1: Biosafety and Biosecurity (PRELIMS) Flashcards
A microbial entity capable of replication or transferring genetic material that provokes infections, allergies, toxicity, or other effects in organisms
Biological Agent
Are also referred as “infectious agents” that can cause injury to the host
Biological Agent
These may be cellular or not and naturally occurring or engineered
Ex: bacteria, fungi, virus, and endo- & ectoparasites
Biological Agent
What are the corresponding infections to the given biological agents?
Bacteria: __________
Fungi: ___________
Virus: __________
Endo & Ecto Parasites: _________
Bacteria: Bacterial infection
Fungi: Fungal infection
Virus: Viral Infection
Endo & Ecto Parasites: Parasitic infection
Comprised of, containing, or that may contain biological agents or harmful products
Ex: toxins and allergens, lab equipments such as soiled gloves, biological specimen
Biological Material
Refers to personnel safety— containment principles, technologies, and practices that prevent unintentional/accidental exposure to biological agents or their unintentional release
Biosafety
“Protecting people from bad bugs”
Biosafety
The protection, control, and accountability for biological materials in labs prevents their unauthorized access, loss, theft, misuse, diversion, or intentional release
Biosecurity
“Protecting bad bugs from bad people”
Biosecurity
A concept under biosecurity which are defined as “biological agents are used to cause harm to the environment and others”
Biological weapons
Identify if the scenario given is a classification of biosafety or biosecurity:
Recapping of needles
Biosafety
Identify if the scenario given is a classification of biosafety or biosecurity:
Lab personnel not provided with PPEs
Biosafety
Identify if the scenario given is a classification of biosafety or biosecurity:
Work overload
Biosafety
Identify if the scenario given is a classification of biosafety or biosecurity:
Wastes from lab are not segregated
Biosafety
Identify if the scenario given is a classification of biosafety or biosecurity:
Lack of staff training
Biosafety
Identify if the scenario given is a classification of biosafety or biosecurity:
Staff with huge debt
Biosecurity and Biosafety (this is so discriminatory HABDHCBASHBHA EME)
What are the 4 Principles of Biosafety?
- Standard Microbiological Practices
- Safety Equipment
- Facility design and construction
- Increasing levels of protection
FISS
4 Principles of Biosafety:
→ The most important concept
→ Adherence to standard practices and techniques in handling microorganisms
→ Awareness of hazards and training
Ex: decontamination and aseptic techniques, trainings, programs, seminars, special practices and precautions (occupational health programs)
Standard Microbiological Practices
4 Principles of Biosafety:
→ The primary containment barrier
→ The protection of personnel and immediate lab environment from exposure to infectious agents
→ The engineering controls and equipment
Ex: personal protective equipment (PPE) and biosafety cabinets
Safety Equipments
4 Principles of Biosafety:
→ The secondary barriers
→ Contributes to worker protection
→ protects the outside of the laboratory
Ex: restricted access from public, autoclaves, directional airflow (ventilation), HEPA filter units (installed in biosafety cabinets), and airlocks at lab entrances
Facility design and construction
4 Principles of Biosafety:
→ Biosafety levels 1-4 (BSL)
→ Increasing levels of employee and environmental protection
→Guidelines for working safely in research and clinical laboratory facilities
Increasing levels of protection
These are combination of lab practices and procedures, safety equipment (primary), and laboratory facilities (secondary)
Biosafety levels
Biosafety levels are also called as?
Containment levels
T or F:
The safety level increases the less a specimen poses a threat to the environment and staff
F (The safety level increases the MORE a specimen poses a threat to the environment and staff)
Identify what category the biosafety 1 & 2 practices below belong to:
→ biohazard warning signs and symbols must be displayed on doors of rooms
→ only authorized personnel should be allowed to enter the lab working areas
→ lab doors should be kept closed
Access
Identify what category the biosafety 1 & 2 practices below belong to:
→ wear PPEs
→ wash hands after handling infectious materials before leaving
→ no eating, drinking, smoking, applying cosmetics, handling contacts, or storing food and drinks
Personal Protection
Identify what category the biosafety 1 & 2 practices below belong to:
→ lab should be neat and clean
work surfaces must decontaminated before and after use
→ all contaminated materials must be decontaminated before disposal or cleaned for reuse
→ packing and transportation must follow applicable national and international regulations
→ open windows should be fitted with arthropod-proof (insects) screens
Lab Working Areas
Identify what category the biosafety 1 & 2 practices below belong to:
→ it is the lab director’s responsibility to ensure development and adoption of a management plan and safety or operations manual
→ training in lab safety should be provided
there should be an arthropod and rodent control program
→ appropriate medical evaluation, surveillance, and treatment should be provided in case of need, and medical records should be maintained
Biosafety Management
What biosafety level are the following practices shown:
→ labs have doors and sinks
→ surfaces are easy to clean as tables are water-resistant (must not be made of wood)
→ windows are screened to prevent arthropod entrance
→ agents are well characterized
→ present minimal potential hazard to lab personnel and the environment
Biosafety Level 1
What biosafety level are the following practices shown:
→ all of BSL 1 practices
→ access is restricted to trained personnel
→ lab doors should be self-closing and have locks
→ BSCs are used when there is potential aerosol production
→ sealed centrifuge cups/rotors
→ decontamination methods for lab waste should be available in the facility
Biosafety Level 2
What biosafety level are the following practices shown:
→ all of BSL 2 practices
→ access is restricted through a series of 2 self-closing doors
→ all manipulations are done in a BSC, other containment, or when wearing proper PPE
→ protective clothing with a solid front, wrap around gowns, and scrubs or coveralls are worn
→ eye, face, and respiratory protection may be worn
→ a hands-free sink near the exit door (may be foot-operated or sensor-operated)
→ surfaces of walls, floors, and ceilings should be water-resistant
→ directional airflow must be maintained
Biosafety Level 3
What biosafety level are the following practices shown:
→ all of BSL 3 practices
→ a separate facility and has a 2- person rule
→ agents handled in class III BSCs or with one-piece positive pressure
→ negative pressure must be maintained in the facility
→ shower out practices
→ lab clothing is decontaminated prior to laundering
→ liquid effluent is decontaminated prior to release to sewer
Biosafety Level 4
What Biosafety Level is being described?
Laboratory type: basic teaching, research
Biosafety Level 1
What Biosafety Level is being described?
Laboratory practices: Good Microbiological Techniques, protective clothing, biohazard sign
Biosafety Level 1
What Biosafety Level is being described?
Safety Equipment: None, open bench work
Biosafety Level 1
What Biosafety Level is being described?
Laboratory type: Primary health and diagnostic services, research
Biosafety Level 2
What Biosafety Level is being described?
Laboratory practices: Level 1 practices, Limited access, Biohazard warning signs, Sharps precautions, Biosafety manual (defining any needed waste decontamination/medical surveillance policies)
Biosafety Level 2
What Biosafety Level is being described?
Safety Equipment: Open bench, BSC for potential aerosols
Biosafety Level 2
What Biosafety Level is being described?
Laboratory type: Special diagnostic services, research
Biosafety Level 3
What Biosafety Level is being described?
Safety equipment: BSC, other primary devices for ALL activities
Biosafety Level 3
What Biosafety Level is being described?
Laboratory practices: Level 2 practices, controlled access, decontamination of waste and laboratory clothing
Biosafety Level 3
What Biosafety Level is being described?
Laboratory type: Dangerous, pathogen units
Biosafety Level 4
What Biosafety Level is being described?
Laboratory practices:
Level 3 practices, clothing change before entering, shower on exit, all material decontaminated on exit from facility
Biosafety Level 4
What Biosafety Level is being described?
Safety equipment: Class III, BSC or positive pressure suits, Class II BSCs, double ended autoclave, filtered air
Biosafety Level 4
The assignment of microorganisms (acc. to the WHO) into groups based on: pathogenicity, mode of transmission and host range availability of effective preventive measures
Risk Groups
T or F
Risk groups are based only on severity they cause on people
F (also based on diff. characteristics of biological agent)
→ No or low individual and community risk
→ Microorganisms unlikely to cause human disease or animal disease
Risk Group 1
→ Moderate individual risk, low community risk
→ Pathogen can cause human or animal disease but is unlikely to be a serious hazard to lab staff, community, livestock, or environment
→ Treatable and preventable
Risk Group 2
→ High individual risk, low community risk
→ Pathogen causes serious human or animal disease but isn’t infectious
Risk Group 3
→ High individual and community risk
→ Pathogen causes serious harm to humans or animals which is directly or indirectly infectious
Risk Group 4
What are the 4 different organizations in the field of biosafety?
- American Biological Safety Association (ABSA)
- Asia-Pacific Biosafety Association (A-PBA)
- European Biological Safety Association (EBSA)
- Philippine Biosafety and Biosecurity Association (PhBBA)
Regional professional society founded in 1948 to promote biosafety and biosecurity
American Biological Safety Association (ABSA)
Their goal is to:
→ provide a professional association that represents the interests and needs of practitioners of biological safety
→ to provide a forum for continuous and timely exchange of biosafety information
American Biological Safety Association (ABSA)
Formed in Feb. 22, 2005 and currently represents over 800 biosafety-practicing professionals from regions across the Asia Pacific
Asia-Pacific Biosafety Association (A-PBA)
Their goal is to:
→ to provide a forum that represents the regional interests and needs of biological safety practitioners
→ to provide a platform for promoting constructive dialogue between the scientific community, governments, civil societies, and private sectors
Asia-Pacific Biosafety Association (A-PBA)
a non-profit organization founded in June 1996
European Biological Safety Association (EBSA)
Different Organizations in the Field of Biosafety
Provides a forum for its members to discuss and debate issues of concern and to represent those working in the field of biosafety and associated activities
European Biological Safety Association (EBSA)
Different Organizations in the Field of Biosafety:
Ensures a safe and secure environment by adhering to international standards in the handling, use, storage, and transport of pathogens
Philippine Biosafety and Biosecurity Association (PhBBA)
→ network of individuals with interests in biosafety
→ promotes biosafety and share knowledge
→ develops and exchanges resources and guidance material
→ training and workshops to implement standardization
Biosafety Associations
What are the 5 Pillars of Biosecurity?
- information security
- physical security
- personal security
- material and control accountability
- transport security
What are the 3 additional components added by WHO?
1.emergency/incident response plan
- emergency biotechnology
- Dual use research of concern
5 Pillars of Biosecurity:
Assurance of safety from physical intrusion
Physical Security
What are the 3 factors to consider in physical security?
- Access control
- Access restriction
- Facility design
Examples of this factor under physical security are CCTV, night vision cameras, motion detectors, sound- recording devices, and physical guards
Access control
Examples of this factor under physical security are regular or electronic locks, biometric scanners, voice recognition, and ID badges
Access restriction
What are the 3 levels of protection in physical security?
- protected area
- Limited area
- Exclusion area
5 Pillars of Biosecurity:
→ Refers to personnel screening
→ Assurance that people who have access to sensitive biological materials should have the appropriate knowledge and credentials
Personnel Management
5 Pillars of Biosecurity:
→ Keeping the inventories up to date
Material Control and Accountability
Material Control and Accountability should be based on accountability for pathogens and toxins that include what? (clue: anim ‘to)
→ type of organism available (include dates)
→ updated inventory with storage location
→ description of use
→ personnel who has access to them
→ identification of those responsible
→ documentation of internal and external transfer within and between facilities
5 Pillars of Biosecurity:
Assurance that sensitive and valuable information stored in the lab is protected from theft
Information Security
T or F
In information security there should be more discussion in open areas
F obvi
T or F
To ensure Information Security, one should avoid carrying sensitive information on home computers or storage devices network security
T
What pillar of biosafety does the example below belong to?
→ hardware firewalls
→ good quality security software (e.g. viruses)—must be licensed and updated
→ user authentication
→ restricted software
Information Security
What pillar of biosafety does the example below belong to?
A laboratory with a cctv and biometric scanner
Physical Security
What pillar of biosafety does the example below belong to?
Specimens with description of use, dates of organism
Material Control and Accountability
5 Pillars of Biosecurity:
→ assurance that the same rigorous process that protects the materials in the lab follow them when they are transported outside the laboratory areas
→ establishing a chain of custody
→ knowing and trusting the recipient
Transport Security
A concept under Transport security wherein this is considered as the “proper documentation of the specimen status (date, time, and place it was handled)”
Chain of Custody
What pillar of biosafety does the example below belong to?
Chain of Custody
Transport Security
What pillar of biosafety does the example below belong to?
Mails, Security softwares
Information Security
3 additional components added by WHO:
This is based on the original risk assessment and must include who to contact even outside the facility
Incident Reporting and Response Plan
T or F
A floor plan must be in place to ensure rapid response to any event
F duh (An Incident Reporting and Response Plan dapat)
T or F
Loss, theft, or unauthorized access to materials must be reported to local law enforcement
T
T or F
There should be drills implemented regularly as part of Incident Reporting and Response Plan
T
3 additional components added by WHO:
Technology that utilizes biological processes, organisms, cells, or cellular components to develop new technologies or create different product
Ex: gene editing, human gene transfer, and recombinant technologies
Biotechnology
3 additional components added by WHO:
→ Measures the risk vs. the benefit of research
→ Life sciences research based on current understanding
→ can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops, and other plants, animals, environment, materials, or national security
Dual-Use Research of Concern
(DURC)
Who stated this “DURC can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops, and other plants, animals, environment, materials, or national security”
National Science Advisory Board for Biosecurity [NSABB]
