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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, effective June 1, 2015, CIBMTR implemented consequences for centers that have particularly high error rates or that consistently fail to meet data quality standards. Centers will only be eligible for audit consequences if they fail an audit occurring after the implementation date (after June 1, 2015). Audits prior to the implementation date may be considered when evaluating the center's performance during the past three audits.

Consequences for Centers that Perform Unsatisfactorily on CIBMTR Data Audits

Any audit resulting in Critical Field Error Rate > 8%

  •  Center's data will not be included in the Center Specific Outcomes national average calculation; however, center's data will continue to be measured, and published, against the national average (relevant only to US centers).
  • Center will be identified on the Center Specific Outcomes webpage as a center that has not met data quality requirements (relevant only to US centers).
  • Data will be quarantined from research activities.
  • If a case report form (CRF) reporting center, the data will remain quarantined from research studies until the next scheduled audit date, unless center pays for an additional audit before the next scheduled audit date. A sufficient number of cases must be eligible for audit to validate data quality. The center will continue to receive forms payment for CRF submission.

Two Consecutive Audits resulting in a Critical Field Error Rate > 5% OR; Three Consecutive Audits resulting in a Critical Field Error Rate > 3%

Domestic Centers and International Centers Reporting U.S. Donors:

  • All of the above consequences apply, plus:
    • Center will be changed to a Transplant Essential Data (TED) reporting only center, if they are a CRF reporting center.
    • Center scientists and staff cannot participate in CIBMTR leadership roles or as a member of CIBMTR administrative committees.

If a National Marrow Donor Program (NMDP) center, access to NMDP donors will only be allowed if an accepted corrective action plan to improve data quality has been submitted.

 International Centers Not Reporting U.S. Donors:

  • CIBMTR membership will be terminated.

 

For Cause Audits

Following an audit, a second visit to the center may be necessary for cause. For cause audits are used to address issues that occurred during the audit or as a result of the audit analysis beyond the audit consequences listed above. For cause audits will be discussed with centers on a case-by-case basis.

 

Interim Audits

In cases where a center would like to request an interim audit, a request will be submitted to the CIBMTR. Interim audits may be requested as part of the audit consequences process described above or for training purposes. Goals of interim audits are to document the error rate in the SCTOD, document the error rate at the transplant center, and identify systemic and non-systemic errors. These audits may be different in scope than a typical CIBMTR data audit. Requests for an interim audit are approved on a case-by-case basis. If an interim audit request is approved by the CIBMTR, the audit will be funded by the transplant center requesting the audit. For more information regarding interim audits or to request an interim audit, please contact the Clinical Trials Assistant responsible for transplant center audits - you can find the most current contact information in the Audit Team section of the Audit Guide

 

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


Last Updated: 12/12/2017 2:42 PM
CIBMTR