08.05.20

FACT Update: Save the Date for Virtual Inspection and Accreditation Workshop

FACT Announces Virtual Inspection and Accreditation Workshop

FACT will host its first virual FACT Inspection and Accreditation Workshop on Sept. 21, 2020. For more information view the flyer here.

FACT Inspections Amid the Pandemic

FACT is eagerly anticipating resumption of accreditation activities. In March 2020, FACT suspended on-site inspections and extended all accreditation deadlines and expiration dates by six months due to the COVID-19 Pandemic.  During this time, FACT staff have continued to review submitted applications and responses, prepared and presented educational webinars, and facilitated the vital committee work in standards development, accreditation, quality, clinical outcomes, data audits, education, immune effector cell initiatives, and international accreditation support.

Although the pandemic is not over, some travel has resumed, and some institutions are opening elective procedures and in person visits. A FACT Task Force will determine the best approach to resumption of on-site inspections. Options include virtual inspections, in-person inspections associated with limited travel, or a combination of methodologies. Factors to be assessed include inspector availability, inspector ability to travel, openness of institutions to non-essential individuals, and characteristics of the applicant program such as prior accreditation and the time remaining until accreditation expiration. Inspector availability and on-site options are being assessed through a survey distributed to inspectors and Program Directors. FACT will publish periodic updates related to inspections through the Newsletter and email communications.

Please Complete Survey to Support Apheresis Cell Collection Standardization Efforts

The following message is sent on behalf of the Standards Coordinating Body for Regenerative Medicine.

As the fields of cell and gene therapies grow, so may the burdens on both apheresis cell collection centers and industry. Standardization of some common collection parameters may reduce this burden on both. Improved consistency and standardization would also improve product quality and potentially improve patient outcomes while reducing errors and audit fatigue.

The Standards Coordinating Body has convened a working group of experts from industry, apheresis cell collection centers, processing laboratories, accreditation bodies, research centers, and other stakeholders to work towards these goals. 

We've developed two surveys to assess current practices, which take approximately 20 minutes to complete:

For Industry: https://cell-collection-for-industry.questionpro.com

For Apheresis/Cell Collection Centers: https://apheresis-center-survey.questionpro.com

On behalf of the subject matter experts who drafted this survey, and the Standards Coordinating Body, thank you for your time and your essential contribution to this standard development initiative.  

FACT Resources to Assist Your Program Throughout the Accreditation Process

FACT aims to provide organizations with valuable resources to aid in achieving and maintaining their accreditation. Our website has useful documents for organizations in all phases of the accreditation process. However, we understand that finding the right information can become overwhelming at times, especially for organizations completing their initial application or for personnel new to the accreditation process.

The following overview provides categories, definitions, and the location of important resources. We encourage you to share this information with all personnel involved in your organization’s FACT accreditation process:

FACT Standards

The FACT Standards webpage contains links to the most recent versions of the four sets of Standards published by FACT:

  • HCT Standards - FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration
  • Common Standards - Common Standards for Cellular Therapies
  • Immune Effector StandardsStandards for Immune Effector Cells
  • Cord Blood Bank Standards - NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration

The pages for each set of Standards contain useful documents relevant to the current editions of FACT Standards, including, but not limited to:

  • FACT Standards and Accreditation Manuals
  • Summary of Changes, Compare, and Crosswalk documents to identify changes between the previous and current versions of FACT Standards, if applicable.
  • Forms used during the compliance application submission, including but not limited to Document Submission Requirements, Educational Activities, Critical Electronic Record Systems, and Facility Site Grids.

The above resources can also be found in the Cellular Therapy Library and Cord Blood Bank Library.

Accreditation Process Requirements

The Cellular Therapy Accreditation Process Requirements and Cord Blood Bank Accreditation Process Requirements provide a structured overview of the accreditation process, from completing the Co Self-

Assessment Tools

The Self-Assessment Tools can be used to assess readiness for FACT accreditation. They are located in the Cellular Therapy (CT) and Cord Blood Bank (CB) Libraries, and you will find individual self-assessment tools for each current set of FACT Standards:

Educational Resources

FACT's comprehensive, robust training and development program is responsive to the current needs of inspectors and organizations, providing extensive opportunities for all skill levels in all corners of the world. With a focus on real-life examples and practical application, FACT educational sessions provide tools not only for achieving accreditation, but for ensuring quality patient care in accordance with the Standards. The Education and Resources page contains links to upcoming and previously recorded events:

FACT Accreditation Coordinator

FACT’s Accreditation Coordinators provide these and additional FACT resource links in an email sent to organizations at the beginning of the compliance application process. Your accreditation coordinator is available throughout the accreditation process to answer questions via email or phone. The coordinator’s contact information is available in the accreditation portal.

Clinical Outcomes Resource Center

FACT supports blood and marrow transplant (BMT) programs’ efforts to evaluate one-year survival data to improve patient outcomes, advance the field, and maintain payer and public confidence. The Clinical Outcomes Resource Center includes comparative data sources, educational resources, guidelines for corrective action plans (CAP), as well as CAP examples.

Data Management Resource Center

The FACT-CIBMTR Data Audit Committee reviews implementation, adequacy, and effectiveness of corrective action plans with the goal of providing education and assistance to programs throughout the accreditation cycle to achieve quality improvement in data management. The Data Management Resource Center provides CIBMTR and educational resources, guidelines for data management submissions and examples, and audit report examples and templates.

Immune Effector Cells (IEC) Resource Center

FACT is committed to supporting efforts to make quality immune effector cellular therapy accessible to patients much like it did for blood and marrow transplantation and cord blood banking. Several resources are available to assist with understanding immune effector cells and implementing FACT Standards. The Immune Effector Cells (IEC) Resource Center includes resources to assist with understanding immune effector cells and implementing applicable FACT Standards.

Portal Resource Center

The Portal Resource Center provides access to all available resources and training materials for navigating and assisting organizations in completing applications in the portal.

FACT News

Use the links below to access recent news releases, as well as current and previous volumes of our newsletter:

We hope that you find this information useful as you prepare for your next accreditation cycle. If you have additional suggestions regarding how FACT can better inform organizations of the resources available, please email fact@unmc.edu.

REMINDER: Public Comment Period Open for FACT Cellular Therapy Standards and Immune Effector Cell Standards

FACT-JACIE International Standards

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) published the draft Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment. 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, or cord blood.

Description and Instructions for Review and Comment

Summary of Changes

Draft Eighth Edition FACT-JACIE International Standards

Comments regarding the draft Eighth Edition FACT-JACIE International Standards can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.

FACT Standards for Immune Effector Cells 

The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft Second Edition FACT Standards for Immune Effector Cells for inspection and public comment. These Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes, but is not limited to, genetically engineered chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.

Description and Instructions for Review and Comment

Summary of Changes

Draft Second Edition FACT Standards for Immune Effector Cells

Comments regarding the draft Second Edition FACT Standards for Immune Effector Cells can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.

For questions or assistance, please contact Andra Moehring, MHA, Standards Development Manager.

FACT Quality Management Series, Module 10: Validations

The Quality Management Series Module 10 includes four sessions focused on Validation including:

  1. Validation Overview

Presented by Nicole Prokopishyn, PhD

August 19, 2020, 11:00 am ET, 15:00 GMT

Dr. Prokopishyn will discuss the difference between Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.

Register now

  1. Process Validation

Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP

October 14, 2020, 11:00 am ET, 15:00 GMT

Presenters will discuss the following:

  • Range to validate (where to start and when to stop), variables and extreme scenarios
  • Process validations (to include Bone Marrow process)
  • Verification: when is it needed

Register now

  1. Software Validation

Presented by Robyn Rodwell, PhD and Guy Klamer, PhD

December 2, 2020, 4:00 pm ET, 21:00 GMT

Dr. Rodwell and Dr. Klamer will discuss the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include:

  • Critical electronic systems under the control of the organization (facility)
  • Spreadsheets
  • Vendor and organization responsibilities

Register now

  1. Program Perspective on Validation

TBA

Register for the entire module to receive a 15% discount! QM Series Module 10: Validations

Immune Effector Cellular Therapy Webinar: Bringing a Stand-Alone Immune Effector Cell Therapy Program into FACT Compliance

FACT Accreditation a Criterion for 2020-2021 Best Children’s Hospitals List

U.S. News & World Report, published the 2020-2021 Best Children's Hospitals rankings and FACT accreditation was again used as a ranking criterion for the cancer specialty. For the Best Children’s Hospitals list, one point was given for the Cancer specialty if a hospital is autologous only FACT-accredited and two points were given for allogeneic and autologous accreditation.

To accompany the rankings, U.S. News launched the U.S. News Hospital Heroes project, a series of profiles spotlighting the extraordinary efforts being mounted by health professionals in the trenches of fighting the historic coronavirus pandemic. U.S. News will share their experiences, hopes and fears from all corners of the hospital and broader public health landscape, as the country reopens and navigates the road ahead.

Heat-Sealing Label in Cryopreservation Bag Pouch Meets Definition of “Affix”

The Accreditation Committees recently affirmed that inserting a label into a cryopreservation bag pouch and heat sealing the pouch would categorize the contents (label) as affixed. When the definitions of “affix” and “attached” were written, the goal was to distinguish labels connected to the bag with a physical intermediary device (e.g., plastic, string, or metal linkage) from a label that was integral to the bag (e.g., direct bag to label contact). While glue is the most common method, we interpret that a sealed portion of the bag containing the label is equivalent to secure direct contact between bag and label.

Affix: To adhere in physical contact with the cellular therapy product container.

Attach: To fasten securely to the cellular therapy product container by means of a tie tag or comparable alternative. Any information required to be attached to a cellular therapy product container may alternatively be affixed.

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