## Annex 5

Suggested Pre-Event Planning Activities for State and Local Public
Health Authorities

**Annex 5 - Suggested Pre-Event Planning Activities for State and Local
Public Health Authorities**

#### **Development of state and local smallpox bioterrorism preparedness plans**

This annex describes specific recommended pre-event (pre-outbreak)
activities for state and local health authorities. Although essential
public health activities are outlined in the *CDC Smallpox Response Plan
and Guidelines* (CDC Response Plan), state and local health authorities
need to develop their own strategies and outbreak control plans, and the
planning and many key activities need to begin immediately. Although CDC
will advise and assist state and local health departments in the event
of a smallpox outbreak, state and local health departments will have
primary responsibility for outbreak control.

The state or local pre-event plan should describe the necessary
activities and resources for an effective response by local health staff
as well as ensure effective immediate on site coordination with federal
(CDC) roles as outlined in the CDC Response Plan. Ideally, the state or
local plan should be part of, or reference, the state or local
jurisdiction's all-hazard Emergency Operations Plan.

These plans should address:

1.  Establishment of an Executive Planning Committee, including
    identification and involvement of key partners, stakeholders, and
    local elected officials,

2.  Command, control, and management procedures,

3.  Mobilization of necessary staff, resources, and their availability,

4.  Surveillance and epidemiologic investigation procedures, including
    contact identification and tracing, vaccination of contacts,
    mobilizing laboratory resources, and alerting and training of health
    care providers about the identification and reporting of suspected
    cases of smallpox,

5.  Vaccine management, including storage, distribution, protection
    procedures, and vaccination of essential personnel,

6.  Adverse events monitoring,

7.  Legal powers for quarantine and selection of isolation sites and
    plans for how they will be used,

8.  Decontamination of smallpox-contaminated equipment, waste, rooms,
    and vehicles,

9.  Plans for communications with health care providers, the public and
    the media,

10. Training identified health care staff and other first responders
    (e.g., police and firemen) for outbreak control, and

11. Establishment of security procedures in conjunction with local
    police and other law enforcement agencies, including operational
    procedures for essential functions including the maintenance of
    essential systems such as water, electricity, and waste disposal.

These activities are described briefly later in this document. More
detailed descriptions of many of these activities are included in the
guides and annexes of the [*CDC Smallpox Response Plan and
Guidelines*](http://www.bt.cdc.gov/agent/smallpox/response-plan/index.asp).

**Federal Role**

State and local plans must be compatible with the federal plan, so that
if an outbreak occurs, there can be immediate, on site coordination
between CDC and the state and local health department. Some of the
federal roles at present include:

1.  Delivery or standby readiness for delivery of smallpox vaccine and
    vaccination components to designated areas,

2.  Laboratory or confirmation of smallpox infection,

3.  Immediate mobilization and deployment of CDC personnel to assist
    local or state public health officials with epidemiological
    investigations, surveillance, contact identification, vaccination,
    record keeping for vaccine administration and adverse events, and
    monitoring vaccine inventory,

4.  Development of vaccination strategies,

5.  Distribution of guidelines and forms for surveillance, contact
    identification and tracing, vaccination, isolation strategies,
    specimen collection and transport, public/media communications, and
    decontamination,

6.  Development and distribution of training and educational materials
    for the public and health care providers, and

7.  Provision of technical assistance to the national authority
    responsible for coordinating the overall efforts for managing the
    event.

In addition, other federal roles may be added, such as

-   Vaccine research and development,

-   Coordinating national and international surveillance,

-   Assessing the need for and scope of a suitable liability program for
    vaccine manufacturers and persons administering the vaccine,

-   Managing an adverse events surveillance system at the national
    level,

-   Developing a central (national) secure information
    database/exchange/clearinghouse, and

-   Guidelines for distribution and use of antiviral agents.

**Funding resources for state and local plan development**.

At the present time, limited resources are available for state and local
plan development and additional resources are expected from the national
level for plan implementation. Possible funding mechanisms include:

-   Federal contracts and/or grants for the purchase of vaccine,

-   Federal grants and/or reimbursement for vaccine distribution and
    administration,

-   Federal purchase of antiviral agents, if deemed useful,

-   Federal grants for enhanced surveillance,

-   The authority for the release of federal funds would come under the
    auspicies of the Federal Response Plan (Stafford Act; Public Law
    93‑288, as amended), as is done for other natural disasters. (NOTE:
    Criteria to be used for the release of funds have not yet been
    determined.), and

-   Regardless of the options chosen, State and local jurisdictions
    should, for planning purposes, expect to provide supplementary
    resources at the time of a smallpox outbreak, including temporary
    redirection and training of personnel and financial resources from
    other programs.

**Post-Event Response Plan Content**

The format for the post-event response plan should follow that outlined
in the document [*CDC Guidance for Post-Event Smallpox
Planning*](http://www.bt.cdc.gov/agent/smallpox/prep/post-event-guidance.asp)).

Additional ideas for response activities can be found in *[The Public
Health Response to Biological and Chemical Terrorism Guide for State
Public Health
Officials](http://www.bt.cdc.gov/Documents/Planning/PlanningGuidance.PDF)*
and *[Pandemic Influenza: A Planning Guide for State and Local
Officials](http://www.cdc.gov/od/nvpo/pubs/pandemicflu.htm)*

Although smallpox vaccine is not currently licensed by the Food and Drug
Administration, given the short time frame post-event smallpox
preparedness plans should be developed with the overall assumption that
the vaccine will have been licensed at the time a smallpox event occurs
or that emergency provisions will be enacted so that smallpox vaccine
can be widely administered. However, plans should also acknowledge the
possibility that vaccinations may be given [under an IND
protocol](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a.pdf)
and, therefore should also briefly address an approach for rapid
consenting procedures (in groups, if necessary) and monitoring of
vaccinee take rates and adverse events. Planners should also assume that
vaccine will be delivered only by specialized vaccination clinics (as
opposed to by individual private providers) and that liability concerns
related to administration of smallpox vaccine will be addressed on a
national basis.

The following areas should be given immediate consideration in state and
local smallpox preparedness plans:

**1. Isolation and treatment of cases**

Suspected and confirmed cases will need to be quickly moved to
facilities that provide appropriate health care and isolation to prevent
additional spread of smallpox. Limiting spread of smallpox virus from
patients to others is a critical part of the control strategy. Local or
state legal statutes regarding public health authority to isolate or
quarantine infectious or potentially infectious and incubating persons
need to be reviewed and plans for coordinating with federal authorities
should be made. In addition to isolation and quarantine plans, other
transmission control strategies plans should be developed, such as for
suspension of large public gatherings or closing of facilities.
Isolation and Quarantine Guidelines are presented in [*Guide
C*](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-c-part-1.pdf).

Suggested pre-event activities for state and local health departments
are as follows:

-   Identify persons or organizations empowered to invoke and enforce
    isolation and quarantine authorities,

-   Develop plans for emergent vaccination of personnel needed to
    implement and enforce quarantine measures during a bioterrorism
    event (e.g., first responders, health care workers, law enforcement
    personnel, and essential service providers),

-   Identify appropriate facilities for isolation as described in
    [*Guide
    C*](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-c-part-1.pdf)
    and establish procedures for activating them,

-   Establish procedures for monitoring access to facilities,

-   Establish laundry service arrangements (onsite, if possible) and
    appropriate disposal of medical waste (see [*Guide
    F*](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-f.pdf)),

-   Arrange for food service support for facility occupants,

-   Establish procedures for monitoring health status of facility staff,
    and

-   Develop campaigns which focus on educating the public and health
    care providers about smallpox and the potential need for using
    population-quarantine measures as a means to interrupt disease
    transmission.

**2. Diagnosis**

Laboratory confirmation is important for a first case in a geographic
area. Laboratory diagnostic testing for Variola virus is conducted in
Level C or D laboratories only. Level D laboratories include the CDC and
USAMRIID. Initial confirmation of a smallpox outbreak requires testing
in a Level D laboratory. Level C laboratories will assist with testing
of clinical specimens [following]{.underline} initial confirmation of an
outbreak by CDC.

Suggested pre-event activities for state and local health departments
are as follows:

-   Train and maintain staff to assist in the initial evaluation of
    suspected smallpox patients,

-   Establish procedures for packaging and shipping specimens to the
    Level D laboratory,

-   Establish procedures for packaging and shipping specimens to the
    nearest Level C laboratory after the initial case has been confirmed
    in a geographic region, and

-   Establish policy outlining the priority for laboratory testing,
    should the number of cases overwhelm laboratory testing capacity.

More information on diagnosis and laboratory testing can be found in
[*Guide
A*](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a.pdf),
[*Guide
D*](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-d.pdf),
and *[Annex
1](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/annex-1-part1of3.pdf).*

**3. Vaccination of public health and healthcare response personnel and
first responders in affected communities**

A large number of public health personnel (e.g., public health and law
enforcement personnel and first responders) will be needed to control
the outbreak. Healthcare workers that will be needed to diagnose,
manage, and treat cases are likely to be exposed to smallpox as part of
their work responsibilities. These individuals must be vaccinated as
soon as possible after the first case is confirmed. For additional
information on prioritization of health care workers for vaccination,
see [ACIP Smallpox Vaccination Recommendations, October 21,
2002](http://www.bt.cdc.gov/agent/smallpox/vaccination/acip-recs-oct2002.asp).

Guidelines for conducting smallpox vaccination operations are in [Guide
B](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part1of3.pdf),
[Annex
2](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/annex-2.pdf)
and [Annex
3](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/annex-3.pdf).
To prepare for the possibility of rapid vaccination if a smallpox
outbreak occurs, a number of pre-event activities should be started at
the state and local levels.

**4. Surveillance for new cases**

It will be important to quickly and efficiently diagnose new cases to
ensure that the ring vaccination program (below) will quickly control
the outbreak. Pre-event planning should include the development of
enhanced surveillance and epidemiologic protocols to respond to a
smallpox emergency. These protocols should include the following:

-   A listing of surveillance partners (hospitals, clinics, private
    practices, medical examiners, laboratories, county/local health
    departments, and pharmacists),

-   Alerting and training health care providers about the identification
    and reporting of suspected cases of smallpox

    -   Establishing multiple (redundant) mechanisms for reporting
        confirmed, probable, and suspected cases to public health
        surveillance personnel (potential redundant mechanisms include:
        secured fax, secured Web-based reporting, telephone reporting,
        and e-mail).

    -   Establishing a centralized place for initial reporting and
        informing potential reporting sources of the location and
        methods of reporting,

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-   Establishing points of contact with potential reporting sources and
    redundant means for communicating information [back]{.underline} to
    these sources in an emergency,

-   Reviewing and preparing for the use of the CDC surveillance report
    forms in a smallpox emergency,

-   Developing and establishing the laboratory capability for handling
    specimens, for confirmation of cases, and for secure shipment of
    specimens to CDC,

-   Establishing methods for retrieving laboratory diagnosis for
    probable and suspected cases, and

-   Establishing sentinel surveillance in health care settings; this
    will involve coordination with infection control professionals from
    the Association of Professionals in Infection Control (APIC),
    infectious disease epidemiologists and clinicians, emergency
    department physicians, National Nosocomial Infections Surveillance
    (NNIS) and National Surveillance System for Healthcare Workers
    (NASH) hospitals

**5. Containment Activities**

Contact and Contact-of-Contact Tracing -- Identification of contacts of
smallpox cases (contact with cases beginning with the initial symptoms
\[fever\]) and household contacts of these contacts will need to be
identified, vaccinated and isolated if they develop illness. Contacts of
cases should be vaccinated as soon as possible to maximize the
effectiveness of post exposure vaccination and minimize the number of
new cases. (With a highly suspicious clinical case of smallpox this can
be done while diagnostic confirmation is being done). It will also be
important to track patient movement (where they have been) after onset
of symptoms and identify all possible contacts of the case.

Vaccination and Monitoring of Contacts -- Post exposure vaccination may
prevent or ameliorate disease. Vaccination may protect from additional
exposures from other contacts that develop smallpox. Contacts are
monitored for illness to ensure that they can be isolated to prevent
transmission to others and given appropriate medical care, if they
develop smallpox.

Community Vaccination -- It may be necessary to vaccinate all persons in
exposed communities in addition to contacts and household contacts of
contacts.

-   Algorithms for investigation procedures (including methods and data
    sources for rapid case ascertainment under emergency conditions),

-   Review CDC procedures and forms for case investigation, and conduct
    practice sessions of various smallpox exposure scenarios (see
    [Training](#Training)),

-   Review CDC forms for collection of travel and contact information
    from confirmed, probable, and suspected cases,

-   Review CDC procedures for collection of specimens from suspected
    smallpox patients ([Guide
    D](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-d.pdf)),

-   Develop procedures to maintain surveillance of potentially exposed
    persons, and

-   Identify and establish mechanisms to generate electronic maps for
    all reported cases to show patient addresses, the geographic
    presentation of outbreaks and/or patients, and the types of
    properties surrounding the reported cases that might affect outbreak
    containment procedures.

**6. Epidemiologic investigation**

Rapid and thorough epidemiologic investigation will be vital to the
description and control of the outbreak. All patients must be
investigated for linkages that might indicate a common exposure. This
information will also be important for determining if there are others
who may have been exposed. A two to three week travel history prior to
symptom onset can help to pinpoint these issues. Also, additional
contacts can be discovered so that they can be vaccinated, monitored and
isolated, as necessary.

To assist in these efforts, legal authorities should exist to ensure
include the collection of records and data, including:

-   Reporting of diseases, unusual clusters, and suspicious events

-   Access to hospital and provider records

-   Data sharing with law enforcement agencies

-   Veterinary reporting

-   Reporting of workplace absenteeism

-   Reporting from pharmacies

**7. Large Scale Vaccination**

A decision may be made by public health officials and/or political
leaders to offer vaccine to all persons within the city, county or
state. Although smallpox vaccine is not currently licensed, plans should
be developed with the assumption that the vaccine will have been
licensed by the time a smallpox event occurs or that emergency
provisions will be enacted so that smallpox vaccine can be administered
without adherence to an investigational new drug protocol.

-   Guidelines for conducting smallpox vaccination operations are in
    [Guide
    B](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part1of3.pdf),
    [Annex
    2](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/annex-2.pdf),
    and [Annex
    3](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/annex-3.pdf).
    To prepare for the possibility of rapid vaccination if a smallpox
    outbreak occurs, a number of pre-event activities should be started
    at the state and local levels,

-   Review scenarios 1 to 6 in the [Training section](#Training) and
    plan appropriate local responses. The vaccination response will be
    based on:

    -   Size of the initial outbreak,

    -   Amount of vaccine available,

    -   Probability that new cases will be identified in subsequent
        days,

    -   Size and distribution of the population to be vaccinated,

    -   Amount of time available to prevent infection after exposure,

    -   Number of clinic sites,

    -   Number of vaccine administrators available,

    -   Average capacity of each vaccine administrator in doses per
        hour,

    -   Number of sessions per site, and

    -   Number of hours of each clinic session,

-   Identify sites for vaccination clinics for case contacts and large
    numbers of the public,

-   Identify separate nonhospital sites to vaccinate response teams, all
    health care workers, and other essential community workers (See
    [Annex
    2](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/annex-2.pdf)
    for a suggested list),

-   Identify potential central, regional and local vaccine storage
    facilities, and necessary security,

-   Establish or update vaccine management, storage, handling, and
    secure distribution procedures to include smallpox vaccine (See
    [Guide
    B](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part1of3.pdf)
    and [Annex
    2](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/annex-2.pdf)),

-   Identify supplies and equipment that would be needed for conducting
    smallpox vaccination clinics (including supplies for patient
    registration and education, vaccine administration, and response to
    adverse events),

-   Develop an outline of the organizational structure, clinic position
    responsibilities, operational flow and set-up diagram for large
    clinics (See [Guide
    B](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part1of3.pdf)
    and [Annex
    2](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/annex-2.pdf)).
    This outline should also address security maintenance, parking and
    traffic control, communications, and client comfort,

-   Review CDC recommended smallpox vaccination procedures and train
    immunization personnel with smallpox vaccination techniques,

-   Develop a description of the precautionary measures and guidelines
    staff must observe when conducting smallpox vaccination clinics,
    including vaccine handling, prevention of exposure to blood-borne
    pathogens, use of protective barriers (gloves and masks), use of
    sharps containers, and possible resterilization of bifurcated
    needles,

-   Review CDC-suggested sample documents and develop or obtain all
    documents and forms that will be used in large clinics, including
    medical standing orders, Vaccine Information Statement (with
    informed consent if needed because of state regulation or law, or
    because of Investigational New Drug \[IND\] regulations), fact
    sheets, immunization records, adverse reactions, and vaccination
    follow-up,

-   Become familiar with the protocols for receiving vaccine from the
    Strategic National Stockpile,

-   Review state laws and regulations regarding the qualifications and
    licensing requirements for personnel to administer smallpox vaccine
    if unclear, obtain a legal opinion,

-   Determine if sufficient local and state public health legal
    authority exists for mandating smallpox vaccination,

-   Establish medical screening procedures for receipt of smallpox
    vaccine; develop a smallpox vaccination screening tool to detect
    persons with contraindications to vaccination (see [Guide
    B](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part1of3.pdf)),

-   Review guidelines for exposed persons who refuse vaccine,

-   Once CDC has issued guidelines for pre-event vaccination, vaccinate
    appropriate personnel, and

-   Develop methods to document vaccination and vaccine take; create a
    database or modify an existing immunization registry for this
    purpose

The overall risk of serious complications following vaccination with
vaccinia vaccine is low. Complications occur more frequently in persons
receiving their first dose and among young children ([\<]{.underline}5
years of age). Details on complications and treatment of complications
due to vaccinia vaccine are given in [Guide
B](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part1of3.pdf)
and
[Annex1](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/annex-1-part1of3.pdf).

-   Review suggested procedures for reporting and follow-up of adverse
    events following vaccination and plan for possible implementation
    (see [Annex
    4](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/annex-4.pdf)),

-   State and local health departments should prepare an inventory of
    the documents and forms that will be required to recognize, treat,
    and report adverse events.

-   Documents that each vaccine provider will need include:

    -   Vaccine Adverse Events Reporting System (VAERS) report form,
        instructions on how to access the form electronically, and
        instructions on submitting it at [www.vaers.org,]{.underline}

    -   Vaccine Information Statements (VIS),

    -   Clinical descriptions of known vaccinia vaccine complications,
        and

    -   Vaccinia immune globulin (VIG) information,

-   Each state health department should have in place:

    -   A designated state health contact (SHC) trained and available
        for overseeing vaccine safety activities. The SHC will be
        responsible for the review of reports for completeness and if
        not complete, obtaining necessary critical information and
        ensuring the reporting of adverse event cases to VAERS,

    -   Designated staff trained and available for active surveillance
        tracking, follow up of serious reports submitted to VAERS and
        for providing assistance in completing VAERS forms, and

    -   Outline procedures so that at the time of vaccination, vaccine
        recipients or their parent/guardians will be give a VIS with
        instructions on how to contact VAERS and the respective State
        Health Department and a vaccine adverse events diary card and
        instructions,

-   Develop plans for treating and managing patients with severe adverse
    events, including use of vaccinia immune globulin (VIG), and
    possibly antiviral agents (e.g., Cidofovir), and

-   Outline procedures for managing persons with severe adverse events.

**8. Information Management**

Detailed information will be needed on an ongoing, real-time basis to
inform policy makers, health officials, clinic managers, and the public
about the status of smallpox response activities. Data must be analyzed
and shared continuously to enable managers at all levels to identify and
resolve problems, evaluate progress toward program objectives and
redirect the activities, as necessary. Options to explore include data
systems distributed by CDC, or other in-house systems. All systems
should comply with PHIN guidelines to facilitate the secure sharing of
data across jurisdictions, as appropriate.

**9. Communications**

To address public questions, minimize false rumors and misinformation,
and reassure the public that the public health system is responding
effectively, it is imperative that public health officials acknowledge
the seriousness of a smallpox outbreak and provide accurate, timely
information to the public through the media.

A smallpox outbreak is a communication crisis, as well as a public
health crisis. How communication is handled can affect the response from
the media, the response from the public, and the public's confidence in
the government. It will also influence the way the public health system
handles the crisis.

Full details of communication plans and activities are given in [Guide
E](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-e.pdf).
However, some activities should take place:

-   Identification of public health officers,

-   Dissemination of accurate information, rumor control, 1-800 number,

-   Establishment of a command center,

-   Access to elected officials,

-   Access to experts in human relations and post-traumatic stress
    syndrome, and

-   Diversity in training, cultural differences, and dissemination of
    information in multiple languages.

State and local health departments should:

-   Become sufficiently informed about smallpox to be able to answer
    questions from media and the public, including general information
    on smallpox infection, how smallpox is spread, the incidence of
    smallpox, and recommendations for vaccination,

-   Develop and produce or obtain informational material such as:

    -   Fact sheets,

    -   Frequently asked questions (FAQs) and Question and Answers (Q&A)
        sheets for the public and media, and

    -   Technical bulletins for health care providers,

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-   Make arrangements to be able to establish a special around the clock
    hotline on short notice,

-   Develop an outline of how and through what media the public will be
    provided information about the availability of smallpox vaccine,
    clinic locations, and who should be vaccinated,

-   Review and, if needed, upgrade rapid-alert communication systems to
    ensure rapid communication capability between local and state public
    health and medical communities,

-   Delineate the relative roles of state and local public relations
    offices,

-   Prepare sample alert messages for key public health partners.
    Consider multiple mechanisms for communicating these messages to
    partners. Offer regular teleconferences to partner organizations,

-   Prepare sample community alert messages. Format these messages for
    broadcast and print media; develop plans for conducting regular
    press conferences, and

-   Assure that spokespersons are technically knowledgeable and trained
    for media communications.

**Other Considerations**

**1. The establishment of an Executive Coordinating Committee**

An Executive Coordinating Committee, with a named leader, should be
established that is responsible for the overall planning and
implementation of pre-event activities; this committee would:

-   Select lead persons that will develop each individual plan component
    and be responsible for overseeing implementation of pre-event
    activities and coordination with CDC,

-   Be responsible for ensuring the completion of the pre-event plan and
    sharing the plan with key partners and stakeholders, other states,
    and the CDC,

-   Pilot the pre-event plan using table top exercises and adapt and
    revise the plan as appropriate,

-   Review quarantine laws and authorities, and

-   Designate personnel that will participate in a proposed CDC
    train-the-trainer course.

**2. Command control and management procedures**

Pre-event planning should include establishing roles and
responsibilities for managing an emergency situation. Suggested
activities to include in command control and management plans follow.

-   The state health officer should designate a person to be in charge
    of developing and implementing smallpox control efforts,

-   Individuals should be identified and made responsible for all of the
    activities listed in the plan,

-   An outline should be written that describes all necessary
    administrative tasks needed in response to an occurrence of a
    smallpox case. This outline should address:

    -   The line of command,

    -   The person(s) that would make decisions on scope of the
        response,

    -   The personnel that would comprise an initial response team,

    -   Plans for communicating with health care providers, the public,
        and media, and

    -   Coordination with law enforcement agencies, state emergency
        management, hazard, and response authorities,

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-   A primary public health authority contact should be named in each
    local public health and state health department, with at least one
    backup contact,

-   Primary contacts should be named and communication procedures
    established for:

    -   Law enforcement agencies (e.g., local police and FBI),

    -   Medical facilities (hospitals, clinics, private physician
        offices, and laboratories),

    -   Local emergency response coordinators (including city and county
        offices),

    -   Local media, and

    -   The CDC.

**3. Emergency Personnel and Resource Mobilization and Needs**

In order to ensure a rapid response to a smallpox emergency, certain
pre-event activities need to be started now. These activities include
the following:

-   Identify state and local leads for coordinating surveillance and
    epidemiologic investigation activities in a smallpox emergency,

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-   Identify state and local personnel that will conduct smallpox
    surveillance and manage relevant databases,

-   Identify state and local personnel responsible for conducting the
    initial epidemiologic investigation that will determine the initial
    source of outbreak, population at risk, and epidemiological features
    of outbreak,

-   Determine other non health department personnel that will be
    involved in the initial epidemiologic investigation,

-   Identify state and local leads to oversee interviews of confirmed,
    probable, and suspected cases to determine travel history and
    contact lists,

-   Identify state and local personnel that will conduct the interviews
    of confirmed, probable, and suspected cases,

-   Identify personnel for contact tracing during a smallpox emergency:

> At least 30 people, divided into 2 person teams should be designated,
> with contingencies for additional people. Potential local and state
> resources for such personnel include STD/HIV/TB public health staff
> and community medical training resources such as nursing or medical
> schools,

-   Identify state and local resources for daily telephone monitoring of
    identified contacts,

-   Identify personnel responsible for coordinating the staffing and
    maintenance of quarantine and isolation activities,

-   Arrange public notification procedures and establish the specific
    roles of state and local public relations offices, and

-   Identify reliable smallpox subject matter experts from local and
    state communities, and establish procedures to direct media
    inquiries to these experts for reliable disease information. (Check
    with CDC for any such experts already in place, such as from the
    Infectious Diseases Society of America.)

**4. Decontamination**

State and local health authorities should review the CDC Guideline for
Decontamination ([Guide
F](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-f.pdf))
and make plans for resources and personnel to handle decontamination of
smallpox-contaminated medical equipment, medical waste, clothing,
surfaces, bedding, rooms, and vehicles.

**5.** []{#Training .anchor}**Training**

An effective response requires that those overseeing operations as well
as those in the field know what is in the response plan and know how to
act accordingly. State and local health departments' pre-event training
activities should focus on training the Case Investigation and
Contact-Tracing personnel on the disease and its management.

Investigational personnel should be able to:

-   Recognize the symptoms and clinical signs of smallpox,

-   Identify cases and suspect cases,

-   Understand reporting procedures,

-   Know which forms are required, and

-   Know how to arrange for isolation,

The personnel interviewing and counseling skills should include:

-   Interviewing case/suspect cases on:

    -   Recent (prior 3 weeks) travel, activities and possible sources
        of exposure,

    -   Day-by-day close contacts and contact sites since onset of fever
        or rash,

-   Tracing close contacts in order to arrange for their vaccination,
    and conduct surveillance of contacts for fever or rash,

-   Counseling contacts, household members regarding:

    -   Smallpox symptoms,

    -   Fever surveillance guidelines,

    -   Restrictions, and

    -   What to do and who to contact if a fever or other symptoms
        (rash) occur,

-   Screening for contraindications to smallpox vaccination,

-   Counseling household members with contraindications to vaccination
    to avoid contact with contacts to smallpox cases, and other
    vaccinated household members.

-   Administering vaccine to contacts and household members, and

-   Assessing a smallpox vaccination take,

-   Counseling vaccinees regarding:

    -   Care of the vaccine site,

    -   Expected vaccine reactions, and

    -   Adverse events.

Case Investigators and Contact-Tracing personnel should engage in
training exercises based on CDC-suggested smallpox exposure scenarios.
The exercises to be conducted should be included as part of the response
plan.

> Scenario 1 - Exposure to substance claimed or suspected to be
> smallpox.
>
> Scenario 2 - A single case of clinically compatible illness presents
> to hospital; local surveillance detects no other cases.
>
> Scenario 3 - Several clinically compatible cases are identified at a
> hospital; local surveillance identifies other clinical cases; case
> investigation may or may not indicate a common exposure of up to a few
> hundred persons; over the next 2 days a total of 5 to 10 cases are
> identified.
>
> Scenario 4 - Several clinically compatible cases are identified at a
> hospital; local surveillance identifies other clinical cases; case
> investigation indicates a common exposure at an event/site where up to
> a few hundred persons may have been exposed; over the next 2 days a
> total of 50 to 100 cases are identified.
>
> Scenario 5 - Several clinically compatible cases are identified at a
> hospital; local surveillance identifies other clinical cases; case
> investigation indicates a common exposure at an event/site where
> thousands of persons would have been exposed simultaneously; over the
> next few days, hundreds of potential cases present for evaluation.
>
> Scenario 6 - Several clinically compatible cases are identified at a
> hospital; over the next 2 days additional cases are identified locally
> and at hospitals in several other major urban areas; no common
> exposure is identified leading to a conclusion of multiple exposures.

**6. Security**

Law enforcement personnel may need to guard vaccine storage facilities,
guard vaccine as it is transported, provide a secure environment at
clinic sites, and accompany public health field workers that make home
visits to provide vaccine. In addition to securing vaccine supplies,
extra security measures will be needed for smallpox patients in
isolation at hospitals and in quarantine facilities and may be needed
for suspect cases and contacts. Health authorities should coordinate
their plans and have contact lists for local police or other law
enforcement agencies.

In addition, state and local health authorities need to be familiar with
emergency procedures for maintaining essential systems such as water,
electricity, and waste disposal at vaccine, isolation, quarantine, and
other sites.

**Response Plan Review Checklist**

**Organization and Management**

+-------+---------------------------+----------------------------------+
| O&M 1 | Is there a smallpox       | \- Smallpox coordinating         |
|       | response organizational   | unit/lead\                       |
|       | description?              | - Smallpox coordination response |
|       |                           | units (public health &           |
|       |                           | hospital)\                       |
|       |                           | -Org chart & listing with        |
|       |                           | integration within framework     |
+-------+---------------------------+----------------------------------+
| O&M 2 | Is there a smallpox       | Decision model needed for\       |
|       | emergency response        | - Contact vaccination\           |
|       | management decision       | - Mass vaccination               |
|       | model?                    |                                  |
+-------+---------------------------+----------------------------------+
| O&M 3 | Are there defined roles & | \- Roles & responsibilities      |
|       | responsibilities for key  | chart or list describing         |
|       | operational functions?    | positions\                       |
|       |                           | - Coordination units\            |
|       |                           | - Structure                      |
+-------+---------------------------+----------------------------------+
| O&M   | Is there a list of key    | \- Collaborative partners\       |
| 4a    | state contacts that will  | - state/local health department  |
|       | be involved in smallpox   |                                  |
|       | response efforts?         | \- public safety\                |
|       |                           | - Integrated response\           |
|       |                           | - emergency management           |
|       |                           |                                  |
|       |                           | \- hospitals & hospital          |
|       |                           | organizations                    |
+-------+---------------------------+----------------------------------+
| O&M   | Is there a list of key    | \- Collaborative partners\       |
| 4b    | local contacts that will  | - state/local health department  |
|       | be involved in smallpox   |                                  |
|       | response efforts?         | \- public safety\                |
|       |                           | - Integrated response\           |
|       |                           | - emergency management           |
|       |                           |                                  |
|       |                           | \- hospitals & hospital          |
|       |                           | organizations                    |
+-------+---------------------------+----------------------------------+
| O&M   | Is there a list of key    | \- Collaborative partners\       |
| 4c    | federal contacts that     | - state/local health department  |
|       | will be involved in       |                                  |
|       | smallpox response         | \- public safety\                |
|       | efforts?                  | - Integrated response\           |
|       |                           | - emergency management           |
|       |                           |                                  |
|       |                           | \- hospitals & hospital          |
|       |                           | organizations                    |
+-------+---------------------------+----------------------------------+
| O&M 5 | Is there documentation of | \- integrated relationships with |
|       | integrated relationships  | hospitals & hospital             |
|       | with hospitals and        | organizations\                   |
|       | hospital organizations to | - contacts within hospitals\     |
|       | develop a treatment plan  | - description of working         |
|       | for smallpox cases?       | relationship (e.g. MOU, working  |
|       |                           | group)                           |
+-------+---------------------------+----------------------------------+

**Response Teams**

  ------------- ---------------------------- ----------------------------------
  Sub-Section   Guidance Comments            Critical Observations and Keywords
                                             or Phrases

  Roles 1       The number of response       Description of repsonse team;
                teams, their composition by  Estimation of \# of clinics/teams
                position title and agency    needed; NPS mentioned; Sources for
                affiliation                  teams; Multiples agencies;
                                             Geographic locations; Titles of
                                             those filling functions; NPS
                                             identified as part of plan;
                                             Clinics IDed; Roles Described;
                                             People vaccinated

  Roles 2       Plans to ensure adequate     
                staffing to receive, provide 
                security for and distribute  
                vaccine and other National   
                Pharmaceutical Stockpile     
                items                        

  Roles 3       A description of the sources 
                for clinic personnel (e.g.,  
                local health departments,    
                community health centers,    
                Visiting Nurses Association, 
                community volunteers)        

  Roles 4       A generic staffing plan for  
                each clinic, including a     
                listing of individual staff  
                responsibilities             

  Roles 5       Plans to add or reassign     Surge capacity (adding more
                staff to handle potential    people). Describes who is needed
                influx of specimens          where. Shows if personnel are
                submitted for testing to the vaccinated? Agreements in place;
                state laboratory             Integrated with other agencies;
                                             Multiagency; Trained; Practices.

  Roles 6       A strategy for ensuring a    
                *rapid* response throughout  
                the state                    

  Roles 7       A strategy for completing    Estimates of those who need
                vaccination of all workers   vaccination; Locations of workers;
                involved in control          Dates of clinics/vaccination;
                activities within 1-3 days   Staff adequate for outbreak
                of the confirmation of the   control; Staff adequate for mass
                first smallpox case          immunization
  ------------- ---------------------------- ----------------------------------

**Enhanced Surveillance**

  ------------- ---------------------------- ----------------------------------
  Sub-Section   Guidance Comments            Critical Observations and Keywords
                                             or Phrases

  Surv 1        Plans to enhance             Define/discuss components of
                surveillance systems after   enhanced surveillance (e.g.,
                an initial case is confirmed personnel, roles, reporting
                (within jurisdiction or      mechanism)
                elsewhere) to ensure rapid   
                identification and reporting 
                of additional cases          

  Surv 2        Plans to conduct              
                epidemiological analysis to  
                estimate the population at   
                risk, identify unexpected    
                epidemiological features of  
                the outbreak, and evaluate   
                the characteristics and      
                extent of the outbreak to    
                develop the most effective   
                containment and              
                communications strategies    

  Surv 3        Plans to enhance laboratory  Plan for specimen handling,
                testing capabilities to      shipping and receiving, and
                respond to the need to       reporting out from LRN lab.\
                quickly diagnose cases of    Surge capacity: personnel,
                smallpox and differentiate   reagents. Are there comments about
                from other illnesses and     specimen packaging, testing,
                adverse reactions to the     training, certification,
                vaccine                      qualification mechanism (do they
                                             describe package)
  ------------- ---------------------------- ----------------------------------

**Clinic Sites**

  ------------- ---------------------------- ----------------------------------
  Sub-Section   Guidance Comments            Critical Observations and Keywords
                                             or Phrases

  Sites 1       Plan includes site selection  
                rationale/criteria           

  Sites 2       Plan includes list of clinic Maturity Scale:\
                sites                        Criteria selection stated but
                                             nothing more\
                                             Potential sites are listed\
                                             Actual sites are listed\
                                             Mock clinic held in one of the
                                             planned sites

  Sites 3       Clinic Plan is scalable for  Maturity Scale:\
                volume/time                  Plan to use a modeling method\
                                             A modeling method is described\
                                             Modeling tool selected or under
                                             development\
                                             Modeling tool tested

  Sites 4       Arrangements are in place    Maturity Scale:\
                for use of clinic sites      No action taken, but have plans to
                                             do so\
                                             Discussions are underway\
                                             MOA (or) MOU contract (or) in
                                             place\
                                             Mock clinic conducted in actual
                                             clinic site\
                                             Interjurisdictional
  ------------- ---------------------------- ----------------------------------

**Training and Education**

  ------------- ---------------------------- ----------------------------------
  Sub-Section   Guidance Comments            Critical Observations and Keywords
                                             or Phrases

  Train 1       Are there core smallpox      \- Core public health personnel
                public health staff          named\
                identifed who will be        - Education training team\
                trained by CDC (trainers who - BT coordinator
                will train others)?          

  Train 2       Is there a detailed plan for \- lists of comprehensive
                training Case Investigators  audiences\
                and Contact-Tracing          - calendars\
                personnel?                   - dates\
                                             - venues for training (location
                                             and modality)

  Train 3       Are there procedures for     \- CD-ROMS, e-mail, list serves,
                quickly reproducing and      web sites\
                distributing CDC materials?  - organizational structure\
                                             - MOUs or contracts\
                                             - Process

  Train 4       Are key training and         \- Professional organization\
                communications partners      - Medical and non-Medical
                identifed by names and       organization\
                positions (e.g. infectious   - Names and positions and topics
                disease or training          
                specialists who are          
                designated to receive        
                educational materials and    
                coordinate training          
                activites about disease,     
                vaccine, adverse events,     
                contraindications, screening 
                process, vaccinations, and   
                post vaccination take        
                reading)?                    

  Train 5       Is there a plan for          Adverse events.\
                providing clinic personnel   1. Strategy- including SME and
                with national and state      other resources\
                specific educational         2. Logistical discussion\
                materials and training on    3. Health care professional access
                adverse events and           to training on adverse events.
                procedures for responding    Means of reporting the adverse
                when patients present        event.
                potential adverse events?    
  ------------- ---------------------------- ----------------------------------

**Data Management**

  ------------- ---------------------------------------------------------------------------- ----------------------------------
  Sub-Section   Guidance Comments                                                            Critical Observations and Keywords
                                                                                             or Phrases

  Data 1        The name and position of the individual designated to oversee, coordinate    Dedicated smallpox data management
                and collaborate with state, local, and CDC data management and information   professional
                experts to facilitate full knowledge, understanding, acceptance and support  
                of the system, its implementation and maintenance, and its evaluation;       

  Data 2        A description of how patient information will be entered into CDC's record   If applicable they may have ther
                keeping and data system;                                                     own.

  Data 3        Plans for ensuring adequate electronic connectivity at each clinic site and  HAN, HL7 Exchange
                other data access areas;                                                     

  Data 4        A description of technical assistance potentially needed from CDC to support NEDDS System\
                the information technology needs of State and clinic sites; and              electronic disease reporting

  Data 5        Plans to acquire computers, printers and other related supplies for all       
                vaccination clinic sites and other access points;                            

  Data 6        [Plans for compliance with the Information Technology Functions and          Address sub-elements of PHIN
                Specifications of the Public Health Information Network                      (approximately 8)\
                (www.cdc.gov/cic/functions-specs)](http://www.cdc.gov/cic/functions-specs)   (Assess and Plan for compliance
                                                                                             with PHIN standards)
  ------------- ---------------------------------------------------------------------------- ----------------------------------

**Case Investigation**

  ------------- ---------------------------- ---------------------------------------------------------------------------
  Sub-Section   Guidance Comments            Critical Observations and Keywords or Phrases

  Case 1        A smallpox diagnosis         Refers to [*Guide
                classification and case      A*](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a.pdf)
                definition                   of SPRG

  Case 2        Procedures for identifying    
                tracing, vaccinating and     
                monitoring contacts          

  Case 3        Plans to impose isolation of  
                confirmed, probable, and     
                suspected cases              

  Case 4        Plans to monitor the outcome  
                of confirmed cases           

  Case 5        A strategy for maintaining   Surge capacity
                case investigations and      
                vaccination/monitoring of    
                contacts at all costs        
                despite demands for large    
                scale vaccination efforts or 
                other urgencies              
  ------------- ---------------------------- ---------------------------------------------------------------------------

**Vaccination Strategy**

  ------------- ---------------------------- ----------------------------------
  Sub-Section   Guidance Comments            Critical Observations and Keywords
                                             or Phrases

  Strat 1       Outbreak Control: The        A plan to identify contacts,
                process and procedures for   vaccinate contacts; a plan to
                vaccinating and monitoring   isolate exposed; legal
                contacts and potential       documentation
                contacts;                    

  Strat 2       Outbreak Control: A strategy A plan to identify contacts,
                for isolating contacts who   vaccinate contacts; a plan to
                refuse vaccination;          isolate exposed; legal
                                             documentation

  Strat 3       Outbreak Control: Plans for  A plan to identify contacts,
                implementing quarantine      vaccinate contacts; a plan to
                requirements, if necessary;  isolate exposed; legal
                                             documentation

  Strat 4       Outbreak Control:            A plan to identify contacts,
                Documentation of state legal vaccinate contacts; a plan to
                authority for invoking       isolate exposed; legal
                quarantine; and              documentation

  Strat 5       Mass Immunization: A         A plan to activate staff roles and
                strategy for vaccinating     responsibilities
                health care providers and    
                public safety workers who    
                may be required to play a    
                role in response efforts and 
                who have not yet been        
                vaccinated;                  

  Strat 6       [Mass                        A plan to activate staff roles and
                Immunization:]{.underline} A responsibilities
                description of the decision  
                and approval process in      
                concert with CDC and PHS for 
                expanding the scope of the   
                vaccination program from     
                surveillance and containment 
                (ring strategy) to wide area 
                vaccination                  
  ------------- ---------------------------- ----------------------------------

**Vaccine Logistics and Security**

  ------------- ---------------------------- ----------------------------------
  Sub-Section   Guidance Comments            Critical Observations and Keywords
                                             or Phrases

  Logis 1a      Is there a named primary     P.O.C. for SNS collaboration and
                contact who will be          receipt (Street Address \[NO P.O.
                responsible for              Box\], redundant contact numbers &
                collaborating with CDC NPS   e-mail, plan for redistribution)
                with complete contact        
                information (street address, 
                phone, cell, email, fax)?    

  Logis 1b      Is there a named alternate   P.O.C. for SNS collaboration and
                who will be responsible for  receipt (Street Address \[NO P.O.
                collaborating with CDC NPS   Box\], redundant contact numbers &
                with complete contact        e-mail, plan for redistribution)
                information (street address, 
                phone, cell, email, fax, and 
                pager)?                      

  Logis 2       Are there plans for          Accountability method for
                documenting and reporting    documenting and tracking doses,
                vaccine usage in accordance  wastage minimization plan
                with CDC specifications?     

  Logis 3a      Are there plans to ensure    Security plan for Transport,
                security of vaccine during   Storage, Clinic Operations
                transport?                   

  Logis 3b      Are there plans to ensure    Security plan for Transport,
                security of vaccine during   Storage, Clinic Operations
                clinic operations?           

  Logis 4       Is there a description of    Store, Maintained, Monitored, Cold
                the facilities (including    Chain Management maintained
                refrigeration equipment to   throughout distribution process
                store and continuously       
                monitor temperature of       
                vaccine)?                    

  Logis 5a      Is there a description of    Storage (cold chain management)\
                how the vaccine will be held Locked/Guarded
                between vaccination          
                sessions?                    

  Logis 5b      Is there a description of    Storage (cold chain management)
                where the vaccine will be    
                held between vaccination     
                sessions?                    

  Logis6a       Is there a detailed          #2
                description of how           
                accountability for vaccine   
                will be accomplished daily   
                at the state level?          

  Logis 6b      Is there a detailed          #2
                description of how           
                accountability for vaccine   
                will be accomplished daily   
                at the clinic level?         

  Logis 7       Is there a strategy for      #2
                minimizing wastage of        
                vaccine by maximizing number 
                of doses administered per    
                100-dose vial?               
  ------------- ---------------------------- ----------------------------------

**Clinic Operations Management**

  ------------- ---------------------------- ----------------------------------
  Sub-Section   Guidance Comments            Critical Observations and Keywords
                                             or Phrases

  Ops 1         Clinic staffing needs are    Clinic model tested\
                addressed                    Maturity Scale Indicators\
                                             1 - role needs to be identified\
                                             2 - job descriptions and roles\
                                             3 - assignment of training\
                                             4 - clinic model tested

  Ops 2         Clinic supply needs are      forms\
                addressed                    medical supplies\
                                             office supplies\
                                             etc.\
                                             See maturity continuum

  Ops 3         Facility-related issues are  phone lines\
                addressed                    computers\
                                             furnishings\
                                             waste disposal\
                                             staff assignment\
                                             sharps disposal\
                                             See maturity continuum

  Ops 4         Vaccine management plan is   cold chain\
                described                    security\
                                             accountability\
                                             staff assignments\
                                             See maturity continuum

  Ops 5         Clinic flow functions are    triage\
                described                    screening\
                                             PT. Ed.\
                                             consent\
                                             vaccination\
                                             take read\
                                             See maturity continuum

  Ops 6         Community linkage is         transportation\
                described                    security\
                                             volunteers\
                                             public info. Campaigns\
                                             See maturity continuum
  ------------- ---------------------------- ----------------------------------

**Vaccine Adverse Events Monitoring**

  ------------- ---------------------------- ----------------------------------
  Sub-Section   Guidance Comments            Critical Observations and Keywords
                                             or Phrases

  Safe 1        Is there a named individual  Named individual
                designated to oversee and    
                coordinate vaccine safety    
                activities?                  

  Safe 2        Are there plans for a        Details of hotline (staff details,
                jurisdiction-wide 24/7       training timelines, telephone
                hotline to answer questions  scripts, provision of numbers)
                from the public about        24/7 coverage, all-hour access
                vaccine safety?              

  Safe 3        Is there a process for       Screening plan for
                referring eligible potential contraindications, informed
                vaccines to medical          consent plans prior to vaccination
                providers for additional     
                consultation and laboratory  
                testing?                     

  Safe 4        Is there a procedure to      Education/communications with all
                alert providers about        providers, plans, methods of
                smallpox vaccine safety      communication
                issues?                      

  Safe 5        Is there a list of the       Dermatology, neurology,
                potential sub specialists    allergy/immunology, ophthalmology.
                that will be available to    List: details, 24 call list,
                evaluate, treat, and consult schedule
                on smallpox vaccine adverse  
                events?                      

  Safe 6        Is there a training plan for Timeline for training, materials
                staff assigned to vaccine    used for training; existence of a
                safety monitoring?           plan, timeline, content,
                                             materials\
                                             contraindicators/adverse events

  Safe 7        Is there a timeline for      Look for acknowledgement of IND
                completing follow-up of      protocol & requirements
                persons with adverse events  
                that is consistent with the  
                CDC's IND protocol?          
  ------------- ---------------------------- ----------------------------------

**Communications**

  ------------- ----------------------------- ----------------------------------
  Sub-Section   Guidance Comments             Critical Observations and Keywords
                                              or Phrases

  Com 1         The plan designates staff to  Lists of spokespersons, Ensure
                coordinate communications     spokespersons are adequately
                across state and local        trained (FBI, evidence, etc.),
                agencies and all other        Media content/contact lists.\
                partner groups.               Specify titles and positions.\
                                              Specify procedures and systems for
                                              compliance.\
                                              Designate partner groups.

  Com 2         This plan designates a        
                spokesperson to carry         
                critical communication.       

  Com 3         This plan designates          Define pool of clinically trained
                medically trained personnel   personnel.\
                to respond to large volumes   State criteria for \"large volume
                of calls from health care     of calls.\"
                professionals.                

  Com 4         This plan describes           Detail how translation and special
                arrangements for              populations will be identified &
                translations/interpretation   received.
                services for specific         
                population groups that do not 
                speak english.                
  ------------- ----------------------------- ----------------------------------