2012-Tissue Distribution

Transcription

1 2012-Tissue Distribution Form Approved OMB Exp. Date 06/30/2020 Welcome to the 2012 Tissue Distribution 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

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 TISSUE FROM DECEASED DONORS Did your facility distribute tissue from deceased donors? Which of the following types of Musculoskeletal TISSUES did your tissue bank distribute for transplantation? [HCT/Ps regulated solely under Section 361 of the PHSA] bone cartilage (e.g., costal, articular) meniscus osteochondral grafts (i.e., an allograft consisting of a section, condyle, or plug of bone with an intact articular surface) osteoarticular grafts (i.e., a large weight bearing allograft with intact articular surfaces consisting of a joint with associated soft tissue and bone) bone + cellular tissue Which of the following types of SOFT TISSUES did your tissue bank distribute for transplantation? [HCT/Ps regulated solely under Section 361 of the PHSA] fascia lata ligaments (i.e. patellar) tendons (e.g., Achilles, gracillis, anterior/posterior tibialis, semitendinosus, flexors/extensors, peroneus longus) rotator cuff pericardium nerves peritoneal membrane dura mater

4 Which of the following types of CARDIAC TISSUES did your tissue bank distribute for transplantation? [HCT/Ps regulated solely under Section 361 of the PHSA] valved conduits non-valved conduits patch grafts aortoiliac grafts Which of the following types of VASCULAR TISSUES did your tissue bank distribute for transplantation? [HCT/Ps regulated solely under Section 361 of the PHSA] arteries vein grafts Which of the following types of SKIN did your tissue bank distribute for transplantation? [HCT/Ps regulated solely under Section 361 of the PHSA] split thickness (fresh, cryopreserved) dermal tissue (including acellular/decellularized) lyophilized dehydrated dessicated Indicate if there were other types of tissues your tissue bank distributed for transplantation. [HCT/Ps regulated solely under Section 361 of the PHSA] other tissue from deceased donors, please specify... other tissue from deceased donors, please specify... other tissue from deceased donors, please specify...

5 TISSUE FROM LIVING DONORS Did your facility distribute tissue from living donors? Which of the following types of tissues did your tissue bank distribute for transplantation? [HCT/Ps regulated solely under Section 361 of the PHSA] amniotic membrane chorionic membrane amniotic fluid Wharton s jelly placental/chorionic disc umbilical cord tissue umbilical vein surgical bone skin for allogeneic use autologous bone autologous parathyroid Other tissue from living donors, please specify... Other tissue from living donors, please specify... Other tissue from living donors, please specify... TISSUE FROM DECEASED DONORS Did your facility distribute MUSCULOSKELETAL GRAFTS from deceased donors?

6 How many of the following musculoskeletal grafts were distributed by your tissue demineralized cortical bone demineralized cancellous bone cancellous bone (cubes or morselized) corticocancellous bone proprietary spinal grafts non-proprietary spinal grafts (traditional) (e.g., ICWs, Clowards, fibula rings) osteochondral grafts fresh/refrigerated (i.e., an allograft consisting of a section, condyle, or plug of bone with an intact articular surface) osteochondral grafts frozen/cryopreserved (i.e., an allograft consisting of a section, condyle, or plug of bone with an intact articular surface osteoarticular grafts fresh/refrigerated (i.e., a large weight bearing allograft with intact articular surfaces, consisting of a joint with associated soft tissue and bone osteoarticular grafts frozen/cryopreserved (i.e., a large weight bearing allograft with intact articular surfaces consisting of a joint with associated soft tissue and bone) meniscus frozen meniscus lyophilized cartilage (e.g., costal, articular) large segment (articular surface not preserved) (i.e., shaft, proximal large bone, distal large bone) Other musculoskeletal grafts distributed from deceased donors, please specify: Other musculoskeletal grafts Number of grafts

7 Other 4 Other 5 Did your facility distribute SOFT TISSUE GRAFTS from deceased donors? How many of the following soft tissue grafts were distributed by your tissue fascia lata ligaments (i.e. patellar) tendons (i.e., Achilles tendons, gracilis, anterior/posterior tibialis, semitendinosus, flexors/extensors, peroneus longus) rotator cuff pericardium nerves peritoneal membrane dura mater Other soft tissue grafts distributed from deceased donors, please specify: Other soft tissue grafts Number of grafts

8 Other 4 Other 5 Did your facility distribute CARDIAC TISSUE GRAFTS from deceased donors? How many of the following cardiac tissue grafts were distributed by your tissue Valved conduit - (aortic valves) acellular / decellularized Other valved conduit - (aortic valves) distributed by your tissue bank: Other valved conduit - (aortic valve) Number of grafts How many of the following cardiac tissue grafts were distributed by your tissue Valved conduit - (pulmonic valves)

9 acellular / decellularized Other valved conduit - (pulmonic valves) distributed by your tissue bank: Other valved conduit - (pulmonic valve) Number of grafts How many of the following cardiac tissue grafts were distributed by your tissue Patch graft (i.e. pulmonic patch, pulmonic hemi-artery (with or without leaflet), etc.) acellular / decellularized Other cardiac tissue distributed by your tissue bank: Other patch graft Number of grafts How many of the following cardiac tissue grafts were distributed by your tissue n-valved conduit - (aortic) acellular / decellularized

10 Other non-valved conduit - (aortic) distributed by your tissue bank: Other non-valved conduit - (aortic) Number of grafts How many of the following cardiac tissue grafts were distributed by your tissue n-valved conduit - (pulmonic) acellular / decellularized Other non-valved conduit - (pulmonic) distributed by your tissue bank: Other non-valved conduit - (pulmonic) Number of grafts How many of the following cardiac tissue grafts were distributed by your tissue Aortoiliac graft acellular / decellularized

11 Other aortoiliac grafts distributed by your tissue bank: Other aortoiliac Number of grafts Other cardiac tissue grafts distributed by your tissue bank: Other cardiac Number of grafts Did your facility distribute VASCULAR TISSUE GRAFTS from deceased donors? How many of the following vascular tissue grafts were distributed by your tissue Arteries acellular / decellularized Other arteries distributed by your tissue bank Other arteries Number of grafts

12 How many of the following vascular tissue grafts were distributed by your tissue Vein grafts - (saphenous) acellular / decellularized Other vein grafts - (saphenous) distributed by your tissue bank: Other vein grafts - (saphenous) Number of grafts How many of the following vascular tissue grafts were distributed by your tissue Vein grafts - (iliac) acellular / decellularized Other vein grafts - (iliac) distributed by your tissue bank: Other vein grafts - (iliac) Number of grafts

13 Other vascular tissue distributed by your tissue bank: Other vascular tissue Number of grafts Did your facility distribute SKIN from deceased donors? How much skin did your tissue bank distribute [Report both in # square feet and # of units/packages for each type, if possible.] square feet number of units/packages How much of the following categories of skin did your tissue bank distribute? [Report both in # of square feet and # of units/packages for each type if possible.] # of square feet # of units/packages fresh frozen/cryopreserved acellular/decellularized lyophilized TOTAL

14 How much skin did your tissue bank distribute to the following? [Report both in # of square feet and # of units/packages for each type if possible.] # of square feet # of units/packages hospitals/burn centers physicians tissue distribution intermediaries Other places your tissue bank distributed skin: Distributed to # of square feet # of units/packages Did your facility distribute DURA MATTER grafts from deceased donors? How many dura mater grafts were distributed by your tissue bank to the following? hospitals/medical facilities physicians tissue distribution intermediaries

15 Other dura mater grafts distributed by your tissue bank: Distributed to Number of grafts TISSUE FROM LIVING DONORS Did your facility distribute tissue from living donors? How many of the following tissues from living donors were distributed by your tissue amniotic membrane chorionic membrane amniotic fluid Wharton s jelly placental/chorionic disc umbilical cord tissue umbilical veins surgical bone skin for allogeneic use autologous bone

16 autologous parathyroid Other tissue distributed by your tissue bank: Other tissue from living donors Number of grafts Other tissue 1 Other tissue 2 Other tissue 3 Other tissue 4 Other tissue 5 IMPLANT REPORTS Indicate the percentages (as a range) of allografts distributed by your tissue bank that had an implant report submitted by the hospitals/surgeons/dentists regarding the allograft s use. 0% 25% 26% 50% 51% 75% 76% 100% Did your facilities electronically track the number of implant cards submitted? Did your tissue bank distribute outside of the U.S. any tissue that was from donations made in the U.S.?

17 TISSUE FROM DECEASED AND LIVING DONORS Considering all distribution of tissue from your facility(ies), estimate the percentage of overall distribution that occurred to destinations outside of the United States: