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
A tissue bank discovers a mislabeled product after it has been shipped but before implantation. The MOST critical immediate action is to:
Answer: Initiate a recall and notify all consignees who received the product
Mislabeled tissue distributed to multiple sites requires a formal recall with notification to all consignees to prevent implantation of incorrectly labeled tissue.
What is the purpose of a 'dry shipper' (liquid nitrogen dry shipper) in tissue distribution?
Answer: To transport cryopreserved tissue without free liquid nitrogen in a safe, compliant manner
Dry shippers use nitrogen-saturated adsorbent material to maintain cryogenic temperatures without free liquid, making them compliant for air transport.
Which federal regulation governs the establishment registration and listing requirements for human tissue establishments?
Answer: 21 CFR Part 1271
21 CFR Part 1271 is the FDA regulation that governs human cells, tissues, and cellular and tissue-based products (HCT/Ps), including registration and listing.
A tissue bank is validating a new freezer for bone allograft storage at -40°C. What is the MINIMUM requirement for the validation process?
Answer: Map temperature distribution under loaded conditions and verify alarm function
Freezer validation requires temperature mapping under representative loaded conditions and functional alarm testing to confirm the unit maintains required temperatures throughout.
When is a tissue bank REQUIRED to submit a Biological Product Deviation Report (BPDR) to the FDA?
Answer: When a deviation may have caused or contributed to a serious adverse reaction in a recipient
BPDRs are required when a distributed HCT/P has a deviation that may have caused or contributed to a serious adverse reaction in a recipient.
For freeze-dried (lyophilized) bone allograft, what storage condition is typically required to maintain product integrity?
Answer: Room temperature (15–25°C) in sealed, moisture-proof packaging
Lyophilized bone allograft has moisture removed and can be stored at controlled room temperature in moisture-proof packaging, making it convenient for operating room storage.
A consignee reports that a tissue shipment arrived with a broken cold pack but acceptable temperature log readings. The bank's BEST response is to:
Answer: Document the complaint, investigate packaging performance, and evaluate whether tissue can be released
A packaging failure must be documented and investigated even if logger data is acceptable, as the investigation informs corrective action and risk assessment.