Addressing Shortages; An Update from the FACT Professional Relations Committee on Fludarabine and Cord Blood Processing Device Shortages
Drug and supply shortages have been frequently plaguing cellular therapy programs. Current shortages include, but are likely not limited to, Fludarabine, Albumin, marrow collection kits, and apheresis circuits. Such shortages have been topics of discussion by the FACT Professional Relations Committee. Professional societies and registries advocate for solutions to the operational, regulatory, and quality challenges these shortages cause.
The American Society for Transplantation and Cellular Therapy (ASTCT) and the National Marrow Donor Program (NMDP)/Be the Match have been reporting their efforts to the FACT Professional Relations Committee regarding the Fludarabine Phosphate Injection shortage in the United States. This shortage is forcing centers to use non-FDA approved lymphodepleting regimens that may negatively influence the outcome of blood and marrow transplantation and CAR-T cell therapy. In June 2022, the two organizations submitted a letter to the U.S. Food and Drug Administration (FDA) outlining the issue, the negative impact on patients, and potential solutions. ASTCT and NMDP/Be the Match are continuing to advocate for solutions and work with the FDA to alleviate the issue. During the most recent committee meeting in October 2022, updates included reports of current availability from Teva Pharmaceuticals and expected availability from Fresenius Kabi and Areva Pharmaceuticals in late October.
Preparative regimens must be documented within Standard Operating Procedures or clinical guidelines per FACT Standards. If Fludarabine is specifically used as part of a preparative regimen but other drugs must be used due to the shortage, then this is a deviation and must comply with established deviation processes as outlined in an accredited organization’s Quality Management Plan. For ongoing situations such as Fludarabine shortages, guidelines could also include alternative protocols when the main protocol is not possible due to shortages. Since this would be an established and approved approach to handling shortages, then it would not be a deviation every time one occurs.
An additional shortage of processing technology that is impacting cell processing at cord blood banks and transplant programs results from the exit of Cytiva (formerly GE/BioSafe) from the medical device market. Banks and programs must identify new processing technology and, if applicable, submit pre-approval supplements to the FDA. Collaboration among cord blood banks to share validation protocols could ease the burden on individual banks and result in standardized processes. For more information on how you can help, please reach out to Donna Regan at dregan2@nmdp.org.
FACT Celebrates World Cord Blood Day with a Weekly Series: Choosing a FACT-Accredited Cord Blood Bank Matters
By Mikaela A. VanMoorleghem, MPA, FACT Education and Training Coordinator
World Cord Blood Day, organized by Save the Cord Foundation, raises awareness of current and future uses of cord blood stem cells. To mark the occasion, The Save the Cord Foundation will host a free online conference on November 15th, welcoming parents, doctors, nurses and midwives.
World Cord Blood Day started from a need to expand cord blood education globally. To date there have been over 40,000 cord blood transplants worldwide. Cord blood stem cells are currently used to treat over 80 different life-threatening diseases such as leukemia, lymphoma, and sickle cell anemia. Cord blood stem cells are also proving critical to new areas of regenerative medicine to potentially treat spinal cord injuries, cerebral palsy, autism, type 1 diabetes and much more (Save the Cord Foundation website).
As an inspiring partner, and in anticipation of World Cord Blood Day on November 15th, the Foundation for the Accreditation of Cellular Therapy (FACT), invites you to view a four-episode, weekly series on why choosing a FACT-accredited family or public cord blood bank is important when considering donating or storing your child’s cord blood stem cells.
Each episode is presented by a Cord Blood Banking expert from a FACT-accredited program. Episode topics include:
- Episode One, October 18th: Linda Peltier, Laboratory Manager at the McGill University Health Centre Stem Cell Transplant Program, outlines the benefits of choosing a FACT-accredited family or public cord blood bank.
- Episode Two, October 25th: Phillip Johnson, Scientific Director of the Queensland Cord Blood Bank at the Mater, discusses how FACT accreditation promotes safety and quality of cord blood units.
- Episode Three, November 1st: Dr. Guy Klamer, from the Sydney Cord Blood Bank, presents on how FACT-accredited banks were prepared for the COVID-19 pandemic.
- Episode Four, November 8th: Thibaut Gervais, from Saint-Luc University in Brussels, Belgium, educates donors on the uses of cord blood.
To view each weekly episode, please visit the FACT YouTube channel! If you have questions about FACT cord blood bank accreditation, please contact Nancy Schulte.
Reference:
Why do we need World Cord Blood Day?, Save the Cord Foundation. Retrieved October 18, 2021, from
https://www.worldcordbloodday.org/learn-about-world-cord-blood-day.html
FACT Cord Blood Educational Events Announced
Join FACT for a cord blood inspection and accreditation workshop and quality boot camp on Wednesday, September 29, 2021, from 7:00 am – 4:00 pm CT, 12:00 – 21:00 GMT. The FACT workshop morning sessions will begin with an overview of FACT accreditation, detailing the accreditation process from application to accreditation. Sessions continue with a guided tour of a cord blood bank in which the presenter will review requirements in the FACT Cord Blood Banking Standards that can be identified and evaluated during the tour (on-site or virtual). Next, presenters will discuss common citations in cord blood banking and how to avoid them. Examples will be provided, and case studies presented. Finally, the morning workshop will end with short presentations from cord blood banks with different organizational models including public, private, and hybrid, who will discuss maintaining operations and compliance through various cord blood banking challenges. Afterwards, participants can ask questions to an expert panel.
The afternoon quality boot camp sessions begin with a presentation on developing a Quality Management Plan and assessing its effectiveness. The presentation will be followed by a question and answer session and an interactive break-out session. The second half of the afternoon will focus on stability studies in cord blood banking and includes a presentation on the results of the AABB/ISCT stability studies survey, presentations on establishing and maintaining a stability program within a public or private cord blood bank, and ends with a panel discussion.
During lunch, attend an optional featured session! Listen to FACT’s new president, Dr. Catherine Bollard, reflect on the accomplishments and the future of FACT.
Register now for early bird pricing!
FACT workshop and quality boot camp hosts:
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| Roger Horton, PhD Cord Blood Bank Director The Anthony Nolan Cord Blood Bank |
Diane Fournier, PhD Laboratory Head and Scientific Director Héma-Québec Cord Blood Bank |
Eighth Edition NetCord-FACT Cord Blood Banking Standards Development Begins
The eighth edition of the NetCord-FACT Cord Blood Banking Standards is officially in development under the leadership of FACT’s new Standards Committee Chair, Dr. Nicole Prokopishyn. The Cord Blood Standards Steering Committee kicked off the process on April 22, 2021.
Any suggestions or comments regarding the Cord Blood Standards are welcome. Please provide feedback to FACT’s new Standards Development Manager, Monique Summers, at monsummers@unmc.edu.
View the FACT Virtual Workshop that Everyone is Talking About
As reported in a previous newsletter article, the first FACT Inspection & Accreditation Virtual Workshop on September 21, 2020 was well received by those in attendance, and we are pleased to provide everyone with an opportunity to view the recording of the workshop.
The workshop began with an overview of the FACT accreditation process and continued with hands-on activities to guide the applicant through the accreditation process. Workshop objectives include:
- Describe the accreditation process.
- Evaluate documentation to ensure compliance.
- Organize the on-site inspection process.
- Plan a program tour.
- Identify strategies to support a successful inspection.
- Practice evaluating deficiencies.
A digital download of the workshop recording can be purchased from the FACT online store at competitive prices. As always, inspectors and inspector trainees may download the recording for free!
Purchase the virtual workshop recording
FACT Hosts First Virtual Exhibit Hall Booth at Cord Blood Connect International Congress
Giveaway Winner Announced!
FACT hosted its first virtual exhibit hall booth at the Cord Blood Association’s (CBA) 2020 Cord Blood Connect international congress on September 10 and September 17, 2020. FACT is one of 14 exhibitors in CBA’s virtual exhibit hall which will remain accessible to congress participants through August 2022.
FACT’s virtual booth provides visitors with multiple online resources to learn about obtaining and maintaining FACT accreditation and becoming a FACT inspector. Resources include videos, presentations, and website links.
Booth visitors were able to register to win a FACT webinar. The lucky winner was Sally McCollum, PharmD from Duke University School of Medicine. Dr. McCollum was pleased to learn that FACT offers several complimentary webinars to the general public, which gave her the opportunity to download her first choice at no charge, and then choose another webinar as her giveaway prize.
Congratulations Dr. McCollum!
Learn more about Cord Blood Connect
Access the Cord Blood Connect recordings and virtual exhibit hall
FACT is a Proud Supporter of World Cord Blood Day
The Save the Cord Foundation hosted the annual World Cord Blood Day on November 17, 2020. In addition to a virtual conference, many organizations conducted outreach and hosted educational events to promote cord blood banking.
FACT was again an inspiring partner of World Cord Blood Day. In support of this event, FACT hosted a webinar with Héma-Québec and Liège Cord Blood Banks. Dr. Catherine Faucher and Dr. Maude Dumont-Lagace discussed the current progress using UM171-expanded cord blood transplantation, as well as the effect of the COVID-19 pandemic on cord blood collection and transplantation in France. The webinar was complimentary and presented in French. The recording is now available free of charge in the FACT Store!
Learn more about World Cord Blood Day
Download the free FACT webinar in French
FACT Invites You to Join Us for a Webinar in Support of World Cord Blood Day
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:
- Log into Webinar: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
- Meeting ID: 922 6984 5238
- Passcode: WCBD
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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:
- Connexion au webinaire: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
- Identification de la conférence: 922 6984 5238
- Mot de passe: WCBD
SAVE THE DATE: FACT Announces Virtual Inspection & Accreditation Workshop
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-CBA Webinar: The Effect of the COVID-19 Pandemic on Cord Blood Banking
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
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
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
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
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 Announces Cord Blood Inspection and Accreditation Workshop at the 2020 ISCT Annual Meeting, Paris
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
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.
