CTBS Storage and Distribution 5

Question 1

Which AATB accreditation standard addresses the requirement for tissue banks to have a written policy for managing expired tissue?

Accepted Answer

Inventory management and disposition standards

Answer

AATB standards for inventory management require written policies for identifying, segregating, and disposing of expired tissue to prevent inadvertent distribution.

Question 2

What information is REQUIRED on the label of a distributed allograft per FDA 21 CFR Part 1271?

Accepted Answer

Establishment name, unique identifier, description, and expiration date

Answer

FDA requires labels to include the establishment name, unique identifier, description of the HCT/P, and expiration date to ensure traceability and proper use.

Question 3

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?

Accepted Answer

28 days

Answer

Osteochondral allografts are typically stored at 4°C in culture media and have a maximum storage time of 28 days to maintain chondrocyte viability.

Question 4

During inventory reconciliation, a technician discovers one unit is unaccounted for. The FIRST action should be to:

Accepted Answer

Initiate a physical search and document the discrepancy per SOP

Answer

Inventory discrepancies require a documented physical search and investigation per SOP before any conclusion or regulatory notification is made.

Question 5

A tissue bank wants to begin distributing tissue to a new hospital. Under AATB standards, what must be established BEFORE the first shipment?

Accepted Answer

A written agreement addressing responsibilities, traceability, and adverse event reporting

Answer

AATB standards require a written agreement with each consignee that defines responsibilities including traceability, storage requirements, and adverse event reporting.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Storage and Distribution 5