Preparing for the Implementation of an Agnis Enabled Data Reporting System and Comprehensive Research Level Data Repository for All Cellular Therapy Patients

Background Dana-Farber Cancer Institute (DFCI) includes both a pediatric and adult transplant program. Though there are many shared resources each program is accredited individually, and they are separate CIBMTR reporting centers. With consistent growth and increasingly demanding reporting requirements, it was determined that one comprehensive internal database that filled the needs of both programs was necessary. Aim/Goals Establish a comprehensive internal database that streamlined multiple unmet needs within two large cellular therapy programs including: • Pre and post therapy case management data • Ability to fulfill all CIBMTR regulatory reporting requirements • A comprehensive research level data repository for all cellular therapy patients Methods • Workgroups were formed to map out the current and future state workflow • Gaps in the workflow and areas of vulnerability and data entry duplication were identified • Testing scripts were developed and data entry into the test environment began • During the testing period end user job aids were created and modified • Entry into historical data systems halted prior to go-live • Electronic and manual data conversion began • Data management staff validated the historical data converted to the new system • End users were trained in preparation of software “go-live” • Full production database was successfully launched • Throughout this process meetings were held between the pediatric and adult joint working group to share best practices and pinpoint opportunities for collaboration. Conclusions • “You don't know what you don't know” • The amount of time dedicated to rolling out the new system and the magnitude of change that accompanied this was far larger than anyone could anticipate • The time commitment required of team members placed significant constraints on completion of their day-to-day responsibilities • Adapting to the new system with confidence and ease took much longer than originally projected • Data managers shifted pre-transplant data entry to real time, allowing case coordinators and clinical staff to access data during the patient's work-up period • A better understanding of the correlation between the pre and post transplant data was realized Next steps • Continue progress on the work flow mapping project to solidify job roles • Maintain system stability by implementing change control policies • Preserve data integrity with newly developed audit and validation guidelines