by Farah Moulvi
Both the Animal Welfare Act (9 CFR §2.31 subpart c) and the Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals (IV.B.) require that every organization’s institutional animal care and use committee (IACUC) inspect all institutional animal facilities at least once every six months using the Guide for the Care and Use of Laboratory Animals (the Guide) as a basis for evaluation.
The question, of course, becomes how can IACUC administrators and staff assist IACUC members with these inspections when so many different vivaria are involved? My institution has put in place several key policies and procedures in an effort to overcome this obstacle.
As per the requirements, the IACUC must use a subcommittee consisting of at least two voting members of the IACUC. At my institution, we schedule at least three IACUC members for each site visit, in addition to an attending veterinarian, biosafety officer, and IACUC staff member.
Approximately two months before the scheduled start of the site visit, IACUC members and their alternates confirm their availability for the five-week period and select tentative dates and time slots. Involving alternates increases the pool of available site visitors. However, it is important to ensure that a regular member and his/her alternate are not scheduled for the same day.
Once all members have responded with their availability, we provide attendees with a calendar, maps, and participant list for the five-week inspection period. Typically, an IACUC member is scheduled for two inspections that last from two to four hours.
Participation by all IACUC members is very important to limit the burden of the inspections on any given member. Making a time commitment to the semiannual facility and program review process is a vital part of the IACUC member’s responsibilities. Members at my institution are encouraged to participate in multiple inspections and can attend any site inspection irrespective of their assignments. IACUC members are also rotated to different inspection sites to ensure members bring a fresh perspective.
At this point, IACUC members are enrolled in the occupational health program so they are aware of the requirements and informed of any risks involved in inspecting the animal facilities or laboratories. Members are also provided with additional resources such as previous site visit reports, institutional policies, and lists of protocols for PIs using outside vivarium laboratories. A team member also has the Guide available during inspections.
In preparation for the inspection, we send notifications to investigators and animal care facility managers so that appropriate personnel are available for questions, educational opportunities, and to foster dialogue with researchers and staff.
Forty-eight hours before the scheduled inspection day, IACUC members are given a courtesy reminder by telephone to confirm attendance.
During site visits, a member of the IACUC staff is assigned to take notes. Items identified include deficiencies, concerns needing attention, and recommendations for improvement or enhancement. The deficiencies are classified as either minor or major. Before leaving the facility, a verbal debriefing of the findings is provided by the IACUC site visit team to the animal care facility manager or the principal investigator (PI). The animal care staff is also given kudos for items that are well maintained.
The final report, prepared by the IACUC administrator, is then provided to the IACUC at a convened meeting. The discussion focuses on the classification of the deficiencies, a reasonable and specific corrective action plan and schedule, and the inclusion of minority reviews, if applicable. The report is finalized by a vote before its transmission to the institutional official (IO). After the IO signs off on the report, the IACUC administrator distributes copies to the facility managers. Letters are also sent to individual investigators with a description of the noted deficiency, the referenced policy or regulation, and the required corrective action and timeline for correction.
Once all deficiencies are corrected, and an appropriate response is provided, a report is compiled that is sent to the IO and IACUC members. Items are tracked on a monthly basis until all deficiencies are addressed in the time specified in the original inspection report.
Needless to say, depending on the size of an institution, the preparation, scheduling, coordination, documentation, and follow-up can take several months. Some institutions determine that these semiannual inspections should all be done over a one- or two-month period, while others stagger the inspections throughout the year. It’s no wonder that most administrators go through this process, and soon after it is finalized, the next inspection is almost due, producing the feeling of “Didn’t we just do this inspection?”
I’ve shared the process at my institution—now, it’s your turn! Please share your experiences, methods, and ideas for preparing and coordinating a robust and meaningful semiannual facility inspection through this blog forum.
by Farah Moulvi
What would you do if an already scheduled inspection has to be postponed due to external circumstances (like hurricane, or quarantine of all IACUC members)?
Would you be considered non-compliant? Until you finish the inspections? Do you have to stop any activity until inspections are finished?