benjamin fontes, mph, cbsp citi developers meeting key west, fl may 20, 2009
TRANSCRIPT
Genesis of the Project Growing need for Biosafety training
information (requests to CITI) Very few (one) academic program
highlighting biological safety in graduate school
Biosafety is a large and complex discipline
Multiple components Wide spectrum of trainings required
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Genesis of the ProjectFormal Biological Safety education
required to address:Expanded compliance initiatives
NIH OBA IBC inspections (> 800 registered IBC’s) State and federal site visits (regulatory,
accreditation) Upcoming regulations (BSL3/BSL4)
Growth need for trained professionalsExpanded funding for research with BiohazardsRise in number of biocontainment facilitiesBioterrorism, Biosecurity, Biosurety and related
regulations3
CITI Biosafety Project Modules1) Program Overview2) Lab Associated Infections3) Risk Assessment 4) Medical SurveillanceRisk Management
5) Work Practices6) Personal Protective Equipment7) Engineering Controls8) Facility Design
CITI Biosafety Project Modules9) Emergency ResponseRegulations
10) OSHA Bloodborne Pathogens11) NIH rDNA Guidelines12) Human Gene Transfer experiments13) Select Agents/Biosecurity14) Shipping/Transport of biological
materials
15) Animal Biosafety16) BSL3 Containment
Module DesignWritten textCase studies (CITI Stories)Quiz questionsSupplemental information
Generic registration documentsLinks to video clips – preference based accessLinks to documents for additional review
Possible Training Configurations1) & 2) Initial and annual Biosafety training
Modules #1 -9, Modules #5 - 9Augment with site specific information
Contact phone numbers Emergency response information
3) Personal Protective Equipment training for researchers handling biohazards (Module #6)
4) Training for researchers handling small research animals exposed to biohazards (Module #15)
Possible Training Configurations5) Annual training for IBC chairs and members
Modules #2, #3, #11 and #12
6) Awareness Lab Design training for architects and project managersModule #8 (Facility Design for biohazards)
Basic Labs: BSL1, BSL2Containment Labs: BSL3 laboratoriesSpecialized Labs: i.e. Insectaries
Possible Training Configurations7) Modules for principal investigators and lab
managers who have to register experiments involving:
Modules #10 – 16 (as applicable) Human or animal pathogens Recombinant or synthetic nucleic acid
molecules Human materials BSL3 Pathogens Select Agents Human Gene Transfer Experiments
Possible Training Configurations8) Comprehensive Biosafety Awareness
Training Modules #1 - #16 New Biosafety Officers and Assistant BSO’s EHS Directors Safety Advisors
Possible Training Configurations9) OSHA Bloodborne Pathogens Awareness
Training Module #10 Provides regulatory backboneDetails 14 OSHA required training elements
Locations provide site-specific informationSite exposure control plan and infoLocal contact numbersSite-specific hazardsLocations for suppliesEmergency response locations/contacts
Possible Training Configurations10) Select Agent Awareness Training (Module #13)
Introduction to BiosecurityLearn key aspects of Select Agent regulationsUse as generic training
Follow up with site specific info
11) Introduction to BSL3 Compliance Programs (Module #16)
Overview of pertinent regulations Onsite hands-on component most important
Management structureGuidance documents
Possible Training Configurations12) Shipping Training (Module 14)
Exempt human and animal specimensCategory B Infectious SubstancesDry IceAwareness of Category A shipments
Need follow up with host site for hands on training verification
Module 1: Overview and Biosafety Program Management
Describe the multiple components of a Biosafety Program at a research institution
Discuss the Biosafety Program’s role in protecting employees handling hazardous biological agents, and those within the institution, and the community
Examine the roles and responsibilities of the groups responsible for Biosafety at an institution, including the:
Principal Investigator, laboratory staff, Department Chairs, the Biosafety Officer, the Institutional Biological Safety Committee, and Administration
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Module 1: Biosafety Overview Course Introduction and Overview Review of the Profession of Biological
Safety Laboratory-Acquired Infections Biosafety Resources
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Modules 2 & 3: Lab-Associated Infections and Risk Assessment Review the components of risk
assessment as it applies to Biosafety Examine the various groups of
professionals, expertise, and resources required to conduct a risk assessment.
Outline the risk assessment pathway from development, review, and assignment of appropriate risk management factors.
Review the definitions of the four Risk Groups and the routes of exposure for biohazards
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Module : Medical SurveillanceOccupational Health Programs
Enrollment Screening Serum banking Immunizations
Risk reviewClearance (written authorization for high risk
work)Training
Awareness of signs/symptoms of infection Emergency response procedures
Periodic updates
Modules 5 - 9: Risk Management Define the foundational work practice used to
protect researchers handling infectious agents
Outline the range of protective clothing and equipment options available for worker protection
Discuss Respiratory Protection and review the range of respirators worn to protect researchers against hazardous biological agents
Review the selection, use, limitations, reprocessing and disposal of protective clothing and equipment
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Modules 5 - 9: Risk Management Review consensus best practices to follow
when handling hazardous biological agents, encompassing:
Safe sharps precautions; Use of the biological safety cabinet; Centrifugation; Transport; Laboratory do’s and don’ts
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Modules 5 - 9: Risk Management Review the four Biosafety Levels for the
containment of biological agents Describe the laboratory design features for
each biocontainment level Introduce the concepts of primary and
secondary containment Explore the various engineering controls
utilized as primary containment devices Review the major types of biological safety
cabinets Outline the features, operation, effective use,
and limitations of biological safety cabinets
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Modules 5 - 9: Risk Management Introduce the concepts of antisepsis,
disinfection, decontamination, and sterilization
Review chemical and physical methods used to inactivate hazardous biological agents
Discuss the situations and incidents that require decontamination
Review criteria for the selection of a disinfectant based on risk assessment
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Module 9: Emergency Response Outline immediate response measures
for occupational exposures to biological hazards
Review documentation, monitoring and follow-up for occupationally exposed individuals
Examine the initial steps and remediation procedures for addressing biohazard spills and releases
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Modules 10 - 14: Regulations, Standards, and Guidelines
Describe the federal, state, and local regulations and codes that deal with biological safety
Review the prescriptive requirements of regulations
Highlight the major compliance elements from key standards and guidelines in biological safety
Examine performance-based standards, guidelines and regulations applicable to biosafety
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Module 10: Bloodborne Pathogens Provide an overview of the OSHA BBP
Standard 29 CFR 1910.130 Provide training information on the 14
required elements needed to complete initial and annual BBP retraining
Provide host site responsibilities to ensure that training is site-specific for the individual and their exposures.
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Modules 11 and 12: rDNA and Human Gene Transfer Discuss the risk factors that must be
evaluated prior to the approval of a human gene transfer experiment
Outline the requirements for the safe conduct and oversight of a human gene transfer experiment
Describe the reporting requirements for adverse events associated with a human gene transfer experiment
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Module 13: Biosecurity and Biological Terrorism
Outline historical and recent bioterrorism events Provide an overview of the major microorganisms
that have been utilized or studied for biowarfare Describe the preliminary response procedures for
responding to reports of suspicious packages or suspicious materials
Review the notifications that must be made in a bioterrorism event
Discuss the application of the hazardous material response to a bioterrorism event
Review Biosecurity Requirements groups in possession of regulated potential biowarfare agents
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Module 14: Shipping of Biological Materials
Exempt human and animal specimensCategory B infectious substancesDry IceIntroduction to Category A infectious
substancesNeed hands-on training onsiteDocumentation of proficiency with:
Packaging Shipping Declaration Forms and record keeping
Module 15: Animal Biosafety Review the biohazard containment and
control mechanisms for safe housing and handling of infected research animals
Outline administrative controls used to control biohazards in animal research
Provide an overview of the regulatory and resource groups applicable to research involving laboratory animals
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Module 15: Animal Biosafety Review the range of hazards unique to
animal facilities Outline risks for laboratory animal allergies
and allergen control methods Discuss risk assessment as it pertains to
experiments involving research animals
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Module 16: Biosafety Level 3 Containment Discuss the significant risks involved
with the use of Risk Group 3 agents in research
Review the training and experience required by personnel conducting research at Biosafety Level 3 containment
Outline the range of personal protective equipment options for BSL3 research
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Module 16: Biosafety Level 3 Containment Demonstrate BSL3 work practices for
both cell culture and animal experiments Provide a description of the facility entry
and exit requirements, required for BSL3 research.
Review disinfection and decontamination procedures for the termination of BSL3 research
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