Routines for collection and handling of specimens and reporting of specific patient information vary depending on agency protocols, the clinical setting, and specialty laboratory requirements. Chart B.1 defines various substances and diagnostic specimens that can be encountered in a clinical setting for possible transport. The primary objective in the transport of diagnostic specimens is to maintain the sample as near to its original state as possible with minimum deterioration and to minimize hazards to specimen handlers. Specimens should be collected and transported as quickly as possible to the laboratory for analysis. For urine transport, a small amount of boric acid may be used; a holding or transport medium can be used for most other specimen types. Carefully follow the instructions for handling and transport of specimens provided on the kit by the manufacturer or by the laboratory that has provided these collection kits. Infectious substances must be handled with the utmost care. Chart B.2 lists the current classifications of substances and diagnostic specimens. Chart B.3 lists examples of category A infectious substances.
Definitions of Substances and Diagnostic Specimens
Infectious substances are defined as substances known to contain, or reasonably expected to contain, pathogens.
Pathogens are defined as microorganisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other proteinaceous infectious particles (e.g., prions) that can cause disease in humans or animals.
Cultures are the result of a process by which pathogens are intentionally propagated. (Note: Cultures do not include human or animal specimens.)
Patient specimens are those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment, and prevention.
From Transporting Infectious Substances Safely. (2006, October 1). Federal register hazardous materials: Infectious substances.
Classification of Substances and Specimens
Exempt human specimen: Substances with minimal likelihood that pathogens are present; for example, blood or urine for screening tests such as glucose and cholesterol screens.
Infectious substances are now classified as category A infectious substances (UN2814) affecting humans or animals or affecting animals only (UN2900) and biologic substances category B (UN3373).
Infectious substances category A: Substances in a form that, when exposure to it occurs, is capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals (see Chart B.3). Refer to the most current edition of the IATA Dangerous Goods Regulations manual for a complete list.
Biological substances category B: Substances that do not meet the criteria for inclusion in category A, for example, blood or urine samples for detection of pathogens such as HIV and HBV.
It is recommended to work with the reference laboratory to:
Obtain the correct shipping containers and labels.
Obtain the needed training to meet compliance.
From Transporting Infectious Substances Safely. (2006, October 1). Federal register hazardous materials: Infectious substances.
Examples of Category A Infectious Substancesa
African swine fever virus (cultures only)
Avian paramyxovirus type 1—velogenic Newcastle disease virus (cultures only)
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)
Classical swine fever virus (cultures only)
Clostridium botulinum (cultures only)
Coccidioides immitis (cultures only)
Coxiella burnetii (cultures only)
CrimeanCongo hemorrhagic fever virus
Dengue virus (cultures only)
Eastern equine encephalitis virus (cultures only)
Escherichia coli, verotoxigenic (cultures only)
Ebola virus
Flexal virus
Foot and mouth disease virus (cultures only)
Francisella tularensis (cultures only)
Goatpox virus (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)
HIV (cultures only)
Highly pathogenic avian influenza virus (cultures only)
Japanese encephalitis virus (cultures only)
Junin virus
Kyasanur Forest disease virus
Lassa virus
Lumpy skin disease virus (cultures only)
Machupo virus
Marburg virus
Monkeypox virus
Mycobacterium tuberculosis (cultures only)
Mycoplasma mycoides—contagious bovine pleuropneumonia (cultures only)
Nipah virus
Omsk hemorrhagic fever virus
Peste des petits ruminants virus (cultures only)
Poliovirus (cultures only)
Rabies virus (cultures only)
Rickettsia prowazekii (cultures only)
Rickettsia rickettsii (cultures only)
Rift Valley fever virus (cultures only)
Rinderpest virus (cultures only)
Russian spring-summer encephalitis virus (cultures only)
Sabia virus
Sheeppox virus (cultures only)
Shigella dysenteriae type 1 (cultures only)
Swine vesicular disease virus (cultures only)
Tick-borne encephalitis virus (cultures only)
Variola virus
Venezuelan equine encephalitis (cultures only)
Vesicular stomatitis virus (cultures only)
West Nile virus (cultures only)
Yellow fever virus (cultures only)
Yersinia pestis (cultures only)
From the International Air Transportation Dangerous Goods Regulations, January 2015.
When the patient delivers the specimen directly, provide a biohazard bag and include clearly written directions about the specific handling precautions, storage conditions, and specific directions for locating the physical facility.
Specimens may be mailed or transported to specialty laboratories located in other cities or distant areas. To avoid delays in specimen analysis, it is important to follow specific instructions for collection, packaging, labeling, and transporting of specimens. Some specimens must be received in the laboratory within an exact time frame, under specified storage conditions. Regulatory agencies (e.g., the Department of Transportation [DOT] or the International Air Transport Association [IATA]) require training to ensure that samples are properly packaged. The DOT requires training every 3 years, whereas IATA requires training every 2 years.
When packaging a specimen for shipping to a specialty laboratory, place the specimen in a securely closed, watertight container (e.g., a test tube, vial, or other primary container), and then enclose the entire primary container in a second durable, watertight container (secondary container). Each set of primary and secondary containers should then be enclosed in a sturdy, strong outer shipping container.
Follow appropriate labeling for etiologic agents and biomedical materials (Figures B.1 and B.2). If the package becomes damaged or leaks, the carrier is required, by federal regulations, to isolate the package and notify the Biohazards Control Office, Centers for Disease Control and Prevention, in Atlanta, Georgia. The carrier must also notify the sender that (improper) packaging not meeting regulatory requirements can cause a significant delay in specimen analysis, reporting of results, and medical diagnosis and treatment of the patients problem. Examples of specialty laboratory requirements for transporting, packaging, and mailing of specific specimens are shown in Table B.1.
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Clinical Alert
No person may knowingly transport or cause to be transported in interstate traffic, directly or indirectly, any material, including, but not limited to, diagnostic specimens and biological products which such persons reasonably believe may contain an etiologic agent unless such material is packaged to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation.
The Code of Federal Regulations governing the shipment of etiologic agents (42 C.F.R. 72.2 Transportation of Diagnostic Specimens, Biological Products, and Other Materials; Minimum Packaging Requirements) reads as follows: