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.

Application

  1. Complete and submit the Eligibility Application that describes your organization and accreditation goals. 
  2. Submit a nonrefundable registration fee (initial applicants only). Refer to the accreditation fee page for more details about initial registration and annual accreditation 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 set of 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 Accreditation Process Requirements
    Cord Blood Bank Applicant Guidelines 

Coordination

Each organization is assigned a FACT Accreditation Coordinator to assist with questions or concerns you may 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 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 personnel 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 accreditation to the FACT Board for final approval.  Significant questions, problems, and controversial or precedent-setting issues will be referred to the Board for resolution.  
  3.  The organization director and primary contact 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 for final determination.  
  2.  Once all FACT Standards have been met, the organization director receives a FACT accreditation certificate and the organization is listed on the FACT website.  
Ask FACT

FAQ

FACT Consulting

Accreditation Success Story

The Héma-Québec Public Cord Blood Bank (CBB) was created in 2004 to meet the needs of Quebecers and to contribute to the international effort towards a high-quality global inventory of cord blood units. Read more