Biosafety is the prevention of largescale loss of biological integrity, focusing both on ecology and human health. Who laboratory biosafety manual lbm revision update. Biosafety laboratory risk assessment sciencedirect. The biosafety act, 2007 arrangement of sections part i preliminary section 1. International best practices regarding biosafety and. Annual risk assessments are performed in all laboratories, media preparation, washroom, and the warehouse at least once a year.
Biosafety is a two way path to be biosafe implies creating a safe working environment for all personnel and ensuring that the work being done does not impact the environment. 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. A biosecurity risk assessment has unique considerations compared to biosafety and other risk assessments. Biological safety training, module 8 risk management. Biosafety level ii applicable to facilities in which work is done with indigenous moderaterisk agents present in the community and associated with human disease of varying severity. General considerations worksheet this is intended to be used in conjunction with the conducting a biosafety risk assessment standard operating procedure. Management of biological safety and security risks is a difficult and costly venture.
In this booklet you will find all the information that was already present in the earlier editions. Biosafety management list of high impact articles ppts. Biosafety risk assessment and management of laboratoryderived influenza a h5n1 viruses trans missible in ferrets aline baldo 1, amaya leunda 1, chuong dai do thi 1, didier breyer 1, katia. Biosafety risk assessment and management process five step process. Levels are designated in ascending order, by degree of protection provided to personnel, the environment, and the community. Biosafety and biosecurity laboratory biorisk management guidelines for implementation cwa 16393 laboratory.
The analysis of ways and development of strategies to minimize the likelihood of the occurrence of biorisks. Barbeito, 1997, a history of the american biological safety association part iii. It is the policy of california state university, fullerton to maintain, insofar as is reasonably. Notice autoclave guidance 47 kb, pdf chair covers for fabric chairs. Laboratory biosafety and biosecurity mitigate different risks, but they share a common. Site and activityspecific biosafety risk assessments should be performed to determine if additional biosafety precautions are warranted based on situational needs, such as high testing volumes, and the likelihood to generate infectious droplets and aerosols. The maximum containment laboratory biosafety level 4. A second equally important facet of the process is documentation of compliance to the standards of good science as set by regulatory bodies. Select agent regulations sar section 12 biosafetybiocontainment an individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of. Biorisk management asean best practices for implementation of a biorisk management system iso 35001. The log is available on the risk management services biosafety program website. Biosafety is used to protect from harmful incidents.
The university risk manager and biosafety officer from environmental health and. The hsw act places duties on employers and others, where the risks from exposure to biological agents may arise from work activities. Overview of risk assessment and risk management in. Only a few alterations have been made, especially in the text concerning decontamination and inactivation. Biosafety risk management and safety university of. For biosafety, likelihood refers to the probability of infection and exposure via an infectious route of a biological agent. Institutional biosafety committee environmental health. Footnote 5 it is a guidance document for canadian facilities where human and terrestrial animal pathogens are handled, that updates the guidelines originally published as part ii of the. Conducting a biosafety risk assessment healthiest state in the nation. Laboratory biosafety and biosecurity risk assessment sandia.
Bsl ii is appropriate when work is done with any humanderived blood, body fluids, tissues, or primary human cell. Standard for managing biological risk in the veterinary diagnostic laboratory and animal facilities quality management in veterinary testing laboratories. Quality management system for all stakeholders in health laboratory processes, from management, to administration, to benchwork laboratorians. Laboratory biosafety and biosecurity risk assessment technical. Biosafety management the biosafety program assesses and manages the potential dangers in examination tasks including biohazardous materials through preparing, office and gear affirmation and exploration convention audit. Biosafety risk assessments federal select agent program.
The goal of this session is to provide the tools to build and enhance biosafety and biosecurity practices. Biosafety professionals that perform this function should have training and field experience that includes methods used to control biohazards and knowledge of the design, application, and testing of biosafety cabinets. Biosafety resource book food and agriculture organization of the. The biosafety risk management program is to maintain biosafety within laboratories. The risk assessment guides the selection of appropriate.
Canadian biosafety handbook, second edition canada. The objective of a biosafety system is to prevent, manage, minimize or eliminate hazards to human. Medical waste management act, california health and safety code sections 117600. Management and operation of microbiological containment laboratories. A risk assessment should clearly define the risk being assessed and avoid over complication. This manual has been developed by the office of biosafety, risk management services, ubc, with the endorsement of the universitys biosafety committee. The scope of the assessment involves evaluation of pathogenic microbial hazards, experimental activities, facilities and equipment, personnel, experimental methods, etc.
Laboratory biosafety guidance related to the novel coronavirus 2019ncov pdf icon external icon. Biosafety levels 1, 2, 3the concept of biosafety levels bsl is the basis for laboratory practices designed to prevent laboratory acquired infections. Public interest report fall 2011 6 there are four basic biosafety levels as determined by cdc and nih which describe the microbiological techniques, lab practices, safety equipment and lab facilities necessary to protect workers and the environment. Many laboratories lack the knowledge and skills to conduct a structured and systematic risk assessment, as a result most biosafety risk assessments are based purely on subject matter expert. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. This is the third, revised edition of the booklet biosafety in the laboratory.
The biosafety manual has all of the biohazardous waste information and more. Laboratory biosafety manual world health organization. Risk assessment 1 perform comprehensive hazard evaluation and determine initial biosafety level bsl. Biosafety is a wellestablished concept with a widelyaccepted meaning and international guidance on how it is put into practice at the national level. Consequences are defined as the effects of disease to the atrisk population. Information on engineering controls including the functions of biosafety cabinets are found in section 3 of the biosafety training manual pdf.
A biosecurity risk assessment, as described in this guideline, is concerned with biosecurity events that have the potential to cause adverse consequences to public. The third edition of the who laboratory biosafety manual is a helpful reference and guide to nations that accept the challenge to develop and establish national codes of practice for securing microbiological assets, yet ensuring their availability for clinical. Biosafety risk management program delaware health and. Concepts of biosafety and biosecurity deal with related but distinctly different issues. Through dls work with other cdc programs, federal and state agencies, professional societies, and international organizations, the division supports the development and adoption of standards, guidelines, recommendations, and tools for improved quality and safety in clinical and public health laboratories. Biosafety level 2 are applicable to clinical, diagnostic, teaching and other laboratories in which work is done with the broad spectrum of indigenous moderaterisk agents that are present in the community and associated with human disease of varying severity. Absa risk group database url biosafety sop template 349 kb, word doc autoclave out of service 8 kb, pdf red bags. A biosafety risk assessment should consider every activity and procedure in a laboratory that involves infectious disease agents. Clinical laboratory biosafety risk management program assessment checklist page 3of 21. Management of veterinary laboratories collection, submission and storage of diagnostic specimens transport of specimens of animal origin biosafety and biosecurity. Management, supervisors, and laboratory workers should be involved in performing the risk assessment and implementing the safety measures that are decided upon. The risk assessment should determine the most appropriate control measures, and how the system will measure the effectiveness of those control measures. The canadian biosafety handbook cbh, 2 nd edition, 2016 is intended as a companion document to the canadian biosafety standard cbs, 2 nd edition, 2015. This handbook covers topics that are essential for quality management of a public health or clinical laboratory.
Biohazardous materials include any organism that can cause disease in humans, or cause significant environmental or agricultural impact, such as. Risk assessment, biosafety programme management, laboratory design and maintenance, biological safety cabinets and isolators, ppe, decontamination and waste management, and emergencyoutbreak response publication of a position paper prior to release of the lbm to outline the rationale for the changes. Laboratory biosafety and biosecurity risk assessment. Biosafety laboratory risk assessment is a dynamic and systematic work. Risk and decision analysis for biosafety management. This biosafety manual applies to all university of notre dame lab personnel. In addition, risk management services rmsbso is always available to address health. The use of a structured, practical, process for implementing risk governance that supports understanding of the risk, and supports decision making regarding the risk is key for biosafety management. The third edition of the who laboratory biosafety manual is a helpful reference and guide to nations that accept the challenge to develop and establish national codes of practice for securing microbiological assets, yet ensuring their availability for clinical, research and epidemiological purposes.
Risk assessment best practices pdf icon external icon. The uw biosafety manual provides students, staff, and faculty at uw with information that is necessary to protect them and the surrounding community from possible hazards associated with the use of biohazardous agents and recombinant or synthetic dnarna recdna molecules all laboratories and facilities using biohazards should have an electronic or paper copy of the current biosafety manual. Health and safety executive management and operation of. Since 2014, given the occurrence of ebola virus and other infectious organisms, the safety of laboratory staff and other personnel attracted much attention and concern. Biosafety and biosecurity laboratory biorisk management guidelines for implementation cwa 16393 laboratory biosafety. Biosafety risk management program standard operating procedure delaware public health laboratory 3 quality control. The purpose of the nus laboratory biorisk management manual is to detail the universitys biological safety programme and to provide guidelines for all university personnel for the safe operation of laboratories involving biological materials. For additional information, refer to the following. The center for disease control cdc and national institutes of health nih identify four levels of containment. Are biosafetyrelated policies and procedures managed in a document control system to ensure that the most current documents are in use and available. They can decide to eliminate the risk or substitute it.
It is intended to provide information to protect workers and the surrounding environment from possible exposure to biohazardous agents. Clinical laboratory biosafety risk management program. Each decision to use bsl3 practices in a bsl2 laboratory must be made via the risk assessment process. Are selfaudits of the biosafety management systems and accidentincident reports performed annually to. Risk managers must understand the various options that can be used to mitigate risks because no matter how well planned a facility is, the mission will inevitably.