What type of documentation is required for exempt patient specimen shipments?

Shipping biological samples is heavily regulated, with many rules and protocols that must be followed

Once learned, the process is straightforward. Always remember that you, the shipper, are solely responsible for your package, and not following these guidelines may result in delays, failed deliveries and/or fines. 

If you’re reading this, you’re planning to ship an “exempt” biological substance, one that doesn’t fall into Category A or B. If you need a refresher on which category your substance falls under, see our companion article. Here, we’ll review requirements for packaging, labeling, marking and documentation for shipping exempt biological substances.

How to Identify an Exempt Patient/Human/Animal Specimen

“Exempt” materials are a broad and common categorization, yet this category is often the most unfamiliar to many. Exempt materials are defined as “those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissues and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment, and prevention.” IATA/DOT/USPS doesn’t want to overburden medical professionals shipping relatively benign samples, so these fall under more lax regulations.

Some examples of Exempt Patient/Human/Animal Specimens: 

• Routine testing of blood or urine tests ordered for a medical examination
• Cholesterol, Blood Glucose
• Insurance or employment tests
• DNA tests
• Pregnancy tests
• Tests done for other than testing for the presence of pathogens
• Patient specimens for which there is minimal likelihood that pathogens are present
• Substances which do not contain infectious substances or substance which are unlikely to cause disease in humans or animals
• Substances containing micro-organism which are non-pathogenic to humans or animals
• Substances in a form that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk (unless the chemical itself is regulated)
• Environmental samples (including food and water) which are not considered to pose a significant risk of infection
• Dried blood spots, collected by applying a drop of blood onto absorbent material
• Fecal occult blood screening samples
• Blood or blood components collected for transfusion or prep to be used for transfusion or transplantation; organs and tissues to be used in transplantation

If you’re unable to make a professional judgment on the presence of pathogens, don’t use the “exempt” classification, instead use UN3373 Category B unless there is a pathogen on the Category A list.

Packaging Instructions

Follow and save any instructions provided with boxes and validated thermal shippers you purchase, so you always have something to reference. Triple packaging is the best practice for all classifications of biological shipments. Here are the four elements you need for your packaging: 

1. Leak-proof Primary Receptacle 

This contains your sample — make sure it has a leak-proof seal, tape or parafilm screw cap.

1. Leak-proof Secondary Packaging 

This is your inner container. Ensure the primary or secondary receptacle can withstand:

Pressure: not less than 95kPa.

Temperature:- 40°C to 55°C 

1. Cushioning and Absorbent Material
   
   If you have a liquid substance, sufficient absorbent material must be included to absorb the entire contents of all primary receptacles. Acceptable absorbent materials include cellulose wadding, cotton balls, super-absorbent packets, and paper towels. This generally goes in between the primary and secondary packaging.
   
   

   Cushioning material is also necessary — and needs to be distinct from absorbent material. Generally this is between the secondary and outer packaging.

2. Rigid Outer Packaging 
   
   The outer box must be able to meet a drop test of 1.2m. 
   
   The smallest external dimension must be at least 100x100mm — look to the manufacturer’s instructions for this info. 
   
   Before sealing the outer packaging, you must make an itemized list of the contents of the package and enclose the list between the secondary packaging and outer packaging.

Note: This does not include Styrofoam layer, if using wet/dry ice. Express carriers such as FedEx and UPS do not accept packages with a Styrofoam container as the outside packaging so add rigid outer packaging such as a cardboard box or validated thermal shipper.

Disposing of or Repurposing Rigid Outer Packaging

Before empty packaging is returned to the consignor, or sent elsewhere, it must be disinfected or sterilized to nullify any hazard and any label or mark indicating that it contained an infectious substance must be removed.

When shipping blood samples

A biohazard symbol is required on any sample that contains human blood and other potentially infectious materials (OPIM). This label must be affixed to the primary receptacle or secondary packaging. 

Overpack

An overpack is an extra outside packaging used when shipping multiple boxes to the same address or used to refrigerate materials being shipped in a smaller box. All markings and labels must be on the outside of the box along with the word “OVERPACK”. Since your inside package is the “triple package” you need all markings and labels on that package as well.

Labeling Instructions

Standardized labeling must be affixed to the outside. When the package dimensions are adequate, labels must be located on the same surface of the package near the Proper Shipping Name mark. 

Except for the orientation arrows, mount all labels and markings on the front side of the box — all on one surface area. “Cargo Aircraft Only” labels are required when applicable. 

The outer shipping container must be marked on the address side with the words “Exempt human specimen” or “Exempt animal specimen,” as appropriate.

Orientation Arrows Label

If you are shipping a liquid, orientation arrows are required. Label must be affixed on 2 opposite sides and perpendicular to the front of the package. Orientation arrows should be red or black on a contrasting background.

Overpack Label 

Overpack labels have a height Requirement of 12mm (~0.5 inch). Either of these styles is acceptable: 

Documentation Requirements 

All Shipments must include: 

• Bill of Lading (if ground transport), or Airway Bill (if air transport)
• Appearance of form will vary between carriers
• 5 copies of the Commercial Invoice for international shipments

• It's best practice to save all commercial Invoices, airway bills and lists of contents in a binder for at least two years. 

Contact the Receivers

Make sure you contact the receivers prior to shipping. Keep in mind that some labs only receive Monday to Thursday. If you ship on Friday, it might sit over the weekend, or arrive on Saturday and nobody's there. If they are open on Saturday, make sure you label for Saturday delivery so the carrier knows they can deliver on Saturday and not hold the package over the weekend.

Know the stability of your sample and how long it can last, roughly 6% of Express Carrier shipments are not delivered on the requested date for a variety of reasons. Think carefully of the day you’re shipping and the stability of the shipment to avoid a potential re-draw from the patient.

Other FedEx and UPS Requirements

• There are far fewer restrictions shipping exempt human or animal specimens than UN3373 B or Category A samples.
• Use a FedEx or UPS pouch and insert the airway bill so that it is laying flat-not folded.
• Be sure to remove the sender’s copy and save this documentation for 2 years. Affix the adhesive pouch to the top of the fiberboard box.
• If there is a commercial invoice (5 copies is good practice) to include for international shipments, you may fold these together in half and place them behind the airway bill inside the pouch.

International shipments

Before you ship any material abroad, you should answer the following questions:

• What are you shipping and is an export or import license required?
• Who will receive it (are they on the Restricted Parties List)?
• Where is it going (is it on the Embargoed Destinations list)?
• What are they going to do with it?
• Is the shipment over $2,500 or subject to a license? If so, you need to file a report with the U.S. Census called an Electronic Export Information (EEI).
• International shipments require a commercial invoice. 

Penalties and Fines 

Shipping biological substances is a tightly regulated activity. If you need more reasons to get it right, here is a list of violations and the minimum assessments for each: 

Which of the following can be shipped as exempt human specimens?

What is the maximum package quantity limit for a liquid exempt patient specimen?

Which of the following is a requirement for the outside container when shipping diagnostic specimens?

Which special provisions apply to UN 3373 biological substance Category B shipments?