CITI Biosafety Training Information Project Benjamin Fontes, MPH, CBSP CITI 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

Genesis of the Project Formal 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 professionals Expanded funding for research with Biohazards Rise in number of biocontainment facilities Bioterrorism, Biosecurity, Biosurety and related regulations

CITI Biosafety Project Modules 1) Program Overview 2) Lab Associated Infections 3) Risk Assessment 4) Medical Surveillance Risk Management 5) Work Practices 6) Personal Protective Equipment 7) Engineering Controls 8) Facility Design

CITI Biosafety Project Modules 9) Emergency Response Regulations 10) OSHA Bloodborne Pathogens 11) NIH rDNA Guidelines 12) Human Gene Transfer experiments 13) Select Agents/Biosecurity 14) Shipping/Transport of biological materials 15) Animal Biosafety 16) BSL3 Containment

Module Design Written text Case studies (CITI Stories) Quiz questions Supplemental information Generic registration documents Links to video clips – preference based access Links to documents for additional review

Possible Training Configurations 1) & 2) Initial and annual Biosafety training Modules #1 -9, Modules #5 - 9 Augment 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 Configurations 5) Annual training for IBC chairs and members Modules #2, #3, #11 and #12 6) Awareness Lab Design training for architects and project managers Module #8 (Facility Design for biohazards) Basic Labs: BSL1, BSL2 Containment Labs: BSL3 laboratories Specialized Labs: i.e. Insectaries

Possible Training Configurations 7) 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 Configurations 8) Comprehensive Biosafety Awareness Training Modules #1 - #16 New Biosafety Officers and Assistant BSO’s EHS Directors Safety Advisors

Possible Training Configurations 9) OSHA Bloodborne Pathogens Awareness Training Module #10 Provides regulatory backbone Details 14 OSHA required training elements Locations provide site-specific information Site exposure control plan and info Local contact numbers Site-specific hazards Locations for supplies Emergency response locations/contacts

Possible Training Configurations 10) Select Agent Awareness Training (Module #13) Introduction to Biosecurity Learn key aspects of Select Agent regulations Use 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 structure Guidance documents

Possible Training Configurations 12) Shipping Training (Module 14) Exempt human and animal specimens Category B Infectious Substances Dry Ice Awareness of Category A shipments Need follow up with host site for hands on training verification

CITI Biosafety Training Information Project Benjamin Fontes, MPH, CBSP CITI 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

Module 1: Biosafety Overview Course Introduction and Overview Review of the Profession of Biological Safety Laboratory-Acquired Infections Biosafety Resources

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

Yale’s Sabia Virus incident in August 1994 Yale’s Sabia Virus incident in August 1994. The News reporters cited that he has been cut by a tube – but this was actually an airborne infection from a leak in the centrifuge. The response to the incident was horrible. The researcher didn’t immediately evacuate the lab; He wore a surgical mask which is not a respirator; He cleaned the spill later and stayed in the lab for about 4 hours breathing in “contaminated air” during the early part of this time; He never reported the incident to anyone; He didn’t recognize the signs/symptoms of the infection later when he started getting sick 3 to 4 days later; He traveled to Boston to meet with fellow scientists in a small meeting; The initial thought was the he had a recurrence of Malaria and was given anti-parasitic compounds; After this drug treatment didn’t work, he got worse and went to the YNHH Emergency Room; They called in the Infectious Disease Experts to try to figure out where he may have traveled to get such a disease; Only after being asked about travel to Africa and South America did he recall that he was working with a new pathogen and had an accident in the laboratory; He didn’t realize the potential AIRBORNE route of transmission; The only “new” quarantine area at YNHH was the very new Maternity Ward – the expectant mothers were moved to the old Maternity ward and the infected individual was the only patient in the entire ward!!!! The State of CT, City of New Haven, and the CDC were notified to report of the public health risk; 175 individuals in the Building and in his travels were identified as “exposed” and had to be followed up for 3 months to check if they were infected; Thankfully, nobody was infected and this was not a communicable disease! 6 to 9 months later, Sabia Virus was classified as a Risk Group 4 Pathogen. As a result of this infection, the State of CT dusted off an old set of regulations that were not directed to research laboratories previously, but started the discussions that led the registration and inspection of each research laboratory in the State of CT that were working with infectious agents.

Module : Medical Surveillance Occupational Health Programs Enrollment Screening Serum banking Immunizations Risk review Clearance (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

Donning PPE

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

Working Safely with Sharps

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

Effective Use of a Biosafety Cabinet

Doffing PPE

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

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

Show if you can’t do

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

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.

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

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

Module 14: Shipping of Biological Materials Exempt human and animal specimens Category B infectious substances Dry Ice Introduction to Category A infectious substances Need hands-on training onsite Documentation 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

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

Control of Biohazards During Work with Animals

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

Video Clip: BSL3 Containment Laboratory

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