CTBS Tissue Banking Regulations & Standards 2 — Questions and Answers
Question 1: Under FDA 21 CFR Part 1271, which of the following is classified as a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P)?
- Whole blood collected for transfusion
- Corneal tissue for transplantation (Correct answer)
- Solid vascularized organs such as kidneys
- Secreted products like insulin
Correct answer: Corneal tissue for transplantation
Corneal tissue is an HCT/P regulated under 21 CFR Part 1271, whereas whole blood, vascularized organs, and secreted products fall under different regulatory frameworks.
Question 2: What is the primary purpose of the AATB Standards for Tissue Banking?
- To replace FDA regulations entirely
- To establish voluntary accreditation benchmarks that exceed federal minimums (Correct answer)
- To set reimbursement rates for tissue allografts
- To govern international tissue export requirements
Correct answer: To establish voluntary accreditation benchmarks that exceed federal minimums
AATB Standards serve as voluntary accreditation criteria that typically exceed FDA regulatory minimums to promote best practices in tissue banking.
Question 3: Which FDA regulation specifically addresses the registration and listing requirements for tissue establishments?
- 21 CFR Part 820
- 21 CFR Part 211
- 21 CFR Part 1271 Subpart B (Correct answer)
- 21 CFR Part 606
Correct answer: 21 CFR Part 1271 Subpart B
21 CFR Part 1271 Subpart B covers registration and listing requirements for HCT/P establishments with the FDA.
Question 4: A tissue bank discovers a potential infectious disease transmission from an allograft. Under FDA regulations, this must be reported as a:
- MedWatch Safety Report
- Biological Product Deviation Report (BPDR) (Correct answer)
- Adverse Event Report (AER)
- Quality System Deviation Notice
Correct answer: Biological Product Deviation Report (BPDR)
Biological Product Deviation Reports (BPDRs) are required under 21 CFR 1271.350 when an HCT/P may have caused or contributed to serious adverse reactions.
Question 5: The AATB accreditation cycle for tissue banks requires re-inspection every:
- 1 year
- 2 years
- 3 years (Correct answer)
- 5 years
Correct answer: 3 years
AATB requires accredited tissue banks to undergo re-inspection every three years to maintain their accreditation status.
Question 6: Which of the following activities would trigger the need for a tissue bank to submit a Biologics License Application (BLA) to the FDA?
- Processing minimally manipulated autologous tissue
- Manufacturing more than minimally manipulated allogeneic tissue for homologous use (Correct answer)
- Storing cryopreserved corneas
- Recovering bone from a deceased donor
Correct answer: Manufacturing more than minimally manipulated allogeneic tissue for homologous use
HCT/Ps that are more than minimally manipulated or used for non-homologous purposes are regulated as biologics and require a BLA.
Question 7: Under AATB Standards, which document must accompany each tissue distributed to a transplanting facility?
- Chain of custody log
- Distributor certificate of conformance
- Tissue tracking form with required labeling information (Correct answer)
- Donor next-of-kin authorization
Correct answer: Tissue tracking form with required labeling information
AATB Standards require that distributed tissue be accompanied by a tracking form that includes all required labeling information to ensure traceability.
CTBS Tissue Banking Regulations & Standards 2
Under FDA 21 CFR Part 1271, which of the following is classified as a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P)?