Biorisk Management - Pharm 304 Lab PDF

PHARM 304 LAB BIORISK MANAGEMENT Biorisk Management ⮚ What is the purpose of a Biosafety Level (BSL) Biorisk management is the effective in laboratory settings? management of risks posed by working with...

PHARM 304 LAB BIORISK MANAGEMENT Biorisk Management ⮚ What is the purpose of a Biosafety Level (BSL) Biorisk management is the effective in laboratory settings? management of risks posed by working with ⮚ Why is Personal Protective Equipment (PPE) infectious agents and toxins in laboratories important in biorisk management? Biorisk management includes the full ⮚ What are Standard Operating Procedures spectrum of safety and security measures for (SOPs), and why are they essential in a laboratories, from standard operating laboratory's biorisk management plan? procedures to physical measures to individual ⮚ What is the significance of regular training practices in the laboratory. and education in biorisk management? ⮚ Why is it essential to have an emergency RISKS response plan in place as part of biorisk management? How do you identify biorisks? What are some things you can do to manage KEY TERMS these risks? How do you know that your risk management “Biosafety”, “biosecurity”, and “biorisk is working, and will continue to work? management system” are common biorisk terms that relate to and support each other. KEY COMPONENTS OF BIORISK MANAGEMENT AMP (Assessment, Mitigation and Performance) is a simple but powerful model Biorisk Assessment managing biorisks. Process of identifying the hazards and Implementing a comprehensive biorisk evaluating the risks associated with biological management system is critical to reduce both agents and toxins, taking into account the the safety and security risks associated with adequacy of any existing controls, and biological agents. deciding whether or not the risks are Laboratory Biosafety: containment principles, acceptable. technologies, and practices implemented to prevent unintentional exposure to pathogens Biorisk Mitigation and toxins, or their unintentional release. Actions and control measures that are put Laboratory Biosecurity: protection, control into place to reduce or eliminate the risks and accountability for valuable biological associated with biological agents and toxins materials within laboratories, in order to prevent their unauthorized access, loss, theft, Performance misuse, diversion or intentional release. The implementation of the entire biorisk management system, including evaluating BIOSAFETY and BIOSECURITY and ensuring that the system is working the way it was designed. What is one example of a biosafety measure? What is one example of a biosecurity Biorisk Management: AMP Model measure? BIORISK MANAGEMENT = WHAT IS BIORISK? Biorisk= Biosafety + Biosecurity Risks Assessment, Mitigation, Performance  What results would you expect in a situation 4.4 Implementation and Operation with a good management system in place VS 4.5 Checking and Corrective Action NO Management system at all? 4.6 Review Management System Assessment A set of interrelated elements used to Hazard Identification establish policy and objectives and to Risk Assessment achieve those objectives. IMPORTANT ELEMENTS OF A MANAGEMENT SYSTEM Mitigation ✔ Top Management Commitment Good microbiological technique ✔ Documentation and Document Control Waste management ✔ Teamwork and Communication Physical security ✔ Planning, Establishing Goals and Objectives Performance ✔ Training and Staff Awareness Performance measurement and analysis of data Laboratory Biorisk Management Management review System or process to control safety and security risks associated with the handling or Biorisk Management storage and disposal of biological agents and toxins in laboratories and facilities Process for the implementation of a biorisk management system Laboratory Biorisk Management 1. What needs to be in place before starting? (CWA 15793) 2. Where would you start? Comprehensive framework for a biosafety 3. Are there past experience that may provide and biosecurity (biorisk) program guidance? Based on a management systems approach Designed for all laboratories that handle WHAT IS RISK? biological materials Risk International Approach Risk is the likelihood of an undesirable event happening, that involves a specific hazard or Derived from the current WHO Biosafety and threat and has consequences Biosecurity Guidelines Risk= f (likelihood, consequences) Consistent with other International standards Risk is a function of both the Likelihood of such as ISO 9001, ISO 14001 and OSHAS18001 something happening and Consequences of Not country specific that occurrence Local solutions possible Compliance with national and local regulations mandatory Major Sections (CWA 15793) 4.1 General Requirements 4.2 Policy 4.3 Planning EXAMPLE SCENARIO: You are at the zoo observing a mellow, tiger cab located behind a strong glass window. Laboratory BiosecuritY INTRODUCTION TO BIOSECURITY RISK ASSESSMENT A biosecurity risk assessment is an analytical procedure designed to characterize security risks in a laboratory. To be comprehensive: A laboratory biosecurity risk assessment should consider every asset, adversary and vulnerability in an institution and its component laboratories and units. Biorisk Risk Assessment A biosecurity risk assessment allows an institution or laboratory to determine the A risk assessment assigns values for likelihood relative risk of security threats and/ or and consequence, which allows us to vulnerabilities to help guide risk mitigation represent the risk of a particular adverse event decisions so these are targeted to the most on a graph. important risk. In Biosecurity Risk Assessment, we are concerned with intentional adverse events involving laboratory disease agents and/or their products. What factors should be considered in a laboratory biosecurity risk assessment? What are the factors that affect Likelihood and Consequences? Risk Characterization Refers to the process of identifying all the ADVERSARY CHARACTERIZATION factors that should be considered in a The process of determining specific attributes biosecurity risk assessment. of potential adversaries that enable them to It is the process of determining the likelihood pose a threat to a biological agent or toxin. and consequences of a particular risk and is associated with a particular adverse event. ADVERSARY CHARACTERIZATION Characterizing biosecurity risk includes an Some characteristics of potential adversaries in-depth analysis of laboratory assets, that could help determine the risk they pose, potential adversaries, and laboratory include: vulnerabilities. ○ Motive ○ Means ASSET CHARACTERIZATION ○ Opportunity The process of gathering information about Analyzing each of these characteristics in the biological agents and toxins that could terms of likelihood and consequences is potentially be targeted by notional necessary for a biosecurity risk assessment. adversaries. An insider is a person who has authorized These biological agents and toxins will be access to a facility, its units (such as referred to as “assets”. laboratories), and its assets. Determining the ease or difficulty of malicious An outsider is a person who does not have use (likelihood) should involve assessing the authorized access. following: Insiders tend to pose a greater threat than The difficulty of acquiring the agent outsiders because they typically have both The difficulty of processing the agent greater means and opportunity than an into a suitable quantity in a suitable outsider. form Insiders, however, do not necessarily have The difficulty of disseminating the different motives than outsiders. agent to cause harm SCENARIOS ASSET CHARACTERIZATION Each evaluated scenario should involve a Determining the potential consequences of specific biological agent, a specific the malicious use (consequence) of a adversary, and a particular way that particular agent or toxin should involve adversary will attempt to steal and misuse the assessing the following: agent or toxin. The physical impact of an attack on a The criteria used for screening should be population documented in the assessment. The impact of an attack on the economy The impact of changes in public perception EXERCISE: The impact on facility operations Your facility works with wild-type Ebola virus in How might the environmental stability of an a developing country with poor infrastructure infectious disease agent affect the likelihood and an active, wide-spread insurgency. of theft and misuse? Suppose your facility stores large volumes of How might the host range of an infectious Foot and Mouth Disease Virus for use in animal disease agent affect the consequences of research. Your facility’s building is new and theft and misuse? has excellent physical security.  Risk Evaluation is the process of determining 1. What is the likelihood of theft? subjectively, whether a risk is high or low, and 2. What are the consequences of theft? whether it’s acceptable or not. 3. What are some factors that should be considered? The evaluation of risk is highly related to the concept of Risk Acceptance. VULNERABILITY ASSESSMENT Risk evaluation and acceptance can vary Biosecurity vulnerabilities can be assessed with culture, experience, resources, based on each of the biosecurity system’s management and even current events. individual components. The curves on the graph called “isoquants”, ○ Physical Security show the different levels of risk, from Very Low ○ Personnel Management to Very High. ○ Material Control and Accountability It is important to recognize that the precise ○ Transport Security locations of these isoquants on the graph are ○ Information Security in fact arbitrary. This is the essence of Risk Evaluation. For Example: Is the Physical Security of a facility adequate to prevent an outsider from entering a particular laboratory and stealing several vials of an agent? ○ Are doors consistently locked? ○ Are the locks reliable? ○ If doors are locked, are there large windows in the laboratory that an outsider could enter from instead? An institution that considers a certain risk high RISK CHARACTERIZATION might be motivated to spend a large amount It is important that the Risk Characterization of resources mitigating that risk. process be as robust as possible. Another institution that considers the same risk Comparability is the ability trust the accuracy to be moderate might decide to spend a of differences between assessments, due to small amount of resources in mitigation similarities in their bases, assumptions, instead. procedures and protocols. Repeatability is the ability to conduct the Laboratory Biorisk Management / Biorisk Controls same process in the same way for the same hazard or threat and situation over a period of time, or for different hazards, threats, and situations at the same time. RISK EVALUATION Risk Evaluation is a crucial intermediary step between Risk Characterization and taking active steps towards mitigating risk. Administrative Control Examples http://www.oie.int/publications‐and‐documentation Laboratory policies and management /general‐information programmes. Qualified, trained, and competent personnel; Engineering Control Examples Training in the safe & secure handling of biological agents & toxins; Health and safety programmes (e.g. health care, vaccinations); Incident and accident investigation programmes; emergency response and contingency plans; Biological agents and toxin inventory management requirements (e.g. access, storage, transfer, destruction, and audit); Waste management policies; Personal Protective Equipment Examples Security policies (e.g. facility security, visitor access, personnel security, access to biological agents and toxins, data security). (OIE Biosafety and Biosecurity, October 14, 2018) Retrieved from http://www.oie.int/publications‐and‐documentation /general‐information, Operational Control Examples Standard Operating Procedures for all safety Laboratory Biorisk Management System and laboratory biosecurity‐relevant 1. )biohazard identification, processes; 2. )biorisk assessment, Good Microbiological Technique and 3. )biorisk management, and Laboratory Safety practices; 4. )biorisk communication. Use of appropriate disinfection and decontamination practices; Biorisk Identification Transportation procedures for potentially infectious materials and specimens; Operational Control Examples Specimen and reagent handling and storage practices; Accident/incident reporting, response, and review protocols; Emergency exercise drills. (OIE Biosafety and Biosecurity, October 14, 2018) Retrieved from  precautions and practices to ensure the safe handling of biological agents. Biorisk Assessment Why is Personal Protective Equipment (PPE) important in biorisk management? Personal Protective Equipment (PPE) is crucial in biorisk management because it provides a physical barrier between individuals and potentially hazardous biological materials. PPE, such as gloves, lab coats, safety goggles, and masks, helps prevent exposure to biological agents, minimizing the risk of infection or contamination. Biorisk Assessment What are Standard Operating Procedures (SOPs), and 1. Identify the likelihood and the potential why are they essential in a laboratory's biorisk consequences (severity of harm) associated management plan? with exposure to or release of the agent: Standard Operating Procedures (SOPs) are human disease (probability and detailed written instructions that specify the severity) correct and safe procedures for handling, animal disease (probability and storing, and disposing of biological materials. severity) — susceptible species in the They are essential in biorisk management to vicinity — environmental factors in the ensure consistency, minimize human error, vicinity (routes of transmission) and provide a reference for personnel to economic consequences of the follow when working with hazardous materials. disease and associated disease SOPs help maintain a high level of safety and control costs. reduce the risk of accidents or incidents. potential for theft, misuse, or deliberate release. Why is it essential to have an emergency response plan in place as part of biorisk management? 2. Decide if the risk of handling the agent in the An emergency response plan is critical in laboratory can be controlled and is the cost biorisk management because it outlines justifiable. procedures and protocols to follow in case of accidents, spills, or incidents involving POST LABORATORY QUESTIONS: biological materials. What is the purpose of a Biosafety Level (BSL) in This plan ensures that laboratory personnel laboratory settings? know how to react quickly and appropriately The purpose of a Biosafety Level (BSL) is to to mitigate risks, protect themselves, and define and categorize laboratories based on prevent the release of hazardous agents into the level of containment and safety measures the environment. required when working with various biological materials. What is the significance of regular training and BSL levels range from 1 (low risk) to 4 (high risk), education in biorisk management? with each level specifying the appropriate Regular training and education are significant in biorisk management because they:  ○ Keep personnel informed about the latest safety protocols and guidelines. ○ Enhance awareness of potential risks associated with biological materials. ○ Ensure that laboratory staff are skilled in safe handling practices. ○ Promote a culture of safety, reducing the likelihood of accidents or incidents in the laboratory. REVIEW TIME: A risk assessment is defined as a procedure that analyzes a particular process or situation in order to determine the likelihood and consequences of a certain adverse risk.