CTBS Regulatory Standards 5 — Questions and Answers
Question 1: A tissue bank receives bone allografts from a foreign supplier. Which regulation governs the importation of these tissues into the United States?
- 21 CFR Part 1271 applies, and the foreign supplier must meet all applicable HCT/P requirements (Correct answer)
- Foreign tissue is exempt from FDA oversight if processed under ISO 13485
- The CDC Import Permit Program is the sole governing authority
- Only state health department approval is required for imported tissue
Correct 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.
Question 2: What is the significance of a 'Warning Letter' issued by the FDA to a tissue establishment?
- It is informal guidance with no regulatory consequences
- It communicates significant violations and requires a written response with corrective actions (Correct answer)
- It automatically suspends the tissue bank's distribution license
- It is the first step toward criminal prosecution
Correct 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.
Question 3: Under 21 CFR Part 1271, which of the following triggers a mandatory recall of distributed tissue?
- A routine processing deviation with no impact on tissue quality
- Discovery that distributed tissue was from a donor later determined to be ineligible (Correct answer)
- A minor labeling omission corrected before shipment
- Expiration of the tissue's storage period
Correct 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.
Question 4: Which AATB Standards requirement addresses the handling of infectious disease test results that fall outside acceptable limits?
- Only results flagged by the testing laboratory need documentation
- The tissue must be quarantined and assessed by the Medical Director before any release decision (Correct answer)
- The tissue can be released if a second test on a different sample is negative
- No action is required if the donor's physical examination was normal
Correct 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.
Question 5: What is the regulatory definition of a 'Serious Adverse Reaction' (SAR) in the context of HCT/P regulations?
- Any patient complaint received within 30 days of transplantation
- 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 (Correct answer)
- Any unexpected transplant outcome that requires hospitalization
- A reaction rated as Grade 2 or higher on a standardized toxicity scale
Correct 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.
Question 6: Which quality system element requires a tissue bank to identify and control products or processes that do not conform to specifications?
- Nonconformance (NC) control procedures (Correct answer)
- Preventive maintenance schedules
- Personnel training records
- Supplier qualification files
Correct 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.
Question 7: Under 21 CFR 1271.200, what is required for the quarantine of tissue pending donor eligibility determination?
- Tissue must be labeled to indicate its quarantine status and stored separately or in a manner that prevents distribution (Correct answer)
- Tissue may be processed but not labeled until eligibility is confirmed
- Quarantine is only required for tissue from high-risk donors
- Tissue must be frozen immediately upon receipt from the procurement team
Correct 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.
CTBS Regulatory Standards 5
A tissue bank receives bone allografts from a foreign supplier.
Which regulation governs the importation of these tissues into the United States?