The FACT
Accreditation
Process

First you'll need to submit an Eligibility Application to verify your eligibility for accreditation. Here's how:

1. Confirm Eligibility: Review the eligibility requirements. Contact the FACT office to verify which set of FACT Standards apply to your organization and discuss any questions you may have. You can reach us at 402-920-7001 or by emailing fact@factglobal.org.

2. Submit Eligibility Application: Create an organization profile in the FACT portal, and request an application. Complete and submit the application based on the instructions you receive.

3. Submit Business Associate Agreement: Submit a completed BAA, and a countersigned copy will be returned.

4. Pay Registration Fee: First-time applicants will submit a nonrefundable fee.
   
   

Learn more about the eligibility requirements for FACT accreditation

Once your Eligibility Application has been approved, you’ll be assigned an Accreditation Coordinator who will help you with completing and submitting the Compliance Application including:

1. Approve Compliance Application: Upon the Organization Director’s review and approval of accreditation goals and sites to be inspected, a customized Compliance Application will be provided.

2. Review the Accreditation Process Requirements for Cellular Therapy or Cord Blood Banking: Use these guidelines to gain a clear understanding of the FACT accreditation process, required documentation, and key steps from application through inspection.

3. Create a Crosswalk: Identify your organization’s documents to demonstrate compliance with each Standard, determine any missing documentation, and create or update policies or Standard Operating Procedures (SOP).

4. Complete Compliance Application: Upload documents in the Accreditation Portal ensuring all questions have been answered and submit completed application.

5. Application Review: Following review by your Accreditation Coordinator, respond to any requests for Information (RFI) if requested.

After you submit your Compliance Application, FACT will work with you to schedule an on-site inspection. Before the inspection, ensure the Team Leader sends the inspection agenda to the Organization Director at least one week in advance. The Organization Director may contact the Team Leader or Accreditation Coordinator at any time to discuss the agenda or any inspection details. Once finalized, the agenda is shared by the Organization Director with key personnel.

Plan to begin the inspection with an introductory meeting between key personnel and the inspection team. During the inspection, assign a knowledgeable staff member to each inspector to help facilitate the review, answer questions, and locate documents as needed. Inspectors will observe relevant procedures and will summarize major findings during the exit interview. Final accreditation decisions are made by the FACT Cellular Therapy Accreditation Committee and approved by the FACT Board of Directors.

• Sample Cellular Therapy On-Site Inspection Agenda

• Sample Cord Blood Bank On-Site Inspection Agenda

After the on-site inspection, the inspection team will submit a report for the FACT Accreditation Committee to review. The report will outline any deficiencies or suggestions from the inspector. Once you receive the report, correct the deficiencies and submit your response via the Accreditation Portal. After deficiencies are corrected, FACT accreditation will be awarded. You will be invited to submit feedback on the process.