Vol. 21 • Issue 9 • Page 20
Regulatory Compliance
Editor’s note: This is the first of a special 3-part series on initiatives and updates surrounding specimen transport and Department of Transportation (DOT) regulations. Part 2 will address DOT’s authority regarding inspections, recent fines and ways a shipper can avoid fines.
“Treat any potentially infectious substance as if it is infectious” is the universal precaution for everyone in laboratory and medical settings who handle patient specimens. To ensure the safety of healthcare workers, standard operating procedures (SOPs) are based on this universal precaution. Some SOPs and personal ðprotective equipment (PPE) measures are required by various regulatory bodies, while others are common sense.
Although these precautions continue with the specimens when transported from one facility to another, regulations governing the transportation of these substances are distinctly different from the regulations for handling specimens in the laboratory. This series explores the various regulatory bodies responsible for shipments of patient specimens (as well as biological and infectious substances) and outlines the authority these organizations have, including inspections and the levying of fines. Recent fines will be examined and information provided as to how you, the shipper, can avoid these fines.
DOT Regulations
The main source for regulations governing specimen and biological shipments in the U.S. is the Department of Transportation (DOT). The DOT regulates all hazardous shipments, including laboratory specimens, when they are transported in commerce, which means in public by a plane, train, ship or motor vehicle. The transport regulations do not apply to shipments on private property, whether it is by a motor vehicle or not. However, once the shipment enters the public in commerce, all aspects of the shipment are subject to U.S. hazardous materials transport regulations, starting with and including the preparation of the shipment.
The responsibility for the preparation of the shipment falls on the individual (or group of individuals) that plans to offer the specimen for transport, and this person (or group of people) is referred to as the “shipper.” The shipper is responsible for ensuring the specimen intended for transport is classified correctly, placed in the proper type of packaging and that all related marks, labels and documents are completed correctly. If any of these steps are not completed according to the U.S. hazardous materials transport regulations, the shipment may be rejected or delivery potentially delayed, and the shipper faces the possibility of being fined.
HAZMAT Regulations
Before offering a specimen for transport, it is essential that you have a clear understanding of the hazardous materials transportation regulations. The regulations that govern all hazardous materials shipments within the U.S. are published by the Pipeline and Hazardous Materials Safety Administration (PHMSA), a branch of the DOT. PHMSA is responsible for all hazardous materials shipments, including infectious and biological substances. The regulations are published in the Code of Federal Regulations (CFR) under the Transportation section, or Title 49. While this contains the regulations pertaining to all aspects of transportation, only sections 100-185 deal directly with transporting dangerous goods or hazardous materials. The Hazardous Material Regulations (HMR) found in parts 100-185 of the 49 CFR cover all of the different types of hazardous materials (flammable, explosive, corrosive, radioactive, toxic and infectious, among others), by all modes of transport.
The Federal Aviation Administration (FAA, another branch of the DOT), assists PHMSA in enforcing regulations for the transportation of hazardous materials by air. Both PHMSA and FAA employ inspectors who regularly visit and inspect laboratories where infectious and biological substances are offered for transport. When these inspectors discover violations of the regulations, they are authorized to issue corrective action, including fines or other penalties.
Air Transport
Additional regulations pertain specifically to air shipments. The International Air Transport Association (IATA) is a membership-driven industry organization that helps regulate all shipments on aircraft or by air carriers. Membership in IATA is not mandatory; however, over 240 airlines, including a majority of the foremost (FedEx, UPS, United and Delta) are members of IATA. If you offer a shipment to an IATA member carrier, the shipment is not only subject to the U.S. DOT regulations, but also to the IATA Dangerous Goods Regulations (DGR). There is some harmonization between the national and international regulatory bodies, so if you are in compliance with IATA, you are most likely in compliance with the 49 CFR.
Although IATA and IATA-member carriers don’t have the authority to issue fines or penalties, they do have the right to reject any package for transport if it violates their regulations (IATA DGR). If your package contains a valuable or sensitive shipment, the rejection by the airline could be more costly than a fine. Consequently, it is highly recommended that shippers be aware of, and comply with, all the regulations that could affect their shipments.
Fines, Package Rejection
The training required for each lab will depend on the substances they ship. Training must cover the regulations for both DOT and IATA to avoid package rejection and fines. IATA training will guard against package rejection, while DOT training protects against potential fines. The next article in this series will address the authority the DOT has with regard to inspections, look at some recent fines and explore ways a shipper can avoid these potential fines.
David Creighton is the regulatory and training manager at Saf-T-Pak. He is engaged in a number of national and international organizations and sits on the Dangerous Goods Training Association’s Board of Certification.
