CTBS Tissue Recovery 3 — Questions and Answers
Question 1: Which federal regulation primarily governs the recovery of human tissue intended for transplantation in the United States?
- 21 CFR Part 820
- 21 CFR Part 1271 (Correct answer)
- 45 CFR Part 46
- 42 CFR Part 493
Correct answer: 21 CFR Part 1271
21 CFR Part 1271 establishes FDA requirements for human cells, tissues, and cellular/tissue-based products (HCT/Ps) including recovery standards.
Question 2: What is the correct technique for maintaining sterility when packaging tissue recovered in a non-sterile environment such as a funeral home?
- Use a single sterile bag and seal immediately
- Double-bag the tissue with inner and outer sterile packaging (Correct answer)
- Package in saline only without additional wrapping
- Wrap in sterile gauze and place in a cooler
Correct answer: Double-bag the tissue with inner and outer sterile packaging
Double-bagging with sterile inner and outer packaging maintains containment and reduces contamination risk during transport to the processing facility.
Question 3: A tissue recovery technician notices the donor's skin has marbling and green discoloration. What is the BEST course of action?
- Proceed with recovery, noting the finding in the chart
- Halt recovery and notify the medical director for evaluation (Correct answer)
- Recover only bone tissue and discard soft tissue
- Request additional serology testing before proceeding
Correct answer: Halt recovery and notify the medical director for evaluation
Marbling and green discoloration indicate significant decomposition, which requires medical director evaluation before continuing recovery.
Question 4: Which type of consent is generally required for tissue donation in the United States?
- Implied consent from hospital admission
- First-person authorization or next-of-kin authorization (Correct answer)
- State medical examiner authorization only
- Written consent from the attending physician
Correct answer: First-person authorization or next-of-kin authorization
Tissue donation requires first-person authorization (e.g., donor registry) or, if unavailable, next-of-kin authorization per UAGA guidelines.
Question 5: What is the recommended storage temperature for recovered musculoskeletal tissue during transport to the processing lab?
- Room temperature (20–25°C)
- 1–10°C (Correct answer)
- -20°C
- -80°C
Correct answer: 1–10°C
Musculoskeletal tissue recovered without cryopreservation should be stored and transported at 1–10°C to slow cellular degradation.
Question 6: Which of the following donor medical histories would MOST likely require referral to a medical director before proceeding with recovery?
- Seasonal allergies treated with antihistamines
- History of Creutzfeldt-Jakob disease (Correct answer)
- Controlled hypertension managed with beta-blockers
- Mild anemia detected at annual physical
Correct answer: History of Creutzfeldt-Jakob disease
Creutzfeldt-Jakob disease is a transmissible spongiform encephalopathy and an absolute contraindication to tissue donation, requiring immediate medical director review.
Question 7: What does the acronym 'UAGA' stand for in the context of tissue recovery?
- Universal Anatomical Gift Act
- Unified Agency for Graft Authorization
- Uniform Anatomical Gift Act (Correct answer)
- United Alliance for Graft Allocation
Correct answer: Uniform Anatomical Gift Act
The Uniform Anatomical Gift Act (UAGA) is the model legislation governing the donation of human bodies and organs/tissues for medical purposes.
CTBS Tissue Recovery 3
Which federal regulation primarily governs the recovery of human tissue intended for transplantation in the United States?