CTBS Tissue Banking Regulations & Standards 3 — Questions and Answers
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:
- Removed from one patient and implanted into a different patient in the same OR
- Removed from and implanted into the same individual during the same surgical procedure (Correct answer)
- Processed in-house and used within 24 hours
- Donated by a living donor and used on the same day
Correct answer: Removed from and implanted into the same individual during the same surgical procedure
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?
- Section B — Procurement
- Section C — Testing
- Section D — Donor Evaluation (Correct answer)
- Section A — Quality Systems
Correct answer: Section D — Donor Evaluation
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:
- Logged and reviewed only if the tissue was implanted
- Evaluated to determine if it constitutes a reportable event to FDA (Correct answer)
- Discarded if no adverse patient outcome occurred
- Forwarded only to the transplanting surgeon
Correct answer: Evaluated to determine if it constitutes a reportable event to FDA
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?
- 5 years
- 10 years
- At least 10 years after distribution, transplantation, or disposal (Correct answer)
- Indefinitely
Correct answer: At least 10 years after distribution, transplantation, or disposal
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?
- Using tissue from a genetically identical twin
- Performing the same basic function in the recipient as in the donor (Correct answer)
- Processing tissue using only mechanical means
- Using tissue within the same anatomical location in recipient and donor
Correct answer: Performing the same basic function in the recipient as in the donor
Homologous use means the HCT/P performs the same basic function or functions in the recipient as it performed in the donor.
Question 6: AATB Standards require that a medical director of a tissue bank must be:
- A PhD with laboratory management experience
- A licensed physician responsible for medical and technical policies (Correct answer)
- An RN with at least 5 years of tissue banking experience
- A certified tissue bank specialist (CTBS) with administrative duties
Correct answer: A licensed physician responsible for medical and technical policies
AATB Standards specify that the medical director must be a licensed physician who is responsible for the medical and technical policies of the tissue bank.
Question 7: An FDA inspection of a tissue bank focuses on compliance with 21 CFR Part 1271. Which type of inspection specifically evaluates donor eligibility and infectious disease testing processes?
- Premarket Approval Inspection
- Compliance Program 7341.002 Inspection (Correct answer)
- Quality System Inspection Technique (QSIT)
- Pre-Approval Inspection (PAI)
Correct answer: Compliance Program 7341.002 Inspection
FDA's Compliance Program 7341.002 governs inspections of HCT/P establishments and covers donor eligibility determination, infectious disease testing, and current good tissue practice.
CTBS Tissue Banking Regulations & Standards 3
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: