Letter from the President
“It was great to see you!” After two long years of only virtual connection, we finally were able to say this again. FACT had a wonderful time over the past few weeks seeing colleagues in person at the annual meetings of various professional societies including ISCT and the Tandem Meetings with ASTCT and CIBMTR. In some ways, it was like no time has passed, and in other ways, it was like reuniting with long-lost friends. Our popular and interactive workshops returned to their hands-on format, the quality boot camp resumed their group-based learning, and we are thrilled to have had the opportunity to train many new inspectors. I personally would like to give you a heartfelt, “Welcome to the team!”
A major theme of this newsletter is highlighting the participation of FACT members in the public review and comment periods of multiple draft publications. Calling on the expertise within several FACT committees, we have submitted comments to numerous requests from related organizations and governmental agencies as highlighted in this newsletter. As a Standards setting organization, FACT understands the importance of soliciting and providing critical feedback for the development of appropriate, relevant, and useful guidelines; therefore, we encourage your participation in this important process. Thank you as always for your engagement and support!
Catherine Bollard, MD
DUE JUNE 30, 2022: Standards Coordinating Body Seeks Comments on Chain of Identity Identifier Definitions and Requirements
The Standards Coordinating Body (SCB) assembled a multi-stakeholder working group, including FACT, to develop proposed definitions and requirements for Chain of Identity (COI) identifiers titled, “Key Requirements and Definitions for Chain of Identity Identifier.” Standard definitions and requirements have become increasingly important as the number of players in the cellular therapy supply chain has increased and become more diverse. FACT strongly recommends its accredited organizations and inspectors review the draft and submit comments. Comments are due by June 30, 2022.
As SCB explains in the draft, COI identifiers are essential to demonstrating adequate control of biological material. FACT-accredited organizations have expressed concern about the challenges of implementing several identification systems at a single institution and how they pose risks of mix-ups. These definitions will hopefully lead to consistent use of COI identifiers and potentially allow the development of common COI identification systems for multiple cellular therapy products.
Please review the draft and submit your comments via the commenting template to Dawn Henke at firstname.lastname@example.org.
Supervisor, 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 FACT at email@example.com, or 402.920.7001, if there are any concerns related to the next on-site inspection.
A recent in-depth organizational assessment identified several new growth opportunities for FACT to help support the needs of the cell and gene therapy community. As the field continues to develop at a rapid pace, FACT is also anticipating growth and seeks candidates for several leadership positions. If you are interested or have a colleague that may be interested, please review the duties and qualifications of the following positions:
- Director of Development
- Business Development Director
- Deputy Medical Officer
- Chief Scientific Officer/Director of Education
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:
- Proposed NMDP/Be the Match Participation Criteria A00960, titled, “U.S. Apheresis and Collection Center Participation Criteria”: FACT expressed support for NMDP/Be the Match’s efforts to simplify and streamline criteria, requested clarification regarding whether the proposed criteria reflect a change in current practice regarding Apheresis Centers’ option to decline the opportunity to share NMDP collection center adult results with other NMDP clients, and reiterated support of retaining this option for NMDP collection centers.
- Draft Version of 25th Edition NMDP Standards: FACT expressed support for the National Marrow Donor Program (NMDP)/Be the Match’s efforts to streamline and simplify its Standards and provided recommendations for increasing clarity regarding the requirements and the scope of related accrediting organizations (e.g., FACT, the Joint Accreditation Committee of ISCT & EBMT (JACIE), and WMDA/NetCord).
- Draft guidance from the FDA proposed rule titled, “Medical Devices; Immunology and Microbiology Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests”: FACT expressed its support of the comments submitted under separate cover by the American Society for Histocompatibility & Immunogenetics (ASHI) and opposed FDA’s proposal to classify HLA devices into class II with special controls.
Read the proposed FDA rule
- Draft guidance from the Food and Drug Administration (FDA), titled: “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products”: FACT comments focused on the importance of relationships between cellular therapy product manufacturing companies and the health care institutions in their collection and treatment site networks to enhance patient safety, product efficacy, and patient access while minimizing the burdens on the health care institutions. FACT also recommended references to ISBT 128 coding and labeling and ASTCT consensus criteria for grading cytokine release syndrome and neurologic toxicities.
Read the draft FDA guidance
Robert A. Preti, PhD was awarded the 2022 ISCT Career Achievement Award at the ISCT Annual Meeting. This award is the highest honor awarded by the society and recognizes, “long and distinguished service to advancing the overall cell and gene therapy field, resulting in significant achievements that benefit patients.”
Dr. Preti played a key role in establishing FACT, and accreditation was just one of many areas he helped develop in cellular therapy. His contributions span scientific, academic, industry, and regulatory advancements.
Cytotherapy Article Reviews Progress of ISBT 128 Labeling, Provides Example of Successful Standardization in Cellular Therapy
Cytotherapy published a review article titled, “Standardization of cellular therapy terminology, coding and labeling: a review” (Ashford et. al, 2022)* that describes the introduction of ISBT 128 labeling to cellular therapy in the late 1990s and efforts since then to use the coding and labeling system to promote product identification and traceability. The article also describes the importance of multistakeholder collaboration and ongoing maintenance of standardization amidst continued evolution in the field.
The full abstract states, “The 1990s saw rapid growth in international activity in hematopoietic cell transplantation. As national donor registries were established and international collaboration increased, a need to transfer cellular therapy products across national borders emerged. A lack of international standards for identification, terminology and labeling resulted in significant challenges for import and export. Twenty years of effort by a large group of experts supported by professional societies and accreditation bodies has today achieved a high degree of standardization. This review highlights the main landmarks in this journey and serves as a reminder of the importance of taking the “long view” when working toward international standardization. It demonstrates the need for continual maintenance and enhancement of standards to meet the changing needs of the cell therapy industry and highlights recent developments in ISBT 128.”
*Ashford, P. et al (2022). Standardization of cellular therapy terminology, coding and labeling: a review.” Cytotherapy. 24(6). 577-582. https://doi.org/10.1016/j.jcyt.2022.02.009
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, C22.214.171.124, 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:
- Keeping labels in a batch record.
- Limiting the number of labels that are printed at a given time, and defining in policies what the use of each label will be.
- Utilizing a form that details the number of labels printed or received, used, passed to another unit, or destroyed. This could be on a collection form or a separate label reconciliation form.
- Affixing unused labels to the relevant form and crossing through or annotating labels that will no longer be used.
- Numbering labels (e.g., for 12 labels, label them 1 of 12, 2 of 12, and so on) to facilitate documentation of which label was used where.
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 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!
This year’s quality boot camp will focus on a program’s Quality Management Plan and the annual review of the effectiveness of the overall Quality Management Program. How do you evaluate each key quality topic and incorporate them into your program’s report? The boot camp will discuss tools you may use and how topics may be presented to different groups within your program. Join us for the day and work on Building Your Annual Quality Report.
- Writing Your Program’s Story: The Annual Quality Report
- Illustrating Collaborations and Relationships
- Evaluating the Impact of Validations Performed
- Using Occurrences to Drive Process Improvement
- Telling the Story: Presenting and Distributing the Annual Report
The day will also include various roundtable discussions to expand on and explore questions related to the information covered during the sessions.
Quality Boot Camp Host:
Kimberly Kasow, DO
UNC Bone Marrow Transplant and
Cellular Therapy Program
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 Cord Blood Connect 2022 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. FACT representatives will be in attendance to assist programs in organizing and preparing for the accreditation process and to address quality principles of cord blood banking.
Early bird pricing is available through July 14th!
FACT Inspector Training Course
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!
- Affiliated with a FACT accredited or applicant organization.
- Meets educational and professional qualifications and has the appropriate work experience related to his/her area(s) of expertise.
Approved inspector trainees should register here for the Inspector Training Course on September 8th. Approved trainees attend free of charge.
If you have any questions about upcoming FACT Events, please contact Mikaela VanMoorleghem.
Implement and Assess Effectiveness of Corrective Action Plans
August 24, 2022
Join us on Wednesday, August 24, 2022, at 11:00 ET/17:00 GMT, for the FACT QM 11 Webinar: Implement and Assess Effectiveness of Corrective Action Plans. Presenters will discuss:
- Implementation of corrective action plans.
- Monitoring corrective action plans. Assessing the effectiveness of a corrective action plan.
Folashade Otebeye, MBChB, MPH
Kerri Hill, BSN, RN
UAMS Cancer Institute
Corrective Action Plans: Program Perspective
November 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.
John McCarthy, MD
Leigh Gates, CPHQ
University of Colorado
Phillip Johnson, MMedSc(Path)
Queensland Cord Blood Bank at the Mater
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.
Other webinars in this series include:
- Overview of Corrective Action Plans (February 16. 2022)
- Developing a Corrective Action Plan (May 11, 2022)
General Concepts and Need for Harmonization of Standards
September 28, 2022
Join us on Wednesday, September 28, 2022, at 11:00 am ET/15:00 GMT, for the FACT IEC Webinar: General Concepts and Need for Harmonization of Standards. Basem William, MD, MRCP, FACP, from Ohio Health Blood and Marrow Transplant and Cellular Therapy Program, and Sarah Nikiforow, MD, PhD, from Dana-Farber Cancer Institute / Cell Manipulation Core Facility, will discuss the following:
- Introduction to IEC in solid tumors
- Unique challenges with IEC in solid tumors
- Subtypes of IEC in solid tumors; TIL, CAR-T, TCR, others
- Unique consideration in solid tumor IEC manufacturing
- Need for harmonization of IEC standards; how FACT can help
Tumor Infiltrating Lymphocytes
January 17, 2023
Join us on Tuesday, January 17, 2023, at 11:00 am ET/16:00 GMT, for the FACT IEC Webinar: Tumor Infiltrating Lymphocytes. Parameswaran Hari, MD, MRCP, DRCPath, MS, from Iovance Biotherapeutics, and John Mullinax, MD, from H. Lee Moffitt Cancer Center & Research Institute Blood and Marrow Transplant Program, will discuss the following:
- Introduction to TIL therapy?
- Review of current clinical experience with TIL
- Unique consideration in TIL manufacturing
- Need for establishing safety and efficacy quality benchmarks for TIL; how FACT can help
Other webinars in this series include:
CAR-T Cells and T-Cell Receptor Cells (TCR) in Solid Tumors (Date TBD)
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