Which forms are eligible for audit?

See “Form Eligibility” on the Audit Eligibility page.

Are auditors evaluating CPI status?

No. Auditors only evaluate forms that have been submitted as complete to the CIBMTR. A transplant center’s CRC assesses CPI status. However, if a center is struggling with CPI compliance, auditors may be asked to discuss any issues during the audit.

Someone else completed the forms you selected for audit; can you review more of the forms that I completed? Why am I being held accountable for someone else’s work?

All transplants that were performed since the date of the last audit are eligible for audit regardless of any staff changes that have occurred. One of the goals of the audit is to ensure the quality and accuracy of the entire CIBMTR research database.

Forms are randomly selected for audit and, typically, transplants selected for audit are usually distributed across the entire four year audit cycle to establish an error rate for all of the center’s data in the time period.

If there are concerns about the center’s data quality, we suggest the center conduct an internal audit of their data to identify the scope of the issue and develop a plan to proactively update the data, prior to any official audit from the CIBMTR.

Where can I find my previous audit results?

The audit report from the previous audit were emailed to the medical director and primary contact at the time of the previous audit. If you are unable to locate your previous audit results, please contact the clinical trials assistant (contact information on Audit Team page) responsible for transplant center audits.

Will you be reviewing every data field on every form?

No. Two types of fields are selected for audit: critical fields and random fields.

Critical fields are those data fields that have been identified as being essential to the accurate completion of outcomes analyses. These fields will be audited for each recipient, though may differ based on disease and transplant type.

Random fields are additional data fields added to the audit to increase the validity of the audit error rates. At least thirty random fields will be selected per recipient. The random fields that are selected will differ between recipients.

Fields not selected for audit are visible to auditors and may be updated as necessary, though will not count in the error rates. Changes made to these types of fields are called “non-audit changes.”

Are you able to tell me what fields are considered critical?

We are updating the critical field document at this time.

Are you able to tell me which random fields you will be auditing?

No. Random fields differ between recipients. Therefore, it would be very difficult to provide a list of all random fields prior to the audit. Most non-critical data fields are eligible for selection as random fields on forms selected for audit. This increases the reliability and validity of the audit.

How are recipients selected for audit?

For previously audited centers, 16 transplant events are randomly selected from all the transplants that have been submitted to the CIBMTR research database since the date of the last audit for those centers that have been audited previously. For those centers that have never been audited by the CIBMTR, any reported transplants occurring since December 3, 2007 will be eligible for audit.

Audited transplants can include any combination of allogeneic (related and unrelated) and autologous transplants. In addition, if a recipient has had more than one transplant, each transplant that meets the eligibility criteria may be audited.

How is the process different from the last audit?

Depending on when your last audit was performed, parts of the audit process may have changed.

Critical Field Passing Rate
Prior to January 2011, the Critical Field Passing Rate at one time was ≤5%. Since the inception of the federally mandated Stem Cell Therapeutics Outcome Database (SCTOD) act, which is part of the HRSA-funded CW Bill Young Cell Transplantation Program that collects data on all allogeneic hematopoietic cell transplant performed in the US and on transplants done elsewhere using cellular products that originated in the US, the CIBMTR goal has been to improve the quality of the data submitted to the FormsNet database. This data is submitted as part of the SCTOD act and is used to for required center outcomes reporting.

In January 2011, the CIBMTR Advisory Committee, comprised of several transplant center Medical Directors and the CIBMTR Executive staff, held a discussion and determined that the critical field error rate should be lowered to be more consistent with the CIBMTR’s overall data quality standards which ensure the quality of data submitted under the SCTOD contract. Sites were notified of the change in the passing rate during the 2011 Tandem Meeting (held in February) as well as during the audit process itself as each site’s on-site audit was conducted.

Data Change Summary versus Error Correction Forms
In late 2013, the audit program stopped sending individual error correction forms (ECFs) for each change made during the audit and started sending a data change summary document. This document contains a table of all changes made to the database as a result of the audit and includes the CRID, HCT date, form sequence number, form type, visit type, question instance number, question number, question description, current value, correct value, error type assigned, and field type. For more information regarding error type assignment and field type, please see the Audit Process page.

Will I still be able to complete new forms for this patient, even though they are being audited?

Yes. Only forms selected for audit will be locked. Any forms that were not completed prior to forms being locked for audit will still be available for completion. Any new forms submitted as complete between the time forms are locked for audit and the actual audit will not be reviewed during the audit.

Will autologous patients be audited?

Only autologous patients who have signed an IRB or ethics committee approved research database consent form to submit data to the CIBMTR will be audited. During the audit, if auditors discover that an autologous patient never consented to the research database, the auditors will not audit that patient and corrective action will be assigned to address the consent issue.

What if we cannot get electronic record access for the auditors?

If your center uses an electronic medical record (EMR), it is expected that CIBMTR auditors will have access to the EMR. Obtaining access to the complete record is vital for completing the audit in a timely and accurate manner. The data transmission agreement (DTA) that exists between the CIBMTR and all centers that submit data is typically sufficient to attain access to the EMR for auditors. Additionally, the auditors will provide additional information, sign confidentiality agreements, and complete training necessary to obtain access to a center’s EMR.

If a center is not able to provide access to the EMR, the recipient’s entire medical record must be printed from the EMR for auditor review. Once printed, the medical record should be organized into categories chronologically (progress notes, labs, pathology, MARs, chemotherapy orders, platelet transfusions, etc.). This method is not recommended.

Are shadow charts okay for the auditors to use? Are shadow or floor charts needed for the auditors?

If your site keeps shadow charts, they are frequently a helpful outline of the patient’s pre- and post-transplant course. However, the auditors require full access to the recipients’ entire medical record. Shadow charts are not a satisfactory substitution for medical record access.

Last modified: Dec 11, 2017

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