CTBS Tissue Banking Regulations & Standards 5

Question 1

Under AATB Standards, the 'suitable' donor eligibility determination for a deceased musculoskeletal donor must be made by:

Accepted Answer

A licensed physician or medical director based on review of all required records

Answer

AATB Standards require that donor suitability determination be made by a licensed physician, typically the medical director, after reviewing all required donor records.

Question 2

A tissue bank's SOP for cleaning and disinfecting processing rooms must be validated to demonstrate:

Accepted Answer

That the procedures effectively reduce bioburden to acceptable levels

Answer

Cleaning and disinfection SOPs must be validated to confirm that they reduce microbial contamination to levels that protect tissue sterility.

Question 3

Which of the following is an example of a 'more than minimally manipulated' tissue under FDA's 21 CFR Part 1271 framework?

Accepted Answer

Demineralized bone matrix (DBM) formulated with a carrier substance that alters original characteristics

Answer

Adding a carrier substance to DBM that alters its original relevant characteristics constitutes more than minimal manipulation, potentially requiring a BLA.

Question 4

A tissue bank is audited by AATB and cited for lack of documented temperature excursion responses in its cold chain records. This finding most directly relates to which AATB Standard area?

Accepted Answer

Storage and Transportation

Answer

Temperature excursion documentation is a core component of the Storage and Transportation standards, which require defined responses and records for cold chain deviations.

Question 5

FDA's 'tissue establishment registration' under 21 CFR 1271.21 must be completed:

Accepted Answer

Before performing any manufacturing step with HCT/Ps, with updates within 30 days of changes

Answer

Establishments must register with FDA before performing any manufacturing step and must update registration within 30 days of any changes to required information.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Tissue Banking Regulations & Standards 5