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Specimen Transportation and Management

Specimen Transportation and Management: the physical logistics of getting a specimen from the patient to the laboratory, alongside (but distinct from) the electronic Laboratory Order (LAB-1) message. Generally this is a manual process at present and does not feature in automated interactions.

References

1. IHE PaLM Technical Framework Supplement - Specimen Event Tracking (SET) - a specification for tracking specimen progress along this process (not adopted here - background/reference only)
2. GS1 UK Healthcare - UK barcode standards that can be used with this process/workflow (not mandated here - background/reference only)
3. Laboratory Testing Workflow (LTW) - Laboratory Order (LAB-1) - the electronic order this physical process runs alongside
4. Diagnostic Model Overview - the identifiers referenced throughout this page
5. Specimen

Overview

A Laboratory Order (LAB-1) message and its physical specimen travel to the laboratory by two different routes that have to be reconciled when the specimen arrives - the order may arrive electronically ahead of, behind, or (if it has not been sent electronically at all) not before the specimen itself. The identifiers described below are what let sample reception match a physical specimen back to the correct order (and, if the order was never sent electronically, are what let the order be entered onto the LIMS from the specimen and its paperwork alone).

flowchart TD
    A["Test request created<br/>(Laboratory Order) -<br/>may be sent electronically"] --> B[Specimen collected<br/>- may include a biopsy]
    B --> C[Specimen container<br/>packaged for transport]
    C --> D[Package shipped -<br/>tracking number assigned]
    D --> E[Package received at<br/>laboratory specimen reception]
    E --> F{Test request already<br/>received electronically?}
    F -->|No| G[Test request transcribed<br/>onto LIMS from specimen/<br/>paperwork - barcodes assist]
    F -->|Yes| H[Test request reconciled<br/>with specimen on LIMS]
    G --> H

Current Process

This is generally a manual process today, and does not feature in automated interactions. The terms below follow common laboratory/logistics usage, with the equivalent term used elsewhere in this IG noted in brackets where it differs:

1. A test request is created (a laboratory order, or requisition - see Laboratory Order (LAB-1)). This can be sent electronically, ahead of the specimen, or printed and sent with it.
2. A specimen is collected from the patient (which may include a biopsy) into a labelled specimen container.
3. The specimen container is packaged for transport, generally alongside a printed copy of the test request.
4. The package is shipped and given a tracking number. Key identifiers - patient NHS Number, hospital/medical record number (MRN), order/ requisition number, episode/account number, the specimen's own identifier (see Specimen), and the shipment tracking number itself - are normally printed as barcodes on the test request paperwork and/or the shipping package.
5. The package is received at the laboratory (specimen reception/accessioning).
6. If the test request has not already arrived electronically, it is transcribed onto the LIMS from the specimen and its paperwork - barcodes normally speed this up by letting reception scan rather than re-key each identifier.

Key Identifiers

IHE Specimen Event Tracking (SET)

IHE Specimen Event Tracking (SET) is a specification for tracking the progress of specimens along this process, from collection through to storage, biobanking or disposal. It defines a Specimen Event Informer (SEI) actor, which sends specimen lifecycle event messages (LAB-40) to a Specimen Event Tracker (SET) actor - covering around 15 distinct event types across collecting, shipping, receiving and accepting a specimen. This would be the natural specification to formalise the manual steps above, were this process ever automated - not adopted here.

Barcoding (GS1 UK Healthcare)

GS1 UK Healthcare publishes UK barcode standards (typically carried in a GS1 DataMatrix or GS1-128 symbol) that could be used to encode the key identifiers above on the test request paperwork or shipping package, so they can be scanned rather than re-keyed - not mandated here. GS1 identifies people, places and things using a small number of standard identification keys, each with its own numeric Application Identifier (AI, shown in brackets) inside the barcode:

Only NHS Number (via GSRN-Recipient) and Specimen Number (via GIAI) have well-established, GS1 UK-documented healthcare mappings; the remaining identifiers are locally-defined numbers that GS1 UK Healthcare does not itself standardise a barcode for - they would typically continue to be carried as plain text or a locally-agreed barcode alongside the GS1 keys above.

Data Models

• Specimen
• The identifier profiles listed under Key Identifiers above

Security Considerations

Includes:

• OAuth2 Standard for Authorisation
  • including use of JWT access tokens and future support for SMART-on-FHIR Scopes
• FHIR AuditEvent/IHE BALP for Audit Logging
• TLS for Transport Security/Encryption