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LATG > LATG 05: Managing Compliance > Flashcards

LATG 05: Managing Compliance Flashcards

1
Q

True or False: USDA does not require that IACUC meeting minutes be recorded.

A

False

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2
Q

Which agency is authorized to develop regulations based on the Animal Welfare Act?

A

Animal Plant and Health Inspection Service

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3
Q

True or False: The IACUC has an obligation to identify whistleblowers who report possible animal abuse or neglect so they can receive recognition from the institution.

A

False

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4
Q

True or False: Birds bred for research are NOT presently covered under the Animal Welfare Act.

A

True

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5
Q

True or False: Research facilities using regulated species must register with USDA and the registration must be updated every year.

A

False- every 3 years

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6
Q

True or False: Amphibians, reptiles, and fish are exempt from coverage under the Animal Welfare Act.

A

True

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7
Q

True or False: OLAW requires that institutions submit an assurance document affirming that they will comply with all PHS Policy requirements.

A

True

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8
Q

True or False: Rats and mice bred for research are covered under the PHS Policy.

A

True

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9
Q

True or False: Freedom of Information Act (FOIA) information requests are sent to the institution.

A

False

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10
Q

True or False: The AWA Regulations and PHS Policy both require that the IACUC conduct semiannual inspection of all areas where live animals are housed or used.

A

True

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11
Q

What groups has/have a right to conduct unannounced inspections of the animal facility?

A

USDA APHIS personnel and DEA

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12
Q

True or False: USDA APHIS inspectors are NOT allowed to take photographs while inspecting a facility.

A

False

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13
Q

True or False: USDA APHIS inspectors have the authority to make copies of required records kept in the facility.

A

True- they can not take originals

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14
Q

True or False: USDA inspections may be conducted in response to public complaints.

A

True

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15
Q

True or False: Many drugs used for analgesia and tranquilization are controlled substances.

A

True

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16
Q

True or False: In addition to federal regulations, there are local and state regulations that need to be followed.

A

True

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17
Q

True or False: GLPs describe the training requirements for personnel involved in covered studies.

A

True

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18
Q

True or False: An intent of the GLPs is to ensure that studies can be reconstructed accurately if they need to be repeated.

A

True

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19
Q

What regulatory agency codifies GLPs for laboratory studies?

A

FDA, EPA, OECD

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20
Q

True or False: Nonclinical studies of the effect of pesticides on the embryonic development of fish would fall under the Good Laboratory Practices regulations.

A

True

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21
Q

True or False: The importation of animals such as dogs, cats, and turtles is regulated by the Centers for Disease Control.

A

True

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22
Q

True or False: The importation of animals such as dogs, cats, and turtles is regulated by the Centers for Disease Control.

A

True

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23
Q

True or False: The Centers for Disease Control is one of the agencies that regulates the care and welfare of research animals.

A

False

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24
Q

True or False: Under no circumstances can a manufacturer withhold information about a potentially hazardous material.

A

False- trade secrets

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25
True or False: There are federal regulations that set limits on noise exposure in the animal facility.
True
26
True or False: The Radiation Safety Officer must monitor the exposure level of all employees who work with low-level radiation sources.
True
27
True or False: The Nuclear Regulatory Commission regulates use of nuclear materials for medical and academic uses through regulations, licensing, and safety oversight.
True
28
Where is low-level waste generally stored?
on site
29
True or False: All medical waste should be considered infectious.
False
30
Which publication describes microbiological practices?
Biosafety in Microbiological and Biomedical Laboratories
31
True or False: The Centers for Disease Control may perform biosafety and biosecurity inspections of registered facilities.
True
32
True or False: A post-approval monitoring (PAM) program provides review before a study has been started.
False
33
True or False: Noncompliance can lead to citations and major financial penalties against the institution through enforcement action by regulatory agencies.
True
34
True or False: The IACUC may be made aware of noncompliance through the post-approval monitoring program.
True
35
What should be the IACUC's first step in responding to a report of noncompliance?
Identify the underlying causes
36
Providing each staff member with specific training regarding GLPs is whose responsibility at the institution?
Quality Assurance Unit
37
What is an acceptable method of dealing with noncontrolled drugs that are past their expiration date?
Label them as "Not for Use in Live Animals."
38
Which agency administers the Animal Welfare Act
APHIS
39
Which institutional office generally has the responsibility for monitoring the handling of radioactive materials in the laboratory?
Radiation Safety Officer
40
Where should a laboratory animal technologist obtain specific information regarding regulations on the transport of research animals?
regulatory documents
41
Who makes unannounced facility inspections at least once a year?
Veterinary medical officers from APHIS
42
Who is responsible for approving the written procedures for providing dogs in the facility with opportunities for exercise?
Facility Veterinarian
43
How often must the PHS Assurance be resubmitted?
every 5 years
44
According to Federal law, which controlled substances must DEA registrants store in a securely locked cabinet?
Schedules II-V
45
What statement best apply to Good Laboratory Practices regulations?
They apply to nonclinical studies for the assessment of the safety of chemicals to humans, animals, and the environment.
46
To be compliant with OLAW, what document should be the basis of the IACUC review of the institution's program for the use and care of animals?
The Guide
47
What is the most important component of the Hazard Communication Standard (HCS) right-to-know program?
Employee training and information program
48
How often should a research facility using regulated species update their USDA registration?
Every 3 years
49
What does the National Institutes of Health require of facilities performing research using recombinant DNA?
A biosafety committee
50
When a report of noncompliance is deemed by OLAW to be a violation of the Animal Welfare Act, who does OLAW inform?
The USDA
51
Which organization accredits research institutions with high-quality programs that meet federal laws and guidelines?
AAALAC
52
How many schedules of controlled substances are there?
5
53
What most accurately describes the Office of Laboratory Animal Welfare?
An NIH office that oversees compliance with the PHS policy
54
Which agency is responsible for issuing permits for importing or exporting wild species?
The US Fish and Wildlife Service (FWS)
55
Which method of reporting an incident is most likely to lessen consequences from funding or regulatory agencies?
self-reported
56
What agency administers the Animal Welfare Act?
APHIS
57
What is the definition of "animal" in the Animal Welfare Act?
any live or dead dog, cat, hamster, NHP, Guinea pig, rabbit or other warm-blooded species covered in USDA regulations
58
True or False: Research facilities using regulated species must register with USDA.
True
59
True or False: In the annual report that each research facility using regulated species sends to the USDA, pain category information is included.
True
60
If an animal study lasted 3 years, what is the earliest time any records from this study can be destroyed?
three years after completion of study
61
True or False: Rats and mice are covered species under the PHS Policy for the Humane Care and Use of Laboratory Animals.
True
62
What are the 4 sets of guidelines for which the PHS Policy for the Humane Care and Use of Laboratory Animal requires compliance?
The Guide, AWR, AVMA Guidelines for Euthanasia of Animals, US Government Principles for Utilization and Care of Vertebrate Animals
63
What document requires that an institution have an occupational health and safety program?
PHS Policy for the Humane Care and Use of Laboratory Animals
64
True or False: A copy of all IACUC-approved protocols should be readily available to all laboratory personnel.
False
65
True or False: USDA APHIS inspectors are allowed to take photographs to document conditions and areas of noncompliance.
False
66
In what way can laboratory animal technologists generally participate in inspections?
can retrieve documentation and provide information as requested
67
True or False: All regulations regarding obtaining, storing, and disposing of controlled substances are federal statutes.
False
68
True or False: The GLP regulations describe the inspection authority of the regulating agency, the definitions of terms used in the regulations, and the consequences of noncompliance.
True
69
What organizations publish regulations for the transport of dangerous goods and/or animals that may contain hazardous materials?
USDA Department of Transportation's Pipeline and Hazardous Materials Safety Administration and International Civil Aviation Organization
70
What is referred to as the Worker Right-to-Know legislation?
OSHA's Hazard Communication Standard
71
When does the Hazard Communication Standard require that employees receive training on the use of hazardous materials?
at initial assignment and whenever a new hazard is used
72
True or False: Federal standards on limits for noise exposure are applicable to the animal facility.
True
73
What are the 4 categories generally used to classify medical waste?
infectious, hazardous, radioactive, other general waste
74
What kinds of medical waste are regulated at a federal level?
mercury and other toxic metals, radioactive isotopes, infectious materials
75
What publication provides information on laboratory standards and special microbiological practices recommended when virulent pathogens are used in research?
CDC's Biosafety in Microbiological and Biomedical Laboratories
76
Registration with what agency is required for institutions which posses, use, or transfer biological agents or toxins that could pose a severe risk to public health and safety or to animal or plant health?
US Department of Health and Human Services or US Department of Agriculture
77
True or False: DEA registrants are allowed to store stocks of Schedule V controlled substances in the open for easy access.
False
78
To be compliant with OLAW, how often should the IACUC review the institution's program for care and use of animals?
every 6 months
79
What regulatory agencies codify GLPs for laboratory studies?
FDA, EPA, OECD

LATG (24 decks)

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