By Mikaela VanMoorleghem, FACT Education and Training Coordinator
Help FACT Design Education Just for YOU
We would like to hear from YOU! FACT wants to provide the education that you need. Please help us develop education that is tailored to fit your needs by filling out this short 3-question survey.
Complete the Education Suggestions survey.
--
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
This workshop on September 12, 2019 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
--
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.
--
Inspector Insight Story: Dr. Abba Zubair Shares his Love of Learning and Friendships to Motivate Inspectors
Dr. Abba Zubair is the Medical Director at Blood and Marrow Transplantation Program of Mayo Clinic and Nemours Children’s Clinic and Wolfson Children’s Hospital located in Jacksonville, Florida. Dr. Zubair has 17 years of education and training including a Medical Degree from Ahmadu Bello University in Zaire, Nigeria. He completed his internship at Murtala Mohammed General Hospital located in Kano, Nigeria where Abba grew up. He was awarded Best Intern for Kano State. Dr. Zubair also earned a PhD. in Tumor Immunology from the University of Sheffield; Post-Doctorial Fellowship and Pathology and Laboratory Residency at the University Of Pennsylvania School Of Medicine; and a Clinical Fellowship in Transfusion Medicine and Masters of Clinical Science at Harvard Medical School. In 2011, Dr. Zubair completed the Quality Academy at the Mayo Clinic. Dr. Zubair has also published over 40 peer-reviewed articles.
Dr. Zubair has been a FACT inspector for 14 years, and has performed 12 Cellular Therapy and 14 Cord Blood Inspections. Dr. Arthur Jones, his chairperson at the time, encouraged him to apply after a successful FACT inspection at their program. Dr. Zubair volunteered as a FACT inspector to keep up-to-date with the FACT Standards. This has certainly proven effective. Dr. Zubair remarks, “Every time I go through the inspection process, it is like going through an entire practice of cell therapy. I get to rehearse and revise each aspect of the program’s activities, both old and new. It helps me remain current because it forces me to read and be up-to-date with current literature in the field.”
“In addition to having greater opportunity to shape the practice of cellular therapy, I benefit by developing friendships with people in my own discipline. There are two kinds of people that I am privileged to meet and establish relationships with including my team members, who join me during the inspection process, and the inspected program’s leadership and supporting staff. We share both professional and personal stories, and truly bond together. I learn about many different cultures around the world which expands my network and connections with people in the field,” states Dr. Zubair.
His experience as an inspector has contributed to improvements at his program in Jacksonville, Florida. “I observe many ways to meet the same FACT Standard and some programs meet the Standards in a better way than my own program. Every experience makes me a better leader and practitioner,” remarks Dr. Zubair.
Dr. Zubair is the current chairperson of the FACT Inspector Advisory Committee, a member of the FACT Board of Directors, and member of the FACT Cellular Therapy Accreditation Committee. His leadership qualities have made a great impact on FACT. Dr. Zubair sees many benefits of serving on FACT Committees and the Board of Directors. In his view, “Being a member of the FACT Board of Directors contributes to my leadership development which in turn strengthens my career. By being an active participant in FACT activities, I have a greater opportunity to shape the practice of cellular therapy. My contributions help generate new FACT Standards that improve the practice and application of cell therapy in medical practice.”
Dr. Zubair states that he believes knowledge is the best gift you can give someone, and the giver and the receiver both feel gratified. “Participating in FACT workshops and webinars provides a gratifying feeling that one is contributing to his own professional community.”
Dr. Zubair encourages others to volunteer as a FACT inspector because he truly believes it improves your program practice of cellular therapy and ultimately benefits the patient. Dr. Zubair’s advice to new inspectors includes:
- Prepare ahead and manage your time during the process.
- Have an open and positive approach to the inspection process.
- Stay focused on the Standards - not your own institutional practice.
- Enjoy the process!
Dr. Zubair was asked about his distinguished accomplishments and he commented, “I am the most proud of being a father of four children. Two have graduated from college, one is working as a software developer, and the other is in Medical School. My two younger children are in elementary school.”
There are many different FACT inspector categories and we encourage anyone interested in training as a FACT Inspector to apply today.
Previous Inspector Insights:
Paul Eldridge, PhD
Michele Sugrue, MS, MT(ASCP)SBB
Patrick Hanley, PhD
Richard Meagher, PhD
Jean Sanders, MD
Leonor Fernando, MD
Frank Smith, MD
Dennis Gastineau, MD
--
Education Events
WMDA-NetCord & FACT Cord Blood Day at 2019 Cord Blood Connect International Congress
September 12, 2019
Miami, FL
The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp track, and a FACT Inspector Training Track. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.
Topics will include
- Global perspectives of the regulation of cord blood banking,
- WMDA serious adverse events and reactions,
- Analysis of CD34+ and CD45+ cells in thawed cord blood samples,
- Analysis of cellular viability in thawed cord blood,
- Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards, and
- Essential Quality Management Principles
The afternoon offers two tracks:
WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.
FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.
This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. We encourage banks to send multiple personnel to be able to attend both the Quality Boot Camp and nominate a member of your team to train to become a FACT inspector! Register before August 31st to receive the special advanced rate!
--
FACT Cellular Therapy Inspection and Accreditation Workshop at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI
This workshop on September 12, 2019 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
- Quality managers
The day includes an applicant track and inspector training track. Inspector trainees are required to attend the inspector orientation track.
View meeting details and register
View meeting agenda
--
ISCT-FACT Quality Boot Camp at the 2019 ISCT North America Meeting
September 12, 2019
Madison, WI
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
--
ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 2
September 25, 2019
Webinar
The second webinar in this two-part webinar series will be on Thursday, September 25, 2019 at 11:00 am ET. Part two includes information from Dr. Joseph Alvarnas from City of Hope. Dr. Alvarnas will give his perspective as a hospital administrator concerning the following:
- Agreements with Manufacturers
- Reimbursement
View meeting details and register
--
Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar
This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.
View meeting details and register