Summary1

ABSTRACT Concern about bioterrorism and potential infectious disease epidemics has spurred interest in developing ways to detect biological threats as quickly as possible. The Department of Homeland Security’s (DHS’s) BioWatch program has air samplers deployed in more than 30 major U.S. cities intended to swiftly detect the presence of certain aerosolized biological agents to help local and state health officials respond promptly. In response to congressional questions about BioWatch’s technological capabilities and plans for a new generation of devices, DHS asked the National Academies to examine the BioWatch program and its costs and merits in relation to methods for disease surveillance through the public health and health care systems.

The current BioWatch system needs better technical and operational testing to establish its effectiveness. It also needs better collaboration with public health systems to improve its usefulness. The proposed enhancements of the BioWatch system will be possible only if significant scientific and technical hurdles are overcome. In principle, however, BioWatch and surveillance through the public health and health care systems are complementary. BioWatch has the potential to provide a more timely alert than the public health and health care systems under certain specific conditions:

1

This report is a public version of the document provided to the Department of Homeland Security on October 2, 2009. It has been modified slightly to omit operational details about the BioWatch system that the Department of Homeland Security considers sensitive information. The modifications have not resulted in any changes to the wording of the committee’s recommendations.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 1
Summary ABSTRACT Concern about bioterrorism and potential infectious disease epidemics has spurred interest in developing ways to detect biological threats as quickly as possible. The department of Homeland Security’s (dHS’s) BioWatch program has air samplers deployed in more than 30 ma- jor u.S. cities intended to swiftly detect the presence of certain aerosolized biological agents to help local and state health officials respond promptly. In response to congressional questions about BioWatch’s technological capabilities and plans for a new generation of devices, dHS asked the National Academies to examine the BioWatch program and its costs and merits in relation to methods for disease surveillance through the public health and health care systems. The current BioWatch system needs better technical and operational testing to establish its effectiveness. It also needs better collaboration with public health systems to improve its usefulness. The proposed enhance- ments of the BioWatch system will be possible only if significant scientific and technical hurdles are overcome. In principle, however, BioWatch and surveillance through the public health and health care systems are comple- mentary. BioWatch has the potential to provide a more timely alert than the public health and health care systems under certain specific conditions: 1 This report is a public version of the document provided to the Department of Homeland Security on October 2, 2009. It has been modified slightly to omit operational details about the BioWatch system that the Department of Homeland Security considers sensitive informa- tion. The modifications have not resulted in any changes to the wording of the committee’s recommendations. 

OCR for page 1
 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE if a large-scale aerosol attack occurs where BioWatch is deployed, if an air sampler lies in the path of the release, and if the pathogen used is one of those included in the BioWatch laboratory assays. To date, the BioWatch system has generated dozens of BioWatch Actionable Results, none of which has been associated with bioterrorism or human illness. The annu- alized direct cost of continuing the current program (generation ) over the next 0 years is estimated to be $80 million; if the planned transition to the timelier and more widely deployed generation 3 is successful, the estimated annualized direct cost for acquisition and operation over 0 years is $00 million. given the BioWatch system’s serious technical and operational chal- lenges and its costs, dHS should assess its effectiveness and frame program goals from a risk-management perspective; conduct systematic operational testing of current and proposed BioWatch technologies; establish an exter- nal advisory panel with technical and operational expertise; and strengthen collaboration and coordination with public health officials in BioWatch jurisdictions. Infectious disease surveillance through the public health and health care systems is broader and more flexible than BioWatch, having the potential to detect infectious diseases resulting from various exposures. Surveillance is an essential activity for health departments at local, state, and federal levels and relies on information from health care providers and laboratories in the public and private sectors. But insufficient data are available to measure the overall costs and effectiveness of infectious disease surveillance. To enhance disease surveillance capabilities, the department of Health and Human Services (HHS) should lead efforts to develop, test, and evalu- ate new disease surveillance methods and technologies to improve clinical recognition and reporting of infectious diseases of concern. dHS and HHS should aim to integrate BioWatch’s health protection role more effectively into a stronger, nationally coordinated public health surveillance system and should further the development of mechanisms for improving situ- ational awareness of biological threats, including secure sharing of relevant intelligence information with state and local health officials. dHS and HHS should also collaborate to build and sustain essential state and local work- force and operational capacities for detecting and responding to disease outbreaks and biological attacks. Concern about the possibility of bioterrorism and epidemics of emerg- ing infectious diseases has spurred interest among the national security, public health, and health care communities in developing new and better ways to detect biological threats as quickly as possible so that preven- tive measures or treatment can be started in time to reduce illnesses and deaths.

OCR for page 1
3 SummARy In 2003, the Department of Homeland Security (DHS) rapidly intro- duced BioWatch—a federal environmental monitoring system intended to speed detection of specific biological agents that might be released in aerosolized form in a biological attack. BioWatch air sampling devices are currently deployed, primarily in outdoor locations, in more than 30 major urban areas. Samples are typically collected and analyzed in designated laboratories once every 24 hours to test for genetic material from specified pathogens. DHS plans to replace the current “Generation 2” BioWatch system with an expanded deployment of a new biodetection system capable of more frequent, more rapid, and more comprehensive automated analysis and reporting of results (“Generation 3”). In response to congressional direction, DHS asked the National Acad- emies to evaluate the current and potential capabilities of BioWatch in detecting biological threats; examine the capabilities of the current and an enhanced surveillance system that relies on hospitals and public health agencies to detect biological threats; examine the costs of BioWatch and surveillance based in public health and health care; and consider whether BioWatch and traditional surveillance are redundant or complementary. The committee concluded that the current BioWatch system requires better testing and validation and better collaboration with the public health system. The proposed enhancements to the BioWatch system are appropri- ate but very ambitious; they will be possible only if significant advances can be made against long-standing scientific and technical challenges. But in principle, BioWatch and surveillance through the public health and health care systems are complementary. BioWatch has the potential to provide a more timely alert than the public health and health care systems if a large-scale aerosol attack using certain pathogens were to occur in the localities where BioWatch is deployed, and if BioWatch successfully detects the pathogen. In addition, the proposed Generation 3 technology, if it can be successfully tested and deployed, should be able to provide timelier detection than Generation 2. However, surveillance through the public health and health care systems is broader and more flexible than BioWatch, permitting detection of infectious diseases arising from a broader range of exposures. Moreover, it is already an essential element of daily public health activities at local, state, and federal levels. Furthermore, DHS needs to conduct systematic technical and opera- tional testing and evaluation of current as well as future BioWatch tech- nologies, and to evaluate the effectiveness of the BioWatch system from a risk-management perspective. Similarly, the Department of Health and Human Services (HHS) should lead efforts to evaluate and improve infec- tious disease surveillance and detection resources for the public health and health care systems. To achieve its health protection goals, the BioWatch system should be better linked to a broader and more effective national

OCR for page 1
 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE BOX S-1 Statement of Task 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 effective- ness 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 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 genera- tions of BioWatch, (2) current human health-related surveillance sys- tems, 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 bio- terrorist attack or other biothreat event. . . . The IOM/NRC will: 1. Evaluate the relative merits, and current and potential capabili- ties 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 biosurveillance framework that will help provide state and local public health authorities, in collaboration with the health care system, with the information they need to determine the appropriate response to a possible or confirmed attack or disease outbreak. SCOPE OF THE STUDY The study committee was asked to evaluate the effectiveness of Bio- Watch and compare it to an enhanced national surveillance system that relies on the health care and public health systems (see Box S-1). The charge

OCR for page 1
 SummARy 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 surveil- lance 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, includ- ing initiation of pre-infection prophylaxis and expedited response and recovery. 4. Reach a conclusion as to whether the two systems are redun- dant 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 assess- ment 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 practices of the National Acad- emies. The publication process for the final report will be completed following its public release. focuses specifically on surveillance and detection of infectious diseases or biological agents that pose a serious threat to human health. Bioterrorism, as the primary context for the BioWatch program, was the principal focus of attention.2 2 This study focused on the detection of biological threats to the civilian population in the United States. While recognizing the need to monitor and potentially respond to international disease activity, the committee did not examine disease surveillance systems in other countries or ones operated by international organizations. Disease threats to animals and plants per se are also excluded, although surveillance tools to monitor animal health and the presence of animal pathogens that can infect humans are an important component of public health surveillance systems.

OCR for page 1
 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE Three issues are beyond the scope of the study but are, nevertheless, fundamental to the committee’s assessment and recommendations. 1. Systems for surveillance and detection of disease threats need to be accompanied by the capability to respond with appropriate public health or medical measures that will minimize illness and death. 2. The BioWatch program is designed to detect certain biological agents that could be intentionally released in aerosolized form. Detecting a bioterrorism event involving other pathogens or routes of exposure requires other approaches. 3. There is considerable uncertainty about the likelihood and magni- tude of a biological attack, and how the risk of a release of an aerosolized pathogen compares with risks from other potential forms of terrorism or from natural diseases. EVALUATING BIOWATCH BioWatch is a federal program led by DHS that operates in collabora- tion with federal partners and with the states and localities where BioWatch air samplers are deployed. The federal partners include the Centers for Dis- ease Control and Prevention (CDC) in HHS, the Environmental Protection Agency (EPA), the Federal Bureau of Investigation (FBI) in the Department of Justice, and the Department of Defense (DoD). The review of BioWatch identified several concerns about program management and priorities, and about the system’s technical performance. Recommendations regarding enhancing the response to BioWatch alerts are made with the assumption that the current BioWatch system can be shown through operational testing to provide useful information. Strengthen the BioWatch Interface with State and Local Jurisdictions The BioWatch system needs to establish a more effective relationship with public health systems where it is deployed. Public health officials particularly need greater assistance in developing the necessary capabilities to interpret and respond to BioWatch Actionable Results (BARs). A BAR signals detection of segments of the DNA of a target organism, but the committee finds the term to be misleading because it sees a BAR alone as unlikely to be a sufficient basis for public health action. Detection of DNA consistent with that of a bioterrorism agent does not automatically mean that an attack has occurred, that an infectious agent has been released, or that people have been exposed. The committee concluded that local officials

OCR for page 1
 SummARy will generally need to gather and assess additional information to determine the proper response to a BAR. The apparent lack of systematic assessment of dozens of BARs that have occurred—none of which has been associated with bioterrorism or human illness—is a missed opportunity to capture and share lessons learned among the BioWatch jurisdictions and to inform program planning and de- velopment by DHS, CDC, and other federal partners. A formal mechanism is needed for the creation and sharing of BAR after-action reports. Local jurisdictions would also benefit from improved decision support tools to help in the synthesis and analysis of information relevant to decisions after a BAR is declared. DHS should continue its efforts to develop such tools. RECOMMENDATION 1: DHS and its federal BioWatch partners should provide coordinated and collaborative support to local juris- dictions to improve their ability to respond to a BAR. This support should include • strengthening relationships with state and local health officials and other key responder agencies (law enforcement, emergency man- agement, environmental protection) through additional and improved training, exercises, and information exchange; • developing, validating, and implementing rapid environmental sampling and testing methodologies to characterize the scale and scope of the incident immediately post-BAR. As validated methodologies are developed, situational awareness and decision support systems with analytical tools to facilitate analysis of critical information needed to inform decisions in response to a BAR should be developed; • preparing detailed guidance for local and state public health of- ficials with specific recommendations on public health measures and decisions following a BAR; • ensuring that a team, with specific training in reacting to BARs and relevant subject matter expertise (e.g., infectious disease epidemiol- ogy, laboratory science, environmental assessment, risk communication), would be available to provide around-the-clock expert federal assistance following a BAR; and • developing a formal mechanism for reviewing and sharing the “lessons learned” from the operation of BioWatch, including all BARs and interagency exercises. The states and local jurisdictions where BioWatch is deployed have been incurring unreimbursed financial and in-kind costs to support its op- eration. These costs, even if limited, are an added burden, especially with the current significant fiscal constraints for state and local government.

OCR for page 1
8 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE RECOMMENDATION 2: DHS should provide funding to cover local costs incurred in support of BioWatch resulting from space utilization, laboratory management oversight of BioWatch staff, training and ex- ercises, and other support functions. Conduct Systematic Testing and Evaluation of Current and Planned Technology The rapid initial deployment of BioWatch did not allow for sufficient testing, validation, and evaluation of the system and its components. The suspension of plans for the deployment of an interim technology and a delay in the acquisition and deployment of a Generation 3 system provide DHS with a needed opportunity to establish a more systematic, scientifically sound, and stakeholder-approved approach to technology acquisition, de- velopment, testing, and deployment than was possible when the BioWatch program began. DHS has developed plans for testing and evaluation for Generation 3. However, these plans reveal that technology goals for Generation 3 will be very difficult to achieve, and the planned test and evaluation time line may be too short. There is little allowance for delays to respond to problems that often emerge during testing, and there is limited provision for operational testing under diverse environmental conditions. Moreover, the operational test results must be evaluated against measures of effectiveness that should be developed through a genuine collaboration between the BioWatch pro- gram office and the public health community. The results of this and other BioWatch testing should be made available to public health stakeholders, with appropriate provisions for security requirements. With the delay in the planned deployment of Generation 3, a clearer understanding of the capabilities of Generation 2 is critical, and operational testing of Generation 2 should be undertaken now. Improvements are needed in the laboratory assays as well. The committee endorses DHS collaboration with CDC, EPA, and the FBI to develop validated and consistent assays and assay platforms that will be used in continued operation of Generation 2. RECOMMENDATION 3: DHS should conduct operational testing of BioWatch Generation 2 at sites where it is currently deployed to provide agent-specific performance specifications (based on use of ap- propriate surrogates as necessary) that are needed to refine Generation 3 requirements and to make effective use of BioWatch results (e.g., risk-management decisions). Generation 3 should undergo thorough operational testing before deployment. Results should be formally and thoroughly documented and made available to public health stakehold- ers in BioWatch jurisdictions.

OCR for page 1
 SummARy Within DHS, operational responsibility for the BioWatch program moved in 2007 from the Science and Technology Directorate to the Office of Health Affairs. These two organizations must have an effective collabo- ration plan to ensure that BioWatch’s operational needs are reflected in the research and technology development activities. RECOMMENDATION 4: DHS should improve the level of coopera- tion and collaboration between its Office of Health Affairs and its Science and Technology Directorate to promote effective research and technology development in support of the BioWatch program. Opportunities to Advance Future Biodetection Systems A continuing research and development effort is needed to provide the technology and knowledge for effective and sustainable outdoor and indoor environmental monitoring in urban environments. This program should focus on lowering the cost of biodetection, improving the knowledge base for interpreting surveillance results, providing flexibility for addressing un- known threats, and allowing for multiple applications (e.g., surveillance for both bioterrorism and natural disease agents) to make resource-intensive systems more cost effective. RECOMMENDATION 5: As part of its response to the technical and operational challenges posed by the development and launch of Gen- eration 3 BioWatch, DHS should collaborate with HHS, DoD, EPA, the National Science Foundation, and other agencies doing relevant work to develop and execute an aggressive research and development plan focused on (1) shorter-term goals to improve the capabilities and cost- effectiveness of the environmental monitoring for airborne biological threats performed by the BioWatch system, and (2) longer-term goals to improve the knowledge base needed to support transformational inno- vations in environmental biosurveillance. Work in support of shorter- term goals should focus on • Advancement of the state of science needed for the development of an autonomous field-deployable detector with capabilities to meet Generation 3 BioWatch operational requirements and beyond. Work supporting longer-term goals should include • Temporal and spatial characterization of pathogen and near- neighbor populations in air and natural reservoirs in urban areas, including those near BioWatch sites, and

OCR for page 1
0 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE • Participation in the work by others on host–pathogen interac- tions, surveillance, and epidemiologic research investigations and estab- lishment of shared databases. Make BioWatch Planning Risk-Based and Responsive to User Needs To be successful, BioWatch requires well-functioning, sophisticated de- tection technology. But to contribute to saving lives, it also requires effective coordination and communication with the public health decision makers and responders who must be able to determine with confidence whether BioWatch signals call for initiation of prophylaxis or other actions before clinical evidence of illness is evident. DHS has tended to assess BioWatch in terms of its technology. But the program should operate from the perspective of a more complete system that includes not only its detector technology and equipment and associated assays, but also the responsibilities that fall to state and local public health officials for additional information gathering to confirm and characterize a BAR; for communication with varied federal, state, and local authorities and with the public; and for response planning and training. DHS should emphasize its stated goal of timely response to mitigate illness and deaths from a biological attack, not just successful detection of genetic material that may indicate a terrorist event, and should collaborate with federal, state, and local stakeholders to develop BioWatch program objectives. Most importantly, DHS should ensure that the BioWatch program evaluates its planning within the framework of both a careful analysis of the risks of an airborne biological attack and the most effective ways to manage these risks. DHS’s existing Bioterrorism Risk Assessment (BTRA) program was developed for the specific purpose of providing input for this kind of decision making. A close link between BioWatch and the BTRA, modified as recommended in a 2008 National Research Council (NRC) report,3 would allow for careful evaluation and analysis of BioWatch’s po- tential contributions to improving health outcomes under realistic scenarios for public health decision making and response. This evaluation should include all risk scenarios, each pathogen that BioWatch monitors, and outdoor and indoor monitoring. The BioWatch program should not expand its coverage of biological agents or jurisdic- tions without a clear understanding of the change’s contribution to reducing mortality or morbidity in conjunction with clinical case finding and public 3 NRC (National Research Council). 2008. department of Homeland Security Bioterrorism Risk Assessment: A call for change. Washington, DC: The National Academies Press.

OCR for page 1
 SummARy health surveillance. Furthermore, changes to the BioWatch program, includ- ing those recommended by this committee, should be subjected to rigorous analysis of their costs and benefits. RECOMMENDATION 6: DHS should use its existing and periodically conducted bioterrorism risk assessment and other analyses to evaluate the overall effectiveness of the BioWatch system, examine the costs and benefits of the system’s current configuration and of significant pro- posed changes, and articulate its program goals and associated perfor- mance metrics, using risk-assessment and risk-management principles. To accomplish this, DHS should • Actively solicit input from and collaborate closely on all aspects of the program with key partners and stakeholders at the federal, state, and local levels; and • Conduct comprehensive modeling and analysis to evaluate the potential contributions of the BioWatch system to public health deci- sion making and outcomes using, where appropriate, a Bioterrorism Risk Assessment (BTRA) that has been modified according to the recommendations in a 2008 NRC report. Such analyses should be performed for all pathogens for which BioWatch will test and for both outdoor and indoor monitoring programs. In the continued development of the BioWatch system, DHS and HHS should work collaboratively, and their joint effort should be guided by advice from an independent panel of external stakeholders and subject matter experts having operational, decision-making, and technical exper- tise. This panel should advise on setting program goals and objectives, evaluating progress toward them, and decision making and planning for the BioWatch system. Advisors should include state and local public health officials with decision-making roles in response to a BAR. Areas of expertise should include epidemiology, environmental health, public health labora- tory systems, infectious diseases, biochemistry, genetics, law enforcement, emergency management, detection technology, meteorology, systems engi- neering, decision and information science, and operations research. RECOMMENDATION 7: DHS and HHS should jointly establish a formal mechanism for receiving ongoing external advice on all techni- cal and operational issues related to the BioWatch system. The advisory panel should include both technical experts and state and local officials who have experience working with the BioWatch system and would have decision-making roles in the event of a BAR.

OCR for page 1
 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE ENHANCING NATIONAL SURVEILLANCE CAPACITY AND RESOURCES The public health and health care systems face many challenges in meeting preparedness goals, including achieving more effective infec - tious disease surveillance and capabilities for analysis and exchange of information. Capabilities vary across local and state health departments, contributing to inefficiencies and the potential for surveillance gaps. In- vestments, especially increases in federal funding since 2001, have brought improvements; but further improvements are needed and federal funding covering all aspects of preparedness has declined since the initial post- 2001 increases. Develop and Evaluate New Opportunities in Infectious Disease Surveillance and Detection Detecting and responding to infectious disease threats is a core function for the public health and health care systems. Efforts are being made at the local, state, and federal levels, spurred in part by funding for bioterrorism and public health emergency preparedness, to strengthen existing resources and develop improved surveillance techniques. For example, enhancement of public health laboratory capability and capacity to conduct molecular subtyping to detect clusters of genetically similar pathogens isolated from patients has the potential to detect and characterize bioterrorism or out- breaks more quickly. “Syndromic” surveillance programs have been devel- oped to aggregate and analyze various types of data to identify unusual statistical patterns that may signal a disease outbreak. But their value for early detection of disease outbreaks, especially for detection of bioterror- ism, is still uncertain and requires additional evaluation. Approaches to improving automated aggregation and analysis of surveillance data and interoperability of data systems are still evolving. HHS, in partnership with state and local public health agencies, should coordinate a strategic, goal-oriented program of intra- and extramural research and development, pilot-testing, and operational evaluation of improved public health surveillance methods. The program should identify and address evidence gaps, unevenness in the geographic deployment and quality of public health surveillance, evaluation of promising methods and technologies, costs and effectiveness, and integration and harmonization of approaches across the many surveillance programs used by CDC and the public health community. Cost-effective methods resulting from this effort should be deployed across state and local jurisdictions through a combina- tion of federal funding and local investments.

OCR for page 1
3 SummARy RECOMMENDATION 8: HHS should support the development, test- ing, and evaluation of improved methods for surveillance for infec- tious disease outbreaks. HHS, through CDC, should take a stronger leadership role in evaluating and enhancing efforts for automating both traditional provider and laboratory reporting and syndromic and other approaches to surveillance, including the development of standards, coordination of state and local initiatives, and integration of federal programs with state and local activities. HHS should assign this leader- ship role to those responsible for the prevention and control programs these surveillance systems are intended to serve, and it should rigor- ously evaluate these surveillance efforts. Achieve Better Information Sharing and Situational Awareness Much of the information that enables detection, characterization, and ongoing management and mitigation of natural and bioterrorism-related in- fectious disease outbreaks is generated by health care providers and labora- tories, collected at the local or regional level, assembled at a statewide level, and then reported to CDC at the federal level. However, geographic and programmatic compartmentalization of this information can impede iden- tification of regional, national, and international health events. Appropriate and timely exchange of health information also depends on the willingness of local and state authorities to provide it, which, in turn, is related to the value and costs of the process for those providing the information. Better information sharing can contribute to quicker and more effective outbreak detection, improved communication between public health officials and clinical providers, and improved situational awareness and response capa- bilities. The scope of information access should include information on animal health, vector control, water and air quality, meteorology, and other informa- tion to aid in monitoring or assessing potential threats to human health. Efforts are also being made to increase information sharing between public health agencies and law enforcement and the intelligence community in ways that respect the privacy of individuals and the confidentiality of personal health information that public health agencies are entrusted to collect. Federal efforts to improve situational awareness are still evolving. For example, DHS’s National Biosurveillance Integration Center is intended to bring together national and international information that could enhance advance warning of potential biological threats. In HHS, the BioSense pro- gram is emphasizing aggregation of data from hospitals and other health care sources, and the BioPHusion program is focusing on providing analy- sis of public health data such as that collected by BioSense. Ensuring that information from BioWatch is effectively integrated into such systems will help maximize its value.

OCR for page 1
 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE RECOMMENDATION 9: DHS and HHS should enhance the efforts to develop a mechanism for providing a national situational aware- ness of biological threats and significant disease outbreaks, to better inform rapid decision making and response through cross-jurisdictional data sharing and analysis of data. To this end, DHS and HHS should facilitate the development of an interoperable, secure, bidirectional, nationwide information-sharing infrastructure and ensure that local and state health officials have ready access to the system. Develop and Evaluate Decision Support for Clinical Case Recognition and Reporting by Health Care Providers Early detection of a bioterrorism event or the emergence of a naturally occurring disease threat may depend on the ability of astute clinicians to diagnose the first few cases, or recognize suspicious clinical presentations that require special scrutiny by experts in infectious diseases. However, this requires busy clinicians to recognize a rare disease they may well be seeing for the first time—a challenging prospect in the best of circumstances. Index case recognition is particularly difficult in the early stages of disease, when symptoms may be vague or consistent with other, much more common (and less dangerous) diseases. Clinically useful, bidirectional, and modifiable decision support tools for use by emergency departments and other acute care settings should be developed and evaluated as means to improve the speed and consistency of the clinical recognition, reporting, and management of index cases of diseases of greatest public health concern, as well as other reportable public health conditions. Providing effective tools of this sort to emergency depart- ments and other acute care settings, many of which already face challenges in adequately serving patients under routine circumstances, is a high pri- ority. Other technologies under development, such as rapid point-of-care diagnostic testing, may also enhance timely case recognition. RECOMMENDATION 10: HHS should promote the development, testing, and evaluation of technologies that strengthen the accuracy, timeliness, consistency, and completeness of clinical diagnosis of infec- tious diseases of public health importance, and that facilitate timely reporting of these diagnoses to public health authorities. COMPLEMENTARY SURVEILLANCE ROLES FOR BIOWATCH AND PUBLIC HEALTH AND HEALTH CARE While recognizing the need for more and better testing of the BioWatch system’s ability to meet its technical and operational requirements, the com-

OCR for page 1
 SummARy mittee concluded that BioWatch in its current form (Generation 2), or with planned enhancements (Generation 3), has the potential to fill a unique and complementary functional niche in the nation’s biosurveillance resources. However, this potential can be realized only if a large-scale aerosol attack occurs in a locality where BioWatch is deployed, if an air sampler lies in the path of the release, and if the pathogen used is one of those included in the BioWatch laboratory assays. In particular, some modeling analyses show that under these conditions, BioWatch has the potential to provide a more timely alert than the public health and health care systems. The potential benefit appears likely to be greater for the detection of anthrax spores than other monitored threat agents, given the potential for aerosolized distribu- tion of anthrax spores, the rapid progression and high case fatality rate of inhalation anthrax, and the opportunity to limit infections with timely post-exposure prophylaxis and to lower morbidity and mortality with early treatment. But BioWatch is specialized, and it does not eliminate the need for the broader and more flexible surveillance activities of the public health and health care systems, either in their current forms or with various enhance- ments. Infectious disease surveillance is an essential part of daily activities at local, state, and federal levels to protect the public’s health from various threats, including bioterrorism or naturally occurring infectious disease. With or without BioWatch, the public health system needs to be capable of monitoring disease trends and accessing information from multiple sources (e.g., animal health, environmental monitoring, and law enforcement) to identify or characterize situations that may signal a public health emer- gency. At best, BioWatch is only one source of such information. Table S-1 provides a broad-brush summary of key features of BioWatch and traditional disease surveillance systems. This kind of summary com- parison is challenging because of the differences in the purpose and scope of the BioWatch system and infectious disease surveillance activities through the public health and health care systems. A cost comparison of the BioWatch system and enhanced surveillance by the public health and health care systems is especially problematic. BioWatch is supported by a relatively well-defined federal program, albeit imposing some poorly identified costs on states and localities in supporting daily operations and responding to periodic BARs. Projections suggest that the average annual direct federal costs over the next 10 years will be ap- proximately $80 million for continuing the BioWatch program in its current form (Generation 2). If the transition is made to the planned Generation 3 system, the annualized direct costs will be about $200 million for acquisi- tion, deployment, and operation. The costs of the broader infectious disease surveillance activities in the public health and health care systems are difficult to determine. Current

OCR for page 1
 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE TABLE S-1 Capabilities and Costs of the BioWatch System and Surveillance Through the Public Health and Health Care Systems Detection Sensitivity and System Capability Coverage Specificity BioWatch System Generation 2 Certain biological > 30 major Not publicly agents; environ- metropolitan areas available mental presence of (i.e., BioWatch Dozens of BARs to airborne genetic jurisdictions) date; none linked material to bioterrorism Generation 3 Biological agents Expanded coverage System not yet covered by selected (proposed) Generation 2, with goal of including additional agents; environmental presence of airborne pathogens Public Health and Health Care Systems Disease recognition All human health Entire country, Not readily and reporting hazards (e.g., reports of quantified; varies by health care biologic, chemical, uneven quality by disease, providers and environmental) submitted to provider, location, laboratories that result nearly 3,000 local reporting system, to health in clinically and state health epidemiologic departments recognized disease departments expertise, and or injury other resources

OCR for page 1
 SummARy Other Timeliness Benefits Annual Costs Considerations Typical 24-hour If aerosolized $80 million (10-year Need for testing sample collection pathogen is average) and evaluation cycle; 10- to detected, potential Costs of recom- of technology, 36-hour window reduction in mended program holistic evaluation from release to casualties if changes not of goals, better confirmation of distribution of included tools to aid public screening test prophylaxis health response, and treatment and assessment of can be started environmental risk sooner; potential after a BAR interruption of contagion or environmental spread* Proposed 4- to Potential for $200 million (10- System not yet 6-hour time to reduction in year average) selected; actual detect; automated casualties may for acquisition, performance sample processing be greater than deployment, and may differ from and testing and with Generation 2 operation proposed specifica- reporting of because of plans Costs of recom- tions; significant results for more frequent mended program technological hurdles testing* changes not must be overcome included to achieve desired system capabilities May depend Provide ongoing Unknown; data Need for additional on disease, detection of necessary to integration and skill of health intentional estimate costs information sharing care provider, and naturally of disease across federal, state, availability of occurring surveillance and local levels; appropriate outbreaks for systems or need for evaluation analysis tools, prevention or marginal cost and incorporation of scale of pathogen treatment of surveillance new techniques exposure, for significant reporting system; infectious disease depends on threats not evidence of available infection, so not likely to detect before environmental surveillance continued

OCR for page 1
8 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE TABLE S-1 Continued Detection Sensitivity and System Capability Coverage Specificity Syndromic Varies by system Currently > 80% of Varies by system surveillance design and state, tribal, large design and application local jurisdictions application, scale have some form of outbreak NOTE: BAR, BioWatch Actionable Result. *Achieving a reduction in mortality with the BioWatch system depends on the BioWatch technology and communication of a BioWatch Actionable Result, expeditious information gathering to confirm a bioterrorist event, and having the capability to distribute mass prophy- laxis or treatment to prevent or reduce illness and mortality. budgeting and accounting systems at the local, state, and federal levels do not usually provide this information, and the surveillance costs incurred by the private-sector components of the health care system are even less read- ily captured. Furthermore, surveillance for significant biological threats, or specifically for bioterrorism threats, cannot be readily separated from other health surveillance programs. Annual governmental expenditures on all public health activities are estimated at approximately $64 billion. But the committee was unable to obtain information that would allow a determina- tion of the portion of these costs attributable to infectious disease surveil- lance. Better data are needed to assess the costs of surveillance systems, and innovative strategies will be needed to assess the cost-effectiveness of any surveillance system enhancements. A NATIONAL BIOSURVEILLANCE SYSTEM A national biosurveillance system should aid in protecting the nation’s population from significant, time-critical biological threats of all types. “National” in this context means encompassing the information needs of potential users across the country and facilitating access to data that can help in the recognition of and response to either localized health emergen- cies or geographically dispersed events that may arise from circumstances such as contamination of widely distributed foodstuffs or a bioterrorism event that targets a transportation hub.

OCR for page 1
 SummARy Other Timeliness Benefits Annual Costs Considerations May depend on May help detect and Would be included Requires further scale of pathogen track sporadic in costs of disease testing and exposure, but and recurring surveillance; cost evaluation to assess not likely to infectious disease of developing strengths and detect before outbreaks and operating limitations as tool environmental individual systems to aid detection of surveillance expected to vary infectious disease widely outbreaks This system would employ a layered approach that includes 1. judicious use of environmental surveillance tools, such as Bio- Watch, to detect a small number of current and potential future airborne threats that could harm a large number of people; 2. an enhanced capacity to recognize, isolate, and report index cases from clinical settings; 3. refined approaches to analyzing epidemiologic data to detect aber- rant signals that may indicate a disease outbreak and track its spread; 4. improved and more rapid methods for use in the laboratory or at the point of care to detect, verify, and characterize a biological threat; 5. improved tools for data management and for communication of information among all appropriate stakeholders; 6. streamlined approaches at the federal, state, and local levels to intelligence and information sharing and to decision making to minimize delay between the emergence of a threat and appropriate action to minimize its consequences, and timely after-action analysis to identify strengths and weaknesses in policies and procedures; and 7. sustainable funding that encourages integration of data across programs. At present, the nation lacks a clear, overarching architecture of inter- locking interagency goals, metrics, and accountability to assure a seam- less process from detection of biological threats through response and recovery.

OCR for page 1
0 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE BUILDING AND SUSTAINING CAPACITY TO DETECT AND RESPOND TO HEALTH EMERGENCIES Despite substantially increased federal funding since 2001 to improve emergency preparedness in state and local health departments and in the health care system, long-standing concerns about the nation’s capacity to respond to health emergencies remain. The infusion of federal funds for public health and medical preparedness has improved the general level of preparedness, but the categorical nature of the funding and some uncer- tainty about its continuation has generally discouraged public health agen- cies from integrating new capacities with traditional programs. At the same time, investment in the basic public health infrastruc- ture, such as staffing and electronic information management and analysis systems, has been more limited. The unevenness of organizational and technical capacity at state and local levels across the public health system weakens the nation’s preparedness to detect and, especially, to respond to and manage the consequences of a major health emergency. With reductions in federal funds and financial challenges facing state and local governments in 2009, these weaknesses may worsen. Federal assistance is needed to achieve the desired minimum state and lo- cal capacities for surveillance for bioterrorism and infectious disease threats, but the task will be challenging, requiring effective coordination and collabo- ration in state and local public health systems and in the complexities of both state and federal relationships and federal interagency action. RECOMMENDATION 11: HHS and DHS should give high priority to building and sustaining sufficient public health workforce strength and competencies, along with associated laboratory and information management capacities, needed by all states and communities to detect a bioterrorism attack or other public health emergency. They should pursue a nationally consistent minimum level of disease surveillance and communication sufficient to provide early warning and tracking of bioagent attacks and outbreaks of natural disease. Key state and local capacities should include the following: • Adequate amounts and types of staff expertise, including infec- tious diseases, veterinary health, laboratory science, environmental health, applied epidemiology and biostatistics, and health informatics; • Adequate public health reference laboratory capacity; • Electronic laboratory reporting systems to ensure timely and complete transmission of notifiable disease reports from commercial and hospital-based laboratories to public health;

OCR for page 1
 SummARy • Universal access to public health reference laboratory services for detecting and confirming biothreats and other emerging infectious diseases and performing molecular typing to link cases in outbreaks; • Robust surveillance and outbreak management information systems; • Electronic death registration systems; • Health alert networks that connect public health departments with all health care facilities and providers in their jurisdictions; and • Integration of public health needs and systems into emerging health information exchanges. CONCLUDING OBSERVATIONS The federal BioWatch program faces the challenge of supporting both a national security mission and the health care and public health systems, at state and local levels, in monitoring threats to human health. The Bio- Watch system has the potential to contribute to its health protection goal by providing early warning of a biological attack, but only if the attack uses certain aerosolized pathogens and if BioWatch air samplers lie in the path of the release. BioWatch’s potential contribution to minimizing illness and death re- lies upon an awkward and organizationally challenging arrangement for responding to BARs and depends heavily on the ability of health depart- ments and the health care system to analyze the nature of a detected threat and to take quick and decisive action. It is therefore essential that the op- eration and management of the BioWatch system be well integrated with the jurisdictions where it operates. State and local authorities, whose legal responsibilities as well as knowledge of endemic health risks and available resources cannot be replicated at the federal level, must be recognized as essential and valuable partners not only in the BioWatch program but also in broader national biosurveillance and emergency preparedness efforts. It is essential that policy makers recognize that the benefits of any form of infectious disease surveillance will not be realized if states and communi- ties do not also have the capability to respond effectively to a public health emergency. Despite the substantial progress that many localities have made in advancing mass dispensing capacity, having the ability to administer an- tibiotic prophylaxis to hundreds of thousands, if not several million, urban area residents within a few days following detection of a bioterrorist attack remains challenging.