If you are sending specimens outside of your lab for testing or for other purposes, there are many things to consider. Not just anyone in the laboratory should prepare the specimens for shipment, specific training is required. Staff needs to have knowledge about packing procedures, specimen safety considerations, and how to fill out the necessary paperwork.
The safe transport of laboratory specimens is regulated by at least four different agencies. The United States Department of Transportation (DOT) generates specimen packaging and shipping regulations and updates them every October. They become effective on April first of the following year. The International Civil Aviation Organization (ICAO) provides technical instructions for domestic and international air shipments. Dangerous Goods regulations are published by the International Air Transportation Association (or IATA). These annual updates take effect every first of January, and they comply with ICAO instructions as well. The fourth regulatory body affecting specimen shipping is the United States Postal Service (USPS). The USPS regulations are synchronized with those of both the DOT and IATA. In fact, most of these regulatory agency’s shipping regulations are similar because they have been harmonized with the United Nations Model Regulations.
Dangerous Goods are categorized under classes and divisions, and laboratory specimens fall under Class 6, Division 2; Infectious substances. For the purposes of shipping, these infectious substances are further divided into Category A (specimens known or reasonably expected to contain pathogens) and category B (human or animal specimens which do not contain pathogens). Very specific training for lab staff is required for those who will package and ship these types of products. A laboratory that sends such specimens is considered the shipper, and shippers are viewed in the eyes of the law as responsible for the package until it reaches its final destination. That responsibility involves proper and regular training, specific packaging instructions, and management of shipping paperwork.
Dangerous Goods packing and shipping training includes General Awareness information. This includes an overview of the various regulations surrounding specimen shipment as well as enabling the trainee to recognize and identify the hazardous materials that fall under the regulations. Function-Specific training is general instruction on how to package dangerous goods, how to properly label parcels, and how to fill out the required paperwork. Training shippers about Safety is also required. Staff must be given information about the hazards associated with handling dangerous goods, and there must also be training given about how to handle emergencies such as accidents or spills. Lastly, Security training is required because the materials being shipped could be misused in a way that could cause harm to others (i.e. a terrorism event).
The paperwork that must be filled out and that must accompany the package is called a waybill or a shipper’s declaration. A lab must have two original completed and signed forms. Two of the signed forms travel with the shipment to its final destination, and one will be retained by the carrier. There are very specific instructions about how to fill out a shipper’s declaration, and only those trained should do so.
Not all specimens and chemicals shipped by a lab are considered Dangerous Goods, and they may not fall under the regulations for labs that transport them. The DOT designates some items as “Materials of Trade,” and they are not regulated under transport laws. Material of Trade are those items which are carried on a motor vehicle to directly support a principal business of a private motor carrier (such as a private courier). That means that many diagnostic specimens and some hazardous chemicals (under 8 gallons depending on the chemical) may be transported without shipping papers, emergency response plans, and specialized training.
Proper training for those shipping Dangerous Goods takes time, and the information included in the training is much more in-depth than what has been discussed here. Those who are trained should be tested on the information taught, or they can provide a demonstration of proper packaging and paperwork management. Each successful trainee should be given a certificate of completion, and that record needs to be retained for at least 36 months. Training should be repeated every two years in order to satisfy the requirements of all regulatory agencies.
Laboratories across the country package and send diagnostic specimens for testing or for other purposes. Sometimes, depending on how and where those specimens will be transported, very specific regulations will apply, and specialized staff training will be required. Before you get those samples packed and ready for their trip, make sure your lab is following the regulations that will keep your staff (and those who will transport and receive the packages) safe from harm.
–Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.