FACT Publishes Second Edition Immune Effector Cell Standards

Posted in :: 2024 Volume 1 :: Friday, January 26th, 2024

FACT has published the second edition FACT Standards for Immune Effector Cells to be effective March 15, 2024.

These Standards promote quality medical and laboratory practice in immune effector cell therapies. These therapies include a wide range of cells that effect or modulate an immune response for therapeutic intent, whether genetically modified or not, such as T-cells, B-cells, natural killer cells, dendritic cells, genetically engineered chimeric antigen receptor T-cells (CAR-T cells), and therapeutic vaccines.

The FACT Standards for Immune Effector Cells were developed by consensus of experts in the field, reviewed during two public comment periods, and harmonized with the eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Significant changes were introduced to reflect advances in the field and incorporate evolving cell collection types and practices. The FACT Standards for Immune Effector Cells are specifically intended for programs and persons using these therapies outside of hematopoietic cell transplantation.

These Standards are available for download, or printed copies can be ordered.


Adverse Event Reporting to FACT

Posted in :: 2024 Volume 1 :: Friday, January 26th, 2024

By Stacy Freeburg, FACT Accreditation Coordinator

Programs monitor adverse events for patient safety and report events to third party organizations (FDA, Trial Sponsors), who consider the implications of single adverse events and compile the data to identify potential trends. Management of adverse events within an organization related to the administration of cellular therapy products is required by the FACT Standards.

FACT defines an adverse event as any unintended or unfavorable sign, symptom, abnormality, or condition temporally associated with an intervention that may or may not have a causal relationship with the intervention, medical treatment, or procedure. An adverse reaction is classified as a type of adverse event. In the standards, references are made to adverse events that encompass required detection, investigation, documentation, reporting, corrective and preventive action, and the responsibility to report incidents to different entities.

If an unexpected or serious adverse reaction occurs due to cellular therapy product collection or administration for which there is a reasonable possibility that the response may have been caused by the product, the report of the adverse reaction and its outcome and investigation should be communicated to all facilities associated with collection, processing, and/or administration of the product.

Organizations must comply with FACT Standards and policies throughout their accreditation cycle, including submission of the Annual and Renewal Report within 30 days of receipt (refer to the FACT Maintaining Accreditation Policy). The Annual Report is sent on the 12-month anniversary of current accreditation, whereas the Renewal Report is sent 14 months prior to expiration.

These reports allow organizations to update FACT regarding their demographics, changes in key personnel, facilities, or services, and submit required documentation of corrective action, as applicable. The report also requires programs to provide an explanation of any serious or unexpected adverse event that occurs during the reporting period. As defined by the FDA, serious adverse events have a severe impact on an individuals’ health, potentially leading to life-threatening consequences, permanent damage, or extended hospital stays (refer to the FDA, “What is a Serious Adverse Event?”).

When reporting an adverse event, organizations must include an explanation and supporting documentation that demonstrates compliance with the FACT Standards and includes the following:

  • A description of relevant patient details. Do not include Protected Health Information (PHI).
  • A description of relevant product details, if applicable.
  • A summary of how the event was identified and investigated, corrective action(s) implemented, and that appropriate follow-up of implemented corrective action(s) was performed to ensure the corrective action(s) were effective.

Referenced Standards:

  • 3.4.8 Management of complications related to the administration of cellular therapy products.
  • B/C/D4.10.4.2 Occurrences shall be reported to other facilities performing cellular therapy product functions on the affected cellular therapy product and to the appropriate regulatory and accrediting agencies, registries, grant agencies, sponsors, IRBs, or Ethics Committees,

FACT Launches 2024 Education Season

Posted in :: 2024 Volume 1 :: Friday, January 26th, 2024

We are thrilled to announce the launch of the 2024 FACT Education season! This year offers an array of enriching experiences both virtually and in-person across the globe.

Visit FACT’s Calendar of Events to register for upcoming education opportunities.

The 2024 FACT Quality Boot Camp spotlight shines on Process Validation, where FACT instructors delve into the intricacies of developing validation plans and will cover aspects such as purpose, responsibilities, acceptance criteria, data collection, risk assessment, and summary of results. The day kicks off with an enlightening overview of validations, verifications, and qualifications. Participants will actively engage in developing validation plans for critical processes, including Bone Marrow Collection, Preparation for Administration, and Infusion, ensuring a highly interactive learning environment.

Our interactive Cell Therapy Accreditation Workshop takes a deep dive into FACT’s Standards and accreditation process, offering a dynamic format facilitated by experienced instructors. Through case studies and collaborative discussions with peers, participants will gain insight into accreditation requirements, positioning their organizations for accreditation success, maintaining readiness, and addressing common citations. The workshop covers audits, corrective action plans, and strategies for enhancing clinical outcomes and data management.

For those aspiring to become FACT inspectors, training opportunities await. Tailored exclusively for inspector trainees who have completed prerequisites, the FACT Inspector Training Course offers practical, hands-on sessions led by experienced FACT inspectors, simulating the actual inspection process. Covering technology tools, preparation essentials, common citations, inspection procedures, and post-inspection expectations, this course provides a comprehensive foundation for those looking to contribute as FACT inspectors. To explore this exciting opportunity, contact Suzanne Birnley or visit https://www.factglobal.org/inspectors/.

Get ready for a season of unparalleled learning and professional growth with FACT Education in 2024!

Thank you to our partners for their generous support:

         

 

 


Year 2023 Was a Year Full of FACT Accomplishments

Posted in :: 2023 Volume 7 :: Monday, December 11th, 2023

FACT is celebrating a wonderful 2023! Below is a listing of many accomplishments over the past year. These successes are only possible with the volunteer inspectors and committees and the cellular therapy and cord blood banking organizations who pursue and maintain FACT accreditation. The entire FACT community should all be proud of everything we accomplished together! 

FACT Standards Development Committees Update Several Sets of Standards  

The FACT Standards Committees have been actively updating all four sets of Standards over the past year. The following are the major accomplishments:  

  • December 2022: The third edition of the FACT Common Standards for Cellular Therapies was published, accompanied by the first Accreditation Manual for this set of Standards.  
  • March 2023: A survey was distributed to the FACT community to request feedback on the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration in advance of the ninth edition revisions.  
  • March 2023: A special public comment period for the draft second edition of the FACT Standards for Immune Effector Cells was offered to solicit input on updates made to accommodate differences in collection of cells, such as from solid tumors or other tissues.  
  • June 2023: The draft eighth edition of the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration was published for public comment.  

 FACT Strategic Plan Focuses on Increasing Patient Access to Quality Cellular Therapy  

FACT regularly adopts three-year strategic plans to advance its organizational mission of promoting quality for patients in the evolving field of cellular therapy. On the heels of a worldwide pandemic and in anticipation of a burgeoning list of advanced therapies, FACT’s strategic plan for 2023-2025 is intended to strengthen and streamline its infrastructure to support accredited organizations and to expand beyond core accreditation activities to serve new stakeholders that are driving development in the cell therapy industry.  

Pilot FACT Audit & Assessment Services Project is Initiated  

FACT hosted an industry focus group meeting during Advanced Therapies Week in January 2023 to present preliminary plans for FACT Audit & Assessment Services (FAAS) and gather feedback from manufacturers and other stakeholders. This feedback was used to develop a menu of services, a standardized assessment and audit checklist, proposed deliverables, and a pricing structure. Beginning in Summer 2023, a pilot assessment project was launched. As part of this project, three companies selected three sites for a pilot assessment based on the companies’ needs. The pilot assessments were successful and lessons learned will be incorporated into the FAAS processes. Official launch will take place in 2024.  

Major Upgrade to FACT Accreditation Portal Launched  

In February 2023, a major upgrade of the online FACT Accreditation Portal included new capabilities available to both applicants and inspectors. The improved portal interface has been modernized and streamlined to provide a better overall user experience and increased security. There were also enhancements to many of the pre-existing features including:  

  • Document Library.  
  • Application Export.  
  • User Creation. 
  • RFI Processes.
  • Two Factor Authentication.
  • Director Approval Processes.

FACT Advocates for Multistakeholder Consensus Building Efforts in the ISCT Telegraft Hub  

FACT provided an article in the ISCT Telegraft Hub that described its efforts to build consensus among multiple stakeholders and perspectives to promote quality cellular therapy in the next wave of advancements. Titled, “Continuing FACT’s Tradition of Consensus Building into the Next Wave of Cellular Therapies: Incorporating Multistakeholder Perspectives into FACT Accreditation and Assessment & Audit Services,” the article provides a history of FACT’s consensus-building roots and then describes the organization’s current efforts:  

  • The early collaborations among ASTCT, ISCT, FACT, JACIE, NetCord, and more.  
  • The advent of commercially manufactured cellular therapies and the need for multistakeholder cooperation.  
  • FACT participation in multistakeholder groups.  
  • FACT implementation of multistakeholder solutions to reduce duplicative assessments and audits: 
    • Soliciting manufacturer input in the FACT Standards development process.  
    • Supporting manufacturers’ efforts to leverage FACT accreditation.  
    • Advocating for the implementation of multistakeholder solutions.  
  • Building FACT Audit & Assessment Services.  

FACT Launches Fund Development Initiatives  

FACT welcomed its first Director of Development, Meredith Lambe, to develop and implement a fundraising plan to support FACT’s mission and vision by enriching FACT’s education and training program, prevent increased service costs, and expand access to patient therapies. To oversee fundraising efforts, a Fund Development Committee led Dr. Alan Balch, was established. FACT has initiated its fund development program to broaden and enhance its educational activities and expand training to more inspectors internationally. In addition, funding will aid in conducting additional accreditation workshops to provide essential information and resources to site personnel awaiting accreditation and ultimately accelerate delivery of quality therapies to the market safely and promptly.  

FACT Education Continues Robust Schedule Despite Pandemic Challenges  

Although adjustments were continuously made to adapt to surges in the COVID-19 rates, the FACT Education calendar remained full in 2023. In 2023, FACT hosted 12 all-day events, 5 webinars, and 5 portal sessions. These included accreditation workshops, inspector training courses, quality boot camps, Quality Management webinar series, and Immune Effector Cells for Solid Tumor webinar series. 

Global Affairs – International Tour a Success  

International efforts to assist with the development of cellular therapy programs and quality systems were in high demand in 2023. Special thanks to our dedicated and generous volunteers Daniel Couriel, Carlos Bachier, and Federico Rodriguez for organizing, educating, and serving as invaluable resources for our global partners throughout Latin America. Accreditation and quality sessions were conducted in conjunction with FACT’s partners during the GATMO Congress in Buenos Aires, Argentina; Mexican Society of Cellular Therapy and Bone Marrow Transplants & Transplantation (SMTT) in Puebla, Mexico; and the Brazilian Society of Cellular Therapy and Bone Marrow Transplantation (SBTMO) Congress in Curitba, Brazil. FACT also held its inaugural education and training event in conjunction with the ISCT Australia & New Zealand Regional Meeting in Perth, Australia and look forward to this being an annual event. 


Comments Requested on Draft Eighth Edition NetCord-FACT Cord Blood Banking Standards

Posted in :: 2023 Volume 4 :: Thursday, July 27th, 2023


 

 

 

 

 


By Monique Summers
, RN, MSN, MPA, FACT Standards Development Manager

FACT has published the draft eighth edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration for public comment through September 15, 2023.

These comprehensive Standards promote quality medical and laboratory practices throughout all phases of cord blood collection, processing, and banking to consistently achieve quality placental and umbilical cord blood units for administration and to improve patient outcomes. These Standards are applicable to both unrelated donor units and family units and cover 1) collection of cord blood cells, regardless of the methodology or site of collection; 2) screening, testing, and eligibility determination of the maternal and infant donor according to Applicable Law; 3) all phases of processing, cryopreservation, and storage; 4) testing and characterization of the cord blood unit; 5) making the cord blood unit available for administration, either directly or through listing with a search registry; 6) the search process for selection of specific cord blood units; 7) reservation and release of cord blood units for clinical use; 8) transport or shipment of fresh or cryopreserved cord blood units; and 9) clinical follow up. The final Standards will be published in December 2023.

The purpose of this public comment period is to receive your comments and suggestions on this edition of the Standards. The published draft is a redline document intended to highlight the significant changes. Some changes are new standards; however, others are intended to clarify rather than change the intent, or to provide consistency with other sets of FACT Standards. Minor reorganization and clarifications are not tracked.

Review the Draft Eighth Edition Cord Blood Standards

For instructions and to submit your comments(s), go to the Cord Blood Public Comments Survey.


Reminder! Input Requested on FACT Standards

Posted in :: 2023 Volume 2 :: Thursday, April 27th, 2023

Comments Requested on Draft Second Edition FACT Standards for Immune Effector Cells

FACT published the draft second edition FACT Standards for Immune Effector Cells for public comment during a thirty-day period. Comments will be accepted through April 30, 2023.

To access the draft Standards and submit public comments, visit the Public Comments webpage on the FACT website.

FACT-JACIE Standards Feedback Requested

Preparation of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, ninth edition, will commence in May 2023. Final publication is expected in early 2025.

FACT and JACIE invite you to complete a short survey to provide feedback and suggestions regarding the Standards. Survey results will be reviewed by the Standards Steering Committee for potential inclusion in the next edition of the Standards. Responses will be accepted through April 28, 2023.

Complete Survey


HCT Accreditation Manual Provides Additional Examples of Proof of Death

Posted in :: 2023 Volume 2 :: Thursday, April 27th, 2023

Standard D12.1.3.1 of the FACT-JACIE Hematopoietic Cell Therapy Standards1 requires proof of death of the intended recipient of any hematopoietic progenitor cell (HPC) product before it is discarded. Many cellular therapy programs noticed an additional sentence added to the examples in the accompanying Accreditation Manual2:

Eighth Edition Standards:

D12.1.3 Documentation of no further need for the cellular therapy product before any product is discarded.

D12.1.3.1 For HPC products, this shall include documentation of the designated recipient’s death, if applicable.

Examples in the Eighth Edition Accreditation Manual:

FACT Seventh Edition: Proof of death includes an autopsy report, a dictated clinical note, or the Social Security index in the U.S. Secondary sources of information, such as newspaper articles, do not satisfy this requirement.

FACT Eighth Edition: Proof of death includes an autopsy report, a signed statement by the treating physician, or the Social Security index in the U.S. The institution registry or the governmental regional registries are also adequate sources. Secondary sources of information, such as newspaper articles, do not satisfy this requirement.

The Standards Committee’s intent is to no longer require the Processing Facility to obtain primary documentation of death for every discarded cellular therapy product. As stated in the Explanation, the facility may use an institutional process for documentation of death, such as having the patient listed as deceased in the electronic medical record. However, the institutional process must be based on primary documentation. Examples of acceptable primary sources are a death certificate, death at the institution, or the Social Security Index. The facility may consider doing a process validation of the institutional process to document death and confirm that it is based on a primary record. This confirmation would only need to be performed as part of the validation and not for every death record that the facility obtains.

The institutional cancer registry worksheet would suffice for the Processing Facility’s records, as long as the facility has confirmed that the registry’s process for noting death does include a primary source.

The term “governmental regional registries” was included at the request of international groups, and would include death registries maintained by states.

Most informed consent processes now state a time limit for how long a cellular therapy product will be stored, or when a product will be moved to long-term storage. For informed consent that states that products will be stored until death, FACT recommends that the Processing Facility consults with its legal department if it desires to dispose of the product.

[1] FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Eighth Edition, Version 8.1

[2] FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual, Eighth Edition, Version 8.2


Comments Requested on Draft Second Edition FACT Standards for Immune Effector Cells

Posted in :: 2023 Volume 1 :: Thursday, March 30th, 2023

The Foundation for the Accreditation of Cellular Therapy (FACT) will publish the draft second edition FACT Standards for Immune Effector Cells on March 31, 2023, for public comment during a thirty-day period. Comments will be accepted through April 30, 2023.

These Standards promote quality practice in immune effector cell therapies and apply to a wide range of immune effector cells used to modulate an immune response for therapeutic intent, whether genetically modified or not. This includes, but is not limited to, dendritic cells, natural killer cells, T cells, B cells, genetically engineered chimeric antigen receptor T cells (CAR-T cells), and therapeutic vaccines. The final Standards will be published in November 2023 and will become effective in February 2024.

The FACT Standards for Immune Effector Cells were reviewed and commented upon during an initial public comment period in association with the eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. The majority of comments received have been addressed through harmonizing these two publications.

Comments submitted during the first comment period clearly indicated a need to enhance standards related to cell collection. These comments have been addressed in B2.12, B2.12.1, and in a reorganized Section C that now includes general standards applicable to any cell collection followed by sections C9, C10, and C11 specific to apheresis and whole blood collection, marrow collection, and collection of other tissues such as tumor-infiltrating lymphocytes (TILs).

The purpose of this comment period will be to specifically request your comments on these new sections. Two versions of the published draft are available. One is a clean version, and the other is a redline document intended to highlight the changes made to these Standards. Minor reorganization and clarifying changes are not tracked. Some changes are new standards; however, some are intended to clarify rather than to change the intent. In addition, many changes were made to provide consistency among all sets of FACT Standards:

If you have any questions, please contact Monique Summers, FACT Standards Development Manager at monique.summers@factglobal.org or 402-920-7010.


FACT-JACIE Standards Feedback Survey

Posted in :: 2023 Volume 1 :: Thursday, March 30th, 2023

Preparation of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, ninth edition, will commence this summer. Final publication is expected in early 2025.

FACT and JACIE invite you to complete a short survey to provide feedback and suggestions regarding the Standards. Survey results will be reviewed by the Standards Steering Committee for potential inclusion in the next edition of the Standards.

You are also encouraged to share the survey with your colleagues and promote the survey in your professional societies. Responses will be accepted through April 28, 2023.

Complete Survey

If you have any questions or need additional information, please contact the Standards Development Manager at Monique.Summers@factglobal.org.


FACT Publishes Third Edition of the Common Standards for Cellular Therapies with a New Accompanying Accreditation Manual

Posted in :: 2023 Volume 1 :: Thursday, March 30th, 2023

The major objective of the FACT Common Standards for Cellular Therapies is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application throughout product development and clinical trials.

This third edition of Common Standards remains consistent with previous editions, requiring a comprehensive quality management plan and established clinical, collection, and processing procedures. Additionally, this edition reflects the maturation of cellular therapy and the inclusion of more and diverse products such as genetically modified products. Quality management requirements include specific training in good manufacturing practice appropriate to the products being collected or processed; development and review of robust written agreements with entities providing services or products; comprehensive document control; and expanded auditing, outcome analysis, and data management and reporting requirements.

“The revisions were focused on harmonization with other parallel FACT standards and on advances (real and anticipated) of novel cellular therapies that would be covered under the Common Standards,” according to Dr. Paul Eldridge, Chair of the Common Standards Committee.

In this edition, emphasis is also placed on the criticality of labeling and chain of identity / chain of custody as product manufacturing frequently involves several cooperating entities to achieve collection of the cellular starting material, manufacture of the final product, transport of the cells and products among facilities, and clinical therapy administration. Because of its value in accurate and unambiguous identification, encoding information, and labeling of medical products of human origin, full implementation of ISBT 128 coding and labeling is required where possible.

FACT is excited to announce the publication of the first Accreditation Manual to accompany the third edition Standards. Significant thanks is given to Dr. Carolyn Keever-Taylor for her work in drafting the initial document for the committee to review. The Accreditation Manual “provides a valuable tool for users to self-assess their compliance with the Standards and ensure that they are inspection ready,” Dr. Paul Eldridge.

The Common Standards Committee consists of 13 expert members. Members reviewed clinical, collection, processing, and quality requirements. Following months of reviews and revisions, comments were submitted during an open public comment period. The committee considered all feedback, which totaled almost 100 comments, submitted by professionals from industry, clinical, non-profit, and regulatory settings. Final revisions were drafted by the committee and approved by the FACT Board of Directors. The FACT leadership expresses its gratitude to the committee members for their dedication and work to revise this third edition.

The third edition Common Standards became effective on March 30, 2023. All organizations accredited under these Standards are now expected to be in compliance with the requirements. Compliance Applications and inspections under the Common Standards will now only be accepted for the third edition.

Third Edition Common Standards [free download]

Third Edition Common Standards Accreditation Manual [free download]

Purchase printed copies of Standards

Purchase printed copies of the Accreditation Manual


FDA Publishes Draft Guidance on Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

Posted in :: 2022 Volume 3 :: Wednesday, August 17th, 2022

The United States Food and Drug Administration (FDA) is responding to needs for regulatory predictability and leverage of stakeholder efforts for standardization in regenerative medicine therapies, including cellular therapy, via a draft guidance that introduces a voluntary consensus standards recognition program.

Published in June 2022, Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies: Draft Guidance for Industry acknowledges many unique challenges caused by the novelty of regenerative medicine therapy products. The proposed standards recognition program for regenerative medicine therapies (SRP-RMT) is intended to:

  • Use agency expertise to evaluate and recognize voluntary consensus standards.
  • Provide transparency to industry and other stakeholders regarding CBER’s thinking about a particular method or approach.
  • Promote the visibility and use of standards applicable to the agency’s mission.

The draft guidance describes the purpose of the program, procedures for evaluating standards for recognition, documenting the use of a recognized standard, and questions and answers.

Comments on the draft guidance are due by September 14, 2022. Comments may be submitted to https://www.regulations.gov, Docket No. FDA-2022-D-0745-0001.

A public workshop to discuss the guidance will be hosted by the Standards Coordinating Body (SCB) free of charge on August 24, 2022 at 12 pm ET. Register online.


Standards Development Updates

Posted in :: 2022 Volume 3 :: Wednesday, August 17th, 2022

By Monique Summers, RN, MSN, MPA
FACT Standards Development Manager

Standards Committee members have risen to the challenges of COVID-19 over the past two years, and all four sets of FACT Standards have been in the active phase of the review process.  Members have incorporated feedback from constituents, discussed new developments in cellular therapy, and edited drafts. Updates for each set of Standards are provided below. As progress continues, important updates will be announced.

FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and AdministrationEighth Edition

FACT and JACIE finalized the eighth edition Hematopoietic Cellular Therapy Standards in August 2021 with a revision in December 2021.  These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, cord blood, or other tissues and administered by a blood and marrow transplant (BMT) team.

The FACT Accreditation Services department is working with accredited and applicant programs that are beginning the accreditation process under the eighth edition and is available for questions.

FACT Standards for Immune Effector Cells, Draft Second Edition

The FACT Standards for Immune Effector Cells apply to immune effector cellular (IEC) therapy programs that are independent of a transplant program. Standards specific to IEC therapy are also contained within the FACT-JACIE Hematopoietic Cellular Therapy Standards for programs that perform both transplant and IEC therapy.  To ensure that the Standards reflect emerging changes in the field, FACT delayed the publication of the second edition to incorporate the expertise of providers with Tumor Infiltrating Lymphocyte (TIL) experience.  The committee has resumed its work and plans to publish the draft for a second public comment period in late 2022.

FACT Common Standards for Cellular Therapies, Draft Third Edition

The draft third edition FACT Common Standards for Cellular Therapies was published in 2021 for public comment. The Common Standards Committee consists of members representing a wide variety of specialties to ensure the Common Standards continue to represent the basic fundamentals applicable to any type of cellular therapy.  This includes HPC transplantation, IEC therapy, cardiovascular medicine, cord blood banking, cell collection, and cell processing with minimal and more-than-minimal manipulation. The third edition is scheduled to be published soon.

NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, Draft Eighth Edition

The Steering Committee kicked off the drafting of the eighth edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration in May 2021, and subcommittees have been meeting for the past year.  The Steering Committee will meet during the 2022 Cord Blood Connect meeting in Miami, Florida to complete a final review of the draft prior to public comment, which is scheduled for late 2022.


Examples of Label Reconciliation Methods to Prevent Mix-Ups of Cellular Therapy Products

Posted in :: 2022 Volume 2 :: Friday, June 17th, 2022

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, C7.2.2.1, 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.

Updated Versions of FACT-JACIE Hematopoietic Cellular Therapy Standards and Accreditation Manual Available

Posted in :: 2022 Volume 1 :: Monday, March 7th, 2022

The Eighth Edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration has been updated to Version 8.1, and its accompanying Hematopoietic Cellular Therapy Accreditation Manual has been updated to Version 8.2.

Version 8.1 of the Standards became effective on January 14, 2022. The changes from Version 8.0 to 8.1 are clerical in nature, and organizations accredited under these Standards should already be in compliance. Most of the changes in the Accreditation Manual from Version 8.1 to 8.2 are also clerical. Substantive content changes to the manual reaffirm and clarify donor screening and donor lymphocyte infusion (DLI) eligibility requirements. Reference Appendix V in both documents for a summary of the changes.

The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products.

FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.

The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.

Download the updated Standards, Manual, and Summary of Changes

Purchase printed copies of the 8.1 Edition FACT-JACIE Standards

Purchase printed copies of the 8.2 Edition Hematopoietic Cellular Therapy Accreditation Manual


FACT and JACIE Remained Committed to Publishing the Eighth Edition Hematopoietic Cellular Therapy Standards Despite Worldwide Pandemic

Posted in :: 2021 Volume 4, Uncategorized :: Wednesday, July 14th, 2021

As an international Standards Committee, the FACT-JACIE Hematopoietic Cellular Therapy (HCT) Standards Committee is accustomed to remote collaboration. Its ability to work primarily online was brought to the test during the COVID-19 pandemic in 2020, and the committee rose to the challenge! The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and its accompanying Accreditation Manual were published on May 17, 2021.

“Even with the challenges of a pandemic combined with very rapid advances in the field, amiable dedicated colleagues allowed successful completion of the task,” says Dr. Paul Eldridge, Chair of the Standards Committee. “I want to express my thanks and gratitude to everyone.”

Dr. Kim Orchard, Co-Chair of the Clinical Standards Subcommittee, adds, “The preparations for the eighth edition of the Standards proceeded with only minimal delays due to the COVID-19 pandemic. Credit is due to all those involved who continued to review and prepare the Standards despite the impact on their work and personal lives.”

“It was a challenge to continue with everything during the pandemic,” according to Dr. Nina Worel, Co-Chair of the Collection Standards Subcommittee. “Not so much with the FACT-JACIE team working on the eighth edition as the time schedule is perfect. We are used to working remotely and the meetings always close on time, but this time there were a lot of other additional meetings that were remote.”

“We managed to have the second face-to-face meeting of the combined FACT and JACIE teams just before the full impact of the first wave occurred, and all subsequent meetings were held by remote means which were already planned,” says Dr. Orchard. “Credit is due to all those involved who continued to review and prepare the Standards despite the impact on their work and personal lives.”

The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products. FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.

The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.

The HCT Standards Committee consists of 64 expert members among a Steering Committee and five subcommittees that reviewed clinical, collection, processing, quality, and immune effector cell (IEC) requirements. These members reside in 14 countries, contributing a truly international perspective to the Standards.

Following months of initial reviews and revisions, the HCT Standards Committee considered approximately 770 comments, submitted by 78 participants from 20 countries, during the public comment period. Additionally, other experts from FACT and JACIE participated in discussions related to new developments in the field, including Dr. John Snowden, member of the JACIE Committee and secretary of the European Society for Blood and Marrow Transplantation (EBMT), the FACT Immune Effector Cell Task Force, and others. These experts provided the HCT Standards Committee advice to consider when finalizing the Standards, with revisions ultimately drafted by the Standards Committee and approval granted by the FACT and EBMT Boards of Directors.

“It was really exhausting [with the other remote meetings]. However, we managed to finalize a great new edition of Standards for best quality in cellular therapy for our patients,” says Dr. Worel.

“It was a pleasure to work with committee members on the new edition of standards,” says Dr. Eldridge. “The opportunity to learn from such a diverse group of international experts is amazing.”

The eighth edition Standards become effective on August 16, 2021. All organizations accredited under these Standards are expected to be in compliance with the requirements by that date. Although there may be a few inspections remaining to be completed under the previous edition due to COVID 19-related delays, all other inspections scheduled after this date will be under the eighth edition.

Review the Summary of Changes for the eighth edition FACT-JACIE Standards

Download the eighth edition FACT-JACIE Standards for free

Download the eighth edition Hematopoietic Cellular Therapy Accreditation Manual for free

Purchase printed copies of the eighth edition FACT-JACIE Standards

Purchase printed copies of the eighth edition Hematopoietic Cellular Therapy Accreditation Manual

Download additional supporting documents


The X Factor: What is GxP and What Training is Required?

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration requires that physicians and staff have annual training in current GxP appropriate to the processes performed in accordance with Applicable Law. (See Standards CM3.3.4, C4.4.2.5, and D4.4.2.5).

What is GxP?

The Standards define GxP as, “Good practice following various quality standards and regulations. The “x” is variable, with further definition of good practices defined by different Applicable Law and industry standards. The type of work that is being performed will define which GxPs should be followed.”

Different facilities will follow different GxPs based on the activities they perform. These may include, but are not limited to, Good Manufacturing Practices (GMPs), Good Tissue Practices (GTPs), Good Documentation Practices (GDPs), Good Clinical Practices (GMPs), and Good Laboratory Practices (GLPs).

What GxPs require annual training per the Standards?

 FACT requires training in all GxPs that are required by law. Accredited facilities must determine which GxPs apply to the activities they perform and for the types of cellular therapy products for which the cells will be used. This includes an assessment of all activities and determination of which GxPs are required by law for each of those activities. Facilities must document this assessment so 1) the program has a defined list of GxPs that require training and 2) inspectors can verify appropriate training is performed.

All Apheresis Collection and Processing Facilities will have activities applicable to GTPs and GDPs. All Marrow Collection Facilities will have activities applicable to GDPs, but may also perform activities related to GTPs. Collection and Processing Facilities may also need to follow GMPs, GCPs, or GLPs. The extent and level of GMPs implemented is dependent on the type of manufacturing that is performed (e.g., manufacturing of allogeneic minimally manipulated HPC cellular therapy products verses investigational and licensed cellular therapy products).

How much training is required each year?

Comprehensive training on every aspect of GxPs each year is not expected; rather, there must annually be some training based on a GxP topic.

Many of the procedures performed by personnel already require training in GxPs to perform the work; therefore, GxP training is not required to be separate. However, documentation must provide evidence that the GxPs were included. For example, training in environmental control could include an overview of GTPs or GMPs, the relevant requirements based on the work to be performed, and the specific tasks performed by personnel.

Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards

Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual


Navigating the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards Webinar

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

The eighth edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards was published on May 17, 2021 and will be effective on August 16, 2021. To support FACT accredited and applied programs during this transition, FACT is offering a webinar, titled Navigate the Eighth Edition Cellular Therapy Standards, on July 21, 2021 at 10 am CT, 3 pm GMT. Dr. Paul Eldridge from Levine Cancer Institute, the Standards Committee Chair, will explain changes including:

 

  • Genetically-modified cellular therapy products
  • Training in GxP
  • Quality management
  • Informed consent
  • Labeling
  • Storage