IACUC Protocol Review and Site Visit

• Audit 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

• Are the animals utilized USDA covered species?

  Yes

  No

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

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:

Aesthetics:

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

  Concerns

  No Concerns

• Discuss any concerns or issues:

Analgesia:

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

  Concerns

  No Concerns

• Discuss any concerns or issues:

Antibiotics:

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

  Concerns

  No Concerns

• Discuss any concerns or issues:

Other Drugs and Reagents:

• Are there any concerns with other drugs or reagents used?

  Concerns

  No Concerns

• Discuss any concerns or issues:

Euthanasia:

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

  Compliant

  Non-compliant

• Explain the non-compliant issue(s):

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

  Compliant

  Non-compliant

• Explain the non-compliant issue(s):

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

• Discuss concerns or issues:

Laboratory Site Visit

Use of Injectable Anesthetics:

• Are injectable anesthetics used for non-surgical survival procedures?

  Yes

  No

• Is an anesthetic/procedure log kept?

  Compliant

  Non-compliant

• Complete records include:

• Date

• AP number

• Name of person performing the procedure:

• Number of animals for the procedure

• Procedure being performed

• Injectable anesthetic used

• Dose and route

• Time of induction

• Time of recovery

• Post-procedure monitoring ( per AP)

Special Equipment/Caging/Devices:

• 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

• Are surgical procedures performed outside the OAR vivarium?

  Yes

  No

• List locations where surgeries are performed?

• Have all personnel performing survival surgery been observed performing a procedure by a designated IACUC observer?

  Yes

  No

  Not Applicable

• List personnel who need to be observed performing a survival surgery:

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 all drugs and reagents administered to animals pharmaceutical grade?

  Yes

  No

  Not Applicable

• Has the use of non-pharmaceutical grade drugs been justified in the AP?

  Yes

  No

  Not Applicable

• Explain why no justification has been given:

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

  Compliant

  Non-compliant

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

  Yes

  No

  Not Applicable

• List records that need to be kept:

• Complete records for controlled substance use should include: biennial inventory reports, purchase/invoice records, distribution/use records, waste records, destruction/disposal records, and theft/loss records.

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 locations where animals are kept:

• 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

• Is the procedure space uncluttered?

  Yes

  No

  Not Applicable

• Is a sharps container present?

  Yes

  No

  Not Applicable

• Are there biohazard waste containers?

  Yes

  No

  Not Applicable

• Are gas cylinders secured properly?

  Yes

  No

  Not Applicable

• 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 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

  N/A

• 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

• 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 Be Addressed" 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 do not hesitate to contact me (335-9687) or e-mail me at iacuc-pam@uiowa.edu.

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 Be Addressed:

• 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

• There no corrective actions that 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 Be Addressed are to be completed within two weeks of receiving this report, and the IACUC Training & Compliance Coordinator should be contacted 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:

• General comments and notes: