Diagnostic Specimen Packing and Transportation Requirements

 Key Points to Remember

• Always use triple packaging (primary + secondary + outer).
• Use absorbent materials and leak-proof containers.
• Label with UN3373 for diagnostic (Category B) samples.
• Follow DOT and IATA rules for safety and compliance.
• Handle ice or dry ice carefully with correct labels and ventilation.

Introduction

When laboratories or health departments send biological or diagnostic specimens (like blood, stool, or tissue samples) for testing, they must follow strict safety and transport rules.
These rules prevent leakage, damage, or infection during shipping.

1. Who Regulates the Shipment

• In the United States, specimen shipments are regulated by the Department of Transportation (DOT) under the Hazardous Materials Regulations (HMR).
• For international shipments, the rules are set by the International Air Transport Association (IATA) under Dangerous Goods Regulations (DGR).
• These rules make sure all infectious or potentially infectious materials are packaged safely.

2. What Is an Infectious Substance?

An infectious substance contains (or may contain) microorganisms like bacteria, viruses, fungi, parasites, or prions that can cause disease in humans or animals.

Examples include:

• Biological products
• Cultures and stocks
• Diagnostic specimens
• Medical waste
• Sharps (needles, blades)
• Used healthcare products

3. IATA Categories

IATA divides infectious substances into two main groups:

• Category A: Dangerous pathogens that can cause serious or fatal diseases (e.g., Ebola virus, anthrax).
• Label as: UN2814 (for humans) or UN2900 (for animals).
• Category B: Less dangerous or low-risk samples (most diagnostic samples).
• Label as: UN3373.

4. What Are Patient or Diagnostic Specimens?

These are samples taken from humans or animals for testing, diagnosis, or research — for example:

• Blood
• Urine
• Swabs
• Tissues
• Stool or vomit samples

These are treated as potentially infectious, so proper packaging is essential.

5. Triple Packaging System

All diagnostic specimens must be packed in three layers for safe transport.

1. Primary Container

• Leak-proof, sealed container holding the actual specimen.
• Must have a tight cap (screw-on lid).
• Should hold no more than 500 ml (liquid) or 500 g (solid).
• Must survive temperature changes and pressure differences during air travel.
• Example: Sample tubes, transport vials, or stool containers.

2. Secondary Container

• A leak-proof bag or plastic container that holds the primary container(s).
• Each primary container must be wrapped or separated to prevent contact.
• Add absorbent material (cotton, paper towels, etc.) to soak up leaks.
• Place an itemized list of samples between the secondary and outer container.
• Don’t overfill — leave some space to prevent breakage.

3. Outer Container

• A strong, rigid box made of cardboard, plastic, metal, or wood.
• Protects samples during handling, vibration, and temperature changes.
• For liquids: total volume ≤ 4 liters.
• For solids: total weight ≤ 4 kilograms.
• Must pass a 4-foot drop test (proving it won’t break or leak).

6. Shipping with Ice or Dry Ice

If the samples need to stay cold:

• Place ice or dry ice outside the secondary container.
• Ensure containers remain stable even after ice melts.
• Use leak-proof outer packaging when using ice.
• For dry ice, make sure the box can release gas safely to avoid pressure buildup.
• Attach a “Class 9 – Miscellaneous Hazard” label when dry ice is used.

7. Labeling Requirements

Each shipment must clearly display:

1.     The UN3373 label with the words “Biological Substance, Category B.”

2.     The shipper’s and receiver’s full name, address, and phone number.

3.     For couriers like DHL or FedEx, add the waybill number on the secondary container.

4.     No Infectious Substance label or Dangerous Goods declaration is needed for Category B specimens.

8. Pre-Shipping Checklist

Before shipping, make sure:

• Containers are leak-proof and tightly sealed.
• Each sample is clearly labeled with patient ID and date.
• Absorbent material is included.
• Documentation (like lab forms or EpiForms) is inside.
• Outer box is sturdy and the correct size.
• Ice or dry ice is properly packed and labeled.
• Package passes drop test and meet DOT/IATA standards.