Initial Accreditation Step by Step

 

Preparation

1. Review the current edition of the Cellular Therapy Standards 
    Download or purchase current Cellular Therapy standards

2. Determine Eligibility
    Eligibility requirements

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

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

Application

4. To confirm eligibility for accreditation, submit:
        4.1. Application form 
        4.2. Nonrefundable initial registration fee

Submission

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

    Note: If your program consists of more than one clinical, collection, or processing facility, each facility 
               must submit the appropriate inspection checklist.

Coordination

    Note: Each program is assigned a FACT accreditation coordinator to assist you with any questions or 
               concerns you have throughout the accreditation process.

6. FACT coordinator contacts the program.

7. Program submits on-site inspection dates.

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

9. Program is notified of the inspection team.
    Note: If there are objections to any members of the inspection team, your program 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 program director an agenda for the on-site 
        inspection.

On-site Inspection

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

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 program director is notified in writing of the inspection outcome.

16. The program 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 program 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