Download Peter A. Shult, Ph.D., Wisconsin State Laboratory of Hygiene

Laboratory Biosafety
WSLH Teleconference
June 27, 2007
Peter A. Shult, Ph.D.
Director, Communicable Disease Division
and Emergency Laboratory Response
Wisconsin State Laboratory of Hygiene
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1
Laboratory Biosafety
• Historical perspective
• Principles of biosafety
• Elements of containment including the
Biological Safety Cabinet (BSC)
• Biosafety levels
• Biosafety risk assessment
• Biosafety beyond the laboratory walls
• Biosecurity
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Laboratory Biosafety
Key Resources (I)
• Biosafety in Microbiological and Biomedical
Laboratories (BMBL),5th Ed.
U.S. Department of Health and Human Services
http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm
http://www.slh.wisc.edu/wps/wcm/connect/extranet/comdis/
• Laboratory Biosafety Manual, 3rd Ed.
World Health Organization, 2004
http://www.who.int.csr/resources/publications/biosafety/
WHO_CDS_CSR_LYO_2004_11/en/
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Laboratory Biosafety
Key Resources (II)
•
Primary Containment for Biohazards: Selection, Installation and
Use of Biological Safety Cabinets, 2nd Edition
U.S. Department of Health and Human Services
Public Health Service
Centers for Disease Control and Prevention and
National Institutes of Health
September 2000
http://www.cdc.gov/od/ohs/biosfty/bsc/bsc.htm
•
Control of Communicable Disease Manual, 18th Edition
David L. Heyman, MD, Editor
APHA
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Laboratory Biosafety
Key Resources(III)
• Public Health Guidance for Community-Level
Preparedness and Response to Severe Acute Respiratory
Syndrome (SARS),Version 2.3; July 20 2004
http://www.cdc.gov/ncidod sars/guidance
• Biological Safety: Principles and Practices, 4th Ed
ASM Press, 2006
• Laboratory Security and Emergency Response
Guidance for Labs Working with Select Agents
MMWR, December 6, 2002; Vol.51/ No. RR-19
http://www.cdc.gov/mmwr/PDF/RR/RR5119.pdf
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Laboratory Biosafety
Historical perspective (I)
• Landmark studies by Pike and Sulkin
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•
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Questionnaire assessment
Between 1930 – 1978, 4,079 LAIs with 168 deaths
Most common causative agents of overt infection include:
1. Brucella spp.
6. M.tuberculosis
2. C. burnetti
7. B. dermatidis
3. HBV
8. VEE
4. S. typhi
9. C.psittaci
5. F. tularensis
10. C.immitis
No specific accident or exposure event in > 80%
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Laboratory Biosafety
Historical perspective (II)
•
Followup worldwide literature search, 1979-2004
• 1, 141 overt infections, 24 deaths
• Most common causative agents of overt infection include:
1. M. tuberculosis
6. HBV
2. Arboviruses
7. Shigella spp.
3. C. burnetti
8. Salmonella spp
4. Hantavirus
9. HCV
5. Brucella spp.
10. N. meningitidis
• Many asymptomatic infections
• Many newer agents, e.g. SARS-CoV, Cryptosporidium, etc.
• No specific exposure event in most cases
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Laboratory Biosafety
Historical perspective (III)
What types of laboratories involved ?
% of LAIs according to laboratory type
1930-1975
1979-2004
Clinical
17%
46%
Research
59%
50%
Production
3%
3%
Teaching
3%
1%
Unknown
18%
< 1%
• Reasons for increase in LAIs in clinical labs?
• Better surveillance and reporting
• Absence of biosafety containment equipment
• Failure to use adequate containment procedures early in
diagnostic process
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Laboratory Biosafety
Historical perspective (IV)
What were the predominant means of exposure?
• As mentioned before no specific exposure event
identified in most cases
• Those identified included:
• Inhalation of aerosols generated by work
practices or procedures or spills
• Percutaneous inoculation
• Contamination of mucous membranes
• Ingestion
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Laboratory Biosafety
Principles of Biosafety
• The objective of biosafety is the containment of
potentially harmful biological agents
• The purpose of containment is to reduce/eliminate
exposure of lab workers, other persons and outside
environment to biohazardous agents
• Key elements of containment include:
• Laboratory practice and technique
• Safety equipment (primary barriers and PPE)
• Facility design and construction (secondary
barriers)
• Risk Assessment of the work to be done with a specific
agent or under specific circumstances determines the
appropriate combination of these elements to employ
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Laboratory Biosafety
Elements of Containment
Laboratory Practice and Technique
• Arguably the most important element of containment
• Awareness of potential hazards and training and experience
are critical
• Applies to pre-analytical, analytical and post-anaytical
processes
• What about non-traditional testing sites and personnel?
• Behavioral factors
• Need for clear focus on work – all ages
• “Creative innovation” and risk taking
• Suggested age relation
• Lose the bad habits: sniffing, “hot looping”, etc.
• Working in absence of other containment elements
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Laboratory Biosafety
Elements of Containment
Safety Equipment (Primary barriers and PPE)
• Available for each possible route of exposure
•
•
•
•
Aerosol: BSCs, covered centrifuge carriers, loop
incinerators or disposable loops, PPE (respirators, PAPRs)
Percutaneous: sharps disposal; retractable needles
Mucous membrane contact: goggles or safety glasses,
face shields, gloves
Ingestion: automatic pipetting devices
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Laboratory Biosafety
Elements of Containment
The Biological Safety Cabinet (I)
Arguably the single most important piece of safety
equipment in the laboratory!
• Information Resources
• Importance of the Biological Safety Cabinet
• The principal device used to provide containment
of infectious splashes or aerosols generated by
many microbiological procedures
• Provides protection to the operator, the laboratory
environment and work materials
• Which type is for you?
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Laboratory Biosafety
Elements of Containment
The Biological Safety Cabinet (II)
• Follow proper BSC work practices and procedures
•
BMBL5, Appendix A
• They don’t work at all if you don’t use them!
• Need for a lab-specific algorithm for BSC use
• A POLICY ISSUE
• Tie into risk assessment
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Laboratory Biosafety
Element of Containment
Facility Design and Construction (Secondary Barriers)
• Contributes to laboratorian safety, however, primary
role is to protect persons outside of the lab and persons
in the community from agents that might be
accidentally released.
• Recommended secondary barriers depend on the risk of
transmission of specific agents
•
BSL-1/BSL-2 vs. BSL-3
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Laboratory Biosafety
Biosafety Levels
• 4 biosafety levels
• Consist of combinations of lab practices and techniques,
safety equipment and lab facilities
• Purpose: To categorize risk associated with infectious agent and
define the appropriate safety practices, equipment and facilities
for handling the agent safely
• Appropriate BSL determined by:
• Microbiological agent Risk Group
• Mode of transmission
• Procedural protocols
• Experience of staff
• Likelihood of aerosol generation
• Work involves use of amplified agent
• __________________________________________________________WSLH
Other?
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W.H.O. Agent Risk Group Classification
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Recommended Biosafety Levels for Infectious Agents
“Biosafety in Microbiological and Biomedical Laboratories”,5th Ed
BSL
Agents
Microbiology
Practices
Safety Equipment
(Primary Barriers)
Facilities
(Secondary Barriers)
Standard Microbiological
Practices
None required
1
Not known to
consistently cause
disease in healthy
adults
Open bench top sink
required
BSL-1 plus: Limited access,
biohazard warning signs,
“sharps” precautions,
biosafety manual defining
waste decontamination &
medical surveillance policies
3
Indigenous or exotic
agents with potential
aerosol transmission;
may have serious or
lethal consequences
BSL-2 plus: Controlled
access; Decontamination of
all waste & lab clothing
before laundering; Baseline
serum
Class I or II BSCs or other
physical containment for
manipulations of agents
that cause splashes or
aerosols of infectious
materials, PPE: lab coats,
gloves, face protection as
needed
Class I or II BCSs or other
physical containment for
all manipulations; PPE:
protective clothing;
gloves; respiratory
protection as needed
BSL-1 plus: Autoclave
2
Associated with human
disease, hazard equals
percutaneous injury,
ingestion, mucous
membrane exposure
4
BSL-2 plus: Physical
separation from corridors;
Self-closing, double-door
access; Exhausted air not
recirculated; Negative
airflow into laboratory
Dangerous/exotic
BSL-3 practices plus:
All procedures in Class III BSL-3 plus: Separate
agents with high risk of Clothing change before
BSCs or Class I or II
building or isolated zone,
life-threatening disease, entering, shower on exit, all
BSCs in combination with dedicated supply, exhaust,
aerosol-transmitted
material decontaminated on
full-body, air-supplied,
vacuum, & decon
infections; or related
exit
positive pressure
systems; other
agents
with unknown
personnel suit
requirements.
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risk of transmission
Laboratory Biosafety
Risk Assessment
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Handling Unusual Test Requests in the
Clinical Lab
What is meant by “unusual test request”?
• “Novel” agents, high public health impact
•
SARS, Monkeypox, Avian influenza, smallpox
• Agents of particular public health importance
•
Mumps, measles, rubella, hantavirus, etc.
• “Novel” agents, impact uncertain
hMNV, Coronaviruses (non-SARS), Bocavirus, HPV
• Rare or exotic agents
• __________________________________________________________WSLH
B virus, HFVs, chikungunya, dengue, etc.
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•
Handling Unusual Test Requests
Considering the request
Assessments needed
• Type of request
• Diagnostic capability
• Does it exist in lab? Should it be used?
• Can it/should it be developed?
• Biosafety considerations
• Expertise and Experience
• Regulatory restrictions on testing
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Laboratory Biosafety
Risk Assessment(I)
• Whose responsibility?
• Technically, the lab director
• Practically, the bench microbiologist
• Primary factors to consider:
•
•
•
Agent hazards
Laboratory procedures planned
• Potential for aerosol generation
• Consider facility, equipment needed; appropriate PPE
Capability of the staff
• Training, technical proficiency, good habits
• Known vs. unknown agent risk
•
•
For known or suspected agent, consult BMBL agent summary
statements, other references
For unknown agent…
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Laboratory Biosafety
Risk Assessment(II)
Risk Assessment for Unknown Agents
• Reason for the need
• The Age of Emerging Diseases
• SARS, avian influenza, influenza A (H2N2)
• Key element of the assessment
• In addition to above, patient information is critical
• Evaluate completeness of patient information to assess
risk of specimen testing
• When should it be undertaken?
• During emergency response (BT or EID) vs. routinely?
• Need new biosafety model in the laboratory!
• Standard (“Universal”) precautions for blood and
fluids
• Enhanced precautions for respiratory (and other?)
specimens needed???
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Laboratory Biosafety
Risk Assessment(III)
Other Considerations in the Clinical Laboratory
• Strict BSL-2 practices and procedures should be the minimum
standard
• Biosafety cabinets (BSCs) are a must!
But the reality is…
• Needs to be an organizational priority
• At minimum, develop algorithm for their use based on
risk
• What about a possible BSL3 agent but no BSL3 lab?
“Mix &match” PPE and good practice with equipment and
facility based on risk assessment → BSL 2+
• Be aware of the potential for exposure to a BSL4 agent
• Look for “just in time” guidance, e.g. SARS
•
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Laboratory Biosafety
Biosafety Beyond the Laboratory Walls
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Specimen collection sites
Specimen transport: route and packaging
Specimen labeling and requisition – “A heads up”
Close communication with ICP and clinicians
Don’t forget your rapid test sites!
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Locations of Sentinel Laboratories and Rapid Test
Sites in Wisconsin-2005
Bayfield
Douglas
Ashland
Iron
Washburn
Vilas
Sawyer
Burnett
Price
Oneida
Polk
Barron
Florence
Forest
Rusk
Marinette
Lincoln
Taylor
St. Croix
Dunn
Langlade
Chippewa
Pierce
Menominee
Marathon
Clark
Shawano
Eau Claire
Pepin
Buffalo
Oconto
Wood
Trempealeau
Door
Waupaca
Portage
Kewaunee
Outagamie
Jackson
Brown
Adams Waushara
Juneau
Monroe
LaCrosse
Manitowoc
Winnebago
Calumet
Marquette
Fond du Lac
Vernon
Sheboygan
Green Lake
Sauk
Columbia
Dodge
Richland
WashingtonOzaukee
Crawford
Dane
Sentinel Laboratories
Grant
Rapid Test Sites
Jefferson
Iowa
LaFayette
Green
Rock
Waukesha
Walworth
Milwaukee
Racine
Kenosha
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Laboratory Biosafety
Addressing Rapid Test Site Biosafety Needs
• Obvious need for basic biosafety training
• Role for WSLH and clinical labs to participate in training
• Strategies to enhance biosafety & reduce potential exposure
• Collect & communicate patient travel history and risk factors
to testing staff
• In most cases, no BSC. Therefore:
• Techniques to minimize aerosol production
• Consider use of personal protective equipment (PPE)
during test performance
• Consider use of physical barriers for test performance
(e.g., bench shields)
• Sequester/isolate testing area
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Biosecurity
• What is biosecurity?
• Select Agent Regulations
• Elements of a facility security plan
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Biosecurity
What is biosecurity?
• Protection of high-consequence microbial agents and
toxins, or critical relevant information, against theft or
diversion by those who intend to pursue intentional
misuse
• A concern in light of recent terrorism events
• Relationship to biosafety
• Its all about risk assessment and containment!
• Need for general biosecurity planning???
• No current federal requirement for such a plan
• Excellent review in Section VI of BMBL 5th Ed.
• Enhanced emphasis under Select Agent regulations
• Specific requirement for a facility security plan
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Biosecurity
Select Agent Regulations
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
Requires a Facility Security Plan
http://www.cdc.gov/od/sap
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Biosecurity
Select Agent Regulation
• Clinical labs likely to be exempt unless they possess S.A.’s
• What are diagnostic/clinical labs required to do if they
encounter* a select agent?
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Notification
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•
•
Select agent handling protocol
•
•
Contact WSLH
Contact CDC by phone
Within 7 days of identification:
• Transfer to registered entity
• Destroy---autoclave, incinerate
Documentation
APHIS/CDC form 4; maintain copy for 3 years
• APHIS/CDC form 2 if transferred*
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Biosecurity
Elements of a Facility Security Plan
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•
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Required under Select Agent Regulations
Pragmatic applications apart from select agents
Conduct risk assessment as precursor to security plan
Element of plan include:
Physical security
• Data and IT security
• Personnel security assessment policy
• Controlled access to areas containing select agents
• Select Agent accountability including receipt and transfer
• Emergency response plan
• Incident reporting system
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Laboratory Biosafety
Any Questions?
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