Just the FACTs, Volume 8
This summer has been busy with travel! FACT staff made a trip to Brazil to launch the FACT and Brazilian Society of Bone Marrow Transplant (SBTMO) Joint Accreditation Program, and also found their way to Barcelona, Spain where the FACT-JACIE Standards Steering Committee initiated the development of the Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Soon, FACT representatives will land in Paraguay for the Worldwide Network for Blood & Marrow Transplantation (WBMT) meeting where they will conduct a half-day work workshop on FACT-JACIE accreditation.
Articles in this issue include:
- CMS Releases Final Decision on National Coverage Determination for CAR T-cell Therapy for Cancers
- FACT-SBTMO Joint Accreditation Program Launched in Brazil
- Development of the Eighth Edition FACT-JACIE Standards
- Preparations for the Seventh Edition NetCord-FACT International Cord Blood Standards
- FACT Accreditation Used as Criterion in Best Hospitals List
- In Memory of Dr. John Hansen
- Join ASTCT for a Webinar on Consensus Grading for CAR-T
- FACT Education Events
I hope you all had a wonderful summer and I look forward to seeing many of you throughout the rest of 2019!
Sincerely,
Dennis Gastineau, MD
FACT President
CMS Releases Final Decision on National Coverage Determination for CAR T-cell Therapy for Cancers
The United States Centers for Medicare & Medicaid Services (CMS) finalized its National Coverage Determination (NCD) for CAR T-cell Therapy for Cancers on August 7, 2019. Among other changes, the decision no longer requires Coverage with Evidence Development (CED) and now allows coverage for indications on FDA-approved indications and uses recommended by a citation in CMS-approved compendia. FACT appreciates CMS’s consideration of our comments and of those submitted by several of our stakeholders. Many of the changes will promote patient access to CAR T-cell therapy.
The American Society for Transplantation and Cellular Therapy (ASTCT), one of FACT’s parent organizations, indicated that it is also pleased with many of the changes from the proposed decision memo and responded with a comment letter about suggestions for continuing to improve reimbursement for this therapy.
We believe in the utility of FACT Standards to promote safety and efficacy of CAR T-cell therapies; increase harmonization across requirements of regulators, payers, and manufacturers; and reduce burden on hospitals. We will continue to work with all of these stakeholders to do our part to promote patient access.
FACT-SBTMO Joint Accreditation Program Launched in Brazil
SBTMO President, Dr. Nelson Hamerschlak, pictured with Dr. Phyllis Warkentin and Dr. Carlos Bachier.
Approximately 70 representatives of bone marrow transplant centers attended the FACT-SBTMO Accreditation Program Workshop on July 31, 2019; an initiative that is the result of the partnership between the Brazilian Society of Bone Marrow Transplant (SBTMO) and the Foundation for the Accreditation of Cellular Therapy.
The meeting clarified the requirements and the operational dynamics of the accreditation process for Brazilian cell therapy transplant centers.
As Carlos Bachier and Phyllis Warkentin of the FACT Global Accreditation Committee have reported, it may seem complex at first, but it is certainly possible to complete each of the gradual steps in the process toward accreditation.
The accreditation will be valid for 3 years. The estimated time to complete the initial certification cycle is 2 years. The program was designed taking into account the structure and operations of the Brazilian centers, including the interest of the 39 TMO centers that responded to the SBTMO Online Survey distributed to gather the demographics of the national transplant programs.
For over 20 years, FACT has established international standards for the collection, processing and administration of hematopoietic cell therapy products. It is worth mentioning that Brazil was the pioneer in Latin America when in 2012 Hospital Israelita Albert Einstein (HIAE) was awarded FACT accreditation. Albert Einstein has been re-accredited in 2015 and 2018.
In addition to Brazil, FACT has accredited 255 cell therapy programs in 6 countries: Canada, Mexico, New Zealand, Australia, Singapore, United States.
It is noteworthy that FACT accreditation is based on the FACT-JACIE (The Joint Accreditation Committee ISCT-Europe & EBMT) Standards, which is Europe’s only official accreditation body in the field of HSCT and cell therapy.
Expression of Interest
If you wish to express your interest in joining the accreditation program in Brazil, please send the following data to SBTMO – via contato@sbtmo.org.br or FACT – via fact@unmc.edu
Data
- Transplant Center Name
- Name of Contact Person
- Full address
Put in the subject line of the message : “FACT-SBTMO Accreditation”
Development of the Eighth Edition FACT-JACIE Standards
By: Andra Moehring, MHA, FACT Standards Development Manager
The FACT-JACIE Standards Steering Committee initiated the development of the Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration this summer.
On July 2, 2019, FACT-JACIE Steering Committee members met in Barcelona, Spain to review the Standards Development process and timeline, and discuss specific issues that require review and consideration for this edition.
During the meeting, the committee reviewed and discussed feedback submitted by our colleagues via the FACT-JACIE Standards survey that was distributed in April 2019. FACT and JACIE appreciate the time and effort that went into providing feedback to help us improve our Standards. The survey was completed by 106 total respondents, in 19 different countries, who provided over 800 comments. Thank you for your feedback!
The subcommittees will begin their review next month, and will provide our colleagues with another opportunity to submit feedback during the public comment period scheduled for April 2020.
Final publication of the Eighth Edition FACT-JACIE International Standards is scheduled for March 2021.
FACT- JACIE Standards Steering Committee in Barcelona, Spain, on July 2, 2019 preparing for the development of the Eighth Edition Standards.
Preparations for the Seventh Edition NetCord-FACT International Cord Blood Standards
By: Andra Moehring, MHA, FACT Standards Development Manager
FACT is preparing for the publication of the Seventh Edition NetCord-FACT International Cord Blood Standards and we are here to help you do the same! The following upcoming events will provide information regarding changes to the Standards and how to comply:
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!
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
The Seventh Edition NetCord-FACT International Cord Blood Standards for Collection, Banking, and Release for Administration will be published on October 15, 2019 and will become effective on January 15, 2020.
FACT Accreditation Used as Criterion in Best Hospitals List
U.S. News and World Report released its 2019-2020 Best Hospitals List, and FACT accreditation was again used as a ranking criterion for the cancer specialty. Since 2007, accredited programs receive a point value based on their accreditation. One point was given if accreditation was only for autologous transplants, and two points were given if accreditation was for allogeneic transplants. All 50 hospitals with rankings in the cancer specialty have programs that are FACT-accredited. Congratulations to these programs!
View the list of best hospitals in the cancer specialty
In Memory of Dr. John Hansen
By Andra Moehring, MHA, FACT Standards Development Manager
Dr. John Hansen has made major contributions to the development of bone marrow transplantation, which has now offered the chance for a cure to over a million people worldwide.
Photo by Robert Hood / Fred Hutch
Dr. John Hansen, physician scientist and emeritus faculty member of Fred Hutchinson Cancer Research Center, died of pancreatic cancer on July 31, 2019. Dr. Hansen was well known for his innumerable contributions to the field of blood and marrow transplantation, his pioneering research and discoveries in Immunogenetics, his pivotal role in establishment of global registries of potential unrelated stem cell donors, and his generosity in mentoring others.
Dr. Hansen was also a founding member of the volunteer expert panel that became FACT’s Histocompatibility Committee, responsible for development of the guidelines by which to measure organizations that accredit histocompatibility services in hematopoietic cellular therapy. FACT accreditation of clinical transplant programs and cord blood banks requires histocompatibility laboratories to meet appropriate standards. As FACT extends accreditation services globally, these histocompatibility guidelines are critical to advancing quality care for patients. Dr. Hansen’s foundational contributions and willingness to share his expertise will continue to impact patients and the cellular therapy field worldwide.
Join ASTCT for a Webinar on Consensus Grading for CAR-T
CAR T cell therapy is considered one of the most promising new treatments for patients battling relapsed and refractory leukemia, lymphoma and other forms of cancer. The assessment and grading of CRS and ICANS have varied considerably across clinical trials, academic studies, and commercial products, which has made it difficult to compare the safety and measure toxicity across all of these settings. This also has hindered the ability of researchers to develop the best strategies to manage these toxicities. Join Drs. Stephan Grupp and Sattva Neelapu on October 2, 2019, at 2:30 pm CT, for an ASTCT webinar discussing the new definitions and grading for CRS and neurotoxicity that more accurately categorize the severity of these toxicities.
FACT Education Events
WMDA-NetCord & FACT Cord Blood Day
September 12, 2019
Miami Florida
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. We look forward to seeing you in Miami!
View meeting details and register
View meeting agenda
FACT Events at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI
FACT is hosting two events on pre-conference day at the ISCT North American 2019 Regional Meeting. On September 12, colleagues have the opportunity to attend the FACT Cellular Therapy Inspection and Accreditation Workshop, or the ISCT – FACT Quality Boot Camp.
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 workshop meeting details and register
View workshop agenda
View boot camp details and register now
View boot camp 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 in regard to 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
