CTBS Documentation 4

Question 1

What action is required when a tissue bank identifies a distributed allograft that may pose a risk to recipients?

Accepted Answer

Initiate a formal recall and document all notification and retrieval activities

Answer

When a safety concern is identified post-distribution, a formal recall must be initiated and all notification, retrieval, and disposition activities must be documented.

Question 2

What is the role of a Master Processing Record (MPR) in tissue banking documentation?

Accepted Answer

It provides the approved template of all steps, materials, and controls for processing a specific tissue type

Answer

The MPR is the approved master template that defines all required steps, materials, equipment, and acceptance criteria for processing a specific tissue type.

Question 3

A Batch Processing Record (BPR) differs from a Master Processing Record primarily because the BPR:

Accepted Answer

Documents the actual performance of each step for a specific tissue lot, including real-time data and technician initials

Answer

The BPR is the executed record for a specific tissue lot, capturing real values, observations, and signatures as each step is performed.

Question 4

Which regulatory body must tissue banks notify when they identify a biologic product deviation that may have affected distributed human tissue?

Accepted Answer

Food and Drug Administration (FDA)

Answer

FDA requires tissue establishments to submit a Biological Product Deviation Report (BPDR) when a distributed HCT/P may have been affected by a deviation.

Question 5

What information must be captured in a tissue bank's equipment maintenance and calibration log?

Accepted Answer

Date of service, type of maintenance or calibration performed, results, and identity of who performed the work

Answer

Calibration and maintenance logs must capture the date, nature of the work, results, and the identity of the technician to demonstrate equipment reliability.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Documentation 4