The CIBMTR Audit Program Amy Hays and Krista Sullivan November 7, 2008
Objectives Audit rationale and goals Overview of audit program Audit process Audit follow-up
Why are audits performed?
Audit Rationale Data audits are performed at CIBMTR Transplant Centers as part of the CIBMTR s overall data quality assurance program
What are the goals of an audit?
Audit Goals Quality/accuracy of research database Identify systematic/non-systematic errors Implement systems to help prevent errors Additional training for transplant centers
Why we audit
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
CIBMTR Audit Program
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
Audit Frequency Transplant centers will be audited once in a four year cycle
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
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
Transplant Type Random selection of all transplants Allogeneic, related Allogeneic, unrelated Autologous
3-4 day audit Audit Visit 1-2 auditors Place to work All records in one location
What happens during the audit?
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
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
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
What is considered source documentation? ti
Source Document Document in which data are first recorded Permanent record kept by physicians or institutions Used to complete report forms
Source Document Examples Progress Notes & Consultations Face Sheet Referring Physician Correspondence Laboratory Reports Medication Administration Records Pathology & Radiology Reports
What type of data are audited?
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
Audited Fields Critical Fields Random Fields
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)
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
What happens after the audit?
Database Changes Auditor makes database changes Auditors provide data manager with list of database changes (ECFs) for all discrepancy and omission errors
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
Current Audit Team Contact Information Deb Christianson Senior Manager, Auditing and Monitoring 612-362-3426, dchristi@nmdp.org Amy Hays Senior Clinical Research Associate 612-884-8559, ahays@nmdp.org Krista Sullivan Senior Clinical Research Associate 612-884-8514, ksulliva@nmdp.org Jody Avery Clinical Research Associate 612-617-8322, 617 javery@nmdp.org Kristin Lawman Clinical Research Associate 612-617-8329, klawman@nmdp.org Lauren Wendland d Clinical Research Associate 612-884-8616, lwendlan@nmdp.org
Questions?