Benjamin Fontes, MPH, CBSPCITI Developers Meeting

Key West, FL May 20, 2009

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

Benjamin Fontes, MPH, CBSPCITI Developers Meeting

Key West, FL May 20, 2009

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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Donning PPE

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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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Working Safely with Sharps

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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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Effective Use of a Biosafety Cabinet

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Doffing PPE

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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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Show if you can’t do

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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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Control of Biohazards During Work with 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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Video Clip: BSL3 Containment Laboratory

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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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