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Guide > Chapter 2: Program Management > Flashcards

Chapter 2: Program Management Flashcards

1
Q

US federal law requires with three roles? What are their responsibilities?

A

IO, AV, IACUC
1. Establish policies and procedures
2. Ensure regulatory compliance
3. Monitor program performance
4. Support high-quality science and humane animal use

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2
Q

Definition - IO

A

Individual who, as a representative of senior administration, bears ultimate responsibility for the program and is responsible for resource planning and ensuring alignment of program goals with the institution’s mission

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3
Q

Definition - AV

A

Veterinarian responsible for the health and well-being of all lab animals at the institution

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4
Q

What rights must the institution provide the AV?

A

Institution must provide the AV with sufficient authority, including access to all animals and resources to manage the program of vet care.

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5
Q

If a full-time vet is not available, how often should a consulting vet be available? How does this impact animal care?

A

Should be available in visits at intervals appropriate to programmatic needs. Must be an individual with assigned responsibility for daily animal care and use and facility management.

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6
Q

What is the role of the IACUC?

A

Assessment and oversight of the institution’s Program components and facilities. Should have sufficient authority and resources to fulfill this responsibility.

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7
Q

In case of collaboration involving animal use, what should participating institutions have? What should this address?

A

Formal written understanding that addresses responsibility of offsite animal care and use, animal ownership, and IACUC review/oversight.

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8
Q

What MUST statement involves training?

A

All personnel involved in the care and use of animals MUST be adequately educated, trained, and/or qualified in basic principles of lab animal science to help ensure high-quality animal science and animal well-being.

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9
Q

Who provides resources for training? Who provides oversight and evaluates effectiveness?

A

Resources: Institution
Oversight: IACUC

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10
Q

What MUST statement involves vet training? What SHOULD statements? (2)

A

Vets providing clinical care and/or program oversight and support MUST have the experience, training, and expertise necessary to appropriately evaluate the health and well-being of the species used in the context of the animal use at the institution. Vets providing broad program direction SHOULD be trained or have relevant experience in lab animal facility admin. and management. Institution SHOULD provide opportunities and support for regular professional development and continuing education.

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11
Q

Five SHOULD statements for training of animal care personnel.

A
  1. Personnel SHOULD be appropriately trained.
  2. Institution SHOULD provide formal or on-the-job training.
  3. SHOULD receive training and/or have the experience to complete the tasks they are responsible for.
  4. SHOULD engage in continuing education activities and SHOULD be encouraged to participate in local and national LAS meetings and relevant professional organizations
  5. On-the-job training, institution-sponsored discussion, training programs, and references materials SHOULD be provided.
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12
Q

Four SHOULD statements for training research personnel.

A
  1. Institution SHOULD provide appropriate education and training to members of research teams to ensure knowledge and expertise for procedure and species
  2. Training SHOULD be tailored to needs of research group, but all groups should receive specific training
  3. Continuing education SHOULD be offered
  4. Frequency of training SHOULD ensure all animal users have adequate training before beginning animal work
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13
Q

What training SHOULD be provided to all labs? (9)

A
  1. Animal care and use legislation
  2. IACUC function
  3. Ethics and 3Rs
  4. Reporting
  5. Occ Health and safety
  6. Handling
  7. Aseptic surgical technique
  8. Anesthesia and analgesia
  9. Euthanasia
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14
Q

Occupational health and safety MUSTs (2), SHOULD (1), and may (1)

A

Each institution MUST establish and maintain an OHSP and it MUST be consistent with federal, state, and local regulations. SHOULD focus on maintaining safe and healthy workplace. MAY include establishment of safety committee.

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15
Q

Who does operational and day-to-day responsibility for safety in the workplace reside with? Safety depends on the work practices of who?

A

Laboratory or facility supervisor, all employees

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16
Q

What hierarchy of controls SHOULD be implemented?

A
  1. Engineering 2. SOPs 3. PPE
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17
Q

Who’s responsibility is it to ensure IACUC members are provided training opportunities to understand their work and role?

A

Institution

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18
Q

What SHOULD training of the IACUC include? (4)

A
  1. Formal orientation to introduce new members to the Program
  2. Relevant legislation, regulations, guidelines, and policies
  3. Animal facilities and laboratories where animal use occurs
  4. Processes of animal protocol and program review
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19
Q

What is the role of the OHSP in identifying risks?

A

SHOULD identify potential hazards in work environment and conduct critical assessment of associated risks to ensure they are identified and reduced to minimal and acceptable levels. Health and safety specialists with knowledge in relevant disciplines SHOULD be involved.

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20
Q

What potential hazards exist? (6) What happens once hazards have been identified?

A

Biologic, chemical, radiation, physical, unusual experimental conditions as in field studies or with wildlife, and those inherent in or intrinsic to animal use. Once potential hazards identified, ongoing assessment of risks SHOULD be conducted to determine minimization and management strategies.

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21
Q

What should the extend and level of participation of personnel in the OHSP be based on? (4)

A
  1. Hazards post (severity of the risk)
  2. Exposure intensity, duration, and frequency (prevalence)
  3. Susceptibility of personnel
  4. History of occupational illness and injury in workplace
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22
Q

The design of facilities should preferentially use what type of controls? (2)

A

Engineering and equipment

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23
Q

What hygiene facilities should be available to staff?

A

Changing, washing, and showering facilities.

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24
Q

What two documents provide guidance when biologic agents are used?

A

CDC and NIH BMBL and USDA standards

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25
Q

How should access to biologic facilities be limited? (3)

A
  1. SHOULD be separated from other areas
  2. SHOULD be appropriately identified
  3. SHOULD have limited access to authorized personnel
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26
Q

Facilities, equipment, and procedures should be designed, selected, and developed to limit what?

A

Physical injury or health risk to personnel, including ergonomic, allergic, and repetitive motion injury

27
Q

What does selection of appropriate animal housing systems require? What factors should be considered? (4)

A

Professional knowledge and judgement.
1. Nature of the hazards
2. Animal use
3. Limitations or capabilities of institution
4. Experiment design

28
Q

When should methods for assessing and monitoring exposure be used? (2)

A

When required, or when the possibility of exceeding permissible exposure limits exists.

29
Q

As a general rule, what does safety depend on?

A

Trained personnel who rigorously follow safe practices.

30
Q

What SHOULD personnel at risk be provided?

A

Clearly defined procedures and PPE (in specific situations)

31
Q

Good personal hygiene helps reduce what?

A

Risk of occupational injury and cross contamination.

32
Q

What entity SHOULD supply suitable attire and PPE for use in the animal facility and laboratories in which animals are used?

A

Institution

32
Q

Who should dispose of, launder, or decontaminate soiled PPE? Special provisions may be required in what situation?

A

Institution. If outside vendors are used.

33
Q

How often should personnel wash their hands and change clothing?

A

As often as necessary to maintain good hygiene.

34
Q

What should occur with outer garments when leaving the animal facility?

A

Must be covered.

35
Q

What are personnel not permitted to do in rooms and laboratories where animals are housed?

A

Eat or drink, use tobacco products, apply cosmetics, or handle contact lens

36
Q

What procedures SHOULD be given special attention when selecting safeguards for animal experimentation with hazardous agents? (7)

A
  1. Animal care and housing
  2. Storage and distribution of agent
  3. Dose prep and administration
  4. Body fluid and tissue handling
  5. Waste and carcass disposal
  6. Items temporarily removed from site
  7. Personal protection
37
Q

What should an oversight process (safety committee) review?

A

Procedures and facilities

38
Q

A formal safety program SHOULD be established to do what? (4) Who SHOULD ensure compliance?

A
  1. Assess hazards
  2. Determine safeguards needed for control
  3. Ensure staff have training
  4. Ensure facilities adequate
    Technical support should be provided to monitor and ensure compliance.
39
Q

What organizations recommend practices and procedures, safety equipment, and facility requirements for working with hazardous biologic agents and materials?

A

BMBL and NRC

40
Q

Facilities that handle agents of unknown risk SHOULD consult who?

A

CDC

41
Q

The use of highly pathogenic “select agents and toxins” requires what?

A

Institutions develop a program and procedures for procuring, maintaining, and disposing of these agents

42
Q

What three research models pose and increased risk to the health and safety of personnel?

A
  1. Use of immunodeficient or genetically modified animals susceptible to or shedding human pathogens
  2. Use of human tissues and cells lines
  3. Any infectious disease model
43
Q
A
44
Q

How often should clean, institution-issued protective clothing be provided?

A

As often as necessary.

45
Q

Protective clothing and equipment should not be worn beyond where?

A

The boundary of the hazardous agent work area or animal facility.

46
Q

Personnel working in areas where they might be exposed to contaminated airbone particulate material or vapors should have what?

A

Suitable respiratory protection with respirator fit testing and training in proper use and maintenance of respirator

47
Q

What is advisable to assess potential health risks for individual employees?

A

Preemployment health evaluation

48
Q

Periodic medical evaluations are advisable for what personnel?

A

Those is specific risk categories, for example respiratory protection

49
Q

An appropriate immunization schedule SHOULD be adopted and should include what agents? When is vaccination recommended?

A

Tetanus. Pre-exposure immunization should be offered to people at risk with specific agents (rabies or hepatitis B). Recommend vaccination is research is to be conducted on infectious agents with effective vaccines.

50
Q

Is routine preemployment/preexposure serum collection advisable? What are risks of collection?

A

No, only in special circumstances as determined by occupational health and safety professional. SHOULD consider identification, traceability, retention, and storage. Purpose for which serum samples are used MUST be consistent with applicable federal and state laws.

51
Q

The medical surveillance program SHOULD do what two things in regards to animal allergen surveillance?

A

Promote early diagnoses and include evaluation of individual’s history for preexisting allergies.

52
Q

What SHOULD personnel training about allergens include?

A

Information about allergies, prevention, early recognition and reporting, and proper technique for working with animals.

53
Q

Can PPE replace engineering or process controls?

A

No, duh

54
Q

Zoonosis should be a part of what program?

A

OHSP

55
Q

Who SHOULD personnel notify in the event of potential/known hazard exposure or suspect health hazard/illness?

A

Supervisor

56
Q

Individuals who have contact with NHPS, their tissues or body fluids, or have duties in their housing areas should be screened routinely for what agent?

A

TB

57
Q

Personnel with potential risk to Herpes B SHOULD have access to and be instructed in the use of what? What should happen following exposure?

A

Bite and scratch emergency care stations. Injuries should be carefully evaluated with appropriate postexposure treatment and follow-up.

58
Q

What preventative measures regarding criminal activities SHOULD be considered?

A

Preemployment screening and physical and information technology security.

59
Q

Who at a Program is responsible for safeguarding animal welfare?

A

All individuals

60
Q

What MUST an institution develop regarding reporting? What SHOULD employees be aware of?

A

Institution MUST develop methods for reporting and investigating animal welfare concerns. Employees SHOULD be aware of the importance of and mechanisms for reporting welfare concerns.

61
Q

Who is responsible for review and investigation of animal welfare reports? What SHOULD the response include?

A

IACUC and IO. Response SHOULD include communication of findings to concerned employee, corrective actions, and a report to the IO of the issue, findings, and actions taken.

62
Q

Where SHOULD mechanisms for reporting concerns be posted? What SHOULD this postings include?

A

Prominent locations in the facility and on applicable institutional websites. Should include instructions on how to report and to whom. Recommend multiple points of contact and SHOULD include a mechanism of anonymity, compliance with whistleblower policies, nondiscrimination, and protection from reprisals.

Guide (20 decks)

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