LATg Chapter 5

Which standard reflects what USDA inspectors look for during an inspection? a. That professionally accepted standards of care are followed in the facility. b. That compliance is maintained with the PHS Policy. c. That scientific standards are used in the conduct of animal studies. d. That facility staffing levels correspond with the workload in animal care.

A

Which of the following represents a difference between the Animal Welfare Act and the PHS Policy? a. The Animal Welfare Act applies only to research institutions; PHS Policy applies to all organizations that house animals. b. PHS Policy requires conformity with the Guide for the Care and Use of Laboratory Animals; the Animal Welfare Act does not. c. PHS Policy covers mice, rats, and birds. d. Birds are covered in the Animal Welfare Act but not the PHS.

C

Which group of compounds falls within the scope of GLPs? a. Food and color additives b. Veterinary drugs c. Biological products d. All of the above

D

Where is low-level radioactive waste generally stored? a. On site in the institution b. In state-controlled waste holding facilities c. In regional military facilities d. None of the above

A

Which of the following groups have regulatory authority to conduct unannounced inspections of the animal facility? a. IACUC and USDA personnel b. AAALAC c. Accredited members of the media d. Any community group who submits a written request to perform an inspection

A

Which requirement is part of the IACUC inspection criteria? a. All records required by the AWA and PHS must be available for review. b. The institution's Occupational Health and Safety office must be inspected for copies of all SOPs. c. Breeding operations of vendors supplying animals for the research program must be inspected. d. All of the above

A

Most regulated medical waste is generally regulated at the level. a. facility b. institutional c. state and local d. federal

C

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

D

USDA does not require that IACUC meeting minutes be recorded. a. True b. False

B

What most accurately describes the Office of Laboratory Animal Welfare? a. A branch of the Centers for Disease Control b. An alternative to the institutional IACUC c. An NIH office that oversees compliance with the PHS policy d. An agency of the federal government

C

Which publication describes microbiological practices? a. Guide for the Care and Use of Laboratory Animals b. Occupational Health and Safety in the Care and Use of Laboratory Animals c. Biosafety in Microbiological and Biomedical Laboratories d. All of the Above

C

Which of the following is NOT included in the general provisions of the GLP regulations? a. Animal food additives b. Veterinary drugs c. Human medical devices d. Sterilization procedures

D

Which statement best describes AAALAC's program status evaluation? a. It is a confidential peer review process. b. It is conducted every 2 years. c. Any deficiency is put in writing and provided to USDA. d. It is conducted by federal inspectors.

A

Which statement is FALSE regarding staff responsibilities during a USDA inspection? a. Inspectors should be provided as much information as possible. b. Senior personnel typically accompany the inspection team. c. Anyone in the vivarium may be questioned regarding the program. d. When the inspection team arrives, all personnel should be notified.

A

Which step is recommended in managing inspections? a. Develop an SOP outlining the process to follow for an inspection. b. Identify the people on the staff who will be authorized to answer the inspectors' questions. c. Limit the amount of time inspectors spend in each area of the facility. d. All of the above

A

Which agency is authorized to develop regulations based on the Animal Welfare Act? a. Occupational Safety and Health Administration b. Food and Drug Administration c. Environmental Protection Agency d. Animal Plant and Health Inspection Service

D

Which of the following are mandated by the Animal Welfare Act? a. Establishment of an IACUC b. Training of all animal care personnel c. Information on how to report deficiencies in animal care d. All of the Above

D

Which of the following best describes controlled substances? a. Drugs that have no therapeutic value b. Dangerous drugs c. Drugs that are only available in limited amounts d. Drugs that have the potential of being addictive

D

What agency has regulations that control the receipt, possession, use, transfer, and disposal of nuclear materials? a. National Radiation Control Office b. Nuclear Regulatory Commission c. Occupational Health and Safety Administration d. Office of Hazardous Materials Safety

B

What does the National Institutes of Health require of facilities performing research using recombinant DNA? a. A disaster planning team b. A biosafety committee c. A Radiation Safety Officer d. An occupational health and safety program

B

What is a good reference for those who are responsible for managing controlled substances? a. Guide for the Care and Use of Laboratory Animals b. DEA's Practitioner's Manual c. PHS Policy d. Animal Welfare Act

B

What method of disposal is most generally used for medical waste? a. Burial in landfills b. Incineration c. Disinfection in autoclaves followed by disposal as regular waste d. Long-term storage in sealed containers until all living organisms have been killed

B

What type of training is NOT required by the Animal Welfare Act? a. Training in how to report animal care deficiencies b. AALAS certification training c. Training in humane animal restraint d. Training in research or testing methods that minimize or eliminate the use of animals

B

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

B

A substance that is classified as a Schedule I controlled substance has potential for addiction than one that is in Schedule III. a. a greater b. a lesser c. an equal d. no difference in

A

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

A

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

A

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

A

During their inspection, IACUC members will want to see documentation showing that warm-blooded animals are observed how often? a. Every day b. Twice a day c. At least weekly d. Twice a week

A

GLPs describe the training requirements for personnel involved in covered studies. a. True b. False

A

Many drugs used for analgesia and tranquilization are controlled substances. a. True b. False

A

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

A

Rats and mice bred for research are covered under the PHS Policy. a. True b. False

A

What is the minimum time period that all USDA reports and records must be kept after completion of the study? a. 1 year b. 3 years c. 5 years d. As long as those animal species are present in the facility.

B

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

B

All medical waste should be considered infectious. a. True b. False

B

Providing each staff member with specific training regarding Good Laboratory Practices is the responsibility of the institution's: a. biosafety office. b. quality assurance unit. c. human resources office. d. occupational health and safety office.

B

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

B

According to Federal law, which controlled substances must DEA registrants store in a securely locked cabinet? a. Schedules IV and V b. Schedules I through III c. Schedules II through V d. Schedules III through V

C

How often must the PHS Assurance be resubmitted? a. Every year b. Every time a new researcher is hired by an institution c. Every 5 years d. Every 3 years

C

Which method of reporting an incident is most likely to lessen consequences from funding or regulatory agencies? a. Post-approval monitoring (PAM) program b. Communication with AAALAC c. Self-report d. Whistleblower

C

Which of the following is NOT a requirement that is found in the Animal Welfare Act and its amendments? a. There must be a 5-day holding period for cats and dogs held at a research facility before they can be used in experiments. b. Dogs must be provided with the opportunity to exercise. 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

Which of the following is NOT part of the Hazard Communication Standard guidelines and requirements? a. All chemicals in the workplace must be labeled. b. Employers must maintain a list of all hazardous chemicals used in the workplace. c. The amount of any hazardous chemical kept in the workplace must be just the amount needed for a period of 30 days or less. d. Employees must receive training in the handling of hazardous materials and the interpretation of MSDS.

C

Which of these international organizations has developed standards and guidelines to help prevent the transmission of zoonoses via the importation of animals? a. International Air Transportation Association b. Convention on International Trade in Endangered Species c. World Organisation for Animal Health d. European Union

C

What needs to be specifically addressed in the required plan for environmental enhancement for nonhuman primates? a. Social grouping b. Nutritious food c. Restraint devices d. Both a. & c.

D

Medical waste does NOT include which of the items listed below? a. Blood-soaked bandages b. Swabs used to inoculate cultures c. Organs of animals used in research d. Mops used to wash floors in quarantine rooms

D

When responding to a reported noncompliance, the IACUC: a. can work with the researcher to establish a plan. b. should begin a process of information gathering. c. may elect to suspend a protocol to protect animal welfare. d. All of the Above

D

Where should a laboratory animal technologist obtain specific information regarding regulations on the transport of research animals? a. US Food and Drug Administration (FDA) b. Office of Laboratory Animal Welfare (OLAW) c. US Department of Transportation d. The regulatory documents

D

Which agency has some regulations that relate to medical waste? a. Department of Transportation Office of Hazardous Materials Safety b. Food and Drug Administration c. The US Postal Service d. All of the above

D

Which group of compounds falls within the scope of the Good Laboratory Practices regulations? a. Veterinary drugs b. Food and color additives c. Biological products d. All of the above

D

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

B

The US Drug Enforcement Administration has how many schedules of controlled substances? a. Two b. Three c. Four d. Five

D

Which agency requires that every research facility must establish an Institutional Animal Care and Use Committee? a. United States Department of Agriculture b. Food & Drug Administration c. American Veterinary Medical Association d. AAALAC International

A

What addition was made to the Animal Welfare Act in the 1985 amendments regarding the care of nonhuman primates? a. They must have an adequate environment for psychological well-being. b. Lights must be kept on at least 14 hours per day for maintaining physiological cycles. c. They must be given 2 fruits per day for nutritional and environmental enrichment. d. They must have regular one-to-one interaction with humans for social adjustment.

A

The USDA, through is required to inspect animal facilities . a. FDA; semi-annually b. APHIS; annually c. NIH; semi-annually d. PHS; annually

B

In addition to federal regulations on animal research, there are local and state regulations that need to be followed. a. True b. False

A

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

A

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

A

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 b. False

A

The AWA amendments of 1985 require that enrichment be provided to promote psychological well- being of which of the following species? a. Primates b. Rodents c. Aquatic species d. Horses

A

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

A

The DEA may conduct unannounced inspections of the animal facility. a. True b. False

A

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

A

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

A

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

A

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

A

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. Guide for the Care and Use of Laboratory Animals b. Guidelines for Ethical Conduct In the Care and Use of Animals c. Animal Welfare Act d. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

A

USDA inspections may be conducted in response to public complaints. a. True b. False

A

According to PHS, all animals should be housed in a manner that and . a. provides them with companionship; allows them to interact with others of the same species b. facilitates the expression of species-specific behavior; minimizes stress-induced behaviors c. provides them with mental and physical stimulation; promotes the expression of colony behaviors d. mimics natural conditions; optimizes dominance-submission hierarchies

B

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

B

During USDA inspections, facilities must demonstrate compliance with provisions of which federal regulations? a. Good Laboratory Practice regulations b. Animal Welfare Act c. Guide for the Care and Use of Laboratory Animals d. PHS Policy

B

How often do USDA APHIS personnel make unannounced inspections of a research facility? a. At least every 6 months b. At least once a year c. Once every 3 years d. Each time a new grant is funded

B

If an animal study last 3 years, what is the earliest time any records from this study can be destroyed? a. Three years from the beginning of the study b. Six years from the beginning of the study c. As soon as the study is completed d. One year after the end of the study

B

Semiannual inspections conducted by the IACUC should: a. be limited to a physical inspection of areas where animals are housed. b. use the Guide for the Care and Use of Laboratory Animals as the basis for the inspection. c. inspect only those areas where NIH-supported research is conducted. d. All of the above

B

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

B

Which organization accredits research institutions that meet national laws and guidelines? a. American Association for Laboratory Animal Science b. AAALAC International c. Office of Laboratory Animal Welfare d. United States Department of Agriculture

B

Which statement best applies to Good Laboratory Practices regulations? a. They apply to studies of the effect of inorganic compounds on animal subjects. b. They apply to nonclinical studies for the assessment of the safety of chemicals to humans, animals, and the environment. c. They apply to studies that are done on nonhuman primates that have the potential to cause pain and distress. d. They must be applied only under supervised conditions in registered institutions.

B

How often should a research facility using regulated species update their USDA registration? a. Every year b. Every 2 years c. Every 3 years d. Every 5 years

C

Which of the following is a requirement included in the 1985 amendment to the Animal Welfare Act? a. Dogs must have at least one chew toy in each pen. b. Dogs must be bathed once a week. c. Dogs must be given the opportunity to exercise. d. Dogs must have a regular opportunity for socialization with people.

C

Which publication provides additional clarifications and guidance in support of the Animal Welfare Act? a. Animal Care Policy Manual b. Guide for the Care and Use of Laboratory Animals c. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training d. AVMA Guidelines for the Euthanasia of Animals

C

Which statement correctly describe the PHS assurance? a. It must be approved by AAALAC before any research is conducted in the facility. b. It must be renewed every year. c. It must describe the essential components of an institution's animal care and use program. d. It is optional for institutions that house rodents only.

C

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

C

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

C

USDA APHIS inspectors have the authority to: a. have an animal euthanized if they determine that the animal is suffering as a result of noncompliance. b. take photographs of areas of noncompliance. c. make copies of required records in the facility. d. All of the above

D

Which of these agencies have regulations or guidelines that regulate the transportation of animals? a. Food & Drug Administration b. US Department of Transportation c. US Fish and Wildlife Service d. All of the above

D

Which regulatory agency codifies GLPs for laboratory studies? a. Food & Drug Administration b. Environmental Protection Agency c. Organization for Economic Co-operation and Development d. All of the Above

D

Which statement concerning SOPs is FALSE? a. SOPs provide consistency in performance evaluations. b. SOPs facilitate staff and researcher training. c. SOPs provide consistency in the way research is conducted. d. SOPs set direction for the organization to follow.

D