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accreditation statistics

As of April 1, 2021

Cellular Therapy Entities

  • Accredited: 237
  • Applicants: 21

Cord Blood Banks

  • Accredited: 58
  • Applicants: 8

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

Congratulations to the following organization for achieving its initial FACT accreditation:

GW Cancer Center Stem Cell Transplantation and Cellular Therapy Program, Washington, DC

Director: John Barrett, MD

Adult Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation

ICCBBA Releases Registration and Licensing Information for ISBT 128

Posted in :: 2021 Volume 1 :: Friday, January 29th, 2021

Interest in the new ISBT 128 coding and labeling standard, Labeling of Collection Products for Cellular Therapy Manufacturing, has led to many inquiries to ICCBBA regarding registration and licensing. To assist entities with determining how the standard applies to their scope of work and the applicable fees, ICCBBA created a flyer that outlines this information. There are also step-by-step registration instructions on its website.

We are encouraged by this interest in this new standard to improve efficiency and patient safety. Further questions can be directed to the ICCBBA help desk at iccbba@iccbba.org.

License Fee Flyer

Step-by-step registration instructions


Now Published: ISBT 128 Labeling Standard for Collection for Cellular Therapy Manufacturing

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

It is official! The final ISBT 128 Labeling of Collection Products for Cellular Therapy Manufacturing Standard is published.

Following multistakeholder efforts to standardize labels for cells collected for further manufacturing, and two rounds of public input, ICCBBA has finalized this ISBT 128 labeling Standard.  The Standard is for use only in situations where the sponsor or manufacturer has adopted it.

This Standard may reduce the variations in labeling requirements for apheresis collections for different sponsors or manufacturers, minimizing the risk of errors and increasing patient safety. ISBT 128 is a well-established and international coding and labeling system. Standardizing labeling requirements using this system enhances cellular therapy product traceability and reduces the number of systems that must be adopted, implemented, validated, and maintained at health care institutions.

FACT-accredited apheresis collection facilities are encouraged to review this Standard, work with their ISBT 128 vendors regarding implementation and validation, and inquire with clinical trial sponsors and manufacturers about their intentions for adopting it.


ISBT 128 Labeling Standard for Cells Collected for Cellular Therapy Manufacturing: Comments Due October 18th

Posted in :: 2020 Volume 7 :: Thursday, September 17th, 2020

Thanks to the teamwork of several stakeholders in apheresis cell collection, the field is one step closer toward label standardization. Comments are needed in the most recent draft ISBT 128 label published by ICCBBA by October 18, 2020.

As reported in previous Just the FACTs newsletters, a multi-stakeholder working group led by the Standards Coordinating Body and the Deloitte NextGen Industry Working Group, consisting of industry, registries, accrediting organizations, technology providers, and apheresis and quality subject matter experts, released a draft standard labeling proposal for collected cells.

Public comments following the release of that draft indicated support for ISBT 128 labeling for starting material intended for further manufacturing. After reviewing these comments, ICCBBA has released a draft Standard for Labeling of Collection Products for Cellular Therapy Manufacturing.

This Standard builds on existing ISBT 128 standards, including compatible label dimensions and essential traceability information, but also accommodates sponsor/manufacturer information. As stated by the ICCBBA website, “it is for use only in situations where the sponsor/manufacturer has adopted this standard and has provided the necessary information to populate the sponsor/manufacturer section of the label.” Although the standard was written with apheresis in mind, the label could be used on products collected from other sources and intended for further manufacturing.

View more details

Draft Labeling of Collection Products for Cellular Therapy Manufacturing

Submit Comments


New Product Description Codes for Convalescent Plasma COVID-19

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

In response to recent requests from blood transfusion services, ICCBBA has fast-tracked the release of new product description codes for COVID-19 Convalescent Plasma. The new codes can be found in the latest release of ISBT 128 Standard Product Description Code Database available at the ICCBBA website,. Inquiries and new PDC requests can be sent to iccbba@iccbba.org.


Comments Requested on Standard Labeling Proposed for Apheresis Collection Products: Due April 24, 2020

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

FACT is pleased to announce that ICCBBA, administrator of the ISBT 128 coding and labeling standard, has released a draft document and label for public review and comment. The document, “Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing,” and the described label applies to collected cells, commonly referred to as “starting material,” intended for further manufacturing in support of clinical cellular therapy trials and commercial cell products. This draft is a result of a multi-stakeholder effort to standardize labeling requirements of apheresis collection facilities, including the Standards Coordinating Body, the Deloitte NextGen Industry Working Group, FACT, and many others.

Variations in sponsors’ labeling requirements have been a notable challenge for apheresis facilities in recent years and introduce risks of errors and misinterpretation of patient data. The use of an ISBT 128-compliant label will reduce manual transcription errors and promote chain of identity, including for autologous cells. Furthermore, the use of ISBT 128 for these collections will allow the use of processes, labels, equipment, and software compatible with those already in use for other types of cellular therapy products collected by apheresis facilities for clinical application.

The next step of this important standardization effort is to solicit input from the entire community. Please review this document and provide comments by April 24, 2020 to Dawn Henke of the Standards Coordinating Body (dhenke@regenmedscb.org). Equally important, please distribute this announcement to your industry, hospital, vendor, and professional colleagues to make them aware of this opportunity and encourage them to review the document and submit feedback.

Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing
Submit Comments (due April 24, 2020)


ISBT 128 Audit Tool for Cellular Therapy Provides Additional Resource for Verifying Labels

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

It has been a long time coming, but now it is official. Full implementation of ISBT 128 coding and labeling is required of cellular therapy programs.

ICCBBA released an ISBT 128 compliance audit tool for use with cellular therapy products. The tool provides a means of determining compliance with the ISBT 128 Standard, and can be used by any cellular therapy facility around the world. It includes both interactive and printable audit checklists. FACT recommends use of this tool to verify correct implementation of ISBT 128 and to verify ongoing compliance. It may also be useful as an educational reference.

It is important to note that the tool does not take into consideration requirements from national regulatory bodies and may not cover all labeling requirements of cellular therapy accreditation bodies. Additionally, the tool does not ensure that proper Product Codes have been selected. Rather, it verifies correct placement and format of complete information.

Although ICCBBA has made validation tools available in the past, this is the first time an audit tool has been released. Input was received from industry experts and the international Cellular Therapy Coding and Labeling Advisory Group that is co-sponsored by ICCBBA, AABB, FACT, ISCT, and others. An instructional video is available on the ICCBBA website at www.iccbba.org.