Just the FACTs, Volume 7
I am just going to assume that wherever many of you may be, you either are or have been hot and sticky this month. Despite the heat, there are some cool things going on.
First, I recently finished performing my first inspection with the new portal. Both inspectors and programs who have not used it yet are in for a treat. Far faster response times allow you to review much more data in much less time. I chatted with the program’s frontline folks, and they said the uploading was much better as well. I am confident you will have a reaction similar to mine when you are next scheduled to inspect.
Second, in this newsletter you can read about the Clinical Outcomes Committee process (and you might even want to read the whole journal article!). The process has evolved to the point that both the FACT office and the committee are able to give a great deal of guidance to programs as they look to improve their programs and thereby the outcomes for their patients. From humble beginnings, Michael Lill took the committee to a much more sophisticated and helpful level. That evolution continues today.
Join us in this continued progress and support of cellular therapy programs!
Dennis Gastineau, MD
FACT President
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Biology of Blood and Marrow Transplantation Publishes Article on FACT Clinical Outcome Review Process
The journal Biology of Blood and Marrow Transplantation (BBMT) has electronically published the article, Integration of Publicly Reported Center Outcomes into Standards and Accreditation: The FACT Model (LeMaistre et al, 2019). Combining historical information with aggregate data collated from corrective action plans (CAPs) submitted to FACT, the article provides an overview of FACT’s process for evaluating one-year survival and preliminary themes found in CAPs.
The full abstract states:
“The rapid evolution of Blood and Marrow Transplant (BMT), coupled with diverse outcomes associated with heterogeneous groups of patients, led to the formation of two important organizations early in the development of the field: the Center for International Blood and Marrow Transplant Research (CIBMTR) and the Foundation for the Accreditation of Cellular Therapy (FACT). These organizations have addressed two of the nine elements identified by the National Quality Strategy (NQS) [1] for achieving better health care, more affordable care, and healthy people and communities: first, a registry that promotes improvement of care and, second, accreditation based on quality standards. More recently, a federally-mandated database in the United States addresses the third element of the NQS: public reporting of treatment results.
This paper describes the current process by which FACT incorporates patient outcomes reported by the CIBMTR into standards for accreditation, the requirements for accredited programs whose performance is below expected outcomes to maintain accreditation, and preliminary findings in assessing corrective action plans intended to improve outcomes.”
The paper is a useful reference for understanding FACT requirements for evaluating one-year survival, generating ideas for outcome analyses within transplant programs, and understanding the value of setting expectations for patient outcomes within the context of voluntary accreditation programs.
LeMaistre, C.F., Wacker, K., Akard, L., et al. (in press). Integration of publicly reported center outcomes into standards and accreditation: The FACT model. Biology of Blood and Marrow Transplantation. doi: 10.1016/j.bbmt.2019.06.035
FACT Accreditation a Criterion for 2019-2020 Best Children’s Hospitals List
The U.S. News & World Report released the 2018-19 Best Hospitals and Best Children’s Hospitals rankings. The rankings help patients and their families find medical care.
FACT accreditation is used as a criterion that represents high quality, hospital-based care in the cancer specialty. For the Best Children’s Hospitals list, one point was given for the Cancer specialty if a hospital is FACT-accredited as a pediatric or adult service provider for either autologous or allogeneic transplants. Congratulations to these hospitals!
See list of Best Children’s Hospitals
Review ranking methodology
Updated Donor History Questionnaires Now Available
The hematopoietic progenitor cell (HPC), Apheresis and HPC, Marrow Donor History Questionnaire (DHQ) materials were developed by the AABB Interorganizational Uniform Donor History – HPC Task Force to provide establishments with a standardized tool to screen allogeneic HPC donors for communicable disease risk factors in accordance with requirements of the Food and Drug Administration (FDA), AABB, the Foundation for the Accreditation of Cellular Therapy (FACT), and the National Marrow Donor Program (NMDP).
HPC, Apheresis and HPC, Marrow DHQ Version 2.0, June 2019
The HPC, Apheresis and HPC, Marrow Donor History Questionnaire materials have been updated to version 2.0. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.9.
The HPC, Cord Blood DHQ materials were developed by an AABB interorganizational Uniform Donor History – HPC task force to provide establishments with a standardized tool to screen allogeneic as well as related cord blood (HPC, Cord Blood) donors for communicable disease risk factors in accordance with requirements of the Food and Drug Administration (FDA), AABB, Foundation for the Accreditation of Cellular Therapy (FACT), and the National Marrow Donor Program. Allogeneic donors are usually collected at public cord blood banks for use by the general public. Private cord blood banks generally collect related donors for either allogeneic use in a first or second degree relative, or for autologous use. Allogeneic and related cord blood donors are screened for the same risk factors; however, the regulations for using related units allow much more flexibility for distributing the cord blood units for transplantation.
HPC, Cord Blood DHQ Version 1.7, June 2019
The HPC, Cord Donor History Questionnaire materials have been updated to version 1.7. The changes update some FDA guidance document names, dates, and/or website links, located within the DHQ, to the current version. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.6.
Join Your Cord Blood Colleagues at the Second Annual WMDA-NetCord & FACT Cord Blood Day
The World Marrow Donor Association (WMDA) and Foundation for the Accreditation of Cellular Therapy (FACT) are teaming up to host the second annual pre-conference WMDA-NetCord & FACT Cord Blood Day. The workshop incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp, and FACT Inspector Training.
We encourage banks to send multiple personnel to attend the various tracks and enlist a member to become a FACT inspector. Registration fees are waived for FACT inspectors and trainees. Apply to become a FACT inspector!
Join leading cord blood experts from around the world for a day of education and hands-on breakout sessions. Register by August 31st and save $135!
View meeting details and register
View meeting agenda
Agenda Announced for the FACT Cellular Therapy Inspection and Accreditation Workshop at the 2019 ISCT North America Meeting – September 12
This workshop in Madison incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy. Several hot topics include quality management in novel cell therapies, environmental monitoring, and occurrence management. These sessions are designed to help applicants navigate the evolving changes in the field. The agenda also includes training for new inspectors with real-world examples and exercises to guide them through the inspection process. This is a must-see event for the following audiences:
• Blood and marrow transplant (BMT) programs
• Cell processing laboratories
• Physicians, scientists, and principal investigators
• Unit supervisors, laboratory managers, administrators, nurses, and medical technologists
The day includes an applicant track and inspector training track. Inspector trainees are required to attend the inspector orientation track.
We encourage programs to send multiple personnel to attend the various FACT events on September 12. The FACT Cellular Therapy Inspection and Accreditation Workshop is a must-see for cell processing laboratories, physicians, scientists, and principal investigators, and unit supervisors, laboratory managers, administrators, nurses, and medical technologists. The ISCT-FACT Quality Boot Camp, which takes place on the same day as the workshop, is essential for program quality managers.
View meeting details and register
View meeting agenda
View quality boot camp details and register
FACT Announces ISCT-FACT Quality Boot Camp at the 2019 ISCT North America Meeting – September 12
Is your lab FACT accredited or looking to comply with FACT standards? Strengthen your quality management programs through this interactive workshop with FACT experts and real world applications.
Focused on issues identified by FACT compliant programs, these sessions will include activities and discussion regarding Document Control, Risk Assessment in the Processing Laboratory, Supply Qualification, and Audit Plans and Writing the Report. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution. This boot camp is applicable not only to academic labs but also relevant for commercial operations.
We encourage programs to send multiple personnel to attend the various FACT events on September 12. The ISCT-FACT Quality Boot Camp is essential for all quality and laboratory personnel. The FACT Cellular Therapy Inspection and Accreditation Workshop taking place on the same day, is a must-see for cell processing laboratory personnel, physicians, scientists and principal investigators, administrators and nurses.
View details and register now
View preliminary agenda
Accreditation Portal Training On Your Terms
The new Accreditation Portal launched in October 2018, and the number of applications in the new portal are increasing steadily. Prepare for your upcoming application or inspection by reviewing training materials available on demand. To aid in the transition between portals FACT has developed a Portal Resource Center filled with feature-specific How-To Guides and Training Videos. All training materials have been divided by audience. If you are looking for generic guides, proceed into the Applicant Area. If you are looking for inspector specific feature guides, proceed into the Inspector Area.
Training Videos Now Available On Demand:
Each session is 45 min in length and is free of charge.
- How-To: Complete an Annual, Renewal, or Eligibility Application in the Portal (for applicants)
- How-To: Complete a Compliance Application in the Portal (for applicants)
- How-To: Perform an Inspection in the Portal (for inspectors)
Register Now for the ISCT North America 2019 Regional Meeting
Centered on the theme ‘’Engineering the Future of Cell & Gene Therapies’’, the ISCT North America Regional Meeting showcases the latest emerging engineering strategies in regenerative medicine, ‘’off the shelf’’ cell therapy, advanced genome engineering tools and results from the clinic, including products with Fast Track and RMAT designations.
This program is complemented by technical workshops as well as a dedicated Quality & Operations Track addressing regulatory considerations for cell and gene therapies, stability programs, managing growth in the laboratory, CMC strategies for commercial approval, and the value of real world evidence.
Don’t miss this opportunity to connect with leading experts and peers in ‘’Mad City’’ Madison, Wisconsin.
Visit www.isct-na2019.com for the full speaker line-up and program schedule.
Special Registration Offers
- Groups of 5+ registrations receive 25% off
- Student Rate of $50 USD for undergraduate, graduate, medical and pharmacy students. Rate includes 2020 ISCT E-Membership *
- All registered delegates receive 25% off 2020 ISCT E-Membership*
*certain conditions apply, visit the registration page for details
