What are the date ranges for the patients to be audited?

Any recipient that received a transplant after the date of your last audit will be eligible for audit.

For those centers that have never been audited by the CIBMTR, all transplants since December 3, 2007 or the start date of data entry to the research database (if after the 2007 date) will be eligible for audit.

When will the forms be locked?

The forms that are selected for audit are locked approximately eight weeks prior to the audit.

When will you send me the recipients to be audited?

The list of recipients to be audited will be sent to the primary contact immediately after the forms are locked, eight weeks prior to the audit.

Should ECFs be made for the recipients being audited?

No. Do not create ECFs after the forms are locked prior to the audit. The auditors will review the forms on- site and will make any necessary changes at that time. If, following the audit, changes are identified that need to be made to locked forms, please submit error correction forms (ECFs) with the changes and supporting documentation to CIBMTR Center Support.

When will I know who the auditors will be?

The auditors’ names and contact information will be sent twelve weeks prior to the audit.

What materials do you need us to pull from the Stem Cell Laboratory? If we have the cell counts in the EMR, will that be enough?

The entire stem cell processing record is needed to effectively audit the HCT Infusion Form (Form 2006). This form collects processing information, adverse events, manipulation, donor information, and cell counts; the stem cell processing laboratory’s records are the best source documents for verifying these data fields.

Are you familiar with common medical record systems?

The auditors have experience with many electronic medical record systems from major vendors, although configurations of the systems do vary from center to center. When the auditors arrive on site, they will ask for a brief tour of the medical record from data management staff regarding the location of key source documentation.

Do you need access to any/all of the medical records for the entire audit (including lab charts)?

Yes. The auditors should have access to all medical records for the entire audit. If stem cell product records cannot be removed from the stem cell processing lab, the auditors may schedule a time to visit the stem cell processing lab and review those records.

Are the auditors willing to complete training or sign confidentiality agreements to get access to my site’s medical records?

Yes. The auditors will provide additional information, sign confidentiality agreements, and complete short, remote training required to obtain access to a site’s EMR. Please send any training or confidentiality agreements to the auditors as soon as possible to ensure ample time for completion prior to the audit.

If medical records are at two different sites, will the auditors be traveling to both sites or do you require records to be at one site?

To the extent possible, efforts should be made to ensure that the records are at one site. One exception is the stem cell processing records, which sometimes may not be removed from the stem cell processing lab. In this case, the auditors may schedule a time to visit the stem cell processing lab and review those records.

What sort of room requirements are there?

The room should have enough space for two to three auditors. The room should have electrical outlets for the auditors’ computers.

Can the auditors use only one computer (if electronic records)?

No. Auditors must audit records concurrently in order to finish the audit in a timely manner and therefore will need access to electronic records at the same time on two computers unless the EMR is able to accessed from the auditors’ computers.

Last modified: Sep 15, 2022


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