Accreditation Statistics

As of May 2, 2024

Cellular Therapy Entities

  • Accredited: 262
  • Applicants: 30

Cord Blood Banks

  • Accredited: 48
  • Applicants: 10

 

Initial Accreditations

  • Abu Dhabi Stem Cell Center, Abu Dhabi, United Arab Emirates | Cellular Therapy Product Processing with Minimal Manipulation
  • CHN - Complexo Hospitalar de Niterói, Rio de Janeiro, Brazil | Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Marrow and  Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation

     

A complete list of accredited organizations can be found at https://accredited.factglobal.org/.

Tata Medical Center is First Cellular Therapy Program in India to Earn FACT Accreditation

Posted in :: 2024 Volume 2 :: Tuesday, April 9th, 2024

FACT is pleased to announce that Tata Medical Center in Kolkata, India, received internationally recognized FACT accreditation. Directed by Jeevan Kumar, MD, MBBS, it is the first and only cellular therapy program in India to be recognized by FACT. Dr. Mammen Chandy, former Director of Tata Medical Center, committed years ago to enhancing quality throughout the program and attaining FACT accreditation. The program achieved accreditation February 29, 2024, for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation. Tata Medical Center is part of the FACT India Working Group, led by Nadim Mahmud, MD, PhD.

Dr. Mahmud states, “This marks a significant milestone for the FACT India Working Group and for India. We are encouraged by Tata Medical Center’s achievement in obtaining FACT accreditation, which demonstrates a commitment to quality and ensuring the best possible outcomes for patients undergoing stem cell transplants. We believe that other transplant centers in India will recognize the benefits and join us in pursuing FACT accreditation. I am indebted to Professor Mammen Chandy from Tata Medical Center for his wisdom in facilitating the process and advocating the need for FACT accreditation, not only for Tata Medical Center in Kolkata, but for all BMT centers in India.”

Dr. Kumar notes, “The FACT accreditation cements our commitment to provide the highest quality of patient care. It is recognition of our founding director’s vision to establish evidence based best practices in cellular therapy at Tata Medical Center. The unwavering support of the administration and our team’s hard work has resulted in successfully completing the accreditation process. It marks the inclusion of the first Indian center into the global consortium of accredited institutions. Even though the accreditation process was rigorous, it helped us to consolidate our strengths and identify opportunities for improvement. The FACT team has continuously supported us in this endeavor. The on-site inspection served as a peer-review by international experts and boosted the morale of our team members. As an active member of the FACT India Working Group, we are happy to share our experiences and quality improvement initiatives with like-minded centers in India and abroad.”

Dr. Phyllis Warkentin, FACT Chief Medical Officer, states, “Tata Medical Center’s achievement of FACT accreditation in Hematopoietic Cell Transplantation and Cellular Therapy as the first program in India to reach this milestone demonstrates its commitment to providing quality care for the patients it serves. FACT commends the leadership and staff of Tata Medical Center for their dedication and resilience in pursuit of accreditation, their contributions to the FACT India Working Group, and their leadership in the field and the region.”


FACT India Working Group

Posted in :: 2024 Volume 2 :: Tuesday, April 9th, 2024

By Nadim Mahmud, MD, PhD
University of Illinois College of Medicine, Chicago

India has a population of more than 1.4 billion, and about 105 bone marrow transplant (BMT) centers performing approximately 2,000 stem cell transplants annually. In North America, Europe, or Australia there are more than 300 transplants performed per 10 million people. Based on this transplant utilization number, India may need to perform about an estimated 39,000 transplants per year. Since only 2,000 transplants are performed, a gap of 37,000 transplants per year exists. Thus, there remains a huge gap in capacity to perform BMT for its population need. On the other hand, even for 105 existing BMT centers, there is a notable lack of trained transplant physicians, nurses, and quality managers.

The first BMT center in Vellore was established in 1986 (Christian Medical College), yet there had been no FACT-accredited transplant centers in India until recently. During one of my visits to the Haematocon (Indian Society of Haematology & Blood Transfusion) meeting in Bangalore, I had an informal meeting with Dr. Mammen Chandy. Dr. Mammen is also the pioneer in establishing the first BMT center in India. This conversation led to an informal visit to Tata Medical Transplant Center in Kolkata in 2017.

Since 2012, FACT has attempted to actively engage with transplant centers in India. FACT offered a workshop during the Asia-Pacific Blood and Marrow Transplantation Group (APBMT) Congress held in Hyderabad, India , outlining the benefits and scope of FACT accreditation. The FACT India Working Group (IWG) was formed in 2018 to encourage BMT centers to attempt to take part in the FACT accreditation process. A broad group of ten participating centers from various parts of India is participating in the IWG designed to address the regional needs of the country. The centers are completing self-assessments of their programs to identify any potential barriers to compliance with FACT Standards, clarify the intent of requirements, and assess their readiness for accreditation. Tata Medical Center (Kolkata) is one of the active participants in IWG.

Having BMT programs accredited by organizations like FACT would facilitate a standard quality management program outlining policies, procedures, and deviation management. Such awareness can greatly improve patient care and transplant outcomes. Having a stringent quality management program and data sharing among peer transplant groups would enable establishing outcome benchmarks to stride towards overcoming barriers.

This year, the Tata Medical Center in Kolkata is the first ever BMT center in India to be awarded FACT accreditation. This is a huge milestone for having a BMT program with an established quality management program.  There are only two other FACT-accredited BMT centers in Asia: one in Singapore and one in Saudi Arabia. As the FACT IWG chair, along with the working group’s staff liaison Sarah-Litel Smith (FACT Accreditation Supervisor) and the FACT office, we are encouraged to see interest in achieving FACT accreditation and thus fulfilling a commitment to patients undergoing stem cell transplants anywhere to have the best outcomes possible. We firmly believe that other transplant centers in India will see the benefits and join this endeavor to achieve FACT accreditation.

This was only possible due to the tremendous support and faith from the FACT Chief Operating Officer, Ms. Linda Miller, and Chief Medical Officer, Dr. Phyllis Warkentin, for IWG to carry on despite slow progress at the beginning. Personally, I am indebted to Professor Mammen Chandy from Tata Medical Center for his wisdom facilitating the process and advocating the need for FACT accreditation not only for Tata Medical Center but for all BMT centers in India. FACT is also grateful to the organizers of Haematocon, the annual conference of the Indian Society of Haematology and Blood Transfusion (ISHBT), for facilitating FACT Quality workshops over the years.


ISCT Releases Second Global Regulatory Report

Posted in :: 2024 Volume 2 :: Tuesday, April 9th, 2024

ISCT published its second Global Regulatory Report, which covers Quarter 3 and Quarter 4 of 2023. This report is developed by ISCT in partnership with Citeline, and provides an overview of the cell and gene therapy regulatory landscape, including pipeline, late-stage (Phase III and pre-registration), and approved products, covering cell, genetically modified cell, and gene therapies.

Highlights of the current report include:

  • 2,960 therapies in the global pipeline (2% increase from H1 2023)
  • 80 products are under regulatory review globally of which 71 products are in Phase III clinical trials
  • 96 products approved globally (9% increase from H1 2023)
  • 6 products received their first approvals globally including.
    • Elevydis (delandistrogene moxeparvovec-rokl)
    • Lantidra (donislecel)
    • Fucaso® (equecabtagene autoleucel)
    • CNCT19 (inaticabtagene autoleucel)
    • Casgevy™ (exagamglogene autotemcel)
    • Lyfgenia™ (lovotibeglogene autotemcel)
  • Key Global Legislative/Framework Changes by US FDA, EMA, ICH, and NZ Ministry of Environment

We encourage personnel at accredited programs to review the report to learn more about what occurred in late 2023 and what is to come.

Learn more and access the Global Regulatory Report


Year 2023 Was a Year Full of FACT Accomplishments

Posted in :: 2023 Volume 7 :: Monday, December 11th, 2023

FACT is celebrating a wonderful 2023! Below is a listing of many accomplishments over the past year. These successes are only possible with the volunteer inspectors and committees and the cellular therapy and cord blood banking organizations who pursue and maintain FACT accreditation. The entire FACT community should all be proud of everything we accomplished together! 

FACT Standards Development Committees Update Several Sets of Standards  

The FACT Standards Committees have been actively updating all four sets of Standards over the past year. The following are the major accomplishments:  

  • December 2022: The third edition of the FACT Common Standards for Cellular Therapies was published, accompanied by the first Accreditation Manual for this set of Standards.  
  • March 2023: A survey was distributed to the FACT community to request feedback on the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration in advance of the ninth edition revisions.  
  • March 2023: A special public comment period for the draft second edition of the FACT Standards for Immune Effector Cells was offered to solicit input on updates made to accommodate differences in collection of cells, such as from solid tumors or other tissues.  
  • June 2023: The draft eighth edition of the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration was published for public comment.  

 FACT Strategic Plan Focuses on Increasing Patient Access to Quality Cellular Therapy  

FACT regularly adopts three-year strategic plans to advance its organizational mission of promoting quality for patients in the evolving field of cellular therapy. On the heels of a worldwide pandemic and in anticipation of a burgeoning list of advanced therapies, FACT’s strategic plan for 2023-2025 is intended to strengthen and streamline its infrastructure to support accredited organizations and to expand beyond core accreditation activities to serve new stakeholders that are driving development in the cell therapy industry.  

Pilot FACT Audit & Assessment Services Project is Initiated  

FACT hosted an industry focus group meeting during Advanced Therapies Week in January 2023 to present preliminary plans for FACT Audit & Assessment Services (FAAS) and gather feedback from manufacturers and other stakeholders. This feedback was used to develop a menu of services, a standardized assessment and audit checklist, proposed deliverables, and a pricing structure. Beginning in Summer 2023, a pilot assessment project was launched. As part of this project, three companies selected three sites for a pilot assessment based on the companies’ needs. The pilot assessments were successful and lessons learned will be incorporated into the FAAS processes. Official launch will take place in 2024.  

Major Upgrade to FACT Accreditation Portal Launched  

In February 2023, a major upgrade of the online FACT Accreditation Portal included new capabilities available to both applicants and inspectors. The improved portal interface has been modernized and streamlined to provide a better overall user experience and increased security. There were also enhancements to many of the pre-existing features including:  

  • Document Library.  
  • Application Export.  
  • User Creation. 
  • RFI Processes.
  • Two Factor Authentication.
  • Director Approval Processes.

FACT Advocates for Multistakeholder Consensus Building Efforts in the ISCT Telegraft Hub  

FACT provided an article in the ISCT Telegraft Hub that described its efforts to build consensus among multiple stakeholders and perspectives to promote quality cellular therapy in the next wave of advancements. Titled, “Continuing FACT’s Tradition of Consensus Building into the Next Wave of Cellular Therapies: Incorporating Multistakeholder Perspectives into FACT Accreditation and Assessment & Audit Services,” the article provides a history of FACT’s consensus-building roots and then describes the organization’s current efforts:  

  • The early collaborations among ASTCT, ISCT, FACT, JACIE, NetCord, and more.  
  • The advent of commercially manufactured cellular therapies and the need for multistakeholder cooperation.  
  • FACT participation in multistakeholder groups.  
  • FACT implementation of multistakeholder solutions to reduce duplicative assessments and audits: 
    • Soliciting manufacturer input in the FACT Standards development process.  
    • Supporting manufacturers’ efforts to leverage FACT accreditation.  
    • Advocating for the implementation of multistakeholder solutions.  
  • Building FACT Audit & Assessment Services.  

FACT Launches Fund Development Initiatives  

FACT welcomed its first Director of Development, Meredith Lambe, to develop and implement a fundraising plan to support FACT’s mission and vision by enriching FACT’s education and training program, prevent increased service costs, and expand access to patient therapies. To oversee fundraising efforts, a Fund Development Committee led Dr. Alan Balch, was established. FACT has initiated its fund development program to broaden and enhance its educational activities and expand training to more inspectors internationally. In addition, funding will aid in conducting additional accreditation workshops to provide essential information and resources to site personnel awaiting accreditation and ultimately accelerate delivery of quality therapies to the market safely and promptly.  

FACT Education Continues Robust Schedule Despite Pandemic Challenges  

Although adjustments were continuously made to adapt to surges in the COVID-19 rates, the FACT Education calendar remained full in 2023. In 2023, FACT hosted 12 all-day events, 5 webinars, and 5 portal sessions. These included accreditation workshops, inspector training courses, quality boot camps, Quality Management webinar series, and Immune Effector Cells for Solid Tumor webinar series. 

Global Affairs – International Tour a Success  

International efforts to assist with the development of cellular therapy programs and quality systems were in high demand in 2023. Special thanks to our dedicated and generous volunteers Daniel Couriel, Carlos Bachier, and Federico Rodriguez for organizing, educating, and serving as invaluable resources for our global partners throughout Latin America. Accreditation and quality sessions were conducted in conjunction with FACT’s partners during the GATMO Congress in Buenos Aires, Argentina; Mexican Society of Cellular Therapy and Bone Marrow Transplants & Transplantation (SMTT) in Puebla, Mexico; and the Brazilian Society of Cellular Therapy and Bone Marrow Transplantation (SBTMO) Congress in Curitba, Brazil. FACT also held its inaugural education and training event in conjunction with the ISCT Australia & New Zealand Regional Meeting in Perth, Australia and look forward to this being an annual event. 


FACT Global Affairs Committee Continues Successful International Tour

Posted in :: 2023 Volume 5 :: Monday, September 25th, 2023

International efforts to assist with the development of cellular therapy programs and quality systems were in high demand in 2023. The FACT Global Affairs Committee and its several working groups has worked directly with specific regions around the world to address regional needs. We extend a special thank you to our dedicated and generous volunteers Daniel Couriel, Carlos Bachier, and Federico Rodriguez for organizing, educating, and serving as invaluable resources for our global partners throughout Latin America. Accreditation and quality sessions were conducted in conjunction with FACT’s partners during the GATMO Congress in Buenos Aires, Argentina; Mexican Society of Cellular Therapy and Bone Marrow Transplants & Transplantation (SMTT) in Puebla, Mexico; and the Brazilian Society of Cellular Therapy and Bone Marrow Transplantation (SBTMO) Congress in Curitiba, Brazil. FACT also held its inaugural education and training event in conjunction with the ISCT Australia & New Zealand Regional Meeting in Perth, Australia and look forward to this being an annual event.


King Abdulaziz Medical City – Riyadh, Saudi Arabia is first Cellular Therapy Program in Saudi Arabia to earn FACT Accreditation

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

OMAHA, Neb. – King Abdulaziz Medical City – Riyadh, Saudi Arabia received internationally recognized accreditation by FACT. Directed by Mohsen Alzahrani, MD, it is the first and only cellular therapy program in Saudi Arabia to be recognized by FACT.  The program received accreditation on July 1, 2022 and is accredited for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Marrow and Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing.

“The FACT accreditation process has been a long and exciting journey with a significant learning experience. Our entire transplant team, with the help from the hospital’s multidisciplinary support services, worked tirelessly to make this major achievement possible. It is a great privilege to hold the distinction of being the very first institution in Saudi Arabia and the region to be awarded FACT accreditation. This remarkable achievement demonstrates clinical excellence, spirit of teamwork, collaboration, professional commitment, and administrative support,” stated Dr. Alzahrani. “It is our belief that FACT Accreditation will make our colleagues and patients aware of our facility’s commitment to providing the best possible care for cellular therapy and that we are committed to uphold the highest possible standards of care.”

Dr. Phyllis Warkentin, FACT Chief Medical Officer, states, “Achievement of FACT accreditation requires dedication and perseverance, and demonstrates that Dr. Mohsen Alzahrani and staff have established a high-quality program in hematopoietic cellular therapy and transplantation.  I congratulate these leaders in the region on this accomplishment.”


FACT-SBTMO Joint Accreditation Program Launched in Brazil

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

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.

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 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”

 


Upcoming Educational Events

Posted in :: 2019 Volume 2 :: Tuesday, February 12th, 2019

FACT Events at the 2019 Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR

Cellular Therapy Inspection & Accreditation Workshop
February 19, 2019
Houston, Texas

The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. Clinical programs are currently adapting to immune effector cellular therapy accreditation requirements and changes in the FACT-JACIE Seventh Edition Hematopoietic Cellular Therapy Standards. This workshop will address important topics in the cellular therapy field including:

• Overview of FACT Accreditation Processes
• Common Citations Overview
• Integration of Immune Effector Cells into Accreditation
• Using the Tracer Methodology to Assess Compliance with FACT Standards
• Risk Evaluation and Mitigation Strategies (REMS)
• How to prepare for and conduct inspections
• Data Management
• Clinical Outcomes

The workshop includes two tracks: New Inspector Training and General Sessions for active inspectors, applicants, and accredited programs. The Inspector Training track includes sessions on pre-inspection review, the ins and outs of performing an on-site inspection, how to conduct an exit interview, and how to prepare an inspection report. The General Sessions will review commonly cited deficiencies in the areas of quality management, personnel, and donor selection, evaluation, and management. This track also includes sessions on how to use the Tracer Methodology to assess compliance with FACT Standards and risk evaluation and mitigation strategies. Sessions are accompanied by exercises and group discussions to apply lecture concepts to real-world experiences.

Note: Inspector trainees are required to attend the New Inspector Training Track.

Register for the FACT workshop

Cellular Therapy Leadership Course at TCT Meetings – 101
February 20, 2019
Houston, TX 

Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome. The course is open to anyone who has (or aspires to) a leadership position in cell therapy – whether you direct a transplant center or laboratory, lead a cell collection service or cord blood bank, head a staff of nurses or transplant coordinators, hold an office or board position in a volunteer organization, chair a committee, or have any position in which you are expected to motivate and lead a team.

View meeting details and register

Cellular Therapy Advanced Leadership Course at TCT Meetings – 201
February 20, 2019
Houston, TX 

If you completed FACT’s Cell Therapy Leadership 101 course in a previous year and want more, the 201 course is for you.

This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.

View meeting details and register online
View workshop agenda

FACT-ASBMT Quality Boot Camp
February 20, 2019
Houston, Texas

Join us for the FACT-ASBMT Quality Boot Camp at the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 20 in Houston, TX.

This year’s boot camp will focus on core quality concepts and quality processes programs have implemented. Members of the FACT Quality Committee and the ASBMT Administrative Directors SIG Quality Working Group will distribute a self-assessment prior to the TCT Meetings to review key features of your quality program and identify ongoing challenges.  Strengthen your quality assurance processes by completing the self-assessment, attending the in-person workshop, and joining the roundtable discussions.

View meeting details and register
View Quality Boot Camp agenda

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 21, 2019
Houston, TX

The Foundation for the Accreditation of Cellular Therapy (FACT) invites international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 from 5:00 pm to 7:00 pm.

View meeting details and register

FACT Inspectors are Invited to Social Hour during TCT Meetings

In honor of their dedication and service provided to the cell therapy community, FACT Inspectors are cordially invited to attend the FACT Inspector Social Hour on Friday, February 22, 2019 at the Hilton Americas-Houston Hotel, Room 335B from 5 pm – 6 pm. Light hors d’oeuvres and cocktails will be provided.

Visit FACT at Exhibit Booth 2254!

During the 2019 TCT Meetings, FACT invites you to visit us at exhibit booth #2254! FACT staff will be available to answer your questions about standards, accreditation services, inspections, and FACT consulting.

Whether you are a new inspector or a long-time friend, please stop by and say hello. We would enjoy the opportunity to thank our committee members and inspectors in person for their hard work and dedication.

2019 TCT Exhibit Booth Hours:

Wednesday, February 20

7:00 a.m. – 2:00 p.m.

Thursday, February 21

7:00 a.m. – 2:00 p.m.

Friday, February 22

7:00 a.m. – 1:00 p.m.

Saturday, February 23

7:00 a.m. – 1:30 p.m.

QM Series 9: Auditing: Summarizing and Evaluating the Data
March 6, 2019
Webinar

This webinar will be on March 6, 2019, at 11:00 am ET. Ed Brindle MSc, MLT, BMT Quality Manager at UHN Blood and Marrow Transplant Program, will discuss writing the audit report, determining WHY the errors occurred, and assigning appropriate corrective action and preventive action. This is the second webinar in the QM Series 9: Audits.

Register online

FACT Cellular Therapy Collection Workshop at 2019 Annual ASFA Meeting
May 15, 2019
Portland, Oregon

Join FACT on Wednesday, May 15, at the Hilton Portland Downtown in Portland, OR, for a workshop designed to explain the requirements for FACT accreditation of cellular therapy programs, with special emphasis on apheresis collection facilities.

FACT representatives will be in attendance to discuss cellular therapy collection challenges, provide examples on how to maintain quality when faced with different collection protocols, and present a common citations overview. This workshop also includes inspector trainee sessions on how to perform a FACT inspection from start to finish.

View meeting details and register

FACT Cellular Therapy & Cord Blood Inspection at Accreditation Workshop at the 2019 Annual ISCT Meeting
May 28, 2019
Melbourne, Australia

This workshop will provide well-rounded information on the process of accreditation, requirements in the FACT Standards, and how immune effector cellular therapy fits within the realms of cellular therapy and cord blood banking. This event is a must-see opportunity for the following audiences.

  • Blood and marrow transplant (BMT) programs
  • Cord blood banks
  • Cell processing laboratories
  • Physicians, scientists, and principal investigators
  • Unit supervisors, laboratory managers, administrators, nurses, and medical technologists
  • Quality managers

Separate tracks will be available for cellular therapy programs and cord blood banks, followed by training specific to inspector trainees.

View meeting details and register

ISCT-FACT Quality Boot Camp at 2019 ISCT Annual Meeting Pre-Conference Day
May 29, 2019
Melbourne, Australia

Is your cell processing facility FACT accredited or looking to comply to FACT standards? Strengthen your quality assurance program through this interactive workshop with FACT experts and real world applications.

Focused on issues identified by FACT-compliant transplant programs, these sessions will include activities and discussion in four main topic areas. Come prepared with your quality program questions and leverage quality experts to identify process improvement opportunities you can apply at your organization.

View information and register for ISCT pre-conference day

FACT Cellular Therapy Inspection and Accreditation Workshop at CBMTG Annual Meeting
June 5, 2019
Calgary, Alberta, Canada

The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. This workshop will address important topics in the cellular therapy field including:

o Overview of FACT Accreditation Processes
o Common Citations Overview
o Integration of Immune Effector Cells into Accreditation
o Using the Tracer Methodology to Assess Compliance with FACT Standards
o Risk Evaluation and Mitigation Strategies (REMS)
o How to Prepare for and Conduct Inspections
o Data Management
o Clinical Outcomes

The workshop includes two tracks: New Inspector Training and General Sessions for active inspectors, applicants, and accredited programs. The Inspector Training track includes sessions on pre-inspection review, the ins and outs of performing an on-site inspection, how to conduct an exit interview, and how to prepare an inspection report. The General Sessions will review commonly cited deficiencies. This track also includes sessions on how to use the Tracer Methodology to assess compliance with FACT Standards and risk evaluation and mitigation strategies. Sessions are accompanied by exercises and group discussions to apply lecture concepts to real-world experiences.
Note: Inspector trainees are required to attend the New Inspector Training Track.

View meeting details and register online

WMDA-NetCord & FACT Cord Blood Day at 2019 Cord Blood Connect International Congress
September 12, 2019
Miami, FL

Join your cord blood colleagues for a day of presentations from renowned cord blood experts at the 2019 WMDA-NetCord & FACT Cord Blood Day! The event will be held in Miami, Florida on September 12, 2019, in conjunction with the Cord Blood Connect International Congress.

The WMDA-NetCord & FACT Cord Blood Day will highlight recent advances in cord blood transplantation and include global perspectives of cord blood transplants, common FACT-NetCord inspection citations, and more. The afternoon consists of two breakout sessions: a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track. We encourage banks to send multiple personnel to attend the various tracks as well as enlist a member to become a FACT inspector.

This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. Registration fees are waived for FACT active and trainee inspectors. Apply to be a FACT inspector!

View meeting details and register online


FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session

Posted in :: 2019 Volume 1 :: Wednesday, January 16th, 2019

FACT International Accreditation

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 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. 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. Register to attend!


Upcoming Educational Events

Posted in :: 2019 Volume 1 :: Wednesday, January 16th, 2019

Exceptional Release of Commercial Cellular Therapy Products
January 30, 2019
Webinar

Join FACT on January 30, 2019, at 11:00 am ET, 1600 GMT, for a webinar titled, Exceptional Release of Commercial Cellular Therapy Products. Autologous cellular therapy products can be irreplaceable, and exceptional release of nonconforming products may be necessary to the well-being of patients. FACT-accredited programs are increasingly using autologous products that are licensed by regulatory authorities, and sometimes these products do not meet specifications. In this webinar, presenters will discuss FACT requirements for exceptional release, and then share their centers’ processes for release of nonconforming commercial cellular therapy products in the United States.

Webinar presenters include:

Dr. Phyllis I. Warkentin, Chief Medical Officer of FACT
Dr. Premal Lulla, Baylor College of Medicine, Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital
Dr. Elizabeth Shpall, MD Anderson Cord Blood Bank Medical Director, MD Anderson Cellular Therapy Transplant Program Director, and co-director of the MD Anderson CARTOX program.
Dr. Phillip McCarthy, of Roswell Park Comprehensive Cancer Center – Transplant and Cellular Therapy Program for Adult Inpatient, Outpatient, and Pediatric Outpatient Programs – John R. Oishei Children’s Hospital

Register online

Validation Principles and Protocols for Cellular Therapies
February 6, 2019
Webinar

Join FACT for a webinar, Validation Principles and Protocols for Cellular Therapies, on Wednesday, February 6, 2019, at 11:00 am ET, 16:00 GMT. Dr. Tom Leemhuis, Laboratory Director at Hoxworth Blood Center University of Cincinnati Academic Health Center, will discuss the Validation Principles and Protocols for Cellular Therapies, and the FACT-JACIE Seventh Edition Standards requirements.

Register online

FACT Events at the 2019 Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR

Cellular Therapy Inspection & Accreditation Workshop
February 19, 2019
Houston, Texas

The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. Clinical programs are currently adapting to immune effector cellular therapy accreditation requirements and changes in the FACT-JACIE Seventh Edition Hematopoietic Cellular Therapy Standards. This workshop will address important topics in the cellular therapy field including:

• Overview of FACT Accreditation Processes
• Common Citations Overview
• Integration of Immune Effector Cells into Accreditation
• Using the Tracer Methodology to Assess Compliance with FACT Standards
• Risk Evaluation and Mitigation Strategies (REMS)
• How to prepare for and conduct inspections
• Data Management
• Clinical Outcomes

The workshop includes two tracks: New Inspector Training and General Sessions for active inspectors, applicants, and accredited programs. The Inspector Training track includes sessions on pre-inspection review, the ins and outs of performing an on-site inspection, how to conduct an exit interview, and how to prepare an inspection report. The General Sessions will review commonly cited deficiencies in the areas of quality management, personnel, and donor selection, evaluation, and management. This track also includes sessions on how to use the Tracer Methodology to assess compliance with FACT Standards and risk evaluation and mitigation strategies. Sessions are accompanied by exercises and group discussions to apply lecture concepts to real-world experiences.

Note: Inspector trainees are required to attend the New Inspector Training Track.

Register for the FACT workshop

Cellular Therapy Leadership Course at TCT Meetings – 101
February 20, 2019
Houston, TX 

Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome. The course is open to anyone who has (or aspires to) a leadership position in cell therapy – whether you direct a transplant center or laboratory, lead a cell collection service or cord blood bank, head a staff of nurses or transplant coordinators, hold an office or board position in a volunteer organization, chair a committee, or have any position in which you are expected to motivate and lead a team.

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Cellular Therapy Advanced Leadership Course at TCT Meetings – 201
February 20, 2019
Houston, TX 

If you completed FACT’s Cell Therapy Leadership 101 course in a previous year and want more, the 201 course is for you.

This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.

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FACT-ASBMT Quality Boot Camp
February 20, 2019
Houston, Texas

Join us for the FACT-ASBMT Quality Boot Camp at the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 20 in Houston, TX.

This year’s boot camp will focus on core quality concepts and quality processes programs have implemented. Members of the FACT Quality Committee and the ASBMT Administrative Directors SIG Quality Working Group will distribute a self-assessment prior to the TCT Meetings to review key features of your quality program and identify ongoing challenges.  Strengthen your quality assurance processes by completing the self-assessment, attending the in-person workshop, and joining the roundtable discussions.

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View preliminary agenda

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 21, 2019
Houston, TX

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 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. 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.

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Visit FACT at Exhibit Booth 2254!

During the 2019 TCT Meetings, FACT invites you to visit us at exhibit booth #2254! FACT staff will be available to answer your questions about standards, accreditation services, inspections, and FACT consulting.

Whether you are a new inspector or a long-time friend, please stop by and say hello. We would enjoy the opportunity to thank our committee members and inspectors in person for their hard work and dedication.

2019 TCT Exhibit Booth Hours:

Wednesday, February 20

7:00 a.m. – 2:00 p.m.

Thursday, February 21

7:00 a.m. – 2:00 p.m.

Friday, February 22

7:00 a.m. – 1:00 p.m.

Saturday, February 23

7:00 a.m. – 1:30 p.m.

QM Series 9: Auditing: Summarizing and Evaluating the Data
March 6, 2019
Webinar

This webinar will be on March 6, 2019, at 11:00 am ET. Ed Brindle MSc, MLT, BMT Quality Manager at UHN Blood and Marrow Transplant Program, will discuss writing the audit report, determining WHY the errors occurred, and assigning appropriate corrective action and preventive action. This is the second webinar in the QM Series 9: Audits.

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Global Affairs

Posted in :: 2018 Volume 4 :: Friday, November 9th, 2018

FACT continues to develop its international collaborations through regional initiatives aimed at providing educational assistance and accreditation activities tailored to the needs of the global communities.

FACT-JACIE Stepwise Accreditation in Latin America

In an effort to provide an incremental approach to accreditation, FACT and JACIE have partnered to offer a stepwise accreditation program in Latin America. This stepwise approach to accreditation would enable programs to focus on their quality systems first and ensure operations for patient and donor safety.  The second phase would build on the established foundation to develop a complete quality management program and provide for efficacious care. The final step evaluates the effectiveness of the quality program, ensures reporting to the appropriate regulatory and accrediting agencies, and evaluates clinical outcomes. The first FACT-JACIE Stepwise Inspection is scheduled to be conducted in Argentina on November 20-21, 2018.

India

A broad group of ten participating bone marrow transplant centers throughout India is participating in the new India Working Group designed to address the regional needs of the country. The centers are completing self-assessments of their programs to identify any potential barriers to compliance with FACT Standards, clarify the intent of requirements, and assess their readiness for accreditation.

Asia-Pacific

A FACT Standards and Accreditation Workshop was held on November 2, 2018 during the annual meeting of the Asia-Pacific Blood and Marrow Transplantation Group (APBMT) in Taipei, Taiwan. Presentations included the importance of integrating a quality management system throughout the clinical, collection and cell processing activities; the accreditation experience of the National University Health System in Singapore; the incentives for seeking international accreditation from the Tata Medical Center in Kolkata; and the need for standardization and accreditation in China.

Brazil

Following the execution of a formal Memorandum of Understanding (MoU) in August, FACT and the Sociedade Brasileira de Transplante de Medula Óssea (SBTMO) created a FACT-SBTMO Task Force.  The first meeting of the Task Force was conducted on October 17, 2018 to review the strategic goals and operational aspects of the joint FACT-SBTMO Accreditation Program.  A survey of the Brazil transplant centers will be distributed in November to gather data related to the volume and type of transplants performed, program structure, personnel, facilities, and quality management systems. The information will be used to identify areas of educational need and ascertain readiness for accreditation.