CERTIFIED TISSUE BANK
SPECIALIST CTBS
PRACTICE TEST
COMPLETE
Question 1: A tissue establishment discovers that a released graft was distributed with an incorrect expiration date. What is the most appropriate �rst quality-system action?
Choices:
1) Initiate a documented investigation and assess potential product impact 2) Delete the original distribution record 3) Wait for the end user to report a problem 4) Relabel all remaining inventory without documenting the event Correct Answer: Initiate a documented investigation and assess potential product impact Explanation: A labeling discrepancy on distributed tissue requires a documented quality investigation to determine scope, root cause, product impact, and whether noti�cation, correction, or recall is needed.Page 1
Question 2: Which element best demonstrates that an employee is quali�ed to perform a critical tissue-processing step independently?
Choices:
1) The employee has read the procedure once 2) Training and competency have been documented for the assigned function 3) The employee has worked in health care before 4) A supervisor is available somewhere in the facility Correct Answer: Training and competency have been documented for the assigned function Explanation: Critical functions should be performed by trained, quali�ed personnel, and the establishment should maintain documented evidence of training and competency.Question 3: What is the primary purpose of change control in a tissue bank quality program?
Choices:
1) To prevent any procedure from ever being revised 2) To replace corrective action investigations 3) To evaluate and document the impact of planned changes before implementation 4) To eliminate the need for sta� retraining
Correct Answer: To evaluate and document the impact of planned changes before
implementation Explanation: Change control provides a structured way to assess proposed changes, identify risks, obtain approvals, update documents, validate as needed, and train a�ected sta� before implementation.Page 2
Question 4: An internal audit repeatedly �nds incomplete temperature-review records. Which action best addresses the problem?
Choices:
1) Correct only the most recent record 2) Stop performing internal audits 3) Accept the �nding because temperatures remained in range 4) Perform root-cause analysis and implement corrective and preventive actions Correct Answer: Perform root-cause analysis and implement corrective and preventive actions Explanation: Repeated documentation failures indicate a systemic issue. Root-cause analysis and appropriate CAPA are needed to prevent recurrence, even if no temperature excursion occurred.
Question 5: Which document should provide the approved instructions for
performing a standardized tissue-bank activity?
Choices:
1) A controlled standard operating procedure 2) An informal sta� email 3) A vendor brochure 4) An unsigned training note
Correct Answer: A controlled standard operating procedure
Explanation: A controlled SOP provides approved, current, traceable instructions for routine operations and is maintained under document-control procedures.Page 3