CTBS Storage and Distribution 2

Question 1

What is the maximum acceptable temperature for storing cryopreserved tissue in liquid nitrogen vapor phase?

Accepted Answer

-130°C

Answer

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:

Accepted Answer

Quarantine remaining inventory from the same lot

Answer

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?

Accepted Answer

Certificate of Analysis

Answer

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:

Accepted Answer

Quarantine and evaluate per SOPs before any release decision

Answer

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:

Accepted Answer

3 years beyond the expiration date or 10 years from distribution

Answer

FDA requires records be retained for 10 years after distribution or 3 years beyond the labeled expiration date, whichever is longer.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Storage and Distribution 2