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
What is the maximum acceptable temperature for storing cryopreserved tissue in liquid nitrogen vapor phase?
Answer: -130°C
Vapor phase liquid nitrogen storage must maintain temperatures at or below -130°C to ensure tissue viability and prevent ice recrystallization.
When a tissue bank receives a distributor complaint about packaging integrity, the FIRST action should be to:
Answer: Quarantine remaining inventory from the same lot
Quarantining remaining inventory from the same lot prevents further distribution of potentially compromised tissue while the investigation proceeds.
Which document must accompany every allograft shipment to enable traceability from donor to recipient?
Answer: Certificate of Analysis
A Certificate of Analysis provides test results and release criteria confirmation, enabling donor-to-recipient traceability as required by AATB standards.
A frozen musculoskeletal allograft is found at -15°C during a routine temperature log review. The MOST appropriate action is to:
Answer: Quarantine and evaluate per SOPs before any release decision
Temperature excursions require quarantine and SOP-driven evaluation to determine tissue suitability before any release or discard decision.
Under 21 CFR Part 1271, tissue establishments must maintain distribution records for a minimum of:
Answer: 3 years beyond the expiration date or 10 years from distribution
FDA requires records be retained for 10 years after distribution or 3 years beyond the labeled expiration date, whichever is longer.
What is the primary purpose of a consignment inventory agreement between a tissue bank and a hospital?
Answer: To allow tissue to remain bank property until used or returned
Consignment agreements allow tissue to be stored at a facility while ownership remains with the tissue bank until the tissue is implanted or returned.
Which condition would MOST likely require immediate notification to consignees and potential field safety corrective action?
Answer: Discovery that a distributed tissue donor had a reactive HCV NAT result post-release
A reactive infectious disease test result discovered after tissue distribution triggers urgent consignee notification and potential recall to protect recipients.