Tissue storage
National Tissue Recovery through Utilization Survey (NTRUS)
NTRUS Survey_Section 5
Tissue storage
OMB: 0990-0457
Form Approved
OMB No. 0990-
Exp. Date XX/XX/20XX
THE NATIONAL TISSUE RECOVERY
THROUGH UTILIZATION SURVEY
SECTION 5 – Tissue Distribution
The Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), through a contract with the American Association of Tissue Banks, is conducting the 2016 National Tissue Recovery through Utilization Survey (NTRUS).
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Your responses will remain anonymous in the final dataset. While results of this survey will be released in aggregate form and data may be made available in the form of a de-identified dataset, no specific institutional identifiable information will be included.
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 0990-xxxx. The time required to complete this information collection is estimated to average 20 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. 20201, Attention: PRA Reports Clearance Officer
Tissue Distribution |
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The survey provides definitions for specific tissue types. To facilitate accurate totals, provide counts using the descriptions provided. Use the definitions found at AATB Standard A2.0000 DEFINITIONS OF TERMS. Some terms and/or definitions are new and some have been revised. To avoid double reporting, please 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:
(need capability for multiple lines/entries)
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Which of the following types of tissues did your tissue bank distribute for transplantation: TISSUE FROM DECEASED DONORS
HCT/Ps regulated solely under Section 361 of the PHSA musculoskeletal □ 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
soft tissue □ 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
cardiac tissue □ valved conduits □ non-valved conduits □ patch grafts □ aortoiliac grafts
vascular tissue (HCT/Ps regulated solely under Section 361 of the PHSA) □ arteries □ vein grafts
skin (HCT/Ps regulated solely under Section 361 of the PHSA) □ fresh □ cryopreserved □ acellular/decellularized □ lyophilized □ other tissue from deceased donors (specify) __________________________
tissue as a device ______ (i.e., products and combination products requiring PMA or 510k clearance; regulated under the FD&C Act as well as under 21 CFR Part 1271 from Section 361 of the PHSA)
tissue as a biological product ______ (i.e., products requiring BLA or IND; regulated under Section 351 of the PHSA and/or the FD&C Act, as well as under 21 CFR Part 1271 from Section 361 of the PHSA) tissue as a drug ______ (i.e., products requiring IND/NDA; regulated under Section 201 of the FD&C Act, as well as under 21 CFR 1271 from Section 361 of the PHSA)
TISSUE FROM LIVING DONORS
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 (specify) ____________________________
tissue as a device ______ (i.e., products and combination products requiring PMA or 510k clearance; regulated under the FD&C Act as well as under 21 CFR Part 1271 from Section 361 of the PHSA)
tissue as a biological product ______ (i.e., products requiring BLA or IND; regulated under Section 351 of the PHSA and/or the FD&C Act, as well as under 21 CFR Part 1271 from Section 361 of the PHSA)
tissue as a drug ______ (i.e., products requiring IND/NDA; regulated under Section 201 of the FD&C Act, as well as under 21 CFR 1271 from Section 361 of the PHSA)
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Indicate how many finished tissue grafts were distributed to the following: hospitals/medical facilities ____________ tissue distribution intermediaries – United States (an intermediary agent in the United States) ______________ tissue distribution intermediaries – International (an intermediary agent outside of the United States) ______________ physicians/dentists _________ another tissue bank ________ other (specify) __________
□ Check here if the information above is actual, tracked information (not an estimate)
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Did your tissue bank provide tissue for any of the following: □ medical education/training Would this tissue have been suitable for transplant? □ aways □ sometimes □ never
□ research Would this tissue have been suitable for transplant? □ always □ sometimes □ never
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MUSCULOSKELETAL DISTRIBUTION
How many of the following musculoskeletal grafts were distributed by your tissue bank? (Enter 0 if applicable) TISSUE FROM DECEASED DONORS # of Grafts 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 from deceased donors; (specify)______; indicate number for each _______
TOTAL musculoskeletal grafts (from deceased donors) _________
□ Check here if the information above is actual, tracked information (not an estimate)
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SOFT TISSUE DISTRIBUTION How many of the following grafts from deceased donors were distributed by your tissue bank? (Enter 0 if applicable) 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 from deceased donors (specify)______; indicate number for each _______ TOTAL soft tissue grafts (from deceased donors) ______
□ Check here if the information above is actual, tracked information (not an estimate)
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CARDIAC TISSUE AND VASCULAR TISSUE DISTRIBUTION How many of the following tissues were distributed by your tissue bank? (Enter 0 if applicable)
cardiac tissue # of grafts valved conduit - aortic valves _____ cryopreserved (only) _____ acellular / decellularized_______ other (specify) _____
valved conduit - pulmonic valves _____ cryopreserved (only) _____ acellular / decellularized_______ other (specify) _____
patch graft _____ cryopreserved (only) _____ acellular / decellularized_______ other (specify) _____
non-valved conduit - aortic _____ cryopreserved (only) _____ acellular / decellularized_______ other (specify) _____
non-valved conduit - pulmonic _____ cryopreserved (only) _____ acellular / decellularized_______ other (specify) _____
aortoiliac graft _____ cryopreserved (only) _____ acellular / decellularized_______ other (specify) _____
other cardiac tissue (specify)______; indicate number for each _______
TOTAL cardiac tissue distributed _____
□ Check here if the information above is actual, tracked information (not an estimate)
Vascular tissue # of grafts arteries _____ cryopreserved (only) _____ acellular / decellularized_______ other (specify) _____
vein grafts - saphenous____ cryopreserved (only) _____ acellular / decellularized_______ other (specify) _____
vein grafts - iliac____ cryopreserved (only) _____ acellular / decellularized_______ other (specify) _____
other vascular tissue (specify) _____ ; indicate number for each _______
TOTAL vascular tissue distributed _____
□ Check here if the information above is actual, tracked information (not an estimate)
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SKIN GRAFT DISTRIBUTION How much skin did your tissue bank distribute (enter 0 if not applicable)
square feet _____ number of units/packages ______
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How much of the following categories of skin did your tissue bank distribute? (enter 0 if not applicable. Report both in # of square feet and # of units/packages for each type)
□ Check here if the information above is actual, tracked information (not an estimate) |
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How much skin did your tissue bank distribute to the following? (enter 0 if not applicable. Report both in # of square feet as well as #s of units/packages for each type)
□ Check here if the information above is actual, tracked information (not an estimate)
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How many requests to distribute skin did you receive in [calendar year] that you were not able to fill? (enter 0 if you were able to fill all requests) number of requests unable to fill _____ TOTAL number of square feet of skin in requests unable to fill _____
Indicate for what types of skin you were unable to fill the requests □ fresh - if checked: Indicate why you were unable to fill these requests: _________________ □ frozen/cryopreserved - if checked: Indicate why you were unable to fill these requests: _____________ □ acellular/decellularized - if checked: Indicate why you were unable to fill these requests: _____________ □ lyophilized - if checked: Indicate why you were unable to fill these requests: _________________
□ Check here if the information above is actual, tracked information (not an estimate) |
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TISSUE as a DEVICE - DISTRIBUTION (i.e., products and combination products requiring PMA or 510k clearance; regulated under the FD&C Act as well as under 21 CFR Part 1271 from Section 361 of the PHSA.) List the tissue devices distributed by your tissue bank and the quantities distributed Tissue Device Name Quantity (units) ____________________ ______________ ____________________ ______________ ____________________ ______________ TOTAL ______________ |
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TISSUE as a BIOLOGICAL PRODUCT - DISTRIBUTION (i.e., products requiring BLA or IND; regulated under Section 351 of the PHSA and/or the FD&C Act, as well as under 21 CFR Part 1271 from Section 361 of the PHSA)
List the biological products distributed by your tissue bank and the quantities distributed Biological Product Name Quantity (units) ____________________ ______________ ____________________ ______________ TOTAL ______________
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TISSUE as a DRUG - DISTRIBUTION (i.e., products requiring IND/NDA; regulated under Section 201 of the FD&C Act, as well as under 21 CFR 1271 from Section 361 of the PHSA)
List the drug distributed by your tissue bank and the quantities distributed Drug Name Quantity (units) ____________________ ______________ ____________________ ______________ TOTAL ______________ |
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DURA MATER DISTRIBUTION How many dura mater grafts were distributed by your tissue bank to the following: (enter 0 if not applicable)
hospital/medical facilities ______ physicians ________ tissue distribution intermediaries ________ other (specify) ___________________; indicate number for each _______ TOTAL dura mater grafts ______
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DISTRIBUTION OF TISSUE FROM LIVING DONORS How many of the following tissues from living donors were distributed by your tissue bank? (enter 0 if not applicable) 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 _____ autologous parathyroid _____ other tissue from living donors (specify) ___________________; indicate number for each _______
TOTAL grafts from living donors _____ □ Check here if the information above is actual, tracked information (not an estimate) |
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SUPPLY AVAILABILITY □ Check here if you DID NOT have an adequate supply of tissue grafts to meet all the requests that you received in [calendar year]
Indicated the annual number of grafts of each tissue type that would have been necessary in addition to your available supply to meet the clinical demand: Achilles tendons _____ valved conduits aortic valves _____ - enter size (annulus diameter in mm): ____ _____ _____ _____ _____ _____ _____ _____ pulmonic valves _____ - enter size (annulus diameter in mm): ____ _____ _____ _____ _____ _____ _____ _____ cancellous (bone, chips, crushed, cubed, wedges) _____ cartilage(e.g., costal articular) _____ femoral head _____ frozen whole rib _____ iliac crest wedges (posterior ramps, cervical spacers, tricortical blocks) _____ matchsticks _____ meniscus _____ patella (ligaments, wedges) _____ semitendinosus (tendons) _____ tibialis tendons (anterior and posterior) _____ other (specify)_________________
□ Check here if the information above is actual, tracked information (not an estimate) |
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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. Indicate if this is an actual, known range or it is an estimate (not tracked) □ 0% – 25% □ 26% – 50% □ 51% – 75 % □ 76% – 100% □ Check here if the information above is actual, tracked information (not an estimate) |
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□ Check here if your tissue bank distributed outside of the U.S. any tissue, tissue as a device, tissue as a biological product, or tissue as a drug that was from donations made in the U.S. (a) List countries to which tissues were distributed TISSUE FROM DECEASED DONORS HCT/Ps regulated solely under Section 361 of the PHSA musculoskeletal (i.e., bone, cartilage, meniscus, osteoarticular grafts, osteochondral grafts, bone+cellular tissue) _______________________________________________________ soft tissue (i.e., fascia lata, ligaments, tendons, pericardium, rotator cuff, nerves) _________________________ cardiac tissue_______________________________________________________ vascular tissue ____________________________________________________________ skin-derived grafts ______________ dura mater ______________ tissue as a device ______________ - specify: ______________ tissue as a biological product ______________ - specify: ______________ tissue as a drug ______________ - specify: ______________
TISSUE FROM LIVING DONORS
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 (specify) ____________; countries: _____________________________ tissue as a device ______________ - specify: ______________
tissue as a biological product ______________ - specify: ______________
tissue as a drug ______________ - specify: ______________
(b) Considering all distribution of tissue, estimate the percentage of overall distribution that occurs to destinations outside of the United States: ______________
□ Check here if the information above is actual, tracked information (not an estimate) |
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| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Windows User |
| File Modified | 0000-00-00 |
| File Created | 2021-01-23 |
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