The CIBMTR Audit Program

Transcription

1 The CIBMTR Audit Program Amy Hays and Krista Sullivan November 7, 2008

2 Objectives Audit rationale and goals Overview of audit program Audit process Audit follow-up

3 Why are audits performed?

4 Audit Rationale Data audits are performed at CIBMTR Transplant Centers as part of the CIBMTR s overall data quality assurance program

5 What are the goals of an audit?

6 Audit Goals Quality/accuracy of research database Identify systematic/non-systematic errors Implement systems to help prevent errors Additional training for transplant centers

7 Why we audit

8 Stem Cell Therapeutic Outcomes Database (SCTOD) CIBMTR awarded contract for SCTOD Component of C. W. Bill Young Cell Transplantation Program Outcomes data collected on all transplant recipients where either donor or recipient resides in U.S. All allogeneic transplants, both related and unrelated

9 CIBMTR Audit Program

10 Overview One comprehensive audit program Each center audited once in 4 year cycle Minimum of 20 eligible recipients; minimum of 16 audited Combination of allogeneic related, allogeneic unrelated, and autologous transplants 3-4 day audit performed by 1-2 auditors

11 Audit Frequency Transplant centers will be audited once in a four year cycle

12 Audit Eligibility Transplant Center Eligibility 20 transplants have been completed Patient Eligibility Pre & Post-TED, and/or Baseline & 100 day follow-up form in database and error-free Minimum of 16 recipient records audited at each transplant center

13 Audit Eligibility, cont. Recipients only audited once Only recipients transplanted since last audit date are eligible For new centers all recipients will be For new centers, all recipients will be eligible

14 Transplant Type Random selection of all transplants Allogeneic, related Allogeneic, unrelated Autologous

15 3-4 day audit Audit Visit 1-2 auditors Place to work All records in one location

16 What happens during the audit?

17 Audit Process Auditors compare data submitted to CIBMTR with source documentation in recipient s medical record and research chart E f d d i th dit Errors found during the audit are reviewed with center staff

18 What we need from you Complete and return all requested information pre-audit Have all charts for each recipient available If electronic record keeping is used: 1 computer per auditor Individual access A space to work Schedule flexibility

19 Error Types No Source Documentation: No supporting documentation to verify data submitted on data collection form Discrepancy: Data found on source documents that differ from data reported on data collection form Omission: Data found on source documents but not reported on data collection form

20 What is considered source documentation? ti

21 Source Document Document in which data are first recorded Permanent record kept by physicians or institutions Used to complete report forms

22 Source Document Examples Progress Notes & Consultations Face Sheet Referring Physician Correspondence Laboratory Reports Medication Administration Records Pathology & Radiology Reports

23 What type of data are audited?

24 Audited Data Forms included but not limited to: Pre-TED and Post-TED Comprehensive Report Forms Disease-specific Forms Infusion Form Death Data Research Database consent form Research Repository consent form

25 Audited Fields Critical Fields Random Fields

26 Critical Fields Audited for each recipient Determined to be most important t for accurate completion of outcome analyses Examples: Karnofsky/Lansky scores Date of diagnosis ANC engraftment data CMV status (recipient)

27 Random Fields Increases audit validity and reliability Questions may vary for each audited d recipient Examples: GVHD prophylaxis drugs Pre-transplant conditioning drug doses Pulmonary toxicities Pre-transplant laboratory results

28 What happens after the audit?

29 Database Changes Auditor makes database changes Auditors provide data manager with list of database changes (ECFs) for all discrepancy and omission errors

30 Audit Report Transplant Centers receive audit report approximately 8-12 weeks after the audit. General observations Discussion Comparison of previous CIBMTR audit results (if applicable) Required Corrective Action Conclusion

31 Current Audit Team Contact Information Deb Christianson Senior Manager, Auditing and Monitoring , Amy Hays Senior Clinical Research Associate , Krista Sullivan Senior Clinical Research Associate , Jody Avery Clinical Research Associate , 617 Kristin Lawman Clinical Research Associate , Lauren Wendland d Clinical Research Associate , [email protected]

32 Questions?