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. Begin the process of applying for your FACT accreditation by creating your organization's profile in FACTWeb. If you do not have a FACTWeb profile, you will be able to create one. Chapter Two of the FACTWeb user guide provides detailed information about creating a FACTWeb profile.  
    Access or create a FACTWeb profile
    FACTWeb User Guide

Application

  1. Complete and submit the eligibility application that describes your organization and accreditation goals.  Chapter Three of the FACTWeb user guide provides detailed information about creating an online Eligibility Application for your organization.
  2. Submit a nonrefundable registration fee (initial applicants only). See the summary of fees page below for more details about registration and annual fees. 
    FACT Fee Page

Submission

  1. Once your Eligibility Application has been approved by FACT, complete the online Compliance Application to indicate compliance with the appropriate Standards. Your organization will have 12 months from your Eligibility Application approval to complete the Compliance Application. 
  2.  Refer to the appropriate Applicant Guidelines for detailed information:
    Cellular Therapy Applicant Guidelines 
    Cord Blood Bank Applicant Guidelines 

Coordination

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

  1. Your FACT accreditation coordinator will contact your organization after you have submitted your organization's Compliance Application. 
  2. Your accreditation coordinator will request any additional or missing documentation. 
  3. Your organization will submit potential dates for the on-site inspection to FACT.
  4. Your organization will be notified of the inspection team.  Note: If there are objections to any members of the inspection team, your organization may 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 will present a 10-15 minute overview of the program. 
  2.  On the day of the on-site inspection, the inspection team will:
    • Visit all facilities and complete inspection checklist(s).
    • Present an exit interview, which will include a summation of the general impressions of the inspection team.  The inspection team will not make an accreditation determination at this time. 

Outcome

  1. The inspection team will submit an inspection report to FACT after the on-site inspection. 
  2. The FACT Accreditation Committee will review the inspection summary and submit a recommendation for cellular therapy accreditation to the FACT Board and for cord blood bank accreditation to FACT and NetCord Boards for final approval.  Significant questions, problems, and controversial or precedent-setting issues will be referred to the Board(s) for resolution.  
  3.  The organization director is notified of the inspection outcome. 
  4.  The organization is given a specified period of time to submit documentation addressing all cited deficiencies and/or variances noted during the inspection process. 

Response

  1. Inspection findings are reviewed by the FACT Cellular Therapy or Cord Blood Accreditation Committee and an accreditation recommendation is submitted to the FACT Board of Directors (and NetCord Board of Directors, if the organization is a cord blood bank) for final determination.  
  2.  Once all FACT Standards have been met, the organization director receives a certificate indicating FACT accreditation.  
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As a Matter of FACT

FACT inspectors have free access to all FACT training and educational opportunities.

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