Data Audit Policy Update

Posted in :: 2019 Volume 10 :: Thursday, October 31st, 2019

FACT-JACIE Standards for Hematopoietic Cellular Therapy require that accredited clinical programs keep complete and accurate data, including all data necessary to complete the Transplant Essential Data Forms of the CIBMTR or the Minimum Essential Data-A forms of EBMT.

In August 2016, FACT and CIBMTR announced their collaborative program of data auditing, designed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited programs. Over the past three years, the FACT-CIBMTR Data Audit Committee has reviewed corrective action plans related to data accuracy and has provided individual assistance to programs for performing data audits and for reporting and submitting audit results. In addition, the Committee developed the Data Management Resource Center to assist all programs and to ensure that education offered by FACT and CIBMTR is readily available.

Recently, FACT announced a revision to its Data Audit Policy to link CIBMTR Data Audit results to FACT accreditation. To be compliant with Standard B9, a clinical program will be expected to meet the CIBMTR passing benchmark of ≤ 3.0% critical field error rate at its on-site CIBMTR Data Audit.

  • Programs with >3.0% critical field error rate will have failed the CIBMTR Data Audit and be required to submit corrective action plans and follow up reports to the FACT-CIBMTR Data Audit Committee to maintain their FACT Accreditation.
  • Following a second consecutive CIBMTR Data Audit failure, the program’s FACT accreditation may be suspended. Reaccreditation will require a passing CIBMTR Data Audit and may require a reinspection by FACT.
  • No program’s accreditation will be immediately impacted. The FACT Accreditation Data Audit Consequences Policy began October 1, 2019.  Results from CIBMTR data audits performed after October 1, 2016 apply to this policy.
  • Each FACT-accredited Clinical Program has been individually notified of its current status, including guidance for required actions.
  • Refer to the FACT Data Audit Policy  for additional details.

This change coincides with the CIBMTR Audit Policy, and aligns FACT and CIBMTR consequences according to the same timeline. The CIBMTR processes for submission of corrective action plans addressing systemic errors, milestone report requirements, and management of informed consent issues will not change.

Complete and accurate data are critical for self-assessment in individual cellular therapy programs, for research and outcomes reporting, and for compliance with FACT-JACIE Standards. Improvements in data accuracy will enhance the quality of clinical care and laboratory services for the benefit of patients. FACT and CIBMTR are committed to working with programs to improve data accuracy through internal audits and corrective action plans as appropriate to successfully complete CIBMTR audits and maintain continuous FACT accreditation.