Audit – What to Expect ......

Prior to the audit, 16 transplants are randomly selected from transplants done at the center being audited, within the previous four years. Transplants are eligible for audit if the pre-transplant form (the F2400 and/or F2000) and a 100 day post-transplant form (F2100 or F2450) are completed. All forms associated with the transplant are audited.

Fields that are deemed crucial to outcomes based research, termed critical fields, are audited for each transplant. Examples of critical fields include the product type, diagnosis date, transplant date, Karnofsky/Lansky performance scores, preparative regimen therapies, acute/chronic GVHD, ANC recovery,etc. Additional fields are randomly selected for audit, termed randomfields, to ensure the validity and reliability of the audit results. During the audit, source documentation within the medical records is compared to the data submitted to the observational database for accuracy and errors are assigned for any inconsistencies. In addition to reviewing critical and random data fields, auditors also review the CIBMTR/NMDP Research Database and Research Sample Repository consent form(s) to ensure that proper and full informed consent was given to participate in the database and repository, if applicable.

A Corrective Action Plan is required if a center has a critical field error rate above 3% to address reporting issues found during the audit. Additional issues requiring corrective action include systemic errors in a reporting area, even if the critical field error rate is less than three percent (e.g., the date of diagnosis was wrong on the majority of audited transplants) and any issues found on database or repository sample consent forms.

When preparing for your CIBMTR data audit, please consider the following timeframes:

TIMEPOINT / Data Management Staff Actions
8-10 weeks prior to audit / Return Pre-audit questionnaire (logistical details regarding audit and layout of medical records)
Request recipient medical records (inpatient, outpatient, stem cell lab, laboratory, etc)
Request access to Electronic Medical Records (EMR)
Arrange a workspace for audit team
1-2 weeks prior to audit / If EMR access given, ensure that proper access has been granted (i.e., that the auditor would be able to log-in and audit upon arrival)
Determine that all paper records have arrived and are complete

During the audit, a data manager may expect the following:

TIMEPOINT / Data Management Staff Actions
Day 1 of Audit / Be available during the pre-specified time and place to welcome auditor(s) to center
Participate in initial audit opening meeting
Describe the layout of the records, ensure proper EMR access
General auditing time / Check on auditor(s) every few hours
Be available to answer questions
Triage “medical” questions to clinical staff
Provide troubleshooting help for medical records or EMR navigation
Utilize audit as a training opportunity and ask questions to auditors
Last day of Audit / Complete any outstanding data requests
Participate in closing meeting

Finally, following the audit, a data manager may expect:

TIMEPOINT / Data Management Staff Actions
One week following the audit / Receive missing documentation checklist, retrieve missing source documentation and submit for auditor review.
6 – 8 weeks following the audit / Receive the audit report and Corrective Action Plan Checklist (if applicable)
4 weeks following the audit report / 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

Audit Team:

Deb Christianson, Senior Manager, Auditing and

Ashley Birch, Senior Clinical Research

Edna Eich, Assistant Clinical Research

Kari Gunderson, Clinical Research

Katie Newcomb, Clinical Research

Lauren Wendland,Senior Clinical Research

Matthew Petcoff, Senior Clinical Research

Wendy Elasky, Clinical Research Associate

Will Affield, Clinical Research