PRECISIONBIOLOGICS
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Regulatory

Donor eligibility determination

Donor eligibility determination is the screening process a tissue establishment performs on a donor before tissue is released for use, combining a review of medical and social history with laboratory testing for communicable disease markers. A donor is found eligible or ineligible based on that combined record, not on a single test result alone.

Donors undergo medical and social history review and serology testing for communicable disease markers, performed on a blood sample collected at the time of donation. Request the donor eligibility summary to see how a specific donor's screening and testing were documented. The combined record, not any single data point, supports a documented eligible or ineligible decision for that donor.

For perinatal tissue collected at a scheduled delivery, eligibility screening sits alongside, and is separate from, decisions a mother makes about banking cord blood for her own family's use. Donation for allograft manufacturing and cord blood banking are distinct processes with their own consent and screening paths, and choosing one does not require giving up the other.

A buyer evaluating a supplier can ask whether donor eligibility records are retained and available for review, what testing panel was performed, and how the determination is documented per donor and per lot. These records, together with lot-level testing results, form part of the documentation a clinic should be able to request before adding a product to inventory.

Donor eligibility documentation is one of the core records a clinic should be able to request and keep on file to support its own recordkeeping for any tissue product it stocks.

Sources

  1. 21 CFR 1271.10 - Are my HCT/Ps regulated solely under section 361 of the PHS Act ↗eCFR