CTBS Regulatory Standards 3 — Questions and Answers
Question 1: Under 21 CFR Part 1271, what is the required retention period for records related to a specific donor?
- 5 years from the date of distribution or 10 years after the donor's date of birth, whichever is later (Correct answer)
- 3 years from the date of processing
- 10 years from the date of distribution
- Until the recipient's death
Correct answer: 5 years from the date of distribution or 10 years after the donor's date of birth, whichever is later
21 CFR 1271.270 requires that donor records be retained for 10 years after the date of distribution or for 10 years after the date of the donor's birth, whichever is later.
Question 2: Which of the following is a required element of labeling for a tissue allograft under 21 CFR 1271.370?
- The name and address of the transplanting surgeon
- Donor identification number or alphanumeric code (Correct answer)
- Recipient's full name and medical record number
- Cost per unit of tissue
Correct answer: Donor identification number or alphanumeric code
FDA regulations require the label to include a distinct identification code (such as a donor ID number) to enable bidirectional traceability.
Question 3: What action is required when a tissue establishment discovers a processing deviation that may affect tissue safety?
- Quarantine the affected tissue and conduct an investigation (Correct answer)
- Immediately distribute the tissue before investigation begins
- Notify the recipient hospital verbally within 24 hours
- Discard all tissue from that processing lot automatically
Correct answer: Quarantine the affected tissue and conduct an investigation
Affected tissue must be quarantined and a thorough investigation conducted before any distribution decision is made, per Good Tissue Practice (GTP) requirements.
Question 4: The AATB Standards require that a tissue bank's Medical Director hold which qualification?
- Any doctoral degree (MD, PhD, or PharmD)
- A license to practice medicine in the state of operation (Correct answer)
- Board certification in pathology only
- Certification as a CTBS
Correct answer: A license to practice medicine in the state of operation
AATB Standards require the Medical Director to be a licensed physician, ensuring medical oversight of donor eligibility and tissue safety decisions.
Question 5: Which of the following best describes 'minimal manipulation' as defined in 21 CFR Part 1271?
- Processing that does not alter the original relevant characteristics of the tissue (Correct answer)
- Removing fewer than 25% of cells from the tissue
- Any processing performed in a cleanroom environment
- Sterilization of tissue using gamma irradiation
Correct answer: Processing that does not alter the original relevant characteristics of the tissue
Minimal manipulation means processing that does not alter the original relevant characteristics of the tissue relating to its utility for reconstruction, repair, or replacement.
Question 6: What must a tissue bank do when it receives a complaint alleging that a tissue allograft caused a serious adverse reaction in a recipient?
- Log the complaint, investigate, and report to FDA if a serious unexpected adverse reaction is suspected (Correct answer)
- Only notify the Medical Director verbally
- Discard all remaining inventory from that donor immediately
- Report the complaint directly to the CDC within 24 hours
Correct answer: Log the complaint, investigate, and report to FDA if a serious unexpected adverse reaction is suspected
Under 21 CFR 1271.350, tissue banks must investigate complaints and report to FDA any serious unexpected adverse reactions that are associated with the use of HCT/Ps.
Question 7: Under AATB Standards, what is the minimum frequency for internal audits of a tissue bank's quality system?
- Every 5 years
- Annually (Correct answer)
- Every 6 months
- Monthly
Correct answer: Annually
AATB Standards require that tissue banks conduct internal audits of their quality systems at least annually to verify ongoing compliance.
CTBS Regulatory Standards 3
Under 21 CFR Part 1271, what is the required retention period for records related to a specific donor?