Review of Laboratory Response Protocols

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Review of Laboratory Response Protocols

• Carol Kirk
• Laboratory Network Coordinator
• Joni Wedig
• Assistant Laboratory Network Coordinator
• Wisconsin State Laboratory of Hygiene

September 19, 2007
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Review of Laboratory Response Protocols
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Review of Laboratory Response Protocols

• Objectives
• Identify circumstances when emergency laboratory
  response protocols should be followed/activated
• Understand the importance of notifying WLSH prior
  to shipping emergency response samples
• Review the instructions for packaging/shipping
  for both emergency response and exercise protocols

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Review of Laboratory Response Protocols

• Purpose of this Review
• Respond to questions that arose during/after
  previous notification shipping exercises
• Provide a reminder of the protocols
• Present an opportunity for direct questions

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Review of Laboratory Response Protocols

• What is the Emergency Laboratory
• Response Protocol?
• Notify public health agency
• Notify the Wisconsin State Laboratory of Hygiene
• 24/7 message center
• Notify internal contacts per protocol
• Implement appropriate biosafety, security, and
  chain of evidence protocols
• Classify and package the sample
• Arrange transport to the WSLH

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Review of Laboratory Response Protocols

• Emergency
• An unexpected situation or sudden occurrence of
  a serious and urgent nature that demands
  immediate action.
• (Websters definition)

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Review of Laboratory Response Protocols

• Common Laboratory Emergencies
• ER Trauma
• Equipment Failure
• Controls Out of Range
• Short Staffing
• These do not require activation of emergency
  laboratory response protocols described here.

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Review of Laboratory Response Protocols

• When is the Emergency Laboratory
• Response Protocol Required?
• When a chemical terrorism event is suspected or
  confirmed
• When a bioterrorism event is suspected or
  confirmed
• When you suspect or are unable to rule out a
  priority agent of bioterrorism or select agent
• When you suspect an emerging infectious disease
  of urgent public health significance

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Review of Laboratory Response Protocols

• When is the Emergency Laboratory
• Response Protocol Not Required?
• Routine testing and sample submission
• Agents of public health importance, but not
  laboratory emergencies (depending on
  circumstances)
• Following are examples
• Measles
• Mumps
• Rubella
• Pertussis
• Arboviruses (e.g., West Nile Virus, LaCrosse
  Encephalitis)
• E. coli and other enteric pathogens

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Review of Laboratory Response Protocols

• Frequently Asked Questions
• When is Chain of Evidence Required?
• For all specimens where a bioterrorism event or
  chemical terrorism event is suspected or
  confirmed
• For any specimen for which you believe that legal
  action may be involved
• When do you begin Chain of Evidence
  documentation?
• As soon as need for documentation is recognized
• At specimen collection, if possible

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Review of Laboratory Response Protocols

• Frequently Asked Questions
• Why Notify WSLH?
• Prior notification allows WSLH to allocate staff
  and reschedule testing, if needed

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Review of Laboratory Response Protocols

• Scenario 1 Suspected or Confirmed Chemical
  Terrorism Event
• Laboratory Response
• Notify public health
• Notify WSLH before collecting any specimens
• Specific instructions will be provided - May be
  updated CDC instructions
• Collect specimens as instructed
• Institute chain of evidence procedures
• Package as instructed
• Transport as instructed probable authorization
  for emergency pick-up and delivery

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Review of Laboratory Response Protocols

• Scenario 2 Suspected or Confirmed Bioterrorism
• Event
• Laboratory Response
• Notify public health
• Notify WSLH
• Discuss whether on-site testing is appropriate
• Collect clinical specimens using appropriate
  safety precautions
• Institute chain of evidence procedures
  immediately at specimen collection
• Classify and package as Category A - Infectious
  Material or Category B - Biological Substance,
  depending on suspected agent.
• Transport as instructed probable authorization
  for emergency pick-up and delivery

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Review of Laboratory Response Protocols

• Scenario 2
• Suspected or Confirmed
• Bioterrorism Event
• REMINDER
• No powders
• in clinical laboratories!

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Review of Laboratory Response Protocols

• Scenario 3 Suspected or Confirmed Bioterrorism
  Agent or Select Agent
• Examples
• Bacillus anthracis
• Francisella tularensis
• Brucella species
• Yersinia pestis
• Botulinum toxin
• Smallpox
• Coxiella burnetii
• Burkholderia mallei and pseudomallei
• Viral hemorrhagic fever

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Review of Laboratory Response Protocols

• Scenario 3 Suspected or Confirmed Bioterrorism
  or Select Agent (continued)
• Laboratory Response
• Notify public health agency
• Notify WSLH
• Discuss whether on-site testing and additional
  safety precautions are appropriate
• Notify internal contacts per your procedures
• Collect samples/isolates
• Secure all material

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Review of Laboratory Response Protocols

• Scenario 3 Suspected or Confirmed Bioterrorism
  or Select Agent (continued)
• Laboratory Response
• Package as Category A Infectious Material
• Transport as instructed possible authorization
  for emergency pick-up and delivery
• If Select Agent confirmed
• Notify CDC per WSLH guidance
• Complete CDC Form(s)
• Transfer or dispose of remaining material within
  7 days of notification

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Review of Laboratory Response Protocols

• Scenario 4 Suspected or Confirmed Infectious
  Disease of Urgent Public Health Significance
• Examples
• Severe Acute Respiratory Syndrome (SARS)
• Monkeypox
• Human Case of H5N1 (Avian) Influenza

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Review of Laboratory Response Protocols

• Scenario 4 Suspected or Confirmed Infectious
  Disease of Urgent Public Health Significance
  (continued)
• Laboratory Response
• Notify public health agency
• Discuss whether on-site testing and additional
  safety precautions are appropriate
• Notify WSLH
• Notify internal contacts per your procedures
• Collect samples/isolates
• Package and transport as instructed possible
  authorization for emergency pick-up and delivery

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Emergency Laboratory Response Specific
Scenario A
Review of Laboratory Response Protocols
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Review of Laboratory Response Protocols
Specific Scenario Growth on Sheep Blood Agar

• Rapid Grower
• Non Hemolytic
• Irregular Edges
• Comma-Like Projections
• Ground Glass Appearance
• Tenacious Colonies

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Review of Laboratory Response Protocols

• Gram Stain demonstrates Gram positive rods with
  central to sub terminal spores (image on right)

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Review of Laboratory Response Protocols

• Additional Biochemical Testing
• Catalase Result Positive
• Motility Result Negative
• NOTE All additional testing and/or manipulation
  is done inside of a Biological Safety Cabinet
  (BSC)

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Review of Laboratory Response Protocols
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Review of Laboratory Response Protocols

• Suspect Bacillus Anthracis
• What are the laboratorys responsibilities?
• Contact WSLH 24/7 messaging system
• Notify Infection Control and Local Health
• Secure or Destroy culture plates
• Complete CDC Form(s)

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Review of Laboratory Response Protocols

• If growth from a significant source takes at
  least 48 hours or more to get visible growth
• Use the following algorithm

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Review of Laboratory Response Protocols
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Review of Laboratory Response Protocols

• Inside the BSC
• Gram Staining
• Catalase
• Oxidase

Perform Rule-Out Testing
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Review of Laboratory Response Protocols

• Inside the BSC
• Urea
• Nitrate
• Motility
• Recommendation for Laboratories that do not
  routinely perform these tests
• Develop testing for use in all cases that meet
  criteria or establish protocol to refer to WSLH
  or reference laboratory

Perform Rule-Out Testing
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Review of Laboratory Response Protocols
Refer to WSLH or Reference Lab

• If sending to WSLH - Use Dunham Express or your
  courier
• Take the initiative to collect Patients history
• If Patients history has red flags, such as
  travel, then send as Infectious Substance -
  Category A
• If Patients history has no red flags then send
  as a Biological Substance - Category B

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Review of Laboratory Response Protocols

• Bioterrorism Preparedness Exercises
• 2 events per year
• 2 bacterial isolates/Bioterrorism agent
  surrogates
• Laboratories perform testing and report results
• NOTE Gram staining timing is critical!
• Must be performed within 15 minutes of hydrating
  the loops!

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Review of Laboratory Response Protocols

• Bioterrorism Preparedness
• Notification/Shipping Exercise
• Selected laboratories are contacted by WSLH in
  advance for participation
• Only contacted laboratories should send an
  isolate back to WSLH
• Follow instructions included with the isolates
  and the WERG binder, including contacting WSLH
  via 24/7 messaging/pager system

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Review of Laboratory Response Protocols

• Bioterrorism Preparedness
• Notification/Shipping Exercise
• ALL communications MUST be preceded by the
  following announcement
• This is a Wisconsin State Laboratory of
  Hygiene BT Preparedness Response Exercise
• Do NOT contact Infection Control and/or Local
  Health (but consider who you would contact in a
  true emergency!)

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Emergency Laboratory Response Specific Scenario
B
Review of Laboratory Response Protocols
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Suspect Human Case of H5N1 Influenza
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Review of Laboratory Response Protocols

• Scenario Suspected Human Case of
• H5N1 Avian Influenza
• Laboratory Response
• Notify Division of Public Health for testing
  approval
• Notify WSLH
• Collect samples using appropriate safety
  precautions
• Package and transport as instructed possible
  authorization for emergency pick-up and delivery
  in special circumstances

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Review of Laboratory Response Protocols

• Scenario Suspected Human Case of H5N1
  Avian Influenza
• Specimen Collection
• Consult LHD or DPH about safety precautions and
  PPE
• Collect one throat swab AND one NP swab place in
  the same vial of viral transport medium
• Use swabs with Dacron tip and aluminum or plastic
  shaft
• Place specimens at 4?C immediately maintain at
  refrigerator temperatures during transport
• Specimens should arrive at the WSLH within 24
  hours of collection

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Review of Laboratory Response Protocols

• Scenario Suspected Human Case of
• H5N1 Avian Influenza (continued)
• Reminders
• Do not perform viral culture in-house
• Do not rely on in-house rapid tests
• Do not transport to central lab or reference lab
  for transport to WSLH

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Packaging and Transport
Review of Laboratory Response Protocols
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Category B Packaging RequirementsGround
Transport
Review of Laboratory Response Protocols
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Category A Packaging Requirements Ground
Transport
Review of Laboratory Response Protocols
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Review of Laboratory Response Protocols

• Contact Information
• Carol Kirk
• Laboratory Network Coordinator
• Telephone [phone]
• Email cjk_at_mail.slh.wisc.edu
• Joni Wedig
• Asst. Laboratory Network Coordinator
• Telephone [phone]
• Email wedigjl_at_mail.slh.wisc.edu

WSLH 24/7 Emergency Answering Service (608)
263-3280