Printable Update for Insertion Into Standards D4.357

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CHANGES TO AATB STANDARDS FOR TISSUE BANKING

SECTION D - ACQUISITION OF TISSUE: CONSENT, DONOR SCREENING, ANDTISSUE RECOVERY AND COLLECTION

D4.000 DONOR SUITABILITY



D4.300 Disease Screening



D4.350 Blood Tests

 

D4.357 Archived Samples
A serum or plasma sample from each donor shall be archived if any sample remains after testing. A policy shall be established to collect and archive serum, plasma, or hematopoietic tissue samples from donors to ensure that retrospective testing can be performed as new tests are adopted for donor screening. Samples shall be retained for ten years aftertheRecovery or Collection date either the expiration date of the tissue, or, if there is no expiration date, ten years after the date of Distribution. If a donor is determined to be unsuitable, archived serum, plasma, or hematopoietic tissue samples should still be retained for use for possible unforeseen future investigational purposes (e.g., emerging infectious diseases,  medical/legal, blood borne pathogen exposure, etc.).

Publication date: January 4, 2011 (AATB Bulletin No. 11-01)
Effective date: immediately