Tissue Banking Regulations & 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 Tissue Banking Regulations & Standards flashcards as text
Under AATB Standards, the 'suitable' donor eligibility determination for a deceased musculoskeletal donor must be made by:
Answer: A licensed physician or medical director based on review of all required records
AATB Standards require that donor suitability determination be made by a licensed physician, typically the medical director, after reviewing all required donor records.
A tissue bank's SOP for cleaning and disinfecting processing rooms must be validated to demonstrate:
Answer: That the procedures effectively reduce bioburden to acceptable levels
Cleaning and disinfection SOPs must be validated to confirm that they reduce microbial contamination to levels that protect tissue sterility.
Which of the following is an example of a 'more than minimally manipulated' tissue under FDA's 21 CFR Part 1271 framework?
Answer: Demineralized bone matrix (DBM) formulated with a carrier substance that alters original characteristics
Adding a carrier substance to DBM that alters its original relevant characteristics constitutes more than minimal manipulation, potentially requiring a BLA.
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?
Answer: Storage and Transportation
Temperature excursion documentation is a core component of the Storage and Transportation standards, which require defined responses and records for cold chain deviations.
FDA's 'tissue establishment registration' under 21 CFR 1271.21 must be completed:
Answer: Before performing any manufacturing step with HCT/Ps, with updates within 30 days of changes
Establishments must register with FDA before performing any manufacturing step and must update registration within 30 days of any changes to required information.
Which scenario would most likely require a tissue bank to submit a Biological Product Deviation Report (BPDR) to the FDA?
Answer: A released allograft later found to have failed sterility testing after implantation
A sterility failure discovered after implantation represents a distributed HCT/P that may have caused serious injury, which must be reported as a BPDR under 21 CFR 1271.350.
Under AATB Standards, a tissue bank's corrective action process (CAPA) must include which key element to be considered complete?
Answer: Verification that the corrective action was effective in preventing recurrence
An effective CAPA must include verification steps that confirm the corrective action resolved the root cause and prevented recurrence of the deviation.