Organizational Facts Flashcards
What are the first 3 steps of the scientific process?
1)Define question, 2) Formulate effective framework, 3) Establish hypothesis
What are the last 4 steps of the scientific process?
4) Create research design, 5) identify variables, 6) collect/analyze data, 7) report data/conclusion
What organization donates the most to biomedical research?
NIH (National Institute of Health)
Grants are usually given for what time period?
3-5
NIH is a branch of what organization?
PHS (public health service)
The main public granting agencies for scientific research are what?
NIH and NSF (national science foundation)
Universities and colleges get most of their grant money from where?
NIH
NIH is the primary granting agency for biomedical research. Which organization is the primary granting agency for non-biomedical research?
NSF. (Think biology, behavior, math engineering, etc.
Granting agencies require proof of approval from whom before dispensing funds?
IACUC
Who appoints the members of the IACUC?
The institutional officer or IO.
The AWR (animal welfare regulations) are enforced by who?
THe USDA
Under the AWR, who are the members of the IACUC?
Chairperson, veterinarian, nonaffiliated member
Under PHS regulations, who are the IACUC members?
Chairperson, veterinarian, scientist, nonaffiliated member, community member (nonaffiliated member and community member can be same person).
According to the AWR, the IACUC can only approve studies w/ USDA covered species for how long? How long for non-USDA covered species?
1yr, 3yrs
How often does the IACUC review programs?
Every 6 months
PAM: Post Approval Monitoring. What does this group do?
Make sure IACUC approval protocols are being followed.
AWR & PHS require that IACUC monitor studies on what timeframe?
A continuous basis.
The 28hr law ensures what? When was it established?
That animals could not be transported for more that 28 hours w/o being unloaded for a 5hr break. Established 1873.
British Parliament passed the Cruelty to animals Act in what year? Why is this significant?
1876, first law limiting animal experimentation.
The Animal Welfare Act was passed in what year? Why is this significant?
1966, first law in the US regarding animal research
What two legal documents established the standards for research animals in the US?
AWA and AWR (animal welfare act and animal welfare regulations)
The AWA and AWR are enforced by who?
USDA
The AWA covers what animals?
All warm blooded animals
The AWA requires research animals dealers to be:
licensed
The AWA defines animals as:
Cat, dog, guinea pig, hamster, rabbit, non-human primate, other warm blooded vertebrates/animals.
What organisms are not defined as animals under the AWA?
Birds, rats of the genus “rattus”, mice of the genus “mus”, farm animals, horses not used for research purposes.
AWA requires that institutions have an IACUC with what authority?
oversight authority
What are the 4 sections of the AWR?
1) Definitions and terms, 2) Regulations, 3) Standards, 4) Rules of practice
What organization, under the USDA, is tasked with administering the AWA and AWR?
APHIS
USDA Veterinary Medical Officers (VMOs) are responsible for conducting inspections at LEAST how often?
annually
VMOs use the USDA animal care inspection guide as well as what to help the with inspections?
APHIS animal care policy manual
Non-federal research facilities must still register with the USDA under what conditions?
They use species covered by the USDA.
Facilities registered w/ the USDA must update registration how often?
Every 3 years
All facilities registered with the USDA must submit a report to them how often? Who must it be signed by?
annually, by the IO
What law establishes licensing requirements for research animal suppliers and researchers?
AWR
What are the 2 classes of dealers and what are their main differences?
Class A: dealers raise and sell animals themselves.
Class B: dealers purchase and resell animals.
Animals from what class dealer are “purpose bred”?
Class A
Animals purchased form the shelter must be held for how many days before removal and why?
5 days in order to give possible owners a chance to reclaim animal.
What are the USDA pain categories?
B,C,D,E
What is USDA pain category B?
Animals being bred for research but not getting used.
What is USDA pain category C?
Research conducted on animal but does not cause pain or stress.
What is USDA pain category D?
Painful experiment done, but appropriate drugs were used.
What is USDA pain category E?
Painful experiment w/ no drugs used.
The Animal Welfare Assurance is regulated by who? Which is a branch of what organization?
OLAW, a branch of PHS
The Animal Welfare Assurance is signed by who?
Institutional Officer (IO)
Which group requires IACUC review protocols every 6 months?
PHS
The Guide requires what programs have IACUC reviews?
All animal programs receiving federal funding.
What regulating body ensures compliance w/ PHS policy?
OLAW
How frequent are OLAW inspections?
A handful of research institutions are inspected annually, some are also inspected for cause.
Who can restrict approval of AWA?
OLAW
Who enforces the AWA & AWR?
USDA and APHIS
What are defined as animals in PHS policy?
All vertebrates. (does not specify “warm-blooded, like AWA policy. For example: fish are vertebrates but not warm blooded).
PHS inspections are for:
for cause
Registration for PHS is through:
AWA
Who enforces PHS policy?
OLAW
PHS policy defines animal facilities as what?
Any place that stores animals for 24hrs. +
AWR defines animal facilities as what?
Any place that stores animals for 12hrs+
PHS and AWR require IACUC inspections how often?
every 6 months
The Guide suggests inspections be done how frequently?
“At least”annually.
What are the 3 R’s?
Reduction, Refinement, Replacement
____is used in the Guide to describe essential or imperative tasks.
“Must”
____is used in the Guide for strong reccomendation.
“Should”
“The Guide is not a regulation, but has regulatory authority through who? (2)
PHS & AAALAC
Primary management & oversight falls to who?
The IO
USDA, OLAW &AAALAC require facilities to follow what regulations for euthanasia?
AVMA’s Guideline for euthanasia of animals.
CITES prevents the endangerment or extinction of species due to international trade. What do the letters stand for?
Convention on International Trade in Endangered Species of Wild Fauna and Flora.
CITES appendices lists species that are protected. What does each appendix stand for? (3)
Appendix I: endangered, Appendix II: likely to become endangered, Appendix III: prevent exploitation
How is CITES enforced?
Through US Fish and Wildlife
BMBL was created by what agencies? (2)
CDC & NIH
There are 4 Categories of risk when working w/ infectious agents. How are they labeled?
BSL1 -4
Animal Biosafety Levels (ABL) are similar to BSL levels, ranging from 1-4 w/ 4 being the highest. True or false?
True
The FDA and EPA (environmental protection agency) mandate the GLP, which stands for what?
Good Laboratory Practices
The FDA & EPA may conduct unannounced inspections for what reason?
For cause
For GLP studies, a Quality Insurance Unit (QAU) must be assigned. Who can participate as part of the QAU?
Can be a department employee or contractor. but CANNOT participate in the study or be a director.
Archived GLP data is kept how long after the study?
5 years after the study or marketing permit was not approved.
If discontinued or no permit was given to the study, how long is GLP study data archived?
2 yrs
What does the acronym AAALAC stand for?
Association for Assessment & Accreditation of Laboratory Animal Care International
In Europe, AAALAC standards are set by what agency?
European Convention for the Protection of Vertebrate Animals Used for Experimental & Other Scientific Purposes.
How often are AAALAC site visits?
Every 3 years
IACUC submits reports to this person, who sends the reports to OLAW & USDA.
IO
Inventory list of controlled substances must be updated how often?
Every 2 years.
What are examples of Direct Costs?
animals, maintenance of animals, salaries, cost of food, fringe benefits, facility operational expenses.
Example of Indirect Costs.
Cost of facility operation and maintenance, security, administrative salaries, depreciation.
What are Fixed Costs?
Are set throughout the budget period. (rent, utilities, preventative maintenance)
Variable costs are what?
Based upon demand. Ex: expendable supplies & labor costs, for husbandry and technical staff.
Cost Centers are what?
Have expenses but do not provide revenue. Ex: husbandry, cage washing, animal services.
Simple Corridor floor plan
Has no separation of clean & dirty traffic. Animal rooms have one entrance. Most common and economical design.
Airlocks are what?
Doors that cannot be opened simultaneously. Minimizes air pressure changes.
What floor plan has a designated clean and dirty corridor, where traffic is one way and animal rooms have 2 doors?
Two corridor floor plan
What floor plan has a single “control” clean corridor, w/ outer dirty corridors, w/ animal rooms on either side? (most expensive design).
Three corridor floor plan
What is a mixed floor plan?
a combination of one-way & two way floor plans.
Is air pressure positive or negative in bioexclusion rooms? Air pressure is regulated to avoid contamination . Used w/ specific pathogen free rooms (spf).
positive
Temperature and humidity should be measured how often?
Daily
What are the standard temperature and humidity of animal rooms?
Standard temp: 21.1C-24.5C (70F-76F)
Standard humid: 20-70% for mammals
What has been known to cause ringtail in rice and rats?
Low humidity
What measures humidity?
hygrometer
How many air changes should there be in an animal room on average?
10-15 air changes
What hand held device measures airflow?
Anemometer
What unit is airflow measured in? (on anemometer)
Cubic ft per minute (CFM)
If there is a CFM of 750 in a 20ft X 15ft X 15ft room, how many air changes are there per hour?
750CFM X 60 min/hr = 45,000 CFH (cubic ft per hr)
20ft X 15ft X 15ft = 4,500
45,000/4,500 = 10 air changes
Surgical suites, barrier rooms and animal rooms have what type of air pressure and why?
Positive (+), bc air rushes out of these rooms when the door is open, preventing contaminants from entering.
Animal quarintine rooms tend to have what type of air pressure and why?
Negative (-) , because the animal may be contaminated and negative air pressure causes air to rush into the room so that contaminants cannot leave.
Lux measurements are what? How far off the ground are they taken?
Measurement of light intensity, 1 meter.
Sudden noises above this level should be avoided.
> 80 decibels
True or False: THE AWA specifically mandates written plans outlining exercise for dogs and psychological enrichment for non-human primates.
True
Agents used for cleaning are regulated by who?
The EPA
Sanitizers do what?
reduce microbes from inanimate objects
Disinfectants do what?
Destroy/irreversibly inactivate fungi/bacteria. NOT spores.
Sterilizers/sporocides do what?
Kill ALL microbes, including spores and viruses.
Antiseptics and Germicides do what?
Inhibit microbial growth on ppl or animals.
Who regulates cleaning agents?
FDA
What 3 things must be considered before using a cleaning agent?
Distribution, penetration, and contact time.
Disenfectants are also regulated by the EPA under who?
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act
What component of water is important when making compunds?
Hardness level
How do you know a disinfectant can kill tuberculosis?
It is labeled tuberculocidal
Can disinfectants kill viruses?
Some can kill enveloped viruses, see labels for insight.
Alcohols are considered what type of cleaner?
Antiseptic
Why are alcohols not recommended as a disenfectant?
Evaporates quickly, fire hazard, can cause harm to individual.
Household bleach is a type of what kind of cleaner?
hypochlorite, strong oxidizer, can corrode metal.
How can hypochlorite and chlorine solutions be used?
1:50 mixture, though 1:10 mixtures are recommended to ensure decontamination.
What should Hypochlorites/chlorines not be mixed with and why?
Amonias and acids. Such mixtures can cause a toxic gas.
Why might someone use a hypochlorite or chlorine?
used for blood and organic material, but is compromised by it.
Iodophors contain what common substance?
Iodine
Iodophors are a strong____.
Oxidizer
Why would one use an Iodophor?
Fairly non-toxic, used in hand soaps. (can be compromised by organic material.
What is a phenolic?
A phenol based compound used to disinfect surfaces.
When are phenolics affective?
In the presence of proteins, some may be tuberculocidal at high concentrations.
When is phenolics not affective?
With wood, rubber plastic, less effective w/ cations (+_ for example Quaternary Ammonium compounds.
What are some phenolic safety issues?
Odor, toxic, burns. Especially hazardous to cats and amphibians.
Quaternary Ammonium compounds are what?
Catonic (+), stable, noncorrosive, non-irritating and mostly non-toxic. Can be tuberculocidal.
When is Quaternary ammonium not effective?
With soap, plastic, protein and hard water.
What is sterilization?
Killing everything, including spores.
What is the compound that has been used the longest for room decontamination and why?
Formaldehyde gas. Inexpensive and can be used w/ hotplate. Does leave some residue in room.
What are some downsides to using Formaldehyde gas?
Combustible, should not be mixed w/ other agents, degrades in light and air, carcinogen.
What is the humidity needed and contact time for formaldehyde gas to work?
70% humidity and 12 hrs contact time.
What is used after the initial gassing to neutralize formaldehyde residue?
Ammonium gas
What are pros to using Vaporized Hydrogen Peroxcide (VHP) as a room sterilizer?
Non-carcinogenic and leaves no residue. By products are hydrogen and oxygen, contact time is 6-8hrs.
What are cons to using VHP?
Oxidizer, corrosive, expensive
How is VHP used to sterilize room?
A 30-35% solution is put through”flash evaporation”.
There are 2 types of VHP room steriliztion, what are they?
Dry (vapor) and wet (condensation).
What are pros to using chlorine dioxide gas for room sterilization?
No residues or carcinogens, 3-4 hour sterilization time, gas at room temperature.
What are cons to using chlorine dioxide gas for room sterilization?
toxic when inhaled, liquid form is corrosive to metals.
What are the 2 sterilization forms of chlorine dioxide?
dry (gas) and wet (fogging)
Peracetic acid is used as a room sterilant, what are its other uses?
flushing endoscopes and irrigation connectors.
What are cons to using peracetic acid?
severe irritant to skin, eyes, and respiratory tract, flammable.
Pros to using parecetic acid?
30 min sterilization cycle.
Aldehydes (glutaraldehyde and orthophtalaldahydes or OPA) disinfectants that can do what at a high enough temperature and a long enough contact time?
Kill spores
Aldehydes are related to what commonly used room sterilant?
formaldehyde
Ethylene oxide or EtO is:
flammable, effective against bacterial spores.
Plasma Hydrogen Peroxide is:
ionized gas produced by electric field.
Plasma Hydrogen Peroxide pros:
no toxic residues and kill rate is higher than VHP.
Plasma Hydrogen Peroxide cons:
Not feasible for room strilization.
What are the settings for autoclaving materials?
15min 121 degrees C (250F), or 5min 132.2C (270)F.
Either with 15 PSI (pound per square inch) pressure.
Pros to Dry heat Sterilization:
Economical, does not dull instruments, works well on powders.
Cons to Dry Heat Sterilization:
Does not kill spores.
dry heat sterilization is for __hrs at __C.
1-hr @ 160C
What are the two types of radiation that can be used for sterilization?
Ionizing (gamma or beta rays) or non-ionizing (UV)
How does radiation sterilize items?
It disrupts the structure of cell walls, membranes and genetic material.
Do items that have been radiated become radioactive?
No they do not become radioactive/irradiated
What are RODAC plates?
Replicate Organism Detection & Counting. Has sterile growth media for multiple samples.
How is Bioluminescence used to detect microbes?
Uses ATP detection for the presence of microbes . Gives immediate results, while other methods take up to 4hrs.
Primary Barriers are what:
PPE, biological safety cabinets (bsc), microisolation type mouse cage.
BSC Class I
open-faced, safe for most, HEPA filter for exhaust
BSC Class II
Class I + HEPA filter for incoming air.
BSC Class III
Gas-tight spacing w/ non-opening view. Has either a dunk tank or double-door entrance w/ items decontaminated btwn doors (autoclave). HEPA filter for in-and-out, exhaust may be incinerated.
What are secondary barriers?
Are design features of the building.
