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Biosafety Program Management

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  1. Biosafety ProgramManagement EMD Lecture #3

  2. Biosafety Program • Institutional oversight & acceptance • President, CEO, CFO • Institutional Biosafety Committee (IBC) • peer review, adopt/establish policies • Biosafety Office • inform, administer program, assist • Faculty, staff, students & visitors • merge biosafety into work

  3. Related Compliance Entities • IRB • IACUC • ICC • Grants & Contracts • Police, Security • Other

  4. Regulations/Responsibilities • 1970 OSH Act • 5(a)(1) General Duty Clause • Related OSHA Standards • PPE, BBP, EtO, Labels, HAZWOPER, etc. • NIH Guidelines (rDNA) • Applicability, scope • Transport • DOT, IATA, USDA, CDC/PHS, DoC, other

  5. Regulations/Responsibilities • Agencies • FDA, EPA, NIH OHRP, State, City • Guidelines • CDC/NIH BMBL, CDC TB, APIC, WHO, NSF 49, etc. • Training • BBP, TB, Shipping, Biosafety, Lab Safety, PPE, Infection Control, special hazards

  6. Information to Employees • Hazard awareness • Risk (toxicity/disease), signs/symptoms • Exposure limits/infectious dose • Employer’s responsibilities • Protective measures (controls) • Medical surveillance/monitoring • Emergency response procedures

  7. Biosafety Program Management • I GO WHERE I’M TOWED TO!

  8. Biosafety Program Management • IBC as DMV • speed limits, rules/regulations • registrations/renewals, fines • Program is tow truck and pace car • safely deliver to desired location • BSO as State Police • inform, assist, control, emergency response

  9. Biosafety ProgramManagement • Employees • luxury, economy, SUV’s, dragsters, stalled, etc. • AAA • Administrative support • Active (pro-active biosafety program = awareness) • Accountability for compliance at all levels

  10. Biosafety ProgramManagement • Adopt/mandate required policies • Apply OSHA General Duty Clause elsewhere • Establish policies where needed

  11. Rationale • Control hazards • Anticipate • Identify • Evaluate • Prevent lab-acquired infections • Interaction • Proactive • Assumption of responsibility

  12. Prevention • Interaction • Registration/reauthorization • Initial and periodic training & inspections • Sanctions • Evaluation • Risk assessment/risk management • Incidents/near misses

  13. Risk Assessment &Risk Management Prior Planning Prevents Poor Performance

  14. Risk Assessment &Risk Management • Pathogen • Procedures • Personnel • Place • Protective Equipment

  15. Ineffective Program Management • Morbidity/mortality • Perceived lack of institutional control • Regulatory visit/action • Legal action (civil/criminal penalties) • Bad press • Low morale

  16. Biosafety ProgramManagement • “I go where I’m towed to!” • “Tell ‘em where you’re going to tow them” • “Tow ‘em where you want them” • “Tell ‘em why you’ve towed them there”

  17. Identification of Biological Agents

  18. Identification of Agents • Department • PI/Lab Director • Type of Lab • Lab Supervisor • Building(s)/room(s) • Phone/fax/email/campus address

  19. Identification of Agents • rDNA • exempt/non-exempt, IBC, NIH-OBA registration • Human material • OSHA regulated, other • Plants • low risk, plant pests, pathogens, USDA APHIS requirements

  20. Identification of Agents • Human Pathogens • Risk group • local, state, federal registrations • Animals • natural infections • work with biohazards • work with animal pathogens

  21. Identification of Agents • Human subjects • Healthcare/clinical locations • Toxins of biological origin • Shipping/transport of regulated agents • Other?

  22. Identification of Equipment • Autoclaves • Biosafety cabinets, clean benches, glove boxes • Eyewashes, showers • Centrifuge containment

  23. Identification of Handlers • Name, employee ID Number • Campus address/contact information • Identify work experience • Observe work practices if necessary • Refresher training as needed

  24. Biosafety Database Management

  25. Occupationally exposed workers • Bloodborne Pathogen training (initial/annual) • Biosafety Training (initial/periodic) • HBV Vaccination program (other immunizations) • TB Training, PPD Test • Shipping/Transport Training (biennial) • BSL3 Training/certification of researchers • Select Agent registration/training/review

  26. Equipment & Facilities • Autoclave (location, testing) • Clean air device (location, certification) • biosafety cabinets, ventilated enclosures • repairs, moves • BSL3 facilities • commissioning • annual air balancing • HEPA filter testing

  27. Research Registration • Comprehensive Biohazard Registration Form (all biological materials used) • rDNA protocols (new, updates, new personnel) • Human pathogens (biennial) • Select Agent transfers (inventory, tracking) • Inspections (semi-annual, annual) • BSL1, BSL2, BSL3, Animal, Select Agents

  28. Institutional Documentation • IBC minutes (subcommittee deliberations) • Approval letters • Safety Manuals (periodic updates) • Incidents • Non-compliance reports • Accidents, exposure investigations and recommendations • Serious adverse events (human subjects)

  29. Biosafety Manual

  30. Biosafety Manual • Introduction/Contact Info/Overview • Responsibilities • Chairperson • Principal Investigator/Manager • Researcher/Employee • Safety Office • IBC

  31. Biosafety Manual • Requirements • Annual registration • Human etiologic agents/select agents • rDNA • Regulated human material • Biohazards in animals/USDA Regulated agents • Clean air device program • Training

  32. Biosafety Manual • Medical Surveillance/Employee Health • Screening • Immunization • Medical restrictions • Serum storage • Incident reporting/evaluation/follow-up • Counseling • Records

  33. Biosafety Manual • Risk Assessment/Risk Management • Biosafety levels • Routes of transmission • Signs/labels • Work practices • Personal protective equipment • Protective equipment/engineering controls

  34. Biosafety Manual • Decontamination • Disinfectants • Sterilization methods • Medical waste program • Treatment of mixed wastes

  35. Biosafety Manual • Spill/Emergency Response • Spill kits/training/preparation • BSL1, BSL2, BSL3 spill response • Mixed spills

  36. Biosafety Manual • Shipping/Transport • Clinical, diagnostic specimens • Etiologic agents, toxins of biological origin • Packaging • Shipping declaration forms • Import/export requirements

  37. Biosafety Training

  38. Biosafety Training • Lab safety • chemical, biological, fire, security, incident response • Biosafety • human/animal pathogens • RG2/BSL2 • rDNA • proficiency/competency

  39. Biosafety Training • Bloodborne Pathogens • Initial @ time of hire • specific components of standard • targeted to audience • Annual retraining • Sharps Safety Devices • Evaluation & training

  40. Biosafety Training • BSL3 Training • work practices, PPE, controls • biosafety cabinet • facility operations • spill/incident response • formal evaluation of proficiency • inspection of proposed SOP

  41. Biosafety Training • Shipping/Transport of Infectious Substances • IATA (initial and every 2 years) • DOT (initial and every 3 years) • labs working with etiologic & other regulated agents • provide info to those handling clinical specimens • Shipper/transporter/receiver • general awareness • function specific

  42. Biosafety Training • Tuberculosis • At time of hire, screening • Infection control • Proposed annual training requirement • Respiratory protection • Healthcare and beyond!

  43. Biosafety Training • Effective Use of the Biosafety Cabinet • recommended • part of Biosafety training • can require based on audit results

  44. Institutional Biosafety Committee

  45. Role of the IBC • Established by highest administrator • Oversight for potentially hazardous work • Set policy for safe conduct of biohazard research • Oversee rDNA projects; ensure compliance • Responsibilities not restricted to rDNA

  46. IBC Membership (NIH rDNA) • varied disciplines (rDNA, microbiology, lab safety, engineering, lab technical staff, legal, community) • > 5 members (2 from community) • plant pathogen/containment expertise • animal containment expertise • biosafety officer if BL3/BL4 or large scale

  47. IBC Membership • consult with other scientists as needed • annual report to NIH/OBA • suggest opening meetings to public • minutes available to public upon request

  48. Suggested IBC Subcommittees • Human Gene Transfer Clinical Trials • Xenotransplantation • Medical Surveillance • Biosafety Level 3 • All report back/through IBC

  49. IBC Function • review rDNA research • assess physical/biological containment level • assess: • facilities • procedures • practices • training/expertise of personnel