G
Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation, Letter Report #6

July 6, 2004

Dr. Julie Gerberding

Director

Centers for Disease Control and Prevention (CDC)

1600 Clifton Road, NE Atlanta, GA 30333

Dear Dr. Gerberding:

The Institute of Medicine (IOM) Committee on Smallpox Vaccination Program Implementation is pleased to offer you the sixth in a series of brief reports.

This report may seem like a departure from the committee’s previous work, which focused on smallpox vaccination as a part of public health preparedness. However, this report responds to a CDC request for guidance as the agency moves toward comprehensive preparedness for bioterrorism and other public health disasters and toward broad smallpox preparedness efforts. The committee was asked to look specifically at preparedness exercises, which are required by CDC grant guidance and are being conducted by public health agencies. In general, the public health community has somewhat limited experience with exercises, so the committee was asked to describe the state of the science in evaluation of exercises, to identify leadership and experience to build on, and to identify



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The Smallpox Vaccination Program: Public Health in an Age of Terrorism G Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation, Letter Report #6 July 6, 2004 Dr. Julie Gerberding Director Centers for Disease Control and Prevention (CDC) 1600 Clifton Road, NE Atlanta, GA 30333 Dear Dr. Gerberding: The Institute of Medicine (IOM) Committee on Smallpox Vaccination Program Implementation is pleased to offer you the sixth in a series of brief reports. This report may seem like a departure from the committee’s previous work, which focused on smallpox vaccination as a part of public health preparedness. However, this report responds to a CDC request for guidance as the agency moves toward comprehensive preparedness for bioterrorism and other public health disasters and toward broad smallpox preparedness efforts. The committee was asked to look specifically at preparedness exercises, which are required by CDC grant guidance and are being conducted by public health agencies. In general, the public health community has somewhat limited experience with exercises, so the committee was asked to describe the state of the science in evaluation of exercises, to identify leadership and experience to build on, and to identify

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism issues or concerns about the use of exercises as a means to performance measurement. At its fifth meeting, on March 29, 2004, the committee heard presentations about: CDC’s recent efforts in public health preparedness; the modeling workgroup of the Department of Health and Human Services (DHHS) Secretary’s Council on Public Health Preparedness; the theory and science related to preparedness and exercises1 from both a sociological and a disaster management and response perspective; the perspective of a Center for Public Health Preparedness; and the Department of Homeland Security’s experience with planning, conducting, and evaluating exercises. This letter report contains the committee’s findings and recommendations based on information from that meeting and additional though limited (given time constraints) review of what public health may learn from disaster research and from the practice of disaster response. INTRODUCTION Charge to the Committee One way to measure public health agencies’ performance in achieving preparedness is by performing and evaluating exercises.2 Whereas exercises have been conducted and evaluated in the emergency management field for many years, public health has had less experience with exercises and is currently beginning to assess their value for relationship building, training, and performance measurement. To place the role of exercises appropriately into the broader definition of what it means to be prepared and to identify specific aspects for which measures can be developed, CDC asked the Committee on Smallpox Vaccination Program Implementation to: Describe the state of the science in exercises and related preparedness strategies; Identify leadership and experience to build upon, from other fields and other federal agencies; and Identify issues or concerns about this approach to performance measurement (Sosin, 2004). 1   The Federal Emergency Management Agency (FEMA) defines exercise as “a focused practice activity that places the participants in a simulated situation requiring them to function in the capacity that would be expected of them in a real event” (FEMA/EMI, 2003). 2   Initially, the committee’s discussion was concerned with both exercises and drills, as they are related categories along a spectrum of possible activities used for training, performance measurement, etc. However, since drills tend to be very narrowly focused and they typically take place within a single agency, their usefulness is more easily verified. Therefore, they are less relevant to the present broad discussion of preparedness exercises and evidence of their usefulness.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism To meet the charge presented by CDC, the committee has endeavored to: (1) examine conceptual issues and challenges related to integrating public health into disaster preparedness and response; (2) review some of the evidence base from disaster research and practice that is germane to public health preparedness; (3) learn from the public health response to proxy events; (4) discuss the usefulness of modeling; and (5) discuss the usefulness of exercises, including a description of some of the exercise activities occurring in the federal government. Summary of Recommendations The report’s recommendations revolve around the issues of interagency and intersectoral coordination, learning from experience and research, and continuously improving performance. Recommendation 1: The committee recommends that all federal entities concerned with bioterrorism preparedness (e.g., CDC, the Health Resources and Services Administration [HRSA], the Office of Domestic Preparedness [ODP]) should more actively coordinate guidance and funding activities. Federal agencies should also work together to develop mechanisms that facilitate coordination and collaboration among their grantees at the state and local levels. Such mechanisms may include, but are not limited to, regular meetings to familiarize CDC and ODP program staff with each other’s program priorities and activities, a database for informing ODP and other partners of exercises planned by CDC grantees, etc. Federal coordination efforts should also include the clarification of primary responsibility and authority in bioterrorism events, to ensure that CDC can fulfill its unique role as the nation’s public health agency. Recommendation 2: The committee recommends that CDC should collaborate with all of its partners to strengthen preparedness by applying research findings and experience in public health emergency response, bioterrorism preparedness, and disaster management. In order to strengthen the evidence base for public health preparedness, CDC should: Strengthen the link between public health research and practice; Participate in and promote interdisciplinary research about preparedness; Support a system to assure the ongoing collection, synthesis, and sharing of lessons learned and best practices from public health preparedness exercises and public health response to proxy events; and

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism In coordination with the appropriate federal-level partners, such as the Agency for Healthcare Research and Quality, evaluate the effectiveness, design, and opportunity costs of preparedness strategies, such as exercises. Recommendation 3: The committee recommends that CDC should use the Evidence-Based Performance Goals for Public Health Disaster Preparedness to develop standards against which CDC, states, and localities may regularly measure their performance in exercises and in response to proxy events. Public health agency performance in exercises and proxy events should be used to identify gaps in preparedness and to improve planning, communication, and coordination at the agency and interagency levels, as part of a process of continuous quality improvement in preparedness planning and response. Preparedness drills and exercises should not be evaluated individually, but their cumulative and long-term impact on preparedness, such as generalizability to other potential hazards, must be considered in the evaluation process INTEGRATING PUBLIC HEALTH INTO DISASTER PREPAREDNESS AND RESPONSE: CONCEPTUAL ISSUES The public health community has become an active partner in the world of emergency and disaster preparedness and response, joining other members in the traditional emergency management and response field who have defined roles and established ways of doing work (Landesman et al., 2001). Although public health workers and agencies have played active roles after many emergency events (and in some states, the emergency medical services [EMS] entity is part of the state public health agency), public health workers have not necessarily counted themselves or been counted among emergency responders (Landesman et al., 2001; Kahsai and Kare, 2002). Some important conceptual issues must be considered in the process of more effectively integrating public health into the disaster preparedness and response field. These issues include (1) the history of public health disaster response, and its relevance to contemporary public health preparedness; (2) the unique role of public health in disasters and primary role in disasters that involve biological agents; and (3) the heterogeneity that characterizes the field of emergency and disaster preparedness and response. A History of Public Health Disaster Response History provides myriad examples of public health emergencies and disasters (e.g., cholera outbreaks, toxic spills), that wreaked destruction

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism akin to or greater than that of major natural disasters and to which the evolving discipline of public health responded. Epidemiologic and other public health skills and knowledge also have been advanced through lessons learned in such responses (Landesman et al., 2001). The threat of bioterrorism has mobilized the engagement of many disciplines and government agencies both to prevent and to respond. The reemergence of infectious diseases in part related to demographic change and globalization has elevated interest in public health’s role as both a responder to and a preventer of epidemics and infectious disease outbreaks. Public health agencies have the ongoing responsibility to prevent disease outbreaks and other emergencies through measures such as immunization, sanitation, and community education. In cases where preventive measures are not successful, or there are barriers to their implementation, or an unexpected threat causes disease, public health becomes a responder, conducting surveillance, controlling the spread of disease, conducting mass immunization, etc. At the same time, public health agencies continue prevention to limit secondary public health problems. The current integration of public health preparedness efforts with those of more traditional “responder” disciplines is based on a growing acknowledgement of public health’s singular capabilities and importance in preparing for and responding to bioterrorism, as well as the health aspects of a range of disasters. These include deliberate attacks with nonbiological weapons, natural disasters that may result in the contamination of food or water supplies and lead to infectious diseases, and technological disasters that may endanger population health with radiation or chemical hazards. Unique Role of Public Health in Disasters, and Primary Role in Response to Bioterrorism Public health generally does not have a formal tradition of disaster preparedness and response. However, notable and instructive exceptions are found in the experience of the following types of public health agencies, some of which have developed varying levels of expertise in planning and exercising for disasters and in managing disasters (e.g., the experience of the state of Georgia described by Werner et al., 1998): Public health agencies located in the vicinity of nuclear facilities and involved in federally mandated training and exercise programs; Public health agencies located in areas with frequent natural disasters (hurricanes, floods, or tornadoes); Public health agencies at sites of one-time or recurring major events or entertainment venues (e.g., auto racing, Olympics, amusement parks); and

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism State public health agencies in states where emergency medical services (EMS) are integrated into the public health agency. The role of public health in disaster preparedness and response is unique and is not performed by any of the other disciplines that typically respond to disasters and that differ from public health in mission, services provided, and personnel training (e.g., EMS, clinical medicine). Therefore, the role of public health as a responder needs to be formalized and become an indispensable and recognizable part of comprehensive response to disasters. One common thread characterizes the work of public health agencies in relation to most types of disasters: they possess the knowledge and skills required to safeguard the health of the public by limiting morbidity and mortality, whether an event poses a threat to health from the outset (i.e., bioterrorism) or creates secondary threats to health, as in the case of natural disasters. The public health community’s role before, during, and after the occurrence of disasters is to some extent anchored in its capacity to conduct routine, noncrisis activities, and is consistent with public health’s assessment, policy development, and assurance functions, but varies with community resources and interagency agreements and service provision roles (Salinsky, 2002). Carrying out these functions requires public health agencies to collect, evaluate, and disseminate information; cooperate and collaborate with other disciplines (including, but not limited to, the health care sector); and to prevent disease and ensure the continuity of health care (Landesman et al., 2001; IOM, 2003d). In addition to the public health effects of most other types of disasters, attacks with biologic agents, as exemplified by the anthrax attacks of 2001, require that governmental public health agencies serve as primary responders. Events that involve biologic agents are different from other types of disasters because their emergence is likely to go unnoticed for some time; biologic agents are microscopic and may be more likely to be introduced silently (e.g., through airborne droplets), rather than with explosions, and become evident over time. Also, the fallout from attacks with biologic agents may not remain confined to a specific physical space; in other words, there may not be a “scene” or a “ground zero” (Perry, 2003) and its impact may not be contained but may ripple outward for some time due to contagion. Preparedness for biologic agents therefore involves at least some different requirements from other types of agents and requires the unique knowledge and skills of trained public health personnel (e.g., case identification and containment) and the unique capabilities (e.g., laboratories, surveillance, communication, community education) and statutory responsibilities (e.g., quarantine) of public health agencies, as well as the complementary facilities, skills, and resources of the health care community (Perry, 2003).

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism FIGURE G-1 Contrasting roles of public health and traditional responders in bioterrorism and other disasters. In order to integrate the preparedness and response efforts of public health most appropriately with those of the traditional emergency management and response field, some key differences need to be identified. For example, disaster preparedness and response is the central mission of local, state, and national civilian and military response organizations and they train and exercise regularly to test and maintain their response capabilities. They have the dual role of responding to disasters and to routine emergencies in their communities. For public health agencies, responding to major crises has been the exception from their usual work; therefore, conducting regular drills and training to prepare for disaster response has generally not been a common practice. Also, even when public health agencies have gained experience dealing with disease outbreaks, these events do not typically reach the scale of a disaster, and response is largely limited to the public health and health care communities. Given the statutory responsibilities and special capabilities of public health, and CDC’s leadership role in the provision of essential public health services under all circumstances, it is clear that CDC and the public health community must be ready to fulfill their primary role in responding to bioterrorism and their support roles in other types of disasters, including terrorism with chemical, nuclear, and other types of weapons (see Figure G-1). The Diverse Field of Emergency and Disaster Preparedness and Response Public health is not entering a monolithic or homogeneous field of emergency and disaster management. Disasters involve people, physical

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism structures, and the broader environment, and they may be caused by a wide range of natural, technological, and deliberately introduced agents. This variety of factors explains the complex array of disciplines and organizations involved in the emergency and disaster response field. The category of first responders has typically included personnel from the fire-fighting, EMS, and law enforcement fields, along with state emergency management agencies and federal agencies (e.g., Federal Emergency Management Agency, Environmental Protection Agency), and nongovernmental organizations, such as the Red Cross and the Salvation Army. Other disciplines involved in preparedness include structural engineers, civic planners, public administrators, etc. Clearly, the set of contributors to emergency and disaster preparedness and response is vast and includes a patchwork of methods, cultures, and disciplines that are in some cases themselves struggling to integrate their activities (Kahsai and Kare, 2002; Tang and Fabbri, 2003). In addition to being multidisciplinary, the field of emergency and disaster preparedness and response is undergoing change toward increased professionalization and an all-hazards3 approach, and is evaluating its assumptions and modes of practice, as discussed elsewhere in this report (Alexander, 2003; NRC, 2003). CHALLENGES AND OPPORTUNITIES INHERENT IN INTEGRATING PUBLIC HEALTH INTO A BROADER FIELD The integration of a relative newcomer into the large and complex field of emergency and disaster preparedness and response presents challenges and tensions. Disasters require rapid decisions and quick action, which may bring about cross-jurisdictional conflicts, professional differences, and questions about authority, expertise, and the appropriate chain of command. Coordination Issues In its fifth report (IOM, 2003a), the committee discussed at some length the importance of close collaboration between the public health and health care communities, from the level of federal agencies such as HRSA and CDC, to local public health agencies and their health care counterparts (health care organizations, hospitals, private providers, long-term care facilities, etc.). Previous reports by this committee also have called for public health and health care organizations and workers to coordinate and col- 3   The term “all-hazards” refers to the full spectrum of causes of disasters, which now includes not only natural and technological, but also deliberate, that is, terrorist-induced (Landesman et al., 2001).

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism laborate with agencies, disciplines, and entities with which they were previously not well acquainted, including, but not limited to, fire authorities, law enforcement, EMS, voluntary organizations, and communities. Research and practical experience show that coordination among all agencies involved is one of the fundamental requirements of effective disaster response and that the lack of adequate coordination is one of the major problems encountered in the field (Auf der Heide, 1989; Tierney et al., 2001). Given the large number of federal, state, and local agencies involved in preparedness efforts, establishing adequate coordination across federal, state, and local levels is proving to be a challenge (Advisory Panel to Assess Domestic Response Capabilities for Terrorism Involving Weapons of Mass Destruction, 2003; GAO, 2003a; Clements and Evans, 2004). Within the federal government, preparedness and response activities are coordinated through the Department of Homeland Security (DHS). Coordination at the top levels of the federal government occurs through the Homeland Security Council (HSC), which is charged with ensuring coordination of all homeland security related activities among executive departments and agencies and promoting the effective development and implementation of all homeland security policies (White House, 2001). Day-to-day coordination of homeland security issues—both within the federal government and among federal, state, and local government agencies—is meant to occur through the Policy Coordination Committees (PCCs) of the HSC (White House, 2001). There are eleven PCCs for different functional areas, including a Medical and Public Health Preparedness PCC. The committee was unable to obtain sufficient information to determine whether and how Medical and Public Health Preparedness PCC actions or policy decisions shape CDC’s preparedness program and whether the PCC plays a role in strengthening CDC’s relationship with DHS. Despite the existence of mechanisms for coordination at the top departmental level, such as the PCCs, it is not evident to the committee that adequate coordination and information sharing are occurring formally at the level of federal program staff involved in the day-to-day work of public health preparedness (GAO, 2003b). Although the creation of DHS holds the promise of streamlined oversight and funding, there are concerns that coordination between DHS and key preparedness functions in DHHS remains a significant challenge (GAO, 2003a). At the committee’s March 2004 meeting, conversation among presenters from federal agencies and the committee revealed that personal relationships and serendipity may be credited with some coordination and information sharing across agencies, but it was not immediately evident that there are sufficient and functioning formal mechanisms for coordination and collaboration between DHS and DHHS. Coordination must be planned with forethought and deliberation, not left simply to chance and the goodwill of program staff. Coordination

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism also must be planned and implemented during the preparedness or pre-event phase, beginning with effective communication about funding objectives and activities. For example, it is important for CDC staff to be familiar with relevant activities occurring in DHS and its programs funded and/or administered through FEMA and ODP, and for DHS staff to be aware of CDC priorities and activities to ensure the best use of limited federal preparedness resources. State and local public health agencies receive funding through CDC’s Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism, and health care entities are funded through HRSA’s National Hospital Bioterrorism Preparedness Cooperative Agreements. These cooperative agreement programs require that grantees conduct exercises that test public health and health care preparedness (and the integration between them) for an attack with biologic or chemical agents. Through the DHS Office of Domestic Preparedness Fiscal Year (FY) 2004 Homeland Security Grant Program and FY 2004 Urban Area Security Initiative Grant Program, states and some local emergency management offices receive funding to conduct exercises that test many of the same capacities and interagency collaborations expected by HRSA and CDC (DHS, 2003). Furthermore, FEMA, which is now under DHS, although its activities seem not yet fully coordinated with those of ODP, also oversees exercises relevant to chemical and radiation emergencies, which include public health components. The committee learned that sometimes states pool different sets of resources to conduct a larger drill or exercise involving a larger number of state and local agencies and community partners, and in other cases, the different funding streams are used to fund separate exercises (Schweitzer, 2004). ODP has released guidelines for exercises and their evaluation through the Homeland Security Exercise and Evaluation Program (HSEEP). Although the committee is not aware of the nature and extent of CDC’s involvement in the development of the HSEEP guidelines, the committee believes it is important that both CDC and DHSODP work to ensure a reasonable level of compatibility and coordination. This is necessary because of the functional overlap between public health and other state agencies, and because some state public health agencies already plan and execute their bioterrorism preparedness exercises in conjunction with their state emergency management offices. While public health preparedness exercises are needed to assess the unique functions and goals of public health, they will ideally be coordinated with other types of exercises where appropriate. Since state emergency management offices will be following the HSEEP guidelines, and some state public health agencies may be participating in exercises that follow these guidelines, a certain level of coordination is necessary between CDC’s public health preparedness exercise guidelines

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism and the HSEEP guidelines. In order to maximize the knowledge, skills, and relationship building that states and local jurisdictions gain from participating in preparedness exercises supported by limited federal resources, the committee encourages CDC to work closely with ODP (as well as HRSA) to coordinate, where appropriate and consistent with agency goals, the funding and guidelines for exercises provided by all federal agencies to states, local jurisdictions, and to private sector entities, such as hospitals. Responding to a public health disaster, such as a smallpox attack, will require coordination with other organizations in the private sector and within the health care community. At the March 2004 meeting, the committee heard about the initiatives of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to engage communities in preparedness planning and exercises. The committee believes it is important that CDC identify other organizations that, like JCAHO, require and set standards for preparedness activities, including exercises, and interact with communities in the area of bioterrorism and disaster preparedness. This is needed to help avoid duplicative efforts as well as ensure the best coordination of preparedness efforts. The range of partners in preparedness should be conceived broadly, to include local community, health care institutions, voluntary organizations, and others. The committee also heard that state grantees funded by the DHS ODP FY 2004 Homeland Security Grant Program are encouraged to share exercise calendars with other partners and to coordinate or integrate efforts with other state and local exercises (Schweitzer, 2004). The committee suggests that CDC develop and maintain a list or database of exercises funded under the current (and future) cycle of the Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism and to share this resource with ODP. Also, regular communication between CDC and ODP would inform both about planned exercises and would provide opportunities for coordination of exercises within a state and between states. CDC and DHS guidance to grantees makes some reference to the need for interdisciplinary and intersectoral coordination (CDC and ODP, 2003; CDC, 2003a, 2004a, 2004b; DHS, 2003). However, it is not clearly spelled out how these linkages function at the federal, state, and local levels, and it is unclear whether the need for coordination is more specifically confirmed with and reinforced with grantees. For example, the CDC guidance for FY 2004 calls for integrating efforts and closely coordinating with “activities funded by the Department of Homeland Security and/or other federal agencies” (CDC, 2004a, 2004b). The guidance does not specifically identify relevant programs funded by DHS, and the committee was unable to locate more detailed explication of the formal linkages and coordination mechanisms that exist or are desirable in the relationship between CDC and DHS grantees.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism A Framework for Performance Evaluation Using Exercises Major outcomes in public health typically involve decreasing mortality and disease rates and progress is measured periodically (e.g., Healthy People 2010 process). Performance measurement in public health is, however, a relatively new field. In the case of public health preparedness for bioterrorism and other events with significant public health impact, outcomes are occasioned by actual events themselves, and the infrequency and huge variation among these events (including the proxy events discussed in preceding pages of this report) make it difficult or nearly impossible to gauge, for example, a decrease in rate of disease from contaminated water or other reductions in mortality and morbidity attributable to the disaster. Due to the nature of disaster-related public health problems, performance measurement in this area is by necessity more process-oriented. When CDC and its state and local partners identify exercise objectives that will be used in evaluating the exercise, these objectives will be most helpful if they are linked with the Evidence-Based Performance Goals for Public Health Disaster Preparedness developed by CDC. Exercises offer an alternative way to measure performance and finetune preparedness before a crisis occurs. Public health preparedness exercises take place at national, state, and local levels, and it is important that evaluation of exercises take place at all levels. The committee believes it is essential to design and conduct exercises that stress and test CDC’s own performance. As noted in the preceding discussion of proxy events, CDC is a vital part of preparedness and response and it is itself a limiting factor in terms of the resources it provides (e.g., laboratory reagents, information, technical assistance) to state and local counterparts. In asking “what if” questions in a proxy event or in an exercise, the limits of availability of such resources must be probed. In addition, modeling could be used to estimate such things as the rate of producing and renewing the supply of needed laboratory reagents, or the speed with which needed field experts could be moved from place to place. In a more dramatic type of exercise, questions could be asked about the potential effect if CDC itself was the target of an attack and critical facilities destroyed. After-action reports will play an important role in facilitating continuous quality improvement. They provide an overview of agency or interagency performance in an exercise and identify areas where there are gaps in planning, unforeseen circumstances that are poorly managed, or areas where communication or the flow of information break down, among other issues. Various types of methods for measuring performance will eventually be determined to be effective and even to have some predictive value (e.g., of future successful response). The link between research and practice requires

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism strengthening, so that as research validates certain practices, such as types of exercises, and the most effective techniques to communicate to or evacuate the public, they may be rapidly translated into practice. The practices demonstrated to be most effective (e.g., specific types of exercises) need to then be institutionalized and adapted to local circumstances, with particular attention to maintaining and updating staff competence and sustaining readiness. Staff turnover itself, which requires regularly updating training and conducting exercises, could be used to create new cohorts for performance evaluation. CDC might wish to consider describing the breadth and depth of exercises needed for public health. The HSEEP Building Block Approach illustrates one typology of training and capacity-building methods, including exercises. CDC could develop a similar representation with specific applications to public health. For example, in the area of exercises, some exercises may be external, conducted in coordination with other agencies at the federal, state, and local level (refer to the section on Coordination Issues), while others will be strictly internal exercises on such issues as how to move from normal to emergency operations, including decisions about closing or curtailing planned clinics, outreach, or investigation; decisions about and use of personal protective equipment under various circumstances; establishment of databases for unexpected investigations or unusual outbreaks. One of the challenges in developing and implementing exercises is to make the mock disaster approximate as closely as possible a real-life one, including as much complexity and unpredictability as possible, and basing scenarios on what is likely to happen according to the microbiological, immunological, epidemiologic, and disaster literature, not on myths or on widely embraced assumptions. Ensuring Compatibility Between the DHS Exercise Doctrine and Public Health Preparedness Exercises The DHS HSEEP describes a yearly cycle of planning and development, followed by training, exercises, and the development and implementation of an improvement plan. The committee has learned that CDC intends to implement a similar cyclical process (target goals → exercise → target goals, etc.) with its grantees (Sosin, 2004). The goals of public health preparedness are a distinct subset of overall preparedness, and public health, as noted elsewhere in this report, has its unique capabilities, responsibilities, and information needs. The use of exercises to measure performance and public health preparedness will differ from their use in other fields in the processes being evaluated, in the skills and knowledge being assessed, in the specific relationships and coordination being tested. However, there will be areas of overlap with other disciplines and programs, and there will be

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism some commonalities in structure and operations (e.g., a type of emergency operations center and/or other mechanisms for interagency collaboration and coordination, communication activities, information infrastructure). It is important to ensure that planning, conduct, and evaluation of public health exercises at the federal, state, and local levels are compatible with those of DHS activities under the HSEEP. For example, HSEEP describes three levels of performance evaluation: task level performance (individual); agency/discipline/function-level performance; and mission-level performance (interagency, interorganizational, and community) (DHS/ODP, 2003). The HSEEP Exercise Evaluation Guides for tabletop and operational exercises include public health personnel/agencies under the “response element” heading in addition to EMS, law enforcement, fire department, HazMat, hospitals, and others, and though the exercise methodology indicates that public health is one of the agencies/disciplines/functions to be evaluated in HSEEP, it understandably does not go into detail. If CDC intends to coordinate with or make its public health exercise evaluation compatible with the HSEEP model, the committee suggests that existing resources, such as the Public Health Competencies for Bioterrorism and Emergency Preparedness be utilized in customizing the individual-level evaluation and that the Local and State Public Health Preparedness and Response Capacity Inventories be included in customizing the agency-level evaluation. In preceding pages, the committee has explored the potential of proxy events and exercises as means to performance measurement. The committee recommends that CDC should use the Evidence-Based Performance Goals for Public Health Disaster Preparedness to develop standards against which CDC, states, and localities may regularly measure their performance in exercises and in response to proxy events. Public health agency performance in exercises and proxy events should be used to identify gaps in preparedness and to improve planning, communication, and coordination at the agency and inter-agency levels, as part of a process of continuous quality improvement in preparedness planning and response. Preparedness drills and exercises should not be evaluated individually, but their cumulative and long-term impact on preparedness, such as generalizability to other potential hazards, must be considered in the evaluation process. CONCLUDING REMARKS In closing, the committee encourages CDC to learn from the experience and research available from other fields, including, but not limited to disaster research and emergency and disaster response, and to develop the evidence base specific to public health preparedness; strengthen and sustain

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism active coordination and communication with all relevant entities and government agencies at the federal, state, and local levels; and focus on continuous improvement in planning and performance to further the process and the goal of preparedness. The committee wishes to thank you for the continuing opportunity to be of assistance to the Centers for Disease Control and Prevention and its partners as they work to protect the nation’s health. Brian L. Strom, Committee Chair Kristine M. Gebbie, Committee Vice Chair Robert B. Wallace, Committee Vice Chair Committee on Smallpox Vaccination Program Implementation REFERENCES Advisory Panel to Assess Domestic Response Capabilities for Terrorism Involving Weapons of Mass Destruction. 2003. Fifth Annual Report to the President and the Congress. Arlington, VA: The RAND Corporation. AHRQ (Agency for Healthcare Research and Quality). 2004. Training of Hospital Staff to Respond to a Mass Casualty Incident. AHRQ Evidence Report/Technology Assessment Number 95. [Online] Available at http://www.ahrq.gov/clinic/epcsums/hospmcisum.pdf. Accessed June 10, 2004. Alexander D. 2000. Scenario methodology for teaching principles of emergency management. Disaster Prevention and Management 9(2):89-97. Alexander D. 2003. Towards the development of standards in emergency management training and education. Disaster Prevention and Management 12(2):113-123. Auf der Heide E. 1989. Disaster Response: Principles of Preparation and Coordination. St. Louis, MO: CV Mosby. Benjamin G. 2003. SARS: How Effective Is the State and Local Response? Testimony on Behalf of the American Public Health Association Submitted to the Senate Government Affairs Committee, Permanent Committee on Investigations. [Online] Available at http://www.apha.org/legislative/testimonies/sars52103.htm. Accessed May 11, 2004. Borio L. 2004. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Five on March 29, 2004, Washington, DC. Bozzette S, Boer R, Bhatnagar V, Brower J, Keeler E, Morton S, Stoto M. 2003. A model for a smallpox-vaccination policy. New England Journal of Medicine 348(5):416-425. Burkle F, Hayden R. 2001. The concept of assisted management of large-scale disasters by horizontal organizations. Prehospital and Disaster Medicine 16(3):87-96. Butler J, Cohen M, Friedman C, Scripp R, Watz C. 2002. Collaboration between public health and law enforcement: new paradigms and partnerships for bioterrorism planning and response. Emerging Infectious Diseases 8(10):1152-1156. CBACI (Chemical and Biological Arms Control Institute). 2002. What Should We Know? Whom Should We Tell?: Leveraging Communication and Information to Counter Terrorism and Its Consequences. [Online] Available at http://www.cbaci.org/summary.pdf and http://www.mipt.org/cbacilevcomm.asp. Accessed May 11, 2004. CDC (Centers for Disease Control and Prevention). 2003a. Continuation Guidance for Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism—Budget Year Four Program Announcement 99051.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism FEMA (Federal Emergency Management Agency). 2004. FEMA’s Involvement in Exercises: A Historical Perspective. [Online] Available at http://www.fema.gov/rrr/section1.shtm. Accessed March 2004. FEMA/EMI (Federal Emergency Management Agency/Emergency Management Institute). 2003. IS 139: Exercises Design. Unit 1: Introduction to Exercise Design. [Online] Available at http://training.fema.gov/EMIWeb/IS/is139lst.asp. Accessed April 1, 2004. Ferguson N, Keeling M, Edmunds W, Gani R, Grenfell B, Anderson R, Leach S. 2003. Planning for smallpox outbreaks. Nature 425:681-685. Gani R, Leach S. 2001. Transmission potential of smallpox in contemporary populations [Letter]. Nature 414(6865):748-751. GAO (U.S. General Accounting Office). 2001. Combating Terrorism: Selected Challenges and Related Recommendations. GAO-01-822. Washington, DC. GAO. 2003a. Major Management Challenges and Program Risks—Department of Homeland Security (Performance and Accountability Series). GAO-03-102. Washington, DC. GAO. 2003b. Major Management Challenges and Program Risks—Department of Health and Human Services (Performance and Accountability Series), Report No. GAO-03-101. Washington, DC. GAO. 2003c. Bioterrorism: Public Health Response to Anthrax Incidents of 2001. GAO-04-152. Washington, DC. Gerber M. 2002, April. Anthrax Delay Blamed on Lack of Ties. The Hill. Giovachino M, Carey N. 2001. Modeling the consequences of bioterrorism response. Military Medicine 166(11):925-930. Granot H. 1999. Emergency inter-organizational relationships. Disaster Prevention and Management 8(1):21-26. Halloran M, Longini I, Nizam A, Yang Y. 2002. Containing bioterrorist smallpox. Science 298:1428-1432. Hilhorst D. 2003. Responding to Disasters: Diversity of Bureaucrats, Technocrats and Local People. International Journal of Mass Emergencies and Disasters 21(1):37-55. Hupert N, Mushlin A, Callahan M. 2002. Modeling the public health response to bioterrorism: using discrete event simulation to design antibiotic distribution centers. Medical Decision Making 22(5 Suppl):S17-S25. IAEM (International Association of Emergency Managers). 2003. Matrix of Federal All-Hazards Grants. [Online] Available at www.iaem.com/grantmatrix.pdf. Accessed June 17, 2003. IOM (Institute of Medicine). 2003a. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation: Letter Report #5. Washington, DC: The National Academies Press. IOM. 2003b. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation: Letter Report #1. Washington, DC: The National Academies Press. IOM. 2003c. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation: Letter Report #2. Washington, DC: The National Academies Press. IOM. 2003d. The Future of the Public’s Health in the 21st Century. Washington, DC: The National Academies Press. Kahsai D, Kare J. 2002. Prehospital disaster management: implications for weapons of mass destruction. Topics in Emergency Medicine 24(3):37-43. Kaplan E, Craft D, Wein L. 2003. Analyzing bioterror response logistics: the case of smallpox. Mathematical Biosciences 185:33-72. Kelkenberg K. 2004. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Five, March 29, 2004, Washington, DC:221-253.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Salinsky E. 2002. Will the Nation Be Ready for the Next Bioterrorism Attack? Mending Gaps in the Public Health Infrastructure. NHPF Issue Brief No. 776. Schweitzer R. 2004. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Five on March 29, 2004, Washington, DC:265. Simpson D. 2002. Earthquake drills and simulations in community-based training and preparedness programmes. Disasters 26(1):55-69. Sosin D. 2004. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Five on March 29, 2004 , Washington, DC. Staiti A, Katz A, Hoadley J. 2003. Has bioterrorism preparedness improved public health? Issue Brief: Findings from HSC, No. 65. Stoll M, Lee H. 2003. State health department develops SARS emergency response plan. Virginia Department of Health News Release, June 23, 2003. Tang N, Fabbri W. 2003. Medical direction and integration with existing EMS infrastructure. Topics in Emergency Medicine 25(4):326-332. Taylor N. 2003. Review of the Use of Models in Informing Disease Control Policy Development and Adjustment. Reading, UK: University of Reading, School of Agriculture, Policy and Development. [Online] Available at http://www.defra.gov.uk/science/Publications/2003/UseofModelsinDiseaseControlPolicy.pdf. Accessed April 1, 2004. Tierney K. 1993. Disaster Preparedness and Response: Research Findings and Guidance from the Social Science Literature. University of Delaware Disaster Research Center Preliminary Paper #193. [Online] Available at http://www.udel.edu/DRC/preliminary/193.pdf. Accessed April 25, 2004. Tierney K, Lindell M, Perry R. 2001. Facing the Unexpected: Disaster Preparedness and Response in the United States. Washington, DC: Joseph Henry Press. WADEM (World Association of Disaster and Emergency Medicine). 2001. Conceptual Framework of Disasters (Part III, Chapters 3-7). In Health Disaster Management: Guidelines for Evaluation and Research in the Utstein Style. [Online] Available at http://wadem.medicine.wisc.edu. Accessed June 1, 2004. Werner L, Naud M, Kellogg A. 1998. Quick Response Report #11—Public Health Emergency Response: Evaluation of Implementation of a New Emergency Management System for Public Health in the State of Georgia. University of Colorado Natural Hazards Center. [Online]. Available at http://www.colorado.edu/hazards/qr/qr111/qr111.html. Accessed May 12, 2004. White House. 2001. Fact Sheet: Homeland Security Council. [Online] Available at www.whitehouse.gov/news/releases/2001/10/print/20011029-16.html. Accessed April 10, 2004. LETTER REPORT #6, APPENDIX 6-A SUMMARY OF RECOMMENDATIONS Recommendation 1: The committee recommends that all federal entities concerned with bioterrorism preparedness (e.g., CDC, the Health Resources and Services Administration, the Office of Domestic Preparedness [ODP]) should more actively coordinate guidance and funding activities. Federal agencies should also work together to develop mechanisms that facilitate coordination and collaboration among their grantees at the state and local levels. Such mechanisms may include, but are not lim-

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism ited to, regular meetings to familiarize CDC and ODP program staff with each other’s program priorities and activities, a database for informing ODP and other partners of exercises planned by CDC grantees, etc. Federal coordination efforts should also include the clarification of primary responsibility and authority in bioterrorism events, to ensure that CDC can fulfill its unique role as the nation’s public health agency. Recommendation 2: The committee recommends that CDC should collaborate with all of its partners to strengthen preparedness by applying research findings and experience in public health emergency response, bioterrorism preparedness, and disaster management. In order to strengthen the evidence base for public health preparedness, CDC should: Strengthen the link between public health research and practice; Participate in and promote interdisciplinary research about preparedness; Support a system to assure the ongoing collection, synthesis, and sharing of lessons learned and best practices from public health preparedness exercises and public health response to proxy events; and In coordination with the appropriate federal-level partners, such as the Agency for Healthcare Research and Quality, evaluate the effectiveness, design, and opportunity costs of preparedness strategies, such as exercises. Recommendation 3: The committee recommends that CDC should use the Evidence-Based Performance Goals for Public Health Disaster Preparedness to develop standards against which CDC, states, and localities may regularly measure their performance in exercises and in response to proxy events. Public health agency performance in exercises and proxy events should be used to identify gaps in preparedness and to improve planning, communication, and coordination at the agency and interagency levels, as part of a process of continuous quality improvement in preparedness planning and response. Preparedness drills and exercises should not be evaluated individually, but their cumulative and long-term impact on preparedness, such as generalizability to other potential hazards, must be considered in the evaluation process.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism LETTER REPORT #6, APPENDIX 6-B ACRONYMS AND GLOSSARY Acronyms CDC Centers for Disease Control and Prevention CHER-CAP Community Hazards Emergency Response Capability Assurance Program CSEPP Chemical Stockpile Emergency Preparedness Program DHHS Department of Health and Human Services DHS Department of Homeland Security EMS Emergency Medical Services Epi-Aid Epidemic Assistance Investigation FBI Federal Bureau of Investigations FEMA Federal Emergency Management Agency GAO General Accounting Office HAN Health Alert Network HSAC Homeland Security Advisory Council HSC Homeland Security Council HRSA Health Resources and Services Administration HSEEP Homeland Security Exercise Evaluation Program ICS Incident Command System LLIS Lessons Learned Information Sharing (www.llis.org) MIPT Memorial Institute for the Prevention of Terrorism ODP Office of Domestic Preparedness PCC Policy Coordination Committee (of the HSC) REP Radiological Emergency Preparedness Program WMD Weapons of Mass Destruction Glossary All-hazards: generally contrasted with “agent-specific,” refers to a broad preparedness and response approach to all possible hazards to population health and safety, whether the complete range of known disasters, or specifically the complete range of public health disasters (from naturally occurring to deliberately introduced). Disaster: phenomena caused by natural, technological, or deliberate causes. Term is sometimes used interchangeably with emergency, although the two are not only quantitatively but also qualitatively different. A key difference is that while emergencies call upon largely local resources and response, disasters are of sufficient magnitude to require external resources and personnel for response and recovery (Mothershead, 2003).

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Drill: similar to exercises, but more narrowly focused activities used for training, testing, and refining capacities, and frequently involving a specific area of preparedness within only one agency rather than more complex processes and relationships at an interagency level. Emergency manager: a title used for increasingly professionalized personnel in local or state government who are charged with coordinating or overseeing the jurisdiction’s multiagency response to an emergency or disaster. Emergency responder/first responder/traditional emergency responder: term refers to a set of disciplines and responsibilities, including, but not limited to Emergency Medical Services (EMS), fire, law enforcement, hazardous materials specialists, etc. Personnel in such agencies and the practitioners of such disciplines prepare for emergencies and disasters and are responsible for carrying out response when emergencies and disasters occur.