Federal regulations concerning the shipment of diagnostic and infectious substances by air or surface are now strictly enforced. The shipper is entirely responsible for properly classifying, identifying, packing, marking, labeling and documenting shipments for transport.
All isolates submitted to the OLS must be packaged properly and shipped accordingly. Isolates received NOT meeting the current regulations will be subject to rejection criteria. This page will provide sufficient information to providers seeking to ship specimens to the OLS. If you would like to review the complete regulations, please see the REGULATIONS section below.
Based on these new and updated regulations, it is now acceptable to ship ALL culture/isolate specimens (with the exception of those listed as Category A) to OLS as “Diagnostic”. This would include: Salmonella, Streptococcus, Campylobacter, Shigella (non-dysenteriae Type 1), Neisseria, etc. Specimens may now be shipped as per PI 650 and must be labeled as UN3373 (Infectious Substance, Category B). Shiga-toxin positive Escherichia coli cultures/isolates must be shipped as Category A.
EXAMPLE OF CATEGORY B SHIPPING CONTAINER (NOTE: This example is for demonstration only. Actual container may
EXAMPLE OF CATEGORY A SHIPPING
(NOTE: This example
is for demonstration only. Actual container may vary.)
International Air Transport Association (IATA): IATA is the source for all current shipping regulations. This website provides packaging and labeling requirements for Category A Infectious Substances and Category B Biological Substances. These regulations are derived from the Committee of Experts on the Transport of Dangerous Goods, United Nations Secretariat, and the Technical Instructions for the Transport of Dangerous Goods by air which is provided by the International Civil Aviation Organization (ICAO). A copy of the DGR may be obtained by calling (800) 716-6326.
Code Of Federal Regulations (DOT): Included in this website are Hazardous Materials Regulations from 49 CFR Parts 171-178. These apply to the shipment of both biological agents and clinical specimens. Scroll down to SUBCHAPTER C - HAZARDOUS MATERIALS REGULATIONS.
Code Of Federal Regulations (USPS): This website includes 39 CFR Part 111 (Mailability of Etiologic Agents) and Domestic Mail Manual 124.38 (Etiologic gents Preparations). A copy of the Domestic Mail Manual may be obtained from the Government Printing Office by calling (202) 512-1800.
US Department Of Transportation/Pipeline And Hazardous Materials Safety Administration : The USDOT PHMSA has the public responsibility for safe and secure movement of hazardous materials.
USPS Hazardous Materials Summary
Diagnostic Mailing Kits
Below is a list of just some of the companies who provide diagnostic shippers:
DG Supplies, Inc.
(DISCLAIMER: Recommendations of these websites do not constitute endorsement by the OLS, BPH, DHHR, or any other State agency.)