Initial Impressions From the Front Lines of FACT’s Community IEC Standards and Accreditation
By Lauren Capone, RN, BMTCN, Accreditation Coordinator
In November 2025, FACT reached an important milestone toward our strategic imperative to expand patient access to cellular therapies. With the support of the Community CAR T Working Group, comprised of physicians from community- and academic-based health care systems and representatives from collaborating organizations, the first edition of the FACT Standards for Immune Effector Cells in the Community Clinical Setting was published. The Community IEC Standards adapted the FACT-JACIE International Standards for Immune Effector Cells to meet the “fit for purpose” needs of community-based oncology programs. The associated accreditation program was implemented shortly thereafter.
Since that time, six community programs have applied and are progressing toward initial accreditation under this new pathway. We are thrilled to be working with these dedicated clinical providers and staff as they pursue accreditation. Together, we share the goal of expanding patient access to high-quality care closer to where they live. The table below summarizes the progress of Community IEC programs that have either expressed interest in FACT accreditation or are actively pursuing accreditation.
Table: Number of Community IEC Programs Exploring or Pursuing FACT Accreditation
| Exploratory | Assessment | Preparation | Inspection | Responses |
|---|---|---|---|---|
| 5 | 0 | 4 | 2 | 0 |
The work we have done so far with these accreditation applicants have grown our experience in applying standards and accreditation to this new cohort of providers, and we believe outlining our experience will benefit others who are expanding cellular therapies to more places. The following represents shared learning, in Q&A format, as we work to continue making FACT’s accreditation process as clearly understood and navigable as possible.
Where do we start?
We highly recommend contacting us as soon as you begin considering FACT accreditation. There is no cost or obligation to do this. We are here to help you and will seek to learn more about your program and goals and provide guidance. These conversations have proved valuable for helping programs with their decisions on timing, service providers, relevant Standards, potential gaps, resources, and more.
Once you’ve decided to pursue FACT accreditation, request an account in our online accreditation portal to begin. In short, the steps to accreditation are to:
- Confirm eligibility via an online Eligibility Application
- Submit the online, pre-inspection Compliance Application
- Conduct the on-site inspection
- Respond to the Accreditation Report
How do we learn more about what the Community IEC Standards require?
The FACT website contains a plethora of resources to learn about the Standards and quality management in general.
- The Community IEC Accreditation Manual is a great place to start. This document provides extensive guidance:
- Explanations that help with interpreting and implementing the Standards
- Examples and practical considerations for community oncology programs
- Examples of evidence to demonstrate compliance
- Resources to support quality management and patient care activities
- The FACT Quality Handbook contains examples of SOPs, validations, and audits.
- Created by Quality Managers in cellular therapy
- Recommended resource for supporting the development of a Quality Management Program
- The FACT website has been redesigned with new users in mind and includes resources for:
- The FACT Learning Academy includes live and on-demand learning opportunities.
- Webinar recommended for new CAR-T programs: Bringing Cell Therapies Closer to Home: An Introduction to the FACT Standards for Immune Effector Cells in the Community Clinical Setting
- The Self-Assessment Tool is a free resource that helps evaluate compliance readiness for accreditation. A tool is available for each set of Standards including the Community IEC Standards. All Standards-specific tools can be found on the FACT Standards webpage.
What if I still have a question about a specific standard?
It is common to have follow-up questions about specific requirements, including how to interpret a standard, how to comply with it, or what evidence to provide. The resources above will help, and you can contact FACT at any time with questions. Once you apply for accreditation, you will also be assigned a designated FACT Accreditation Coordinator who will be your direct contact for anything you need.
Below are questions that we have commonly received from initial Community IEC accreditation applicants and a brief answer for each. Do you need more information or have questions about any other standards? If so, see the Accreditation Manual for more guidance or contact us via email at fact@factglobal.org or via phone at 1-402-920-7001. We are here to help!
Selected Standards & FAQs
Standard B1.2.1: The Clinical Program shall be licensed, registered, or accredited as required by the appropriate governmental authorities for the activities performed.
Which documents should a Community IEC Clinical Program provide?
Community IEC Clinical Programs that are hospitals, and inpatient units collaborating with Clinical Programs for adverse event management, must be accredited by the Joint Commission, Healthcare Facilities Accreditation Program of the American Osteopathic Association, DNV Healthcare, Inc., or Centers for Medicare & Medicaid Services.
Community-based clinics’ licenses, registrations, or accreditations may be variable because states differ in their regulatory requirements, and what is submitted to FACT may differ from program to program based on local applicable law. When completing the Compliance Application, denote the license, registration or accreditation for the activities the program performs.
Standard B1.3: The Clinical Program shall have a designated team that includes a Clinical Program Director, a designated Quality Manager, and a minimum of one (1) additional physician trained or experienced in cellular therapy. The designated team shall have been in place and performing cellular therapy for at least twelve (12) months preceding initial accreditation.
Do we have to wait to apply for accreditation until the designated team has been in place for 12 months?
You do not have to wait until the team has been in place for the minimum 12 months. Clinical Programs are welcome to apply sooner, and this is a way to expedite the accreditation process. Programs may progress through the process while they are accumulating this length of experience. If the accreditation process is completed before 12 months have passed, FACT will wait to officially award accreditation (i.e., provide the accreditation certificate and list the program on the website) until this milestone is reached.
If a new program has also not met the minimum required number of new patients for initial accreditation (five patients), it may wish to consider seeking provisional accreditation.
Standard B2.1: There shall be a designated inpatient unit of appropriate location and adequate space and design that protects the patient from transmission of infectious agents and allows, as necessary, for appropriate patient isolation, confidential examination, and evaluation.
Does the Clinical Program have to be located within a hospital?
Clinical Programs do not have to be located within a hospital and will often provide services in a clinic. The program does, however, need to have a close working relationship with a collaborating hospital that can manage adverse events of cellular therapies when inpatient care is needed by a patient.
Standard B3: Personnel (Clinical Program Director, Attending Physicians, Advanced Practice Providers/Professionals, Nurses, Pharmacists, Consulting Specialists, Quality Manager, Data Management Staff, Support Services)
Do each of the personnel listed have to be dedicated to cellular therapy as 100% Full Time Equivalents?
No, the personnel do not need to be 100% dedicated to cellular therapy on a full-time basis. Individuals will often fulfill their cellular therapy-related roles in addition to other roles within their organization. The Standards require that individuals be designated for each of these roles and have the required training, education, experience, and competency as outlined in the substandards.
As Clinical Programs grow and serve more patients, there may come a time when full-time personnel are required. The Clinical Program will determine this need, and FACT inspectors will verify adequate staffing during inspections.
Standard B3: Continuing Education
What is required for continuing education?
Several key personnel listed in B3 are required to complete a minimum of 10 hours of continuing education related to cellular therapy and/or their roles in the Clinical Program. There are many ways to meet this requirement, and the Standards are intentionally not meant to be prescriptive. Recognized educational activities include both certified continuing medical education (CME) credits (preferable) and non-credit educational hours, including internal presentations and conferences.
As referenced above, the Community IEC Accreditation Manual has very detailed explanations and examples that may be helpful to Clinical Programs determining how to satisfy this requirement.
Standard B3.5: Requirements for Nurses
What type of training and competency is required?
In addition to the outpatient clinic nurse(s), the hospital/inpatient nurses need documented competencies for the care they administer to cell therapy patients. The substandards outline the subjects that must be included in the training and competencies.
Standard B4.6: The QM Plan shall include, or summarize and reference, policies and Standard Operating Procedures for the establishment and maintenance of written agreements with external parties providing critical services that could affect the quality and safety of the cellular therapy product or the health and safety of the donor or recipient.
What types of external parties need to be included?
The clinical program should consider external parties such as laboratories and pharmaceutical manufacturers, cell collection services if contracted, and any external facility whose activities are not under the control of the Clinical Program Director.
Standard B4.16.1: Feedback shall be obtained from recipients or legally authorized representatives.
What type of feedback is included?
This includes any feedback from patients, patients’ families, and external facilities, including documentation of review of this feedback. A Clinical Program may use the same system used by its overall institution for requesting and receiving feedback as long as it is included in the system and receives and reviews the feedback.
B9: Data Management
Do we have to submit data to CIBMTR?
Although FACT recommends submission of data to CIBMTR (i.e., denoted with the word “should” in Standard B9.2 and its substandards), Community IEC Clinical Programs are obligated to comply with the data reporting requirements outlined by the manufacturers of commercial cellular therapy products or the sponsors of investigational products. These entities, and those that use their products, must comply with data reporting requirements that are part of the U.S. FDA-approved Biological License Applications (BLAs) or Investigational New Drug (IND) applications. Some of these entities do require submission to CIBMTR.
Note that U.S. federal law requires data reporting for genetically modified cellular therapy products, so the collection and reporting of data are not solely FACT requirements.
How do we efficiently complete the pre-inspection, online Compliance Application?
The Compliance Application includes questions related to each requirement in the FACT Standards that are applicable to the accreditation applicant. We encourage programs to prepare for the workload required by the Compliance Application by designating who will be responsible for completing it, and who will support this effort by identifying and providing documentation to upload.
In some cases, it may be feasible to designate and delegate personnel to complete the application; however, in other programs this may not be possible due to limited staff. It is time well spent to have a discussion among team members about where the time can be found to complete the application, including discussions about distribution of workload, how to set aside time needed, and establishing regular check-ins.
The Self-Assessment Tool is not only educational but is a productive planning resource because it contains all the questions that are in the Compliance Application, including each standard. Because it takes time to complete the Compliance Application, programs are encouraged to review the Self-Assessment Tool before FACT creates the Compliance Application. Note that the tool may contain some standards that are not applicable to the services provided by your program, and you can indicate those as “not applicable.”
The Compliance Application is automatically customized by the accreditation portal, which removes questions that are not relevant to an applicant based on responses it enters as it progresses through the Compliance Application. For this reason, while completing the application in the portal, it is beneficial for a program to work through the Compliance Application from beginning to end, rather than jumping between sections.
As you approach the onsite inspection, the Compliance Application can serve as a blueprint for assembling evidence of compliance. Prepare to support your responses in the application with documentation that can be reviewed by the FACT inspector, including related policies and/or examples.
We are grateful for the opportunity to work together toward the shared goal of high-quality patient care in cellular therapies and want to provide programs the best opportunity to complete the application in preparation for a productive onsite inspection.
