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.


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


Updated Donor History Questionnaires Now Available

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

The hematopoietic progenitor cell (HPC), Apheresis and HPC, Marrow Donor History Questionnaire (DHQ) materials were developed by the AABB Interorganizational Uniform Donor History – HPC Task Force to provide establishments with a standardized tool to screen allogeneic HPC donors for communicable disease risk factors in accordance with requirements of the Food and Drug Administration (FDA), AABB, the Foundation for the Accreditation of Cellular Therapy (FACT), and the National Marrow Donor Program (NMDP).

HPC, Apheresis and HPC, Marrow DHQ Version 2.0, June 2019
The HPC, Apheresis and HPC, Marrow Donor History Questionnaire materials have been updated to version 2.0. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.9.

The HPC, Cord Blood DHQ materials were developed by an AABB interorganizational Uniform Donor History – HPC task force to provide establishments with a standardized tool to screen allogeneic as well as related cord blood (HPC, Cord Blood) donors for communicable disease risk factors in accordance with requirements of the Food and Drug Administration (FDA), AABB, Foundation for the Accreditation of Cellular Therapy (FACT), and the National Marrow Donor Program. Allogeneic donors are usually collected at public cord blood banks for use by the general public. Private cord blood banks generally collect related donors for either allogeneic use in a first or second degree relative, or for autologous use. Allogeneic and related cord blood donors are screened for the same risk factors; however, the regulations for using related units allow much more flexibility for distributing the cord blood units for transplantation.

HPC, Cord Blood DHQ Version 1.7, June 2019
The HPC, Cord Donor History Questionnaire materials have been updated to version 1.7. The changes update some FDA guidance document names, dates, and/or website links, located within the DHQ, to the current version. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.6.


Education Events

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

FACT-SBTMO Cell Therapy Accreditation Workshop
July 31, 2019
Brasília, Brazil

This training workshop is designed to explain the requirements of the FACT-SBTMO joint cell therapy accreditation program in Brazil. FACT and SBTMO representatives will be in attendance to:
• Provide an overview of the FACT Standards and accreditation process
• Explain how to integrate quality management into clinical, collection, and cell processing programs
• Examine how to prepare for a successful inspection
• Summarize how controlling documentation can improve your program
• Review commonly cited Standards
• Outline the inspector orientation process
• Answer questions

This workshop is from 8:00 to 13:15 on Wednesday, July 31, 2019.

View meeting details and register 

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! Register before August 31st to receive the special advanced rate!

View meeting agenda

FACT Cellular Therapy Inspection and Accreditation Workshop at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI

This workshop in Madison incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy. Several hot topics include quality management in novel cell therapies, environmental monitoring, and occurrence management. These sessions are designed to help applicants navigate the evolving changes in the field. The agenda also includes training for new inspectors with real-world examples and exercises to guide them through the inspection process. This is a must-see event for the following audiences:

• Blood and marrow transplant (BMT) programs
• Cell processing laboratories
• Physicians, scientists, and principal investigators
• Unit supervisors, laboratory managers, administrators, nurses, and medical technologists

The day includes an applicant track and inspector training track. Inspector trainees are required to attend the inspector orientation track.

We encourage programs to send multiple personnel to attend the various FACT events on September 12.  The FACT Cellular Therapy Inspection and Accreditation Workshop is a must-see for cell processing laboratories, physicians, scientists, and principal investigators, and unit supervisors, laboratory managers, administrators, nurses, and medical technologists.  The ISCT-FACT Quality Boot Camp, which takes place on the same day as the workshop, is essential for program quality managers.

View meeting details and register
View meeting agenda

ISCT-FACT Quality Boot Camp at the 2019 ISCT North America Meeting
September 12, 2019
Madison, WI

Is your lab FACT accredited or looking to comply with FACT standards? Strengthen your quality management programs through this interactive workshop with FACT experts and real world applications.

Focused on issues identified by FACT compliant programs, these sessions will include activities and discussion regarding Document Control, Risk Assessment in the Processing Laboratory, Supply Qualification, and Audit Plans and Writing the Report. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution. This boot camp is applicable not only to academic labs but also relevant for commercial operations.

We encourage programs to send multiple personnel to attend the various FACT events on September 12. The ISCT-FACT Quality Boot Camp is essential for all quality and laboratory personnel. The FACT Cellular Therapy Inspection and Accreditation Workshop, taking place on the same day, is a must-see for Cell processing laboratory personnel, physicians, scientists and principal investigators, administrators and nurses.

View details and register now
View preliminary agenda

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 2
September 25, 2019
Webinar

The second webinar in this two-part webinar series will be on Thursday, September 25, 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, 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 


Education Events

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

Using an Electronic Platform for Accreditation Preparation and Continuous Readiness Webinar
Wednesday, June 26, 11:00 am ET
Webinar

This webinar will be on June 26, 2019 at 11:00 am ET and is FREE OF CHARGE. Trisha Deason, MHA, MSN, RN, NE-BC, Eryn Draganski, AGCNS-BC, OCN, and Jay Maningo-Salinas, PhD, RN, NE-BC, CPHQ, FACHE, from Mayo Clinic Arizona, have graciously agreed to share their tool designed in Microsoft OneNote to be used for continuous readiness and compliance with FACT requirements.

Collecting supporting evidence for accreditation standards can be a daunting task and include a tremendous amount of resources (e.g., paper, binders, charts). Workflows may be inefficient if duplication of efforts occurs across personnel and departments. Use of an electronic source provides an updated mechanism to gather, retain, and share evidence, as well as an organized approach to present all supporting documents to on-site surveyors. Presenters will provide step-by-step instructions on how to build a OneNote FACT e-binder and organize evidence to be used for continuous readiness and/or as a platform to deliver evidence to the FACT survey team.

View meeting details and register online

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 1
Thursday, July 25, 11:00 am ET
Webinar

The first webinar in this two-part webinar series will be on Thursday, July 25, 2019 at 11:00 am ET.  Part one includes information from two centers regarding their journey to successful implementation of commercialized CAR T-cell products. Clinicians will address the challenges faced during the site on-boarding process, where they are in the process, commonly faced impediments to timely delivery of therapy to patients, and suggestions for centers initiating implementation of commercial CAR T-cell products. Topics in this webinar will include required training, maintenance of chain of custody, and mechanisms for reporting outcomes data. FACT accreditation will also be covered.

This is part one of two in the Centers’ Experience with Implementing Commercial CAR T-cell Products series.  Part two will take place in September of 2019 and will include the perspective of a hospital administrator in regard to the following:

  • Agreements with Manufacturers
  • Reimbursement
  • FACT accreditation

View meeting details and register

FACT-SBTMO Cell Therapy Accreditation Workshop
July 31, 2019
Brasília, Brazil

This training workshop is designed to explain the requirements of the FACT-SBTMO joint cell therapy accreditation program in Brazil. FACT and SBTMO representatives will be in attendance to:
• Provide an overview of the FACT Standards and accreditation process
• Explain how to integrate quality management into clinical, collection, and cell processing programs
• Examine how to prepare for a successful inspection
• Summarize how controlling documentation can improve your program
• Review commonly cited Standards
• Outline the inspector orientation process
• Answer questions

This workshop is from 8:00 to 13:15 on Wednesday, July 31, 2019.

View meeting details and register 

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! Register before August 31st to receive the special advanced rate!

FACT Cellular Therapy Inspection and Accreditation Workshop at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will be in attendance to 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.

Two tracks are available for this workshop. The Inspector Track will provide FACT inspectors guidance on how to assess compliance with the Standards. The Applicant Track will give programs and facilities insight into how to comply with the Standards and demonstrate compliance.

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, 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 Countdown is on to Register for FACT Events at the ISCT Annual Meeting!

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

Register Now and Save!

FACT Accreditation Workshop
Join your fellow cellular therapy and cord blood colleagues for several FACT events at the 2019 ISCT Annual Meeting in Melbourne, Australia.  On May 28th FACT will host a Cellular Therapy and Cord Blood Inspection and Accreditation Workshop from 8:00 am to 5:00 pm.  This workshop incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy and cord blood banking. Several hot topics include quality management in novel cell therapies, written agreements, and occurrence management.  Register before May 28th and save $100!

Fees are waived for active and trainee inspectors.  Apply to volunteer and train as a FACT inspector.

ISCT-FACT Quality Boot Camp
On May 29th ISCT and FACT will host a cellular therapy Quality Boot Camp for sessions that include activities and discussions addressing the following: IECs in Your Organizations Quality Plan and Written Agreements, Document Control, Performing Risk Assessment: Real Life Applications, Process Validation 101, and Evaluating and Reporting Audit Results. Register online for the ISCT Pre-Conference Day and attend the ISCT-FACT Cellular Therapy Quality Boot Camp! Note: ISCT Pre-Conference Day registration requires separate registration from the main ISCT Annual Meeting.

FACT Exhibit Booth
FACT representatives will be at exhibit booth #36 to provide information about FACT Standards and Accreditation. We would love to see new and familiar faces!

Exhibit Booth Dates and Times:

Wednesday, May 29th: 19:30 – 21:30
Thursday, May 30th: 09:00 – 19:30
Friday, May 31st: 09:00 – 18:30

Take advantage of these exciting FACT events by registering now! We look forward to seeing you in Melbourne!

 


Education Events

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

FACT Cellular Therapy & Cord Blood Inspection at Accreditation Workshop at the 2019 Annual ISCT Meeting
May 28, 2019
Melbourne, Australia

This workshop incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy and cord blood banking. Several hot topics include quality management in novel cell therapies, written agreements, and occurrence management. These sessions are designed to help applicants navigate the evolving changes in the field. The agenda also includes training for new inspectors with real-world examples and exercises to guide them through the inspection process. This is a must-see event for the following audiences:

• Blood and marrow transplant (BMT) programs
• Cord blood banks
• Cell processing laboratories
• Physicians, scientists, and principal investigators
• Unit supervisors, laboratory managers, administrators, nurses, and medical technologists
• Quality managers

The day includes a general track for attendees with separate breakout sessions for cellular therapy and cord blood participants. Inspector trainees are required to attend the inspector orientation track.

View meeting details and register
View preliminary agenda

ISCT-FACT Quality Boot Camp at 2019 ISCT Annual Meeting Pre-Conference Day
May 29, 2019
Melbourne, Australia

Is your cell processing facility FACT accredited or looking to comply with FACT standards? Strengthen your quality assurance program through this interactive workshop with FACT experts and real world applications.

Sessions include activities and discussions addressing the following: IECs in Your Organizations Quality Plan and Written Agreements, Document Control, Performing Risk Assessment: Real Life Applications, Process Validation 101, and Evaluating and Reporting Audit Results. Register online for the ISCT Pre-Conference Day and attend the ISCT-FACT Cellular Therapy Quality Boot Camp! Note: ISCT Pre-Conference Day registration requires separate registration from the main ISCT Annual Meeting.

View information and register for ISCT pre-conference day

FACT Cellular Therapy Inspection and Accreditation Workshop at CBMTG Annual Meeting
June 5, 2019
Calgary, Alberta, Canada

The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. This workshop will address important topics in the cellular therapy field including:

• Overview of FACT Accreditation Processes
• Common Citations Overview
• Building Quality into Clinical Immune Effector Cell Therapy Programs
• Using the Tracer Methodology to Assess Compliance with FACT Standards
• Improving Data Management Through Follow-Up
• FACT Process for Reviewing Clinical Outcomes

View meeting details and register online

Quality Management Series 9 Webinar: Performing follow-up to assess the effectiveness of the actions implemented on correcting the errors – June 11, 2019

The Quality Management Series Module 9 includes four sessions focused on auditing. The first session, Auditing: Planning and Executing, was held on January 23, 2019. Leigh Poston, BMT Program Quality Management Coordinator at UF Health Shands Hospital, discussed designing audit strategies, identifying specific audits to perform, creating an audit schedule, determining the scope of the audit, and executing the audit. View on-demand webinar

The second session, Auditing: Summarizing and Evaluating the Data, was live on March 6, 2019. Ed Brindle MSc, MLT, Quality Manager at UHN Blood and Marrow Transplant Program, discussed writing the audit report, determining WHY the errors occurred, and assigning appropriate corrective action and preventive action. View on-demand webinar

The third webinar in the QM series 9: Audits, titled Performing follow-up to assess the effectiveness of the actions implemented on correcting the errors, will be on June 11, 2019 at 11:00 am ET. Gordana Svajger, Quality Compliance Program Manager at The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy Program, will identify methods for verification of corrective actions, interpret when corrective actions are effective, and determine when to close an audit.  View webinar details and register

The last session in the series will be, A Program’s Perspective: Auditing. The date and time will be announced when determined.

Register for the entire module to receive a 15% discount! QM Series Module 9: Auditing

Exceeding Expectations: How We Maintain High One-Year Survival
Wednesday, June 12, 3:00 pm ET
Webinar

The FACT Education Committee, in conjunction with the Clinical Outcomes Improvement Committee, is presenting a webinar on June 12, 2019, at 3:00 pm ET, to highlight transplant programs that consistently exceed expected one-year survival rates as reported in the CIBMTR Transplant-Center Specific Survival Report. This webinar will consist of presentations from the Blood and Marrow Transplant Program at Northside Hospital, Vanderbilt University Medical Center, and the FACT inspectors who evaluated them during the most recent inspections. This will be a one-hour webinar, which includes a question and answer session.

Program representatives will discuss the following:
1) how the program analyzes and trends clinical outcomes including survival,
2) aspects of the program believed to contribute to consistently high one-year survival (e.g., processes, guidelines, education, and any other aspect), and
3) any examples of instances in which the program made adjustments after detecting declining survival rates for a given set of patients.

The inspector from each program will discuss his impression of the program and opinions on why the program consistently achieves high survival rates.

View meeting details and register online

Using an Electronic Platform for Accreditation Preparation and Continuous Readiness Webinar
Wednesday, June 26, 11:00 am ET
Webinar

This webinar will be on June 26, 2019 at 11:00 am ET and is FREE OF CHARGE. Trisha Deason, MHA, MSN, RN, NE-BC, Eryn Draganski, AGCNS-BC, OCN, and Jay Maningo-Salinas, PhD, RN, NE-BC, CPHQ, FACHE, from Mayo Clinic Arizona, will provide instruction on design and use of Microsoft OneNote that may be used for continuous readiness and presentation during on site FACT inspections.

Collecting supporting evidence for accreditation standards can be a daunting task and include a tremendous amount of resources (e.g., paper, binders, charts, etc.). Workflows may be inefficient if duplication of efforts occurs across personnel and departments. Use of an electronic source provides an updated mechanism to gather, retain, and share evidence, as well as an organized approach to present all supporting documents to on-site surveyors. Presenters will provide step-by-step instructions on how to build a OneNote FACT e-binder and organize evidence to be used for continuous readiness and/or as a platform to deliver evidence to the FACT survey team.

View meeting details and register online

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! Register before August 31st to receive the special advanced rate!

FACT Cellular Therapy Inspection and Accreditation Workshop at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will be in attendance to 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.

Two tracks are available for this workshop. The Inspector Track will provide FACT inspectors guidance on how to assess compliance with the Standards. The Applicant Track will give programs and facilities insight into how to comply with the Standards and demonstrate compliance.

View meeting details and register


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

FACT Standards Development Activities

Posted in :: 2019 Volume 2 :: Tuesday, February 12th, 2019

FACT Common Standards, Second Edition Nearing Publication

The Second Edition FACT Common Standards for Cellular Therapies will be published on March 15, 2019. Once published, the updated Standards, summary of changes, and crosswalks will be available on the FACT website for reference, and printed copies of the Standards will be available for purchase from the FACT store.

The major objective of the FACT Common Standards for Cellular Therapies is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials. In early stage product development and early phase clinical trials, these Standards provide the quality management infrastructure to facilitate patient and data accrual to advance the therapy.

NetCord-FACT International Cord Blood Standards, Seventh Edition Available for Public Review and Comment

The NetCord-FACT Standards Committee completed its initial review of the draft Seventh Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration.

The draft Standards and accompanying Accreditation Manual are published for inspection and public comment for a 90-day period. Comments will be accepted through April 1, 2019.

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.

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

Comments regarding the draft Seventh Edition NetCord-FACT Cord Blood Standards can be submitted by accessing the Comment Form. Comments will be accepted through April 1, 2019.

Standards Committee to Initiate FACT-JACIE International Hematopoietic Cellular Therapy Standards and FACT Immune Effector Standards Development

FACT is creating the Steering Committee and Subcommittees that will develop the  Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and the Second Edition FACT Immune Effector Cell Standards.

In addition to the existing subcommittees (clinical, collection, processing, and quality management), an immune effector cell subcommittee will be added to the Hematopoietic Cellular Therapy Standards development process to ensure consistency between the two sets of Standards.

Standards development will begin this summer, with the first draft scheduled for public comment in April 2020.

 

 


Cellular Therapy Accreditation Committee News and Notes

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

Article written by Suzanne Birnley, FACT Accreditation Coordinator

The Cellular Therapy Accreditation Committee reviews Accreditation Reports for programs inspected under the FACT-JACIE International Standards for Hematopoietic Cellular Therapy, the FACT Common Standards for Cellular Therapies, and the FACT Standards for Immune Effector Cells.  After review, the committee makes recommendations to the FACT Board of Directors regarding an applicant’s accreditation status.

The first quarter of 2018 has been an exciting and busy one for the committee.  Despite no meeting in February due to the BMT Tandem meetings, the committee was still able to review 13 programs for renewal accreditation in January and March 2018.  Additionally, the committee reviewed the first program to apply for standalone accreditation under the FACT Standards for Immune Effector Cells.

The following are some notes regarding the function of the Cellular Therapy Accreditation Committee:

  • At each meeting, as deficiencies indicate potential needs for revisions or additions to future sets of FACT Standards, the issues are compiled into a list for future review by the Standards Committee. This feedback from the Cellular Therapy Accreditation Committee promotes improvement and greater clarity with each publication of Standards.
  • As programs complete the renewal accreditation process, in addition to the inspector’s assessment, they will be reviewed by the FACT-CIBMTR Data Audit Committee and possibly the Clinical Outcomes Improvement Committee. Recommendations related to data management and clinical outcome deficiencies are considered by the Cellular Therapy Accreditation Committee when determining the accreditation outcome for an applicant.
  • One of the most commonly cited requirements is validation. A satisfactory validation will include the following at a minimum:
    • An approved validation plan, including conditions to be validated
    • Acceptance criteria
    • Data collection
    • Evaluation of data
    • Summary of results
    • References, if applicable
    • Review and approval of the validation plan, validation report, and conclusion by the Quality Manager or designee and the Clinical Program Director/Facility Director or designee

The seventh edition of the FACT-JACIE Standards for Hematopoietic Cell Therapy was published at the beginning of March 2018.  Programs must be compliant with this set of Standards by May 30, 2018.  It is important for programs to remember that as they add new accredited services, such as immune effector cellular therapy or more than minimal processing, these must be implemented in compliance with the FACT Standards and reported to FACT.  Additionally, if your program uses or plans to use contracted services in your organization, you are responsible for notifying FACT and monitoring the accreditation status of those service providers.


Cellular Therapy Accreditation Committee News and Notes

Posted in :: 2018 Volume 1 :: Thursday, February 15th, 2018

The Cellular Therapy (CT) Accreditation Committee has been busy in 2017 reviewing inspection results for 107 programs, including 5 new programs applying for their initial accreditation.  The committee reviews accreditation reports for programs inspected under the FACT-JACIE International Standards for Hematopoietic Cellular Therapy, the FACT Common Standards for Cellular Therapies, and the FACT Standards for Immune Effector Cells.  After review, the Committee makes recommendations to the FACT Board of Directors regarding an applicant’s accreditation status.

The following are points of interest regarding the CT Accreditation Committee:

  • The committee is comprised of volunteer members from FACT-accredited programs representing clinical, collection, and processing expertise.
  • Inspectors are encouraged to join committee meetings when their reports will be discussed to provide answers to committee members’ questions. This provides a helpful source of information to the committee when making accreditation outcome decisions.
  • Compliance issues noted by inspectors are used for recommendations to the Education Committee to incorporate into inspector training and for FACT workshops and boot camps.
  • Commonly cited deficiency data is compiled for publication along with recommendations for programs to avoid those deficiencies. The data is also considered by FACT when revising standards.

The next year looks to be busier than ever with increasing numbers of accredited programs, programs expanding their range of accredited services, and the publication of the seventh edition of the Hematopoietic Cellular Therapy Standards.  Also in the coming year will be a public comment period for the next edition of the Common Standards.  Additional information about the new Standards will be published leading up to March, so be sure to keep an eye on the FACT website and your email inbox for more information.

Article written by Suzanne Birnley, MS, MBA


Now Available – Interim FACT-JACIE Standards for Immune Effector Cells

Posted in :: 2017 Volume 1 :: Thursday, January 26th, 2017

Through the work of the Immune Effector Cell Task Force, led by Co-Chairs Dr. Helen Heslop, Dr. EJ Shpall, and Dr. Michael Lill, FACT has published interim standards for the sixth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Collection, Processing, and Administration. The interim standards are intended to promote quality in administration of immune effector cell products, such as chimeric antigen receptor T cells (CAR-T cells), natural killer cells, virus-specific T cells, therapeutic cellular vaccines, and others. The requirements primarily highlight unique aspects of administration and toxicities of immune effector cells.

These requirements will become effective on March 1, 2017. All FACT-accredited cellular therapy programs that administer immune effector cells must be in compliance with the new standards by this date. If you have any questions, contact the FACT office at fact@unmc.edu.

The updated Standards, accompanying Accreditation Manual, and summary of changes are available on the FACT website for reference. Printed copies of the Standards and Accreditation Manual may be purchased from the FACT store.

FACT-JACIE Hematopoietic Cell Therapy Standards

Cellular Therapy Accreditation Manual

Changes to 6th Edition FACT-JACIE Standards

Frequently Asked Questions

Purchase Printed Copies


FACT Achieves Major Accomplishments in 2016

Posted in :: 2017 Volume 1 :: Thursday, January 26th, 2017

The 20th year of FACT successfully built upon its history of successes to advance cellular therapy and regenerative medicine. As physicians and scientists continue to make advancements, opportunities arise for FACT to play a supporting role to educate all programs on new approaches and therapies. The following are highlights from 2016:

1. FACT Celebrates 20th Anniversary

FACT celebrated its 20th year as the leading organization in standards setting and accreditation for cellular therapy, hematopoietic stem cell transplantation, and regenerative medicine. FACT welcomed visitors to a dynamic exhibit booth at the BMT Tandem Meetings and the ISCT Annual Meeting to celebrate with the organization. Attendees who wore their commemorative FACT 20th anniversary pin received gifts and were entered in a daily drawing for prizes.

FACT also hosted anniversary receptions at these meetings, and many FACT colleagues, volunteers, and friends enjoyed hors d’oeuvres and refreshments as FACT celebrated two decades of working together in the community to improve patient care and safety. Guests enjoyed watching a short video highlighting FACT’s past 20 years, and saw some familiar faces who have been an integral part of FACT since its beginning.

2. FACT Commences Review of Corrective Action Plans for Low One-Year Survival

The FACT Clinical Outcomes Improvement Committee began formally reviewing corrective action plans submitted by Clinical Programs that did not meet expected one-year survival as outlined by comparative data. The emphasis of the committee is to help programs identify ways to improve their outcomes for patients. After several months of reviewing corrective action plans, the committee has articulated its expectations for these plans using six guidelines:

  • The corrective action plan must identify specific causes of death.
  • The corrective action plan must provide quantitative data.
  • The assessment must identify reasonable causes of the low one-year survival rate.
  • The corrective action plan must address the identified causes.
  • There must be a measurable outcome improvement.
  • The program must provide updates on corrective actions at the time of inspection, at the time of annual reporting, or as otherwise directed by the committee.

3. FACT Presents Comments at FDA Hearing

The Food and Drug Administration (FDA) hearing to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) occurred on September 12-13, 2016. Dr. Phyllis Warkentin spoke on behalf of FACT and presented the following comments to the FDA:

  • FDA should fulfill its responsibilities to protect patients in search of cellular therapies. FACT supports its parent society, the International Society for Cellular Therapy (ISCT), in its position on unproven therapies and agrees on the importance of providing adequate education for patients. Development of professional standards and voluntary accreditation can play an important role in providing a bridge from basic research to clinical application.
  • The tiered unified approach to HCT/P regulation fails to acknowledge the complexity of some tissues with multiple native functions and many cell types. It is difficult to strictly categorize complex tissues such as adipose tissue as only structural or cellular. Dr. Warkentin offered solutions for applying regulations to such tissues.
  • There appear to be some inconsistencies in the definitions and examples of homologous use that would benefit from clarification.
  • FACT suggests that the Agency expand upon its expectation for cord tissue, to include which regulations apply and when they apply, based upon the processes in place.
  • International harmonization is important to facilitate product development and world-wide availability of cell-based therapies for patients.

4. Sixth Edition NetCord-FACT Cord Blood Standards Published

NetCord and FACT published the 6th edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration and its accompanying Accreditation Manual on July 1, 2016. These Standards became effective after 90 days, and all accredited cord blood banks were required to comply with the requirements by that time.

These Standards cover 1) collection of cord blood cells, regardless of the methodology or site of collection; 2) screening, testing, and eligibility determination of the maternal and infant donor according to Applicable Law; 3) all phases of processing, cryopreservation, and storage, including quarantine, testing, and characterization of the cord blood unit; 4) making the cord blood unit available for administration, either directly or through listing with a search registry; 5) the search process for selection of specific cord blood units; 6) reservation and release of cord blood units for clinical use;  and 7) all transport or shipment of cord blood units, whether fresh or cryopreserved.

5. Draft 1st Edition Immune Effector Cell Standards Published for Public Comment

FACT published a draft of the 1st edition FACT Standards for Immune Effector Cells for inspection and public comment in July 2016. Interim standards for the 6th edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration were also proposed to include immune effector cell programs within blood and marrow transplant units. These Standards are intended to promote quality in administration of immune effector cells and will be incorporated into a voluntary FACT accreditation in this field.

The 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 chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.

Commenters included, among others, pharmaceutical companies, the FDA, the American Society of Cell & Gene Therapy (ASGCT), and the Society for Immunotherapy of Cancer (SITC). A total of 131 comments were received, and reviewers generally expressed support for the Standards and posed worthy questions to consider.

6. CYCORD is First Cord Blood Bank in Cyprus to Earn FACT Accreditation

CYCORD Public Allogeneic Cord Blood Bank in Cyprus received internationally recognized FACT accreditation.  CYCORD, directed by Paul Costeas, PhD, is the first and only cord blood bank in Cyprus to be recognized by FACT.  The bank received accreditation on June 13, 2016, and is accredited for banking cord blood for both public and private family use.

7. Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario is First Cellular Therapy Program in Mexico to Earn FACT Accreditation

Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario in Mexico received internationally recognized FACT accreditation. Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario, directed by David Gomez-Almaguer, MD, is the first and only cellular therapy program in Mexico to be recognized by FACT.  The program received accreditation on September 6, 2016, and is accredited for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing.

8. StemCyte India Therapeutics is First Cord Blood Bank in India to Earn FACT Accreditation

StemCyte India Therapeutics Cord Blood Bank, directed by Bhavin Kapadiya, MD, is the first and only cord blood bank in India to be recognized by FACT. The bank received accreditation on December 21, 2016, and is accredited for banking cord blood for both public and private family use.

9. FACT Hosts Quality Initiatives with Parent Organizations

FACT hosted a Quality Boot Camp at the annual meeting of the American Society for Blood and Marrow Transplantation (ASBMT). The goal of the boot camp program is to strengthen quality assurance activities through pre-meeting exercises and an in-person workshop. Members of the FACT Quality Committee encouraged registrants in the months leading to the in-person workshop to review specific aspects of their quality programs. Quality experts then presented important concepts and led roundtables that allowed participants to ask questions and help each other reach their goals during the boot camp. FACT also partnered with ISCT at their regional meeting to co-host sessions in the Quality and Operations Track. Presentations focused on outcome analysis from the processing perspective and the anatomy of an audit.

10. New Webinar Collaboration Between ASHI and FACT

FACT and the American Society for Histocompatibility (ASHI) began collaborating to offer webinars on transplant immunology. Establishing best practices in transplant immunology in different parts of the world requires both deep understanding of the unique challenges that face different parts of the world, and building on the experiences of well-established labs and international histocompatibility professional societies.

11. FACT Joins Standards Coordinating Body as a Charter Member

The Advancing Standards in Regenerative Medicine Act directs the Secretary of the United States Health and Human Services Agency to establish a public-private Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. The Standards Coordinating Body (SCB) includes membership of the entire cross-section of regenerative medicine stakeholders. FACT was pleased to join as a charter member, and will organize its efforts as part of a consortium of non-government stakeholders that seeks to partner with one or more government organizations and regulatory agencies to coordinate consensus standards development efforts.  More specifically, the SCB seeks to enable more efficient and successful clinical and commercial development of cellular/gene and regenerative medicine therapies through coordinating and prioritizing development of national/international standards for measurement assurance (among other objectives).


Updated Donor History Questionnaires Now Available

Posted in :: 2017 Volume 1 :: Thursday, January 26th, 2017

The interorganizational Donor History Questionnaire materials have been updated to reflect recommendations made by the FDA’s Guidance for Industry: “Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates,” published in November 2016.

The Donor History Questionnaire (DHQ) materials were developed to screen allogeneic HPC donors for communicable disease risk factors in accordance with requirements of the Food and Drug Administration (FDA), AABB, FACT, and the National Marrow Donor Program (NMDP).

The FDA does not mandate use of any particular tool to fulfill donor screening requirements for communicable disease risks and has determined that “official” recognition of DHQ materials in a guidance document is not warranted. The task force believes the DHQ materials, which are harmonized with applicable regulations and guidance documents, will optimize donor comprehension of the questions and provide donor historians with the tools needed to evaluate donor responses. Facilities should read the “User Instructions” carefully before adopting the materials for use.

When a facility implements a new version of these DHQ materials, it should follow its established change control process for the incorporation of the new DHQ materials. The change control process should address validation of the use of the new version with other existing processes and appropriate staff training.

View chart detailing changes

Donor History Questionnaire for Allogeneic HPC, Apheresis and HPC, Marrow – Version 1.6 December 2016

Donor History Questionnaire for HPC, Cord Blood DHQ Version 1.3, December 2016


Transporting Cellular Therapy Products Intended for High-Dose Chemotherapy Recipients

Posted in :: 2017 Volume 1 :: Thursday, January 26th, 2017

The FACT-JACIE Hematopoietic Cell Therapy Standards state, “If the intended recipient has received high-dose therapy, the cellular therapy product shall be transported.” (CM10.3.2, C10.3.2, D10.7) Some have asked what the purpose of this standard is because a product always needs to be distributed to the recipient.

The key word in this standard is “transported.” As stated by the FACT-JACIE definitions in Part A of the Standards, “transport” is the physical transfer of a cellular therapy product within or between facilities during which it does not leave the control of trained personnel at the transporting or receiving facility. In other words, someone who is trained to transfer a product must be with it at all times. This is in contrast to shipping, during which the product does leave the control of trained personnel (such as shipment on a commercial distributing company’s truck or airplane).

If a patient has undergone high-dose marrow ablative treatment in preparation for transplant, the cellular therapy product is essential for the patient’s survival since it may not be possible to obtain additional marrow or blood from the original donor or a second donor in time to prevent complications from aplasia. For this reason, it is important that the product be entrusted to a knowledgeable individual who accompanies it from the distributing facility to the receiving facility.