Laboratory Testing Services Manual - Guidelines for Specimen Shipping and Mailing

Shipping Overview: Submitter Responsibilities

The submission of proper specimens under optimum conditions is an important responsibility of all submitters. Please exercise care when submitting specimens and requesting tests. 

The Laboratory enforces the principles of Good Laboratory Practices (GLP); a defined set of rules and criteria that ensure the reliability, reproducibility, quality, and integrity of the laboratory tests we carry out. GLP informs the laboratory’s policies, licensure, and mission, therefore, services may be withdrawn from a submitter in cases of misuse or improper specimen submission, since reliable tests cannot be performed on inadequate or substandard specimens. 

Submitters have several responsibilities for the safe packing and shipping of specimens before we can reliably test them, 

• Submitters should first determine the mode of transportation to be used to ship their specimen(s) to the Laboratory. The federal transportation rules that apply depend on the mode of transport used (surface: road or rail, or air freight, for example). Refer to the section Regulatory Reference Resources for Submitters of Hazardous/Infectious Substances for more details. 
• Submitters must determine the correct classification of their specimen before submission. The classification of the specimen as either an “infectious substance” or as “exempt”, determines what carriers can be used to ship the specimen and how it needs to be packaged for shipping. Refer to the section Category A, Category B, or Exempt? Determining a Biological Specimen’s Classification, for details.
• Submitters who ship infectious substances are REQUIRED to receive training. Without exception, anybody who ships specimens considered Infectious Substances (Category A or Category B) is REQUIRED TO COMPLETE the appropriate training and to maintain their certification(s) for review. The shipping process can include packaging, preparing paperwork, assembling the package, labeling, or any other activity associated with transport of packages. Training is required by the International Civil Aviation Organization (ICAO), International Air Transport Association (IATA), the U.S. Department of Transport (DOT), and the U.S. Pipeline and Hazardous Materials Safety Administration (PHMSA) . Failure to properly pack and ship infectious substances materials is a violation of federal law and punishable with fines and/or imprisonment. Refer to the section Required Training for Submitters of Hazardous/Infectious Substances.
• Submitters must pack specimens according to their classification. It is important for submitters to review and be knowledgeable of the federal regulatory standards for the transport of biological and infectious specimens, such as those of IATA, DOT, and PHMSA. All infectious substances must be triple contained. 
  Please note: The shipping guidance provided on these pages is not a substitute for the required training. The DSHS Laboratory may provide specimen shipping guidance to submitters but cannot take responsibility for training personnel or improperly shipped specimens. Refer to sections Packaging and Labeling of Category A Biological Substances and Packaging and Labeling of Category B Biological Substances for more details on available training resources.
• Submitters are responsible for shipping specimens in accordance with all safety and labeling regulations. It is important for submitters to review and be knowledgeable of the federal regulatory standards for the transport of biological and infectious specimens, such as those of IATA, DOT, and PHMSA. The Laboratory may provide specimen shipping guidance to submitters but cannot take responsibility for improperly shipped specimens. Refer to the sections Regulatory Reference Resources for Submitters; Shipping Infectious Substances: Important Definitions to Know; Packaging and Labeling of Category A Biological Substances and Packaging and Labeling of Category B Biological Substances for more details/resources.
• Submitters must ensure ALL required specimen information and documentation is provided. For the laboratory to be able to test received specimens, each one must arrive with the required documentation, including being labeled correctly and accompanied with a completed specimen submission form. Use only the most recent available version of a submission form as older versions may have obsolete tests. Refer to the Guidelines for Specimen Collection and Submission sections Required Fields on Submission Forms; Sample Submission Form Showing Required Fields and Providing Patient Information on Specimens and Submission Forms to identify the required patient information and submission form information.
• Submitters must ensure specimens are shipped to the laboratory promptly. Delays in shipping specimens may result in them being too old to test when they arrive at the laboratory. Test results from old specimens are not reliable and cannot be reported.
• Submitters must ensure transport media and collection kits are not expired. The laboratory cannot test specimens that arrive on or in expired media or containers. Expired specimens and will be considered unsat. Check the expiration dates on specimen collection tubes, kits, and transport media. Refer to the Specimen Collection and Submission section of this guidance for more information. 

Required Training for Submitters of Hazardous/Infectious Substances    

Anybody, including public health and laboratory staff involved in handling or preparing specimens for transport, the procurement of specimen couriers/carriers, and transporting specimens is required to take handling and transporting infectious substances training.

Shipping regulations and training requirements to ship infectious substances are in place to ensure infectious substances are shipped as safely as possible. Failure to properly pack and ship infectious substances materials is a violation of federal law and punishable with fines and possibly imprisonment. The DOT/PHMSA rules that apply to the transport of infectious substances are found in the Hazardous Materials Regulations (HMR). Medical facility/provider personnel who are required to complete infectious substance training include medical and laboratory staff who are involved in the preparation of specimens that are classified as infectious substances for shipping.

Training Requirements for Shipping Infectious Substances, Category A

Anybody who ships specimens classified as Infectious Substances, Category A is REQUIRED TO COMPLETE TRAINING every two years OR if regulations change. The Category A shipping process can include packaging, preparing the paperwork, assembling the package, labeling, or any other activity associated with transport.
Shippers of Infectious Substances, Category A are bound by regulations that come from several international and national agencies. These regulations have been harmonized across agencies and are in place to ensure infectious substances are transported as safely as possible.

IATA Training resources for the shipping of Category A biological substances include:
IATA - Infectious Substances Shipping Guidelines Course (partner-taught or self-study)- Available infectious substance shipping trainings from IATA include initial training and recertification classes. An IATA Certificate is awarded to participants who successfully pass the final exam. 

PLEASE NOTE:

• The IATA’s training courses on handling dangerous goods and infectious substances are not free! Participants are required to purchase the coursework.
• It is the responsibility of submitters to research available Category A Infectious Substances training and to train their personnel.
• “Personnel” includes anyone who handles or prepares specimens for transport, procures specimen carriers, and or transports specimens.
• The DSHS Laboratory does not provide Category A Infectious Substances training.

Training Requirements for Shipping Infectious Substances, Category B

Per the Code of Federal Regulations, 49 CFR §173.199: Handling and Transporting Infectious Substances, personnel responsible for handling and packing Category B infectious substances must be trained on correct specimen handling and correct submission protocols. “Personnel” includes anyone who handles or prepares specimens for transport, procures specimen carriers, and or transports specimens. In addition, per IATA regulation, a dangerous goods certificate of training is required for any person who submits dangerous goods to a public carrier for transportation.
 

Free Training Resources: Handling and Shipping of Infectious Substances, Category B

The DSHS Emergency Preparedness Branch offers online and frequent in-person training on Shipping Infectious Biological Substances through
NOTE: DSHS online class access requires a Media Lab account; set-up instructions are found in the link https://www.dshs.texas.gov/lab/eprTraining.shtm.

CDC: Packaging and Shipping
https://www.cdc.gov/labtraining/training-courses/packing-shipping-division-6.2-materials.html

CDC TRAIN
Home - CDC TRAIN - an affiliate of the TRAIN Learning Network powered by the Public Health Foundation

U.S. Pipeline and Hazardous Materials Safety Administration (PHMSA): Hazardous Goods Handling
Hazardous Materials One-Day Workshops | PHMSA (dot.gov)

Please note that as a state agency, DSHS cannot endorse or recommend a specific vendor for training services.

Regulatory Reference Resources for Submitters of Hazardous/Infectious Substances

Additional resources on requirements for the handling and shipping of Category B infectious substances include:

U.S. Department of Transport (DOT)

• 7 Tips E_resource Guide fn_0.pdf (dot.gov)

International Air Transport Association (IATA)

• Dangerous Goods Regulations 63rd Edn.

U.S. Pipeline and Hazardous Materials Safety Administration (PHMSA)

• https://www.phmsa.dot.gov/transporting-infectious-substances/transporting-infectious-substances-overview

PHMSA’s Check the Box Initiative (General information about shipping hazardous materials; targeted toward the general public.)

• https://www.transportation.gov/check-the-box

Category A, Category B, or Exempt? Determining a Biological Specimen’s Classification

There are three classifications for biological specimens: Category A, Category B, and Exempt Specimen. Before submission, providers should first determine the correct classification for their biological specimens.

The Category A/Category B Infectious Substance classification criteria for transporting biological specimens were developed (adopted in 2006) to help clarify labeling and shipping requirements and to improve safety by increasing compliance. The classification requirements, based on criteria developed by the UN Committee of Experts, the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), among other experts, are now consistent with international standards. More details on the types of specimens classified as Category A and Category B Biological Substances may be found at USDOT PHMSA.
Important definitions that submitters of Biological Substances to the DSHS Laboratory must be knowledgeable of include

• Infectious Substance: A material known or reasonably expected to contain pathogens such as bacteria, viruses, parasites, fungi, or prions that can cause disease in humans or animals. An infectious substance may also be referred to as a Division 6.2 Infectious Substance, which is a reference to its classification in Hazardous Division 6.2 of the Hazardous Materials Table.
• Exempt Patient Specimen A material that is known, or that can be reasonably expected to not pose an infectious health risk. Exempt patient specimens can be transported in a triple-layer packaging system similar to Category A or Category B specimens, without being subject to any further infectious substance regulations. The term “Exempt human specimen” or “Exempt animal specimen” must appear on the shipping package.
• Category A: An infectious substance that is in a form that can cause permanent disability or a life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. Correct shipping terms include:
  Category A Infectious Substances Affecting Humans, UN2814
  Category A Infectious Substances Affecting Animals, UN2900
  Classification as Category A must be based on the known medical history or symptoms of the source patient or animal, endemic local conditions, or a professional judgment concerning the individual circumstances of the specimen’s source human or animal.
• Category B: An infectious substance not in a form generally able to cause a permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. This includes Category B infectious substances transported for diagnostic or investigational reasons. Correct shipping name is Biological Substance, Category B, UN3373.

The PHMSA provides a list of examples of Category A Infectious Substances Affecting Humans, UN2814 and Category A Infectious Substances Affecting Animals, UN2900. The PHMSA notes the examples are provided as guidance only; the list may be subject to change.

For more information on what substances classify as Category A, refer to the most recent World Health Organization (WHO) guidance on regulations for the Transport of Infectious Substances.

Shipping Exempt Specimens (Not Classified as Infectious Substances)

Several specimens tested at the DSHS Laboratory do not qualify as infectious substances because they can be reasonably expected to not pose an infectious health risk. Newborn screening (NBS) cards, for example have dried bloodspots on them and can be reasonably expected to not contain microbial pathogens. And in specific cases, infectious substances (Category B) do not require labeling when being shipped by certain contracted courier services, which qualifies them as “exempt specimens”.

For the purpose of transport, any material defined as an “Exempt human specimen” or “Exempt animal specimen” may be transported in a triple-layer packaging system similar to those required for infectious substances, without being subject to infectious substance regulations. However, the term “Exempt human specimen” or “Exempt animal specimen” must appear on the package. In addition, there is no limit to the quantity of exempt human or animal specimen that may be carried per package, on any mode of transport. Submission and shipping guidelines for NBS specimens can be found at DSHS Newborn Screening Specimen Collection Requirements (texas.gov).

Shipping Infectious Substances: Important Definitions to Know

All specimens classified as Infectious Substances submitted to the laboratory for testing are required to be packaged in a way that minimizes the likelihood of spills and breakages and protects transportation workers, the general public and others who may come in contact with the package while it’s in transit. Some definitions and details specific to shipping such specimens to the laboratory include

• Mailable “Infectious Substance”: A human or animal material known or reasonably expected to contain a pathogen, including but not limited to excreta (stool), secreta, blood and its components, tissue, and tissue fluids being transported for medical or veterinary use, diagnostic, or investigational purposes. All mailable infectious substances must be marked “Biological Substance, Category B, UN3373”.
  Please Note: Category A infectious substances are never mailable through USPS.
• Required Packaging: Specimens must be triple packaged in a way that withstands shocks, pressure changes, leaks, and other conditions related to ordinary handling in transit.
• Absorbent Material A material such as cotton balls, cellulose wadding, or paper towels that can soak up the entire contents of the specimen(s) in the primary container(s) should they break or leak.
• Primary Receptacle (Container): Must be leakproof if carrying a liquid and sift proof if carrying a solid. Must be able to maintain its shape during shipping. Swab collection/transport tubes qualify as a primary receptacle. A single primary receptacle should not contain more than 34 fluid ounces (1L) of liquid specimen or 8.8 pounds (4kg) of solid specimen. Two or more primary receptacles with a combined volume not exceeding 1 gallon (4 L) of liquids or 8.8 pounds (4kg) of solid may be shipped in a single secondary container.

Example of a primary receptacle: A sterile wrapped collection swab and collection tube.
Image source: DSHS AR Lab https://www.dshs.state.tx.us/lab/ARLN/SwabShippingInstructions.shtm

• Secondary Container (Liner): Must be leakproof if carrying a liquid and sift proof if carrying a solid. Must be constructed of a durable material and have a means of being sealed securely. Must also contain sufficient absorbent materials to absorb the entire contents of the primary container in case of breakage or leakage. Must be labeled with the international biohazard symbol, as shown in the photo below. Biohazard symbols for Category B must not be affixed to the outer mailer.

_{Examples of secondary containers for shipping Category B Biological Substances. Depending on the specimen, containers may be rigid plastic such as the liner tube at left, or resealable plastic bags, as shown at right. Note the pad of absorbent material in the plastic biohazard bag. The secondary container should be labeled with a biohazard sticker. Biohazard bag photo source: ARLN Candida Swab Shipping Instructions.}

• Outer Shipping Container (Mailer): Must be made of a rigid material that can withstand the knocks and bumps of transit. Must fully enclose the primary and secondary receptacles. At least one surface must have a minimum area of 3.9 inches by 3.9 inches (100 mm by 100 mm) for appropriate labeling. The surface of the outer container should be clearly and durably marked with the required labeling.

Acceptable Outer Containers for Infectious Biological Substances

Unacceptable Outer Containers for Infectious Biological Substances

_{Outer packaging/mailers for shipping infectious substances must be able to withstand being dropped from a height of 1.2 meters (4 feet) without breaking. Bare polystyrene boxes, resealable plastic bags, and paper envelopes are not suitable as outer packaging}

Packaging and Labeling of Category A Biological Substances

While the majority of specimens the laboratory receives are Category B Biological and Exempt Substances, occasionally Category A infectious substances are submitted for testing. Without exception, all Category A biological substances MUST be triple packaged. The secondary container must be leakproof and sealable. The outer mailer must be rigid and sturdy. If multiple fragile primary receptacles (for example, glass tubes) are placed in a single secondary receptacle, they must be individually wrapped or separated by packaging to prevent contact and reduce the likelihood of breakage. The regulatory requirements for packing Category A Biological Substances may be found at 49 CFR § 173.196. 
Patient information and/or submissions forms should be not be affixed to the outer mailer. 
Submitters of Category A specimens must provide their own shipping material since the DSHS Laboratory does not provide mailing supplies for Category A specimens. 
Please note that Category A specimens should NEVER be shipped to the laboratory via the US Postal Service (USPS). The diagram below identifies the components of a correctly packaged Category A specimen. 
 

 Unacceptable Outer Containers for Infectious Biological Substances

Outer packaging/mailers for shipping infectious substances must be able to withstand being dropped from a height of 1.2 meters (4 feet) without breaking. Bare polystyrene boxes, resealable plastic bags, and paper envelopes are not suitable as outer packaging

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Mailing Containers/Completion of Forms

The Laboratory provides specimen mailing containers and labels to physicians and public health laboratories and water sample containers to any citizen upon request. The containers are the property of the State of Texas and must not be used for any purpose other than the shipment of specimens to the TDSHS laboratory.  The mailing containers and labels meet current Department of Transportation (DOT) and United States Postal Service (USPS) regulations for shipping Biological Substance, Category B. 

• Shipping infectious specimens requires special mailing containers that the Lab does not supply.
   
• TDSHS request form must be included with every specimen in the same container.

Forms should be completed as follows:

• Use BOLD CAPITAL BLOCK LETTERS to complete all information that is requested on the form.
   
• If the patient is Medicaid eligible, you must provide the Medicaid number.
   
• For THSteps (EPSDT) specimens, you must provide the Medicaid number.
   
• Date of Birth, Date of Collection and test request are required.
   
• Unidentified or improperly identified specimens are unsatisfactory and they will not be tested.

We will test specimens identified by number only; however, we will not report the results until a patient's name is provided. Good laboratory practice recommends, and our federal license requires, the patient's name on the specimen vial.

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Submitting Specimens through the U.S. Postal System

The requirements for the submission of Biological Substance, Category B through the U.S. Postal Services system are:

1. Definition:  “Biological Substance, Category B means any human or animal material, including excreta, secreta, blood and its components, tissue, and tissue fluids being transported for diagnostic or investigational purposes.”
    
2. Quantity:   50 ml or less per mail piece. Two or more primary receptacles may be included per mail piece.
    
3. Secondary container (liner):  must contain sufficient absorbent materials to absorb the entire contents of primary containers in case of breakage or leakage.
    
4. Outer mailer: must be properly labeled.
    
5. Mailing unit must pass current shipping regulations for Biological Substance, Category B.

The definition of an acceptable triple container is:

1. Primary receptacle:  a bottle or tube in which the specimen is collected or held, such as a feces bottle, test tube, or tube (vacutainer) of blood or serum; leak proof and securely sealed; surrounded by absorbent material capable of taking up the entire contents of the primary receptacle(s); held within the secondary container;
    
2. Secondary container:  leak proof, securely sealed; placed within the strong outer mailer; Biohazard sticker affixed;
    
3. Outer mailer or container constructed of fiberboard or other equivalent material, clearly and durably marked “Biological Substance, Category B.” 

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