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.
