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Appendix A Draft Smallpox Indicators and Suggested Criteria The committee reviewed the draft 10 smallpox indicators included in CDC's reacliness 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 ant! unclear, whereas others seem to incorporate multiple activities, and it is not eviclent whether and how they couict represent a carefully selected, concise set of the most relevant measures of smallpox preparedness. The committee outlined four scenarios, cliscussed 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 summarizer! by a given indicator. Unless otherwise noted, the committee believes that the criteria it clevelopec} 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 ]. ]. 9. ]: Legal issues related to smallpox vaccination (e.g., liability, compensation, licensure for administration of vaccine, investigational new drug issues) have been reviewed ant! addressed. This indicator should! be broaclenec] to more fully reflect the wide range of legal issues pertaining not only to vaccination, but to smallpox preparedness in general. Such issues would include quarantine, isolation, access to medical records, legal authority to nanciate employees to work, emergency medical technicians' scope of practice, etc. Within the framework proviciec! 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 I, and less for 2-4) (either state or focal levels, as appropriated 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 policymakers? (state [eve: Is information about relevant public health laws inclucled in new employee orientation hanclbooks? (state anc! focal{ levels) Is there documentation of legal authority for emergency licensing and creclentialing? Are there information sheets describing the relevant legal issues in appropriate language to all relevant stakehoiciers, including the general public? (state or ~local, depencling on the state's plan) What evidence is there of a review of federal legislation and decisions made? (most important in scenario 4) 25

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. Have federal agencies provicled state/Iocal agencies with documentation of fecieral legal authority and clescribed uncler what circumstances federal agencies wouic] become involved ant! what they wouic! cto (or other material cleaning the transition from one level of authority to another)? (most important in scenario 4) Indicator 1.3.3. ~ Local and/or state public health has identified and secured governmental and non-governmental agencies for surge capacity at mass distribution sites for medical countermeasures (e.g., vaccinations Indicator l.3.4.] Local and/or state public health has trained governmental and non- governmental agencies for surge capacity at mass distribution sites for medical countermeasures fe.g., vaccination) Inclicator 1.3.5.] 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 countermeasures). The new, joint indicator might react as follows: Local anchor state public health has icientifieci, engaged, ant! trained governmental anc! non-governmental agencies to participate in anc! taken the necessary steps to establish sites for mass distribution of vaccine (or other countermeasures9. Within the framework provided by the Ten Essential Public Health Services, these indicators correspond to Essential Service 7 and S. Suggested Criteria: Does the agency have lists with contact information, acictresses, and letters of agreement with all planned distribution sites in the community? (state or focal, clepending on which is managing the distribution processJ Does the operational plan (which should be consistent with CDC guicielines) 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 al] agencies that would be involved in some aspect of vaccination/distribution of countermeasures (school districts, EMS, law enforcement, etch? (state or focal, depending on which is managing the distribution process) indicator 2.3.~.~: focal and/or state public health maintains core personnel who are trained to provide technical assistance in the differential diagnosis of smallpox syndrome 26

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Indicator 3.~.10.~: Local and/or state public health trains health care personnel to provide differential diagnosis of smallpox syndrome "Differential ." The new, These indicators are closely relater! and should be integrated. diagnosis" is more clearly worrier! as "confirming the diagnosis of... combined indicator might react as follows: Local anchor state public heoith agency has trainee! 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 ant! evidence of its implementation? (state or local, depending on specific state plan" Do local public health agencies have contact information at every hospital ant! a communication methoc! for immecliately informing all hospital and community-based proviclers 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 ant! where to send them)? Does the alert system inclucle information on how a provider can immecliately access "just-in-time" provider training on the diagnosis of smallpox? All these criteria (except the firsts would be evidences! by retrospective analysis of actual test cases (monkeypox, varicella) or a (unannounced) test case/cirill. Indicator 3.~.12.~: Local and/or state public health has secures! 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 provider! bv the Ten Essential Public Health Services. this . 1 J indicator corresponds to Essential Services 4 and 7. Suggested Criteria Is there a community plan for the distribution of initial smallpox cases for meclical care? Is there a triage plan for making space for an escalating number of cases? Are there resources (workforce, builclings, access to emergency funds) or plans to access resources to operationalize the triage plan? O 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? O e.g., is there a list of all appropriate isolation rooms in the community? Is there a plan for the clisposal of remains? 27

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. Do facility/agency plans identify the other services or functions that wouIc! need to be maintained during the emergency (what MUST be provided ant! what can temporarily be suspenctect)? 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 ant! first responders? Is there a plan for the recovery of facilities after the epidemic is encled? Indicator 3.].3.]: Local and/or state public health identified members of epiclemiology investigation and surveillance teams targetedfor immediate smallpox vaccination This indicator is unclear in several ways. First, it should be clarified whether "immediate" means "pre-event," and whether "epiclemiology investigation ant! 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 shouic! be maple 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 I; it is presumed uncler scenarios 2, 3, and 4 Within the framework proviclec! by the Ten Essential Public Health Services, this indicator corresponds to Essential Services ~ ant! 2. Suggester! 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 rolets)? Is there an effective, efficient notification system for contacting team members? Indicator 3. ~.9. I: 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 shouIc! be clarified to explain what "notification of an outbreak" really means. Does this mean when an outbreak is officially clecIared? Immecliately after a single case is identifieci? When an outbreak occurs anywhere in the world or in the United States? Also, as in 3.~.3.T, does "epidemiology investigation and surveillance teams" mean the public health response teams commonly clescribed in the CDC guidance? 28

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The indicator also implies three different tasks, and it is unclear which task is being evaluatecI, 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 I, 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 clue to enhanced surveillance needs. Within the framework provicied by the Ten Essential Public Health Services, this indicator corresponds to Essential Services ~ and 2. Suggested Criteria . . Is there an updated list/registry for each locate 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 immecliately after notification of an outbreak? Has the notification system for contacting team members been tester! ant! is it effective in mobilizing the team within the desired time frame With a time parameter if that can he identif~ecI]? Indicator 3.3.2.~: Local and/or state public health wig stockpile at [east 20 doses of smallpox vaccine per 100,000 population to be available at aR times (or a minimum of 1000 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 intenclect to be short-term ant! limitecI. It is unclear whether states are acivisecI 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 post-event, 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 I. Is the stockpiler! smallpox vaccine in an appropriate storage facility ("appropriate" to be clefinecT by CDC)? 2. 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 cliscussed to a greater extend in the text of the report. As CDC moves forward! in refining en c! pilot-testing the indicators, some 29

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additional areas should be considered to ensure that even a limited set of indicators provides a comprehensive assessment of readiness. Such aciclitional 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 drilIs/exercises ant! how sloes it do?) 30