Laboratory Testing Services Manual - Guidelines for Specimen Shipping and Mailing

A phlebotomist writes patient information on a blood collection tube. Specimen labels may be printed or handwritten. If handwritten, a fine point, permanent pen should be used to produce legible labels. Image Source: CDC/ Jim Gathany (2004)
Each year, the DSHS Laboratory in Austin receives over 1,000,000 (one million!) specimens of infectious and food-borne diseases, biological and chemical compounds, and biological agents for testing. The newborn screening program alone receives more than 800,000 newborn screening specimens each year to test newborns’ blood for 55 metabolic and genetic disorders. The laboratory also tests water from over 6800 public water systems in Texas.* Such large volumes of specimens means that every day, the laboratory staff is kept busy helping Texans remain safe and healthy!
An important contributing factor to specimen testing success is receiving correctly labeled, satisfactory specimens from our submitters. However, we receive specimens every day that are determined to be “unsatisfactory for testing” (unsat, for short), because they were either incorrectly collected, incorrectly shipped, incorrectly labeled, or are missing required information. When an unsat specimen is identified, laboratory staff will notify the submitter and in certain cases request another specimen be submitted for testing. A goal of the laboratory is to optimize the submission process by providing educational resources (such as this guidance) for submitters to maximize the number of testable specimens we receive. More testable specimens arriving at the laboratory means more prompt and accurate detection and diagnoses of diseases and disorders for Texans.
This guidance was developed with the intention of addressing the most frequently encountered reasons for specimen unsats. Please note the information provided within is not a substitute for the training that submitters of infectious substances are required to take by law.
*While the majority of specimens received by the laboratory are submitted by healthcare facilities, drinking water samples and rabies specimens may also be submitted by the general public.
Note: The inclusion of external weblinks is for informational purposes only. The links do not represent an endorsement by Texas Department of State Health Services of the good and/or services provided by these entities. These external sites may also not be accessible to people with disabilities.
Table of Contents
- Shipping Overview: Submitter Responsibilities
- Required Training for Submitters of Hazardous/Infectious Substances
- Free Training Resources: Handling and Shipping of Infectious Substances, Category B
- Regulatory Reference Resources for Submitters of Hazardous/Infectious Substances
- Category A or B, or Exempt? Determining a Specimen’s Infectious Substance Classification
- Specimen Classification Decision Algorithm
- Shipping Exempt Specimens (Not Classified as Infectious Substances)
- Shipping Infectious Substances: Important Definitions to Know
- Packaging and Labeling of Category A Biological Substances
- Packaging and Labeling of Category B Biological Substances
- Providing Patient Information on Specimens and Submission Forms
- Instructions for Packing Ambient-Temperature Specimens for Shipment
- Instructions for Shipping Temperature-Sensitive Biological Substances
- Important Considerations for Submitting Biological Specimens to the Laboratory via U.S. Postal System (USPS) and Paid Courier Services
- Obtaining and Ordering Shipping Supplies from the Laboratory
- Laboratory Business Hours
- Laboratory Shipping Addresses
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Shipping Overview: Submitter ResponsibilitiesThe 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,
Required Training for Submitters of Hazardous/Infectious SubstancesAnybody, 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. IATA Training resources for the shipping of Category A biological substances include: PLEASE NOTE:
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 BThe DSHS Emergency Preparedness Branch offers online and frequent in-person training on Shipping Infectious Biological Substances through CDC: Packaging and Shipping U.S. Pipeline and Hazardous Materials Safety Administration (PHMSA): Hazardous Goods Handling 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 SubstancesAdditional resources on requirements for the handling and shipping of Category B infectious substances include: U.S. Department of Transport (DOT) International Air Transport Association (IATA)
U.S. Pipeline and Hazardous Materials Safety Administration (PHMSA) PHMSA’s Check the Box Initiative (General information about shipping hazardous materials; targeted toward the general public.) ![]()
Category A, Category B, or Exempt? Determining a Biological Specimen’s ClassificationThere 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.
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 KnowAll 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
Example of a primary receptacle: A sterile wrapped collection swab and collection tube.
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.
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
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
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.
Forms should be completed as follows:
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.
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:
The definition of an acceptable triple container is:
![]() Packaging and Shipping Blood Tubes Containers are available in three sizes for blood specimens. You may order for: 1 specimen, 4 specimens, and 7 specimens. In order to insure the satisfactory receipt and proper testing of your specimens in our Laboratory, it is necessary to:
Cholesterol, Lipid Profile, Glucose, and Creatinine Packing Instructions and Diagram Required Specimen Type for Cholesterol, Lipid Profile, and Creatinine:
Required Specimen Type for Glucose:
General Instructions:
For questions about shipment of cholesterol, lipid profile, glucose, or creatinine specimens, please call 512-776-6236 or toll free 1-888-963-7111, extension 6236. For cholesterol, lipid profile or glucose specimens that are part of THSteps medical checkups, prepaid air bills are provided to enrolled THSteps providers. For non-THSteps cholesterol, lipid profile, glucose, and all creatinine specimens, the provider must pay the shipping costs, using a courier of their choice. Flow Chart for Collection and Shipping of Cholesterol, Lipid Profile, Glucose and Creatinine
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To ensure proper packaging, please follow these instructions:
- Obtain enough dry ice to keep the specimens frozen or enough ice packs to keep specimens cold for the duration of the shipment.
- Place the frozen specimen(s) in mailing canister and seal. Place up to 4 canisters in the bottom of the Styrofoam box.
- Fill the Styrofoam box with dry ice or ice packs. Ensure canisters are completely covered with dry ice or ice packs, and secured.
- Place the lid on the Styrofoam box. Make sure the date and time is documented on each G-1B form when specimens are removed from the freezer. Please circle freezer to indicate specimens were removed from the freezer not the "fridge".
- Place the completed G-1B form(s) in a plastic “zip lock” bag. Then place the plastic “zip lock” bag on top of the closed Styrofoam box and seal the fiberboard box.
- Secure the outer fiberboard box with packing tape.
- Ensure that a diamond-shaped UN 3373 label is on exterior of the fiberboard box, when shipping Biological Substance, Category B.
- Dry ice is considered a “dangerous good”. If using dry ice:
- Use less than 5 lbs of dry ice.
- Mark the blank box and write “dry ice” in the Special Instructions section of the air bill.
- Attach a diamond-shaped dry ice label on the package with the number “9” and “UN1845” on it. This label must include the amount of dry ice used. Ensure that this is legible and does not overlap any other label on the fiberboard box.
- Fill out the air bill and place it inside the sleeve and attach to the top of the sealed fiberboard box.
NOTE: If overnight carrier does not make regular pick-ups at your facility, call the carrier and let them know you need a pick-up.
DHL: (800) 225-5345
UPS: (800) 742-5877
CAUTION: MAKE SURE THAT YOUR STYROFOAM BOX IS NOT AIRTIGHT, IF USING DRY ICE!
By following these instructions when shipping Biological Substance, Category B, your responsibility should be fulfilled.
Shipping Instructions:
Check elsewhere in this section for specific test instructions and information about tube types.
Shipping containers for cold shipment are available upon request; call (512) 776-7661 or toll free (888) 963-7111, extension 7661.