Cellular Therapy and Cord Blood Bank Accreditation Process Overview

Preparation

1. Review the current edition of the Cellular Therapy or Cord Blood Bank Standards and Accreditation Manual.
   Download or purchase these documents from our store.
2. Determine eligibility requirements.
   Cellular Therapy Program eligibility requirements
   Cord Blood Bank eligibility requirements
3. Review all the forms and documents required by FACT. They can be accessed at FACTWeb.  If you do not have a FACTWeb profile, you will be able to create one for yourself.
4. To confirm eligibility for accreditation you must submit:
   1. Application form.  You can access the application form in the Document Library located in FACTWeb.
   2. Nonrefundable initial registration fee for first time applicants only.
      Accreditation fees

Submission

1. To demonstrate compliance with the Standards, complete and submit the documents listed below.  You can access them in the Document Library located in FACTWeb.
   1. Document Checklist
   2. Inspection Checklist
      Note: If your program consists of more than one clinical, collection, or processing facility, each facility must submit the appropriate inspection checklist.
   3. Annual accreditation fee
      

Coordination

Each organization is assigned a FACT Accreditation Coordinator to assist you with any questions or concerns you have throughout the accreditation process.

1. Your FACT accreditation coordinator will contact your organization.
2. Your FACT accreditation coordinator requests any missing compliance documentation in a pre-inspection letter, which is sent to the organization director and/or designated contact person.
3. Your organization submits potential dates for the on-site inspection.
4. Your organization is notified of the inspection team.
   Note: If there are objections to any members of the inspection team, your organization should notify the FACT office within five days of receiving notice of the proposed team of inspectors.
5. The inspector team leader creates and coordinates with the organization an agenda for the on-site inspection.

On-site Inspection

1. Key personel at your organization present a 10-15 minute overview of the program.
2. On the day of the on-site inspection, the inspection team will:
   1. Visit all facilities and complete inspection checklist(s).
   2. Present an exit interview: Summation of the general impressions of the inspection team, no accreditation determination will be made at this time.

Outcome

1. The inspection team submits the inspection report to FACT.
2. The FACT Accreditation Committee reviews the inspection summary and submits a recommendation for cellular therapy accreditation to the FACT Board and for cord blood bank accreditation to FACT and NetCord Boards for final approval/determination. All significant questions, problems, controversial or precedent-setting issues will be referred to the FACT or FACT and NetCord Boards for resolution.
3. The organization director is notified in writing of the inspection outcome.
4. The organization has a specified period of time to submit documentation addressing all cited deficiencies and/or variances noted during the inspection process.

Response

1. The Accreditation Committee or designee reviews the documentation submitted in response to the cited deficiencies and variances and submits a recommendation to the FACT board or FACT and NetCord Boarda for final approval/determination on the accreditation status.
2. Once all FACT Standards have been met, the organization director receives a letter and a certificate indicating FACT accreditation for the services they provide.
   Note: For more details regarding the inspection process, please see the Inspection Process Standard Operating Procedure located in the FACTWeb under Policies and Procedures.