M6 Flashcards
An inadvertent occurrence that results in actual harm such as infection, illness, injury in humans or contamination of the environment.
Accident
The assessment and attestation of competency.
Accreditation
Liquid or solid particles suspended in air and of a size that may allow inhalation into the lower respiratory tract (usually less than 10 micrometres in diameter).
Aerosol
A microorganism, virus, biological toxin, particle or otherwise infectious material, either naturally occurring or genetically modified, which may have the potential to cause infection, allergy, toxicity or otherwise create a hazard to humans, animals, or plant
Biological agent
enclosed, ventilated working space designed to provide protection to the operator, the laboratory environment and/or the work materials for activities where there is an aerosol hazard.
Containment is achieved by segregation of the work from the main area of the
laboratory and/or through the use of controlled, directional airflow mechanisms.
Exhaust air is passed through a high- efficiency particulate air (HEPA) filter before recirculating into the laboratory or into the building’s heating, ventilation and air conditioning system. There are different classes (I,II and III) of BSCs that provide different levels of containment.
Biological safety cabinet (BSC)
Containment principles, technologies and practices that are implemented to prevent unintentional exposure to biological agents or their inadvertent release.
Biosafety
Principles, technologies and practices that are implemented for the protection, control and accountability of biological materials and/or the equipment, skills and data related to their handling. Biosecurity aims to prevent their unauthorized access, loss, theft, misuse, diversion or release.
Biosecurity
A tank of a minimum height used to contain spills which can then be drained or pumped under control. It is usual to provide bunding which has a volume equivalent to 110% of the potential spill volume.
Bunding
Establishment of the relationship between the measurement provided by the instrument and the corresponding values of a known standard, allowing correction to improve accuracy. For example, laboratory equipment such as pipetting devices may need calibration periodically to ensure proper performance.
Calibration
A third-party testimony based on a structured assessment and formal documentation confirming that a system, person or piece of equipment conforms to specified requirements, for example, to a certain standard.
Certification
Visually free of soil and below specified levels of analytes.
Clean
Process of bringing an item into operation and ensuring that it is in good working order. On building projects, commissioning refers primarily to building services.
Commissioning
Individual or company independent of the builder that does the commissioning work.
Commissioning agent
A set of minimum requirements defined in the fourth edition of the World Health Organization (WHO) Laboratory biosafety manual to describe a combination of risk control measures that are both the foundation for, and an integral part of, laboratory biosafety. These measures reflect international standards and best practice in biosafety that are necessary to work safely with biological agents, even where the associated risks are minimal.
Core requirements
Process of stopping work, decontaminating and making safe a facility such that residual risk in the facility is reduced to an acceptable risk. It may be followed by re-commissioning, repurposing or demolition.
Decommissioning
Reduction of viable biological agents or other hazardous materials on a surface or object(s) to a pre-defined level by chemical and/or physical means.
Decontamination
Practical and commonly used design solutions used to meet and satisfy stated design requirements. This could be a hand-washing basin with a knee-operated water tap, or a window allowing vision through a door or into a space.
Design features
Stated features required by a needs assessment which must be included in the design and which are set out in the user requirement specification.
Design requirements
A group of (professional) people brought together with the
main purpose of designing a building, including specifications and drawings, schedules and programmes. They may be the same as, different to, or part of a construction team.
Design team
Air moving from an active (caused by an intentional force) or passive (air movement as a secondary effect) air source to an active extraction location.
Directional airflow
Agents capable of eliminating viable biological agents on
surfaces or in liquid waste. These will have varying effectiveness depending on the properties of the chemical, its concentration, shelf life and contact time with the agent.
Disinfectant
An outline of the behaviours, processes and procedures to be followed when handling sudden or unexpected situations, including exposure to or release of biological agents. The goal of an emergency response is to prevent injuries or infections, reduce damage to equipment or the environment, and accelerate resumption of normal operation.
Emergency response
Risk control measures that are built into the design of a laboratory or laboratory equipment to contain the hazards. Biological safety cabinets (BSCs) and isolators are forms of engineering control in order to minimize the risk of exposure to and/or unintended release of biological agents.
Engineering controls:
An event during which an individual comes in contact with, or is in close proximity to, biological agents with the potential for infection or harm to occur. Routes of exposure can include inhalation, ingestion, percutaneous injury and absorption and are usually dependent upon the characteristics of the biological agent. However, some infection routes are specific to the laboratory environment and are not commonly seen in the general community.
Exposure
Use of a poisonous gas or vapour to remove contamination of a biological agent from a surface, piece of equipment or area.
Fumigation
A basic laboratory code of practice applicable to all types of laboratory activity with biological agents, including general behaviours and aseptic techniques that should always be observed in the laboratory. This code serves to protect laboratory personnel and the community from infection, prevent contamination of the environment and provide protection for the work
Good microbiological practice and procedure (GMPP)
An important and irreversible event when ownership of and all responsibility for the project passes from the builder to the user or owner.
Handover
An important and irreversible event when ownership of and allresponsibility for the project passes from the builder to the user or owner.
Handover
An object or situation that has the potential to cause adverse effects when an organism, system or (sub)population is exposed to it. In the case of laboratory biosafety, the hazard is defined as biological agents which have the potential to cause adverse effects to personnel and/or humans, animals, and the wider community and environment. A hazard does not become a “risk” until the likelihood and consequences of that hazard causing harm are taken into account.
Hazard
A set of risk control measures as described in the WHO Laboratory biosafety manual that may need to be applied in a laboratory facility because the outcome of a risk assessment indicates that the biological agents being handled and/or the activities to be performed with them are associated with a risk that cannot be brought to an acceptable risk with the core requirements only.
Heightened control measures
These filters are composed of many randomly oriented fibres that create a fibrous matrix through which air can pass. Particles travelling with the air may be captured by the fibres, effectively filtering the air.
High efficiency particulate air (HEPA) filter
Removal of the activity of biological agents by destroying or inhibiting reproductive or enzyme activity.
Inactivation
An occurrence that has the potential to, or results in, the exposure of laboratory personnel to biological agents and/or their release into the environment that may or may not lead to actual harm
Incident
The amount of biological agent required to cause an infection in the host, measured in number of organisms. Often defined as the ID50, the dose that will cause infection in 50% of those exposed.
Infectious dose
Passive or active airflow that comes from outside a room or device.
Inward airflow
The probability of an incident (that is exposure to and/or a release of a biological agent) occurring in the course of laboratory work.
Likelihood (of a laboratory incident)
A set of highly detailed and stringent risk control measures described in the fourth edition of the WHO Laboratory biosafety manual that are considered necessary during laboratory work where a risk assessment indicates that the activities to be performed pose very high risks to laboratory personnel, the wider community and/or the environment, and therefore an extremely high level of protection must be provided.
Maximum containment measures
These are especially needed for certain types of work with biological agents that may have catastrophic consequences if an exposure or release were to occur.
Maximum containment measures
A structured analysis to determine what purpose the proposed building and its systems are required to serve based on all planned activities to be carried out.
Needs assessment
Equipment and/or clothing worn by personnel to provide a barrier against biological agents, thereby minimizing the likelihood of exposure.
Personal protective equipment (PPE)
The process of purchasing goods or services. There are many different routes by which the design and construction of a building can be procured.
Procurement
a specialist adviser who represents the laboratory management/facility owner and is responsible for the day-to-day management of a project.
Project manager
A performance ensuring process typically associated with validation of complex systems and equipment.
Qualification
Repetitions of systems or parts of a system to provideprotection in the case of a primary system failure. For example, a series of HEPA filters in case one or more fail when used to move laboratory air to the outside environment.
Redundancy
Risk that remains after carefully selected risk control measures have been applied. If residual risk is not acceptable, it may be necessary to apply additional risk control measures or to stop the laboratory activity.
Residual risk
A combination of the likelihood of an incident occurring and the severity of the consequences (harm) if that incident were to occur.
Risk
A systematic process of gathering information and evaluating the likelihood and consequences of exposure to or release of workplace hazard(s) and determining the appropriate risk control measures to reduce the risk to an acceptable risk.
Risk assessment
Use of a combination of tools, which include communication, assessment, training, and physical and operational controls, to reduce the risk of an incident/event to an acceptable risk. The risk assessment cycle will determine the strategy that should be used to control the risks and the specific types of risk control measures required to achieve this.
Risk control measure
A set of values, beliefs and patterns of behaviour instilled and facilitated in an open and trusting atmosphere by individuals and organizations working together to support or enhance best practice for laboratory biosafety, irrespective of whether it is stipulated in applicable codes of practice and/or regulations.
Safety culture
Any device or object that is a puncture or wound hazard because of its pointed ends or edges. In the laboratory, sharps can include needles, syringes with attached needles, blades, scalpels or broken glass.
Sharps
A water soluble cleaning compound used for cleaning skin and other materials. Note, soap does not necessarily inactivate biological agents.
Soap
A set of well-documented and validated stepwise instructions outlining how to perform laboratory practices and procedures in a safe, timely and reliable manner, in line with institutional policies, best practice and applicable national or international regulations.
Standard operating procedures (SOPs)
A process that kills and/or removes all biological agents including spore.
Sterilization
A physical check that an entity meets a specified need or target figure.Testing is normally included with other activities such as commissioning, validation and verification. For example, tests can be of water pressure, water quality and/or light level.
Testing (of laboratory design features and equipment during
construction and/or maintenance)
The transfer of biological agent(s) from objects to living things, or between living things, either directly or indirectly via aerosols, droplets, body fluids, vectors, food/water or other contaminated objects.
Transmission
An outline documented statement defining the requirements identified by the user that must be fulfilled by the completed project.
User requirement brief
A detailed documented statement defining all the requirements identified by the user (during the needs assessment) that must be fulfilled and verified by the completed project.
User requirement specification
Systematic and documented confirmation that the specified requirements are adequate to ensure the intended outcome or results. For example, in order to prove a material is decontaminated, laboratory personnel must validate the robustness of the decontamination method by measurement of the remaining biological agents against the detection limit by chemical, physical or biological indicators.
Validation
Confirmation that a given item (product, process or system) satisfies the specified requirements. For example, verification that the performance of an autoclave meets the standards specified by the manufacturer should be performed periodically.
Verification
A stepwise analysis of planned processes in the laboratory that enables understanding and communication of the sequential steps in each process and what facilities, services, systems and space are required at each step. The workflow can be further broken down into the flow of personnel, specimens, materials and waste.
Workflow
laboratory design that is the most important step in ensuring the site of the laboratory has enough floor space for the intended laboratory activity.
planning phase
aka “Standard System for the Identification of the Hazards of Materials for Emergency Response
NFPA 704
This standard provides a widely-recognized system for hazardous material identification.
NFPA 704
aka “safety square”
NFPA Fire Diamond
