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LAM Regulatory Jan 2017 > BMBL > Flashcards

BMBL Flashcards

1
Q

What are the fundamentals of containment?

A

microbiological practices, safety equipment, and facility safeguards that protect laboratory workers, environment, and public
–BMBL Section I

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2
Q

what are the two principles of biosafety first introduced in the BMBL

A

containment
risk assessment
–BMBL Section I

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3
Q

what is risk assessment

A

process that enables appropriate selection of microbiological practices, safety equipment, facility safeguards that prevent lab-associated infections
–BMBL Section I

process that identifies hazardous characteristics of a known infectious/potentially infectious material, activities that can result in exposure to the agent, likelihood that the exposure will cause lab-acquired infection, probable consequences of the infection–BMBL Section II

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4
Q

what are the 10 most common lab associated infections first identified in a 1978 survey?

A 
Brucella
Coxiella burnettii (Q fever)
hepatitis B virus (HBV)
salmonella typhi
Franciscella tularensis
Mycobacterium tuberculosis 
Blastomyces dermatiditis 
Venezuelan equine encephalitis viru
Chlamydia psittaci
Coccidioides immitis
--BMBL Section I
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5
Q

What are the two most at-risk locations for Lab-acquired infections?

A

research laboratories
clinical diagnostic laboratories
–BMBL Section I

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6
Q

When was the Classification of Etiologic Agents on the Basis of Hazard published, and who published it?

A

1974
CDC
–BMBL Section I

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7
Q

When were the National Cancer Institute Safety Standards for Research Involving Oncogenic Viruses published, and who published it?

A

1976
NIH
–BMBL Section I

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8
Q

When were the NIH Guidelines for Research Involving Recombinant DNA Molecules published, and who published it?

A

1976
NIH
–BMBL Section I

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9
Q

What document initially set the foundation for developing a code of practice for biosafety in laboratories?

A

NIH Guidelines for Research Involving Recombinant DNA Molecules
–BMBL Section I

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10
Q

When was the BMBL first published, and who publishes it?

A

1984
US DHHS (primary), PHS, CDC, NIH
–BMBL Section I

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11
Q

What are the primary risk criteria used to define ascending levels of containment (BSL 1-4)?

A 
infectivity
severity of disease
transmissibility
nature of the work being conducted
origin of the agent (indigenous or exotic)
--BMBL Section I
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12
Q

What BSL level is basic and appropriate for agents that don’t cause disease in healthy, normal humans?

A

BSL1

–BMBL Section I

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13
Q

What BSL level is appropriate for moderate-risk agents that cause human disease of varying severity by ingestion or through percutaneous or mucous membrane exposure?

A

BSL2

–BMBL Section I

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14
Q

What BSL level is appropriate for agents with a known potential for aerosol transmission, may cause serious and potentially lethal infections, and that are indigenous or exotic in origin

A

BSL3

–BMBL Section I

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15
Q

What BSL level is appropriate for exotic agents that pose a high individual risk of life-threatening disease by infectious aerosol and for which no treatment is available?

A

BSL4

–BMBL Section I

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16
Q

What is the most important operational risk factor for procedures, which supports the need for containment equipment and facility safeguards?

A

potential to release microorganisms into the air as aerosols and droplets
–BMBL Section I

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17
Q

You are working with an agent without an agent summary statement in BMBL. Is it safe to use at BSL1?

A

NO.
Just because a summary statement is absent doesn’t mean that it is safe in BSL1 conditions or that a risk assessment isn’t necessary to determine appropriate BSL levels.
–BMBL Section I

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18
Q

What procedure should be done before beginning work with an agent or procedure new to the lab?

A

A risk assessment by the laboratory director

–BMBL Section I

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19
Q

Is following the BMBL voluntary or required by law?

A

It is a voluntary code of practice but should be followed as if it was law
–BMBL Section I

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20
Q

What is the most likely cause of many lab-acquired infections?

A

Accidental release of microbial aerosols

–BMBL Section I

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21
Q

Who is responsible for risk assessment in laboratories?

A

Ultimately, the director and principal investigator
IBC, ACUCs, biological safety professionals, lab animal vets share responsibility
–BMBL Section II

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22
Q

What are the primary factors to consider in risk assessment?

A

Agent hazards
Laboratory procedure hazards
(Also capability of lab staff to control hazards
–BMBL Section II

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23
Q

What are the principal hazardous characteristics of a given agent?

A

Capability to infect and cause disease in susceptible human or animal host
virulence as measured by severity of disease
availability of preventive measures and effective treatments for disease
(Others that aren’t primary: probable route of transmission/infection, infective dose, environmental stability, host range, endemic nature)
–BMBL Section II

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24
Q

What 2 organizations have risk group classifications for infectious agents?

A

WHO
NIH
Note: these systems correlate with but don’t equate to BSL levels
–BMBL Section II

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25
Q

What WHO and NIH risk group would an agent fall under with the following characteristics?
WHO- no/low individual and community risk
NIH- not associated with dz in healthy adult humans

A

Risk group 1

–BMBL Section II

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26
Q

What WHO and NIH risk group would an agent fall under with the following characteristics?
WHO- Moderate individual risk, low community risk
NIH- associated with human dz that is rarely serious and for which preventive or therapeutic interventions are often available

A

Risk group 2

–BMBL Section II

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27
Q

What WHO and NIH risk group would an agent fall under with the following characteristics?
WHO- High individual risk, low community risk
NIH- serious/lethal human dz for which therapeutic interventions may be available

A

Risk group 3

–BMBL Section II

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28
Q

What WHO and NIH risk group would an agent fall under with the following characteristics?
WHO-high individual, high community risk
NIH- likely to cause serious/lethal human disease for which preventative or therapeutic interventions are not usually available

A

Risk group 4

–BMBL Section II

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29
Q

You are working with an agent that may cause human/animal disease but is unlikely to be a serious hazard for lab workers, community, livestock or the environment. Effective treatments and preventive measures are avaialable and risk of infection spreading is limited. What WHO risk category would this agent fall under?

A

Risk group 2

–BMBL Section II

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30
Q

You are working with an agent that has a serious risk of disease for humans, but a preventive/therapeutic intervention may be available under the right circumstanes. What NIH risk category would this agent fall under?

A

Risk group 3

–BMBL Section II

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31
Q

What are the most likely routes of transmission for an infectious agent used in a laboratory?

A

(1) direct skin, eye, or mucosal membrane exposure
(2) parenteral inoculation by a contaminated sharp or bites from infected animals/vectors
(3) ingestion of liquid suspension or contaminated hand-mouth exposure
(4) inhalation of infectious aerosols
- -BMBL Section II

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32
Q

What agent characteristics are particularly important in establishing risk of airborne transmission of a disease?

A

infective dose
agent stability
–BMBL Section II

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33
Q

What situations indicate the potential for zoonotic hazard?

A

(1) evidence that experimental animals shed zoonotic agents in saliva, urine, or feces
(2) demonstrated transmission of disease between infected and uninfected cagemates
Note: lack of demonstrated transmission doesn’t rule out zoonotic hazard
–BMBL Section II

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34
Q

You are importing an agent that causes human disease What organization do you need a permit from?

A

CDC

–BMBL Section II

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35
Q

You are importing an agent that causes livestock, poultry, or other animal disease. What organization do you need a permit from?

A

USDA APHIS

–BMBL Section II

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36
Q

You are conducting a risk assessment involving recombinant DNA. What is the key reference you should use?

A

NIH Guidelines for Research Involving Recombinant DNA Molecules
–BMBL Section II

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37
Q

Define recombinant DNA.

A

A molecule constructed outside of a living cell with the capability to replicate in a living cell.
–BMBL Section II

38
Q

Is compliance with NIH Guidelines for Research Involving Recombinant DNA Molecules voluntary or mandatory for investigators?

A

It is MANDATORY for investigators at a facility that receives NIH funding and constitutes best practice at other facilities
–BMBL Section II

39
Q

What is required for recombinant DNA research that is subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules?

A

One of the following:

(1) Approval by NIH director, review by NIH Recombinant DNA Advisory Committee (RAC), AND approval by IBC
(2) review by the NIH Office of Biotechnology Activities (OBA) AND approval by IBC
(3) review by the RAC AND approvals by the IBC and IRB
(4) approval by the IBC prior to work beginning
(5) notification of the IBC when work begins
- -BMBL Section II

40
Q

What was the first document to formulate the concept of an IBC as the responsible entity for biosafety issues due to use of recombinant DNA?

A

NIH Guidelines for Research Involving Recombinant DNA Molecules
–BMBL Section II

41
Q

Who is ultimately responsible for the effectiveness of the IBC?

A

the institution

–BMBL Section II

42
Q

What are the 5 principle routes of laboratory transmission of agents?

A

(1) parenteral inoculation
(2) spills and splashes
(3) ingestion (mouth pipetting, gross!)
(4) animal bites and scratches
(5) inhalation
- -BMBL Section II

43
Q

Why are aerosols so hazardous?

A

They are ubiquitous in lab procedures
usually undetected
extremely pervasive
–BMBL Section II

44
Q

What type of procedures will produce aerosols?

A

Anything that imparts energy to a microbial suspension.
EX: pipetting, blending, centrifuges, sonicators, vortex mixers
–BMBL Section II

45
Q

What parameters can help characterize the hazard potential of an aerosol?

A 
inhalation infective dose
viability in aerosol
aerosol concentration
particle size
--BMBL Section II
46
Q

What areas have the most risk of exposure to droplet contamination?

A

Surfaces and hands may be widely contaminated

–BMBL Section II

47
Q

What is the first line of defense when working with hazards in the laboratory?

A

The workers themselves–>good microbiological practices and correct use of safety equipment
–BMBL Section II

48
Q

What is the greatest concern of worker using hazards in the laboratory?

A

carelessness- can not only compromise safeguards but place others at risk
–BMBL Section II

49
Q

What are needed for laboratory staff to reduce risk of hazards?

A 
Training
Experience
Knowledge of agent and procedure hazards
Good habits, caution, attentiveness
Concern for the health of coworkers
--BMBL Section II
50
Q

Who is responsible for training new staff in laboratory procedures?

A

Lab directors or principal investigators

–BMBL Section II

51
Q

You are using a biological safety cabinet while working with an infectious agent. What could compromise the containment capability of this unit?

A

poor location, room air currents, decreased airflow, leaky filters, raised sashes, crowded work surfaces, poor user technique
–BMBL Section II

52
Q

What is the major determinant of whether directional airflow exists in a lab?

A

operational integrity of lab’s HVAC system

–BMBL Section II

53
Q

What is the purpose of a facility safeguard?

A

To prevent release of a pathogen from the laboratory

–BMBL Section II

54
Q

What is the 5-step approach to risk assessment?

A

(1) Identify agent hazards, perform initial risk assessment
(2) Identify laboratory procedure hazards
(3) Make a determination of appropriate BSL and select additional precautions indicated by risk assessment
(4) Evaluate staff proficiency in safe practices and integrity of safety equipment
(5) review risk assessment with a biosafety professional, subject matter expert, and IBC
- -BMBL Section II

55
Q

You are working with a diagnostic specimen. What BSL level should you assume until additional info suggests the need for higher containment?

A

BSL2

–BMBL Section II

56
Q

What organizations should you consult for interim guidance for emergent pathogens?

A

WHO and CDC

–BMBL Section II

57
Q

You are working with a new attenuated pathogen derived from an agent whose wild-type parent pathogen is a BSL2 hazard. Which BSL level should you work at while determining risk of infection?

A

AT LEAST BSL2 until experimental data supports that the attenuated pathogen is less hazardous than the parent pathogen
–BMBL Section II

58
Q

What are the principle laboratory procedure hazards?

A 
Agent concentration
suspension volume
equipment
procedures that generate small particle aerosols or droplets
use of sharps
complexity of procedure
animal involvement 
--BMBL Section II
59
Q

Who should validate additional facility safeguards for a given biosafety level?

A

a biological safety professional

–BMBL Section II

60
Q

What is the purpose of containment?

A

To reduce or eliminate exposure of la workers, the community, and the outside environment to potentially hazardous agents
–BMBL Section III

61
Q

What is the most important element of containment?

A

strict adherence to standard microbiological practices and techniques
–BMBL Section III

62
Q

What should a laboratory biosafety or operations manual contain?

A

Hazards that could be encountered
practices and procedures designed to minimize or eliminate exposures to these hazards
–BMBL Section III

63
Q

What should personnel entering a laboratory using hazardous agents or materials be advised of?

A

Any special hazards present. Should also be required to read and follow required practices and procedures for that lab
–BMBL Section III

64
Q

Who is responsible for selecting additional safety practices above standard practices in keeping with hazards associated with a given agent or procedure?

A

The laboratory director

–BMBL Section III

65
Q

What is the principal device used to provide containment of infectious droplets or aerosols generated by microbiological procedures?

A

biological safety cabinet (BSC)

–BMBL Section III

66
Q

What class of BSC provides the highest attainable level of protection to personnel and the environment?

A

Class III BSC

–BMBL Section III

67
Q

In what situations may PPE form the primary barrier between personnel and infectious materials instead of a BSC?

A

When it is impractical to use a BSC- ex. animal work, necropsy, or maintenance/service/support of the lab
–BMBL Section III

68
Q

Who is responsible for providing facilities commensurate with the lab’s function and recommended BSL for agents being manipulated?

A

the lab director

–BMBL Section III

69
Q

What should form the primary barrier between an agent and personnel/the environment?

A

safety equipment and PPE

–BMBL Section III

70
Q

What should form a secondary barrier between an agent and personnel/the environment?

A

Facility design and construction (engineering controls)

–BMBL Section III

71
Q

What are the primary exposure risks in BSL1 and BSL2 laboratories?

A

exposure via direct contact with the agent
inadvertent contact exposure through contaminated work environment
–BMBL Section III

72
Q

What should determine the BSL level at which an agent should be worked with in the lab?

A 
NIH/WHO risk group
mode of transmission
procedural protocols
experience of staff
others
--BMBL Section III
73
Q

Who is specifically and primarily responsible for assessing risks of using an agent and applying the appropriate BSL?

A

the lab director

–BMBL Section III

74
Q

When should an institution have a biosafety officer and IBC?

A

if the institution is working with pathogenic agents

–BMBL Section III

75
Q

When might an agent require increased BSL level above baseline?

A

With large volumes or high concentrations of the agent

–BMBL Section III

76
Q

What BSL level is generally appropriate for undergraduate and secondary educational training and teaching laboratories?

A

BSL1

–BMBL Section III

77
Q

Are vaccine strains that have undergone multiple in vivo passages considered avirulent?

A

No- don’t assume they are avirulent just because they are vaccine strains
–BMBL Section III

78
Q

What BSL level is generally appropriate for work with human-derived tissues or blood/body fluids?

A

BSL2

–BMBL Section III

79
Q

What is the minimum secondary barrier recommended for all BSL levels?

A

A sink to wash hands!

–BMBL Section III

80
Q

What are the primary hazards for personnel working with BSL2 agents?

A

accidental percutaneous or mucous membrane exposure or ingestion
–BMBL Section III

81
Q

What are the primary hazards for personnel working with BSL3 agents?

A

autoinoculation, ingestion, exposure to infectious aerosol

–BMBL Section III

82
Q

You are working with an emerging disease related to a BSL4 agent. What is the minimum BSL level that should be used when initially characterizing the potential hazard of the agent?

A

BSL4

–BMBL Section III

83
Q

What are the primary hazards for personnel working with BSL4 agents?

A

respiratory exposure to infectious aerosol, mucous membrane or broken skin exposure to infectious droplets, autoinoculation
–BMBL Section III

84
Q

Who is specifically and primarily responsible for the safe operation of the laboratory?

A

lab director

–BMBL Section III

85
Q

What are the 5 potential animal biosafety levels

A

ABSL 1-4
BSL 3-Ag
–BMBL Section III

86
Q

What constitutes a BSL-3-Ag study?

A

Activity involving large or loose-housed animals +/- studies involving agents designated as High ConsequencePathogens by the USDA
–BMBL Section III

87
Q

What is unique about BSL-3-Ag facilities?

A

The lab facility itself acts as a primary barrier to prevent release of infectious agents into the environment
–BMBL Section III

88
Q

Who is responsible for establishing standard procedures for clinical/diagnostic labs that realistically address infectious hazard of clinical specimens?

A

the lab director (noticing a pattern yet?)

–BMBL Section III

89
Q

What OSHA standard coincides with Universal or Standard precautions for clinical laboratories that may handle blood or other infectious materials?

A

Occupational Exposure to Bloodborne Pathogens
Universal/Standard precautions established by US hospital Infection Control Practices Advisory Committee
–BMBL Section III

90
Q

What regulations set requirements for importation of etiologic agents and vectors of human disease?

A

PHS Foreign quarantine Regulations
companion regulations from PHS and Department of Transportation
–BMBL Section III

91
Q

Who regulates importation and interstate shipment of animal pathogens?

A

USDA

–BMBL Section III

LAM Regulatory Jan 2017 (3 decks)

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