FACT-SBTMO Joint Accreditation Program Launched in Brazil

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. 

Check out the chat between Dr. Nelson Hamerschlak, Dr. Carlos Bachier, and Dr. Phyllis Warkentin on SBTMO's official YouTube. 

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 information to SBTMO - via contato@sbtmo.org.br or FACT - via fact@unmc.edu  

• Transplant Center Name
• Name of Contact Person
• Full address

Development of the Eighth Edition FACT-JACIE Standards

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.

Preparations for the Seventh Edition NetCord-FACT International Cord Blood Standards

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!

View meeting details and register

View meeting agenda

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

FACT Education Events

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

Mikaela VanMoorleghem is an Education and Training Coordinator at the Foundation for the Accreditation of Cellular Therapy. To learn more about FACT, visit its website.

Tags: FACT Update, FACT, accreditation