654 - Do It the Same Way, Every Time

Abstract

Background: In most instances, newly hired data managers (DMs) spend a period of time learning and understanding new procedures and work responsibilities. During this period of transition, errors and inefficiencies commonly occur and have generally become accepted as part of the learning process. Standard Operating Procedures (SOPs) provide a framework to assist current DMs to avoid omitting key tasks necessary to existing routines. SOPs provide structure for current DMs, ease the transition of new DMs, and increase accuracy and proficiency in data collection. SOPs assist DMs complete work tasks by utilizing the motto “do it the same way, every time” which ensures consistency and compliance with good clinical practices. To ensure SOPs remain current and accurate as Electronic Data Capture (EDC) technology changes, all DMs are required to revise and review them on a regular basis. The purpose of this project was to implement an SOP for DMs in a Blood and Marrow Transplant (BMT) program. Method: The lead BMT DM and BMT Program Manager developed an SOP outlining the day-to-day responsibilities for staff performing DM functions. The required BMT SOP format is referenced in the program's SOP 1.0 Preparation and Review of Standard Operating Procedures. The SOP is reviewed regularly by experienced personnel who are affected by the SOP. This includes other DMs, the BMT Program Manager, the BMT Quality Manager, and the BMT Director. When a new DM is being oriented, the lead DM will review the SOP with them. Results: We found that key information must be highlighted to successfully implement an SOP for DMs in a BMT program. This information includes the following: 1) data extraction from the electronic medical record is performed by the DM to complete case report forms; 2) EDC technology utilized by the DM includes the BMT software program, as well as Center for International Blood and Marrow Transplant Research's (CIBMTR) FormsNet3 program; and 3) quality assurance measures utilized by DMs include the internal BMT Data Monitoring Plan which identifies processes for loop closure should error rates exceed 3%, as well as maintaining compliance with CIBMTR's Continuous Process Improvement. The goal in implementing a DM SOP is hoped to result in a significant decrease of error rates as well as enhance the probability of a successful FACT and CIBMTR audit. Conclusion: Developing an SOP for DM is essential for all transplant centers as it promotes organization of the required tasks expected of the DM. Uniform SOPs require ongoing review and updates as applicable to maintain relevance and reflect current practice.