Laboratory transport: how specimens travel between collection point, practice and laboratory, and who is responsible for what

A specimen goes through a fixed series of steps: collection, packaging and marking, presentation to the carrier, the transport itself, receipt and registration at the laboratory, and only then the analysis. Everything before the analysis is called the pre-analytical phase, and that is where things often go wrong without anyone noticing: a specimen that was in transit too long, got too warm or too cold, or was left at the wrong desk gives a result that looks reliable but is not.

How long a specimen may be in transit and at which temperature differs per test. The receiving laboratory decides that and instructs the sender; the Dutch National Institute for Public Health (RIVM), for example, gives a temperature condition per specimen type in its submission information and prescribes shipment by courier for urgent tests. A carrier follows that instruction; it does not set it.

The rest of this article follows the chain: what the sender does, what the courier checks and transports, and what is recorded at the handover.

In everyday use the terms get mixed up. A sample or specimen is the material itself. The ADR calls material collected directly from humans or animals and transported for research, diagnosis or treatment a patient specimen. Whether such a specimen falls under the ADR depends on whether it contains, or can reasonably be expected to contain, pathogens.

If it does, and it is not a life-threatening Category A substance, it is 'Biological Substance, Category B', with the number UN3373. According to the World Health Organization most shipments of infectious substances can be transported that way. If the likelihood of pathogens is minimal, it can be an exempt human specimen, which is not a dangerous good but must still be transported leakproof, in three layers and marked 'Exempt human specimen'; the ADR names tests for cholesterol, glucose, hormones, PSA, organ function and pregnancy as examples. The full explanation is in what UN3373 means.

The decision on classification lies with the sender, that is with the laboratory, practice or collection point that offers the specimen. The ADR obliges the sender to ascertain that the goods are classified and authorised for carriage, to give the carrier the necessary information and to use only approved and properly marked packagings. The ILT puts it more briefly: the sender classifies, informs and packs; it may outsource that, but remains responsible. The WHO adds that the sender must be able to justify the classification and that a carrier may advise, but never takes over the responsibility.

For a UN3373 specimen, packing means: in accordance with packing instruction P650, with a primary receptacle, a secondary packaging and a rigid outer packaging, absorbent material for the entire contents in the case of liquids, a primary or secondary packaging that withstands 95 kPa, and the diamond-shaped UN3373 mark with the proper shipping name on the outside. The supplier of the packaging has to provide filling and closing instructions for this; those instructions are part of the sender's procedure.

In practice this means a laboratory or practice needs a written rule: who classifies, which packaging is used for which specimen, and who checks that before the shipment leaves the building.

The carrier has its own duties under the ADR: checking that the goods are authorised for carriage and that the prescribed information has been provided, and ascertaining by visual inspection that the load shows no obvious defects, leakage or cracks. It may rely on the sender's information. If it finds an infringement, it may not continue the transport until it has been remedied.

For specimens that comes down to: mark present and legible, outer packaging intact and dry, announced as agreed, condition known. What the courier cannot check is the inside: whether the secondary packaging is sealed, whether there is enough absorbent material and whether the 95 kPa requirement was met. That is why the distinction between sender and carrier is no formality; it is exactly where the risk lies.

A UN3373 shipment packed and marked in accordance with P650 is exempt through special provision 319 from all other ADR provisions. No dangerous goods transport document is then needed, no ADR training certificate for the driver and no marking of the car. A carrier that claims to be 'ADR-certified' for UN3373 promises something the rules do not ask for.

The laboratory decides, per test, which condition a specimen needs, and the carrier asks for it in advance. Some specimens must be cooled; others must not, because cold disturbs the test; for yet others, the time until processing matters most. So there is no standard condition for 'lab samples'.

What a carrier can offer is measurement and recording: the temperature at pickup and at delivery, with time and method, and by agreement a logger that records the course. What should happen in the event of an excursion is explained in temperature excursion during transport. Fixed collection rounds along collection points and practices also help to keep the time between collection and processing predictable.

Chain of custody means, in practice, that for every handover it is recorded who handed what to whom, when and in which condition. In specimen transport there are two handovers: from the sender to the courier, and from the courier to the laboratory. At both moments the time, the name and, where agreed, the measured temperature should be recorded. The signature or the photo of the handover is personal data and therefore calls for careful handling, but it is the evidence with which a laboratory can answer a question about a result afterwards.

Delivery means handover to someone who receives and registers the specimen. For COVID-19 material, for example, the RIVM prescribes a courier with clear delivery instructions and personal handover to a laboratory employee. Leaving it at an unattended desk is not delivery.

Two ISO standards touch this subject, each from a different side. ISO 15189:2022 sets requirements for the quality and competence of medical laboratories; the standard is aimed at the laboratory, not at the carrier. A laboratory working to this standard has to control and demonstrate its processes; for specimen transport that means, in practice, that it wants to have times and temperatures. The carrier supplies that data; it cannot itself be 'ISO 15189-compliant'.

ISO 20658:2023 covers the collection and transport of samples for medical laboratory examinations and, according to its public scope, is also aimed at service providers involved in the transport independently of the laboratory. It is therefore the standard that deals directly with this work. It is voluntary. What exactly it contains is only available for a fee and is not reproduced here; anyone wanting to apply the standard has to purchase the text.

The chain becomes reliable through agreements made before the first ride.

How UrgentX transports laboratory specimens, what we check at pickup and what is recorded per ride is described under transport of laboratory samples; for collection points and practices there are fixed routes.

• A written classification rule: who decides Category A, B or exempt, and where that is recorded.
• Packaging in accordance with P650 (or the exempt variant), with the supplier's filling and closing instructions at hand.
• Per specimen type the condition and the maximum time until processing, as prescribed by the examining laboratory.
• A fixed delivery and receiving point with someone who signs, also outside office hours if the ride falls then.
• What happens in the event of an excursion: who is called and who decides.
• Which data the carrier supplies per ride, in a form that fits the laboratory's own quality system.