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Use of Human Anatomical Material: Difference between revisions
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: '''10/23/19'''<br /> | ||
Reviewed Date: <br /><br /> | Reviewed Date: '''10/23/19'''<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 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:mailto:sarah.glodencarlson@unmc.edu Compliance Officer] of the University of Nebraska Medical Center (UNMC) shall be responsible for implementing and monitoring compliance with this policy. | 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:mailto:sarah.glodencarlson@unmc.edu Compliance Officer] of the University of Nebraska Medical Center (UNMC) shall be responsible for implementing and monitoring compliance with this policy. | ||
==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 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. | |||
== Definitions == | == Definitions == | ||
'''''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 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 /> | ||
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== 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 a UNMC Nebraska State Anatomical Board Representative or iEXCEL<sup>SM</sup> Manager, Advanced Simulation Operations. Other methods for obtaining anatomical material | # 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 are 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]and UNMC Policy No. 8013, [[Human Tissue Use and Transfer]]. Research on cadavers does not require IRB approval. The IRB | # 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, however, does serve 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 an Anatomical Tissue Request Form and submit it to a UNMC Nebraska State Anatomical Board Representative or an iEXCEL Anatomical | # Individuals shall complete an [https://www.unmc.edu/academicaffairs/_documents/compliance/AnatomicalTissueRequestForm.pdf Anatomical Tissue Request Form] and submit it to a UNMC Nebraska State Anatomical Board Representative or an [https://www.unmc.edu/academicaffairs/_documents/compliance/iEXCELAnatomicalMaterialRequestForm.pdf iEXCEL Anatomical Material 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. | # 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 or iEXCEL. | ||
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::'''iv.''' Transportation Documentation<br /> | ::'''iv.''' Transportation Documentation<br /> | ||
:::'''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 /> | :::'''a.''' Whole bodies. The delivery person shall hand-carry the [https://www.unmc.edu/academicaffairs/_documents/compliance/AnatomicalTissueRequestForm.pdf Anatomical Tissue Request Form] or [https://www.unmc.edu/academicaffairs/_documents/compliance/iEXCELAnatomicalMaterialRequestForm.pdf 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 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 /> | :::'''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 /> | ||
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::'''vi.''' Disposition of Human Anatomical Material<br /> | ::'''vi.''' Disposition of Human Anatomical Material<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 /> | :::'''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 by the State Anatomical Board or iEXCEL, 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 either an Anatomical Tissue Request Form or an iEXCEL Anatomical Material Request Form.<br /> | :::'''b.''' Body parts may not be distributed to anyone who is not listed on either an [https://www.unmc.edu/academicaffairs/_documents/compliance/AnatomicalTissueRequestForm.pdf Anatomical Tissue Request Form] or | ||
an [https://www.unmc.edu/academicaffairs/_documents/compliance/iEXCELAnatomicalMaterialRequestForm.pdf iEXCEL Anatomical Material Request Form].<br /> | |||
::'''vii.''' Program Inspection/Reporting Violations<br /> | ::'''vii.''' Program Inspection/Reporting Violations<br /> | ||
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:::'''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 /> | ||
:::'''c.''' Anyone who knows of or suspects that a violation of this policy has occurred shall notify the Compliance Officer at 402-559-9576 or 402-559-6767 or the Compliance Hotline at 1-844-348-9584 or www.nebraska.ethicspoint.com so that an investigation can be conducted and corrective action taken as appropriate. | :::'''c.''' Anyone who knows of or suspects that a violation of this policy has occurred shall notify the Compliance Officer at 402-559-9576 or 402-559-6767 or the Compliance Hotline at 1-844-348-9584 or www.nebraska.ethicspoint.com so that an investigation can be conducted and corrective action taken as appropriate. | ||
==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] | *[https://www.unmc.edu/academicaffairs/_documents/compliance/AnatomicalTissueRequestForm.pdf Anatomical Tissue Request Form] | ||
*[ iEXCEL Anatomical Material Request Form] | *[https://www.unmc.edu/academicaffairs/_documents/compliance/iEXCELAnatomicalMaterialRequestForm.pdf iEXCEL Anatomical Material Request Form] | ||
*[https://net.unmc.edu/rss/ UNMC Guidelines for the Protection of Human Subjects in Research Studies] | *[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]. | ||