Module 2

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Module 2
CDC/UNMC Biosafety Level-3 Training
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Who needs this training?

• All individuals who work with or have access to
  indigenous or exotic agents which may cause
  serious or potentially lethal disease as a result
  of exposure by the inhalation route.
• Laboratory personnel are required to have
  specific training in handling pathogenic and
  potentially lethal agents.
• Training is required on an annual basis.

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Biosafety Level 3Outline

• Introduction
• Standard practices and equipment
• Laboratory facilities
• Special practices
• Medical surveillance
• Emergency response

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Biosafety Level 3Introduction

• Suitable for work with infectious agents which
  may cause serious or potentially lethal disease
  as a result of exposure by the inhalation route.

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Biosafety Level 3Introduction

• Exposure potential to pathogens spread by
  aerosol
• Infection is serious and possibly lethal
• Examples
• Mycobacterium tuberculosis
• Francisella tularensis
• Coxiella burnetii

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Standard Practices and Equipment
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Biosafety Level 3Standard Microbiological
Practices
As used in BSL-1 2
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Biosafety Level 3Safety Equipment (Primary
Barriers)

• BSL-1 and 2 Safety Equipment PLUS
• Class II A or B
• biological safety
• cabinet to
• manipulate
• infectious
• materials

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Biosafety Level 3Safety Equipment (Primary
Barriers)

• Respiratory protection may be recommended but not
  always required
• Laboratory specific requirement
• N95 respirator commonly used
• Fit testing required through Employee Health

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Laboratory Facilities
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Biosafety Level 3Laboratory Facilities
(Secondary Barriers)

• BSL-1 and 2 Facilities PLUS
• Separate building or isolated zone
• Double-door entry doors are self-closing
• Directional inward airflow (negative pressure)
• Single-pass air 12 or more air changes/hour
• Hands-free or automatically operated sink with
  eye wash station

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Biosafety Level 3Laboratory Facilities
(Secondary Barriers)

• Enclosures required for aerosol generating
  equipment
• Room penetrations sealed
• Walls, floors and ceilings are water resistant
  for easy cleaning
• Visual and audible alarms for air system failure
  notification

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Biosafety Level 3Laboratory Facilities
(Secondary Barriers)

• Documented facility design and operational
  procedures.
• Facility tested for operational verification
  prior to use following remodeling.
• Facility re-verified, at least annually,

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Special Practices
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Biosafety Level 3Special Practices

• Work in certified biological safety cabinet
• Certified annually!!!
• Use bioaerosol-containing equipment
• Decontaminate spills promptly

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Biosafety Level 3 Special Practices

• Lab Personnel must
• Strictly follow guidelines
• Demonstrate proficiency
• Receive appropriate training
• Report incidents
• Participate in medical surveillance program
• Be trained in biosecurity procedures

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Medical Surveillance
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Medical SurveillanceCriteria
Biosafety Level 3

• Medical Surveillance criteria is based on a risk
  assessment of the biological agents used.

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Medical SurveillanceRisk Assessment
Biosafety Level 3

• What is the natural host of the biological agent?
• Does the agent cross species barriers?
• Is it a wild-type agent or attenuated?
• Is the agent infectious for a normal healthy
  adult?
• What effect will the agent have on an adult if
  immunocompromised? if pregnant?

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Medical SurveillanceRisk Assessment
Biosafety Level 3

• What is the mode of transmission for the agent?
• contact
• mucous membrane exposure
• ingestion
• inoculation
• inhalation

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Medical SurveillanceRisk Assessment
Biosafety Level 3

• What volume of the agent is being manipulated?
• What is the concentration of the agent?
• What is the infectious dose of the agent?

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Medical SurveillanceRisk Assessment
Biosafety Level 3

• Prophylaxis
• What, if any immunizations are required?
• What pharmaceuticals are available?
• What is the effectiveness of prophylaxis?
• Post-Exposure
• What are the anti-microbial agents available for
  treatment?
• What is the effectiveness of treatment?

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Medical SurveillanceRisk Assessment
Biosafety Level 3

• When dealing with an unknown agent
• Is there any known epidemiological data?
• Are there any patterns parallel to other agents?
• Is there any data from animal studies?
• Is the route of infection known?

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Emergency Response
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Biosafety Level 3Emergency Response

• Must be outlined for each laboratory and include
• 24/7 Contact information
• Security/Dispatch personnel
• Laboratory Safety and Security Officer
• Institutional Biosafety Officer
• A list of
• agents secured in laboratory
• researchers allowed access to each agent
• the personal protective equipment and
  immunizations required

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Biosafety Level 3Emergency Response

• Procedures must be outlined for the following
• Major and minor spills outside the biological
  safety cabinet
• Failure of the biological safety cabinet
• Loss of power
• Fire
• Security breaches

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Biological Spill

• All biological spills must be reported
  immediately to the PI or supervisor
• Follow procedures outlined in the Biological
  Spill Clean-up procedure (IBC04)
• Report the incident to the IBC

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Biosafety Level 3Reference

• For additional information consult the
• UNMC Biosafety Manual
• Biosafety Officer
• Institutional Biosafety Committee

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This completes Module 2 on General Biosafety.
Please continue with the test.An 80 pass on
the test is required for successful completion of
this training