Infectious Material. hazmat.dot.gov/regs/rules.htm iata.org/dangerousgoods

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1 Infectious Material Most medical specimens sent to an esoteric laboratory such as Mayo Medical Laboratories are flown on passenger aircraft or are carried by common air carrier such as FedEx. The International Civil Aviation Organization (ICAO) and International Air Transport Association (IATA) have established stringent rules to protect passengers and package handlers from exposure to these potentially infectious substances. These regulations are enforced by the Federal Aviation Administration (FAA) or other similar enforcement agencies around the world who can levy significant fines against shippers and carriers who violate the regulations. You should be aware that your test send-out area is considered the shipper when they send specimens to a reference laboratory. Therefore, your send-out area must understand and follow regulations for shipping infectious substances affecting humans. It is the responsibility of the shipper to ensure correct identification, classification, packaging, labeling, marking, and documentation for all shipments of infectious substances. In addition, the shipper is responsible for ensuring that all persons involved in the transport of infectious substances receive the required initial and recurrent training. Information on these requirements can be found in the following Web sites: hazmat.dot.gov/regs/rules.htm iata.org/dangerousgoods We will focus on the regulations for shipping infectious substances by air. If you use a ground service, you must follow U.S. Department of Transportation (DOT) regulations. If you use the U.S. Postal Service, you must follow Post Office regulations. In either case, contact the Dangerous Goods Departments of the carrier you plan to use for details. IATA and ICAO have established 2 categories of specimens, Category A and Category B. 1,2 Both specimen types require specific packaging and handling procedures designed to protect anyone who comes in contact with the package. The shipper (your send-out staff) must decide in which category specimens belong. With the implementation of Universal Precautions, all blood and body fluids are considered potentially infectious. To clarify the situation for air transport, the regulators redefined Infectious Substances. Infectious substances are substances known to contain, or reasonably expected to contain, pathogens. 3 These specimens must be packaged as infectious substances, following IATA Packing Instruction On the other hand, specimens sent for diagnostic or investigational purposes are classified as biological substance, Category B. Similarly, most clinical laboratory tests (eg, sodium, thyroid-stimulating hormone) are considered Category B specimens. These specimens must be packaged following IATA Packing Instruction Note: For a list of Category A infectious substances, see TABLE 3.6.D below. Shipping Cultures of Microorganisms Aerobic and Anaerobic Bacteria, Mycobacteria, Fungi, and Yeast Use either of the following methods for isolating the organism for transportation (Agar plate is not acceptable.): Method A. Transfer organism to appropriate agar slant, broth, or anaerobic transport vial. Incubate agar slant or broth for 18 to 24 hours or until actively growing. Method B. Cut out a nickel-sized piece of the agar on which there is a colony of the organism to be tested. Place the agar in a screw-capped, sterile (serum) vial, and cap the vial tightly. Note: Organism must be in pure culture, actively growing. (Agar plate is not acceptable.) Mixed cultures will not be processed. Prepack the culture specimens for shipping using large Mayo Medical Laboratories infectious containers (Supply T146). Mayo Medical Laboratories procedure for prepacking the mailers is shown below. You may also use commercial packaging. Follow instructions carefully. Mayo Medical Laboratories general procedure is described below; a more detailed copy may be ordered from Mayo Medical Laboratories.

2 Mayo Medical Laboratories Procedure for Prepacking Infectious Specimens General Infectious Blood, Cultures, and Serum Under Universal Precautions, all specimens should be considered potentially infectious; however, not all specimens should be sent as Category A infectious substances. Your send-out staff must decide which specimens must be shipped as Category A infectious substances. If the name of the test you are sending to Mayo Medical Laboratories includes 1 of the pathogens listed in IATA Dangerous Goods Regulations TABLE 3.6.D, it should presumptively be considered Category A infectious. Of course, medical knowledge can override generalities. Some specimens may not be capable of transmitting disease. The judgement of your medical director should prevail. Regulators require that the technical name of a Category A infectious substance (eg, culture s name) must be on the Shipper s Declaration for Dangerous Goods form. This poses a problem when a specimen is being sent for identification; its name is unknown. We suggest it is better to send the specimen as Category A infectious, and enter the technical name on the Shipper s Declaration for Dangerous Goods form as Suspected Category A Infectious Substance. If the culture being sent is not listed in IATA TABLE 3.6.D, then it can legally be sent as a Category B infectious substance, eliminating the need to prepare a Shipper s Declaration for Dangerous Goods or to use a UN certified container with the Class 6 hazard label. Mayo Medical Laboratories policy is to treat ALL actively growing cultures with extra care and to transport them inside the large Mayo Medical Laboratories infectious mailer (Supply T146). The specimen bag, the Styrofoam lid, and the box must each have affixed to them a blue C label (Supply T549) which will alert the send-out laboratory, the courier, and the receiving laboratory that the box contains a culture. Please affix a blue C label to each specimen bag containing any culture, whether that culture is classified as Category A or as Category B. If you do not have a Mayo Medical Laboratories courier who picks up and ships your specimens for you, then we ask that you affix a blue C label on the Styrofoam lid and to the outside of the box as well.

3 Shipping Category A Infectious Specimens Once specimens are prepacked, they must be boxed for shipment. If you are using a commercially available infectious mailer, follow their instructions carefully. If you are using a Mayo Medical Laboratories mailer, someone must place the prepacked specimens into a certified Mayo Medical Laboratories shipping box for shipment. Mayo Medical Laboratories couriers have been trained to follow our standard procedures for shipping infectious substances. If your send-out area must ship the specimens themselves, be warned that the process requires the shipper to follow the Letter of the Law. We suggest that you contact Mayo Medical Laboratories for a copy of our Courier Procedure for Shipping Infectious Substances to Mayo Medical Laboratories. Preprinted documentation for shipping Mayo Medical Laboratories packages can also be obtained as needed. The basics of the infectious shipping procedure are shown below. Once the above labels are attached and documentation is completed, tender the box with a common carrier. If any part of the labeling or documentation is incorrect, the box will be returned on the next working day. BE SURE to complete every label and document correctly. Packages Damaged While in Transit to Mayo Medical Laboratories If a package leaks in transit, the carrier will first contact Mayo Medical Laboratories for instructions and then will notify: Centers for Disease Control and Prevention (CDC) Attn: Biohazards Control Office 1600 Clifton Road Northeast Atlanta, GA (phone: )

4 The carrier shall also notify the sender whose name appears on the infectious label and airbill. Carriers will insist on seeing the information in both places. TABLE 3.6.D Bacillus anthracis (cultures only) Brucella abortus (cultures only) Brucella melitensis (cultures only) Brucella suis (cultures only) Burkholderia mallei - Pseudomonas mallei - Glanders (cultures only) Burkholderia pseudomallei - Pseudomonas pseudomallei (cultures only) Chlamydia psittaci - avian strains (cultures only) Clostridium botulinum (cultures only) Coccidioides immitis (cultures only) Coxiella burnetii (cultures only) Crimean-Congo hemorrhagic fever virus Dengue virus (cultures only) Eastern equine encephalitis virus (cultures only) Ebola virus Escherichia coli, verotoxigenic (cultures only) Flexal virus Francisella tularensis (cultures only) Guanarito virus Hantaan virus Hantaviruses causing hemorrhagic fever with renal syndrome Hendra virus Hepatitis B virus (cultures only) Herpes B virus (cultures only) Human immunodeficiency virus (cultures only) Highly pathogenic avian influenza virus (cultures only) Japanese encephalitis virus (cultures only) Junin virus Kyasanur Forest disease virus Lassa virus Machupo virus Marburg virus Monkeypox virus Mycobacterium tuberculosis (cultures only) Nipah virus Omsk hemorrhagic fever virus Poliovirus (cultures only) Rabies virus (cultures only) Rickettsia prowazekii (cultures only) Rickettsia rickettsii (cultures only) Rift Valley fever virus (cultures only) Russian spring-summer encephalitis virus (cultures only) Sabia virus Shigella dysenteriae type 1 (cultures only) Tick-borne encephalitis virus (cultures only) Variola virus Venezuelan equine encephalitis virus (cultures only) West Nile virus (cultures only) Yellow fever virus (cultures only) Yersinia pestis (cultures only) References 1. Section 3 Classification, Dangerous Goods Regulations, 49th Edition, International Air Transport Association, Montreal- Geneva, 2008, pp Technical Instructions for the Safe Transport of Dangerous Goods by Air, International Civil Aviation Organization, Montreal, Quebec, Canada, Edition, pp to Infectious Substances, Section , Dangerous Goods Regulations, 49th Edition, International Air Transport Association, Montreal-Geneva, 2008, p Packing Instruction 602, Dangerous Goods Regulations, 49th Edition, International Air Transport Association, Montreal- Geneva, 2008, pp

5 5. Packing Instruction 650, Dangerous Goods Regulations, 49th Edition, International Air Transport Association, Montreal- Geneva, 2008, pp Shipper s Declaration for Dangerous Goods