Chapter 5: Managing Compliance Flashcards by Lori Akin

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

B- APHIS

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

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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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

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

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True or False

Research facilities using regulated species must register with USDA

True

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True or False

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

True

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

Three years after the completion of the study

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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

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

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True or False

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

True

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

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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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

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

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True or False

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

True

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

Label them as “Not for use in live animals”

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True or False

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

True

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

They can retrieve documentation and provide supporting information as requested

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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

D - recommend records and reports for the inspector to review

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True or False

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

False

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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

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

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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- OSHA’s Hazard Communication Standard

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

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

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

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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True or False

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

True

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Give three examples of low-level radioactive waste

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

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

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

1- waste containing mercury or other toxic metals | 2- waste containing radioactive isotopes

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

CDCs Biosafety in Microbiological and Biomedical Laboratories

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?

US Dept of Health and Human Service or US Dept of Agriculture

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

False

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

Every 6 months

Which regulatory agencies codify GLPs for laboratory studies?

FDA, EPA, OECD

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

C- drugs that have the potential of being addictive

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

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

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

The US Fish and Wildlife Service (FWS)

``` 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 ```

D- Sterilization procedures

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

B- Incineration

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

C- Guide for the Care and Use of Laboratory Animals

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- An NIH office that oversees compliance with the PHS policy

``` 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- Animal Welfare Act

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- Theft of a select agent

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

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

C- Animal Care Policy Manual

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

B- Through a semiannual facility inspection

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

D- It is a confidential peer review process

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

Greater

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

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

C- United States Department of Agriculture

``` 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 ```

C- Radiation Safety Officer

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- 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

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

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

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.”

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

How many schedules of controlled substances are there?

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

B- Quality assurance records

``` 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- Husbandry logs

``` 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 ```

B- Every 6 months

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- PHS Policy covers mice, rats, and birds

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

C- Veterinary medical officers from APHIS

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

B- Ferrets

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

C- Inspectors should be provided as much information as possible

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 biosafety committee

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

Schedules II through V

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

C- animals with restricted activity

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

``` 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 ```

B- Quality Assurance Unit

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

C- SOPs set direction for the organization to follow

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

C- Animal Plant and Health Inspection Service

``` 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 ```

D- 3 years

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

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

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

C- Mops used to wash floors in quarantine rooms

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

C- Siz years from the beginning of the study

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

C- Theft of a select agent

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

B- Self-report

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

B- AAALAC, International

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

C- OSHA’s Hazard Communication Standard

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

B- The World Organization for Animal Health

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

C- Employee training and information program