Use of Human Anatomical Material: Difference between revisions
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Policy No.:'''8007'''<br /> | |||
Effective Date: '''08/10/05'''<br /> | |||
Revised Date: '''08/10/05'''<br /> | |||
Reviewed Date: '''08/10/05'''<br /><br /> | |||
<big>Appropriate Use of Human Anatomical Material Policy</big> | <big>'''Appropriate Use of Human Anatomical Material Policy'''</big> | ||
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== 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 proper disposal/disposition;(2) to ensure that use of human anatomical material meets [http://uniweb.legislature.ne.gov/laws/search_range_statute.php?begin_section=71-4824&end_section=71-4845 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:swrobel@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 proper disposal/disposition;(2) to ensure that use of human anatomical material meets [http://uniweb.legislature.ne.gov/laws/search_range_statute.php?begin_section=71-4824&end_section=71-4845 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:swrobel@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. | 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 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 entire human body or body segment (part) from a deceased individual.<br /> | |||
'''Human Anatomical Material''' means entire human body or body segment (part) from a deceased individual. | '''''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. | |||
'''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. | |||
'''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=== | |||
# Faculty, researchers and staff who need human anatomical material for educational or research purposes shall obtain it from the UNMC Anatomical Board Representative or the Nebraska State Anatomical Board only. Other methods for obtaining human bodies or body parts directly from other sources is prohibited. | # Faculty, researchers and staff who need human anatomical material for educational or research purposes shall obtain it from the UNMC Anatomical Board Representative or the Nebraska State Anatomical Board only. Other methods for obtaining human bodies or body parts directly from other sources is 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 [ | # 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. | ||
# Individuals shall complete a "[http://webmedia.unmc.edu/policy/requestforhumananatomicalmaterial.pdf Request for Human Anatomical Material]" form and submit it to Nebraska Anatomical Board for approval. | # Individuals shall complete a "[http://webmedia.unmc.edu/policy/requestforhumananatomicalmaterial.pdf Request for Human Anatomical Material]" form and submit it to Nebraska Anatomical Board for approval. | ||
# When human anatomical material is removed from the Anatomical Board facility, a copy of an approved request signed by a member of the Anatomical Board must accompany the body or body part. | # When human anatomical material is removed from the Anatomical Board facility, a copy of an approved request signed by a member of the Anatomical Board must accompany the body or body part. | ||
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#:ii. Body parts 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 Campus 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. | #:ii. Body parts 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 Campus 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. | ||
#:iii. Whole cadavers 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 cadaver bag 7 mil. or thicker). Note that if a plastic cadaver 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 cadaver/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. | #:iii. Whole cadavers 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 cadaver bag 7 mil. or thicker). Note that if a plastic cadaver 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 cadaver/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. | ||
#:iv. Transportation Documentation | #:iv. Transportation Documentation | ||
#::a. Whole bodies. The delivery person shall hand-carry the [http://webmedia.unmc.edu/policy/requestforhumananatomicalmaterial.pdf Request for Human Anatomical Material 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. | #::a. Whole bodies. The delivery person shall hand-carry the [http://webmedia.unmc.edu/policy/requestforhumananatomicalmaterial.pdf Request for Human Anatomical Material 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. | ||
#::b.Human Anatomical Material Specimens. The [http://webmedia.unmc.edu/policy/requestforhumananatomicalmaterial.pdf Request for Human Anatomical Material 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. | #::b.Human Anatomical Material Specimens. The [http://webmedia.unmc.edu/policy/requestforhumananatomicalmaterial.pdf Request for Human Anatomical Material 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. | ||
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#::a. Research laboratories using human anatomical material are subject to no-notice inspection by Safety, Infection Control, Compliance, and Nebraska State Anatomical Board representatives to verify compliance with this policy. | #::a. Research laboratories using human anatomical material are subject to no-notice inspection by Safety, Infection Control, Compliance, and Nebraska State Anatomical Board representatives to verify compliance with this policy. | ||
#::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. | #::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. | ||
#::c. Anyone who knows of or suspects that a violation of this policy has occurred shall notify the Compliance Officer at 559-6767 or the Compliance Hotline at 1-866-568-5430 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 559-6767 or the Compliance Hotline at 1-866-568-5430 so that an investigation can be conducted and corrective action taken as appropriate. | ||
==Additional information== | |||
[http://webmedia.unmc.edu/policy/requestforhumananatomicalmaterial.pdf Request for Human Anatomical Material] | *[mailto:swrobel@unmc.edu Compliance Officer]. | ||
*[http://webmedia.unmc.edu/policy/requestforhumananatomicalmaterial.pdf Request for Human Anatomical Material] | |||
*[http://webmedia.unmc.edu/policy/DepartmentalInventory.pdf Departmental Inventory for Human Bodies and Body Parts] | |||
This page maintained by [mailto:dpanowic@unmc.edu dkp]. | This page maintained by [mailto:dpanowic@unmc.edu dkp]. | ||