Notice
- Important: This guidance is under active development by NHS England and content may be added or updated on a regular basis.
- This Implementation Guide is currently in Draft and SHOULD NOT be used for development or active implementation without express direction from the NHS England Genomics Unit.
Primary Sample
Purpose
For samples directly obtained from a patient. To track samples, direct storage, handling and testing decisions including ensuring volumes received match what was sent. Further detail which may support testing and interpretation. To enable patient to opt out of having a sample/biopsy stored.
Notes
Mapped to Specimen. Extensions lifted from mCODE are currently under review. Observation codes linked to samples are pending addition to SNOMED-CT
Additional observation code fields from MDS v1.04 mappings are still under review
Mapping
| ID | Source Data item | Target FHIR Element | HL7v2.5.1 Mapping | Description |
|---|---|---|---|---|
| PS-2 | Primary Sample - Local identifier | Specimen.identifier.value | SPM-2 | Local ids applied to a sample |
| PS-3 | Primary Sample - ODS code of organisation which assigned local id | Specimen.identifier.assigner | SPM-2.1.2 | ODS code of the organisation which assigned the local sample id. |
| PS-10 | Primary Sample - Obtained date | Specimen.collection.collectedDateTime | SPM-17 | Date at which a specimen/biopsy was obtained from patient. |
| PS-11 | Primary Sample - Primary Sample | Specimen.type | SPM-4 | The primary sample material. |
| PS-12 | Primary Sample - Primary Sample State | Specimen.condition | SPM-24 | The state of the primary sample. |
| PS-25 | Primary Sample - Preservative/Container | Specimen.container.additiveCodeableConcept | SPM-6 (TBC) | How the primary sample is preserved. |
| PS-30 | Primary Sample - Block identifier | Specimen.parent.identifier | SPM-3 | Sample block identifier. |
| PS-31 | Primary Sample - Fixative type | Specimen.processing.additive | SPM-6 | Sample fixative type. |
| PS-32 | Primary Sample - Hours to fixation | Difference between Specimen.collection.collectedDateTime and Specimen.processing.timeDateTime | N/A, though SPM-6.9 could be used (TBC) | Sample hours to fixation. |
| PS-33 | Primary Sample - Hours in fixative | Specimen.processing.timePeriod | N/A, though SPM-6.9 could be used (TBC) | Sample hours in fixative. |
| PS-34 | Primary Sample - Tumour enrichment method | Additional Specimen.processing elements | N/A Not part of the HL7v2 spec | Method used for tumour enrichment. |
| PS-13 | Primary Sample - Necrosis | Observation.code( code=405921002 (TBC), focus=Specimen ) | OBX segment with appropriate code | % necrotic (dead) cells in primary sample. |
| PS-14 | Primary Sample - Nucleated cell count | Observation.code( code=1022461000000100, focus=Specimen ) | OBX segment with appropriate code | Nucleated (with nucleous) cell (non tumour and tumour) count in the primary sample (Solid Tumour and Haem-Onc). |
| PS-15 | Primary Sample - Tumour nuclear content in whole section | Observation.code( code=371510003 (TBC), focus=Specimen ) | OBX segment with appropriate code | Neoplastic (tumour) cell content in the primary sample whole section(Solid Tumour) - sourced at local lab. (%) |
| PS-26 | Primary Sample - Tumour nuclear content in marked area | Observation.code( code=(TBC), focus=Specimen ) | OBX segment with appropriate code | Neoplastic (tumour) cell content in the primary sample marked area(Solid Tumour) - sourced at local lab. (%) |
| PS-17 | Primary Sample - Solid tumour morphology | BodyStructure.morphology( patient=Patient ), referenced from Specimen.collection.bodysite.extension:bodySiteReference if in reference to a specimen, or referenced from a Condition if in relation to the patient's condition (pending profiling of bodySiteReference backport to R4 Condition) | Additional SPM-4/5 qualifiers | The histology and likely course of development of a tumour. |
| PS-18 | Primary Sample - Solid tumour topography | BodyStructure.location(patient=Patient), referenced from Specimen.collection.bodysite.extension:bodySiteReference if in reference to a specimen, or referenced from a Condition if in relation to the patient's condition (pending profiling of bodySiteReference backport to R4 Condition) | SPM-8 | The tumour sample site. eg from colon, stomach etc. |
| PS-29 | Primary Sample - Is biopsy | Specimen.collection.method(code=129314006) | SPM-7 with appropriate SNOMED CT/LOINC code for Biopsy | Digital confirmation that the sample is a biopsy. |
| PS-19 | Primary Sample - Biopsy site | Specimen.collection.bodySite | SPM-8/SPM-9 | Site where the primary sample was taken from. |
| PS-21 | Primary Sample - Observed maternal cell contamination (MCC) | Observation.valueBoolean( code=726741007, focus=Specimen ), assume no observed MCC if not provided | OBX segment with appropriate code | An observed outcome which may indicate MCC |
| PS-27 | Primary Sample - Test confirmed maternal cell contamination (MCC) | Observation.valueQuantity( code=726741007, focus=Specimen ) | OBX segment with appropriate code | Analytically confirmed MCC levels |
| PS-22 | Primary Sample - Option for all products of conception | Additional Specimen.collection.extension:specimen-specialHandling with appropriate code/text | SPM-15 | Future management for products of conception. |
| PS-23 | Primary Sample - Blasts % | Observation.code( code=1015521000000107, focus=Specimen ) | OBX segment with appropriate code | Blast (immature blood cells) count in the primary sample (Haemonc) - sourced at local SIHMDS. |
| PS-24 | Primary Sample - High infection risk reason | Specimen.collection.extension:specimen-specialHandling.valueCoding.code | SPM-16.2 | The high contamination risk reason for a sample/biopsy. |
| PS-28 | Primary Sample - Patient life status at the time of collection | Inferred though Specimen.collection.collectedDateTime after Patient.deceasedDateTime | Inferred through SPM-17 later than PID-30 | If the patient was alive or deceased at the point of collecting a sample. |
| PS-35 | Primary Sample - Solid tumour type | Specific Condition.code e.g. child concepts of 128462008 for metastatic tumours (potentially linked from mCODE extension on BodyStructure) | DG1-3 | The origin or context of a tumour sample. |