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Laboratory Biosafety

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WSLH Teleconference June 27, 2007 Peter A. Shult, Ph.D. Director, Communicable Disease Division and Emergency Laboratory Response Wisconsin State Laboratory of Hygiene – PowerPoint PPT presentation

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Title: Laboratory Biosafety


1
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

2
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

3
Laboratory BiosafetyKey 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/extran
    et/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/

4
Laboratory BiosafetyKey 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

5
Laboratory BiosafetyKey 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

6
Laboratory BiosafetyHistorical perspective (I)
  • Landmark studies by Pike and Sulkin
  • 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 gt 80

7
Laboratory BiosafetyHistorical 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

8
Laboratory BiosafetyHistorical 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
    lt 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

9
Laboratory BiosafetyHistorical 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

10
Laboratory BiosafetyPrinciples 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

11
Laboratory BiosafetyElements 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

12
Laboratory BiosafetyElements 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

13
Laboratory BiosafetyElements 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?

14
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15
Laboratory BiosafetyElements of Containment
  • The Biological Safety Cabinet (II)
  • Follow proper BSC work practices and procedures
  • BMBL5, Appendix A
  • They dont work at all if you dont use them!
  • Need for a lab-specific algorithm for BSC use
  • A POLICY ISSUE
  • Tie into risk assessment

16
Laboratory BiosafetyElement 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

17
Laboratory BiosafetyBiosafety 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
  • Other?

18
W.H.O. Agent Risk Group Classification
19
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)
1 Not known to consistently cause disease in healthy adults Standard Microbiological Practices None required Open bench top sink required
2 Associated with human disease, hazard equals percutaneous injury, ingestion, mucous membrane exposure BSL-1 plus Limited access, biohazard warning signs, sharps precautions, biosafety manual defining waste decontamination medical surveillance policies 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 BSL-1 plus Autoclave
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 BCSs or other physical containment for all manipulations PPE protective clothing gloves respiratory protection as needed BSL-2 plus Physical separation from corridors Self-closing, double-door access Exhausted air not recirculated Negative airflow into laboratory
4 Dangerous/exotic agents with high risk of life-threatening disease, aerosol-transmitted infections or related agents with unknown risk of transmission BSL-3 practices plus Clothing change before entering, shower on exit, all material decontaminated on exit All procedures in Class III BSCs or Class I or II BSCs in combination with full-body, air-supplied, positive pressure personnel suit BSL-3 plus Separate building or isolated zone, dedicated supply, exhaust, vacuum, decon systems other requirements.
20
Laboratory Biosafety
  • Risk Assessment

21
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
  • B virus, HFVs, chikungunya, dengue, etc.

22
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

23
Laboratory BiosafetyRisk 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

24
Laboratory BiosafetyRisk 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???

25
Laboratory BiosafetyRisk 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

26
Laboratory BiosafetyBiosafety Beyond the
Laboratory Walls
  • Specimen collection sites
  • Specimen transport route and packaging
  • Specimen labeling and requisition A heads up
  • Close communication with ICP and clinicians
  • Dont forget your rapid test sites!

27
Locations of Sentinel Laboratories and Rapid Test
Sites in Wisconsin-2005
Bayfield
Douglas
Ashland
Iron
Vilas
Sawyer
Washburn
Burnett
Price
Oneida
Florence
Forest
Barron
Rusk
Marinette
Polk
Lincoln
Taylor
Oconto
Langlade
Chippewa
St. Croix
Dunn
Menominee
Marathon
Clark
Pierce
Shawano
Eau Claire
Door
Pepin
Waupaca
Wood
Portage
Kewaunee
Buffalo
Outagamie
Trempealeau
Jackson
Brown
Manitowoc
Waushara
Winnebago
Juneau
Adams
Monroe
Calumet
LaCrosse
Marquette
Fond du Lac
Sheboygan
Vernon
Green Lake
Sauk
Columbia
Dodge
Richland
Ozaukee
Washington
Crawford
Sentinel Laboratories
Dane
Milwaukee
Jefferson
Waukesha
Iowa
Grant
Rapid Test Sites
Green
Walworth
Racine
LaFayette
Rock
Kenosha
28
Laboratory BiosafetyAddressing 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

29
Biosecurity
  • What is biosecurity?
  • Select Agent Regulations
  • Elements of a facility security plan

30
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

31
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

32
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?
  • Notification
  • Contact WSLH
  • Contact CDC by phone
  • Select agent handling protocol
  • 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

33
Biosecurity
  • Elements of a Facility Security Plan
  • 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

34
Laboratory Biosafety
  • Any Questions?
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