CTBS Storage and Distribution 2 — Questions and Answers
Question 1: What is the maximum acceptable temperature for storing cryopreserved tissue in liquid nitrogen vapor phase?
- -80°C
- -130°C (Correct answer)
- -150°C
- -196°C
Correct answer: -130°C
Vapor phase liquid nitrogen storage must maintain temperatures at or below -130°C to ensure tissue viability and prevent ice recrystallization.
Question 2: When a tissue bank receives a distributor complaint about packaging integrity, the FIRST action should be to:
- Issue a full product recall
- Quarantine remaining inventory from the same lot (Correct answer)
- Notify the FDA immediately
- Discard all affected units
Correct 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.
Question 3: Which document must accompany every allograft shipment to enable traceability from donor to recipient?
- Certificate of Analysis (Correct answer)
- Chain of Custody form
- Bill of Lading
- Packing Slip
Correct 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.
Question 4: A frozen musculoskeletal allograft is found at -15°C during a routine temperature log review. The MOST appropriate action is to:
- Re-freeze immediately and continue distribution
- Quarantine and evaluate per SOPs before any release decision (Correct answer)
- Discard immediately without evaluation
- Distribute immediately to avoid further temperature deviation
Correct 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.
Question 5: Under 21 CFR Part 1271, tissue establishments must maintain distribution records for a minimum of:
- 5 years
- 10 years
- 3 years beyond the expiration date or 10 years from distribution (Correct answer)
- 20 years
Correct 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.
Question 6: What is the primary purpose of a consignment inventory agreement between a tissue bank and a hospital?
- To transfer ownership of tissue upon receipt by the hospital
- To allow tissue to remain bank property until used or returned (Correct answer)
- To eliminate the need for traceability documentation
- To bypass FDA registration requirements
Correct 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.
Question 7: Which condition would MOST likely require immediate notification to consignees and potential field safety corrective action?
- Minor labeling font size deviation
- Discovery that a distributed tissue donor had a reactive HCV NAT result post-release (Correct answer)
- A single shipment arriving 2 hours later than scheduled
- Packaging color change without functional impact
Correct 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.
CTBS Storage and Distribution 2
What is the maximum acceptable temperature for storing cryopreserved tissue in liquid nitrogen vapor phase?