From Failure to Excellence: A Capa Plan for Improving CIBMTR Data Submission

Abstract

Topic Significance & Study Purpose/Background/Rationale Transplant centers that maintain membership in the Center for International Blood & Marrow Transplantation Research (CIMBTR) are required to submit clinical treatment and patient outcome data. To ensure data integrity, the CIMBTR performs audits of submitted data. The audit benchmark is to have a data reporting error rate that is less than or equal to three percent (≤3%) on Transplant Essential Data (TED) and other selected forms. Adverse consequences are instituted if repeated audit failures occur. Audits at our center in 2007, 2011, and 2015 all exceeded the CIMBTR benchmark (>3%). Corrective action plans were implemented after each audit; however, they were not fully completed or successful. Methods, Intervention, & Analysis After the third audit failure in 2015, a systemic review of the data reporting process was performed by the BMT Clinical Nurse Specialist, Research Nurse and Data Manager. Deficiencies were identified in numerous areas: inadequate staffing for data management, lack of ongoing training/development of the data manager, lack of retention of critical documents in the shadow charts, infrequent consultation with content experts, poor design of physical space for storage, and conversion from a paper-based medical records system to an electronic medical record (EMR). A comprehensive corrective action/preventive action plan (CAPA) was implemented to improve the data reporting process and decrease the error reporting rate. The following actions influenced a reduction in errors: structured shadow charts; additional data management support, expansive training of a new data manager, robust internal audit process, and re-commitment by medical staff as content experts for disease-based and GVHD reporting. Findings & Interpretation Internal audits demonstrated improvement over the next three years. A formal audit by CIMBTR in 2019 demonstrated an overall audit error rate of less than one percent ( Discussion & Implications We found the focused use of TED form instructions, extensive auditing and real time audit feedback to be beneficial. The key factor of success for improvement in the data reporting process and subsequent decreased error rate was collaborative work of multiple team members from multiple disciplines within the transplant program.