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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: '''01/24/18 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 /> | ||
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===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 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 [https://net.unmc.edu/rss/ UNMC Guidelines for the Protection of Human Subjects in Research Studies]. | # 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. 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 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. | ||
# If a requested body or body part | # If a requested body or body part cannot be supplied by the Nebraska Anatomical Board, the UNMC Anatomical Board representative shall assist in obtaining bodies or body parts from reputable sources, using criteria approved by the Nebraska State Anatomical Board. A copy of an approved request signed by a member of the Anatomical Board must accompany the body or body part at all times. | ||
# 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. | # 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. | ||
# The UNMC Anatomical Board representative 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 part was provided to, purpose of the study, storage facility, estimated and actual date of return, authorization for cremation, and plan for final disposition. | # The UNMC Anatomical Board representative 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 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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# Transporting Human Anatomical Material<br /> | # 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. | #: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. | ||
#: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 | #: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 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. | ||
#: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. | #::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. | ||
#:v. Use of Human Anatomical Material | #:v. Use of Human Anatomical Material | ||
#::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. | #::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. | ||
#::b. Staff shall follow the UNMC bloodborne pathogen standards when handling human anatomical material and 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 [http://webmedia.unmc.edu/policy/requestforhumananatomicalmaterial.pdf Request for Human Anatomical Material form]. The anatomical material may not be distributed to or handled by anyone who is not listed on the form. | #::b. Staff shall follow the UNMC bloodborne pathogen standards when handling human anatomical material and 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 [http://webmedia.unmc.edu/policy/requestforhumananatomicalmaterial.pdf Request for Human Anatomical Material form]. The anatomical material may not be distributed to or handled by anyone who is not listed on the form. | ||
#::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. | #::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. | ||
#:vi. Disposition of Human Anatomical Material | #:vi. Disposition of Human Anatomical Material | ||
#::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. | #::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. | ||
#::b. Body parts may not be distributed to anyone who is not listed on the [http://webmedia.unmc.edu/policy/requestforhumananatomicalmaterial.pdf Request for Human Anatomical Material form]. | #::b. Body parts may not be distributed to anyone who is not listed on the [http://webmedia.unmc.edu/policy/requestforhumananatomicalmaterial.pdf Request for Human Anatomical Material form]. | ||
#:vii. Program Inspection/Reporting Violations | #:vii. Program Inspection/Reporting Violations | ||
#::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 Environmental Health and 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- | #::c. Anyone who knows of or suspects that a violation of this policy has occurred shall notify the Compliance Officer at 559-9576 or 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] | *Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer] | ||