Biosafety and Security (PPT) Flashcards
- Any microbial entity, cellular or non-cellular structurally, occurring or engineered, capable of replication or of transferring genetic material that may be able top provoke infection, allergy, toxicity, or other adverse effects in humans, animals, or plants (ISO 35001:2019)
- example: HIV, SARS-COV2
Biological agent
- Any material comprised of, containing, or that may contain biological agents and/or their harmful products such as toxins and allergens (ISO 35001:2019)
- example: blood in the test tube, sputum in the mask
biological material
potential source of harm caused by biological materials (ISO 35001:2019)
biohazard
containment principles, technologies, and practices implemented to prevent unintentional/accidental exposure to pathogens and toxins, or their unintentional/accidental release (WHO laboratory manual 3rd edition)
laboratory biosafety
institutional and personal security measures designed to prevent that loss, theft, misuse, diversion, or intentional release of pathogens and toxins (WHO laboratory manual 3rd edition)
laboratory biosecurity
Biosafety or biosecurity?
recapping of needles
biosafety
Biosafety or biosecurity?
medtech is a member of terrorist group
biosecurity
Biosafety or biosecurity?
lab personal is not provided with PPE
biosafety
Biosafety or biosecurity?
disgruntled staff
biosecurity
Biosafety or biosecurity?
workload overload
Biosafety
Biosafety or biosecurity?
waste from lab are not segregated
biosafety
Biosafety or biosecurity?
lack of staff training
biosafety
Biosafety or biosecurity?
staff with a huge debt
biosafety (lack of prioritization on procedures performed) and biosecurity (may risk the pathogens for selling to settle debt)
Organizations in the field of biosafety:
* Internationally: ABSA, EBSA, A-PBA
What are the names of these abbreviations?
- American Biological Safety Association (ABSA)
- European Biological Safety Association (EBSA)
- Asia-Pacific Biosafety Association (A-PBA)
Organizations in the field of biosafety:
* locally: PhBBA, and BRAP
PhBBA, and BRAP means?
- Philippine Biosafety and Biosecurity Association (PhBBA)
- Biological Risk Association of the Philippines (BRAP)
Difference between PhBBA and BRAP?
PhBBA is a govt institution and aids DOH and DOA. Meanwhile, BRAP is a NGO
– Most important concept/ strict adherence
– Aware of potential hazard
– Trained and proficient in techniques
– Supervisors responsible for appropriate laboratory facilities, personnel and training
standard practices
Includes:
– Occupational health programs
special practices and procedures
What is under the first principle of biosafety, A. Practice and procedures?
- standard practices
- special practices and procedures
– Primary containment barrier
– Minimize exposure to hazard (prevent contact/contain aerosols)
– Engineering controls, equipment, PPE, Biosafety cabinet, covered animal cage system, sealed centrifuge rotors
Safety and equipment
– Secondary barrier
– Protects outside the laboratory
– Building and lab design, ventilation, autoclaves, cage wash facility, sealed laboratory walls/floors, HEPA filters
facility design and construction
also referred as Containment levels. It is the combination of laboratory practices and procedures, safety equipment (primary barriers) and laboratory facilities (secondary barriers)
biosafety levels
- Student training and teaching laboratory
- Well-defined and characterized agents
– Nonpathogenic organism
❑Bacillus subtilis, non pathogenic strain of E.coli
❑Naegleria gruberi
❑Saccharomyces cerevisiae - No harm to humans
- Relies on standard microbiology practices
Biosafety Level 1
Practices
* Standard microbiological practices are followed.
* Work can be performed on an open lab bench or table
Biosafety level 1
- Safety equipment
- Personal protective equipment, (lab coats, gloves, eye protection) are worn as needed.
biosafety level 1
- Facility construction
- A sink must be available for hand washing.
- The lab should have doors to separate the working space with the rest of the facility
biosafety level 1
- Clinical, diagnostic, and teaching laboratories handling moderate risk agents
– e.g. Staphylococcus aureus, Hepatitis B, HIV, Salmonella, and Toxoplasma - Lab personnel should have specific training in handing pathogens
biosafety level 2
Practices
* Access to the laboratory is restricted when work is being conducted
biosafety level 2
- Safety equipment
- Appropriate personal protective equipment (PPE) is worn
- All procedures that can cause infection from aerosols or splashes are performed within a biological safety cabinet (BSC)
- An autoclave or an alternative method of decontamination is available for proper disposals.
Biosafety level 2
- Facility construction
- The laboratory has self-closing doors.
- A sink and eyewash are readily available
biosafety level 2
- Builds upon the containment requirements of BSL-2
-
Clinical, research and production laboratories
– Indigenous or exotic agents
– Potential for respiratory transmission
– Mycobacterium tuberculosis, St. Louis encephalitis, Coxiella - Primary hazard: infectious aerosol
- Emphasis on primary (protective clothing) and secondary barriers
- Emphasis on procedures, must have written and validated. Standard operating procedures
Biosafety level 3
- Practices
- Laboratorians are under medical surveillance and might receive immunizations for microbes they work with.
- Access to the laboratory is restricted and controlled at all times
biosafety level 3
- Safety equipment
- Appropriate PPE must be worn, and respirators (N95) might be required.
- All work with microbes must be performed within an appropriate BSC
biosafety level 3
- Facility construction
- hands-free sink and eyewash
- Entrance to the lab - two sets of self-closing and locking doors
- Biosecurity management system
– Active security, CCTV, ID cards for accountability - Directional air flow
– provides “zone of control” of hazards and odors - Effluent decontamination
– in and out of the sample
– Passbox, autoclave, dunktank
biosafety level 3
- Dangerous / exotic agents
– via aerosol route
– no vaccines or treatment
– Ebola and Marburg viruses - Extreme containment
- Maximum containment
biosafety level 4
- Practices
- Change clothing before entering.
- Shower upon exiting.
- Decontaminate all materials before exiting
biosafety level 4
- Safety equipment
- Class 3 Biosafety cabinet
- Full body, air supplied positive air pressure suits
biosafety level 4
- Facility construction
- Separate buildings or completely isolated zone complex, specialized ventilation requirements
- Special waste management
biosafety level 4
- Laboratories where work with microorganisms is conducted in a BSL2 lab with biosafety practices and procedures typically found in BSL3
- Risk assessment based
- Challenging since it is not a recognized level in biosafety guidance documents.
biosafety level 2+
Clean Room
▪Protection of sensitive sample from contaminant exposure
▪Positive pressure areas
Biosafety level
▪ Protection of personnel and the environment from biological exposure
▪ Negative pressure area
Biosafety level 2+
- Importance of disease or severity of infection
- Infectivity
- Host range of microorganism
- Potential survival and dissemination in the community
- Availability and effectiveness of prophylactic measures
Properties inherent to biological materials
___ are not absolute and may change after further studies
Risk group
▪ (no or low individual an community risk) A microorganism that is unlikely to cause human or animal disease.
▪ e.g. Lactobacillus, Saccharomyces
risk grp 1
▪ (moderate individual risk, low community risk) A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection,but effective treatment and preventive measures are available and
the risk of spread of infection is limited.
▪ e.g. E. coli, Staphylococcus
RISK GRP 2
▪ (high individual risk, low community risk) A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available
▪ e.g. Bacillus anthracis, M. tuberculosi
risk grp 3
▪ (high individual and community risk) A pathogen that usually
causes serious human or animal disease and that can be readily
transmitted from one individual to another, directly or indirectly.
Effective treatment and preventive measures are not usually
available. ▪ e.g. Ebola
risk grp 4
▪ Is the assurance of safety from physical intrusion
▪ Graded layers of Protection
o Different areas of a facility will have different levels of security based on risk
o Concentric rings of increasing security spanning from outside to inside the facility
physical security
▪ Assurance that the people that are given access to sensitive
biological materials should have that access.
▪ Reduce the risk of theft and fraud, reduce scientific misconduct
personnel management
▪ Assurance that there is an awareness of what exists in the
laboratory, where it is, and who is responsible for it.
▪ Ensure the complete and timely knowledge of:
o What materials exist?
o Where the materials are?
o Who is accountable for them?
material control and accountability
▪ Assurance that the sensitive and valuable information stored in a laboratory is protected from theft or diversion
▪ Protection of information that is too sensitive for public distribution
▪ Communication and network security
information security
▪ Research that could be misused for malevolent purpose
Dual use research of concern (DURC)
▪ Monitoring and assessing the scientific, ethical, and social implications of certain biotechnologies and, as warranted, monitoring the development and integration of those technologies into scientific and clinical practice.
▪ e.g. Gene editing, Human gene transfer, recombinant technologies
emerging biotechnology
To limit the damage and restore operation after an incident
EMERGENCY INCIDENT RESPONSE PLAN
- ____-– protecting people form BAD BUGS
- ________- – protecting BAD BUGS from BAD PEOPLE
BIOSAFETY, BIOSECURITY
An object or situation that has the potential to cause adverse effects when an organism, system or (sub)population is exposed to it.
hazard
A combination of the likelihood of an incident and the severity of the harm (consequences) 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
Part of risk assessment where the likelihood of exposure to a hazard is weighed against the potential severity of harm under a set of predefined circumstances, such as a specific laboratory procedure
Risk evaluation
is the risk associated to biological toxins or infectious
biorisk
– is the integration of biosafety and biosecurity to manage risks when working with biological toxins and infectious agents (CWA 15793 Laboratory Biorisk Management Standard)
biorisk management
- “a system or process to control SAFETY and SECURITY risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities.
- encompasses the identification, understanding, and management aspects of a system in interrelated processes.
- It is divided into three (3) PRIMARY COMPONENTS:
Biorisk management
3 primary components of BRM
- assessment
- mitigation
- performance
- A framework that integrates BEST PRACTICES and PROCEDURES
- Ensures that an organization can effectively achieve all of its OBJECTIVES
- Frequently built around the Plan, Do, Check Act cycle
CWA 15793:2011
In which part of the CWA 15793:2011 Plan, Do, Check, Act cycle does this belong in?
* identification of potential for improvement
* analysis of current situation
* development of new concepts
* hazard identification risk assessment
Plan
In which part of the CWA 15793:2011 Plan, Do, Check, Act cycle does this belong in?
* Testing and optimization of new concepts by basic means at one working place
* Policy, objectives, procedures, and programs
Do
In which part of the CWA 15793:2011 Plan, Do, Check, Act cycle does this belong in?
* careful checking of process and obtained results
* if successful -> full approval as a standard process
* monitoring audit
Check
In which part of the CWA 15793:2011 Plan, Do, Check, Act cycle does this belong in?
* Full implementation as a standard which is periodically checked by audits
* Correct/preventive action
Act
AMP model is like a three-legged stool with the biorisk management as the seat. What are these “legs”?
- assessment
- mitigation
- performance
Identification of hazards and characterization of risks
risk assessment
refers to anything in the environment that has a potential to cause harm
hazard
is generally defined as the possibility that something bad or unpleasant (such as injury or loss) will happen.
RISK
It consists of the following steps:
1. Define the situation
2. Define the risks
3. Characterized the risks
4. Determine if risks are acceptable or not
risk assessment
- Identification of hazards and risks of the biological agents
- Humans and animals inside or outside the laboratory
- Work activities and laboratory environment including location, procedures and equipment
define the situation
- Review of how individuals inside and outside the laboratory may be exposed to the hazards.
define the risks
- evaluating the BioRisk arising from a biohazard take into account the adequacy of any existing controls,
determine if risks are acceptable or not
measures that are put into place to reduce or eliminate the risks associated with biological agents and toxins
biorisk mitigation
in the hierarch of controls of mitigation procedures, enumerate them from bottom (easiest to implement, least effective) to the top (most difficult, most effective)
- PPE
- Administrative controls
- engineering controls
- Substitution
- Elimination
- Involves a systematic process intended to achieve organization objectives and goals.
- Helps to highlight BioRisk strategies that are not working effectively and measures that are ineffective or unnecessary.
- A reevaluation of the overall mitigation strategy.
Performance evaluation
The most difficult and most effective control measure, involves the total decision not to work with a specific biological agent or even not doing the intended work
elimination
- the second control measure, is the replacement of procedures or biological agent with a similar entity in order to reduce the risks
- example: a laboratory conducting research with the pathogen Bacillus anthracis, responsible for causing the acute fatal disease anthrax, could potentially substitute a less dangerous experimental surrogate, Bacillus thuringiensis
substitution
- includes physical changes in work stations, equipment, production facilities, or any other relevant aspect of the work environment that can reduce or prevent exposure to hazards
- ex: installation of biosafety cabinets, safety equipment, facility design enabling proper airflow, ventilation system to ensure directional airflow, and air treatment system to decontaminate or remove agents from exhaust air, controlled access zones, airlocks as laboratory entrances, or separate bldgs/modules to isolate the lab
(setting of) engineering controls
refers to the policies, standards, and guidelines used to control risks
(setting of) administrative controls
last mitigation control, devices worn by workers to protect them against chemicals, toxins, and pathogenic hazards in the lab
(using of PPE)
Simply a reevaluation of the overall mitigation strategy
performance management
