Emergency Response Protocol Review

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Emergency Response Protocol Review

• Pete Shult, Ph.D.
• Director, Communicable Disease Division
• Emergency Laboratory Response
• Wisconsin State Laboratory of Hygiene
• Phone [phone]
• Email shult_at_mail.slh.wisc.edu

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The Laboratory Response Network

• An integrated network of state local public
  health, clinical, federal, military,
  international laboratories to respond to
  bioterrorism, chemical terrorism and other public
  health emergencies.
• National Labs CDC, FBI USAMRIID
• Reference Labs - State local PHLs, state agency
  labs
• Sentinel Labs Hospital community clinical labs

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Locations of Reference and Sentinel Laboratories
in Wisconsin
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Increased Testing Capability Bioterrorism Agents

• Category A Agents
• Anthrax (Bacillus anthracis)
• Botulism (Clostridium botulinum toxin)
• Plague (Yersinia pestis)
• Smallpox (variola major)
• Tularemia (Francisella tularensis)
• Viral hemorrhagic fevers (e.g., Ebola, Marburg,
  Lassa)

• Category B Agents
• Brucellosis (Brucella)
• Epsilon toxin of C. perfringens
• Food Threats (e.g., Salmonella, E. coli O157H7,
  Shigella)
• Glanders (Burkholderia mallei)
• Melioidosis (Burkholderia pseudomallei)
• Psittacosis (Chlamydia psittaci)
• Q Fever (Coxiella burnetii)
• Ricin toxin from castor beans
• Staphylococcal enterotoxin B
• Typhus fever (Rickettsia prowazekii)
• Viral encephalitis (e.g., VEE, EEE)
• Water threats

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What Difference Does All of This Make?
Influenza H2N2 2005
Avian Influenza 2004-2006
Powders 2001
SARS 2003
Monkeypox 2003
Pertussis 2003-2005

• All Hazards Capabilities Developed
• ? Courier ? Shipper Repositories
• Messaging ? Rapid Testing
• Rapid Reporting ? Surge Capacity
• ? Collaboration/Communication with Other
  Laboratories

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Overt vs. Covert EventsRecognition
Overt Event
Responder Community
Public Health Community
Health Care Community
Covert Event
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Wisconsins Two-Tiered Laboratory Communications
Plan
Response Just in Time
Preparedness Just In Case
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WLRN RESOURCES - 2006
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Emergency Response Protocol Review

• When to contact
• WSLH and how?

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Emergency Response Protocol Review

• When to contact WSLH?
• Suspicion of bioterrorism event
• Suspicion of chem-terrorism event
• Suspicion of or inability to rule out BT agents
• Consultation for problematic isolates
• Specimen/isolate transport guidance
• Guidance for transfer/disposal of
• Select Agents
• How to contact WSLH?
• Emergency Response 24/7 Messaging
• Center 608-263-3280

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Emergency Response Protocol Review

• Who else to contact
• and how?

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Emergency Response Protocol Review

• Who else to contact and how?
• Your Local Health Department
• Wisconsin Division of Public Health
• FBI

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Emergency Response Protocol Review

• How to submit specimens?

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Emergency Response Protocol Review

• Do you know where your specimen kit repositories
  are?

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Increased Specimen Transport Capability
Wisconsin Emergency Response Shipper Repository
Sites by County, March, 2005
WisconsinEmergency Response Shippers
distributed to 89 Local Health Departments
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Chain of Custody What Is It?

• Chronological record of who had custody of or
  access to evidence from acquisition to disposal

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Chain of Custody Why Do We Care?

• Terrorism is a criminal activity.
• All patient samples and property associated with
  a terrorism incident are potential evidence.
• Any personnel could be required to testify.
• Process documentation must meet legal
  requirements.

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Chain of Custody When to Initiate?

• At sample collection if suspected or announced
  terrorism event
• As soon as recognized a terrorism event has
  occurred
• Note C of C documentation cannot be established
  retrospectively
• When it is suspected/confirmed that isolate may
  be priority BT agent

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Chain of Custody How to ensure?

• At sample collection
• At sample transport
• At sample receipt
• At sample aliquotting or splitting
• At sample storage
• Records retention
• Maintaining C of C documentation

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WSLH Chain of Custody Form
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Chain of Custody Other Recommendations

• Identify a location that can be locked secured
  with limited/controlled access.
• Complete chain of custody every time you handle
  specimen or remove specimen for testing.
• Keep chain of custody form secure even after
  evidence discarded or returned.
• Maintain and follow SOPs for laboratory
  procedures in compliance with regulations
• Note Many chain of custody requirements are
  simply enhancements of what laboratories must do
  to meet CLIA/CAP/JCAHO requirements.
• If questions, consult law enforcement

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Biosafety and Laboratory Security
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Biosafety

• Principles of biosafety
• Elements of personnel and lab environment
  protection
• Laboratory practice and technique
• Safety equipment (primary barriers)
• Facilities (secondary barriers)
• Biosafety levels
• 4 levels
• Purpose To categorize risk associated with
  infectious agent and define the appropriate
  safety practices for handling the agent safely
• Exposure risk increases when agent is amplified
  or lab practices that generate aerosols are used
• Be aware of the potential for exposure to a BSL4
  agent

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Biosafety

• Minimum biosafety level for emergency response
• Strict BSL2 practices, equipment and facility
  required for safe BT response in sentinel lab
• Biosafety cabinets (BSCs) are a must!
• But the reality is
• Needs to be an organizational priority
• How can we help?
• What about a BSL3 agent but no BSL3 lab?
• A solution to both of these problem
• Mix match PPE and good practice with
  equipment and facility based on risk assessment

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Biosafety

• Importance of Risk Assessment

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Wisconsin Influenza Rapid Testing Sites
Identified in 2004-2005

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Laboratory Security

• Do you have a laboratory security plan?

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Select Agent Regulations

• What are Select Agents, what is the Select
• Agent Regulation and who is affected?
• Establishes a listing of agents thought to
• pose a threat to public safety
• Requires entities that possess any of
• these agents to follow the guidelines
• within this regulation
• http//www.cdc.gov/od/sap
• http//www.aphis.usda.gov/programs/
• agselectagent/index.html

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Select Agent RegulationsFor those of us who
may possess these agents

• Registration
• Personnel
• Facilities
• Access control
• Security
• Inventory Records

• Documentation
• Transfer of agents
• Reporting
• Training
• Emergency Response Plan
• Biologic exposure response

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Select Agent Regulations

• However, the good news is
• Most clinical or diagnostic laboratories do not
• store Select Agents.
• You, however, may encounter them in the
• course of diagnostic testing. So what then?

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Select Agent Reporting

• If you think you are dealing with a Select Agent
• Contact Dr. David Warshauer, Ph.D at the WSLH
  (608-265-9115)
• or
• Call the WSLH Emergency Answering Service
  (608 263-3280

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Select Agent Reporting

• After confirmation of a Select Agent
• Refer to guidance document
• Contact CDC by telephone, fax, or e-mail
• Phone [phone]
• Fax [phone]
• E-mail lrsat_at_cdc.gov
• Within 7 days of identification
• Transfer select agent to a registered entity or
• Destroy on-site by a recognized sterilization or
  inactivation process e.g. autoclave, incinerate,
  bleach
• Documentation
• CDC Form 4
• Maintain a copy of the record for 3 years

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Select Agent RegulationsHow Seriously Are They
Taken

• Zero tolerance to any violations
• Severe penalties for egregious violations

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Emergency Response Protocol Review

• Questions?