Pathology and laboratory medicine standards implementation

NHS England is delivering the ability to share pathology and laboratory medicine test results (reportables) from labs to GP practices. Using SNOMED CT and FHIR, we have created 2 key data products to support pathology reporting and defined the information standard that governs their use.

Reference: Pathology networks - NHS England, SNOMED Code Usage in Primary Care – NHS England

To help providers and system suppliers integrate our data products and reach conformance with DAPB4101, 4 NHS England teams (Core Services, Digital Services for Integrated Care, Diagnostic Digital Capability, and Terminology Design) are working together to create a roadmap for national adoption.

Pathology and laboratory medicine test reports currently flow from labs to GP practices using the ISB 1557 EDIFACT Pathology Messaging Standard (Amd 39/2003 EDIFACT v1.003) (PMIP EDIFACT). Originally designed more than 25 years ago, PMIP EDIFACT has the following fundamental limitations:

It is unable to carry SNOMED CT. It can only support Read Pathology Bounded Code List (PBCL) codes.

Read PBCL is a fully withdrawn part of the standard. There can never be a new Read PBCL reportable to represent a new lab test. Therefore, PMIP EDIFACT itself cannot be used to send pathology reports for new lab tests.

As a message syntax, PMIP EDIFACT is unable to support complex report structures containing fully atomic, coded results such as microbiology or histopathology results. These currently flow to GPs only as non-machine-readable text.

In short, PMIP EDIFACT is outdated, and cannot handle modern, structured pathology data. This limits interoperability, automation, and clinical insight. The transition to DAPB4101 is required to ensure richer, machine-readable pathology data flows across NHS systems.

Implementation of this standard is also a professional requirement supported by the Royal College of GPs, the Institute of Biomedical Science, and the Royal College of Pathologists.

Conformance with DAPB4101 will bring many benefits to patients, clinicians and commissioners of NHS pathology services, including:

• the ability to code new pathology tests - new reportables can be created using a standardised, interoperable terminology
• modern, event-based, standards-compliant, 'platinum' service architecture – allows for more direct communication of vital clinical data, providing more options for consumption without the need for complex integrations, and better payload validation with message-by-message error handling
• improved clinical safety - pathology results can be shared and accessed by clinicians across the NHS in a format that is clear and unambiguous
• improved data quality - standardised, semantically interoperable and unambiguous pathology result data that supports machine-readability will enable AI-aided analytics, research and clinical decision support
• reduction of costs - clear, unambiguous pathology reporting will reduce the need for duplicate testing by clinicians and enable providers to review commissioning costs
• adoption of modern, internationally recognised standards - SNOMED CT and FHIR will replace the outdated, localised, non-maintainable suite of data products, future-proofing the interoperable flow of pathology reports

We are developing new architecture designed to replace MESH that will enable the interoperable flow of diagnostic data across the estate.

To support DAPB4101, the proposed solution involves:

• laboratory information management systems to create pathology and laboratory medicine reports in various formats
• pathology middleware to transform these into FHIR/SNOMED reports
• sending reports to the 'Pathology API', a RESTful interface serving as a gateway for diagnostic data
• the Pathology API linking to the Patient Data Manager which will validate the reports against the Pathology FHIR Specification
• the Pathology API then publishing the messages to the Multicast Notification Service, in turn delivering them to GP systems
• a synchronous integration, with acknowledgements flowing accordingly
• a platinum service
• alpha/beta testing to test and assure the solution and establish the onboarding process for suppliers

An 'Alpha/Beta' pilot is underway. This will establish and prove how a FHIR/SNOMED pathology report can be sent safely and ingested using the new architecture.

The Alpha phase will flow synthetic data between test environments. The Beta phase will flow live data from labs to GP practices, thereby proving and assuring the end-to-end flow.

The Alpha/Beta will involve a GP IT supplier(s) and a pathology middleware supplier(s).

The intention is for Alpha/Beta to complete by April 2026.

Once Beta has completed, implementing DAPB4101 can then go onto GP system suppliers’ managed roadmap of work, leading to eventual national roll-out.

We are clinically assuring maps between the most-used SNOMED PBCL reportables and SNOMED PaLM, to allow GP systems to record equivalent SNOMED PaLM reportables safely.

Full implementation of SNOMED PaLM will be gradual because of the impact to GP systems. Consequently, SNOMED PBCL will continue to flow in the interim.

We are establishing the requirements for a replacement for the National Messaging Assurance Service that supports PMIP EDIFACT.

The date for full conformance with DAPB4101 will be extended to align with the new timescales.