Expert blood and marrow transplant and cord blood banking senior consultants are available to provide information for what is needed to establish a new transplant program, immune effector cell therapy program, collection facility, cell processing facility, or cord blood bank.

Our consultants can perform an on-site assessment of compliance with applicable FACT Standards for cell therapy or cord blood banking. This assessment will mirror a FACT inspection including a consultant’s review of your accreditation application or renewal documents. The consultant(s) will tour your facility, interview personnel and review documents. At the end of the visit, our consultant(s) will provide overall findings and recommendations and follow up with a written report.

This mock inspection will serve two purposes: (1) to give our client’s personnel a realistic preview of the on-site review process and (2) to provide client’s staff with feedback on how to improve performance during the onsite review.

Our consultants can perform audits and assessments on behalf of industry, cell therapy programs, and other stakeholders to enable treatment centers and collection sites to focus on the health care of their patients. Consultants will provide an unbiased and unified auditing system applicable to quality, operational, and regulatory requirements of any stakeholder with the goal of optimizing patient care and access to cellular therapies through rapid site qualification, comprehensive evaluation, and reduced duplicative audit burden.

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.

If your facility is new and has few or no formal procedures and protocols or if you’ve had a change in quality management personnel, we can work with you to develop or review policies, procedures and practices that comply with FACT Standards.

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.

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 the FACT Accreditation Portal. 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.

Do you need help with your quality management 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.

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.

Consultants are available to present on-site instructive and engaging workshops on quality, safety, audits, and process management systems.

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.