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


FACT Education Events

Posted in :: 2019 Volume 9 :: Thursday, September 26th, 2019

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 2
October 9, 2019
Webinar

The second webinar in this two-part series will be on Wednesday, October 9, 2019 at 11:00 am ET. Part two includes information from Dr. Joseph Alvarnas from City of Hope. Dr. Alvarnas will give his perspective as a hospital administrator in regard to the following:

  • Agreements with Manufacturers
  • Reimbursement

View meeting details and register

Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar

This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, FACT Standards Development Chair, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.

View meeting details and register

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!

FACT will conduct a Cellular Therapy Inspection & Accreditation workshop on February 18, 2019, at the World Center Marriott in Orlando, Florida. This workshop will provide an immersive experience for personnel preparing for the accreditation process and a full day training session for FACT inspector trainees.

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


Development of the Eighth Edition FACT-JACIE Standards

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

By: Andra Moehring, MHA, FACT Standards Development Manager

The FACT-JACIE Standards Steering Committee initiated the development of the Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration this summer.

On July 2, 2019, FACT-JACIE Steering Committee members met in Barcelona, Spain to review the Standards Development process and timeline, and discuss specific issues that require review and consideration for this edition.

During the meeting, the committee reviewed and discussed feedback submitted by our colleagues via the FACT-JACIE Standards survey that was distributed in April 2019. FACT and JACIE appreciate the time and effort that went into providing feedback to help us improve our Standards. The survey was completed by 106 total respondents, in 19 different countries, who provided over 800 comments. Thank you for your feedback!

The subcommittees will begin their review next month, and will provide our colleagues with another opportunity to submit feedback during the public comment period scheduled for April 2020.

Final publication of the Eighth Edition FACT-JACIE International Standards is scheduled for March 2021.

FACT- JACIE Standards Steering Committee in Barcelona, Spain, on July 2, 2019 preparing for the development of the Eighth Edition Standards.


Preparations for the Seventh Edition NetCord-FACT International Cord Blood Standards

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

By: Andra Moehring, MHA, FACT Standards Development Manager

FACT is preparing for the publication of the Seventh Edition NetCord-FACT International Cord Blood Standards and we are here to help you do the same! The following upcoming events will provide information regarding changes to the Standards and how to comply:

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

The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp track, and a FACT Inspector Training Track. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.

Topics will include:

  • Global perspectives of the regulation of cord blood banking,
  • WMDA serious adverse events and reactions,
  • Analysis of CD34+ and CD45+ cells in thawed cord blood samples,
  • Analysis of cellular viability in thawed cord blood,
  • Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards, and
  • Essential Quality Management Principles

The afternoon offers two tracks:

WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.

FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.

This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. We encourage banks to send multiple personnel to be able to attend both the Quality Boot Camp and nominate a member of your team to train to become a FACT inspector!

View meeting agenda

Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar

This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.

View meeting details and register

The Seventh Edition NetCord-FACT International Cord Blood Standards for Collection, Banking, and Release for Administration will be published on October 15, 2019 and will become effective on January 15, 2020.


Comments Requested About Needed Standards for Regenerative Medicine

Posted in :: 2019 Volume 6 :: Thursday, June 13th, 2019

The Standards Coordinating Body (SCB) and Nexight are requesting comments on a report titled, Community Perspectives: Needed Standards in Regenerative Medicine. The report outlines prioritized areas in cell therapy, gene therapy, and tissue engineering. Comments are due by June 19, 2019.

Per the SCB website, “One of SCB’s goals since its inception has been to strengthen the identification and prioritization process for advancing regenerative medicine standards through greater community engagement, a goal we outlined in Realizing the Promise of Regenerative Medicine Therapies: Strengthening the Standards Development Process. The methodology we used to create the report on needed standards allowed us to implement many of these process improvements.”

This report was drafted under contract for the United States Food and Drug Administration (FDA) and has the potential to be influential in the direction the cellular therapy field takes toward standardization. Your comments as experienced professionals are critical to charting the path.

Send comments to Sarah Lichtner at slichtner@nexightgroup.com by June 19.


The Standards Coordinating Body Gives Cellular Therapy Programs and Cord Blood Banks a Voice

Posted in :: 2019 Volume 6 :: Thursday, June 13th, 2019

The Standards Coordinating Body (SCB) was formed as an answer to the Advancing Standards in Regenerative Medicine Act, and holds contracts with the Food and Drug Administration (FDA) to advise the agency on needed standards in regenerative medicine. It formally supports many standards development efforts in conjunction with other organizations. FACT is an engaged member organization and participates in SCB projects and provides regular feedback as requested by the SCB.

Did you know that the transplant and cord blood banking communities are critical to the SCB’s efforts?

Although “regenerative medicine” is a very broad term with connotations related to “new” or “novel” therapies, many of the SCB’s projects relate to issues in which FACT-accredited organizations have decades of experience. Accredited organizations are often the facilities that collect cellular starting material, perform contract manufacturing or supportive processing and cryopreservation procedures, or clinically support specialties not yet experienced in cell and gene therapies. Even those organizations that are not directly involved have had to evaluate, resolve, and manage solutions to the very challenges newer players in cell and gene therapies are struggling with now.

Please share your experiences and expertise with the Standards Coordinating Body!

Your input will assist the SCB with its mission, inform commercial manufacturers and other specialties on inherent differences in cell and gene therapies, and promote solutions that harmonize with existing Standards and regulations. The SCB’s outputs could directly impact your daily work and, more importantly, help expedite availability of therapies to patients sooner rather than later. Express your interest in participating in SCB projects to Dawn Henke, SCB Senior Technical Program Manager, at dhenke@regenmedscb.org.

The following are notable SCB initiatives that are likely of interest to many FACT-accredited organizations. There are many more that may be intriguing based on professional interests. For a full listing of projects and reports, visit the SCB’s website at https://www.standardscoordinatingbody.org.

  • Cell Collection Standards for Cell Therapies: FACT, SCB, commercial manufacturers, and many other organizations have heard, loud and clear, that apheresis facilities are struggling with the increasing volume of effort required of variable collection and audit requirements. This project group is currently formulating surveys to distribute to industry and apheresis facilities to learn what needs could be reconciled and then standardized.
  • Cryopreservation of Cells (PDA-led project): Many commercial manufacturers have sought best practices related to cryopreservation and have had to adjust those practices to fit the needs of their particular cellular therapy products. This project group is drafting a framework on which to establish cryopreservation procedures in the hope to standardize requirements when possible.
  • Transportation Requirements of Cells for Therapeutic Use: Shipping and transportation have a direct and significant influence on chain of custody and chain of identify of cellular therapy products, and is of great interest to commercial manufacturers. This project group is working to identify gaps in current Standards. Due to the emphasis on shipping and transportation requirements in FACT Standards, efforts to remain harmonization with these existing Standards will prevent conflicting requirements.
  • Community Perspectives: Needed Standards in Regenerative Medicine Report: This report, based on input from many stakeholders, outlines needed standards that could have the greatest benefit to the safety and quality of regenerative medicine products. The draft is currently available, and will be updated as needed based on comments the SCB received during its recent public comment period in May 2019.

 

 

 


Prepare for the NetCord-FACT International Cord Blood Standards, Seventh Edition

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

By: Andra Moehring, MHA, FACT Standards Development Manager

The Seventh Edition NetCord-FACT International Cord Blood Standards for Collection, Banking, and Release for Administration will be published on October 15, 2019 and will become effective on January 15, 2020.

Programs currently pursuing renewal or initial accreditation under the Sixth Edition Standards must remain mindful of these dates and ensure timely submission of pre-inspection materials and completion of the inspection. All cord blood banks obtaining accreditation under the Sixth Edition Standards must submit Compliance Applications and associated documents by October 15, 2019, and be inspected by January 15, 2020.

After October 15, 2019, materials for the Seventh Edition Standards will be available. The FACT Accreditation Services department has contacted accredited and applicant cord blood banks who will begin the accreditation process at the time of publication to discuss the transition. We understand the effort required to complete the accreditation process and will be ready to assist banks with timely submission of the Compliance Application in accordance with the new edition.

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

As FACT is preparing for the Seventh Edition Standards, we are here to help you do the same! The following upcoming events will provide information regarding changes made and how to comply:

Thursday, September 12, 2019:  Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards presentation at the WMDA-NetCord & FACT Cord Blood Day at the Cord Blood Connect International Congress.

View meeting details and register

Wednesday, October 23, 2019: Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards webinar. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards and provide examples for effective implementation.

View webinar details and register


Feedback Requested: FACT-JACIE Standards

Posted in :: 2019 Volume 4 :: Wednesday, April 17th, 2019

By: Andra Moehring, MHA, FACT Standards Development Manager

Preparation of the Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration will commence this summer. Final publication is expected in March 2021.

FACT and JACIE invite you to complete a short survey focusing on general concepts of interest. You are also encouraged to promote this survey in your national or regional professional society. Responses will be accepted through June 1, 2019.

The results of this survey will be reported to the Standards Steering Committee for review and consideration.

Complete Survey


College of American Pathologists Recognized as an Accrediting Organization Providing Histocompatibility Services Appropriate for Hematopoietic Cellular Therapy Transplant Patients

Posted in :: 2019 Volume 4 :: Wednesday, April 17th, 2019

By: Andra Moehring, MHA, FACT Standards Development Manager

The Seventh Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration require (B2.14) “Clinical Programs performing allogeneic transplantation shall use HLA laboratories that are … accredited by the American Society for Histocompatibility and Immunogenetics (ASHI), the European Federation for Immunogenetics (EFI), or other accrediting organizations providing histocompatibility services appropriate for hematopoietic cellular therapy transplant patients.” Similar standards exist in the FACT Common Standards (B2.9), the NetCord-FACT Cord Blood Standards (B5.6), and in the FACT Immune Effector Cell Standards (B2.9).

To facilitate a fair and objective assessment of appropriateness, the HLA Typing Accreditation Committee of FACT, JACIE, NetCord, and NMDP developed Guidelines for Histocompatibility Typing Standards and Accreditation Programs. These Guidelines will be reviewed every three years and revised appropriately. Each applicant accrediting organization is required to submit documentation to FACT for review by the HLA Typing Accreditation Committee that demonstrates appropriateness of its standards and accreditation program for the relevant population.

The College of American Pathologists (CAP) submitted its documentation to FACT for review. During the review and feedback process, it was clear that CAP had a significant commitment to being recognized by FACT as an accrediting organization providing histocompatibility services appropriate for hematopoietic cellular therapy transplant patients.

The FACT Board of Directors voted to approve CAP as an accrediting organization providing histocompatibility services appropriate for hematopoietic cellular therapy transplant patients. With this approval, CAP will be accepted in FACT Accreditation applications and included in FACT Standards. CAP will include the HLA Typing Accreditation Committee during its review and revisions of Standards and Checklists on an annual basis to ensure continued appropriateness for inclusion in FACT’s Standards and Accreditation Program.

 

 

 

 


FACT Remote Director Policy

Posted in :: 2019 Volume 4 :: Wednesday, April 17th, 2019

By: Cassie Kennedy, BS, FACT Accreditation Coordinator

All editions of FACT-JACIE International Standards for Hematopoietic Cellular Therapy, NetCord-FACT Standards for Cord Blood Banking, FACT Common Standards, and FACT Immune Effector Cell Therapies require that there be Directors and Medical Directors of the program, bank, and participating facilities. Standards define specific qualifications and responsibilities, but are silent on residency requirements and on the distances among accredited programs or facilities for which one individual serves as director.

Remote Directors and Medical Directors are those directors with professional responsibilities in more than one metropolitan geographic area, or those whose residence is outside of the metropolitan geographic area of the accredited facility. The FACT Accreditation Committees have increasingly noted instances of remote directors who purportedly are responsible for two or more accredited facilities outside of a single metropolitan area, hundreds of miles apart, or in another country. Most commonly, these facilities are apheresis centers, processing facilities, or cord blood banks; however, clinical program directors also have raised similar questions. The concern is whether or not the Collection and Processing Facility Directors who oversee multiple sites in various states or regions,  or who live in states or countries distant from the accredited facilities they oversee, are present enough to fulfill the role as intended in the Standards.

The Remote Directors Task Force

The Task Force was constituted in July 2017 to develop recommendations regarding minimal on-site requirements, or suitable alternative arrangements, for Directors and Medical Directors of FACT-Accredited Apheresis Collection Facilities, Processing Facilities, and Cord Blood Banks.

The Task Force membership was diverse, including directors, medical directors, and non-directors in Cellular Therapy Programs (Clinical, Collection, and Processing) and Cord Blood Banks.

The Task Force reviewed the Director and Medical Director responsibilities as detailed in the Standards. They considered examples of facilities wherein citations were generated at the on-site inspection due to questionable level of director involvement or known location of the director in another state. They also considered the various infrastructures that exist in accredited facilities; the presence or absence of supporting, ancillary, or professional personnel in the facility, including cross-coverage of various functions among the clinical, collection, and processing staff members; and the impact of technology. The Task Force was not able to come to a consensus minimum number of hours or days that any director or medical director must physically be present in a facility to meet the standard.

Guidance for Remote Directors and Medical Directors

Responsibilities for remote directors do not differ from the responsibilities of any director, however, there may be more challenges in completion and documentation of these responsibilities. The following are requirements for remote directors:

  • A director must be fluent in the language of the facility and must meet the minimum credentials, training, experience, competency, and continuing education requirements as defined in the current edition of Standards.
  • A director is responsible to lead the accredited program, facility, or bank and to provide oversight of the services, personnel, products, and procedures.
  • A director is expected to be actively engaged in the decision-making process, policy and procedure development, and quality management activities. This involvement must be documented.
  • When a director is physically not present at the facility site, there must be a qualified designee named and documented to manage those responsibilities that require immediate or in-person attention. Further, all critical director functions must be covered.
  • A qualified designee must meet minimum director qualifications for the delegated function, and have a defined scope of authority and activity.
  • Specific responsibilities of each director and medical director type are defined in the applicable set of Standards and are summarized in the table below. Documentation of director involvement in these responsibilities must be available on-site for review.

Documentary evidence of the remote director’s specific involvement in leadership and oversight of the program, in addition to performance of designated responsibilities, must be available on-site for review by the inspector. Examples of documentation include, but are not limited to:

  • Meeting minutes
  • Record review
  • Personnel review
  • SOP review and approval
  • Donor or recipient management
  • Investigation report review
  • Qualification/validation studies: plan and final report review and approval
  • Planned deviation pre-approval
  • Product release authorization
Cellular Therapy Director TypeApplicable Standards (7th Edition)
Clinical Program DirectorB3.1.3, B3.1.4, B3.1.5, B3.1.5.1, B4.1.1, B4.2.1, B4.7.3.2, B4.10.3.2, B4.13.3, B4.14.2.7, B4.17, B4.18, B5.3.8, B5.3.9, B5.7
Marrow Collection Facility Medical DirectorCM3.1.2.1-CM3.1.2.8, CM5.3.8, CM5.3.9, CM5.7, CM7.2.2, CM7.2.3
Apheresis Collection Facility DirectorC3.1.2, C4.1.1, C4.2.1, C4.10.3.2, C4.13.3, C4.14.2.7, C4.17, C4.18, C5.3.8, C5.3.9, C5.7, C7.2.2, C7.2.3
Apheresis Collection Facility Medical DirectorC3.2.2, C4.10.3.2, C5.3.8, C5.3.9, C5.7
Processing Facility DirectorD3.1.2, D4.1.1, D4.2.1, D4.10.3.2, D4.13.3, D4.14.2.7, D4.17, D4.18, D5.3.7, D5.3.8, D5.7, D7.2.2, D7.2.3, D8.1.1, D8.1.4.5, D8.7.1, D8.9, D11.1.1, D11.1.2.1, D11.1.3.1, D11.3.6, D11.3.8.1
Processing Facility Medical DirectorD3.2.2, D4.9.4, D4.10.3.2, D5.3.7, D5.3.8, D5.7, D8.1.7, D8.10, D11.1.2.2, D11.1.2.3, D12.1.4
Cord Blood Director TypeApplicable Standards (6th Edition)
Cord Blood Bank DirectorAppendix I, B2.11.5, B2.12.3.3, B2.12.5.1, B2.12.5.2, B2.12.5.3, B2.12.6.4, B2.13.1, B2.14.1, B2.14.2.7, B2.19, B3.2.3, B6.2.4.1, B6.2.5, B12.2, D6.4.2
Cord Blood Bank Medical DirectorAppendix I, B2.11.5, B2.12.5.1, B2.12.5.2, B2.12.6.4, B5.5.4.1, B5.5.5, E4.2, E4.3.1
Cord Blood Collection DirectorCord Blood Collection Director
Cord Blood Processing Facility DirectorAppendix I, B2.11.5, B2.12.6.4, D9.2.7

Additional FACT Volunteer Opportunities

Posted in :: 2019 Volume 4 :: Wednesday, April 17th, 2019

By: Andra Moehring, MHA, FACT Standards Development Manager

The Foundation for the Accreditation of Cellular Therapy (FACT) has several committees to help FACT achieve its vision of being the premier organization setting standards and awarding accreditation to programs in the evolving field of cellular therapy.

In addition to other standing committees, FACT has a special committee for which we are seeking volunteers. We invite you to review the charge for the FACT Standards Committee and either nominate yourself or a colleague to serve as a committee member.

­­­­­­­­­­­­­­­Purpose

The FACT Standards Committee drafts standards and guidance for cellular therapy product collection, processing, and administration; and cord blood collection, banking, and release for administration, using evidence-based science and considering evolving uses of cellular therapy.

The committee’s goal is to provide clear and user-friendly FACT standards and effective transition between editions of Standards.

Commitment

  • 3 year term
  • Minimum of 2 three-month periods with weekly or bi-weekly teleconferences
  • Complete initial edits prior to the public comment period
  • Review of public comments submitted
  • Ongoing participation until the development of the next edition of Standards

The majority of the hard work is completed during subcommittee discussions that take place several months before the actual publication of the Standards. The experience and expertise of our volunteer subcommittee members is invaluable to the development of each edition of Standards.

Standard Development Schedule

FACT currently has four sets of Standards, with multiple subcommittees (e.g., Clinical, Collection, Processing, Quality Management, Immune Effector Cell) under each set. The Standards Development process for each upcoming edition of Standards is below:

  • FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (July 2019)
  • FACT Standards for Immune Effector Cells (July 2019)
  • FACT Common Standards for Cellular Therapies (May 2020)
  • NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration. (January 2021)

Volunteers are an essential resource for FACT. Our success and accomplishments are directly attributable to the selfless commitment of our knowledgeable volunteers. FACT’s volunteers bring new ideas and energy to the Foundation. Your volunteering makes a difference in the organization and the cell therapy community.

Please submit your interest in serving as a committee member along with a description of your qualifications to Andra Moehring, FACT Standards Development Manager, at andra.moehring@unmc.edu by May 1, 2019.


Publication of the FACT Common Standards, Second Edition

Posted in :: 2019 Volume 3 :: Thursday, March 14th, 2019

By Andra Moehring, FACT Standards Development Manager

Congratulations to Dr. Paul Eldridge, FACT Standards Chair, and the FACT Common Standards Steering Committee on publishing the Second Edition FACT Common Standards for Cellular Therapies on March 15, 2019. The Standards will become effective on June 15, 2019.

Committee Overview
The Second Edition FACT Common Standards Steering Committee is comprised of 12 representatives who worked for 23 months on the development of the Standards. 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 cellular therapy program. These changes maintain the relevance of the Standards in the field of cellular therapy.

Public Comment Period
During the 60-day public comment period, 240 comments were submitted by 19 contributors. The committee was responsive to public comments and requests made on behalf of related organizations.

FACT greatly appreciates contributors taking the time to review the draft Standards and submit comments.

Accessing the Standards and Other Resources
The Standards, summary of changes, and crosswalks are available on the FACT website at http://www.factwebsite.org or by using the links provided below:

FACT Common Standards, Second Edition
Purchase Printed Copies
Summary of Changes to FACT Common Standards, Second Edition
FACT Common Standards Crosswalk First to Second Edition
FACT Common Standards Crosswalk Second to First Edition

If you have questions related to the Second Edition FACT Common Standards, contact your FACT Coordinator or submit your questions to askfact@unmc.edu.

Thank you for all of your contributions!


Draft Seventh Edition Cord Blood Standards Public Comment Period Extended

Posted in :: 2019 Volume 3 :: Thursday, March 14th, 2019

By Andra Moehring, FACT Standards Development Manager

The draft Seventh Edition NetCord-FACT Cord Blood Standards and accompanying Accreditation Manual were published for public review and comment for a 90-day period on November 30, 2018.  To ensure that members of the cord blood community have reviewed the proposed significant changes in the draft Standards, and have had an opportunity to provide their input, the comment period is extended for an additional 30 days. Comments will now be accepted through April 1, 2019. Links are provided below to the draft Standards, Accreditation Manual, and comment form.

These Standards apply to all phases of cord blood collection, banking, and release for administration, including donor management, collection, processing, testing, cryopreservation, storage, listing, search, selection, reservation, release, and distribution to clinical programs.

Comments on any aspect of the draft are welcome. However, members of the cord blood community are strongly encouraged to specifically review and provide comment on three significant changes proposed in the draft Seventh Edition:

  1. ISBT 128 and Eurocode Coding and Labeling (B6.1.2, Appendix II)
  2. Supplies and Reagents of the Appropriate Grade (B8.4.1)
  3. Viability of CD45 Testing and Specification Requirements (Appendix IV, Appendix V)

Comments regarding the draft Seventh Edition NetCord-FACT Cord Blood Standards can be submitted by accessing the Comment Form.

Description and Instructions for Review and Comment
Draft NetCord-FACT Cord Blood Standards
Draft NetCord-FACT Accreditation Manual

Comments will be accepted through April 1, 2019.

For questions or assistance, please contact Andra Moehring.