CTBS Quality Control & Risk Management in Tissue Banking 5 — Questions and Answers
Question 1: Under AATB Standards, what is required when a tissue bank transfers processing responsibilities for a specific tissue type to another accredited establishment?
- Informal verbal agreement between directors
- A written agreement defining quality responsibilities and standards (Correct answer)
- FDA pre-approval for the transfer
- Reaccreditation of both establishments
Correct 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.
Question 2: Which trending analysis would BEST identify if a specific technician's processing consistently produces lower sterility pass rates?
- Lot-to-lot trend analysis
- Personnel-stratified quality data review (Correct answer)
- Supplier qualification trending
- Environmental monitoring trend report
Correct answer: Personnel-stratified quality data review
Stratifying sterility data by processing technician reveals personnel-specific patterns that may indicate training gaps or technique issues.
Question 3: 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?
- Move tissue to another freezer and resume normal operations
- Quarantine the tissue and conduct a formal temperature excursion investigation (Correct answer)
- Discard all tissue immediately
- Document the event and continue distribution if tissue appears intact
Correct 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.
Question 4: Which accreditation body specifically accredits tissue banks in the United States and publishes the Standards for Tissue Banking?
- College of American Pathologists (CAP)
- American Association of Tissue Banks (AATB) (Correct answer)
- Joint Commission (TJC)
- CLIA (Clinical Laboratory Improvement Amendments)
Correct 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.
Question 5: When performing a supplier audit for a critical reagent vendor, which finding would be MOST significant from a risk perspective?
- Vendor uses paper-based rather than electronic records
- Vendor has no formal CAPA system for product complaints (Correct answer)
- Vendor facility is located internationally
- Vendor packages reagents in glass rather than plastic containers
Correct 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.
Question 6: In tissue banking, 'process capability' is best described as:
- The number of tissue units a facility can process per day
- The ability of a process to consistently produce output within specified limits (Correct answer)
- Staff capacity to handle emergency tissue requests
- Equipment throughput measured in units per hour
Correct 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.
Question 7: What is the significance of the 21 CFR Part 1271.320 requirement for tissue establishments to investigate and report adverse reactions?
- It mandates immediate shutdown of processing for any adverse event
- It requires establishments to investigate and report serious adverse reactions associated with HCT/Ps to FDA (Correct answer)
- It applies only to bone marrow transplant centers
- It requires publication of adverse event data in peer-reviewed journals
Correct 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.
CTBS Quality Control & Risk Management in Tissue Banking 5
Under AATB Standards, what is required when a tissue bank transfers processing responsibilities for a specific tissue type to another accredited establishment?