2015-Recovery & Acquisition

Transcription

1 2015-Recovery & Acquisition Form Approved OMB No Exp. Date 06/30/2020 Welcome to the 2015 Recovery & Acquisition 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 30 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 State 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 DECEASED DONATION Recovery Did your facility(ies) recover tissue from deceased donors for transplantation? [Count one donor only once. Do not report donors or tissues recovered by another organization on your behalf; only report your own activity.] How many deceased donors did your tissue bank/facility recover tissue from for transplantation? How many had an autopsy performed? Yes No How many were also organ donors? How many were also ocular donors? Provide the number of deceased donors in the following categories from whom your tissue bank/facility recovered these tissue types for transplantation: [A donor may be counted more than once, depending on tissue types recovered.] musculoskeletal (i.e., bone, cartilage, osteoarticular grafts/joints, and the following soft tissue: fascia lata, ligaments, tendons, pericardium, nerves, and adipose other than from full-thickness skin) cardiac tissue vascular tissue skin dura mater Other tissue from deceased donors: Other tissue Number of deceased donors Other 1 Other 2

4 Other 3 Of the total number of deceased donors recovered for transplantation, indicate how many tissue recoveries occurred at each of the following recovery sites: health care facility operating room hospital morgue funeral home dedicated tissue recovery site medical examiner office (dedicated room) medical examiner office (open autopsy area) Other recovery sites: Other recovery site Number of deceased donors Other recovery site 1 Other recovery site 2 Other recovery site 3 Indicate the number of deceased donors whose tissues were recovered for transplantation in each of the following age and gender categories: newborn 12 years Male Female 13 years 20 years 21 years 30 years

5 31 years 40 years 41 years 50 years 51 years 60 years 61 years 70 years 71 years 80 years Over 80 years Provide the number of deceased donors where (any) tissues were recovered specifically for research: LIVING DONATION - Recovery and Acquisition Did your facility(ies) receive tissue from living donors that was recovered/acquired for transplantation? Yes No How many living donors provided tissue to your tissue bank that was recovered/acquired for transplantation? [Count each living donor only once. Do not report donors or tissues recovered/acquired by another organization on your behalf; only report your own activity. For this question, do Not include autologous tissue donors in your count.] Provide the number of living donors in the following categories from whom your tissue bank received tissue for transplantation: [A donor may be counted more than once, depending on tissue types donated.]

6 surgical bone skin for allogeneic use autologous bone autologous parathyroid Other autologous tissue from living donors: Other autologous tissue Number of donors Other autologous 1 Other autologous 2 Other autologous 3 Other allogeneic tissue from living donors (do not include birth tissue): Other allogeneic tissue Number of donors Other tissue 1 Other tissue 2 Other tissue 3 Provide the number of birth tissue donors in the following categories from whom your tissue bank acquired these tissue types for transplantation: placenta (includes amniotic membrane, chorionic membrane, placental/chorionic disc) amniotic fluid Wharton s jelly umbilical cord (includes umbilical vein)

7 Indicate how many birth tissue donors from whom your tissue bank acquired tissue from the following: hospital delivery/birth centers freestanding birth centers (not at a hospital) Donors acquired from: Other site Number of birth tissue donors Other 1 Other 2 Other 3 Indicate how many donors of birth tissue delivered by: cesarean section vaginally Provide the number of living donors where (any) tissues were recovered/acquired specifically for research: Indicate the number of living donors whose tissues were recovered/acquired for transplantation in each of the following age and gender categories: [Do NOT include autologous tissue donors in your counts.] Male Female newborn 12 years 13 years 20 years

8 21 years 30 years 31 years 40 years 41 years 50 years 51 years 60 years 61 years 70 years 71 years 80 years Over 80 years DECEASED DONATION Eligibility Did your facility(ies) recover tissue from deceased donors for transplantation? [Count one donor only once. Do not report donors or tissues recovered by another organization on your behalf; only report your own activity.] Yes No How many deceased tissue donors were determined ineligible at the recovery site? Indicate the number of deceased tissue donors determined ineligible at the recovery site for the following reasons: [Select the primary reason for each donor.] related to blood samples (e.g. plasma dilution, no sample available) chart findings physical assessment findings

9 logistics (e.g. insufficient body cooling, time expired, body no longer available) authorization rescinded results of rapid infectious disease testing performed at recovery post-incision findings Other reason for ineligible donors at recovery site Other reason Number of deceased donors Other reason 1 Other reason 2 Other reason 3 How many deceased tissue donors were determined ineligible after recovery? [Tissue Processors: For OPOs and Tissue/Eye Banks that recovered tissue on your behalf, please provide these facilities with sufficient information so that tissue donors are counted only once.]: Indicate the number of deceased tissue donors determined ineligible after recovery for the following reasons: [Tissue Processors: For OPOs and Tissue/Eye Banks that recovered tissue on your behalf, please provide these facilities with sufficient information so that tissue donors are counted only once. Select the primary reason for each donor.] infectious disease testing pre-processing cultures medical history behavioral risk history

10 autopsy results tissue quality Other reason for ineligible donors after recovery: Other reason Number of deceased donors Other reason 1 Other reason 2 Other reason 3 LIVING DONATION Eligibility Did your facility(ies) receive tissue from living donors that was recovered/acquired for transplantation? [Do not report donors or tissues recovered/acquired by another organization on your behalf. Only report your own activity. Do Not include autologous tissue donors in your count.] Yes No How many living tissue donors were determined ineligible at recovery/acquisition? Indicate the number of living donors determined ineligible at recovery/acquisition for the following reasons: [Select the primary reason for each donor.] related to blood samples (e.g. plasma dilution, no sample available) chart findings

11 physical examination findings logistics informed consent rescinded Other reason for ineligible donors at recovery/acquisition: Other reason Number of living donors Other reason 1 Other reason 2 Other reason 3 How many living tissue donors were determined ineligible after recovery/acquisition? Indicate the number of living tissue donors determined ineligible after recovery/acquisition for the following reasons: [Tissue Processors: For OPOs and Tissue/Eye Banks that recovered tissue on your behalf, please provide these facilities with sufficient information so that tissue donors are counted only once. Select the primary reason for each donor.] infectious disease testing pre-processing cultures medical history behavioral risk history tissue quality

12 Other reason for ineligible donors after recovery/acquisition? Other reason Number of living donors Other reason 1 Other reason 2 Other reason 3 DECEASED AND LIVING DONATION Did your tissue bank forward tissue for processing into cell therapy products, biologics, or drugs? Yes No What type of tissue was sent? bone adipose Other, please specify... Other, please specify...