Risk Assessment in Animal Biosafety Risk Assessment Factors
Risk Assessment in Animal Biosafety ► Risk Assessment Factors § Pathogen/agent § Animal Model (species) § Procedures ►Proposed manipulations ►Assigned safe work practices
Risk Assessment in Animal Biosafety ► Risk Assessment Factors § Personnel § Protective Equipment ►Personal Protective Equipment/Clothing ►Engineering Controls/Safety Devices § Place/Facility for proposed research
Risk Assessment in Animal Biosafety ► Species ► Natural infections ► Unpredictable - physical hazards § Bites/scratches/splashes ► Permissive species ► Immune system of animal ► Shedding (urine, feces, sputum) ► Data? Transmission between cage mates? Between cages within room?
Risk Assessment Process ► Prior to initiation of work ► Principal Investigator submits written risk assessment § Written proposal § Registration Form ► Submitted Office to the IBC/IACUC/Biosafety
Committee Risk Assessment ► Questions/clarification ► Has PI started w/ Risk Group? Worked towards Biosafety Level? § Verify that PI has identified: ► Risks involved ► Routes of exposure (nature/ lab settings) ► Signs/symptoms of infection ► Potential for shedding from animals ► At risk personnel (those contraindicated from work) ► Any special medical surveillance requirements § Serum banking, immunizations, screening/evaluation
Committee Risk Assessment ► Questions/clarification § Verify that PI has Selected the Appropriate: ►BSL ►Work Practices ►PPE ►Containment Equipment § To maximize protection of staff § Does Facility meet requirements for BSL selected?
Risk Assessment – Proposed Procedures ► Manipulations planned with the animal § Blood collection § Tissue harvesting/necropsy § Aerosols, splash risk § Sharps § Genetic manipulation
Working Safely with Sharps
Risk Assessment - Personnel ► Immune status of host § Altered competency – suppression (disease, therapy) § Experience/Training WITH: ►Agent ►Animals ►Procedures ►Equipment ►Facility § Safety Record/Attitude
Risk Assessment ► Ensure that the PI’s group is involved in development of the SOP! § Take ownership
Risk Assessment – Equipment ► Cages/housing § Open § Static, MI (Filtration Efficiency) § Ventilated Cage Racks w/ HEPA filters ► PPE § Coat, gown, jump suits, full clothes change/shower § Masks, face protection, Respirators
Handling Microisolator Cages
Risk Assessment – Facility ► Conformity w/ § ABSL-1, ABSL-2, and ABSL-3 Facilities ► Compliance with pertinent: § Guidelines § Regulations § Standards ► Enhanced Facilities
Risk Assessment - Process ► Professional Judgment Required ► Expertise § IACUC ►Animal model, animal care and use, animal regulations § IBC/BSO ►Agent, exposure routes, med. Surveillance, facility design, equipment use/certification § Principal Investigator ►Disease under study, scientific aim, lab techniques
Risk Assessment - Process ► After review of Risk Assessment Factors: ► Select most appropriate BSL § § PPE Work Practices Engineering Controls Facility Controls ► SOP’s prepared and approved ► Clearance for each researcher/animal handler ► Written Emergency Response Plans
Risk Assessment Process ► When you don’t have all the answers? § Be Cautious/Conservative § RA is evolving/dynamic process § Change as info comes in ► Communicate involved RA and RM decisions to all
LCMV – Risk Assessment Example ► National Risk Group Classification § RG 3 – neurotropic strains, RG 2 – nonneurotropic strains ► Previous LAI via airborne route ► Shedding from animal (urine) ► Clone 13 (persistent shedding) ► Environmental stability (survives for weeks in animal waste)
LCMV – Risk Assessment Example ► Use of sharps § Inoculations, bleeds, necropsies ► Transport of tissues, infected cells, virus ► Protective Clothing § Gowns, 2 pair of gloves, booties, face protection, Respiratory Protection ► Protective Equipment § Microisolator cages, biosafety cabinets ► Place – ABSL-3 facility
Case Study Example ABSL-2 r. DNA Protocol – Vaccinia Virus ► Location A ► Registration(s) § IACUC § IBC ► Location B ► Registration(s) § § § IACUC IBC ARC Haz. Agent Form EHS RTUIA-Animals State Human Pathogen registration
Case Study Example ABSL-2 r. DNA – Vaccinia Virus ► Location A ► Review of Training § IACUC Orientation § Animal Handling ► Location B ► Review of Training § § § IACUC Orientation Animal Handling EHS Classes ► Biosafety, BBP, Chem § Researcher Experience Form
Case Study Example ABSL-2 r. DNA – Vaccinia Virus ► Location A ► Specific SOP created § none ► Location B ► Specific SOP created Entry, exit, supplies Protective clothing Biosafety cabinet use Safe sharps (devices/use) § Decontamination § Emergency response § §
Case Study Example ABSL-2 r. DNA – Vaccinia Virus ► Location A ► Additional Requirements § Medical Surveillance ► Health history form ► Location B ► Additional Requirements § Medical Surveillance ► Health history form ► Vaccinia immunization consult ► Employee Health review
Case Study Example ABSL-2 r. DNA – Vaccinia Virus ► Location A ► Training/Inspection § Facility orientation ► Location B ► Training/Inspection Facility orientation State DPH Inspection ARC/EHS/VC start-up meeting w/ researcher § Researcher work practice observation § § §
Case Study Example ABSL-2 r. DNA – Vaccinia Virus ► Location A ► Implementation Vaccinia needlestick No incident report Vaccinia LAI and bacterial sepsis § Hospitalization § Report to State DPH § Report to NIH OBA (significant incident/illness) § § § ► Location B ► Implementation § No incidents to date
- Slides: 24