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LATG > Chapter 5: Managing Compliance > Flashcards

Chapter 5: Managing Compliance Flashcards

1
Q 
Which agency administers the Animal Welfare Act?
A- OSHA
B- APHIS
C- FDA
D- OLAW
A

B- APHIS

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2
Q

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

A

Any live or dead dog, cat, nonhuman primates, mammal, guinea pig, hamster, rabbit, or any warm-blooded species included in the AWA Regulations

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3
Q

Which of the following is NOT a requirement that is found in the Animal Welfare Act and its amendments?
A- dogs just be provided with the opportunity to exercise
B- there’s must be a 5-day holding period for cats and dogs held at a research facility before they can be used in experiments
C- young animals may not be used in research before they are weaned
D- no animal may be used for more than one major surgery from which it is allowed to recover; except under special circumstances

A

C- young animals may not be used in research before they are weaned

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4
Q

True or False

Research facilities using regulated species must register with USDA

A

True

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5
Q

True or False

In the animal report that each research facility using regulated species sends to the USDA, pain category information is included.

A

True

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6
Q

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

A

Three years after the completion of the study

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7
Q

Which statement is true about the Animal Care Policy Manual?
A- the Animal Care Manual is primarily a training resource for USDA/APHIS inspectors
B- the Animal Care Manual mandates compliance standards for animal programs
C- the Animal Care Manual is a guidance document for AAALAC accreditation
D- the Animal Care Manual is a handbook which research institutions are required to have

A

B- the Animal Care Manual mandates compliance standards for animal programs

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8
Q

True or False

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

A

True

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9
Q

List the four sets of guidelines for which the PHS Policy for the Humane Care and Use of Laboratory Animals requires compliance

A

1- Guide for the Care and Use of Laboratory Animals
2- US Govt Principles for the Utilization and Care of Vertebrate Animals
3- Animal Welfare Regulations
4- AVMA Guidelines for the Euthanasia Of Animals

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10
Q

Which if the following documents require that an institution have an occupational health and safety program?
A- Animal Welfare Act
B- PHS Policy for the Humane Care and Use of Laboratory Animals
C- Both PHS Policy for the Humane Care and Use of Laboratory Animals and Animal Welfare Act
D- Neither PHS Policy for the Humane Care and Use of Laboratory Animals and Animal Welfare Act

A

B- PHS Policy for the Humane Care and Use of Laboratory Animals

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11
Q

True or False

A copy of all IACUC-approved protocols should be readily available to laboratory personnel

A

True

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12
Q

What is an acceptable method of dealing with non controlled drugs that are expired?

A

Label them as “Not for use in live animals”

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13
Q

True or False

USDA APHIS inspectors are allowed to take photographs to document conditions and areas of noncompliance

A

True

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14
Q

In what way do Laboratory animal technologist generally participate in inspections?

A

They can retrieve documentation and provide supporting information as requested

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15
Q

Which of the following is NOT recommended for improving the conduct of a federal inspection of an animal facility?
A- develop an SOP on facility inspections
B- designate knowledgeable persons to accompany an inspector in the facility
C- discuss the inspection report with the inspector at the conclusion of the visit
D- recommend records and reports for the inspector to review

A

D - recommend records and reports for the inspector to review

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16
Q

True or False

All regulations regarding obtaining, storing, and disposing of controlled substances are federal statutes.

A

False

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17
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

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18
Q

Among the organizations listed below, which ones publish regulations for the transport of dangerous goods and/or animals that may contain hazardous materials?
A- US Dept of Transportation’s Pipeline and Hazardous Materials Safety Administration
B- International Civil Aviation Organization
C- AAALAC International
D- Food and Drug Administration
E- Occupational Safety and Health Administration
F- National Institute for Occupational Safety and Health
G- Office of Laboratory Animal Welfare

A

A- US Department of Transportation’s Pipeline and Hazardous Materials Safety administration
B- International Civil Aviation Organization

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19
Q

Which of the following is often referred to as the Worker Right-To-Know legislation?
A- OSHA’s Hazard Communication Standard
B- Public Health and Food Safety
C- Hazardous Materials Regulations
D- Health and Consumer Protection Directorate General

A

A- OSHA’s Hazard Communication Standard

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20
Q

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

A

At the time of initial assignment and whenever a new hazard is introduced into workspace

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21
Q

Describe five key components of the training that must be provided to employees under the right-to-know program.

A

1- the nature of the hazard posed by the chemical
2- appropriate work practices, PPE, & special emergency procedures
3- protective measures available
4- Information on what safety data sheets are and how to use them
5- explanation of the institution’s hazard communication policy, including the labeling of chemicals

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22
Q

True or False

Federal standards on limits for noise exposure are applicable to the animal facility

A

True

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23
Q

Give three examples of low-level radioactive waste

A

1- contaminated protective shoe-covers and clothing
2- wiping rags, mops, and filters which have been exposed to radioactive materials
3- equipment and tools used with radioactive materials

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24
Q

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

A

1- infectious
2- hazardous
3- radioactive
4- other general waste

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25
Q

Give two examples of medical waste that are regulated at the federal level

A

1- waste containing mercury or other toxic metals

2- waste containing radioactive isotopes

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26
Q

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

A

CDCs Biosafety in Microbiological and Biomedical Laboratories

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27
Q

Registration with what agency is required for institutions which possess 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 Dept of Health and Human Service or US Dept of Agriculture

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28
Q

True or False

DEA registrants are allowed to store stocks of schedule V controlled substances in the open for easy access

A

False

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29
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

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30
Q

Which regulatory agencies codify GLPs for laboratory studies?

A

FDA, EPA, OECD

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31
Q

Which of the following best describes controlled substances?
A- drugs that have no therapeutic value
B- drugs that are only available in limited amounts
C- drugs that have the potential of being addictive
D- dangerous drugs

A

C- drugs that have the potential of being addictive

32
Q

Which of the following is NOT part of the Hazard Communication Standard guidelines and requirements?
A- employers must maintain a list of all hazardous chemicals used in the workplace
B- the amount of any hazardous chemical kept in the workplace must be just the amount needed for a period of 30 days or less
C- all chemicals in the workplace must be labeled
D- employees must receive training int he heralding of hazardous materials and the interpretation of MSDSs

A

B- the amount of any hazardous chemical kept in the workplace must be just the amount needed for a period of 30 days or less

33
Q

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

A

The US Fish and Wildlife Service (FWS)

34
Q 
Which of the following is NOT included in the general provisions of the GLP regulations?
A- Human medical devices
B- Veterinary drugs
C- Animal food additives
D- Sterilization procedures
A

D- Sterilization procedures

35
Q

What method is generally used for disposal of potentially infectious medical waste?
A- Disinfection in an autoclave followed by disposal as regular waste
B- Incineration
C- Long-term storage in sealed containers until all living organisms have been killed
D- Burial in a landfill

A

B- Incineration

36
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 US Government Principles for the Utilization and Care of Vertebrate Animals
B- The Animal Welfare Act
C- Guide for the the Care and Use of Laboratory Animals
D- The Good Laboratory Practice Regulations

A

C- Guide for the Care and Use of Laboratory Animals

37
Q

What most accurately describes the Office of Laboratory Animal Welfare?
A- An NIH office that oversees compliance with the PHS policy
B- An agency of the federal government
C- An alternative to the institutional IACUC
D- A branch of the Centers for Disease Control

A

A- An NIH office that oversees compliance with the PHS policy

38
Q 
Which of the following provides standards for the humane transport of laboratory animals?
A- Animal Welfare Act
B- Good Laboratory Practice Regulations
C- AAALAC Manual
D- USDA APHIS Annual Report
A

A- Animal Welfare Act

39
Q

Which of the following should be reported to the Centers for Disease Control and Prevention (CDC)?
A- Theft of a select agent
B- Improper use of a controlled substance
C- An animal with a broken leg that is not being treated
D- Negligent documentation of the source from which dogs acquired

A

A- Theft of a select agent

40
Q

Which item must be included int he annual report that research facilities submit to USDA?
A- Assurance that professionally acceptablele standards of care, treatment, and use were followed, and documented
B- Assurance that only adult animals were used for procedures that involve pain
C- Assurance that investigators did not remove any animals from the animal facility
D- Assurance that all employees are enrolled in the occupational health and safety program

A

A- Assurance that professionally acceptable standards of care, treatment, and use were followed, and documented.

41
Q

Which USDA publication clarifies the intent of the Animal Welfare Act?
A- Public Health Service Policy on Humane Care and Use of Laboratory Animals
B- Occupational Safety and Health Act of 1970
C- Animal Care Policy Manual
D- Guide for the Care and Use of Laboratory Animals

A

C- Animal Care Policy Manual

42
Q

How does the IACUC address the animal and physical plant chapters of the semiannual Program and Facility Review Report it must file with OLAW?
A- By recording all rule exemptions that were granted in protocols submitted during the time period of the report
B- Through a semiannual facility inspection
C- By conducting a survey of all researchers using the facility’s animals
D- By establishing a permit system

A

B- Through a semiannual facility inspection

43
Q

Which statement best describes AAALAC’s program status evaluation?
A- It is conducted everyday 2 years
B- It is conducted by federal inspectors
C- Any deficiency is put in writing and provided to USDA
D- It is a confidential peer review process

A

D- It is a confidential peer review process

44
Q

A substance that is classified as a Schedule I controlled substance has __________ potential for addiction than one that is in Schedule III.

A

Greater

45
Q

Which statement is FALSE regarding post-approval monitoring programs?
A- There are many state regulations with specific requirements for post-approval monitoring programs
B- A post-approval monitoring program may include more than just monitoring protocols
C- The post-approval monitoring staff can be dedicated full-time to the program or have other responsibilities
D- The USDA does not require institutions to have a post-approval monitoring program

A

A- There are many state regulations with specific requirements for post-approval monitoring programs

46
Q

When a report of noncompliance is deemed by OLAW to be a violation of the Animal Welfare Act, who does OLAW inform?
A- Food and Drug Administration
B- Environmental Protection Agency
C- United States Department of Agriculture
D- United States Fish and Wildlife Service

A

C- United States Department of Agriculture

47
Q 
Which institutional office generally has the responsibility for monitoring the handling of radioactive materials int he laboratory?
A- Occupational Health and Safety Office
B- Nuclear Regulatory Office
C- Radiation Safety Officer
D- Office of Hazardous Materials
A

C- Radiation Safety Officer

48
Q

Which statement(s) correctly describes the PHS Assurance?
A- It must be approved by OLAW before any research is conducted in the facility
B- It must describe the essential components of an institution’s animal use and care program
C- It is optional for institutions that only house rodents
D- It must be renewed every year

A

A- It must be approved by OLAW before any research is conducted in the facility
B- It must describe the essential components of an institution’s animal use and care program

49
Q

Which statement regarding the disposal of low-level radioactive waste is FALSE?
A- All waste disposal facilities in the US are in Agreement States
B- The Agreement States are responsible for the disposal of low-level radioactive waste in all states
C- Radioactivity can decay away when waste is in storage and then it can be disposed of as ordinary trash
D- The Department of Transportation must approve containers used to ship low-level waste

A

B- The Agreement States are responsible for the disposal of low-level radioactive waste in all states.

50
Q

What is an acceptable method of dealing with non controlled drugs that are past their expiration date?
A- use them at a higher dosage than originally recommended
B- Use them as soon as possible
C- Only use them on noncovered species
D- Label them as “Not for Use in Live Animals.”

A

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

51
Q

How many schedules of controlled substances are there?

A

5

52
Q

Which of the following is NOT included in semiannual IACUC reports and recommendations as required by the USDA?
A- Program review
B- Quality assurance records
C- Recommendations to the Institutional Official
D- Inspectional records

A

B- Quality assurance records

53
Q 
Which documents would NOT be accessible through FOIA?
A- Husbandry logs
B- Dog/cat acquisition records
C- IACUC meeting minutes
D- Accrediting body determinations
A

A- Husbandry logs

54
Q 
To be compliant with OLAW, the IACUC must review the institution’s program for the use and care of animals:
A- Every year
B- Every 6 months
C- At every IACUC meeting
D- Every 5 years
A

B- Every 6 months

55
Q

Which of the following represents a difference between the Animal Welfare Act and the PHS Policy?
A- PHS Policy covers mice, rats, and birds
B- Birds are covered in the Animal Welfare Act but not the PHS
C- PHS Policy requires conformity with the Guide for the Care and USe of Laboratory Animals; the ANimal Welfare Act does not
D- The Animal Welfare Act applies only to research institutions; PHS Policy applies to all organizations that house animals

A

A- PHS Policy covers mice, rats, and birds

56
Q

Who makes unannounced facility inspections at least once a year?
A- National Institutes of Health (NIH) reviewers
B- Officials from the Office of Laboratory ANimal Welfare (OLAW)
C- Veterinary medical officers from APHIS
D- AAALAC evaluators

A

C- Veterinary medical officers from APHIS

57
Q

Which species are covered under the Animal Welfare Act?
A- Farm animals intended for use in agricultural research
B- Ferrets
C- Rats of the genus Rattus
D- Mic elf the genus Mus

A

B- Ferrets

58
Q

Which statement is FALSE regarding staff responsibilities during a USDA inspections?
A- Senior personnel typically accompany the inspection team
B- Anyone in the vivarium may be questioned regarding the program
C- Inspectors should be provided as much information as possible
D- When the inspection team arrives, all personnel should be notified

A

C- Inspectors should be provided as much information as possible

59
Q

What does the National Institutes of Health require of facilities performing research using recombinant DNA?
A- A biosafety committee
B- A Radiation Safety Officer
C- an occupational health and safety program
D- a disaster planning team

A

A- A biosafety committee

60
Q

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

A

Schedules II through V

61
Q

In facilities housing nonhuman primates, special considerations must be documented for:
A- animals involved in neurology studies
B- group-housed animals
C- animals with restricted activity
D- animals involved in short term studies

A

C- animals with restricted activity

62
Q

Which statement is FALSE regarding actions taken after a USDA inspection?
A- Elements on an inspection report can be negotiated after the exit briefing
B- Inspection reports are posted online after they are reviewed by the USDA
C- Documents removed by the inspectors can be marked as confidential
D- Institutional officials should discuss findings with the inspectors

A

A- Elements on an inspection report can be negotiated after the exit briefing

63
Q 
Providing each staff member with specific training regarding GLPs is whose responsibility at the institution?
A- Human Resource Office
B- Quality Assurance Unit
C- Occupational Health and Safety Office
D- Biosafety Office
A

B- Quality Assurance Unit

64
Q

Which statement concerning SOPs is FALSE?
A- SOPs facilitate staff and researcher training
B- SOPs provide consistency in performance evaluations
C- SOPs set direction for the organization to follow
D- SOPs provide consistency in the way research is conducted

A

C- SOPs set direction for the organization to follow

65
Q

Which agency administers the Animal Welfare Act?
A- Food and Drug Administration
B- Occupational Safety and Health Administration
C- Animal Plant and Health Inspection Service
D- Office of Laboratory Animal Welfare

A

C- Animal Plant and Health Inspection Service

66
Q 
What is the minimum time period that all USDA reports and records must be kept?
A- 2 years
B- 5 years
C- 1 year
D- 3 years
A

D- 3 years

67
Q

Which of the following is NOT a requirement that is found in the Animal Welfare Act and its amendments?
A- No animal may be used for more than one major surgery from which it is allowed to recover, except under special circumstances
B- Young animals may not be used in research before they are weaned
C- There must be a 5-day holding period for cats and dogs held at a research facility before they can be used in experiments
D- Dogs must be provided with the opportunity to exercise

A

B- Young animals may not be used in research before they are weaned

68
Q

Which of the following is NOT defined as medical waste?
A- Swabs used to inoculate cultures
B- Organs of animals used in research
C- Mops used to wash floors in quarantine rooms
D- Blood-soaked bandages

A

C- Mops used to wash floors in quarantine rooms

69
Q

If an animal study last 3 years, what is the earliest time any records from this study can be destroyed?
A- As soon as the study is completed
B- Three years from the beginning of the study
C- Six years from the beginning of the study
D- One year after the end of the study

A

C- Siz years from the beginning of the study

70
Q

Which of the following should be reported to the Centers for Disease Control and Prevention (CDC)?
A- Improper use of a controlled substance
B- An animal with a broken leg that is not being treated
C- Theft of a select agent
D- Negligent documentation of the source from which dogs acquired

A

C- Theft of a select agent

71
Q

Which method of reporting an incident is most likely to lessen consequences from funding or regulatory agencies?
A- Communication with AAALAC
B- Self-report
C- Post-approval monitoring (PAM) program
D- Whistleblower

A

B- Self-report

72
Q

Which organization accredits research institutions with high-quality programs that meet federal laws and guidelines?
A- Office of Laboratory Animal Welfare
B- AAALAC, International
C- United States Department of Agriculture
D- American Association for Laboratory Animal Science

A

B- AAALAC, International

73
Q

Which of the following is often referred to as the Worker Right-to-Know legislation?
A- Public Health and Food Safety
B- Health and Consumer Protection Directorate General
C- OSHA’s Hazard Communication Standard
D- Hazardous Materials Regulations

A

C- OSHA’s Hazard Communication Standard

74
Q

Which organization has developed standards and guidelines to help prevent the transmission of zoonoses through importation of animals?
A- The International Air transportation Association
B- The World Organization for Animal Health
C- The Convention on International Trade in Endangered Species
D- The European Union

A

B- The World Organization for Animal Health

75
Q

What is the most important component of the Hazard Communication Standard (HCS) right-to-know program?
A- State and local laws and regulations
B- Safety data sheets and standard operating procedures (SOPs)
C- Employee training and information program
D- Chemical labeling and storage requirements

A

C- Employee training and information program

LATG (23 decks)

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