Packing and transporting clinical samples

How a clinical sample is packaged depends on:

1. Its virulence in humans or animals
   • The first step is to classify the clinical specimen as Category A, Category B, or exempt. The sample classification determines what regulations must be followed when packing and transporting the clinical specimen.
2. The transportation service that will move the sample to the State Lab
   • The second step is to decide if you will use the State courier service or commercial ground transportation (e.g., FedEx, UPS, USPS) to transport the specimen. The transportation service will also determine what regulations must be followed when packing and transporting the clinical specimen.

It is an employer’s responsibility to ensure that people performing packaging and shipping of infectious material are trained and in compliance with the Department of Transportation (DOT) or the International Air Transport Association (IATA).

Resources

• Specimen classification resources: Specimen classification flowchart and list of Category A substances
• Labels and markings for packing and transporting clinical samples
• CDC - Specimen storage and shipping guidance

Step 1: Classify the specimen (Category A, Category B, exempt).

The Pipeline and Hazardous Materials Safety Administration of the U.S. Department of Transportation develops the regulations that apply to transporting biological specimens and the U.S. Department of Justice enforces them.

The regulation that applies to packaging and shipping biological materials is 49 CFR Part 173.134 Class 6, Division 6.2.

Use the specimen classification flowchart and the definitions and classification criteria to determine if your clinical specimen is Category A, Category B, or exempt.

§ 173.134, Class 6, Division 6.2

1. Division 6.2 (infectious substance)

A material known or reasonably expected to contain a pathogen. A pathogen is a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a prion, that can cause disease in humans or animals. An infectious substance must be assigned the identification number UN2814, UN2900, UN3373, or UN3291, as appropriate, and must be assigned to one of the following categories:

i. Category A

Category A infectious material is capable of causing permanent disability or life-threatening or deadly disease in otherwise healthy humans or animals when exposure to it occurs. An exposure occurs when an infectious substance is released outside of its protective packaging, resulting in physical contact with humans or animals. A Category A infectious substance must be assigned to identification number UN2814 or UN2900, as appropriate:

• UN2814, Infectious substances, affecting humans
• UN2900, infectious substances, affecting animals

Assignment to UN2814 or UN2900 must be based on the known medical history or symptoms of the source patient or animal, endemic local conditions, or professional judgment concerning the individual circumstances of the source human or animal.

List of Category A infectious substances

ii. Category B

Category B infectious material is not in a form generally capable of causing permanent disability or life-threatening or deadly disease in otherwise healthy humans or animals when exposure to it occurs. This includes Category B infectious substances transported for diagnostic or investigation purposes. A Category B infectious substance must be described as “Biological substance, Category B” and assigned identification number UN3373. This does not include medical waste, which must be assigned identification number UN3291.

Patient specimens
Specimens collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimens include excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (e.g., transwabs, culture media, and blood culture bottles).

b. Exceptions
Substances exempt from strict regulations do not contain biological agents, or any biological agents present are incapable of causing disease. Therefore, if certain protocols are followed, these materials do not have to follow transport regulations.

The following are not subject to the requirements of this subchapter as Division 6.2 materials.

• Dried blood spots or specimens for fecal occult blood detection placed on absorbent filter paper or other material. 
• 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.

Step 2: Decide how you are transporting your classified sample.

After you have classified your clinical specimen (Category A, Category B, exempt), the next step is to decide if you will use the State’s courier service or commercial ground transportation to move the sample to the State Lab.

Transporting using the State’s courier service | Transporting using commercial ground transportation (FedEx, UPS)

Transporting using the State’s courier service

Category A | Category B and exempt substances

The State Lab offers a courier service at no cost to Colorado clinical and local public health agencies. Request a courier to pick up your samples using the courier request form 24-48 hours in advance.

Category A: State courier service

Infectious substances must meet packaging, marking, and labeling requirements to be transported. Category A infectious substance packaging requirements must:

• Meet the standards of CFR §173.609
• Consist of triple packaging, including leakproof primary container, leakproof secondary container, and rigid outer packaging
• Have UN certification markers on the outer packaging

It is highly recommended to use packaging that is purchased and certified to satisfy the parameters that are required by the International Air Transport Association (IATA) and the U.S. Department of Transportation (DOT).

Packaging

The packaging is the same for both types of Category A samples (UN2814 and UN2900), where only the UN mark and proper shipping names are different.

The sample must consist of triple packaging with a primary, secondary, and tertiary packaging:

Primary package

1. The specimen is contained inside of a watertight glass, metal, or plastic receptacle. Fragile receptacles should be cushioned or separated to prevent breakage. 
2. For shipments containing liquids, use an absorbent material in sufficient quantity to absorb the entire contents of a spill. Place the absorbent material within the secondary container and outside of the primary receptacle.
3. Affix a biohazard label, if one is not already present on the receptacle.

Secondary package

1. Place the primary receptacle within a watertight, leakproof secondary package. 
2. Affix a biohazard label, if one is not already present or if one was not placed on the primary receptacle.
3. Place an itemized list of contents between the secondary and tertiary package or written on the secondary package.

Tertiary (outer) package

1. Place the secondary container into a rigid UN-certified tertiary (outer) packaging.
2. Secure the primary and secondary packages within the tertiary package, so they are unable to move within the tertiary packaging.
3. If dry ice is being used, make sure that there is room for it to “breathe” within the package.

Labeling and marking on tertiary packaging

The following are labeling/marking requirements for Category A substances that are transported by the State courier:

Labeling

• Manufacturer’s UN specification marking affixed/printed on tertiary packaging 
• Division 6 Infectious Substance biohazard label 
• Orientation arrows on two opposite sides

DOT does not require Division 9 labels for dry ice, but specific couriers might. It is best practice to label packages that contain dry ice:

• Division 9 Miscellaneous Hazard label 
• UN1845 Dry Ice labeled
• The total amount of dry ice, in kilograms written/labeled

Marking

• UN2814 Infectious Substance, Affecting Humans or UN2900 Infectious Substance, Affecting Animals written/labeled. The technical name is not displayed on the tertiary package.
• Name, address, and phone number of the shipper present 
• Name, address, and phone number of the consignee (receiver) present
• “Overpack” label, if applicable

Be sure the proper shipping name (UN2814 Infectious Substance, Affecting Humans) does not include the technical name (e.g., variola virus, Mycobacterium tuberculosis, etc.). Including the technical name makes a package a target for theft and possible malicious use.

Documentation

1. Create and include an itemized list of contents.
   1. Include the following for each specimen:
      1. Volume or mass (estimates are allowed)
      2. Specimen container type 
      3. Specimen type (e.g., serum)
   2. Place the itemized list of contents between the secondary container and tertiary packaging. 
2. Complete the Shipper’s Declaration of Dangerous Goods (SDDG).
   1. Print three copies. 
      1. Place one copy of the SDDG between the secondary container and tertiary package.
      2. Place two copies of the SDDG in an envelope or plastic sleeve and attach it to the tertiary container. 
3. Place a Guide 158 between the secondary container and tertiary (outer) packaging.
    

Category B and exempt substances: State courier service

Packaging 

The sample must consist of triple packaging with a primary, secondary, and tertiary packaging:

Primary package

1. The specimen is contained inside of a leakproof glass, metal, or plastic receptacle. Fragile receptacles should be cushioned or separated to prevent breakage. 
2. For shipments containing liquids, use an absorbent material in sufficient quantity to absorb the entire contents of a spill. Place the absorbent material within the secondary container and outside of the primary receptacle.

Secondary package

1. Place the primary package inside of a rigid or flexible secondary package. A biohazard bag is an adequate secondary container for exempt specimens.
2. Affix a biohazard label, if one is not already present. 
3. Place an itemized list of contents between the secondary and tertiary package or written on the secondary package.

Tertiary (outer) package

1. Place the primary and secondary packages inside of a rigid or flexible tertiary packaging, such as a Styrofoam cooler or another biohazard bag. Tertiary packaging must be leak proof. If you plan to use the courier’s cooler and are not using dry ice, place the primary and secondary packages inside of a sealable consolidation bag and hand this to the courier.
2. Secure the primary and secondary packages within the tertiary package, so they are unable to move within the tertiary packaging.
3. If dry ice is being used, make sure that there is room for it to “breathe” within the package.

Labeling and marking on tertiary packaging

The following are labeling/marking requirements for exempt substances that are transported by the State’s courier:

Labeling

• Division 9 Miscellaneous Hazard label for dry ice, if using

Marking

• UN1845 Dry Ice. Include the amount in kg, if using dry ice.
• Name, address, and phone number of the shipper present 
• Name, address, and phone number of the consignee (receiver) present

Documentation

There are no required shipping documents for transporting an exempt clinical specimen using the State’s courier service, unless it is classified as Category A.

Transporting using commercial ground transportation (FedEx, UPS)

Category A | Category B | Exempt substances

Packing checklists

• Category A, commercial ground transport packing and shipping checklist
• Category B, commercial ground transport packing and shipping checklist

Category A: Commercial ground transport (FedEx, UPS)

The United States Postal Service (USPS) does not accept Category A substances.

Packaging

The packaging is the same for both types of Category A samples (UN2814 and UN2900), where only the UN mark and Proper Shipping Names are different.

The sample must consist of triple packaging with a primary, secondary, and tertiary packaging:

Primary package

1. The specimen is contained inside of a watertight glass, metal, or plastic receptacle. Fragile receptacles should be cushioned or separated to prevent breakage. 
2. For shipments containing liquids, use an absorbent material in sufficient quantity to absorb the entire contents of a spill. Place the absorbent material within the secondary container and outside of the primary receptacle. 
3. Affix a biohazard label, if one is not already present on the receptacle.

Secondary package

1. Place the primary receptacle within a watertight, leakproof secondary package. 
2. Affix a biohazard label, if one is not already present or was not placed on the primary receptacle.
3. Place an itemized list of contents between the secondary and tertiary package or written on the secondary package.

Tertiary (outer) package

1. Place the primary and secondary packages into a rigid UN-certified tertiary (outer) packaging.
2. Secure the primary and secondary packages within the tertiary package, so they are unable to move within the tertiary packaging.
3. If dry ice is being used, make sure that there is room for it to “breathe” within the package.

Labeling and marking on tertiary packaging

The following are labeling/marking requirements for Category A substances that are transported by a commercial ground service (FedEx, UPS):

Labeling

• Manufacturer’s UN specification marking affixed/printed on tertiary packaging 
• Division 6 Infectious Substance biohazard label 
• Orientation arrows on two opposite sides
• Division 9 Miscellaneous Hazard label for dry ice, if using
  • DOT does not require Division 9 labels for dry ice, but specific couriers might. It is best practice to label packages that contain dry ice.

Marking

• UN2814 Infectious Substance, Affecting Humans OR UN2900 Infectious Substance, Affecting Animals written/labeled. The technical name is not displayed on the tertiary package.
• UN1845 Dry Ice. Include the amount in kg, if using dry ice.
• Name, address, and phone number of the shipper present 
• Name, address, and phone number of the consignee (receiver) present
  • “Overpack” label, if applicable

Be sure the proper shipping name (UN2814 Infectious Substance, Affecting Humans) does not include the technical name (e.g., variola virus, Mycobacterium tuberculosis, etc.). Including the technical name makes a package a target for theft and possible malicious use.

Documentation

1. Create and include an itemized list of contents.
   1. Include the following for each specimen:
      1. Volume or mass (estimates are allowed)
      2. Specimen container type 
      3. Specimen type (e.g., serum)
   2. Place the itemized list of contents between the secondary container and tertiary packaging. 
2. Complete the Shipper’s Declaration of Dangerous Goods (SDDG). 
   FedEx requires customers to use the proper software to generate a Shipper’s Declaration such as FedEx Ship Manager Software (CAFE) or FedEx Web Services (WSXI). FedEx will reject a Category A sample if you do not use the correct software.
   1. Print three copies. 
      1. Place one copy of the SDDG between the secondary container and tertiary package.
      2. Place two copies of the SDDG in an envelope or plastic sleeve and attach it to the tertiary container. 
3. Place a Guide 158 between the secondary container and tertiary (outer) packaging.

Category B: Commercial ground transport (U.S. Postal Service, FedEx, UPS)

Packaging

The sample must consist of triple packaging with a primary, secondary, and tertiary packaging:

Primary package

1. The specimen is contained inside of a leakproof glass, metal, or plastic receptacle. Fragile receptacles should be cushioned or separated to prevent breakage. 
2. For shipments containing liquids, use an absorbent material in sufficient quantity to absorb the entire contents of a spill. Place the absorbent material within the secondary container and outside of the primary receptacle.
3. Affix a biohazard label, if one is not already present on the receptacle.

Secondary package

1. Place the primary package inside of a rigid or flexible secondary package. 
2. Affix a biohazard label, if one is not already present or was not placed on the primary receptacle.
3. Place an itemized list of contents between the secondary and tertiary package or written on the secondary package. 

Tertiary (outer) package

1. Place the primary and secondary packages inside of a rigid tertiary package.
2. Secure the primary and secondary packages within the tertiary package, so they are unable to move within the tertiary packaging.
3. If dry ice is being used, make sure that there is room for it to “breathe” within the package.

Labeling and marking on tertiary packaging

The following are labeling/marking requirements for Category B substances that are transported by commercial ground transport (USPS, FedEx, UPS):

Labeling

• UN3373 label
• Division 9 Miscellaneous Hazard label for dry ice, if using
  • DOT does not require Division 9 labels for dry ice, but specific couriers might. It is best practice to label packages that contain dry ice.

Marking

• Biological Substance, Category B. The technical name is not displayed on the tertiary package.
• UN1845 Dry Ice. Include the amount in kg, if using dry ice.
• Name, address, and phone number of the shipper present 
• Name, address, and phone number of the consignee (receiver) present
  • “Overpack” label, if applicable

Documentation

1. Create and include an itemized list of contents. 
   1. Include the following for each specimen:
      1. Volume or mass (estimates are permissible)
      2. Specimen container type 
      3. Specimen type (e.g., serum)
   2. Place the itemized list of contents between the secondary container and tertiary packaging.
       

Exempt substances: Commercial ground transport (U.S. Postal Service, FedEx, UPS)

Packaging

The sample must consist of triple packaging with a primary, secondary, and tertiary packaging:

Primary package

1. The specimen is contained inside of a leakproof glass, metal, or plastic receptacle. Fragile receptacles should be cushioned or separated to prevent breakage. 
2. For shipments containing liquids, use an absorbent material in sufficient quantity to absorb the entire contents of a spill. Place the absorbent material within the secondary container and outside of the primary receptacle.
3. Affix a biohazard label, if one is not already present on the receptacle.

Secondary package

1. Place the primary package inside of a rigid or flexible secondary package. A biohazard bag is an adequate secondary container for exempt specimens.
2. Affix a biohazard label, if one is not already present or was not placed on the primary receptacle.

Tertiary (outer) package

1. Place the primary and secondary packages inside of a rigid tertiary packaging.
2. Secure the primary and secondary packages within the tertiary package, so they are unable to move within the tertiary packaging.
3. If dry ice is being used, make sure that there is room for it to “breathe” within the package.

Labeling and marking on tertiary packaging

The following are labeling/marking requirements for exempt substances that are transported by commercial ground transport (USPS, FedEx, UPS):

Labeling

• Exempt human specimen or exempt animal specimen labels
• Division 9 Miscellaneous Hazard label for dry ice, if using.
  • The U.S. Department of Transportation does not require Division 9 labels for dry ice, but specific couriers might. It is best practice to label packages that contain dry ice.

Marking

• UN1845 Dry Ice. Include the amount in kg, if using dry ice.
• Name, address, and phone number of the shipper present 
• Name, address, and phone number of the consignee (receiver) present
  • “Overpack” label, if applicable

Documentation

There are no required shipping documents required by DOT for exempt substances. Follow the directions of the shipping provider you are using. 

Labels and markings

It is important to properly label or mark on the tertiary packaging to let handlers and recipients know the hazards of the contents of the package. Improperly labeled packaging can result in exposures to the hazardous substance and fines from regulatory agencies.

Below are approved labels for the different categories of shipments. Labels can be purchased pre-printed from vendors. They may also be printed for use. Labels must be a minimum of 3” x 3” in size.

Size requirement for diamond-shaped labels

The size requirement for diamond-shaped labels must be at least 100 mm (3.9 inches) on each side, with each side having a solid line inner border approximately 5 mm (.2 inches) inside and parallel to the edge. The 5 mm (.2 inches) measurement is from the outside edge of the label to the outside of the solid line forming the inner border.

Diamond-shaped labels are used for Category A, Category B, and Dry Ice - Class 9.