Mikaela VanMoorleghem, MPA, Education and Training CoordinatorFoundation for the Accreditation of Cellular TherapyOmaha, NE USA
FACT Announces Return to In-person Inspections October 1, 2022Sarah Litel-SmithSupervisor, Accreditation Services
FACT is excited to announce the return of in-person on-site inspections beginning October 1, 2022. Virtual inspections for renewal applicants were implemented in 2020 in response to the COVID-19 pandemic. While these virtual inspections have generally been successful as an interim measure, there have been some challenges and more delays than anticipated.
A recent survey of active inspectors indicates that most are comfortable with travel, at least domestically; their institutions permit travel; and applicant organizations are able to accommodate inspection teams. The return to in-person inspections will allow more expeditious inspection scheduling and facilitate much needed inspector trainee participation. The 40 new inspectors who completed an Inspector Training Workshop this spring at the ASTCT, ASFA, and ISCT meetings are anxious to complete their required trainee inspection. Please volunteer to be a mentor if you are an inspector and welcome a trainee inspector when your program schedules its on-site inspection.
Virtual inspections already scheduled through the end of September will be performed virtually as planned. If deemed necessary to protect the health and safety of inspectors, staff, and patients, or in response to other restrictions, FACT may conduct additional virtual inspections as needed. Contact your Accreditation Coordinator or the FACT Office if there are any concerns related to the next on-site inspection.
Examples of Label Reconciliation Methods to Prevent Mix-Ups of Cellular Therapy Products
Label reconciliation is now required in the eighth edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Specifically, Standards CM18.104.22.168, C7.2.21, and D7.2.3 state: “A system of label reconciliation shall be used to ensure the final disposition of all labels allocated to a specific product is documented.”
The purpose of this requirement is to prevent cellular therapy product mix-ups. As the FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual states, “The purpose of reconciliation is to ensure that all labels have been accounted for and no mix-up occurred. A system for label reconciliation that documents the number and type of labels received by the Collection/Processing Facility, the number of labels used, and the number of labels passed to the Processing Facility or destroyed shall be used.” The scope includes labels with unique identifiers of final products. It does not include labels for patient demographics or internal tracking numbers if they are not uniquely identifying a product, though these labels must still be controlled.
Print-on-demand systems for labels reduce risks of label mix-ups; however, there are instances in which a batch of labels is printed to facilitate processes. Label reconciliation does not need to be performed in real-time but should at least occur at the end of a process (for example, during cleanup of a processing procedure.)
In addition to the labeling operations requirements outlined in the FACT Coding and Labeling Cellular Therapy Products sections of the Standards (CM7, C7, D7), the following are example methods that may facilitate label reconciliation:
FACT Events Returned to In-Person Format in April and May 2022!
FACT hosted several in-person education events this spring and one fundamental truth that became apparent following the COVID-19 pandemic is that we are social creatures who crave interaction! Despite the quick pivot we did to successfully do business virtually, we were anxious to get back to in-person meetings and conferences.
FACT educational events at the 2022 Tandem, ASFA, and ISCT Annual Meetings were a success!FACT and ASTCT hosted a Quality Boot Camp on April 22 at the 2022 Tandem Meetings. Approximately 100 people participated in the boot camp. This year’s agenda focused on the program's Quality Management Plan and the annual review of the effectiveness of the overall Quality Management Program.
FACT also welcomed visitors to its exhibit booth at the 2022 Tandem Meetings to provide information about accreditation and educational activities.
On May 3, FACT hosted a Cellular Therapy Collection Accreditation Workshop at the 2022 ASFA Annual Meeting. Topics included growing variations in collection requirements, labeling, and chain of identity and custody for IEC products collected in apheresis facilities, and creating a cohesive quality management program with an outside collection center.
Additionally, FACT hosted inspector training courses for clinical hematopoietic, immune effector cellular therapy, marrow collection, apheresis collection, and cell processing trainees at the meetings. The courses guided trainees through the inspection experience including accepting an inspection assignment, submitting the inspection report, and participating in the relevant Accreditation Committee meeting.
All events were successful, and FACT looks forward to future in-person education events!
FACT Provides Input to Donor Registry and Regulatory Agency
Just like cellular therapy itself, donor registry and regulatory requirements evolve over time. As a voluntary, peer-based accrediting organization, FACT reviews updates to requirements that are relevant to our Standards and affect our accredited organizations. We take every opportunity to provide input on these requirements as a value-added service to the FACT community.
There have been notable requests for public comments in the first half of 2022, and FACT committees, task forces, and leadership have evaluated draft requirements and submitted comments when determined to be appropriate. These include:
Upcoming Cord Blood Banking Educational Events to be In-Person at Cord Blood Connect!
We are excited to gather in-person with the cord blood banking community once again. FACT's recent in-person events reminded us that connecting face-to-face is an unparalleled experience, and we look forward to spontaneous hallway conversations, the sound of chatter, the joy of networking, and the reactions from a live audience. No computer screen, virtual call, or digital experience can replace the benefits and positive experiences of meeting in-person.
Without further ado, FACT invites you to join us for the following education events in conjunction with the 2022 Cord Blood Connect Meeting in Miami, Florida. We hope to see you there!
FACT Cord Blood Accreditation and Quality Principles Workshop on September 8, 2022
This workshop is designed to explain the requirements for FACT cord blood bank accreditation and examine quality principles.
Register for the Workshop
FACT Cord Blood Inspector Training Course on September 8, 2022
In addition to the workshop, FACT will host an Inspector Training Course on September 8, 2022. The purpose of this course is to train eligible individuals to serve as FACT cord blood bank inspectors. The course is designed to guide the trainee through the inspection process including document review, on-site assessment, and Accreditation Committee review.
FACT is actively seeking new cord blood inspectors. If you are interested in training as a FACT inspector and meet the following requirements, we encourage you to apply!
Approved inspector trainees should register here for the Inspector Training Course on September 8th. Approved trainees attend free of charge.
Bring your colleagues! Receive a $1,000 discount for group registrations of 5 or more personnel from the same cord blood bank. Please contact FACT Education Coordinator, Mikaela VanMoorleghem, for more information
Quality Management Series 11: Corrective Action Plans
Implement and Assess Effectiveness of Corrective Action PlansAugust 24, 2022
Join us on Wednesday, August 24, 2022, at 11:00 am ET/17:00 GMT, for the FACT QM 11 Webinar: Implement and Assess Effectiveness of Corrective Action Plans. Presenters will discuss:
Corrective Action Plans: Program PerspectiveNovember 9, 2022
Join us on Wednesday, November 9, 2022, at 3:00 pm ET/21:00 GMT, for the FACT Quality Management Series 11 Webinar: Program Perspective. Presenters will discuss corrective action plans from the Clinical, Collection, Processing, and Cord Blood Bank programs' perspectives.
Additional webinars in this series are open for registration at the following links. Advance registration and post-webinar recordings of all webinars in this module can be purchased at a discounted rate.Register now
Other webinars in this series include:
General Concepts and Need for Harmonization of StandardsSeptember 28, 2022
This webinar offers an introduction to Immune Effector Cellular (IEC) Therapy for the treatment of solid tumors. Presenters will discuss unique challenges and considerations in IEC manufacturing; list subtypes of IECs in solid tumors including TILs, CAR-T cells, and TCRs, and examine the need for quality standards.
Tumor Infiltrating LymphocytesJanuary 17, 2023
Tumor-infiltrating lymphocytes (TILs) can recognize and kill cancer cells. This webinar will provide a broad introduction to TILs and a review of current clinical experience and unique considerations in TIL manufacturing. Presenters will also discuss the need for establishing safety and efficacy quality benchmarks for TILs.
CAR-T cells and T-cell Receptor Cells (TCR) in Solid TumorsMarch 30, 2023
CAR-T and TCR cell therapy has demonstrated encouraging potential for the treatment of solid tumors. During this webinar, presenters will highlight current clinical experience with CAR-T cells in solid tumors and unique considerations in manufacturing. Presenters will also discuss the need for establishing safety and efficacy quality benchmarks for CAR-T cells and TCRs.
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