Packing and Transport of BIOLOGICAL SUBSTANCE, CATEGORY A, SPECIMENS

Category A, Infectious Disease Tests

Infectious Substances, Category A, are substances that are known or are reasonably expected to contain pathogens. Pathogens are defined as microorganisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents, such as prions, which can cause disease in humans or animals.

Definition: A specimen that is transported in a form that is capable of causing permanent disability, life threatening condition or fatal disease to humans or animals when exposure to it occurs, is considered an Infectious Substance, Category A, specimen. For a complete list, refer to IATA Dangerous Goods Regulations, 49th Edition, 2008.

Only specimens that meet the criteria for inclusion as a Category A substance must be shipped as “Infectious Substance.”

Submissions to ARUP that require Infectious Substance shipping are limited to cultivated identified pathogens of: Bacillus anthracis, Francisella tularensis, Brucella species, Mycobacterium tuberculosis, Coccidioides immitis, Yersinia pestis, Pseudomonas pseudomallei.

Cultures (laboratory stocks) are the result of a process by which pathogens are amplified or propagated in order to generate high concentrations, thereby increasing the risk of infection when exposure to them occurs. This definition refers to cultures prepared for the intentional generation of pathogens and does not include cultures intended for diagnostic and clinical purposes.

INFECTIOUS SHIPPING TRAINING

When shipping Infectious Substances, the contents must be packed by someone who has been trained in accordance with the provisions contained in the United States Department of Transportation (DOT) and/or International Air Transportation Association (IATA) regulations for shipping Infectious Substances. Training is available through ARUP. Consult your Business Development Manager.

DOT AND IATA TRAINING REQUIREMENTS FOR INFECTIOUS SUBSTANCES

When preparing and shipping Infectious Substances, it is essential that each specimen be packaged and shipped properly. Complying with the regulations set forth by the DOT and the IATA will control or eliminate many health and financial liabilities, both criminal and civil.

The regulations specify that anyone who ships or prepares hazardous materials to be shipped must have received training from a certified source within the last two years. A record of this training must be maintained during the term of employment and for one year following termination of employment. The training record must include the following:

  • Individual’s name
  • Most recent training completion date
  • Description, copy, or reference to training materials used to meet the training requirement
  • Name and address of the organization that provided the training
  • Copy of the certification issued when the individual was trained, indicating that a test has been completed satisfactorily

Infectious Substance training is available online through ARUP. For more information, consult your Business Development Manager.

If clients ship their own specimens, the person packing the shipment is the client’s designated employee, and the client is the shipper. If the courier ships specimens, the client is required to mark the Infectious Substance, Affecting Humans label with the total number and volume of specimens being shipped, and the courier packs the shipment and becomes the shipper.

The following instructions do not meet the requirements for certified training as set forth in DOT and IATA regulations. ARUP is providing this information for shipping via air transport, not as training material, but as a reference for our clients. Other similarly stringent regulations apply for those who ship via ground or mail service. Questions regarding specific regulations may be directed to ARUP Transportation and Logistics Services at (800) 242-2787, extension 5119.

INFECTIOUS SUBSTANCE, CATEGORY A Shipping Containers

There are three types of pressure vessels provided by ARUP that are used for the inner packaging of Infectious Substances. Selection of the container depends on the number of Infectious Substances or the type of specimens to be shipped. Use only containers provided by ARUP.

  • Large plastic container with a screw cap, O-ring lid, foam plug, and supplied plastic bag. ARUP Supply Number: 19813

    Primary usage: For transport of slants, irregularly shaped specimens, or larger specimens. (pic of large container for slants and other large specimens. NO serum tubes. Place NO additional identifiers or stickers on container.)

    Instructions for Use: Put the primary container that holds the specimen in the opening of the foam plug. Place the foam plug inside the plastic bag and seal the bag. Place the plastic bag with the foam plug in the pressure vessel, making sure the foam cushions are in place on the top and bottom of the secondary container. Screw the lid on to sufficiently engage the O-ring for proper sealing. Infectious Substances should only be shipped ambient. Be sure to mark the “Ambient” shipping temperature on the outside of the pressure vessel. Place the secondary container in the outer packaging, using the Instructions for Clients Packing and Shipping Their Own Infectious Substances section.
  • Medium plastic container with a white screw-top lid and a sheet of absorbent material in a zippered plastic bag. ARUP Supply Number: 19814

    Primary Usage: For transport of multiple individual transport tubes or similar whole blood tubes. (pic of Medium container for multiple transport tubes or ONE body fluid (e.g. AFP) specimen. Place NO additional identifiers or stickers on container.)

    Instructions for Use: Unfold the absorbent material as a sheet. Insert the primary container that holds the specimen in a pouch in the absorbent material, adding up to six primary containers. Place the sheet holding the primary containers in the plastic bag and seal the bag. Place the bag in the secondary container. Tighten the screw-cap lid to engage the O-ring for proper sealing. Infectious Substances should only be shipped ambient. Be sure to mark the “Ambient” shipping temperature on the outside of the pressure vessel. Place the secondary container in the outer packaging, using the Instructions for Clients Packing and Shipping Their Own Infectious Substances section.
  • Clear plastic tube with screw-top lid and absorbent material. ARUP Supply Number: 19815

    Primary Usage: For an individual transport tube. (pic of clear plastic tube container for individual transport tubes)

    Instructions for Use: Wrap the primary container that holds the specimen in the absorbent material. Place the primary container and absorbent material in a bag, then into the pressure vessel. Tighten the screw-cap lid until it engages the tamper seal. Infectious Substances should only be shipped ambient. Be sure to mark the “Ambient” shipping temperature on the outside of the pressure vessel. Place the secondary container in the outer packaging using the Instructions for Clients Packing and Shipping Their Own Infectious Substances section.

PREPARING INFECTIOUS SUSTANCE, CATEGORY A, SPECIMENS

Instructions for preparing Infectious Substance, Category A specimens:

  • If using an Interface and/or ARUP System 2000®, print out a packing list for each temperature and bag these specimens separately. Do the same for all manual test request forms.
  • For Infectious Substances, a positive means of closure is required for all ambient specimens. If screw caps are used, they must be secured with adhesive tape, not parafilm.
  • Use the large, medium, or clear plastic tube pressure container depending on the quantity and type of specimens that you will be sending. A Declaration of Dangerous Goods form, two Class 6 Infectious Substance labels and two Infectious Substance, Affecting Humans labels will need to accompany each container.
  • 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.
  • Infectious Substances must be shipped in their own shipping container, with no other specimen types, and must not contain dry ice.
  • Locate the packet that consists of the Shipper’s Declaration for Dangerous Goods form, two Class 6 Infectious Substances labels and two Infectious Substance, Affecting Humans labels.
  • The client is responsible for filling out two Infectious Substance, Affecting Humans labels. Indicate the total number and volume of specimens being sent (refer to example). If sending specimens via courier, leave shipper information blank for the ARUP courier to fill out.

    For example:     For three slant specimens being sent for AFB Identifi cation with approximately 10 mL in each, enter 3 x 10 ml as the total volume in the area marked “Volume.” The courier will complete the remaining documents.
  • Take the above-mentioned packet, along with the packing list, and place them in the outside pouch of the green color-coded specimen bag.
  • Place the pressure vessel into the green color-coded specimen bag. Completely fi ll out the information on the outside of the bag. Remove the perforated section of the bag for your tracking records.
  • Place the green color-coded bag in the appropriate temperature location for courier to pick up.

ARUP prefers specimens submitted for cultures to be bagged individually to maintain specimen integrity. If identity of the specimen is unknown, or does not match an organism listed under Tests Considered Infectious, it DOES NOT need a Shipper’s Declaration for Dangerous Goods form.

INSTRUCTIONS FOR CLIENTS PACKING AND SHIPPING THEIR OWN INFECTIOUS SUBSTANCES

  • Place the pressure vessel in the green color-coded bag and then in the ambient section of the outer packaging.
  • Fill out the Infectious Substance, Affecting Humans label. The technical name is not required on this label. Total number and volume of the infectious specimen being shipped must be on the Infectious Substance, Affecting Humans label. Shipper’s name (client), address, and phone number of the person responsible for the shipment must also be entered. If courier picks up the specimens, they will fill out this section.
  • Place the Class 6 label and the Infectious Substance, Affecting Humans label on both sides of the outer packaging on the ARUP yellow shipping container or other certified shipping container.
  • Make sure to place the foam plug on top of the specimens inside the shipping container.
  • Seal the yellow shipping container by folding the flaps down and securing the nylon strap.
  • Complete the Shipper’s Declaration for Dangerous Goods form. Note: One copy of the declaration form should be retained for two years.
  • Complete the Air Waybill (see Preparing the Airline Air Waybill) and place it on the shipping container.

Preparing the Shipper’s Declaration for Dangerous Goods

Information in red will be preprinted by ARUP on the Shipper’s Declaration for Dangerous Goods form.

  • Shipper: Enter the full name and address of the shipper. If the client prepares the shipment, the client is the shipper. If the courier receives a properly labeled specimen, the courier is the shipper.
  • Consignee: Enter the full name and address of the consignee and the name and telephone number of a responsible person for contact in case of an emergency. Use the name, “Paul H. Brinton, (801) 584-5136.”
  • Air Waybill Number: Enter the number of the Air Waybill. In the case of DHL, special Air Waybills are available that combine the Air Waybill and the Shipper’s Declaration into one document.
  • Page of Pages: Enter the page number and the total number of pages.
  • Airport of Departure: Enter the full name of the airport or city of departure. Do not use the three-letter airport code.
  • Airport of Destination: Enter the full name of the airport or city of destination. Do not use the three-letter airport code.
  • Nature and Quantity of Dangerous Goods: The following should be included in this section:
    • UN or ID No.: Enter “UN 2814” for the specimens.
    • Proper Shipping Name: Enter “Infectious Substance, Affecting Humans” with the technical name “Suspected Category A Infectious Substance.”
    • Class or Division: Enter the number “6.2” for the infectious substance.
    • Packing Group: Enter nothing on the line for the specimen.
    • Quantity and Type of Packing: Enter the total number and volume of specimens of the infectious substance within the shipping container.
    • Packing Instruction: Enter the number “602” for the specimens.
    • Authorization: You may no longer ship a quantity of blood or blood product larger than 50 mL.
    • Additional Handling Information: Do not enter information in this field.
  • Name and Title of Signatory: Enter the name and title of the person who is signing the declaration. This information may be printed or stamped (on all copies). Enter the date and the location where the declaration form is signed. The shipper must sign the declaration, and the signature must be written by hand and not typed.
  • The Shipper’s Declaration for Dangerous Goods (provided by ARUP) includes three copies; two copies should be sent with the shipment, and the shipper should keep the last copy of the Shipper’s Declaration for Dangerous Goods form with a copy of the airbill for two years.

When Shipping via Federal Express or DHL

  • Fill in the shipper information on the Air Waybill, including the name and phone number of the person sending the shipment. If the Shipper’s Declaration for Dangerous Goods is part of the Air Waybill, follow the procedures above for filling out this form.
  • On the Air Waybill under the section entitled Handling Information, write the statement: “Dangerous goods as per attached Shipper’s Declaration.”
  • Enter the number of boxes being sent and the weight of the boxes in the appropriate section.
  • Attach the Air Waybill by removing the adhesive tape and applying the sticker to the shipping container.
  • Retain the top copy of the Air Waybill as a record of the shipment.
  • Two copies of the Shipper’s Declaration for Dangerous Goods must be presented to the forwarder with the shipment. The shipper keeps one copy. The copy must be kept for two years following receipt of the shipment.
  • Call (800) 242-2787, #4, with the Air Waybill number, so that your shipment can be tracked by ARUP. Please advise the person receiving the call that the shipment contains infectious substances and include the quantity of the organism(s) being shipped.

Shipments sent via Federal Express or DHL should only be shipped Monday through Friday. Do not ship on Saturday.

If specimens are shipped on Friday, the Air Waybill must be marked for Saturday Delivery under the Special Instructions section, or the shipment will not be delivered until Monday.

Preparing the Airline Air Waybill

  • Fill in the shipper and consignee information on the Air Waybill, including the name and phone number of the person sending the shipment. Refer to Shipper under Preparing the Shipper’s Declaration for Dangerous Goods on page 15.
  • On the Air Waybill under the section entitled Handling Information, write the statement: “Dangerous goods as per attached Shipper’s Declaration.”
  • Under the section entitled Nature and Quantity of Goods, a description of the contents of the shipment must be listed. This description will include “Medical Specimens” (infectious). No dry ice information is required when shipping Infectious Substances since these types of specimens are shipped ambient.
  • Two copies of the Shipper’s Declaration for Dangerous Goods must be presented to the forwarder with the shipment. The shipper should keep one copy with a copy of the Air Waybill. The copy must be kept for two years following the receipt of the shipment.
  • Call (800) 242-2787, #4, with the Air Waybill number, so that your shipment can be tracked by ARUP. Please advise the person receiving the call that the shipment contains Infectious Substances and include the quantity of the organism(s) being shipped.

Please note: Some regional carriers will not carry specimens identified as Category B and Infectious on their aircraft. In those cases, priority mail, such as DHL or Federal Express must be used. For questions please contact the ARUP Transportation Department.