Preparing for the CIBMTR Data Audit

Transcription

1 Preparing for the CIBMTR Data Audit Fiscal Year Prior to Audit Send notice of upcoming audit to Receive additional audit related center materials Send additional audit educational materials to audit contact Schedule dates of audit (3-4 days with 2 auditors, 4-5 with 1 auditor) 8-10 weeks prior to audit 16 recipients are randomly selected for 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 1-2 weeks prior to audit Lead auditor will contact center to confirm logistical details, organization of the week, outstanding questions, and arrival times Medical Director assigned primary audit contact Return Pre-Audit Questionnaire 1 Return Transplant History list 2 Request recipient medical records (inpatient, outpatient, stem cell lab, laboratory, etc) Request access to Electronic Medical Records (EMR) Arrange a workspace for audit team 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.

2 During the CIBMTR Data Audit Day 1 of Audit Arrive at center at pre-determined time and place Be available during the prespecified time and place to welcome auditor(s) to center Hold an initial audit meeting with data management staff to describe the week, confirm logistical details, and explain the audit process Participate in initial audit meeting Describe the layout of the records, ensure proper EMR access General auditing time Last day of Audit Compare data submitted on case report forms to source documentation in medical records Assign discrepancy, omission, missing documentation, or nonaudit errors to audit worksheets based on audit findings 3 Create list to address missing documents or outstanding questions for each recipient audited Meet with co-auditor to discuss initial findings 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 Complete any outstanding data requests Meet with data management staff Participate in closing meeting and medical director to discuss initial audit findings, deficiencies, and outstanding items 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; non-audit error: the auditors would like to change a data field in the database without assigning an error.

3 Following the CIBMTR Data Audit One week following the audit Send out missing documentation checklist 4 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 area 5 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 4 see Appendix A: Missing Documentation Checklist 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 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. 6 see Appendix B: Corrective Action Plan Checklist

4 Appendix A: Missing Documentation Checklist MISSING DOCUMENTATION CHECKLIST XXXXX, CCN XXXXX Audit Date: XXXXX 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. CRID Form Form Version Question Number Question Value Required Action Potential Source Documents If no source documentation is available, provide explanation Performance score pre-preparative regimen 90 confirm value. If source documentation cannot be located, a Pre-transplant work-up note, physician may independently review progress note (approximately one the recipient's record and document a month prior to transplant) score that reflects the performance status just prior to transplant Performance score pre-preparative regimen 70 confirm value. If source documentation cannot be located, a Pre-transplant work-up note, physician may independently review progress note (approximately one the recipient's record and document a month prior to transplant) score that reflects the performance status just prior to transplant Key Field Ethnicity Non- Hispanic Key Field Race White confirm ethnicity. confirm race. Patient demographics, intake forms, progress note Patient demographics, intake forms, progress note Submit the completed information via fax or to: Auditor, Clinical Research Associate Fax: Medical Director Signature: Date: Data Coordinator Signature: Date:

5 Appendix B: Corrective Action Plan Checklist