Week_4_-_Domain_C_-_Part_I[1].pdf

16.10.23 | VIRTUAL Implementing a Biorisk Management System Domain C  Domain A Review Discussion Question The BRM is based on the concept of continual improvement through a cycle of PDCA. The best strategy for an effective continual improvement program is: A. Short Cycles of PDCA B. Long C...

16.10.23 | VIRTUAL Implementing a Biorisk Management System Domain C  Domain A Review Discussion Question The BRM is based on the concept of continual improvement through a cycle of PDCA. The best strategy for an effective continual improvement program is: A. Short Cycles of PDCA B. Long Cycles of PDCA C. Monitor and measure processes after planning D. Stop the work after each cycle until the assessment results are available 2  Domain A Review Discussion Question Maintenance Engineers are visiting a high containment facility for preventive maintenance of an equipment. What steps regarding the equipment decontamination should they take? A. Ask/confirm with the laboratory workers that the equipment is decontaminated B. Assume it’s the responsibility of laboratory workers so they should have done it and proceed with the maintenance C. Decontaminate the equipment themselves D. Just do their work without thinking about the decontamination as they are engineers not lab workers 3  Domain C – Implementing a Biorisk Management System Likelihood and Consequence Likelihood (of a laboratory incident): the probability of an incident (that is exposure to and/or a release of a biological agent) occurring during laboratory work. Consequence: refers to the severity of the outcome from exposure, if it were to occur. 5  Domain C – Implementing a Biorisk Management System Working with biological materials is risky (low to high, but never zero). An effective biorisk management system is needed 6 Domain C – Implementing a Biorisk Management System How does one develop a biorisk management system? Is there a one-size-fits-all model???? Risks vary form one lab to another. Risk does not remain constant, even within the same lab. 7  Domain C – Implementing a Biorisk Management System Where does the variation exist? Risks of manipulating any biological agent depend on many dynamic factors: type and condition of equipment available condition of the facility whether the biological agent is endemic in the population susceptibility of local populations competency of laboratory personnel carrying out the work and so on…… 8  Domain C – Implementing a Biorisk Management System A biorisk management system can and should be different for each lab. Then, how can one develop a situational approach to biorisk management that is risk and evidence-based????? 9  Domain C – Implementing a Biorisk Management System The answer is biorisk assessment. Risk assessment is a systematic process of gathering information and evaluating risks to support a risk management strategy that is informed by the likelihood and consequences of an inadvertent release of and/or exposure to a biological agent. 10  Domain C – Implementing a Biorisk Management System Biorisk Assessment Select control measures to address your specific risks saves money, time and effort locally relevant proportionate to needs (by selecting measures to control facility-specific risks) sustainable facilitates risk mitigation decisions provides quality control documentation 11  Domain C – Implementing a Biorisk Management System Biorisk Assessment – Who? A team including Principal investigators Laboratory and quality managers Laboratory technicians Biosafety officers 12  Domain C – Implementing a Biorisk Management System Biorisk Assessment – When? Equipment or environment changes Regulatory changes Changes in Personnel Changes in the pathogen status 13  Domain C – Implementing a Biorisk Management System Biorisk Assessment – When? Ideally, a laboratory should perform an initial risk assessment before any work is started. A risk assessment should also be done whenever a change occurs. Examples of activities or events that will change risk and warrant a reassessment include: New infectious agents, toxins, reagents or other dangerous substances New animal species, model, or route of administration of biological agents New equipment, procedures and practices Aging of equipment 14  Domain C – Implementing a Biorisk Management System Biorisk Assessment – When? Advances in scientific understanding and technology, a relocation, or renovation A recent or “near-miss” accident, laboratory-acquired infection (LAI), theft, or security violation National or regional changes in disease status (endemicity of disease or disease eradication) National, regional or local changes in the greater threat or security environments New local or national regulations 15  Domain C – Implementing a Biorisk Management System Biorisk Assessment – How? Risk assessments must always be conducted in a standardized and systematic way to ensure they are repeatable and comparable in the same context. 16  Domain C – Implementing a Biorisk Management System Biorisk Assessment – How? How do you assess risks in your setting? 17  Domain C – Implementing a Biorisk Management System Biorisk Assessment – How? Quantitative Qualitative Checklist method Failure mode & effect analysis (FMEA) Job safety analysis (JSA) Fault-Tree Hazard and Operability Analysis (HAZOP) Bow tie analysis SWIFT analysis SWOT analysis Risk Matrix etc. 18  Domain C – Implementing a Biorisk Management System Matrix Method Advantages Simple - can easily be understood Can be adopted by all levels of workers Provides a standard way of assessing risk Useful in identifying low and high-risk areas 19  Domain C – Implementing a Biorisk Management System Matrix Method Disadvantages Poor resolution Very subjective Cannot differentiate between moderate and high risks very well Based on experience May result in suboptimal allocation of resources 20  Domain C – Implementing a Biorisk Management System Biorisk Assessment – How? 21  Domain C – Implementing a Biorisk Management System Exercise - 1 Differential detection of IgM and IgG antibodies covering different stages of 2019- nCoV infection 22  Domain C – Implementing a Biorisk Management System 1 – Gather Information Where should we gather information from??? Procedural Human Based Based Equipment Substanc and Facility e Based Based 23  Domain C – Implementing a Biorisk Management System 1 – Gather Information What Biological Agents will be handled and what are their pathogenic characteristics? What type of laboratory work will be conducted? What type of equipment(s) will be used? What type of laboratory facility is available? What human factors exist (e.g. what is the level of competency of personnel)? What other factors exist might effect laboratory operations (e.g. legal, cultural, public perception)? 24  Domain C – Implementing a Biorisk Management System 1 – Gather Information Mention a few facility specific hazards 25  Domain C – Implementing a Biorisk Management System 1 – Gather Information Mention a few people specific hazards 26  Domain C – Implementing a Biorisk Management System 1 – Gather Information Mention a few equipment-specific hazards 27  Domain C – Implementing a Biorisk Management System 1 – Gather Information Mention a few procedure-specific hazards 28  Domain C – Implementing a Biorisk Management System Other aspects Agent properties: morbidity, mortality, treatment and prevention, routes of transmission, communicability, agent stability Financial aspects: availability of resources 29  Domain C – Implementing a Biorisk Management System 2 – Evaluate the risks Likelihood x Consequence = Risk 30  Domain C – Implementing a Biorisk Management System Determine the likelihood Rare (1): almost impossible to occur Unlikely (2): not very possible to occur Possible (3): might occur Likely (4): very possible to occur Almost certain (5): highly probable to occur 31  Domain C – Implementing a Biorisk Management System Assess the Consequence Negligible: Trivial incident or near miss requiring reporting and follow up Minor: Incident with self-limiting consequences Moderate: Incident that requires medical treatment and/or has insignificant environmental consequences Major: Incident with potential lost time due to infection but non-permanent consequence and/or limited environmental impact Severe: Potential fatality or serious illness with permanent disability and/or serious environmental impact 32  Domain C – Implementing a Biorisk Management System 2 - Evaluate the risks How could an exposure/release occur? What is the likelihood of an exposure? What information gathered influences likelihood the most? What are the consequences of an exposure/ release? Which information gathered influences consequences the most? What is overall inherent risk of the activities? What is the risk tolerance level? Can the acceptable risks be controlled, or should the work not proceed at all? 33  Domain C – Implementing a Biorisk Management System Factors that affect the likelihood of an Incident occurring FACTORS HAVING HIGH LIKELIHOOD OF INCIDENTS Laboratory activities causing aerosolization Laboratory activities associated with sharps Low personnel competency Highly environmentally stable biological agents Inadequate or poor availability of electrical power, dilapidated laboratory facilities and building systems, malfunctioning equipment, damage from frequent severe weather and access of insects and rodents to the laboratory 34  Domain C – Implementing a Biorisk Management System Factors associated with greater consequences (if incident happens) FACTORS ASSOCIATED WITH GREATER CONSEQUENCES (IF INCIDENT HAPPENS) Low Infectious Dose High communicability High severity and mortality Limited availability of effective prophylaxis interventions or therapeutic interventions Large susceptibility population (including lab personnel at increased risk Lack of endemicity 35  Domain C – Implementing a Biorisk Management System Factors associated with both a high likelihood of and greater consequences from a potential incident FACTORS ASSOCIATED WITH BOTH (HIGH LIKELIHOOD & GREATER CONSEQUENCE) High concentration of biological agent Large volume of biological agent Airborne route of transmission 36  Domain C – Implementing a Biorisk Management System 3 – Develop a Risk Control Strategy What resources are available for risk control measures? What risk control strategies are most applicable for the resources available? Are resources sufficient to obtain and maintain those risk control measures? Are proposed control strategies effective, sustainable and achievable in the local context? 37  Domain C – Implementing a Biorisk Management System 4 – Select and Implement Risk Control Measures 38  Domain C – Implementing a Biorisk Management System Inherent Risk vs Residual Risk Residual Risk = Inherent Risk — Control Measures Risk Assessment Inherent Risk Control Measures Residual Risk 39  Domain C – Implementing a Biorisk Management System Risk reduction measures needed based on the likelihood and consequence level of exposure or release. 40  Domain C – Implementing a Biorisk Management System The hierarchy of controls is a method of identifying and ranking safeguards to protect workers from hazards. They are arranged from the most to least effective and include elimination, substitution, engineering controls, administrative controls and personal protective equipment. It is important to note that while a hierarchy of risk control measures has been defined by many countries, it cannot be assumed that one risk control measure is always preferable to another (such as engineering controls versus personal protective equipment). WHO Fourth edition 41  Domain C – Implementing a Biorisk Management System 4 - Select and Implement Risk Control Measures Are there any national/ international regulations required? What control measures are locally available? Are available controls adequate or should multiple controls be used? Do selected controls align with risk control strategy? What is the level of residual risk after control measures have been applied? Are additional resources required? Are operational and maintenance procedures in place? Have persons been appropriately trained? 43  Domain C – Implementing a Biorisk Management System Determining risk acceptance Established by an organization itself. Proportionate to the organization’s situation and resources. 44  Domain C – Implementing a Biorisk Management System Activity – crossing the road 45  Domain C – Implementing a Biorisk Management System Activity – crossing the road 46  Domain C – Implementing a Biorisk Management System 5 – Review Risks and Risk Control Measures Risk assessments must be reviewed routinely and revised when necessary: new information about the biological agent changes in laboratory activities or equipment new risk control measures that may need to be applied Confirmation that measures are effective and that training has been carried out appropriately through: inspection review and audit of processes documentation 47  Domain C – Implementing a Biorisk Management System Exercise - 2 Routine smear preparation and microscopy of sputum specimens Biological agent with a low infectious dose transmitted through aerosols Conducted by competent personnel in a diagnostic laboratory 48 Domain C – Implementing a Biorisk Management System 49  Domain C – Implementing a Biorisk Management System Exercise - 3 Large-scale culture of drug-resistant strains Biological agent with a low infectious dose transmitted through aerosols Conducted by competent personal in a pharmaceutical laboratory 50  Domain C – Implementing a Biorisk Management System Discussion Question You are implementing the BRM system in a new organization. What will you do first? A. Risk Assessment B. Evaluate Performance C. Identify hazards D. Competence assessment 52  Domain C – Implementing a Biorisk Management System Biosafety vs Biosecurity Risk Assessment The biosafety risk assessment is concerned with the fundamental biological properties of an agent and how the agents are used in the laboratory For a biosecurity risk assessment, the agent’s potential for malicious use is considered, including the consequences of malicious use 53  Domain C – Implementing a Biorisk Management System Biosecurity Risk Assessment Different from the biosafety risk assessment Likelihood = [(motive + capability + historical frequency (proximity + distance)]/4 Motive = a reason for doing something Capability = e.g., ability to circumvent mitigation measures and to culture a pathogen or to extract a toxin Historical frequency = done using available data, or it can be based on knowledge of employees and subject matter experts. Consequence = impact value x vulnerability value Risk = Likelihood x Consequences 54  Domain C – Implementing a Biorisk Management System Biosafety and biosecurity risk assessment 56  Domain C – Implementing a Biorisk Management System Common components of Biosafety and Biosecurity Good laboratory practices: good laboratory biosafety practices reinforce and strengthen laboratory biosecurity systems Risk assessment Management oversight Personnel qualifications Control and accountability of organisms such as inventory management Access control Training Emergency Planning (some conflicts also exist) 57  Domain C – Implementing a Biorisk Management System Conflicts: laboratory biosafety vs laboratory biosecurity Various aspects of biosafety may conflict with laboratory biosecurity controls that reduce unauthorized access might also hinder an emergency response by fire or rescue personnel. biohazard signs placed on laboratory doors identified the biological agents present in the laboratory. However, as a laboratory biosecurity measure to better protect sensitive valuable biological materials, guidelines now recommend limiting the information on biohazard signs to the laboratory biosafety level, the name and telephone number of the responsible investigator, and emergency contact information Biosafety signage vs biosecurity signage 58  Domain C – Implementing a Biorisk Management System Conflicts Between Biosafety and Biosecurity Biosafety Biosecurity Open information Restricted information Open communication Restricted communication Recognizable samples Coding of samples in storage Rescuing lab workers in case of Close barrier in case of emergency emergency Transport by protocol Tackle the gap between sender and receiver Contingency plan Restricted information to contingency (first aid) teams 59 Thank you! 60