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FACT Update July 2022

  

FACT Update July 2022

by:

Mikaela VanMoorleghem, MPA, Education and Training Coordinator
Foundation for the Accreditation of Cellular Therapy
Omaha, NE USA

FACT Announces Return to In-person Inspections October 1, 2022
Sarah Litel-Smith
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 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 CM7.2.2.1, 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:

  • 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 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:

 

  • 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

 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.

Topics include:

  • Overview of the FACT Accreditation process
  • Virtual tour of a cord blood bank
  • Case studies to determine compliance
  • Correction of deficiencies
  • Cord blood bank accreditation success
  • Five Whys method of root cause analysis including roundtable activity
  • How to maintain FACT readiness 

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 Plans
August 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:

  1. Implementation of corrective action plans
  2. Monitoring corrective action plans
  3. Assessing the effectiveness of a corrective action plan

Register now

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.

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:

Quality Immune Effector Cellular Therapy for the Treatment of Solid Tumors

General Concepts and Need for Harmonization of Standards
September 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.

Register now



Tumor Infiltrating Lymphocytes
January 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.

Register Now




CAR-T cells and T-cell Receptor Cells (TCR) in Solid Tumors
March 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.

Register Now


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