risk assessment, and evaluation of risks. The data it provides
includes daytime and nighttime population distribution.
External collaborating partner: DOD, EPA, HHS
System is in development
Used primarily by incident commanders FY 2002 IT cost:
$600,000
Est. FY 2003 IT cost:
$1,500,000
Future plans: Not available. SensorNet Type of system: Detection SensorNet
is expected to be a comprehensive, national system for managing incidents
for real- time detection, identification, and assessment of chemical,
biological, radiological, and nuclear threats. It is intended to bring
together and coordinate all necessary knowledge and response assets
quickly and effectively. SensorNet is to consist of sensor technologies,
real- time threat assessment, nationwide coverage, and nationwide real-
time remote communications. SensorNet is currently under development as a
standardsbased architecture with encryption and access controls.
External collaborating partner: NOAA System is in
development Used primarily by first responders and personnel in
intelligence, regulatory agencies and transportation
FY 2002 IT cost:
$215,000 Est. FY 2003 IT cost: $230,000
Future plans: To continue operational prototypes and refine design for
nationwide system.
Sandia National Laboratory (SNL) Enabling Analytical and Modeling Tools
for Enhanced Disease Surveillance Type of system: Supporting technology
Enabling Analytical and Modeling Tools for Enhanced Disease Surveillance
are analytical tools to detect unusual events from a natural background.
These tools have been tested with influenza, respiratory illnesses, and
dengue fever and are expected to be incorporated into ongoing projects.
The flexibility of this project allows for tailoring to specific diseases.
External collaborating partner: None
System is in development Used primarily by public
health officials FY 2002 IT cost:
$440,000 Est. FY 2003 IT cost: $0
Future plans: Provide a distributed software framework for integrating
information from disparate sources; develop and integrate analytical tools
for earlier detection of disease outbreaks.
Appendix VI: Department of Energy*s Systems Inventory
Page 67 GAO- 03- 139 Federal Bioterrorism IT Intelligent Sensing Modules
(ISMs) Type of system: Detection ISMs are expected to be an intelligent
integration of detection systems supporting wireless ad hoc networking.
ISMs are intended to
be used in support of DOD*s BDI testbed, PROTECT, PROACT, and a project
for the Mint.
External collaborating partner: None
System is in development User information not
available FY 2002 IT cost:
$110,000 Est. FY 2003 IT cost: $210,000
Future plans: ISMs are currently under development; more capable
computational components are to be integrated when available. uChemLab/ CB
Type of system: Detection
uChemLab is a portable, hand- held chemical analysis system, which is
fully self- contained and incorporates "lab on a chip" technologies. It is
a sensitive device with fast response times in a low- power, compact
package used for monitoring facilities. While uChemLab is currently being
developed for chemical detection, it can also be used for biological agent
detection. Portable, standalone
devices for the analysis of chemical agents and protein biotoxins have
been developed and tested at the research prototype stage. Current
research is focused on improving the performance and expanding the
capability of these and other such devices.
External collaborating partner: DOD/ JSRG
System is being piloted Used primarily by first
responders FY 2002 IT cost:
$2,732,000
Est. FY 2003 IT cost: $3,100,000
Future plans: Analysis of additional agents.
Rapid Syndrome Validation Project (RSVP) Type of system:
Surveillance/ Communication RSVP is designed to facilitate rapid
communications. It provides early warning and response to emerging
biological threats, as well as to emerging epidemics and diseases, by
providing real- time clinical information about current symptoms, disease
prevalence, and geographic location. RSVP provides a mechanism to inform
health care providers about health alerts and to facilitate the process of
collecting data on reportable diseases. RSVP is designed to overcome
existing barriers to reporting suspicious or unusual symptoms in patients,
and to capture clinician judgment regarding the severity of an illness and
the likely category of the disease. RSVP fully supports on- line data
entry, reducing the paperwork associated with reporting infectious
diseases. RSVP immediately catalogs all reports in a summary, which is
instantaneously available to local public health officials and physicians.
External collaborating partner: None
System is operational Used primarily by
family practice doctors FY 2002 IT cost:
$403,000 Est. FY 2003 IT cost:
$560,000
Future plans: Development of neural networks and maps. Source: GAO
analysis of DOE data.
Appendix VII: Department of Health and Human Services* Systems Inventory
Page 68 GAO- 03- 139 Federal Bioterrorism IT Within HHS, six agencies work
on bioterrorism issues. Combined, these agencies have a budget of $3.6
billion for bioterrorism in fiscal year 2004. HHS*s Office of the
Assistant Secretary for Public Health and Emergency
Preparedness will have $42 million in fiscal year 2004 to direct and
coordinate the implementation of HHS*s bioterrorism programs and to
support the Department of Homeland Security by providing health and
medical leadership. CDC*s bioterrorism budget for fiscal year 2004 will be
$1.1 billion, $940 million of which will fund CDC*s ongoing state and
local preparedness program, which supports state surveillance and
epidemiology capacity, laboratory capacity, communication and IT
infrastructure, education and training, and health information
dissemination. In addition, CDC has its own office, the Office of
Terrorism Preparedness and Response, to coordinate efforts. CDC plans to
upgrade its own system and laboratory capacity and to expand oversight of
interlaboratory transfers of dangerous pathogens and toxins, laboratory
safety inspections, and anthrax research. The Health Resources Services
Administration also provides grants to hospitals for bioterrorism
preparedness and response.
The Agency for Healthcare Research and Quality funded research on the use
of information systems and decision support systems to enhance
preparedness for the delivery of medical care in the event of a
bioterrorist attack. FDA is increasing its food safety responsibilities by
improving its laboratory preparedness and food monitoring and inspections
in accordance with the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002. The National Institutes of Health
is planning to implement its strategic plan for biodefense research and
research agenda for CDC Category A, B, and C agents. HHS identified 28
information systems and supporting technologies. Appendix VII: Department
of Health and
Human Services* Systems Inventory
Appendix VII: Department of Health and Human Services* Systems Inventory
Page 69 GAO- 03- 139 Federal Bioterrorism IT Department of Health and
Human Services Centers for Disease Control and Prevention
122 Cities Mortality Reporting System Type of system: Surveillance As part
of CDC*s national influenza surveillance effort, CDC receives weekly
mortality reports from 122 cities and metropolitan areas in the United
States within 2- 3 weeks from the date of death. These reports summarize
the total number of deaths occurring in these cities/ areas each week due
to pneumonia and influenza. This system provides CDC with preliminary
information with which to evaluate the impact of influenza on mortality in
the United States and the severity of the currently circulating virus
strains. The advantage of this system is that it provides timely data 2- 3
years before finalized mortality data are available from CDC*s National
Center for Health Statistics. Deaths are reported to CDC by place of
occurrence, not by residence. This system is part of BioWatch. External
collaborating
partner: 122 Cities* Registrars
System is operational
Used primarily by epidemiologists FY 2002 IT cost:
$49,070
Est. FY 2003 IT cost: $61,202
Future plans: Not available. Active Bacterial Core Surveillance (ABCs)
Type of system: Surveillance As part of CDC*s Emerging Infections Program,
ABCs determines the incidence and epidemiological characteristics of
invasive bacterial disease due to pathogens of public health importance,
determines the molecular patterns and microbiological characteristics of
disease- causing elements, and provides an infrastructure for nested
special studies to identify risk factors and to evaluate prevention
policies. ABCs is a population- and laboratory- based surveillance system.
External collaborating partner: None
System is operational Used primarily by
epidemiologists FY 2002 IT cost:
$78,641 Est. FY 2003 IT cost: $87,372
Future plans: Measuring the impact of newly licensed vaccines on disease
and drug resistance and harnessing molecular techniques to characterize
bacteria. Bioterrorism Event Notification Type of system: Communications
The Bioterrorism Event Notification system tracks emergency- related phone
calls to CDC*s Emergency Preparedness and
Response Branch, which maintains the 24- by- 7 emergency contact numbers
for CDC. The system provides a data set that can be used to quantify the
number and types of incoming requests for emergency assistance.
External collaborating partner: None
System is operational Used primarily by CDC
officials FY 2002 IT cost:
Not available Est. FY 2003 IT cost: Not available
Future plans: Not available.
Appendix VII: Department of Health and Human Services* Systems Inventory
Page 70 GAO- 03- 139 Federal Bioterrorism IT Border Infectious Disease
Surveillance Project (BIDS) Type of system: Surveillance BIDS helps public
health officials to better understand and detect important infectious
diseases along the U. S.- Mexico border. The
system conducts active, sentinel surveillance for syndromes consistent
with hepatitis and febrile- rash illness at clinical facilities on both
sides of the border. As an infectious disease surveillance system
combining syndromal surveillance with appropriate laboratory diagnostic
testing, BIDS can directly enhance bioterrorism surveillance in this key
region. External
collaborating partner: Mexico Ministry of Health System is operational
Used primarily by state
and local public health epidemiologists at the U. S.- Mexico border
FY 2002 IT cost:
$30,000 Est. FY 2003 IT cost: $35,000
Future plans: Expansion of the number of sites and syndromes and complete
development of the next BIDS software version, involving Web- based data
entry, which will be consistent with the National Notifiable Disease
Surveillance System standards. CaliciNet Type of system: Surveillance
CaliciNet is used to assist public health officials to more quickly
identify contaminated food products associated with outbreaks by allowing
for the linking of epidemiological and laboratory information from
specimens that are collected as part of outbreak investigations for viral
gastroenteritis. While caliciviruses are not on the CDC list of
bioterrorism agents, they could be used in an attack.
External collaborating partner: None
System is operational Used primarily by state public health officials FY
2002 IT cost:
$57,783
Est. FY 2003 IT cost: $6,586
Future plans: CaliciNet will be replaced by a larger system, which is
still in the process of being named. DPDx Type of system: Supporting
technology DPDx uses the Internet to strengthen the level of laboratory
professionals* expertise in diagnosing foodborne and other parasitic
diseases. DPDx offers reference and training and diagnostic assistance.
Laboratory professionals can transmit images to CDC and obtain answers to
their inquiries in minutes to hours. This allows them to more efficiently
address difficult diagnostic cases in normal or outbreak situations and to
disseminate information more rapidly. In addition, this method
substantially increases the interaction between CDC and public health
laboratories. External
collaborating partner: None System is operational Used primarily by
pathologists, laboratory technicians, and other health care workers
FY 2002 IT cost:
$7,000
Est. FY 2003 IT cost: $7,000
Future plans: Training and continuing education of laboratory
professionals; provision to health facilities worldwide of diagnostic
assistance by CDC staff supported, when needed, by experts from other
institutions; diagnostic quizzes to assess the skills of laboratory
professionals; and informal, early detection of unusually clustered,
atypical, or emerging parasitic diseases. Plans also include ensuring
communication and functionality with all state public health departments.
Appendix VII: Department of Health and Human Services* Systems Inventory
Page 71 GAO- 03- 139 Federal Bioterrorism IT Early Aberration Reporting
System (EARS) Type of system: Communications EARS is a SAS- based, Web-
enabled reporting tool that allows the analysis of public health
surveillance data using aberration
detection methods. Its goal is to assist public health officials in the
early identification of disease outbreaks, as well as bioterrorism events.
It assesses whether the current number of reported cases of an event is
higher than usual. EARS provides results from its aberration detection
analysis, as well as quick data summaries and graphs.
External collaborating partner: None
System is operational Used primarily by public
health officials FY 2002 IT cost:
$88,000 Est. FY 2003 IT cost: $240,000
Future plans: Incorporating bioterrorism detection methods in future
versions. Plans also include the implementation of a GIS system that will
allow for maps of syndromic or disease events and the incorporation of
additional methodologies.
Electronic Foodborne Outbreak Reporting System (EFORS) Type of system:
Surveillance EFORS replaces the Foodborne Disease Outbreak Surveillance
System. EFORS enables a Web- based application for states to report
foodborne outbreaks electronically rather than on the former paper- based
system. Data are then used for annual summary reports and monitoring for
multi- state outbreaks.
External collaborating partner: None
System is operational Used primarily by state and county public health
officials
FY 2002 IT cost:
$156,157 Est. FY 2003 IT cost: $126,949
Future plans: Improving the database structure to allow immediate viewing
of reports as changes occur. EFORS intends to provide data for estimates
of the burden of foodborne illness by food commodity. Epidemic Information
Exchange (Epi- X) Type of system: Communications Epi- X connects state and
local public health officials so that they can share information about
outbreaks and other acute health
events, including those possibly related to bioterrorism. It is intended
to provide epidemiologists and others with a secure, Webbased platform
that can be used for instant emergency notification of outbreaks and
requests for CDC assistance. Epi- X provides tools for searching,
tracking, discussing, and reporting on diseases. EPI- X is being used in
DHS*s BioWatch program.
External collaborating partner: None
System is operational Used primarily by epidemiologists, veterinarians,
and other relevant health professionals
FY 2002 IT cost:
$1,354,828 Est. FY 2003 IT cost: $1,382,199
Future plans: Increasing its user base to ensure rapid, secure
communications at all levels of public health, such as linking to CDC*s
Emergency Operations Center and to state and local public health
departments. Plans also include linking with comparable state level
systems, providing secure communication for multistate outbreak response
teams, and automating the recognition of
disease outbreaks across jurisdictions.
Appendix VII: Department of Health and Human Services* Systems Inventory
Page 72 GAO- 03- 139 Federal Bioterrorism IT Federal Facilities
Information Management System (FFIMS) Type of system: Supporting
technology FFIMS aids in collecting, managing, and analyzing data that
originate outside the agency. Its primary use is as an investigative
system to aid in public health assessments at specific sites. It has been
most useful in the collection and analysis of voluminous environmental
sampling data. FFIMS can be used to investigate an anomaly after it has
been identified and to help determine the source of health outcomes or the
potential risk of adverse health outcomes.
External collaborating partner: None
System is operational Used primarily by CDC epidemiologists FY 2002 IT
cost:
$1,004,986
Est. FY 2003 IT cost: $1,129,483
Future plans: Addition of remote data collection and conversion to a Web-
based application.
Foodborne Disease Active Surveillance Network (FoodNet) Type of system:
Surveillance As part of CDC*s Emerging Infections Program, FoodNet
provides a network for responding to new and emerging foodborne diseases
of national importance, monitoring the burden of foodborne diseases, and
identifying the sources of specific foodborne diseases. It consists of
active surveillance and a related epidemiological study, which helps
public health officials better understand the epidemiology of foodborne
diseases in the United States.
External collaborating partner: USDA and HHS/ FDA
System is operational Used primarily by epidemiologists and public health
officials
FY 2002 IT cost:
$475,500
Est. FY 2003 IT cost: $515,900
Future plans: Estimate the burden of foodborne illnesses in the United
States, follow trends in the incidence of foodborne infectious disease,
and attribute foodborne infections to specific food vehicles. Geographic
Information Systems (GIS) Type of system: Supporting technology
GIS tracks the spread of environmental contamination through a community,
identifies geographic areas of particular health concern, and identifies
susceptible populations. Among other things, GIS can be used to help
identify spatial clustering of abnormal events as the data is collected.
This can assist under emergency conditions by identifying affected areas,
predicting dispersion of the agent, and sharing information with personnel
who are responsible for incident management.
External collaborating partner: None
System is operational Used primarily by CDC
officials FY 2002 IT cost:
$2,105,977
Est. FY 2003 IT cost: $2,091,737
Future plans: Expansion of GIS services (e. g., for field- based use),
integration with the Hazardous Substances Emergency Event System, and
possible integration with CDC's NEDSS.
Appendix VII: Department of Health and Human Services* Systems Inventory
Page 73 GAO- 03- 139 Federal Bioterrorism IT Global Emerging Infections
Sentinel Network (GeoSentinel) Type of system: Surveillance GeoSentinel is
a Web- and provider- based sentinel network. It consists of travel/
tropical medicine clinics around the world
participating in surveillance to monitor geographic and temporal trends in
morbidity among travelers and other globally mobile populations. Passive
surveillance and response capabilities are also extended to a broader
network of GeoSentinel Network members.
External collaborating partner: International Society of Travel Medicine
System is operational Used primarily by physicians in travel/ tropical
medicine clinics
FY 2002 IT cost:
$59,282 Est. FY 2003 IT cost: $10,000
Future plans: Increasing the number and geography of involved clinics,
expanding partnerships, and enhancing electronic infrastructure to include
simultaneous conferencing in real time with all global sites in
preparation for global disease outbreaks or bioterrorism threats.
Hazardous Substances Emergency Event System (HSEES) Type of system:
Surveillance
HSEES collects and analyzes information on events involving hazardous
substances as well as threatened releases that result in a public health
action. Information about the chemical, victims, and event is recorded by
state health departments and transmitted to CDC in near real time for
analysis and dissemination of reports. It can be easily enhanced to
collect biological agents in addition to chemical agents.
External collaborating partner: None
System is operational Used primarily by state public health officials FY
2002 IT cost:
$528,954 Est. FY 2003 IT cost: $580,866
Future plans: Inclusion of additional state health departments and
integration with GIS. Health Alert Network (HAN) Type of system:
Communications HAN is a nationwide system serving as a platform for the
distribution of health alerts, dissemination of prevention guidelines and
other information, distance learning, national disease surveillance, and
electronic laboratory reporting, as well as for CDC's bioterrorism and
related initiatives to strengthen preparedness at the local and state
levels. Among other things, HAN is to provide early warning alerts and to
ensure capacity to securely transmit surveillance, laboratory, and other
sensitive data.
External collaborating partner: Local, state, and territorial public
health agencies
System is operational Used primarily by state public health officials FY
2002 IT cost:
$624,000 Est. FY 2003 IT cost: $624,000 Future plans: Not available.
Appendix VII: Department of Health and Human Services* Systems Inventory
Page 74 GAO- 03- 139 Federal Bioterrorism IT Influenza Sentinel Provider
Surveillance System Type of system: Surveillance The Influenza Sentinel
Provider Surveillance System is one of four separate components that
allows CDC to, among other things,
detect changes in influenza and monitor influenza- like illness. It is
accessible through the Internet and provides data on the circulation and
impact of influenza year- round. It also provides information on new
influenza strains in circulation that can be used to determine the
components of the vaccine for the next influenza season and as a pandemic
warning. External collaborating
partner: None System is
operational Used primarily by CDC
officials, physicians, state public health officials and WHO
FY 2002 IT cost:
$52,623
Est. FY 2003 IT cost: $54,063
Future plans: Not available. Laboratory Information Tracking System (LITS
Plus*) Type of system: Supporting technology LITS Plus* is a laboratory
data management system, which is used to enter, edit, analyze, and report
laboratory test results electronically. Users can examine all the data
about a specimen, including data from all laboratories that performed
tests on the specimen. It provides seamless integration of laboratory
data, including laboratory instrument data and incorporates extensive
laboratory data management functionality.
External collaborating partner: DOD and Global AIDS Program (Africa)
System is operational Used primarily by public health, CDC, DOD, and
Global AIDS officials
FY 2002 IT cost:
$1,769,098 Est. FY 2003 IT cost: $1,831,522
Future plans: Develop and implement standardized modules in LITS Plus* for
all CDC Category A bioterrorism labs and to comply with CDC*s Public
Health Information Network.
Laboratory Response Network (LRN) Type of system: Communications LRN is an
integrated network of public health and clinical laboratories that provide
laboratory diagnostics and disseminated testing capacity for public health
preparedness and response. It ensures that all member laboratories
collectively maintain state- of- the- art biodetection and diagnostic
capabilities as well as surge capacity for all biological and chemical
agents likely to be used by terrorists. LRN is based on the use of
standard protocols and reagents, integrated data management, and secure
communications.
External collaborating partner: DOD, FDA, FBI, and Association of Public
Health Labs
System is operational Used primarily by state and local public health
officials
FY 2002 IT cost:
$385,000
Est. FY 2003 IT cost: $502,500
Future plans: Update and revise laboratory protocols for biological and
chemical agents on the LRN Web site; develop new screening assays for
biological agents and obtain FDA approval for in vitro diagnostic use of
new rapid screening assays; link to NEDSS; expand domestic partnership;
and upgrade restricted Web site for interoperability and data exchange
with key clinical entities.
Appendix VII: Department of Health and Human Services* Systems Inventory
Page 75 GAO- 03- 139 Federal Bioterrorism IT National Botulism
Surveillance Type of system: Surveillance The National Botulism
Surveillance system compiles information on cases of foodborne and wound
botulism. CDC provides clinical, epidemiological, and laboratory
consultation for suspected botulism cases 24 hours a day and is the only
source for antitoxin in the
United States. Also, CDC conducts a yearly survey of state and territorial
epidemiologists and of state public health laboratory directors to
identify additional cases that have not been previously reported.
External collaborating partner: None
System is operational Used primarily by clinicians, laboratory
professionals, and epidemiologists FY 2002 IT cost:
$2,000 Est. FY 2003 IT cost: $2,000
Future plans: Use electronic near real- time reporting of botulism testing
results, which will be integrated with reports of clinical consultations
and antitoxin releases for suspect cases and for rapid case updates.
National Electronic Disease Surveillance System (NEDSS) Base System Type
of system: Surveillance The NEDSS base system is a component of CDC's
overall NEDSS initiative. It will provide a NEDSS architecture- compliant
option for states to use as a platform for disease surveillance. The NEDSS
base system is a CDC- developed system that provides a platform upon which
many public health surveillance systems, processes, and data can be
integrated in a secure environment. It will provide the foundation for
state and program area needs, data collection, and processing, including
the development of modules
that can be used for data entry and for management of core demographic and
notifiable disease data via a Web browser. The first release supports the
electronic processes involved in notifiable disease surveillance and
analysis, replacing the functionality currently supported by the NETSS
system. States also have the option to develop systems or elements on
their own through the
use of grants provided for this purpose rather than using the NEDSS base
system.
External collaborating partner: State, local, and territorial public
health agencies, and various public health- related professional
associations a System is currently
being piloted Used primarily by state
and local public health officials and CDC officials
FY 2002 IT cost:
Not available
Est. FY 2003 IT cost: $27,609,000
Future plans: Additional functionality to support other programs, such as
chronic disease and environmental health programs, for use by
epidemiologists, laboratory personnel, and data managers from various
program areas.
a Professional associations* involvement includes the Association of State
and Territorial Health Officials (ASTHO), the Association of Public Health
Laboratories (APHL), the Council of State and Territorial Epidemiologists
(CSTE), the National Association of Health
Data Organizations (NAHDO), the National Association of County and City
Health Officials (NACCHO), and the National Association for Public Health
Statistics and Information Systems (NAPHSIS).
Appendix VII: Department of Health and Human Services* Systems Inventory
Page 76 GAO- 03- 139 Federal Bioterrorism IT National Electronic
Telecommunications Systems for Surveillance (NETSS)
Type of system: Surveillance NETSS provides weekly data regarding cases of
nationally notifiable diseases. It serves a supportive role for
bioterrorism- related surveillance allowing the transmission of limited
epidemiological information describing cases of infectious disease that
may or may not be related to bioterrorism. As needed, local and state
health departments can use well- established, routine NETSS information
exchange protocols to augment more focused or specific bioterrorism
surveillance data exchange.
External collaborating partner: State, local, and territorial public
health agencies, and various public healthrelated professional
associations a System is operational Used primarily by state
public health officials, CDC officials, and health care providers
FY 2002 IT cost:
$586,301 (includes the cost for the National Notifiable Disease
Surveillance System)
Est. FY 2003 IT cost: $620,929 (includes the estimated cost for the
National Notifiable Disease Surveillance System) Future plans: NETSS will
be phased out as NEDSS is deployed and implemented. National Molecular
Subtyping Network for Foodborne Disease Surveillance
(PulseNet) Type of system: Supporting technology
PulseNet is an early warning system for outbreaks of foodborne diseases.
It is a national network of public health laboratories that perform DNA
"fingerprinting" on foodborne bacteria. It permits rapid comparisons of
these fingerprint patterns through an electronic database and provides
critical data for the early recognition and timely investigation of
outbreaks.
External collaborating partner: USDA/ FSIS, HHS/ FDA, Health Canada
System is operational Used primarily by public health officials and food
regulatory agency officials
FY 2002 IT cost:
$221,400 Est. FY 2003 IT cost: $235,000
Future plans: Expansion to include additional pathogens (including those
that may be used by bioterrorists) and to facilitate the establishment of
compatible networks in Europe, the Pacific Rim region, and Latin America.
National Respiratory and Enteric Virus Surveillance System (NREVSS) Type
of system: Surveillance/ Communications NREVSS is a laboratory- based
system that monitors temporal and geographic patterns associated with the
detection of respiratory syncytial viruses (RSV), human parainfluenza
viruses (HPIV), respiratory and enteric adenoviruses, and rotaviruses.
Influenza
specimen information, also reported to NREVSS, is integrated with CDC
influenza surveillance. While these agents are not on the CDC list, they
could be potentially used for bioterrorism. NREVSS is a Web- based and
telephone dial- in system.
External collaborating partner: None
System is operational Used primarily by state public health officials and
professionals
FY 2002 IT cost:
$61,835
Est. FY 2003 IT cost: $2,685
Future plans: Replace the telephone dial- in functionality to be Web-
based once all users have access capabilities.
Appendix VII: Department of Health and Human Services* Systems Inventory
Page 77 GAO- 03- 139 Federal Bioterrorism IT Plague Type of system:
Surveillance The plague surveillance system is comprised of clinical,
epidemiological, and ecologic information on presumptive and confirmed
cases reported by state public health departments. Basic descriptive
statistical analyses are performed on these data, such as
regional- and county- specific incidence rates. Plague is also one of
three internationally quarantinable diseases, and, according to the
International Health Regulations, all cases must be investigated and
reported to the World Health Organization in Geneva.
External collaborating partner: None
System is operational Used primarily by state and local public health
officials and Indian Health Services* officials
FY 2002 IT cost:
$2,350 Est. FY 2003 IT cost: $2,350
Future plans: Integrate with CDC*s bioterrorism preparedness programs.
Public Health Laboratory Information System (PHLIS) Type of system:
Surveillance PHLIS is designed for use in public health laboratories for
the reporting and analysis of a variety of conditions of public health
importance, which have a significant laboratory- testing component, e. g.,
salmonella. PHLIS reports standard demographic data that are associated
with a laboratory isolate as well as laboratory test results, information
about laboratory procedures, and outbreakrelated information.
External collaborating partner: None
System is operational Used primarily by state public health officials FY
2002 IT cost:
$149,091 Est. FY 2003 IT cost: $154,160
Future plans: Not available.
Statistical Outbreak Detection Algorithm (SODA) Type of system:
Surveillance SODA processes pathogen information (i. e., salmonella,
shigella, and e. coli) on a daily basis to detect anomalies or unusual
clusters in the reported versus expected counts at the state, regional,
and national levels. Its main goal is to provide users with an interface
to view reports, generate graphs and produce maps from the state,
regional, and national perspectives. SODA utilizes a cumulative sums
algorithm commonly used in the manufacturing industry. The output is a
statistical measure that is flagged for review by CDC's foodborne staff.
SODA uses general information from lab specimen data, such as date and
location.
External collaborating partner: None
System is operational Used primarily by epidemiologists FY 2002 IT cost:
$112,350 Est. FY 2003 IT cost: $116,169 Future plans: Addition of other
pathogens for monitoring.
Appendix VII: Department of Health and Human Services* Systems Inventory
Page 78 GAO- 03- 139 Federal Bioterrorism IT Unexplained Deaths and
Critical Illnesses Surveillance System Type of system: Surveillance As
part of CDC*s Emerging Infections Program, the Unexplained Deaths and
Critical Illnesses Surveillance System is expected
to contain limited epidemiological and clinical information on previously
healthy persons aged 1 to 49 years who have illnesses with possible
infectious causes. It is also expected to provide active population- based
surveillance through coroners and medical examiners at limited sites.
National and international surveillance will be passive for clusters of
unexplained deaths and illnesses.
External collaborating partner: None
System is in development
Used primarily by epidemiologists FY 2002 IT cost:
$28,980
Est. FY 2003 IT cost: $37,290
Future plans: Further development of an integrated data management system
for clinical, epidemiological, specimen tracking, and test results data,
including novel diagnostics and pathogen discovery.
Food and Drug Administration Electronic Laboratory Exchange Network
(eLEXNET) Type of system: Surveillance eLEXNET provides a Web- based
system for real- time sharing of food safety laboratory data among
federal, state, and local agencies. It is seamless and secure, allowing
public health officials at multiple government agencies engaged in food
safety activities to compare and coordinate laboratory analysis findings.
It captures food safety sample and test result data from participating
laboratories and uses them for risk assessment and decision- support
purposes, improving early detection of problem products and enabling
active food safety surveillance and evaluation of potential threats to the
American food supply. External collaborating
partner: USDA; DOD System is operational Used primarily by
public health and agricultural food safety officials
FY 2002 IT cost:
$5,096,000 Est. FY 2003 IT cost: $3,750,000
Future plans: Expanding participating food safety laboratory partnerships
and developing an integrated short- and long- term strategic plan and
communications planning approach. Source: GAO analysis of HHS data.
Appendix VIII: Department of Veterans Affairs* Systems Inventory
Page 79 GAO- 03- 139 Federal Bioterrorism IT VA manages one of the
nation*s largest health care systems and is the nation*s largest drug
purchaser. The department purchases
pharmaceuticals and medical supplies for the Strategic National Stockpile
Program and the National Medical Response Team stockpiles. VA identified
one information system.
Department of Veterans Affairs Emerging Pathogens Initiative (EPI) Type of
system: Surveillance
EPI identifies antibiotic- resistant and otherwise problematic pathogens
within the Veterans Health Administration facilities. This information is
used to help formulate plans on a national level for intervention
strategies and resource needs. Results of aggregate data may also be
shared with appropriate public health authorities for planning on the
national level for the non- VA and private health care sectors. EPI
provides general surveillance on specific pathogens and diseases.
External collaborating partner: None
System is operational
Used primarily by VA medical staff FY 2002 IT cost:
Not available
Est FY 2003 IT Cost
Not available
Future plans: Addition of new diseases or organisms as they are
identified. Source: GAO analysis of VA data.
Appendix VIII: Department of Veterans Affairs* Systems Inventory
Appendix IX: Environmental Protection Agency*s Systems Inventory
Page 80 GAO- 03- 139 Federal Bioterrorism IT EPA has responsibilities to
prepare for and respond to emergencies, including those related to
biological materials. EPA can be involved in detection of agents by
environmental monitoring and sampling. EPA is
responsible for protecting the nation*s water supply from terrorist attack
and for prevention and control of indoor air pollution. EPA*s National
Homeland Security Research Center is in the process of preparing an online
virtual library of homeland security- related documents and tools intended
to assist decision making during emergency situations. Data in the library
will include exposure guidelines, databases, publications, and Web sites
applicable to biological, chemical, and radiological threats.
EPA identified five supporting technologies.
Environmental Protection Agency Indoor Air Quality and Inhalation Exposure
(IAQX) Type of system: Supporting technology
IAQX is an indoor air quality simulation package that consists of a
general- purpose simulation program and a series of stand- alone, special
purpose programs. Relatively simple mass transfer models are provided by
the general- purpose simulation program, and more complex models are
implemented by the stand- alone, special purpose simulation programs. In
addition to performing conventional indoor air quality simulations, which
calculate the pollutant concentration and personal exposure as a function
of time, IAQX can estimate the adequate ventilation rate when certain air
quality criteria need to be satisfied. This feature is useful for product
stewardship and risk management.
External collaborating partner: None
System is operational Used primarily by advanced users* EPA officials and
the public
FY 2002 IT cost:
Not available Est. FY 2003 IT cost: Not available
Future plans: Addition of more special purpose programs, such as models
for indoor air chemistry and indoor application of pesticides. Appendix
IX: Environmental Protection Agency*s Systems Inventory
Appendix IX: Environmental Protection Agency*s Systems Inventory
Page 81 GAO- 03- 139 Federal Bioterrorism IT EPANET Type of system:
Supporting technology EPANET was developed to help water utilities
maintain and improve the quality of water delivered to consumers through
their
distribution systems. It is a computer modeling software package that can
be used to simulate drinking water distribution systems and to simulate
water flow patterns in those systems. The model is also used to simulate
contaminant dispersion patterns if chemical or biological contaminants are
introduced into a water system. It can be used to inform water utilities
where critical points (valves, pumps, etc.) are located in the system and
what the impact of the system would be if those points were attacked.
External collaborating partner: None
System is operational Used by EPA officials and the public FY 2002 IT
cost:
Not available Est. FY 2003 IT cost: Not available
Future plans: Not available. RISK Type of system: Supporting technology
RISK is an indoor air quality model developed by the Indoor Environment
Management Branch of EPA*s National Risk Management Research Laboratory.
It was developed as a tool to carry out the mission of the engineering
portion of the EPA*s indoor air research program to provide tools
necessary to reduce individual exposure to and risk from indoor air
pollutants. RISK uses the concepts of
buildings and scenarios, including fixed information about a building (the
number of rooms, the room dimensions, and the arrangement of the rooms)
and changing information sources (sinks, air exchange, room- to- room
flows, etc.). The model provides risk, exposure, and concentration
information. RISK allows analysis of the impact of multiple pollutants on
the indoor environment.
External collaborating partner: None
System is operational Used primarily by EPA officials and the general
public
FY 2002 IT cost:
Not available
Est. FY 2003 IT cost: Not Available
Future plans: Addition of more risk calculations and of models and
suggested values for indoor particulate.
Safe Drinking Water Accession and Review System (SDWARS) Type of system:
Supporting technology SDWARS tracks monitoring results for specific lists
of unregulated chemical contaminants to indicate occurrences in public
drinking water systems. Public water systems submit Unregulated
Contaminant Monitoring Rule (UMCR) data elements through SDWARS for
inclusion in the National Drinking Water Contaminant Occurrence Database.
SDWARS is a one- entry approach to the electronic reporting process to
improve reporting quality, reduce reporting errors, and reduce the time
involved in investigating and correcting errors at all levels (e. g.,
laboratories, states, and EPA).
External collaborating partner: None
System is operational Used primarily by EPA officials and the general
public
FY 2002 IT cost:
$350,000 Est. FY 2003 IT cost: $300,000
Future plans: Accommodate additional contaminants, including microbial
contaminants.
Appendix IX: Environmental Protection Agency*s Systems Inventory
Page 82 GAO- 03- 139 Federal Bioterrorism IT Safe Drinking Water
Information System Federal (SDWIS/ FED) Type of system: Supporting
technology SDWIS/ FED is a database designed and implemented by EPA to
meet its needs in the oversight and management of the Safe
Drinking Water Act. It contains public water system inventory information
and summary violation data submitted by states and EPA regions in
conformance with reporting requirements established by statute,
regulation, and guidance.
External collaborating partner: None
System is operational Used primarily by EPA officials FY 2002 IT cost:
$2,100,000 Est. FY 2003 IT cost: $1,700,000
Future plans: Replace with a new drinking water data warehouse. Source:
GAO analysis of EPA data.
Appendix X: Federal Agencies* Information Technology Initiatives Page 83
GAO- 03- 139 Federal Bioterrorism IT In addition to the agencies*
individual systems that they identified, there are several other IT
initiatives in process or being planned to better
support agencies* abilities to prepare for, respond to, and communicate
during public health emergency events. These projects are intended to
provide integration and interoperability among systems, improve
communications, and better support the public health infrastructure.
Information technology initiatives Lead agency Collaborating agencies
Status of development
Public Health Information Network (PHIN) HHS/ CDC State, territorial, and
local public health agencies and various public healthrelated professional
associations a Planning The PHIN is an effort initiated by the CDC to
provide interoperability across public health functions and organizations,
such as state
and federal agencies, local health departments, public health labs,
vaccine clinics, clinical care, and first responders. It is intended to,
among other things, (1) deliver industry standard data to public health,
(2) investigate bioterrorism detection, (3) provide disease tracking
analysis and response, and (4) support local, state, and national data
needs. It builds on existing CDC investments from HAN, NEDSS, EPI- X, LRN,
and the CDC Web. The PHIN will not replace any of these systems but will
provide an *umbrella* to support the interoperability of existing CDC
surveillance, communications, and reporting systems.
National Electronic Disease Surveillance System (NEDSS) Architecture HHS/
CDC State, territorial, and local public health agencies and various
public healthrelated professional associations a Development
In fiscal year 2001, CDC implemented the NEDSS architecture project to
replace or enhance the interoperability of its numerous existing
surveillance systems. NEDSS promotes the use of data and information
standards to advance the development of efficient, integrated, and
interoperable surveillance systems at the federal, state, and local
levels. When completed, NEDSS will electronically integrate a wide variety
of surveillance activities and will facilitate more accurate and timely
reporting of disease information to CDC and state and local health
departments. NEDSS is also designed to reduce provider burden in the
provision of information and enhance both the timeliness and quality of
information provided. The NEDSS architecture will include (1) data
standards, (2) an Internet- based communications infrastructure built on
industry standards, and (3) policy- level agreements on data access,
sharing, burden reduction, and protection of confidentiality.
a Professional associations* involvement includes the Association of State
and Territorial Health Officials (ASTHO), the Association of Public Health
Laboratories (APHL), the Council of State and Territorial Epidemiologists
(CSTE), the National Association of Health
Data Organizations (NAHDO), the National Association of County and City
Health Officials (NACCHO), and the National Association for Public Health
Statistics and Information Systems (NAPHSIS). Appendix X: Federal
Agencies* Information Technology Initiatives
Appendix X: Federal Agencies* Information Technology Initiatives Page 84
GAO- 03- 139 Federal Bioterrorism IT Information technology initiatives
Lead agency Collaborating agencies Status of
development National Environmental Public Health Tracking Network (NEPHTN)
HHS/ CDC EPA Planning The NEPHTN is a collaborative effort between CDC and
EPA to develop a national environmental tracking network that will (1) be
standards- based; (2) allow direct electronic data reporting and linkage
within and across health effect, exposure, and hazard data; and (3) be
interoperable with other public health systems. Environmental public
health tracking is the ongoing collection, integration, analysis, and
interpretation of data about: environmental hazards, exposure to
environmental hazards, and health effects potentially related to exposure
to environmental hazards. The goal of environmental public health tracking
is to protect communities by providing information to federal, state, and
local agencies. These agencies then use this information to plan, apply,
and evaluate public health actions to prevent and control environmentally
related diseases. Currently, no systems exist at the state or national
levels to track many of the exposures and health effects that may be
related to environmental hazards. FSIS Automated Corporate
Technology Suite (FACTS)
USDA/ FSIS None Planning The FACTS initiative establishes an agencywide,
integrated information management and data- sharing resource. It is
intended to replace existing stovepipe application systems with a suite of
components that can interact with each other and share data. FACTS is a
technology suite composed of a centralized database that will (1) unite
several smaller databases and projects that are interrelated and (2)
provide a central point of access that will decrease data redundancy and
inaccuracy. FACTS* main purpose is to support the FSIS mission by
substantially improving the ability to provide information that is
accurate, complete, and timely for use by agency decision makers. Although
this initiative will not consolidate all food safety information systems
into one system, it will allow interoperability between systems in USDA
agencies and at the U. S. Customs Service. In addition, FSIS and APHIS
will take major steps toward establishing an integrated data- sharing
effort that will specifically define the roles of each agency and will
better safeguard the United States against foreign animal diseases and
food safety hazards.
Biological Defense Initiative (BDI) DOD/ DTRA DOE Cancelled DTRA was
executing the BDI program to determine the value of integrating systems
with each other. This program was intended to deliver a national model for
biological incidents detection capabilities and to integrate and
synthesize information from exiting detectors and surveillance systems,
such as BASIS, Portal Shield, RSVP, ESSENSE, and B- Safer. The intended
partners in the BDI were to be CDC, Veterans Health Administration, NIH,
USDA, and Interior*s Fish and Wildlife Service. However, the scope of the
project was drastically narrowed as a result of funding reductions* from
$215 million dollars to $29 million dollars. BDI has
recently been cancelled.
Epidemic Outbreak Surveillance (EOS)
DOD/ Air Force Navy, Army, DTRA, and civilian and academic partners
Development EOS is a DTRA- supported initiative that leverages and tests
existing and emerging biodefense technologies within a real- world
testbed. The objectives of the EOS project are to (1) develop a scalable
biodefense system for early threat warning, rapid threat identification,
focused disease treatment, and outbreak containment and (2) enable the use
of emerging technologies for testing, verification, and validation in a
real- world, testbed environment. EOS is currently used to identify
epidemics of infectious respiratory disease among USAF basic military
trainees. It is the first diagnostic platform using DNA- based microarray
technologies to be
tested, verified, and validated.
Appendix X: Federal Agencies* Information Technology Initiatives Page 85
GAO- 03- 139 Federal Bioterrorism IT Information technology initiatives
Lead agency Collaborating agencies Status of
development Bio- ALIRT DOD/ DARPA Walter Reed Army Institute for
Research, academic and commercial partners
Development Bio- ALIRT is being developed by DARPA to scientifically
determine the value of nontraditional data sources, such as human
behavior, to enable the detection of a biological outbreak from artificial
or natural causes up to two days earlier than with traditional means. The
Bio- ALIRT program will continue to monitor nontraditional data sources,
such as animal sentinels, behavioral indicators, and prediagnostic medical
data, to determine which could effectively serve as early indicators of a
biological pathogen release. Data sources and algorithms will be evaluated
in testbeds. The knowledge and technology developed from the testbeds
would be suitable for use in any syndromic surveillance system. Future
plans for Bio- ALIRT include development of new techniques, such as
advanced data fusion, detection, and privacy protection algorithms, to
differentiate between naturally occurring and deliberate bioreleases.
Program for Response Options and Technology Enhancements for Chemical/
Biological Terrorism (PROTECT)
DOE/ SNL None Development PROTECT*s objective is to protect people in
public facilities, such as subways and airports, from chemical attacks. It
is intended to addresses vulnerabilities of civilians that were
highlighted in the 1995 chemical agent attack in the Tokyo subway system.
PROTECT rapidly detects the presence of a chemical agent and transmit
readings to an emergency management information system. It demonstrates
the use of integrated systems for the defense of infrastructure
facilities. PROTECT does not currently have a bioagent use; however, it
can provide a near- term solution for 24- by- 7 facility monitoring for
airborne biological agent releases. PROTECT is a DOE Domestic
Demonstration and Application Program (i. e., a prototype system to
address specific problems in order improve infrastructure facility
protection). The program takes advantage of recent advances in technology
to prepare for and respond to attacks in subways, airports, and office
buildings where people are concentrated. PROTECT is jointly funded by DOE
and the Department of Justice.
National Food Safety Laboratory System (NFSLS) USDA/ FSIS and
HHS/ FDA USDA/ APHIS, DOD/ Army, selected state food laboratories
Development
The NFSLS is a newly initiated project to integrate systems for sharing
information. It is currently a pilot program involving federal food
laboratories at FSIS, FDA, the Army, and state food laboratories in
Tennessee, Florida, New Hampshire, Massachusetts, and municipal food
laboratories in Milwaukee, Wisconsin, and Cincinnati, Ohio. The program
will also focus on the assurance of rapid sharing of reliable data through
FDA*s e- LEXNET system. USDA and HHS will collaborate with federal, state,
and local agencies to: (1) provide a national seamless data exchange
system for food laboratory information; (2) provide an infrastructure that
is portable, intuitive, and ready to exchange data from state, local, and
federal databases and varying internal network designs; (3) enhance
communication and collaboration among food safety partnerships; (4)
provide the ability to detect, compare, and communicate current findings
in food laboratory analysis; and (5) demonstrate that multiple agencies
engaged in food safety regulatory activities could leverage the resources
necessary to achieve the common goal of reducing the incidence of
microbial foodborne illness.
Appendix X: Federal Agencies* Information Technology Initiatives Page 86
GAO- 03- 139 Federal Bioterrorism IT Information technology initiatives
Lead agency Collaborating agencies Status of
development National Infrastructure Project HHS/ CDC None Development The
purpose of the National Infrastructure Project is to strengthen CDC*s
infrastructure and network management in order to help ensure continuity
of operations for the NCEH during emergencies. Its objectives are to
achieve zero latency on all network operations and to provide redundancy
and higher network uptime. The center is implementing cluster technology
to help achieve redundancy without latency, thus increasing the
reliability of the network. Storage area networks are being used to
provide logical and physical disk drives with connected servers. Other
commercial tools are used to monitor the network and detect problems
before they occur. NCEH is also purchasing UPS paging to allow early
detection of problems within the facility. For example, pagers will go off
whenever water sensors or smoke detectors are activated. NCEH has a triage
plan, which includes the use of E- mails, pagers, and phone calls combined
with paging systems.
Forensics Internet Research Exchange (FIRE)
DOE/ LANL None Development FIRE is an initiative to develop an internet-
based research exchange system for laboratories and government agencies.
It is intended to allow the sharing of biothreat information over a secure
VPN. It is anticipated that the system will be able to tie identified
bioagent strains to particular organizations based upon previous
identification of strains and their origins. Molecular Recognition- based
Real
Time Detection
DOE/ LANL None Planning The Molecular Recognition- based Real Time
Detection initiative is intended to develop new sensors for biological and
chemical warfare agents. The work may provide more specific and sensitive
sensors, having very low or no false positives that can be used to collect
samples and provide data to information systems. Future plans include the
development of single receptors for multiple bioagents or for a
combination of biological and chemical agents. Source: GAO analysis of
agency data.
Appendix XI: List of Selected Health Care Standards
Page 87 GAO- 03- 139 Federal Bioterrorism IT Several organizations have
defined standards for health care data and communications. Several
important standards development initiatives and the vocabulary and
messaging standards that they have defined are
described below:
Standard Description
Health Level Seven (HL7) HL7 is an ANSI- accredited standards development
organization that creates message format standards. Version 2.3 provides a
protocol that enables the flow of data between systems. Version 3.0 is
being developed through the use of a formalized methodology involving the
creation of a Reference Information Model to encompass the ability, not
only to move data, but to use data once it is moved.
Logical Observations Identifiers Names and Codes (LOINC) LOINC is a set of
code standards that identifies clinical questions, variables, and reports.
It comprises a database of 15, 000 variables with synonyms and cross-
mappings; it covers a wide range of laboratory and clinical subject areas.
The formal structure has six parts: component, property measured, time
aspect, system, precision, and method.
Systemized Nomenclature of Medicine (SNOMED) SNOMED is a nomenclature
classification for indexing medical vocabulary, including
signs, symptoms, diagnoses, and procedures; it defines code standards in a
variety of clinical areas called coding axes. It can identify procedures
and possible answers to clinical questions that are coded through LOINC.
Unified Medical Language System (UMLS) The National Library of Medicine
developed UMLS as a standard health vocabulary that
enables cross- referencing to other terminology and classification systems
and includes a metathesaurus, a semantic network, and an information
sources map. Its purpose is to help health professionals and researchers
retrieve and integrate electronic biomedical information from a variety of
sources, irrespective of the variations in the way similar concepts are
expressed in different sources and classification systems.
Common Information for Public Health Electronic Reporting (CIPHER)
CIPHER*s objective is to establish standards for the data used in
surveillance, to allow
for a consistent definition and a consistent implementation across
programs. The following objectives have been defined for CIPHER: (1)
establish consistent definitions for information collected and used by
surveillance systems; (2) define standards for how questions are to be
formatted and information is to be collected on surveillance case report
forms; (3) identify standards for the processing of data in electronic
data entry
systems, including value/ label displays, reference table look- ups, and a
minimum level of edit- checking; (4) identify storage standards; (5)
provide guidance on electronic data interchange; and (6) provide guidance
on coding for the display of data in statistical analyses and reports.
Source: GAO. Appendix XI: List of Selected Health Care Standards
Appendix XII: Comments from the Department of Defense
Page 88 GAO- 03- 139 Federal Bioterrorism IT Appendix XII: Comments from
the Department of Defense
Appendix XIII: Comments from the Department of Energy
Page 89 GAO- 03- 139 Federal Bioterrorism IT Appendix XIII: Comments from
the Department of Energy
Appendix XIV: Comments from the Department of Health and Human Services
Page 90 GAO- 03- 139 Federal Bioterrorism IT Appendix XIV: Comments from
the Department of Health and Human Services
Note: GAO comments supplementing those in the report text appear at the
end of this appendix.
Appendix XIV: Comments from the Department of Health and Human Services
Page 91 GAO- 03- 139 Federal Bioterrorism IT See comment 1.
Appendix XIV: Comments from the Department of Health and Human Services
Page 92 GAO- 03- 139 Federal Bioterrorism IT See comment 6. See comment 4.
See comment 2. See comment 5. See comment 3.
Appendix XIV: Comments from the Department of Health and Human Services
Page 93 GAO- 03- 139 Federal Bioterrorism IT
Appendix XIV: Comments from the Department of Health and Human Services
Page 94 GAO- 03- 139 Federal Bioterrorism IT The following are GAO*s
comments on the Department of Health and Human Service*s letter dated May
15, 2003.
1. In the background section of the report, we discuss the state and local
government roles in dealing with public health emergencies, using a
graphic to further illustrate the different roles. In this section, we
have attempted to make a clear distinction between federal
responsibilities and the responsibilities of other entities involved in
responding to the release of a biological agent.
2. As we stated in our report, the Consolidated Health Informatics
Initiative is an interagency work group lead by HHS, which recently
announced the first set of standards. While we are encouraged by the
interagency coordination involved in this initiative, additional work is
still needed* in defining activities for ensuring
further coordination and consensus on the adoption and use of additional
standards, in establishing milestones for defining and implementing all
standards, and in creating a mechanism to monitor the implementation of
these standards throughout the health care industry. We recognize that the
adoption of standards is an issue for the entire health care industry.
3. In response to these comments, we have added information on HHS*s
cooperative agreements with states and local governments to the background
section of the report.
4. We have included information we received about PHIN in appendix X. 5.
We agree with HHS that IT is one of several components that support the
core
activities of public health surveillance; we discussed this in the Agency
Comments and Our Evaluation section of the report.
6. While FoodNet may be a collaborative scientific activity for
surveillance of foodborne diseases, it also includes an IT component for
data exchange, which was reported to us by CDC officials.
Appendix XV: Comments from the Department of Veterans Affairs Page 95 GAO-
03- 139 Federal Bioterrorism IT Appendix XV: Comments from the Department
of Veterans Affairs
Appendix XVI: GAO Contacts and Acknowledgments
Page 96 GAO- 03- 139 Federal Bioterrorism
David A. Powner, (202) 512- 9286, (303) 572- 7316 or pownerd@ gao. gov M.
Yvonne Sanchez, (202) 512- 6274 or sanchezm@ gao. gov
In addition to those named above, Larry E. Crosland, Neil J. Doherty,
Amanda C. Gill, Pamlutricia Greenleaf, Joanne Fiorino, M. Saad Khan,
Teresa F. Tucker, and Caroline C. Villanueva, made key contributions to
this report. Appendix XVI: GAO Contacts and
Acknowledgments GAO Contacts Acknowledgments
(310432)
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