Accreditation Statistics

As of January 2, 2024

Cellular Therapy Entities

  • Accredited: 260
  • Applicants: 26

Cord Blood Banks

  • Accredited: 49
  • Applicants: 10

Congratulations to the following organizations for achieving initial FACT accreditation:

  • Houston Methodist Ann Kimball & John W. Johnson Center for Cellular Therapeutics
  • Blood Assurance
  • American National Red Cross, Salt Lake City, Utah HCT/P Program

A complete list of accredited organizations can be found at www.factglobal.org.

Spotlight on Workforce Development Events Hosted by FACT Principal Members

Posted in :: 2024 Volume 1 :: Friday, January 26th, 2024

Workforce development is a critical need to fill the growing demand for cellular therapy, and the following are two events aimed to train up new professionals.

ASTCT Clinical Research Training Course Applications Open
July 10-13, 2024 in Park City, UT

Apply today to take part in the ASTCT Clinical Research Training Course (CRTC). This four-day program is specifically designed for fellow and junior faculty to advance research protocols. Scholars will have the opportunity to work one-on-one with expert faculty and statisticians through formal presentations, extensive follow-up dialogue and small-group discussion.

Twelve scholars will be selected for this exclusive training course, which has led to academic and career growth for past participants. Applications close March 15, 2024.

Learn more about the curriculum and eligibility requirements on the ASTCT website.

 

ISCT & CMaT Hands-On Laboratory Boot Camp for Cell Therapy Biomanufacturing
April 29-May 3, 2024 at Georgia Institute of Technology

This five-day, hands-on training covers techniques central to cell and gene therapy manufacturing, including aseptic cell culture, small- to large-scale cell manufacturing, product characterization, cell banking and documentation using GLP/GMP-like best practices.

Gain practical knowledge on:

  • The key steps to initiate, maintain, and expand cells in culture.
  • Downstream processes such as harvesting and cryopreservation.
  • How to perform sterility testing and cell product assessments.
  • How to apply GLP and GMP guidelines to document cell products.

Learn more about the course and how to register on the ISCT website. Registration is due March 29, 2024. Discounted rates are available for students and academia. Inquire at Raymond@ISCTGlobal.org.


Register for the 2023 AcCELLerate Forum: Join in Person or Virtually

Posted in :: 2023 Volume 4 :: Thursday, July 27th, 2023

ASTCT™, CIBMTR® and the National Marrow Donor Program®(NMDP)/Be The Match® are excited to announce that registration is now open for the 2023 AcCELLerate Forum!

Participate in person or virtually in impactful conversations regarding patient needs, therapies, and access to cell and gene therapy with advocates, industry representatives, researchers, and providers. Together we will identify needs and opportunities in the field for advocacy and sustainability.

Preliminary agenda topics include:

  • 80/20 Updates
  • Access and Care Disparities in Cellular Therapy
  • Cost-Mitigating Approaches in Cellular Therapy
  • Future Directions in Cellular Therapy
  • Histocompatibility Impact on Safety and Efficacy
  • Logistics for Cell Therapy Delivery in Different Settings
  • Point-of-Care Manufacturing and Production
  • Regulatory Process for Approving New Products

View the up-to-date agenda (subject to change)

Register for the forum

Follow #accellerate23 for updates


Join the 2023 FACT Education Tour!

Posted in :: 2022 Volume 6 :: Tuesday, December 20th, 2022

As the new year approaches, so does our upcoming tour of educational events! We are excited to see you in person or virtually. The following is a list of locations and sessions – which stop will you join?

Register for the FACT Cellular Therapy Accreditation Workshop! 

We invite you to attend the Cellular Therapy Accreditation Workshop in conjunction with the 2023 Tandem Meetings on Tuesday, February 14, from 8:00 am to 5:00 pm, at the World Center Marriott in Orlando, Florida. FACT’s Accreditation Workshops make learning about the accreditation process and related Standards an up-close and personal experience. Accreditation Workshops are collaborative events where you will be able to work through a series of scenario-based case studies supplemented with presentations facilitated by experienced FACT instructors.

The Cellular Therapy Accreditation Workshop provides a high-level overview of topics including requirements and expectations for accreditation, how to position your organization to pursue accreditation, and the most commonly cited Standards. Additional areas of discussion include manufacturer audits and corrective action plans and audits to improve outcomes and data management.

Book your ticket NOW!

FACT Clinical Inspector Training Course 

We invite you to attend the FACT Clinical Inspector Training Course in conjunction with the 2023 Tandem Meetings on Tuesday, February 14, from 8:00 am to 5:00 pm, at the World Center Marriott in Orlando, Florida. FACT’s Inspector Training Courses make learning about the inspection process an up-close and personal experience with practical, hands-on sessions simulating performing an inspection supplemented with presentations facilitated by experienced FACT inspectors.

The FACT Inspector Training Course is for clinical inspector trainees only. Trainees must complete all pre-training course requirements before attending. The training course is a collaborative event where the trainee will work with an experienced FACT inspector to review the entire inspection process from beginning to end.

FACT instructors will educate inspector trainees on the following topics during the inspector training course:

  • Inspection preparation essentials
  • Important technology tools
  • Advance review of documents
  • Clinical program tour
  • Facility documents
  • Patient record review
  • Post-inspection requirements

If you are interested in training as a FACT inspector, please contact Suzanne Birnley at suzanne.birnley@factglobal.org or visit https://www.factglobal.org/inspectors/.

Book your ticket NOW!

Register for the FACT – ASTCT Quality Boot Camp!

We invite you to attend the FACT – ASTCT Quality Boot Camp on Wednesday, February 15, from 8:00 am to 5:00 pm, at the World Center Marriott in Orlando, FL. This is a collaborative event where you will participate in a series of roundtable activities supplemented with presentations facilitated by experienced FACT inspectors and quality personnel.

The theme of the FACT – ASTCT Quality Boot Camp is: Strengthen your Quality Management Program through the Effective Use of Quality Tools. Using the right quality tool can help reduce errors, improve communication, help maintain compliance, and save programs time and resources while improving the overall quality of your program and processes.

During the quality boot camp, FACT instructors will discuss tools and techniques most commonly used in quality management and process improvement including:

  1. SWOT Analysis (Strengths, Weaknesses, Opportunities, and Threats)
  2. Risk Assessment and Failure Mode and Effects Analysis (FMEA)
  3. The Five Whys
  4. Fishbone/Ishikawa Diagram

Book your ticket NOW!

If you cannot join us in Orlando, future stops include:

FACT Virtual Apheresis Collection and Processing Accreditation Workshop

Virtual, Wednesday, April 19, 2023

8:00 am – 5:00 pm CT

Book your ticket now! 

FACT Apheresis Collection Inspector Training Course

Minneapolis, MN April 2023

8:00 am – 5:00 pm CT

Book your ticket now!

FACT Cord Blood Accreditation Workshop

Paris, France, May 30, 2023

8:00 am – 5:00 pm CT

Book your ticket now! 

FACT Cord Blood Inspector Training Course

Paris, France, May 30, 2023

8:00 am – 5:00 pm CT

Book your ticket now! 

FACT Collection, Processing, and Cord Blood Virtual Quality Boot Camp

Virtual, June 23, 2023

8:00 am – 5:00 pm

Book your ticket now!

FACT Accreditation and Quality Principles Workshop

Perth, Australia, August 7, 2023

8:00 am – 5:00 pm

Registration Open Soon!

FACT Processing Inspector Training Course

Houston, TX, September 7, 2023

8:00 am – 5:00 pm

Book your ticket now!


ASTCT Announces Clinical Education Conference for APPs, Nurses, Fellows, and Trainees

Posted in :: 2022 Volume 3 :: Wednesday, August 17th, 2022

The ASTCT Clinical Education Conference, in Orlando, Florida, from October 13-15, will include educational tracks on the foundations of bone marrow transplantation (BMT), adult care, and pediatric care. There will also be exhibitors and product demonstrations.

The event is open to APPs, nurses, trainees, and fellows, and offers 16.5 hours of ACCME and ANCC continuing education. These hours can also be applied to FACT requirements for continuing education.

View the program agenda

Join ASTCT (ASTCT members save 50 USD on registration)


WBMT and ASTCT Announce Webinar on Allogeneic Stem Cell Transplantation for Non-malignant Disorders

Posted in :: 2021 Volume 5 :: Tuesday, October 26th, 2021

The Worldwide Network for Blood and Marrow Transplantation (WBMT) and the American Society for Transplantation and Cellular Therapy (ASTCT) invite you to join the webinar: “Allogeneic Stem Cell Transplantation for Non-malignant Disorders: a Global Perspective”, which will take place on November 24, 2021, from 13:00 to 14:30 CET.

This webinar will summarize the current knowledge and best practices for allogeneic stem cell transplantation (HCT) in patients with non-malignant disorders (NMD). Find the full program here and register via this link.


ASTCT Fundamentals of HCT Training Course Takes Place This Weekend – Registration is Still Open! Course Can be Applied Toward FACT Requirements for Continuing Education

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

FACT encourages you to take advantage of the ASTCT Fundamentals of HCT Training Course. Hosted by one of our parent organizations, this course can be applied toward FACT requirements for continuing education.

The Fundamentals of HCT Training Course is a two-day conference that will be taking place virtually on Saturday, April 24 – Sunday, April 25. This course provides a broad overview and introduction of hematopoietic cell transplantation (HCT), also referred to as blood and marrow transplantation (BMT), as well as cellular immunotherapy (CI). Throughout the lectures, participants will be introduced to numerous aspects of the HCT-CI processes, which are designed to develop or enhance skills required in the management of patients undergoing these procedures. This course incorporates case-based learning to emphasize application of concepts taught through didactic lecture with a strong focus on the pharmacotherapeutic management. Additional details, guidance, and review of clinical materials can also be found in the supplemental electronic handbook. The target audience for this course includes new practitioners, residents, fellows, pharmacists, and nurses or those training in this discipline.

Registration to the virtual conference includes access to the newly revised Fundamentals of HCT eBook. The Fundamentals of HCT eBook provides up-to-date clinical information and covers the entire transplant process from pre-transplant consultation to post-transplant care. This is a great resource!

Registration will close at 4PM CT on Friday, April 23.

Register for the ASTCT Fundamentals of HCT Training Course


FACT, ASTCT, CIBMTR, ISCT, and EBMT Publish Joint Statement Against Racism

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

Racism has no place in our society and profession. The American Society for Transplantation and Cellular Therapy (ASTCT), the Center for International Blood and Marrow Transplant Research (CIBMTR), Foundation for the Accreditation of Cellular Therapy (FACT), the International Society for Cell & Gene Therapy (ISCT), and the European Society for Blood and Marrow Transplantation (EBMT) all find these acts of racism reprehensible and inexcusable. This cannot be ignored any longer by the global community and our respective organizations.

We stand for the advancement of innovative, life-saving medicine. We know the importance of moving the needle forward in order to enact positive, powerful change. When it comes to issues of racism and violence, we realize the need for change, too.

We recognize that racism is an institutional problem in health care, and we are committed to doing our part to bridge that gap. We stand behind those who promote equality, diversity and inclusion. As a health care community, we have to do better—for not only the patients we serve, but the communities they live in as well.

As we work toward improving diversity and denouncing racism in health care and cities around the world, we commit to having the important conversations and supporting critical initiatives within our community that move us toward equality both in the transplantation, cellular and gene therapy workforce and in access to lifesaving therapies.

Please use this resource from the National Museum of African American History & Culture to educate yourself on the importance of talking about race and to find tools on combating racism in your own communities. We ask that you stand with us in denouncing racism and violence.


COVID-19 Update: FACT Accreditation

Posted in :: 2020 Volume 2 :: Monday, March 16th, 2020

 

 

UPDATE: 17 March 2020

Program Directors, Medical Directors, and Quality Managers:

The health and safety of our cellular therapy community continues to be our utmost concern as we all work to mitigate the effect of the COVID-19 pandemic. Due to travel restrictions and CDC recommendations for social distancing, FACT has postponed all scheduled on-site inspections through June 30, 2020.  Rescheduling of these and additional inspections will resume when an appropriate timeline can be determined. We will continue to follow recommendations from the CDC, health officials, and governmental agencies.

There have been many questions related to delays and postponements of on-site inspections due to travel restrictions and recommendations for social distancing.

Effective immediately, the accreditation expiration date for all FACT-accredited organizations will be extended by six months. This includes all clinical hematopoietic cell transplant programs, immune effector cell programs, apheresis centers, laboratory facilities, and cord blood banks, regardless of the current expiration date. This is our current best estimate of an appropriate timeline, however, if circumstances warrant, additional extensions will be implemented. New accreditation certificates will be prepared and distributed to eliminate confusion. The official list of accredited organizations is available at factwebsite.org.

To the extent possible, programs should continue to submit documents and complete Compliance Applications during this period when on-site inspections are not being scheduled. FACT staff are available by phone or email to receive and review this information, and to provide other assistance as needed.

FACT also continues to receive questions related to patients, donors, and other COVID-19 related issues. A Frequently Asked Questions document is available at factwebsite.org.

If you have further questions or concerns, please contact me (402-559-6781; pwarkent@unmc.edu) or the FACT office (402-559-1950; fact@unmc.edu).

Published March 13, 2020

The health and well-being of our cellular therapy community, volunteers, staff, and patients is our utmost concern as new cases of Coronavirus are reported across the US and around the world.  We are continuing to monitor recent developments surrounding the coronavirus (COVID-19) pandemic and are focused on recommendations from the CDC, health officials, and government agencies.

Numerous institutions have implemented travel policies banning both domestic and international travel for their employees, including our FACT inspectorate. Organizations should anticipate postponements and delays in scheduling.  We understand the inconvenience; however, these restrictions represent the best effort to safeguard the health of all involved. We thank you for your understanding and cooperation as we work together to meet the challenges posed by COVID-19. Please be assured that organizations’ accreditation will not lapse due to these circumstances. Additional time will be allotted in the accreditation process.

Our parent society, the American Society for Transplantation and Cellular Therapy (ASTCT) and its Infectious Disease Special Interest Group have developed interim guidelines for COVID-19 management of HCT and cellular therapy patients. These guidelines will be modified as new information becomes available, including more data on epidemiology, clinical outcomes, and efficacy of drug therapies including clinical trials of novel therapeutics.

COVID-19 Interim Patient Care Guidelines 

In addition, FACT global partner The World Marrow Donor Association (WMDA), has provided international blood and tissue donor guidelines and resources for cord blood banking including:

For additional resources, please consult the World Health Organization and the Centers For Disease Control.

If you have questions, or concerns, please contact the FACT office at 402-559-1950 or fact@unmc.edu.


2020 FACT-ASTCT Quality Manager Engagement and Resiliency Survey

Posted in :: 2020 Volume 2 :: Monday, March 16th, 2020

 

Resilience is the ability to recover from or adjust easily to change.  Highly resilient individuals thrive in an environment of change. The Quality Manager’s capacity to be resilient during change, a constant in their work life, is a critical skillset.

Since 2017, the FACT Quality Management Committee and the ASTCT Administrative Directors SIG Quality Working Group have collaborated to identify opportunities to increase the QM’s resiliency During that year, the quality groups developed an anonymous survey to collect data on Quality Manager personal resilience and their perceived benefits of improved resilience. The survey included a validated “Brief Resilience Scale”2 (BRS) which quantitatively measures resilience (1 = low to 5 = high).

To assess possible work stressors, Quality Managers were queried about their responsibilities, program size/complexity, and the nature of interactions with others, e.g. direct supervisors. Respondents were also asked to rank selected resources for increasing resiliency.

Since that initial survey, results have been analyzed and presented as abstracts during TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR.  Additionally, survey findings have been used to identify resources to help, among others, build resilience through improved workplace communications, workload management.   This resources list was uploaded to the FACT website at:  http://www.factwebsite.org/WorkArea/DownloadAsset.aspx?id=1898.

It’s come time to reassess…Quality managers, we need you! 

The committees are reaching out more broadly to cellular therapy program and cord blood bank Quality Managers around the world requesting that you complete a follow-up survey.   This year’s anonymous survey takes approximately 20 minutes to complete.  The survey can be accessed at the web address or by scanning the QRS code included below.

 

https://www.surveymonkey.com/r/FACT-ASTCT2020QMResiliency

 

 

 

The FACT Quality Management Committee and the ASTCT Administrative Directors SIG Quality Working Group plan to analyze information provided by respondents later this year and publish early in 2021.


NEW in 2020! ASTCT Institutional Bulk Membership for Affiliate Members

Posted in :: 2019 Volume 11 :: Monday, November 25th, 2019

ASTCT announced last month that it would be offering a new type of membership: Institutional Affiliate Membership. The new system allows institutions or organizations to purchase memberships as a group, offering a single invoice for multiple affiliate members. This type of membership offers the same benefits as an individual one: Access to the communities, ability to join a SIG or committee, and a subscription to BBMT, to name a few.

Institutional Bulk Membership can be purchased for Affiliate Members in groups of 5 or more individuals. Pricing is set at $140 per person. The Institutional Bulk Membership will go into effect on January 1, 2020. Current members may sign up to convert their membership to an Institutional Bulk Membership. Non-members should complete the form linked below, and ASTCT staff will contact you to finalize your membership.

ASTCT Institutional Bulk Membership details
ASTCT Institutional Membership Form


FACT Education Events

Posted in :: 2019 Volume 10 :: Thursday, October 31st, 2019

FACT – Héma-Québec – Liège Cord Blood Bank Cord Blood Webinar in Support of World Cord Blood Day
November 14, 2019
10:00 am ET, 15:00 GMT, 16:00 CET

In anticipation of World Cord Blood Day, FACT, along with Héma-Québec and Liège Cord Blood Bank, invites you to attend a special Cord Blood webinar on Thursday, November 14, 2019 at 10:00 am ET, 15:00 GMT, and 16:00 CET. The purpose of this webinar is to better understand immunogenetic diversity in registries and cord blood banks, as well as cord blood transplantation and emerging pathogens. This webinar is free of charge and will be presented in French. Slides will be available in both English and French. Topics include:

• Immunogenetic Diversity in Registries and Cord Blood Banks: Dr. Eliane Gluckman
• Cord Blood Transplantation and Emerging Pathogens: Is there reason for concern? Dr. Gilles Delage
• Personal experience from a cord blood recipient

FACT also encourages you to join the Save the Cord Foundation on November 15 for a free live virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood.

Instructions for joining the FACT Webinar on November 14:
1. Log into webinar:
https://factwebsite.webex.com/factwebsite/onstage/g.php?MTID=eda55e6eaf311dc8ea9de4e66281dde89
2. Enter your name and email. Click “Join Now.”
3. If requested, enter the event number: 666 195 982
4. Adjust computer audio to desired volume.
_____________________________________________

French Translation

En préparation de la Journée Mondiale du Sang de Cordon Ombilical, nous vous invitons à participer à un séminaire en ligne spécial qui aura lieu jeudi le 14 Novembre 2019 à 10:00 HNE, 15:00 GMT, and 16:00 CET. L’objectif de ce séminaire est de mieux comprendre la diversité immunogénétique dans les registres et les banques de sang de cordon, ainsi que les agents pathogènes émergents dans le cadre de transplantation. Ce séminaire est gratuit et sera présenté en Français. Les diapositives seront disponibles en français et en anglais.
Liste des sujets:

• Diversité immunogénétique dans les registres et banques de sang de cordon: Dr. Eliane Gluckman
• Transplantation de sang de cordon et pathogènes émergents: est-ce un sujet d’inquiétude? Dr. Gilles Delage
• Expérience personnelle du receveur d’une greffe de sang de cordon.

FACT vous encourage également à vous joindre à la Fondation Save the Cord le 15 Novembre pour une conférence virtuelle gratuite. Le programme comprendra des présentations pour le grand public ainsi que des présentations académiques par des chercheurs et des médecins transplanteurs réputés sur les récentes avancées et thérapies utilisant le sang de cordon ombilical.

1. Se connecter au séminaire:
https://factwebsite.webex.com/factwebsite/onstage/g.php?MTID=eda55e6eaf311dc8ea9de4e66281dde89
2. Saisir votre nom et adresse email. Cliquer “Join Now.”
3. si demandé, entrer le numéro de l’événement: 666 195 982
4. Ajuster le volume de votre ordinateur au niveau désiré.

FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm

We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will clarify the intent of the FACT-JACIE Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.

The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.

Register for the FACT workshop

FACT Cellular Therapy Leadership Course 101 at TCT Meetings
February 18, 2020
8:00 am – 12:00 pm

Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you recognize your leadership skills and acquire new ones that effectively encourage innovation, achieve consensus, build momentum, turn ideas into reality, eliminate distractions and guide a team toward goals.

Register for the FACT Leadership 101 course

FACT Cellular Therapy Advanced Leadership Course 201 at TCT Meetings
February 18, 2020
1:00 pm – 4:30 pm

If you completed FACT’s Cellular Therapy Leadership 101 course and want more, the 201 course is for you.

This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cellular Therapy Leadership 101 course in the morning, or if attended in a previous year, are eligible to register for the 201 course in the afternoon.

Register for the FACT Advanced Leadership 201 course

FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm

Join us for the FACT-ASBMT Quality Boot Camp at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 19 in Orlando, FL.

Focused on issues identified by FACT compliant transplant programs, sessions will include activities and discussion designed to strengthen your quality assurance processes. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution.

Register for the FACT-ASTCT Quality Boot Camp

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 20, 2020
5:00 pm – 7:00 pm

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Orlando, FL at the Orlando World Center Marriott on Thursday, February 20, 2020, from 5:00 pm to 7:00 pm.

Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. This program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.

Register for the FACT Global Affairs session

FACT Cord Blood Inspection & Accreditation Workshop
May 26, 2020
8:00 am – 5:00 pm

This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will clarify the intent of the NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.

The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.

Apply to train as a FACT inspector.  If approved, you can attend the workshop FREE of charge!

Register for the FACT workshop


FACT Education Events

Posted in :: 2019 Volume 9 :: Thursday, September 26th, 2019

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 2
October 9, 2019
Webinar

The second webinar in this two-part series will be on Wednesday, October 9, 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, FACT Standards Development Chair, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.

View meeting details and register

FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm

We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!

FACT will conduct a Cellular Therapy Inspection & Accreditation workshop on February 18, 2019, at the World Center Marriott in Orlando, Florida. This workshop will provide an immersive experience for personnel preparing for the accreditation process and a full day training session for FACT inspector trainees.

Register for the FACT workshop

FACT Cellular Therapy Leadership Course 101 at TCT Meetings
February 18, 2020
8:00 am – 12:00 pm

Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you recognize your leadership skills and acquire new ones that effectively encourage innovation, achieve consensus, build momentum, turn ideas into reality, eliminate distractions and guide a team toward goals.

Register for the FACT Leadership 101 course

FACT Cellular Therapy Advanced Leadership Course 201 at TCT Meetings
February 18, 2020
1:00 pm – 4:30 pm

If you completed FACT’s Cellular Therapy Leadership 101 course and want more, the 201 course is for you.

This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cellular Therapy Leadership 101 course in the morning, or if attended in a previous year, are eligible to register for the 201 course in the afternoon.

Register for the FACT Advanced Leadership 201 course

FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm

Join us for the FACT-ASBMT Quality Boot Camp at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 19 in Orlando, FL.

Focused on issues identified by FACT compliant transplant programs, sessions will include activities and discussion designed to strengthen your quality assurance processes. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution.

Register for the FACT-ASTCT Quality Boot Camp

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 20, 2020
5:00 pm – 7:00 pm

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Orlando, FL at the Orlando World Center Marriott on Thursday, February 20, 2020, from 5:00 pm to 7:00 pm.

Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. This program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.

Register for the FACT Global Affairs session


CMS Releases Final Decision on National Coverage Determination for CAR T-cell Therapy for Cancers

Posted in :: 2019 Volume 8 :: Thursday, August 29th, 2019

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.

View the CMS Decision Memo

View the ASTCT Letter to CMS


Join ASTCT for a Webinar on Consensus Grading for CAR-T

Posted in :: 2019 Volume 8 :: Thursday, August 29th, 2019

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.

Register for webinar


Webinar Series on Implementing Commercial CAR T-cell Products

Posted in :: 2019 Volume 6 :: Thursday, June 13th, 2019

The American Society of Gene & Cell Therapy (ASGCT) has partnered with FACT and the American Society for Transplantation and Cellular Therapy (ASTCT) to bring you the two-part webinar series, “Centers’ Experience with Implementing Commercial CAR T-cell Products.”

The first webinar will be on Thursday, July 25, 2019 at 11:00 am ET.  Part one includes information from two centers regarding their journey to successful implementation of commercialized CAR T-cell products. Clinicians will address the challenges faced during the site on-boarding process, where they are in this process, commonly faced impediments to timely delivery of therapy to patients, and suggestions for centers initiating implementation of commercial CAR T-cell products. Topics in this webinar will include required training, maintenance of chain of custody, and mechanisms for reporting outcomes data. FACT accreditation will also be covered.

Part two will take place in September of 2019 and will include the perspective of a hospital administrator in regard to the following:

  • Agreements with Manufacturers
  • Reimbursement
  • FACT accreditation

View meeting details and register


FACT Events at the 2019 TCT Meetings Were a Success

Posted in :: 2019 Volume 3 :: Thursday, March 14th, 2019

FACT hosted several popular events at the 2019 TCT | Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR in Houston, Texas. Over 150 people joined FACT on February 19 for the Cellular Therapy Inspection and Accreditation Workshop, which included topics such as building quality into clinical immune effector cell programs, risk evaluation and mitigation strategies, using the Tracer Methodology to assess compliance with standards, common citations, reviewing clinical outcomes, and improving data management through follow-up. Also on February 19, FACT hosted two cellular therapy leadership courses for anyone who has, or aspires to, a leadership position in cell therapy.

On February 20, FACT teamed up with ASBMT to host the 4th annual Quality Boot Camp.  Over 130 people participated in the boot camp. This year’s agenda focused on topics such as dashboards and scorecards, record retention, risk assessment, integrating IECs into your HCT program, and evaluating the quality of your program through auditing. Quality experts presented core concepts, led roundtables, and answered questions to help others reach their quality management goals.

Special invitations were extended to all international delegates attending the TCT Meetings for a wine and cheese reception on February 21. The FACT Global Affairs: International Accreditation session provided attendees information about the international accreditation program featuring a stepwise certification approach. The new program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.

On February 21, in the session titled, Quality in HCT: Center-Specific Outcomes, Dr. Dennis Gastineau, FACT President and member of the FACT Clinical Outcomes Improvement Committee, shared guidelines for corrective action plans, and trends noted in the plans reviewed, including causes of death, challenges in root cause analysis, and ideas for improving one-year survival.

On February 22, FACT hosted a social hour for all FACT inspectors and inspector trainees in honor of their dedication and service provided to the cell therapy community. FACT relies on volunteer inspectors and appreciates their superior service, time, and expertise.

In addition to these events, FACT welcomed visitors to its exhibit booth to provide information about accreditation and educational activities.

All events were successful and FACT looks forward to the 2020 Transplantation and Cellular Therapy Meetings in Orlando, Florida!

FACT welcomed 150 attendees to the Cellular Therapy Inspection and Accreditation Workshop at the 2019 TCT Meetings.


Dr. Helen Heslop Receives Lifetime Achievement Award

Posted in :: 2019 Volume 3 :: Thursday, March 14th, 2019

Director of the Center for Cell and Gene Therapy Dr. Helen Heslop was recently recognized with the American Society for Blood and Marrow Transplantation Lifetime Achievement Award at the Transplantation & Cellular Therapy Meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood and Marrow Transplant Research.

The ASBMT Lifetime Achievement Award is presented annually and recognizes an individual who has made continuing contributions to the field of blood and marrow transplantation.

Dr. Heslop is Professor of Pediatrics and Medicine and Director of the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston Methodist Hospital and Texas Children’s Hospital. She serves on the FACT Cellular Therapy Accreditation Committee, the Immune Effector Cellular Therapy Task Force, and various other FACT committees.  Dr. Heslop is a member of the FACT Board of Directors, and served as the President of FACT from 2012 to 2016.

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