IACUC Protocol Review and Site Visit - updated 1/4/17

• Protocol Review and Site Visit Title

• PI

• Protocol Review and Site Visit Conducted With:

• Laboratory Address
  Address

• Animal Protocol Number

• IACUC Designated Post-approval Monitor

• Conducted on

  Date

Animal Protocol Review

Personnel:

• List personnel approved on the Animal Protocol:

• Do any personnel need to be removed?

  Yes

  No

• List personnel to be removed:

• Do any personnel need to be added?

  Yes

  No

• List personnel to be added:

Anesthetics:

• Are there any concerns or issues with the anesthetic regime?

  Concerns

  No Concerns

  Needs Updating

• Discuss any concerns or issues:

• Discuss what needs updating.

Analgesia:

• Are there any concerns or issues with the analgesic regime?

  Concerns

  No Concerns

  Needs Updating

• Discuss any concerns or issues:

• Discuss what needs updating.

Antibiotics:

• Are there any concerns or issues with the antibiotic regime?

  Concerns

  No Concerns

  Needs Updating

• Discuss any concerns or issues:

• Discuss what needs updating.

Justification of Non-pharmaceutical Grade Drugs, Reagents, and Compounds:

• Are all drugs, reagents, and compounds pharmaceutical grade?

  Yes

  No

• Is the use of non-pharmaceutical grade drugs, reagents, and/or compounds justified in the animal protocol?

  Yes

  No

• The animal protocol must be amended to justify the use of non-pharmaceutical grade drugs, reagents, and/or compounds.

Euthanasia:

• Are animal euthanasia methods in compliance with Federal regulations and IACUC policy and guidelines?

  Compliant

  Non-compliant

  Not Applicable

  Needs Updating

• Explain the non-compliant issue(s):

• Explain the update that is needed.

• Are the physical methods to confirm euthanasia in compliance with Federal regulations and IACUC policy and guidelines?

  Compliant

  Non-compliant

  Not Applicable

  Needs Updating

• Explain the non-compliant issue(s):

• Discuss what needs updating.

Animal Protocol and Procedure Review:

• Concerns or issues with sections of the Animal Protocol, or listed procedures:

Protocol and procedures

• Are there any concerns or issues with sections of the Animal Protocol, or listed procedures?

  Concerns

  No Concerns

  Needs Updating

• Discuss concerns or issues:

• Discuss what needs updating.

Social Housing of Social Species

• Are animals single-housed for experimental purposes?

  Yes

  No

  Not Applicable

• Is the single-housing of the animals justified in the Animal Protocol?

  Yes

  No

  Not Applicable

• The Animal Protocol will need to be amended to justify single housing of a social species.

Animal Protocol Comprehension

• Questions to assess protocol comprehension

Assessment

• Question to assess AP comprehension

• Did the lab person give the correct answer?

  Yes

  No

  N/A

• CORRECT!

• Did the lab personnel give the wrong answer?

  Yes

  No

  N/A

• Answer to question.

Laboratory Site Visit

Use of Anesthesia for Non-surgical Procedures

• Are anesthetics used for non-surgical survival procedures?

  Yes

  No

• Is an anesthetic/procedure log kept for non-surgical survival procedures?

  Compliant

  Non-compliant

  Not Applicable

  Needs Updating

• Complete records include:

• Date

• AP number

• PI Name

• Animal ID(s)

• Animal Weight(s)

• Procedure being performed

• Injectable anesthetic used

• Dose and route

• Time of induction

• Time of recovery

• Post-procedure monitoring ( per AP)

• You must begin keeping the required anesthesia records.

Use of Special Caging or Equipment

• Is any special equipment, caging, or devices used with the animals?

  Yes

  No

• Special equipment, caging, or devices used:

Special Equipment/Caging/Devices

• Is the special equipment/caging/device located in the OAR vivarium?

  Yes

  No

• List equipment/device and its location:

• Is the special equipment/caging/device clean and disinfected after each use?

  Yes

  No

  Not Applicable

• Are the animals monitored when the equipment/caging/device is in use?

  Yes

  No

  Not Applicable

• Explain why animals are not monitored:

Survival/Non-survival Surgery:

• Are either survival or non-survival surgeries being performed?

  Yes

  No

  Not Applicable

• Are surgical procedures performed outside the OAR vivarium?

  Yes

  No

• List locations where surgeries are performed?

Drugs, Reagents, and Controlled Substances:

• Are all drugs and reagents administered to animals within their expiration date?

  Yes

  No

  No Expiration Date Given

• List expired drugs and reagents:

• Are controlled substances stored per DEA regulations and Institutional guidelines?

  Compliant

  Non-compliant

  Not Applicable

  Needs Updating

• Are all the necessary records being kept for controlled substance use?

  Yes

  No

  Not Applicable

• Biennial Inventory

• Purchase Records and Invoices

• Distribution/Daily Use Log

• Waste/Destruction/Disposal

• Theft/Loss

• List of Personnel Granted Access to CS Lockbox

• Limited Power of Attorney for Purchasing/Disposing of CS

• SOP for transportation of controlled substances

• Animal Protocol of lab(s) controlled substances are provided to

• Is a special diet administered to the animals?

  Yes

  No

• Is the diet stored in the OAR?

  Yes

  No

• Is the food stored correctly?

  Yes

  No

  Not Applicable

• Is the food still within its expiration date?

  Yes

  No

  No Expiration Date Given

• Is the lab keeping a husbandry log of when food is checked and changed?

  Yes

  No

  Not Required

Food and Water Restrictions

• Is food and/or water restricted or withheld from animals?

  Yes

  No

• Is the duration that food/water is restricted or withheld < 12 hours?

  Yes

  No

• What is the duration of food and/or water restriction?

  >12 hours < 24 hours

  > 24 hours

  > 1 week

  Extended period

• Is body weight measured and recorded at least weekly ( more frequently if restriction is more severe)?

  Yes

  No

  Not Applicable

• Explain why body weight is not measured and recorded:

• Is food ( or water, if restricted) consumption measured and recorded daily?

  Yes

  No

  Not Applicable

• Explain why food ( or water) consumption is not measured:

Transportation of Animals Outside of the OAR Vivarium:

• Are animals transported outside of the OAR vivarium?

  Yes

  No

• Are animals and cages covered during transport from the OAR vivarium?

  Yes

  No

  Not Applicable

• Are animals, animal carcasses, empty cages, and caging supplies covered during transport back to the OAR vivarium?

  Yes

  No

  Not Applicable

• How long are animals kept outside the OAR vivarium?

  < 12 hours

  > 12 hours, < 24 hours

  > 24 hours

• List location animals are kept:

Lab Spaces Where Animals Are Utilized (Non-surgical Spaces)

• Is non-surgical animal procedure space located in the OAR vivarium?

  Yes

  No

• Is non-surgical animal procedure space shared with other labs?

  Yes

  No

• List other labs sharing the space:

• Is the procedure space clean and disinfected after each use?

  Yes

  No

  Not Applicable

• Discuss what the issue(s) is (are):

• Is the procedure space uncluttered?

  Yes

  No

  Not Applicable

• Add media

  Media

• Is a sharps container present?

  Yes

  No

  Not Applicable

• Are there biohazard waste containers?

  Yes

  No

  Not Applicable

• Is CO2 used for euthanasia in the Lab?

  Yes

  No

  Not Applicable

• Is the gas cylinder secured appropriately?

  Yes

  No

• Does the CO2 gas cylinder have a flow meter attached to it?

  Yes

  No

• Is proper PPE used when working with animals?

  Yes

  No

  Not Applicable

• Proper PPE is lab coats/surgical gowns/surgical scrubs, and gloves. It may also include: eye protection, ear protection, and respiratory protection.

• Are lab coats laundered on a regular basis?

  Select Yes No Not Applicable

  • Yes
  • No
  • Not Applicable

• Are volatile anesthetics used for non-surgical procedures?

  Yes

  No

• Is a vaporizer or drop jar used to administer the anesthetic?

  Vaporizer

  Drop Jar

• Has the vaporizer been recalibrated or recertified in the past year?

  Yes

  No

  Not Applicable

• Are they anesthetic gases scavenged?

  Yes

  No

  Not Applicable

• How are gases scavenged?

  Fume Hood

  Dedicated Exhaust System

  Scavenging Canisters

  Other

• Has the scavenging canister been weighed and labeled with its initial weight, and the date it is put into service?

  Yes

  No

  Not Applicable

• Does the canister or a log sheet have a record of the date of use and the measurement of the canister's weight?

  Yes

  No

  No Expiration Date Given

• Are animals prevented from coming into direct contact with the anesthetic?

  Yes

  No

  Not Applicable

• Are the anesthetic gases scavenged?

  Yes

  No

• Is the guillotine sharp and tight fitting?

  Yes

  No

  Not Applicable

• Have all members of the lab who work with animals read the entire contents of the Animal Protocol?

  Yes

  No

  Not Applicable

Cleaning/Disinfecting Animal Procedure Areas:

• Are animal procedure areas clean and disinfected?

  Yes

  No

  Not Applicable

• Do the disinfectants used have expiration dates?

  Yes

  No

• Is the disinfectant within its expiration date?

  Yes

  No

  Not Applicable

• Is the disinfectant labeled with an expiration date?

  Yes

  No

  Not Required

• When are disinfectants used?

  Select Before Procedures After Procedures As Needed During Procedures

  • Before Procedures
  • After Procedures
  • As Needed During Procedures

• Are instructions posted for making/using disinfectants?

  Yes

  No

  Not Required

• The site visit is completed.

Protocol Review and Site Visit Report

• Are the animals utilized in this protocol USDA covered species?

  Yes

  No

• This protocol review and site visit report incorporates the Annual IACUC Animal Protocol Review required by the USDA.

• Thank you for facilitating this protocol review and site visit. This report is a summary of any proposed amendments and any requirements or recommendations to correct observations and areas of concern identified during the protocol review and laboratory site visit.
  
  Any procedures that are not outlined in the Animal Protocol (AP) or any discrepancies or conflicts between the AP and current laboratory procedures are summarized below in either the "Proposed Amendments" section, or the "Concerns to Address" and "Significant Deficiencies" sections. Please understand that not all discrepancies or negative responses are considered to be a non-compliance of a requirement.
  
  If you have any questions, concerns, or comments, please contact (Name), the IACUC Training & Compliance Coordinator at (xxx-xxxx)or by e-mail at (e-mail address).

Proposed Amendments:

• Are there any proposed amendments?

  Yes

  No

• There are no proposed amendments at this time.

• To amend a protocol:
  
  The PI (or designee) must modify the most current approved Animal Protocol with the new information in red text.
  > Remember to modify responses to all related number sections of the protocol.
  > If removing text, indicate with a strike through
  > Be sure to change the color of any previously approved amendment text to blue or black.
  E-mail the modified Animal Protocol to iacuc-amendment@uiowa.edu
  > Include in the e-mail text: PI name, AP number(s) to be amended, and list of sections which have been modified.

• List proposed amendments:

Concerns to Address:

• Are there any concerns that need to be addressed?

  Yes

  No

• There are no concerns to be addressed at this time.

• List concerns to be addressed:

Significant Deficiencies:

• Are the any significant deficiencies?

  Yes

  No

• There are no significant deficiencies.

• List significant deficiencies:

Corrective Actions:

• Are there any corrective actions that need to be taken?

  Yes

  No

• No corrective actions need to be taken.

• Per USDA regulations, corrective actions for any Significant Deficiencies that affects the health or safety of a USDA covered species must be completed within a specified time which is to be determined by the Institutional Official (IO), the IACUC Chair, the University Attending Veterinarian (AV), the IACUC Director, and the OAR Clinical Veterinarians.
  
  Corrective actions for Concerns to Address are to be completed by mm/dd/2017 and the IACUC Training & Compliance Coordinator should be contacted by e-mail (e-mail address) and informed that the corrective actions have been completed.

• List the corrective actions:

Recommended Actions:

• Are there any recommended actions?

  Yes

  No

• There are no recommended actions at this time.

• Recommended actions are not requirements, but rather suggestions for better laboratory practices, and/or advice to help comply with regulatory policies and guidelines

• List recommended actions:

Comments/Notes:

• Site visit rating:

  Outstanding

  Excellent

  Good

  Needs Improvement

• General comments and notes: