Just the FACTs Volume 1
Inaugural Letter from FACT’s New President: Catherine M. Bollard, MBChB, MD, FRACP, FRCPA
Dear Friends and Colleagues,
I am extremely excited to introduce myself as your new FACT President. It is truly an honor and privilege to serve in this capacity. For those of you who don’t know me, I received my medical degree from the University of Otago, New Zealand and am Board Certified in Pediatrics and Adult/Pediatric Hematology. My background is in cell therapies for cancer and post transplant viral infections, and for the past 20 years I have investigated the efficacy of virus and tumor specific T cells for the prophylaxis and treatment of viral infection after transplant and cancer respectively. I was formally the Director of the Pediatric Lymphoma program and the co-Director of the BMT QA Program at Texas Children’s Hospital / Baylor College of Medicine (Houston, TX). In 2013, I was recruited to head the new Program for Cell Enhancement and Technologies for Immunotherapy (CETI) and The Center for Cancer and Immunology Research at Children’s National Hospital and The George Washington University (Washington, DC).
Taking over this role from Dennis Gastineau as 2021 begins, and at a time that cell therapy is rapidly evolving and expanding to new applications, is extremely energizing for me. I therefore look forward to outlining my 5-10 year vision for FACT in the next newsletter. I would, however, like to take this opportunity to profoundly thank Dr. Gastineau for his dedication and commitment to FACT over his tenure. Thank you, Dennis, for all your hard work over this time and I look forward to continuing to work with you in your Past President role!
Cheers,
Cath
Update on FACT Virtual Inspections
FACT has initiated its accreditation renewal process with virtual inspections starting with two programs whose renewal inspections were delayed in March 2020 due to the COVID-19 pandemic. By all accounts, the virtual inspections were successful! The applicant programs were well prepared, the processes were generally effective, inspectors were able to verify compliance with Standards, and both inspectors and program staff continued to learn throughout the process. As a result, FACT is now scheduling virtual inspections for additional programs whose inspections were delayed, followed by those who were in the process of scheduling inspections when the pandemic started. Program Directors, Quality Managers, and primary contact persons at eligible programs should expect direct communications from their FACT Accreditation Coordinators to begin this scheduling.
The FACT Virtual Inspection Task Force developed this virtual process over the past several months to closely mimic the in-person experience to the extent possible, including submission of the same documents to the FACT Accreditation Portal in advance and review of these documents by the Inspection Team. The FACT Accreditation staff participated in training the applicants and inspectors in the technical skills required for the virtual process. Members of the Task Force volunteered their own programs to serve as pilot programs for the virtual inspection process, and volunteered themselves to be the first inspectors. The two pilot programs included clinical transplant and immune effector cellular therapy sites, bone marrow and apheresis collection services, and cellular therapy product processing facilities with minimal and more than minimal manipulation processing. Each pilot inspection took place over two days using individual secure Zoom calls, during which the inspectors were able to view documents and pre-recorded facility video tours and interview various members of the applicant program (including nurses; advanced practice professionals; pharmacists; ICU, ER, and Radiation Oncology staff; data managers; and clinical research associates. Program staff shared records, minutes, policies, SOPs, and other documentation by sharing a computer screen for electronic or scanned documents or by using a cell phone or document camera for other types of documentation such as paper files, logs, and records.
Task Force members and FACT staff observed portions of these pilot inspections and are currently assessing the processes. At least two important themes have been identified to date. First, it is important for the applicant program to be well organized with documentation prepared in the order of the FACT Standards. Use of Microsoft OneNote or other electronic programs to link program documentation to a specific FACT Standard is very helpful to allow efficient location and display of relevant policies and SOPs. Once created, this tool can be used to continuously update documentation and maintain inspection-readiness through the accreditation cycle. Second, the inspection goal is to demonstrate implementation of required policies and SOPs through examples. Identification and organization of these patient records, meeting minutes, validation studies, audit reports, and other quality documents according to the specific standard facilitates demonstration of compliance. While neither of these concepts is new, the virtual process magnifies the importance of careful organization.
Additional details of the inspection process are available on the FACT Virtual Inspection Resource Center at: http://www.factwebsite.org/virtualinspections/. Numerous documents are available, including timelines, sample inspection agendas, applicant and inspector guidelines for the virtual process, organization tips, and technical information related to Zoom and document sharing methodologies.
As the next group of programs is ready for inspection, additional training will be held for currently active cellular therapy program inspectors. A full inspector training course for new inspectors that will include both the in-person and virtual inspection processes is planned for early summer. This virtual inspection process is intended for renewal applications only. Initial accreditation visits will be in person and will be scheduled when it is safe to do so and appropriate inspectors are available to travel. Virtual inspections for cord blood banks will begin this spring. New applicants for initial accreditation will require an in-person inspection that will be scheduled and fulfilled as appropriate inspectors are available.
FACT is grateful for the extra effort on the part of these pilot programs and inspectors. The Virtual Inspection Task Force includes members of the Cellular Therapy Accreditation Committee, the Inspector Development Committee, and the Board of Directors.
Happy 25th Anniversary to the FACT Community!
Join FACT in celebrating 25 years of working with our colleagues in the field to improve cellular therapy, cord blood banking, and regenerative medicine. Congratulations to all FACT’s volunteer inspectors, committee members, leadership, accredited organizations, staff, and supporters for making this milestone possible.
We invite readers to sign our 25th Anniversary Guest Book and leave a greeting, photo, or video. Additional celebratory events and activities will take place throughout the year.
FACT’s new president, Dr. Catherine Bollard, reflects on this accomplishment and the future of FACT in the following video.
FACT Past Presidents Dr. Helen Heslop and Dr. Elizabeth Shpall Receive Prestigious Awards
Congratulations are in order for two dedicated FACT leaders! Dr. Helen Heslop and Dr. Elizabeth Shpall will be presenting honorary lectures at the 2021 TCT Meetings Digital Experience.
Helen Heslop, MD, past FACT President and current Chair of the FACT Immune Effector Cell Task Force, will be presenting the Mortimer M. Bortin Lecture on Friday, February 12, 2021 from 11:00 AM – 11:30 AM CT. Her lecture is titled, T Cell Immunotherapy via Native and Chimeric Receptors. Read Dr. Heslop’s full bio for details on her prolific research activities and contributions to several professional societies.
Elizabeth Shpall, MD, the first FACT President and current Board member, will present the E. Donnall Thomas Lecture on Friday, February 12, 2021 from 11:30 AM – 12:00 PM CT, with her lecture titled, Cord Blood: Forerunners and New Horizons. Dr. Shpall’s full bio outlines numerous awards for her important translational work.
Register for the 2021 TCT Meetings Digital Experience
New Members Appointed to the FACT Board of Directors
Two new members representing FACT’s parent society the American Society for Transplantation and Cellular Therapy (ASTCT) join the FACT Board of Directors for three-year terms (2021-2023).
Navneet S Majhail MD, MBBS, MS is the Program Director of FACT-accredited Cleveland Clinic Blood and Marrow Transplant Program. Dr. Majhail served as ASTCT’s President from 2019-2020, and FACT will benefit from his continued leadership in this new capacity.
Eneida Nemecek, MD is a FACT inspector from FACT-accredited Northwest Marrow Transplant Program at Oregon Health & Science University, Legacy Good Samaritan Hospital and Medical Center and Doernbecher Children’s Hospital. She has also begun serving on FACT’s Clinical Outcomes Improvement Committee.
Welcome Dr. Navneet Majhail and Dr. Eneida Nemecek!
New Chair of Standards Development Announced
The FACT Board of Directors is pleased to announce the appointment of Dr. Nicole Prokopishyn to serve as the next Chair of Standards Development beginning with the 8th Edition of Cord Blood Standards slated to kick off in Spring 2021. Dr. Prokopishyn currently serves as the Cellular Therapy Lab Director at the Alberta Blood and Marrow Transplant Program: Foothills Medical Centre, Alberta Children’s Hospital, Tom Baker Cancer Centre, and Calgary Laboratory Services, and has several years of experience serving as a member of the Standards Committee.
Dr. Prokopishyn follows the dedicated leadership of Dr. Paul Eldridge, who chaired the Standards Committee during the review and updating of each set of Standards. Thank you for your valuable contributions, Dr. Eldridge!
New Editions of FACT-JACIE Hematopoietic Cell Therapy and FACT Immune Effector Cell Standards to be Published in May
The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is completing the final review of the draft eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. FACT committee representatives are also nearing completion of the draft second edition FACT Standards for Immune Effector Cells.
FACT thanks the many participants of the public comment period for providing useful feedback on the drafts. Approximately 770 comments, submitted by 78 participants from 20 countries, enriched the Standards development process and edits have been made in response when appropriate. FACT will provide a response to comments at the time of final publication of the Standards.
The updated editions will be published by May 17, 2021. Following a 90-day transition period, the requirements will be effective on August 16, 2021. To receive announcements of the publications and direct links to the new Standards, Accreditation Manual, and associated documents, subscribe for the FACT newsletter by creating an account at www.factwebsite.org.
U.S. Food and Drug Administration Publishes Updated Donor Eligibility Information Amid COVID-19
The U.S. Food and Drug Administration (FDA) continues to provide updates regarding donor eligibility determination amid the COVID-19 pandemic. In January, it posted an announcement with information about considerations for donor eligibility and vaccines.
The FDA does not recommend testing asymptomatic donors of human cells, tissues, and cell and tissue based products (HCT/Ps), but does offer considerations for donor screening based on information known at this time. HCT/P establishments may wish to consider whether the donor in the 28 days prior to collection:
- cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19 infection; or
- had been diagnosed with or suspected of having COVID-19 infection; or
- had a positive diagnostic test (e.g., nasopharyngeal swab) for SARS-CoV-2 but never developed symptoms.
The FDA also states that, based on information available at this time, donors who have received non-replicating, inactivated, or RNA-based COVID-19 vaccines are not precluded from donating HCT/Ps.
ICCBBA Releases Registration and Licensing Information for ISBT 128
Interest in the new ISBT 128 coding and labeling standard, Labeling of Collection Products for Cellular Therapy Manufacturing, has led to many inquiries to ICCBBA regarding registration and licensing. To assist entities with determining how the standard applies to their scope of work and the applicable fees, ICCBBA created a flyer that outlines this information. There are also step-by-step registration instructions on its website.
We are encouraged by this interest in this new standard to improve efficiency and patient safety. Further questions can be directed to the ICCBBA help desk at iccbba@iccbba.org.
Step-by-step registration instructions
Upcoming Events
To provide the cellular therapy community with important educational content, FACT will continue hosting virtual events until it is safe to resume in person meetings. We are excited to announce two events in February 2021: a FACT Inspection and Accreditation Workshop and a FACT-ASTCT Quality Boot Camp.
FACT Inspection and Accreditation Workshop
February 4, 2021
This virtual workshop is on Thursday, February 4, from 7:30 am – 4:30 pm CT, 13:30-22:30 GMT. Applicants interested in accreditation are invited to this interactive workshop. Information will interest initial applicants and those who have attended previously.
Additional workshop content will include common citations, data management, clinical outcome analysis, and an update on FACT virtual inspections.
Workshop Objectives:
• 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.
• Prepare for a FACT Virtual Inspection.
• Identify significant changes to the eighth edition Cellular Therapy Standards.
• Summarize the expectations of inspectors and applicants for data management.
• Utilize tools to evaluate outcome data.
Attend an optional lunch session with two FACT-accredited programs who will share how FACT accreditation is beneficial while managing the COVID-19 pandemic.
Register for the virtual workshop
FACT-ASTCT Quality Boot Camp
February 5, 2021
Join us for the 2021 FACT-ASTCT Quality Boot Camp: Navigating a Changing Environment Using Quality Systems.
Discuss and explore core quality concepts throughout the day and learn how to apply those concepts to an example. “Adding immune effector cells to program services” will be used to illustrate concepts learned and navigate components of the quality system from beginning to end, including:
- Perform a Facility Needs Assessment
- Develop a Change Control
- Execute Risk Assessments
- Determine what to Validate and Audit
- Perform Validation(s)
- Establish Quality Indicators
- Perform Audits
At the end of the day, boot camp participants will be able to apply learned concepts to their own program needs when adding or changing components to their program.
Register for the virtual boot camp
SITC Publishes Guidelines on Immune Effector Cell-Related Adverse Events
The Society for Immunotherapy of Cancer (SITC) published The Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events in the Journal for ImmunoTherapy of Cancer (JITC). Developed by an expert panel, the guideline includes recommendations for risk assessment, identification, and management for clinically significant side effects associated with immune effector cells (IECs).
This guideline was created with the assistance of several organizations, including FACT. For more details about its purpose and scope, read the full press release from SITC.
