News Hub

Whitney Fritzinger, MBA, Education and Training Coordinator
Foundation for the Accreditation of Cellular Therapy
Omaha, NE 
USA

It's Here! FACT Accreditation Portal Version Launched on February 1, 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 the 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.

While we are planning to distribute a formal survey soon to obtain specific feedback regarding the FACT Portal Upgrade, we encourage all users of the upgraded FACT Portal to send us feedback on their experience to portal@factglobal.org.  We’d like to hear about your experiences with the usability, reliability, and overall satisfaction with the portal as you use it.

FACT is Seeking New Apheresis Collection Inspectors!

At FACT, our mission is to promote quality clinical and laboratory practice of cellular therapy and regenerative medicine. We would not be able to achieve this mission without our volunteer inspectors and are committed to providing our inspectors with training and resources to ensure successful inspections.

The benefits of becoming an inspector include:

•    Opportunity to observe other programs
•    Networking with peers and experts
•    Contribute to Standards Development
•    Access to complimentary educational resources
•    High quality professional development
•    Opportunity to serve on FACT Committees
•    Giving back to the field of cellular therapy and regenerative medicine

Consider attending FACT's upcoming Apheresis Collection Inspector Training in conjunction with the ASFA Annual Meeting on Tuesday, April 25th from 8:00 am - 5:00 pm CT in Minneapolis, Minnesota!

To become a FACT inspector and learn about inspector qualifications, visit https://www.factglobal.org/inspectors/.

FACT Service Award Presented to Ngaire Elwood, PhD
















FACT recently celebrated the service of Dr. Ngaire Elwood, an ISCT-appointed member of the FACT Board of Directors, whose tenure on the Board recently concluded. With heartfelt gratitude and admiration, FACT President Dr. Catherine Bollard presented Dr.  Elwood with a Service Award in recognition of her servant leadership and guidance to FACT during a time of significant organizational growth and global challenges. Thank you, Ngaire, for all you do for FACT and your colleagues!

Request for Public Review and Comment:
Draft Second Edition, FACT Standards for Immune Effector Cells

FACT has published the draft second edition FACT Standards for Immune Effector Cells at www.factglobal.org for public comment during a thirty-day period. Comments will be accepted through April 30, 2023.

These Standards promote quality practice in immune effector cell therapies and apply to a wide range of immune effector cells used to modulate an immune response for therapeutic intent, whether genetically modified or not. This includes, –  but is not limited to, –  dendritic cells, natural killer cells, T cells, B cells, genetically engineered chimeric antigen receptor T cells (CAR-T cells), and therapeutic vaccines. The final Standards will be published in November 2023 and will become effective in February 2024.

The FACT Standards for Immune Effector Cells were reviewed and commented upon during an initial public comment period in association with the eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing and Administration. The majority of comments received have been addressed through harmonizing these two publications.  

Comments submitted during the first comment period clearly indicated a need to enhance standards related to cell collection. These comments have been addressed in B2.12, B2.12.1, and in a reorganized Section C that now includes general standards applicable to any cell collection followed by sections C9, C10, and C11 specific to apheresis and whole blood collection, marrow collection, and collection of other tissues such as tumor-infiltrating lymphocytes (TILs).  

The purpose of this comment period is to specifically request your comments on these new sections. The published draft is a redline document intended to highlight the changes made to these Standards. Minor reorganization and clarifying changes are not tracked. Some changes are new standards; however, some are intended to clarify rather than to change the intent. In addition, many changes were made to provide consistency among all sets of FACT Standards.

Instructions for Submitting Public Comments

To submit comments regarding the draft second edition FACT Immune Effector Cells Standards at https://www.factglobal.org/standards/public-comments/ , follow the steps below. Comments will be accepted through April 30, 2023.

1. Access the Comment Form at 
https://redcap.link/IEC2ndEdPublicComments

2. Type in your contact information and comments on the form. Fill in all fields to ensure the Standards Committee fully understands your position.

3. Submit the form when you are finished. Once the form has been submitted, it cannot be changed. However, additional comments may be submitted by completing the form again. There is no limit to the number of forms that can be submitted.

Upcoming FACT Events

Virtual Accreditation Workshop: Register Now!

We invite you to attend a virtual accreditation workshop focused on FACT requirements for Apheresis Collection and Processing on Wednesday, April 19, 2023 from 8:00 am to 5:00 pm CT to learn about FACT’s accreditation standards, the accreditation process, and how you can position your program for accreditation success. During the workshop, instructors will provide a high-level overview of requirements and expectations for accreditation, commonly cited Standards, labeling, and chain of identity and custody for IEC products. 

Click Here to Register

Virtual Quality Boot Camp: Register Now!

We invite you to attend the FACT Virtual Quality Boot Camp focused on quality principles for Collection, Processing, and Cord Blood Banking on Friday, June 23, 2023, from 9:00 am to 6:00 pm CT.  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 Virtual 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 time and resources while improving the overall quality of your program and processes.

Click Here to Register

We invite you to attend the FACT Cellular Therapy Accreditation and Quality Principles Workshop in conjunction with the ISCT ANZ 2023 Regional Meeting on Tuesday, August 15, 2023, from 8:00 am to 5:00 pm AWST.  This workshop will combine a high-level overview of requirements and expectations for accreditation, commonly cited Standards, and how to position your program for accreditation success with collaborative instruction and roundtable activities focused on the quality principles surrounding validation, risk assessment, and risk management.

Registration is coming soon!

We invite you to attend the FACT Laboratory Processing Inspector Training Course on Thursday, September 7, from 8:00 am to 5:00 pm CT, at the Hilton Americas in Houston, TX.  FACT’s Inspector Training Courses make learning about the inspection process an up-close and personal experience. 
The FACT Inspector Training Course, in conjunction with the 2023 ISCT North America Regional Meeting, is for laboratory processing inspector trainees only.  Trainees must complete pre-training course requirements before attending. The training course is a collaborative event where the trainee will work with an experienced FACT inspector and practice the entire inspection process from beginning to end. 

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