Just the FACTs Newsletter – May 2026
CEO Welcome
On behalf of our Board leadership, our dedicated committee members and inspectors, and our headquarters team colleagues, I’m privileged to welcome all stakeholders in the field of cellular therapy to this issue of Just the FACTs.
“FACT Forward” is a newly adopted theme behind our efforts to maximize our mission of improving the quality of cellular therapy through peer-developed standards, education, and accreditation for the benefit of patients. Advancing our strategic imperatives, continually improving daily operations and service excellence, and applying foresight to prepare for future developments are tied together through our commitment to FACT Forward.
Expanding eligible patient access to safe and quality-based cellular therapies in America’s communities is an imperative embraced by everyone within FACT. We’re thrilled to be supporting the inaugural wave of community-based oncology clinics and hospitals in their decisions to pursue FACT accreditation (full or provisional) in conformance with our recently published “fit-for-purpose” Community IEC Standards. Collaboration and shared learnings with these community leaders will assuredly help us all accelerate subsequent efforts. See how we’re tracking these initial efforts within this issue. FACT invites and is actively working to collaborate with all community oncology stakeholders to advance this imperative.
Supporting our Community IEC accreditation pathway, we’ll soon publish our inaugural Community IEC Accreditation Manual. This asset will help our community oncology stakeholders understand steps, processes, and “how to” guidance related to our community IEC accreditation pathway. And if you haven’t already, please visit our re-designed website offering improved user navigation, concise information, and more.
FACT’s volunteer inspectorate, an essentially vital cohort of dedicated and trained peer leaders, is growing (including members from community oncology) to 261 professionals, a high-water mark in our 30-year history. We thank ALL these essential contributors to our mission.
FACT Forward is also driving an examination of FACT’s governance, including Bylaws, Committees, and Policies. A second FACT imperative, this work aims to bring optimal representation of diverse stakeholders into our decision and policy-making processes, with heightened, clear transparency.
This issue also highlights a significant growth in programs seeking initial accreditation(s), reminds our colleagues to submit feedback on our draft Common Standards for Cellular Therapies, and answers some frequently asked questions about our Accreditation Portal.
The value FACT brings to quality and safety for the benefit of patients is carried on the shoulders of hundreds of peer volunteers. We remain grateful as ever for their contributions, and are committed to serving and supporting them with excellence.
Please always contact us with feedback or suggestions, as our peer developed, consensus-driven assets and offerings depend on this.
Respectfully, David
Last Chance – Submit Your Comments on the Draft FACT Common Standards by May 11!
The draft fourth edition of the FACT Common Standards for Cellular Therapies is available for public comment through May 11, 2026.
The objective of the FACT Common Standards is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application throughout product development and clinical trials. They are applied to cellular therapy programs that collect, process, or administer cellular therapies that are not yet ready for more specific standardization.
As the field of cellular therapy continues to evolve, our goal for each new edition of the Standards is to accurately capture and reflect those changes to maintain a relevant and valuable resource for programs. Information received during the public comment period is essential to achieving this goal. We encourage you to submit comments on the draft Standards as it provides an opportunity for the community at large to directly share feedback, and each comment is reviewed by the Standards Committee.
These Standards also provide a foundation for FACT’s other sets of Standards for hematopoietic progenitor cell transplantation, immune effector cell therapy, and cord blood banking, and feedback received on the Common Standards will be informative for the other more specific sets of Standards.
Download the following documents located at the bottom of the FACT Standards web page:
- Draft Fourth Edition Common Standards
- Redline Draft Fourth Edition Common Standards
- Summary of Changes (high-level overview)
The public comment survey and additional instructions are available at:
https://redcap.link/Common4-public-comment.
There is no limit to the number of comments that can be submitted. This survey allows up to ten (10) comments per section. To submit additional comments, please start a new survey.
For questions regarding the survey, please contact Standards@factglobal.org.
The FACT Community Continues to Grow in Numbers of Accredited Organizations and Inspectors
The footprint of FACT accreditation continues to grow around the world. More organizations continue to pursue accreditation as part of their commitment to quality and safe cellular therapy for their patients. This increase in demand, and FACT’s enhanced abilities to support it in a thorough and efficient manner, is directly supported by our prestigious volunteer inspectorate. We extend our genuine appreciation to FACT’s record number of 261 active inspectors. We are also grateful to the many inspector trainees who have attended in-person training sessions so far this year, with many more planning to attend upcoming training courses.
As of May 4, 2026, there are 337 FACT-accredited cellular therapy programs and cord blood banks spanning 27 countries around the globe, with 10 programs achieving initial accreditation in the first four months of the year. We currently have 53 cellular therapy applicants and 4 cord blood applicants in the accreditation process. This includes applicant community-based IEC programs. The following table outlines the progress of the first wave of community-based IEC programs seeking or achieving accreditation:
Please join us in congratulating the following organizations who have achieved initial accreditation so far in 2026:
American Red Cross Puerto Rico Region, San Juan, Puerto Rico
Cellular Therapy Product Collection by Apheresis for Administration and Further Manufacturing, and Cellular Therapy Product Processing with Minimal Manipulation
City of Hope Atlanta, Newnan, Georgia
Adult Autologous Hematopoietic Progenitor Cell Transplantation, Immune Effector Cellular Therapy, Cellular Therapy Product Collection by Apheresis for Administration and Further Manufacturing, and Cellular Therapy Product Processing with Minimal Manipulation
Grupo GSH, São Paulo, Brazil
Marrow Cellular Therapy Product Collection for Administration; Cellular Therapy Product Collection by Apheresis for Administration and Further Manufacturing; and Cellular Therapy Product Processing with Minimal Manipulation
Hoag Family Cancer Institute
Immune Effector Cellular Therapy and Apheresis for Further Manufacturing
Hospital Auxilio Mutuo Bone Marrow Transplant and Cellular Immunotherapy Program, San Juan, Puerto Rico
Adult Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Immune Effector Cellular Therapy, Marrow Cellular Therapy Product Collection for Administration, Cellular Therapy Product Collection by Apheresis for Administration and Further Manufacturing, and Cellular Therapy Product Processing with Minimal Manipulation
KK Women’s and Children’s Hospital, Blood Marrow Transplant and Cellular Therapy (BMTCT) Programme, Singapore, Singapore
Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation; Immune Effector Cellular Therapy; Marrow Cellular Therapy Product Collection for Administration; Cellular Therapy Product Collection by Apheresis for Administration and Further Manufacturing; Cellular Therapy Product Processing with Minimal Manipulation
The MetroHealth System, Cleveland, Ohio
Adult Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Immune Effector Cellular Therapy, Cellular Therapy Product Collection by Apheresis for Administration and Further Manufacturing, and Cellular Therapy Product Processing with Minimal Manipulation
OhioHealth Blood and Marrow Transplant Program
Adult Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Immune Effector Cellular Therapy, Marrow Cellular Therapy Product Collection for Administration, Cellular Therapy Product Collection by Apheresis for Administration and Further Manufacturing, and Cellular Therapy Product Processing with Minimal Manipulation
Ramaiah Memorial Hospital, Bengalaru, Karnataka, India
Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Cellular Therapy Product Collection by Apheresis for Administration, and Cellular Therapy Product Processing with Minimal Manipulation
Royal North Shore Hospital Bone Marrow Transplant and Cellular Therapies Program, St Leonards, New South Wales, Australia
Adult Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Immune Effector Cellular Therapy, Cellular Therapy Product Collection by Apheresis for Administration and Further Manufacturing, and Cellular Therapy Product Processing with Minimal
Insights from the Field: Frequently Asked Questions about the Accreditation Portal
By Elizabeth Jolley, Quality Coordinator
FACT values the thoughtful feedback we receive from our volunteer inspectors and accredited organizations through the Inspection and Accreditation Process evaluations. Your input provides meaningful insight, supports our continuous improvement efforts, and helps us better understand how we can serve you more effectively.
Over the past several months, several common questions have emerged prompting us to compile the list of frequently asked questions below. Remember, we are always here to help. If you have questions or need additional support, do not hesitate to contact your FACT Accreditation Coordinator.
FAQ 1: How can I view documents without losing my place in the Site Checklist?
- When in the portal, right-click on the FACT Accreditation Portal tab and select Duplicate. This will duplicate the current window. In the new window, navigate to the desired section (e.g., Document Library).
- Toggle between the two tabs or separate the tabs by detaching them into their own windows by dragging a tab down from the tab bar.
- The two windows can be placed side-by-side (Windows: press Windows logo key and right arrow) or viewed on multiple monitors by dragging one window to the secondary monitor.
FAQ 2: Can I search or filter the Site Checklist?
- Access the Site Checklist in the left navigation pane. Select the light blue bar FILTERS and SEARCH: Expand to view all filter options.
- SEARCH: You may search by Standard #, Standard Text, or Question Text by entering text in the search fields.
- FILTER: You may filter by selecting one or more of the checkboxes under Question Statuses, Comment Types, Documents, Other, or Hide Comments.
- In the Example below, we have filtered by RFI and selected Quick View. This results in only those standards with RFIs being reported.
FAQ 3: How can I search and filter within the Document Library?
- Access the Document Library in the left navigation pane. Here you may filter by File Name, Site, Tags, Latest Version, Standard, and FACT Only. You may also sort by selecting the arrows in the column header.
- In the example below, we have filtered by standard C3.1.4. This returns documents that have been uploaded and marked for this standard.
FAQ 4: How can I adjust the Site Checklist for printing?
FACT encourages applicants and inspectors to download and print the Site Checklist to support preparation for – and use during – the inspection. The checklist is provided in .xlsx format and is currently configured for printing on 8.5” × 11” paper, with all columns set to fit on a single page. These settings can be customized to suit your needs. A few tips for adjusting the format are provided below.
Tips on Improving Readability of Site Checklist:
After downloading the Site Checklist
- Select the triangle “Select All” button at the top-left corner.
- From the Home tab, select the desired font size, e.g., 12.
- From the Home tab, adjust row height by selecting Format then AutoFit Row Height.
- From the Home tab, highlight undesired columns, select Delete Sheet Columns to remove.
- From the Page Layout tab, change paper size to Legal 8.5” x 14” paper.
- Select File then select Print. If desired, adjust scaling under Settings (pre-set to Fit All Columns on One Page).
Upcoming FACT Education Events to Mark on Your Calendar!
Access FACT’s flexible education offerings—available live, on-demand, virtual and in-person—to support your ongoing learning and professional development in cellular therapy. Visit learn.factglobal.org to register.
July 30, 2026 – Virtual FACT Accreditation Workshop
Participants will gain practical strategies for achieving and maintaining accreditation, improving audits and corrective actions, and avoiding common citations to support stronger clinical and data outcomes.
September 10, 2026 – Virtual FACT Quality Boot Camp
