Term
| Which organization has developed standards and guidelines to help prevent the transmission of zoonoses through importation of animals? |
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Definition
| The World Organization for Animal Health |
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Term
| Who makes unannounced facility inspections at least once a year? |
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Definition
| Veterinary medical officers from APHIS |
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Term
| Which item must be included in the annual report that research facilities submit to USDA? |
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Definition
| Assurance that professionally acceptable standards of care, treatment, and use were followed and documented |
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Term
| Along with the Nuclear Regulatory Commission, who administers the licensees of nuclear material? |
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Definition
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Term
Which statement is FALSE regarding post-approval monitoring programs?
The USDA does not require institutions to have a post-approval monitoring program.
There are many state regulations with specific requirements for post-approval monitoring programs.
The post-approval monitoring staff can be dedicated full-time to the program or have other responsibilities.
A post-approval monitoring program may include more than just monitoring protocols. |
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Definition
| There are many state regulations with specific requirements for post-approval monitoring programs. |
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Term
| In facilities housing nonhuman primates, special considerations must be documented for: |
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Definition
| animals with restricted activity. |
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Term
| Where should a laboratory animal technologist obtain specific information regarding regulations on the transport of research animals? |
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Definition
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Term
Which of the following is NOT included in the general provisions of the GLP regulations?
Human medical devices
Veterinary drugs
Animal food additives
Sterilization procedures |
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Definition
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Term
Which of the following is NOT part of the Hazard Communication Standard guidelines and requirements?
All chemicals in the workplace must be labeled.
The amount of any hazardous chemical kept in the workplace must be just the amount needed for a period of 30 days or less.
Employers must maintain a list of all hazardous chemicals used in the workplace.
Employees must receive training in the handling of hazardous materials and the interpretation of MSDSs. |
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Definition
| The amount of any hazardous chemical kept in the workplace must be just the amount needed for a period of 30 days or less. |
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Term
| How does the IACUC address the animal and physical plant chapters of the semiannual Program and Facility Review Report it must file with OLAW? |
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Definition
| Through a semiannual facility inspection |
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Term
Which species are covered under the Animal Welfare Act?
Farm animals intended for use in agricultural research
Rats of the genus Rattus
Ferrets
Mice of the genus Mus |
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Definition
|
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Term
| Who is responsible for approving the written procedures for providing dogs in the facility with opportunities for exercise? |
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Definition
|
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Term
Which statement regarding the disposal of low-level radioactive waste is FALSE?
The Department of Transportation must approve containers used to ship low-level waste.
All waste disposal facilities in the US are in Agreement States.
Radioactivity can decay away when waste is in storage and then it can be disposed of as ordinary trash.
The Agreement States are responsible for the disposal of low-level radioactive waste in all states. |
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Definition
| The Agreement States are responsible for the disposal of low-level radioactive waste in all states. |
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Term
| What method is generally used for disposal of potentially infectious medical waste? |
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Definition
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Term
| What is the minimum time period that all USDA reports and records must be kept? |
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Definition
|
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Term
| When a report of noncompliance is deemed by OLAW to be a violation of the Animal Welfare Act, who does OLAW inform? |
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Definition
| United States Department of Agriculture |
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Term
| Which agency administers the Animal Welfare Act? |
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Definition
| Animal Plant and Health Inspection Service |
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Term
| What is a good reference for those who are responsible for managing controlled substances? |
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Definition
| DEA's Practitioner's Manual |
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Term
| What is an acceptable method of dealing with noncontrolled drugs that are past their expiration date? |
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Definition
| Label them as "Not for Use in Live Animals." |
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Term
| To be compliant with OLAW, the IACUC must review the institution's program for the use and care of animals: |
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Definition
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Term
Which statement concerning SOPs is FALSE?
SOPs provide consistency in performance evaluations.
SOPs facilitate staff and researcher training.
SOPs provide consistency in the way research is conducted.
SOPs set direction for the organization to follow. |
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Definition
| SOPs set direction for the organization to follow. |
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Term
Which statement is FALSE regarding staff responsibilities during a USDA inspection?
Senior personnel typically accompany the inspection team.
Inspectors should be provided as much information as possible.
Anyone in the vivarium may be questioned regarding the program.
When the inspection team arrives, all personnel should be notified. |
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Definition
| Inspectors should be provided as much information as possible. |
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Term
| Which agency is responsible for issuing permits for importing or exporting wild species? |
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Definition
| The US Fish and Wildlife Service (FWS) |
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Term
| What best describes controlled substances? |
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Definition
| Drugs that have the potential of being addictive |
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Term
| Which statement would best describe AAALAC's program status evaluation? |
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Definition
| It is a confidential peer review process. |
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Term
| Which agency is authorized to develop regulations based on the Animal Welfare Act? |
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Definition
| Animal Plant and Health Inspection Service |
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Term
Which of the following is NOT a requirement that is found in the Animal Welfare Act and its amendments?
There must be a 5-day holding period for cats and dogs held at a research facility before they can be used in experiments.
No animal may be used for more than one major surgery from which it is allowed to recover, except under special circumstances.
Dogs must be provided with the opportunity to exercise.
Young animals may not be used in research before they are weaned. |
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Definition
| Young animals may not be used in research before they are weaned. |
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Term
Which of the following are mandated by the Animal Welfare Act?
Information on how to report deficiencies in animal care
Establishment of an IACUC
Training of all animal care personnel |
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Definition
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Term
What needs to be specifically addressed in the required plan for environmental enhancement for nonhuman primates?
Nutritious food
Restraint devices
Placement of cage in the room
Social grouping |
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Definition
Social grouping
Restraint devices |
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Term
| Research facilities using regulated species must register with USDA and the registration must be updated every year. |
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Definition
| false registration is every three years. |
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Term
| Birds bred for research are NOT presently covered under the Animal Welfare Act. |
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Definition
|
|
Term
| USDA does not require that IACUC meeting minutes be recorded. |
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Definition
|
|
Term
| Amphibians, reptiles, and fish are exempt from coverage under the Animal Welfare Act. |
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Definition
|
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Term
| The IACUC has an obligation to identify whistleblowers who report possible animal abuse or neglect so they can receive recognition from the institution. |
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Definition
|
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Term
| OLAW requires that institutions submit an assurance document affirming that they will comply with all PHS Policy requirements. |
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Definition
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Term
| OLAW requires that institutions submit an assurance document affirming that they will comply with all PHS Policy requirements. |
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Definition
| The IACUC can use the Guide as the basis for the inspection. |
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Term
| Rats and mice bred for research are covered under the PHS Policy. |
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Definition
|
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Term
| Freedom of Information Act (FOIA) information requests are sent to the institution. |
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Definition
| False, Information requests are sent to the federal agency, not to the institution. |
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Term
| The AWA Regulations and PHS Policy both require that the IACUC conduct semiannual inspection of all areas where live animals are housed or used. |
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Definition
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Term
| USDA inspections may be conducted in response to public complaints. |
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Definition
|
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Term
| USDA APHIS inspectors have the authority to make copies of required records kept in the facility. |
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Definition
| true but Agencies do not copy or remove the materials from the research facilities’ premises unless there is an alleged violation under investigation or enforcement. |
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Term
| Which group(s) has/have a right to conduct unannounced inspections of the animal facility? |
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Definition
|
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Term
Which of the following is an authority granted to USDA APHIS inspectors?
To take photographs of areas of noncompliance
To make copies of documents in the facility that are required by the regulations
To require euthanizing an animal if it is determined that the animal is suffering as a result of noncompliance |
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Definition
|
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Term
| USDA APHIS inspectors are NOT allowed to take photographs while inspecting a facility. |
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Definition
|
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Term
| All regulations regarding obtaining, storing, and disposing of controlled substances are federal statutes. |
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Definition
| False, Many states also have statutes for the use and management of controlled substances, and most require a controlled substance license and other procedures in addition to those of the US DEA. Typically, state licenses are administered by a state department of professional regulation. |
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Term
| DEA registrants “are required to store stocks of Schedule II through V controlled substances in a securely locked, substantially constructed cabinet.Several factors are used to determine the adequacy of these security controls. |
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Definition
The location of the premises
The type of building and office construction
The type and quantity of controlled substances stored on the premises
The type of storage medium (e.g., safe, vault, or steel cabinet)
The control of public access to the facility
The adequacy of registrant’s monitoring system (e.g., alarms and detection systems)
The availability of local police protection |
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Term
The law requires that DEA registrants maintain records including the following information:
When acquiring controlled substances: |
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Definition
Name of the substance
Form and quantity per container
Number of containers acquired
The date the controlled substance was acquired
The name and address from where the substance was acquired |
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Term
| The law requires that dea registrants maintain records including the following information:When dispensing controlled substances: |
|
Definition
Name of individual to whom it was dispensed
Date of dispensing
Volume or quantity dispensed
Name or initials of dispenser |
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Term
| The law requires that DEA registrants maintain records including the following information:Biennial inventory – DEA registrants are required to conduct an inventory of any controlled substances they have on hand. This inventory must be conducted at least every two years. The following information should be included in the inventory: |
|
Definition
Name of the substance (e.g., Ketamine)
Form and quantity per container (e.g., 100 mg/mL, 10 mL vials)
Number of containers on hand, opened and unopened |
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Term
| Controlled substances that are not dispensed and those that are lost, stolen, spilled, arrive in a damaged container, or are otherwise unusable must be? |
|
Definition
| documented and reported. Federal law and the DEA have strict regulations governing the disposal of controlled substances, and disposal may not occur without authorization from the DEA. A Reverse Distributor can be contacted to arrange disposition, or a completed copy of DEA Form 41 can be submitted to the Special Agent in Charge in the area. |
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Term
| The DEA and state authorities may inspect the establishment of a registrant or applicant for registration and review the documentation and regulated procedures. Anyone with responsibility for managing controlled substances should refer to |
|
Definition
| the DEA’s Practitioner’s Manual9, a helpful resource on the website of the DEA Office of Diversion Control. |
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Term
| Laboratory animal technologists must be familiar with the regulations and guidelines that affect their particular institutions. There may be regulations related to the animals or to work practices, such as |
|
Definition
| discharge restrictions, waste disposal, or safety. Institutions should be aware of and comply with all local and state regulations. |
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Term
Which group of compounds falls within the scope of GLPs?
Veterinary drugs
Food and color additives
Biological products |
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Definition
|
|
Term
| An intent of the GLPs is to ensure that studies can be reconstructed accurately if they need to be repeated. |
|
Definition
|
|
Term
| GLPs describe the training requirements for personnel involved in covered studies. |
|
Definition
|
|
Term
| Which regulatory agency codifies GLPs for laboratory studies? |
|
Definition
FDA
Environmental Protection Agency
Organization for Economic Co-operation
and Development
The USFDA GLPs are codified in 21CFR Part 5810.
The US Environmental Protection Agency (EPA) GLPs are codified in 40 CFR, Chapter I: Subchapter R—Toxic Substances Control Act, Part 79211; and in Subchapter E—Pesticide Programs, Part 16012.
An international body of GLP regulations are maintained by the Organization for Economic Co-operation and Development (OECD), and these GLPs are codified in their Principles of Good Laboratory Practice and Compliance Monitoring13. |
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Term
| The importation of animals such as dogs, cats, and turtles is regulated by the Centers for Disease Control. |
|
Definition
|
|
Term
Which agency has regulations or guidelines that regulate the transportation of animals?
Food and Drug Administration
US Fish and Wildlife Service
US Department of Transportation |
|
Definition
|
|
Term
| The Centers for Disease Control is one of the agencies that regulates the care and welfare of research animals. |
|
Definition
| false,Both the US FDA and the Centers for Disease Control and Prevention (CDC) have authority to control transportation of animals from one state to another when there is a concern regarding the spread of disease. |
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Term
| An important resource document for the laboratory animal technologist is the-------------- , which addresses the issues and makes recommendations for use by government agencies, institutions and companies, and individuals (such as investigators and animal facility managers). |
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Definition
| NRC Guidelines for the Humane Transportation of Research Animals |
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