1. CITI Biosafety Training Information Project
Benjamin Fontes, MPH, CBSP
CITI Developers Meeting
Key West, FL May 20, 2009

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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)

8. 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

9. 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

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

11. 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

12. 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

13. 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

14. CITI Biosafety Training Information Project
Benjamin Fontes, MPH, CBSP
CITI Developers Meeting
Key West, FL May 20, 2009

15. 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

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

17. 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

18. Yale’s Sabia Virus incident in August 1994
Yale’s Sabia Virus incident in August 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.

19. 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

20. 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

21. Donning PPE

22. 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

23. Working Safely with Sharps

24. 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

25. Effective Use of a Biosafety Cabinet

26. Doffing PPE

27. 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

28. 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

29. Show if you can’t do

30. 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

31. Module 10: Bloodborne Pathogens
Provide an overview of the OSHA BBP Standard 29 CFR
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.

32. 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

33. 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

34. 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

35. 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

36. 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

37. Control of Biohazards During Work with Animals

38. 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

39. Video Clip: BSL3 Containment Laboratory

40. 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