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Bioterrorism Plan

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Section 1

Detection of Outbreaks Caused by Agents of Bioterrorism:

Rapid response to a bioterrorism-related outbreak requires prompt identification of its onset. Because of the rapid progression to illness and potential for dissemination of some of these agents, it may not be practical to await diagnostic laboratory confirmation. Instead, it will be necessary to initiate a response based on the recognition of high-risk syndromes. Each of the agent-specific plans in Section II includes a syndrome description (i.e., typical combination of clinical features of the illness at presentation), that should alert healthcare personnel to the possibility of a bioterrorism-related outbreak.

A bioterrorism event may be recognized in the following ways:
1.Covert event: persons are unknowingly exposed and an outbreak is suspected only upon recognition of unusual *disease clusters or symptoms. Health care personnel should contact the Administrator on call and Infection Control.
2.Announced event: persons are warned that an exposure has occurred. The Emergency Department (ED) would likely be notified by Emergency Service Management or Police. In the event a bioterrorism event is suspected, Chatham Hospital personnel will follow the Chatham Hospital Disaster Plan.

Potential Agents:

Four diseases with recognized bioterrorism potential (anthrax, botulism, plague, and smallpox) and the agents responsible for them are described in Section II of this document.
Other agents will be added as developed by the Association of Professionals in Infection Control and Epidemiology (APIC.org). The agents are not prioritized in any order of importance or likelihood of use. Appendix 3 contains a brief description of certain agents, mode of transmission and risk of human to human transmission.

Epidemiologic Features:

Epidemiologic principles must be used to assess whether a patient's presentation is typical of an endemic disease or is an unusual event that should raise concern. Features that should alert healthcare personnel to the possibility of a bioterrorism-related outbreak include:

A rapidly increasing disease incidence (e.g., within hours or days) in a normally healthy population.

An epidemic curve that rises and falls during a short period of time.

An unusual increase in the number of peoples seeking care, especially with fever, respiratory, or gastrointestinal complaints.

An endemic disease rapidly emerging at an uncharacteristic time or in an unusual pattern.

Lower attack rates among people who had been indoors, especially in areas with filtered air or closed ventilation systems, compared with people who had been outdoors.

Clusters of patients arriving from a single locale.

Large numbers of rapidly fatal cases.

Any patient presenting with a disease that is relatively uncommon and has bioterrorism potential (e.g., pulmonary anthrax, tularemia, or plague).

INFECTION CONTROL PRACTICES FOR PATIENT MANAGEMENT:

Isolation precautions – Section II outlines specific disease management
All patients including symptomatic patients with suspected or confirmed bioterrorism-related illnesses shall be managed utilizing Standard Precautions.

Standard Precautions are designed to reduce transmission from both recognized and unrecognized sources of infection in healthcare facilities, and are recommended for all patients receiving care, regardless of their diagnosis or presumed infection status.

For certain diseases or syndromes (e.g., smallpox and pneumonic plague), additional precautions may be needed to reduce the likelihood for transmission.  See Section II for specific diseases and requirements for additional isolation precautions.

Standard Precautions routinely practiced by healthcare personnel include:

Handwashing:
     Hands are washed after touching blood, body fluids, excretions, secretions, or items contaminated with such body fluids, whether or not gloves are worn.  Hands are washed immediately after gloves are removed, between patient contacts, and as appropriate to avoid transfer of microorganisms to other patients and the environment.

Gloves:
     Clean, non-sterile gloves are worn when touching blood, body fluids, excretions, secretions, or items contaminated with such body fluids.  Clean gloves are put on just before touching mucous membranes and non-intact skin.  Gloves are changed between tasks and between procedures on the same patient if contact occurs with contaminated material.  Hands are washed promptly after removing gloves and before leaving a patient care area.

Masks/Eye Protection or Face Shields:
     A mask and eye protection (or face shield) are worn to protect mucous membranes of the eyes, nose, and mouth while performing procedures and patient care activities that may cause splashes of blood, body fluids, excretions, or secretions.

Gowns:
     A gown is worn to protect skin and prevent soiling of clothing during procedures and patient-care activities that are likely to generate splashes or sprays of blood, body fluids, excretions, or secretions.  Selection of gowns and gown materials should be suitable for the activity and amount of body fluid likely to be encountered. Soiled gowns are removed promptly and hands are washed to avoid transfer of microorganisms to other patients and environments.

Patient Placement – Section II outlines specific disease management:
In small-scale events, routine facility patient placement and infection control practices shall be followed.  PACU may be utilized for patients who present with similar symptoms.  Available beds, stretchers and other necessary equipment will be transported to PACU by appointed personnel.

In large scale events, when the number of patients presenting to Chatham Hospital is too large to allow routine triage and isolation strategies (if required), patients will be transported to a response center to be announced by Chatham County Emergency Management Team.

Patient Transport – Section II outlines specific disease management:

The transport and movement of patients with bioterrorism-related infections, as for patients with any epidemiologically important infections (e.g., pulmonary tuberculosis, chickenpox, measles), should be limited to movement that is essential to provide patient care, thus reducing the opportunities for transmission of microorganisms within healthcare facilities.

Cleaning, Disinfection, and Sterilization of Equipment and Environment – Section II outlines specific disease management:

Rooms and bedside equipment of patients with bioterrorism-related infections shall be cleaned using the same procedures that are used for all patients as a component of Standard precautions, unless the infecting microorganism and the amount of environmental contamination indicates special cleaning as outlined in Section II.

Patient linens shall be handled as with all hospital linen.

Contaminated waste is sorted and discarded in accordance with Chatham Hospital's Regulated Medical Waste Policy (found in the Infection Control Manual) which is in compliance with federal, state and local regulations.

Policies should be followed for the prevention of occupational injury and exposure to bloodborne pathogens in accordance with the Exposure Control Plan for Bloodborne Pathogens.

Discharge Management – Section II outlines specific disease management:

In the event that large numbers of persons exposed may preclude admission of all
infected patients, discharge instructions shall address appropriate barrier precautions, handwashing, waste management, and cleaning and disinfection of the environment and patient-care items.  Refer to handouts.

Post-mortem Care – Section II outlines specific disease management:

The Chatham Hospital Laboratory and Lab Corp Department of Pathology must be informed of a potentially infectious outbreak prior to submitting any specimens for examination or disposal. If the agent is suspected or known to be spread by the airborne route, personnel should follow Airborne Precautions.

Post Exposure Management – Section II outlines specific disease management
*Decontamination of Patients and Environment

Decisions regarding the need for decontamination may be made in consultation with the Chatham County Health Department and the State Health Department.

If decontamination is required, the patient should enter the decontamination room in the ED from the outside for removal of clothing and showering.

Depending on the agent, the likelihood for re-aerosolization, or a risk associated with cutaneous exposure, clothing of exposed persons may need to be removed.

Clean water, saline solution, or commercial ophthalmic solutions are recommended for rinsing eyes. If indicated, after removal at the decontamination site, patient clothing should be handled only by personnel wearing appropriate personal protective equipment, and placed in an impervious bag to prevent further environmental contamination. Decontamination requirements for specific potential agents of bioterrorism are listed in Section II.  The FBI may require collection of exposed clothing and other potential evidence for submission to FBI or Department of Defense laboratories to assist in exposure investigations.

*Prophylaxis and post-exposure immunization

Current recommendations for post-exposure prophylaxis and immunization are provided in Section II for relevant potential bioterrorism agents. Up-to-date recommendations should be obtained in consultation with Chatham County Health Department and CDC.

*Triage and management of large scale exposures and suspected exposures

Triage and management of large-scale exposures and suspected exposure events will be coordinated by the Administrator On Call utilizing the Hospital Disaster Plan and may include some or all:
     *Coordinate on-site care.
     *Cancel non-emergency services and procedures.
     *With assistance from local and state health departments, contact sources able to supply available vaccines, immune globulin, antibiotics, and botulinum anti-toxin.
     *Plan the efficient evaluation and discharge of patients.
     *Develop discharge instructions for patients determined to be non-contagious or in need of additional on-site care, including details regarding if and when they should return for care or if they should seek medical follow-up.
     *Determine availability and sources for additional medical equipment and supplies (e.g., ventilators) that may be needed for urgent large-scale care.
     *Plan for the allocation or re-allocation of scarce equipment in the event of a large-scale event (e.g., duration of ventilator support of terminally afflicted individuals).
     *With assistance from the Chatham County Health Department, identify the location to manage a sudden increase in the number of cadavers.

*Psychological aspects of bioterrorism

In the likely event of fear and panic responses following a bioterrorism-related event, Chatham Hospital Volunteer Clergy and Chatham County Mental Health may be asked to assist the Administrator on call.

Laboratory Support and Confirmation

Currently the Bioterrorism Emergency Number at CDC is at the Emergency Response Office, NCEH, 770/488-7100.

Obtaining diagnostic samples

See specific recommendations for diagnostic sampling for each agent.  Sampling should be performed in accordance with Standard Precautions.

In all cases of suspected bioterrorism, collect an acute phase serum sample to be analyzed, aliquotted, and saved for comparison to a later convalescent serum sample.  Chatham Hospital Laboratory will coordinate with the State Lab.

*Laboratory criteria for processing potential bioterrorism agents

To evaluate laboratory capacity in the United States, a proposal is being made to group laboratories into one of four levels, according to their ability to support the diagnostic needs presented by an event.  The proposed laboratory levels in the planning stages are:

Chatham Hospital Laboratory has Level A capabilities

Level A: Clinical laboratories – minimal identification of agents

Level B: County/ State/ other laboratories – identification, confirmation, susceptibility testing

Level C: State and other large facility laboratories with advanced capacity for testing – some molecular technologies

Level D:  CDC or select Department of Defense laboratories, such as U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) – Bio Safety Level (BSL) 3 and 4 labs with special surge capacity and advanced molecular typing techniques.

*Transport Requirements
Specimen packaging and transport must be coordinated with CDC.  For specific instructions, contact the Bioterrorism Emergency Number at the CDC Emergency Response Office, 770/488-7100.  Advance planning should include identification of appropriate packaging materials and transport media in collaboration with the clinical laboratory at individual facilities.

Patient, Visitor, and Public Information

Visitors may be strictly limited to prevent potential exposure from suspected biological agents.

The Administrator or Administrator on call in accordance with the Hospital Disaster Plan regarding Public Relations will provide all communication with the public.

SECTION II:  AGENT-SPECIFIC RECOMMENDATIONS:
Anthrax

Description of Angent/Syndromes

Etiology

Anthrax is an acute infectious disease caused by Bacillus anthracis, a spore forming, gram-positive bacillus.  Associated disease occurs most frequently in sheep, goats, and cattle, which acquire spores through ingestion of contaminated soil.  Humans can become infected through skin contact, ingestion, or inhalation of B. anthracis spores from infected animals or animal products (as in “woolsorter's disease” from exposure to goat hair). Person-to-person transmission of inhalational disease does not occur.  Direct exposure to vesicle secretions of cutaneous anthrax lesions may result in secondary cutaneous infection.

Clinical Features

Human anthrax infection can occur in three forms: pulmonary, cutaneous, or gastrointestinal, depending on the route of exposure. Of these forms, pulmonary anthrax is associated with bioterrorism exposure to aerosolized spores. Clinical features for each form of anthrax include:

Pulmonary

Non-specific prodrome of flu-like symptoms follows inhalation of infectious spores.

Possible brief interim improvement.

Two to four days after initial symptoms, abrupt onset of respiratory failure and hemodynamic collapse, possibly accompanied by thoracic edema and a widened mediastinum on chest radiograph suggestive of mediastinal lymphadenopathy and hemorrhagic mediastinitis.
8Gram-positive bacilli on blood culture, usually after the first two or three days of illness.

Treatable in early prodromal stage. Mortality remains extremely high despite antibiotic treatment if it is initiated after onset of respiratory symptoms.

Cutaneous

Local skin involvement after direct contact with spores or bacilli.

Commonly seen on the head, forearms or hands.

Localized itching, followed by a papular lesion that turns vesicular, and within 2-6 days develops into a depressed black eschar.

Usually non-fatal if treated with antibiotics.

Gastro-intestinal

Abdominal pain, nausea, vomiting, and fever following ingestion of contaminated food, usually meat.

Bloody diarrhea, hematemesis.

Gram-positive bacilli on blood culture, usually after the first two or three days of illness.

Usually fatal after progression to toxemia and sepsis.

Modes of transmission

The spore form of B. anthracis is durable. As a bioterrorism agent, it could be delivered as an aerosol. The modes of transmission for anthrax include:

Inhalation of spores.

Cutaneous contact with spores or spore-contaminated materials.

Ingestion of contaminated food.

Incubation period

The incubation period following exposure to B. anthracis ranges from 1 day to 8 weeks (average 5 days), depending on the exposure route and dose:

2-60 days following pulmonary exposure.

1-7 days following cutaneous exposure.

1-7 days following ingestion.

Period of communicability

Transmission of anthrax infections from person to person is unlikely. Airborne transmission does not occur, but direct contact with skin lesions may result in cutaneous infection.

Preventive Measures

Vaccine availability

Inactivated, cell-free anthrax vaccine (Bioport Corporation 517/327-1500, formerly Michigan Biologic Products Institute*) – limited availability.

Use of trade names and commercial sources is for identification only and does not constitute endorsement by CDC or the U.S. Department of Health and Human Services

Immunization Recommendations:

Routinely administered to military personnel.  Routine vaccination of civilian populations not recommended.

Treatment of Patients

Symptomatic patients with suspected or confirmed infections with B. anthracis should be managed according to current guidelines specific to their disease state.  Recommendations for chemotherapy are beyond the scope of this document.  For up-to-date information and recommendations for therapy, contact the local and state health department and the Bioterrorism Emergency Number at the CDC Emergency Response Office, 770/488-7100.

Infection Control Practices for Patient Management

Isolation precautions

Standard Precautions are used for the care of patients with infections associated with B. anthracis.   Standard Precautions include the routine use of gloves for contact with nonintact skin, including rashes and skin lesions.

Patient placement

Private room placement for patients with anthrax is not necessary.  Airborne transmission of anthrax does not occur.  Skin lesions may be infectious, but requires direct skin contact only.

Patient transport

Standard Precautions should be used for transport and movement of patients with B. anthracis infections.

Cleaning, disinfection, and sterilization of equipment and environment

Principles of Standard Precautions should be generally applied for the management of patient-care equipment and for environmental control (see Section I for more detail).

Discharge Management

No special discharge instructions are indicated. Home care providers should be taught to use Standard Precautions for all patient care (e.g., dressing changes).

Post-mortem care

Standard Precautions should be used for post-mortem care.  Standard Precautions include wearing appropriate personal protective equipment, including masks and eye protection, when generation of aerosols or splatter of body fluids is anticipated.5

Post Exposure Management

Decontamination of patients/enviornment

The risk for re-aerolization of B. anthracix spores appears to be extremely low in settings where spores were released intentionally or were present at low or high levels.  In situations where the threat of gross exposure to B. anthracis spores exists, cleansing of skin and potentially contaminated fomites (e.g. clothing or environmental surfaces) may be considered to reduce the risk for cutaneous and gastrointestinal forms of disease.  The plan for decontaminating patients exposed to anthrax may include the following:

Instructing patients to remove contaminated clothing and store in labeled, plastic bags.

Handling clothing minimally to avoid agitation.

Instructing patients to shower thoroughly with soap and water (and providing assistance if necessary) in the decontamination room.

Instructing personnel regarding Standard Precautions and wearing appropriate barriers (e.g. gloves, gown, and respiratory protection) when handling contaminated clothing or other contaminated fomites.

Decontaminating environmental surfaces using an EPA-registered, facility-approved sporicidal/germicidal agent or 0.5% hypochlorite solution (one part household bleach added to nine parts water).

Prophylaxis and post-exposure immunization

Recommendations for prophylaxis are subject to change.  Up-to-date recommendations should be obtained in consultation with local and state health departments and CDC.
Prophylaxis should be initiated upon confirmation of an anthrax exposure (Table 1).

Prophylaxis should continue until B. anthracis exposure has been excluded.  If exposure is confirmed, prophylaxis should continue for 8 weeks.  In addition to prophylaxis, post-exposure immunization with an inactivated, cell-free anthrax vaccine is also indicated following anthrax exposure.  If available, post-exposure vaccination consists of three doses of vaccine at 0, 2 and 4 weeks after exposure.  With vaccination, post-exposure antimicrobial prophylaxis can be reduced to 4 weeks.

Triage and management of large scale exposures / potential exposures

Advance planning should include identification of:

Sources of prophylactic antibiotics and planning for acquisition on short notice.

Locations, personnel needs and protocols for administering prophylactic post-exposure care to large numbers of potentially exposed individuals.

Means for providing telephone follow-up information and other public communications services.

Intensive care medical director will need to consider how limited numbers of ventilators will be distributed in the event of a large number of patients arriving with abrupt pulmonary decompensation.

How additional ventilators can be obtained.

In the event of severely limited ventilator availability, whether and when ventilator support will be discontinued for a terminally ill individual.

See Section I for additional general details regarding planning for large-scale patient management.

Laboratory Support and Confirmation

Diagnosis of anthrax is confirmed by aerobic culture performed in a BSL -2 laboratory.

Diagnostic samples

Diagnostic samples to obtain include:

Blood cultures.

Acute serum for frozen storage.

Stool culture if gastrointestinal disease is suspected.

Laboratory selection

Handling of clinical specimens should be coordinated with local and state health departments, and undertaken in BSL -2 or -3 laboratories.  The FBI will coordinate collection of evidence and delivery of forensic specimens to FBI or Department of Defense laboratories.

Transport requirements

Specimen packaging and transport must be coordinated by Lab Corp with local and state health departments, and the FBI.  A chain of custody document should accompany the specimen from the moment of collection. For specific instructions, contact the Bioterrorism Emergency Number at the CDC Emergency Response Office, 770/488-7100.  Advance planning should include identification of appropriate packaging materials and transport media in collaboration with the clinical laboratory at individual facilities.

Patient, Visitor, and Public Information

Fact sheets for distribution should be prepared, including explanation that people recently exposed to B. anthracis are not contagious, and antibiotics are available for prophylactic therapy along with the anthrax vaccine.  Dosing information and potential side effects should be explained clearly.  Decontamination procedures, i.e., showering thoroughly with soap and water; and environmental cleaning, i.e., with 0.5% hypochlorite solution (one part household bleach added to nine parts water), can be described.

Botulism

Description of Agent/Syndrome

Etiology

Clostridium botulinum is an anaerobic gram-positive bacillus that produces a potent neurotoxin, botulinum toxin. In humans, botulinum toxin inhibits the release of acetylcholine, resulting in characteristic flaccid paralysis. C. botulinum produces spores that are present in soil and marine sediment throughout the world.  Foodborne botulism is the most common form of disease in adults. An inhalational form of botulism is also possible. Botulinum toxin exposure may occur in both forms as agents of bioterrorism.

Clinical Features

Foodborne botulism is accompanied by gastrointestinal symptoms.  Inhalational botulism and foodborne botulism are likely to share other symptoms including:

Responsive patient with absence of fever.

Symmetric cranial neuropathies (drooping eyelids, weakened jaw clench, difficulty swallowing or speaking).

Blurred vision and diplopia due to extra-ocular muscle palsies.
8Symmetric descending weakness in a proximal to distal pattern (paralysis of arms first, followed by respiratory muscles, then legs).

Respiratory dysfunction from respiratory muscle paralysis or upper airway obstruction due to weakened glottis.

No sensory deficits.

Mode of Transmission

Botulinum toxin is generally transmitted by ingestion of toxin-contaminated food. Aerosolization of botulinum toxin has been described and may be a mechanism for bioterrorism exposure.

Incubation period

Neurologic symptoms of foodborne botulism begin 12 – 36 hours after ingestion.

Neurologic symptoms of inhalational botulism begin 24- 72 hours after aerosol exposure.

Period of communicability

Botulism is not transmitted from person to person.

Preventive Measures
Vaccine Availability

A pentavalent toxoid vaccine has been developed by the Department of Defense.  This vaccine is available as an investigational new drug (contact USAMRIID, 301/619-2833).  Completion of a recommended schedule (0, 2, 12 weeks) has been shown to induce protective antitoxin levels detectable at 1-year post vaccination.

Immunization recommendations

Routine immunization of the public, including healthcare workers, is not recommended.

Treatment of Patients

Symptomatic patients with suspected or confirmed botulism should be managed according to current guidelines.  Recommendations for therapy are beyond the scope of this document.  For up-to-date information and recommendations for therapy, contact CDC or state health department.

Infection Control Practices for Patient Management

Isolation precautions

Standard Precautions are used for the care of patients with botulism.

Patient placement

Patient-to-patient transmission of botulism does not occur.  Patient may be placed in private or semi-private room.

Patient transport

Standard Precautions should be used for transport and movement of patients with botulism.

Cleaning, disinfection, and sterilization of equipment and environment

Principles of Standard Precautions should be generally applied to the management of patient-care equipment and environmental control (see Section I for more detail).

Discharge management

No special discharge instructions are indicated.

Post-mortem care

Standard Precautions should be used for post-mortem care

Post Exposure Management

Suspicion of even single cases of botulism should immediately raise concerns of an outbreak potentially associated with shared contaminated food.  In collaboration with Infection Control, local and state health departments, attempts should be made to locate the contaminated food source and identify other persons who may have been exposed.   Any individuals suspected to have been exposed to botulinum toxin should be carefully monitored for evidence of respiratory compromise.

Decontamination of patients / environment

Contamination with botulinum toxin does not place persons at risk for dermal exposure or risk associated with re-aerosolization.  Therefore, decontamination of patients is not required.

Prophylaxis and post-exposure immunization

Trivalent botulinum antitoxin is available by contacting state health departments or by contacting CDC (404/639-2206 during office hours, 404/639-2888 after hours). This horse serum product has a <9% percent rate of hypersensitivity reactions.  Skin testing should be performed according to the package insert prior to administration.

Triage and management of large scale exposures / potential exposures

Patients affected by botulinum toxin are at risk for respiratory dysfunction that may necessitate mechanical ventilation. Ventilatory support is required, on average, for 2 to 3 months before neuromuscular recovery allows unassisted breathing.

See Section I for additional general details regarding planning for large-scale patient management.

Laboratory Support and Confirmation

Obtaining diagnostic samples
Routine laboratory tests are of limited value in the diagnosis of botulism. Detection of toxin is possible from serum, stool samples, or gastric secretions.  For advice regarding the appropriate diagnostic specimens to obtain, contact state health authorities or CDC (Foodborne and Diarrheal Diseases Branch, 404/639-2888).

Laboratory selection

Handling of clinical specimens should be coordinated with local and state health departments. The FBI will coordinate collection of evidence and delivery of forensic specimens to FBI or Department of Defense laboratories.

Transport requirements

Specimen packaging and transport must be coordinated with McLendon Labs.  For specific instructions, contact the Bioterrorism Emergency Number at the CDC Emergency Response Office, 770/488-7100.  Advance planning should include identification of appropriate packaging materials and transport media in collaboration with the clinical laboratory at individual facilities.

Patient, Visitor, and Public Information

Fact sheets for distribution should be prepared, including explanation that people exposed to botulinum toxin are not contagious.  A clear description of symptoms including blurred vision, drooping eyelids, and shortness of breath should be provided with instructions to report for evaluation and care if such symptoms develop.

Plague

Description of Agent/Syndrome

Etiology

Plague is an acute bacterial disease caused by the gram-negative bacillus Yersinia pestis, which is usually transmitted by infected fleas, resulting in lymphatic and blood infections (bubonic and septicemia plague).  A bioterrorism-related outbreak may be expected to be airborne, causing a pulmonary variant, pneumonic plague.

Clinical Features

Clinical features of pneumonic plague include:

Fever, cough, chest pain.

Hemoptysis.

Muco-purulent or watery sputum with gram-negative rods on gram stain.

Radiographic evidence of bronchopneumonia.

Modes of Transmission

Plague is normally transmitted from an infected rodent to man by infected fleas.

Bioterrorism-related outbreaks are likely to be transmitted through dispersion of an aerosol.

Person-to-person transmission of pneumonic plague is possible via large aerosol droplets.

Incubation period
The incubation period for plague is normally 2 – 8 days if due to fleaborne transmission. The incubation period may be shorter for pulmonary exposure (1-3 days).

Period of communicability

Patients with pneumonic plague may have coughs productive of infectious particle droplets. Droplet precautions, including the use of a mask for patient care, should be implemented until the patient has completed 72 hours of antimicrobial therapy.

Preventive Measures

Vaccine availability
Formalin-killed vaccine exists for bubonic plague, but has not been proven to be effective for pneumonic plague.  It is not currently available in the United States.

Immunization recommendations

Routine vaccination requires multiple doses given over several weeks and is not recommended for the general population.  Post-exposure immunization has no utility.

Treatment of Patients

Symptomatic patients with suspected or confirmed plague should be managed according to current guidelines.  Recommendations for specific therapy are beyond the scope of this document.  For up-to-date information and recommendations for therapy, contact CDC or state health department.

Infection Control Practices for Patient Management

Isolation precautions

For pneumonic plague, Droplet Precautions should be used in addition to Standard Precautions.

Droplet Precautions are used for patients known or suspected to be infected with microorganisms transmitted by large particle droplets, generally larger than 5 in size, that can be generated by the infected patient during coughing, sneezing, talking, or during respiratory-care procedures.

Droplet Precautions require healthcare providers and others to wear a surgical-type mask when entering the room of the infected patient.

Droplet Precautions should be maintained until patient has completed 72 hours of antimicrobial therapy.

Patient placement

Patients suspected or confirmed to have pneumonic plague require Droplet Precautions. Patient placement recommendations for Droplet Precautions include:

Placing infected patient in a private room.

Cohort in symptomatic patients with similar symptoms and the same presumptive diagnosis (i.e. pneumonic plague) when private rooms are not available.

Maintaining spatial separation of at least 3 feet between infected patients and others when cohorting is not achievable.

Avoiding placement of patient requiring Droplet Precautions in the same room with an immunocompromised patient.

Special air handling is not necessary and doors may remain open.

Patient transport

Limit the movement and transport of patients on Droplet Precautions to essential medical purposes only.

Minimize dispersal of droplets by placing a surgical mask on the patient when transport is necessary.

Cleaning, disinfection, and sterilization of equipment and environment

Principles of Standard Precautions should be generally applied to the management of patient-care equipment and for environmental control (see Section I for more detail).

Discharge management

Generally, patients with pneumonic plague would not be discharged from a healthcare facility until no longer infectious (completion of 72 hours of antimicrobial therapy) and would require no special discharge instructions. In the event of a large bioterrorism exposure with patients receiving care in their homes, home care providers should be taught to use Standard and Droplet Precautions for all patient care.

Post-mortem care

Standard Precautions and Droplet Precautions should be used for post-mortem care.

Post Exposure Management

Decontamination of patients / environment

The risk for re-aerosolization of Y. pestis from the contaminated clothing of exposed persons is low. In situations where there may have been gross exposure to Y. pestis, decontamination of skin and potentially contaminated fomites (e.g. clothing or environmental surfaces) may be considered to reduce the risk for cutaneous or bubonic forms of the disease.3 The plan for decontaminating patients may include:

Instructing patients to remove contaminated clothing and storing in labeled, plastic bags.

Handling clothing minimally to avoid agitation.

Instructing to patients to shower thoroughly with soap and water (and providing assistance if necessary) in the decontamination room of the ED.

Instructing personnel regarding Standard Precautions and wearing appropriate barriers (e.g. gloves, gown, face shield) when handling contaminated clothing or other contaminated fomites.

Performing environmental surface decontamination using an EPA-registered, facility-approved sporicidal/germicidal agent or 0.5% hypochlorite solution (one part household bleach added to nine parts water).

Prophylaxis

Recommendations for prophylaxis are subject to change. Up-to-date recommendations should be obtained in consultation with Chatham County, NC state health departments and CDC.
Post-exposure prophylaxis should be initiated following confirmed or suspected bioterrorism Y. pestis exposure, and for post-exposure management of healthcare workers and others who had unprotected face-to-face contact with symptomatic patients (Table 2).

Prophylaxis should continue for 7 days after last known or suspected Y. pestis exposure, or until exposure has been excluded.

Triage and management of large scale exposures / potential exposures

Advance planning should include identification of sources for appropriate masks to facilitate adherence to Droplet Precautions for potentially large numbers of patients and staff. Instruction and reiteration of requirements for Droplet Precautions (as opposed to Airborne Precautions) will be necessary to promote compliance and minimize fear and panic related to an aerosol exposure.

Advance planning should also include identification of:

Sources of bulk prophylactic antibiotics and planning for acquisition on short notice.

Locations, personnel needs and protocols for administering prophylactic post-exposure care to large numbers of potentially exposed individuals.

Means for providing telephone follow-up information and other public communications services.

See Section I for additional general details regarding planning for large-scale patient management.

Laboratory Support and Confirmation

Laboratory confirmation of plague is by standard microbiologic culture, but slow growth and misidentification in automated systems are likely to delay diagnosis. For decisions regarding obtaining and processing diagnostic specimens, contact Lab Corp, State laboratory authorities or CDC may be contacted for assistance.

Diagnostic samples

Diagnostic samples to obtain include:

Serum for capsular antigen testing.

Blood cultures.

Sputum or tracheal aspirates for Gram's, Wayson's, and fluorescent antibody staining.

Sputum or tracheal aspirates for culture.

Laboratory selection

Handling of clinical specimens should be coordinated with Chatham County, NC state health departments, and undertaken in Bio-Safety Level (BSL) -2 or -3 laboratories. The FBI will coordinate collection of evidence and delivery of forensic specimens to FBI or Department of Defense laboratories.

Transport requirements

Specimen packaging and transport must be coordinated with Lab Corp.  For specific instructions, contact the Bioterrorism Emergency Number at the CDC Emergency Response Office, 770/488-7100.  Advance planning should include identification of appropriate packaging materials and transport media in collaboration with the clinical laboratory at individual facilities.

Patient, Visitor, and Public Information

Prepared fact sheets for including a clear description of Droplet Precautions, symptoms of plague, and instructions to report for evaluation and care if such symptoms are recognized should be developed.  The difference between prophylactic antimicrobial therapy and treatment of an actual infection should be clarified.  Decontamination by showering thoroughly with soap and water can be recommended.

Smallpox

Description of Agent/Syndrome

Etilogy

Smallpox is an acute viral illness caused by the variola virus. Smallpox is a bioterrorism threat due to its potential to cause severe morbidity in a nonimmune population and because it can be transmitted via the airborne route.  A single case is considered a public health emergency.

Clinical features

Acute clinical symptoms of smallpox resemble other acute viral illnesses, such as influenza. Skin lesions appear, quickly progressing from macules to papules to vesicles.  Other clinical symptoms to aid in identification of smallpox include:

2-4 day, non-specific prodrome of fever, myalgias.
rash most prominent on face and extremities (including palms and soles) in contrast to the truncal distribution of varicella.

rash scabs over in 1-2 weeks.

In contrast to the rash of varicella, which arises in “crops,” variola rash has a synchronous onset.

Mode of transmission

Smallpox is transmitted via both large and small respiratory droplets. Patient-to-patient transmission is likely from airborne and droplet exposure, and by contact with skin lesions or secretions.  Patients are considered more infectious if coughing or if they have a hemorrhagic form of smallpox.

Incubation period

The incubation period for smallpox is 7-17 days; the average is 12 days.

Period of communicability

Unlike varicella, which is contagious before the rash is apparent, patients with smallpox become infectious at the onset of the rash and remain infectious until their scabs separate (approximately 3 weeks).

Period of communicability

Unlike varicella, which is contagious before the rash is apparent, patients with smallpox become infectious at the onset of the rash and remain infectious until their scabs separate (approximately 3 weeks).

Preventive Measures

Vaccine availability

A live-virus intradermal vaccination is available for the prevention of smallpox.

Immunization recommendations

Since the last naturally acquired case of smallpox in the world occurred more than 20 years ago, routine public vaccination has not been recommended.  Vaccination against smallpox does not reliably confer lifelong immunity.  Even previously vaccinated persons should be considered susceptible to smallpox.

Treatment of Patients

Symptomatic patients with suspected or confirmed smallpox should be managed according to current guidelines.  Recommendations for specific therapy are beyond the scope of this document.  For up-to-date information and recommendations for therapy, contact the CDC or state health department.

Infection Control Practices for Patient Management

Isolation precautions

For patients with suspected or confirmed smallpox, both Airborne and Contact Precautions should be used in addition to Standard Precautions.
Airborne Precautions are used for patients known or suspected to be infected with microorganisms transmitted by airborne droplet nuclei (small particle residue, 5 or smaller in size) of evaporated droplets containing microorganisms that can remain suspended in air and can be widely dispersed by air currents.

Airborne Precautions require healthcare providers and others to wear an N95 respirator when entering the patient room.  In the case of a large patient population, additional employees might need to be fit tested to wear the N95.

Contact Precautions are used for patients known or suspected to be infected or colonized with epidemiologically important organisms that can be transmitted by direct contact with the patient or indirect contact with potentially contaminated surfaces in the patient's care area.

Contact precautions require healthcare providers and others to:

Wear clean gloves upon entry into patient room.

Wear gown for all patient contact and for all contact with the patient's environment. Gown must be removed before leaving the patient's room.

Wash hands using an antimicrobial agent.

Patient Placement

Patients suspected or confirmed with smallpox require placement in rooms that meet the ventilation and engineering requirements for Airborne Precautions, which include:

Monitored negative air pressure in relation to the corridor and surrounding areas.

6 – 12 air exchanges per hour.

Appropriate discharge of air to the outdoors, or monitored high efficiency filtration of air prior to circulation to other areas in the healthcare facility.

A door that must remain closed.

Patient placement in a private room is preferred. However, in the event of a large outbreak, patients who have active infections with the same disease (i.e., smallpox) may be cohorted in rooms that meet appropriate ventilation and airflow requirements for Airborne Precautions.

Patient transport

Limit the movement and transport of patients with suspected or confirmed smallpox to essential medical purposes only.
When transport is necessary, minimize the dispersal of respiratory droplets by placing a surgical mask on the patient, if possible.

Cleaning, disinfection, and sterilization of equipment and environment

A component of Contact Precautions is careful management of potentially contaminated equipment and environmental surfaces.

When possible, noncritical patient care equipment should be dedicated to a single patient (or cohort of patients with the same illness).

If use of common items is unavoidable, all potentially contaminated, reusable equipment should not be used for the care of another patient until it has been appropriately cleaned and reprocessed. Policies should be in place and monitored for compliance.

Discharge management

In general, patients with smallpox will not be discharged from a healthcare facility until determined they are no longer infectious. Therefore, no special discharge instructions are required.

Post-mortem care

Airborne and Contact Precautions should be used for post-mortem care.

Post Exposure Management

Decontamination of patients / environment

Patient decontamination after exposure to smallpox is not indicated.
Items potentially contaminated by infectious lesions should be handled using Contact Precautions.

Prophylaxis and post-exposure immunization

Recommendations for prophylaxis are subject to change.  Up-to-date recommendations
should be obtained in consultation with Chatham County, NC state health departments and CDC.

Post-exposure immunization with smallpox vaccine (vaccinia virus) is available and effective.  Vaccination alone is recommended if given within 3 days of exposure.  Passive immunization is also available in the form of vaccinia immune-globulin (VIG) (0.6ml/kg IM).  If greater than 3 days has elapsed since exposure, both vaccination and VIG are recommended. 12 VIG is maintained at USAMRIID, 301/619-2833.

Vaccination is generally contraindicated in pregnant women, and persons with immunosuppression, HIV–infection, and eczema, who are at risk for disseminated vaccinia disease.  However, the risk of smallpox vaccination should be weighed against the likelihood for developing smallpox following a known exposure. VIG should be given concomitantly with vaccination in these patients.

Following prophylactic care, exposed individuals should be instructed to monitor themselves for development of flu-like symptoms or rash during the incubation period (i.e., for 7 to 17 days after exposure) and immediately report to designated care sites selected to minimize the risk of exposure to others.

Triage and management of large scale exposures / potential exposures

Advance planning should include identification of sources for appropriate masks to facilitate adherence to Droplet Precautions for potentially large numbers of patients and staff.  Instruction and reiteration of requirements for Droplet Precautions (as opposed to Airborne Precautions) will be necessary to promote compliance and minimize fear and panic related to an aerosol exposure.

Laboratory Support and Confirmation

Diagnostic samples to obtain

For decisions regarding obtaining and processing diagnostic specimens, contact state laboratory authorities for North Carolina or CDC.

Laboratory selection

Handling of clinical specimens must be coordinated with state health departments, CDC, and USAMRIID.  Testing can be performed only in BSL - 4 laboratories. The FBI will coordinate collection of evidence and delivery of forensic specimens to FBI or Department of Defense laboratories.

Transport requirements

Specimen packaging and transport must be coordinated with Lab Corp.  For specific instructions, contact the Bioterrorism Emergency Number at the CDC Emergency Response Office, 770/488-7100.  Advance planning may include identification of appropriate packaging materials and transport media in collaboration with the clinical laboratory at individual facilities.

Patient, Visitor, and Public Information

Fact sheets for distribution should be prepared, including a clear description of symptoms and where to report for evaluation and care if such symptoms are recognized. Details about the type and duration of isolation should be provided.  Vaccination information that details who should receive the vaccine and possible side effects should be provided.  Extreme measures such as burning or boiling potentially exposed materials should be discouraged.

Implementation

Implementation of this policy is the responsibility of Nursing, Medical Staff, Administration, Infection Control, and Hospital Security.

APPROVED BY HOSPITAL INFECTION CONTROL COMMITTEE

Reference List

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10. Franz D, Jahrling PB, Friedlander AM, McClain DJ, Hoover DL, Bryne WR, et al.  Clinical recognition and management of patients exposed to biological warfare agents. JAMA 1997;278:399-411.
11. U.S.Army medical research institute of infectious diseases. Medical management of biological casualties. Fort Detrick:USAMRIID; 1998.
12. Anonymous. Drugs and vaccines against biological weapons. Med Lett Drugs Ther 1999;41:15-6.
13. Shapiro RL, Hatheway C, Becher J, Swerdlow DL. Botulism surveillance and emergency response. JAMA 1997;278:433-5.
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15. Federal Register.  Respiratory protective devices; final rules and notice. 1995.

Appendix 2: Telephone Number of NC Public Health Director

North Carolina
NC Department of Health and Human Services
State Health Director
Phone No. (919) 733-4392
Fax No. (919) 715-4645

US Patent Numbers 7,720,998 B2, 7,836,207