The Beacon Volume 5, Issue 4


September 2020 Newsletter

Content

2020 IACUC Deadlines and Meeting Dates

Investigators are encouraged to submit protocols that are due for 3-year renewal early to allow time for pre-review of the protocol by the research liaisons and the veterinarians. This will expedite the review and approval of the protocol in the MAPS environment. Should you have any questions, please contact OARS at iacuc@yale.edu.

OARS Departmental and Organizational Changes

The pre-approval (Protocol Liaison) and post-approval (Research and Safety Services Specialist) monitoring functions of the Office are being combined to create the new role of Research Liaison.  With this change, the Research Liaisons will develop a deeper understanding of the work conducted in the labs, thus being able to improve customer service to the research community, gain efficiencies with operational activities, and enhance their professional development. 

Shrilatha Balakrishna has been promoted to Assistant Director for IACUC Administration. In her new role, Shri will be part of the OARS senior leadership team and will focus on quality control of IACUC protocol-related data, assuring that the IACUC runs smoothly, and directly managing the required documentation associated with federal and state regulations.

Changes in Anesthetic Vaporizer Servicing

The IACUC, in conjunction with EHS, initially approved the Anesthetic Vaporizer and Ventilator Maintenance Policy in 2006 to ensure the proper functioning of anesthetic machines and limit exposure to waste gases based on the Guide for the Care & Use of Laboratory Animals. Vaporizers that do not receive periodic service have the potential to leak anesthetic gases, which poses an occupational health risk to personnel, as well as delivering an incorrect dose to the animals. As such, EHS and the IACUC have required calibration at least once every 12 months with appropriate documentation.

When research activities were suspended in late March 2020 due to the COVID pandemic, vaporizer use in laboratories was likely discontinued or very limited. Even though Research Reactivation is in Phase 2 and approaching Phase 3, restrictions remain for service providers being on campus (see Vendor Site Access Requirements page).

Recognizing the impact of the restrictions for contractors/service providers, the IACUC has authorized an extension of the deadline for servicing vaporizers that appear to be functioning correctly through 2020. The requirement for annual servicing will be re-assessed at that time.

Prior to resuming vaporizer use, inspect the system for any visible damage, including cracked or damaged hoses, sticking valves or knobs, or discoloration of the “Fill” sight glass. If you have reason to believe that there is an unidentifiable leak, e.g. unexplained anesthetic odor or increased gas usage to maintain surgical plane of anesthesia, discontinue use immediately and contact the manufacturer.

Upcoming USDA Facility Inspection

Recently, Jim Macy (Attending Veterinarian), Gary Cline (IACUC Chair), and Troy Hallman (OARS Director) had a conversation with our USDA Veterinary Medical Officer (inspector) about the Yale requirements for her upcoming visit to campus for the annual inspection.

The USDA uses its own at risk-based county-by-county map to determine the priority of inspecting registered facilities. New Haven County is currently in the second risk level.

What this means is that because of our very good compliance history with the USDA, we will likely not be inspected for the foreseeable future. That said, if New Haven County is reduced to the first risk-level, the USDA could come to inspect Yale at any time, like usual.

Update on IACUC and OARS “Business as Usual”

As the University’s response to the spread of COVID-19 continues to evolve, so does how the IACUC and OARS manages the institution’s regulatory responsibilities.

The IACUC approved an extension through the end of 2020 that facility managers (or designees) and PIs with satellite housing or lab managers may conduct self-assessments of their own facilities and laboratories.

OARS Research Liaisons will notify PIs and lab managers at the beginning of each month that a lab audit is due. Please use the Yale Laboratory Self-Evaluation Checklist for guidance or the fillable version Yale Laboratory Self-Evaluation Checklist fillable (must be logged into CAS). We are relying on the honor code, so please send all findings with plan for correction to iacucinspects@yale.edu.

This initiative will be limited to rodents, aquatics, and other non-USDA-covered species. Inspections of USDA-covered species will continue to be conducted by the IACUC.

As a reminder, if you are conducting experiments during this time, be sure that you continue to follow practices that the IACUC has approved in your protocols, especially monitoring plans and treatment following procedures.

If you are unable to fulfill this responsibility, you may contract Rodent Services (rodentservices@yale.edu) or VCS (vcsstaff@yale.edu) to monitor your animals for you on a fee-for-service basis, or you should cease the experiment until you are better able to meet this expectation.

Update on OARS and Lab In-Person Training

When non-essential research activities were suspended in late March 2020 due to the COVID pandemic, the Office of Animal Research Support (OARS) in-person training was temporarily halted.  From that point through July, OARS-conducted in-person training increased from safety training only for coronavirus-related studies to training upon request during Phase 2 of Research Reactivation. We overcame some of the social distancing challenges by utilizing additional PPE when training research personnel for both department- and university-prioritized studies. 

We have recently been reminded that 6’ social distancing is required, regardless of any additional safety precautions. We realize that for new research projects to begin with new research personnel, training must continue, whether by existing means or by exploring alternatives.

We need your help to ensure that the University remains compliant with animal care and use training expectations from outside regulators. For the foreseeable future, the program will be relying even more on the expertise of seasoned researchers to conduct training for new lab recruits. 

Lab-Based Training Logs

As you may recall, in early 2016, OARS began distributing laboratory-based training logs to Principal Investigators when Personnel Qualification Forms (PQFs) were approved. These logs were intended to be used by PIs or their designees to document training performed by research personnel. With this temporary shift in the training model, we will be requiring full completion of these lab-based training logs.

Please ensure that training requirements for any PQF approved on or after April 1st, 2020, are fulfilled and documented on the lab-based training log. We will be collecting and archiving the logs in Fall 2020 to confirm that training has been completed. 

If you do not have a training template, please contact OARS at IACUC@yale.edu and your inquiry will be directed to the appropriate OARS staff member. If you have any questions or concerns, please feel free to contact Troy Hallman directly (troy.hallman@yale.edu).

Policy Updates August/September

Housing: Aquatic Species REVISED

  • The following statements were updated or added in reference to recordkeeping/reporting:
    • A log containing animals that are dead, injured, sick, or those displaying abnormal behaviors
    • This is to be used to determine frequency of morbidity or mortality wildtype or mutated lines within the colony.
    • A notable increase over the course of a week in the frequency of morbidity or mortality specific to wildtype or mutated lines within the colony must be reported to the Clinical Veterinarians (203-785-2501, vets@yale.edu) or by submission of a Request for Animal Health Services (RAHS) form.

Expired Materials REVISED

  • The following statement was added for clarification:
    • Expired drugs excluding anesthetics, analgesics, emergency drugs, and euthanasia drugs can be used in terminal procedures with prior IACUC approval.

Standard Procedure Updates

Blood Collection - Mice REVISED

  • Needle sizes were added to specific routes of collection.
  • The numbering system was updated in such a way that investigators can still indicate specific steps they may not do or that they do differently.

Blood Collection - Rats  REVISED

  • Needle sizes were added to specific routes of collection.
  • The numbering system was updated in such a way that investigators can still indicate specific steps they may not do or that they do differently.

Guideline Update

Aquatics Satellite Housing NEW

This document is intended as general guidance for Aquatics Satellite Housing areas.  For existing colonies with previously approved SOPs, please ensure that current documents are submitted to OARS.  New investigators should contact OARS regarding any fish species other than Danio rerio and any frog species other than Xenopus laevis.

Compliance Corner

Important Reminder Regarding Genotyping

OARS has recently received reports of a spike in non-compliance incidents regarding toe and tail clipping, where procedures are being performed beyond the age limitations for genotyping.

If you were unable to genotype your animals due to the COVID shutdown and are now resuming studies, you MUST comply with the Rodent Identification & Genotyping Policy. Inability to gain access to your animals during the shutdown is not justification for going outside of the policy requirements.

As a reminder, oral swabs (saliva) and ear punch tissue may be collected at any age for genotyping purposes. Tail biopsies performed after 21 days of age MUST be justified and approved in your protocol, and MUST be performed using anesthesia, pre-emptive opioid injection +/- a local anesthetic, followed by post-operative analgesics for a minimum of 48 hours. Toe clipping is ONLY acceptable for neonatal mice up to 12 days of age and for rats no older than 7 days.

To ensure that animals do not experience any unanticipated or unalleviated pain or distress, it is imperative that you consult with Veterinary Clinical Services prior to performing genotyping on older animals, as well as with OARS to ensure your protocol is updated.

Please contact OARS (iacuc@yale.edu) with any questions or concerns.