FACT Invites You to Join Us for a Webinar in Support of World Cord Blood Day

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

In anticipation of World Cord Blood Day, FACT invites you to attend a special Cord Blood webinar on Monday, November 16, 2020 at 10:00 am ET, 15:00 GMT. The purpose of this webinar is to discuss the current progress using UM171-expanded cord blood transplantation, as well as to understand the effect of the COVID-19 pandemic on cord blood collection and transplantation in France. This webinar is 90-minutes, complimentary, and will be presented in French. Slides will be available in both English and French.

Presenters include:

  • Maude Dumont-Lagacé, PhD, a clinical scientist at ExCellThera Inc. (Canada)
  • Catherine Faucher, Md, clinical hematologist and currently in charge of the strategic pole “collection and transplantation of HSC” at the Agence de Biomédecine. (France)

FACT also encourages you to join the Save the Cord Foundation on November 17 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 16:

  1. Log into Webinar: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
  2. Meeting ID: 922 6984 5238
  3. Passcode: WCBD

_____________________________________________

French Translation

En préparation de la Journée Mondiale du Sang de Cordon, FACT vous invite à participer à un webinaire spécial le lundi 16 Novembre 2020 à 10.00 ET, 15:00 GMT. L’objectif de ce webinaire est de discuter les progrès récents liés à l’utilisation de la méthode d’expansion de cellules UM171 en transplantation de sang de cordon, et également de comprendre l’effet de la pandémie COVID-19 sur la collecte et la transplantation de sang de cordon en France. Ce webinaire de 90 minutes est gratuit et sera présenté en français. Les orateurs seront:

  • Maude Dumont-Lagacé, PhD, Spécialiste en Sciences Cliniques à ExCellThera Inc (Canada)
  • Catherine Faucher, MD, Hématologue Clinicienne, actuellement en charge du pôle “Prélèvement et greffes de CSH” à l’Agence de biomédecine (France)

FACT vous encourage également à rejoindre la Fondation Save the Cord le 17 Novembre pour une conférence virtuelle gratuite. Le programme comprendra des présentations d’introduction pour le public et des présentations académiques par des chercheurs et médecins transplanteurs renommés, sur les dernières avancées et les traitements utilisant le sang de cordon.

Instructions pour rejoindre le webinaire le 16 Novembre:

  1. Connexion au webinaire: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
  2. Identification de la conférence: 922 6984 5238
  3. Mot de passe: WCBD

SAVE THE DATE: FACT Announces Virtual Inspection & Accreditation Workshop

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 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-CBA Webinar: The Effect of the COVID-19 Pandemic on Cord Blood Banking

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

The Effect of the COVID-19 Pandemic on Cord Blood Banking
Monday, June 22, 2020, at 9:00 am ET, 13:00 GMT

Presenters will discuss how cord blood banks have been managing through the COVID-19 pandemic:

Heidi Elmoazzen, PhD
Canadian Blood Services’ Cord Blood Bank & Stem Cell Manufacturing

Dr. Elmoazzen will discuss the impact of the COVID-19 Pandemic on stem cell transplantation in Canada including Canadian Blood Services’ Cord Blood Bank Stem Cell Registry and Public Cord Blood Bank.

Roger Horton, PhD
Anthony Nolan Cord Blood Bank, United Kingdom

Dr. Horton will summarize the demand for UK cords between Jan-May 2019 and 2020, and compare both years to give an idea on the impact of the pandemic on operations. He will provide detail on collections, processing, storage, distribution, product protection, and staffing to demonstrate how Anthony Nolan has adapted or mitigated each issue. Where possible Dr. Horton will compare Anthony Nolan practices with other European partners.

Arvin Faundo, MD
Cordlife Group Limited, Singapore

Dr. Faundo will discuss how the coronavirus pandemic is affecting the operations of the Cordlife Group Limited bank and identify the pandemic-related problems that are specific to private or family cord blood banks.

Donna Regan MT(ASCP), SBB
NMDP

Donna will present statistics before and through the pandemic (CB orders, shipments, transplants) and the promotion of services that supported this activity. She will also highlight the unique steps taken by the registry to support unrelated transplant, not least of which is leveraging the cord blood story to cryopreserve all unrelated products prior to patient conditioning.

Lydia Foeken, LN
WMDA, Executive Director

Register now:
The Effect of the COVID-19 Pandemic on Cord Blood Banking


COVID-19 Update: FACT Accreditation

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

 

 

 

 

 

 

FACT continues to receive questions related to patients, donors, and other COVID-19 related issues, therefore we will provide weekly updates to the Frequently Asked Questions  document available on the FACT website.

The health and safety of our cellular therapy community continues to be our utmost concern as we all work to mitigate the effect of the COVID-19 pandemic.

The Effect of the COVID-19 Pandemic on Cord Blood Banking
Monday, June 22, 2020, at 9:00 am ET, 13:00 GMT

Presenters will discuss how cord blood banks have been managing through the COVID-19 pandemic:

Heidi Elmoazzen, PhD
Canadian Blood Services’ Cord Blood Bank & Stem Cell Manufacturing

Dr. Elmoazzen will discuss the impact of the COVID-19 Pandemic on stem cell transplantation in Canada including Canadian Blood Services’ Cord Blood Bank Stem Cell Registry and Public Cord Blood Bank.

Roger Horton, PhD
Anthony Nolan Cord Blood Bank, United Kingdom

Dr. Horton will summarize the demand for UK cords between Jan-May 2019 and 2020, and compare both years to give an idea on the impact of the pandemic on operations. He will provide detail on collections, processing, storage, distribution, product protection, and staffing to demonstrate how Anthony Nolan has adapted or mitigated each issue. Where possible Dr. Horton will compare Anthony Nolan practices with other European partners.

Arvin Faundo, MD
Cordlife Group Limited, Singapore

Dr. Faundo will discuss how the coronavirus pandemic is affecting the operations of the Cordlife Group Limited bank and identify the pandemic-related problems that are specific to private or family cord blood banks.

Donna Regan MT(ASCP), SBB
NMDP

Donna will present statistics before and through the pandemic (CB orders, shipments, transplants) and the promotion of services that supported this activity. She will also highlight the unique steps taken by the registry to support unrelated transplant, not least of which is leveraging the cord blood story to cryopreserve all unrelated products prior to patient conditioning.

Lydia Foeken, LN
WMDA, Executive Director

Register now:
The Effect of the COVID-19 Pandemic on Cord Blood Banking

Guidance for Autologous Transplant Patients
Is there any specific guidance for autologous transplant patients, specifically about screening
for COVID-19, documentation of screening, sedation, and other issues?

  • For documentation of screening of autologous transplant patients prior to transplant, prior to collection of the hematopoietic cellular therapy product, or prior to a clinic or apheresis visit, FACT recommends this documentation follow routine medical record documentation practices.
  • There may be specific institutional screening policies that should also be followed. Programs that want to implement enhanced screening for COVID-19 prior to collection of autologous HCT/Ps should follow FDA recommendation to include questions whether in the previous 28 days, the patient/donor has:
    • Cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19 infection; or
    • Been diagnosed with or suspected of having COVID19 infection.
  • For specific guidance about sedation, medications, consideration for delay of transplant, or other clinical issues, refer to the recently updated ASTCT Interim Guidelines for COVID-19 Management in Hematopoietic Cell Transplant and Cellular Therapy Patients at: https://higherlogicdownload.s3.amazonaws.com/ASBMT/a1e2ac9a-36d2-4e23-945c-45118b667268/UploadedImages/COVID-19_Interim_Patient_Guidelines_4_20_20.pdf

Written Agreements
HPC products destined for our clinical program are being cryopreserved at the collection center or occasionally by a third party facility due to COVID-19 travel restrictions and other concerns. Is our program expected to have written agreements in place to be in compliance with standards B4.6.1 and D12.1.1?

  • Presumably these products are unrelated donor products facilitated by a donor registry. Most likely, any single program will receive only one such product from a specific collection site or cryopreservation facility. This makes it impractical to have an individual written agreement in place with each collection or cryopreservation facility. FACT would consider these services of cryopreservation and shipment to be an extension of the program’s written agreement with the Donor Registry.

When our laboratory cryopreserves an unrelated donor product for another transplant center, what records should we include with the shipment?

  • FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Seventh Edition, require [D13.5.2] the Processing Facility to provide “a copy of all records relating to the collection, processing, and storage procedures performed related to the safety, purity, or potency of the cellular therapy product”. This would include at a minimum, the volume, total nucleated cell count, cell viability, CD34+ and CD3+ cell counts if performed, microbial culture results, testing, processing, and cryopreservation methods, identification and quantification of additives and cryoprotectants, and the freezing curve. The Processing Facility records should also identify any other facility participating in the collection or processing, and the extent of its responsibility [D13.5.3].

In addition, the Donor Registry will provide registry-specific product analysis forms and potentially, additional data forms related to collection, processing, or storage that should be included with the product shipment. Data required will include identifiers for the donor and recipient, collection date, and product characteristics, including anticoagulants, additives, and the results of all testing performed.

If the Collection Center or Laboratory providing products to an accredited Clinical Program is not FACT or JACIE accredited, the Clinical Program may have to specifically request processing information, including the data listed above.

Laboratories undertaking cryopreservation for another transplant program should obtain recipient information necessary to perform the optimal pre-cryopreservation processing. Particularly in the case of bone marrow products, documentation of the donor and recipient ABO group is critical to ensure red cell reduction strategies are used prior to cryopreservation in the case of incompatibility.

Frequently Asked Questions
Other topics addressed in the FAQ document include:

  • Donor Screening for Allogeneic Transplants
  • Written Agreements
  • Unrelated Donor Products
  • Annual Report
  • Accreditation Extension
  • Updated Accreditation Certificate
  • Allogeneic Donor Screening and Testing Requirements
  • COVID-19 Trials and HCT Accreditation

If you have further questions or concerns, please contact Dr. Phyllis Warkentin (402-559-6781), or the FACT office (402-559-1950).

Other Resources Available:

ASTCT Resources
WMDA Resources
BMT Resources
Centers for Disease Control
World Health Organization


FACT Cord Blood Inspection and Accreditation Workshop at the 2020 Cord Blood Connect International Congress Officially Cancelled

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

The CBA Board of Directors has announced that this year’s Cord Blood Connect international congress will be a virtual event.  The directors agreed that the risks to participant health and safety in the midst of a worldwide pandemic are just too great for the planned in-person gathering. The congress was scheduled for Sept. 10-12 in Miami Beach and will now be held virtually on two non-consecutive days, Sept. 10 and 17. For more information, please visit the Cord Blood Virtual Connect meeting website. 

Because the Cord Blood Connect international congress will now be a virtual event, the in-person FACT Cord Blood Inspection and Accreditation Workshop scheduled for September 9, 2020, is cancelled. FACT is currently evaluating the options for virtual meetings this fall.


Update for HRSA-contracted Cord Blood Banks

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

FACT is a designated accrediting body for the Health Resources and Services Administration (HRSA)-contracted Cord Blood Banks participating in the National Cord Blood Inventory (NCBI).  These cord blood banks have been required to maintain FACT accreditation and also to meet HRSA-specific criteria that were detailed for FACT inspectors on Part H of the Compliance Checklist.

In April 2020, HRSA determined that the HRSA-specific criteria were not useful in monitoring the NCBI contracts and that these criteria had become obsolete. Therefore, these HRSA-specific criteria have been deleted.  Part H of the FACT Compliance Checklist has been archived, and FACT inspectors will no longer be required to complete additional information for HRSA-contracted cord blood banks. All accredited cord blood banks will be assessed similarly against the current edition of NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration.


FACT Cord Blood Inspection and Accreditation Workshop at the 2020 Cord Blood Connect International Congress on Hold

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

Given the rapidly evolving COVID-19 pandemic, a temporary moratorium has been placed on pre-registrations for the Cord Blood Connect international congress, scheduled for Sept. 10-12 in Miami Beach. The acceptance of abstracts also has been suspended while CBA leaders continue to assess the viability of this year’s congress.

For the same considerations, registrations for the FACT Cord Blood Inspection and Accreditation Workshop scheduled for September 9, 2020 are also on a temporary hold.

Options being evaluated include re-scheduling, as well as alternatives for the in-person conference. Updates will be provided by FACT as information is made available.


FACT Education Events

Posted in :: 2020 Volume 1 :: Monday, January 27th, 2020

We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!

FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm

This training workshop is designed to explain the FACT accreditation requirements. FACT representatives will clarify the intent of the FACT-JACIE Standards and assist programs in organizing and preparing for the accreditation process. In addition, individuals interested in becoming a FACT inspector are encouraged to attend inspector training.

The workshop includes two tracks: Applicant training and inspector training. 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. In order to attend this track, you must be pre-approved as an inspector trainee. This track is designed to guide the trainee through the inspection experience; from accepting an inspection assignment, through submitting the inspection report, and participating in the Accreditation Committee review. Each trainee will receive an inspection checklist accompanied by applicable inspection documents.

Interested in becoming a FACT Inspector? Apply to train as an inspector. If eligible, trainees attend free of charge!

Register for the FACT workshop

FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm

Join us for a day focused on core quality concepts. The sessions will include quality processes programs have implemented and incorporating Immune Effector Cells into all parts of your quality program. A self-assessment will be distributed prior to the TCT Meeting to review key features of your quality program and identify ongoing challenges. Complete the self-assessment, join the roundtable discussions, participate in the activities, and leverage QA experts for ideas on how to take your program’s quality program to the next level.

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 ASTCT & 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 in Latin America, the new joint FACT-SBTMO Accreditation Program in Brazil, and efforts to provide guidance to transplant centers in India. 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 FACT accreditation requirements. FACT representatives will clarify the intent of the NetCord-FACT Standards and assist programs in organizing and preparing for the accreditation process. In addition, individuals interested in becoming a FACT inspector are encouraged to attend inspector training.

The workshop includes two tracks: Applicant training and inspector training. 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. In order to attend this track, you must be pre-approved as an inspector trainee. This track is designed to guide the trainee through the inspection experience; from accepting an inspection assignment, through submitting the inspection report, and participating in the Accreditation Committee review. Each trainee will receive an inspection checklist accompanied by applicable inspection documents.

Interested in becoming a FACT Inspector? Apply to train as an inspector. If eligible, trainees attend free of charge!

Register for the FACT workshop

FACT Cord Blood Inspection & Accreditation Workshop
September 9, 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!

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 applicant and inspector training track!


FACT Announces Cord Blood Inspection and Accreditation Workshop at the 2020 ISCT Annual Meeting, Paris

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

FACT Cord Blood Inspection and Accreditation Workshop
Tuesday, May 26
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. Inspector trainees have required assignments to complete before attending the workshop. In order to attend this track, you must be pre-approved as an inspector trainee.

Apply to train as a FACT inspector.  If approved, you can attend the workshop FREE of charge! Eligible Cord Blood Bank personnel are encouraged to serve as a volunteer FACT inspector and enjoy the following value-added benefits:

Exposure to Exemplary Practices

As an inspector, you can observe how other facilities meet FACT Standards and bring home new ideas. Interaction with inspection team members also provides the opportunity to network and collaborate.

Professional Development

Improve your knowledge of FACT requirements and serve as an asset in ensuring your organization meets Standards. “FACT Inspector” also looks great on a curriculum vitae.

Influence

Inspectors have influence over FACT policies and requirements. Input from FACT inspectors is sought in the process of developing new editions of Standards.

Free Access to FACT Educational Resources

As a volunteer, you will have free access to both in-person and online educational events with an annual value over$1,800.

Information about qualifications and how to apply to become a FACT inspector can be found on the FACT website. If you have any questions, please contact Mikaela VanMoorleghem or the FACT office.

Are you ready?


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

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

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

Committee Overview

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

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

Accessing the Standards and Other Resources

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

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

Accreditation Services

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

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


FACT Education Events

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

FACT – Héma-Québec – Liège Cord Blood Bank Cord Blood Webinar in Support of World Cord Blood Day
November 14, 2019
10:00 am ET, 15:00 GMT, 16:00 CET

In anticipation of World Cord Blood Day, FACT, along with Héma-Québec and Liège Cord Blood Bank, invites you to attend a special Cord Blood webinar on Thursday, November 14, 2019 at 10:00 am ET, 15:00 GMT, and 16:00 CET. The purpose of this webinar is to better understand immunogenetic diversity in registries and cord blood banks, as well as cord blood transplantation and emerging pathogens. This webinar is free of charge and will be presented in French. Slides will be available in both English and French. Topics include:

• Immunogenetic Diversity in Registries and Cord Blood Banks: Dr. Eliane Gluckman
• Cord Blood Transplantation and Emerging Pathogens: Is there reason for concern? Dr. Gilles Delage
• Personal experience from a cord blood recipient

FACT also encourages you to join the Save the Cord Foundation on November 15 for a free live virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood.

Instructions for joining the FACT Webinar on November 14:
1. Log into webinar:
https://factwebsite.webex.com/factwebsite/onstage/g.php?MTID=eda55e6eaf311dc8ea9de4e66281dde89
2. Enter your name and email. Click “Join Now.”
3. If requested, enter the event number: 666 195 982
4. Adjust computer audio to desired volume.
_____________________________________________

French Translation

En préparation de la Journée Mondiale du Sang de Cordon Ombilical, nous vous invitons à participer à un séminaire en ligne spécial qui aura lieu jeudi le 14 Novembre 2019 à 10:00 HNE, 15:00 GMT, and 16:00 CET. L’objectif de ce séminaire est de mieux comprendre la diversité immunogénétique dans les registres et les banques de sang de cordon, ainsi que les agents pathogènes émergents dans le cadre de transplantation. Ce séminaire est gratuit et sera présenté en Français. Les diapositives seront disponibles en français et en anglais.
Liste des sujets:

• Diversité immunogénétique dans les registres et banques de sang de cordon: Dr. Eliane Gluckman
• Transplantation de sang de cordon et pathogènes émergents: est-ce un sujet d’inquiétude? Dr. Gilles Delage
• Expérience personnelle du receveur d’une greffe de sang de cordon.

FACT vous encourage également à vous joindre à la Fondation Save the Cord le 15 Novembre pour une conférence virtuelle gratuite. Le programme comprendra des présentations pour le grand public ainsi que des présentations académiques par des chercheurs et des médecins transplanteurs réputés sur les récentes avancées et thérapies utilisant le sang de cordon ombilical.

1. Se connecter au séminaire:
https://factwebsite.webex.com/factwebsite/onstage/g.php?MTID=eda55e6eaf311dc8ea9de4e66281dde89
2. Saisir votre nom et adresse email. Cliquer “Join Now.”
3. si demandé, entrer le numéro de l’événement: 666 195 982
4. Ajuster le volume de votre ordinateur au niveau désiré.

FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm

We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will clarify the intent of the FACT-JACIE Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.

The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.

Register for the FACT workshop

FACT Cellular Therapy Leadership Course 101 at TCT Meetings
February 18, 2020
8:00 am – 12:00 pm

Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you recognize your leadership skills and acquire new ones that effectively encourage innovation, achieve consensus, build momentum, turn ideas into reality, eliminate distractions and guide a team toward goals.

Register for the FACT Leadership 101 course

FACT Cellular Therapy Advanced Leadership Course 201 at TCT Meetings
February 18, 2020
1:00 pm – 4:30 pm

If you completed FACT’s Cellular Therapy Leadership 101 course and want more, the 201 course is for you.

This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cellular Therapy Leadership 101 course in the morning, or if attended in a previous year, are eligible to register for the 201 course in the afternoon.

Register for the FACT Advanced Leadership 201 course

FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm

Join us for the FACT-ASBMT Quality Boot Camp at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 19 in Orlando, FL.

Focused on issues identified by FACT compliant transplant programs, sessions will include activities and discussion designed to strengthen your quality assurance processes. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution.

Register for the FACT-ASTCT Quality Boot Camp

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 20, 2020
5:00 pm – 7:00 pm

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Orlando, FL at the Orlando World Center Marriott on Thursday, February 20, 2020, from 5:00 pm to 7:00 pm.

Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. This program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.

Register for the FACT Global Affairs session

FACT Cord Blood Inspection & Accreditation Workshop
May 26, 2020
8:00 am – 5:00 pm

This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will clarify the intent of the NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.

The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.

Apply to train as a FACT inspector.  If approved, you can attend the workshop FREE of charge!

Register for the FACT workshop


FACT Invites You to Join Us for a Webinar in Support of World Cord Blood Day

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

In anticipation of World Cord Blood Day, FACT invites you to attend a special Cord Blood webinar on Wednesday, 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.

View meeting details and register
Register for Save the Cord’s live virtual conference

Instructions for joining the FACT Webinar on November 14:

  • Log into Webinar  
  • Enter your name and email. Click “Join Now.”
  • If requested, enter the event number: 666 195 982
  • Adjust computer audio to desired volume.

French Translation

En partenariat avec les banques de sang de cordon de Liège et d’Héma-Québec, FACT vous convie à un séminaire en ligne à l’occasion de la Journée Mondiale  du Sang de Cordon Ombilical.

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 mercredi 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.

Voir les détails et s’inscrire
S’inscrire à la conférence virtuelle Save the Cord

Instructions pour joindre le séminaire en ligne FACT du 14 novembre:

  • Se connecter au séminaire
  • Saisir votre nom et adresse email. Cliquer “Join Now.”
  • si demandé, entrer le numéro de l’événement: 666 195 982
  • Ajuster le volume  de votre ordinateur au niveau désiré.

WMDA-NetCord & FACT Events at the Second Annual Cord Blood Connect International Congress Were a Success

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

The WMDA and FACT hosted a pre-conference Cord Blood Day at the 2019 Cord Blood Connect International Congress in Miami, Florida on September 12. Over 50 members of the cord blood community from eleven countries attended. The day included topics such as trends in cord blood banking, emerging pathogens, harmonization of testing procedures between cord blood banks and cellular therapy laboratories, and cord blood selection services for transplant centers. Breakout sessions in the afternoon included a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track.

In addition to the WMDA-NetCord & FACT Cord Blood Day, FACT welcomed visitors to its exhibit booth!

 

 

 

 

 

All events were successful and FACT looks forward to the next Cord Blood Connect International Congress September 10-12, 2020, in Miami Beach!

WMDA-NetCord & FACT presenters: Robyn Rodwell, Dunia Jawdat, and Heidi Elmoazzen

FACT Chief Medical Officer Phyllis I. Warkentin and WMDA-NetCord & FACT Cord Blood Day Chair Ngaire Elwood

WMDA-NetCord & FACT presenters: Alexander Platz, Gesine Koegler, and Phillip Johnson

 


Become a FACT Cord Blood Inspector

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

Members of FACT-accredited cord blood banks are aware that FACT’s mission is to promote quality clinical and laboratory practice of cellular therapy and regenerative medicine. Eligible Cord Blood Bank personnel are encouraged to serve as a volunteer FACT inspector to enjoy the following value-added benefits:

Exposure to Exemplary Practices

As an inspector, you can observe how other facilities meet FACT Standards and bring home new ideas. Interaction with inspection team members also provides the opportunity to network and collaborate.

Professional Development

Improve your knowledge of FACT requirements and serve as an asset in ensuring your organization meets Standards. “FACT Inspector” also looks great on a curriculum vitae.

Influence

Inspectors have influence over FACT policies and requirements.  Input from FACT inspectors are sought in the process of developing new editions of Standards.

Free Access to FACT Educational Resources

As a volunteer, you will have free access to both in-person and online educational events with an annual value of $1,840.

Information about qualifications and how to apply to become a FACT inspector can be found at www.factwebsite.org/becomeinspector. If you have any questions, please contact Mikaela VanMoorleghem or the FACT office.

Are you ready?


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


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

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

By: Andra Moehring, MHA, FACT Standards Development Manager

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

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

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

Topics will include:

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

The afternoon offers two tracks:

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

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

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

View meeting agenda

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

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

View meeting details and register

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