Scott Brubaker - American Association of Tissue Banks

More documents

Recommendations

Info

AATB Standards B2.200 Medical Director B2.220 Responsibilities B2.222 Adverse Outcomes The Medical Director shall establish policies and procedures regarding Adverse Outcomes and shall require that all potential Adverse Outcomes are investigated and documented. Corrective actions shall also be documented. All final summary reports shall be reviewed and approved by the Medical Director. Adverse Outcomes must be reported as required by applicable federal, state and/or local laws and/or regulations.
AATB Standards G3.000 Labeling Information G3.210 Package Insert Content 11) Statement that Adverse Outcomes potentially attributable to the cells and/or tissue must be reported promptly to the tissue supplier H5.000 Recalls - General H5.400 Recalls <strong>of</strong> Transplanted <strong>Tissue</strong> .....shall be handled as a potential Adverse Outcome investigation...
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 and 8: AATB Standards • 1996 (7th editio
Page 9: AATB Standards In A2.000 Definition
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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?