F
Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation, Letter Report #5

December 19, 2003

Dr. Julie Gerberding

Director

Centers for Disease Control and Prevention (CDC)

1600 Clifton Road, NE Atlanta, GA 30333

Dear Dr. Gerberding:

The Committee on Smallpox Vaccination Program Implementation is pleased to offer you the fifth in a series of brief reports providing timely advice to assist CDC in preparing for a potential smallpox emergency. CDC asked the Institute of Medicine (IOM) committee to review CDC’s smallpox readiness indicators, which are part of a larger set of public health emergency preparedness indicators being developed through the Public Health Preparedness Project.1 The IOM committee reviewed the smallpox readiness indicators and heard from panelists representing public health, health care providers, health care institutions, and first responders at its

1  

CDC has used the terms “readiness” and “preparedness” relatively interchangeably in their description of the goals, purpose, and implementation of the Public Health Preparedness Project. Accordingly, the committee also has used both terms to describe essentially the same concept throughout this report.



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The Smallpox Vaccination Program: Public Health in an Age of Terrorism F Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation, Letter Report #5 December 19, 2003 Dr. Julie Gerberding Director Centers for Disease Control and Prevention (CDC) 1600 Clifton Road, NE Atlanta, GA 30333 Dear Dr. Gerberding: The Committee on Smallpox Vaccination Program Implementation is pleased to offer you the fifth in a series of brief reports providing timely advice to assist CDC in preparing for a potential smallpox emergency. CDC asked the Institute of Medicine (IOM) committee to review CDC’s smallpox readiness indicators, which are part of a larger set of public health emergency preparedness indicators being developed through the Public Health Preparedness Project.1 The IOM committee reviewed the smallpox readiness indicators and heard from panelists representing public health, health care providers, health care institutions, and first responders at its 1   CDC has used the terms “readiness” and “preparedness” relatively interchangeably in their description of the goals, purpose, and implementation of the Public Health Preparedness Project. Accordingly, the committee also has used both terms to describe essentially the same concept throughout this report.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism November 6, 2003, meeting and offers this report based on the information gathered at that meeting and during its ongoing assessment of the smallpox vaccination program. INTRODUCTION The committee commends CDC for communicating more clearly that the focus of the smallpox preparedness effort is on all components of smallpox readiness (e.g., preparedness, detection, response,2 containment, and recovery). Development of the smallpox readiness indicators—and the overall public health preparedness indicators—has helped to put preparedness for one hazard (e.g., smallpox) into the context of all-hazards public health preparedness. By planning to use the public health preparedness indicators to assess readiness and establish a baseline during the first year of their use, CDC has helped cast preparedness within the broader work of public health. The committee also applauds CDC for responding to the needs of state and local public health agencies by beginning the development of smallpox—and overall public health emergency—preparedness indicators. CDC’s state and local partners have stated that they need assistance in determining what constitutes a minimum level of preparedness (Selecky, 2003) and the most likely scenarios for which they should be preparing. The IOM committee echoed these concerns in its second report by encouraging CDC to define smallpox preparedness and to work with states to decide what more is needed to achieve smallpox preparedness (IOM, 2003a), and again in its fourth report by recommending that CDC assist states in establishing a baseline level or minimum standard of smallpox preparedness (IOM, 2003b). CDC has begun important work in this area by launching the Public Health Preparedness Project to ensure national preparedness for bioterrorism. The committee commends CDC for aiming toward indicators that will help state and local public health agencies document their progress on preparedness. Description of the Public Health Preparedness Project CDC has long recognized the importance of preparedness for bioterrorism and other public health threats. Prior to September 11, 2001, 2   In this report, the committee uses the terms “response” and “respond” to mean all the activities that are necessary following identification of an infectious disease outbreak or bioterrorism event (e.g., epidemiologic investigation, activation of communication plans, implementing mass vaccination plans, enhanced surveillance, etc.).

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism CDC had awarded over $120 million to state and local public health agencies to support bioterrorism preparedness and response activities (CDC, 2003a). Through the Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism (Program Announcement 99051) (hereafter, referred to as the “CDC cooperative agreement”), CDC awarded $918 million in fiscal year 2002 and $870 million in fiscal year 2003 (with an additional $100 million for smallpox preparedness) to support state and local agencies’ bioterrorism preparedness activities. In the past 6 months, CDC has launched the Public Health Preparedness Project to help define a baseline level of public health preparedness and to assess how states are using the funds received through the CDC cooperative agreement. The goals of the Public Health Preparedness Project are (Henderson, 2003b): Define and establish a fundamental level of public health preparedness—initially associated with the CDC bioterrorism preparedness and response cooperative agreement program. Serve as the basis of score-carding state and local preparedness. Provide the framework for the fiscal year 2004 cooperative agreement guidance;. Assist in identifying technical assistance needs of state and local public health agencies. At the time of the November meeting, the score cards were intended to be used for identifying states’ gaps in preparedness and areas where more resources are needed and were not intended to be used to reduce funding to states that are not performing as well as others (Henderson, 2003a). The committee endorses this view and believes that it is important that the score cards be used as opportunities for improvement. In developing and implementing this project, CDC has made the following assumptions (Henderson, 2003a): It is important to focus first on bioterrorism and other infectious disease outbreaks, and then on chemical and radiological/nuclear terrorism. Flexibility is needed to address jurisdictional variability. Little science-based evidence exists for clear-cut criteria. Current resources may not be sufficient to fully address indicators. State and local health agencies have primary responsibility for assuring community capacity. After an internal CDC workgroup, an external workgroup of national stakeholders, public health partners, and the IOM committee (through this report) provide feedback on the 4 goals, 22 objectives, and 127 indicators,

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism CDC will pilot test the indicators at five cooperative agreement recipient sites and some local health jurisdictions (Henderson, 2003a). Revisions will be made based on the pilot testing. In the summer of 2004, CDC will begin state and local assessments (based on the indicators) to establish a baseline, against which states will be assessed in subsequent years (Henderson, 2003b). Committee Tasks CDC asked that the IOM Committee on Smallpox Vaccination Program Implementation address the following tasks in their deliberations after the November 6, 2003 meeting (Henderson, 2003b): Review the smallpox readiness indicators to determine if they are appropriate in assessing smallpox preparedness; Develop/identify criteria or evidence that could be used to qualify a “Yes” response to a smallpox readiness indicator; and Develop a smallpox case study/scenario (addressing jurisdictional variability) that can be used to test the relevance of the smallpox readiness indicators. In the first task, the committee was asked to focus on a subset of 10 smallpox-specific indicators within the full set of 127 indicators and also to consider smallpox-related indicators from the larger set. In the report text, the committee makes some general observations about the entire set of all-hazards public health preparedness indicators. In Appendix 5-A, the committee offers specific comments about the 10 smallpox indicators and some criteria to aid in validating “yes” answers to the questions asked by the indicators (second task). The third task is addressed below. GENERAL PARAMETERS OF FOUR SCENARIOS TO ASSESS SMALLPOX READINESS INDICATORS Utility of Smallpox Scenarios Learning from Real-Life Experiences and Hypothetical Scenarios There are aspects of all-hazards public health preparedness that are hypothetical, because the nation has not experienced smallpox or certain other types of bioterror attacks, and the range of potential agents, extent of attack or outbreak, locations, and other variables are nearly limitless. Nevertheless, there are at least two ways to develop a useful framework for conceptualizing public health emergency response activities: designing sce-

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism narios that illustrate what could happen, and examining responses to real-life public health crises that have occurred already. Scenarios and real-life experiences help program planners consider the range of possibilities and complications that must be considered and addressed when responding to a public health emergency. Some recent public health challenges highlight how real-life lessons can help inform future planning activities and the development of scenarios to test and improve planning (IOM, 2003b). The anthrax attacks of October 2001 underscored that successful mass prophylaxis activities are dependent upon clarity of mission, clear eligibility criteria for prophylaxis, well-defined lines of authority and responsibilities, effective communication, collaboration among all agencies involved in a response, and coordination of staffing and supplies (Blank et al., 2003). The emergence of Severe Acute Respiratory Syndrome (SARS) in early 2003 suggests that even though the modes of transmission of a virus may not be understood fully, health care workers will report to work if health care administrators institute procedures to maximize the safety of health care workers (Emanuel, 2003). The monkeypox outbreak in the summer of 2003—and the 2-week delay in reporting the first case to public health authorities—reminded the public health community that more work is needed to educate health care providers about when and how to report unexpected infectious diseases, and that overall communication between the health care and public health communities needs to be improved (Edmiston et al., 2003; MacKenzie, 2003). These recent public health challenges illustrate the range of issues that must be considered when designing detailed scenarios to help guide planning efforts. Purpose, Development, and Use of Four Smallpox “Scenarios” At the November 6, 2003, committee meeting, CDC asked the committee to develop a smallpox case study/scenario (addressing jurisdictional variability) that can be used to test the relevance of the smallpox readiness indicators (Henderson, 2003b). Accordingly, the committee developed four smallpox “scenarios” (described in detail below) that it used as an organizing framework for assessing the 10 draft smallpox readiness indicators and developing their subsequent evaluative criteria. In developing these “scenarios,” the committee recognized that these are not detailed scenarios that can be used for broad planning purposes but, rather, are general parameters of scenarios that are only meant to be used for the committee’s purpose—to help test the draft smallpox readiness indicators. The simple descriptions of four smallpox contingencies that the committee has laid out below could be called many things—scenarios, case studies, vignettes. For the sake of simplicity, the committee decided to use

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism the term “scenario,” though recognizing that the descriptions below are mere sketches and at most can be called general parameters of smallpox scenarios. Due to time limitations and their limited purpose, these particular scenarios are simply four possible situations, and the activities that would need to receive particular attention in each scenario. These scenarios were chosen because they represent a range of possible situations, without focusing on the extremes (i.e., assuming that there is zero risk of a smallpox attack or assuming that smallpox will infect every single person in the United States). Should CDC and its partners deem these four scenarios a useful starting point, providing an illustrative range of smallpox contingencies, more work would be needed to fill in the details to lead to more elaborate scenarios that are useful for conceptualizing the federal, state, and local response to a smallpox outbreak. As described in previous reports (IOM, 2003b), the committee believes that detailed smallpox planning scenarios are necessary to assist states in planning their response activities and evaluating their level of preparedness. If CDC intends to use scenarios as a planning tool, the committee recommends that the scenarios represent a range of possible situations, be used to help guide state and local planning activities, and facilitate state and local assessment of their level of preparedness. Description of Smallpox “Scenarios” Used to Assess Readiness Indicators Scenario #1: No smallpox case(s)/known presence of virus3 This scenario assumes that preparedness activities continue, with no new data on degree of risk (most recent statement from the President about risk: “no information that a smallpox attack is imminent” [White House, 2002]). This scenario can be thought of as the “maintenance state,” and would also include any false alarms (i.e., pseudo-case). For this “no case” scenario, state and local public health agencies would need to focus, in particular, on training, vaccinating new members of response teams due to turnover, surveillance, planning, exercises, public information for false alarms, and clear lines of authority for decision-making. 3   By “known presence of virus,” the committee means the existence of the smallpox virus (i.e., in a vial or in the environment) outside of the two laboratories in the U.S. and Russia with known secured stocks of the smallpox virus.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Scenario #2: Limited number of confirmed smallpox case(s)/known presence of virus outside United States This scenario assumes that one or a very limited number of confirmed smallpox cases have been identified somewhere in the world, but there is no immediate evidence of cases in the United States. For this scenario, state and local public health agencies would need to focus, in particular, on criteria for deciding if, when, and how strongly to encourage vaccination of the general public, communication with the public, risk communication, enhanced surveillance (including surveillance by clinicians), laboratory capacity, and plans for enhanced clinical capacity. Scenario #3: Limited number of confirmed smallpox case(s)/known presence of virus in United States, outside of own jurisdiction This scenario assumes that one or a very limited number of confirmed smallpox cases have been identified somewhere in the United States, but there is no immediate evidence of cases in the particular jurisdiction. For this scenario, state and local public health agencies would need to focus, in particular, on enhanced surveillance (particularly focusing on travel hubs), communication with the public, risk communication, decision-making about distribution and delivery of vaccine, enhanced clinical capacity, enhanced laboratory capacity, interjurisdictional issues, and anticipation of legal issues. Scenario #4: Multiple confirmed smallpox case(s)/known presence of virus in multiple U.S. jurisdictions, with at least one case in one’s own jurisdiction This scenario assumes that multiple confirmed smallpox cases exist in multiple U.S. jurisdictions, with at least one confirmed case in the local jurisdiction. For this scenario, state and local public health agencies would need to focus, in particular, on frequent communication with the public, risk communication, close working relationships with the media, shifting legal authority among federal, state, and local entities, decision making about distribution and delivery of vaccine, clinical capacity, laboratory capacity, plans for disposal of human remains and coordination with Disaster Mortuary Operational Response Teams (DMORT), and recovery plans. Caveats to Consider in Proposed “Scenarios” Even though bioterror agents differ in important ways, many preparedness activities will be the same, no matter what the specific agent is. Whereas

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism scenarios for different agents will require some activities unique to that particular agent, scenarios reflecting a continuum of possibilities for one agent (e.g., smallpox) will require escalating activities. Detailed smallpox planning scenarios that represent the range of response activities that might be necessary could help state and local jurisdictions assess how this range of activities correlates to different levels of preparedness. It is important to recognize, however, that a real-life event probably is not going to proceed exactly according to any of the simple “scenarios” proposed by the committee, or more detailed scenarios yet to be developed. For planning purposes, communities will have to assess the pace at which they can respond to the different situations represented by each possible scenario. The committee recognizes the value of also developing scenarios for other threats (e.g., anthrax, botulinum toxin, chemical attacks), but due to the scope of its charge, it only offers comments on smallpox scenarios that can be used for assessing the readiness indicators. The embedding of smallpox within an all-hazards approach also means that some of what might be considered smallpox preparedness (e.g., mass vaccination clinics) is really a specific example of a more general response (i.e., mass distribution of any vaccine, prophylaxis, or medication). Irrespective of specific scenarios that may be chosen eventually, the committee believes that the number used by state and local agencies should be relatively small, so that the multitude of specific details for the set of scenarios does not confuse planning activities and even detract from preparedness. Meta-scenarios that transcend individual bioterror agents—and address the possibility that two or more public health emergencies may occur at the same time—may be needed, and their use would reinforce the all-hazards approach to preparedness. Applicability of Scenarios to Specific Local Circumstances The committee used the general parameters of smallpox scenarios described above to evaluate the smallpox readiness indicators. If scenario parameters such as these are used as a starting point for developing detailed smallpox scenarios, state and local jurisdictions will have to use some judgment in determining to which scenario they want to apply their jurisdiction’s limited resources. For example, some may say that it would be imprudent for jurisdictions that have already experienced a terrorist attack (e.g., New York City, Washington, DC, area) to assume that a smallpox attack in their community is not a possibility, whereas others may say that it would be ill-advised for a small, rural, Midwestern town with numerous other public health problems to assume that a smallpox attack in their community is a high probability and put all their resources into preparing for this scenario. A whole range of scenarios is possible for any community,

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism but it will be the role of state and local health departments, local boards of health, and communities to assess the possible scenarios and decide how they want to allocate public health and bioterrorism preparedness funds. No matter where an attack initially occurs, it can spread to other areas, so communities will need to consider how they would respond to such an event. Little Variability in Types of Planning Activities Across Scenarios The general parameters of four scenarios that the committee used to assess the smallpox readiness indicators highlight key differences in the scope of response activities—the pace of the response, the overall timeline for accomplishing response activities, supplies and personnel that are readily available—but in terms of the planning activities that are required before the event, most of the same activities are needed. By examining the 10 proposed smallpox indicators, the committee determined that most of the indicators deal with planning activities that would be required of any community should smallpox appear anywhere in the world (e.g., enhanced surveillance, preparations for increased laboratory capacity, more frequent and widespread communications, expanded education and training). Even the indicator addressing the activation of mass vaccination clinics shows little variability in terms of planning activities across the four scenarios (except for the “no cases” scenario) since CDC has stated that a case of smallpox anywhere in the world would lead to a decision to offer mass vaccination to the public (Henderson, 2003b). The main variability in planning that emerges across scenarios is for those indicators that are related to the response to a case in one’s own jurisdiction (e.g., activation of quarantine and isolation procedures, designation of medical surge capacity sites). Since it would not be prudent to only plan for the “no case” scenario, most communities will find that most of the readiness indicators are applicable to a majority of their planning activities. However, variability does exist in the response activities that would be required for different scenarios. If any of these scenarios occurs, the actions needed for that particular situation, the time frame in which those actions will need to be accomplished, and the resources that will be required for the response will be very different from what is required for another scenario. Applicability of Scenarios to Decision-Making and Management Structure of a Smallpox Response Although the four smallpox scenarios described above (or any range of scenarios) may be of limited utility for differentiating planning efforts that

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism must take place prior to an event, scenarios are useful tools for designing a decision-making and management structure for a smallpox response. Scenarios provide a framework for characterizing the decisions that will need to be made once a smallpox case is identified and the range of decisions that will be necessary, depending upon the circumstances of the outbreak. Since decisions will need to be made rapidly once there is evidence of a smallpox outbreak, a decision-making and management structure should be agreed upon by federal, state, and local entities before an event—when there is time to consider the options and generate support for the planned decision-making process—so that all parties involved understand how decisions will be made post-event and precious time will not be wasted on process issues. Such a decision-making and management structure should specify how the stages of the progression of the outbreak will be defined and, at each stage, who will make the key decisions, who will be the spokesperson, who will advise those decisions, who will be consulted, who will be informed of the decision, and what types of external validation and advice will be needed. A decision-making and management structure for a smallpox outbreak also should specify the criteria that will be used to decide: if, when, and how strongly to encourage vaccination of the general public; the necessary speed of vaccination activities; when to close social institutions (e.g., schools, public transportation, workplaces) for epidemic control; and when and how to institute isolation and quarantine procedures. By having these decision-making and management process issues specified a priori, the likelihood of confusion, public mistrust, delay, and rushed decision-making will be reduced. Although it is outside state and local agencies’ purview to plan for a nation-wide smallpox emergency that would affect all corners of the country and all segments of the national infrastructure (and the committee chose not to test the smallpox readiness indicators against such a catastrophic scenario), it is important for the federal government to create the necessary linkages across all federal agencies for such a possibility (this could be an extension of the Federal Response Plan coordination activities, with a focus on smallpox). Pandemic influenza planning is characterized by many of the same decision-making challenges, and any work on these decision-making issues for pandemic influenza planning that could assist smallpox response planning should be utilized. The swine flu event of 1976 provided important lessons and insights into the complications and nuances of responding to an infectious disease outbreak. Since a smallpox outbreak would share many of the characteristics of an influenza pandemic (e.g., surprise emergence, need for vaccination, importance of communication to the public), many of the same guiding principles for decision-making would apply to both types of incidents. The swine flu incident underscored that decision-making dur-

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism ing this type of infectious disease outbreak must be incremental and science-based, flexible, designed for efficiency and speed, show clear lines of authority, and have public acceptance (Neustadt and Fineberg, 1978). Because it is impossible to foreshadow the exact circumstances of a smallpox outbreak, the committee recommends that a flexible, incremental, science-based decision-making and management structure for smallpox response that includes all levels of government be developed and communicated to state and local agencies so that the consequences of a smallpox outbreak can be managed effectively. Key message #1: Preparedness must include a greater emphasis on planning, management, and decision-making. COMMENTS ABOUT THE DRAFT READINESS INDICATORS The committee reviewed CDC’s draft readiness indicators and at its November 2003 meeting received thoughtful input from representatives of the public health, health care, and first responder communities. A significant proportion of the testimony complemented many of the committee’s own observations—that some readiness indicators seem unevenly matched (with some very broad and others too detailed and minor), that there is an unnecessarily large number of indicators, and that some indicators are redundant or could be condensed. Furthermore, the committee discussed the issue of score-carding vis-à-vis the greater principle of continuous quality improvement, the purpose of the indicators, a framework for the indicators, and several important elements of preparedness that are underrepresented if not completely overlooked in the indicators. Due to time limitations and because the broader set of all-hazards indicators was still under development, the committee chose not to conduct a “big picture” determination of whether the 10 smallpox indicators are true predictors of smallpox preparedness. The committee did not systematically discuss the full scope of what is required for smallpox and overall preparedness, except to acknowledge that measuring preparedness requires asking “prepared for what?” and hence implies the need for scenarios. Nevertheless, the committee had some detailed comments about each of the 10 smallpox indicators, as described in Appendix 5-A. Committee members also identified important areas initially included in the CDC planning materials and cooperative agreement guidance, but not evident within the larger

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism role of DMORTS and whether their services can fulfill all the surge capacity needs in multiple communities are still unclear (Dunn, 2003). Panelist Comments about Mental Health It is unclear how much federal coordination exists around mental health issues during a smallpox emergency. SAMHSA’s role in a smallpox emergency should be characterized more clearly (Benjamin, 2003; Temte, 2003). Panelist Comments about Populations with Special Needs Special issues and concerns of the uninsured and undocumented immigrants need to be considered to a greater extent, as well as the needs of those who are homeless or have disabilities (Benjamin, 2003; Peterson, 2003; Temte, 2003). CONCLUDING REMARKS The committee commends CDC for responding to the needs of state and local public health agencies by developing smallpox and overall public health readiness indicators. These indicators are an important step in ensuring that states receive clear guidance on how to become more prepared to respond to a public health emergency, understand how they will be held accountable, and are assured of the federal role in national preparedness for a public health emergency. By addressing the three tasks with which CDC asked for advice (reviewing the smallpox readiness indicators, identifying criteria that could be used for the smallpox indicators, and developing smallpox scenarios that could be used to test the smallpox indicators), the committee has attempted to assist CDC with the important work of assessing the nation’s readiness to respond to a smallpox outbreak. In closing, the committee will summarize the report’s key messages: Preparedness must include a greater emphasis on planning, management, and decision-making. Readiness to respond to public health emergencies (including smallpox emergencies) should be part of overall continuous quality improvement of the public health system. CDC should address its immediate need of measuring cooperative agreement compliance with a concise and simple set of indicators, and then use this set of indicators as the foundation of a longer, deliberative, national process to develop measures that address the full range and appropriate balance of preparedness activities.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Federal agencies bear unique responsibilities in emergency response, and they should be held accountable and assessed on their progress, similar to their state and local counterparts. Public health readiness indicators need to address each of the distinct roles of federal, state, and local jurisdictions in the planning for and response to a public health or, specifically, smallpox emergency. The current set of readiness indicators provides a useful start to measuring preparedness, but many indicators seem too broad and redundant, and not based on any evident framework, such as one common to the public health system. The draft readiness indicators do not reflect the significance of active and sustained collaboration and communication among the public health system, the health care system, first responders, and the community (conceived in the broadest sense). 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 Austin B. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC:9-11, 13. Benjamin G. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC:144. Blank S, Moskin LC, Zucker JR. 2003. An ounce of prevention is a ton of work: mass antibiotic prophylaxis for anthrax, New York City, 2001. Emerging Infectious Diseases 9(6):615-622. CDC (Centers for Disease Control and Prevention). 2003a. Unpublished. Information and Instructions on Review of CDC’s Smallpox Readiness Indicators for the Institute of Medicine’s Smallpox Committee. CDC. 2003b. Local Public Health System Performance Assessment Instrument in National Public Health Performance Standards Program. [Online] Available at http://www.phppo.cdc.gov/nphpsp/Documents/Local_v_1_OMB_0920-0555.pdf. Accessed November 14, 2003. CDC. 2003c. National Public Health Performance Standards Program. [Online] Available at http://www.phppo.cdc.gov/nphpsp/. Accessed November 14, 2003. CDC. 2003d. State Public Health System Performance Assessment Instrument in National Public Health Performance Standards Program . [Online] Available at http://www.phppo.cdc.gov/nphpsp/Documents/State_v_1_OMB_0920-0557.pdf. Accessed November 14, 2003.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism DOJ (U.S. Department of Justice). 2000. Fiscal Year 1999 State Domestic Preparedness Support Program. [Online] Available at http://www.ojp.usdoj.gov/odp/assessment.pdf. Accessed November 14, 2003. Dunn V. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC:195-196, 207, 220. Edmiston CE, Graham MB, Wilson PJ, Grahn B. 2003. The monkeypox virus outbreak: reflections from the frontline. American Journal of Infection Control 31:382-384. Emanuel EJ. 2003. The lessons of SARS. Annals of Internal Medicine. 139(7):589-591. Fischler D. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC: 228-239, 252. GAO (U.S. General Accounting Office). 2000. West Nile Virus Outbreak: Lessons for Public Health Preparedness. GAO/HEHS-00-180. Washington, DC: Health, Education, and Human Services Division. GAO. 2003. Infectious Diseases: Gaps Remain in Surveillance Capabilities of State and Local Agencies. GAO-03-1176T. Washington, DC: Health, Education, and Human Services Division. Henderson J. 2003a. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC:26-108. Henderson J. 2003b. Update on National Smallpox Preparedness: Smallpox Preparedness Indicators. Presented to the IOM’s Committee on Smallpox Vaccination Program Implementation on November 6, 2003. Hirshon JM. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC:180. IOM (Institute of Medicine). 2001. Tools for Evaluating the Metropolitan Medical Response System Program: Phase I Report. Washington, DC: National Academy Press. IOM. 2002a. The Future of the Public’s Health in the 21st Century. Washington, DC: The National Academies Press. IOM. 2002b. Preparing for Terrorism: Tools for Evaluating the Metropolitan Medical Response System Program. Washington, DC: The National Academies Press. IOM. 2003a. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation: Letter Report #2. Washington, DC: The National Academies Press. IOM. 2003b. Review of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation: Letter Report #4. Washington, DC: The National Academies Press. Kelley K. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003 in Washington, DC:141-142. MacKenzie D. 2003, June 21. Slow Response to Monkeypox Reveals Glaring Gap in Bioterror Defenses. New Scientist, 12. Maniscalco P. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC:243-244, 260-261. NACCHO (National Association of County and City Health Officials). 2002. Compendium of Resolutions. [Online] Available at http://www.naccho.org/files/documents/compendium-May-2002.pdf. Accessed November 14, 2003. Neustadt RE, Fineberg HF. 1978. The Swine Flu Affair: Decision-Making on a Slippery Disease. U.S. Department of Health, Education, and Welfare. Peterson C. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC:151-157, 166. Plough A. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC:109-151.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Ricci K. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC:190. Roquemore J. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC: 241-242. 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. Washington, DC: National Health Policy Forum. Selecky M. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Three on May 1, 2003, Washington, DC:93-94. Schulman R. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC:213-214. Temte J. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC: 157-159, 165-166, 173-174, 186. Trimble M. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC. White House. 2002. President Delivers Remarks on Smallpox. [Online] Available at http://www.whitehouse.gov/news/releases/2002/12/20021213-7.html. Accessed January 8, 2003. WHO (World Health Organization). 2003. Unpublished. Strengthening National Health Preparedness and Response for Chemical and Biological Weapons Threats. Williamson D. 2003. Transcript from the IOM’s Committee on Smallpox Vaccination Program Implementation Meeting Four on November 6, 2003, Washington, DC:109-151. APPENDIX 5-A DRAFT SMALLPOX INDICATORS AND SUGGESTED CRITERIA The committee reviewed the draft 10 smallpox indicators included in CDC’s readiness indicators document. The committee’s analysis does not reflect an endorsement of the current indicators as indicative of readiness for smallpox attack. In fact, some of the indicators seem narrow and unclear, whereas others seem to incorporate multiple activities, and it is not evident whether and how they could represent a carefully selected, concise set of the most relevant measures of smallpox preparedness. The committee outlined four scenarios, discussed the indicators as they would operate in each scenario, and developed some examples of criteria that might help assess a jurisdiction’s work in an area summarized by a given indicator. Unless otherwise noted, the committee believes that the criteria it developed would apply to all scenarios. The committee has also indicated, as appropriate, whether a criterion is applicable to state public health agencies, local public health agencies, or both. Indicator 1.1.9.1: Legal issues related to smallpox vaccination (e.g., liability, compensation, licensure for administration of vaccine, investigational new drug issues) have been reviewed and addressed. This indicator should be broadened to more fully reflect the wide range of legal issues pertaining not only to vaccination, but to smallpox prepared-

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism ness in general. Such issues would include quarantine, isolation, access to medical records, legal authority to mandate employees to work, emergency medical technicians’ scope of practice, etc. Within the framework provided by the Ten Essential Public Health Services, this indicator corresponds to Essential Services 5 and 6. Suggested Criteria Are appropriate consent forms available and in use? (most relevant for scenario 1, and less for 2-4) (either state or local level, as appropriate) Are copies of relevant public health law available in all appropriate agencies? Is there documentation of thorough legal review to ensure that the jurisdiction’s law is current, including a record of changes and decisions made with policy-makers? (state level) Is information about relevant public health laws included in new employee orientation handbooks? (state and local levels) Is there documentation of legal authority for emergency licensing and credentialing? Are there information sheets describing the relevant legal issues in appropriate language to all relevant stakeholders, including the general public? (state or local, depending on the state’s plan) What evidence is there of a review of federal legislation and decisions made? (most important in scenario 4) Have federal agencies provided state/local agencies with documentation of federal legal authority and described under what circumstances federal agencies would become involved and what they would do (or other material defining the transition from one level of authority to another)? (most important in scenario 4) Indicator 1.3.3.1: Local and/or state public health has identified and secured governmental and nongovernmental agencies for surge capacity at mass distribution sites for medical countermeasures (e.g., vaccination). Indicator 1.3.4.1: Local and/or state public health has trained governmental and nongovernmental agencies for surge capacity at mass distribution sites for medical countermeasures (e.g., vaccination). Indicator 1.3.5.1: Local and/or state public health has identified and secured community resources for surge capacity as mass distribution for medical countermeasures (e.g., facilities). The three indicators above can be easily grouped into one, because they are all related to preparation for mass distribution of vaccine (or other

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism countermeasures). The new, joint indicator might read as follows: Local and/or state public health has identified, engaged, and trained governmental and nongovernmental agencies to participate in and taken the necessary steps to establish sites for mass distribution of vaccine (or other countermeasures). Within the framework provided by the Ten Essential Public Health Services, these indicators correspond to Essential Service 7 and 8. Suggested Criteria Does the agency have lists with contact information, addresses, and letters of agreement with all planned distribution sites in the community? (state or local, depending on which is managing the distribution process) Does the operational plan (which should be consistent with CDC guidelines) include rosters of staff, with contact information, functional role descriptions, and evidence of training for all personnel on the roster? (state or local, depending on which is managing the distribution process) Are there written collaborative agreements with all agencies that would be involved in some aspect of vaccination/distribution of countermeasures (school districts, EMS, law enforcement, etc.)? (state or local, depending on which is managing the distribution process) Indicator 2.3.1.1: Local and/or state public health maintains core personnel who are trained to provide technical assistance in the differential diagnosis of smallpox syndrome. Indicator 3.1.10.1: Local and/or state public health trains health care personnel to provide differential diagnosis of smallpox syndrome. These indicators are closely related and should be integrated. “Differential diagnosis” is more clearly worded as “confirming the diagnosis of….” The new, combined indicator might read as follows: Local and/or state public health agency has trained health care personnel and has core personnel available to provide technical assistance in confirming the diagnosis of smallpox syndrome. Within the framework provided by the Ten Essential Public Health Services, these indicators correspond to Essential Service 2 and 8. Suggested Criteria Is there a plan for ongoing education and training of health care providers and evidence of its implementation? (state or local, depending on specific state plan) Do local public health agencies have contact information at every

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism hospital and a communication method for immediately informing all hospital and community-based providers of a smallpox case? Is there a system for 24/7 two-way communication between the public health agency and health care providers (including what samples to get and where to send them)? Does the alert system include information on how a provider can immediately access “just-in-time” provider training on the diagnosis of smallpox? All these criteria (except the first) would be evidenced by retrospective analysis of actual test cases (monkeypox, varicella) or a (unannounced) test case/drill. Indicator 3.1.12.1: Local and/or state public health has secured community resources for surge capacity as sites for medical care and monitoring for potential victims of a smallpox outbreak (e.g. facilities). Within the framework provided by the Ten Essential Public Health Services, this indicator corresponds to Essential Services 4 and 7. Suggested Criteria Is there a community plan for the distribution of initial smallpox cases for medical care? Is there a triage plan for making space for an escalating number of cases? Are there resources (workforce, buildings, access to emergency funds) or plans to access resources to operationalize the triage plan? e.g., is there a current contact list for health care providers who have agreed to participate in the treatment of victims, including their vaccination status and multiple means to contact them? e.g., is there a list of all appropriate isolation rooms in the community? Is there a plan for the disposal of remains? Do facility/agency plans identify the other services or functions that would need to be maintained during the emergency (what must be provided and what can temporarily be suspended)? Are plans in place to support the environmental sampling surge capacity needs of public health laboratories? Is there a plan for the psychological management and general mental health issues of the worried well and of the families of health care providers and first responders? Is there a plan for the recovery of facilities after the epidemic is ended?

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Indicator 3.1.3.1: Local and/or state public health identified members of epidemiology investigation and surveillance teams targeted for immediate smallpox vaccination. This indicator is unclear in several ways. First, it should be clarified whether “immediate” means “pre-event,” and whether “epidemiology investigation and surveillance teams” refers to the public health response teams commonly described in the CDC guidance. Second, the wording used implies three related tasks: the identification of teams, defining the qualifications required for teams, and the vaccination of teams. It should be made clear exactly which task(s) the indicator aims to evaluate. Because this indicator only applies to pre-event activities, it is only applicable to scenario 1; it is presumed under scenarios 2, 3, and 4. Within the framework provided by the Ten Essential Public Health Services, this indicator corresponds to Essential Services 1 and 2. Suggested Criteria Is there an updated list or registry for each locale with smallpox public health response team members’ names, contact information, and vaccination status? Does the team possess the minimum public health bioterrorism response competencies appropriate to their role(s)? Is there an effective, efficient notification system for contacting team members? Indicator 3.1.9.1: Local and/or state public health identifies members of epidemiology and investigation teams targeted for immediate smallpox vaccination following the notification of an outbreak. The indicator wording should be clarified to explain what “notification of an outbreak” really means. Does this mean when an outbreak is officially declared? Immediately after a single case is identified? When an outbreak occurs anywhere in the world or in the United States? Also, as in 3.1.3.1, does “epidemiology investigation and surveillance teams” mean the public health response teams commonly described in the CDC guidance? The indicator also implies three different tasks, and it is unclear which task is being evaluated, whether it is the identification of teams, the vaccination of teams, or the expansion of teams with functional role descriptions for needed expertise. This indicator is not applicable to scenario 1, which is pre-event (i.e., before an outbreak), but it may apply to scenario 2 and is most relevant to scenarios 3 and 4 due to enhanced surveillance needs.

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism Within the framework provided by the Ten Essential Public Health Services, this indicator corresponds to Essential Services 1 and 2. Suggested Criteria Is there an updated list/registry for each locale with smallpox emergency team members’ names, contact information, and vaccination status? Does the team possess the minimum team competencies as described above? If not, is there a plan for acquiring members with those competencies immediately after notification of an outbreak? Has the notification system for contacting team members been tested and is it effective in mobilizing the team within the desired time frame (with a time parameter if that can be identified)? Indicator 3.3.2.1: Local and/or state public health will stockpile at least 20 doses of smallpox vaccine per 100,000 population to be available at all times (or a minimum of 1,000 doses [=10 vials] for states with population <3 million) in order to respond initially to a smallpox outbreak using search and containment strategies. It seems that the terms “search and containment” imply that this stockpile is meant for commencing ring vaccination and intended to be short-term and limited. It is unclear whether states are advised to have one or multiple storage sites. Furthermore, is there a plan (and ways to communicate it) for prioritizing access to the vaccine in the initial 24 hours postevent, including considering vaccinating the families of responders? This indicator applies to all scenarios. Within the framework provided by the Ten Essential Public Health Services, this indicator corresponds to Essential Service 7. Suggested Criteria Is the stockpiled smallpox vaccine in an appropriate storage facility (“appropriate” to be defined by CDC)? Is there a distribution plan for the stockpile, with a timeline for distribution? Possible Additional Indicators The set of smallpox indicators, as well as that of overall readiness indicators, seems to lack several important measures. Some, such as measures to assess communication and collaboration, were discussed to a greater extend in the text of the report. As CDC moves forward in refining and

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism pilot-testing the indicators, some additional areas should be considered to ensure that even a limited set of indicators provides a comprehensive assessment of readiness. Such additional measures include, but are not limited to: Sentinel indicators of diversion of effort, such as childhood immunization rates. The implementation of exercises and drills (which are both a way to test some of the criteria for various indicators, and an indicator on their own—does public health agency conduct drills/exercises and how does it do?). APPENDIX 5-B SUMMARY OF RECOMMENDATIONS If CDC intends to use scenarios as a planning tool, the committee recommends that the scenarios represent a range of possible situations, be used to help guide state and local planning activities, and facilitate state and local assessment of their level of preparedness. The committee recommends that a flexible, incremental, science-based decision-making and management structure for smallpox response that includes all levels of government be developed and communicated to state and local agencies so that the consequences of a smallpox outbreak can be managed effectively. The committee recommends that CDC consider conducting the preparedness assessments on a multiyear basis. The committee recommends that CDC address its immediate need of measuring cooperative agreement compliance with a concise and simple set of indicators, and then use this set of indicators as the foundation of a longer, deliberative, national process to develop measures that address the full range and appropriate balance of preparedness activities. The committee recommends that federal agencies and CDC, specifically, be held accountable for their unique federal responsibilities in an emergency response and assessed on their progress in facilitating national public health emergency preparedness. The committee recommends that CDC consider utilizing the Ten Essential Public Health Services as a framework for the readiness indicators. The committee recommends that CDC collaborate with HRSA to integrate the preparedness indicators into one document, in order to help the health care and public health communities work hand-in-hand to plan, implement plans, and evaluate their readiness to respond to threats (includ-

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The Smallpox Vaccination Program: Public Health in an Age of Terrorism ing, but not limited to, a smallpox attack) and to avoid requiring duplicate reporting from states. APPENDIX 5-C ESSENTIAL CAPABILITIES NEEDED FOR PREPAREDNESS Source: IOM. 2002. Preparing for Terrorism: Tools for Evaluating the Metropolitan Medical Response System Program. Washington, DC: The National Academies Press, pp. 115-159. Relationship development Communication system development Hazard assessment Training Equipment and supplies Mass immunization and prophylaxis Addressing the information needs of the public and the news media First responder protection Rescue and stabilization of victims Diagnosis and agent identification Decontamination of victims Transportation of victims Distribution of supplies, equipment, and pharmaceuticals Shelter and feeding of evacuated and displaced persons Definitive medical care (includes mass immunization or distribution of drugs or vaccines) Mental health services for responders, victims, caregivers, and their families Volunteer utilization and control Crowd and traffic control Evacuation and quarantine decisions and operations Fatality management Environmental cleanup, physical restoration of facilities, and certification of safety Follow-up study of responder, caregiver, and victim health Process for continuous evaluation of needs and resources