Initial Accreditation Step by Step

Preparation

1. Review the current edition of the Cord Blood Bank Standards.
    Download or purchase current FACT Standards

2. Determine eligibility
    Eligibility requirements

3. Download the following documents from the Document Library:
    Application form
    Document checklist
    Inspection checklist

    Note: All FACT downloadable documents and forms are available in the Document Library located 
               under the Cord Blood Bank Accreditation navigation link.

Application

4. To confirm eligibility for accreditation, submit:
        4.1. Application form 
        4.2. Non refundable application fee

Submission

5. To show compliance with the Standards, submit:
        5.1. Document checklist
        5.2. Inspection checklist. 
        5.3. Inspection fee

    Note: If the cord blood bank consists of more than one collection site submit a separate checklist 
               and all the documentation outlined in the document checklist for each collection site.

Coordination

     Note: Each cord blood bank is assigned an accreditation coordinator to assist them with any 
                questions or concerns they have throughout the accreditation process.

6. FACT coordinator contacts the bank.

7. Cord Blood Bank submits on-site inspection dates.

8. FACT Coordinator requests any missing items in a pre-inspection letter, which is sent to the cord 
    blood bank director and/or designated contact person.

9. The bank is notified of the inspection team.
      Note: If there are objections to any members of the inspection team, your cord blood bank should 
                notify the FACT office within five days of receiving notice of the names of the proposed inspectors.

10. The team leader creates and coordinates with the cord blood bank director an agenda for the on-site 
       inspection.

 
On-site Inspection

11. Key personnel present a 10-15 minute overview of the bank.

12. On the day of the on-site inspection, the inspection team will:
        12.1.  Visit all facilities and complete inspection checklist(s). 
        12.2.  Present an exit interview: Summation of the general impressions of the inspection team, no 
                   accreditation determination will be made at this time.

Outcome

13. Inspection team submits the inspection reports to FACT.

14. The FACT Accreditation Committee reviews the inspection summary and determines the outcome in 
       accordance with FACT policies and procedures.

15. The cord blood bank director is notified in writing of the inspection outcome.

16. The cord blood bank has a specified period of time to submit documentation addressing all 
       cited deficiencies and/or variances noted during the inspection process.

 
Response

17. The Accreditation Committee or designee reviews the documentation submitted in response to the 
       cited deficiencies and variances and a determination is made on accreditation status.

18. Once all FACT Standards have been met, the cord blood bank director will receive a letter and a 
       certificate indicating FACT accreditation for the services they provide.

        Note: For more details regarding the inspection process please see:
        Inspection Process Standard Operating Procedure