FACT-JACIE Standards Feedback Survey
Preparation of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, ninth edition, will commence this summer. Final publication is expected in early 2025.
FACT and JACIE invite you to complete a short survey to provide feedback and suggestions regarding the Standards. Survey results will be reviewed by the Standards Steering Committee for potential inclusion in the next edition of the Standards.
You are also encouraged to share the survey with your colleagues and promote the survey in your professional societies. Responses will be accepted through April 28, 2023.
If you have any questions or need additional information, please contact the Standards Development Manager at Monique.Summers@factglobal.org.
Updated Versions of FACT-JACIE Hematopoietic Cellular Therapy Standards and Accreditation Manual Available
The Eighth Edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration has been updated to Version 8.1, and its accompanying Hematopoietic Cellular Therapy Accreditation Manual has been updated to Version 8.2.
Version 8.1 of the Standards became effective on January 14, 2022. The changes from Version 8.0 to 8.1 are clerical in nature, and organizations accredited under these Standards should already be in compliance. Most of the changes in the Accreditation Manual from Version 8.1 to 8.2 are also clerical. Substantive content changes to the manual reaffirm and clarify donor screening and donor lymphocyte infusion (DLI) eligibility requirements. Reference Appendix V in both documents for a summary of the changes.
The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products.
FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.
The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.
Download the updated Standards, Manual, and Summary of Changes
Purchase printed copies of the 8.1 Edition FACT-JACIE Standards
Purchase printed copies of the 8.2 Edition Hematopoietic Cellular Therapy Accreditation Manual
FACT and JACIE Remained Committed to Publishing the Eighth Edition Hematopoietic Cellular Therapy Standards Despite Worldwide Pandemic
As an international Standards Committee, the FACT-JACIE Hematopoietic Cellular Therapy (HCT) Standards Committee is accustomed to remote collaboration. Its ability to work primarily online was brought to the test during the COVID-19 pandemic in 2020, and the committee rose to the challenge! The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and its accompanying Accreditation Manual were published on May 17, 2021.
“Even with the challenges of a pandemic combined with very rapid advances in the field, amiable dedicated colleagues allowed successful completion of the task,” says Dr. Paul Eldridge, Chair of the Standards Committee. “I want to express my thanks and gratitude to everyone.”
Dr. Kim Orchard, Co-Chair of the Clinical Standards Subcommittee, adds, “The preparations for the eighth edition of the Standards proceeded with only minimal delays due to the COVID-19 pandemic. Credit is due to all those involved who continued to review and prepare the Standards despite the impact on their work and personal lives.”
“It was a challenge to continue with everything during the pandemic,” according to Dr. Nina Worel, Co-Chair of the Collection Standards Subcommittee. “Not so much with the FACT-JACIE team working on the eighth edition as the time schedule is perfect. We are used to working remotely and the meetings always close on time, but this time there were a lot of other additional meetings that were remote.”
“We managed to have the second face-to-face meeting of the combined FACT and JACIE teams just before the full impact of the first wave occurred, and all subsequent meetings were held by remote means which were already planned,” says Dr. Orchard. “Credit is due to all those involved who continued to review and prepare the Standards despite the impact on their work and personal lives.”
The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products. FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.
The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.
The HCT Standards Committee consists of 64 expert members among a Steering Committee and five subcommittees that reviewed clinical, collection, processing, quality, and immune effector cell (IEC) requirements. These members reside in 14 countries, contributing a truly international perspective to the Standards.
Following months of initial reviews and revisions, the HCT Standards Committee considered approximately 770 comments, submitted by 78 participants from 20 countries, during the public comment period. Additionally, other experts from FACT and JACIE participated in discussions related to new developments in the field, including Dr. John Snowden, member of the JACIE Committee and secretary of the European Society for Blood and Marrow Transplantation (EBMT), the FACT Immune Effector Cell Task Force, and others. These experts provided the HCT Standards Committee advice to consider when finalizing the Standards, with revisions ultimately drafted by the Standards Committee and approval granted by the FACT and EBMT Boards of Directors.
“It was really exhausting [with the other remote meetings]. However, we managed to finalize a great new edition of Standards for best quality in cellular therapy for our patients,” says Dr. Worel.
“It was a pleasure to work with committee members on the new edition of standards,” says Dr. Eldridge. “The opportunity to learn from such a diverse group of international experts is amazing.”
The eighth edition Standards become effective on August 16, 2021. All organizations accredited under these Standards are expected to be in compliance with the requirements by that date. Although there may be a few inspections remaining to be completed under the previous edition due to COVID 19-related delays, all other inspections scheduled after this date will be under the eighth edition.
Review the Summary of Changes for the eighth edition FACT-JACIE Standards
Download the eighth edition FACT-JACIE Standards for free
Download the eighth edition Hematopoietic Cellular Therapy Accreditation Manual for free
Purchase printed copies of the eighth edition FACT-JACIE Standards
Purchase printed copies of the eighth edition Hematopoietic Cellular Therapy Accreditation Manual
Download additional supporting documents
ASTCT Fundamentals of HCT Training Course Takes Place This Weekend – Registration is Still Open! Course Can be Applied Toward FACT Requirements for Continuing Education
FACT encourages you to take advantage of the ASTCT Fundamentals of HCT Training Course. Hosted by one of our parent organizations, this course can be applied toward FACT requirements for continuing education.
The Fundamentals of HCT Training Course is a two-day conference that will be taking place virtually on Saturday, April 24 – Sunday, April 25. This course provides a broad overview and introduction of hematopoietic cell transplantation (HCT), also referred to as blood and marrow transplantation (BMT), as well as cellular immunotherapy (CI). Throughout the lectures, participants will be introduced to numerous aspects of the HCT-CI processes, which are designed to develop or enhance skills required in the management of patients undergoing these procedures. This course incorporates case-based learning to emphasize application of concepts taught through didactic lecture with a strong focus on the pharmacotherapeutic management. Additional details, guidance, and review of clinical materials can also be found in the supplemental electronic handbook. The target audience for this course includes new practitioners, residents, fellows, pharmacists, and nurses or those training in this discipline.
Registration to the virtual conference includes access to the newly revised Fundamentals of HCT eBook. The Fundamentals of HCT eBook provides up-to-date clinical information and covers the entire transplant process from pre-transplant consultation to post-transplant care. This is a great resource!
Registration will close at 4PM CT on Friday, April 23.
Register for the ASTCT Fundamentals of HCT Training Course
FACT-JACIE Hematopoietic Cellular Therapy Standards to be Published in May
The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is finalizing the eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (HCT Standards). The updated editions will be published by May 17, 2021. Following a 90-day transition period, the requirements will be effective on August 16, 2021. To receive announcements of the publications and direct links to the new Standards, Accreditation Manual, and associated documents, subscribe for the FACT newsletter by creating an account at www.factwebsite.org.
FACT committee representatives are also nearing completion of the draft second edition FACT Standards for Immune Effector Cells. Publication of these Standards is planned following publication of the HCT Standards. This change in schedule will allow FACT to place priority on updating related accreditation documents for programs accredited under the HCT Standards, whose inspections were disproportionally affected by COVID-related delays.
New Editions of FACT-JACIE Hematopoietic Cell Therapy and FACT Immune Effector Cell Standards to be Published in May
The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is completing the final review of the draft eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. FACT committee representatives are also nearing completion of the draft second edition FACT Standards for Immune Effector Cells.
FACT thanks the many participants of the public comment period for providing useful feedback on the drafts. Approximately 770 comments, submitted by 78 participants from 20 countries, enriched the Standards development process and edits have been made in response when appropriate. FACT will provide a response to comments at the time of final publication of the Standards.
The updated editions will be published by May 17, 2021. Following a 90-day transition period, the requirements will be effective on August 16, 2021. To receive announcements of the publications and direct links to the new Standards, Accreditation Manual, and associated documents, subscribe for the FACT newsletter by creating an account at www.factwebsite.org.
Last Call! Submit Comments on Draft Standards by August 30
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
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
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
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 Standards – FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration
- Common Standards – Common Standards for Cellular Therapies
- Immune Effector Standards – Standards for Immune Effector Cells
- Cord Blood Bank Standards – NetCord-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:
- Hematopoietic Cellular Therapy Self-Assessment Tool, Seventh Edition
- Common Standards Self-Assessment Tool, Second Edition
- Immune Effector Cells Self-Assessment Tool, First Edition, Version 1.1
- CB Self-Assessment Tool, Seventh Edition
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
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
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
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.
Updated Donor History Questionnaires Now Available
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
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 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
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!
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
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
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
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