Cellular Therapy Standards FAQ

FACT provides informational emails regarding updates if you are subscribed to our mailing list. The Standards and the Accreditation Manual are available for download in the FACT Store.

Clinical Program personnel requirements may be found in section B3 of the Cellular Therapy Standards.

Collection Facility personnel requirements may be found in section C3 of the Cellular Therapy Standards.

Processing Facility personnel requirements may be found in section D3 of the Cellular Therapy Standards.

For its inspection process, FACT uses the data elements in CIBMTR Data Collection Forms 2400, 2450, and 2100 as applicable.  For allogeneic transplants, inspectors are required to review the following five data points:  disease, stem cell source, donor type, engraftment data, and survival.  For autologous transplants, inspectors are required to review the following five data points:  primary disease, disease status at transplant, stem cell source, engraftment date, and survival.  The inspectors may then choose other data points to audit at random.  Refer to the Applicant Preparation Guidelines document in the Cellular Therapy Document Library on FACTWeb for additional details.
CIBMTR Data Forms

No. FACT requires research protocols to be conducted under approved Investigational New Drug (IND) applications in the United States and under applicable regulatory requirements per Cellular Therapy Standards B1.3, B8.1, C1.2, D1.2, D6.17 and Cord Blood Standards B1.2, B4.13, D4.2.7. Organizations are required to comply with all applicable laws and regulations.

Yes. Both accrediting bodies are acceptable under FACT Standards.

Release criteria from collection and processing require a test for ABO group and Rh type at collection. For allogeneic cellular therapy products containing red blood cells at the time of administration, a test for ABO group and Rh type shall be performed on the first product collected or on blood obtained from the donor at the time of the first collection.

The current FACT-JACIE Standards require all allogeneic donors to be typed for HLA-A, B, DRB1 type. Unrelated donors and related donors other than siblings must also be typed for HLA-C (Standard B6.7.2). Additionally, DNA high resolution molecular typing must be used for Class II typing (Standard B6.7.2.1).

Many programs have asked questions about the requirement for high resolution typing, such as:
1. Do all Class II genes have to be typed?
2. Do we only use high resolution typing if we choose to type Class II genes?
3. Is high resolution typing only required for DRB1 genes?
4. Is high resolution typing really only intended to be required for DRB1?

The implied interpretation requires high resolution typing only for DR genes because B6.7.2.1 is a substandard to B6.7.2, which only requires DR. Of the DR genes, DRB1 is the one of importance in cell transplantation; the implication of this is that the Standards Committee’s intent was to require typing for DRB1 in B6.7.2, which has to be tested using DNA high resolution typing.

These are minimum requirements, and a Clinical Program may choose to use high resolution typing for other Class I and Class II genes also.

The organization should ensure the temporary storage facility meets FACT Standards.

In general, the answer is no, since it would be restraint of trade; however, Section B8 of the Cellular Therapy Standards applies.

Standard B1.5.2 states that a combined Clinical Program caring for pediatric and adult patients at the same site shall perform a minimum of five HPC transplants for each population annually. Refer to the Applicant Preparation Guidelines document in the Cellular Therapy Document Library on FACTWeb for additional details.

With the upcoming 5th Edition of Standards out the beginning of next year, the requirement will be to complete a total of five pediatric and five adult by the time you obtain initial accreditation

The FDA requires products from an ineligible donor to be "prominently labeled" with biohazard legends and warning statements in 21 CFR 1271.65(b)(2). Furthermore, the FACT requirements for biohazard and warning labels are based upon the inter-organizational consensus of several organizations involved in the progress and improvement of cellular therapy as outlined in the Circular of Information for Cellular Therapy Products.

Information about ISBT 128 Requirements may be found under our Resources page.