Quality Control & Risk Management in Tissue Banking 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 Quality Control & Risk Management in Tissue Banking flashcards as text
A tissue bank receives a complaint that a bone allograft had an unusual odor upon opening. Under the AATB Standards, what is the FIRST documented step?
Answer: Assign a complaint number and begin investigation
AATB Standards require every complaint to be logged with a unique identifier and investigated, with documentation of all findings and actions.
Which environmental monitoring parameter is most critical to verify in a Class 10,000 (ISO 7) cleanroom used for tissue processing?
Answer: Viable and non-viable particle counts
Both viable (microbial) and non-viable (total particle) counts must be monitored to confirm cleanroom classification and contamination control.
When a tissue bank changes its antibiotic cocktail formulation, which validation activity is MANDATORY before implementing the change?
Answer: Process revalidation demonstrating equivalent or superior microbial reduction
Any change to a critical process component like antibiotic formulation requires revalidation to confirm the new formulation achieves equivalent microbial reduction.
In risk management terminology, what is the difference between 'risk mitigation' and 'risk acceptance'?
Answer: Mitigation reduces probability or impact; acceptance acknowledges residual risk as tolerable
Risk mitigation implements controls to reduce likelihood or severity, while risk acceptance formally acknowledges that remaining residual risk is within acceptable limits.
Which document formally authorizes the release of a tissue lot for distribution after all QC checks are complete?
Answer: Certificate of Analysis
A Certificate of Analysis (CoA) documents the results of all required testing and quality checks and serves as the formal release authorization for a tissue lot.
What is the purpose of a 'lookback' procedure in tissue banking?
Answer: Investigating previously distributed tissue when new donor risk information emerges
A lookback procedure investigates tissue already distributed when new information—such as a subsequent reactive test result—suggests potential donor risk.
An employee reports that a colleague skipped the required 30-minute antibiotic soak step to meet a production deadline. This should be handled FIRST as:
Answer: A nonconformance requiring quarantine of affected tissue and CAPA
Skipping a validated critical processing step is a nonconformance requiring formal documentation, quarantine of affected tissue, investigation, and corrective action.