CTBS Quality Assurance 3

Question 1

Under AATB standards, how often must a tissue bank's quality system be audited internally at a minimum?

Accepted Answer

Annually

Answer

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?

Accepted Answer

Document the event, quarantine affected tissue, and initiate an investigation

Answer

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?

Accepted Answer

Establishing documented evidence that a process consistently produces a result meeting its specifications

Answer

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?

Accepted Answer

Root cause analysis followed by implementation and effectiveness verification

Answer

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?

Accepted Answer

Document the complaint and initiate an investigation

Answer

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.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Quality Assurance 3