Cord Blood Banking 2 — Questions and Answers
Question 1: Which federal agency regulates cord blood banks in the United States?
- Centers for Disease Control and Prevention
- Food and Drug Administration (Correct answer)
- National Institutes of Health
- Department of Health and Human Services
Correct answer: Food and Drug Administration
The FDA regulates cord blood banks under 21 CFR Parts 1270 and 1271, treating cord blood as a human cell and tissue product.
Question 2: What is the typical annual storage fee range for private cord blood banking in the US?
- $10–$50 per year
- $100–$300 per year (Correct answer)
- $500–$1,000 per year
- $2,000–$5,000 per year
Correct answer: $100–$300 per year
Most private cord blood banks charge between $100 and $300 per year for ongoing cryogenic storage after an initial processing fee.
Question 3: A cord blood bank that is AABB-accredited must demonstrate compliance with which standard?
- Minimum 1 billion total nucleated cells per unit
- Written policies covering collection through release (Correct answer)
- At least 10 years of storage history
- Transplant success rate above 80%
Correct answer: Written policies covering collection through release
AABB accreditation requires banks to maintain comprehensive written policies and procedures covering all steps from collection through unit release.
Question 4: When a family uses directed donation to a public bank for a specific sibling, who typically pays processing costs?
- The federal government
- The receiving hospital
- The family (Correct answer)
- The cord blood bank
Correct answer: The family
In directed donations to public banks for a specific family member, the family generally assumes the processing and storage costs, unlike standard public donations.
Question 5: What minimum total nucleated cell (TNC) count do most public banks require before banking a unit?
- 50 million TNCs
- 200 million TNCs
- 900 million TNCs (Correct answer)
- 5 billion TNCs
Correct answer: 900 million TNCs
Most public cord blood banks require a minimum of approximately 900 million total nucleated cells to ensure the unit is large enough for transplant use.
Question 6: Which statement best describes a hybrid cord blood banking arrangement?
- The unit is split and stored in two different private banks
- Part of the unit is publicly listed and part is privately reserved for the family (Correct answer)
- The bank stores both cord blood and cord tissue in one contract
- Federal and state governments share storage costs
Correct answer: Part of the unit is publicly listed and part is privately reserved for the family
A hybrid arrangement allows a portion of the cord blood unit to be publicly listed for unrelated transplants while reserving a private portion for the donating family.
Question 7: Under FDA regulations, cord blood intended for allogeneic use by an unrelated recipient must be licensed as a:
- Medical device
- Dietary supplement
- Biological product (Correct answer)
- Controlled substance
Correct answer: Biological product
The FDA requires cord blood for unrelated allogeneic transplant to be licensed as a biological product under the Public Health Service Act Section 351.
Cord Blood Banking 2
Which federal agency regulates cord blood banks in the United States?