CTBS Documentation 3

Question 1

What is the significance of a 'chain of custody' document in tissue banking?

Accepted Answer

It tracks possession and handling of tissue from recovery through distribution to ensure accountability

Answer

Chain of custody documentation establishes accountability by recording each transfer of possession and the condition of tissue at each step.

Question 2

Under AATB standards, what must be documented when a tissue bank receives a customer complaint about an allograft?

Accepted Answer

The complaint details, investigation findings, and any corrective actions taken

Answer

AATB requires tissue banks to document the nature of the complaint, the investigation process, findings, and any corrective or preventive actions.

Question 3

Which document type is used to formally approve a change to a tissue bank's standard operating procedure?

Accepted Answer

Change control record

Answer

Change control records document the review, approval, and implementation of changes to SOPs, ensuring changes are authorized before use.

Question 4

A tissue bank must document the identity of personnel who performed each critical processing step primarily to:

Accepted Answer

Enable traceability and accountability if a quality issue arises

Answer

Documenting personnel identity at each critical step allows investigators to trace actions back to specific individuals if a quality or safety problem is identified.

Question 5

What type of document communicates a temporary authorized departure from a standard operating procedure during tissue processing?

Accepted Answer

Approved deviation or variance

Answer

An approved deviation (or variance) formally authorizes and documents a temporary departure from an SOP for a specific situation.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Documentation 3