Transfusion medicine
Quality and compliance
FACT compliance
Editorial Board Member: Melissa R. George, D.O.
Last staff update: 2 April 2025 (update in progress)
Copyright: 2020-2025, PathologyOutlines.com, Inc.
PubMed Search: Foundation for the Accreditation of Cellular Therapy (FACT)
Table of Contents
Definition / general | Essential features | Terminology | Diagrams / tables | Pursuing accreditation | Application process | Lab inspection | Accreditation process | Board review style question #1 | Board review style answer #1 | Board review style question #2 | Board review style answer #2Cite this page: Potochny EM, Kesterson S. FACT compliance. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/transfusionmedFACTcompliance.html. Accessed April 2nd, 2025.
Definition / general
- The Foundation for the Accreditation of Cellular Therapy (FACT) is an accrediting agency established to assist eligible facilities involved in cellular therapy in meeting acceptable standards of quality patient care and to promote international access to donors and cell products
- FACT accreditation is voluntary for eligible facilities and inspections are peer driven
Essential features
- FACT accreditation requires documentation showing compliance with current standards and an onsite inspection (Cytotherapy 2003;5:299)
- FACT provides standards for the program you wish to have accredited, as well as common standards for all cellular therapies
- Common standards for cellular therapies
- International standards for hematopoietic cellular therapy product collection, processing and administration
- Standards for immune effector cells
- International standards for cord blood collection, banking and release for administration
- FACT standards are always evolving and are revised every 3 years (Transplant Cell Ther 2022;28:455)
Terminology
- HSC: hematopoietic stem cells
- FACT: Foundation for the Accreditation of Cellular Therapy
- JACIE: Joint Accreditation Committee ISCT-Europe and EBMT, Europe’s official accreditation body in the field of hematopoietic stem cell transplantation and cellular therapy (EBMT: JACIE [Accessed 14 February 2025])
- ISCT: International Society for Cell and Gene Therapy, a society whose standards inform part of the FACT standards (ISCT: International Society for Cell and Gene Therapy [Accessed 14 February 2025])
- EBMT: formerly known as the European Society for Blood and Marrow Transplantation, a nonprofit medical and scientific organization dedicated to expanding knowledge of transplantation of HSCs or immunomodulatory cells (EBMT: The EBMT [Accessed 14 February 2025])
- ASTCT: American Society for Transplantation and Cellular Therapy (ASTCT: American Society for Transplantation and Cellular Therapy [Accessed 14 February 2025])
- FACT-JACIE: using the same standards in Europe and the United States, accreditation may be referred to as FACT accreditation or FACT-JACIE accreditation
- ASBMT: American Society for Blood and Marrow Transplantation, a society whose standards inform part of the FACT standards
- FDA: Food and Drug Administration; assists FACT members in staying abreast of potential future FDA policies / regulations that may affect cellular therapy
- Accreditation: approval by accrediting agency, indicating compliance with standards set forth by that agency
Diagrams / tables
Contributed by Evelyn M. Potochny, D.O. and Sarah Kesterson, M.D.
General steps in successful FACT accreditation process
FACT common standards categories
Pursuing accreditation
- Eligibility requirements are extensive, including factors such as
- Minimum number of procedures completed within the year prior to accreditation and annually thereafter
- Criteria for facility directors, medical directors and presence of a dedicated team for these products
- Use of FACT-JACIE accredited facilities for all stages of the product
- Comparison of clinical outcomes to national or international outcome data
- Use of coding and labeling technologies using ISBT 28 or Eurocode
- Having met or exceeded all current, applicable standards (Aljurf: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy - The JACIE Guide, 1st Edition, 2021)
- Facilities seeking accreditation begin by reviewing the respective standards for which they are seeking FACT accreditation (hematopoietic cell therapy [HCT], immune effector cells or cord blood banking) as well as the common standards for cellular therapies (FACT: Hematopoietic Cell Therapy Standards [Accessed 14 February 2025])
- For initial applicants who self identify as eligible for accreditation, checklists must be submitted to FACT within 12 months from approval of their eligibility application; a registration fee and business associate agreement, a legal form addressing an entity's role in protected health information, will also be required (FACT: Accreditation Eligibility Requirements [Accessed 14 February 2025])
- For FACT accredited institutions, checklists must be submitted 3 months in advance for renewal
- Applications for accreditation / renewal are reviewed by a coordinator and a summary is then provided to the accreditation committee
- Benefits of FACT accreditation include access to patient and research resources, reimbursement potential through insurance or government agencies and an increased likelihood of Center of Excellence designation (FACT: Navigating the FACT Accreditation Process [Accessed 14 February 2025])
Application process
- Accreditation requires the completed application from an eligible program, the compliance checklist and a satisfactory onsite inspection
- Once an applicant is confirmed eligible for an onsite inspection by a coordinator, the coordinator reviews the required documentation provided by that organization
- Applicants will then provide dates available for inspection and identify knowledgeable personnel to be involved at least 6 months in advance of expiration date (for renewal cycle or initial accreditation) (FACT: Navigating the FACT Accreditation Process [Accessed 14 February 2025])
Lab inspection
- Applying facility will be given a 3 month window in which the onsite inspection will take place
- Coordination for lodging / transportation for the peer inspection team should be provided
- Adequately sized conference rooms for preinspection and exit meetings for a large group should be secured
- Work rooms for inspectors to review hard copy and digital records should also be established (Cytotherapy 2003;5:299)
- Tours of relevant patient care and laboratory spaces should be given
- For those seeking accreditation renewal, new standard operating procedures (SOP) or documents should be highlighted
- Inspectors review relevant standard operating procedures, documents and charts and may observe processes or procedures in the part of the facility they are focusing on, relevant to their area of expertise
- If a potential deficiency is identified, discussion with personnel may yield an onsite correction that avoids a citation for that deficiency
- Each inspector then completes an online submission that goes to the team leader for additional review and final submission of the report
- Team leader and all inspectors may convene as a group to prepare for the exit meeting
- During the exit meeting, a summary of findings and possible deficiencies will be shared and an inspection report will be submitted to the FACT office by the team leader within 3 days (FACT: Navigating the FACT Accreditation Process [Accessed 14 February 2025])
Accreditation process
- Accreditation committee reviews and revises the report before determining the accreditation outcome or next steps
- Report sent to the applying facility includes
- List of the deficient areas (noncompliance with standards)
- Description of each deficiency
- Explanation of the response expected from the facility in order to become compliant
- Response timeline
- Applicants then have 3 months to address and provide corrective actions for each deficiency
- Potential outcomes, assigned by the accreditation committee, include
- Full accreditation
- Full accreditation pending corrections and additional documentation
- Full accreditation pending accreditation committee review and assessment of responses
- Partial focused reinspection
- Full focused reinspection
- Complete reinspection
- Once accreditation is awarded, the director of the institution's program will receive a letter and FACT accreditation certificate
- FACT accreditation covers a period of 3 years, with the renewal process beginning 2 years from the accreditation date (FACT: Accreditation Process Requirements [Accessed 14 February 2025])
- FACT is an independent accreditation agency, it does not preclude or require accreditation from any other agency
- FACT does not have any deemed status relationships with other accrediting agencies or with Centers for Medicare and Medicaid Services (CMS)
Board review style question #1
Your hospital's hematopoietic stem cell laboratory maintains Association for the Advancement of Blood and Biotherapies (AABB) accreditation every 2 years but wishes to also pursue Foundation for the Accreditation of Cellular Therapy (FACT) accreditation. Which of the following is true?
- AABB and FACT accreditation cannot be maintained simultaneously
- AABB and FACT are separate accreditation bodies; you may pursue either or both
- If your hematopoietic stem cell laboratory is AABB accredited, you have deemed status for FACT
- If your hematopoietic stem cell laboratory is FACT accredited, you have deemed status with Centers for Medicare and Medicaid Services (CMS)
Board review style answer #1
B. AABB and FACT are separate accreditation bodies; you may pursue either or both. Answer A is incorrect because FACT and AABB are separate, voluntary accreditation bodies and they both may be pursued simultaneously. Answers C and D are incorrect because FACT has no deemed status relationship with AABB or CMS.
Comment Here
Reference: FACT compliance
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Reference: FACT compliance
Board review style question #2
Which of the following is the window for the onsite inspection portion of the Foundation for the Accreditation of Cellular Therapy (FACT) accreditation process?
- 2 years
- 3 months
- 3 years
- 12 months
Board review style answer #2
B. 3 months. The onsite inspection occurs within a 3 month window. Answer A is incorrect because the accreditation renewal process begins 2 years after the accreditation date. Answer C is incorrect because the entire FACT accreditation process occurs every 3 years. Answer D is incorrect because new applicants must submit all required documents to FACT within 12 months from the time their eligibility application is approved.
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Reference: FACT compliance
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Reference: FACT compliance
