FDA Publishes Draft Guidance on Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

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

The United States Food and Drug Administration (FDA) is responding to needs for regulatory predictability and leverage of stakeholder efforts for standardization in regenerative medicine therapies, including cellular therapy, via a draft guidance that introduces a voluntary consensus standards recognition program.

Published in June 2022, Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies: Draft Guidance for Industry acknowledges many unique challenges caused by the novelty of regenerative medicine therapy products. The proposed standards recognition program for regenerative medicine therapies (SRP-RMT) is intended to:

  • Use agency expertise to evaluate and recognize voluntary consensus standards.
  • Provide transparency to industry and other stakeholders regarding CBER’s thinking about a particular method or approach.
  • Promote the visibility and use of standards applicable to the agency’s mission.

The draft guidance describes the purpose of the program, procedures for evaluating standards for recognition, documenting the use of a recognized standard, and questions and answers.

Comments on the draft guidance are due by September 14, 2022. Comments may be submitted to https://www.regulations.gov, Docket No. FDA-2022-D-0745-0001.

A public workshop to discuss the guidance will be hosted by the Standards Coordinating Body (SCB) free of charge on August 24, 2022 at 12 pm ET. Register online.


Standards Development Updates

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

By Monique Summers, RN, MSN, MPA
FACT Standards Development Manager

Standards Committee members have risen to the challenges of COVID-19 over the past two years, and all four sets of FACT Standards have been in the active phase of the review process.  Members have incorporated feedback from constituents, discussed new developments in cellular therapy, and edited drafts. Updates for each set of Standards are provided below. As progress continues, important updates will be announced.

FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and AdministrationEighth Edition

FACT and JACIE finalized the eighth edition Hematopoietic Cellular Therapy Standards in August 2021 with a revision in December 2021.  These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, cord blood, or other tissues and administered by a blood and marrow transplant (BMT) team.

The FACT Accreditation Services department is working with accredited and applicant programs that are beginning the accreditation process under the eighth edition and is available for questions.

FACT Standards for Immune Effector Cells, Draft Second Edition

The FACT Standards for Immune Effector Cells apply to immune effector cellular (IEC) therapy programs that are independent of a transplant program. Standards specific to IEC therapy are also contained within the FACT-JACIE Hematopoietic Cellular Therapy Standards for programs that perform both transplant and IEC therapy.  To ensure that the Standards reflect emerging changes in the field, FACT delayed the publication of the second edition to incorporate the expertise of providers with Tumor Infiltrating Lymphocyte (TIL) experience.  The committee has resumed its work and plans to publish the draft for a second public comment period in late 2022.

FACT Common Standards for Cellular Therapies, Draft Third Edition

The draft third edition FACT Common Standards for Cellular Therapies was published in 2021 for public comment. The Common Standards Committee consists of members representing a wide variety of specialties to ensure the Common Standards continue to represent the basic fundamentals applicable to any type of cellular therapy.  This includes HPC transplantation, IEC therapy, cardiovascular medicine, cord blood banking, cell collection, and cell processing with minimal and more-than-minimal manipulation. The third edition is scheduled to be published soon.

NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, Draft Eighth Edition

The Steering Committee kicked off the drafting of the eighth edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration in May 2021, and subcommittees have been meeting for the past year.  The Steering Committee will meet during the 2022 Cord Blood Connect meeting in Miami, Florida to complete a final review of the draft prior to public comment, which is scheduled for late 2022.


Examples of Label Reconciliation Methods to Prevent Mix-Ups of Cellular Therapy Products

Posted in :: 2022 Volume 2 :: Friday, June 17th, 2022

Label reconciliation is now required in the eighth edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Specifically, Standards CM7.2.2.1, C7.2.2.1, and D7.2.3 state: “A system of label reconciliation shall be used to ensure the final disposition of all labels allocated to a specific product is documented.”

The purpose of this requirement is to prevent cellular therapy product mix-ups. As the FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual states, “The purpose of reconciliation is to ensure that all labels have been accounted for and no mix-up occurred. A system for label reconciliation that documents the number and type of labels received by the Collection/Processing Facility, the number of labels used, and the number of labels passed to the Processing Facility or destroyed shall be used.” The scope includes labels with unique identifiers of final products. It does not include labels for patient demographics or internal tracking numbers if they are not uniquely identifying a product, though these labels must still be controlled.

Print-on-demand systems for labels reduce risks of label mix-ups; however, there are instances in which a batch of labels is printed to facilitate processes. Label reconciliation does not need to be performed in real-time but should at least occur at the end of a process (for example, during cleanup of a processing procedure.)

In addition to the labeling operations requirements outlined in the FACT Coding and Labeling Cellular Therapy Products sections of the Standards (CM7, C7, D7), the following are example methods that may facilitate label reconciliation:

  • Keeping labels in a batch record.
  • Limiting the number of labels that are printed at a given time, and defining in policies what the use of each label will be.
  • Utilizing a form that details the number of labels printed or received, used, passed to another unit, or destroyed. This could be on a collection form or a separate label reconciliation form.
  • Affixing unused labels to the relevant form and crossing through or annotating labels that will no longer be used.
  • Numbering labels (e.g., for 12 labels, label them 1 of 12, 2 of 12, and so on) to facilitate documentation of which label was used where.

Updated Versions of FACT-JACIE Hematopoietic Cellular Therapy Standards and Accreditation Manual Available

Posted in :: 2022 Volume 1 :: Monday, March 7th, 2022

The Eighth Edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration has been updated to Version 8.1, and its accompanying Hematopoietic Cellular Therapy Accreditation Manual has been updated to Version 8.2.

Version 8.1 of the Standards became effective on January 14, 2022. The changes from Version 8.0 to 8.1 are clerical in nature, and organizations accredited under these Standards should already be in compliance. Most of the changes in the Accreditation Manual from Version 8.1 to 8.2 are also clerical. Substantive content changes to the manual reaffirm and clarify donor screening and donor lymphocyte infusion (DLI) eligibility requirements. Reference Appendix V in both documents for a summary of the changes.

The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products.

FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.

The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.

Download the updated Standards, Manual, and Summary of Changes

Purchase printed copies of the 8.1 Edition FACT-JACIE Standards

Purchase printed copies of the 8.2 Edition Hematopoietic Cellular Therapy Accreditation Manual


FACT and JACIE Remained Committed to Publishing the Eighth Edition Hematopoietic Cellular Therapy Standards Despite Worldwide Pandemic

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

As an international Standards Committee, the FACT-JACIE Hematopoietic Cellular Therapy (HCT) Standards Committee is accustomed to remote collaboration. Its ability to work primarily online was brought to the test during the COVID-19 pandemic in 2020, and the committee rose to the challenge! The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and its accompanying Accreditation Manual were published on May 17, 2021.

“Even with the challenges of a pandemic combined with very rapid advances in the field, amiable dedicated colleagues allowed successful completion of the task,” says Dr. Paul Eldridge, Chair of the Standards Committee. “I want to express my thanks and gratitude to everyone.”

Dr. Kim Orchard, Co-Chair of the Clinical Standards Subcommittee, adds, “The preparations for the eighth edition of the Standards proceeded with only minimal delays due to the COVID-19 pandemic. Credit is due to all those involved who continued to review and prepare the Standards despite the impact on their work and personal lives.”

“It was a challenge to continue with everything during the pandemic,” according to Dr. Nina Worel, Co-Chair of the Collection Standards Subcommittee. “Not so much with the FACT-JACIE team working on the eighth edition as the time schedule is perfect. We are used to working remotely and the meetings always close on time, but this time there were a lot of other additional meetings that were remote.”

“We managed to have the second face-to-face meeting of the combined FACT and JACIE teams just before the full impact of the first wave occurred, and all subsequent meetings were held by remote means which were already planned,” says Dr. Orchard. “Credit is due to all those involved who continued to review and prepare the Standards despite the impact on their work and personal lives.”

The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products. FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.

The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.

The HCT Standards Committee consists of 64 expert members among a Steering Committee and five subcommittees that reviewed clinical, collection, processing, quality, and immune effector cell (IEC) requirements. These members reside in 14 countries, contributing a truly international perspective to the Standards.

Following months of initial reviews and revisions, the HCT Standards Committee considered approximately 770 comments, submitted by 78 participants from 20 countries, during the public comment period. Additionally, other experts from FACT and JACIE participated in discussions related to new developments in the field, including Dr. John Snowden, member of the JACIE Committee and secretary of the European Society for Blood and Marrow Transplantation (EBMT), the FACT Immune Effector Cell Task Force, and others. These experts provided the HCT Standards Committee advice to consider when finalizing the Standards, with revisions ultimately drafted by the Standards Committee and approval granted by the FACT and EBMT Boards of Directors.

“It was really exhausting [with the other remote meetings]. However, we managed to finalize a great new edition of Standards for best quality in cellular therapy for our patients,” says Dr. Worel.

“It was a pleasure to work with committee members on the new edition of standards,” says Dr. Eldridge. “The opportunity to learn from such a diverse group of international experts is amazing.”

The eighth edition Standards become effective on August 16, 2021. All organizations accredited under these Standards are expected to be in compliance with the requirements by that date. Although there may be a few inspections remaining to be completed under the previous edition due to COVID 19-related delays, all other inspections scheduled after this date will be under the eighth edition.

Review the Summary of Changes for the eighth edition FACT-JACIE Standards

Download the eighth edition FACT-JACIE Standards for free

Download the eighth edition Hematopoietic Cellular Therapy Accreditation Manual for free

Purchase printed copies of the eighth edition FACT-JACIE Standards

Purchase printed copies of the eighth edition Hematopoietic Cellular Therapy Accreditation Manual

Download additional supporting documents


The X Factor: What is GxP and What Training is Required?

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

The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration requires that physicians and staff have annual training in current GxP appropriate to the processes performed in accordance with Applicable Law. (See Standards CM3.3.4, C4.4.2.5, and D4.4.2.5).

What is GxP?

The Standards define GxP as, “Good practice following various quality standards and regulations. The “x” is variable, with further definition of good practices defined by different Applicable Law and industry standards. The type of work that is being performed will define which GxPs should be followed.”

Different facilities will follow different GxPs based on the activities they perform. These may include, but are not limited to, Good Manufacturing Practices (GMPs), Good Tissue Practices (GTPs), Good Documentation Practices (GDPs), Good Clinical Practices (GMPs), and Good Laboratory Practices (GLPs).

What GxPs require annual training per the Standards?

 FACT requires training in all GxPs that are required by law. Accredited facilities must determine which GxPs apply to the activities they perform and for the types of cellular therapy products for which the cells will be used. This includes an assessment of all activities and determination of which GxPs are required by law for each of those activities. Facilities must document this assessment so 1) the program has a defined list of GxPs that require training and 2) inspectors can verify appropriate training is performed.

All Apheresis Collection and Processing Facilities will have activities applicable to GTPs and GDPs. All Marrow Collection Facilities will have activities applicable to GDPs, but may also perform activities related to GTPs. Collection and Processing Facilities may also need to follow GMPs, GCPs, or GLPs. The extent and level of GMPs implemented is dependent on the type of manufacturing that is performed (e.g., manufacturing of allogeneic minimally manipulated HPC cellular therapy products verses investigational and licensed cellular therapy products).

How much training is required each year?

Comprehensive training on every aspect of GxPs each year is not expected; rather, there must annually be some training based on a GxP topic.

Many of the procedures performed by personnel already require training in GxPs to perform the work; therefore, GxP training is not required to be separate. However, documentation must provide evidence that the GxPs were included. For example, training in environmental control could include an overview of GTPs or GMPs, the relevant requirements based on the work to be performed, and the specific tasks performed by personnel.

Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards

Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual


Navigating the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards Webinar

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

The eighth edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards was published on May 17, 2021 and will be effective on August 16, 2021. To support FACT accredited and applied programs during this transition, FACT is offering a webinar, titled Navigate the Eighth Edition Cellular Therapy Standards, on July 21, 2021 at 10 am CT, 3 pm GMT. Dr. Paul Eldridge from Levine Cancer Institute, the Standards Committee Chair, will explain changes including:

 

  • Genetically-modified cellular therapy products
  • Training in GxP
  • Quality management
  • Informed consent
  • Labeling
  • Storage

 

 


FACT-JACIE Hematopoietic Cellular Therapy Standards to be Published in May

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

The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is finalizing the eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (HCT Standards). The updated editions will be published by May 17, 2021. Following a 90-day transition period, the requirements will be effective on August 16, 2021. To receive announcements of the publications and direct links to the new Standards, Accreditation Manual, and associated documents, subscribe for the FACT newsletter by creating an account at www.factwebsite.org.

FACT committee representatives are also nearing completion of the draft second edition FACT Standards for Immune Effector Cells. Publication of these Standards is planned following publication of the HCT Standards. This change in schedule will allow FACT to place priority on updating related accreditation documents for programs accredited under the HCT Standards, whose inspections were disproportionally affected by COVID-related delays.


Eighth Edition NetCord-FACT Cord Blood Banking Standards Development Begins

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

The eighth edition of the NetCord-FACT Cord Blood Banking Standards is officially in development under the leadership of FACT’s new Standards Committee Chair, Dr. Nicole Prokopishyn. The Cord Blood Standards Steering Committee kicked off the process on April 22, 2021.

Any suggestions or comments regarding the Cord Blood Standards are welcome. Please provide  feedback to FACT’s new Standards Development Manager, Monique Summers, at monsummers@unmc.edu.


New Chair of Standards Development Announced

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

The FACT Board of Directors is pleased to announce the appointment of Dr. Nicole Prokopishyn to serve as the next Chair of Standards Development beginning with the 8th Edition of Cord Blood Standards slated to kick off in Spring 2021. Dr. Prokopishyn currently serves as the Cellular Therapy Lab Director at the Alberta Blood and Marrow Transplant Program: Foothills Medical Centre, Alberta Children’s Hospital, Tom Baker Cancer Centre, and Calgary Laboratory Services, and has several years of experience serving as a member of the Standards Committee.

Dr. Prokopishyn follows the dedicated leadership of Dr. Paul Eldridge, who chaired the Standards Committee during the review and updating of each set of Standards. Thank you for your valuable contributions, Dr. Eldridge!

 

 

 


New Editions of FACT-JACIE Hematopoietic Cell Therapy and FACT Immune Effector Cell Standards to be Published in May

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

The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is completing the final review of the draft eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. FACT committee representatives are also nearing completion of the draft second edition FACT Standards for Immune Effector Cells.

FACT thanks the many participants of the public comment period for providing useful feedback on the drafts. Approximately 770 comments, submitted by 78 participants from 20 countries, enriched the Standards development process and edits have been made in response when appropriate. FACT will provide a response to comments at the time of final publication of the Standards.

The updated editions will be published by May 17, 2021. Following a 90-day transition period, the requirements will be effective on August 16, 2021. To receive announcements of the publications and direct links to the new Standards, Accreditation Manual, and associated documents, subscribe for the FACT newsletter by creating an account at www.factwebsite.org.

 


Standards Coordinating Body Requesting Feedback on Needed Standards: Comments Due November 6

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

The Standards Coordinating Body (SCB) is seeking input from the regenerative medicine community to update its report: Community Perspectives: Needed Standards in Regenerative Medicine. The content and potential impact of this report on the development of future standards may impact FACT stakeholders, and we encourage volunteer inspectors and personnel from accredited organizations to complete the survey. The survey will be available until November 6, 2020 at 12 pm Eastern Standard Time.

Per the SCB, this report, “is intended to align community efforts around the standards that could have the greatest benefit to the regenerative medicine field and improve the safety and quality of regenerative medicine products. Your input will ensure that the report reflects the current needs and perspectives of stakeholders in the community, helping to direct time and resources toward the highest-priority standards.”

Take the survey


Last Call! Submit Comments on Draft Standards by August 30

Posted in :: 2020 Volume 6 :: Monday, August 24th, 2020

Feedback on draft Standards is a critical step of updating requirements to remain relevant and useful to the current state of cellular therapy. Comments will be accepted on two sets of draft Standards through August 30, 2020. This is a direct way to make your thoughts known on any requirement because each comment is reviewed by the Standards Committee. Do you support the new requirements? Is there a standard that you find to be unclear? Let us know!

The following are descriptions and pertinent links for the two drafts available for review. As a peer-driven organization, we look forward to your feedback!

For questions or assistance, please contact Andra Moehring, MHA, Standards Development Manager.

FACT – JACIE International Cellular Therapy Standards

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) published the draft Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment. These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, or cord blood.

Description and Instructions for Review and Comment

Summary of Changes

Draft Eighth Edition FACT-JACIE International Standards

Comments regarding the draft Eighth Edition FACT-JACIE International Standards can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.

FACT Standards for Immune Effector Cells

The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft Second Edition FACT Standards for Immune Effector Cells for inspection and public comment. These Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes, but is not limited to, genetically engineered chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.

Description and Instructions for Review and Comment

Summary of Changes

Draft Second Edition FACT Standards for Immune Effector Cells

Comments regarding the draft Second Edition FACT Standards for Immune Effector Cells can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.


FACT Resources to Assist Your Program Throughout the Accreditation Process

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020

FACT aims to provide organizations with valuable resources to aid in achieving and maintaining their accreditation. Our website has useful documents for organizations in all phases of the accreditation process. However, we understand that finding the right information can become overwhelming at times especially for organizations completing their initial application or for personnel new to the accreditation process.

The following overview provides categories, definitions, and the location of important resources. We encourage you to share this information with all personnel involved in your organization’s FACT accreditation process:

FACT Standards

The FACT Standards webpage contains links to the most recent versions of the four sets of Standards published by FACT:

  • HCT StandardsFACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration
  • Common StandardsCommon Standards for Cellular Therapies
  • Immune Effector StandardsStandards for Immune Effector Cells
  • Cord Blood Bank StandardsNetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration

The pages for each set of Standards contain useful documents relevant to the current editions of FACT Standards, including, but not limited to:

  • FACT Standards and Accreditation Manuals
  • Summary of Changes, Compare, and Crosswalk documents to identify changes between the previous and current versions of FACT Standards, if applicable.
  • Forms used during the compliance application submission, including but not limited to Document Submission Requirements, Educational Activities, Critical Electronic Record Systems, and Facility Site Grids.

 The above resources can also be found in the Cellular Therapy Library and Cord Blood Bank Library.

Accreditation Process Requirements

The Cellular Therapy Accreditation Process Requirements and Cord Blood Bank Accreditation Process Requirements provide a structured overview of the accreditation process, from completing the Compliance Application to requirements after the on-site inspection.

Self-Assessment Tools

The Self-Assessment Tools can be used to assess readiness for FACT accreditation. They are located in the Cellular Therapy (CT) and Cord Blood Bank (CB) Libraries, and you will find individual self-assessment tools for each current set of FACT Standards:

Educational Resources

FACT’s comprehensive, robust training and development program is responsive to the current needs of inspectors and organizations, providing extensive opportunities for all skill levels in all corners of the world. With a focus on real-life examples and practical application, FACT educational sessions provide tools not only for achieving accreditation, but for ensuring quality patient care in accordance with the Standards. The Education and Resources page contains links to upcoming and previously recorded events:

FACT Accreditation Coordinator

FACT’s Accreditation Coordinators provide these and additional FACT resource links in an email sent to organizations at the beginning of the compliance application process. Your accreditation coordinator is available throughout the accreditation process to answer questions via email or phone. The coordinator’s contact information is available in the accreditation portal.

Clinical Outcomes Resource Center

FACT supports blood and marrow transplant (BMT) programs’ efforts to evaluate one-year survival data to improve patient outcomes, advance the field, and maintain payer and public confidence. The Clinical Outcomes Resource Center includes comparative data sources, educational resources, guidelines for corrective action plans (CAP), as well as CAP examples.

Data Management Resource Center

The FACT-CIBMTR Data Audit Committee reviews implementation, adequacy, and effectiveness of corrective action plans with the goal of providing education and assistance to programs throughout the accreditation cycle to achieve quality improvement in data management. The Data Management Resource Center provides CIBMTR and educational resources, guidelines for data management submissions and examples, and audit report examples and templates.

Immune Effector Cells (IEC) Resource Center

FACT is committed to supporting efforts to make quality immune effector cellular therapy accessible to patients much like it did for blood and marrow transplantation and cord blood banking. Several resources are available to assist with understanding immune effector cells and implementing FACT Standards. The Immune Effector Cells (IEC) Resource Center includes resources to assist with understanding immune effector cells and implementing applicable FACT Standards.

Portal Resource Center

The Portal Resource Center provides access to all available resources and training materials for navigating and assisting organizations in completing applications in the portal.

FACT News

Use the links below to access recent news releases, as well as current and previous volumes of our newsletter:

We hope that you find this information useful as you prepare for your next accreditation cycle. If you have additional suggestions regarding how FACT can better inform organizations of the resources available, please email fact@unmc.edu.


REMINDER: Public Comment Period Open for FACT Cellular Therapy Standards and Immune Effector Cell Standards

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020

FACT – JACIE International Cellular Therapy Standards

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) published the draft Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment. These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, or cord blood.

Description and Instructions for Review and Comment
Summary of Changes
Draft Eighth Edition FACT-JACIE International Standards

Comments regarding the draft Eighth Edition FACT-JACIE International Standards can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.

FACT Standards for Immune Effector Cells

The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft Second Edition FACT Standards for Immune Effector Cells for inspection and public comment. These Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes, but is not limited to, genetically engineered chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.

Description and Instructions for Review and Comment
Summary of Changes
Draft Second Edition FACT Standards for Immune Effector Cells

Comments regarding the draft Second Edition FACT Standards for Immune Effector Cells can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.

For questions or assistance, please contact Andra Moehring, MHA, Standards Development Manager.


Publication of the NetCord-FACT International Cord Blood Standards, Seventh Edition

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

FACT is pleased to announce the publication of the Seventh Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration on October 15, 2019. The Standards will become effective on January 15, 2020. Congratulations to Dr. Paul Eldridge, FACT Standards Chair, and the NetCord-FACT Cord Blood Standards Committee on publishing the new edition of Cord Blood Standards.

Committee Overview

The Seventh Edition NetCord-FACT Cord Blood Standards Committee is comprised of one steering committee, three subcommittees, and a total of 30 representatives. The standards development process commenced in January 2018. The committee’s commitment, expertise, and experience is invaluable to the development of these Standards.

The Standards contain important additions and changes to requirements to reflect current processes typical in a cord blood bank. These changes maintain the relevance of the Standards in the cord blood field.

Accessing the Standards and Other Resources

To improve your experience on our website, the FACT Standards webpage was updated with the Cord Blood Standards, accompanying Accreditation Manual, and other associated documents. These are available to download for free at: http://www.factwebsite.org/cbstandards/. Printed copies can be purchased online at the FACT Store.

There is a new tool highlighting the changes.  A redlined compare document highlighting edits from the 6th to 7th edition is now available.

Accreditation Services

FACT Accreditation Services notified cord blood banks affected by the new edition prior to  publication to discuss the transition. We understand the effort required to complete the accreditation process and are ready to assist banks with timely submission of compliance applications in accordance with the new edition of Standards.

If you have additional questions, please contact your FACT Accreditation Coordinator.


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