Tissue Collection and Accreditation: What Programs Need to Know
By Suzanne Birnley, MS, MBA, Director of Operations
With the publication of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Ninth Edition, and FACT-JACIE Standards for Immune Effector Cells, Third Edition, questions have arisen regarding tissue collection requirements for licensed products and collection of other tissue for further manufacturing. These questions have fallen into two main categories: the surgical suite and the Medical Directorship. Although Part C includes specific questions about tissue collection, Clinical Programs—not surgery centers—are responsible for providing evidence of compliance. Surgery centers are not inspected for collection of cellular starting material for FDA-licensed products unless they are seeking FACT accreditation for collection.
Surgical Suite:
For licensed products, compliance is typically confirmed through the commercial manufacturer’s authorization of surgery centers in accordance with the FDA-approved Biologics License Application (BLA). As a result, programs generally face little to no additional burden in demonstrating compliance. The Clinical Program will be asked to provide the Certificate of Qualification from the commercial manufacturer.
In contrast, some investigator-initiated clinical trials involve products that are not yet licensed. In these cases, the accredited Clinical Program oversees the surgically collected material and is responsible for verifying that participating surgery centers hold appropriate accreditation. FACT does not intend to inspect or accredit surgery centers that are properly licensed and authorized unless the program voluntarily seeks accreditation for collection at that site.
Medical Director for Other Tissue:
For programs collecting tissues such as tumor-infiltrating lymphocytes (TILs), the Medical Director must be trained in cellular therapy product collection methods or the diseases treated by these therapies. The Collection Facility Medical Director for Other Tissue must be knowledgeable regarding risks and benefits and demonstrate competence in at least one tissue collection procedure—whether for diagnostic, therapeutic, or manufacturing support purposes. If they have not performed collections for manufacturing, they must understand how these procedures differ from those performed for diagnostic or therapeutic purposes.
When evaluating the Medical Director for Other Tissue, FACT expects the individual to meet the experience requirements in Marrow, Apheresis, or Other Tissue. FACT does not require the Medical Director to have experience in all categories; experience in one area is sufficient, provided certain responsibilities and tasks are appropriately delegated.
For example, an individual who qualifies as an Apheresis Collection Facility Medical Director may also serve as the Other Tissue Medical Director and delegate the actual tissue collection to a qualified individual. However, the Medical Director would retain responsibility for oversight of the tissue collection process and the quality management program. If responsibilities are delegated, FACT expects the program to maintain a policy or Standard Operating Procedure (SOP) that clearly defines:
- The duties the Collection Facility Medical Director for Other Tissue may delegate.
- The required qualifications of the individual performing each delegated task.
- Confirmation that the Collection Facility Medical Director for Other Tissue retains ultimate responsibility for all delegated activities.
