CTBS Quality Assurance 3 — Questions and Answers
Question 1: Under AATB standards, how often must a tissue bank's quality system be audited internally at a minimum?
- Every 5 years
- Every 3 years
- Annually (Correct answer)
- Every 6 months
Correct answer: Annually
AATB standards require that tissue banks conduct internal quality audits at least annually to assess compliance with standards and procedures.
Question 2: What action should be taken when a temperature excursion is detected in a tissue storage freezer?
- Discard all tissue immediately without further evaluation
- Document the event, quarantine affected tissue, and initiate an investigation (Correct answer)
- Notify the FDA before taking any other action
- Transfer all tissue to another freezer without documentation
Correct answer: Document the event, quarantine affected tissue, and initiate an investigation
A temperature excursion requires immediate documentation, quarantine of affected tissue, and a formal investigation to assess impact on tissue quality before disposition.
Question 3: In the context of tissue bank QA, what does 'validation' of a process mean?
- Confirming that a process is the least expensive option
- Establishing documented evidence that a process consistently produces a result meeting its specifications (Correct answer)
- Verifying that a process has received FDA clearance
- Ensuring a process complies with ISO 9001 standards
Correct answer: Establishing documented evidence that a process consistently produces a result meeting its specifications
Validation provides documented evidence that a process, when operated within established parameters, consistently produces a product meeting its predetermined specifications.
Question 4: Which of the following is a key element of an effective CAPA (Corrective and Preventive Action) system?
- Immediate dismissal of employees involved in the nonconformance
- Root cause analysis followed by implementation and effectiveness verification (Correct answer)
- Mandatory reporting to accreditation bodies for all CAPAs
- Assignment of CAPAs exclusively to senior management
Correct answer: Root cause analysis followed by implementation and effectiveness verification
An effective CAPA includes identifying the root cause, implementing corrective actions, and then verifying that those actions were effective in preventing recurrence.
Question 5: A tissue bank receives a complaint that a transplanted allograft caused an adverse reaction in a recipient. What is the FIRST step in handling this complaint?
- Immediately recall all tissue from the same donor
- Document the complaint and initiate an investigation (Correct answer)
- Issue a press release to inform the public
- Destroy all records related to the tissue
Correct answer: Document the complaint and initiate an investigation
The first step in complaint handling is to document the complaint fully and initiate a formal investigation to determine the nature and cause of the adverse reaction.
Question 6: What is the role of the Quality Assurance Director in a tissue bank?
- To perform all tissue processing steps personally
- To oversee the quality management system and ensure regulatory compliance (Correct answer)
- To negotiate contracts with hospitals and transplant centers
- To manage payroll and human resources functions
Correct answer: To oversee the quality management system and ensure regulatory compliance
The QA Director is responsible for overseeing the entire quality management system, ensuring that operations comply with regulations, accreditation standards, and internal policies.
Question 7: What is the significance of maintaining a 'chain of custody' for donor tissue?
- It ensures tissue is sold to the highest bidder
- It provides a traceable record of tissue handling from donor to recipient (Correct answer)
- It tracks employee work hours associated with each tissue
- It is required only for pediatric donors
Correct answer: It provides a traceable record of tissue handling from donor to recipient
Chain of custody documentation ensures full traceability of tissue from donor recovery through processing, storage, distribution, and ultimately transplantation.
CTBS Quality Assurance 3
Under AATB standards, how often must a tissue bank's quality system be audited internally at a minimum?