Work

Impact of a Routine Internal Audit of 100-Day TED Track Follow up Forms

Year: 2025

Type: article

Abstract: Background Data accuracy remains the cornerstone of research in hematopoietic cell transplantation (HCT) outcomes. The CIBMTR conducts comprehensive audits at centers every 4 years to ensure data integrity and accuracy. The extended period between CIBMTR audits, changes to reporting guidelines, and data manager turnover may all contribute to reporting errors. Regular auditing within a center serves as an effective tool for detecting and reducing systemic errors. Aim To develop a routine audit process that identifies and corrects systemic errors in reporting and tracks commonly missed questions to facilitate regular review of reporting guidelines. Methods An internal audit process was initiated in July 2023 to review all 100-day 2450 forms completed since the last CIBMTR audit in 2021 (pre-audit) and all future 100-day 2450 forms (post-audit). Each research analyst audited 1-2 forms per week. Audits were completed by a different analyst than the analyst who submitted the form. An audit tool, created from modifying the CIBMTR's Microsoft Excel-based audit form, was used to collect data on each audited form (Figure 1). All errors were addressed with the original analyst and if necessary, presented at team meetings or to the CIBMTR. The data from each audit tool was collated into a second Excel file and used to calculate the results of the audit. Error rate and critical error rate were calculated by dividing total and critical errors by total and critical fields. The average errors per form for each question were calculated by dividing the number of times a question was in error across all forms by the total number of forms audited. This was done for convenience and to favor the most frequently asked questions for reporting review. However, it is not a true error rate per question as not all questions are asked on every form. Results Between July 2023 and August 2024, the BUMC BMT Data Management team audited a total of 237 forms. Of these forms, 145 had been completed and submitted to the CIBMTR prior to the introduction of the audit (pre-audit), and 92 were completed and submitted after (post-audit). Forms submitted after the implementation of the audit showed a 44% reduction in total error rate and a 53% decrease in critical error rate (Figure 2). Significant decrease in errors per form were observed in 9 out of the 10 most missed data fields, 6 of which were critical fields (Figure 3). Conclusion Routinely auditing forms drastically reduced our total and critical error rates. It also greatly decreased the errors per form of nearly all individual fields. The reduction of errors on commonly missed questions is strong evidence of the detection and correction of systemic reporting errors. These corrections are often applicable to many other forms. As a result, we believe that addressing these systemic errors also lowered the error rates in those forms, amplifying the overall positive effect of the audit.

Source: Transplantation and Cellular Therapy

DOI: 10.1016/j.jtct.2025.01.877