6
BioWatch and Enhanced National Biosurveillance Resources

The previous chapters describe aspects of the current and planned environmental monitoring technology of the Department of Homeland Security’s (DHS’s) BioWatch program and current and potentially enhanced surveillance practices in the public health and health care systems. Here the committee compares the BioWatch program to enhancing current surveillance practices in the public health and health care systems.1

EXPLORING THE EFFECTIVENESS OF BIOSURVEILLANCE RESOURCES

Evaluating the effectiveness of the BioWatch program is problematic for several reasons.

  • Definitive information about the likelihood of a catastrophic bioterrorist attack of the kind that BioWatch is intended to detect and about the specific nature, costs, and effectiveness of an enhanced surveillance system implemented through the public health and health care systems is not available.

  • No bioterrorism events have tested the currently deployed Generation 2 BioWatch system, and risk-management analyses do not appear to be available for all of the pathogens currently included in BioWatch testing.

1

As noted in Chapter 1, the public health and health care “systems” of the United States are highly decentralized.



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6 BioWatch and Enhanced National Biosurveillance Resources T he previous chapters describe aspects of the current and planned en- vironmental monitoring technology of the Department of Homeland Security’s (DHS’s) BioWatch program and current and potentially enhanced surveillance practices in the public health and health care systems. Here the committee compares the BioWatch program to enhancing current surveillance practices in the public health and health care systems.1 EXPLORING THE EFFECTIVENESS OF BIOSURVEILLANCE RESOURCES Evaluating the effectiveness of the BioWatch program is problematic for several reasons. • Definitive information about the likelihood of a catastrophic bio- terrorist attack of the kind that BioWatch is intended to detect and about the specific nature, costs, and effectiveness of an enhanced surveillance system implemented through the public health and health care systems is not available. • No bioterrorism events have tested the currently deployed Genera- tion 2 BioWatch system, and risk-management analyses do not appear to be available for all of the pathogens currently included in BioWatch testing. 1 As noted in Chapter 1, the public health and health care “systems” of the United States are highly decentralized. 

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 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE • The Generation 3 BioWatch system has not yet been selected, so its assessment can be based only on the proposed operational requirements (DHS, 2008, 2009). • The public health and health care systems regularly face the need to recognize and respond to naturally occurring disease outbreaks and sea- sonal illness and are also expected to be able to detect and respond to bio- terrorism events. Assessments of the effectiveness of surveillance systems in detecting disease outbreaks are limited, especially for newer syndromic sur- veillance techniques (Bravata et al., 2004; CDC, 2004; Buckeridge, 2007). In trying to determine their effectiveness in the event of bioterrorism, it is necessary to rely on simulations because actual data are not available. • Biosurveillance within the public health system is composed of numerous separate systems, varying in maturity, whose integrated cost and performance is difficult to assess for detection of either natural disease outbreaks or bioterrorist events, whether alone or in conjunction with BioWatch. • Natural outbreaks are heterogeneous, differing in size, location, agent, and mechanism of spread, as are the capabilities of state and local public health departments to recognize and respond to outbreaks and the availability of health care resources to provide treatment. Assessing the effectiveness of a potentially enhanced surveillance system is even more challenging. • The digitalization of health information that could improve the speed and ease of disease surveillance remains incomplete. Despite these challenges, it is possible to make a basic but informative comparison of BioWatch with surveillance through the public health and health care systems. Performance of the BioWatch System A fundamental question is whether BioWatch can perform in a use- ful way. Answering this question requires considering several interrelated events that are necessary for BioWatch to contribute to the reduction of illness and loss of life (see Table 6-1). The official estimates of the prob- abilities of some of these events, especially that a bioterrorism attack will occur, that it will take place in a BioWatch jurisdiction, and that it will be delivered in a manner that BioWatch has the potential to detect, have not been made available to the committee. With the understanding that judgments about these probabilities will be crucial to policy decisions that must be made about the refinement and further deployment of BioWatch, the committee looked at the system’s potential performance assuming there is a detectable attack, that is, a large-scale airborne release of one of the

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 BIOWATCH ANd ENHANCEd NATIONAl BIOSuRVEIllANCE TABLE 6-1 Steps Necessary for BioWatch to Help Reduce Illness and Loss of Life Necessary Step Likelihood Evidence Large airborne release of a Uncertain* bioagent Release occurs in BioWatch Uncertain* jurisdiction Bioagent among those Uncertain* detectable by BioWatch Bioagent remains viable and Depends on agent processing Military testing is of suitable particle size method, dissemination for infection method, agent vulnerability to ultraviolet light, and other environmental factors Bioagent plume reaches a Depends on size and location Military testing, modeling BioWatch detector of release relative to location and density of detectors; and on meteorological conditions that control dispersion (e.g., wind velocity, stability) Analysis of BioWatch sample Likely (?) Genetic material from naturally produces positive reading occurring organisms when target agent is present successfully identified from (result of many substeps) Generation 2 filters Decision makers receive Variable, by jurisdiction; in No experience yet with a positive BioWatch result and general, uncertain BAR later determined to other information sufficient result from a bioterror to promptly recognize a event BioWatch signal as indication Testimony from public health of a true bioterror event officials Effective prophylaxis or Depends on the agent Medical literature treatment exists Decision makers initiate Depends on the detected Experience from multiple prophylaxis or treatment agent, other available BARs, but response to a information, and BAR for anthrax may differ circumstances Testimony from public health officials Prophylaxis or treatment Depends on the agent, Modeling is carried out in time dose, time elapsed Exercises to reduce mortality and since human exposures, morbidity ability to define and target prophylaxis to the population exposed, and dispensing capabilities NOTE: BAR, BioWatch Actionable Result. *Information about this step may be available to those conducting the threat analysis but was not part of this committee’s review.

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8 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE pathogens included in the BioWatch assays in a location where a BioWatch device can obtain a sample for analysis. The BioWatch system currently operates in more than 30 major met- ropolitan areas, with most of the collectors deployed in outdoor locations. Given the relatively modest number of devices available for BioWatch juris- dictions, their placement is a major factor in determining whether at least one collector would be in the path of an aerosol release. But their alloca- tions were based upon dispersion models of urban environments that are especially challenging and sensitive to assumptions about parameter values (GAO, 2008b). Operational testing will be important to better understand collector efficacy and aerosol behavior in the complex microclimates of the urban environments of BioWatch jurisdictions, and the probability of plume detection. On a few dozen occasions since implementation the BioWatch system, samples have produced positive findings that were interpreted as being ge- netic material from an organism among those currently being monitored. These BioWatch Actionable Results (BARs) have demonstrated that the cur- rent BioWatch technology can collect analyzable genetic material and that the current laboratory assays can detect this genetic material. In each BAR, BioWatch jurisdictions concluded that no terrorist release had occurred and that there was no indication of increased human illness. (The committee notes that it heard testimony from public health officials in some of these jurisdictions, but it did not have the opportunity to review the information available to the public health authorities in each case.) However, as discussed in Chapter 3, several concerns about the Bio- Watch system’s technical performance remain, including questions about sample collection, laboratory analysis, siting practices, and program priorities. One concern is the usefulness of the analyses of the BioWatch air samples. The information provided to the committee about BARs does not indicate whether viable organisms were collected. In addition, more needs to be learned about the genetic near neighbors of the pathogens that BioWatch targets and about the microbial ecology of the areas where BioWatch operates. All of the BARs to date appear to be the result of procedurally accurate analyses of BioWatch samples. Although none of them has been determined to be due to bioterrorism, these BARs have been unplanned opportunities to test the BioWatch program’s plans and procedures. Nevertheless, they amount to false alarms that are costly to evaluate. Repeated false alarms may eventually create a sense of skepticism or complacency that could delay or hinder an appropriate response to a true bioterrorism event. The opposite, but related concern is determining the likelihood that the BioWatch collection and analysis process may fail to detect the presence of targeted organisms.

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 BIOWATCH ANd ENHANCEd NATIONAl BIOSuRVEIllANCE Realizing Benefits from the BioWatch System The expected benefits from the BioWatch system derive primarily from the anticipation that it will decrease the time that elapses between a large- scale airborne release of a bioterrorism agent and the distribution and use of post-exposure prophylaxis and post-infection treatment. For BioWatch Generation 2, the time from the release of a biological agent to confirma- tion of positive results—the declaration of a BAR—would typically be 10 to 36 hours (depending on when an event occurs during the 24-hour collection cycle and allowing for filter recovery, primary screening, and agent-specific testing). As discussed in Chapter 3, plans for BioWatch Generation 3 in- clude a 4- to 6-hour time to detect a pathogen. The committee is most confident about the potential for early detection via BioWatch to reduce morbidity or mortality in the event of a massive aerosol attack using Bacillus anthracis spores, assuming an effective public health response capability is in place. This conclusion is based on evidence that includes the environmental stability of B. anthracis spores; empiri- cal findings about infection and mortality rates from natural outbreaks, the Sverdlovsk release, and the 2001 anthrax letters; the relatively rapid incubation period of anthrax (during which victims have no symptoms); the potential for effective post-exposure antibiotic prophylaxis; and the rapidly decreasing efficacy of treatment after the onset of symptoms (e.g., Jernigan et al., 2001; Inglesby et al., 2002; Holty et al., 2006; Wilkening, 2006, 2008). Several modeling analyses suggest that the timing of the start and completion of a prophylaxis effort following detection of an anthrax release are critical factors in determining subsequent morbidity and mortality (e.g., Hupert et al., 2002; Buckeridge et al., 2005, 2006; Wein and Craft, 2005; Yang et al., 2006; Baccam and Boechler, 2007; Zaric et al., 2008). Early notice of a potentially catastrophic release of anthrax may speed a range of actions up to and potentially including initial distribution of prophylaxis from local supplies while further investigation proceeds and dispatch of prophylactic and therapeutic medications from the national stockpile is arranged. But such presumptive actions have to be weighed against the po- tential for adverse reactions if antibiotics or vaccines are administered and other negative consequences should the BioWatch signal ultimately prove to be a false alarm. For agents other than B. anthracis, however, there is less information and less confidence that the BioWatch system’s early detection potential will result in decreasing morbidity and mortality. Better evidence and thoughtful consequence analysis are needed on other agents’ environmental stability in an aerosol attack, the effectiveness of post-exposure prophylaxis, and the time course and virulence of infection.

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0 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE Although a BAR may present an opportunity to hasten the delivery of pro- phylactic or therapeutic care, it does not automatically trigger a public health response. The type and timing of a response are likely to depend on public health officials’ judicious interpretation of not only the BAR but also other information that may include the number of the BioWatch collectors affected, the strength of the real-time PCR signal in affected collectors, the availability of corroborating information (including follow-up environmental sampling or information from law enforcement or intelligence sources), the effectiveness of public notification, and the resources available to set up distribution centers. Testimony to the committee suggests that, depending on the circumstances, some public health officials may be hesitant to launch a high-regret action that may cause unnecessary alarm or even harm, such as initiating the widespread distribution of prophylaxis or treatment, without confirmed cases of disease in humans or animals. This may reduce but does not necessarily negate the value of BioWatch environmental detection. A BioWatch alert may trigger outreach to health care providers and help them identify early cases of illness that might otherwise be missed or ascribed to other causes. It could also trigger preparation for the delivery of medical countermeasures and shorten the interval from later confirmation to chemoprophylaxis. Plus, a BAR in one jurisdiction may be important context for the interpretation of a closely timed BAR in another location. Thus, a BAR may enhance response even if it does not automatically trigger distribution of prophylaxis. In addition, a BAR can spur investigation and collection of evidence needed in the national security and law enforcement response to bioterrorism. Qualitative Assessment of Enhanced Surveillance Through Public Health and Health Care Systems Detection of bioterrorism or a disease outbreak through the public health and health care systems is, by definition, the detection of symptoms or infection (or behavior related to the onset of illness). Because almost all infectious agents require an incubation period of hours to weeks before signs or symptoms of illness appear, none of the potential enhancements discussed in Chapter 5 can be expected to provide earlier notice of the po- tential for exposure than rapid environmental detection can. However, to varying degrees, many of these enhancements may facilitate earlier recogni- tion of an outbreak that BioWatch cannot or does not detect, or provide confirmatory information after a BAR, and thus they may allow for earlier mobilization of a response than is possible now. These enhancements may also improve the effectiveness of the response by improving decision mak- ers’ situational awareness. The most important enhancements are those that will facilitate rapid diagnosis of infections, and that enable public health authorities to detect

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 BIOWATCH ANd ENHANCEd NATIONAl BIOSuRVEIllANCE incidence patterns consistent with an outbreak. For example, enhancement of public health laboratories’ capability and capacity to conduct molecular subtyping to detect clusters of genetically similar pathogens isolated from cases is used to link cases that might otherwise not be connected to a point source, such as accidental or intentional contamination of food products. Another desirable enhancement is the development and use of effective clin- ical decision support tools for diagnosis, reporting, and case management, because these may enable rapid identification and reporting of the index case in an outbreak. As is true with BioWatch, the benefits of such earlier detection are contingent on informed interpretation and decision making by health care providers, public health personnel, and other officials. CDC has described attributes that should be considered in an evalua- tion of surveillance systems generally (CDC, 2001) and has recommended a framework specifically for evaluating surveillance systems for early detec- tion of outbreaks (CDC, 2004). The overall attributes include a surveillance system’s usefulness, simplicity, flexibility, data quality, acceptability to data contributors, sensitivity, representativeness, predictive value, timeliness, and stability. The expectations for, and the importance of, any given attribute may vary, depending on the purpose of the surveillance system. Sensitiv- ity, timeliness, and predictive value are of particular significance for early detection of outbreaks. With the specific challenges of rapid detection of bioterrorism and other serious infectious disease threats in mind, the committee framed 10 related performance features that could be used to evaluate the potential contributions of BioWatch or enhanced surveillance tools that may be in- tegrated into the public health and health care systems. These performance features are: 1. Facilitates early detection of an attack or the onset of an outbreak 2. Minimizes “false positive” alerts for an attack or outbreak 3. Improves recognition of an index case 4. Facilitates validation of signals of a possible bioterrorist attack or other outbreak and facilitates initial response decisions (e.g., whether to initiate mass prophylaxis) 5. Improves situational awareness during an event (e.g., the extent of exposure, disease trends and characteristics, available health care capacity) and allows characterization of the scale and scope of the incident so that mitigation can be effectively targeted 6. Improves communication among public health personnel and cli- nicians (e.g., event or case detection, event status, patient evaluation or treatment, infection control) 7. Improves communication among public health laboratories, clini- cal laboratories, and public health epidemiologists (e.g., event or case

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 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE detection, event status, specimen management, test procedures, quality assurance) 8. Detects bioterrorism attacks unlikely to be detected by existing environmental surveillance 9. Detects emerging infectious disease and other natural (uninten- tional) outbreaks 10. Aids surveillance of noninfectious health problems (e.g., injuries, chronic disease, intoxication) Specific measures for enhancing surveillance in the public health and health care systems are discussed in Chapter 5 and listed in Box 6-1. Because formal evidence for the benefits of each proposed enhancement is limited and varies depending upon the enhancement, this qualitative assessment is largely based on expert opinion on the potential for improvement. Note that the merits of expanding BioWatch to smaller localities need to be explored in risk-based analyses that account for many factors, in- cluding the probability of an attack in additional localities and the size of the potentially exposed population. With the current deployment in large urban areas, the BioWatch program has had the advantage of working with larger health departments that tend to have greater expertise and response capability than smaller health departments. Expanding BioWatch to more localities would require DHS to work with local health departments that are likely to need more federal interaction and support to be capable of analyzing and responding to a BAR. EXAMINING THE POTENTIAL FOR EARLIER DETECTION TO IMPROVE OUTCOMES To explore the impact of the timeliness of BioWatch detection and com- pare it with other surveillance approaches, the committee commissioned a simulation model to represent the timing of events in the detection of an aerosolized release of B. anthracis. In addition, a committee member (Stephen Pollock) developed an analytic approach (using the same model assumptions and parameters) as an alternative method to address these issues. An anthrax attack was selected as a case study because timely response to inhalation anthrax is critical and because concerns about the threat from anthrax have driven much of the planning and action for bioterror- ism preparedness. The model approaches were not designed to determine the likelihood that an anthrax attack would be detected by environmental sampling, but rather to assess the potential benefit from environmental detection, should an airborne attack occur and be detected. The model

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3 BIOWATCH ANd ENHANCEd NATIONAl BIOSuRVEIllANCE BOX 6-1 Potential Enhancements to Surveillance Through Public Health and Health Care Legally Mandated Disease Reporting Enhance electronic laboratory reporting systems Enhance notifiable disease reporting by clinicians (outreach, elec- tronic reporting procedures, 24/7 call lines) Enhance electronic death reporting systems Automated Health Care Information Systems and Public Health Linkages Enhance/use clinical decision support tools for diagnosis, reporting, and management (e.g., triage, infection control, and treatment) Enhance use of information from EMRs and other electronic health information sources to detect reportable conditions, unusual cases or trends (public health collects and collates information from mul- tiple institutions) Enhance use of regional health information exchanges to detect re- portable conditions, unusual cases or trends (public health inter- faces with area-wide exchange that involves multiple institutions) Enhance public health capacity to electronically alert health care s ector of important public health events (e.g. inform evaluation, triage, infection control, treatment) Laboratory and Diagnostic Testing Expand development and use of rapid multiplexed and point-of-care diagnostic tests for both common pathogens and bioterrorism agents Extend capacities to characterize pathogens and collate reports from geographically dispersed sources to identify related cases of infec- tious disease (e.g., PulseNet model for enteric pathogens) Expand/enhance capacity to collect and test clinical specimens as part of public health surveillance systems, either ongoing or in response to possible alerts Information Integration and Knowledge Sharing Improve integration and analysis of public health information within and across jurisdictions Enhance integration and analysis of public health information with other types of information (e.g., intelligence, law enforcement)

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 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE evaluation does not address the potential merits of environmental sampling for pathogens other than anthrax. A brief overview of the approach and results of the models is presented here. Modeling Approach The models evaluated three approaches for the detection of an anthrax release: clinical case finding, syndromic surveillance, and environmental air sampling. These approaches are defined as follows: • Clinical case finding: Diagnosis may be made each time a patient seeks clinical care following the onset of symptoms. Blood cultures may be ordered as part of routine testing. The time to detection is the time from exposure until the first positive blood culture among all people who seek care. • Syndromic surveillance: Centralized collection and processing of data from primary care settings and emergency departments related to visits for respiratory conditions. For these models, detection is defined as occurring when an alert from a statistical algorithm indicates a higher than expected number of visits. (In practice, such an alert would have to be in- vestigated, and an outbreak identified, to be considered a detection.) • Environmental air sampling: Fixed aerosol monitoring devices (e.g., BioWatch air samplers) may be “hit” by airborne spores. Detection occurs when the presence of B. anthracis is confirmed through polymerase chain reaction (PCR) testing of samples collected by one or more monitors. The specific objectives of the modeling were: 1. To estimate, for each approach to detection, the average time (and, in the analytical model, the distribution of time) to detection and the time to response, defined as the initiation of mass antibiotic prophylaxis. 2. If all three approaches operate in parallel, to estimate the av- erage time to response and the contribution of each approach to early detection. 3. If only clinical case finding operates, to estimate the incremental benefit of adding syndromic surveillance, environmental sampling, or both. Detection through any approach results in a subsequent investigation and preparation to initiate mass antibiotic prophylaxis. Two scenarios are defined for these investigations and preparations: (1) following a “strong” hit and (2) following a “weak” hit. An example of a strong environmental hit would be BARs from multiple environmental monitoring devices; a strong clinical hit

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 BIOWATCH ANd ENHANCEd NATIONAl BIOSuRVEIllANCE might be numerous positive blood cultures. A weak hit, in contrast, might be a BAR from a single monitoring device or a single positive blood culture. Clinical case finding and environmental sampling are assumed to have either a weak or strong hit while syndromic surveillance is assumed to have only a weak hit. For this simulation, a hit is assumed to trigger prophylaxis after a defined interval, and the disease is assumed to respond to prophylaxis or treatment, with subsequent reduction in morbidity and mortality. The discrete-event Monte Carlo simulation model produces many rep- lications of output variables of interest (e.g., time to first detection, time to prophylaxis). Model input parameters and probability distributions for various random times are based on the literature and expert opinion provided by committee members. The analytic model uses identical inputs to provide a direct, numerical computation of probability distributions for the output variables. The simulation model approach has the advantage of flexibility and ability to represent complex probabilistic events. The analytic approach provides exact values of outputs of interest and facilitates the use of sensitivity analyses to understand how assumptions and input parameters affect these outputs. Results of the Modeling Analyses The analyses indicate that, under highly favorable scenarios, BioWatch environmental sampling has the potential to lead to dispensing of antibiot- ics 2 to 3 days sooner after an aerosolized anthrax release than does syn- dromic surveillance or clinical case finding. Such an advantage in the time to dispensing may have a substantial impact on mortality from an anthrax attack, assuming that a prompt and effective mass dispensing program can be implemented. A critical uncertainty in these scenarios is whether an air- borne attack would be detected by environmental sampling. Although envi- ronmental monitoring need not detect a release with certainty to provide a population benefit comparable to other means of detection, the probability of detection must be substantial to provide such a benefit. The benefit from including syndromic surveillance in addition to clini- cal case finding depends on the sensitivity and specificity of the syndromic surveillance system, and on the time between exposure and patients’ pre- senting with symptoms. Based on prior research that indicated that syn- dromic surveillance would detect an anthrax attack in a mean of 84 hours (Buckeridge et al., 2006), the current analysis found that the probability that an attack would be identified by syndromic surveillance before clini- cal case finding ranged from 30 percent (strong hit for clinical case finding) to 50 percent (weak hit for clinical case finding) when the specificity of syndromic surveillance was 0.9. This level of specificity resulted in a false alarm every 10 days. The average time to dispensing was improved only

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8 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE TABLE 6-3 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 of have some form outbreak NOTE: BAR, BioWatch Actionable Result. *As described in the text, achieving a reduction in mortality with the BioWatch system depends not only on the BioWatch technology and communication of a BioWatch Actionable Result, but also on expeditious information gathering to confirm a bioterrorist event and having the capability to distribute mass prophylaxis or treatment to prevent or reduce illness and mortality. Also see Table 6-1. over the same 0 years, the annualized direct costs for acquiring and operating the planned generation 3 enhancement are projected to be roughly $00 million. The committee was unable to obtain information that would allow a determination of the costs attributable to infectious disease surveillance in the public health and health care systems. Better data are needed on these costs as part of any effort to assess the cost- effectiveness of infectious disease surveillance and measure improve- ments. In addition, innovative methods may be needed for assessing the impacts of a multifaceted and multipurpose public health infrastructure such as infectious disease surveillance. INCORPORATING BIOWATCH INTO AN ENHANCED NATIONAL SURVEILLANCE SYSTEM The nation lacks a clear, overarching architecture of interlocking in- teragency goals, metrics, and accountability to support a seamless process from detection of biological threats through response and recovery. This architecture will require strong, high-level leadership along with strong and consistent engagement of on-the-ground experts in federal, state, and local agencies. This architecture is both critical to, and must also be supported by, robust operational capabilities and information systems that allow for merging data from multiple sources and providing critical emergency plan- ning and decision support to biodefense partners across local, state, and federal levels.

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 BIOWATCH ANd ENHANCEd NATIONAl BIOSuRVEIllANCE Other Timeliness Benefits Annual Costs Considerations May depend on May help detect and Would be included Requires further testing scale of pathogen track sporadic in costs of disease and evaluation to exposure, but and recurring surveillance; cost assess strengths and not likely to infectious disease of developing limitations as tool detect before outbreaks and operating to aid detection of environmental individual systems infectious disease surveillance expected to vary outbreaks widely Improving the Integration of BioWatch into Biosurveillance BioWatch is a federally developed, implemented, and directed program to detect certain airborne biological pathogens, but it depends on state and local health departments to act on the information it produces. This configuration invites tensions from competing interests. Some of the chal- lenges of integrating BioWatch functions into surveillance and decision making carried out by the public health community may stem in part from its superimposition onto existing systems that serve other important priori- ties. Local and state public health departments have diverse responsibilities that include both routine and outbreak surveillance activities, independent of the responsibilities that come with participation in the BioWatch pro- gram. As Figure 6-1 illustrates, BioWatch is just one of the many sources of information that health departments must monitor and evaluate on a continuing basis. The imposition of new responsibilities for low probability events may be seen by local jurisdictions as detracting from their daily duties and re- sponsibilities, and therefore may potentially be perceived as inappropriately burdensome. The occurrence to date of numerous BARs, all of which were determined to be unrelated to bioterrorism and each of which required an official and time-consuming response by local and state officials, has served to increase skepticism of the value of the program. Moreover, some com- munities may have been reluctant to participate in BioWatch because of its low perceived value but could not readily decline.

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80 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE The apparently top-down approach that DHS has taken in its interac- tion with public health departments may be symptomatic of a departmen- tal mindset. DHS has been urged before in other arenas to improve its partnerships with state and local stakeholders (e.g., GAO, 2008c). DHS has noted its plans to increase the involvement of state and local officials in their BioWatch planning, and it has taken some steps in this direction through a contract with the Center for Infectious Disease Research and Policy (CIDRAP) to promote communication among epidemiologists in BioWatch jurisdictions and between the epidemiologists and the BioWatch program (CIDRAP, no date). Differences in priorities between local and federal entities are natural and are explicitly acknowledged in the National Response Framework: “Planning for low-probability, high-consequence scenarios is a [f]ederal focus and complements a [s]tate, tribal, and local focus on more likely and frequently experienced smaller-scale events” (FEMA, 2008, p. 71). The committee also recognizes that the BioWatch system was fielded rapidly and had to meet numerous technological, operational, and organizational challenges. Although the deployment of the BioWatch system has been somewhat rocky in terms of coordination and integration with local public health officials, there is a continuing national effort to achieve a more inte- grated system from the multitude of local and state systems for infectious disease surveillance. All told, the BioWatch system needs to be better inte- grated into local surveillance systems that themselves are ultimately better integrated into a whole that resembles more of a national biosurveillance system. With multiple demands on the attention and resources of public health authorities, such integration may be vital to the sustainability of the BioWatch system and its counterterrorism mission. This challenge is only made more urgent under the current conditions of increasing economic constraint. An Enhanced National Biosurveillance System A major challenge to meeting the goal of a “national” biosurveillance system is that authority for public health action resides primarily at the state and local levels, where a multitude of systems and approaches make for a fragmented and difficult-to-coordinate national picture. The federal government has operational responsibilities in certain limited areas of pub- lic health protection, but it wields considerable influence through leadership in developing tools and guidance and especially through funding programs that reflect federal priorities. How can progress be made toward a national system when a top-down approach is not possible? National priorities should include ensuring that state and local health departments can meet and sustain basic performance

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8 BIOWATCH ANd ENHANCEd NATIONAl BIOSuRVEIllANCE standards for surveillance and analysis, in conjunction with essential ca- pabilities to respond both to the often unpredictable demands of public health emergencies and to the array of ongoing obligations to protect the public’s health. It is also important that BioWatch be factored into this view. But with programmatic and budgetary responsibility for BioWatch resting with DHS, the challenges of coordinating related responsibilities and systems that are dispersed across other federal departments only adds to the complexity of coordinating biosurveillance across federal, state, and local levels. It is equally essential that the linkages between the public health and health care systems be strengthened. Health care providers in the public and private sectors, along with the large community of clinical and com- mercial laboratories, are essential partners with public health. Because the surveillance needs of the public health system are not their first priority, it is essential that the public health perspective be effectively represented as health care and laboratory information systems evolve so that technolo- gies are created that serve needs in both enhancing the care of individual patients and protecting the health of the public. In the committee’s view, a national biosurveillance system should aid in protecting the nation from significant, time-critical biological threats of all types, whether intentionally released (i.e., bioterrorism), accidentally dispersed, or naturally arising (i.e., emerging or re-emerging infectious dis- ease). 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 information management and communication among all appropriate stakeholders (e.g., electronic laboratory reporting systems); 6. streamlined approaches at the federal, state, and local levels to (a) intelligence and information sharing, (b) decision making to minimize delay between the emergence of a threat and appropriate action to minimize its consequences, and (c) timely after-action analysis to identify strengths and weaknesses in policies and procedures; and 7. sustainable funding that encourages program integration (in con- trast to categorical funding streams).

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8 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE The committee sees an important federal role in at least three critical areas: (1) helping to develop and validate improved methods for infectious disease surveillance, (2) developing a mechanism to achieve and sustain national situational awareness of biological threats, and (3) building and sustaining critical public health workforce competencies. Improved methods for Infectious disease Surveillance Surveillance is an essential public health practice, but it has long rested on multiple independent data collection activities, often constrained by limited resources and narrow programmatic requirements. As information and communication technologies have evolved and become more accessible to health departments and health care providers, they are making it possible to improve the collection, integration, and analysis of surveillance data. Many novel and promising surveillance techniques and programs have been developed rapidly at the local, state, and federal levels, spurred in part by funding for bioterrorism and public health emergency preparedness. At present, national standards for surveillance data and for interoper- ability between surveillance systems are incompletely developed and un- evenly implemented because of limited funding and inconsistent direction. Insufficient attention has been paid to linking, analyzing, and displaying multiple surveillance platforms for optimal situational awareness, decision making, and response. In addition, many new systems and techniques have not yet received sufficient evaluation to ensure that they are effective and being used appropriately. The committee believes that this complex series of problems must be addressed by a dedicated, strategic, integrated, and adequately funded pro- gram. If the federal government, working collaboratively with state and local officials, were able to strengthen and streamline and, where possible, automate core public health surveillance functions such as clinical case find- ing and laboratory reporting, this could reduce the daily operational stress felt by many local and state health departments and foster better working relationships. Situational Awareness In addition to new and improved surveillance tools, there is a critical need for a means to bring information together to provide situational aware- ness regarding potential or active threats to the public’s health. Most of the information that enables detection, characterization, and ongoing manage- ment and mitigation of both natural and bioterrorism-related outbreaks is generated at the local or regional level and typically assembled at a state- wide level. Compartmentalization of this information based on geography,

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83 BIOWATCH ANd ENHANCEd NATIONAl BIOSuRVEIllANCE agency, or professional subject area may impede detection and interpretation of events that are unfolding on a national or international scale. Health departments also have increased access to electronic information on animal health, vector control, water and air quality, meteorology, and other information to aid in monitoring threats to human health. Resources for situational awareness also need to facilitate communication between pub- lic health officials and clinical providers. In addition, efforts are being made to increase information sharing between public health agencies and others with a role in emergency preparedness and response, including the intelligence, law enforcement, emergency management, and business communities. At the federal level, activities in both DHS and HHS are aimed at more effective integration of information to improve situational awareness. In DHS, the National Biosurveillance Integration Center (NBIC) is intended to bring together national and international information that could enhance awareness of potential and active biological threats of all types. In HHS, the BioSense program is focusing on assembling and sharing data from public health and health care sources to support situational awareness at local, state, and federal levels. Another effort to promote information exchange and situational awareness is the development of state and local “fusion” centers, which facilitate access to and sharing of information between fed- eral, state and local officials. These information-sharing activities face several challenges. On the informatics and technology side, the challenges include reconciling data structures and vocabularies from independent information systems. Policy concerns include finding an appropriate balance between the national se- curity concerns of DHS and the intelligence community, which have tended to favor limited access to the information, and the need for an effective partnership with state and local officials who need better access to informa- tion that will help them recognize and respond to bioterrorism and other significant biological threats. Another consideration is the need to ensure that the exchange of health-related information appropriately calibrates the need for personally identifiable information so that individual privacy is protected. In addition, there is a need to encourage local and state authori- ties to share information within a state, with other states, and with federal agencies. Their willingness to do so will typically be related to the net value they obtain from such exchanges. Public Health Workforce levels and Competencies The committee has recommended (see Chapter 5, Recommendation 11) that HHS and DHS make bolstering the public health workforce a prior- ity. Benefits from new methods or tools will be limited without sufficient, and adequately trained, personnel to employ and deploy them. Public

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8 BIOWATCH ANd PuBlIC HEAlTH SuRVEIllANCE health surveillance to detect and investigate potential bioterrorism events or naturally occurring infectious disease outbreaks requires the continuous availability of well-trained laboratory and epidemiology staff in sufficient numbers to be able to conduct advanced laboratory analyses and epidemio- logic investigations in real time. State and local health departments have faced persistent difficulties in hiring and retaining personnel and now face new budget constraints that are forcing further staff reductions in many places. Moreover, as new tech- nologies and analytic techniques become the norm, there is a need to ensure access to training in their use for the existing workforce and to ensure that academic programs are adequately preparing the workforce of the future to use them. Cooperation between academia and the public health practice community can help identify appropriate competencies and develop creden- tials that foster readiness to respond to biothreats. CONCLUDING OBSERVATIONS BioWatch is a federal program designed by DHS to be operated by the public health system at the state and local levels in order to serve national security interests. This is an awkward and organizationally challenging arrangement. Because the potential for BioWatch to help limit morbidity and mortality depends so heavily on the ability of health departments and the health care system to analyze the nature of the threat and take quick and decisive action, it is essential that the operation and management of BioWatch be well integrated with the jurisdictions in which it operates. State and local authorities, whose knowledge of endemic health risks and available resources cannot be replicated at the federal level, need to be recognized as essential and valuable partners not only in the BioWatch pro- gram but also in broader national biosurveillance and biodefense efforts. Likewise, recognizing that a bioterror attack is a threat against the entire population of the United States, state and local officials need to remain open and willing to partner with the federal government to ensure that resources, expertise, and decisions are used in the most appropriate way to ensure our national security. Finally, it is essential that policy makers recognize that the benefits of any form of infectious disease surveillance will not be realized if states and communities do not also have the capability to respond effectively to a public health emergency. Despite the substantial progress that many lo- calities have made in advancing their mass dispensing capacity, having the ability to administer antibiotic prophylaxis to hundreds of thousands, if not several million, urban area residents within a few days following detection of a bioterrorist attack remains a challenge.

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