Accreditation

How do I apply for accreditation?

Begin the process of applying for your FACT accreditation by creating or updating your organization's profile in FACTWeb. Review the eligibility requirements for your organization, and complete the steps listed in the Accreditation Process Overview.  
  

How do we determine what our application and accreditation fees will be?

Applicants may view the application and accreditation fees on our website.

FACT Accreditation Fees

How do we submit our application fee?

Applicants should submit their application fees to The Foundation for the Accreditation of Cellular Therapy. The mailing address is:
University of Nebraska Medical Center
986065 Nebraska Medical Center
Omaha, NE 68198-6065

What are the eligibility requirements?

FACT Standards detail specific cellular therapy eligibility requirements and cord blood bank eligibility requirements.

CT eligibility requirements
CB eligibility requirements

How long does it take to become accredited?

The maximum time allowed from the submission of an applicant’s Inspection Checklist to correction of deficiencies found during the on-site inspection is one year. However, the actual timeframe will vary dependent upon the length of time for the program to respond to its initial findings and provide evidence of meeting all FACT Standards.

How long is the accreditation valid?

FACT accreditation is valid for three years.

Is assistance available for applicant organizations?

FACT offers workshops, webinars, tutorials, and virtual roundtables to help applicant programs organize and prepare for an on-site inspection. To see all FACT educational offerings, check the FACT Calendar for live events and the FACT Store for recorded sessions, publications, and the Quality Management series.

FACT Calendar
FACT Store

Is it possible for a stand-alone collection and/or processing facility to receive FACT accreditation?

Yes. It is recommended for collection and/or processing facilities to pursue stand-alone FACT accreditation when serving multiple clinical programs. Applicants may review the fees for stand-alone facilities on the fees page.

Where do I find accreditation-related forms?

Login to FACTWeb and click on the applicable (Cellular Therapy or Cord Blood) document library to view accreditation related forms.
FACTWeb Login

How do I receive the renewal forms?

Renewal forms are emailed to each organization 18 months prior to your accreditation expiration date.

How do I ensure that I have the most up to date accreditation documents?

All documents are under document control and the most current documents are available online.

How long do I need to retain FACT inspection materials/results after the accreditation is complete?

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

How do I find out if a cord blood bank follows FACT-NetCord Standards?

FACT states on our website which organizations are accredited.

You may search for FACT accredited organizations using our Search Tool.

How do I find out if a cellular therapy program, collection facility, or processing facility follows FACT-JACIE Standards?

FACT states on our website which organizations are accredited.

You may search for FACT accredited organizations using our Search Tool.

Some organizations specify on their website that they are in the process of FACT accreditation.  How can I confirm this?

FACT states on our website which organizations are accredited. We do not publish in-process applications.  If you believe an organization is misrepresenting its FACT accreditation status, please contact us at FACT@unmc.edu.

You may search for FACT accredited organizations using our Search Tool.

Our clinical center and our collection center are separate entities and are applying for FACT accreditation. Will we need separate applications because we are separate entities or only one?

There are two 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 three years.
We are exploring having our collection staff contracted from an outside dialysis agency. The staff will have to comply with our policies and procedures and we would manage the QI program. Our current collection/dialysis staff would be hired by the outside agency. Can we still claim to have a collection facility accredited by FACT?

The collection facility can maintain FACT accreditation, provided the contract between the collection facility and the outside agency explicitly defines the limits of responsibility for each party. Refer to FACT Cellular Therapy Standards B10.5 and C11.7.

Is there a list I can get that indicates what an organization is accredited for?

FACT provides a list of accredited organizations that is searchable by various parameters, including the details about what organizations are specifically accredited for.

FACT Accredited Organization Search Tool.

How could I get involved in FACT Committees?

You can create a FACTWeb profile so that FACT will be able to include you in our annual call for volunteers that occurs every fall.

Create your FACTWeb profile.

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2 Comments

Rating: 10/10

If a program is currently FACT accredited, can this accreditation extend to satellite sites or affiliated off-site programs?

Rating: 2/10

Does any University get accrediation from FACT, soley for their resarch purpose?

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As a Matter of FACT

FACT is the only accrediting organization that includes requirements for both clinical and laboratory requirements.

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