Bioterrorism: Information Technology Strategy Could Strengthen Federal Agencies' Abilities to Respond to Public Health Emergencies
Published: 2003-05-30T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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 disease-related 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). 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. 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.

section_title: Letter
paragraphs: The October 2001 anthrax attacks highlighted long-standing weaknesses in  the current public health infrastructure and prompted efforts to improve  our nation’s preparedness for and response to public health emergencies,  including bioterrorism. 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 life- threatening 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  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.
subsections: section_title: Background
paragraphs: 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.
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. 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. 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. In addition, other professions,  such as drug store pharmacists and school administrators, are being  identified as new players in bioterrorism preparedness and response.
Public health and private laboratories are another vital part of the  surveillance network because only laboratory results can definitively  identify pathogens. 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  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 anti- bioterrorism 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.
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. 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  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  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. 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). Consolidating the functions of  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.
subsections: section_title: Role of Information Technology for Bioterrorism Preparedness and Response
paragraphs: 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. 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.
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.).
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. 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  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.
section_title: About 70 Bioterrorism-Related Information Technology Activities Identified at Six Federal Agencies
paragraphs: 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.
subsections: section_title: Bioterrorism-Related Systems and Initiatives Identified at Six Federal Agencies
paragraphs: 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. 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. 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.
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  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 air- sampling 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.
VA has one information system that was developed for surveillance  within its health care facilities.
section_title: Coordination Mixed Among the Information Systems and Initiatives Identified
paragraphs: 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.
section_title: Health Care Sector Making Progress on Defining Standards, but Implementation Challenges Remain for Effective Information Sharing
paragraphs: 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.
subsections: section_title: Key Standards for Health Care
paragraphs: IT standards, including data standards, enable the interoperability and  portability of systems within and across organizations. 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.
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  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.
section_title: Need for Standards Has Been Recognized and Federal Actions are Under Way to Define and Implement Them
paragraphs: 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.
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),  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), 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.
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. 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 e- government projects to facilitate the adoption of data standards, among  others, for health care systems within the federal government. The CHI  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.
section_title: Several Standards Implementation Challenges Remain
paragraphs: 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 standards- setting 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.
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.
section_title: Emerging Information Technologies Could Enhance Agencies’ Abilities to Prepare for and Respond to Public Health Emergencies
paragraphs: 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.
subsections: section_title: Examples of Public Health’s Use of Emerging Information Technology
paragraphs: 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):  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  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:  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: 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  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.
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, µChemLab, 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.
section_title: Barriers to Better Use of Emerging Technologies
paragraphs: 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  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.
section_title: Conclusions
paragraphs: 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.
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.
section_title: Recommendations
paragraphs: 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    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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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.
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.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: 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.  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  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,    military systems with no applicability to civilian populations (e.g.,    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 Francisco- Stanford 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.
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.
section_title: Appendix II: CDC Biological Diseases/Agents List
paragraphs: 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  and  arenaviruses )
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)
Melioidosis (Burkholderia pseudomallei)
Psittacosis (Chlamydia psittaci)
Q fever (Coxiella burnetii)
Ricin toxin from Ricinus communis (castor beans)
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.
section_title: Appendix III: Categories of Information Technology for Bioterrorism-Related Systems
paragraphs: 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.
subsections: section_title: Detection
paragraphs: 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. 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  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.
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 Chemical- Biological 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  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.
section_title: Surveillance
paragraphs: 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  each level of government, including IT capabilities. 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.  2.  Hospital-based surveillance—systems that collect data on hospital- acquired 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.  4.  Laboratory and antimicrobial resistance 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. 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. 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.  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.
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 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.
section_title: Diagnostic and Clinical Management
paragraphs: 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. General diagnostic  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, x- rays 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.
section_title: Communications
paragraphs: 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  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 health- related 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.
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  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.
section_title: Supporting Technology
paragraphs: 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  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.
section_title: Other Clinical Systems
paragraphs: 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.
section_title: Appendix IV: Department of Agriculture’s Systems Inventory
paragraphs: 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:    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.
subsections: section_title: Department of Defense
paragraphs: 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 Force- wide, integrated medical surveillance and command and control network. GEMS has four modules: patient encounter, theater  occupational, public health deployed, and theater epidemiology.
Future plans: Complete infrastructure development.
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.
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.
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.
System is operational  Used primarily by military  personnel at fixed asset  sites (e.g., air bases and  port facilities)
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.
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.
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.
Future plans: Establishment of the system in the Americas and continued expansion in Southeast Asia.
Electronic Surveillance System for the Early Notification of Community- based 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.
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.
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.
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.
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.
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.
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.
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.
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.
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 18th Medical Command in Korea and in Navy hospitals is  Yokosuka, Japan and San Diego, California.
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.
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.
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).
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.
subsections: section_title: Lawrence Livermore National Laboratory (LLNL)
paragraphs: 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.
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.
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 program, beginning in February 2003.
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.
Used primarily by  federal agencies (e.g.,  HHS, USDA, and DOD)
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.
Los Alamos National Laboratory (LANL)
Biological Aerosol Sentry and Information System (BASIS)
See BASIS under Lawrence Livermore National Laboratory.
Type of system:  Supporting technology  Bioreactor Simulation Tools model and analyze biological systems (i.e., genetic networks, metabolic networks, and signal  transduction networks).
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.
Future plans: To project potential outcomes of an outbreak and the potential benefit of intervention techniques.
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.
Future plans:  Database and data analysis tool development.
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.
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.
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.
Oak Ridge National Laboratory (ORNL)
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.
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 standards- based architecture with encryption and access controls.
Future plans: To continue operational prototypes and refine design for nationwide system.
Sandia National Laboratory (SNL)
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.
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.
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.
Future plans: ISMs are currently under development; more capable computational components are to be integrated when  available.
Type of system:  Detection  µChemLab 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  µChemLab is currently being developed for chemical detection, it can also be used for biological agent detection. Portable, stand- alone 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.
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.
Future plans: Development of neural networks and maps.
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 inter- laboratory 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.
section_title: Department of Health and Human Services
paragraphs: 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.
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.
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.
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.
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.
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.
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.
Future plans: CaliciNet will be replaced by a larger system, which is still in the process of being named.
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.
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.
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.
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.
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, Web- based 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.
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.
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.
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.
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.
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.
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.
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.
Future plans: Inclusion of additional state health departments and integration with GIS.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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)
subsections: section_title: Future plans: NETSS will be phased out as NEDSS is deployed and implemented.
paragraphs: 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.
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.
Future plans: Replace the telephone dial-in functionality to be Web-based once all users have access capabilities.
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.
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 outbreak- related information.
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.
Future plans: Addition of other pathogens for monitoring.
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.
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.
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.
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.
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.
section_title: Department of Veterans Affairs
paragraphs: 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.
Future plans: Addition of new diseases or organisms as they are identified.
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 on- line 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.
section_title: Environmental Protection Agency
paragraphs: 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.
Future plans: Addition of more special purpose programs, such as models for indoor air chemistry and indoor application of  pesticides.
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.
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.
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).
Future plans: Accommodate additional contaminants, including microbial contaminants.
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.
Future plans: Replace with a new drinking water data warehouse.
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.
subsections: section_title: Information technology initiatives
subsections: section_title: Public Health Information Network (PHIN)
paragraphs: State, territorial, and local public health  agencies and various public health- related professional associations  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.
State, territorial, and local public health  agencies and various public health- related professional associations  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.
National Environmental Public Health  Tracking Network (NEPHTN)
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.
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)
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.
Navy, Army, DTRA, and civilian and  academic partners  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.
Walter Reed Army Institute for  Research, academic and commercial  partners  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 bio- releases.
Program for Response Options and  Technology Enhancements for  Chemical/Biological Terrorism  (PROTECT)
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/APHIS, DOD/Army, selected  state food laboratories  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.
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.
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  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.
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.
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.
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.
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.
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.
section_title: Appendix XII: Comments from the Department of Defense
section_title: Appendix XIII: Comments from the Department of Energy
section_title: Appendix XIV: Comments from the Department of Health and Human Services
subsections: section_title: 1. In the background section of the report, we discuss the state and local
paragraphs: 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.
section_title: Appendix XV: Comments from the Department of Veterans Affairs
section_title: Appendix XVI: GAO Contacts and Acknowledgments
subsections: section_title: Acknowledgments
paragraphs: 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.