CTBS Documentation 5

Question 1

Which document provides written evidence that a tissue bank employee has read, understood, and is competent to perform a specific SOP?

Accepted Answer

Personnel training and competency record

Answer

Training and competency records link specific SOPs to individual employees, documenting that training was completed and competency was verified.

Question 2

A tissue bank's SOP for donor screening is updated. According to documentation best practices, what must happen before staff begin using the new SOP?

Accepted Answer

The new SOP must be approved, effective-dated, distributed, and staff must be trained and documented as competent before use

Answer

New or revised SOPs must go through approval, be assigned an effective date, and staff must receive documented training before implementation.

Question 3

What is the primary purpose of maintaining a tissue distribution log at a tissue bank?

Accepted Answer

To provide a complete record of which allografts were sent to which facilities and when, enabling rapid traceability if a recall is needed

Answer

Distribution logs enable rapid traceability of each allograft to a specific recipient facility, which is critical during recall or adverse event investigations.

Question 4

Under AATB standards, informed consent documentation for tissue donation must include evidence that:

Accepted Answer

Consent was obtained from the legally authorized person and the scope of donation was clearly explained

Answer

Informed consent records must show that an authorized person gave consent and that the nature, scope, and purpose of donation were explained.

Question 5

Which of the following represents a critical content requirement for a tissue bank's environmental monitoring log?

Accepted Answer

Date, location, parameter measured (e.g., temperature or air quality), result, and identity of staff performing monitoring

Answer

Environmental monitoring logs must capture the date, location, measured parameter, result, and responsible staff to demonstrate controlled conditions were maintained.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Documentation 5