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
A tissue bank receives bone allografts from a foreign supplier. Which regulation governs the importation of these tissues into the United States?
Answer: 21 CFR Part 1271 applies, and the foreign supplier must meet all applicable HCT/P requirements
Imported HCT/Ps are subject to the same 21 CFR Part 1271 requirements as domestically sourced tissue, and the importing establishment is responsible for ensuring compliance.
What is the significance of a 'Warning Letter' issued by the FDA to a tissue establishment?
Answer: It communicates significant violations and requires a written response with corrective actions
An FDA Warning Letter informs the establishment of significant regulatory violations and requires a prompt written response detailing corrective and preventive actions.
Under 21 CFR Part 1271, which of the following triggers a mandatory recall of distributed tissue?
Answer: Discovery that distributed tissue was from a donor later determined to be ineligible
If tissue is distributed and the donor is subsequently determined to be ineligible, the establishment must notify consignees and FDA, typically triggering a recall under 21 CFR 1271.320.
Which AATB Standards requirement addresses the handling of infectious disease test results that fall outside acceptable limits?
Answer: The tissue must be quarantined and assessed by the Medical Director before any release decision
AATB Standards require that reactive infectious disease test results trigger quarantine of associated tissue and a Medical Director review before any eligibility or disposition decision.
What is the regulatory definition of a 'Serious Adverse Reaction' (SAR) in the context of HCT/P regulations?
Answer: A noxious and unintended response for which there is a reasonable possibility that the HCT/P caused or contributed to the reaction, resulting in death or life-threatening condition
Under 21 CFR 1271.3(bb), a serious adverse reaction involves death or a life-threatening condition for which there is a reasonable possibility that the HCT/P caused or contributed.
Which quality system element requires a tissue bank to identify and control products or processes that do not conform to specifications?
Answer: Nonconformance (NC) control procedures
GTP and AATB Standards both require established nonconformance control procedures to identify, document, quarantine, and dispositon out-of-specification tissue or process deviations.
Under 21 CFR 1271.200, what is required for the quarantine of tissue pending donor eligibility determination?
Answer: Tissue must be labeled to indicate its quarantine status and stored separately or in a manner that prevents distribution
21 CFR 1271.200 requires that tissue held pending eligibility determination be clearly labeled as quarantined and physically separated or controlled to prevent inadvertent distribution.