Storage and Distribution Flashcards
7 cards from real CTBS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Storage and Distribution flashcards as text
Which AATB accreditation standard addresses the requirement for tissue banks to have a written policy for managing expired tissue?
Answer: Inventory management and disposition standards
AATB standards for inventory management require written policies for identifying, segregating, and disposing of expired tissue to prevent inadvertent distribution.
What information is REQUIRED on the label of a distributed allograft per FDA 21 CFR Part 1271?
Answer: Establishment name, unique identifier, description, and expiration date
FDA requires labels to include the establishment name, unique identifier, description of the HCT/P, and expiration date to ensure traceability and proper use.
A tissue bank is preparing to distribute osteochondral allografts that require fresh storage. What is the MAXIMUM allowable storage time at 4°C before implantation per most AATB guidelines?
Answer: 28 days
Osteochondral allografts are typically stored at 4°C in culture media and have a maximum storage time of 28 days to maintain chondrocyte viability.
During inventory reconciliation, a technician discovers one unit is unaccounted for. The FIRST action should be to:
Answer: Initiate a physical search and document the discrepancy per SOP
Inventory discrepancies require a documented physical search and investigation per SOP before any conclusion or regulatory notification is made.
A tissue bank wants to begin distributing tissue to a new hospital. Under AATB standards, what must be established BEFORE the first shipment?
Answer: A written agreement addressing responsibilities, traceability, and adverse event reporting
AATB standards require a written agreement with each consignee that defines responsibilities including traceability, storage requirements, and adverse event reporting.
When transporting fresh vascular allografts, which shipping method best maintains required 1–10°C temperatures during a 48-hour transit?
Answer: Insulated container with validated wet ice or refrigerant packs
Validated insulated containers with wet ice or refrigerant packs maintain 1–10°C for fresh vascular tissue during transit without risk of freezing damage from dry ice.
Which of the following BEST describes the role of a tissue bank's Medical Director in the distribution process?
Answer: Providing oversight of release criteria and final disposition authority for unusual cases
The Medical Director provides clinical and scientific oversight including final disposition authority for non-conforming or unusual cases and approval of release criteria.