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FACT Consultants can provide assistance before, during, and after inspections. 

Your cell therapy program is unique, and its needs are always evolving. There will be seasons when you have all the skills and experience necessary for quality management and accreditation readiness. There can be other times when help is needed or prudent. In those instances, program depth and breadth can be gained through experienced FACT consultants.

We offer a variety of services to meet your specific needs.

Compliance Assessment

Our consultants can perform an on-site assessment of compliance with applicable FACT Standards for cell therapy or cord blood banking.

Prior to an on-site evaluation, a consultant will review your accreditation application or renewal documents. Then your facility will be toured, personnel interviewed and documents reviewed. At the end of the visit, our consultant will provide overall findings and recommendations, and follow up with a written report.

Policy Review

Our consultants can review your policies and procedures and other documents to be submitted for first-time accreditation or renewal, and provide recommendations for compliance with FACT Standards.

Policy Development

If your facility is new and has few or no formal procedures and protocols, we can work with you to develop policies, procedures and practices that comply with FACT Standards.

Application Assembly

We can assist your staff in assembling an application for FACT accreditation or renewal. We are experts on using FACTWeb, the online accreditation portal, and can either advise on how best to submit documents through the system, or organize and upload documents for you.

Mock Desktop Review

After our client assembles its application but before it submits it to FACT, FACT Consulting Services will conduct a comprehensive mock desktop review. This involves a review of all the documents submitted to FACTWeb, along with all the notes submitted with those documents. Upon completion of the Desktop Review, we will write a Desktop Review Summary that outlines our findings, including recommendations for actions our client should take to address any deficiencies we find in the review process. After submission of our Desktop Review Summary to our client, we will have a conference call with key client staff members to review, in detail, our findings and to discuss the action plan for bringing our client’s submission into full compliance with FACT’s standards.

Mock Onsite Inspection

After submission of the application and before the FACT onsite inspection, FACT Consulting Services will conduct a mock onsite review. This onsite review will serve two purposes: (1) to give our client staff members a realistic preview of the on-site review process and (2) to provide our client staff members with feedback on how to improve its performance during the onsite review.

Continuous FACT-Readiness

Consultants will perform a gap analysis to identify work needed to be completed to ensure compliance with new editions of standards. Consultants will propose a plan on how to implement the transition.

Quality Management

Do you need help with your quality assurance program? Our consultants know the strategies and protocols of QM and can help you design and implement policies and procedures that are practical for your organization.

Training Workshops

Any of our consulting engagements can include formal training for your staff on FACT Standards and the inspection and accreditation process. This can be an on-site workshop or one-on-one coaching.

Customized Services

Or, if you don’t see a service that meets your exact needs in the menu above, explain your unique situation and opportunities to us. Chances are the necessary experience can be found among our consultants for the services that you need.



As a Matter of FACT

FACT is approved as an accrediting organization by the United States Health Resources Services and Administration (HRSA) for the C.W. Bill Young Cord Blood Transplantation Program.

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

Knowledge makes all the difference.

  • FACT Consulting Services
  • 6901 Dodge Street, Suite 207
  • Omaha, NE 68132
  • 402-559-1185