Overview
Inadequately packaged samples pose a health and safety risk due to leakage of contents which may contaminate other mail, postal vehicles and premises, and postal reception facilities at the recipient laboratory.
Regulations
Any-one contemplating the transport of samples should be aware that there is a legal onus on the sender of biological materials to ensure that the packaging conforms to legal requirements contained the Transport Regulations.
There is also a legal requirement to provide adequate training for anyone involved in the transport of the material. Should someone e.g. a postal, courier service or laboratory worker, contract a disease or sustain an injury from an inadequately packaged sample, the sender may be liable to prosecution.
Some of the main requirements for packaging and transporting diagnostic samples are outlined in this article.
Bi-annual recommendations produced by a United Nations Committee of experts are used to up-date European legislation governing the packaging and transportation of Dangerous Goods, including pathological specimens, and this in turn is enacted through national legislation.
The national legislation for road transport in N I are the “The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations (Northern Ireland) 2009 (as amended)”. This implements the current version of the European Agreement for Transportation of Dangerous Goods by Road (ADR) regulations.
The Air Industry Regulations (IATA) are generally used for transport by air, and this also applies to postal services. More information found at:
https://www.iata.org/en/publications/dgr/
Patient Specimens
For all modes of transport a “patient specimen” is defined as “human or animal material including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment or prevention”. Patient specimens are classified as Category “A” or “B” depending on the pathogen they either are known to contain, or potentially contain.
There are much stricter regulations concerning packaging, training and security that apply to Category “A” material however this mainly applies to suspect specimens from Epizootic Diseases and cultures. It is therefore very unlikely that any List “A” packages will be sent into the lab directly from either private practices or farms, so they will not be covered in this article.
Everything that is not Category “A” is Category “B”. The correct shipping name for Category “B” is “Biological Material, Category B”, the identification number is “UN 3373” and the material must be packaged in compliance with Packing Instruction 650.
Labelling
The package labelling must include:
- The UN 3373 hazard diamond and a “Biological Material, Category B” label on the outer package.
- Rolls of “stick on” combination UN 3373 diamond/ “Biological Material, Category B” labels are available from specialist label suppliers.
- The name and address of both the consignor and consignee.
- The name and telephone number of a “Responsible Person” who is familiar with the contents and the hazards it may pose is required either on the waybill if a courier is used, or on the package itself.
Package Construction
Packaging Instruction 650 outlines the labelling and testing requirements for packing used in the transportation of Biological Material, Category “B”.
In practice, the package should include:
- Primary receptacle that is leak-proof and contains no more than 1L or 1 Kg of specimen including fixative or transport media if being sent by road (50 ml/50 mg by post).
- Layer of absorbent material sufficient to absorb the entire volume of any liquid contents in the package.
- Secondary packaging that is leak-proof with a maximum content of 4 L/4 Kg per outer packaging if sent by road (50 ml/50 mg by post).
- Itemized list of contents between the secondary packaging and outer packaging
- Rigid outer packaging with at least one side 100mm X 100mm
The package must be sufficiently robust to survive the transport process.
More robust packaging is therefore required for samples sent through the post or by courier to a diagnostic laboratory, than would be required for transport of a sample directly by car from a farm to either a practice office or the lab. However, it should be noted that the packaging requirements apply at all times, regardless of the means of transport, destination, or who is transporting the material.
Packaging is required to be tested to meet defined rigorous tests and all commercially available sample containers are produced to comply with this specification. If commercial packaging is not used then it is the responsibility of the supplier to ensure that the packaging used meets the required specification.
It is also the responsibility of the provider of the packaging to ensure that full, clear instructions in the use of the packaging are provided to the packer.
Primary receptacles should be packaged so that they cannot break, be punctured or leak their contents into the secondary container. The absorbent material e.g. paper towel or cotton wool, between the primary and secondary containers must be sufficient to absorb all the liquid in the package, in the event of breakage of the primary container.
Dos & Don’ts!
Multiple primary receptacles may be placed in the secondary packaging but must be wrapped individually.
Please note that screw-top vials are preferable for faeces or milk samples that are liable to ferment and push off the cap or bung. (Adhesive tape may be required to ensure that screw-tops do not loosen during transit).
Polystyrene containers may crack under the loads normally experienced during transport by post and are not therefore suitable for diagnostic specimens unless placed within a more robust outer container.
While disposable rectal examination gloves are useful for the collection of faeces samples, they should never be used as specimen containers.
Hypodermic or Vaccutainer needles should never be included with the diagnostic sample!
As professionals, veterinary surgeons should ensure that all biological material dispatched from their practice are packaged in accordance with the regulations. The costs of one potential legal action over a leaking sample could outweigh the costs of many years’ supply of suitable packaging.
Several commercial companies produce cost-effective complete P650-compliant packaging systems and components that can make the task of effective packaging of diagnostic samples relatively painless.