Cellular Therapy Standards
How do I obtain the Standards and Accreditation Manual?
The Standards and Accreditation Manuals for both Cellular Therapy and Cord Blood can be found in the FACT website Store.
How will FACT notify me when the Standards and the Accreditation Manual are updated?
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.
Where can I find FACT requirements for Clinical Program personnel in the Standards?
Clinical Program personnel requirements may be found in section B3 of the Cellular Therapy Standards.
Where can I find FACT requirements for Collection Facility personnel in the Standards?
Collection Facility personnel requirements may be found in section C3 of the Cellular Therapy Standards.
Where can I find FACT requirements for Processing Facility personnel in the Standards?
Processing Facility personnel requirements may be found in section D3 of the Cellular Therapy Standards.
Would you have any guidance for a Data Manager to select the data points to create a checklist of items that must be in patient charts?
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
Are FACT accredited organizations exempt from obtaining IND approvals for their research protocols?
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.
We are in the process of FACT re-accreditation and we switched from Joint Commission to DNV as our accrediting body. Does DNV accreditation meet FACT Standards?
Yes. Both accrediting bodies are acceptable under FACT Standards.
What are the requirements for ABO/Rh testing on PBSC recipients and/or products when more than one collection is required?
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.
What do the FACT Standards require for HLA typing?
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 B126.96.36.199).
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 B188.8.131.52 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.
Is there an issue that would prevent a FACT accredited processing facility from temporarily transferring their LN2 freezers, containing HPC, to a non-FACT facility? If we should store our freezers in this facility is there anything that would prevent a FACT transplant facility from using these cells for transplant?
The organization should ensure the temporary storage facility meets FACT Standards.
If a FDA IND approved 351 product is intended for infusion at a transplant center, is FACT accreditation required for the offsite research lab that processed the product?
In general, the answer is no, since it would be restraint of trade; however, Section B8 of the Cellular Therapy Standards applies.
How many transplants does FACT require in a program that performs adult and pediatric stem cell transplants?
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
What do I need to include on our biohazard labels and warning statements on product labels?
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.
Where can I find more information about the ISBT 128 Labeling Requirements?
Information about ISBT 128 Requirements may be found under our Resources page.