CTBS Regulatory Standards 5

Question 1

A tissue bank receives bone allografts from a foreign supplier. Which regulation governs the importation of these tissues into the United States?

Accepted Answer

21 CFR Part 1271 applies, and the foreign supplier must meet all applicable HCT/P requirements

Answer

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?

Accepted Answer

It communicates significant violations and requires a written response with corrective actions

Answer

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?

Accepted Answer

Discovery that distributed tissue was from a donor later determined to be ineligible

Answer

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?

Accepted Answer

The tissue must be quarantined and assessed by the Medical Director before any release decision

Answer

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?

Accepted 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

Answer

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.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Regulatory Standards 5