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Sue Fletcher, Principal Product Manager at Alpha Laboratories Ltd, discusses the importance of properly understanding your responsibilities to UN3373 Sample Packaging Regulations.

Medical laboratory and clinical personnel often need to transport biological samples from the patient source, between clinics and laboratories, for centralised testing or clinical trials, etc. There are strict regulations governing how such samples are packaged for mailing and it’s vital that all staff understand the legislation and how to be fully compliant. If not, there could be serious consequences, even leading to prosecution.

More and more biological samples are being transported within the UK and around the globe on a daily basis. These specimens fall under the Dangerous Goods Regulations since they may contain pathogens. The transport of dangerous goods is strictly regulated and it is a legal and mandatory requirement to comply with the regulations when transporting human or animal samples. The aim of the regulations is to enable these goods to be transported relatively easily, in a consistent, recognisable manner. This ensures that all such parcels, and their contents, reach their destination in good condition, whilst not endangering the environment or anyone who comes into contact with them during their journey. However, how often do you receive specimens that are inadequately packaged?

The general guideline from the HSE is that samples, such as blood, tissue, excreta, secreta, from humans or animals which are not assigned to Category A Infectious Substances, are considered to be Category B Biological Substances. These samples are then assigned to UN3373 and must be packaged according to the Dangerous Goods IATA or ADR Packing Instruction 650 for transport.

The consequences of non-compliance can be costly. For the patient this could mean a delay in diagnosis, which could lead to a prolonged recovery time. For laboratory staff, it could result in additional workload for clean ups and re-tests. For courier staff handling the package during transit, there could be ill health and time off work. For the laboratory packaging the sample there could be fines, and in the worst case scenario, the person who packaged the sample could be jailed.

Yes that’s right, ultimately the person responsible for the parcel is the person who packaged it!

26 | Tomorrow’s Laboratories

Laboratory personnel are trained to handle human or animal samples correctly, to keep themselves and others safe. But, when it comes to sample transport the legislation can be difficult to interpret and costly to implement, both in terms of time and money.

When samples are being sent as ‘Category B’, the packaging must meet certain minimum conditions. Principally it must consist of three components: the leak proof primary receptacle (blood tube/universal container), a secondary packaging (e.g. sealed plastic bag or rigid container), plus an outer packaging (cardboard box or mailing envelope).

Basic UN3373 Packaging Requirements Primary Receptacle

Secondary Packaging

Outer Packaging

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