Audit Consequences

High quality data provides the foundation for CIBMTR research. To further support the collection of quality data, CIBMTR implemented consequences for centers that have particularly high error rates or that consistently fail to meet data quality standards. Effective October 1, 2020, audit consequences will be applied when a center has two consecutive audits resulting in a Critical Field Error Rate >3%. The first audits applied to the new policy are audits performed on or after October 1, 2016. The updated policy eliminates the critical field error rate tiers and reduces the number of consecutively failed audits to two for the implementation of audit consequences.

Audit Consequences

Implementation of audit consequences at a center is carefully considered by CIBMTR Leadership and is approved by the Chair of the CIBMTR Advisory Committee. The nature and extent of the audit errors are taken into consideration as well as the potential impact on the quality of research data and reporting functions of the CIBMTR.

For Domestic and International Centers Reporting Transplants with US Donors:

Center Specific Survival Analysis (CSA) Reporting:

• Center Specific Survival Analysis (CSA) is performed to meet federal requirements of the Stem Cell Transplant Outcomes Database (SCTOD). The CSA predominantly uses pre-transplant variables, and the survival outcome. Center’s data will not be included in the Center Specific Outcomes. Implementation of this audit consequence will result in the center’s data being excluded from the calculation of the center’s expected performance. Additionally, these centers will be identified on the Center Specific Outcomes webpage as a center that has not met data quality requirements (relevant only to US centers).
  

Research Studies:

• Data may be quarantined from observational research activities; however, continued involvement in prospective studies will be evaluated
  

Transplant Essential Data and Comprehensive Report Form Reporting:

• If the center is a case report form (CRF) reporting center, the center may be changed to a Transplant Essential Data (TED) reporting only center.
  

CIBMTR Leadership Roles

• Participation in CIBMTR leadership roles or membership in CIBMTR administrative committees may be denied.
  

Access to Unrelated Donors

• If the center is a National Marrow Donor Program (NMDP) center, access to NMDP donors may only be allowed if an accepted corrective action plan (CAP) to improve data quality has been submitted, and CPI is up-to-date or has an approved CAP.
  

For International Centers Not Reporting Transplants with US Donors: CIBMTR membership may be terminated.

Removal of Audit Consequences

If any of the audit consequences outlined above are applied to a center, they will remain in place until the center passes the next regularly scheduled CIBMTR data quality audit in four years. Centers can request an interim audit at the site’s expense; however, the interim audit cannot be conducted until the site has successfully implemented the corrective action plan (CAP), which was agreed at the time consequences were applied, and sufficient data has been submitted to assess the effectiveness of the CAP. In order for the center’s CSA data to be released from consequences the interim audit must include data from the current CSA three-year window applicable at the time the interim audit is performed. In addition, systemic errors identified in CSA data fields as a result of the audit must be corrected for all patients included in the current CSA three-year window.

For centers audited in FY2020, the previous audit consequences policy (effective June 1, 2015) will apply to the audit. Please contact the CIBMTR Audit Team for more information.

Copyright © 2004-2024 The Medical College of Wisconsin, Inc. and NMDP. All Rights Reserved.
CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.