Quality Assurance 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 Assurance flashcards as text
Under AATB standards, how often must a tissue bank's quality system be audited internally at a minimum?
Answer: Annually
AATB standards require that tissue banks conduct internal quality audits at least annually to assess compliance with standards and procedures.
What action should be taken when a temperature excursion is detected in a tissue storage freezer?
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.
In the context of tissue bank QA, what does 'validation' of a process mean?
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.
Which of the following is a key element of an effective CAPA (Corrective and Preventive Action) system?
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.
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?
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.
What is the role of the Quality Assurance Director in a tissue bank?
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.
What is the significance of maintaining a 'chain of custody' for donor tissue?
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.