Scott Brubaker - American Association of Tissue Banks

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AATB Standards In A2.000 Definitions of Terms: ADVERSE OUTCOME - An undesirable effect or untoward complication in a recipient consequent to or reasonably related to cells and/or tissue transplantation.
AATB Standards In A2.000 Definitions of Terms: ERROR - A departure, whether or not intentional, from the SOPM, standards, or applicable federal, state, and/or local laws and/or regulations during donor screening, testing, retrieval, processing, quarantine, labeling, storage, distribution, or dispensing of cells and/or tissues that may cause infectious disease transmission, adversely affect the clinical performance of cells and/or tissue, and/or interfere with the ability to trace cells and/or tissue to the donor.
Page 1 and 2: AATB’s Report: Adverse Reporting
Page 3 and 4: Reporting Requirements • Federal
Page 5 and 6: Reporting Requirements • Internat
Page 7: AATB Standards • 1996 (7th editio
Page 11 and 12: AATB Standards G3.000 Labeling Info
Page 13 and 14: AATB Standards K1.000 QUALITY ASSUR
Page 15 and 16: AATB Standards K1.000 QUALITY ASSUR
Page 17 and 18: AATB Standards Section L - Tissue D
Page 20 and 21: “Possible/Suspected” definition
Page 22 and 23: Medical Director Pathway
Page 24 and 25: CAPA; Publications; Meeting Present
Page 26 and 27: “Possible” Definition
Page 28 and 29: Rationale for “Possible” • Po
Page 30 and 31: Probable & Proven
Page 32 and 33: Implant Card Compliance 2006 AATB S
Page 34 and 35: Comments from Tissue Banks • Diff
Page 36: Thank you! (questions will be enter

Scott Brubaker - American Association of Tissue Banks

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