Scott Brubaker - American Association of Tissue Banks

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Current Practices • Adverse event/reaction/outcome reporting requirements ❖ ❖ ❖ Federal, State, International AATB Standards & Accreditation Policy Investigation Practices - Flowchart • Definitions ❖ Possible, Probable, Proven, Indeterminate, or Excluded • Implant Card Experience Tracking
Reporting Requirements • Federal - refer to Melissa’s excellent presentation! • State ❖ New York - Title 10 NYCRR Part 52; and subparts 52-2 Licensure, 52-3 General Technical ๏ ๏ ๏ ๏ Covers tissue banks & transplant centers Adverse outcome reporting & records required for transplant centers Required reporting by tissue banks (within 7 calendar days) <strong>of</strong> “Errors and Accidents” if grafts distributed; relates to reporting above by transplant center Must submit annual activity reports (provides denominator)
Page 1: AATB’s Report: Adverse Reporting
Page 5 and 6: Reporting Requirements • Internat
Page 7 and 8: AATB Standards • 1996 (7th editio
Page 9 and 10: AATB Standards In A2.000 Definition
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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