Annex 3

Guidelines for Large Scale Smallpox Vaccination Clinics

# Logistical Considerations and Guidance for State and Local Planning for Emergency, Large-Scale, Voluntary Administration of Smallpox Vaccine in Response to a Smallpox Outbreak

Table of Contents

[INTRODUCTION 3](#introduction)

[FEDERAL RESOURCES PROVIDED FOR VACCINATION CLINICS
4](#federal_resources)

[VACCINE DELIVERY AND PACKAGING LOGISTICS 5](#vax_delivery_packaging)

[POTENTIAL TYPES OF VACCINE FORMULATIONS 5](#potential_types_vax_form)

[SECURITY CONSIDERATIONS 6](#security_considerations)

[LARGE-SCALE VACCINATION CLINIC ORGANIZATION AND PERSONNEL ESTIMATES
7](#organization_personnel_estimates) [CLINIC ESTIMATES
8](#clinic_estimates) [BREAKDOWN OF CLINIC PERSONNEL PER VC
9](#breakdown_personnel-1)

[CONSIDERATIONS FOR VACCINE NON-TAKES AND ADVERSE EVENTS
11](#considerations_nontakes-1)

[ADDITIONAL CONSIDERATIONS 12](#additional_considerations)

[PUBLIC ANNOUNCEMENTS 13](#public_announcements)

[METRO-CENTRAL HEADQUARTERS 13](#metro_central_headquarters)

[VACCINATION FACILITIES 14](#vaccination_facilities)

[VACCINEE LOGISTICS AND ACCESS TO VC'S 14](#vaccinee_logistics_access)

[FIG. 1 -- SCHEMATA OF MODEL VACCINATION CLINIC
15](#schemata_model_clinic)

[SMALLPOX CLINIC SUPPLIES AND EQUIPMENT
16](#smallpox_clinic_supplies_equipment)

[ADDITONAL SUPPLY CONSIDERATIONS 16](#additional_supply_considerations)

[LOGISITICS FOR IND ADMINISTRATION OF SMALLPOX VACCINE
18](#logistics_IND_admin)

[ANNEX 1 -- EXAMPLES OF SUPPORTING IND FORMS FOR SMALLPOX CLINICS
20](#annex1)

[SCREENING AND CONSENT SIGNATURE FORM 21](#screening_consent_form)

[RECORD OF IMMUNIZATION 22](#record-of-immunization)

[WHAT YOU NEED TO KNOW -- SKIN CONDITIONS 23](#what_you_need_skin)

[WHAT YOU NEED TO KNOW -- CHILD LESS THAN 1 YEAR
25](#what_you_need_child)

[WHAT YOU NEED TO KNOW -- PREGNANCY 27](#what_you_need_pregnant)

[WHAT YOU NEED TO KNOW -- IMMUNODEFICIENCY
29](#what_you_need_immunodeficiency)

[INFORMATION FOR CLOSE CONTACTS 31](#close_contact_info)

[FIG. 2 - INFORMED CONSENT PROCESS FLOW
32](#informed_consent_process_flow)

[ANNEX 2 -- MASS PATIENT CARE: SMALLPOX TEMPLATE FOR LOCAL AND STATE
OFFICIALS 33](#annex2)

[PLANNING CONSIDERATIONS FOR MASS PATIENT CARE
34](#planning_mass_patient_care)

[COMMAND AND CONTROL 35](#COMMAND_AND_CONTROL)

[PERSONNEL REQUIREMENTS 35](#PERSONNEL_REQUIREMENTS)

[TREATMENT 36](#TREATMENT)

[PROVISION OF MENTAL HEALTH SERVICES 36](#PROVISION_MENTAL_HEALTH)

[PATIENT TRACKING 36](#PATIENT_TRACKING)

[FACILITIES 37](#FACILITIES)

[ISOLATION OF PATIENTS 37](#ISOLATION_PATIENTS)

[SECURITY 37](#SECURITY)

[TRAINING AND EXERCISES 38](#TRAINING_EXERCISES)

[PLANNING CONSIDERATIONS FOR MASS FATALITY MANAGEMENT
38](#PLANNING_MASS_FATALITY)

[ANNEX 3 -- CLINIC PREPARATION CHECKLIST 39](#Annex3)

[OVERALL PLANNING AND MANAGEMENT CHECKLIST 40](#checklist_planning_mgmt)

[CLINIC SITE CHECKLIST 41](#checklist_clinic_site)

[SUPPLY AND EQUIPMENT CHECKLIST 42](#checklist_supply_equipment)

[PERSONNEL CHECKLIST 43](#checklist_personnel)

[]{#introduction .anchor}Introduction

This document describes the logistical considerations for voluntary,
large-scale, postevent smallpox vaccination clinics. This example model
may be used to supplement other state and local vaccination planning
considerations for responding to a smallpox outbreak within their
community.

Following a confirmed smallpox outbreak within the United States, rapid
voluntary vaccination of a large population *may* be required to: 1)
supplement priority surveillance and containment control strategies in
areas with smallpox cases, 2) reduce the "at-risk" population for
additional intentional releases of smallpox virus if the probability of
such occurrences is considered significant, or 3) address heightened
public or political concerns regarding access to voluntary vaccination.
Large-scale voluntary smallpox vaccination would be considered part of
an overall national vaccination strategy and would be initiated
following the approval of the Secretary of Health and Human Services.

The following considerations apply:

1.  Current smallpox vaccines are available under an Investigational New
    Drug (IND) protocol only, and informed consent must be obtained.
    (See attached draft combination medical screening/consent form.)

2.  The shortened IND process for obtaining informed consent should be
    followed. (See attached description of shortened IND informed
    consent process and draft supporting documents.)

3.  Separate clinic(s) should be considered for vaccination and
    counseling of identified contacts of smallpox cases, but resources
    must also be available at voluntary clinics because some contacts
    may show up for vaccination at those facilities.

4.  Medical screening for contraindications must be done, and
    vaccination should generally *not* be recommended for persons with
    contraindications who are not otherwise identified as contacts.
    Medical screening planning should include strategies to facilitate
    referral to local public health or medical laboratories or clinics
    for voluntary and confidential HIV or pregnancy testing if requested
    by the participant. Consideration should be given to the potential
    use of rapid HIV tests at laboratories and clinics performing
    voluntary HIV testing if such a test is available and FDA approved.

5.  Appropriate amounts of vaccinia immune globulin (VIG) should be
    available within the National Pharmaceutical Stockpile (NPS) to
    treat anticipated adverse events prior to initiating large-scale,
    voluntary vaccination as a component of the national response to a
    smallpox outbreak.

6.  Treatment of adverse events will occur in facilities separate from
    vaccination clinics.

7.  Existing immunization program resources should be utilized in the
    implementation of voluntary vaccination programs, and coordination
    should occur between state and local immunization program and
    bioterrorism planning personnel.

8.  Predesignated sites or clinics will be established, as part of the
    community smallpox response plan, for the evaluation of symptomatic
    individuals to rule out smallpox. These evaluation sites should be
    separate from designated vaccination clinics, but should also have
    the capability to administer vaccination, using the IND information
    and informed consent process. (Written scripts of the video may be
    used if video viewing facilities are not available.)

9.  The predesignated sites for evaluating symptomatic individuals for
    smallpox will be identified in public service announcements and
    these individuals will be discouraged from presenting to voluntary
    vaccination clinics.

10. Vaccine clinic and transportation personnel should be vaccinated
    prior to beginning vaccination clinic activities in order to provide
    protection against exposure from symptomatic contacts who may
    inadvertently present to the vaccination clinic. Establishment of
    voluntary clinics may need to be done in a stepwise fashion over 2
    to 3 days to accommodate administration of staff vaccinations prior
    to opening a clinic. (NOTE: Vaccination clinic personnel do not
    require a "waiting period" before beginning vaccination activities
    as long as a triage system to prevent admission of ill/potentially
    infectious individuals into the clinic is in place at each clinic
    site. Personnel involved specifically in the triage and/or
    evaluation of ill individuals who may present to vaccination clinics
    should use other personal protective measures until a vaccine take
    is confirmed. Vaccination take rates are expected to be \>95%.)

11. The recommended guidelines for the logistics, design, and
    implementation of a voluntary vaccination clinic are interim and are
    meant to support existing emergency vaccination clinic plans that
    state or local public health authorities have developed.

[]{#federal_resources .anchor}Federal Resources Provided for Vaccination
Clinics

The Federal Government will provide the following resources to state and
local public health authorities for use in voluntary vaccination
programs established following confirmation of a smallpox outbreak:

1.  Smallpox vaccine and the following vaccine administration supplies:
    diluent for reconstitution of vaccine and bifurcated needles.

2.  Vaccine administration directions (written and video demonstration)

3.  IND protocols and supporting materials in major languages (at a
    minimum English and Spanish), including:

    a.  Medical screening and consent form

    b.  Information sheets on:

        i.  Smallpox vaccine

        ii. Vaccine adverse events

        iii. Specialized information for persons with contraindications

        iv. Smallpox disease

    c.  Contact information

    d.  Vaccine take recognition card

    e.  Vaccine site care instructions

    f.  Vaccination card for duplication and use within clinics

4.  VIG and/or Cidofovir for use as IND products for the treatment of
    *serious* adverse events that may be expected to respond to these
    treatments.

5.  Technical assistance with clinic design, development of clinic
    databases, and vaccination tracking systems.

6.  Assistance as otherwise outlined in the Federal Response Plan, if
    activated. \[See Annex 2.\]

The amount of personnel resources provided by the Federal Government
will be dependent upon the scale of the voluntary vaccination program.
Additional government personnel resources available to the state and
local authorities will be limited for any programs implemented on a
large-scale in multiple sites (e.g., implementation of a nationwide
voluntary vaccination program).

[]{#vax_delivery_packaging .anchor}Vaccine Delivery and Packaging
Logistics

Once federal authorities have authorized the release of vaccine, the
initial vaccine shipment to a state or local area may be provided in a
self-contained shipping and storage unit called a Vaxicool. One Vaxicool
unit contains approximately 300 vials of vaccine and can also be used
for continued storage of up to 300 vials of vaccine with an appropriate
outlet power source. The number of vaccine vials contained within a
Vaxicool unit may depend upon the specific vaccine dispensed (e.g.,
Wyeth, Aventis, Acambis, or Baxter vaccine) and the potential need for
refrigeration of the specific diluent during shipping.

Diluent for vaccine reconstitution and needles for single-use vaccine
administration will also be included in all vaccine shipments but may be
in containers separate from vaccine. Shipments will contain vial holders
to secure the vial and prevent accidental tipping during needle
preparation for vaccination.

Subsequent vaccine shipments will be in Styrofoam shipping containers.
These Styrofoam shippers can support 100 to 1500 vials of vaccine,
depending upon the shipment size required. Vaccine shipped in Styrofoam
containers will require arrangements for refrigerated storage at 2 to 8
°C upon arrival. The need for storage of subsequent vaccine shipments of
vaccine should be incorporated into all general smallpox vaccine storage
site plans at the state level and all vaccination clinics planning
logistics at the state and local level.

Current plans for rapid, large-scale shipment of vaccine through the
National Pharmaceutical Stockpile (NPS) system allows for shipment of up
to 500 Vaxicool systems on day 1 (75 million total vaccine doses), with
up to 615 additional vaccine shipments/day in Styrofoam shipping
containers on days 2 through 6. This plan provides for distribution of
280 million doses of smallpox vaccine from the NPS storage sites to
states' field sites within 5 to 7 days. Vaccine shipments can also be
dose adjusted and sent to cities with populations of 10,000 or greater.

> []{#potential_types_vax_form .anchor} Potential Types of Vaccine
> Formulations

  ----------------- ----------------- ----------------- ----------------------------
  **Vaccine**       **Doses per       **Storage**       **Reconstitution/Storage**
                    Vial**                              

  ACAM1000          100               2 to 8 ºC         0.25 ml of diluent. Store at
  (Acambis)                                             2 to 8 ºC once reconstituted

  ACAM2000 (Baxter) 100               2 to 8 ºC         0.25 ml of diluent. Store at
                                                        2 to 8 ºC once reconstituted

  Aventis Pasteur   100               0 ºC or below     0 ºC or below

  Dryvax (Wyeth)    500               2 to 8 ºC         1.25 ml of diluent. Store at
                                                        2 to 8 ºC once reconstituted
  ----------------- ----------------- ----------------- ----------------------------

NOTE: Since the brand of vaccine to be used will not be known
beforehand, storage and handling instructions for the specific vaccine
being used should be reviewed with *all* staff before they begin their
shift.

[]{#security_considerations .anchor}Security Considerations

Specific security needs should be formally assessed and incorporated
into planning efforts to support large-scale vaccination programs.
Provision of appropriate security should be made for the following:

1.  Vaccine storage sites (clinic and non-clinic) to include security
    personnel and locked, limited access areas for vaccine storage.

2.  Backup power sources (generators) should be identified for all sites
    where vaccine is stored (vaccination clinics and storage sites).

3.  Vaccination clinic sites: security personnel for crowd control,
    traffic movement, clinic personnel safety, and related security
    issues.

4.  Vaccine transportation to storage sites and dispensing clinics.

[]{#organization_personnel_estimates .anchor}Large-Scale Vaccination
Clinic Organization and Personnel Estimates

The following section describes a model of a vaccination program that
addresses the different activities needed for the administration of IND
smallpox vaccine as well as an example of personnel estimates for clinic
staffing. [The output goal of this example clinic model would be the
administration of vaccine to 1 million persons over 10
days.]{.underline} The model could be expanded or contracted, as needed,
to address changes in vaccination administration goals for different
population areas. The example staffing estimates were arrived at by: 1)
review of previous large-scale-clinic models and publications, 2)
considerations of requirements for administering an IND vaccine, and 3)
computer modeling for clinic flow and output estimates with different
example staff numbers. Parameters of low and high completion times for
specific activities within the clinic were estimated within the model.
The time requirement for these activities may differ depending upon the
overall demands placed on the vaccine clinic delivery system and could
require adjustment of staffing estimates. State and local planners
should evaluate these activity time estimates and consider what staffing
or flow adaptations may be needed to accommodate increases or decreases
in activity time requirements. The computer modeling of the example
clinic to determine staffing needs utilized the following parameters:

-   97% of people presenting to clinic will be processed through the
    normal clinic flow

    -   1% will have some illness that will require evaluation before
        processing through clinic

    -   2% will be identified as a contact or possible contact to
        smallpox and will be processed through the separate "Contact
        Evaluation" unit

-   20% of people coming through the clinic will require medical
    counseling in addition to the orientation video

    -   Medical counseling/questions will require 5 to 15 minutes (some
        individuals will require \>15 minutes and others will require
        \<5 minutes)

    -   Physician would be available to handle more difficult medical
        screening to keep clinic flowing

-   50% of persons getting additional medical counseling (i.e., the 20%
    above) will be vaccinated, and 50% will defer vaccination because of
    contraindications or other reasons

-   Distributing IND packets and providing initial instructions would
    take between 30 seconds and 2 minutes

-   Video orientations will be done approximately every 30 minutes in 5
    orientation rooms that hold 75 people per room

-   It will take 2 to 3 minutes for individuals to fill out the medical
    history screening forms

-   Vaccination and completing vaccination cards would require between
    0.5 and 2 minutes

**The numbers shown in the table below are examples of the human
resources needed with the above clinic assumptions and configuration.
Alterations in the assumptions regarding clinic activity time estimates
and staffing requirements can be explored to determine ways to further
maximize clinic output and human resource utilization. Although staff
numbers may vary depending upon the assumptions and clinic output
requirements, the general tasks that must be addressed within the clinic
(patient education, medical history screening, medical counseling,
vaccination, etc.) would not change.**

CDC plans to make available to state and local public health officials a
software program (\"Maxi-Vac\") that will allow officials to further
refine human resources allocation needs (e.g., physicians, nurses, and
other staff) in such a manner that will maximize patient flow-through
for target vaccination goals. Conversely, this software program may also
be used to determine maximum vaccination output that may be achieved
with different human resource estimates.

**The example model as outlined assumes that clinics can be operating at
near full efficiency to meet vaccination goals once the decision to
offer voluntary vaccination is made.**

**Overall Vaccination Administration Goal = 1 million persons over 10
days**

**(Approximately 100,000 per day)**

[]{#clinic_estimates .anchor}

Clinic Estimates

+-----------------+--------------------------+-------------------------+
| Vaccination     | 20 clinic sites          | More sites could be     |
| Clinics (VC)    |                          | added to accommodate    |
|                 |                          | larger population bases |
+-----------------+--------------------------+-------------------------+
| Vaccination     | -   8 VS per shift       |                         |
| Stations (VS)   |                          |                         |
|                 | -   1 vaccinator per     |                         |
|                 |     station              |                         |
|                 |                          |                         |
|                 | -   0.5 to 1             |                         |
|                 |     witness/helper per   |                         |
|                 |     station (who can     |                         |
|                 |     also alternate       |                         |
|                 |     vaccinating)         |                         |
|                 |                          |                         |
|                 | -   16                   |                         |
|                 |                          |                         |
|                 |    vaccinators/witnesses |                         |
|                 |     per shift            |                         |
+-----------------+--------------------------+-------------------------+
| Hours of        | At a minimum 16          | Consider expanding      |
| Operation       | hours/day                | hours for higher daily  |
|                 |                          | output or to address    |
|                 |                          | overflow                |
+-----------------+--------------------------+-------------------------+
| Vaccination     | -   \~ 30 to 60          | 30 to 60 vaccinations   |
| Delivery        |     vaccinations per VS/ | per VS/hour allows for  |
|                 |     hour                 | variations caused by    |
|                 |                          | vaccinator rotation,    |
|                 | -   \~ 370               | resupply requirements,  |
|                 |     vaccinated/hr/VC     | completing vaccination  |
|                 |                          | card, and other         |
|                 | -   \~ 5900 per day/VC   | considerations          |
|                 |                          |                         |
|                 | -   \~ 118,000 per day   |                         |
|                 |     total with 20 VC     |                         |
|                 |                          |                         |
|                 | -   1 million vaccinated |                         |
|                 |     in \~ 9 days         |                         |
+-----------------+--------------------------+-------------------------+

[]{#breakdown_personnel-1 .anchor}Breakdown of Clinic Personnel per VC

+-----------------+-----------------+---------------+-----------------+
| **Position**    | **Number per    | **Number per  | **Experience**  |
|                 | 8-h Shift**     | 16-h Day**    |                 |
+-----------------+-----------------+---------------+-----------------+
| Forms           | 9               | 18            | Nonmedical      |
| Distribution+   |                 |               | volunteers      |
+-----------------+-----------------+---------------+-----------------+
| Triage for Ill  | 2               | 4             | Nurse or EMT    |
| or Contact      |                 |               |                 |
+-----------------+-----------------+---------------+-----------------+
| Run Orientation | 8               | 16            | Nonmedical      |
| Video           |                 |               | (five running   |
|                 |                 |               | rooms and three |
|                 |                 |               | floating        |
|                 |                 |               | between rooms   |
|                 |                 |               | to assist)      |
+-----------------+-----------------+---------------+-----------------+
| Referral        | 16              | 32            | Nonmedical      |
| Personnel       |                 |               | volunteers      |
+-----------------+-----------------+---------------+-----------------+
| Medical         | 7               | 14            | Medical         |
| Screeners       |                 |               | training        |
|                 |                 |               | required nurse  |
|                 |                 |               | or MD           |
+-----------------+-----------------+---------------+-----------------+
| Physician       | 2               | 4             | Physicians to   |
| Evaluators      |                 |               | evaluate ill or |
|                 |                 |               | more difficult  |
|                 |                 |               | medical history |
|                 |                 |               | screening       |
+-----------------+-----------------+---------------+-----------------+
| Vacc            | 16 (vaccinator, | 32            | Cross-trained   |
| inators/Witness | witness, surge  |               | to alternate    |
|                 | personnel)      |               | vaccination,    |
|                 |                 |               | fill out        |
|                 |                 |               | vaccine card,   |
|                 |                 |               | and sign as     |
|                 |                 |               | witness         |
+-----------------+-----------------+---------------+-----------------+
| Vaccine         | 2               | 4             | Pharmacist,     |
| Pre             |                 |               | pharmacy tech,  |
| paration/Supply |                 |               | or nurse        |
| to VS           |                 |               | experienced     |
|                 |                 |               | with vaccine or |
| []{.mark}       |                 |               | medication      |
|                 |                 |               | reconstitution  |
+-----------------+-----------------+---------------+-----------------+
| Exit Review     | 2               | 4             | Medical or      |
|                 |                 |               | public health   |
|                 |                 |               | personnel for   |
|                 |                 |               | final           |
|                 |                 |               | questio         |
|                 |                 |               | ns/instructions |
+-----------------+-----------------+---------------+-----------------+
| Medical         | 10              | 20            | Nonmedical,     |
| Records/Data    |                 |               | data entry for  |
| Entry           |                 |               | information     |
|                 |                 |               | collected on    |
|                 |                 |               | vaccinees       |
+-----------------+-----------------+---------------+-----------------+
| Clinic Manager  | 2               | 4             | Existing        |
|                 |                 |               | Vaccine         |
|                 |                 |               | Programs        |
|                 |                 |               | Personnel       |
+-----------------+-----------------+---------------+-----------------+
| Supply Manager  | 2               | 4             | Nonmedical      |
+-----------------+-----------------+---------------+-----------------+
| Clinic Flow/QA  | 8               | 16            | Nonmedical      |
| Reviewer/Forms  |                 |               | volunteers to   |
| Helpers         |                 |               | assist with     |
|                 |                 |               | forms           |
|                 |                 |               | completion,     |
|                 |                 |               | collection, and |
|                 |                 |               | clinic flow     |
+-----------------+-----------------+---------------+-----------------+
| Security        | 20              | 40            | Non-public      |
|                 |                 |               | health resource |
+-----------------+-----------------+---------------+-----------------+
| Traffic Flow    | 2               | 4             | Nonmedical,     |
|                 |                 |               | assist with     |
|                 |                 |               | loading and     |
|                 |                 |               | unloading buses |
|                 |                 |               | at site if      |
|                 |                 |               | offsite parking |
|                 |                 |               | utilized        |
+-----------------+-----------------+---------------+-----------------+
| Translator (not | At least one    | Unknown       | Language        |
| counted in      | per major       |               | fluency with    |
| total clinic    | language per    |               | training        |
| staffing        | shift           |               |                 |
| estimates)      |                 |               |                 |
+-----------------+-----------------+---------------+-----------------+
| Float Staff     | 3               | 6             | Nonmedical      |
|                 |                 |               | volunteers      |
+-----------------+-----------------+---------------+-----------------+
| Contact         | 4               | 8             | Public health   |
| Evaluation      |                 |               |                 |
+-----------------+-----------------+---------------+-----------------+
| EMT             | 1               | 1             | Medical         |
+-----------------+-----------------+---------------+-----------------+
| IT Support      | 1               | 2             | Nonmedical      |
+-----------------+-----------------+---------------+-----------------+
| Total Personnel | **117**         | **234**       |                 |
+-----------------+-----------------+---------------+-----------------+

-   **FORMS/INFO PACKET DISTRIBUTION** -- 9 x 2 shifts = **18 total** --
    Personnel to put together patient forms/information packets and hand
    out packets with information sheets/registration forms/informed
    consent/other IND forms (1 minute/person), clipboards, and pencils.
    People will begin filling in demographic information on forms while
    in line awaiting initial clinic entry for video briefing.

-   **TRIAGE** \[nurse or EMT\] -- 2 x 2 shifts = **4 total** -- Triage
    personnel to direct ill patients to other evaluation facilities and
    direct identified contacts, persons with contact with a case of rash
    illness in last 3 weeks, and their household family members to
    high-priority evaluation location within clinic (1 minute/person).
    Triage should also utilize signs explaining where people should go
    if they are ill or are identified contacts. \[Note: Ill persons
    should be triaged out and evaluated at designated offsite parking
    sites before boarding bus for transportation to clinic if offsite
    parking with busing is used for clinics.\]

-   **VIDEO ORIENTATION** -- 8 people x 2 shifts = **16 total** --
    Personnel to run video orientation regarding clinic procedures,
    paperwork, IND consent information, reasons for vaccination,
    contraindications to vaccination; **5 rooms running concurrently
    that hold 75 people/session with 2 staff/room** (\~20minutes per
    session, allowing for 5 to 10 minutes for moving people into and out
    of orientation room) or a total of approximately **2 sessions/hour**
    (\~750 people oriented/hr).

-   **REFERRAL PERSONNEL**-- 16 people x 2 shifts = **32 total** -- Can
    be trained volunteers with no medical background; to look at medical
    screening/vaccination consent forms and send persons without "yes"
    checked boxes who have signed form on to vaccination station and
    redirect people with contact checked boxes or other "yes" or "maybe"
    checked boxes on to contact or medical screeners. Float staff
    personnel can relieve as needed to allow all stations to continue
    running during staffing breaks.

-   **MEDICAL SCREENERS FOR CONTRAINDICATIONS, EVALUATION/INFORMED
    CONSENT QUESTIONS COUNSELING** (should be medically trained
    personnel, such as physicians, nurses, physician assistants, or
    nurse practitioners) --**--** 7 per shift x 2 shifts **= 14 total**
    -- Medical screeners to review patient history for those with
    contraindications and answer questions for informed consent (est. 5
    to 10 minutes/person); numbers may need to be increased if too many
    people require further screening and lines start to back up at this
    part of clinic.

-   **PHYSICIAN EVALUATORS** -- 2 x 2 shifts = **4 total** -- Physicians
    to evaluate/examine triaged ill persons and provide backup
    counseling if needed to contacts and noncontacts identified with
    possible contraindications by medical screeners (\~ 10
    minutes/person), and evaluate any immediate problems following
    vaccination (e.g., fainting or anaphylaxis).

-   **VACCINATORS/ASSISTANTS** -- 16 x 2 shifts = **32 total --** Eight
    vaccination stations with 1.5 **to** 2 vaccinators per vaccination
    station/shift to trade off vaccination, fill out vaccination card,
    and witness/collect signed vaccination consent/med screening form
    (each of the eight vaccinating stations doing 35 to 45 people/h for
    total of 360 people vaccinated/hr). Vaccinators should consist of
    those allowed to administer vaccine under state law.

-   **VACCINE PREPARATION FOR VS** -- 2 x 2 shifts = **4 total --** For
    preparation of vaccine vials to supply VS as needed. Should be
    pharmacist, pharmacy technician, or other personnel trained in
    preparation of medications or reconstitution of vaccines and as
    allowed by state law.

-   **EXIT REVIEW PERSONNEL** -- (should be medical or public health
    personnel) 2 x 2 shifts = **4 total** **--** Personnel to answer any
    final questions about site care, adverse event symptoms or non-take
    reporting procedures/follow-up, and other issues following
    vaccination.

-   **MEDICAL RECORDS/DATA ENTRY PERSONNEL** -- 10 x 2 shifts = **20
    total --** Collect retained records and enter
    registration/vaccination information (e.g., name, SS#, passport
    number/country, and contact information) into database (estimated 1
    minute/record entry if database already set up) -- important to have
    onsite, if possible, to maintain "real-time" record of number of
    vaccinations and database for later use for adverse events or
    non-takes requiring revaccination; Web-based entry with centralized
    database of all clinics preferable.

-   **CLINIC MANAGERS** -- 2 x 2 = **4 total --** Oversees all clinic
    functions/problem solving.

-   **SUPPLY MANAGERS** -- 2 x 2 = **4 total** -- Oversees all supply
    needs; tracks vaccine supply/lot numbers, distribution, and wastage;
    re-supplies vaccination stations.

-   **CLINIC FLOW/QA/FORMS HELPER PERSONNEL** \[volunteers\] -- 8 x 2 =
    **16 total** -- Help maintain clinic flow, assist with forms,
    quality assurance, retrieve clipboards and forms from VS and takes
    forms to medical record entry personnel and clipboards back to form
    distribution, rotate through waiting areas to answer questions, and
    talk with people to assure them, as needed.

-   **SECURITY PERSONNEL** -- 20 x 2 = **40 total** -- Maintain crowd
    control outside and security within clinic; assist with clinic and
    traffic control, and other security matters. Non-public health
    resource; however, arrangements must be made with appropriate
    agencies or organizations to provide security as part of coordinated
    planning.

-   **TRAFFIC FLOW PERSONNEL** -- 2 x 2 = **4 total** -- Maintain
    traffic flow and order in parking area if parking onsite; if busing
    from offsite parking is used, these personnel may not be needed.

-   **TRANSLATORS** -- One for each major language spoken in community
    per shift; more may be needed depending upon major language of
    clinic population. Translators proficient in sign language should
    also be identified to assist with deaf individuals. Local and state
    authorities should identify language translations needed based on
    makeup of the community. Consider identifying specific clinics for
    referral of populations who need translators.

-   **FLOAT STAFF PERSONNEL \[volunteers\]** -- 3 x 2= **6 total** --
    Float staff personnel to answer telephones, assist clinic personnel
    as needed, collect forms, assist with handicapped and elderly, etc.

-   **CONTACT EVALUATION UNIT PERSONNEL** -- 4 x 2 = **8 total** -- For
    separate medical screening, education, and registering of identified
    contacts and their household contacts. Contacts will also be
    registered for surveillance for smallpox symptoms and given
    instructions on any travel restrictions and reporting requirements.
    Must be educated on contact surveillance process, smallpox
    signs/symptoms, and contact evaluation issues.

-   **EMT** -- 1 x 2 = **2 total** -- To assist with medical
    emergencies, fainting, etc.

-   **IT PERSONNEL --** 1 per shift x 2 = **2 total** -- To support
    computer, programming, electronic equipment maintenance needs, and
    other information technology requirements.

*Although not formally included in the above staffing estimates, the
addition of mental health staff at each clinic site should be
considered.*

**OTHER VOLUNTEERS AS NEEDED FOR FLOAT STAFF, FORMS ASSISTANCE, REFERRAL
PERSONNEL, AND RELATED CLINIC ACTIVITIES**

**VC Staff needed per single VC to cover two 8-h shifts -- approximately
234 (117/shift) + translators** \[NOTE: 40 people are security people
from non-public health resources.\]

**Nonmedical volunteers can be used for:** forms distribution,
orientation video, referral personnel, data entry, supply manager,
clinic flow/QA/forms assistance, security, traffic flow, translators,
float staff, and IT support.

**Total Staff needed for 20 Vaccination Clinics -- 234/VC x 20VC =
4680\*\***

**For 20 VCs operation of two 8h shifts/day + translators**

\[NOTE: \~17%, or 800, of these personnel are non-public health
resources required for security.\]

\*\*Should consider increasing staffing by approximately 20% with
cross-trained personnel to allow for no-shows, breaks, surge needs, and
other contingencies.

Considerations for Vaccine Non-Takes and Adverse Events

[]{#considerations_nontakes-1 .anchor}Telephone hotlines should be
established for the following:

1.  **Reporting and Handling of Vaccination Non-Takes**

**Noncontacts:** Vaccinated individuals who are not otherwise identified
as contacts to a smallpox case will be given vaccination cards and
vaccine take recognition cards at the time of their vaccination (in the
IND packet) and instructed to call a designated number (a hotline set up
by local health officials) if their vaccination site does not resemble
the picture on the card at day 7.

They will be counseled through the hotline to return to a VC with their
vaccination card for revaccination if they are suspected of having a
vaccine non-take. Individuals presenting back to VC for revaccination
would not require repeat medical screening as long as they present their
vaccination card from the previous VC visit, but may be required to
review the informed consent material (video) and sign an additional
consent form. Following this signing, they can be triaged directly to
the vaccination area for revaccination.

**Contacts:** Vaccinated contacts under surveillance and their household
members will also receive vaccine take recognition cards and vaccination
cards. If possible, they will be followed up with visual confirmation of
vaccine take as a part of the contact surveillance process. If visual
confirmation is not possible because of a large number of contacts
requiring surveillance by limited personnel, contacts and their
household members will be instructed to report possible vaccine
non-takes to a designated contact symptom surveillance telephone number
at the local or state health department. Revaccination will be done for
contacts and their household members who do not have a vaccine take at
day 7. This revaccination may be done through referral back to the
contact evaluation unit of a VC, referral to another specified location,
or through direct administration of vaccine by health department
personnel at the time of visual evaluation (dependent upon what is
allowed through the IND process).

2.  **Reporting, Evaluation, and Treatment of Suspected Adverse Events**

Evaluation and treatment for vaccine adverse events should occur at a
designated site or sites [separate]{.underline} from VCs. A local
telephone number for reporting of suspected adverse events should be
established and staffed and included in the Smallpox Vaccine Information
Statement (VIS) that is handed out to vaccine recipients. Staff should
be instructed on where to refer callers for further medical evaluation.
As a part of smallpox bioterrorism (BT) planning, local and state health
authorities should designate the facilities where suspected vaccine
adverse events will be referred, evaluated, and treated. In addition,
state public health authorities should establish a state-based reporting
and consultation mechanism for healthcare providers to report potential
VIG-requiring adverse events \[see Annex 2\].

[]{#additional_considerations .anchor}Additional Considerations

[Mobile Facilities]{.underline}

Consider mobile facilities (for nontransportable populations) if needed
for fixed population vaccination:

-   Retirement communities, nursing homes, hospitals, prisons, or other
    residential facilities

-   Defined high-density areas/facilities, such as apartment and housing
    complexes

[People with Disabilities]{.underline}

-   Must have accessibility for persons with disabilities for clinics
    and transportation vehicles to clinics

-   Consider wheelchairs to assist the elderly who cannot ambulate from
    station to station

[Referral Testing]{.underline}

-   Strategies for the referral of persons who request HIV or pregnancy
    testing to local laboratories or medical clinics that perform
    confidential testing should be considered and communicated as a part
    of the overall clinic planning. Planners should maintain a list of
    local clinics that offer this testing. In addition, consideration
    should be given to the potential use of rapid HIV tests within these
    clinics if an FDA-approved test is available.

[Waste Disposal]{.underline}

-   Two to three disposal-trucks and staff, scheduled to collect medical
    and other waste from 20 VCs at least daily.

[Rest Area]{.underline}

-   An area for staff to rest/sleep if working more than 8 hours or if
    there is inclement weather and staff are unable to return to their
    homes after their shift.

[Transportation for Staff]{.underline}

-   Depending on the location, arrangements may be needed to transport
    staff to the VC.

[]{#public_announcements .anchor}Public Announcements

-   Use national, local and educational TV and radio networks to present
    uniform messages. Planners should consider how these messages could
    be quickly developed, locally, to accommodate sudden changes in
    sites and/or recommendations.

-   Establish list of non-English speaking media outlets that can be
    utilized to deliver messages to immigrants/refugees and other
    non-English speaking communities

-   Messages (videos, tapes, press conferences, experts)

    -   **Pre-Event BT Messages** -- Advising population on various
        BT-related diseases and prevention and treatment messages;
        preparatory steps being taken by the health department (1
        million in 10-day vaccination plan); methods to be used to
        inform public in case of impending event; outline of health
        department plan if an event occurs; adequacy of vaccine supply.

    -   **Event Messages**

        -   State plan that is being put into operation, including:

            -   urgency and patience, but not panic

            -   plan regarding the number of VCs

            -   timing to prevent smallpox

            -   vaccine supply

            -   trained personnel

            -   listing of collection areas where people will be picked
                up by buses

            -   any materials that might be required to prove
                eligibility for admittance into clinic

            -   listing of normal activities being suspended

            -   hotline numbers

            -   review of vaccine recommendations.

        -   Frequently updated "wait-times" for vaccination clinics via
            multiple communication outlets (e.g., local television
            station designated for public service announcements and
            updates, Web sites, or telephone number with automated
            updates) to assist with determining clinic utilization.

[]{#metro_central_headquarters .anchor}Metro-Central Headquarters

-   Management

    -   Devise and continuously update central plan for providing
        vaccinations of the above scale

    -   Convene and maintain a core group of health, administrative,
        media, public services, education, communication, and
        nongovernment collaborative organizations

    -   Identify person(s) responsible for "operationalizing" each of
        the plan components

    -   Solicit personnel to staff each of the above functions in the
        event

    -   Plan and work through a mock event and revise plan, as needed

-   Designate the 20 VCs and staff for each if an event occurs, identify
    safety/security, stock or identify source of supplies; establish
    distribution chain for vaccine, medical supplies, forms, waste
    pickup; plan/provide communication network for VCs

-   Ensure that command and communications center plan is available,
    adequate and realistic and shared with all partners (e.g., emergency
    response, administrators, and clinic sites)

-   Solidify communications and responsibilities among city/state
    officials, press, safety, health, federal/state emergency agencies,
    and other public agencies

-   Colocate Vaccine Clinic Metro-Central Headquarters (MCH) near
    established Emergency Operations Centers to provide for better
    coordination and communications

-   Use MCH to track overall clinic activities and utilization and
    provide hourly updates regarding vaccine clinic activities to
    public, press, and other emergency coordinators etc.

-   Utilize MCH to provide continuous communications regarding clinic
    "wait times"

-   Designate a group of people to function within MCH solely to
    anticipate "future" issues and problems and address these in a
    proactive manner

[]{#vaccination_facilities .anchor}Vaccination Facilities

-   Consider geographic and population density placement.

-   If possible, establish Memorandums of Understanding (MOUs) with
    facilities to serve as vaccination clinics during pre-event planning
    activities.

-   Facility Considerations

    -   Large floor space facility

    -   Handicap accessible

    -   Possible use of schools -- Larger schools, such as high schools
        \[parking lots\] and middle schools, first; primary schools as
        needed to assure adequate population distribution in areas of
        greater population \[choose larger schools and those with larger
        gyms/auditorium/other space\]. Schools are pre-designated

    -   Other public health vaccination clinics if can support daily
        numbers as VC

    -   Supplement with auditoriums, college halls, arenas, conference
        halls, large churches/temples, theaters, perhaps some malls; any
        large, preferably open-area buildings with parking to help
        assure widespread population access

    -   Adequate sanitary facilities at all VCs

-   Publicize VC locations and their suggested catchment areas.

[]{#vaccinee_logistics_access .anchor}Vaccinee Logistics and Access to
VCs

-   Self-access VCs

    -   Regular public bus and metro-type routes -- free transport

    -   Adequate private vehicle parking at VCs -- free parking

-   Offsite parking with collection area (CA) access

    -   Designated bus and metro route stop CA with busing to and from
        VCs -- 20 CAs

    -   Designated peripheral CAs (e.g., malls, movie complexes, parks,
        landmarks, and open areas) with adequate parking for private
        vehicles, with busing to and from VCs -- 20 CAs

    -   Public and school buses commandeered for delivery to and return
        from VCs for each CA

    -   Designation of buses and drivers, along with routes, collection
        points and VCs to be serviced (two shifts); enough buses/drivers
        to deliver approximately 6000 people to each VC/day, average of
        400 h to each VC

    -   CA and VC area transport organizers (4 persons x 100 VC/CA x 2
        shifts = 800)

    -   Adequate sanitary facilities at all major collection areas

    -   Publicize CA areas, their suggested catchments area, and the VC
        each area serves (e.g., TV, radio, newspapers, printed lists,
        and public transport advertisements)

-   Consider ways to organize the population to attend VC on a
    day-by-day schedule, such as the use of the last 3 digits of the
    household head's Social Security number (e.g., Day 1: 000-099; Day
    2: 100-199 ... Day 9: 800-899) or use of other neighborhood
    designations, worksite designations, zip codes, school districts

-   Advise population to bring identification (e.g., Social Security
    card, driver's license, passport, or other ID)

Fig. 1 []{#schemata_model_clinic .anchor}Schemata of Model Vaccination
Clinic

[]{#smallpox_clinic_supplies_equipment .anchor}Smallpox Clinic Supplies
and Equipment

+----------------+---------------------+-------------------------------+
| General        | Vaccine             | ### Emergency                 |
| Supplies and   | Administration      |                               |
| Equipment      | Supplies            | ### Supplies                  |
|                |                     |                               |
| **\_\_\_\_\_\_ | Smallpox vaccine    | Standing orders for           |
| \_\_\_\_\_\_\_ | Cooler/             | emergencies                   |
| \_\_\_\_\_\_** |                     |                               |
|                | refrigerator for    | "Code" kit with defibrillator |
| Tables         | vaccine             |                               |
|                |                     | Ampules of epinephrine 1:1000 |
| Chairs         | Vaccine diluent     | SQ or EPI pen                 |
|                |                     |                               |
| Water and cups | Sterilized          | Ampules of diphenhydramine    |
|                | bifurcated needles  | 50mg IM                       |
| Paper          |                     |                               |
|                | "Sharps" containers | 3cc syringes with 1",         |
| Pens, pencils  |                     | 25-gauge needles              |
|                | Latex gloves        |                               |
| Envelopes      |                     | 1.5" needles                  |
|                | Latex-free gloves   |                               |
| Rubber bands   |                     | Tuberculin syringes with 5/8" |
|                | Antibacterial       | needles (for                  |
| Tape           | handwashing         |                               |
|                |                     | epinephrine)                  |
| S              | solutions           |                               |
| tapler/staples |                     | Alcohol wipes                 |
|                | Acetone             |                               |
| Scissors       |                     | Blood Pressure Cuffs (various |
|                | Rectangle Band-aids | sizes)                        |
| Post-it Notes  |                     |                               |
|                | Gauze               | Oxygen tank with tubing       |
| Clipboards     |                     |                               |
|                | Adhesive tape       | IV Solution and tubing        |
| File boxes     |                     |                               |
|                | Spray bottle of     | Tongue depressors             |
| Telephones     | bleach              |                               |
|                |                     | Adult and Pediatric pocket    |
| FAX machine    | ###  Solution       | masks with                    |
|                |                     |                               |
| Photocopy      | Paper Gowns (for    | one-way valve                 |
| machine        | patients wearing    |                               |
|                | clothes that do not | Adult and Pediatric airways   |
| Paper towels   | give ready access   |                               |
|                | to arm)             | Tourniquet                    |
| Kleenex        |                     |                               |
| tissues        | []{.mark}           | Gurney                        |
|                |                     |                               |
| Table pads and | Screens (for        | Stethoscope                   |
| clean          | changing,           |                               |
|                | counseling, or      | Flashlight                    |
| paper to cover | administration, as  |                               |
| table          | needed)             | Cots                          |
|                |                     |                               |
| for work site  |                     | Blankets                      |
|                |                     |                               |
| Garbage        |                     | Pillows                       |
| containers     |                     |                               |
|                |                     | ER Report Form                |
| and trash bags |                     |                               |
|                |                     | Asthma Inhaler                |
| ID badges for  |                     |                               |
| staff          |                     | Thermometer                   |
|                |                     |                               |
| List of        |                     | Emesis basin                  |
| emergency      |                     |                               |
|                |                     | Aspirin, Tylenol, insulin,    |
| phone numbers  |                     | D50                           |
|                |                     |                               |
| 5 or more      |                     |                               |
| large screen   |                     |                               |
| video setups   |                     |                               |
| with VCRs or   |                     |                               |
| DVD players to |                     |                               |
| show           |                     |                               |
| Orientation    |                     |                               |
| video          |                     |                               |
|                |                     |                               |
| 7 Orientation  |                     |                               |
| videos (allows |                     |                               |
| for extra if   |                     |                               |
| video damaged) |                     |                               |
|                |                     |                               |
| Cleaning       |                     |                               |
| supplies (mop, |                     |                               |
| bucket, etc.)  |                     |                               |
+----------------+---------------------+-------------------------------+
|                |                     | # Co                          |
|                |                     | mputer Equipment and Supplies |
|                |                     |                               |
|                |                     | Computers                     |
|                |                     |                               |
|                |                     | Printers                      |
|                |                     |                               |
|                |                     | Paper                         |
|                |                     |                               |
|                |                     | Internet access for forms or  |
|                |                     | database entry                |
+----------------+---------------------+-------------------------------+
|                | # Crowd Management  |                               |
|                | and Triage Supplies |                               |
|                |                     |                               |
|                | Signs for clinic    |                               |
|                | stations and        |                               |
|                |                     |                               |
|                | between stations,   |                               |
|                | and at Triage area  |                               |
|                |                     |                               |
|                | Queue partitions    |                               |
|                | (to keep            |                               |
|                |                     |                               |
|                | people in lines)    |                               |
+----------------+---------------------+-------------------------------+

[]{#additional_supply_considerations .anchor}Additional Supply
Considerations

[Additional Clinic Supplies and Personnel Support for Each VC (Total of
20 VCs)]{.underline}

-   Duplication -- 1 or more rapid copy machines for duplicating IND
    paperwork as needed; crate of duplicating paper at each VC; extra
    machine toner cartridges.

-   Computers -- 12 desktops and/or laptops for data entry (all need
    internet connection if Web-based database used) with appropriate
    software (need to standardize software, if possible).

-   Centralized supplies warehouse(s) -- Estimate quantity of clinic
    supplies needed for 1 week of operation (paper, pens, staplers,
    etc.) and package accordingly for single unit delivery to each VC,
    weekly deliveries for continued.

-   Shipping -- Dedicated trucks/vehicles, staff, and drivers and
    preplanned routes to support vaccine and supplies delivery to 20
    VCs.

[Communications Equipment]{.underline}

-   Telephones -- 5 telephones/separate lines for each VC + 1 FAX at
    each VC.

-   Cell phones should be considered for nondata/fax needs and/or if
    easy access to phone lines might be difficult within the vaccination
    area (e.g., gymnasiums or auditoriums).

-   Hand-held radio system to communicate on site without having to send
    a runner.

[]{.mark}

[Emergency Management]{.underline}

-   Each VC should have clear, written procedures established to deal
    with emergencies caused by both vaccine adverse reactions and other
    reactions that could be triggered by the stress of the event (e.g.,
    heart attacks, anaphylactic shock, or asthma).

[Provision of Food and Beverages for Clinic Personnel]{.underline}

-   Consider using resources, such as Red Cross.

-   Local businesses may be willing to donate food and beverages.

[Information Materials]{.underline}

-   Obtain 2-day supply of forms (e.g., VIS, IND forms,
    contraindications, vaccine take, adverse event diary, and
    vaccination cards) directly from national stockpile (120,000 sets to
    support 20 VCs for first day) or pre-print forms locally as part of
    planning.

-   Arrange to duplicate adequate numbers of all forms for day 2, day 3,
    etc. (120,000/day).

-   Arrange for dedicated trucks (above), staff, and drivers and
    preplanned route to support delivery to 20 VCs.

-   Provide information on local clinics and laboratories that can
    provide HIV testing to individuals who elect to have testing done
    before getting vaccinated. Payment for HIV testing would be the
    responsibility of the individual.

[]{#logistics_IND_admin .anchor}Logistics for IND Administration of
Smallpox Vaccine

This section outlines the use of smallpox vaccine during the response to
a smallpox emergency. This IND protocol would be implemented as outlined
below if there was a confirmed case of smallpox.

Please refer to Flow Diagram (Figure 2)

-   [Public Service Announcements]{.underline} (PSAs) are the first item
    for the logistics of the vaccination clinic. These PSAs should be
    crafted to include important information on the disease,
    vaccination, contact numbers/vaccination clinics, clinic procedures,
    what to bring or wear to the clinic (identification, loose clothing
    to allow easier vaccination), how to get there, etc. PSAs should be
    in multiple languages and should use media outlets that will reach
    both English and non-English speaking individuals in the community.

-   [Triage for Illness:]{.underline} The first triage point for the
    vaccination clinic is triage for illness and/or contacts of
    confirmed cases of smallpox. This checkpoint is to screen out those
    individuals that may be ill or contacts from the rest of the
    individuals at the clinic so as not to expose the clinic population.

    -   [Ill (e.g., fever or rash)]{.underline}: These individuals will
        be taken out of the mainstream flow prior to entering the clinic
        and will be attended to as required by their symptoms/illness
        (e.g., monitoring, referral, or supportive care).

    -   [Contacts]{.underline}: These individuals will be taken out of
        the mainstream flow to be counseled on follow-up procedures and
        registered for monitoring for symptoms of smallpox. They will
        also be vaccinated.

    -   [Not Ill (mainstream progression through the
        clinic)]{.underline}: Those individuals that will progress to
        the next station within the clinic who have not presented as ill
        or a contact.

-   [Distribution of Information Packet]{.underline}: All individuals
    (contacts and mainstream) will receive the "mainstream" information
    packet that will include all of the following information:

    -   Video script

    -   Screening form

    -   Expanded Vaccine Information Statement (VIS)

    -   Vaccination Site Care Card

    -   Proof of Vaccination Card

***After receiving this information, "mainstream" individuals will
proceed to the video screening area, while "contacts" will proceed to
the contact evaluation area.***

-   [Video Screening Areas]{.underline}: Individuals will view the video
    that contains the essential elements of informed consent as
    promulgated in 21 CFR 50.25. This video viewing will be witnessed to
    comply with FDA regulations for the oral presentation of consent
    information. The script of the video is included in the "mainstream"
    packet and will include, at a minimum, English presentations and
    Spanish language translations. Additional language translations may
    be needed at the local level to address special populations.

***After the video, the individuals will be instructed to complete the
screening form that will move them through the remainder of the
vaccination clinic.***

-   [Postvideo Triage]{.underline}: Individuals will proceed to this
    triage point with their completed screening forms. The screening
    forms are for self-identified contraindications for the individual
    or family members with contraindications (e.g., contact history,
    altered immune status, autoimmune diseases, concomitant medications
    that alter immune status, skin conditions, pregnancy, reactions to
    previous smallpox vaccinations, allergies to vaccine components, and
    children less than 1 year old) and/or questions relating to the
    decision to be vaccinated.

    -   If individuals check "yes" or "maybe" to any of the boxes on the
        Screening form, they will proceed to the Counseling Stations
        where they will receive additional information based on the
        contraindication that they checked.

    -   If individuals have no self-identified contraindications or
        questions, they will proceed to the vaccination area.

    -   If individuals decide to decline vaccination and are not a
        contact, they will be escorted to the exit.

-   [Vaccination Area]{.underline}:

    -   At the vaccination station individuals who did not require
        additional counseling will sign the consent form located on the
        back of their Medical History Screening Form that states that
        they have viewed the video and had all questions answered. They
        will also have the chance here to ask any remaining questions;
        if they do have remaining questions, they may be referred back
        to the counseling area. Once signed by the vaccinee, these forms
        will be signed by the vaccinating assistant as a "witness to
        consent" and then collected.

    -   Individuals who were referred to the vaccination stations after
        receiving additional counseling will have had their consent
        forms witnessed by the medical counselor and will proceed with
        vaccination.

    -   Following vaccination, the "Proof of Vaccination" form will be
        stamped by the vaccinating assistant and returned to the
        vaccinee.

    -   Any noncontact who refuses vaccination will be allowed to exit
        the clinic. (Contacts who refuse vaccination will be instructed
        on appropriate quarantine measures, the symptoms to monitor for,
        and appropriate contact information within the "Contact
        Evaluation Unit" area.)

-   [Postvaccination Information and Review]{.underline}: This is the
    final station in the clinic for any remaining questions. This
    station should also ensure that individuals exit with *all* their
    information sheets and instructions. (A supply of extra information
    sheets should be kept here to distribute, as needed.)

[]{#annex1 .anchor}Attachment 1

[Examples]{.underline} of Supporting IND Forms for Smallpox Vaccine
Clinics\*

\* IND forms are subject to change. The contained example forms should
be utilized for planning and educational/training purposes only. The
most current IND forms will be distributed with vaccine shipments or
available through the state-based co-investigator and should be utilized
for all actual IND program administration within vaccination clinics.

#   {#section .unnumbered}

# Investigational Smallpox Vaccine 

[]{#screening_consent_form .anchor}Screening and Consent Signature Form

Date:

Patient Identifying Number:

(Please check only one: SSN Passport \# Driver's license \# and Issuing
State:\_\_\_\_ Other , List:\_\_\_\_\_\_\_\_\_\_\_\_\_ None available)

**Participant Information:**

Print Name: Date of Birth: Sex: M F

Current Address:

###  *City State Zip code Telephone Number*

**[Contact History:]{.underline}**

***Have you been told that you may have been a contact to someone with
smallpox?*** Yes No

***Have you been in contact with someone who had a bad rash in the past
3 weeks?*** Yes No

**[Screening:]{.underline}**

**Do the following apply to you or your child?**

Yes No Maybe

Immune system problems such as HIV/AIDS, cancer, leukemia, lymphoma,
organ transplant, agammmaglobulinemia

Autoimmune system problem like lupus that weakens your immune system

Currently taking medicines like oral steroids (such as prednisone),
chemotherapy agents/radiation, or organ transplant medications.

Eczema, atopic dermatitis, or a history of eczema or atopic dermatitis

Other skin conditions such as burns, impetigo, contact dermatitis, or
zoster.

Currently pregnant

Allergy to antibiotics polymixin B, streptomycin, chlortetracycline,
neomycin

Age less than 1 year old

Have additional questions about any health conditions you might have and
whether you should be vaccinated

Are you less than 18 years of age and your parent or guardian is not
with you?

Do you have any questions you would like to have answered before you
decide on vaccination?

This adult is incapacitated and this screening/consent signature form is
being completed by the parent or guardian

\[checked box for this question alone does not require additional
screening counseling\]

**Participant Informed [Consent Signature]{.underline} for
Vaccination:**

I HAVE:

-   Viewed the vaccine informational video or read the video script in
    the packet, or talked with a translator.

-   Received the information packet (which includes information on why
    this vaccine is being offered, why it is investigational, voluntary
    participation, benefits, risks, side effects, risks to contacts,
    precautions for vaccination and adverse events, Vaccinia Immune
    Globulin, cidofovir, care of my vaccination site, confidentiality,
    costs, what to do in case of injury, my right to refuse, alternative
    treatments, and contact information for problems or questions.)

-   Completed the medical screening form

-   Received counseling and additional information if I was identified
    as a contact or fell into any of the groups listed on the front of
    this form

-   Had the opportunity to have my questions answered

I have been informed of why smallpox vaccine is being made available,
the risks and benefits associated with vaccination and based on the
information provided to me, I have decided to receive or have my child
receive smallpox vaccination today.

Participant Signature/ Parent or Guardian:

  -----------------------------------------------------------------------
  **FOR VACCINATOR USE ONLY**

  -----------------------------------------------------------------------

Vaccine clinic ID: Vaccinator ID (name or ID number):

Vaccine Name: Dryvax Aventis ACAM1000 ACAM2000 Lot #:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Smallpox Vaccine Investigation of New Drug (IND)

# Record of Immunization

## Bring this card with you if you present for revaccination or for evaluation of a vaccine related illness

Name:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Patient Identifying Number (use same ID# as Medical Screening Form):

> Please identify that this number is:
>
> SSN
>
> Passport \# and Issuing Country\_\_\_\_\_
>
> Drivers license \# and Issuing State:\_\_\_\_\_
>
> Other: List\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> None available

Address:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

(City) (State) (Zip code)

Telephone:
(\_\_\_\_\_\_)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

+----------+----------+----------+----------+----------+------------+
| Date     | Vaccine  | Vaccine  | Vac      | Clinic   | Person     |
| (m       | Type     | LOT \#   | cination | Name     | adm        |
| m/dd/yy) |          |          | Site     |          | inistering |
|          | (check   |          |          |          | vaccine    |
|          | box)     |          | (check   |          |            |
|          |          |          | box)     |          |            |
+----------+----------+----------+----------+----------+------------+
|          | Dryvax  |          | Right    |          |            |
|          |          |          | arm     |          |            |
|          | Aventis  |          |          |          |            |
|          |         |          | Left arm |          |            |
|          |          |          |         |          |            |
|          | ACAM1000 |          |          |          |            |
|          |         |          | Other   |          |            |
|          |          |          |          |          |            |
|          | ACAM2000 |          |          |          |            |
|          |         |          |          |          |            |
+----------+----------+----------+----------+----------+------------+
|          | Dryvax  |          | Right    |          |            |
|          |          |          | arm     |          |            |
|          | Aventis  |          |          |          |            |
|          |         |          | Left arm |          |            |
|          |          |          |         |          |            |
|          | ACAM1000 |          |          |          |            |
|          |         |          | Other   |          |            |
|          |          |          |          |          |            |
|          | ACAM2000 |          |          |          |            |
|          |         |          |          |          |            |
+----------+----------+----------+----------+----------+------------+
|          | Dryvax  |          | Right    |          |            |
|          |          |          | arm     |          |            |
|          | Aventis  |          |          |          |            |
|          |         |          | Left arm |          |            |
|          |          |          |         |          |            |
|          | ACAM1000 |          |          |          |            |
|          |         |          | Other   |          |            |
|          |          |          |          |          |            |
|          | ACAM2000 |          |          |          |            |
|          |         |          |          |          |            |
+----------+----------+----------+----------+----------+------------+
|          | Dryvax  |          | Right    |          |            |
|          |          |          | arm     |          |            |
|          | Aventis  |          |          |          |            |
|          |         |          | Left arm |          |            |
|          |          |          |         |          |            |
|          | ACAM1000 |          |          |          |            |
|          |         |          | Other   |          |            |
|          |          |          |          |          |            |
|          | ACAM2000 |          |          |          |            |
|          |         |          |          |          |            |
+----------+----------+----------+----------+----------+------------+

SMALLPOX VACCINE

[]{#what_you_need_skin .anchor}

WHAT YOU NEED TO KNOW IF YOU HAVE SKIN CONDITIONS SUCH AS ECZEMA, ATOPIC
DERMATITIS, IMPETIGO, UNHEALED BURNS, CONTACT DERMATITIS, OR CHICKEN POX

Please refer to your Smallpox Vaccine General Information Sheet for
additional information about smallpox, smallpox vaccine, vaccine
reactions, and vaccine site care instructions.

**1 What is smallpox?**

Smallpox is a serious disease. It is caused by a virus called
***variola,*** which is spread from person to person through close
contact.

Smallpox can cause:

-   a severe rash, which can leave scars when healed

-   high fever

-   tiredness

-   severe headaches and backache

-   blindness

-   death (in up to 30% of those infected)

The last case of smallpox was in 1978.

**2 Why am I being offered smallpox vaccine today?**

Smallpox vaccine is being offered to you today because one of the
following has happened:

-   you have been exposed to smallpox virus,

-   you have been in close contact with someone who has smallpox,

-   you have not been exposed to the virus, but you live with someone
    who has been exposed and could develop smallpox,

-   you have not been exposed to the virus yet, but there has been a
    smallpox outbreak and you may be exposed in the future.

**3 What do I need to know about smallpox disease with a skin
condition?**

If you have a skin condition and are exposed to smallpox virus, if you
develop the disease, you are at no known additional risk of death from
smallpox than people who do not have a skin condition. Approximately one
person of every three who gets smallpox dies from the disease.

**4 Should I get the smallpox vaccine?**

-   In an outbreak emergency, everyone who has been in contact with a
    person with smallpox or was exposed to the virus is recommended to
    receive the one-dose vaccine, regardless of his or her age,
    allergies, pregnancy, or medical conditions.

-   If you have one of the skin conditions listed above, and ***you have
    been exposed*** to smallpox, you are advised to accept the vaccine
    because your risk of catching the disease is greater than any
    additional risks from the vaccine.

-   If you have one of the skin conditions listed above, and ***you have
    not been exposed*** to smallpox, you are advised to avoid the
    vaccine because your risk of catching the disease is less than any
    special risks from the vaccine.

**5 If I have a skin condition, when should I not be vaccinated, or wait
to be vaccinated?**

-   Anyone who has eczema or has a past history of eczema should not get
    smallpox vaccine unless they have been told that they have been
    exposed to smallpox virus.

-   Anyone with certain skin conditions, such as allergic rash, severe
    burns, impetigo, chickenpox, should wait until the condition clears
    up before getting smallpox vaccine, unless they have been told that
    they have been exposed to smallpox virus.

-   If someone in your household requires vaccination, and you have a
    high-risk skin condition, you should not have contact with that
    person, or live with them, until their vaccination mark has
    completely healed and the scab has fallen off.

**6 What are the additional risks from smallpox vaccine to people with
skin conditions?**

***All*** people receiving smallpox vaccine are at risk for the
complications discussed on your general vaccine information sheet.

In addition, people with skin conditions like eczema and atopic
dermatitis have a high risk of developing a severe rash called "Eczema
Vaccinatum" if they receive smallpox vaccine or touch another person's
vaccination mark, before it is completely healed and the scab has fallen
off. While most people recover from this rash, it can be quite severe,
sometimes leading to death.

Even people who do not have eczema at the time of vaccination, but have
a past history of eczema, have an increased chance of developing Eczema
Vaccinatum.

![](media/image1.jpeg){width="1.9479166666666667in"
height="1.3104166666666666in"}

**7 What special signs should I look for?**

Fever or a severe rash over the entire body, a reaction that spreads
from the vaccination site and does not get better, or blisters on other
parts of the body.

**8 What should I do if I think I am vaccinated and think that I am
having a bad reaction to the vaccine?**

Call a doctor right away. Tell your doctor what is happening, the date
and time it started, and when the vaccination was given. Your doctor
will tell you what to do next.

**9 What are the treatments for Eczema Vaccinatum caused by smallpox
vaccine?**

There are two treatments that may help if you develop eczema vaccinatum.
They are called Vaccinia Immune Globulin (VIG) and Cidofovir**.** Both
of these medications are given by a needle into the vein (intravenous,
IV) and require you to be in the hospital. They are investigational and
may cause a number of serious side effects themselves.

CDC (Centers for Disease Control and Prevention) will pay for the costs
of these medicines. The other costs of hospital and medical care will
not be covered by CDC and will need to be paid by you, your insurer,
Medicare, or Medicaid.

**10 What if I decide not to get the smallpox vaccine?**

-   It is your choice whether or not to get the vaccine.

-   If you ***have*** been in contact with a person who has smallpox and
    you decide ***not*** to get the vaccine, you may be placed in
    isolation for 18 days. This means that you would not be able to be
    in contact with other people who have not been vaccinated. You would
    not be able to stay at home or go to work. You will be watched to be
    sure that you do not develop smallpox and to be sure that you do not
    give smallpox to others.

-   If you ***have not*** been in contact with anyone with smallpox and
    you decide ***not*** to get the vaccine, you should stay away from
    anyone you suspect may have smallpox. You may go to work and school,
    but would probably be safest if you stay close to home.

**11 How can I learn more?**

-   If you have questions about your or your child's vaccination site,
    please call the 24-hour hotline at 1-800-.......

-   If you have questions about smallpox or the vaccine, call your local
    or state health department at telephone number....... Or the Centers
    for Disease Control and Prevention at telephone number......

-   If you have questions about your rights as a vaccine recipient
    please call 1-800-584-8814. You will be connected to the Deputy
    Associate Director for Science at CDC. Please leave a message with
    your name and phone number, including your area code. Someone will
    call you back as soon as possible.

SMALLPOX VACCINE

[]{#what_you_need_child .anchor}

WHAT YOU NEED TO KNOW IF YOUR CHILD

IS LESS THAN 1 YEAR OLD

**Please refer to your Smallpox Vaccine General Information Sheet for
additional information about smallpox, smallpox vaccine, vaccine
reactions, and vaccine site care instructions.**

**1 What is smallpox?**

Smallpox is a serious disease. It is caused by a virus called
***variola***, which is spread from person to person through close
contact.

Smallpox can cause:

-   a severe rash, which can leave scars when healed

-   high fever

-   tiredness

-   severe headaches and backache

-   blindness

-   death (in up to 30% of those infected)

The last case of smallpox was in1978.

2 Why is my child being offered smallpox vaccine?

Your child is being offered smallpox vaccine because one of the
following has happened:

-   your child has been exposed to smallpox virus

-   your child has been in close contact with someone who has smallpox

-   your child has not been exposed to the virus but live with someone
    who was exposed and could develop smallpox

-   your child hasnot been exposed to the virus yet but there has been a
    smallpox outbreak and he/she may be exposed in the future.

**3 What do I need to know about smallpox disease in young children?**

Smallpox in very young children can be very severe. Children less than 4
years old may have a greater risk of dying from smallpox than older
children. Children older than 4 years usually handle smallpox better
than younger children and have less risk of dying from the disease.

**4 What additional risks does my child have from the vaccine if he/she
is younger than 1 year old?**

***All*** people who receive smallpox vaccine can have some risks from
the vaccine. These risks are discussed in your general vaccine
information sheet.

Infants less than 1 year old who are vaccinated may have a greater risk
of developing complications from the vaccine, such as brain swelling or
a total body rash. Brain swelling is a rare complication but can occur
in about 42 out of every 1 million infants who are vaccinated. Brain
swelling can lead to permanent brain damage or even death.

The total body rash than can develop after vaccination is usually mild
and resolves on its own without treatment but can rarely be severe and
require medical treatment.

Young children may also be more likely to touch the vaccination site
with their hands and transfer vaccine virus to another part of the body
(such as the eyelid, face, mouth, genital area), causing a similar sore
to develop there. This may be avoided by covering the site and making
sure the child doesn't touch the site and washes his/her hands well if
they do.

**5 Should my child get the smallpox vaccine?**

In an outbreak emergency, everyone who has been in contact with a person
with smallpox or was exposed to the virus is recommended to receive the
one dose vaccine, regardless of his or her age, allergies, pregnancy, or
medical conditions.

If your child was exposed to smallpox virus, the vaccine would be
recommended for you in order to try and prevent or lessen the severity
of smallpox.

**6 If my child is less than 1 year old,**

**when should they *not* be vaccinated,**

**or wait to be vaccinated?**

You should consider waiting to have your child vaccinated until he/she
is older than 1 year, if he/she has ***not*** been in contact with
smallpox virus or a person with smallpox.

**7 What should I do if my child is vaccinated and I think that my child
is having a bad reaction to the vaccine?**

Call a doctor right away. Tell your doctor what is happening, the date
and time that it started, and when the vaccination was given. Your
doctor will advise you on what to do next.

**8 What are the treatments for reactions to smallpox vaccine?**

There are two treatments that may help if your child has a serious
reaction to the smallpox vaccine. They are called Vaccinia Immune
Globulin (VIG) and Cidofovir. Both of these medications are given by a
needle into the vein (intravenous, IV) and require you to be in the
hospital. They are investigational and may cause a number of serious
side effects themselves. These treatments would not be effective for
brain swelling from vaccination, but other medical treatments would be
used.

CDC (Centers for Disease Control and Prevention) will pay for the costs
of these medicines. The other costs of hospital and medical care will
***not*** be covered by CDC and will need to be paid by you, your
insurer, Medicare, or Medicaid.

**9 What if I decide not to get the smallpox vaccine for my child?**

-   It is your choice whether or not to get the vaccine for your child.

-   If your child ***has*** been in contact with a person who has
    smallpox and you decide ***not*** to get the vaccine for your child,
    your child may be placed in isolation for 18 days. This means that
    your child would not be able to be in contact with other people who
    have not been vaccinated. Your child may not be able to stay at
    home. Your child will be watched to be sure that he/she does not
    develop smallpox and to be sure that they do not give smallpox to
    others if they do develop the disease.

-   If your child ***has not*** been in contact with anyone with
    smallpox and you decide ***not*** to get the vaccine for your child,
    your child should stay away from anyone you suspect may have
    smallpox.

-   If your child is not vaccinated and lives in the same house with a
    person who has been vaccinated because they were exposed to smallpox
    virus, you should consider having your child live elsewhere for a
    while and avoid contact with that person until they are no longer at
    risk of developing smallpox. Public health officials will tell you
    when your household member is no longer at risk for developing
    smallpox. Usually this period is for 18 days after their contact
    with smallpox virus or 14 days after their vaccination.

**10 How can I learn more?**

-   If you are vaccinated and have questions about your vaccination
    site, please call the 24-hour hotline at 1-800-.......

-   If you have questions about this vaccine or smallpox, call your
    local or state health department at telephone number....... Or the
    Centers for Disease Control and Prevention at telephone number......

-   If you have questions about your rights as a vaccine recipient,
    please call 1-800-584-8814. You will be connected to the Deputy
    Associate Director for Science at CDC. Please leave a message with
    your name and phone number, including your area code. Someone will
    call you back as soon as possible.

SMALLPOX VACCINE

[]{#what_you_need_pregnant .anchor}

WHAT YOU NEED TO KNOW IF YOU ARE PREGNANT

**Please refer to your Smallpox Vaccine General Information Sheet for
additional information about smallpox, smallpox vaccine, vaccine
reactions, and vaccine site care instructions.**

**1 What is smallpox?**

Smallpox is a serious disease. It is caused by a virus called
***variola***, which is spread from person to person through close
contact.

Smallpox can cause:

-   a severe rash, which can leave scars when healed

-   high fever

-   tiredness

-   severe headaches and backache

-   blindness

-   death (in up to 30% of those infected)

The last case of smallpox was in 1978.

2 Why am I being offered smallpox vaccine?

You are being offered smallpox vaccine because one of the following has
happened:

-   you have been exposed to smallpox virus

-   you have been in close contact with someone who has smallpox

-   you have not been exposed to the virus but live with someone who was
    exposed and could develop smallpox

-   you have not been exposed to the virus yet but there has been a
    smallpox outbreak and you may be exposed in the future.

**3 What do I need to know about smallpox disease during pregnancy?**

If you are pregnant and are exposed to smallpox virus, if you develop
the disease, you may have a more serious illness and a higher risk of
dying than a woman who is not pregnant. The infection could also cause
the following to occur:

-   miscarriage

-   stillbirth

-   premature birth

-   baby born with no problems or infection

Before smallpox was eradicated in 1980, smallpox infections caused
pregnancies to end early in 75% of pregnant women who developed the
disease early in their pregnancy and in 60% of the women who developed
the disease later in their pregnancy.

**4** **What additional risks do I have from the vaccine if I am
pregnant?**

All people who receive smallpox vaccine can have some risks from the
vaccine. These risks are discussed in your general vaccine information
sheet.

Smallpox vaccine is a live-virus vaccine made from a virus called
***Vaccinia***. In general, vaccination with vaccines that have live
viruses are not recommended during pregnancy. On rare occasions,
smallpox vaccine can cause an infection in the unborn child of a
pregnant woman who was vaccinated during her pregnancy that can lead to
premature delivery, stillbirth, or death in the child soon after
delivery. Even though millions of people have been vaccinated against
smallpox, less than 50 cases of this have been reported.

**5 Should I get the smallpox vaccine?**

In an outbreak emergency, everyone who has been in contact with a person
with smallpox or was exposed to the virus is recommended to receive the
one-dose vaccine, regardless of his or her age, allergies, pregnancy, or
medical conditions

If you are pregnant and were exposed to smallpox virus, the vaccine
would be recommended for you in order to try and prevent or lessen the
severity of smallpox.

**6 If I am pregnant, when should I *not ***

**be vaccinated, or wait to be**

**vaccinated?**

You should consider waiting to be vaccinated until after you have
delivered your baby if you have ***not*** been in contact with smallpox
virus or a person with smallpox.

**7 What should I do if I am vaccinated and think that I am having a bad
reaction to the vaccine?**

Call a doctor right away. Tell your doctor what is happening, the date
and time that it started, and when the vaccination was given. Your
doctor will advise you on what to do next.

**8 What are the treatments for reactions to smallpox vaccine?**

There are two treatments that may help if you have a serious reaction to
the smallpox vaccine. They are called Vaccinia Immune Globulin (VIG) and
Cidofovir. Both of these medications are given by a needle into the vein
(intravenous, IV) and require you to be in the hospital. They are
investigational and may cause a number of serious side effects
themselves.

CDC (Centers for Disease Control and Prevention) will pay for the costs
of these medicines. The other costs of hospital and medical care will
***not*** be covered by CDC and will need to be paid by you, your
insurer, Medicare, or Medicaid.

**9 What if I decide not to get the smallpox vaccine?**

-   It is your choice whether or not to get the vaccine.

-   If you ***have*** been in contact with a person who has smallpox and
    you decide ***not*** to get the vaccine, you may be placed in
    isolation for 18 days. This means that you would not be able to be
    in contact with other people who have not been vaccinated. You would
    not be able to stay at home or go to work. You will be watched to be
    sure that you do not develop smallpox and to be sure that you do not
    give smallpox to others.

-   If you ***have not*** been in contact with anyone with smallpox and
    you decide ***not*** to get the vaccine, you should stay away from
    any one you suspect may have smallpox.

-   If chose not to be vaccinated and you live in the same house with a
    person who has been vaccinated because they were exposed to smallpox
    virus, you should consider living apart from and avoiding contact
    with that person until they are no longer at risk of developing
    smallpox. Public health officials will tell you when your household
    member is no longer at risk for developing smallpox. Usually this
    period is for 18 days after their contact with smallpox virus or 14
    days after their vaccination.

**10 How can I learn more?**

-   If you are vaccinated and have questions about your vaccination
    site, please call the 24-hour hotline at 1-800-.......

-   If you have questions about this vaccine or smallpox, call your
    local or state health department at telephone number....... Or the
    Centers for Disease Control and Prevention at telephone number......

-   If you have questions about your rights as a vaccine recipient,
    please call 1-800-584-8814. You will be connected to the Deputy
    Associate Director for Science at CDC. Please leave a message with
    your name and phone number, including your area code. Someone will
    call you back as soon as possible.

INVESTIGATIONAL SMALLPOX VACCINE

WHAT YOU NEED TO KNOW IF YOU HAVE IMMUNE SYSTEM PROBLEMS (HIV, AIDS,
ORGAN TRANSPLANTS, CANCER CHEMOTHERAPY, HIGH-DOSE STEROID THERAPY,
RADIATION THERAPY, CELLULAR OR HUMORAL IMMUNITY PROBLEMS, AND OTHER
IMMUNE SYSTEM PROBLEMS)

**Please refer to your Smallpox Vaccine General Information Sheet for
other facts about smallpox, smallpox vaccine, vaccine reactions, and
vaccine site care instructions.**

**1 What is smallpox?**

Smallpox is a serious disease. It is caused by a virus called
***variola,*** which is spread from person to person through close
contact.

Smallpox can cause:

-   a severe rash, which can leave scars when healed

-   high fever

-   tiredness

-   severe headaches and backache

-   blindness

-   death (in up to 30% of those infected)

The last case of smallpox disease was 1978.

2 Why am I being offered smallpox vaccine?

You are being offered smallpox vaccine because one of the following has
happened:

-   you have been exposed to smallpox virus

-   you have been in close contact with someone who has smallpox

-   you have not been exposed to the virus but live with someone who was
    exposed and could develop smallpox

-   you have not been exposed to the virus yet, but there has been a
    smallpox outbreak and you may be exposed in the future.

**3 What do I need to know about smallpox disease in people with immune
system problems?**

The last cases of smallpox disease occurred over thirty years ago. At
that time, little was known about immune system problems. While we know
a lot about the immune system now, we do not have experience with people
with immune system problems having smallpox. From what we know about
serious infections in people with immune system problems, we believe
that smallpox infections in these people may be more serious than
smallpox infections occurring in people with healthy immune systems.

**4 What other risks from vaccine do I have if I have immune system
problems?**

***All*** people who receive smallpox vaccine can have some risks from
the vaccine. These risks are talked about in your general vaccine
information sheet.

The smallpox vaccine is made from a live vaccinia virus (not smallpox
virus). People with immune system problems are often advised to avoid
vaccines made from live viruses because their immune systems cannot stop
the growth of the virus in their bodies. In general, the risk for severe
reactions from smallpox vaccine in people with immune system problems is
not known. There have been a few cases of a serious vaccine infection in
people with HIV who have received the smallpox vaccine. This infection
spreads through the body and can occur in two forms: generalized
vaccinia and progressive vaccinia. You can see pictures of these rashes
on your general vaccine information sheet. In rare cases, these rashes
can lead to illnesses that cause death.

There is no proof that receiving smallpox vaccination will cause immune
system problems to happen faster.

There are no facts about the level of immunosupression (T-cell count)
that would put a person with immune system problems at risk for bad
reactions from the vaccine.

**5 Should I get the smallpox vaccine?**

In an outbreak emergency, everyone who has been in contact with a person
with smallpox or was exposed to the virus is advised to receive the
one-dose vaccine, regardless of his or her age, allergies, pregnancy, or
medical conditions.

If you have been exposed to smallpox virus, the vaccine would be advised
for you in order to try and prevent or lessen the seriousness of
smallpox.

**6 When should I *not* be vaccinated or wait to be vaccinated?**

If you have ***not*** been in contact with smallpox virus or a person
with smallpox, you should think about not being vaccinated or waiting to
be vaccinated until you have completed any treatments that affect your
immune system function. Often, the waiting period can be as long as 3
months after finishing treatment. Your personal doctor should advise you
on when it will be safer to receive the vaccination.

**7 What do I do if I am vaccinated and think that I am having a bad
reaction to the vaccine?**

Call a doctor right away. Tell your doctor what is happening, the date
and time that it started, and when the vaccination was given. Your
doctor will advise you on what to do next.

**8 What are the treatments for reactions to smallpox vaccine?**

There are two treatments that may help if you have a serious reaction to
the smallpox vaccine. They are called Vaccinia Immune Globulin (VIG) and
Cidofovir (VISTIDE^®^). Both of these medicines are given by a needle
into the vein (intravenous, IV) and require you to be in the hospital.
They are investigational and may cause a number of serious side effects.
These medicines would be given if supplies are available and both your
doctor and experts at the Centers for Disease Control and Prevention
(CDC) think they are necessary. These treatments are not effective for
brain swelling from vaccination, but other medical treatments would be
used.

CDC will pay for the costs of these medicines. The other costs of
hospital and medical care will ***not*** be covered by CDC and will need
to be paid by your insurer, Medicare, Medicaid or you.

**9 What if I decide not to get the smallpox vaccine?**

-   It is your choice whether or not to get the vaccine.

-   If you ***have*** been in contact with a person who has smallpox and
    you decide ***not*** to get the vaccine, you may be kept apart from
    other people for 18 days. This means that you would not be able to
    be in contact with other people who have not been vaccinated. You
    will not be able to stay at home or go to work. You will be watched
    to be sure that you do not develop smallpox and/or give smallpox to
    others.

-   If you ***have not*** been in contact with anyone with smallpox and
    you decide ***not*** to get the vaccine, you should stay away from
    anyone you suspect may have smallpox. Public health experts can give
    you more facts on special things you can do to protect yourself and
    how long you will need to do these things***.***

-   If you are not vaccinated and live in the same house with a person
    who has been vaccinated because he/she was exposed to smallpox
    virus, you should consider living apart from and avoid contact with
    that person until he/she is no longer at risk of getting smallpox.
    Public health experts will tell you when your household member is no
    longer at risk for getting smallpox. Usually this period is for 18
    days after the contact with smallpox virus or 14 days after the
    vaccination.

**10 How can I learn more?**

-   If you are vaccinated and have questions about your vaccination
    site, please call the 24-hour hotline at 1-800-.......

-   If you have questions about this vaccine or smallpox, call your
    local or state health department at telephone number....... or the
    CDC at telephone number......

-   If you think you have been injured or have questions about your
    rights as a participant in this program please call 1-800-584-8814.
    You will be connected to the Deputy Associate Director for Science
    at CDC. Please leave a message with your name and phone number,
    including your area code. ***Say that you are calling about CDC
    protocol \# 3585.*** Someone will call you back as soon as possible.

INFORMATION FOR PEOPLE WHO HAVE BEEN

[]{#close_contact_info .anchor}IN CLOSE CONTACT

TO A PERSON WITH SMALLPOX

You are receiving this information because you have been in close
contact with someone who has smallpox. People who have been in close
contact with a person who has smallpox are sometimes called "contacts."

What is close contact?

Close contact means that you:

-   Live in the same home (house, apartment, shelter) as someone who has
    smallpox

-   Have spent at least 3 hours in the same room with someone who has
    smallpox

What happens to "contacts?"

-   Contacts are at risk of developing smallpox because the smallpox
    virus may have been spread to them from the person with smallpox.
    The virus is spread through the air on tiny drops of saliva when the
    infected person talks, laughs, coughs, or sneezes.

-   Contacts are offered smallpox vaccination. The vaccine can protect
    some contacts from getting sick with or dying from smallpox if it is
    given within a few days of spending time with the sick person. It is
    considered advisable for contacts to get the vaccine regardless of
    their medical conditions, allergies or age. This is because *for
    contacts* the risk of serious illness or death from getting smallpox
    is greater than the risk of getting sick from the vaccine.

-   Contacts are watched carefully for signs and symptoms that they are
    getting sick with smallpox disease. You will be watched for signs
    and symptoms of smallpox even if you take the vaccine.

-   The signs and symptoms include:

    -   Temperature over 101° F or 38° C orally

    -   A red skin rash

    -   Tiredness

    -   Backache

    -   Headache

    -   Muscle aches

-   Someone from the Department of Health will visit or call you twice
    every day to check you for these signs of getting smallpox, or you
    may be asked to call the Health Department twice a day to let them
    know how you are feeling.

-   You will be watched for these signs and symptoms for 18 days, which
    is the length of time it can take someone to develop smallpox.

-   People you live with and work with *may* also be offered vaccination
    to protect them in case you develop smallpox.

-   If someone you live with cannot take the vaccine because of a
    medical condition, or decides not to take the vaccine, they will
    have to make arrangements to live somewhere else for the 18-day
    period.

-   During the 18-day period, you may leave your house, but you should
    not travel more than 1 hour from your home. This allows you to be
    able to return home quickly if you begin feeling ill.

Please call 1-800-xxx-xxxx, if you have other questions.

[]{#informed_consent_process_flow .anchor}Fig 2. Informed Consent
Process Flow for Use During Emergency Smallpox Vaccination

[]{#annex2 .anchor}Attachment 2

Mass Patient Care

Smallpox Response Planning Template for State and Local Jurisdictions

SMALLPOX RESPONSE PLANNING TEMPLATE

FOR STATE AND LOCAL JURISDICTIONS

Planning parameters for managing the consequences of the release of
smallpox, as a weapon of mass destruction will include a variety of
factors at the local and state levels. All planning efforts must work in
conjunction with established federal support planning. This template,
along with the guidelines set forth by the CDC, will allow local
jurisdictions and state agencies to effectively respond to a smallpox
incident.

[]{#planning_mass_patient_care .anchor}[PLANNING CONSIDERATIONS FOR MASS
PATIENT CARE]{.underline}

The primary consideration needs to be for the rapid expansion of
capacity. This can be accomplished in a number of ways.

-   Expand existing personnel capacity by augmenting staff

> Expansion of physical capacity can be accomplished by opening closed
> beds, wards, and floors. Converting large, interior spaces into
> patient care areas can develop further capacity.
>
> Looking first to some or all of the following local sources can
> augment staff: Medical Schools, Osteopathic Schools, Nursing Schools,
> Physician Assistant Programs, Dental Schools, Veterinary Medicine
> Schools, Vocational Nursing Programs, Physical Therapy Programs, Lab
> Technology Programs, EMT Training Programs, Dental Assistant/Hygienist
> Programs, Medical Records Programs, Nursing Assistant Programs, local
> chapters of the American Red Cross, Salvation Army, Fire Academies,
> and Police Academies. Consider adjacent/nearby military training
> reservations/academies.
>
> NOTE A: Each of these potential sources for augmenting staff may
> require the establishment of a Memorandum of Understanding. This must
> be done ahead of time. In addition to these local sources, the
> Department of Health and Human Services is initiating planning for the
> development of local Volunteer Medical Reserve Corps. (Information on
> building a local Volunteer Medical Reserve Corps will be provided by
> the Department of Health and Human Services.) Guidance for the
> development of a local Medical Reserve Corps will be made available in
> the near future.
>
> NOTE B: Each of these cohorts adds an additional vaccination
> requirement.
>
> An available source(s) of staff augmentation outside of local sources
> are Traveling Nurse companies. These companies advertise in the
> national nursing journals. Beyond that, it may be necessary to turn to
> assets that are available statewide and ultimately to the Federal
> Government for additional assets.

-   Use of auxiliary facilities (e.g. hotels/schools)

> An important consideration in planning for the use of auxiliary
> facilities is that those facilities may not ever be able to be used
> again as originally intended. The use of auxiliary facilities may
> require that some "standards of care" be relaxed. If so, it is
> important to address these legislative issues/concerns during the
> planning stage.

-   Move patients out (non-smallpox)

-   Move Resources In (personnel, portable facilities)

> Department of Defense mobile/portable facilities can be accessed
> through Emergency Support Number 8 of the Federal Response Plan.
>
> Home care may be suitable for the X and R patient cohorts described
> below. Plan for the three facility types recommended by the CDC in the
> referred to document. (C=Smallpox Patients; X=Vaccinated Febrile
> Patients without Rash; R=Asymptomatic Contacts)
>
> [**http://www.bt.cdc.gov/DocumentsApp/Smallpox/RPG/GuideC/guide-C-pages1-18only.pdf**](http://www.bt.cdc.gov/DocumentsApp/Smallpox/RPG/GuideC/guide-C-pages1-18only.pdf)

[]{#COMMAND_AND_CONTROL .anchor}[COMMAND AND CONTROL]{.underline}

All elements of your command and control must be exercised regularly.

-   Utilize the incident command system.

-   Utilize the unified command system.

-   Identify relevant contact information and update regularly.

-   Notify necessary local, state, and federal agencies.

-   Centralize Communications Control Center.

-   Centralize Control of Medical Logistics and Equipment

-   Centralize Control of Transportation.

-   Consider use of non-traditional (alternate) means of emergency
    transportation, such as using public transportation for patient
    movement.

-   Establish procedures for patient movement to appropriate facilities
    and mobility of healthcare providers to/from treatment facilities.

-   Develop a family support center in coordination with the American
    Red Cross for the dissemination of information to family members of
    victims.

[]{#PERSONNEL_REQUIREMENTS .anchor}[PERSONNEL REQUIREMENTS]{.underline}

*Consider a vaccination plan for both personnel and their families.*

Preparing for the consequences of a smallpox outbreak will require
significant numbers of personnel associated with each component of the
response. Resources provided by Federal and State agencies will not be
sufficient to offset the medical human resource needs associated with a
large-scale smallpox outbreak. Appropriate staffing of health and
medical requirements will be critical for the success of this operation.

-   Develop a plan for coordination with other local, state and federal
    agencies to avoid "double counting" potential augmentation
    resources.

-   Address credentialing issues to allow non-local physicians and other
    care providers to legally practice within jurisdiction. Ensure that
    during a smallpox response, unlicensed personnel can be utilized
    under the supervision of licensed personnel.

-   Manage the dissemination of information via Public Affairs.

-   In-hospital providers and first responders who would respond to a
    smallpox case should be identified.

-   Maintain adequate support staff (laundry, housekeeping, central
    supply) to provide mass care.

-   Identify adequate hospital-based infectious disease specialists for
    disease consultation.

-   Establish separate staffing to maintain normal medical functions,
    such as labor and delivery, non-related injuries.

-   Provide for the segregation of providers treating smallpox victims
    from other providers.

-   Establish control procedures to prevent medical personnel from
    fleeing from or flooding into medical treatment facilities.

-   Consider the potential loss of healthcare providers due to smallpox
    exposure or fear of smallpox exposure.

-   Consider auxiliary personnel to assist with mass care (e.g.,
    medical/nursing/veterinary students).

-   Establish vaccination plan for healthcare providers, public health
    officials, and their families.

-   Identify personnel mobilization points.

-   Provide for the welfare and safety of emergency workers. It is
    important to remember that auxiliary response personnel may number
    in excess of 5,000 persons.

-   Provide appropriate personal protective equipment and infection
    control measures for personnel.

-   Include numbers of personnel required by category (physician, nurse,
    EMT).

-   Consider the use of non-traditional personnel as described on Page
    1.

-   Use auxiliary personnel (who may be trained on the spot but will
    require close professional supervision).

-   Train support personnel (e.g., clergy, mental health workers) in the
    use of personal protective equipment and infection control
    procedures.

-   Develop family support plan for medical providers and response
    personnel.

-   Develop plan for the housing, feeding, and clothing needs of
    emergency responders.

[]{#TREATMENT .anchor}[TREATMENT]{.underline}

-   Train medical staff to recognize and manage smallpox patients,
    special considerations include immune compromised patients and
    patients with adverse vaccination reactions.

-   Provider appropriate personal protection equipment.

-   Provide treatment protocols to all providers that include plans for
    immunocompromised patients.

-   Prepare to maintain appropriate documentation.

-   Develop triaging procedures for smallpox victims.

-   Establish a hotline number for information on vaccination takes.

-   Develop information for those whose vaccinations do not take,
    including information about revaccination.

-   Must be prepared to treat persons with adverse reactions to
    vaccination. These patients must not return to the mass vaccination
    site.

-   Utilize telemedicine for consultation.

[]{#PROVISION_MENTAL_HEALTH .anchor}[PROVISION OF MENTAL HEALTH
SERVICES]{.underline}

-   Plan for mental health services for victims and their families.

-   Plan for mental health services for emergency workers and their
    families.

-   Plan for the management of the worried well and provision for
    psychological counseling of the same.

[]{#PATIENT_TRACKING .anchor}[PATIENT TRACKING]{.underline}

-   Match patients with appropriate medical facilities and other
    pre-selected treatment locations.

-   Track patients at all facilities.

[]{#FACILITIES .anchor}[FACILITIES]{.underline}

-   Plan for the three facility types recommended by the CDC in the
    referred to document. (C=Smallpox Patients; X=Vaccinated Febrile
    Patients without Rash; R=Asymptomatic Contacts)

[**http://www.bt.cdc.gov/DocumentsApp/Smallpox/RPG/GuideC/guide-C-pages1-18only.pdf**](http://www.bt.cdc.gov/DocumentsApp/Smallpox/RPG/GuideC/guide-C-pages1-18only.pdf)

-   Home care may be suitable for the cohorts X and R noted above.

-   Plan for admission procedures for smallpox patients into hospitals
    or established treatment facility.

-   Establish a standardized community reporting method to report bed
    availability.

-   Establish plans for the expedient expansion of the existing
    healthcare system capacity.

-   Utilize isolation beds within existing facilities.

-   Maximize utilization of existing healthcare facilities, including
    augmentation of staff.

-   Consider secondary treatment centers for temporary augmentation of
    healthcare capabilities.

-   Consider the use of long-term care facilities.

-   Consider the use of warehouses/schools, keeping in mind that such
    use may render the facilities permanently contaminated and/or may
    require extensive decontamination.

-   Consider the use of neighborhood-based treatment centers versus
    centralized treatment centers.

-   Consider the integration of Federal assets, such as Veteran
    Administration (VA) and Department of Defense (DoD) medical
    treatment facilities and NDMS/DoD field hospitals into existing
    local plans.

-   Establish procedures to staff, equip and transport personnel and
    victims to/from secondary treatment facility.

-   Establish procedures for the movement of patients not infected with
    smallpox to other locales (e.g., NDMS).

-   Ensure adequate monitoring of the food, air and water within medical
    treatment facilities.

-   Enforce strict infection control procedures.

-   Review and utilize CDC's Decontamination Guidelines. (Guide F: Pages
    1-6)

[**http://www.bt.cdc.gov/Age***n***t/Smallpox/Smallpox.asp**](http://www.bt.cdc.gov/Agent/Smallpox/Smallpox.asp)

[]{#ISOLATION_PATIENTS .anchor}[ISOLATION OF PATIENTS]{.underline}

-   Identify personnel responsible for local/state coordination of
    activities.

-   Identify appropriate facilities to be utilized for isolation and
    care.

-   Identify appropriate law enforcement entities to enforce isolation
    and to control access to facilities.

-   Review and coordinate plan with CDC Isolation Guidelines.

-   CDC Isolation and Quarantine Guidelines (Guide C: Pages 1-23)

[**http://www.bt.cdc.gov/Agent/Smallpox/Smallpox.asp**](http://www.bt.cdc.gov/Agent/Smallpox/Smallpox.asp)

[]{#SECURITY .anchor}[SECURITY]{.underline}

-   Provide security for medical treatment facilities and medical
    personnel (e.g., crowd control, preventing a rush of individuals
    wanting treatment and vaccinations).

-   Provide security for medical supplies.

NOTE C: This may create a new cohort requiring vaccination.

[]{#TRAINING_EXERCISES .anchor}[TRAINING AND EXERCISES]{.underline}

-   Train personnel regarding the clinical aspects of a smallpox
    response.

-   Train healthcare and civilian personnel regarding the principles of
    homecare.

-   Train personnel on proper isolation techniques.

-   Exercise mechanisms to adapt and expand existing facilities.

-   Exercise all components of the local response system.

[]{#PLANNING_MASS_FATALITY .anchor}[PLANNING CONSIDERATIONS FOR MASS
FATALITY MANAGEMENT]{.underline}

-   Plan for vaccinating mortuary personnel and their families.

-   Maximize use of existing facilities.

-   Establish plans for the use of non-traditional facilities to augment
    existing facilities (e.g., cold storage, reefers).

-   Establish plans requesting deployment of NDMS/DoD assets (portable
    morgue facilities and personnel to augment local capability).

-   Establish plans to identify the deceased.

-   Establish plans to augment with NDMS/DoD assets, as necessary.

-   Establish decontamination/isolation procedures available to terminal
    care providers.

-   Establish containment procedures for the deceased, following
    established protocols for double-body bagging/double taping.

-   Exclude embalming procedures.

-   Consider use of vaults for burial purposes, if they are available
    and can handle more than one body. Above ground mausoleums will not
    be used.

-   Establish plans for engaging the religious community.

-   Prepare for appropriate documentation.

[]{#Annex3 .anchor}Attachment 3

Clinic Preparation Checklists

Smallpox Post-Even[]{#checklist_planning_mgmt .anchor}t Clinic
Preparation Checklist

Overall Planning and Management

-   Metro-Central Headquarters Identified

-   Location

-   Staffing for General Operations

-   Staffing for Problem-Solving

-   Memoranda of Understanding (as required)

-   Communications Protocol

-   Central Vaccine Storage Site Identification

-   Central facility with security and backup generator

-   Central Supplies Warehouse

-   Shipping Company Selection

-   Printing Company Selection (for mass form production)

-   All Supply Resources Identified (See Supply and Equipment Checklist)

-   Vaccination Clinic Site Identification (x20)

-   Procedure for Designating Vaccination Site/Time (i.e., zip code?
    SSN?)

-   Procedure for Identification

-   Computer Networking Identified for Exchange of Data

-   Standing Orders for Emergencies

-   Agreement(s) with local media for public service announcement
    coverage/production

Smallpox Post-Ev[]{#checklist_clinic_site .anchor}ent Clinic Preparation
Checklist

Clinic Site Checklist

Clinic Site:       Number       of      

Facility Resources

> Large, open space to accommodate clinic flow
>
> Weather Protection for those in line
>
> Ability to be made secure
>
> Backup generator
>
> Accessible for People with Disabilities
>
> Ease of Access for Community
>
> Communication Resources Available
>
> Equipment Resources Available (See Supply and Equipment Checklist)
>
> Tables Available
>
> Screening Rooms Available
>
> Waste Disposal
>
> Rest Area for Staff
>
> Transportation/Parking for Staff?

Transportation Procedures

> Parking Identified
>
> Bus Service Company Selection
>
> Routes for Bus Service

Vaccination Clinic Personnel Identified (See Personnel Checklist)

> Vaccinators
>
> Physician Evaluators
>
> Support Functions

HIV Testing Referral Plan

Equipment Resources Identified (See Supply and Equipment Checklist)

Smallpox Post-Event Clinic Preparation Checklist

[]{#checklist_supply_equipment .anchor}Supply and Equipment Checklist

Clinic Site:       Number       of      

Equipment Needs

> Copier
>
> FAX Machine
>
> 12 Computers or Laptops
>
> 5 DVD or VCR Players
>
> 5 Large-Screen Televisions
>
> Cell Phones
>
> Handheld Radios

General Supplies

Tables

Chairs

Water and Cups

Paper

Pens, Pencils

Envelopes

Rubber Band

Tape

Stapler/Staples

Paper Clips

Scissors

Post-It Notes

File Boxes

Telephone

Paper Towel

Tissues

Table pads and clean paper

Garbage containers

Trash Bags

ID Badges for Staff

7 Copies of Video

Food and Drink for Staff

List of Emergency Phone #s

Cleaning supplies

Crowd Management and Triage Supplies

Queue Partitions

Signs for Site Designation

Signs for Clinic Flow

Vaccine Administration Supplies

Smallpox Vaxicools/Refrigerator

Vaccine Diluent

Sterilized Bifurcated Needles

Sharps Containers

Latex Gloves

Latex-Free Gloves

Anti-Bacterial hand washing solutions

Acetone

Rectangle Band-Aids

Gauze

Adhesive Tape

Spray Bottle of Bleach Solution

Paper Gowns

Vaccination Screens

Emergency Supplies

Standing Orders for Emergencies

"Code" kit with defibrillator

Ampules of Epinephrine 1:1000 SQ, or

EPI Pen Adult/EPI Pen Child

Ampules of diphenhydramine (50mg IM)

3cc syringes with 1", 25-guage needles

1.5" needles

Tuberculinsyringes with 5/8" needles

Alcohol Wipes

Blood Pressure Cuffs (Various Sizes)

Oxygen Tank

Oxygen Tank Tubing

IV Solution

IV Solution Tubing

Thermometer

Aspirin, Tylenol, Regular insulin, D50

Asthma Inhaler

Tongue Depressors

Emesis basis

Adult pocket masks with one-way valve

Pediatric pocket masks with one-way valve

Adult and pediatric airways

Tourniquet

Gurney

Stethoscope

Flashlight

Cots, Blankets, and Pillows

ER Report Form

Smallpox Post-Event Clinic Preparation Checklist

[]{#checklist_personnel .anchor}Personnel Checklist

Clinic Site:       Number       of      

Forms Distribution

> *AM Shift*
>
> 1\.      
>
> 2\.      
>
> 3\.      
>
> 4\.      
>
> 5\.      
>
> 6\.      
>
> 7\.      
>
> 8\.      
>
> 9\.      
>
> *PM Shift*
>
> 1\.      
>
> 2\.      
>
> 3\.      
>
> 4\.      
>
> 5\.      
>
> 6\.      
>
> 7\.      
>
> 8\.      
>
> 9\.      

Triage for Ill or Contacts

*AM Shift*

1\.      

2\.      

*PM Shift*

1\.      

2\.      

Run Orientation Video

*AM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

8\.      

*PM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

8\.      

Referral Personnel

*AM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

8\.      

9\.      

10\.      

11\.      

12\.      

13\.      

14\.      

15\.      

16\.      

*PM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

8\.      

9\.      

10\.      

11\.      

12\.      

13\.      

14\.      

15\.      

16\.      

Medical Screeners

*AM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

*PM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

Physician Evaluators

*AM Shift*

1\.      

2\.      

*PM Shift*

1\.      

2\.      

Vaccinators

*AM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

8\.      

9\.      

10\.      

11\.      

12\.      

13\.      

14\.      

15\.      

16\.      

*PM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

8\.      

9\.      

10\.      

11\.      

12\.      

13\.      

14\.      

15\.      

16\.      

Vaccine Preparation/Supply

*AM Shift*

1\.      

2\.      

*PM Shift*

1\.      

2\.      

Exit Review

*AM Shift*

1\.      

2\.      

*PM Shift*

1\.      

2\.      

Medical Records/Data Entry

*AM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

8\.      

9\.      

10\.      

*PM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

8\.      

9\.      

10\.      

Clinic Manager

*AM Shift*

1\.      

2\.      

*PM Shift*

1\.      

2\.      

Supply Manager

*AM Shift*

1\.      

2\.      

*PM Shift*

1\.      

2\.      

Clinic Flow/QA Reviewer/Forms Helpers

*AM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

8\.      

*PM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

8\.      

Security

*AM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

8\.      

9\.      

10\.      

11\.      

12\.      

13\.      

14\.      

15\.      

16\.      

17\.      

18\.      

19\.      

20\.      

21\.      

22\.      

23\.      

24\.      

25\.      

26\.      

27\.      

28\.      

29\.      

30\.      

*PM Shift*

1\.      

2\.      

3\.      

4\.      

5\.      

6\.      

7\.      

8\.      

9\.      

10\.      

11\.      

12\.      

13\.      

14\.      

15\.      

16\.      

17\.      

18\.      

19\.      

20\.      

21\.      

22\.      

23\.      

24\.      

25\.      

26\.      

27\.      

28\.      

29\.      

30\.      

Traffic Flow

*AM Shift*

1\.      

2\.      

*PM Shift*

1\.      

2\.      

Translators

*AM Shift*

1\.       Language:      

2\.       Language:      

*PM Shift*

1\.       Language:      

2\.       Language:      

Float Staff

*AM Shift*

1\.      

2\.      

3\.      

*PM Shift*

1\.      

2\.      

3\.      

Contact Evaluation

*AM Shift*

1\.      

2\.      

3\.      

4\.      

*PM Shift*

1\.      

2\.      

3\.      

4\.      

IT Support

*AM Shift*

1\.      

*PM Shift*

1\.