Guidelines for Establishing Satellite Animal Facilities at IUB

Guidelines for Establishing Satellite Animal Facilities at IUB

Policy

All animal housing areas must be approved by the Institutional Animal Care and Use Committee (IACUC) prior to use and are subject to semi-annual inspections by the IACUC; regular veterinary rounds by Laboratory Animal Resources; inspection by the USDA-APHIS Veterinary Medical Officer (where applicable); tri-annual visits by the AAALAC-International accreditation team; and other visits and inspections that are deemed necessary (Office of Laboratory Animal Welfare/Public Health Service, Dept. of Labor, etc.).

General

It is the policy of both the Indiana University IACUC and Laboratory Animal Resources (LAR) that all animals requiring facilities for housing and use are maintained in IACUC‐approved, dedicated animal facilities.

The IACUC highly recommends the use of centralized, currently approved animal facilities within our Animal Care and Use Program. Centralized, dedicated facilities allow for enhanced communication at all levels, and consistent and high-quality animal care. Clearly identified roles and responsibilities, and coordinated allocation of resources and funding are additional advantages of centralized and dedicated facilities.

Maintaining animals in areas outside of currently approved, dedicated animal facilities requires significant additional resources from numerous sources, as each animal facility must be maintained in accordance with accreditation standards, oversight agency requirements, and local policies. Satellite housing facilities may not be used merely for convenience.

If an unapproved location for animal housing or procedures is proposed, a formal request must be presented to the IACUC and the Attending Veterinarian for review and approval as an additional animal facility through meeting all requirements in the Checklist for Approval of Satellite Animal Facilities. The request must be completed and approved through review of this document and completion of Section H. in the IACUC protocol submission. To summarize, compelling scientific or other justification must be submitted to the IACUC, with a full explanation as to why other approved facilities could not support the work. Cost and convenience cannot be primary considerations for proposing animal care and use in an unapproved facility. A completed Standard Operating Procedure (SOP) should also be attached.

Prior to any IACUC consideration of housing or procedures outside of IACUC‐approved areas, the PI should contact both the Attending Veterinarian and the IACUC office early in the planning process to discuss available options.

If the request pertains to an upcoming hire, the Department Head should contact both the Attending Veterinarian and the IACUC prior to contract negotiations. EH&S officers, building and facility managers, and others may also need to weigh in on Satellite Animal Facility discussions. Directors and personnel who manage dedicated facilities should be consulted early in the facility proposal process to determine whether the facility can accommodate or support the proposed animal housing or use.

The IACUC will review satellite facility proposals on a case‐by‐case basis, and proposals may require review during a full committee meeting. Please note that the IACUC may withhold approval of a satellite housing request if the location is determined to be inappropriate for the species, proposed use, or incongruent with the needs and requirements of the IUB Animal Care and Use Program. A written approval notice is sent after all facility and SOP requirements and modifications have been met, and the Attending Veterinarian and IACUC representatives have completed a final inspection. A new location can accept animals after written approval of the Satellite Animal Facility is received from the IACUC office.

Written notice of a related protocol approval is not the same as written notice of a Satellite Animal Facility approval, and a protocol approval does not guarantee approval of a related facility.

The IACUC relies primarily on the following references to determine the suitability of housing and procedure locations:

  • IUB's Program Description (AAALAC, International Form)
  • IUB's Assurance ( PHS / OLAW Assurance Form)
  • Animal Welfare Act and Animal Welfare Regulations
  • PHS Policy
  • Guide to the Care and Use of Laboratory Animals
  • Guide for the Care and Use of Agricultural Animals in Research and Teaching
  • IUB IACUC Policies, Guidelines and SOP's as applicable

Definitions

  1. Dedicated Animal Facility
    1. An IACUC-approved animal facility designed specifically for animals, managed by LAR dedicated staff. The use of dedicated facilities is highly recommended.
    2. Examples of dedicated animal housing facilities include LAR managed vivariums.
  2. Satellite Animal Facility (SAF)
    1. Satellite animal housing facilities are locations where animals are maintained or housed for more than 12 hours outside of LAR oversight. Satellite facilities (SF) are not managed or attended to daily by Laboratory Animal Resources (LAR) staff, but instead are overseen by the Principal Investigator (PI) and research staff. The BIACUC has compliance responsibility for all vertebrate animal housing and use areas including satellite facilities. The BIACUC is required to inspect all laboratory animal housing and procedural areas at least once every 6 months. Satellite facilities (SF) must comply with the same regulations as centrally managed facilities. Veterinarians must be provided access to animals housed/maintained in all satellite animal facility locations. SF are IACUC‐approved animal facilities maintained primarily by an investigator, and outside of direct LAR oversight, in which animals are housed for greater than 12 hours.
  3. Procedures
    1. Facilities used for live animal procedures are also considered satellite animal facilities and must be reviewed and approved by the IACUC, prior to use.
    2. Please do not hesitate to contact the IACUC office, the Attending Veterinarian (who also serves as the LAR Director), or LAR veterinary staff if there are any questions about animal facilities.

Guide – Satellite Animal Facilities (SAF)

Approval of an Animal Care and Use Protocol and approval of a Satellite Animal Facility can be related but separate processes. Note that final approval notice of an SAF will be sent from the IACUC to the PI, if the request was made separate from a protocol submission.

This SAF Standard Operating Procedures Guide provides a basic outline to aid in development of an SAF SOP. The SOP must address each topic with detail sufficient for the range of readers who will review and use the document, or provide sufficient explanation if the topic is not applicable to their proposal. The SOP must be approved by the IACUC and the AV, and must be easily accessible within the facility for facility users, veterinary staff, the IACUC, and others in case of emergencies.

SAF Program

  1. IACUC and Veterinary Staff Accessibility: The SAF must be accessible to IACUC and LAR representatives (or designees) at all times. The SAF PI must provide a method (keys, entry codes) to facilitate veterinary staff access to animals in the facility.
  2. Security – Animal and Personnel: The PI is responsible for maintaining and ensuring that the SAF area is secured at all times, and otherwise explain any limits to security.
  3. Biosecurity: Animal entry or departure from the SAF must be in accordance with IACUC, LAR, and other local policies, as applicable. If the PI wishes to bring any satellite facility animal to any other facility, this must be first described in the protocol (or amendment) and SOP, and approved by the IACUC. The PI must provide a detailed description of potential biosecurity concerns, and how they will be mitigated if animals, personnel, caging, equipment, etc., are transported from one area to another.
  4. Standard Operating Procedures are Available in the Facility: The PI is responsible for creating and maintaining Standard Operating Procedures (“SOP”s) that reflect current activities, and are based on current AAALAC, federal, and local standards – see the primary references listed above. SOPs must be reviewed and approved periodically by the IACUC. These SOPs must be present in the SAF and used for training personnel associated with the animal activities.
  5. Participant Training: It is the responsibility of the PI to ensure that each person providing care for animals in the SAF is adequately trained by the PI, LAR staff, LAR veterinarians, or their designees, and training reflects the available SOPs.
  6. Occupational Health: The PI is responsible for ensuring the safety of personnel by verifying their enrollment in the IUB Occupational Health and Safety Program; ensuring incident reports are filed in an accurate and timely manner; and following related requirements and recommendations of local, state, and federal oversight entities.
  7. Adverse Event and Disaster Plan: All Satellite Facilities must have a written plan that addresses potential adverse events, emergencies and disasters. Individuals responsible for daily animal care must have access and be trained on this plan
  8. Drug Storage: Drugs must be used prior to their expiration date and stored according to all applicable rules and regulations. DEA controlled analgesics or anesthetics need to be maintained in a secure and locked manner.
  9. Documents available in the Facility: Current IACUC SOP’s at the cage or pen level, the Satellite Facility SOP, all required safety signage (EH&S), the current Animal Welfare Concerns posting, Room/Animal Daily Check List, and a current Emergency & After‐hours Contact List must be available in the facility.
  10. Record Keeping: The PI is responsible for complying with all applicable documentation and recordkeeping requirements described in the Guide for the Care and Use of Laboratory Animals, and other primary references.
  11. Hazards: The PI is responsible for complying with EH&S and all other applicable rules and regulations regarding any physical, radiation, biological and chemical hazards. The PI is responsible for notifying all facility and laboratory personnel, and the IACUC, of any hazards present, and assure that all personnel are properly trained for the present or potential hazards.

SAF Management

  1. Environment: Environments provided in SAF should closely comply with the performance criteria provided by the current editions of the NIH Guide and FASS Guide.
    1. In general: The room should have "single pass", non-recirculated air. Air should flow into the room, not out, with respect to the hallways, public spaces and other adjoining rooms.
    2. The room must be segregated by a closable door.
    3. There should be a sink for hand washing.
    4. If inhalation anesthetics are administered, anesthetic gas scavenging must be used.
    5. No food or drink for human consumption will be allowed near the animal procedures or housing area.
    6. Animal housing or procedure rooms must be uncluttered and clean, be sanitizable and able to withstand disinfectants or cleaning compounds.
  2. Sanitation: The PI is responsible for providing species‐specific sanitation for the facility per LAR requirements and recommendations. The facility must be easily cleaned and sanitized. Use of any wood product is discouraged.
  3. Husbandry Equipment and Supplies: All caging and materials such as food, water, bedding, enrichment device(s), cage cards and cleaning materials necessary for proper husbandry and care need to be approved by the IACUC, and provided by the PI. Storage should be limited to items necessary for housing the animals. Stored materials should be kept in sealed plastic containers, and cardboard should be discarded. The milling date or date of expiration should be clearly indicated on all stored food, and all short‐term or consumable items must be discarded by the expiration date. There must be a written, executed agreement with LAR regarding any materials borrowed from an LAR facility.
  4. Physical Plant: The facility must meet standards per the applicable IACUC and local policy, AAALAC accreditation guidance, The NIH Guide for the Care and Use of Laboratory Animals or the FASS Guide for the Care and Use of Agricultural Animals in Research and Teaching and federal and local laws, policies, and guidance. A review of applicable OLAW Animal Facility Checklists is highly recommended, as these checklists help ensure that we meet standards in our Assurance (related to funding agency expectations), our Program Description (AAALAC), and USDA‐APHIS‐Animal Care. The PI is responsible for meeting or exceeding established standards at all times.

SAF Veterinary Care

  1. Animal Procurement: Purchase of animals must be approved by the IACUC and reviewed by LAR before ordering.
  2. Acclimation Time: The standard minimum acclimation time for rodents is 2 days and for non-rodent mammals is 7 days.
  3. Animal Room Daily Check List is Posted and Completed Daily: Each day that an animal is held in the SAF, an Animal/Room Daily Check List must be posted and completed. Records must be retained for 3 years from the completion of the project and must be available for inspection by the IACUC, federal regulatory agencies and site visitors from the Association for the Assessment and Accreditation for Laboratory Animal Care, International (AAALAC). Contact LAR or IACUC for guidance and examples regarding daily check lists.
  4. Animal Identification: All animals must be identified by a current IACUC approved protocol (e.g.: with LAR or similar animal identification cage cards or other IACUC-approved method), and animal management records must be kept with relevant information such as individual IDs, dates of animal entry into facility, etc.
  5. Health Reporting: All animals must be checked daily (including weekends and holidays) by the PI or specified designee and reported to the AV per the Daily Health Check requirements and procedures.
  6. Veterinary Care: All veterinary care for animals in the SAF must be provided through the LAR veterinary group or specified veterinary designee.
  7. After Hours (Emergencies, Weekends, and Holidays): The PI is responsible for maintaining and posting an accurate emergency contact information in the facility and must promptly update LAR and IACUC with any changes. The posting must include the contact information for the Principal Investigator, additional lab contacts, the AV, any additional specified veterinary staff, LAR, and IACUC. The PI or the specified designee must be contactable at all times to respond to animal or facility emergencies.

Contact Lab Animal Resources

Lab Animal Resources

lar@iu.edu