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Animal Biosafety-Biosecurity and Risk Assessment: Small or decisive actions?

Animal Biosafety-Biosecurity and Risk Assessment: Small or decisive actions? Luis Alberto Ochoa Carrera, MSc November 14 th , 2018 Cairo, Egypt. What do we want for our staff?.

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Animal Biosafety-Biosecurity and Risk Assessment: Small or decisive actions?

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  1. Animal Biosafety-Biosecurity and Risk Assessment: Small or decisive actions? Luis Alberto Ochoa Carrera, MSc November 14th, 2018 Cairo, Egypt

  2. What do we want for our staff? • We are interested that our staff posses the highest knowledge, “perfect” skills, “sophisticated” at our institutions at a lower cost with greater results…..

  3. What we really need…… • Build a work culture  efficient identification, mitigation and communication of biological risks • Evaluate and demonstrate the technical competence • Contribute to the “One Health” concept….

  4. Overview • Animal pathogens and handling animals pose significant risks to healthcare staff as well as the environment

  5. Why is risk assessment so important? • All staff must be aware of and understand the risk they face before carrying out their activities • Support for the decisions that are taken at institutions Note: a) Identify hazards b) Carry out the evaluation of the risks c) Determine mitigation measures d) Verify the effectiveness of mitigation actions

  6. Elements of a the Animal Biosafety-Biosecurity Program • Elements of an Animal Biosafety-Biosecurity Programs are not different from general biosafety program • However…. • Hazard of organisms with high zoonotic potential • Every aspect more crucial • Need for risk reduction is greater

  7. Elements of ABB program • What is necessary for a good program operation? • Institutional commitment Support for safety….. Adequate funding Adequate staff • Facility Design, commissioning and construction Maintenance Emergency preparedness and response

  8. Elements of ABB program (cont.) • Personnel - Training - Compliance with the Occupational Health Program • Risk assessment  The basis for all decisions • Procedures • Lab equipment, waste management, emergencies… • Program evaluation and inspections • Regulations, guidelines, resources

  9. What is the objetive of the ABB program? • Reduce the risk of acquiring laboratory associated infections • Reduce the risk of contamination of the environment and surrounding community • Conform to prudent biosafety practices • Comply with regulations and guidelines

  10. The backbone of the practice of biosafety-biosecurity is risk assessment….

  11. Risk assessment of animal labs • It is neccessary when….. • New project review Changes in: - Biological agents - Lab equipment or medical devices - SOPs - Facility - Personnel

  12. Risk assessment of animal labs (cont.) • OUTCOMES • Determination of appropriate controls to reduce the risk….. • Evaluation of remaining risk • Effective allocation of resources

  13. Risk assessment of animal labs (cont.) • Containment facility staff • Containment visitors (i.e., maintenance staff) • Persons working in adjacent spaces • Community • Environment (i.e., nearby livestock)

  14. Who needs to be involved? • Principal investigator or lab manager • Biosafety Officer • Institutional Biosafety Committee • Facilities staff • Others: • Peers, consultants • Government agencies • Risk management, Public Relations staff

  15. Risk assessment considerations • Experience • Immunological status • PPE Use • Risk group • Volume • Concentration • Form of transmission • Containment • Facility Setting • Regional Issues • Policies

  16. The results of the RA will determine: • Use of containment measures (primary or secondarybarriers) • Residual risk vs initial risk: acceptable o not-acceptable • Use of the existing resources

  17. Risk Group ≠ Biosafety Level

  18. Lets think….. Can we work with one RG4 biological agent in a BSL-2 lab? • YES • NO ……and why?

  19. Hierarchy of Controls Substitutions-Reductions (surrogate organism)What’s more difficult.. Administrative controlsWhat we do not comply…… Work practices and proceduresWhat we usually forget… Engineering controlsWhat we depend on… Personal protective equipment (PPE)What we think is the most important….

  20. Risk assessment requires careful judgment…..

  21. Some frequent questions…. What is the appropriate biosafety level? What is the best primary/secondary barrier?? Which activities can I do? Which is the best PPE to wear? Is this the best disinfectant that I can use? Which materials should I use? It depends…….

  22. Some frequent questions…. The risk assessment for deciding who, when, how and what will work on containment lab depends on: - Work load - Complexity of algorithm - Time required - Special requisites (i.e., vaccination) - Frecuency of facility use - Special situations

  23. Key considerations • Animal containment facilities are (typically) not generic; one containment facility will not likely be able to support all containment projects… • Facility location, user experience, institutional experience, regional experience • Containment variation….. (Standard, Enhanced, ABSL, BSL-Ag, P-BSL • Services available (i.e., waste disposal, maintenance, emergency response, security requirements, regulatory issues and budget…

  24. Who makes the decisions? • Containment projects should not exceed - Limitations of the facility - Experience of the staff (one individual can not determine this) • Decisions are required to be performed in a joint evaluation: stakeholders, management, and experts…..

  25. Who should be involved? Definitely: • BSO + other safety professionals • Facilities staff • PI or lab director • Management • Oversight committees: IBC, IACUC, etc. If needed: • Architect and engineer consultant(s) • Security staff • Public Relations staff • Risk Management staff

  26. Tools • Site-specific: - Design documents - Commissioning reports - Annual verification plan • Generic: - CWA 15793 standard - WHO Biosafety Manual - Country-specific guidance (i.e., BMBL) - Experience from other facilities

  27. Evaluation factors Architectural features Construction details Critical systems (HVAC) Building infraestructure Security features Equipment

  28. Putting it all together…. • Be as comprehensive as possible… • Ensure qualified review and decision making process… • Identify gaps • Get cost estimates • Be conservative (especially if local experience is limited!)

  29. Comments and questions?

  30. شكرا لدعوتك Contact information: Luis Alberto Ochoa Carrera, MSc Biosafety-Biosecurity Specialist luis.ochoa@amexbio.com

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