Draft Guide A: Smallpox Surveillance and Case Reporting; Contact
Identification, Tracing, Vaccination, and Surveillance; and
Epidemiologic Investigation

Guide A: Smallpox Surveillance and Case Reporting; Contact
Identification, Tracing, Vaccination, and Surveillance; and
Epidemiologic Investigation

<http://www.bt.cdc.gov/agent/smallpox/response-plan>

Guide A summarizes pre-event surveillance activities, as well as
post-event activities necessary for smallpox surveillance and case
reporting; contact identification, tracing, vaccination, and
surveillance; and epidemiologic investigation at the local, state, and
federal levels. This Guide covers the following topics:

I.  Introduction to Smallpox Pre-Event Surveillance

II. Introduction to Smallpox Post-Event Surveillance and Case Reporting;
    Contact Identification, Tracing, Vaccination, and Surveillance; and
    Epidemiologic Investigation

III. Smallpox Clinical Case Definitions, Case Classifications, and
     Clinical Types

IV. Evaluating the Patient with an Acute, Generalized Vesicular or
    Pustular Rash Illness and Determining the Risk of Smallpox

V.  Pre-Event Enhanced Surveillance Strategies

VI. Activities to Prepare for Smallpox Post-Event Surveillance

VII. Post-Event Smallpox Surveillance and Case Reporting; Contact
     Identification, Tracing, Vaccination, and Surveillance; and
     Epidemiologic Investigation

VIII. Appendices

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I.  Introduction to Smallpox Pre-Event Surveillance

> Surveillance for a disease that does not currently exist anywhere in
> the world presents unique challenges. If smallpox disease were to
> reoccur in the United States or elsewhere, the most likely possible
> sources of reintroduction would be:

-   An unintentional infection in a laboratory (currently there are only
    two WHO- approved smallpox virus research and repository
    laboratories which include the CDC in Atlanta, Georgia and the
    Institute of Virus Preparations in Moscow, Russia although there is
    concern that stocks of smallpox virus may exist in other
    laboratories).

-   A bioterrorist attack involving deliberate infection of a person.

-   A bioterrorist attack involving intentional release of smallpox
    virus into the environment.

> For pre-event surveillance purposes, where the likelihood of smallpox
> occurring is considered to be extremely low, the suggested approach to
> surveillance relies on a highly specific clinical case definition,
> which is focused on identifying a classic case (ordinary type) of
> smallpox. This means that the first case of smallpox is unlikely to be
> recognized in the first few days after rash onset when the
> presentation is nonspecific. In addition, atypical presentations of
> smallpox including hemorrhagic smallpox and flat type (velvety)
> smallpox are also likely to be missed. These limitations are accepted
> and weighed against the extremely low risk of disease and the very
> real risks of false-positive laboratory results.
>
> Because the likelihood of reintroduction of smallpox is extremely low,
> and acknowledging that there are many other causes of vesicular and
> pustular rash illnesses, health care providers evaluating such cases
> should familiarize themselves with diseases that were confused with
> smallpox in the past (e.g. varicella, herpes simplex, drug reactions,
> erythema multiforme), as well as the clinical manifestations of
> smallpox disease. In this way, in the unlikely event of a smallpox
> case, the disease will be clearly and quickly recognized.
>
> The goal of pre-event surveillance is to recognize the first case of
> smallpox, should it ever occur, without generating excessive numbers
> of false alarms, unnecessarily disrupting the health care and public
> health systems, or increasing public anxiety. In the absence of known
> smallpox disease, the predictive value of a positive smallpox
> diagnostic test is extremely low, close to zero; therefore, testing to
> rule out smallpox should be limited to cases that fit the clinical
> case definition in order to lower the risk of obtaining a false
> positive test result. It is neither feasible nor desirable, in the
> pre-event scenario, to perform laboratory testing for suspected cases
> that do not meet the clinical case definition.

II. Introduction to Smallpox Post-Event Surveillance and Case Reporting;
    Contact Identification, Tracing, Vaccination, and Surveillance; and
    Epidemiologic Investigation

    Since smallpox no longer exists as a naturally occurring disease, an
    outbreak of smallpox is defined as a single laboratory confirmed
    case. Activities and actions described here may be altered depending
    upon the size and characteristics of the outbreak. In that event,
    information regarding the new procedures or actions will be
    communicated to health department personnel by the state
    epidemiologist, other state health office personnel, or federal
    health authorities.

A single, laboratory confirmed case will initiate implementation of the
CDC and state smallpox response plans. Other criteria for implementation
of the response plan include:

-   A large outbreak of a clinically compatible illness pending
    etiologic confirmation;

-   Reports of suspected or probable cases once an outbreak has been
    identified elsewhere in the country; and

-   Confirmation of smallpox virus in an environmental sample, package,
    or device associated with human exposure.

Surveillance, outbreak investigation and control activities including
contact identification, tracing, vaccination and surveillance will need
to be prioritized once smallpox is confirmed in a local jurisdiction.
Following the confirmation of a smallpox case, especially if it is the
first case confirmed in the United States, an epidemiological
investigation will need to occur in collaboration with law enforcement
and state and federal authorities. If a smallpox case is confirmed
anywhere in the United States or in the world, enhanced surveillance for
smallpox should be initiated and decisions on vaccination will be made
in collaboration with state and federal authorities.

> Although the specific mechanisms and logistics may differ among
> jurisdictional areas, the post-event activities will include:

-   Surveillance and case reporting;

-   Contact identification, tracing, vaccination, and surveillance; and

-   Epidemiologic investigation - investigation for source of infection
    (conducted for initial cases in a geographic area only).

> Forms have been designed to assist with the data collection needs for
> each of these activities.

III. **Smallpox Clinical Case Definition, Case Classifications and
     Clinical Types**

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A.  **Introduction**

Surveillance for a disease that does not currently exist anywhere in the
world presents unique challenges. The goal of pre-outbreak (pre-event)
smallpox surveillance is to recognize the first case of smallpox, should
it ever occur, without generating excessive numbers of false alarms,
unnecessarily disrupting the health care and public health systems, or
increasing public anxiety. In the absence of known smallpox disease, the
predictive value of a positive smallpox diagnostic test is extremely
low; therefore, testing to rule out smallpox should be limited to cases
that fit the clinical case definition in order to lower the risk of
obtaining a false-positive test result. It is neither feasible nor
desirable, in the pre-event scenario, to perform laboratory testing for
suspected cases that do not meet the clinical case definition.

Thus, in the absence of smallpox disease in the world, the suggested
approach to surveillance relies on a highly specific clinical case
definition, which is focused on identifying the classic case
presentation (ordinary type) of smallpox. Before eradication, classic
(ordinary type) smallpox generally accounted for approximately 90% of
smallpox cases in previously unvaccinated individuals and 70% of cases
that occurred in previously vaccinated individuals who were no longer
fully protected by vaccination.

Because the likelihood of reintroduction of smallpox is extremely low,
and acknowledging that there are many other causes of vesicular and
pustular rash illnesses, healthcare providers evaluating such cases
should also familiarize themselves with diseases that can be confused
with smallpox (e.g., varicella, herpes simplex, drug reactions, erythema
multiforme), as well as the clinical manifestations of smallpox disease.
In this way, in the unlikely event of a smallpox case, the disease will
be clearly and quickly recognized.

Several resources to assist a clinician in the evaluation of a febrile,
rash-illness patient for the likelihood of smallpox can be found on the
"Smallpox Diagnosis and Evaluation" page
([www.bt.cdc.gov/agent/smallpox/diagnosis](http://www.bt.cdc.gov/agent/smallpox/diagnosis)).

These resources include:

1.  The algorithm "Evaluating Patients for Smallpox," presented in
    poster format that provides a standard method for evaluating
    patients with acute, severe vesicular or pustular rash illness. The
    purpose of the protocol is to provide a systematic approach for
    evaluating patients with generalized rash illnesses and to direct an
    appropriate clinical and public health response, including
    diagnostic testing:
    [www.bt.cdc.gov/agent/smallpox/diagnosis/evalposter.asp](http://www.bt.cdc.gov/agent/smallpox/diagnosis/evalposter.asp).

2.  An online interactive risk evaluation algorithm (based on the poster
    algorithm above) that can be filled in to quickly determine the
    likelihood of clinical smallpox:
    [www.bt.cdc.gov/agent/smallpox/diagnosis/riskalgorithm](http://www.bt.cdc.gov/agent/smallpox/diagnosis/riskalgorithm).

3.  A downloadable standard worksheet that can be used to collect the
    clinical information to classify the risk of smallpox using the CDC
    criteria outlined in the poster (\"Evaluating Patients for
    Smallpox\"):
    [www.bt.cdc.gov/agent/smallpox/diagnosis/pdf/spox-patient-eval-wksheet.pdf](http://www.bt.cdc.gov/agent/smallpox/diagnosis/pdf/spox-patient-eval-wksheet.pdf).

  -----------------------------------------------------------------------
  **ANY SUSPECTED SMALLPOX CASE SHOULD BE IMMEDIATELY REPORTED TO LOCAL
  PUBLIC HEALTH OFFICIALS.**

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

B.  **Case definition**

    1.  **Smallpox clinical case definition**

> An illness with acute onset of fever [\>]{.underline}101°F (38.3°C)
> followed by a rash characterized by firm, deep seated vesicles or
> pustules in the same stage of development without other apparent
> cause.

2.  **Laboratory criteria for confirmation\***

-   Polymerase chain reaction (PCR) identification of variola DNA in a
    clinical specimen, **OR**

-   Isolation of smallpox (variola) virus from a clinical specimen (WHO
    Smallpox Reference laboratory or laboratory with appropriate
    reference capabilities) **with** variola PCR confirmation.

> \*Laboratory diagnostic testing for variola virus should be conducted
> in a CDC Laboratory Response Network (LRN) laboratory utilizing
> LRN-approved PCR tests and protocols for variola virus. Initial
> confirmation of a smallpox outbreak requires additional testing at
> CDC.
>
> *Note: Generic orthopox PCR and negative stain electron microscopy
> (EM) identification of a pox virus in a clinical specimen are
> suggestive of an **orthopox** virus infection but not diagnostic for
> smallpox.*
>
> The importance of case confirmation using laboratory diagnostic tests
> differs depending on the epidemiological situation. Because of the low
> predictive value of a positive lab test result in the absence of a
> known smallpox outbreak, in the pre-outbreak (pre-event) setting,
> laboratory testing should be reserved for cases that meet the clinical
> case definition and are thus classified as being a potential high risk
> for smallpox according to the rash algorithm poster
> ([www.bt.cdc.gov/agent/smallpox/diagnosis/evalposter.asp](http://www.bt.cdc.gov/agent/smallpox/diagnosis/evalposter.asp)).

C.  **Case classification**

> Since smallpox no longer exists as a naturally occurring disease, a
> single laboratory confirmed case of smallpox would be considered an
> outbreak. Once an outbreak of smallpox has been confirmed, the
> following case classifications should be used:
>
> ***Confirmed case:*** A case of smallpox that is laboratory confirmed,
> or a case that meets the clinical case definition that is
> epidemiologically linked to a laboratory confirmed case.
>
> ***Probable case:*** A case that meets the clinical case definition,
> or a case that does not meet the clinical case definition but is
> clinically consistent with smallpox and has an epidemiological link to
> a confirmed case of smallpox. Examples of clinical presentations of
> smallpox that would not meet the ordinary type (pre-event) clinical
> case definition are: a) hemorrhagic type, b) flat type, and c) variola
> sine eruptione.
>
> ***Suspect case:*** A case with a febrile rash illness with fever
> preceding development of rash by 1-4 days.

D.  **Clinical types of variola major**

> As described by Fenner in his classic textbook "Smallpox and its
> Eradication"
> ([www.who.int/emc/diseases/smallpox/smallpoxeradication.html](http://www.who.int/emc/diseases/smallpox/smallpoxeradication.html)),
> it has long been recognized that several clinical types of variola
> major could be distinguished which differed in prognosis, differential
> diagnosis and transmissibility. In 1968, WHO adopted a classification
> of clinical types based on the type and progression of the rash. This
> classification was shown by Dixon (1962) and Rao (1967) to have
> greater prognostic value than a previous classification based on
> density of focal eruption. In 1972, a WHO Expert Committee reaffirmed
> its acceptance of this classification, used in this Guide. The
> relative frequency and case fatality rate of these clinical types is
> summarized in Table 1.
>
> ***Ordinary type (classic):*** Raised pustular lesions; three
> subtypes:
>
> *Confluent*---confluent rash on face and forearms
>
> *Semi-confluent*---confluent rash on face, discrete elsewhere
>
> *Discrete*---areas of normal skin between pustules, even on face
>
> ***Modified type:*** Like ordinary type but less severe, with an
> accelerated course. (Experience from the smallpox eradication era was
> that the most common reason for an accelerated course in variola major
> was vaccination was vaccination some years earlier \[Fenner\].)
>
> ***Variola sine eruptione:*** Fever w/o rash caused by variola virus;
> serological confirmation required. This presentation was rarely
> observed historically and is thought to have had limited
> epidemiological significance.
>
> ***Flat type\*:*** Pustules remain flat; usually confluent or
> semi-confluent
>
> ***Hemorrhagic type\*:*** Widespread hemorrhages in skin and mucous
> membranes. Two subtypes:
>
> *Early:* with purpuric rash
>
> *Late:* with hemorrhages into base of pustule

\*Both flat type and hemorrhagic smallpox were rare and probably due to
host immunity factors; transmission from such cases did not result in a
similar clinical type indicating that viral virulence was an unlikely
explanation. Hemorrhagic smallpox occurred more commonly among pregnant
women

Table 1: Frequency and case-fatality rates of different clinical types
of variola major, by vaccination status (presence of scar), hospitalized
patients in Madras, India (Rao, 1972)

  ---------------- -------------- --------------- ------------ ---------------
  Clinical Type    Unvaccinated                   Vaccinated   
                   Cases (N=3544)                 Cases        
                                                  (N=3398)     

                   \% of Total    Case-fatality   \% of Total  Case-fatality
                                  rate                         rate

  Ordinary type:   88.8           30.2            70.0         3.2

  Confluent        22.8           62.0            4.6          26.3

  Semi-confluent   23.9           37.0            7.0          8.4

  Discrete         42.1           9.3             58.4         0.7

  Modified type    2.1            0               25.3         0

  Flat type        6.7            96.5            1.3          66.7

  Hemorrhagic type 2.4            96.4            3.4          93.9

  Early            0.7            100.0           1.4          100.0

  Late             1.7            96.8            2.0          89.8

  Total            \-             35.5            \-           6.3
  ---------------- -------------- --------------- ------------ ---------------

IV. Evaluating the Patient with an Acute, Generalized Vesicular or
    Pustular Rash Illness and Determining the Risk of Smallpox

> With ongoing concerns over the use of smallpox virus as a bioterrorist
> agent, health care providers in the United States, the majority of who
> have never seen a smallpox case, need to learn about smallpox disease
> and its clinical presentations. In order to facilitate rapid diagnosis
> of smallpox, should a case occur in the United States, CDC, together
> with a variety of partners, developed an algorithm to assist in
> evaluating patients with febrile vesicular or pustular rash illness.
> This work was a collaborative effort with the American Academy of
> Pediatrics, the American Academy of Dermatology, the Infectious
> Diseases Society of America, the Pediatric Infectious Disease Society,
> the Association of State and Territorial Health officers, the American
> College of Emergency Physicians, the Council of State and Territorial
> Epidemiologists, the Hospital Infection Control Practices Advisory
> Committee, and smallpox and infectious disease experts**.**
>
> Clinicians who evaluate patients with unusual or severe presentations
> of vesicular or pustular rash illnesses need to be able to determine
> quickly if their patient may have smallpox. The main disease likely to
> be confused with smallpox is varicella. With implementation of the
> varicella vaccination program, varicella cases are estimated to have
> declined approximately 75% throughout the country; however, declines
> in disease will vary according to vaccine coverage within each state.
> Even with 1 million cases still occurring in 2003, if 1/1000 varicella
> cases are misdiagnosed or present atypically, we can expect 1,000
> smallpox false alarms per year. There are millions of cases of other
> vesicular rash illnesses in the United States including enteroviral
> infections, herpes simplex infections and non-infectious conditions
> such as erythema multiforme and contact dermatitis (Table 1).
> Implementation of large scale smallpox vaccination among public health
> responders, health care workers, and first responders, is likely to
> result in increased concern about acute rashes in general, with
> specific concerns about rashes due to vaccinia, which historically
> have been confused with smallpox in some settings.

Table2: Common Conditions that might be confused with smallpox and
clinical clues for differentiation

  ------------------------ ----------------------------------------------
  **Condition**            **Clinical Clues**

  Varicella (primary       Most common in children \<10 years; children
  infections with          usually do not have a viral prodrome
  varicella-zoster virus)  

  Disseminated herpes      Immunocompromised or elderly persons; rash
  zoster                   looks like varicella, usually begins in
                           dermatomal distribution

  Impetigo (*Streptococcus Honey-colored crusted plaques with bullae are
  pyogenes, Staphylococcus classic but may begin as vesicles; regional
  aureus*)                 not disseminated rash; patients generally not
                           ill

  Drug eruptions           Exposure to medications; rash often
                           generalized

  Contact dermatitis       Itching; contact with possible allergens; rash
                           often localized in pattern suggesting external
                           contact

  Erythema multiforme      Target, "bull's eye" or iris lesions; often
  minor                    follows recurrent herpes simplex virus
                           infections; may involve hands and feet
                           (including palms and soles)

  Erythema multiforme      Major form involves mucous membranes and
  major (Stevens-Johnson   conjunctivae; there may be target lesions or
  syndrome)                vesicles

  Enteroviruses infection  Summer and fall; fever and mild pharyngitis
  esp. Hand, Foot and      1-2 days before rash onset; lesions initially
  Mouth disease            maculopapular but evolve into whitish-grey,
                           tender, flat often oval vesicles; peripheral
                           distribution (hands, feet, mouth or
                           disseminated)

  Disseminated herpes      Lesions indistinguishable from varicella;
  simplex                  immunocompromised host

  Scabies; insect bites    Itching is a major symptom; patient is not
  (incl. fleas)            febrile and is otherwise well

  Molluscum contagiosum    May disseminate in immunosuppressed persons
  ------------------------ ----------------------------------------------

A.  Patient Evaluation Algorithm and Poster

    The algorithm, "Evaluating Patients for Smallpox: Acute, Generalized
    Vesicular or Pustular Rash Illness Protocol," is presented as a
    poster [**(Appendix
    1)**](http://www.bt.cdc.gov/agent/smallpox/diagnosis/evalposter.asp),
    and provides a standard method for evaluating patients with acute,
    severe vesicular or pustular rash illness, giving clinical clues for
    differentiating smallpox from varicella and other rash illnesses
    likely to be confused with smallpox. This section of Guide A
    describes the algorithm and the related worksheet [**(Appendix
    3)**](http://www.bt.cdc.gov/agent/smallpox/diagnosis/pdf/spox-patient-eval-wksheet.pdf).
    These documents are also available on the CDC website at
    [**http://www.bt.cdc.gov/agent/smallpox/diagnosis/index.asp**](http://www.bt.cdc.gov/agent/smallpox/diagnosis/index.asp)

> Many rash illnesses can present with vesicles and pustules. The
> purpose of the protocol is to provide a systematic approach for
> evaluating patients with generalized rash illnesses and to direct an
> appropriate clinical and public health response.

B.  Contact and Airborne Precautions

> If a patient presents to an emergency department, clinic, or doctor's
> office with an acute generalized vesicular or pustular rash illness,
> care should be taken to decrease the risk of disease transmission.
> Patients should not be left in common waiting areas. The patient
> should be assessed to determine whether there is a high, medium, or
> low risk of smallpox, using the algorithm and the major and minor
> criteria.

1.  If in a doctor's office or clinic, the patient should be placed
    immediately in a private room with the door kept closed.

2.  When admitted or while being held for observation, the facility
    should institute appropriate airborne and contact precautions and
    alert the infection control department. The patient should be placed
    in a private, negative airflow room (airborne infection isolation).
    The door should be kept closed at all times, except when staff or
    the patient must enter or exit.

3.  Staff and visitors should wear properly fitted respirators (N95),
    gloves, and gowns.

4.  The patient should wear a surgical mask whenever he/she must be
    outside of their negative pressure isolation room and must be gowned
    or wrapped in a sheet so that the rash is fully covered.

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C.  History and Physical Examination

> Ask detailed questions about:

-   Any symptoms preceding rash onset, including prodromal symptoms and
    clinical features in the 1-4 days before rash onset,

-   Contact with any ill individuals (especially those with a rash
    illness),

-   Recent travel history,

-   Medical history including medications,

-   History of prior varicella or herpes zoster, and

-   History of varicella vaccination (vaccine available since 1995).

> In adults, take a history of past (routine childhood vaccinations
> stopped in the United States in 1972; health care workers and
> travelers continued to be vaccinated until the late 1970s and military
> personnel were vaccinated until 1990) and recent smallpox vaccinations
> and look for a smallpox vaccine scar.
>
> These questions can be found in the accompanying "Worksheet:
> Evaluating Patients for Smallpox." [(Appendix
> 3)](http://www.bt.cdc.gov/agent/smallpox/diagnosis/pdf/spox-patient-eval-wksheet.pdf)
>
> This information will be helpful in evaluating the patient,
> determining which illnesses are in the differential diagnosis, and
> finally, if smallpox is a consideration, will be used to classify a
> case into low, moderate or high risk categories for smallpox.

D.  Risk Categories for Evaluating Patients for Smallpox (Suspect
    Smallpox Cases)

> High Risk: Meets all three major smallpox criteria\*
>
> Moderate Risk: Febrile prodrome AND 1 other major smallpox criterion
>
> OR
>
> Febrile prodrome AND \>= 4 minor smallpox criteria
>
> Low Risk: No febrile prodrome OR febrile prodrome
>
> AND
>
> \<4 minor smallpox criteria
>
> \* Note: meets the smallpox clinical definition and would therefore be
> classified as a probable smallpox case, pending laboratory test
> results.

E.  Criteria for Determining Risk of Smallpox

> Major Diagnostic Criteria for Smallpox:

1.  Febrile prodrome: occurring 1-4 days before rash onset: fever ≥101ºF
    (38.3ºC) *and* at least one of the following: prostration, headache,
    backache, chills, vomiting or severe abdominal pain

2.  Classic smallpox lesions: deep-seated, firm/hard, round,
    well-circumscribed vesicles or pustules; as they evolve, lesions may
    become umbilicated or confluent

3.  Lesions in the same stage of development: on any ONE part of the
    body (e.g., the face, arms) all the lesions are all in the same
    stage of development (i.e., all are vesicles or all are pustules)

> Minor Diagnostic Criteria for Smallpox:

1.  Centrifugal distribution: greatest concentration of lesions on face
    and distal extremities

2.  First lesions on the oral mucosa/palate, face, or forearms

3.  Severity: Patient appears toxic or moribund

4.  Slow rash evolution: lesions evolved from macules to papules to
    pustules over days (each stage lasts 1-2 days)

5.  Lesions on the palms and/or soles

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F.  Guidance for Clinical and Public Health Management

> High risk: If high risk after assessment with *Evaluating Patients for
> Smallpox* tool, obtain Infectious Disease and/or Dermatology
> consultation (these specialty medical providers are experienced in
> assessing rashes), and if still high risk:

1.  Classify as a probable smallpox case and treat as a medical and
    public health emergency.

2.  Report the case immediately to state/local health department.

3.  State health department will evaluate the case; if state health
    department determines the case to be high risk for smallpox, the
    state will contact CDC at 770-488-7100 for assistance including
    specimen collection and testing.

4.  Take digital photos for consultation with experts.

5.  Treat patient as clinically indicated. Do not delay treatment for
    other likely conditions in the differential diagnosis while awaiting
    response team.

6.  ***Do* *not*** *proceed with laboratory testing for other diagnoses
    until smallpox has been ruled out*.

> Moderate Risk: If moderate risk after assessment, obtain infectious
> diseases and/or dermatology consultation urgently (if available);
> proceed with laboratory testing for confirmation or exclusion of
> varicella or other diagnoses in the differential diagnosis. Initiate
> treatment for likely etiology as clinically indicated. Preferred tests
> for rapid identification of varicella-zoster virus are discussed
> below.
>
> Low Risk: If low risk after assessment, test for varicella if
> diagnosis is uncertain and manage as clinically indicated.

G.  Laboratory and Pathology Testing of Specimens for Varicella-Zoster
    Virus (VZV)

> It is important to collect \>3 good specimens from each patient for
> routine and confirmatory testing. No test can distinguish between
> chickenpox (varicella) and disseminated shingles (disseminated herpes
> zoster) since the same virus causes both conditions. Herpes zoster is
> a reactivation of the virus that persists in a dormant state in the
> body from the time of initial infection with chickenpox. The two
> conditions are distinguished on the basis of prior evidence of
> immunity or previous disease and careful history of an initial locally
> (dermatomal) distributed rash before dissemination.
>
> Preferred tests for rapid diagnosis of varicella-zoster virus include:

1.  Direct fluorescence antibody (DFA)---rapid method for detecting VZV
    directly in cells using anti-VZV antibody conjugated to fluorescein
    dye. This technique is very sensitive and specific, but is
    critically dependent on careful specimen collection. Avoid
    contamination of the specimen with blood, since VZV antibodies
    introduced from the blood can result in false negatives. Do not draw
    fluid from a vesicle using a syringe since cellular material is
    needed for testing. DFA testing is available in many private
    laboratories and in academic medical (tertiary care) centers.

2.  Polymerase chain reaction (PCR) is one of the most sensitive and
    specific methods available; it requires 4-6 hours using real time
    PCR. PCR is not widely available, though some private laboratories
    and tertiary care hospitals have this capability, in addition to
    public health laboratories. Specimens may include skin lesions,
    crust, oropharyngeal secretions, blood, or CSF.

3.  While not specific for VZV, the Tzanck smear is widely available,
    and can be performed in a hospital pathology laboratory. A positive
    smear confirms an alpha herpes virus infection (VZV or HSV).

> Note: Training state health laboratories on rapid diagnostic VZV has
> been provided through the laboratory response network. By the end of
> 2002, all states have the capacity to perform at least one rapid
> diagnostic VZV laboratory test.

V.  Pre-Event Enhanced Surveillance Strategies

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A.  Both smallpox and varicella should be made reportable in each
    jurisdiction to facilitate timely and appropriate public health
    response to a reported case.

B.  Smallpox surveillance should be integrated with varicella
    surveillance. Efficiency is likely to be gained by integration with
    varicella surveillance programs, since varicella is the most common
    illness that will be confused with smallpox. Varicella deaths have
    been reportable since 1999. Since varicella will become a nationally
    notifiable disease in 2003, states and localities should be in the
    process of developing or enhancing disease-specific surveillance.
    Understanding varicella epidemiology in your state or local area and
    understanding how varicella disease presents, especially among
    adults, will be useful in responding to calls of cases of acute
    vesicular or pustular rash illness.

> State enhancements to varicella surveillance that will assist in
> enhancing smallpox surveillance may include:

-   Reporting all varicella hospitalizations,

-   Reporting varicella cases among adults within 12 hours of rash
    onset,

-   Laboratory confirmation of varicella cases resulting in
    hospitalization or death.

C.  State and local health departments are encouraged to undertake
    enhanced surveillance for febrile rash illness. Additional
    strategies to consider include coordination with other existing
    surveillance systems such as measles and rubella surveillance and/or
    fever-rash illness surveillance established as syndromic
    surveillance under the bioterrorism cooperative agreement.

D.  Establishing and/or enhancing rapid laboratory diagnostic testing
    for confirmation of varicella zoster virus (VZV) infections is
    important for evaluation of varicella cases that raise suspicion for
    smallpox. Additional laboratory and pathology diagnostic services
    (e.g., as indicated for a case evaluated as medium or low risk) may
    assist in diagnosis of other diseases that may be confused with
    smallpox.

E.  Personnel Preparedness

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1.  Identify clinical personnel to assist with evaluation of cases that
    are reported to the health department (e.g., infectious disease,
    dermatology).

2.  Identify state/local staff for conducting surveillance activities.

3.  Familiarize key public health and clinical personnel with the
    algorithm and protocol for evaluating patients with febrile
    vesicular-pustular rash illness.

4.  Familiarize key public health personnel with smallpox response plan
    and guidelines, both federal as well as any existing state/local
    plans.

5.  Establish liaison with state and/or local law enforcement and
    emergency management officials.

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F.  Training and Education in High Priority Content Areas for Public
    Health Staff

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1.  Surveillance for febrile vesicular or pustular rash illness.

2.  Smallpox diagnosis and indications for laboratory testing including
    understanding of the predictive value of a positive test (and the
    widespread ramifications of a false positive test).

3.  Case investigation/interview methods and skills.

4.  Isolation and infection control guidelines.

5.  Laboratory specimen collection methods.

6.  CDC Rash Illness Evaluation module, available at
    **(**<http://www.cdc.gov/nip/ed/smallpox-trg/clinician-should-know/default.htm>)

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G.  Training and Education in High Priority Content Areas for Health
    Care Providers

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1.  Evaluation of febrile vesicular-pustular rash illness.

2.  Smallpox diagnosis and indicators for lab testing including
    understanding of the predictive value of a positive test (and the
    widespread ramifications of a false positive test).

3.  Procedures for reporting suspect cases to state/local public health
    authorities.

4.  Isolation and infection control guidelines.

5.  Laboratory specimen collection methods.

6.  CDC Rash Illness Evaluation module, available at
    (<http://www.cdc.gov/nip/ed/smallpox-trg/clinician-should-know/default.htm>)

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H.  Case Reporting

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1.  Promulgation of clinical case definitions and case classifications
    for smallpox and varicella, establishing capability to do rapid
    diagnostic tests for varicella zoster virus infections (both
    varicella and disseminated herpes zoster), developing information
    management systems to monitor calls/reports received, building
    capability for enhanced rash illness surveillance, and designating
    case reporting mechanisms.

2.  Designate centralized location for reporting suspect smallpox cases
    with 24/7 capability.

3.  Identify and test after hours/emergency notification systems; ensure
    that on-call staff has appropriate access to communication resources
    (cell phones, pagers, laptops, etc.).

4.  Pre-event case investigation forms.

5.  Data management procedures.

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I.  Enhance laboratory capacity

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1.  Rapid diagnostic testing for varicella include:

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a.  DFA,

b.  PCR, and

c.  Tzanck smear (indicates alpha herpes virus infection).

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2.  Laboratory capacity for obtaining specimens, handling and shipping
    to CDC or surge laboratory capacity.

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VI. Activities to Prepare for Smallpox Post-event Surveillance

Prior to the identification of a case of smallpox:

1.  The number and kinds of personnel necessary for an adequate response
    to confirmed smallpox case and/or an outbreak should be estimated,

2.  Staff and volunteers should be trained,

3.  Equipment and logistic needs estimated,

4.  Facilities should be identified and equipped, and

5.  Table top or simulation exercises should be performed.

Staff and volunteers should include:

1.  Epidemiologists,

2.  Case interviewers,

3.  Contact tracers,

4.  Supervisors,

5.  Public health advisors,

6.  IT personnel,

7.  Data enterers,

8.  Data analysts,

9.  Administrative personnel,

10. Telephone interviewers,

11. Communications personnel,

12. Security personnel, and

13. Transport staff.

A committee or team may be formed with oversight in the areas of
surveillance and epidemiology, contact related activities
(identification, tracing, vaccination, and surveillance), and data
management. Requirements for equipment and logistics include:

1.  Adequate space,

2.  Office equipment and supplies,

3.  Computer support,

4.  Transport, and

5.  Safety.

Required communications equipment includes:

1.  Telephone lines,

2.  Telephone banks,

3.  Cell phones,

4.  Pagers,

5.  Computers, and

6.  Printers.

Preparatory activities for post-event surveillance include:

1.  Identifying state/local personnel resources available for
    information management with links to laboratories and vaccination
    sites.

2.  Identifying state/local resources (team or committee) for
    coordinating surveillance activities, contact tracing related
    activities, and epidemiological investigation in a smallpox
    emergency.

3.  Establishing redundant mechanisms for information
    collection/reporting from reporting sources.

4.  Establishing points of contact with potential reporting sources and
    redundant means for communicating information to these sources in an
    emergency.

5.  Developing forms for smallpox surveillance, contact identification,
    tracing, vaccination and surveillance, and source of exposure for
    use in a smallpox emergency.

6.  Establishing methods for reporting, retrieving laboratory results,
    confirming diagnoses for probable and suspected cases, and
    follow-up.

7.  Identifying state/local lead for coordinating interviews of
    confirmed, probable, and suspected cases to determine travel history
    and contact lists.

8.  Identifying local/state resources available for conducting
    interviews of confirmed, probable, and suspected cases.

9.  Identifying local/state resources available for contact tracing.

10. Identifying local/state resources available for telephone monitoring
    of identified contacts.

11. Designating local/state personnel responsible for activities
    involving initial epidemiologic investigation, determining initial
    source of outbreak, identifying the population at risk, and
    describing the epidemiological features of the outbreak.

12. Determining other non-personnel resource needs for conducting
    surveillance, contact tracing, epi investigation (e.g., computers,
    database and analytical software, telephone/fax surge capacity, city
    telephone/residence listings, city maps, etc.).

13. Identifying needed vaccination resources (see Guide B---Vaccination
    Guidelines for State and Local Health Agencies).

14. Identifying procedures to use during a smallpox outbreak (e.g., at
    least daily meetings or conference calls) to ensure appropriate
    communication with other programs (communications, vaccination,
    isolation and quarantine, etc.).

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VII. Post-Event Surveillance and Case Reporting; Contact Identification,
     Tracing, Vaccination, and Surveillance; and Epidemiologic
     Investigation

> Although the specific mechanisms and logistics may differ among
> jurisdictional areas, the post-event activities will include:

-   Surveillance and case reporting.

-   Contact identification, tracing, vaccination, and surveillance.

-   Epidemiologic investigation - investigation for source of infection
    (conducted for initial cases in a geographic area only).

The level of investigation and reporting of smallpox cases will depend
on the extent of the outbreak and the resources available to conduct
these activities. In a limited outbreak, all information on the
surveillance form should be obtained, whenever possible. In a larger
outbreak, the state epidemiologist may decide, based on available
resources, to limit data collection to selected variables. In very large
outbreaks, surveillance and case reporting may be limited to aggregate
reporting of cases and deaths by age group.

Forms are available to assist in these investigations, and are
summarized in [Appendix
4](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a-forms-overview.pdf)
of this Guide. The forms are grouped into three categories:

-   Surveillance and case reporting (Form 1),

-   Contact identification, tracing, vaccination, and surveillance (Form
    2 A-F), and

-   Epidemiologic investigation (Form 3 A -- C).

These forms, with instructions for use and completion**,** are found in
Appendices 4-14 for Guide A (Table 3). Interviewers must be trained to
use appropriate interviewing methods and techniques; individual form
completion is strongly recommended. A computer system for data entry and
analysis will be available from the federal health authorities.

A.  **Post-Event Smallpox Surveillance Strategies**

    *The State Health Officer should designate a single person from the
    state and/or local health department to help coordinate overall
    smallpox case surveillance and reporting activities for the state or
    local public health jurisdiction. This person should estimate the
    number and kind of personnel necessary for performing these
    functions and request the needed assistance from the State Health
    Officer, who may then request federal assistance as needed. The
    state or local designee for surveillance coordination should work
    closely with state and Federal health authorities on all aspects of
    smallpox surveillance and case reporting; contact identification,
    tracing, vaccination, and surveillance; and the epidemiologic
    investigation.*

> A written state smallpox response plan that includes a plan or guide
> for pre-event and post-event smallpox surveillance and response should
> be prepared. Once the Smallpox Response Plan has been implemented, the
> state, regional, and local public health authorities with jurisdiction
> in the area where the case or cases were identified should initiate
> immediate active and enhanced passive surveillance for additional
> suspected and confirmed cases. Specific mechanisms and logistics for
> surveillance may differ between jurisdictional areas. However, the
> general guidelines outlined in this section should be followed.

The following surveillance activities are outlined for use in an
outbreak of smallpox. Since smallpox no longer exists as a naturally
occurring disease, an outbreak of smallpox is defined as a single
laboratory confirmed case. Activities and actions described within this
section may be altered depending upon the size and characteristics of
the outbreak. If this occurs, information regarding the new procedures
or actions will be communicated to health department personnel by the
state health officer, other state health office personnel, or federal
health authorities.

Table 3. List of Appendices for Guide A

# 

+-----------------------+--------------------------------------+-------+
| Form Number and Name  | Purpose                              | App   |
|                       |                                      | endix |
|                       |                                      | N     |
|                       |                                      | umber |
+-----------------------+--------------------------------------+-------+
| [Forms Overview for   | # Summarize th                       | 4     |
| Smallpox Response     | e purpose of the forms designed for  |       |
| Plan Guide            |                                      |       |
| A](                   | smallpox surveillance and case       |       |
| http://www.bt.cdc.gov | reporting; contact identification,   |       |
| /agent/smallpox/respo | tracing, vaccination, and            |       |
| nse-plan/files/guide- | surveillance; and epidemiologic      |       |
| a-forms-overview.pdf) | investigation                        |       |
+-----------------------+--------------------------------------+-------+
| [Form 1: Post-Event   | # Smal                               | 5     |
| Survei                | lpox surveillance and case reporting |       |
| llance](http://www.bt |                                      |       |
| .cdc.gov/agent/smallp |                                      |       |
| ox/response-plan/file |                                      |       |
| s/guide-a-form-1.pdf) |                                      |       |
+-----------------------+--------------------------------------+-------+
| [Form 2a: Case        | Records case's activities during     | 6     |
| Travel/Activity       | infectious period for contact        |       |
| W                     | identification                       |       |
| orksheet---Infectious |                                      |       |
| Pe                    |                                      |       |
| riod](http://www.bt.c |                                      |       |
| dc.gov/agent/smallpox |                                      |       |
| /response-plan/files/ |                                      |       |
| guide-a-form-2-a.pdf) |                                      |       |
+-----------------------+--------------------------------------+-------+
| [Form 2b: Primary     | Contact identification &             | 7     |
| Contact/Site          | prioritization and site              |       |
| Works                 | identification                       |       |
| heet](http://www.bt.c |                                      |       |
| dc.gov/agent/smallpox |                                      |       |
| /response-plan/files/ |                                      |       |
| guide-a-form-2-b.pdf) |                                      |       |
+-----------------------+--------------------------------------+-------+
| [Form 2c: Contact     | Contact and site identification      | 8     |
| Transportation        |                                      |       |
| W                     |                                      |       |
| orksheet---Infectious |                                      |       |
| Pe                    |                                      |       |
| riod](http://www.bt.c |                                      |       |
| dc.gov/agent/smallpox |                                      |       |
| /response-plan/files/ |                                      |       |
| guide-a-form-2-c.pdf) |                                      |       |
+-----------------------+--------------------------------------+-------+
| [Form 2d: Contact     | Contact identification, referral for | 9     |
| Tra                   | vaccination and evaluation           |       |
| cing](http://www.bt.c |                                      |       |
| dc.gov/agent/smallpox |                                      |       |
| /response-plan/files/ |                                      |       |
| guide-a-form-2-d.pdf) |                                      |       |
+-----------------------+--------------------------------------+-------+
| [Form 2e: Case        | Contact surveillance for vaccine     | 10    |
| Household and Primary | take, as well as fever and symptoms  |       |
| Contact               |                                      |       |
| Surveill              |                                      |       |
| ance](http://www.bt.c |                                      |       |
| dc.gov/agent/smallpox |                                      |       |
| /response-plan/files/ |                                      |       |
| guide-a-form-2-e.pdf) |                                      |       |
+-----------------------+--------------------------------------+-------+
| [Form 2f: Case        | Contact surveillance for vaccine     | 11    |
| Primary Contact\'s    | take, as well as fever and symptoms  |       |
| Household Members     |                                      |       |
| Surveill              |                                      |       |
| ance](http://www.bt.c |                                      |       |
| dc.gov/agent/smallpox |                                      |       |
| /response-plan/files/ |                                      |       |
| guide-a-form-2-f.pdf) |                                      |       |
+-----------------------+--------------------------------------+-------+
| [Form 3a: Case        | Identify exposure source             | 12    |
| Exposure              |                                      |       |
| Investiga             |                                      |       |
| tion](http://www.bt.c |                                      |       |
| dc.gov/agent/smallpox |                                      |       |
| /response-plan/files/ |                                      |       |
| guide-a-form-3-a.pdf) |                                      |       |
+-----------------------+--------------------------------------+-------+
| [Form 3b: Case        | Identify exposure source (exposure   | 13    |
| Travel/Activity       | period)                              |       |
| Worksheet---Exposure  |                                      |       |
| Pe                    |                                      |       |
| riod](http://www.bt.c |                                      |       |
| dc.gov/agent/smallpox |                                      |       |
| /response-plan/files/ |                                      |       |
| guide-a-form-3-b.pdf) |                                      |       |
+-----------------------+--------------------------------------+-------+
| [Form 3c Case         | Identify exposure source (exposure   | 14    |
| Transportation        | period)                              |       |
| Worksheet---Exposure  |                                      |       |
| Pe                    |                                      |       |
| riod](http://www.bt.c |                                      |       |
| dc.gov/agent/smallpox |                                      |       |
| /response-plan/files/ |                                      |       |
| guide-a-form-3-c.pdf) |                                      |       |
+-----------------------+--------------------------------------+-------+

> A single, laboratory confirmed case will initiate implementation of
> the CDC and state smallpox response plans. Other criteria for
> implementation of the response plan include:

-   A large outbreak of a clinically compatible illness pending
    etiologic confirmation;

-   Reports of suspected or probable cases once an outbreak has been
    identified elsewhere in the country; and

-   Confirmation of smallpox virus in an environmental sample, package,
    or device associated with human exposure.

> Surveillance, outbreak investigation and control activities including
> contact identification, tracing, vaccination and surveillance will
> need to be prioritized once smallpox is confirmed in a local
> jurisdiction. Following the confirmation of a smallpox case,
> especially if it is the first case confirmed in the United States, an
> epidemiological investigation will need to occur in collaboration with
> law enforcement and state and federal authorities. If a smallpox case
> is confirmed anywhere in the United States or in the world, enhanced
> surveillance for smallpox should be initiated and decisions on
> vaccination will be made in collaboration with state and federal
> authorities.

1.  Strategies for post-event enhanced smallpox surveillance include:

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a.  Making smallpox and varicella reportable if they are not already
    reportable.

b.  Establishing active surveillance for smallpox cases from designated
    smallpox facilities, other hospitals, ERs, and laboratories.

c.  Establishing enhanced passive surveillance from all health care
    providers.

d.  Establishing enhanced passive surveillance from institutions such as
    schools, child care centers, homeless shelters, correctional
    facilities, and other institutions.

e.  Establishing a protocol for active surveillance for fatal cases by
    reviewing all deaths from rash illnesses each week; deaths due to
    hemorrhagic conditions and unexplained deaths should be included.

f.  Establishing worksite or event-specific surveillance where the
    initial smallpox attack or exposures may have occurred.

g.  Designating staff at all hospitals (e.g., infection control
    practitioner) to review current and newly admitted hospitalized
    patients for confirmed, probable and suspect cases.

h.  Reviewing and following up on reported varicella cases.

i.  Establishing targeted surveillance, depending on the epidemiology of
    the outbreak, to ensure appropriate case ascertainment in
    hard-to-reach populations (e.g., homeless, migrant workers).

j.  Establishing mechanisms to allow for retrospective surveillance, in
    order to identify the earliest cases that may have occurred before
    the smallpox outbreak was recognized.

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2.  In addition to the recommendations in this Guide, steps for managing
    large numbers of reports of suspected cases for smallpox include:

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a.  Establishing procedures and referral facilities for management,
    isolation, and evaluation of suspect cases.

b.  Providing appropriate communication with the public regarding steps
    to take with suspected smallpox.

c.  Implementation of the recommendations in Guide B for vaccination
    guidelines for state and local health agencies.

d.  Implementation of the recommendations in Guide C for infection
    control measures for healthcare and community settings and
    quarantine

e.  Implementation of the recommendations in Guide D for specimen
    collection and transport.

f.  Implementation of the recommendations in Guide E for communication
    plans and activities.

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B.  **Surveillance and Case Reporting**

    1.  Case Reporting

> Figure 1 describes reporting and information flow for post-event
> smallpox surveillance. Single cases of suspect, probable, and/or
> confirmed smallpox should be reported immediately (by telephone) from
> reporting health care providers. Smallpox facilities should report
> smallpox cases daily, updating the list of suspect, probable, and
> confirmed cases.

Figure 1. Surveillance Reporting and Information Flow

> Each jurisdiction should establish multiple mechanisms for reporting
> confirmed, probable, and suspected cases to public health surveillance
> personnel and should communicate these mechanisms to all reporting
> sources (hospitals, clinics, private physician offices, etc.).
> Designated smallpox facilities (types C and X) should have daily
> communication with public health authorities, to report and update
> lists of confirmed, probable, and suspect cases. Redundant systems may
> be required due to potential communication problems. Such mechanisms
> for reporting may include:

a.  Secured fax,

b.  Secured Web-based reporting,

c.  Database transmission via modem to health department server,

d.  Direct telephone reporting (provide a telephone hotline for
    reporting cases),

e.  E-mail transmission,

f.  Hand-carried reports, and

g.  Other traditional methods of disease reporting that are timely

> [Form 1 (Appendix
> 5)](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a-form-1.pdf),
> the "Smallpox Post-Event Surveillance Form," has been developed to
> provide guidance for the surveillance and reporting of suspect,
> probable, or confirmed cases of smallpox.
>
> Smallpox surveillance forms (Form 1, Appendix 5) should be distributed
> to all reporting sources. In addition, the clinical case definition
> and case classifications should be distributed to all reporting
> sources, including public health staff; hospitals; emergency rooms;
> clinics; and other health care providers. Reporting sources in the
> community, such as correctional facilities, schools, homeless
> shelters, and child care centers should also receive forms and
> instructions.
>
> Public health officials should encourage reporting of all suspected,
> probable and confirmed cases and should coordinate with designated
> staff to ensure appropriate isolation, management, and surveillance of
> cases in specially designated facilities These facilities may include
> Type C, Type X, Type R, and/or even the case's or contact's home
> (e.g., suspect cases that are not ill with no epidemiological link to
> a case). See [Guide C  Infection Control Measures for Healthcare and
> Community Settings and Quarantine
> Guidelines](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-c-part-1.pdf),
> for additional assistance. *(note: this section will be harmonized
> with Guide C as it is revised).*
>
> All reported probable and suspect cases and their contacts should be
> immediately vaccinated (see Guide B ---Vaccination Guidelines for
> State and Local Health Agencies, [part
> 1](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part1of3.pdf),
> [part
> 2](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part2of3.pdf),
> and [part
> 3](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-b-part3of3.pdf)),
> pending laboratory test results for other diagnoses or clinical
> progression of disease.
>
> Laboratory reporting should be strengthened, including variola,
> vaccinia and generic orthopox testing. Reporting from designated
> laboratories is essential for confirmation of other causes of rash
> illness, most importantly varicella zoster virus (VZV) infections.

2.  Data Collection

> While Form 1 is designed to provide complete surveillance and
> reporting information for each case, the size of the outbreak may
> require reprioritization of resources from extensive data collection.
> For those situations, a list of the data of highest priority has been
> identified (circled variables on Form 1). These data should be
> collected by the reporting source and reported to surveillance
> personnel for each suspected, probable, and/or confirmed case. The
> minimum data include:

a.  State,

b.  Case ID,

c.  Name of person reporting case,

d.  Contact telephone number for person reporting case,

e.  Date case reported,

f.  Last name, first name and alias or nickname of
    suspected/probable/confirmed case,

g.  Home address of case ,

h.  Telephone number of case,

i.  Date of birth,

j.  Gender,

k.  Smallpox vaccination ever (yes/no),

l.  Date of smallpox vaccination,

m.  Date of fever onset,

n.  Date of rash onset,

o.  Clinical type of smallpox,

p.  Known exposure to suspected/confirmed or probable case (yes/no),

q.  Name of first hospital or isolation center where case was admitted,

r.  Outcome (complications, death),

s.  Lab confirmation, and

t.  Case status (confirmed, probable, or suspected).

> If time/personnel constraints permit, additional information to be
> collected includes:

a.  Timing of smallpox vaccination and recording of take,

b.  Pre-existing medical conditions and medications,

c.  Pregnancy status, if female,

d.  Details on clinical illness including prodromal symptoms, lesion
    distribution,

e.  Treatment, including anti-viral therapy,

f.  Laboratory test results, and

g.  Transmission setting.

> Out-of-state contacts or places of travel should be immediately
> reported to other states through existing state-to-state reporting
> mechanisms. The reports may also be forwarded to the CDC coordination
> group, especially in the early stages of the first case investigations
> to facilitate interstate communication.

3.  Data Management

> Post-event surveillance and case reporting will be enhanced by data
> management systems designed to address the challenges of smallpox.
> [Appendix
> 15](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/complete-workflow.pdf)
> presents a flow diagram of the forms' physical workflow, as well as
> the data system designed to capture the data collected on the forms
> (Appendices 5-14).
>
> Each jurisdiction should establish a centralized place and dedicated
> telephone numbers for receiving telephoned and faxed reports. In
> addition, dedicated computers for accepting electronic reports should
> be identified.
>
> A database with the collected surveillance information should be
> established and maintained for all confirmed, probable, and suspected
> cases. Links to establish electronic laboratory reporting will enhance
> data management. Surveillance data should be reported on a daily basis
> to the CDC Coordination Group. This group will be responsible for
> maintaining the national surveillance database, reporting national
> data to DHHS and helping with notification for out-of-state contacts,
> if requested by a state.

C.  **Contact identification, tracing, vaccination, and surveillance**

    *A single person should be designated by the state health officer to
    coordinate tracing, interviewing, arranging for vaccination, and
    surveillance of contacts. Additional personnel should be provided
    from state resources as needed. All contact information obtained by
    the case interviewers and the related forms should be given to the
    designated supervisor to coordinate contact tracing activities.
    Vaccination of contacts and their contacts (search and containment,
    also known as ring vaccination) is the primary strategy for outbreak
    control. Contact tracing activities should continue throughout an
    outbreak even if widespread community or mass vaccination is
    offered. After review of contact priority lists and available
    resources, a decision may be made by state authorities to limit
    contact-related activities to the highest priority group(s) only. In
    all situations, however, household contacts should be identified,
    vaccinated, and monitored.*

Contact identification, tracing, vaccination, and surveillance will
require significant personnel resources. It is likely that even in a
small to moderate outbreak of disease, dozens to hundreds of personnel
need to be trained and involved in all aspects of contact tracing,
surveillance, and follow-up. The personnel working on these activities
should be those identified with field experience with contact tracing
(e.g., from STD, TB or HIV control programs). In addition, all personnel
designated for case interviews or contact tracing activities should be
vaccinated prior to initiating their first face-to-face interview with a
suspected, probable, or confirmed case or contact tracing activities.

Forms 2 A -- F were designed to provide guidance for contact
identification, tracing, vaccination, and surveillance. Forms 2 A -- C
allow the interviewer to record information about the case and contacts
during the infectious period, to facilitate contact identification. Form
2 D is for contact tracing, form 2 E provides a form for the primary
contacts to record relevant information about themselves, and 2 F
provides a form for secondary contacts to record vaccination
information.

Forms dedicated to identifying contacts include name, contact
information, and travel history, all of which must also be obtained from
the case or next of kin. Names and contact numbers for face-to-face
contacts from the onset of the case's fever until presentation for
evaluation. This information is collected in order to identify
individuals who may have been exposed to an infectious case. Tracing
contacts following onset of fever allows a time buffer for cases where
date of rash onset, and thus "time of infectiousness," may have not have
been clearly recognized by the case. This information, including places
visited (in daily activities) and travel history since onset of symptoms
(fever), allows the interviewer to identify potential unrecognized
contacts.

#### Identification, tracing, and vaccination of contacts

> A supervisor for the contact tracing team should be identified.
> Personnel assigned to trace contacts will receive names and any known
> address, telephone number(s), or other locating information for the
> primary contacts from the supervisor. The number of contacts for each
> case may require a very large number of personnel to be identified,
> trained, and made available for contact tracing and follow-up
> activities. [Appendix
> 16](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/appendix-16.pdf),
> "Using Forms and Worksheets for Contact Identification, Tracing,
> Vaccination, and Surveillance" provides additional details about the
> use and interrelationship of the forms and data management.

[Contact]{.underline}: a person who has been exposed to the risk of
infection

> [Primary contact]{.underline}: person with contact with a confirmed,
> probable, or suspected case of smallpox during the infectious period.
> Primary contacts include both household and nonhousehold contacts.
> Risk of smallpox transmission is increased with increased duration of
> face-to-face contact of [\<]{.underline} 2 meters ([\<]{.underline}
> 6.5 feet). Priority categories for contacts, from highest priority to
> lowest, are as follows:

a.  Case household family members and others spending 3 or more hours in
    the household since the case's onset of fever.

b.  Nonhousehold members with contact [\<]{.underline} 2 meters
    ([\<]{.underline} 6.5 feet) with case with rash for 3 or more hours.

c.  Nonhousehold members with contact [\<]{.underline} 2 meters
    ([\<]{.underline} 6.5 feet) with case with rash for fewer than 3
    hours.

d.  Nonhousehold members with contact [\<]{.underline} 2 meters
    ([\<]{.underline} 6.5 feet) or more with case with rash for 3 or
    more hours.

e.  Nonhousehold members with contact [\<]{.underline} 2 meters
    ([\<]{.underline} 6.5 feet) or more with case with rash for fewer
    than 3 hours.

> *Household contact:* person who lives or works in the same household
> as the case
>
> *Nonhousehold contact*: person who does not live or work in the case
> household
>
> [Secondary contact]{.underline}: household members of all primary,
> non-household contacts and persons who work in the household of a
> primary contact

####### Contact tracing personnel should:

a.  Trace each contact whose name, address and/or telephone number is
    given to them.

b.  Use work and school contact numbers, telephone directories, voting
    lists, neighborhood interviews, site visits, "hangouts," etc. to
    trace contacts when contact information is unknown or incomplete. If
    contacts cannot be found through these mechanisms, other sources for
    notification of potential contacts (such as media announcements) may
    have to be considered.

c.  Locate and interview each primary contact to confirm contact with
    the suspected, probable, or confirmed smallpox case, the presence or
    absence of symptoms in the contact (fever and/or rash) and to
    identify additional contacts that may not have been listed by the
    case.

d.  Identify household contacts of the primary contact of the smallpox
    case (secondary contacts).

e.  Arrange for immediate vaccination of the primary contact and his/her
    household contacts (secondary contacts). Either vaccinate contacts
    in the household (if this is feasible with vaccine supply, security
    issues, and resources) or provide a vaccination ticket with
    identifying information and designate a vaccination facility for the
    contact(s) to attend as soon as possible. *It is extremely important
    for smallpox outbreak control to vaccinate contacts as an urgent
    priority. In the past, when vaccination was done in the household,
    this task was given priority over transportation of a case to an
    isolation facility.*

f.  If the primary contact is symptomatic with fever or rash,
    arrangements should be made for prompt vaccination and
    transportation of the contact to a Type C facility or other
    designated evaluation site for medical evaluation to rule out
    smallpox. Contacts with symptoms should be counseled, interviewed
    and reported as a suspected case using the appropriate smallpox
    surveillance (case reporting) form and his/her contacts should be
    identified, interviewed, and vaccinated as soon as possible.

g.  If the primary contact does not have fever or rash, vaccinate or
    arrange for prompt vaccination and place the contact under
    surveillance so that if the contact develops fever or rash he or she
    is immediately isolated and evaluated and does not expose other
    persons to smallpox (see below).

h.  If a household member cannot be vaccinated because of
    contraindications, the household member should be instructed to
    avoid physical contact with the primary contact until the incubation
    period of the disease has passed (18 days) or all vaccinated persons
    in the household are noninfectious for vaccinia virus (after the
    scab at the vaccine site has separated, 14 to 21 days after
    vaccination).

i.  Each household contact should be provided with a vaccination ticket
    (this may be with his/her form 2d number according to current draft
    forms) and instructed to attend a designated vaccination clinic site
    as soon as possible.

j.  If they discover that any contacts have left the state, the contact
    tracers should notify the supervisor responsible for out-of-state
    contacts. The supervisor will then notify the appropriate
    authorities.

### Surveillance (monitoring) of health status and vaccine "take" of contacts

> Surveillance is conducted for early signs of smallpox disease (fever
> on 2 consecutive days and/or rash) and for vaccine "take." Contacts
> are provided with a health department phone number to call if they
> develop any of the severe vaccine adverse reactions shown on the
> Vaccine Information Statement. Ideally, and if resources are
> available, primary contacts who do not have fever or rash at the time
> of interview should remain under active surveillance for 21 days after
> their last contact with the smallpox case, or 14 days following
> successful vaccination. [Appendix
> 16](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/appendix-16.pdf),
> "Using Forms and Worksheets for Contact Identification, Tracing,
> Vaccination, and Surveillance" provides additional details about the
> use and interrelationship of the forms and data management.

###### Epidemiological investigation 

Following identification of a smallpox case or cases in a community,
especially the first case(s) confirmed in the United States, a criminal
investigation will be conducted to determine the source of introduction
of smallpox virus. The state epidemiologist or his/her designee should
coordinate the epidemiological investigation in collaboration with
federal health authorities. The lead state and federal staff will
coordinate all aspects of the investigation with other relevant state
and federal authorities including the Federal Bureau of Investigation
(FBI), police, quarantine officials, and others. If indicated, the
epidemiological investigation may be performed in conjunction with
contact identification and verification activities. An estimate of the
number and kind of personnel necessary for performing these functions
should be made and additional assistance requested as needed.

1.  Smallpox occurrence

    Epidemiologic investigation should consider that because smallpox no
    longer occurs as a naturally-acquired infection, there are two most
    likely causes for smallpox initial reappearance into the human
    population, including:

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a.  Infection caused by exposure of a nonimmune person to smallpox as a
    result of accidental release or inoculation during approved
    laboratory research involving the virus or exposure to inadequately
    sterilized material generated during laboratory research involving
    the virus. Currently there are only two WHO-approved smallpox virus
    research and repository laboratories which include the CDC in
    Atlanta, Georgia and the Institute of Virus Preparations in Moscow,
    Russia (both laboratories have undergone frequent WHO inspections
    and have stringent safety and security procedures in place).

b.  Infection caused by exposure of a nonimmune person to smallpox as a
    result of accidental release or inoculation during non-approved
    laboratory research involving the virus or exposure to inadequately
    sterilized material generated during non-approved laboratory
    research involving the virus

c.  Infection caused by an intentional release of the smallpox virus
    into the population either by infecting a person or by releasing
    smallpox virus via an aerosol or other device.

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2.  Data collection

    Much of the epidemiological investigation may be performed in
    conjunction with identification and evaluation of potential smallpox
    cases including contact identification and followup. However,
    because of the urgency of the outbreak, adequate personnel must be
    available to collect and analyze data that would allow rapid:

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a.  Identification of the most likely source of initial exposure
    (hopefully within 24 hours of the first confirmation of smallpox).
    *This may require extensive trace-back capabilities if the initial
    recognition and confirmation of smallpox occurred later than the
    first generation of disease in the outbreak.*

b.  Identification or estimation of the population at risk. To the
    extent possible, the population at risk should be identified.
    Exposure could be due to an infected person present at a specified
    location; use of a specified mode of transportation; or presence at
    a location of suspected smallpox virus release. These persons should
    be placed under surveillance. Public health actions to consider
    would include offering smallpox vaccine to the exposed population
    and to their household contacts.

c.  Identification of any unexpected epidemiological features of the
    outbreak (e.g., unusual presentation, morbidity, mortality,
    incubation period, transmission, and affected population).

d.  Evaluation of characteristics and extent of the outbreak to develop
    the most effective containment strategies.

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```
3.  Expected epidemiological features of smallpox *(Note: historical
    experience may not apply if the smallpox virus is genetically
    altered)*

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a.  Incubation period is about 12 days (range 7 to 17 days).

b.  Person-to-person spread by droplet transmission (most common),
    contact with material from pustules/rash lesions or contaminated
    clothing or bedding (less common), or small particle aerosol (least
    common).

c.  Smallpox cases are generally not infectious to others until the
    onset of rash (approximately 7 to 17 days after exposure). However,
    since exact date of rash onset may not be noted accurately and
    because of the infectious enanthem which may precede rash onset by 1
    to 2 days, cases should be considered potentially infectious from
    date of fever onset.

d.  Period of highest transmissibility is during the first 7 to 10 days
    after onset of rash. However, a person is considered infectious
    until all scabs have separated. The risk of contracting disease
    increases with duration and intensity of exposure.

e.  Persons at greatest risk for disease are household members and
    persons who have had face-to-face contact with a case after the
    onset of rash.

f.  During the smallpox era, the seasonal transmission of disease was
    highest during winter and early spring.

g.  Cases are likely to occur in all age groups due to the lack of
    population immunity in the United States. Cases may be less severe
    among adults \> 30 years who may have received one or more smallpox
    vaccination in the past. Childhood vaccinations were halted in the
    United States in 1972.

h.  Historically, up to 30% of unvaccinated smallpox cases resulted in
    death. The case-fatality ratio (CFR) may be greater because of a:

-   Lack of natural immunity,

-   High percentage of non-vaccinated persons in the U.S. population,
    and

-   Larger immunocompromised population compared to the smallpox era.

    The CFR may be lower because of:

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-   Better intensive care and medical treatment options than were
    available 30 years ago and

-   Partial immunity among the adult population.

i.  Historically, the secondary attack rate among susceptible household
    contacts was approximately 58% (range 38% to 88%).

j.  The outbreak experience in Europe suggested that in a susceptible
    population, a single case of smallpox would be expected to result in
    5-7 secondary cases, which is lower than observed for some other
    vaccine-preventable diseases (e.g., measles, pertussis). The
    relatively low transmission of smallpox resulted from the severe
    initial prostration of persons with smallpox and the prolonged
    contact required for transmission in most instances.

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4.  Information Systems Management

> [**Appendix
> 15**](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/complete-workflow.pdf)
> of this Guide provides a flow diagram describing the information
> management for post-event smallpox surveillance and case reporting;
> contact identification, tracing, vaccination, and surveillance; and
> epidemiologic investigation.

Guide A: List of Appendices

# 

  -----------------------------------------------------------------------------------------------
  **Appendix Name Appendix Number**

  [Poster: Evaluating Patients for
  Smallpox](http://www.bt.cdc.gov/agent/smallpox/diagnosis/evalposter.asp) 1

  [Worksheet: Evaluating Patients for
  Smallpox](http://www.bt.cdc.gov/agent/smallpox/diagnosis/pdf/spox-patient-eval-wksheet.pdf) 3

  [Forms Overview for Smallpox Response Plan Guide
  A](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a-forms-overview.pdf) 4

  [Form 1: Post-Event
  Surveillance](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a-form-1.pdf) 5

  [Form 2a: Case Travel/Activity Worksheet---Infectious
  Period](http://www.bt.cdc.gov/agent/smallpox/response-plan/index.asp) 6

  [Form 2b: Primary Contact/Site
  Worksheet](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a-form-2-b.pdf) 7

  [Form 2c: Contact Transportation Worksheet---Infectious
  Period](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a-form-2-c.pdf) 8

  [Form 2d: Contact
  Tracing](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a-form-2-d.pdf) 9

  [Form 2e: Case Household and Primary Contact
  Surveillance](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a-form-2-e.pdf) 10

  [Form 2f: Case Primary Contact\'s Household Members
  Surveillance](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a-form-2-f.pdf) 11

  [Form 3a: Case Exposure
  Investigation](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a-form-3-a.pdf)
  12

  [Form 3b: Case Travel/Activity Worksheet---Exposure
  Period](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a-form-3-b.pdf) 13

  [Form 3c: Case Transportation Worksheet---Exposure
  Period](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/guide-a-form-3-c.pdf) 14

  [Complete Workflow with
  Forms](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/complete-workflow.pdf) 15

  [Using Forms and Worksheets for Contact Identification, Tracing, Vaccination, and
  Surveillance](http://www.bt.cdc.gov/agent/smallpox/response-plan/files/appendix-16.pdf) 16
  -----------------------------------------------------------------------------------------------