Use of Human Anatomical Material: Difference between revisions

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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: '''07/21/23'''<br />
Revised Date: draft 04/03/24<br />
Reviewed Date: '''07/21/23'''<br /><br />
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) 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: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: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==
==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.
 
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 [https://www.unmc.edu/iexcel/_documents/anatomical-tissue-policies/iexcel-tissue-procurement-standards-of-practice-agreement.pdf iEXCEL Tissue Procurement Standards of Practice Agreement].<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.  
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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> Advanced Surgical Simulation Manager. Other methods for obtaining anatomical material are strictly prohibited. All Human Anatomical Tissue Suppliers must be reviewed and unanimously approved by the Human Anatomical Tissue Review Committee.
1. Faculty, researchers and staff who need human anatomical material for educational or research purposes involving UNMC students shall obtain it from a UNMC Nebraska State Anatomical Board Representative. Faculty, researchers, staff and contracted vendors who require human anatomical material for educational or research purposes, not involving UNMC students, within the Davis Global Center shall work with the iEXCEL Advanced Surgical Simulation Manager to obtain the human anatomical material. All other methods for obtaining anatomical material are strictly prohibited. All Human Anatomical Tissue Suppliers must be reviewed by either a UNMC Nebraska State Anatomical Board member when students are involved or the iEXCEL Human Anatomical Tissue Review Committee otherwise.
# 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 [https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf Anatomical Tissue Request Form] and submit it to a UNMC Nebraska State Anatomical Board Representative or an [https://www.unmc.edu/iexcel/_documents/iexcel-anatomical-material-request-form.pdf iEXCEL Anatomical Material Request Form] and submit to the iEXCEL Advanced Surgical Simulation Manager.
2. 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 about the deceased. Contact the Office of Regulatory Affairs for guidance on how to proceed.
# 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 Advanced Surgical Simulation Manager shall assist in obtaining anatomical material from a source unanimously approved by the Human Anatomical Tissue Review Committee which contains members from UNMC iEXCEL and UNMC Nebraska Anatomical Board Representatives. A copy of an approved request signed by a UNMC Nebraska State Anatomical Board Representative or iEXCEL Advanced Surgical Simulation Supervisor must accompany any requested human anatomical material.
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# 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.
3. Individuals shall complete an [https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf Anatomical Tissue Request Form] and submit it to a UNMC Nebraska State Anatomical Board Representative or an [https://www.unmc.edu/iexcel/_documents/iexcel-anatomical-material-request-form.pdf iEXCEL Anatomical Material Request Form] and submit to the iEXCEL Advanced Surgical Simulation Manager.
# A UNMC Nebraska State Anatomical Board Representative or the iEXCEL Advanced Surgical Simulation Manager 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.
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# 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.
4. '''1.''' Human anatomical material obtained from a UNMC Nebraska State Anatomical Board representative: 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 shall assist in obtaining anatomical material from a source unanimously approved by the Human Anatomical Tissue Review Committee. A copy of an approved request signed by a UNMC Nebraska State Anatomical Board Representative must accompany any requested human anatomical material. All requests for sessions at the Davis Global Center including University students will be made directly to the Nebraska State Anatomical Board by faculty lead.  If human anatomical materials are to be used in the Davis Global Center, transportation to and from the Center shall be arranged by a Nebraska State Anatomical Board member.
# 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.
::
# Anatomical material shall not be removed from approved campus facilities.
:  '''2.''' Human anatomical material obtained from the iEXCEL Human Anatomical Tissue Review Committee: Requests for human anatomical material for teaching and training purposes (not involving University students) within the Davis Global Center will be made to iEXCEL through submission of the [https://www.unmc.edu/iexcel/_documents/anatomical-tissue-policies/anatomical-material-request-form-iexcel.pdf iEXCEL Anatomical Material Request Form] to the iEXCEL Manager, Advanced Surgical Simulation Operations. The iEXCEL Human Anatomical Tissue Review Committee requires completion of a [https://www.unmc.edu/iexcel/_documents/anatomical-tissue-policies/iexcel-tissue-procurement-standards-of-practice-agreement.pdf Tissue Procurement Standards of Practice Agreement]. 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 scheduled and received by the iEXCEL Manager, Advanced Surgical Simulation Operations and follow a strict receiving process ([https://www.unmc.edu/iexcel/_documents/anatomical-tissue-policies/iexcel-surgical-specimen-receipt-flow.pdf iEXCEL Surgical Specimen Receipt Flow]).
# Transporting Human Anatomical Material <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 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 />
5. 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.
::
6. A UNMC Nebraska State Anatomical Board Representative or the iEXCEL Advanced Surgical Simulation Manager 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, the department, the 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.
::
7. 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.
::
8. 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 body parts; development and maintenance of accounting systems; and inspections and other oversight activities necessary to comply with this policy.
::
9.Anatomical material shall not be removed from approved campus facilities.
::
10. Transporting Human Anatomical Material
 
::'''i.''' Human anatomical material obtained from a UNMC Nebraska State Anatomical Board representative 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.  Human anatomical material obtained from iEXCEL Human Anatomical Tissue Review Committee will be scheduled and received by the iEXCEL Manager, Advanced Surgical Simulation Operations and follow a strict receiving process ([https://www.unmc.edu/iexcel/_documents/anatomical-tissue-policies/iexcel-surgical-specimen-receipt-flow.pdf iEXCEL Surgical Specimen Receipt Flow]).


::'''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 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 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 />
::'''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 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 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 6 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 6 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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