CTBS Regulatory Standards 3

Question 1

Under 21 CFR Part 1271, what is the required retention period for records related to a specific donor?

Accepted Answer

5 years from the date of distribution or 10 years after the donor's date of birth, whichever is later

Answer

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?

Accepted Answer

Donor identification number or alphanumeric code

Answer

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?

Accepted Answer

Quarantine the affected tissue and conduct an investigation

Answer

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?

Accepted Answer

A license to practice medicine in the state of operation

Answer

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?

Accepted Answer

Processing that does not alter the original relevant characteristics of the tissue

Answer

Minimal manipulation means processing that does not alter the original relevant characteristics of the tissue relating to its utility for reconstruction, repair, or replacement.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Regulatory Standards 3