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/.

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. 


It’s Here! FACT Accreditation Portal Version Launched on February 1, 2023.

Posted in :: 2023 Volume 1 :: Thursday, March 30th, 2023

We are pleased to announce the launch of major upgrades to the FACT Accreditation Portal! Part of this upgrade includes a new address. For quick access to the portal, bookmark the following link: https://portal.factglobal.org

FACT has prepared user How-To Guides to assist in navigating the portal’s new features. These can be accessed on our website in the Portal Resource Center. Your username and password have not changed.

We are Happy to Announce a New Feature: Tasks

The new Task feature replaces the Request for Information (RFI) for Follow-up when an organization needs to submit information in follow-up to a request or citation. Tasks allow coordinators to create stand-alone requests in response to a citation at the time of the FACT Annual Report or at another time in response to a request from a committee, such as the FACT-CIBMTR Data Audit Committee or the FACT Clinical Outcomes Improvement Committee.

This feature expedites time required to locate and respond to these requests. Please refer to the How-To: Respond to a Task guide.

Your Accreditation Coordinator is a valuable resource for any questions.

Special thanks to our technology partner Forbina Consulting for leading the development of the new version of the Portal.


A New Version of FACT’s Accreditation Portal is Coming!

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

It’s here! Mark your calendars for the upcoming launch of a major FACT Accreditation Portal upgrade. The portal will be inaccessible during the upgrade from January 28-31. Effective February 1, 2023, the new version will be available to all users to access their current applications and reports.  If you have any applications or reports due, please complete these prior to January 27.

FACT has prepared new user How-To Guides to assist in navigating the upgraded portal’s new features.  Your username and password will not change.  Your Accreditation Coordinator is a valuable resource for any questions.

FACT will be communicating individually with those applicants and inspectors who will be most impacted.

Applicants with Open Applications or Reports

For our applicants who are currently working on an application/report or will begin working on an application/report prior to the launch window, all data will be retained and transitioned over to the new version. Your upgraded application/report will be available for you to complete on February 1, 2023.

If you have already completed your compliance application and are waiting for your inspection to be scheduled, your application will be transferred and your Accreditation Coordinator will verify that the transfer was accurate.

Accreditation Portal Open House

To help with transitioning to the upgraded portal, FACT will host an Accreditation Portal Open House at the 2023 ASTCT Tandem Meetings in Orlando, Florida.  FACT’s Director of IT Services will demonstrate the new features in an open forum on Thursday and Friday, February 16 and 17, 2023.  Additional information including times and location will be announced. You are invited to ask questions and experience the new system.


Virtual Inspections Lead to Accreditation Process Improvements

Posted in :: 2021 Volume 4, Uncategorized :: Wednesday, July 14th, 2021

By Suzanne Birnley, MS, MBA, FACT Accreditation Services Manager

It has been a very busy few months at FACT between the implementation of virtual inspections and publishing the eighth edition of the FACT-JACE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration.  These developments have led to some changes and improvements to the FACT Accreditation Process.

  1. Although initially developed for virtual inspections, some changes to submission requirements will continue to be part of the accreditation process moving forward. All applicant programs and banks are now required to submit additional documentation in preparation for their FACT inspection. For applicants currently waiting for their inspection to be scheduled, these documents can be uploaded in the FACT Accreditation Portal Document Library under the Virtual Inspection Documents tab.  These documents are expected to be submitted a minimum of 4 weeks prior to the inspection. These additional submissions have been included with the Eighth Edition Hematopoietic Cellular Therapy (HCT) Compliance Application, and will be included in other Standards as new editions are published. These include:
    • A copy of all policies and Standard Operating Procedures referenced in the Quality Management Plan.
    • The most recently completed Annual Report on the Effectiveness of the Quality Management Program.
  1. Whether for a virtual inspection or on-site, beginning July 1, 2021, all programs are required to use OneNote or the equivalent to organize documents for their inspection. This can be accomplished in several ways:
    • Use the OneNote template provided by FACT.
    • Use a software developed within the organization or a commercially available software.
    • Use the FACT Self-Assessment Tool or checklist from your completed application in the FACT Accreditation Portal, and add additional columns for links to documents and information regarding where to find documentation of compliance for each standard.
    • For on-site inspections, use the binder method. Match each standard to the documentation of compliance in paper form, all organized by standard in three-ring binders.
  1. For virtual inspections, beginning July 1, 2021, all programs are required to use a document camera to display documentation that exists in paper format. This is particularly important in collection or processing facilities that use paper records.

Finally, it is very important that inspectors have access to any updated documents, especially if the Compliance Application was completed a year ago.  FACT Accreditation Coordinators will send Requests for Information (RFIs) to update documentation known to be out of date, such as medical licenses and continuing education.  It is your responsibility to let your coordinator know if there are any other policies or SOPs that were submitted that have since been revised.  If inspectors do not have access to these documents, it is a risk that they may not see evidence of compliance, resulting in deficiencies cited on the Accreditation Report.

FACT greatly appreciates the hard work of the inspectors and applicants as we transition through this challenging time.  We do intend to return to on-site inspections as soon as it is safe to do so.  We are actively seeking and welcoming feedback on both the virtual inspection process and these process changes.  If you have any questions or concerns, please contact your Accreditation Coordinator or the Manager of Accreditation Services, Suzanne Birnley.

 

 

 


How to Access the FACT Accreditation Report with Program Responses

Posted in :: 2020 Volume 9 :: Friday, December 11th, 2020

Some commercial cellular therapy product manufacturers may provide FACT-accredited programs the option to undergo a full site quality audit or provide a copy of the most recent FACT accreditation report and undergo an abbreviated audit. If choosing the second option, programs will want to provide manufacturers the final report complete with program responses to cited deficiencies. Program responses are an opportunity to demonstrate correction of deficiencies and ultimate compliance with FACT Standards.

FACT Accreditation Coordinators will provide a copy of the final Accreditation Report, with the program’s responses, when sending the Accreditation Certificate at the conclusion of the inspection and accreditation process. Additionally, in the current online accreditation portal, the complete report can be downloaded by opening the applicable Compliance Application and clicking “View: Accreditation Report” in the left navigation pane. A version of this report is also automatically saved in the Document Library when the accreditation process is complete.


Accessing the Accreditation Report in the legacy FACTWeb Portal

Not all programs have completed the accreditation process in the current online portal. For these programs, contact your FACT Accreditation Coordinator, who will be happy to email you a copy of the report.

Read more about the FACT Accreditation Report


Accreditation Portal Training On Your Terms

Posted in :: 2019 Volume 7 :: Monday, July 29th, 2019

The new Accreditation Portal launched in October 2018, and the number of applications in the new portal are increasing steadily.  Prepare for your upcoming application or inspection by reviewing training materials available on demand.  To aid in the transition between portals FACT has developed a Portal Resource Center filled with feature-specific How-To Guides and Training Videos.  All training materials have been divided by audience. If you are looking for generic guides, proceed into the Applicant Area. If you are looking for inspector specific feature guides, proceed into the Inspector Area.

Training Videos Now Available On Demand:

Each session is 45 min in length and is free of charge.


FACT Accreditation Portal Launch Update

Posted in :: 2019 Volume 5 :: Friday, May 17th, 2019

FACT Accreditation Portal Launch Update

On October 1, 2018, FACT launched its new Accreditation Portal.  FACTWeb applications already in progress must be completed in the legacy portal but all new applications are created in the new FACT Accreditation Portal. At this time 60% of our applicants have been migrated to the new portal.  All of the beta test organizations for Annual Reports, Renewal Applications, and Eligibility Applications have completed their applications.  The Compliance Application process is significantly longer, but three FACT  beta testers have completed their compliance applications, inspections, and were reaccredited through the new portal.

A very special thank you to all the beta test organizations and their inspectors that continue to clear the way for other organizations and provide valuable feedback regarding their portal experience.

New to FACT

To apply for FACT Accreditation, navigate to the portal at https://portal.factwebsite.org and select “Create an Organizational Profile”.

First Time Users

Your credentials for the new portal are different from the sign-in information used to register for events and log into FACTWeb!

For the new portal, enter your email address as your username. 

First time users can refer to the following guides:

If you do not receive the Reset Password email from portal@factwebsite.org, contact your FACT coordinator to confirm the email address on file.

Training Materials

With the launch of the new portal, FACT published How-To Guides to help mitigate the inevitable learning curve that comes with new technology.  These guides are available in the Portal Resource Center.  Since the launch, FACT published two new training videos to ensure applicants have on-demand access to portal training materials for every learning style.

*As an inspector, reviewing the training materials in the Portal Resource Center is strongly recommended.

Assistance

For questions related to your application, contact your organization’s assigned FACT coordinator or email FACT at fact@unmc.edu.

For technical assistance in the portal(s), contact FACT at portal@factwebsite.org


New FACT Accreditation Portal Launched

Posted in :: 2018 Volume 4 :: Monday, November 12th, 2018

In 2015, FACT began a monumental undertaking to replace the FACTWeb Portal.  FACT’s vision was to create a new system that would revolutionize the accreditation process.  The goal was to improve the applicant’s ability to efficiently submit evidence to FACT; enhance the inspector experience with a streamlined approach for reviewing compliance applications, clinical outcomes, and data management; improve inspector training; and increase system flexibility to allow FACT staff to seamlessly manage the accreditation process from start to finish.

This past April, 10 organizations were selected to serve as beta testers and complete their applications in the new portal.  After a successful beta test period, the new FACT Accreditation Portal launched on October 1, 2018.

“This is a major improvement over the first portal. The ease of use and the speed are complete upgrades! I appreciate everything that was incorporated into this new portal and realize that we will continue to strive to improve it.  Very pleased to have been a beta tester!” states Kim Kasow, DO of the UNC Bone Marrow Transplant and Cellular Therapy Program.

Applicants with pre-existing applications in the legacy FACTWeb portal will continue with the legacy portal until the current application is finished.  Going forward, all new applications will be created in the new FACT Accreditation Portal.

FACT Accreditation Portal

Portal access: https://portal.factwebsite.org

  • To apply for initial FACT accreditation, complete the request for access form accessible from the new portal login page.
  • If your organization has been migrated to the new portal, complete the Recover Password form accessible from the new portal login page to access your account.

Training Materials: Portal Resource Center

Launch Details: FACT Accreditation Portal Launch Updates

Legacy FACTWeb

To access an existing application in the legacy FACTWeb portal, navigate to https://www.factweb.org.

Acknowledgements

A very special thank you to all the people that contributed to this project:

  • The FACT Technology Committee for their leadership and guidance throughout the project
  • Our Beta Testers who courageously entered the new portal and took the time to explore and provide feedback
  • FACT Staff for their patience through countless meetings, working sessions, and months of testing
  • Our software developer, 5th Method, for their support and partnership throughout this project

FACT Prepares for New Portal Launch

Posted in :: 2018 Volume 2 :: Tuesday, May 22nd, 2018

By Alisa Forsythe, IT Business Analyst

In 2015, the FACT Technology Committee committed to replacing the FACTWeb Portal.  This April, after three years, the first users logged into the new FACT Accreditation Portal.  Ten different organizations were selected to serve as beta testers and complete their applications in the new portal.

Feedback on the new portal has been positive:

  • “So much faster than the old portal. It is nice that the tabs do not stay open as you move along the application. […] I generally am not a fan of being a beta site, but in this case, I am glad we are as this portal is such an improvement.”

– Karen Klinker, Dana-Farber Cancer Institute/Brigham and Women’s Hospital Adult Hematopoietic Stem Cell Transplant Program

  • “Easy to move between application components. Easy to see where you are within the application. Color coding is very helpful.”

– Peggy Appel, Northwest Marrow Transplant Program at Oregon Health & Science University, Legacy Good Samaritan Hospital and Medical Center and Doernbecher Children’s Hospital

  • “The new portal is so easy to work with and is a vast improvement from the previous system. It is much easier and quicker to go to the next question and to maneuver around in the portal. Thank you for your hard work in developing this new portal!”

– Sue O’Donnell, The Massachusetts General Hospital Bone Marrow Transplant Program

  • “This is a major improvement over the first portal. The ease of use and the speed are complete upgrades! I appreciate everything that has been put into this new portal and realize that we will continue to strive to improve it. Very pleased to have been a beta tester!”

– Kim Kasow, UNC Bone Marrow Transplant and Cellular Therapy Program

With a successful beta test underway, the new FACT Accreditation Portal is scheduled for launch this August.

Upcoming Training Sessions

Online training opportunities are now available on the FACT Event Calendar.  Advance registration is required.  The first training session of each type will be recorded and made available online for on-demand viewing.


Education Events

Posted in :: 2018 Volume 2 :: Tuesday, May 22nd, 2018

FACT Webinar: ISBT 128 Coding and Labeling
June 14, 2018
Online

Full implementation of ISBT 128 labeling and coding is required by the seventh edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards, which becomes effective this month. On Thursday, June 14, 2018, at 11:00 am ET, Dr. Phyllis I. Warkentin will discuss common questions about ISBT 128 terminology, product codes, FACT Standards, and regulatory requirements. Webinar participants will have a chance to ask Dr. Warkentin questions at the end of the presentation.

View meeting details and register 

WMDA-NetCord & FACT Cord Blood Day
September 14, 2018
Miami, FL

Join your cord blood colleagues for a day of presentations from renowned cord blood experts at the inaugural WMDA-NetCord & FACT Cord Blood Day! The event will be held in Miami, Florida on September 14, 2018, in conjunction with the Cord Blood Connect international congress.

The WMDA-NetCord & FACT Cord Blood Day will highlight issues that affect cord blood banks’ abilities to optimize processes within a challenging environment. The evolving demand for umbilical and cord blood products requires banks to consider changing indications and financial limitations on a continuous basis. Accreditation encourages implementation of efficient, quality-driven processes to meet these demands while banking products suitable for clinical administration.

Morning presentation topics include global perspectives of cord blood transplants, ethical dilemmas in cord blood banking, common FACT-NetCord accreditation citations, and an overview of the WMDA cord blood bank survey. The afternoon has two breakout sessions including 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. Register by August 31 and save $135! Registration fees are waived for FACT active and trainee inspectors.

View meeting details and register 

Completing an Annual/Renewal Report in the Portal
Applicant Training Session
Online

Join FACT’s IT Business Analyst for training on completing an annual or renewal report in the new FACT Accreditation Portal. Alisa Forsythe will discuss the navigation and features within the portal as well as the process for completing the application, the director approval process, and application submission. Webinar participants will have a chance to ask questions at the end of the presentation.

August 1: Register online
September 5: Register online
October 3: Register online
November 7: Register online
December 5: Register online

Completing a Compliance Application in the Portal
Applicant Training Session
Online

Join FACT’s IT Business Analyst for training on completing a compliance application in the new FACT Accreditation Portal. Alisa Forsythe will discuss the navigation and features within the portal as well as the process for completing the application, the director approval process, and application submission. Webinar participants will have a chance to ask questions at the end of the presentation.

August 2: Register online
September 6: Register online
October 4: Register online
November 8: Register online
December 6: Register online

Performing an Inspection in the Portal
Inspector  Training Session
Online

Join FACT’s IT Business Analyst for training on performing an inspection in the new FACT Accreditation Portal. Alisa Forsythe will discuss the inspector specific navigation and features within the portal as well as the process for reviewing the applicant data, entering inspection findings, reviewing the inspection report, and submission. Webinar participants will have a chance to ask questions at the end of the presentation.

August 16: Register online
September 13: Register online
October 18: Register online
November 15: Register online
December 13: Register online