Proper packaging and labelling of the clinical specimens or materials being shipped is vital to maintain the integrity of the specimens, prevent accidents, and to ensure that there are no delays due to failure to adhere to shipping regulations. All specimens collected for analysis must be properly labelled and should be accompanied with paperwork that includes the identification number that matches the label on the vial. In addition, all necessary details about each specimen should be provided to the receiving laboratory, including all relevant clinical and epidemiologic information regarding the suspected case. The onset and collection dates, as well as the date of the most recent vaccination are critical data to include for appropriate testing and interpretation of results. The documentation required and the patient information that should accompany specimens for measles and rubella testing is discussed in Chapter 11. Data management and reporting of laboratory results. A standardised laboratory request form is recommended to ensure that all the pertinent information is provided. An example of an appropriate laboratory request form is provided in Annex 11.1.
Shipment of specimens within the country must meet all national requirements and laboratories should work closely with domestic carriers to ensure that the packaging and description of contents are appropriate. For international shipments of clinical specimens, it is essential that laboratories adhere to requirements for documentation, standardized packaging, and labelling for international shipments of clinical specimens. Successful shipment of materials within the country, region, or the global laboratory network requires advanced planning and communication between the sender, carrier, and the receiver. It is the responsibility of the sender to ensure that all requirements are met for shipment of materials sent to or from the laboratory. While much of this section pertains specifically to international shipments of clinical specimens, the complexity of the process- whether shipments are made within country or shipped internationally- requires an ongoing effort to keep informed of any updates or modifications made to shipping or packaging requirements.
The receiving laboratory should be contacted prior to shipment and informed of the quantity and type of specimens that will be sent. If the clinical specimens are being shipped internationally, the sender should inquire about any import permits required by the receiving laboratory’s national government. The receiving laboratory must obtain the current permit or other required paperwork and provide them (by pdf file, email, or fax) to the shipping laboratory. The sender should inquire whether the receiver prefers a specific carrier or can provide helpful information regarding previous experiences or problems encountered with incoming shipments. The carrier should be familiar with handling infectious substances and diagnostic specimens. The carrier may require specific documents and may provide advice on packaging or specific instructions necessary to ensure safe arrival of the shipment. The sender and receiver should then make advance arrangements for a mutually convenient time for shipment to ensure that the appropriate staff are available to receive the shipment. It is recommended that weekend arrivals are avoided.
The packaging requirements for some types of laboratory materials are subject to international and national regulations. The updated International Air Transport Association (IATA) Dangerous Goods Regulations governing the transportation of biological specimens from 1 January 2017* are applicable. The document entitled, Guidance on Regulations for the Transport of Infectious Substances 2017-2018, covers all aspects of shipping including packaging and documentation [1]. The internet URL is provided in the bibliography at the end of this chapter, however the publication referred to here may be superseded on an annual basis.
Category B agents (viable measles and rubella virus cultures are included in this category) are considered to present a reduced risk because they are not easily transmissible and basic precautions and hygienic practices will serve to prevent exposure and infection in the event of an incident. Specimens or other materials that are not subject to dangerous goods requirements and regulations include patient diagnostic specimens if there is minimal likelihood that pathogens are present and if they are transported in packaging which will prevent any leakage and are correctly labelled. The exterior packaging must be marked as “Exempt human specimen”. For diagrams and more information, refer to Annex 3.1, Shipping clinical samples.
Clinical specimens collected for molecular characterization may be processed and shipped on commercially produced paper cards (FTA® Cards) that inactivate virus but preserve the nucleic acids. Shipment of the FTA cards does not require a cold chain and should be accepted as regular mail. The preparation, shipment and extraction protocols for dried blood spots and dried serum spots is provided in Annex 3.2. Information regarding the use of the FTA cards for molecular testing is discussed in Chapter 5. Virus isolation and identification of measles and rubella in cell culture. Oral fluid samples and dried blood spots (DBS) for serology testing can usually be shipped at ambient temperature, often by regular post shipment. Refer to specific sections in this chapter regarding these specimens.
Inclusion of adequate refrigerants is needed to ship clinical specimens for virus isolation or when virus cultures are being shipped for further analyses. Ice or ice packs that have been frozen at -20°C can maintain temperatures of +4-8°C in a well-insulated shipping container for up to 3 days. Ice should be placed in a leak-proof container outside the secondary receptacle and the outer packaging should also be leak-proof. In order to maintain cold-chain conditions for longer than 3 days, the use of dry ice is recommended if it can be readily obtained and the required packaging for dry ice shipments is available.
Dry ice must not be placed inside the primary or secondary receptacle because of the risk of explosions. A specially designed insulated packaging is used for dry ice shipments which permits the release of carbon dioxide gas as the dry ice undergoes sublimation. Dry ice is regulated as a hazardous material in air transport; ICAO/IATA Packing Instruction PI954 applies. The outermost packaging must carry the hazard label for dry ice and the appropriate marking.
The documentation required for shipping materials is determined by the nature of the materials being sent. In general, each shipment should be accompanied with the airway bill (if shipped by air), any required export/import documentation, and outer packaging should inform the receiving laboratory of the proper contents and proper storage conditions. For example:
URGENT: DO NOT DELAY: Biological specimens – highly perishable – store at 4°C to 8°C
Once the package has been sent, the receiver should be immediately notified of the following:
- estimated number of cartons and weight
- flight and arrival date/time
- airway bill number
A copy of the airway bill should be provided to the sender and the receiving laboratory should confirm that the airway bill was received. Upon receipt of the package and inspection of the contents, the receiver should provide confirmation of delivery and inform the sender of the condition of the materials. This can be facilitated by the sender including a “fax back” form in the shipment. If the quantity or types of specimens received does not match the accompanying documentation or does not conform with the information that was provided prior to shipment. the receiver should immediately contact the sender and resolve the apparent discrepancy.