1. Risk Assessment

2. Risk As defined by Kaplan and Garrick, risk analysis consists of answering three specific questions: what can happen? what is the chance that it will happen? if it happens, what are the consequences?.

3. Risk definition Risks are defined as a function of the likelihood of infection by the agent and the likelihood of exposure through an infectious route based on the procedures and work practices and the consequences of disease assuming infection

4. Biosafety risks is a function of: likelihood of – infection by the agent – exposure through an infectious route consequences

5. Definitions Risk Assessment – Identifying and exploring, preferably in quantified terms, the types, intensities and likelihood of the consequences related to a risk. Risk assessment comprises hazard identification and estimation, exposure and vulnerability assessment and risk estimation Risk Analysis – Risk assessment, risk management, and risk communication Risk Prevention – Measures to stop a risk being realized; typically means stopping the activity giving rise to the risk Risk Reduction – Measures to reduce the level of risk, for example by reducing the likelihood of the risk being realized or reducing the impact of the risk

7. Risk assessment strategy

8. Characteristics risk assessment is CAREFUL judgment risk assessment is proactive rather than reactive quantitative assessments can be qualitative, semi-quantitative or quantitative risk assessment methodology should be: – identified – implemented – maintained risk assessment is first step to control (reduce or eliminate) the hazards risk assessment will provide a guide for the selection of appropriate - biosafety levels needs - microbiological practices - safety equipment - facility safeguards

9. Assess the capability of the laboratory staff to control hazards - training - technical proficiency - good habits of all members of the laboratory - operational integrity of containment equipment - facility safeguards

10. New risk assessment or review of an existing one when: the introduction of new biological agents new work or changes to the programme of work alterations to work flow or volume new construction / modifications to laboratories, equipment or its operation introduction of altered and unplanned staffing arrangements

11. New risk assessment or review of an existing one when: significant alterations to Standard Operating Procedures (SOPs) or working practices (e.g. disinfection/waste management methodologies, PPE provision / usage entry/exit protocols, etc.); unexpected events that may have relevance for the management of biorisks are observed

12. New risk assessment or review of an existing one when: actual or potential non-conformity with internal / external rules and regulations is identified as part of the existing management system review process (e.g. annually or at another appropriate and predetermined frequency)

13. 4 scenarios Risk to individuals in the laboratory Risk to an individual outside the laboratory (the human community) Risk to animals outside the laboratory (the animal community) Risks to humans and animals resulting from a secondary exposure

14. Risk Assessment Basis of all biosafety practices Professional judgement Assessment of: – organisms – equipment – procedures to be employed, – animal models – containment equipment and facilities available Responsibility of Lab Director or Principal Investigator Role of Biosafety Committee and Biosafety Officers

15. Using a Risk Assessment Process A standardized biological risk assessment process allows the risk assessments to be: – Repeatable – Quantifiable A systematic, standardized approach should include: – Accepted criteria for assessing the risk – A standardized approach for evaluating the situation against the criteria (“scoring system”) Ideally this process results in a system that: – Allows analysis of the risk to identify driving factors and allow better realization of mitigation measures – Enables better communication of risk Help to define what is acceptable risk

17. Identify Key Factors For Assessing A Biosafety Risk Example 1: A laboratory researching resistance factors for Mycobacterium tuberculosis Example 2: A clinical laboratory conducting diagnostic tests for diarrheal diseases What are the key factors needed to conduct a risk assessment? – What factors define likelihood? – What factors define consequences? – What are the Agent factors? – What are the Procedure factors?

18. Laboratory Biosafety Risk Risk = F (Likelihood, Consequence) Likelihood - The likelihood of infection by the agent and the likelihood of exposure through an infectious route based on the procedures and work practices Inhalation Percutaneous Direct contact Ingestion Consequen ces - Of disease from accidental exposure Risks - To laboratory workers Researchers Animal care workers Technicians Engineers – Risk of accidental exposure to community – Risk of accidental exposure to animal community 18

19. Risk Assesment What are you working with? – Microbe (risk category) – Chemical (MSDS) – Equipment (?)

20. Declaration of International Federation of Biosafety Association on Advancing Global Biosafety and Biosecurity 2011, the year of building international biosafety communities Longer-term goals Promoting biosafety education, particularly of the younger generation, involving curriculum development within a common framework and a common methodology for evaluation. Supporting appropriate and practical legislative framework development. Developing a strategy to obtain funding for applied biosafety research programs

24. Material Safety Data Sheet (MSDS)

25. Process 1 Assign biosafety level 2 Appropriate personal protective equipment selected, 3 Standard operating procedures (SOPs) incorporating other safety interventions developed to ensure the safest possible conduct of the work

27. Health and medical surveillance The employing authority, through the laboratory director, is responsible for ensuring that there is adequate surveillance of the health of laboratory personnel. The objective of such surveillance is to monitor for occupationally acquired diseases. Appropriate activities to achieve these objectives are: – Provision of active or passive immunization where indicated – Facilitation of the early detection of laboratory-acquired infection – Exclusion of highly susceptible individuals (e.g. pregnant women or immunocompromised individuals) from highly hazardous laboratory work – Provision of effective personal protective equipment and procedures

28. FINAL REMARKS Train and RETRAIN and RETRAIN and.. until good microbiological techniques and safety precautions become second nature Inadequate training on : - PPE use - correct use and maintenance of equipment  FALSE sense of security