FACT aims to provide organizations with valuable resources to aid in achieving and maintaining their accreditation. Our website has useful documents for organizations in all phases of the accreditation process. However, we understand that finding the right information can become overwhelming at times especially for organizations completing their initial application or for personnel new to the accreditation process.
The following overview provides categories, definitions, and the location of important resources. We encourage you to share this information with all personnel involved in your organization’s FACT accreditation process:
The FACT Standards webpage contains links to the most recent versions of the four sets of Standards published by FACT:
- HCT Standards – FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration
- Common Standards – Common Standards for Cellular Therapies
- Immune Effector Standards – Standards for Immune Effector Cells
- Cord Blood Bank Standards – NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration
The pages for each set of Standards contain useful documents relevant to the current editions of FACT Standards, including, but not limited to:
- FACT Standards and Accreditation Manuals
- Summary of Changes, Compare, and Crosswalk documents to identify changes between the previous and current versions of FACT Standards, if applicable.
- Forms used during the compliance application submission, including but not limited to Document Submission Requirements, Educational Activities, Critical Electronic Record Systems, and Facility Site Grids.
Accreditation Process Requirements
The Cellular Therapy Accreditation Process Requirements and Cord Blood Bank Accreditation Process Requirements provide a structured overview of the accreditation process, from completing the Compliance Application to requirements after the on-site inspection.
The Self-Assessment Tools can be used to assess readiness for FACT accreditation. They are located in the Cellular Therapy (CT) and Cord Blood Bank (CB) Libraries, and you will find individual self-assessment tools for each current set of FACT Standards:
- Hematopoietic Cellular Therapy Self-Assessment Tool, Seventh Edition
- Common Standards Self-Assessment Tool, Second Edition
- Immune Effector Cells Self-Assessment Tool, First Edition, Version 1.1
- CB Self-Assessment Tool, Seventh Edition
FACT’s comprehensive, robust training and development program is responsive to the current needs of inspectors and organizations, providing extensive opportunities for all skill levels in all corners of the world. With a focus on real-life examples and practical application, FACT educational sessions provide tools not only for achieving accreditation, but for ensuring quality patient care in accordance with the Standards. The Education and Resources page contains links to upcoming and previously recorded events:
FACT Accreditation Coordinator
FACT’s Accreditation Coordinators provide these and additional FACT resource links in an email sent to organizations at the beginning of the compliance application process. Your accreditation coordinator is available throughout the accreditation process to answer questions via email or phone. The coordinator’s contact information is available in the accreditation portal.
Clinical Outcomes Resource Center
FACT supports blood and marrow transplant (BMT) programs’ efforts to evaluate one-year survival data to improve patient outcomes, advance the field, and maintain payer and public confidence. The Clinical Outcomes Resource Center includes comparative data sources, educational resources, guidelines for corrective action plans (CAP), as well as CAP examples.
Data Management Resource Center
The FACT-CIBMTR Data Audit Committee reviews implementation, adequacy, and effectiveness of corrective action plans with the goal of providing education and assistance to programs throughout the accreditation cycle to achieve quality improvement in data management. The Data Management Resource Center provides CIBMTR and educational resources, guidelines for data management submissions and examples, and audit report examples and templates.
Immune Effector Cells (IEC) Resource Center
FACT is committed to supporting efforts to make quality immune effector cellular therapy accessible to patients much like it did for blood and marrow transplantation and cord blood banking. Several resources are available to assist with understanding immune effector cells and implementing FACT Standards. The Immune Effector Cells (IEC) Resource Center includes resources to assist with understanding immune effector cells and implementing applicable FACT Standards.
Portal Resource Center
The Portal Resource Center provides access to all available resources and training materials for navigating and assisting organizations in completing applications in the portal.
Use the links below to access recent news releases, as well as current and previous volumes of our newsletter:
We hope that you find this information useful as you prepare for your next accreditation cycle. If you have additional suggestions regarding how FACT can better inform organizations of the resources available, please email firstname.lastname@example.org.
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.
To assess compliance with FACT standard B9, the FACT-CIBMTR Data Audit Committee reviews a program’s most recent CIBMTR data audit results including implementation of the corrective action plan (CAP), adequacy of the CAP, and effectiveness of CAP. The committee’s goal is to provide education and assistance to programs throughout the accreditation cycle to achieve quality improvement in data management. At the time of accreditation renewal, the FACT Accreditation Committee assesses the completeness and accuracy of a program’s data management based on the clinical inspector’s report and the report of the FACT-CIBMTR Data Audit Committee.
To assist programs, the FACT-CIBMTR Data Audit Committee developed a Data Management Resources Center. This center contains CIBMTR resources, FACT educational resources, guidelines for data management submissions, templates, and examples.
FACT and CIBMTR are pleased to announce our long-awaited collaborative program of data auditing, designed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited programs. In this collaboration, the joint FACT-CIBMTR Data Audit Committee acknowledges the importance of complete and accurate data for self-assessment in individual hematopoietic cell therapy programs, for research and outcome reporting, and for compliance with FACT-JACIE Standards.
The essential elements of the collaboration are:
- FACT clinical inspectors will no longer perform a data audit at the on-site FACT inspection. This will eliminate the need for data sheets to be prepared only for FACT inspectors, and allow the clinical inspector to focus on adequacy of corrective actions and quality improvement.
- All verification of the accuracy of data against source data will be performed by the CIBMTR audit teams on site according to their current practices and schedules. The current CIBMTR process will not change.
- The FACT-CIBMTR Data Audit Committee will review CIBMTR audit reports and corrective action plans to assess compliance with Standards, implementation of effective corrective action, and improvements.
- Timeliness and completeness of data submission will also be assessed by the Committee using CPI reports from CIBMTR indicating “in good standing”.
On-site, FACT clinical inspectors will have access to this information and CIBMTR reports. The expectation is that clinical inspectors will look at documentation of internal data audits and implementation of corrective action plans (CAP). Where data management is outstanding and there are no corrective action plans to review, the on-site inspectors may ask to see these commendable practices that have resulted in exemplary data management.
Over the years, both FACT inspectors and CIBMTR auditors have continued to observe some programs and personnel who struggle with data accuracy and completeness. We hope that intensified support between inspections, increased emphasis on implementation of CAPs, and follow up to document continuous improvement will assist programs in data management improvement. We also hope the expertise in commendable practices in data management can be more widely shared and adopted where problems are being encountered. Ultimately, successful FACT accreditation will depend on satisfactory progress through these stages.
The following are answers to frequently asked questions. There are still some details to be finalized; however, do not hesitate to contact Heather Conway, Quality Manager in the FACT office (email@example.com or 402-559-1968) if you have concerns or questions.
- When will this start?
The new data audit program will be phased in starting late fall, 2016. Programs submitting an Annual Report or Renewal Application to FACT after this time will find new questions related to data on those reports. Programs that have already submitted renewal applications will notice there is no change in the upcoming inspection. There may be some overlap in processes as reports and applications are not always received in an orderly manner.
- How does this help my program?
FACT-accredited programs will no longer have to prepare data sheets for review by the on-site FACT inspector and will not have a data audit during the on-site FACT inspection. Programs will have the opportunity for enhanced review of corrective action plans and assistance with self-audits and other follow up to ensure compliance and improvements are made following any CIBMTR audit. Programs with outstanding Data Management will have the opportunity to share their expertise with their colleagues in webinars, writing, or other educational forums and be recognized for their accomplishments. On-site clinical inspectors will review internal quality management activities that support improvement in data management. Commendable practices in Data Management will be available to programs and persons to adopt as appropriate to their setting.
- What will this cost us?
There is no added cost to accredited programs for this collaborative process.
- How will the FACT inspectors be trained?
Over the next months, webinar presentations and written materials will be made available to current FACT inspectors. FACT Staff will observe portions of a CIBMTR audit to gain understanding and assist in training. This collaborative program will also be covered at the FACT Inspector Training at Tandem Meetings in February 2017. FACT Coordinators will be trained and will work with each program and inspector to ensure needed information is available.
- If we have had difficulty with our CIBMTR audits, will we lose our accreditation next year?
Not immediately. Initially, centers will be given a grace period to show improvement in critical field and random error rates. During this time, programs will be expected to learn from prior difficult audits, design appropriate investigations, implement effective corrective actions, and follow up to ensure that improvements are sustained. This new process is designed to help you identify the issues that may be barriers to improvement and to develop strategies to be successful. When this process has been fully implemented, FACT-accredited programs will be required to remain in good standing with the CIBMTR data audit program.
- How will the FACT and CIBMTR schedules change to accommodate this program?
There will not be a change in either FACT or CIBMTR schedules for on-site visits. CIBMTR audits will remain every four years as scheduled (unless you request and pay for an interim special audit). You will respond to these audits to the principal auditor as usual and according to the time frames defined by CIBMTR. FACT will receive information from you annually, and will manage the processes on an on-going basis, depending on the needs of the program. FACT on-site inspections will continue to occur every three years.
- Will the CIBMTR auditors know this is happening?
Yes. This process is intended to be completely transparent. Over the next several months, educational presentations will be available for CIBMTR staff related to FACT-JACIE Standards, the FACT accreditation process, and this data management collaboration. The committee charged with implementation of this program is a combined FACT-CIBMTR committee, with representation from both organizations.
- If we submit a corrective action plan to CIBMTR related to consent issues, will FACT review these also?
No. While FACT does have Standards related to informed consent, the consent issues managed by CIBMTR are outside the scope of this data project.
- If we fail a CIBMTR audit, will we have to request and pay for a special interim audit?
Not necessarily. This option is open to you; however, there will be other mechanisms defined through which you should be able to demonstrate appropriate implementation of corrective action and improvements in data management.
- Will we still have to submit a patient accrual list to FACT?
Yes. The patient list is used in many ways by the FACT staff to document new patient numbers, pediatric and adult recipients, and types of transplants.
- What happens if I disagree with the CIBMTR audit results?
There is no change in the processes available through CIBMTR to appeal or further discuss the results, either individually or cumulatively. FACT will not intervene in these processes.