CTBS Donor Screening & Eligibility 2 — Questions and Answers
Question 1: Which behavioral risk factor within the past 12 months is a standard deferral criterion for tissue donation under FDA 21 CFR 1271?
- Non-prescription use of injectable drugs (Correct answer)
- Consumption of alcohol more than twice per week
- Travel to a tropical country
- Use of prescription anticoagulants
Correct answer: Non-prescription use of injectable drugs
Non-prescription injectable drug use within 12 months is a mandatory exclusion because it carries significant risk of bloodborne pathogen transmission.
Question 2: A potential tissue donor was incarcerated for 72 consecutive hours within the past 12 months. According to AATB standards, this donor should be:
- Deferred due to increased behavioral risk (Correct answer)
- Accepted if all serology is negative
- Evaluated only if incarceration exceeded 6 months
- Accepted with a notation in the medical record
Correct answer: Deferred due to increased behavioral risk
AATB standards require deferral of donors who were incarcerated for 72 or more consecutive hours in the 12 months prior to donation due to elevated bloodborne pathogen risk.
Question 3: Which of the following recipients of a blood or organ transplant is NOT automatically deferred as a tissue donor?
- A recipient of an autologous blood transfusion (Correct answer)
- A recipient of a corneal transplant
- A recipient of a cadaveric kidney transplant
- A recipient of a human dura mater graft
Correct answer: A recipient of an autologous blood transfusion
Autologous blood transfusions use the donor's own blood, so there is no risk of transmissible disease from another person.
Question 4: When reviewing a potential tissue donor's medical records, evidence of which condition in the preceding 12 months would result in exclusion under AATB guidelines?
- Diagnosis of syphilis with documented treatment (Correct answer)
- A single episode of bacterial pneumonia
- Controlled type 2 diabetes mellitus
- Surgically corrected mitral valve prolapse
Correct answer: Diagnosis of syphilis with documented treatment
Active or recently treated syphilis may indicate high-risk sexual behavior that is a deferral criterion under AATB guidelines.
Question 5: A donor's next-of-kin interview reveals that the donor received a tattoo from a licensed facility using sterile equipment 18 months ago. This finding should be:
- Documented but does not preclude donation (Correct answer)
- Used to automatically defer the donor
- Reported to the FDA as a potential hazard
- Treated as equivalent to injection drug use
Correct answer: Documented but does not preclude donation
A tattoo applied by a licensed shop using sterile equipment is generally not a deferral criterion; only tattoos in unregulated settings within 12 months raise concern.
Question 6: Under FDA 21 CFR 1271.85, which of the following laboratory tests is REQUIRED for all allogeneic tissue donors?
- HIV-1/2 antibody and NAT testing (Correct answer)
- Herpes simplex virus serology
- West Nile Virus PCR year-round
- Zika virus NAT for all US donors
Correct answer: HIV-1/2 antibody and NAT testing
HIV-1/2 antibody and nucleic acid testing (NAT) are mandatory for all allogeneic tissue donors under 21 CFR 1271.85.
Question 7: Which of the following physical examination findings in a deceased donor would most likely lead to exclusion from tissue donation?
- Unexplained lymphadenopathy involving multiple nodes (Correct answer)
- A healed appendectomy scar
- Mild jaundice consistent with documented gallstones
- Peripheral edema related to documented heart failure
Correct answer: Unexplained lymphadenopathy involving multiple nodes
Unexplained multi-node lymphadenopathy is a sign that may indicate an undiagnosed infection, malignancy, or immunodeficiency, which would exclude the donor.
CTBS Donor Screening & Eligibility 2
Which behavioral risk factor within the past 12 months is a standard deferral criterion for tissue donation under FDA 21 CFR 1271?