SAFETY TIPS FOR CLINICAL RESEARCH PERSONNEL:

SAMPLE COLLECTION & TRANSPORT

Infectious agents that may be present in human body fluids may be spread from person-to-person
indirectly through hygiene breaks, or directly through injuries involving contaminated sharp items or
splashes to the eyes, nose or mouth. This document outlines practices that will minimize your
exposure risk to human body fluids when collecting and transporting human-derived materials
(samples) to support clinical research protocols.

1. Know before you go.

a. Review your protocol thoroughly ahead of time and ensure that you have assembled all
sample collection and safety-related supplies that you will need before your sample
collection appointment. Ensure that all items are in good working order.
b. If your role will require you to enter a patient care area, ensure that you have all the
information that you need regarding additional safety practices or logistical restrictions.
Your PI or Study Coordinator should be able to assist with this.
c. Whenever permitted by protocol, do any manual tasks required for the sample collection
(such as preparing labels, organizing forms, etc.) ahead of time. In doing so, you will
reduce the potential to inadvertently handle these items once you are wearing gloves and
handling sample materials.

2. Contain samples to protect yourself and others.

a. When planning your sample collection and transport tasks, consider all the ways that a
release of materials could occur and adopt the use of devices that would contain a spill.
For point of collection activities, work over a tray or plastic backed disposable pad. Adopt
practices or use devices (such as racks) that will keep primary containers upright when
protocol permits.
b. For non-sharps procedure waste collection (i.e., gloves, packaging, tips, towelettes, etc.),
line a small, solid-walled container constructed of cleanable material (i.e., plastic) with a
small biohazard bag (zip-loc style recommended). For ease of transport, select a container
with a secure lid. Deposit wastes directly into the lined container as generated. At the
conclusion of procedures, and after disinfection is complete, securely close the bag. The
waste bag needs to be placed in a securely closed, solid walled secondary container with a
biohazard label for transport to a location where it can be discarded with other
biohazardous waste.
c. For specimen transport, the provisions of Transporting Clinical Research Samples from
Offsite Locations or Transporting Biological Research Materials on Campus must be
followed as applicable to the situation. Additional pointers for sample transport include:
• If you must transport specimens in a personal vehicle, these materials are subject
to Department of Transportation’s Hazardous Materials Regulations. You must
keep a copy of the Transporting Clinical Research Samples from Offsite Locations
document with your materials while in transit.
• If your samples need to be kept cold, avoid the use of wet ice and place ice packs in
a zip-loc style bag to minimize the potential for condensation in the container.

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 • If your outer transport container does not have a positive means of closure, secure
it closed for transport. Packing tape or straps are good alternatives.
• If your outer transport container does not have a gasketed seal (some may not,
especially if dry ice is necessary), then ensure that primary containers are
contained in a closed plastic bag.
• Don’t use double-bagging, Styrofoam containers or cardboard boxes as a substitute
for a solid-walled, cleanable, securely closed secondary container. The only
exception to this would be a scenario where your study protocol permits you to
package samples at the point of collection for immediate shipment. If this scenario
applies, you should be currently IATA-trained and certified to ship clinical samples.
See this link for more information regarding shipping requirements.

3. Wear personal protective equipment (PPE) suitable for the task at hand.
a. Minimally, all sample collection tasks will require the use of fluid-resistant disposable
gloves. Make sure that you have gloves available in your size. Also, have at least 2 pair
more than you will need to perform the procedure.
b. In the case of collecting or handling samples from a known infected source, double-gloving
is recommended if technically feasible. By double-gloving, you can easily reduce
contamination spread by removing the outer layer after the sample has been collected.
This will allow you to continue with sample handling procedures without having to wash
hands and re-glove for the remaining steps.
c. Don’t wear gloves in public areas if possible. If you are carrying a transport container and
prefer to handle that with a gloved hand, ensure that your other hand is not gloved so that
you do not inadvertently touch door handles, elevator buttons, or common contact
surfaces with a gloved hand. Don’t handle your cell phone or any other personal items
with gloved hands. NOTE: See VUMC Infection Control Guidance: Clinical Personnel (PPE
and hygiene) link at end of this document for more information regarding SARS-CoV-2 PPE
requirements if this applies to your studies.
d. Always wash your hands (preferably with soap and running water) after glove removal.
Collect used gloves in a biohazard bag for disposal.
e. Additional PPE may be required depending on the task. Safety glasses and a body covering
that is impermeable to body fluids should be worn if any sample handling steps at the
point of collection may create a splash or spray.

4. Don’t get stuck: practice sharps safety.

a. If your collection activities will require the use of a sharp (especially needle/syringe sets),
ensure that you fully understand the device design and are proficient in using the device in
a way that is safe for you and the subject. Seek assistance from your PI or designated
trainer for the study when in doubt.
b. Place a sharps container (in good working order and not overfilled) within arm’s reach
before assembling a sharp for use. Discard the sharp immediately into that container after
use.
c. Do not bend, break, recap or re-sheath a sharp device. Putting physical stress on a sharp
device or moving your hands in a manner that will put your non-dominant hand in front of
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 the blade or needle can result in injury. Learn more about sharps safety practices at this
link.

5. Prepare for the unexpected (spills and exposure).

a. While the potential for spills and exposures may seem low, these can occur during sample
collection and transport, especially if blood draws or bulk body fluid samples are part of
the study. Reduce your spill potential by always using secondary containers as outlined in
point2.
b. Ensure that you have spill cleanup supplies assembled and available that would be
sufficient and appropriate for the largest spill that could occur. Minimally, supplies should
include the following:
• extra biohazard bags,
• extra fluid-resistant gloves,
• safety glasses,
• paper towels or other absorbent,
• extra disinfectant, and
• a small broom and dustpan.

More information about biomaterial spill kit assembly and procedures can be found at this
link.
c. If during the course of your sample collection and transport activities an incident occurs
that exposes you to human body fluids through a sharps-related injury or splash to the
eyes, nose or mouth, take the following steps:
• Immediately flush/cleanse the exposure site with running water (and soap if it was
a cut or puncture) for 15 minutes. Apply first aid if needed.
• Notify your supervisor (if available) and report immediately to the Vanderbilt
Occupational Health Clinic (7 am to 5:30 pm; Monday through Friday), or
Vanderbilt Adult Emergency Room (if outside the OHC hours of operation).
NOTE: If you will be collecting samples from locations outside the metro Nashville
area, you will want to verify with your PI or Study Coordinator ahead of time what
your options are for exposure follow up.

6. Leave no contamination behind. (Disinfection)

a. At the conclusion of any procedures where samples were collected or handled, all “touch
points” should be cleaned and disinfected. This includes surfaces where the samples,
wastes and sharps container (if applicable) were placed and any items in the immediate
area that may have been impacted. Because of this, it’s important when setting up your
“workstation” to select an area with minimal non-essential or personal items and to
remove items that cannot be easily cleaned and disinfected (like cloth-covered furniture).
b. Use a ready-to-use disinfectant that is EPA-rated for destruction of viruses including SARS-
CoV-2. Examples of listed products include: Super Sani-Cloths, Virex and most Lysol
products. You can determine the rating of your product by cross-checking the EPA
registration number from the product label with EPA’s list at this link.
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 c. Disinfection is only effective if visible contaminants are removed first. Remove visible
contamination, then apply disinfectant and leave it wet for the contact time stated on the
product label.
d. Remember that most disinfectants have a hazardous chemical component. For your safety
and the safety of your subjects, ensure that you:
• Review the Safety Data Sheet (SDS) for the product that you are using and have a
copy available if questions arise.
• Wear gloves when handling the product.
• Close the container and store/transport this in an upright fashion (secondary
container/spill containment is also advised).

COVID-19 Considerations
If you are collecting and/or transporting samples to support a study involving subjects who are known or
strongly suspected to have COVID-19, visit these links for additional considerations that may apply:
VICTR COVID-19 Guidance: Human Subjects Research
https://victr.vumc.org/covid-19-guidance-for-the-vanderbilt-research-community/
VUMC Infection Control Guidance: Clinical Personnel (PPE and hygiene)
https://www.vumc.org/coronavirus/clinical-guidance
VEHS Biosafety Guidance: COVID-19 Sample Handling in Research Labs (Biosafety
Action Grid)
https://www.vumc.org/safety/bio/emerging-infectious-agents

FULL LINKS MENTIONED IN THIS DOCUMENT

Transporting Clinical Research Samples from Offsite Locations
https://www.vumc.org/safety/sites/default/files/public_files/bio/materials-of-trade-exceptions-clinical-
research.pdf
Transporting Biological Research Materials On Campus
https://www.vumc.org/safety/sites/vumc.org.safety/files/public_files/bio/transport-bio-on-campus.pdf
Clinical Specimens Shipping Training Requirements
https://www.vumc.org/safety/training/biosafety-training#Ship_Bio-Clinical
Using Sharps Safely in Research
https://www.vumc.org/safety/sites/vumc.org.safety/files/public_files/bio/using-sharps-in-lab.pdf
Responding to Spills and Personnel Exposures Involving Biological Materials
https://www.vumc.org/safety/sites/vumc.org.safety/files/public_files/bio/responding-to-bio-exposures-and-
spills.pdf
EPA List N: Disinfectants for Use Against SARS-CoV-2
https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2

Guidance document prepared by:

Robin Trundy, Assistant Director & Institutional Biosafety Officer
Robin.trundy@vumc.org
Vanderbilt Environment Health & Safety
4/22/2020
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