Leveraging a software application to prepare for regulatory inspection within a hematopoietic cellular therapy program.

Abstract

142 Background: The Sarah Cannon Blood Cancer Network (SCBCN) is comprised of seven Hematopoietic Cellular Therapy (HCT) programs. Regulations require that programs have a consistent and continuous process to identify and measure compliance to ensure standards are met. Every 3 years, programs undergo inspections by the Foundation for the Accreditation of Cellular Therapy (FACT). Historically, programs would prepare for inspections by utilizing paper documents that support and demonstrate compliance with standards. The goal of this project was to develop an electronic platform to manage the FACT inspection. COMAIBA (Compliance Management Actionable Intelligence Business Analytics) was selected as a development partner. Methods: Within our HCT programs, a thorough analysis was performed to determine the current processes by which inspections took place. The FACT assessment questionnaire was reviewed and each standard was evaluated. Quality coordinators within the programs highlighted the key documentation necessary to meet each standard. Results: In collaboration with COMAIBA, a regulatory compliance module was developed which allows the programs to electronically prepare for and manage FACT inspections. There are currently over 1600 questions within the application broken down into clinical, apheresis, marrow collection and processing facility subsections. Programs upload supporting documentation to demonstrate how they comply with each standard. From a programmatic level, administrators and key personnel can, at any time, view the preparation process via a dashboard and view the compliance measures electronically. Conclusions: This electronic solution allows quality teams to proactively prepare for inspections and keep information current and up to date on an ongoing basis. As standards evolve, the design of the COMAIBA application allows versatility in updating and maintaining compliance. COMAIBA is working to utilize this format for other regulatory and accrediting bodies i.e. CoC, UNOS. In addition, allowing the inspectors to view information electronically prior to coming onsite may enhance the inspection process and allow for a more comprehensive review.