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- An analytical procedure designed to characterize safety risks in a laboratory. A biosafety risk assessment allows a laboratory to determine the relative level of risks its different activities pose and helps guide risk mitigation decisions so they are targeted to the most important risk.
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What is a Biosafety Risk Assessment Framework?
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Dec 21, 2020 · This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis.
- Laboratory biosafety manual, 4th edition: Risk Assessment
The WHO Laboratory Biosafety Manual (LBM) has been in broad...
- RISK ASSESSMENT - apps.who.int
Biosafety: Containment principles, technologies and...
- LABORATORY BIOSAFETY MANUAL FOURTH EDITION
7.5 Biosafety and biosecurity risk assessment 80 7.6...
- Laboratory biosafety manual, 4th edition: Risk Assessment
Biosafety assessments (illustrated in yellow) evaluate risks associated with agent and the laboratory processes that are used when handling the agent. A biosecurity risk assessment (illustrated in blue) is focused on an agent’s potential for misuse and the consequences of such misuse.
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Dec 20, 2020 · The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets trends in biosafety.
- Introduction
- How is it conducted?
What is it?
CDC’s Division of Laboratory Systems knows that incidents involving biological, chemical, physical, and radiological hazards can have a significant impact on the safety and health of those who work in laboratory settings. Risk management is a continuous process to identify, assess (evaluate), control, and monitor risks. The risk assessment components of the overall risk management process are:
Risk Management Process
See ISO 35001external icon for the complete risk management process.
Process Steps
Step 1: Identify the hazards and risks. Step 2: Evaluate the risks. Steps 3-4: Implement a risk mitigation plan, as needed. Step 5: Evaluate effectiveness of controls.
Overview of the Risk Assessment Process
In general, risk assessments can be broken down into Steps 1-2 in the figure above. The risk assessment should include considerations about the hazards (e.g., biological agent), the specific processes and procedures, existing control measures, the facility and testing environment, and the competency of the testing personnel. Step 1: Identify the hazards and risks In this section, learn how to answer these questions: •What, where, and how is the work occurring? •Who is involved in the work? •What can go wrong? •How likely is a risk and how severe is it? •Is the risk acceptable or unacceptable? a. Characterize the risks There are various and multiple risks involved in performing laboratory testing. The risk assessment should evaluate each risk against a standard set of criteria so that the assessed risks can be compared against each other. The criteria should focus on both the likelihood of the undesirable incidents occurring and the consequences if those undesirable incidents were to occur. Source: Sandia National Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document, 2014. Likelihood and Consequences of Risk The likelihood component of risk includes factors that affect whether or not the incident happens and occurs before the actual incident occurs; the consequences of risk considers factors that affect the severity of an incident after it has occurred. It is important to define what is being evaluated because some factors can affect the likelihood and consequences. For example, the availability of appropriate personal protective equipment (PPE) can reduce the likelihood of exposure but wearing the appropriate PPE correctly can also reduce the consequences if an exposure occurs. Likelihood of Risk Some factors to consider that can affect the likelihood of an undesirable incident (such as exposure to a biological agent in this example) include: •Biological agent factors •Stability in the environment (e.g., ability to produce spores, resistance to disinfectants) •Potential routes of transmission (direct mucosal contact, inhalation, ingestion, injection) •Endemicity of biological agent in the local environment and population (e.g., endemic or exotic) and host range •Life stage/form of the biological agent (e.g., dimorphic fungi, antigenic shift) •Communicability •Laboratory/testing environment factors •Physical infrastructure and existing controls: the type of facility, presence of engineering/safety controls, type of equipment used, function/reliability of ventilation systems •Procedural: existence of administrative controls such as policies and training; availability of appropriate PPE; generation of aerosols and use of sharps; amplification of the biological agent by culturing, and the types and complexity of procedures being conducted •Human factors •Competency of personnel, level of training •Behavioral aspects •Stress, risk perception, risk tolerance •Following safe work practices To evaluate the consequences after an undesirable incident occurs, assess the characteristics of the hazard(s) or biological agents, the health and immune status of the laboratory/testing personnel, and the availability of vaccines, prophylaxis, or therapies. Consequences of Risk Some factors to consider that can affect the consequences of an undesirable incident (such as infection in this example) include: •Biological agent factors •Virulence factors: adhesion, invasiveness, toxigenesis, production of exoenzymes, antigenic variation, resistance to antibiotics, tissue tropism, multiple replication sites within-host, ability to elicit autoantibodies against host) •High communicability •Severity of infection/disease (morbidity/mortality rate) •Infectious dose •Administrative controls •Availability of vaccines, prophylaxis, therapeutic interventions, and emergency response procedures •Host factors •Health and immune status of staff: immunocompetent or immunocompromised, pregnancy, pre-existing medical conditions, allergies, age, large susceptible population •Behavioral aspects •Willingness to accept vaccines •Adherence to safe work practices and proper use of PPE Step 5: Evaluate Effectiveness of Controls The effectiveness of implementing additional controls (e.g., engineering controls, administrative and work practice controls, and use of PPE) should be reviewed and evaluated. For more information on mitigation and evaluation of the performance of controls, see Biosafety in Microbiological and Biomedical Laboratories (BMBL) (6th Edition)pdf icon.
Resources
•Biosafety in Microbiological and Biomedical Laboratories (BMBL) (6th Edition)pdf icon •Association of Public Health Laboratories (APHL) Risk Assessment Best Practices and Examples (2016) pdf icon[PDF]external icon •Introduction to Laboratory Risk Management (LRM) •Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories, MMWR 61(01)pdf icon •Public Health Agency of Canada Pathogen Safety Data Sheetsexternal icon •ABSA International Risk Group Databaseexternal icon •WHO Laboratory Biosafety Manual, 4th Editionexternal icon •ISO 35001 Laboratory biorisk management system for laboratories and other related organizations;external icon note that users will have to purchase the standard to view the full document •CWA 15793 Laboratory biorisk managementpdf iconexternal icon •CLIA Standards: •Clinical Laboratory Improvement Amendments (42 USC 263a)pdf iconexternal icon •Standards and Certification: Laboratory Requirements (42 CFR 493)external icon •Clinical and Laboratory Standards Institute (CLSI); note that users will need a CLSI subscription to view these resources •M29-A4 Protection of Laboratory Workers From Occupationally Acquired Infections-4th Edition •GP17-A3 Clinical Laboratory Safety-3rd Edition •EP23 Laboratory Quality Control Based on Risk Management, 1st Edition •OSHA Job Hazard Analysispdf iconexternal icon •OSHA Mitigation Planexternal icon
Contact Us
For more information about this Division of Laboratory Systems biorisk assessment resource, contact us at DLSinquiries@cdc.gov.
Biosafety: Containment principles, technologies and practices that are implemented to prevent unintentional exposure to biological agents or their inadvertent release. Biosafety officer: An individual designated to oversee facility or organizational biosafety (and possibly biosecurity) programmes. The person fulfilling this function may
7.5 Biosafety and biosecurity risk assessment 80 7.6 Supporting programmes and plans 80 7.7 Reports and reviews 81 SECTION 8 Laboratory biosecurity 83 8.1 Biosecurity risk assessment 84 8.2 Inventory control 85 8.3 Information control 85 8.4 Personnel control 86 8.5 Physical security control 86 8.6 Transport control 87 8.7 Emergency/incident ...
Jun 21, 2024 · the biological risk management and prevent biosafety and biosecurity incidents. To develop the Laboratory biosecurity guidance, the WHO engaged international experts to address biosecurity needs at the laboratory, institutional, and national levels.
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