Many firsts in 2020, and much to leave behind! But one “first” is the ISBT 128 labeling standard for cells collected for further manufacture. While voluntary for manufacturers, I would strongly encourage everyone to request of manufacturers that they comply with ISBT 128 labeling standards as they will contribute to the safety of our patients and to the efficiency of our laboratories, collection groups, and electronic records. If we all speak with the same voice perhaps headway will be made.
Our virtual accreditation task force continues to refine the process for virtual inspections, which we plan to begin soon. As other accrediting bodies perform virtual inspections and we all have more experience with virtual meetings, I think the overall process will not be that different. But we all look forward to the day we can do in-person inspections again, as nothing replaces the direct interactions and the ability to make new friends and acquaintances.
As we face the biggest peak yet of COVID-19 infections and the pressure at work increases, the importance of taking care of yourself away from work increases, too. Please stay safe—there is a light at the end of the tunnel – not an oncoming train, but vaccines with a level of efficacy that is truly remarkable. Happy Holidays with your friends and families!
To provide the cellular therapy community with important educational content, FACT will continue hosting virtual events until it is safe to resume in person meetings. We are excited to announce two events in February 2021: a FACT Inspection and Accreditation Workshop and a FACT-ASTCT Quality Boot Camp.
FACT Inspection and Accreditation Workshop
February 4, 2021
This virtual workshop is on Thursday, February 4, from 7:30 am – 4:30 pm CT, 13:30-22:30 GMT. Applicants interested in accreditation are invited to this interactive workshop. Information will interest initial applicants and those who have attended previously.
Additional workshop content will include common citations, data management, clinical outcome analysis, and an update on FACT virtual inspections.
• 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.
• Prepare for a FACT Virtual Inspection.
• Identify significant changes to the eighth edition Cellular Therapy Standards.
• Summarize the expectations of inspectors and applicants for data management.
• Utilize tools to evaluate outcome data.
Attend an optional lunch session with two FACT-accredited programs who will share how FACT accreditation is beneficial while managing the COVID-19 pandemic.
FACT-ASTCT Quality Boot Camp
February 5, 2021
Join us for the 2021 FACT-ASTCT Quality Boot Camp: Navigating a Changing Environment Using Quality Systems.
Discuss and explore core quality concepts throughout the day and learn how to apply those concepts to an example. “Adding immune effector cells to program services” will be used to illustrate concepts learned and navigate components of the quality system from beginning to end, including:
- Perform a Facility Needs Assessment
- Develop a Change Control
- Execute Risk Assessments
- Determine what to Validate and Audit
- Perform Validation(s)
- Establish Quality Indicators
- Perform Audits
At the end of the day, boot camp participants will be able to apply learned concepts to their own program needs when adding or changing components to their program.
It is official! The final ISBT 128 Labeling of Collection Products for Cellular Therapy Manufacturing Standard is published.
Following multistakeholder efforts to standardize labels for cells collected for further manufacturing, and two rounds of public input, ICCBBA has finalized this ISBT 128 labeling Standard. The Standard is for use only in situations where the sponsor or manufacturer has adopted it.
This Standard may reduce the variations in labeling requirements for apheresis collections for different sponsors or manufacturers, minimizing the risk of errors and increasing patient safety. ISBT 128 is a well-established and international coding and labeling system. Standardizing labeling requirements using this system enhances cellular therapy product traceability and reduces the number of systems that must be adopted, implemented, validated, and maintained at health care institutions.
FACT-accredited apheresis collection facilities are encouraged to review this Standard, work with their ISBT 128 vendors regarding implementation and validation, and inquire with clinical trial sponsors and manufacturers about their intentions for adopting it.
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
Some commercial cellular therapy product manufacturers may provide FACT-accredited programs the option to undergo a full site quality audit or provide a copy of the most recent FACT accreditation report and undergo an abbreviated audit. If choosing the second option, programs will want to provide manufacturers the final report complete with program responses to cited deficiencies. Program responses are an opportunity to demonstrate correction of deficiencies and ultimate compliance with FACT Standards.
FACT Accreditation Coordinators will provide a copy of the final Accreditation Report, with the program’s responses, when sending the Accreditation Certificate at the conclusion of the inspection and accreditation process. Additionally, in the current online accreditation portal, the complete report can be downloaded by opening the applicable Compliance Application and clicking “View: Accreditation Report” in the left navigation pane. A version of this report is also automatically saved in the Document Library when the accreditation process is complete.
Accessing the Accreditation Report in the legacy FACTWeb Portal
Not all programs have completed the accreditation process in the current online portal. For these programs, contact your FACT Accreditation Coordinator, who will be happy to email you a copy of the report.
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!
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!
The second edition of the FACT-SBTMO Accreditation Workshop for transplant centers in Brazil occurred during an online event on October 27, 2020. The pre-conference event took place prior to the SBTMO 2020 Congress and was simulcast in both Portuguese and English. The virtual platform enabled program personnel throughout Brazil to participate in the workshop. Interactive sessions provided an overview of FACT Cellular Therapy Standards, emphasized the importance of a quality management program including document control and validation, and addressed areas that are challenging for new centers. Members from Hospital Israelita Albert Einstein, the first FACT-accredited program in Brazil, shared their experience in organizing and preparing for a successful inspection and accreditation process. Nearly 40 transplant centers in Brazil have expressed their interest and commitment to improving quality and safety through the FACT-SBTMO accreditation program.
FACT-SBTMO workshop presenters enjoy interacting with workshop participants. Pictured from top to bottom are Andrea Kondo, Carlos Bachier, Carlos Ramos, Phyllis Warkentin, and Daniel Kota.