2015-Activities, Tissue Types and Inspections

Transcription

1 2015-Activities, Tissue Types and Inspections Form Approved OMB No Exp. Date 06/30/2020 Welcome to the 2015 Activities Tissue Types and Inspections survey. Please refer to the following instructions as you complete this section of the survey. To facilitate accurate totals, provide counts or mark boxes according to the descriptions given. If the answer is none enter zero. If the information is not obtainable for a specific question enter 999. When you respond to certain questions, subsequent questions may change or disappear based on the services you provide. When you get to the end of a page, click Next to advance to the next page (or click Back to return to the previous page). When you reach the end of the survey click Submit. A survey must be completed in one sitting. Please do NOT include ocular-only and organ-only referrals or donors in this survey. Except where noted, all donations are for transplantation. Do NOT enter percentages unless requested. We are providing a document of definitions for certain terms within the survey. Most definitions are from the AATB Standard A2.000 DEFINITIONS OF TERMS; however, some are new or have been revised. To access pdf versions of the electronic surveys and the NTRUS Definitions of Terms, please go to aatb.org, click on the Standards & Regulatory tab at the top of the page and then click on NTRUS Documents". Paper surveys are for reference only, the final data must be submitted on the electronic survey. If you have any questions regarding the survey, please send an to aatb@aatb.org. Your responses are very important to us, and we appreciate your help! According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is The time required to complete this information collection is estimated to average 10 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C , Attention: PRA Reports Clearance Officer OMB No

2 To avoid double reporting, include numbers only for your main facility and your satellite facilities (if applicable). The information you are reporting is for the following physical locations(s) by name, city and state. Name City Location 1 Location 2 Location 3 Location 4 Location 5 Location 6 Location 7 Location 8 Location 9 Location 10 Location 11 Location 12 Location 13 Location 14 Location 15 Location 16 Location 17 Location 18

3 Which activity(ies) did your facility (specific to tissue banking) perform? authorization informed consent donor eligibility assessment recovery acquisition (BT) storage processing distribution donor testing (order or perform infectious disease testing ) What type(s) of human tissue did your tissue bank/facility handle? [ Handle refers to any activities listed in the question above.] musculoskeletal tissue osteoarticular grafts cardiac tissue vascular tissue skin dura mater birth tissue (BT) surgical bone (from a living donor for allogeneic use) autologous tissue (e.g., bone, parathyroid) cellular tissue Indicate inspections of your facility (specific to tissue banking): [Complete the columns for rows that apply.] Inspection Authority American Association of Tissue Banks inspected (including satellite facilities) noncompliance (e.g., FDA 483s; AATB nonconformities, but not observations; etc)

4 United s Food and Drug Administration Australia TGA Korean FDA National Inspection Authorities: Inspection Authority inspected (including satellite facilities) noncompliance (e.g., FDA 483s; AATB nonconformities, but not observations; etc) National Inspection Authority 1 National Inspection Authority 2 National Inspection Authority 3 Indicate inspections of your facility (specific to tissue banking): [Complete the columns for rows that apply.] Florida inspected (including satellite facilities) noncompliance (e.g., FDA 483s; AATB nonconformities, but not observations; etc) New York California

5 Maryland Georgia : Agency inspected (including satellite facilities) noncompliance (e.g., FDA 483s; AATB nonconformities, but not observations; etc) Indicate inspections of your facility (specific to tissue banking): [Complete the columns for rows that apply.] Identify any other that inspected your organization CLIA inspected (including satellite facilities) noncompliance (e.g., FDA 483s; AATB nonconformities, but not observations; etc) ISO CAP AOPO

6 EBAA A tissue bank (or a party on behalf of another tissue bank) that inspected your organization: inspected (including satellite facilities) noncompliance (e.g., FDA 483s; AATB nonconformities, but not observations; etc)