Just the FACTs, 2020 Volume 5
Hello colleagues—as COVID becomes a marathon with no real end in sight, and Zoom and Skype are as personal as we get (and our conference rooms are all being used for social distancing), we all look for the pace and combination of communication techniques that allow us to remain in touch with one another beyond our purely professional relationships. The silver lining has been a tendency to try harder to communicate and talk to those we have always meant to call, and I urge each one of you to choose one of your friends this week to call, FaceTime, Zoom, or any way to be in touch and reduce the isolation they might feel and in so doing reduce your own.
We mourn the passing of one of the pioneers of our discipline, Roger Herzig, who was attending on his transplant service. Dr. Herzig was loved by his patients, his program colleagues, as well as colleagues around the world. We all send condolences to his wife and family.
We invite you to a virtual workshop for inspection and accreditation, and the Education Committee is working hard optimizing the virtual experience for you. And don’t forget to look at the 8th Standards and send in your comments by the end of August.
Our community has continued to provide transplant services to patients needing them, and volumes of transplants are remaining remarkably high with all the competing demands on hospital resources—tell each other how much you appreciate the creativity and dedication continuing such complex care, I know our patients feel the same.
I’m grateful to see so many colleagues working so hard in these times, but try to give yourselves a break and a little time to reflect on what you are grateful for.
Sincerely,
Dennis Gastineau, MD
FACT President
SAVE THE DATE: FACT Announces Virtual Inspection & Accreditation Workshop
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 Standards – Standards 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 Compliance Application to requirements after the on-site inspection.
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:
- Hematopoietic Cellular Therapy Self-Assessment Tool, Seventh Edition
- Common Standards Self-Assessment Tool, Second Edition
- Immune Effector Cells Self-Assessment Tool, First Edition, Version 1.1
- CB Self-Assessment Tool, Seventh Edition
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 Cellular Therapy 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.
Immune Effector Cellular Therapy Webinar: Bringing a Stand-Alone Immune Effector Cell Therapy Program into FACT Compliance
Register now:
Bringing a Stand-Alone Immune Effector Cell therapy Program into FACT Compliance
Quality Management Series, Module 10: Validations
The Quality Management Series Module 10 includes four sessions focused on Validation including:
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.
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
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
Program Perspective on Validation
TBA
Register for the entire module to receive a 15% discount! QM Series Module 10: Validations
