2015-Tissue Bank Processing

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1 2015-Tissue Bank Processing Form Approved OMB No Exp. Date 06/30/2020 Welcome to the 2015 Tissue Processing 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 60 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 TISSUE FROM DECEASED DONORS Did your facility(ies) process tissue from deceased donors? Yes No Which of the following types of tissue did your tissue bank process? [Check all that apply] musculoskeletal (i.e., bone, cartilage, osteochondral grafts or osteoarticular grafts) soft tissue (i.e., fascia lata, ligaments, tendons, pericardium, nerves, peritoneal membrane or adipose) cardiac tissue vascular tissue skin cellular tissue dura mater other tissue from deceased donors, please specify... other tissue from deceased donors, please specify... other tissue from deceased donors, please specify... How many deceased donors did your tissue bank process? [Count one donor only once] What was the total number of grafts your tissue bank processed from deceased donors? What was the highest number of grafts your tissue bank processed from a deceased donor? How many deceased donors of the following types of tissues did your tissue bank process: [A donor may be counted more than once, depending on tissue types processed.]

4 Musculoskeletal Tissue bone 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) cartilage (e.g., costal, articular) How many deceased donors of the following types of tissues did your tissue bank process: [A donor may be counted more than once, depending on tissue types processed.] 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 adipose

5 How many deceased donors of the following types of tissues did your tissue bank process: [A donor may be counted more than once, depending on tissue types processed.] Cardiac Tissue valved conduits non-valved conduits patch graft aortoiliac graft How many deceased donors of the following types of tissues did your tissue bank process: [A donor may be counted more than once, depending on tissue types processed.] Vascular Tissue arteries vein grafts How many deceased donors of the following types of tissues did your tissue bank process: [A donor may be counted more than once, depending on tissue types processed.] Skin split thickness (fresh, cryopreserved) dermal tissue (including acellular/decellularized) lyophilized dehydrated

6 dessicated How many deceased donors of the following types of tissues did your tissue bank process: [A donor may be counted more than once, depending on tissue types processed.] cellular tissue dura mater 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) Other tissue from deceased donors: Other tissue from deceased donors Number of donors Other tissue 1 Other tissue 2 Other tissue 3 TISSUE FROM LIVING DONORS Did your facility(ies) process tissue from living donors? Yes No

7 Which of the following types of tissue did your tissue bank process? [Check all that apply] How many living donors did your tissue bank process? (Count one donor only once) What was the total number of grafts your tissue bank processed from living donors? What was the highest number of grafts your tissue bank processed from a living donor? living donor tissue (i.e., birth tissue, surgical bone, skin for allogeneic use, autologous parathyroid or autologous bone) other tissue from living donors, please specify... How many living donors of the following types of tissues did your tissue bank process: [A donor may be counted more than once, depending on tissue types processed.] Birth Tissue amniotic membrane (only) chorionic membrane (only) amniotic+chorionic membrane amniotic fluid Wharton s jelly placental/chorionic disc umbilical cord tissue umbilical vein

8 Other birth tissue from living donors: Other birth tissue from living donors Number of donors other tissue 1 other tissue 2 other tissue 3 How many living donors of the following types of tissues did your tissue bank process: [A donor may be counted more than once, depending on tissue types processed.] surgical bone skin for allogeneic use autologous bone autologous parathyroid 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 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 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) Other tissue from living donors: Other tissue from living donors Number of donors other tissue 1 other tissue 2

9 other tissue 3 TISSUE FROM DECEASED AND LIVING DONORS How did your tissue bank treat tissues with radiation PRIOR to processing (nonterminal irradiation)? [Check all that apply] we did not treat tissues with radiation prior to processing gamma radiation only, below 1.5 Mrads (15 kgy) gamma radiation only, Mrads (15-25 kgy) gamma radiation only, above 2.5 Mrads (25 kgy) electron beam radiation only Electronic beam radiation only, indicate dose: How did your tissue bank treat tissues with radiation to reduce/eliminate microorganisms as a FINAL treatment (terminal irradiation)? [Check all that apply] we did not treat tissues with radiation as a final treatment gamma radiation only, below 1.5 Mrads (15 kgy) gamma radiation only, Mrads (15-25 kgy) gamma radiation only, above 2.5 Mrads (25 kgy) electron beam radiation only Electronic beam radiation only, indicate dose: TISSUE FROM DECEASED DONORS Did your facility(ies) process tissue from deceased donors? Yes

10 No MUSCULOSKELETAL GRAFTS Indicate how many musculoskeletal GRAFTS were processed using the following methods: electron beam radiation (only) gamma radiation (only) ethylene oxide (only) no terminal sterilization Indicate how many musculoskeletal GRAFTS were processed using the following methods: Types of proprietary/patented processing (only) Allowash ATP BioCleanse Process Clearant Process Tutoplast Process NovaSterilis (supercritical CO2) Other proprietary methods: Other method Number of musculoskeletal grafts processed other method 1 other method 2

11 other method 3 Combinations of Antibiotics and Radiation Musculoskeletal For each combination used specify antibiotic(s), radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods: Antibiotic(s) (specify) Antibiotic 1 Antibiotic Radiation Target Dose Number of grafts Antibiotic 2 Antibiotic 3 Combinations of Proprietary/Patented Processing then Radiation Musculoskeletal For each combination used please specify proprietary processing method, radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods: Proprietary/Patented Method (specify) Method Radiation Target Dose Number of grafts Proprietary/patented method 1 Proprietary/patented method 2 Proprietary/patented method 3 Report any other combinations of methods used:

12 SOFT TISSUE GRAFTS Indicate how many soft tissue GRAFTS (i.e., fascia lata, ligaments, tendons, pericardium, nerves, peritoneal membrane or adipose) were processed using the following methods: electron beam radiation (only) gamma radiation (only) ethylene oxide (only) no terminal sterilization Indicate how many soft tissue GRAFTS were processed using the following methods: Types of proprietary/patented processing (only) Allowash ATP BioCleanse Process Clearant Process Tutoplast Process NovaSterilis (supercritical CO2) Other proprietary methods: Other method Number of soft tissue grafts processed other method 1 other method 2 other method 3

13 Combinations of Antibiotics and Radiation Soft Tissue Grafts For each combination used specify antibiotic(s), radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods: Antibiotic(s) (specify) Antibiotic 1 Antibiotic Radiation Target Dose Number of grafts Antibiotic 2 Antibiotic 3 Combinations of Proprietary/Patented Processing then Radiation Soft Tissue Grafts For each combination used please specify proprietary processing method, radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods: Proprietary/Patented Method (specify) Method Radiation Target Dose Number of grafts Proprietary/patented method 1 Proprietary/patented method 2 Proprietary/patented method 3 Report any other combinations of methods used:

14 CARDIAC TISSUE GRAFTS Indicate how many cardiac tissue GRAFTS were preserved using the following methods: refrigerated only (i.e., provided for use as fresh) controlled-rate electronic programmable freezing Other methods-cardiac: Other method Number of cardiac tissue grafts preserved other method 1 other method 2 other method 3 Indicate how many cardiac tissue GRAFTS were processed into finished tissue for each of the following types: acellular/decellularized not acellular/decellularized Other type-cardiac: Other type Number of cardiac tissue grafts processed into finished tissue other type 1 other type 2 other type 3

15 VASCULAR GRAFTS Indicate how many vascular tissue GRAFTS were preserved using the following methods: refrigerated only (i.e., provided for use as fresh) controlled-rate electronic programmable freezing Other methods-vascular: Other method Number of vascular tissue grafts preserved other method 1 other method 2 other method 3 Indicate how many vascular tissue GRAFTS were processed into finished tissue for each of the following types: acellular/decellularized not acellular/decellularized Other type-vascular: Other type Number of vascular tissue grafts processed into finished tissue other type 1 other type 2 other type 3

16 Indicate how many skin GRAFTS were processed using the following methods: electron beam radiation (only) gamma radiation (only) ethylene oxide (only) no terminal sterilization Indicate how many skin GRAFTS were processed using the following methods: [Types of proprietary/patented processing (only)] Allowash ATP BioCleanse Process Clearant Process Tutoplast Process NovaSterilis (supercritical CO2) Other proprietary methods-skin: Other method Number of skin grafts processed other method 1 other method 2 other method 3

17 Combinations of Antibiotics and Radiation Skin For each combination used please specify antibiotic(s), radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods: Antibiotic(s) (specify) Antibiotic 1 Antibiotic Radiation Target Dose Number of grafts Antibiotic 2 Antibiotic 3 Combinations of Proprietary/Patented Processing then Radiation Skin For each combination used please specify proprietary processing method, radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods: Proprietary/Patented Method (specify) Method Radiation Target Dose Number of grafts Proprietary/patented method 1 Proprietary/patented method 2 Proprietary/patented method 3 Report any other combinations of methods used: Did your facility(ies) process tissue from living donors? Yes No

18 BIRTH TISSUE GRAFTS Indicate how many birth tissue GRAFTS were processed using the following methods: electron beam radiation (only) gamma radiation (only) ethylene oxide (only) no terminal sterilization filtration (only) ultraviolet light (only) Indicate how many birth tissue GRAFTS were processed using the following methods: [Types of proprietary/patented processing (only)] Allowash ATP BioCleanse Process Clearant Process Tutoplast Process NovaSterilis (supercritical CO2) Purion Process Cryotek Process

19 Other proprietary methods-birth tissue: Other method Number of birth tissue grafts processed other method 1 other method 2 other method 3 Combinations of Antibiotics and Radiation Birth Tissue Grafts For each combination used specify antibiotic(s), radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods: Antibiotic(s) (specify) Antibiotic 1 Antibiotic Radiation Target Dose Number of grafts Antibiotic 2 Antibiotic 3 Combinations of Proprietary/Patented Processing then Radiation Birth tissue grafts For each combination used please specify proprietary processing method, radiation target dose (below 1.5 Mrads, between 1.5 and 2.5 Mrads, and above 2.5 Mrads) and number of grafts processed using these combination methods: Proprietary/Patented Method (specify) Method Radiation Target Dose Number of grafts Proprietary/patented method 1 Proprietary/patented method 2

20 Proprietary/patented method 3 Report any other combinations of methods used: DEMINERALIZED BONE For what applications did your tissue bank process demineralized bone? [Check all that apply] we did not process demineralized bone orthopedic surgery dental/periodontal procedures neurosurgery other applications, please specify... SKIN Did your tissue bank process skin for use as fresh grafts (not cryopreserved)? no, we did not process skin no, we processed skin, but not for use as fresh grafts yes, we processed skin for use as fresh grafts Indicate how much skin (in square feet) was preserved by each of the following methods: refrigerated only controlled-rate electronic programmable freezing heat sink freezing method lyophilized dessicated

21 dehydrated Other methods-skin by square foot: Other method Skin in square feet other method 1 other method 2 other method 3 Indicate how much skin (in square feet) was processed into finished tissue for each of the following types: acellular/decellularized not acellular/decellularized BIRTH TISSUE Did your facility(ies) process birth tissue from living donors? Yes No Indicate how many units of birth tissue were preserved using the following methods; this refers to the preservation method used only for finished tissue: refrigerated only (i.e., provided for use as fresh) simple freezing controlled-rate electronic programmable freezing lyophilized dehydrated

22 dessicated Other methods-birth tissue: Other method Units of birth tissue preserved other method 1 other method 2 other method 3 Indicate how many units of birth tissue were processed into finished tissue for each of the following types: acellular/decellularized not acellular/decellularized For what applications did your tissue bank process birth tissue? [check all that apply] ophthalmic leg/foot ulcers orthopedic dental/periodontal neurosurgical and spine burns general surgical other general uses, please specify... RECOVERY ENTITIES Indicate how many donors of SKIN were recovered by the following: AATB-accredited OPOs/tissue banks

23 non-aatb accredited OPOs/tissue banks health care facilities (e.g., hospital or surgical center) Indicate how many donors of MUSCULOSKELETAL TISSUE were recovered by the following: AATB-accredited OPOs/tissue banks non-aatb accredited OPOs/tissue banks health care facilities (e.g., hospital or surgical center) Indicate how many donors of SOFT TISSUE were recovered by the following: AATB-accredited OPOs/tissue banks non-aatb accredited OPOs/tissue banks health care facilities (e.g., hospital or surgical center) Indicate how many donors of CARDIAC TISSUE were recovered by the following: AATB-accredited OPOs/tissue banks non-aatb accredited OPOs/tissue banks health care facilities (e.g., hospital or surgical center) Indicate how many donors of VASCULAR TISSUE were recovered by the following: AATB-accredited OPOs/tissue banks non-aatb accredited OPOs/tissue banks

24 health care facilities (e.g., hospital or surgical center) Indicate how many donors of BIRTH TISSUE were provided by the following: hospital delivery/birth centers freestanding birth centers (not at a hospital) AATB-accredited OPOs/tissue banks non-aatb accredited OPOs/tissue banks Other provider-birth tissue: Other provider Number of donors other provider 1 other provider 2 other provider 3 Indicate how many donors of birth tissue delivered by: cesarean section vaginally FURTHER MANUFACTURING Did your tissue bank send any human tissue to another tissue bank for further manufacture? Yes No

25 What tissue was sent for further manufacture? [Check all that apply] demineralized bone matrix cancellous bone bone shafts other tissue, please specify... other tissue, please specify... PROCESSING AND DISTRIBUTION - OTHER COUNTRIES Did your tissue bank process any human tissue from non-u.s. sources? Yes No List the non - U.S. countries: Did your tissue bank import human tissue from other countries for processing and distribution in the U.S.? Yes No List the countries from which donors were imported, the number of donors processed, the general types of tissue grafts, and the quantities distributed: Did your tissue bank process tissue from other countries only for distribution by countries other than the U.S. (i.e., processing contract only)? Yes No

26 Indicate the tissue received and the country of origin (tissue from deceased donors): musculoskeletal (i.e., bone, cartilage, osteochondral grafts or osteoarticular grafts) Country of origin soft tissue (i.e., fascia lata, ligaments, tendons, pericardium, nerves, peritoneal membrane or adipose): dura mater cardiac tissue vascular tissue skin Country of origin Country of origin Country of origin Country of origin Country of origin Indicate the tissue received and the country of origin (tissue from living donors): surgical bone Country of origin skin for allogeneic use autologous bone birth tissue Country of origin Country of origin Country of origin

2015-Tissue Storage. Welcome to the 2015 Tissue Storage survey. Please refer to the following instructions as you complete this section of the survey.

2015-Tissue Storage. Welcome to the 2015 Tissue Storage survey. Please refer to the following instructions as you complete this section of the survey. 2015-Tissue Storage Form Approved OMB No. 0990-0457 Exp. Date 06/30/2020 Welcome to the 2015 Tissue Storage survey. Please refer to the following instructions as you complete this section of the survey.