Medical laboratories are accustomed to dealing with specimens that are potentially dangerous. They routinely operate within established work-safety practices as well as specific protocols for handling, storage and disposal.
"But transporting laboratory specimens adds another layer of risk and responsibility," noted Glen McDaniel, MS, MBA, MT, CLS, CLDIR, medical laboratory scientist and healthcare consultant, Atlanta, Ga. Shipped material goes through several hands and each handler is not necessarily familiar with the material, aware of the risk, aware of any contamination, or prepared to deal with an exposure if it does occur. "Those who might encounter a laboratory specimen during shipment might not be aware of risks or have appropriate personal protective equipment [PPE] on hand. It is the legal and moral responsibility of the shipping laboratory to reduce risk as much as possible," McDaniel added.
Southwest Airlines, which counts Quest and LabCorp laboratories among its customer base, handles a lion's share of lab specimen shipments. Colin Rogers, Southwest's senior manager of cargo and charters marketing, said that air shipping - often the preferred method by virtue of the time savings it offers - requires a great deal of trust between shipper and lab. "We want to get a specimen to its intended destination quickly and efficiently, yet at the same time we must safeguard our employees and passengers," he said. Rogers noted that while their regular lab customers know and follow verifiable, safe-shipping protocols, new lab-based shipping customers may benefit by a visit from a Southwest cargo customer service or sales team representative who makes sure all expectations can be met and assures that packaging requirements are understood and met.
Training and Certification
"Laboratory staff assigned to handling specimens for transport must be trained and certified," said McDaniel. "Indeed, regulations apply from the moment lab personnel start filling out paperwork to when the package is received at the end point. Staff must know how to handle, pack and complete required paperwork, mandated by regulatory agencies."
McDaniel said initial training must take place before a laboratorian is assigned to packing/shipping any specimens, and continuing certification will take place periodically (e.g., every 2 years) thereafter. "When changes occur - such as new policies, new regulations or additional items are being shipped - training must be upgraded to reflect the current situation," said McDaniel. "The triad of initial training, certification and retraining as required are designed to increase safety and to meet regulatory requirements."
While exacting protocols and regulations for safe air (from the International Air Transportation Association (IATA) and the International Civil Aviation Organization (ICAO), a UN special agency) and ground (from Department of Transportation) are in place, Rogers said that most mistakes occur due to human error - not container failure or temperature faults.
"People present the biggest challenge," said Rogers. "A lab may hire a driver - someone with a driver's license, that's the skill set -to drive a package to the airport. But then it morphs into picking up other specimens at a lab, and suddenly the scope of responsibilities has changed. What if a lab has done very little training with this driver on package handling, time requirements, etc.? Then your specimen may be compromised; this is an exacting situation."
Rogers cited an example of a lab staff member, highly trained in packing, calling off sick and a substitute packer stepping in. "This could be a red flag, because you need consistent performance. That's mainly where we see problems. We have had to turn down packages on occasion," Rogers said, "not to be mean to a customer, but simply to insure the integrity of their specimen."
How can a lab make sure its shipping process is on point? Pathology Associates Medical Laboratories (PAML) offers a checklist on its Packaging and Shipping Laboratory Specimen Guide (www.paml.com/Files/Logistics/Shipping%20Guide.pdf) to get the ball rolling. The basics to check off include:
• Facility staff is trained and certified to package and ship specimens.
• Hazmat/Dangerous Goods certifications are on file.
• Dangerous Goods shipping documents are in order.
• Specimen supplies are available (polyseal bag, specimen racks, manifest or requisitions).
• Packaging supplies are available (boxes, labels, air waybills).
• Courier contact information is readily available.
• Destination information is readily available.
Once those basics are established, it's on to the finer points of packaging and shipping. There are three main classifications of shippable specimens. The first is Exempt Human Specimens - inactive or neutral pathogens, dried blood spots, samples or specimens for transplant or transfusion - which are not regulated when packed in leak-proof packaging marked "Exempt Human Specimen," according to PAML.
Regulated Specimen Categories
The remaining two regulated categories of specimens established by IATA and ICAO are Category A and Category B specimens. Both specimen types are regulated and require specific packaging and handling procedures designed to protect anyone who comes in contact with the package.
According to the Mayo Medical Laboratories guidelines (www.mayomedicallaboratories.com/it-mmfiles/Infectious_Specimen_Shipping_Guidelines.pdf), "Under Universal Precautions, all blood and body fluids are considered potentially infectious. To clarify the situation for air transport, the regulators redefined 'Infectious Substances.' Infectious substances are substances known to contain, or reasonably expected to contain, pathogens. These specimens must be packaged as infectious substances, following IATA Packing Instruction 620.4." [For a list of Category A infectious substances, see Infectious Substances Classification at www.iata.org/whatwedo/cargo/dgr/Documents/DGR52_InfectiousSubstances(DGR362).pdf].
Regulators require that the technical name of a Category A infectious substance (the pathogen's name) be included on the mandatory Shipper's Declaration for Dangerous Goods form. However, when a specimen is being sent for identification, and its name is unknown, Mayo suggests entering the technical name as "Suspected Category A Infectious Substance."
Mayo's site also clarifies, "Specimens sent for diagnostic or investigational purposes are classified as biological substance, Category B. Similarly, most clinical laboratory tests (e.g., sodium, thyroid-stimulating hormone) are performed on what are considered to be Category B specimens. These specimens must be packaged following IATA Packing Instruction 650.5. If the culture being sent is not listed by IATA as a Category A infectious substance, then it can legally be sent as a Category B infectious substance, eliminating the need to prepare a Shipper's Declaration for Dangerous Goods or to use a UN-certified container with the Class 6 hazard label."
The bottom line, according to Mayo, is that every lab must understand and follow regulations for shipping infectious substances affecting humans. "It is the responsibility of the shipper [the send-out lab] to ensure correct identification, classification, packaging, labeling, marking and documentation for all shipments of infectious substances. In addition, the shipper is responsible for ensuring that all persons involved in the transport of infectious substances receive the required initial and recurrent training. Information on these requirements can be found at: hazmat.dot.gov/regs/rules.htm and iata.org/dangerousgoods."
Rogers noted that Southwest is offering a GPS innovation available to labs sending specimens which must be carefully tracked. Called "Cargo Companion," a small GPS device is available to be included with the packaging. The GPS delivers what Rogers called "cradle to grave tracking capable of sending proactive messages to tell you where your specimen is at any given moment."
Valerie Neff Newitt is on staff at ADVANCE.
Additional Sources for specimen shipping information are available from:
• World Health Organization: www.who.int/csr/emc97_3.pdf
• Quest Laboratories: www.questdiagnostics.com/home/physicians/testing-services/specialists/hospitals-lab-staff/
• CDC: www.cdc.gov/laboratory/specimen-submission/shipping-packing.html
• Department of Transportation: www.phmsa.dot.gov/pv_obj_cache/pv_obj_id_54AC1BCBF0DFBE298024C4C700569893C2582700/filename/Transporting_Infectious_Substances_brochure.pdf
• FedEx: www.fedex.com/us/packaging/guides/clinical_fxcom.pdf
• ICAO: www.icao.int/safety/DangerousGoods/Working%20Group%20of%20the%20Whole/DGPWG.05.IP.001.en.pdf
• IATA: www.iata.org/whatwedo/cargo/dgr/Documents/DGR52_InfectiousSubstances(DGR362).pdf