Preparing for the CIBMTR Data Audit

Preparing for the CIBMTR Data Audit

TIMEPOINT CIBMTR Actions Data Management Staff Actions

Fiscal Year Prior to Audit

Send additional audit educational materials to audit contact

Schedule dates of audit (3-4 days with 2 auditors, 4-5 with 1 auditor)

 Receive additional audit related materials

 Medical Director assigned primary audit contact

8-10 weeks prior to audit

Forms are locked in FormsNet Audit team sends primary audit

contact list of recipients for audit and materials to return

Auditor contacts center for introduction

 Return Pre-Audit Questionnaire1

 Return Transplant History list2

 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

confirm logistical details, organization of the week,

outstanding questions, and arrival times

 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)

 Confirm all paper records requested have arrived and are complete

1

includes questions about: who/where to meet upon arrival, working hours (normally 8am-6pm), EMR access, wireless internet availability, lodging recommendations, and chart organization

2

a complete list of all transplants completed at center since 12/3/07, used to evaluate submitted data to FormsNet. Requires date of transplant, type of transplant, and product type.

During the CIBMTR Data Audit

TIMEPOINT CIBMTR Actions Data Management Staff Actions

Day 1 of Audit

Hold an initial audit meeting with data management staff to describe the week, confirm logistical details, and explain the audit process

 Be available during the pre-specified time and place to welcome auditor(s) to center  Participate in initial audit meeting  Describe the layout of the records,

ensure proper EMR access

General auditing time

report forms to source

documentation in medical records Assign discrepancy, omission, missing documentation, or non-audit errors to non-audit worksheets based on audit findings3

Create list to address missing

documents or outstanding questions for each recipient audited

 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

Meet with data management staff and medical director to discuss initial audit findings, deficiencies, and outstanding items

 Complete any outstanding data requests

 Participate in closing meeting

3

discrepancy error: data in medical record was different than data reported on form; omission error: data in medical record was not reported on form, but should have been; missing documentation error: data could not be verified based upon available medical records;

Following the CIBMTR Data Audit

TIMEPOINT CIBMTR Actions Data Management Staff Actions

One week following the audit

Send out any remaining questions to data management staff or CIBMTR subject expert

Send out Audit Evaluation Survey

 Receive Missing Documentation Checklist, retrieve missing source documentation and submit for auditor review.

 Complete and return Audit Evaluation Survey

Within 6-8 weeks following

the audit

Complete Error Correction Form for each data field change in the FormsNet database

Input ECFs into FormsNet database Analyze errors by form, error type, and reporting area5

Write audit report summarizing findings

Create Corrective Action Plan (CAP)Checklist to address reporting concerns, if applicable

Send audit report to Data Management Staff and Medical Director

4 weeks following the audit

report

Review completed CAP items Follow-up with additional queries

regarding CAP submission

Send certificate of audit completion

 Submit a written plan to address each item on the CAP Checklist, collaborating with data

management staff colleagues and medical director in a timely manner

4

see Appendix A: Missing Documentation Checklist

5

The top 5 reporting areas at centers in FY2012 were: 1) disease status pre- and post-transplant/method of latest disease assessment data fields, 2) acute and/or chronic GHVD data fields, 3) HSCT product and infusion data fields, 4) CIBMTR Research Database and Sample Repository Consent Form data fields, and 5) Karnofsky/Lansky Performance Score data fields.

Appendix A: Missing Documentation Checklist

CRID Form Form Version

Question

Number Question Value Required Action

Potential Source Documents

If no source documentation is available, provide explanation

2400 1 21 Performance score pre-preparative

regimen 90

Locate source documentation to confirm value. If source

documentation cannot be located, a physician may independently review the recipient's record and document a score that reflects the performance status just prior to transplant.

Pre-transplant work-up note, progress note (approximately one month prior to transplant)

2400 2 39 Performance score pre-preparative

regimen 70

Locate source documentation to confirm value. If source

documentation cannot be located, a physician may independently review the recipient's record and document a score that reflects the performance status just prior to transplant.

Pre-transplant work-up note, progress note (approximately one month prior to transplant)

2400 2 Key Field Ethnicity

Non-Hispanic

Locate source documentation to confirm ethnicity.

Patient demographics, intake forms, progress note 2400 2 Key Field Race White Locate source documentation to

confirm race.

Patient demographics, intake forms, progress note

Submit the completed information via fax or e-mail to:

Auditor, Clinical Research Associate

Fax: 612 884 8660 E-mail:

For each item on the list below, provide source documentation to address the missing documentation error. If source documentation does not exist or cannot be located, please provide explanation in box provided. Attach additional sheets as necessary . Return to Auditor by Date.

Audit Date: XXXXX XXXXX, CCN XXXXX

MISSING DOCUMENTATION CHECKLIST

Medical Director Signature: ______________________________________________

Date: _______________________________________________________________

Data Coordinator Signature: _____________________________________________