Just the FACTs, 2020 Volume 6
Hi, Friends!
You have a week to get your comments in for the eighth edition FACT-JACIE Standards and the second edition IEC Standards. If you see issues, please submit your suggestions.
While many states in the U.S. still have rising COVID case numbers, others are showing clear signs of decreasing. Australia and New Zealand are working on more localized outbreaks, and, if there is anything to learn from New Zealand, it is that we are all in this together. The world is so small that everyone must do their part to care for each other.
See the article about the Professional Relations Committee on ways to help each other through these unusual times, and be sure to take advantage of all the educational events. A good way to keep everyone in your program up to the 10 hours of annual education!
As caregivers, I don’t need to tell you to take good care of everyone else, but take some time today to do two things: think of someone you haven’t spoken to in a while and make that contact; and consider one thing to be thankful for. I’ll start the second part: I’m thankful to be sitting next to my spouse of 44 years having just returned from a bicycle ride in the north woods of Wisconsin. What’s yours?
Sincerely,
Dennis Gastineau
Registration is Open for the FACT Inspection & Accreditation Virtual Workshop!
September 15, 2020 – 8:00 am to 3:00 pm CDT/13:00 to 20:00 GMT
When one door closes, another one opens – and FACT’s first ever Inspection & Accreditation Virtual Workshop makes these words ring true! We wish all of our stakeholders good health and safety, and are pleased to offer a new workshop format to allow us all to come together again. After all, learning never ends.
The workshop co-chairs, Ngaire Elwood, PhD and Joseph Schwartz, MD, MPH, have been working hard with the FACT Education Committee and the international panel of presenters to offer an elegant and interactive learning experience. Registrants can choose either the cord blood or apheresis track, and will also have the opportunity to ask questions directly to leaders in accreditation, cord blood, or apheresis in the Lunch with Leaders session.
Following a combination of presentations, recordings, activities, games, and discussions; workshop attendees will leave the event being able to:
- Describe the accreditation process.
- Evaluate documentation to ensure compliance.
- Organize the on-site inspection process.
- Plan a program tour.
- Identify strategies to support a successful inspection.
- Practice evaluating deficiencies.
The year 2020 has made it even more obvious that a culture of quality is critical to providing quality patient care. With no travel required and low registration fees, several colleagues at your institutions can register for the event, thereby developing an even deeper understanding of FACT accreditation at your program.
“See” you at the workshop!
Last Call! Submit Comments on Draft Standards by August 30
Feedback on draft Standards is a critical step of updating requirements to remain relevant and useful to the current state of cellular therapy. Comments will be accepted on two sets of draft Standards through August 30, 2020. This is a direct way to make your thoughts known on any requirement because each comment is reviewed by the Standards Committee. Do you support the new requirements? Is there a standard that you find to be unclear? Let us know!
The following are descriptions and pertinent links for the two drafts available for review. As a peer-driven organization, we look forward to your feedback!
For questions or assistance, please contact Andra Moehring, MHA, Standards Development Manager.
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
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
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.
SITC Requests Feedback on Immune Effector Cell-Related Adverse Events Guideline
Comments due by September 11, 2020
The Society for Immunotherapy of Cancer (SITC) announced a public comment period on its upcoming clinical practice guideline, The Society for Immunotherapy of Cancer consensus statement on immune effector cell-related adverse events. Comments are due by the end of September 11, 2020.
This manuscript is part of the SITC Cancer Immunotherapy Guidelines program, which is a collection of clinical practice guidelines available in the open-access, peer-reviewed online journal, Journal for ImmunoTherapy of Cancer (JITC). It was written by an expert panel that included representatives from the American Society of Hematology (ASH), the American Society for Transplantation and Cellular Therapy (ASTCT), and the Foundation for the Accreditation of Cellular Therapy (FACT).
Instructions for accessing the draft manuscript
FACT Professional Relations Committee Provides a Forum for Sharing Experiences in Challenging Year
The cellular therapy community is well known for its spirit of collaboration. One testament to the teamwork enjoyed by the field is the FACT Professional Relations Committee. One of the purposes of this committee is to enhance communications with relevant organizations in the field. This year, 13 organizations are members, and each has nominated a representative to meet at least quarterly to discuss any issues that have captured its attention, new initiatives that might be of interest to other organizations, and requests for input or participation.
Catherine Bollard, MD, inaugural committee chair and Director for the Center for Cancer and Immunology at the Children’s National Medical Center, recently transitioned committee leadership after many years of service to Bruce Levine, PhD, Professor in Cancer Gene Therapy at the University of Pennsylvania. Dr. Levine has called special meetings throughout the COVID-19 pandemic to allow organizations to share ideas, provide updates to processes, and ask questions of each other. The benefits of these discussions were the ability to seek advice and learn from each other, communicate changes impacting cellular therapy programs to a wider audience through multiple channels, and establish some consistency among processes. Topics included, among others, training on caring for transplant patients with COVID-19, cryopreservation of unrelated allogeneic products, virtual meetings, and remote inspections.
FACT thanks the following organizations for their participation on the committee and leadership during this challenging year:
- AABB
- American Association for Tissue Banking (AATB)
- American Society for Apheresis (ASFA)
- American Society for Gene & Cell Therapy (ASGCT)
- American Society for Histocompatibility & Immunogenetics (ASHI)
- American Society for Transplantation and Cellular Therapy (ASTCT)
- College of American Pathologists (CAP)
- Cord Blood Association (CBA)
- International Society Cell & Gene Therapy (ISCT)
- National Marrow Donor Program (NMDP)
- Standards Coordinating Body (SCB)
- World Marrow Donor Association (WMDA)
Upcoming Educational Events
Register now:
Bringing a Stand-Alone Immune Effector Cell therapy Program into FACT Compliance
Upcoming Quality Management Series Module 10: Validation
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 series to receive a 15% discount!
Module 10 includes all of the upcoming webinars and the recording of the first webinar:
Validation Overview
Presented by Nicole Prokopishyn, PhD
August 19, 2020, 11:00 am ET, 15:00 GMT
Dr. Prokopishyn discussed the differences among Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.
