__________________________________________________________WSLH 1 Laboratory Biosafety 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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__________________________________________________________WSLH 1 Laboratory Biosafety WSLH Teleconference June 27, 2007 Peter A. Shult, Ph.D. Director,
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• 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
• 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
• 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 > 80%
Laboratory BiosafetyLaboratory BiosafetyHistorical perspective (II)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
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
• 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
• 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?
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
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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
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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.
Recommended Biosafety Levels for Infectious Agents“Biosafety in Microbiological and Biomedical Laboratories”,5th Ed
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• Don’t forget your rapid test sites!
BiosecurityWhat 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
BiosecuritySelect 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*
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