6 - Fostering Culture of Care Through Continuous Learning and Improvement

Background: A pharmaceutical company's global In Vivo Learning Log was developed to foster a learning culture in line with our company values. The Log supports a no-blame, continuous improvement culture whereby the animal user community is able to learn from events and improve the welfare of our animals and people.

Program

Description: QR codes posted throughout the animal facilities allow easy access to an online Microsoft Forms questionnaire for recording submissions into a SharePoint list. The Log is accessible to global animal user community allowing for full transparency across all sites. Submissions, categorized as events or near misses, are evaluated based on the level of impact to animal welfare, overall event impact, and event type. Anonymous submission is the default setting, but individuals also have the option to include their contact information. Root cause analysis (RCA) is then used to better understand what happened, identify the cause(s) and develop corrective action preventative action. The outcome(s) of this process are then shared with the in vivo community. Retrospective review of past events is used to facilitate discussions on RCA proficiency. Additional training sessions were also offered after the initial uptake period to increase awareness and wider participation in RCA.

Program

Assessment: The Log was implemented in a rolling fashion across the five research and development sites with animal facilities in the company during Q1 of 2022. To facilitate transparency at US sites, submissions to the Log trigger notification to the IACUC Chair, attnding veterinarian, and IACUC administrator. This notification ensures the IACUC is aware of all events that may impact animal welfare and allows the committee to determine whether further review is required. A total of 31 submissions were recorded during the initial implementation, and that has grown to 230 submissions after just one year. And while the default setting is anonymous, 87% of submissions are associated with contact information. We have observed an increase in reporting and willingness to report, as well as requests for additional people to be trained in the facilitation of RCA. Implementation of and learnings coming from the Log have benefited our animals and people, as well as having a positive impact within the in vivo community.

Limitations: The Regulatory Manager supporting their designated site reviews every submission from their location and facilitates the RCA process where appropriate. With the increase in reporting over the past year, Regulatory Managers were often challenged with limited time and resources to conduct quality RCA. Furthermore, personnel at facilities with no prior experience in such open reporting mechanisms appeared to be hesitant to submit events through the Log. Additional training has helped address such concern.

Discussion: The Learning Log does not circumvent or preclude IACUC review; it supplements the IACUC process by providing transparency and learnings across the organization. Implementation of this process has also emphasized the value of root cause analysis in preventing recurrence of reported events, and is now considered best practice for IACUC review of animal-related events. Further RCA training will be provided to IACUC members to support this approach.