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CIBMTR Audit Program

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Audit Results

​Passing Criteria

The CIBMTR has established an acceptable error rate of less than or equal to 3% in critical data fields. Critical fields have been identified as being essential for outcome analyses. Therefore, it is imperative that these data fields are reported accurately. Based on the center’s critical field error rate, a center will: 1) pass, 2) pass with required corrective action, or 3) fail with required corrective action. See the “Corrective Action” section below for more information on this subject.

 

Audit Report

Transplant centers will receive a detailed audit report evaluating the results of the audit. The report is sent to the site Medical Director, primary data management audit contact, and CIBMTR leadership. The report includes:

  • A statement of whether the center passed the audit, passed the audit with corrective action, or failed the audit. Passing the audit requires a critical data field error rate less than or equal to 3%.
  • An overall, critical, and random data field error rate & error rates by form
  • A data management discussion section reviewing grouped critical field errors, termed "reporting areas." Examples of reporting areas include disease status pre- and post-transplant data fields, HCT product and infusion data fields, Karnofsky/Lansky Performance Scores, acute and/or chronic GVHD data fields.
  • A comparison to the center's previous audit, if applicable.
  • A section that itemizes and discusses any issues on IRB-approved CIBMTR Research Database or Research Sample Repository consent forms.

A summary of all changes made to the database as a result of the audit (Data Change Summary) will be sent with the audit report with the Audit Results Letter.

 

Corrective Action and Audit Completion

Centers may be required to submit a Corrective Action Plan (CAP) in response to errors identified during the audit. The submission of a CAP will be requested to address any of the following concerns:

  • A critical field error rate greater than 3.0%.
  • Systemic errors are identified in a single reporting area, even if the critical field error rate is less than or equal to 3.0%.
  • Issues with CIBMTR Research Database or Research Sample Repository consent forms.
  • Outstanding missing documentation.

If systemic issues are identified, corrective action will be required to address the issue on all submitted recipients, not just those identified during the audit.

A Corrective Action Plan checklist which details the issue, the requested corrective action, and signature lines for data management staff and the Medical Director are included with the audit report. Data management staff should submit a written plan to address each item on the Corrective Action Plan Checklist, collaborating with data management staff colleagues and Medical Director in a timely manner. Once returned, the CAP is reviewed and evaluated to ensure that each item was addressed appropriately. As part of the FACT/CIBMTR collaboration, FACT inspectors will evaluate successful implementation of CIBMTR corrective action requirements.

Once each of the items on the Corrective Action Plan checklist has been addressed, the audit process is considered complete and a certificate of completion is sent to the transplant center. If a CAP is unsatisfactory, auditors will request additional information from the site. The effectiveness of any corrective actions will be evaluated during the next audit.

If no corrective action is required, the transplant center will receive an audit completion certificate when the report is sent.

 

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.


 

 

 

For more detailed information about the audit process, a list of General FAQs, and audit contact information, please see the Audit Guide.


Last Updated: 2/12/2020 3:38 PM
CIBMTR