UNR Med Human Biospecimen Transportation Policy

Effective: 2/24/2026

To whom this policy applies

This policy applies to all UNR Med faculty, staff, students, graduate students, residents, fellows, volunteers, licensees, contractors including research personnel involved in the collection, handling, and transportation of human biospecimens for research purposes.

Definitions

Human Biospecimens: Specimens including but not limited to parts of the body like tissue, skin, bone, blood, and muscle, as well as other biological materials obtained from a person, such as blood, urine, or hair. This policy does not apply to the UNR Med Anatomical Donation Program.

Division 6.2 Material (49 CFR 173.134(a)): A material known or reasonably expected to contain a pathogen. A pathogen is a microorganism (including bacteria, viruses, rickettsia, parasites and fungi) or other agents, such as a proteinaceous infectious particle (prion), which can cause disease in humans or animals. A Division 6.2 Material must be assigned to one of the following categories:

Category A: An infectious substance in a form capable of causing permanent disability or life threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs (i.e., Yersinia pestis or Ebola virus)
Biological Substance Category B: An infectious substance that is not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs {i.e., Influenza virus or Salmonella).
Biological product: a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative applicable to the prevention, treatment, or cure of a disease or condition of human beings or animals.
Patient specimen: human or animal material collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. research and biobanking , ensuring adherence to state law, institutional policies, and best practices.

Materials of Trade (MOT) (49 CFR 173.6): Hazardous materials that are carried on motor vehicles for at least one of the following purposes.

To protect the health and safety of the motor vehicle operator or passengers, (e.9. insect repellant, fire extinguishers).
To support the operation or maintenance of motor vehicles/auxiliary. (e.9., engine starting fluid, gasoline, spare battery).
Materials that must be carried by a private motor carrier to directly support a principal business that is not transportation. (Academic and laboratory research, pest control, plumbing, painting).

Division 6.2 Material Exceptions (49 CFR 173.134 (b) (10)): A Division 6.2 material, other than a Category A infectious substance, contained in a patient sample being transported for research, diagnosis, investigational activities, or disease treatment or prevention, or a biological product, when such materials are transported by a private or contract carrier in a motor vehicle used exclusively to transport such materials. Medical or clinical equipment and laboratory products may be transported aboard the same vehicle provided they are properly packaged and secured against exposure or contamination.

MOT Biological Material (49CFR 173,6 (a)(a)): A Division 6.2 material, other than a CategoryA infectious substance, (r.e., biological substance Category B or patient specimen) contained in human or animal samples (including, but not limited to, secreta, excreta, blood and its components, tissue, and tissue fluids, and body parts) being transported for research, diagnosis, investigational activities, or disease treatment or prevention, or is a biological product or regulated medical waste.

Purpose/background

To establish a compliant, safe, and efficient process for transporting human biospecimens from medical facilities in Northern Nevada area to the University of Nevada, Reno School of Medicine for bench research and biobanking, ensuring adherence to state law, institutional policies, and best practices.
This policy applies to all UNR Med faculty, staff, students, graduate students, residents, fellows, volunteers, licensees, contractors including research personnel involved in the collection, handling, and transportation of human biospecimens for research purposes.
Minimize exposure to potential liability for the university and its employees due to the transportation of human biospecimens, and potential exposure to blood borne pathogens.

Policy

Transportation Method: All human biospecimen transportation from medical facilities to UNR Med must be conducted by a licensed medical courier service that meets the following:
1. HIPAA and OSHA compliance.
2. DOT Hazardous Materials certification.
3. Temperature-controlled vehicles or containers.
4. Packaged in leakproof primary containers, absorbent material, and a rigid secondary container with appropriate labeling.
5. Real-time tra~king and documented chain of custody.
6. Only contracted couriers may transport Category A infectious substances.
Approved Vendors: Any licensed medical courier vendors must be pre-approved by EH&S and comply with university regulations.
IRB Compliance: Pis must receive IRB approval, when required, prior to collecting human biospecimens from medical facilities, and must complete and required material transfer usage agreements, which would include details regarding the transportation of such materials.
Pl or Lab Personnel Transportation: Neither the Pl nor staff in the Pl's lab may engage directly in the transportation of human biospecimens from a medical facility to the university. There must be an independent third-party engaged in the transportation process.
Cost Allocation: Transportation costs should be budgeted in grant proposals or other discretionary funds by the Pl or department.
Alternative Method: In exceptional cases where courier service is unavailable, trained and EH&S-authorized personnel may transport Category B biological substance,as defined herein ,by private motor or State-owned vehicles, in compliance with federal , state and local MOT regulations and institutional SOPs.
Category A infectious substances may NOT be transported by private or state owned vehicle.
Use of Private vehicle for Biological Substance Category B under MOT exemption requires:
1. Prior approval from Research Compliance.
2. Documented training and certification (HlPAA, OSHA and DOT Hazardous Materials certificate to include compliance with the Materials of Trade (MOT) exemption
3. Use of approved triple packaging system designated by EH&S, secured in transport against movement and heat exposure, required labeling to include biohazard label, and spill kits.
4. Documented Chain of Custody
5. Compliance with Section 3.4 of this policy
6. Compliance with Risk Management notifications as set forth in UNR UAM 5,100 Vehicle Use Policy
7. Private vehicle used MUST be dedicated to the purpose of transporting the biospecimens from one location to the other, and NOT utilized for any other purposes at the same time. Any authorized passengers must be informed of the presence of the biospecimens being transported. Courtesy rides to individuals are prohibited.
8. In the event of an emergency or vehicle accident:
  - Call for 911 emergency assistance, if needed.
  - Let all emergency responders know that you are transporting potential biohazards.
  - Notify your supervisor.
  - Arrange for alternate transportation if you are not able to get to your destination.
  - A Biological Spill Kit should be available in the vehicle. Minimally the spill kit should include, appropriate gloves, eye protection, absorbent material, and bags for spill debris.
9. When transporting dry ice in a vehicle, the box should not be placed inside the passenger compartment to prevent carbon dioxide accumulation within the vehicle but can be placed in the trunk or open bed of the vehicle
Use of State owned vehicle requires compliance with all provisions of 3.8. ln addition, drivers must comply with State Administrative Manual 0521.0 and UNR UAM 5,100 Vehicle Use Policy to include the Defensive Driving Training requirements.

Review

Approved by Medicol Executive Committee 2/24/2026