Effectiveness of National Biosurveillance Systems: BioWatch and the Public Health System: Interim Report (2009)

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Effectiveness of National Biosurveillance Systems: BioWatch and the Public Health System Interim Report INTRODUCTION In 2001, the United States experienced the effects of bioterrorism when envelopes containing anthrax spores were sent through the postal service to several different recipients, including two U.S. senators. It is likely that several thousand people were exposed to anthrax, with antibiotic prophylaxis widely prescribed for those whose exposure was known or suspected. The consequences of this event included five deaths from inhalational anthrax and another 17 inhalational or cutaneous anthrax infections, as well as substantial economic costs and significant operational challenges in public health and health care from the federal level down to the community level (Gursky et al., 2003). The experience with the anthrax letters combined with long-standing concerns about the threat of biological warfare to give new urgency to ongoing efforts to strengthen domestic biodefense capabilities. Overlapping the “biodefense” concept are related efforts to ensure the capacity to respond effectively to naturally occurring health threats that may arise, such as pandemic influenza or unfamiliar emerging infectious diseases. A presidential policy statement, Biodefense for the 21st Century (The White House, 2004), articulated four “pillars” of a national biodefense program: threat awareness, prevention and protection, surveillance and detection, and response and recovery. Implementation of a biodefense program depends on federal, state, and local components in collaboration with hospitals and health care providers in the private sector, as well as many others. At the federal level, much of the responsibility for civilian biodefense rests with the Department of Homeland Security (DHS) and with the Department of Health and Human Services (HHS). But formal legal authority for public health actions rests with the individual states, and it is exercised at the local level across nearly 2,900 county and city health departments. Surveillance for and detection of disease outbreaks is a traditional responsibility of public health authorities, which rely heavily on diagnosis and case reporting by health care providers and laboratories. The threat of bioterrorism has spurred interest in finding ways to detect health threats as quickly as possible so that preventive measures or treatment can be administered in time to reduce illnesses and deaths. One approach to early detection has focused on developing techniques for collecting and analyzing data streams from health care settings and other sources in an attempt to identify anomalies that might signal impending health events sooner than 1 

2 EFFECTIVENESS OF NATIONAL BIOSURVEILLANCE SYSTEMS standard diagnosis and case reporting. Another approach to earlier detection of health threats has been the BioWatch program, under which DHS has deployed air samplers, primarily in outdoor locations, in more than 30 major cities with the aim of early detection and characterization of aerosolized biological threats. BioWatch air samplers were first deployed in 2003. An available technology package—the Biological Aerosol Sentry and Information System (BASIS)—was adapted to allow for rapid implementation of outdoor air monitoring for six major biological threat agents, including the organisms that cause anthrax (CRS, 2003; DHS, 2008). The current version of this technology, referred to as Generation 2.0, requires daily manual collection and testing of air filters from each monitor. Newer technologies being considered by DHS (Generation 2.5 and Generation 3.0) promise to automate the testing process within the monitoring station, which has the potential to produce results more quickly and at lower cost. The Generation 3.0 devices may also eventually have the capability to test for a greater number of threat agents. DHS plans include deploying the next generation of BioWatch monitors in indoor locations. Questions have been raised about the BioWatch program, including the technological capabilities of BioWatch monitoring devices, operational aspects of the Generation 2.0 deployment, planning for the introduction of Generation 2.5 and Generation 3.0 (e.g., O’Toole, 2007a,b; Downes, 2008; GAO, 2008). Questions have also been raised about the relationship of BioWatch to other surveillance efforts based in the health care and public health sectors, including its contribution to the effectiveness of surveillance and response by the health sectors (e.g., O’Toole, 2007b; Price, 2008), and about the effectiveness of techniques of epidemiologic surveillance such as syndromic surveillance. Because of such questions, the Congress, through the Subcommittee on Homeland Security of the House Appropriations Committee, directed the Office of Health Affairs (OHA) in DHS to ask the National Academies to evaluate the effectiveness of the BioWatch program, to compare the costs and benefits of the current and planned versions of BioWatch monitoring systems, to examine the costs and benefits of an enhanced national surveillance system that relies on hospitals and the public health system, and to compare the effectiveness of BioWatch to such an enhanced system. 1 STUDY COMMITTEE AND STUDY CHARGE To carry out this congressionally mandated study, the National Academies has convened the Committee on Effectiveness of National Biosurveillance Systems: BioWatch and the Public Health System. The committee has the following charge: The Institute of Medicine (IOM) and National Research Council (NRC) will evaluate the effectiveness of BioWatch, including a comparison of benefits and costs for Generations 2 and 3; the costs and benefits of an enhanced national surveillance system that relies on U.S. hospitals and the U.S. public health system will also be assessed, and its effectiveness compared to that of the current BioWatch approach. The evaluation will include examination of the reliability of BioWatch monitoring data and the ability of hospitals and public health officials 1 Joint Explanatory Statement to Accompany Consolidated Appropriations Amendment (H.R. 2764—State, Foreign Operations, and Related Programs Appropriations Act, 2008) Division E—Department of Homeland Security, Appropriations Act, 2008 [p. 60] http://www.rules.house.gov/110/text/omni/jes/jesdive.pdf. 

INTERIM REPORT 3 to respond based on information received from that system. Services under this contract will encompass the evaluation of the effectiveness of both current and enhanced biosurveillance systems to detect biological terrorism or other biothreats to human health, including (1) differing technological generations of BioWatch, (2) current human health-related surveillance systems, including those for zoonotic disease, and (3) describing necessary enhancements to hospital and public health systems based on measures of effectiveness in detecting attacks of bioterrorism or other biothreats. Measures of effectiveness will include the ability of surveillance systems to warn sufficiently to provide effective post-exposure prophylaxis and effective post-infection treatment to affected populations following a bioterrorist attack or other biothreat event. The IOM and the NRC shall provide expert advisors that reflect expertise in relevant fields, such as biological threat assessments, biological detection systems evaluation, environmental monitoring technologies, biological assays, microbiology, virology, epidemiology, health information technology, the U.S. public health system, hospital operations, local emergency management, public health response, statistical methods, infectious disease modeling, syndromic surveillance, systems engineering, operations research, complex database management and analysis; and economic analysis. The following are specific requirements under this requirement. The IOM/NRC shall provide sufficient staff support to organize meetings, generate reports and manage the contract. The IOM/NRC will: 1. Evaluate the relative merits, and current and potential capabilities of the BioWatch monitoring system (Generation 2 and Generation 3) to detect bioterrorist attacks and other biothreats via environmental monitoring, with the aim of early warning and pre-infection prophylaxis and expedited response and recovery. The evaluation will consider both BioWatch Generation 2 and Generation 3 equipment, and the relative advantages and disadvantages of each, including their costs and benefits. 2. Describe the characteristics of an “enhanced national surveillance system” that relies on U.S. hospitals and the U.S. public health system. 3. Examine the costs, merits, and capabilities of the current and a potential “enhanced national surveillance system” to provide a basis for a rapid response to bioterrorist attacks or other biothreats, including initiation of pre-infection prophylaxis and expedited response and recovery. 4. Reach a conclusion as to whether the two systems are redundant or complementary, both in current configuration and potential "enhanced" configuration. The analysis shall include a comparison of the effectiveness of the potential “enhanced” national surveillance system with the current and planned BioWatch approach. 5. Prepare an interim report to outline the progress to date on addressing the major issues under consideration by the committee including the types of information that have been collected for assessment and any obstacles to addressing items in the task. The interim report will also provide any conclusions reached by that date. 6. Utilize the results obtained in items 1 through 4 to compile a comprehensive final report of the study. The final report shall include all findings and results concerning the effectiveness of BioWatch. The contractor shall present and brief the final report to OHA senior management prior to its public release in prepublication form and dissemination according to the regular 

4 EFFECTIVENESS OF NATIONAL BIOSURVEILLANCE SYSTEMS practices of the National Academies. The publication process for the final report will be completed following its public release. The members of the committee bring to the study expertise in areas that include biological threat assessments, evaluation of biological detection systems, environmental monitoring technologies, biological assays, microbiology, virology, epidemiology, syndromic surveillance, health information technology, the U.S. public health sector, hospital systems, emergency medicine, laboratory operations, statistical methods, systems engineering, operations research, and economic analysis. The committee has interpreted its task as focusing on detection of serious disease threats, especially those from bioterrorism, through means that include (a) environmental monitoring technologies used by the BioWatch program, including Generations 2.0, 2.5, and 3.0; (b) reporting from clinical settings to public health systems; and (c) syndromic surveillance systems that use various types of data (e.g., outpatient visits, pharmacy sales, absenteeism) to identify unusual patterns that may signal disease outbreaks. The committee will take into account assessments of biological threats and the implications of surveillance and detection for response to disease outbreaks and expected outcomes, but it is not attempting to evaluate threat assessments or response plans. STUDY PROCESS The committee is gathering information for this study through presentations at meetings, committee and staff discussions with federal officials and subject matter experts, a review of publicly available reports and peer-reviewed literature, and a review of other relevant information provided by DHS and other federal agencies. At the time this interim report was prepared for review, the committee had held three information-gathering meetings: July 2008, September 2008, and November 2008. (See Appendix A for the agendas of information-gathering sessions open to the public.) These meetings provided an opportunity for the committee to learn about the origins and objectives of the study; the BioWatch technology currently in use (Generation 2.0) and planned for deployment within the next few years (Generation 2.5 and Generation 3.0); the analysis underlying the deployment of BioWatch monitoring units; the intersection of the BioWatch program with state and local public health departments, including public health laboratories and the Laboratory Response Network; the use of traditional and syndromic surveillance by health departments to detect disease outbreaks; tools intended to improve diagnosis of diseases of concern in emergency departments and other clinical settings; and organizational and technological challenges in communication and information sharing. Two additional committee meetings will be held. STATUS OF THE COMMITTEE’S INVESTIGATIONS The issues before the committee are complex and require careful consideration of many different matters. Among these are the technological characteristics and capabilities of the devices being used in the BioWatch program, the prospects for the network of deployed monitoring devices to detect an aerosolized biological agent, and the implications of current and anticipated timeliness of data from BioWatch devices for response to a disease threat and mitigation of adverse outcomes. 

INTERIM REPORT 5 Also challenging is understanding the clinical context in which disease detection and reporting occurs and the factors that shape the decision-making process for the state and local public health officials who must interpret data generated by the BioWatch system as well as that from syndromic surveillance or traditional disease reporting. The issues are not only ones of understanding the health implications of the data, but also of sorting out the responsibilities, authorities, and expectations of a complicated mix of federal, state, and local participants. Failure to respond quickly in the face of a significant biological threat may have dire consequences, but initiating an unnecessary response on the basis of misleading information would have its own adverse results. Furthermore, the committee has been asked to consider features of an “enhanced national surveillance system” that relies on hospitals and the public health system. This task demands thoughtful consideration of both the desirable and the feasible. The committee must also understand the costs associated with biosurveillance. This is likely to prove challenging for the BioWatch program, which is new and operates primarily under the aegis of a single federal department but requires planning and involvement from each of the more than 30 localities where BioWatch is deployed. For public health and health care, however, the challenge will be much greater because of the need to understand the implications of biodefense-related surveillance for systems that must meet a broad array of other health surveillance needs. The task given to the committee touches on many subject areas and requires collection and review of a substantial body of information from not only the published peer-reviewed scientific and policy literature but also rapidly evolving policy and technical documents from federal agencies active in biodefense programs. The committee recognizes that information requests to agencies to obtain essential and up-to-date information impose additional burdens and appreciates efforts being made to respond to its requests. The committee is in the midst of its review of information and deliberations. As a result, it does not yet have an adequate basis for presenting any findings or recommendations in this interim report. At the conclusion of its review and deliberations, the committee looks forward to providing a final report that presents constructive findings and recommendations regarding the roles of the BioWatch program and the public health and health care systems in biosurveillance and disease detection for biodefense. REFERENCES CRS (Congressional Research Service). 2003. The BioWatch program: Detection of bioterrorism. RL32152. Washington, DC: Library of Congress. Available: http://www.fas.org/sgp/crs/terror/ RL32152.html (accessed July 9, 2008). DHS (Department of Homeland Security). 2008. Joint Statement of Mr. Robert Hooks; Mr. Eric Myers; Dr. Jeffrey Stiefel; Office of Health Affairs, before the House Committee on Homeland Security, regarding one year later—Implementing the biosurveillance requirements of the 9/11 Act. July 16. Available: http://www.dhs.gov/xnews/testimony/testimony_1216227063453.shtm (accessed January 16, 2009). Downes, F.P. 2008. One year later––Implementing the biosurveillance requirements of the ‘9/11 Act.’ Testimony before the Subcommittee on Emerging Threats, Cybersecurity, and Science and Technology of the Committee on Homeland Security, U.S. House of Representatives, July 16. Washington, DC. GAO (Government Accountability Office). 2008. Biosurveillance: Preliminary observations on Department of Homeland Security’s biosurveillance initiatives. GAO-08-960T. Washington, DC: GAO. 

6 EFFECTIVENESS OF NATIONAL BIOSURVEILLANCE SYSTEMS Gursky, E., T.V. Inglesby, and T. O’Toole. 2003. Anthrax 2001: Observations on the medical and public health response. Biosecurity and Bioterrorism 1(2):97–110. O’Toole, T. 2007a. Hearing on bioterrorism preparedness and the role of DHS Chief Medical Officer. Testimony before the Committee on Appropriations, Subcommittee on Homeland Security, at the Hearing on Bioterrorism Preparedness and the Role of DHS Chief Medical Officer. March 29. Washington, DC. O’Toole, T. 2007b. Six years after anthrax: Are we better prepared to respond to bioterrorism? Testimony before the U.S. Senate Committee on Homeland Security and Governmental Affairs, October 23. Washington, DC. Price, D. 2008. Opening statement by David Price, Chairman, Subcommittee on Homeland Security, U.S. House of Representatives Committee on Appropriations, April 1, at the Hearing on the Office of Health Affairs, Department of Homeland Security. Washington, DC. The White House. 2004. Biodefense and the 21st century. Homeland Security Presidential Directive (HSPD) 10, April 28. Washington, DC. Available: http://www.whitehouse.gov/homeland/ 20040430.html (accessed March 7, 2008).