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
Under AATB Standards, what is required when a tissue bank transfers processing responsibilities for a specific tissue type to another accredited establishment?
Answer: A written agreement defining quality responsibilities and standards
AATB Standards require a written quality agreement between establishments that defines responsibilities, standards, and oversight when processing is transferred.
Which trending analysis would BEST identify if a specific technician's processing consistently produces lower sterility pass rates?
Answer: Personnel-stratified quality data review
Stratifying sterility data by processing technician reveals personnel-specific patterns that may indicate training gaps or technique issues.
A tissue bank's freezer alarm activates at -10°C during a power outage. The validated storage temperature for bone is -40°C or below. What must occur?
Answer: Quarantine the tissue and conduct a formal temperature excursion investigation
A temperature excursion outside validated storage conditions requires quarantine of affected tissue and a formal investigation to determine impact on safety and quality.
Which accreditation body specifically accredits tissue banks in the United States and publishes the Standards for Tissue Banking?
Answer: American Association of Tissue Banks (AATB)
The American Association of Tissue Banks (AATB) is the primary accrediting body for tissue banks and publishes the Standards for Tissue Banking used industry-wide.
When performing a supplier audit for a critical reagent vendor, which finding would be MOST significant from a risk perspective?
Answer: Vendor has no formal CAPA system for product complaints
The absence of a formal CAPA system means the vendor cannot systematically identify and correct product quality problems, posing direct risk to tissue safety.
In tissue banking, 'process capability' is best described as:
Answer: The ability of a process to consistently produce output within specified limits
Process capability measures how consistently a process produces results within defined specification limits, often expressed as Cpk or Cp indices.
What is the significance of the 21 CFR Part 1271.320 requirement for tissue establishments to investigate and report adverse reactions?
Answer: It requires establishments to investigate and report serious adverse reactions associated with HCT/Ps to FDA
21 CFR Part 1271.320 requires tissue establishments to investigate adverse reactions and report those that are serious and associated with HCT/Ps to the FDA.