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Use of Human Anatomical Material (view source)
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Policy No.:'''8007'''<br /> | Policy No.:'''8007'''<br /> | ||
Effective Date: '''08/10/05'''<br /> | Effective Date: '''08/10/05'''<br /> | ||
Revised Date: ''' | Revised Date: '''09/26/19 DRAFT'''<br /> | ||
Reviewed Date: | Reviewed Date: <br /><br /> | ||
<big>'''Appropriate Use of Human Anatomical Material Policy'''</big> | <big>'''Appropriate Use of Human Anatomical Material Policy'''</big> | ||
<br /><br /> | <br /><br /> | ||
== Purpose == | == Purpose == | ||
The purpose of the Appropriate Use of Human Anatomical Material Policy is (1) to establish guidelines to account for all human anatomical material from deceased individuals during initial procurement and use through | The purpose of the Appropriate Use of Human Anatomical Material Policy is (1) to establish guidelines to account for all human anatomical material from deceased individuals during initial procurement and use through final disposition; (2) to ensure that use of human anatomical material meets [http://nebraskalegislature.gov/laws/statutes.php?statute=71-4825 Uniform Anatomical Gift Act], [http://www.osha.gov/SLTC/bloodbornepathogens/standards.html OSHA Bloodborne Pathogen Standard], and other state and federal regulatory standards for the safe and ethical treatment of human anatomical material; (3) to ensure proper handling of human anatomical material; and (4) to protect individuals handling or transporting human anatomical material/specimens from potential exposure to blood and/or body fluids. The [mailto:sglodencarlson@unmc.edu Compliance Officer] of the University of Nebraska Medical Center (UNMC) shall be responsible for implementing and monitoring compliance with this policy. | ||
== Definitions == | == Definitions == | ||
'''''Human Anatomical Material''''' means entire human body or body | '''''Human Anatomical Material''''' means the entire human body or human body segments that are grossly identifiable without the use of any specialized methods of identification. <br /> | ||
'''''Human body segment (part)''''' means a portion of a whole body separated for the purposes of study, evaluation, education or research. Body segments consist of contiguous mixed tissues whose relationships have been altered only at the dissection boundaries.<br /> | '''''Human body segment (part)''''' means a portion of a whole body separated for the purposes of study, evaluation, education or research. Body segments consist of contiguous mixed tissues whose relationships have been altered only at the dissection boundaries.<br /> | ||
'''''Decedent identification number of origin''''' means identification number which was assigned to donor at time of death and which is ultimately traceable to a certified death certificate. | '''''Decedent identification number of origin''''' means identification number which was assigned to donor at time of death and which is ultimately traceable to a certified death certificate. | ||
== Procedures == | == Procedures == | ||
===Procurement of Human Anatomical Material=== | ===Procurement of Human Anatomical Material=== | ||
# Faculty, researchers and staff who need human anatomical material for educational or research purposes shall obtain it from | # Faculty, researchers and staff who need human anatomical material for educational or research purposes shall obtain it from a UNMC Nebraska State Anatomical Board Representative or iEXCEL<sup>SM</sup> Manager, Advanced Simulation Operations. Other methods for obtaining anatomical material is strictly prohibited. | ||
# Any research involving the use of human anatomical material from a living individual requires IRB approval (i.e. amputation, or some post-mortem uses when consent is obtained while the research subject is living). Refer to the [https://net.unmc.edu/rss/ UNMC Guidelines for the Protection of Human Subjects in Research Studies]. Research on cadavers does not require IRB approval. | # Any research involving the use of human anatomical material from a living individual requires IRB approval (i.e. amputation, or some post-mortem uses when consent is obtained while the research subject is living). Refer to the [https://net.unmc.edu/rss/ UNMC Guidelines for the Protection of Human Subjects in Research Studies]and UNMC Policy No. 8013, [[Human Tissue Use and Transfer]]. Research on cadavers does not require IRB approval. The IRB also serves as the privacy board for the institution in the event that the researcher would receive protected health information (HIPAA) about the deceased. Contact the Office of Regulatory Affairs for guidance on how to proceed. | ||
# Individuals shall complete | # Individuals shall complete an Anatomical Tissue Request Form and submit it to a UNMC Nebraska State Anatomical Board Representative or an iEXCEL Anatomical Tissue Request Form and submit to the iEXCEL Manager, Advanced Simulation Operations. | ||
# | # Requests for human anatomical material will be made to the Nebraska State Anatomical Board. If a requested human anatomical material or human body segment cannot be supplied by the Nebraska Anatomical Board, a UNMC Nebraska State Anatomical Board Representative or iEXCEL Manager, Advanced Simulation Operations shall assist in obtaining anatomical material from a source approved by the UNMC Nebraska Anatomical Board Representative. A copy of an approved request signed by a UNMC Nebraska State Anatomical Board Representative or iEXCEL Manager, Advanced Simulation Operations must accompany any requested human anatomical material. | ||
# All human anatomical material shall be identified by the decedent identification number of origin. Identification tags should not be removed, unless temporary removal is necessary to conduct the test/procedure on the material. If identification tags are temporarily removed, the user shall establish another mechanism to account for the material (i.e. the container in which the material is maintained contains the identifier). The identification numbers shall be reaffixed to the material after the test or procedure is complete. If the recipient further subdivides human anatomical material, identification of parts must be maintained. Additional identification tags are available through the Nebraska Anatomical Board or iEXCEL. | |||
# All human anatomical material shall be identified by the decedent identification number of origin. Identification tags should not be removed, unless temporary removal is necessary to conduct the test/procedure on the material. If identification tags are temporarily removed, the user shall establish another mechanism to account for the material (i.e. the container in which the material is maintained contains the identifier). The identification numbers shall be reaffixed to the material after the test or procedure is complete. If the recipient further subdivides human anatomical material, identification of parts must be maintained. Additional identification tags are available through the Nebraska Anatomical Board. | # A UNMC Nebraska State Anatomical Board Representative or the iEXCEL Manager, Advanced Simulation Operations shall maintain a tracking system for human anatomical material, documenting the institutional source of the body or body part, fee schedules and charges of all third party providers, decedent identification number, department body or body part was provided to, purpose of the study, storage facility, estimated and actual date of return, authorization for cremation, and plan for final disposition. | ||
# | # Laboratories using human anatomical material shall maintain an inventory of material received. Inventory logs shall be retained in the department for three years after the return date of the last entry on each sheet. | ||
# Laboratories using human anatomical material shall maintain an inventory of material received | # Costs associated with administration of this policy shall be paid by the requesting party. Costs may include, but are not limited to: procurement and disposition of body parts; development and maintenance of accounting systems; and inspections and other oversight activities necessary to comply with this policy. | ||
# Costs associated with administration of this policy shall be paid by the requesting | # Anatomical material shall not be removed from approved campus facilities. | ||
# | # Transporting Human Anatomical Material <br /> | ||
# Transporting | ::'''i.''' Human anatomical material shall be transported to and from the Nebraska State Anatomical Board to research laboratories in a UNMC-owned vehicle. If a UNMC vehicle is not available, the UNMC Anatomical Board Representative may approve alternative transportation. All human anatomical material obtained from an approved outside source will be delivered directly to the Nebraska State Anatomical Board facility or the Dr. Edwin G. & Dorothy Balbach Davis Global Center. <br /> | ||
::'''i.''' Human anatomical material shall be transported to and from the Nebraska State Anatomical Board to research laboratories in a UNMC-owned vehicle. If a UNMC vehicle is not available, the UNMC Anatomical Board | |||
::'''ii.''' | ::'''ii.''' Anatomical material shall be placed in a primary container with a leak-proof seal that prevents leakage during collection, handling, processing, storage, transport or shipping. The primary container shall then be placed in a secondary leak resistant container that prevents leakage (i.e., a properly sealed zippable plastic bag (like ZIPLOC®, a properly sealed body bag with a minimum 7 mil. thickness or a properly sealed plastic bucket with a screw-on lid, locking lid or a leak-proof lid, disaster bag). The secondary container shall contain absorbent material (i.e., cellulose packing, thick paper towel or cotton wool) which shall be placed around the top, bottom, and sides of the primary container. The secondary container shall have a biohazard label affixed to the container. Frozen specimens, once placed in their secondary container, shall be placed in a cooler with a latchable lid and transported immediately. However, if the specimen is transported on dry ice, a Styrofoam cooler with the lid securely strapped or taped in place, or other container approved by Environmental Health and Safety, shall be used. The outside of the cooler shall be labeled "For Specimens Only" and shall have the biohazard symbol displayed in a prominent place on the container.<br /> | ||
::'''iii.''' Whole bodies and/or larger human anatomical material (limbs) shall be placed in a primary container which is tightly closed and prevents leakage during collection, handling, processing, storage, transport or shipping (i.e., large plastic drum with a seal or screw-top lid or a plastic body bag 7 mil. or thicker). Note that if a plastic body bag is used, these bags are considered to be single-use devices. The primary container shall then be placed in a secondary container which shall prevent leakage (i.e. disaster bag, an air tray with a locking or secured lid). The secondary container shall also contain absorbent material (i.e., cellulose packing, thick paper towel or cotton wool) which shall be placed around the top, bottom and sides of the primary container. If an air tray is used for transport, it may be reused so long as no fluids from the body/anatomical material leak onto the box or the box is otherwise damaged. The secondary container shall have a biohazard label affixed to the container in a prominent place. Specimens shall be transported immediately.<br /> | ::'''iii.''' Whole bodies and/or larger human anatomical material (limbs) shall be placed in a primary container which is tightly closed and prevents leakage during collection, handling, processing, storage, transport or shipping (i.e., large plastic drum with a seal or screw-top lid or a plastic body bag 7 mil. or thicker). Note that if a plastic body bag is used, these bags are considered to be single-use devices. The primary container shall then be placed in a secondary container which shall prevent leakage (i.e. disaster bag, an air tray with a locking or secured lid). The secondary container shall also contain absorbent material (i.e., cellulose packing, thick paper towel or cotton wool) which shall be placed around the top, bottom and sides of the primary container. If an air tray is used for transport, it may be reused so long as no fluids from the body/anatomical material leak onto the box or the box is otherwise damaged. The secondary container shall have a biohazard label affixed to the container in a prominent place. Specimens shall be transported immediately.<br /> | ||
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::'''iv.''' Transportation Documentation<br /> | ::'''iv.''' Transportation Documentation<br /> | ||
:::'''a.''' Whole bodies. The delivery person shall hand-carry the | :::'''a.''' Whole bodies. The delivery person shall hand-carry the Anatomical Tissue Request Form or iEXCEL Anatomical Material Request Form with the donor numbers listed. Upon delivery, the donor numbers shall be checked against the actual donor identification. Any discrepancies shall be reported immediately to the Nebraska State Anatomical Board or the iEXCEL Manager, Advanced Simulation Operations.<br /> | ||
:::'''b.''' Human Anatomical Material Specimens. The | :::'''b.''' Human Anatomical Material Specimens. The Anatomical Tissue Request Form or iEXCEL Anatomical Material Request Form and an itemized list of package contents shall be placed in a watertight receptacle (i.e. a zippable plastic bag or plastic container). These documents shall be placed in the secondary container. Documentation for transportation of human anatomical material should not be separated from the specimen during the transport process.<br /> | ||
::'''v.''' Use of Human Anatomical Material<br /> | ::'''v.''' Use of Human Anatomical Material<br /> | ||
:::'''a.''' Research and educational activities using human bodies or human body parts may only be conducted in facilities with appropriate environmental safeguards. Use of fixed tissue requires proper ventilation.<br /> | :::'''a.''' Research and educational activities using human bodies or human body parts may only be conducted in facilities with appropriate environmental safeguards. Use of fixed tissue requires proper ventilation. <br /> | ||
:::'''b.''' Staff shall follow the UNMC bloodborne pathogen standards when handling human anatomical | :::'''b.''' Staff shall follow the UNMC bloodborne pathogen standards and utilize standard Universal Precautions when handling human anatomical materials. Staff shall maintain a clean and sanitary work environment. All personnel coming in contact with or being exposed to the anatomical material must be listed on the appropriate anatomical material request form. The anatomical material may not be distributed to or handled by anyone who is not listed on the form. Anatomical materials obtained from an outside source will have the serology results, including but not limited to HIV, hepatitis and NAT testing, sent to the department prior to shipping and accompany the anatomical material delivery. These serology results will be reported to the end-user prior to the use of any materials.<br /> | ||
:::'''c.''' Human anatomical material shall be secured within research facilities when staff are not present. Material shall be stored in the primary leak-proof container when not in use.<br /> | :::'''c.''' Human anatomical material shall be secured within research or training facilities when staff are not present. Material shall be stored in the primary leak-proof container when not in use.<br /> | ||
::'''vi.''' Disposition of Human Anatomical Material<br /> | ::'''vi.''' Disposition of Human Anatomical Material<br /> | ||
:::'''a.''' All human anatomical material shall be returned to the State Anatomical Board after use. An accounting of returned material will be conducted. Any irregularities will be reported to the respective department chair and the Compliance Officer.<br /> | :::'''a.''' All human anatomical material obtained from the Nebraska Anatomical Board shall be returned to the State Anatomical Board after use. All human anatomical material obtained from an outside source will be returned to the outside source or an approved crematorium. An accounting of returned material will be conducted. Any irregularities will be reported to the respective department chair and the Compliance Officer.<br /> | ||
:::'''b.''' Body parts may not be distributed to anyone who is not listed on | :::'''b.''' Body parts may not be distributed to anyone who is not listed on either an Anatomical Tissue Request Form or an iEXCEL Anatomical Material Request Form.<br /> | ||
::'''vii.''' Program Inspection/Reporting Violations<br /> | ::'''vii.''' Program Inspection/Reporting Violations<br /> | ||
:::'''a.''' Research laboratories using human anatomical material are subject to no-notice inspection by Environmental Health and Safety, Infection Control, Compliance, and Nebraska State Anatomical Board | :::'''a.''' Research laboratories and training centers using human anatomical material are subject to no-notice inspection by Environmental Health and Safety, Infection Control, Compliance, and Nebraska State Anatomical Board Representatives to verify compliance with this policy.<br /> | ||
:::'''b.''' Policy violations will be reported to the respective department chair, the Compliance Officer, and to the Nebraska State Anatomical Board. Corrective action plans will be developed to address policy violations.<br /> | :::'''b.''' Policy violations will be reported to the respective department chair, the Compliance Officer, and to the Nebraska State Anatomical Board. Corrective action plans will be developed to address policy violations.<br /> | ||
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==Background== | ==Background== | ||
The Uniform Anatomical Gift Act regulates the donation of dead bodies or parts of bodies for transplantation, education and research. There are three types of anatomical gifts: tissue donation including blood, organ donation and whole body donation. The Nebraska State Anatomical Board, located at UNMC, is responsible for the Body Donation Program for the State of Nebraska. UNMC shall follow guidelines set by the Nebraska State Anatomical Board for the use of human anatomical material.<br /> | The Uniform Anatomical Gift Act regulates the donation of dead bodies or parts of bodies for transplantation, education and research. There are three types of anatomical gifts: tissue donation including blood, organ donation and whole body donation. The Nebraska State Anatomical Board, located at UNMC, is responsible for the Body Donation Program for the State of Nebraska. UNMC shall follow guidelines set by the Nebraska State Anatomical Board for the use of human anatomical material.<br /> | ||
The Occupational Safety and Health Act (OSHA) Bloodborne Pathogen Standard (BBP) specifies precautions that shall be observed to prevent contact with blood or other potentially infectious materials. Precautions include use of personal protective equipment (PPE) and implementing engineering and work practice controls. Staff shall follow BBP standards when handling human anatomical material. | The Occupational Safety and Health Act (OSHA) Bloodborne Pathogen Standard (BBP) specifies precautions that shall be observed to prevent contact with blood or other potentially infectious materials. Precautions include use of personal protective equipment (PPE) and implementing engineering and work practice controls. Staff shall follow BBP standards when handling human anatomical material. | ||
==Additional information== | ==Additional information== | ||
*Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer], 402-559-9576 or 402-559-6767 | *Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer], 402-559-9576 or 402-559-6767 | ||
*[ | *[ Anatomical Tissue Request Form] - UNDER CONSTRUCTION | ||
*[ | *[ iEXCEL Anatomical Material Request Form] - UNDER CONSTRUCTION | ||
*[https://net.unmc.edu/rss/ UNMC Guidelines for the Protection of Human Subjects in Research Studies] | |||
This page maintained by [mailto:dpanowic@unmc.edu dkp]. | This page maintained by [mailto:dpanowic@unmc.edu dkp]. | ||