7 - Applying the Plan-Do-Check-Act model for continuous process improvement to the Inspection Program - getting back on track after COVID

Background: At our University, semiannual inspections are scheduled and managed by the IACUC Office. The challenges faced at the end of 2021, as the research was ramping up, were multi-fold. Here we will present some of these challenges and how we are addressing them using the Plan-Do-Check-Act model for process improvement.

Program

Description: The semiannual inspections are conducted December through May and June through November. The inspections are scheduled by building and include animal housing facilities and investigator-managed spaces, warehouse, and transport vehicles. Since the end of 2021, changes have been made at three main points: planning, conduction and post-approval. During planning stage, inspections were transitioned from virtual to in-person, and researchers and inspectors were provided with inspection checklists (preparatory for researchers). Based on inspector feedback, the most game-changing action was providing them with summaries of the work approved in the IACUC protocol. At the post-approval phase, two major changes have been made: tracking the findings in the same electronic system used to manage protocols, and clarifying the language included in the memorandum of action sent to investigators to ensure that the principal investigator and research team understand what the finding was and what the resolution needs to be to prevent future re-occurrences.

Program

Assessment: During the planning phase (PLAN), the focus of improvement included ensuring that the list of spaces managed by investigators was complete. The summaries include procedures in the approved protocol/s. During the inspections (DO), the inspectors were provided the summaries and checklists. During post-inspection, the Committee approves the report, memorandum of actions are generated, and the findings are logged in the system. The Office reviews (CHECK) for example, the types of findings, repeat findings to determine the changes needed before the next inspection cycle starts (ACT). Overall, the changes implemented in the semiannual inspection program generated an increase in investigator engagement and awareness as measured by feedback from the scientific community, and a reduction of repeat findings. The IACUC Office team continues to review the semiannual inspection program at the end of each inspection cycle to determine how the changes were received and if there was a change in the outcome.

Limitations: Limitation of our current program include not having identified the correct issues at the beginning of the inspection cycle, for example, the memorandum of action required generating a monitoring log but did not include the parameters to be monitored. Also, accounting for spaces to be inspected is limited to investigators properly responding to the IACUC office during the planning phase. Another limitation was that investigators did not complete properly the housing section in the smartform.

Discussion: Consistently reviewing findings and pinning areas for improvement allows for prioritization, planning and allocation of resources. The types of findings are presented to the Institutional Official (IO) through the Semiannual Report to the IO, for additional discussion, involvement of other stakeholders (i.e. EHS) and next steps. One lesson learned has been that preparing the inspection summaries provides the inspectors tools to better assess animal care and use. We envision the continuing review of the semiannual inspections as a never-ending process benefiting the research community and animal subjects.