Just the FACTs 2023 Volume 2
Like many other organizations, FACT is in the midst of a busy event schedule to provide training to FACT-accredited and applicant programs and volunteer FACT inspectors. We encourage you to not only attend an event yourself, but to also encourage your colleagues and administrations to support personnel attendance as well. To that end, we are offering in-person events in conjunction with annual and regional meetings across the globe. Moreover, we are offering virtual workshops in case you cannot attend in person. This newsletter provides the details and links to all these upcoming events and I sincerely hope you will be able to attend some of these educational and training opportunities.
I also want to draw your attention to an article in this newsletter about responding to inspection citations. These findings are an opportunity for improvement. FACT accreditation is not a pass-fail event, and we encourage you to consider the process as a mechanism to improve the care you provide to your patients.
Finally, and importantly, we always seek opportunities for improvement at FACT. In particular, I urge you to submit your feedback on the draft second edition of the FACT Standards for Immune Effector Cells and the current edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Further, if there are any other opportunities you would like to communicate, please do not hesitate to reach out. I look forward to hearing from you!
Sincerely,
Catherine M. Bollard, MD
FACT President
Reminder! Input Requested on FACT Standards
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.
Responding to Inspection Citations is an Opportunity to Improve
The FACT Accreditation Committee reviews each inspection report and determines the outcome and required response from the accreditation applicant. A letter explaining the committee’s findings with instructions for documenting corrections, and the report listing the deficiencies and required responses, is sent to the organization following this determination. Each citation requires submission of the complete required response in the accreditation portal through the Request For Information (RFI).
Complete responses must include:
- Explanation of correction.
- Evidence of implementation.
- Supporting Standard Operating Procedures (SOPs) with changes highlighted.
- SOP approval documentation (signatures and date).
- Training documentation.
- Other identified documentation.
Each identified issue is an opportunity for improvement. The response must include an explanation of the correction and demonstrate how the applicable standard is met. Keep in mind that the reviewer of the submission will be less familiar than you with your organization’s operations or document control system. Walk the reviewer through each step in your process and identify where to find the supporting information in the submitted documents (e.g., list the page number and section or highlight the information). Ensure responses do not include Protected Health Information (PHI).
If you feel your process is sufficient or was misinterpreted during the inspection, explain your process, and submit supporting documentation demonstrating that it was in place during the time of the inspection.
Complete submissions must include a thorough explanation of correction and clearly marked supporting documentation to expedite review. The Applicant Response Template includes response examples. Once all citations have been adequately addressed, accreditation will be awarded.
HCT Accreditation Manual Provides Additional Examples of Proof of Death
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
Guy Klamer, PhD to Receive Award at ISCT Annual Meeting
FACT is pleased to share that Guy Klamer, PhD, of Sydney Cord Blood Bank, will be awarded the Inaugural Early-Stage Professional (ESP) Spirit of ISCT Award during the 2023 ISCT Annual Meeting in Paris. This award recognizes an ESP society member who embraces the mission and vision of ISCT through engagement in and contributions to the Society.
Dr. Klamer is a valuable contributor to FACT initiatives. He is a cord blood bank and cord blood processing FACT inspector, and serves on the FACT Cord Blood Standards and Education Committees.
Thank you, Guy, for your many contributions to cord blood banking and cellular therapy and congratulations on your well-deserved award!
Register for the ISCT Annual Meeting
From the Archives: FACT Resources to Assist Your Program throughout the Accreditation Process
FACT provides a voluminous amount of resources – a treasure trove of information for accredited and applied organizations, volunteer inspectors, and external stakeholders. We want everyone to succeed, and we are committed to providing documents, forms, checklists, education, and more to advance cellular therapy.
The time that has passed since the original publication of this Just the FACTs article in 2020 was marked with many transformations. The world endured a pandemic, the cellular therapy field celebrated several advancements, and FACT launched a new website. We’ve also welcomed many new stakeholders, from new personnel at accredited organizations to new manufacturers of cellular therapy products, and have received feedback that not all are aware of the valuable tools available online. (Of special note – the Accreditation Manuals and Quality Management resources are examples of beneficial resources not known by some.)
Revisit this list of online resources through the lens of a new website and updated links, and be sure to share it with all of your colleagues!
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:
- Hematopoietic Cell Therapy– FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration
- Immune Effector Standards– FACT Standards for Immune Effector Cells
- Cord Blood Bank Standards– NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration
- Common Standards– FACT Common Standards for Cellular Therapies
The pages for each set of Standards contain useful documents relevant to the current editions of FACT Standards, including, but not limited to:
- Standards documents: These are the official publications of the FACT Standards, and list the requirements for achieving and maintaining FACT accreditation.
- Accreditation Manuals: These are guidance documents used by accreditation applicants and FACT inspectors that explain the intent and rationale for specific standards, provide examples of alternative approaches that would be considered compliant with standards, and detail the type of documentation that may be used to verify compliance. The examples listed are not requirements and are not all-inclusive.
- Edition-specific information: To assist with transitioning to a new edition of Standards, documents such as a Summary of Changes and crosswalks are provided to identify changes between the previous and current editions of FACT Standards.
- Standards-specific resources: Self-assessment tools, checklists, and forms used to prepare for and conduct the accreditation process are provided. Examples include, but are not limited to, Document Submission Requirements, Educational Activities, Critical Electronic Record Systems, and Facility Site Grids.
Accreditation Process Requirements
The Cellular Therapy Accreditation Process Requirements and Cord Blood Bank Accreditation Process Requirements web pages provide a structured overview of the accreditation process, from determining eligibility for accreditation to requirements after the on-site inspection.
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:
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 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.
Quality Management Resource Center
FACT has developed quality-based educational materials to assist your organization with developing and enhancing your Quality Management Program. The Quality Management Resource Center includes links to the FACT Quality Handbook and recordings to several Quality Management Webinar series.
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. The How-To Guides have been updated to assist users with the upgraded portal.
FACT Accreditation Coordinator
Each applicant organization is assigned a FACT Accreditation Coordinator to provide assistance and direct personnel and inspectors to the above resources and more. 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 and also on the FACT website’s Contact Us page.
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@factglobal.org.
Upcoming FACT Educational Events
FACT Portal Webinars: Completing the Compliance Application
Virtual, Two Sessions:
May 15 – 8 am PT, 10 am CT, 11 am ET
May 16 – 2 pm PT, 4 pm CT, 5 pm ET, 7 am AEST (May 17)
FACT Quality Boot Camp focused on quality principles for Apheresis Collection, Processing, and Cord Blood Banking
Virtual, June 23, 2023
9:00 am – 6:00 pm CT
FACT Clinical, Collection, Processing, & Cord Blood Banking Inspector Training Course
Perth, Australia, August 15, 2023
8:00 am – 5:00 pm AWST
See more information – Registration opening soon!
FACT Accreditation and Quality Principles Workshop
Perth, Australia, August 15, 2023
8:00 am – 5:00 pm AWST
See more information – Registration opening soon!
FACT Processing Inspector Training Course
Houston, TX, September 7, 2023
8:00 am – 5:00 pm CT
