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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: draft 10/18/24<br /> | ||
Reviewed Date: | Reviewed Date: <br /><br /> | ||
<big>'''Appropriate Use of Human Anatomical Material Policy'''</big><br /><br /> | <big>'''Appropriate Use of Human Anatomical Material Policy'''</big><br /><br /> | ||
== Purpose == | == Purpose == | ||
The purpose of the Appropriate Use of Human Anatomical Material Policy is (1) | Anatomical gifts include both living (organ and tissue donation) and non-living (whole body donation). The purpose of the Appropriate Use of Human Anatomical Material Policy is to address non-living, whole body donation and to (1) establish guidelines to account for all human anatomical material from human body donors during initial procurement through final disposition; (2) to ensure that use of human anatomical material meets [https://www.osha.gov/bloodborne-pathogens OSHA Bloodborne Pathogen Standard] and local, state, and federal regulatory standards for the safe and ethical treatment of human anatomical material; (3) to ensure proper handling and disposition of human anatomical material; and (4) to protect individuals handling or transporting human anatomical material from potential exposure to blood and/or body fluids. The [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. | ||
Most research involving the use of human anatomical material from a living individual requires IRB approval. The Office of Regulatory Affairs should be contacted prior to initiating any research using tissue from living individuals. Refer to the [https://net.unmc.edu/rss/auth.php UNMC Guidelines for the Protection of Human Subjects in Research] Studies and UNMC Policy No. 8013, [https://wiki.unmc.edu/index.php/Human_Tissue_Use_and_Transfer Human Tissue Use and Transfer]. Research on whole body donors does not require IRB approval; however, the IRB, does serve as the privacy board for the institution if the researcher would receive protected health information about the deceased. | |||
==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. | 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. | ||
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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. | ||
== Definitions == | == Definitions == | ||
* '''''Human Anatomical Material''''' means the entire human body or human body segments of a human body donor that are grossly identifiable without the use of any specialized methods of identification. | |||
* '''''Human body segment (part)''''' means a portion of a whole human body donor 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. | |||
* '''''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 == | |||
=== Procurement of Human Anatomical Material === | |||
Faculty, researchers, and staff who need human anatomical material for educational or research purposes shall obtain it via one of the two ways listed below. All other methods for obtaining human anatomical material are strictly prohibited. | |||
1.The submission of a completed Anatomical Tissue Request Form to a UNMC Nebraska State Anatomical Board Representative. | |||
* A UNMC Nebraska State Anatomical Board Representative may obtain human anatomical material from the Nebraska State Anatomical Board. | |||
* If the proximity of the research or educational facility requires vehicle transport, human anatomical material obtained from a UNMC Nebraska State Anatomical Board representative shall be transported to and from the Nebraska State Anatomical Board to a research or educational facility in a UNMC-owned vehicle. If a UNMC vehicle is not available, the UNMC Anatomical Board Representative may approve alternative transportation. | |||
* A UNMC Nebraska State Anatomical Board Representative shall maintain a tracking system for the obtained human anatomical material. | |||
* Disposition will include the return of all human anatomical material obtained to the Nebraska State Anatomical Board. | |||
* Costs associated with the administration of this policy shall be paid by the requesting party. Costs may include but are not limited to: procurement and disposition of the human anatomical material, development and maintenance of accounting systems, and inspections and other oversight activities necessary to comply with this policy. | |||
2.The submission of a completed iEXCEL Anatomical Material Request Form to the iEXCEL Advanced Surgical Simulation Manager. | |||
* The iEXCEL Advanced Surgical Simulation Manager will obtain human anatomical material from sources approved by the iEXCEL Human Anatomical Tissue Review Committee. The iEXCEL Human Anatomical Tissue Review Committee requires a Tissue Procurement Standards of Practice Agreement from each approved source for tissue. | |||
* A copy of an approved request, signed by the iEXCEL Manager of Advanced Simulation Operations, must accompany any requested human anatomical material. | |||
* All human anatomical material will be ordered and received by the iEXCEL Manager, Advanced Surgical Simulation Operations as described on the iEXCEL Surgical Specimen Receipt Flow. All human anatomical material obtained will be delivered directly to the Dr. Edwin G. & Dorothy Balbach Davis Global Center. All human anatomical material will be confirmed and itemized when received. Any discrepancies shall be reported immediately to the iEXCEL Advanced Surgical Simulation Manager and the tissue supplier. | |||
* The iEXCEL Advanced Surgical Simulation Manager shall maintain a tracking system for human anatomical material, documenting the institutional source of the whole body or human body segment(s), fee schedules and charges of all third-party providers, decedent identification number, the department the anatomical material was provided to, purpose of the study, storage facility, estimated and actual date of return, authorization for cremation, and plan for final disposition. | |||
* Disposition of all human anatomical will include the use of a local crematorium approved by the iEXCEL Human Anatomical Tissue Review Committee. Accounting and return of cremated human anatomical material, to the institutional source of the human anatomical material, will be conducted by the iEXCEL Advanced Surgical Simulation Manager. | |||
* Costs associated with the administration of this policy shall be paid by the requesting party. Costs may include but are not limited to procurement and disposition of the human anatomical material; development and maintenance of accounting systems; and inspections and other oversight activities necessary to comply with this policy. | |||
=== Transportation of Human Anatomical Material === | |||
* Documentation for transportation of human anatomical material should not be separated from the anatomical material during the transport process. The relevant request form and an itemized list of 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. | |||
* 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 6 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 anatomical material, once placed in their secondary container, shall be placed in a cooler with a latchable lid and transported immediately. If the anatomical material is transported on dry ice, a Styrofoam container and sturdy outer container (i.e., fiberboard box) shall be used. [TM1] The outside of the cooler shall be labeled "For Anatomical Material Only" and shall have the biohazard symbol displayed in a prominent place on the container. | |||
* Human anatomical material or large human body segment 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 6 mil. or thicker). Note that if a plastic body bag is used, these bags are 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. Anatomical material shall be transported immediately. | |||
=== Security, Storage, and Safety of 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. | |||
* 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 or per the contract with an institutional tissue source. Human anatomical material shall not be removed from approved campus facilities. | |||
* 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. | |||
* Research and educational events using human anatomical material may only be conducted in facilities with appropriate environmental safeguards. Use of fixed tissue requires proper ventilation. Events 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 human anatomical material must be listed on the appropriate anatomical material request form. The human anatomical material may not be distributed to or handled by anyone who is not listed on the form. Serology testing, including but not limited to HIV, hepatitis, and NAT, of all lightly embalmed and fresh/frozen human anatomical materials is required. Serology results will be reported to the end-user prior to the use of any lightly embalmed and fresh/frozen 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. | |||
''' ''' | |||
=== '''Policy Inspection and Reporting of Violations''' === | |||
* Research laboratories and training centers using human anatomical material are subject to no-notice inspection by UNMC Environmental Health and Safety, Infection Control, and Compliance to verify compliance with this policy. | |||
* Policy violations will be reported to the respective leadership and the Compliance Officer. Corrective action plans will be developed to address policy violations. | |||
* 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. | |||
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==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 | ||
Revision as of 09:09, October 18, 2024
| Human Resources | Safety/Security | Research Compliance | Compliance | Privacy/Information Security | Business Operations | Intellectual Property | Faculty |
Compliance Program | Compliance Hotline | Investigations by Third Parties | Research Integrity | Export Control | Code of Conduct | Use of Human Anatomical Material | Clinical Research and Clinical Trial Professional and Technical Fee Billing | Contracts | Conflict of Interest | Red Flag Identity Theft Prevention Program | Principles of Financial Stewardship | Human Tissue Use and Transfer | Disclosing Foreign Support and International Activities | Health Care Vendor Interactions | Credit Hour Definition | Whistleblower |Electronic Digital Signatures and Records
Policy No.: 8007
Effective Date: 08/10/05
Revised Date: draft 10/18/24
Reviewed Date:
Appropriate Use of Human Anatomical Material Policy
Purpose
Anatomical gifts include both living (organ and tissue donation) and non-living (whole body donation). The purpose of the Appropriate Use of Human Anatomical Material Policy is to address non-living, whole body donation and to (1) establish guidelines to account for all human anatomical material from human body donors during initial procurement through final disposition; (2) to ensure that use of human anatomical material meets OSHA Bloodborne Pathogen Standard and local, state, and federal regulatory standards for the safe and ethical treatment of human anatomical material; (3) to ensure proper handling and disposition of human anatomical material; and (4) to protect individuals handling or transporting human anatomical material from potential exposure to blood and/or body fluids. The Compliance Officer of the University of Nebraska Medical Center (UNMC) shall be responsible for implementing and monitoring compliance with this policy.
Most research involving the use of human anatomical material from a living individual requires IRB approval. The Office of Regulatory Affairs should be contacted prior to initiating any research using tissue from living individuals. Refer to the UNMC Guidelines for the Protection of Human Subjects in Research Studies and UNMC Policy No. 8013, Human Tissue Use and Transfer. Research on whole body donors does not require IRB approval; however, the IRB, does serve as the privacy board for the institution if the researcher would receive protected health information about the deceased.
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.
iEXCEL will obtain human anatomical material, for training sessions (not involving University of Nebraska Medical Center students) through vendors approved by the iEXCEL Human Anatomical Tissue Review Committee and that have signed the iEXCEL Tissue Procurement Standards of Practice Agreement.
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
- Human Anatomical Material means the entire human body or human body segments of a human body donor that are grossly identifiable without the use of any specialized methods of identification.
- Human body segment (part) means a portion of a whole human body donor 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.
- 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
Procurement of Human Anatomical Material
Faculty, researchers, and staff who need human anatomical material for educational or research purposes shall obtain it via one of the two ways listed below. All other methods for obtaining human anatomical material are strictly prohibited.
1.The submission of a completed Anatomical Tissue Request Form to a UNMC Nebraska State Anatomical Board Representative.
- A UNMC Nebraska State Anatomical Board Representative may obtain human anatomical material from the Nebraska State Anatomical Board.
- If the proximity of the research or educational facility requires vehicle transport, human anatomical material obtained from a UNMC Nebraska State Anatomical Board representative shall be transported to and from the Nebraska State Anatomical Board to a research or educational facility in a UNMC-owned vehicle. If a UNMC vehicle is not available, the UNMC Anatomical Board Representative may approve alternative transportation.
- A UNMC Nebraska State Anatomical Board Representative shall maintain a tracking system for the obtained human anatomical material.
- Disposition will include the return of all human anatomical material obtained to the Nebraska State Anatomical Board.
- Costs associated with the administration of this policy shall be paid by the requesting party. Costs may include but are not limited to: procurement and disposition of the human anatomical material, development and maintenance of accounting systems, and inspections and other oversight activities necessary to comply with this policy.
2.The submission of a completed iEXCEL Anatomical Material Request Form to the iEXCEL Advanced Surgical Simulation Manager.
- The iEXCEL Advanced Surgical Simulation Manager will obtain human anatomical material from sources approved by the iEXCEL Human Anatomical Tissue Review Committee. The iEXCEL Human Anatomical Tissue Review Committee requires a Tissue Procurement Standards of Practice Agreement from each approved source for tissue.
- A copy of an approved request, signed by the iEXCEL Manager of Advanced Simulation Operations, must accompany any requested human anatomical material.
- All human anatomical material will be ordered and received by the iEXCEL Manager, Advanced Surgical Simulation Operations as described on the iEXCEL Surgical Specimen Receipt Flow. All human anatomical material obtained will be delivered directly to the Dr. Edwin G. & Dorothy Balbach Davis Global Center. All human anatomical material will be confirmed and itemized when received. Any discrepancies shall be reported immediately to the iEXCEL Advanced Surgical Simulation Manager and the tissue supplier.
- The iEXCEL Advanced Surgical Simulation Manager shall maintain a tracking system for human anatomical material, documenting the institutional source of the whole body or human body segment(s), fee schedules and charges of all third-party providers, decedent identification number, the department the anatomical material was provided to, purpose of the study, storage facility, estimated and actual date of return, authorization for cremation, and plan for final disposition.
- Disposition of all human anatomical will include the use of a local crematorium approved by the iEXCEL Human Anatomical Tissue Review Committee. Accounting and return of cremated human anatomical material, to the institutional source of the human anatomical material, will be conducted by the iEXCEL Advanced Surgical Simulation Manager.
- Costs associated with the administration of this policy shall be paid by the requesting party. Costs may include but are not limited to procurement and disposition of the human anatomical material; development and maintenance of accounting systems; and inspections and other oversight activities necessary to comply with this policy.
Transportation of Human Anatomical Material
- Documentation for transportation of human anatomical material should not be separated from the anatomical material during the transport process. The relevant request form and an itemized list of 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.
- 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 6 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 anatomical material, once placed in their secondary container, shall be placed in a cooler with a latchable lid and transported immediately. If the anatomical material is transported on dry ice, a Styrofoam container and sturdy outer container (i.e., fiberboard box) shall be used. [TM1] The outside of the cooler shall be labeled "For Anatomical Material Only" and shall have the biohazard symbol displayed in a prominent place on the container.
- Human anatomical material or large human body segment 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 6 mil. or thicker). Note that if a plastic body bag is used, these bags are 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. Anatomical material shall be transported immediately.
Security, Storage, and Safety of 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.
- 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 or per the contract with an institutional tissue source. Human anatomical material shall not be removed from approved campus facilities.
- 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.
- Research and educational events using human anatomical material may only be conducted in facilities with appropriate environmental safeguards. Use of fixed tissue requires proper ventilation. Events 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 human anatomical material must be listed on the appropriate anatomical material request form. The human anatomical material may not be distributed to or handled by anyone who is not listed on the form. Serology testing, including but not limited to HIV, hepatitis, and NAT, of all lightly embalmed and fresh/frozen human anatomical materials is required. Serology results will be reported to the end-user prior to the use of any lightly embalmed and fresh/frozen 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.
Policy Inspection and Reporting of Violations
- Research laboratories and training centers using human anatomical material are subject to no-notice inspection by UNMC Environmental Health and Safety, Infection Control, and Compliance to verify compliance with this policy.
- Policy violations will be reported to the respective leadership and the Compliance Officer. Corrective action plans will be developed to address policy violations.
- 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
- Contact the Chief Compliance Officer, 402-559-9576 or 402-559-6767
- Anatomical Tissue Request Form
- iEXCEL Anatomical Material Request Form
- UNMC Guidelines for the Protection of Human Subjects in Research Studies
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