CTBS Tissue Banking Regulations & Standards 4 — Questions and Answers
Question 1: Under current good tissue practice (cGTP), environmental monitoring of processing areas must be performed:
- Only during initial facility validation
- On a schedule defined by the tissue bank's own SOPs based on risk assessment (Correct answer)
- Monthly regardless of the tissues processed
- Only when a contamination event is suspected
Correct answer: On a schedule defined by the tissue bank's own SOPs based on risk assessment
cGTP requires environmental monitoring to be conducted on a schedule determined by the facility's SOPs, reflecting a risk-based approach to contamination control.
Question 2: Which federal agency shares regulatory oversight of certain HCT/Ps used in reproductive medicine (e.g., semen, oocytes)?
- Centers for Medicare & Medicaid Services (CMS)
- Centers for Disease Control and Prevention (CDC)
- FDA under 21 CFR Part 1271 with additional CDC reporting requirements (Correct answer)
- National Institutes of Health (NIH)
Correct answer: FDA under 21 CFR Part 1271 with additional CDC reporting requirements
Reproductive tissues like semen and oocytes are regulated by FDA under 21 CFR Part 1271, and clinics performing ART procedures must also report outcomes to CDC.
Question 3: A tissue bank wants to process an HCT/P using a novel decellularization method not previously used at the facility. Under FDA regulations, this change most likely requires:
- No action if the tissue type is already registered
- An assessment of whether the change constitutes more than minimal manipulation (Correct answer)
- Immediate BLA submission before any processing begins
- Notification to AATB only, not FDA
Correct answer: An assessment of whether the change constitutes more than minimal manipulation
Novel processing methods must be assessed against the minimal manipulation criteria; if they alter original relevant characteristics, the product may require licensure as a biologic.
Question 4: AATB Standards require that tissue banks establish a Quality Assurance (QA) program that includes which of the following?
- Annual financial audits by a certified accountant
- Internal audits, corrective action processes, and trend analysis of deviations (Correct answer)
- Monthly board of directors review of all SOPs
- Quarterly comparison of tissue pricing with competitor banks
Correct answer: Internal audits, corrective action processes, and trend analysis of deviations
AATB's QA requirements include internal audits, a corrective and preventive action (CAPA) system, and trending of deviations to drive continuous improvement.
Question 5: Under 21 CFR 1271.370, what is the tissue bank's responsibility when it becomes aware that distributed tissue was from an ineligible donor?
- Notify only the FDA within 30 days
- Notify consignees and take steps to retrieve or destroy the affected tissue (Correct answer)
- Quarantine only future lots from the same donor
- Issue a voluntary recall notice to AATB
Correct answer: Notify consignees and take steps to retrieve or destroy the affected tissue
When a bank learns that distributed HCT/Ps came from an ineligible donor, it must notify consignees promptly and work to retrieve or arrange for quarantine and disposal.
Question 6: Which of the following BEST describes the role of a 'designated responsible person' as required under 21 CFR Part 1271?
- A certified CTBS who performs all donor eligibility determinations
- A person who ensures overall compliance with HCT/P regulations and is available around the clock (Correct answer)
- An FDA-appointed compliance officer embedded at the tissue bank
- The medical director who signs all release certificates
Correct answer: A person who ensures overall compliance with HCT/P regulations and is available around the clock
The designated responsible person ensures overall compliance with 21 CFR Part 1271 and must be available 24 hours a day to address compliance issues.
Question 7: An AATB-accredited tissue bank that distributes tissues across state lines is subject to which level of regulatory oversight?
- State health department oversight only
- FDA federal oversight under 21 CFR Part 1271 plus applicable state regulations (Correct answer)
- AATB oversight exclusively as a voluntary accreditation body
- Joint Commission standards for tissue storage
Correct answer: FDA federal oversight under 21 CFR Part 1271 plus applicable state regulations
Interstate distribution of HCT/Ps triggers FDA federal jurisdiction under 21 CFR Part 1271, which operates alongside any applicable state-level tissue banking regulations.
CTBS Tissue Banking Regulations & Standards 4
Under current good tissue practice (cGTP), environmental monitoring of processing areas must be performed: