Packing and Transport of BIOLOGICAL SUBSTANCE, CATEGORY B, SPECIMENS

Category B, Infectious Disease Tests

Biological Substances, Category B, are defined as human or animal material, including excreta, secreta, blood and its components, tissue and tissue fluids, being transported for diagnostic or investigational purposes, but excluding live infected humans or animals. Exempt Human Specimens (above) are excluded from Biological Substances, Category B.

A specimen which meets the definition of Biological Substance, Category B, (being transported for diagnostic or investigational purposes), but is known to originate from a patient with an infectious disease should still be transported as a Biological Substance, Category B, specimen.

To ensure optimum testing conditions for a specimen that is sent to ARUP Laboratories, the client must determine two things:

  • Determine the infectious nature of the specimen to be sent, using the Category B definitions above.
  • Determine the temperature at which the specimen must be maintained during transit, using instructions for individual tests listed in the Laboratory Test Directory.

DOT and IATA Requirements for Shipping Specimens

When shipping specimens, it is essential that each specimen be packaged and shipped properly. Complying with the regulations set forth by the DOT and the International Air Transport Association (IATA) will control or eliminate many health and financial liabilities, both criminal and civil. Other shipping regulations (IATA, CFR 29, 42 and 49, ICAO, and USPS) may also apply, depending on the transport service used. Although ARUP Laboratories strives to ensure that all rules and regulations covered here are up to date, it is the responsibility of the client to ensure that any changes and/or modifications of these rules and regulations are reviewed and implemented in a timely manner.

The following rules apply for all specimens:

  • The primary receptacle must be leak-proof and not contain more than 500 mL or grams.
  • There must be absorbent material placed between the primary receptacle and the secondary packaging sufficient to absorb the entire contents of all primary containers within the secondary package.
  • The primary receptacle or the secondary packaging must be capable of withstanding, without leakage, an internal pressure differential of not less than 95 kPa.

Biological Substances, Category B, are defined as human or animal material, including excreta, secreta, blood and its components, tissue and tissue fluids, being transported for diagnostic or investigational purposes, but excluding live infected humans or animals. Exempt Human Specimens are excluded from Biological Substances, Category B.

A specimen which meets the definition of Biological Substance, Category B, (being transported for diagnostic or investigational purposes), but is known to originate from a patient with an infectious disease should still be transported as a Biological Substance, Category B, specimen.

Exempt Human Specimens are defined as clinical specimens (blood, secreta, excreta, tissue and tissue fluids) not known to contain or suspected to contain a pathogen; or a Biological Substances, Category B, specimen in which the pathogen has been neutralized or inactivated so it cannot cause a disease when exposure to it occurs. Exempt Human Specimens are excluded from hazardous materials regulation.

Instructions for preparing Biological Substances, Category B specimens:

  • If using an Interface and/or ARUP System 2000®, print out a packing list for each temperature and rack and bag these specimens separately. Do the same for all manual test request forms.
  • Place specimens in the ARUP rack in the order the specimens appear on the packing list or in the same order as the test request forms.
  • Place one or two racks in the zip-lock portion of the correct color-coded specimen bag. If racks cannot be used, then the specimen must be packed individually in a specimen bag; or, if multiple specimens are being sent, they must be individually wrapped and placed in a specimen bag.
  • On the front of the bag, completely fill in the date, client number, and specimen count. Place all of the paperwork into the outside pouch.
  • For all bags containing Biological Substances, Category B, specimens: place an ARUP yellow label (ARUP Supply #51150-84) on the specimen bag, or write the word “Category B” on the bag with a black marker. This will alert the courier to pack and ship this bag as a Biological Substance, Category B, specimen.
  • Remove the perforated section of the color-coded bag and keep for your records.
  • Place the color-coded bag in the appropriate temperature location for courier to pick up.

Instructions for shipping Biological Substance, Category B specimens:

  • Clients who ship their own specimens must make sure the shipping container has the words “Biological Substances, Category B” and “UN3373” on both the box and the Air Waybill under “description.”
  • An itemized list of contents must be enclosed between the secondary packaging and the outer packaging.
  • Pack specimens according to temperature type. Pack no more than two bags containing the ARUP tube racks in the small (quarter-sized) section and pack no more than six bags in the medium (half-sized) section. For refrigerated specimens, pack at least two gel packs in the small section (one top and bottom), or at least four gel packs in the medium section (two top and bottom) of the ARUP shipping container. If dry ice is being used, pack the majority of the dry ice (2.2 kg) on top of the specimens inside the small/medium section. When filling out the air waybill, it must include the verbiage, “Exempt Human Specimens” listed under the contents/description section. If dry ice under 2.2 kg (5 lb) is being used, the shipper must write dry ice, and must include the total weight of the dry ice being used in kilograms. If the shipper is using more than 2.2 kg (5 lbs) of dry ice or a class 9 dry ice lab on the container the air way bill must include: UN1845, Dry Ice, 9, and the total weight of the dry ice being used in kilograms.

All microbiology specimens must be bagged separately with the appropriate paperwork. The source of the specimen is required.