Vol. 14 •Issue 5 • Page 24
Lab Limelight: Specimen Transport
On the Road Again
USPS. DOT. IATA. The acronyms alone can have some laboratorians cringing at the thought of specimen transport. With the many terms and guidelines to remember, and the need to stay updated on them annually, can come some confusion. But staying up to date on the guidelines for shipping infectious and diagnostic specimens isn’t as tedious a task as it may seem.
Terry Jo Gile, MT(ASCP)MA Ed, (aka “The Safety Lady”; www.safetylady.com), Gile and Associates, Saint Louis, explains that the U.S. Postal Service (USPS) synchronized itself with all International Air Transport Association (IATA) and U.S. Department of Transportation (DOT) regulations regarding shipments by mail as of Jan. 1, 2004. All USPS packages must be sent using triple packaging according to DOT for ground and IATA for air shipments.
“For diagnostic specimens, use triple packaging consisting of a leakproof primary receptical, a leakproof secondary package and a sturdy outer package with the appropriate UN3373 label,” Gile says. “For infectious supecimens, use triple packaging consisting of a watertight primary receptical, a watertight secondary package and a sturdy outer package with the appropriate UN2814 label.”
Dave Cook, Communications and Regulatory Affairs, Saf-T-Pak, Edmonton, Alberta, Canada, explains that regulators have decided that instead of calling samples infectious substances or diagnostic specimens, they will fall into Category A Infectious substance or Category B Infectious substance. A Category A organism is one that is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease to humans or animals. Category B substances are organisms that don’t meet the criteria of Category A and are assigned to UN3373. Category B includes both diagnostic and clinical specimens.
“Category A is the heavyweight stuff that will make you deathly ill if you get in direct contact with it,” Cook says. “And both of the international air regulators have published a table called the Indicitive Examples of Infectious Substances Included in Category A. If your substance falls on that table you have no choice but to send it as a Category A.”
Cook also says tweaks have been made to The Shipper’s Declaration for Dangerous Goods, a required document that goes along with the shipment. The highlights can be found at www.saftpak.com.
Additionally, a different marking is required now for an overpack. “If you’re shipping three or four infectious packages of Category A, you want to pay one shipping charge and put them in a bigger box. However, the bigger box is not a compliant package…it’s called an overpack,” Cook says. “It has to look like a compliant package with all the required labeling and marking. Because there is no visible UN specification mark on the overpack box, the shippers have to say that the boxes inside do have that mark, which they are obliged to have.” The old marking requirement was: Inner packages comply with prescribed specifications. The new marking is simply: Overpack.
The bulk of laboratories ship Category B substances, which are any human or animal material under UN3373, and that includes diagnostic and clinical specimens. “For the two packing instructions that we deal with, Packing Instruction (PI) 602 for Category A and PI 650 for Category B, the packaging is quite similar. In both cases, a triple level of packaging is required. The primary recepticle and secondary packaging must be leakproof, and one or the other must be pressure compliant,” Cook says. “We want the primary or secondary container to contain the pressure properly, and then there’s a rigid outer box required.”
For air transport nationally and internationally the packer shipping Category B Infectious substances must abide by ICAO/IATA PI 650. For ground transport the marking requirements are different, but the packaging is similar. Cook suggests packaging the specimen as if it’s going by air, then you’ll be fine by road, rail and sea.
Two regulations have caught people offguard with PI 650. This year a diamond-shaped marking (the international symbol of dangerous goods) that says UN3373 inside it is required on a package containing Category B substances. Cook explains, “And the name, address and telephone number of a responsible person must appear either on the completed package or on the shipping document.”
Richie Seaberg, BS, MT(ASCP), senior administrative director of the Clinical Pathology Lab, North Shore University Hospital and Long Island Jewish Medical Center, Manhasset, NY, says the biggest issue in his lab is getting the packaging material because there are certain checks the packaging material needs to conform to such as double-walled cylinders wrapped in a special styrofoam container. It also has to meet a certain drop test level. “We usually buy the product from the vendor so it comes as an attached system,” he explains.
Anyone who ships specimens must be trained every 24 months or if new regulations come into place. Online training programs and training manuals also exist from companies such as Therapak Corp. and HighQ®.
Gile also has developed a PowerPoint® training program complete with a quiz and certificate. The program has applied for CEUs from the ASCLS P.A.C.E. program®.
The only way to ascertain whether the shipment is Category A or B is to be trained to make that decision. Saf-T-Pak offers three ways to train your staff, Cook says:
1) One-day public training seminar. Training in Class 6.2 that is fully comprehensive that covers Category A and B and dry ice shipments. There is a hands-on exercise at the end of the day where participants pack, mark, label and document a Category A shipment as if it’s going out the door. There’s also a final written test in the classroom.
2) Private seminar. Saf-T-Pak comes to your facility to conduct a training session for up to 30 people.
3) Interactive CD that can be run on your own PC. It’s student paced and can take anywhere from two to six hours depending on what you know already. There’s a specific training stream if you are shipping Category B only.
Susan Hopkins is an assistant editor.