CTBS Donor Screening & Eligibility 5 — Questions and Answers
Question 1: When a tissue bank medical director makes a determination of donor eligibility, this decision must be based on:
- A review of all available records including physical assessment, medical/social history, and laboratory results (Correct answer)
- Laboratory test results alone if the cause of death is known
- Next-of-kin interview results and physical assessment only
- Only FDA-required testing results as defined in 21 CFR 1271.85
Correct answer: A review of all available records including physical assessment, medical/social history, and laboratory results
Donor eligibility determination requires integration of all available information: physical assessment, relevant medical records, next-of-kin interview, and laboratory testing.
Question 2: Under 21 CFR 1271, if a tissue bank cannot obtain all required donor screening information before processing, the bank may:
- Quarantine the tissue pending completion of eligibility determination (Correct answer)
- Release the tissue provisionally with a warning label
- Destroy the tissue immediately to prevent risk
- Transfer the eligibility decision to the receiving transplant center
Correct answer: Quarantine the tissue pending completion of eligibility determination
Tissue must be placed under quarantine until all required eligibility information is obtained and a determination is made, preventing premature release of potentially unsafe tissue.
Question 3: A potential donor's next-of-kin cannot be located for an interview. The tissue bank should:
- Document all attempts to contact next-of-kin and use all other available records to make an eligibility determination (Correct answer)
- Automatically disqualify the donor because the interview is mandatory
- Proceed with donation only if serology is negative and cause of death is known
- Defer to the medical examiner's office to conduct the interview
Correct answer: Document all attempts to contact next-of-kin and use all other available records to make an eligibility determination
When next-of-kin is unavailable, the bank must document all contact attempts and make the best eligibility determination possible using all other available information.
Question 4: Which of the following represents an appropriate use of the 'urgent medical need' exception described in FDA regulations for tissue release?
- Releasing tissue that has not yet completed eligibility determination when a patient will die without transplantation (Correct answer)
- Bypassing serology testing for a trauma donor when results are delayed
- Releasing tissue to a foreign hospital that lacks FDA-compliant testing
- Using an unvalidated test kit when the approved kit is out of stock
Correct answer: Releasing tissue that has not yet completed eligibility determination when a patient will die without transplantation
FDA regulations allow tissue to be released before eligibility determination is complete when the physician documents that the patient faces imminent life-threatening need, with full disclosure of incomplete status.
Question 5: A donor is found to have taken finasteride (a 5-alpha reductase inhibitor) at the time of death. This finding is most relevant to eligibility for which tissue type?
- Semen/reproductive tissue (Correct answer)
- Cardiovascular valves
- Musculoskeletal grafts
- Amniotic membrane
Correct answer: Semen/reproductive tissue
Finasteride affects testosterone metabolism and sperm production, making it relevant to eligibility screening for reproductive tissue donation.
Question 6: A living cornea donor discloses a history of refractive surgery (LASIK) performed 5 years ago. This is relevant because:
- Corneas from donors with prior refractive surgery may not be suitable for certain transplant procedures (Correct answer)
- LASIK disqualifies a donor from all eye banking
- The stromal bed thinning from LASIK increases infection transmission risk
- LASIK changes corneal antigenicity, increasing rejection rates
Correct answer: Corneas from donors with prior refractive surgery may not be suitable for certain transplant procedures
Prior refractive surgery alters corneal thickness and curvature, making the tissue unsuitable for full-thickness penetrating keratoplasty but potentially usable for other purposes depending on eye bank criteria.
Question 7: A tissue bank receives a referral for a donor who died from sepsis with a known causative organism that is susceptible to antibiotics. The most appropriate action is to:
- Evaluate each tissue type individually, as some may still be recoverable depending on the infection and tissue bank protocols (Correct answer)
- Automatically exclude the donor from all tissue donation due to active infection at death
- Accept only bone tissue because it can be terminally sterilized
- Accept the donor for all tissues if blood cultures are negative at 48 hours
Correct answer: Evaluate each tissue type individually, as some may still be recoverable depending on the infection and tissue bank protocols
Sepsis does not automatically exclude all tissue types; tissue banks evaluate each tissue individually, and some tissues may be acceptable depending on the infectious organism, its sensitivity, and applicable tissue-specific protocols.
CTBS Donor Screening & Eligibility 5
When a tissue bank medical director makes a determination of donor eligibility, this decision must be based on: