Donor Screening & Eligibility Flashcards

When a tissue bank medical director makes a determination of donor eligibility, this decision must be based on:

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.

Under 21 CFR 1271, if a tissue bank cannot obtain all required donor screening information before processing, the bank may:

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.

A potential donor's next-of-kin cannot be located for an interview. The tissue bank should:

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.

Which of the following represents an appropriate use of the 'urgent medical need' exception described in FDA regulations for tissue release?

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.

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?

Answer: Semen/reproductive tissue

Finasteride affects testosterone metabolism and sperm production, making it relevant to eligibility screening for reproductive tissue donation.

A living cornea donor discloses a history of refractive surgery (LASIK) performed 5 years ago. This is relevant because:

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.

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:

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.