Control the Documents! Revamping a Tct Program's Standard Operating Procedures and Guidelines While Adhering to the Quality Management Plan

Our institute has a long-established Transplant Program which has grown to include cellular therapies. When revamping, it became evident that the number of Standard Operating Procedures (SOP) had grown substantially with the longevity of the program. A goal was established to decrease the number of SOPs resulting in policies that are easily navigated by staff. Our goals were to standardize processes with adults and pediatrics to reduce variability and improve consistency, optimize workflows and resource allocation to enhance efficiency, while prioritizing patient safety and complying with regulatory requirements. We began with a complete review of current SOPs, revealing that the clinical program had 236 SOPs and Guidelines. 12 key SOPs topics were decided on to ensure adherence to our Quality Management Plan and provide quality patient care. A roadmap was created listing current SOPs allowing for easy review and enhanced decision making when converting current SOPs to new ones. The roadmap was utilized to assist in determining which SOPs were no longer needed. Multidisciplinary staff worked together to create new SOPs that merged topics, adults and pediatric material all while reflecting quality patient care. 225 policies were retired, and 19 new policies were created resulting in a total of 21 clinical SOPs and guidelines. Some adjustments were made to the 12 key SOPs topics: adding in new processes and removing topics not maintained by the clinical program. Staff were surveyed to assess the new SOP framework. Results showed that 96% of staff felt the SOPs were easier to navigate, 92% felt that this change had positively affected their practice and helped them have a better understanding of the programs expectations. Since the new SOPs have been implemented, the program has engaged in discussions surrounding policies and staff are more frequently referencing the SOPs.