Documents in medical transport: what the law requires, what is agreed by contract and what the product demands

A document the law requires cannot be left out; a document agreed by contract can differ per client; a product-specific item follows the product; an operational item exists to make the ride go well. Anyone who lumps them together demands too much on one ride and forgets the mandatory on another.

• Statutory: what the ADR or carriage law prescribes, such as a dangerous goods transport document when one is required.
• Contractual: what client and carrier have agreed, such as the order confirmation, a consignment note and the proof of delivery.
• Product-specific: what follows from the product, such as the storage condition on the label, the classification of a specimen and the arrangements from chapter 9 of the GDP guidelines.
• Operational: what the carrier needs in order to drive, such as addresses, contact persons, time windows and instructions for loading dock or ward.

Every ride starts with information, not with paper. The ADR places on the sender the duty to give the carrier the required information and documents; the GDP guidelines require the wholesaler to inform the carrier of the transport conditions. Beyond that nobody prescribes what an order looks like, but without these details no carrier can perform its task.

• Sender and destination: pickup and delivery address, the addressee and instructions for the location.
• Contact persons on both sides, also for a report outside office hours.
• The time window, and what happens if it cannot be met.
• The transport condition and where it comes from: label, manufacturer or the laboratory's instruction.
• The nature of the shipment and, for specimens, the classification the sender has determined.
• How the shipment is packed and whether there is anything on the outside to check at pickup.
• The handover instruction: to whom to deliver, and what the recipient wants to see as proof.

On the way no paper is produced, but records are. What is recorded follows from the order: a document ride asks for less than a refrigerated shipment for a laboratory. None of these records is prescribed by law in this form; they exist because the client wants to be able to see afterwards what happened.

• Time recording: the actual time of pickup and delivery, per stop.
• Temperature: measured at agreed moments for shipments with a condition, with instrument and who measured.
• Status: picked up, on the way, delivered, refused or returned, so that the client knows where the shipment stands.
• Deviations: what deviated, what the carrier did and to whom it was reported.

For medicines covered by the GDP guidelines, the wholesaler's delivery note is the document that steers the delivery: chapter 9 requires delivery to the addressee at the address stated on the delivery note. The storage condition does not come from a transport document but from the product: the manufacturer sets it and prints it on the pack, and the wholesaler passes it on to the carrier. The contract between wholesaler and carrier records what applies on the way, and on request the customer receives temperature information. Who is responsible for what in that chain is explained in GDP responsibilities in outsourced transport; how medicines move through the chain in medicine transport.

This is where most misunderstanding arises. A specimen classified as UN 3373, Biological Substance, Category B, and packed and marked in accordance with packing instruction P650 is, by special provision 319, not subject to the other requirements of the ADR; no dangerous goods transport document is then needed, and the WHO says so in its guidance in as many words. An exempt specimen is not a dangerous good and needs no transport document either. Only for Category A do the full ADR requirements apply, with a transport document showing, under special provision 318, the technical name or 'suspected Category A'.

On acceptance the carrier checks that the prescribed information has been provided and that the documents the ADR requires are on board, and ascertains by visual inspection that the shipment shows no defects, leakage or cracks. What the sender supplies is therefore mainly the classification, the packaging and the mark, and the information about them; the WHO also mentions the name and telephone number of a responsible person on the package, but that is a requirement from the air transport rules, not from the ADR. A ride report does not replace that classification and packaging: it records that the shipment was accepted intact and marked, not that it was classified correctly. What UN3373 means and who classifies is explained in what UN3373 means; the packaging in packing instruction P650; how the ADR applies domestically in ADR and medical specimens; the daily chain in laboratory transport.

The contract of carriage itself requires no particular document. Book 8 of the Dutch Civil Code governs the contract for the carriage of goods by road and obliges the carrier to deliver the goods in the condition received and without delay; departures from those rules are valid only if expressly agreed, per carriage, in a separate document. Whether a consignment note is drawn up and what it states follows, for transport within the Netherlands, from the arrangement between sender and carrier. Under the Dutch General Transport Conditions (AVC), which apply only when expressly agreed, the consignment note and electronic messages have evidential value for receipt in apparently good condition, weight and number. For international road carriage between two countries the CMR convention applies as a rule, with its own consignment note and its own liability rules; for transport within the Netherlands that does not come into play.

After the ride, the documents remain that together form the file. The proof of delivery or ride report records the handover: delivery status, times, who signed, the condition of the shipment. The temperature record shows what was measured, with time, instrument and who measured, and says 'not measured' where no measurement was taken. The deviation report describes what deviated, what was done, to whom it was reported and what the client decided. None of the three is prescribed by law in this form; all three are needed to show afterwards what happened. What belongs in the proof of delivery is explained in proof of delivery and ride report; what a temperature report is worth in temperature logging in medical transport; what should happen in the event of a deviation in temperature excursion during transport.

Instead of one list for everything, four questions help with every shipment.

• Is it a dangerous good under the ADR, and if so in which category? Category B under P650 and exempt specimens: no transport document; Category A: yes.
• Is it a medicine under the GDP guidelines? Then the delivery note, the storage condition and the arrangements with the wholesaler.
• Does the transport cross a national border? Then the CMR convention applies as a rule, with its own consignment note; within the Netherlands Book 8 and, if agreed, the AVC.
• What does the recipient want to be able to see afterwards? That determines the proof of delivery, the temperature record and the deviation report.

UrgentX transports specimens that the laboratory has classified and packed, for UN3373 in accordance with P650; at pickup we check the mark and the outer packaging and do not take an incompletely packed shipment. For medicines we drive under the condition you or the manufacturer prescribe. Per ride we record the actual times and the name and role of the person signing; for shipments with a condition the temperature is measured at pickup and at delivery. In the event of a deviation we report immediately and do not deliver without your release. The file, the reports and the invoices are in the customer portal per organisation. What you provide beforehand and what you receive afterwards is described under medical transport and courier services and under how we work.