CTBS Tissue Banking Regulations & Standards 3

Question 1

The FDA's 'same surgical procedure' exception under 21 CFR 1271.15(b) allows a physician to use HCT/Ps without full regulation if the tissue is:

Accepted Answer

Removed from and implanted into the same individual during the same surgical procedure

Answer

The same surgical procedure exception applies only when the HCT/P is removed from and implanted back into the same patient during a single procedure.

Question 2

Which AATB Standard section specifically addresses donor suitability determination?

Accepted Answer

Section D — Donor Evaluation

Answer

AATB Section D covers Donor Evaluation, which includes the criteria and processes for determining donor suitability.

Question 3

A tissue bank receives a complaint that a processed bone allograft contained unexpected particulate matter. Under ISO 13485, this complaint must be:

Accepted Answer

Evaluated to determine if it constitutes a reportable event to FDA

Answer

ISO 13485 and FDA regulations require all complaints to be evaluated to determine whether they represent reportable events, regardless of whether implantation occurred.

Question 4

Under FDA 21 CFR Part 1271.90, what is the required minimum retention period for donor eligibility records?

Accepted Answer

At least 10 years after distribution, transplantation, or disposal

Answer

FDA requires donor eligibility records to be retained for at least 10 years after the date of administration, transplantation, or disposal of the associated HCT/P.

Question 5

Which of the following best describes 'homologous use' as defined in FDA's HCT/P regulations?

Accepted Answer

Performing the same basic function in the recipient as in the donor

Answer

Homologous use means the HCT/P performs the same basic function or functions in the recipient as it performed in the donor.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Tissue Banking Regulations & Standards 3