FACT and the Center for International Blood and Marrow Transplant Research (CIBMTR) collaborate in a variety of ways to use the power of data to improve patient care within individual transplant programs and the field as a whole. The FACT-CIBMTR Data Audit Committee evaluates corrective action plans (CAPs) for data management in the context of CIBMTR data audit results. The FACT Clinical Outcomes Improvement Committee evaluates CAPs for clinical outcomes, including when risk-adjusted one-year survival does not meet the expected range of the CIBMTR Transplant Center-Specific Survival Report.
Infection data are an important part of both of these efforts. Cause of death is a critical field within CIBMTR’s on-site data audits. Infection is one of the most commonly reported causes of death reported to FACT in clinical outcome CAPs.1 This data is a complex field to report but could hold the key to many ideas to improve patient survival following transplantation.
Fortunately, there is a committee for that. According to the website, cibmtr.org, “The CIBMTR Infection and Immune Reconstitution Working Committee provides scientific oversight for studies about prevention and treatment of post-transplant infections and issues related to recovery of immune function.”
This working committee recently published an update of its challenges and progress in the CIBMTR newsletter. This update provides statistics about infection-related deaths and issues that make the collection of infection data complicated and demanding. The CIBMTR committee also extended its appreciation to data managers for providing the committee with the high-quality data it needs to do its important work. (Please send their thanks to your data management team!) Finally, the committee closed its article with a list of manuscripts that may help your program improve patient survival. We encourage you to take advantage of the knowledge gleaned from the work of this expert committee of physicians and statisticians, made possible by the data you all submit.
1LeMaistre, C.F., Wacker, K.K., Akard, L.P., Al-Homsi, A.S., Gastineau, D.A., Godder, K., Lill, M., Warkentin, P.I. (2019). Integration of Publicly Reported Center Outcomes into Standards and Accreditation: The FACT Model. Biology of Blood and Marrow Transplantation, 25, 2243-2250. https://doi.org/10.1016/j.bbmt.2019.06.035
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.