Frequently Asked
Questions

The first step is to determine which set of Standards applies to your organization. We encourage you to call FACT as soon as you are considering accreditation so that we can discuss your scope of services, the relevant Standards, and your eligibility. Our phone number is 402-920-7001.

After you know which Standards are applicable to your organization, begin the accreditation process by requesting access to the FACT Accreditation Portal and then complete the steps listed in the Accreditation Process Overview.

Eligibility depends on the services you provide, the amount of time you have provided the services, and the number of patients you have treated or the number of cellular therapy products you have managed. See the Eligibility Requirements for more details.

FACT values patient access to cellular therapies, and new cellular therapy programs considering autologous transplant or immune effector cell therapy are eligible for provisional accreditation. If you have not yet treated any patients but are interested in doing so, this may be an option for you. Contact FACT for more details at fact@factglobal.org or 402-920-7001.

FACT does not dictate any specific business model, and we acknowledge the growing diversity of infrastructure to improve access to cellular therapy closer to where patients live and work. If you have any questions about your eligibility, we encourage you to contact us. We are interested in working with you!

After paying the initial registration fee, FACT accreditation fees are based on the scope of services and volume of patients treated or cellular therapy products provided by the organization. They are assessed on an annual basis so that your organization has a predictable payment schedule that helps your budgeting process. Annual fees are customized to your individual accreditation. Contact FACT for an accurate quote for your organization at fact@factglobal.org or 402-920-7001.

The accreditation process generally takes 1 year or less depending on the time required by the applicant organization to complete each step. Some programs can complete the process in a shorter amount of time depending on their inspection readiness. Steps of the process include submission of an Eligibility or Renewal Application, online submission of pre-inspection documentation in the Compliance Application, the on-site inspection, and correction of any identified deficiencies.

When applying for initial accreditation, your organization has the option to utilize an extra year to submit your Compliance Application. Some programs utilize the extra year to work on their crosswalk between each standard and supporting documents, identify missing documentation, and create or update policies and Standard Operating Procedures. You are not required to use this extra time.

Programs that are most prepared for the accreditation process tend to have the most successful results. The following are suggestions for expediting the process:

• Contact FACT as soon as you are interested in FACT accreditation. You can contact us before you are ready to apply. We can provide guidance on the relevant Standards, your eligibility, and the accreditation process. Contact us at fact@factglobal.org or 402-920-7001

• Attend FACT workshops and webinars to learn more about the process

• Complete a gap assessment using the relevant Self-Assessment Tool to identify which requirements you need to implement

• Prioritize the creation of your Quality Management Plan, as compliance with many standards is dependent on thorough quality management

• Consider using outside support. FACT Consulting, a non-profit subsidiary of FACT, provides customizable consulting solutions to help you prepare

FACT accreditation is valid for 3 years. Around the time of your second anniversary, you will begin the renewal accreditation process that must be completed by the accreditation expiration date. The renewal accreditation process is very similar to the initial accreditation process.

There is no standard that requires inspection materials and their results to be maintained after the accreditation process is complete. However, FACT recommends that you keep the documentation until the next accreditation cycle to assist in preparation for the renewal inspection and for internal audits.

There are 2 options for applying for FACT accreditation:

1. The contracted collection facility can be inspected with each clinical program it serves.
The collection facility would submit a checklist for each collection site where services are performed for each applicant clinical program. Each collection site will be inspected at the time the applicant clinical program is inspected.
When an additional cellular therapy clinical program starts using the same contracted collection facility, the contracted collection facility will submit another checklist for each site where services are performed for the new clinical program. Each collection site will be inspected at the time the new clinical program is inspected.
This option could potentially result in the following:

• The contracted collection facility would submit multiple checklists for the same collection site (one for each applicant clinical program if using same site)

• The contracted collection facility would undergo multiple FACT inspections


2. The contracted collection facility could pursue independent accreditation when serving multiple clinical programs. 
This would require the collection facility to pay the one-time registration fee. Once the contracted facility applies to be an independently accredited organization, they would complete the process for being accredited as an independent collection facility.
This option would result in the following:

• The independent collection facility would submit inspection checklist(s) for all collection sites at one time

• The independent collection facility would have all their collection sites inspected once every 3 years

Accredited organizations are listed online at accredited.factglobal.org. Users can filter this list based on geography, services provided, and Standards under which an organization is inspected.

You can search a complete database of accredited organizations on the FACT Accredited Organizations page. We do not publish identifying information about in-process applications, but we do publish the number of applied organizations in our online newsletter, Just the FACTs.

If you believe an organization is misrepresenting its FACT accreditation status, please contact us at FACT@factglobal.org.

FACT addresses complaints and grievances related to its business of accreditation. It is FACT’s goal to conduct investigations, derive conclusions, and enact remedial steps in a respectful and confidential manner to both the complainant and the subject of the complaint or grievance. Refer to FACT's Hearsay Policy and Reviewing Complaints and Grievances SOP.

Please note the following prior to submitting a complaint or grievance:

• FACT will only review complaints and grievances that are specific to the Cellular Therapy Standards; the Cord Blood Standards; and/or the FACT Board of Directors, committee members, inspectors, staff, and/or accreditation process

• FACT does not address grievances related to the individual management of a patient unless it directly relates to a standard

• FACT does not review any complaints related to unaccredited organizations

• For grievances related to the services of a FACT accredited or applied program or bank, the complainant will be instructed to first file a complaint with the program or bank

• If a grievance contains material evidence of violation of laws or regulations, FACT will request legal review and consultation from its attorney

Methods for reporting a complaint or grievance include:

• Written or electronic correspondence, and/or

• Verbal correspondence

If additional information is requested from the complainant, the information must be provided in 30 days, or the complaint or grievance will be closed.

To submit a complaint or grievance, complete the Complaint and Grievance form.

Questions? Contact FACT and request the staff liaison to the Grievance Committee.

The scope of services for each set of Standards can be found on the FACT Standards page. Choose the set of Standards that best matches the services that you provide. We highly recommend contacting FACT to discuss which set of Standards is applicable to you.

Each set of Standards has an accompanying Accreditation Manual that explains the individual standards, lists what could serve as evidence of compliance, and provides examples.

Standards and Accreditation Manuals are available for purchase in either digital or printed form from the FACT Standards page.

Key personnel listed in the Standards do not have to be dedicated full-time to the program. Individuals often fill multiple roles for their organization. To meet the FACT requirements, they must have the required education and experience, demonstrate ongoing and regular completion of job duties, and dedicate an amount of time that is appropriate for the scope and volume of services provided by the organization.

Some organizations will have a single individual fulfill multiple roles, some will use shared resources with other institutional departments or within their network of practices, and some will determine roles best suited for
full-time status.

The Standards are applicable to both unrelated and related (often referred to as public and private) banking of cord blood units. Banks currently accredited by FACT have accepted unrelated units, related units, or both. For recommendations on the allocation of cord blood units on a public or private basis, refer to the experts in the field: American Society of Transplantation and Cellular Therapy (ASTCT), American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Pediatrics (AAP).

FACT uses an online application for inspectors.  The application and other information may be found on the FACT Inspector Application page.

There are different categories for various aspects of cellular therapy programs and cord blood banks. The basic eligibility requirements and categories can be viewed in our Initial Inspector Qualifications policy.

Each year, all inspectors, volunteers, FACT Board Members, and committee and task force members must review and update their Conflict of Interest & Acknowledgements statement. You will be notified when annual updates are due. If you need to submit a new conflict, visit FACT’s COI site and log in.

If you have questions, call FACT at 402-920-7001 or send us an email at fact@factglobal.org.

All of FACT’s educational content, including upcoming events and on-demand sessions, are listed in FACT’s online Learning and Development Academy. Within this system, you can view the full calendar of events and catalog of on-demand sessions, register for or purchase educational sessions, and access accompanying materials.