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REVIEW OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION'S SMALLPOX VACCINATION PROGRAM IMPLEMENTATION Letter Report #5 December 19, 2003 Dr. Julie Gerbercling Director Centers for Disease Control and Prevention (CDC) 1600 Clifton Roact, 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 (TOM) 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. The TOM committee reviewer! the smallpox readiness indicators and heard from panelists representing public health, health care providers, health care institutions, ant! first responders at its November 6, 2003 meeting and offers this report baser} on the information gathered at that meeting and cluring 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, responses, containment, and recovery). Development of the smallpox readiness indicators ant! the overall public health preparedness indicators has helped to put preparedness for one hazard (e.g., smallpox) into the context of all- hazarcls public health preparedness. By planning to use the public health preparedness ~ 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 has also used both terms to describe essentially the same concept throughout this report. 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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indicators to assess readiness ant} establish a baseline cluring the first year of their use CDC has helpec! 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 cleveJopment of srnalIpox and overall public health emergency preparedness indicators. CDC's state anti 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 TOM committee echoed these concerns in its second report by encouraging CDC to clef~ne smallpox preparedness and to work with states to decicie what more is neecied to achieve smallpox preparedness (TOM, 2003a), and again in its fourth report by recommending that CDC assist states in establishing a baseline level or minimum stanciarc! of smallpox preparedness (IOM, 2003b) CDC has begun important work in this area by launching the Public Health Preparedness Project to assure 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 ~ i, 2001, CDC hac! awarder] over $120 million to state ant! 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 adclitional $100 million for smallpox preparedness to support state and local agencies' bioterrorism preparedness activities. In the past six 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 receiver! 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 ant! response cooperative agreement program; 2. Serve as the basis of score-cartlin~ state ant! local crenareciness: 3. ~ ~ 1 1 Provide the framework for the fiscal year 2004 cooperative agreement guidance; and 4. Assist in identifying technical assistance needs of state and local public health agencies. 2

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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 nee(led, and were not intended to be used to recluce 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 (Henclerson, 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; and State ant! 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 TOM committee (through this report) provide feedback on the four goals, 22 objectives, and 127 indicators, CDC will pilot test the indicators at five cooperative agreement recipient sites and some local health jurisdictions (Henderson, 2003a). Revisions will be macle 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 TOM Committee on Smallpox Vaccination Program Implementation adciress the following tasks in their deliberations after the November 6, 2003 meeting Henderson, 2003b): T. Review the smallpox readiness indicators to determine if they are appropriate in assessing smallpox preparedness; 2. Develop/identify criteria or evidence that conic be used to qualify a "Yes" response to a smallpox reacliness indicator; and 3. Develop a smallpox case stucly/scenario (adclressing 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 smalIpox- specific indicators within the full set of 127 indicators, ant! also to consider smalIpox- relatec3 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 A, the committee offers specific comments about the 10 smallpox indicators, anti some criteria to air! in validating "yes" answers to the questions asked by the indicators (second task). The third task is aciciressed below. 3

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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 scenarios that illustrate what could happen, and examining responses to real- life public health crises that have occurred aireacly. Scenarios and real life experiences help program planners consider the range of possibilities and complications that must be considered and aciciressec! when responding to a public health emergency. Some recent public health challenges highlight how real-life lessons can help inform fixture planning activities and the development of scenarios to test and improve planning (TOM, 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-clef~nec3 lines of authority and responsibilities, effective communication, collaboration among all agencies involved in a response, ant! coordination of staffing ant! 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 un~ierstooct fully, health care workers will report to work if health care administrators institute procedures to maximize the safety of health care workers (Emanuel, 20034. The monkeypox outbreak in the summer of 2003 ant! the two-week clelay 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 ant} public health communities needs to be improver! (Edminston et al, 2003; MacKenzie, 20033. These recent public health challenges illustrate the range of issues that must be considered when designing cletailec} 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 stucly/scenario (aciciressing jurisdictional variability) that can be user! to test the relevance of the smallpox readiness indicators (Henderson, 2003b). 4

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Accordingly, the committee developed four smallpox "scenarios" (clescribec! in detail below) that it used as an organizing framework for assessing the ten ciraft smallpox readiness indicators and developing their subsequent evaluative criteria. In cleveloping these "scenarios'" the committee recognized that these are not detailed scenarios that can be used for broad planning purposes, but rather, are genera] parameters of scenarios that are only meant to be user! 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 couch be called many things scenarios, case studies, vignettes. For the sake of simplicity, the committee decided to use the term "scenario," though recognizing that the descriptions below are mere sketches, ant! at most can be caller! 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 wouict 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 U.S.~. 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 leacI to more elaborate scenarios that are useful for conceptualizing the federal, state, and local response to a smallpox outbreak. As described in previous reports (TOM, 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 ant! local planning activities, and facilitate state and local assessment of their level of preparedness. Description of Smallpox "Scenarios" Uses! to Assess Readiness Indicators Scenario #I: No smallpox casefs)/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" tWhite House, 20024~. This scenario can be thought of as the "maintenance state," and wouict also include any false alarms (i.e. pseuclo-case). For this "no case" scenario, state and local public health agencies wouict need to focus on, in particular, training, vaccinating new members of response teams clue to turnover, surveillance, planning, exercises, public information for false alarms, ant! clear lines of authority for clecision-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. 5

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Scenario #2: Limited number of confirmed smallpox caseks)/known presence of virus outside US This scenario assumes that one or a very limited number of confirmed smallpox cases have been identifier! somewhere in the worm, but there is no immediate evidence of cases in the Uniter! States. For this scenario, state and local public health agencies would need to focus on, in particular, criteria for deciding if, when, and how strongly to encourage vaccination of the general public, communication with the public, risk communication, enhances! surveillance (including surveillance by clinicians), laboratory capacity, ant! plans for enhanced clinical capacity. Scenario #3: Limited number of confirmed smallpox casefs)/known presence of virus in US, outside of own jurisdiction This scenario assumes that one or a very limiter! number of conf~rmect 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 on, in particular, enhanced surveillance (particularly focusing on travel hubs), communication with the public, risk communication, ciecision- making about distribution ant! clelivery of vaccine, enhanced clinical capacity, enhanced laboratory capacity, interjurisdictional issues, and anticipation of legal issues. Scenario #4: Multiple confirmed smallpox casefs)/known presence of virus in multiple US 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 on, in particular, frequent communication with the public, risk communication, close working relationships with the media, shifting legal authority among fecleral, state, and local entities, clecision-making about distribution ant! 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 wit] be the same, no matter what the specific agent is. Whereas scenarios for different agents wild require some activities unique to that particular agent, scenarios reflecting a continuum of possibilities for one agent (e.g., smallpox) will require escalating activities. Detaileti smallpox planning scenarios that represent the range of response activities that might be necessary could help state ant! 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 cletailecl scenarios yet to be cievelopecl. For planning purposes, communities will have to assess 6

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the pace at which they can respond to the different situations represented by each possible scenario. The committee recognizes the value of also cleveloping scenarios for other threats (e.g., anthrax, botulinum toxin, chemical attacks), but clue to the scope of its charge, 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 consiclerec! smallpox preparedness (e.g., mass vaccination clinics) is really a specific example of a more genera! response (i.e., mass distribution of any vaccine, prophylaxis, or meclication). Irrespective of specific scenarios that may be chosen eventually, the committee believes that the number used by state ant! local agencies shouIc! be relatively small, so that the multitude of specific details for the set of scenarios does not confuse planning activities ant! even detract from preparedness. Meta- scenarios that transcend individual bioterror agents and aciciress the possibility that two or more public health emergencies may occur at the same timemay be neecleci, 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 clescribec} above to evaluate the smallpox readiness indicators. If scenario parameters such as these are user! as a starting point for developing cletailec! smallpox scenarios, state and local jurisdictions will have to use some judgment in determining to which scenario they want to apply their jurisciiction'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, but it will be the role of state and local health departments, local boards of health, and communities to assess the possible scenarios, and ciecicle how they want to allocate public health ant! bioterrorism preparedness fiends. No matter where an attack initially occurs, it can spread to other areas, so communities will neec] 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 activitiesthe 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 requires! before the event, most of the same activities are needed. 7

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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, expancled 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 states! that a case of smallpox anywhere in the world wouict leac! to a decision to offer mass vaccination to the public (Henclerson, 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 ant! 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 floes exist in the response activities that would be requires! for different scenarios. If any of these scenarios occurs, the actions neecied for that particular situation, the time frame in which those actions wild need to be accomplished, and the resources that will be required for the response wit! be very different than 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 must take place prior to an event, scenarios are useful tools for designing a ciecision-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 ot the outbreak. Since decisions will need to be made rapidly once there is evidence of a smallpox outbreak, a clecision-making and management structure shouic! be agreed upon by fecleral state, and local entities before an event -- - when there is time to consider the options and generate support for the planned ciecision-making process so that all parties involved understand how decisions will be macle post-event ant! precious time will not be waster} on process issues. Such a clecision-making ant! management structure should specify how the stages of the progression of the outbreak will be clefined, and at each stage, who will make the key decisions, who will be the spokesperson, who will advise those decisions, who will be consultecI, who will be informer! of the decision, and what types of external validation and advice will be neediest. A decision-making and management structure for a smallpox outbreak should also specify the criteria that will be used to decided if, when, and how strongly to encourage vaccination of the general public; the necessary speec! of vaccination activities; when to close social institutions (e.g., schools, public transportation, workplaces) for epidemic control; and when and how to institute 8

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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 characterizes! 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 utilizecI. The swine flu event of 1976 provided important lessons and insights into the complications ant! 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 during 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, 19784. Because it is impossible to foreshadow the exact circumstances of a smallpox outbreak, the committee recommends that a flexible, incremental, science-basect 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 #I: * 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-a-vis the greater principle of continuous quality improvement, the 9

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purpose of the indicators, a framework for the indicators, and several important elements of preparedness which are underrepresented if not completely overIookec! in the indicators. Due to time limitations and because the broacIer set of all-hazards indicators was still uncler development, the committee chose not to conduct a "big picture" determination of whether the ten smallpox indicators are true predictors of smallpox preparedness. The committee did not systematically discuss the full scope of what is required for smallpox ant! overall preparedness, except to acknowledge that measuring preparedness requires asking "preparecl for what?" and hence implies the need for scenarios. Nevertheless, the committee hac! some detailed comments about each of the ten smallpox indicators, as clescribed in Appendix A. Committee members also identified important areas initially incluciect in the CDC planning materials and cooperative agreement guidance, but not evident within the larger set of indicators, and offers these areas (describer! below) for consideration as CDC refines its readiness indicators. Furthermore, the committee outlined four scenarios (described above) and the various capabilities needled in each case an exercise which helpec! the committee ciraft some criteria (see Appendix A) to help document "yes" answers to the ten smallpox indicators and ensure welI-rouncled assessment of jurisdictions' capabilities in areas iclentified by the current inclicators. Continuous Quality Improvement Measuring preparedness should be characterized as a process of continuous quality improvement within the public health system (CDC, 2003c) rather than a way to focus on shortcomings in states' capacities. The readiness indicators themselves should be subject to the process of continuous quality improvement (in relevance ant! validity), as they are not static, but coup! be expected to change with time as the Public Health Preparedness Project evolves. Although CDC has stated that it does not intend that the indicators be user! in a punitive fashion (Henderson, 2003a), some panelists perceived the notion of score- carcling as potentially intimidating to jurisdictions ant! not necessarily reflective of quality performance anti preparedness (Schulman, 2003; Dunn, 20034. Also, in a process of developing an entirely new measurement tool to be user} in widely divergent settings ant! requiring many subjective iuciaments~ using a reporting crevice (e.g., a red to green ~ ~ ~ ~ ~ ~ , ~ ~ spectrum) that suggests precision is probably an error. Any version of a numeric or color-coclect scale such as that illustrated in the CDC presentation to the committee seems premature. The use of Likert-type scales is probably appropriate, ant! the CDC is encourages! to look at the four-level scale aIreacly in use in the state and local public health performance indicators as a motley (CDC, 2003b; CDC, 2003cl). Any type of overall score should be similarly baser! on a common public health framework, which is discussed on subsequent pages. 10

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The committee heard from panelists that yearly assessments of states' bioterrorism and infectious disease preparedness capacities could become a burden. Many assessment ant! accreditation programs acknowledge this in their routine use of reviews on a multi-year cycle (e.g., Joint Commission on Accreditation of Healthcare Organizations hospital accreditation, health professional education accreditation). In order to ease the resource strain on grantees, ant! to more clearly separate measures of compliance from measures of preparedness, the committee recommends that CDC consider conducting the preparedness assessments on a multi-vear basis (e.~.. every three to four years). ~ ~ ~ in, ~ concise evaluations or grantee compliance with cooperative agreement requirements could be concluctect yearly to provide more frequent assessments of grantee accountability to policymakers and communities. Key message #2: * Readiness to respond to public health emergencies (inclucling smallpox emergencies) should be part of overall continuous quality improvement of the public health system. Purpose of the Indicators A Dual Purpose in Developing Indicators In its review of the readiness indicators, the committee notes! (and was also informed by CDC "Henderson, 2003b]) that the purpose of the indicators is two-foicI: to measure grantees' compliance with the CDC cooperative agreement guidance, and to measure grantees' preparedness to respond to public health threats. This duality of purpose is a cause of concern to the committee, as it may lead to having an overly large set of indicators and to using indicators that are not indicative of preparedness. Although the two purposescompliance and preparedness are vaTicl and relatecl, one adclresses an immediate need, focuses! on line items to be met by grantees (e.g., meetings held, number of workers trained), while the other is a longer process, focuses! on outcomes. The indicators cievelopec! to address the immediate need of measuring compliance . with the CDC cooperative agreement will accomplish some, but not all, of what is needled for a longer, ongoing assessment of the scope of federal' state, and local preparedness activities. 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 acIdress the full range and appropriate balance of preparedness activities. 11

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Distinct Indicators Needed for Federal, State, and Local Jurisdictions Further questions about the purpose of the indicators ask whose preparedness is being evaluates! ant! whose accountability is being assessed. Most indicators refer to "local and/or state agency" but the committee was unsure whether "local" referrer! to the four local jurisdictions funcIed by CDC or to local public health agencies funded in turn by states. The public health pane! that acicIressec} the committee at its meeting recommended, ant! the committee agreed, that there should be separate indicators (or sets of inclicators) for local and state jurisdictions (Plough, 2003; Williamson, 2003~. It is imperative that the indicators distinguish among the roles of the federal government, states, or local jurisdictions. The indicators shouts! distinctly identify the specific activities for which local jurisdictions are responsible and the specific activities for which states are responsible. The fecleral government also needs to be held accountable for its preparedness activities. The federal government ant! CDC. soecificaliv. are responsible not oniv for , 1 ~ ~ 1 assisting state and local jurisdictions in their preparedness activities and monitoring their progress, but also for carrying out certain activities that must be accomplished at the federal level. The CDC has some unique responsibilities in national smallpox preparedness (e.g., developing a vaccination priority list for the nation, working with FDA for provisional use of smallpox vaccines still under Investigational New Drug 1 1 , 1 1 1 1 1 1 , ~ rr~1 1 ~ protocols, and establishing declslon-maklng and management processes). the role ot CDC in national preparedness must be laid out clearly so that state and local jurisdictions have clear assurance of the federal public health resources that will be available in an emergency. The committee recommends that federal agencies and CDC, specifically, be held accountable for their unique federal responsibilities in an emergency response and assesses! on their progress in facilitating national public health emergency preparedness. Key message #3: * 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 filet range and appropriate balance of preparedness activities. Key message #4: * 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. A Framework for Readiness Indicators It was not apparent to the committee what framework was used to develop and structure the readiness indicators and to ensure that there are indicators identified for every major component of preparedness. CDC noted that it is moving away from the 12

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focus areas described in the CDC cooperative agreement guidance for FY 2003 (CDC, 2003a), but did not explain what, if any, new framework would be used, and one floes not emerge from the indicators document, other than the four chronological goals (pre-event activities; detection and reporting; response ant! containment; recovery). The committee recommends that CDC consider utilizing the Ten Essential Public Health Services as a framework for the readiness indicators (see Box T) There are several reasons for this recommendation. The ten essential services are funciamental in identifying the core responsibilities of public health, and therefore, the capacities ant! resources public health system neecis to be effective. The importance of a strong public health infrastructure for preparedness has been emphasized repeatedly (Salinsky, 2002; GAO, 2000; TOM, 2002a), because preparedness for bioterrorism floes not occur in a vacuum but is one component of a public health system capable of maintaining optimal population health against a wide range of current and potential threats. Also, the ten essential services are a well-establishec! framework widely used by local and state public health agencies in planning and evaluation, and they have served as the foundation for the Department of Justice/CDC Public Health Performance Assessment for Emergency Preparedness (DON, 2000), ant! most importantly, for the National Public Health Performance Standards (CDC, 2003 c) which are used by many public health agencies to measure performance and ensure continuous quality improvement (NACCHO, 2002~. Other sets of indicators could be used to help refine CDC's readiness indicators process. To ensure reasonable alignment with global preparedness efforts, the WorIc! Health Organization's indicators effort should be reviewed (WHO, 20033. Also, the DHHS Metropolitan Medical Response System (MMRS) program conducted some pioneering work in the areas of multi-sectoral coordination for preparedness, bringing together public health, government, first responders, health care, ant! others. TOM's Tools for Evaluating the Metropolitan Meclical Response System Program. Phase ~ Report (IOM, 2001) highlighted the importance of placing the "emphasis on enhancing existing systems rather than building new, perhaps competing tones]" as a principle of preparedness for chemical, biological, and racliological terrorism. Using the Ten Essential Public Health Services as a framework for the indicators wouIc} reinforce these major structuring principles within the public health system. The TOM review of tools for evaluating the MMRS itself Box ~ The Essential Public Health Services 1. Monitor health status to identify community health problems 2. Diagnose and investigate health problems and health hazards in the community 3. Inform, educate, and empower people about health issues 4. Mobilize community partnerships to identify and solve health problems 5. Develop policies and plans that support individual and community health efforts 6. Enforce laws and regulations that protect health and ensure safety 7. Link people to needed personal health services and assure the provision of health care when otherwise unavailable 8. Assure a competent public health and personal health care workforce 9. Evaluate effectiveness, accessibility, and quality of personal and population-based health services 10. Research for new insights and innovative solutions to health problems Source: CDC (2003c). 13

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provides some examples of preparedness indicators as well as a comprehensive framework of 23 essential capabilities of preparedness (see Appendix C) (IOM, 2001; TOM, 2002b). Elements Not Reflected in the Readiness Indicators At its November 6, 2003 meeting, the committee hearct from four groups of stakeholders in public health ant! smallpox preparedness: first responders, health care providers, health care institutions, and the public health community. The panels presented fencings from their review of the CDC readiness indicators, and focused on areas they considered important to preparedness, but were not sufficiently reflected in the indicators: communication, collaboration (in particular, between CDC and the Health Resources and Services Administration), and training ant! education. Collaboration and Communication A recurring theme in the panel presentations is the need for diverse collaborations and the engagement of all relevant stakehoiciers in the work of preparedness. A closely relater! theme is communicationamong levels of government and the various partners in preparedness, with communities ant} the general public, and with the media also an area panelists fount! missing or severely underrepresentec! among the indicators, despite the vital importance of effective communication channels ant! methods in most preparedness activities. The committee fount! that, despite the fact that the pre-event guidance emphasized the neec! for intersectoral relationships among the public health system and the first responder communities (i.e., fire, emergency medical services, law enforcement), the indicators do not reflect this emphasis on collaboration ant! communication. They contain almost no mention of these important partners in preparedness, and little mention of the cross-linkages with health care providers and professional organizations, health care institutions (inclucling, but not limiter! to, hospitals), and health care insurers. With the exception of a few representatives of the public health community, other partners were not involved in the cleve~opment of the readiness indicators, although their critical roles in responding to smallpox attack (and other public health crises) were acknowleciged ant] ciescribeci in earlier planning materials cIeveloped by CDC. To remedy these gaps, formal measures of the strength and effectiveness of collaboration couict be added to the readiness indicators to assess jurisdictions' capacity in these important areas. In recent years, the role of communities in the public health system has been increasingly recognized ant! supported. With their ethnically and culturally diverse populations, service and social organizations, opinion leaders, and faith groups, communities can contribute knowledge and other resources to the work of keeping the population healthy. Bioterrorism is just one of the threats to the public's health, ant! 14 ~ .

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developing purposeful community engagement in preparedness should be part of the range of activities conducted by the public health agencies and their partners. Involving the community in planning and evaluation requires good communication, building partnerships with organizations and community leaders, and including community representatives in decision-making. This investment in counting communities among partners in preparedness could also lead to a better informed citizenry, which may help to decrease the potential for fear and panic in the course of a bioterror event or other emergency. Risk communication is largely absent from the activities measured by the smallpox readiness indicators. As the committee has emphasized in previous reports, in particular its second report (TOM, 2003a), effective communication is key to preparedness, and should include building relationships with the media, designating trained, trusted, knowledgeable spokespersons, developing uniform messages, relaying timely and accurate information to the public, and planning communication strategies and materials to respond to a range of contingencies. The response capacity of the public health system and its partners must include communication strategies and activities, and the readiness indicators should measure communication preparedness. If an event were to occur, would the jurisdiction being assessed have the necessary components of a good communication plan in place and ready to implement immediately, or will it appear unprepared, and thus leading to misinformation, panic, mistrust, and ultimately resulting in a failure to mount an effective emergency response? in a smallpox event (or other emergency), hospital communication capacity may also become overwhelmed by requests for information, and therefore would need readily available communication materials, well-known protocols, and well-established linkages to local and state public health agency spokespersons and resources. ~ , ,, ~ ~ , Collaboration and Communication among Federal Agencies with Health Responsibilities The relationship between CDC and HRSA parallels the connections between public health agencies at all levels and health care providers in hospitals, health centers, and communities. Although the CDC and HRSA cooperative agreement guidance documents are somewhat analogous, and make references to each other (and include an appendix about cross-cutting activities and benchmarks), it seemed to both the committee and the panelists that the agencies themselves have yet to fully coordinate their preparedness planning and their work on preparedness indicators. In addition to planning and collaboration at the administrative level, frequent and productive communication using efficient and redundant channels is needed to facilitate the exchange of information between the health care and public health communities, to clarify reporting requirements and technical assistance resources, to familiarize all health care providers and public health workers with each other's roles and capabilities in a smallpox or other emergency, to address unknowns and concerns, and to jointly implement various preparedness activities. 15

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Strengthening surge capacity, discussed below, is an area that requires particular, joint attention from CDC and HRSA, given the interdependence of the public health and health care communities, and the need for enhanced familiarity with each other's unique and interrelated responsibilities (e.g., public health to conduct surveillance, and health care to report suspect or confirmed cases), capabilities (e.g., public health to conduct mass vaccination or distribution of countermeasures, and health care to provide diagnosis and treatment), and resources. Furthermore, the communication and collaboration between the health care and public health communities and relevant federal agencies should extend to the Centers for Medicare and Medicaid Services (CMS), the Department of Defense (DOD), the Department of Veterans Affairs (VA), the Indian Health Service (1HS), and the Substance Abuse and Mental Health Services Administration (SAMHSA). CMS coordinates the Medicaid and Medicare programs, including developing conditions of participation in the programs. If bioterrorism planning and exercises were included among the conditions of participation in Medicaid and Medicare, this could further hospital preparedness planning. DOD, VA, and {HS operate major health care facilities for specific populations, and would likely play vital roles in the health care response to a smallpox attack or other emergency. SAMHSA would be responsible for addressing the need for mental health services arising from a bioterrorism event. Preparedness indicators are needed to assess the strength, scope, stability, and sustainability of health care-public health linkages. In addition to considering indicators that assess such linkages, 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 (including, but not limited to, a smallpox attack) and to avoid requiring duplicate reporting from states. Training and Education Another component of preparedness not evident among the readiness indicators is the training ant! education of all workers (including first responclers) expecter] to respond to a smallpox attack or other public health threat. Well-trained personnel are essential to mount an effective response, ant! training neecis range widely depending on the type ant! functional responsibilities of personnel. This has been discussed extensively in other committee reports (IOM, 2003a). Several related comments about training and education were proviclect by meeting panelists (see below). Issues Relater! to Surge Capacity Several CDC reacliness indicators focus on surge capacity the ability to rapidly expand facilities (bells), workforce, and other capabilities (cliagnostic, treatment, etc.) in 16

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response to a crisis, such as a smallpox attack or major infectious disease outbreak. All stakeholders who participated in the November meeting shares! concerns about inadequate surge capacity in their respective health care, public health, ant! first response communities. Although health care providers and emergency responders may be able to surge briefly in order to hancTIe an acute event, their surge capacity may be limited if sustained effort is required over a longer period of time. Both the committee and the groups that provided their input at the committee's meeting icientified the need to acknowledge the multiple obstacles to achieving surge capacity ant! the fact that existing systemic strains and limitations will not be resolved by the influx of bioterrorism funds. The emergency responder communities stated that in a crisis, they would be called upon to continue their usual duties and carry out other functions not necessarily related to public health response (Fischier, 2003~. This coulc! limit their ability to help enhance surge capacity for mass vaccination or in other areas. The health care institutions and providers who presenter! to the committee expressed concern about their ability to contribute to surge capacity when their current resources (e.g., hospital emergency departments, staff] are often overwhelmed! by routine needs or even just seasonal spikes (e.g., cases of influenza) (Austin, 2003; Temte, 2003; GAO, 20034. The surge capacity neecIs of public health laboratories also require careful consideration, as laboratories confirm diagnoses and conduct essential surveillance functions. It is important that federal and state public health agencies consider the possibility of weaponizec! smallpox and the need for environmental sampling, as well as the limiting factor of laboratory biosafety level. Furthermore, in a crisis, laboratories share some of the workforce ant} resource concerns of the public health agencies ant! health care entities. Key message #5: * Public health reacliness indicators need to act OCR for page 1
Selected Gaps and Needs of Public Health Preparedness Identified by Stakeholders The following bulleted list is a loosely structured summary of some of the important comments made by panelists representatives of the public health, health care (providers and institutions), and first responder communitiesinvited to address the committee at its November 6, 2003, meeting. CDC has stated that the assessments that will be conducted through the Public Health Preparedness Project will help identify technical assistance needs and gaps in preparedness of state and local public health agencies (Henderson, 2003a). These assessments will be an important tool for gathering information about how preparedness activities across the country need to be improved. To provide some interim guidance, before the systematic assessments of needs and gaps are implemented, the committee summarizes suggestions, problems, and insights offered by panelists. Although these issues are not necessarily incorporated into formal recommendations based on the charge to the committee, CDC is encouraged to consider these issues as appropriate prior to conducting the formal state assessments. Panelist Comments about Training and Education . Fire, police, and EMS personnel expressed a desire for a simple pocket card that they could keep in their wallets that would describe the symptoms of smallpox compared to other rash illnesses and whom they should call if they suspect they are responding to a case of smallpox (Fischier, 2003~. There needs to be greater coordination with primary care clinicians. Many are untrained in how to diagnose a case of smallpox (or the manifestation of any other bioterror or chemical agent), as well as how to report a suspected case. Education needs include "just-in-time" information available in real-time to physicians and other health care providers in the event of a possible case (Temte, 2003~. One way to encourage clinicians to educate themselves on bioterrorism preparedness could be to include some elements of clinical bioterrorism expertise in the regular certification and recertification processes (Hirshon, 2003; Roquemore, 2003~. First responder personnel need to receive additional education. Any educational materials provided to first responders and health care personnel must be easily accessible, organized simply, and provide the necessary information succinctly (Dunn, 2003; Fischier, 2003; Temte, 2003~. Panelist Comments about Resources (e.g., human, equipment and supplies, communication) . Many fire, police, and emergency medical services personnel Lo not have access to personal protective equipment in the case of a bioterror or chemical attack (Peterson, 2003~. 18

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911 centers should be considered important communication nocles in providing information to the public cluring an emergency (though these, of course, should not be considered the primary communication nocles) (Fischier, 2003; Trimble, 2003; Maniscalco, 2003~. ~ . A census of emergency medical technicians and EMS agencies, describing how EMS services are organized across the country (and thus, where the connections Beet! to be made for bioterrorism prepareciness), has not been concluctec3 since the 1970s (Maniscalco, 2003~. Many health care professionals currently are not in active practice. They may be in administration, policy, academia, or other careers. It may be useful to work with related professional associations to determine if any of these non-practicing health care professionals could be mobilizer! to serve in a clinical capacity in the event of an outbreak (Ricci, 2003~. Lists of vaccinated and trainee! health care personnel could be updated using health care professional Jicensure lists (Peterson, 20034. Representatives of both health care and first responder personnel strongly suggested that these personnel ant! their immediate families receive priority vaccination shouic! a smallpox outbreak occur. For some panelists, this problem collie be acIdressed by increasing access to pre-event vaccination for responders ant! their families. Health care workers and first responders may be reluctant to report for duty, or be clistractec! cluring cluty, if they are unsure that their families are protected. Consideration of these issues may be related to supporting surge capacity (Fischier, 2003; Peterson, 2003; Temte, 20039. Panelist Comments about Surge Capacity Changes in the scope of practice of EMS providers for emergencies shouicl be considered, since the health care training that these personnel have received could, where appropriate, contribute to surge capacity in mass vaccination clinics (Fischier, 2003~. The surge capacity needs of public health laboratories must also be considered. A suspected or confirmed} outbreak greatly will increase the number of environmental samples that must be tested by public health laboratories (e.g., testing for anthrax at post offices) (Kelley, 20031. Another area of surge capacity that shouic! not be overlooked pertains to handling human remains in an event with significant mortality. The role of Disaster Mortuary Operational Response Teams (DMORT) ant! whether their services can fulfill all the surge capacity needs in multiple communities are still unclear (Dunn, 20034. . Panelist Comments about Mental Health It is unclear how much federal coordination exists around mental health issues during a smallpox emergency. The Substance Abuse and Mental Health Services 19

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Administration's role in a smallpox emergency shoulci be characterizes! more clearly (Benjamin, 2003; Temte, 20034. Panelist Comments about Populations with Special Needs Special issues and concerns of the uninsured] and unclocumentec! 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 commencis 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 preparer! to respond! to a public health emergency, understand how they will be held accountable, ant! are assured of the federal rote in national preparedness for a public health emergency. By adciressing 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 incticators), 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: I. Preparedness must include a greater emphasis on planning, management, anti decision-making. 2. Readiness to respond to public health emergencies (including smallpox emergencies) should be part of overall continuous quality improvement of the public health system. 3. CDC should acIdress its immediate neec! 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, cleliberative, national process to develop measures that acIdress the field range ant! appropriate balance of preparedness activities. Federal agencies bear unique responsibilities in emergency response, and they shouIc! be held accountable and assessed on their progress, similar to their state and local counterparts. 5. Public health readiness indicators need} to acIcIress each of the distinct roles of federal, state, and local jurisdictions in the planning for ant} response to a public health or, specifically, smallpox emergency. 20

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6. The current set of readiness indicators provides a useful start to measuring preparedness, but many indicators seem too broac! and redunciant, and not baser! 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 sustainer] collaboration and communication among the public health system, the health care system, first responders, ant! 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 ant! 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 21