CTBS Storage and Distribution 5 — Questions and Answers
Question 1: Which AATB accreditation standard addresses the requirement for tissue banks to have a written policy for managing expired tissue?
- Donor screening standards
- Inventory management and disposition standards (Correct answer)
- Serological testing standards
- Surgical technique standards
Correct answer: Inventory management and disposition standards
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?
- Donor's full name and date of birth
- Establishment name, unique identifier, description, and expiration date (Correct answer)
- Recipient's name and surgical date
- Insurance billing code and lot price
Correct answer: Establishment name, unique identifier, description, and expiration date
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?
- 7 days
- 14 days
- 28 days (Correct answer)
- 60 days
Correct answer: 28 days
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:
- Assume it was implanted and close the record
- Initiate a physical search and document the discrepancy per SOP (Correct answer)
- Write off the unit as lost without documentation
- Contact FDA immediately before investigating internally
Correct answer: Initiate a physical search and document the discrepancy per SOP
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?
- Verbal agreement with the hospital's purchasing department
- A written agreement addressing responsibilities, traceability, and adverse event reporting (Correct answer)
- Completion of a single training session for hospital staff
- A 90-day trial period without formal documentation
Correct answer: A written agreement addressing responsibilities, traceability, and adverse event reporting
AATB standards require a written agreement with each consignee that defines responsibilities including traceability, storage requirements, and adverse event reporting.
Question 6: When transporting fresh vascular allografts, which shipping method best maintains required 1–10°C temperatures during a 48-hour transit?
- Ambient room temperature packaging
- Insulated container with validated wet ice or refrigerant packs (Correct answer)
- Dry ice packaging
- Liquid nitrogen dry shipper
Correct answer: Insulated container with validated wet ice or refrigerant packs
Validated insulated containers with wet ice or refrigerant packs maintain 1–10°C for fresh vascular tissue during transit without risk of freezing damage from dry ice.
Question 7: Which of the following BEST describes the role of a tissue bank's Medical Director in the distribution process?
- Personally shipping every allograft to hospitals
- Providing oversight of release criteria and final disposition authority for unusual cases (Correct answer)
- Conducting all incoming inspections of raw materials
- Negotiating pricing contracts with consignees
Correct answer: Providing oversight of release criteria and final disposition authority for unusual cases
The Medical Director provides clinical and scientific oversight including final disposition authority for non-conforming or unusual cases and approval of release criteria.
CTBS Storage and Distribution 5
Which AATB accreditation standard addresses the requirement for tissue banks to have a written policy for managing expired tissue?