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.
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