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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
Q

True or False: There are federal regulations that set limits on noise exposure in the animal facility.

A

True

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26
Q

True or False: The Radiation Safety Officer must monitor the exposure level of all employees who work with low-level radiation sources.

A

True

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27
Q

True or False: The Nuclear Regulatory Commission regulates use of nuclear materials for medical and academic uses through regulations, licensing, and safety oversight.

A

True

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28
Q

Where is low-level waste generally stored?

A

on site

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29
Q

True or False: All medical waste should be considered infectious.

A

False

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30
Q

Which publication describes microbiological practices?

A

Biosafety in Microbiological and Biomedical Laboratories

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31
Q

True or False: The Centers for Disease Control may perform biosafety and biosecurity inspections of registered facilities.

A

True

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32
Q

True or False: A post-approval monitoring (PAM) program provides review before a study has been started.

A

False

33
Q

True or False: Noncompliance can lead to citations and major financial penalties against the institution through enforcement action by regulatory agencies.

A

True

34
Q

True or False: The IACUC may be made aware of noncompliance through the post-approval monitoring program.

A

True

35
Q

What should be the IACUC’s first step in responding to a report of noncompliance?

A

Identify the underlying causes

36
Q

Providing each staff member with specific training regarding GLPs is whose responsibility at the institution?

A

Quality Assurance Unit

37
Q

What is an acceptable method of dealing with noncontrolled drugs that are past their expiration date?

A

Label them as “Not for Use in Live Animals.”

38
Q

Which agency administers the Animal Welfare Act

A

APHIS

39
Q

Which institutional office generally has the responsibility for monitoring the handling of radioactive materials in the laboratory?

A

Radiation Safety Officer

40
Q

Where should a laboratory animal technologist obtain specific information regarding regulations on the transport of research animals?

A

regulatory documents

41
Q

Who makes unannounced facility inspections at least once a year?

A

Veterinary medical officers from APHIS

42
Q

Who is responsible for approving the written procedures for providing dogs in the facility with opportunities for exercise?

A

Facility Veterinarian

43
Q

How often must the PHS Assurance be resubmitted?

A

every 5 years

44
Q

According to Federal law, which controlled substances must DEA registrants store in a securely locked cabinet?

A

Schedules II-V

45
Q

What statement best apply to Good Laboratory Practices regulations?

A

They apply to nonclinical studies for the assessment of the safety of chemicals to humans, animals, and the environment.

46
Q

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?

A

The Guide

47
Q

What is the most important component of the Hazard Communication Standard (HCS) right-to-know program?

A

Employee training and information program

48
Q

How often should a research facility using regulated species update their USDA registration?

A

Every 3 years

49
Q

What does the National Institutes of Health require of facilities performing research using recombinant DNA?

A

A biosafety committee

50
Q

When a report of noncompliance is deemed by OLAW to be a violation of the Animal Welfare Act, who does OLAW inform?

A

The USDA

51
Q

Which organization accredits research institutions with high-quality programs that meet federal laws and guidelines?

A

AAALAC

52
Q

How many schedules of controlled substances are there?

A

5

53
Q

What most accurately describes the Office of Laboratory Animal Welfare?

A

An NIH office that oversees compliance with the PHS policy

54
Q

Which agency is responsible for issuing permits for importing or exporting wild species?

A

The US Fish and Wildlife Service (FWS)

55
Q

Which method of reporting an incident is most likely to lessen consequences from funding or regulatory agencies?

A

self-reported

56
Q

What agency administers the Animal Welfare Act?

A

APHIS

57
Q

What is the definition of “animal” in the Animal Welfare Act?

A

any live or dead dog, cat, hamster, NHP, Guinea pig, rabbit or other warm-blooded species covered in USDA regulations

58
Q

True or False: Research facilities using regulated species must register with USDA.

A

True

59
Q

True or False: In the annual report that each research facility using regulated species sends to the USDA, pain category information is included.

A

True

60
Q

If an animal study lasted 3 years, what is the earliest time any records from this study can be destroyed?

A

three years after completion of study

61
Q

True or False: Rats and mice are covered species under the PHS Policy for the Humane Care and Use of Laboratory Animals.

A

True

62
Q

What are the 4 sets of guidelines for which the PHS Policy for the Humane Care and Use of Laboratory Animal requires compliance?

A

The Guide, AWR, AVMA Guidelines for Euthanasia of Animals, US Government Principles for Utilization and Care of Vertebrate Animals

63
Q

What document requires that an institution have an occupational health and safety program?

A

PHS Policy for the Humane Care and Use of Laboratory Animals

64
Q

True or False: A copy of all IACUC-approved protocols should be readily available to all laboratory personnel.

A

False

65
Q

True or False: USDA APHIS inspectors are allowed to take photographs to document conditions and areas of noncompliance.

A

False

66
Q

In what way can laboratory animal technologists generally participate in inspections?

A

can retrieve documentation and provide information as requested

67
Q

True or False: All regulations regarding obtaining, storing, and disposing of controlled substances are federal statutes.

A

False

68
Q

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.

A

True

69
Q

What organizations publish regulations for the transport of dangerous goods and/or animals that may contain hazardous materials?

A

USDA Department of Transportation’s Pipeline and Hazardous Materials Safety Administration and International Civil Aviation Organization

70
Q

What is referred to as the Worker Right-to-Know legislation?

A

OSHA’s Hazard Communication Standard

71
Q

When does the Hazard Communication Standard require that employees receive training on the use of hazardous materials?

A

at initial assignment and whenever a new hazard is used

72
Q

True or False: Federal standards on limits for noise exposure are applicable to the animal facility.

A

True

73
Q

What are the 4 categories generally used to classify medical waste?

A

infectious, hazardous, radioactive, other general waste

74
Q

What kinds of medical waste are regulated at a federal level?

A

mercury and other toxic metals, radioactive isotopes, infectious materials

75
Q

What publication provides information on laboratory standards and special microbiological practices recommended when virulent pathogens are used in research?

A

CDC’s Biosafety in Microbiological and Biomedical Laboratories

76
Q

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?

A

US Department of Health and Human Services or US Department of Agriculture

77
Q

True or False: DEA registrants are allowed to store stocks of Schedule V controlled substances in the open for easy access.

A

False

78
Q

To be compliant with OLAW, how often should the IACUC review the institution’s program for care and use of animals?

A

every 6 months

79
Q

What regulatory agencies codify GLPs for laboratory studies?

A

FDA, EPA, OECD

LATG (24 decks)

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