Practice Test Geeks(CTBS) Certified Tissue Bank Specialist Practice Test
← All CTBS Flashcard Decks

Regulatory Standards Flashcards

7 cards from real CTBS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Regulatory Standards flashcards as text

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

    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.

  2. Which of the following is a required element of labeling for a tissue allograft under 21 CFR 1271.370?

    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.

  3. What action is required when a tissue establishment discovers a processing deviation that may affect tissue safety?

    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.

  4. The AATB Standards require that a tissue bank's Medical Director hold which qualification?

    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.

  5. Which of the following best describes 'minimal manipulation' as defined in 21 CFR Part 1271?

    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.

  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?

    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.

  7. Under AATB Standards, what is the minimum frequency for internal audits of a tissue bank's quality system?

    Answer: Annually

    AATB Standards require that tissue banks conduct internal audits of their quality systems at least annually to verify ongoing compliance.