# US Core Specimen Profile - Health eData 1 Sandbox v0.1.0

* [**Table of Contents**](toc.md)
* [**Artifacts Summary**](artifacts.md)
* **US Core Specimen Profile**

## Resource Profile: US Core Specimen Profile 

| | | |
| :--- | :--- | :--- |
| *Official URL*:http://hl7.org/fhir/us/core/StructureDefinition/us-core-specimen | *Version*:0.1.0 | |
| Active as of 2026-05-19 | [Maturity Level](http://hl7.org/fhir/versions.html#maturity): 3 | *Computable Name*:USCoreSpecimenProfile |
| *Other Identifiers:*OID:2.16.840.1.113883.4.642.40.2.42.64 | | |

 
The US Core Specimen Profile inherits from the FHIR [Specimen](https://hl7.org/fhir/R4/specimen.html) resource; refer to it for scope and usage definitions. This profile sets minimum expectations for the Specimen resource to record, search, and fetch information about substances associated with a patient being sampled or tested (such as nasopharyngeal swab, whole blood, or serum). It specifies which core elements, extensions, vocabularies, and value sets **SHALL** be present and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption. 

**Example Usage Scenarios:**

The following are example usage scenarios for the US Core Specimen profile:

* Query for a patient's specimen
* [Record or update] a specimen for a patient

### Mandatory and Must Support Data Elements

The following data elements must always be present ([Mandatory] definition) or must be supported if the data is present in the sending system ([Must Support] definition). They are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The [Formal Views] below provides the formal summary, definitions, and terminology requirements.

**Each Specimen Must Have:**

1. a specimen type code1

**Each Specimen Must Support:**

1. business identifier(s)2
1. an accession identifier2
1. a patient

**Additional USCDI Requirements:**

These [Additional USCDI Requirements] elements are not Mandatory or Must Support but are required for ONC Health IT certification testing and are included in the formal definition of the profile and the Specimen examples.

1. specimen collection method
1. specimen collection source site
1. specimen condition3

1,2,3 see guidance below

### Profile Specific Implementation Guidance

This section provides detailed implementation guidance for the US Core Profile to support implementation and certification.

* 1Since the binding is [extensible](http://hl7.org/fhir/R4/terminologies.html#extensible) when a code is unavailable, servers **MAY** use text.[§][CONF-0523]
* 1Although both `Specimen.identifier` and `Specimen.accessionIdentifier` are marked as Must Support, the Server system is not required to support both, but **SHALL** support at least one of these elements.[§][CONF-0524] 
* The Client application **SHALL** support both elements.[§][CONF-0525]
 
* 3The specimen condition is used by the laboratory to determine the acceptability of a specimen for the ordered test. An individual specimen condition may be acceptable for one test and not for another. The specimen condition is typically provided when the specimen does not meet the laboratory's criteria for acceptability, whether the test was performed or not. Examples include but are not limited to hemolyzed, clotted, container leaking, and missing patient names. This element may include information about the contents of the container, the container, and the label.
* In addition to Specimen search criteria, Clients can request Specimen resources be included with the Observation or DiagnosticReport resource query using the `_include` parameter.

### Liquid Script to Generate StructureDefinition All Nice N Pretty Like

{% include structure-table.md sd=sd source="differential" show_must_support=true show_uscdi=true %}

## USCoreSpecimenProfile — US Core Specimen Profile

The US Core Specimen Profile inherits from the FHIR [Specimen](https://hl7.org/fhir/R4/specimen.html) resource; refer to it for scope and usage definitions. This profile sets minimum expectations for the Specimen resource to record, search, and fetch information about substances associated with a patient being sampled or tested (such as nasopharyngeal swab, whole blood, or serum). It specifies which core elements, extensions, vocabularies, and value sets **SHALL** be present and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

* **URL:** `http://hl7.org/fhir/us/core/StructureDefinition/us-core-specimen`
* **Version:** 0.1.0
* **Status:** active
* **Kind:** resource
* **Type:** `Specimen`
* **Base Definition:** `http://hl7.org/fhir/StructureDefinition/Specimen`
* **Derivation:** constraint

### Elements (differential)

| | | | | | |
| :--- | :--- | :--- | :--- | :--- | :--- |
| `Specimen` |   |   | 0..* |   | **Sample for analysis**A sample to be used for analysis. |
| ↳`identifier` | ✅ |   | 0..* | `Identifier` | **Specimen identifier**Id for specimen. |
| ↳`accessionIdentifier` | ✅ |   | 0..1 | `Identifier` | **Identifier assigned by the lab**The identifier assigned by the lab when accessioning specimen(s). This is not necessarily the same as the specimen identifier, depending on local lab procedures. |
| ↳`type` | ✅ |   | 1..1 | `CodeableConcept` | **Kind of material that forms the specimen**The kind of material that forms the specimen.**Binding:** `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54` (extensible) |
| ↳`subject` | ✅ |   | 0..1 | `Reference`target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-patienttarget: http://hl7.org/fhir/StructureDefinition/Grouptarget: http://hl7.org/fhir/us/core/StructureDefinition/us-core-devicetarget: http://hl7.org/fhir/StructureDefinition/Substancetarget: http://hl7.org/fhir/us/core/StructureDefinition/us-core-location | **The patient where the specimen came from.**Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance or a device. |
| ↳`collection` |   | ✅ | 0..1 | `BackboneElement` | **Collection details**Details concerning the specimen collection. |
| ↳`method` |   | ✅ | 0..1 | `CodeableConcept` | **Specimen Collection Method**A coded value specifying the technique that is used to perform the procedure.**Binding:** `http://hl7.org/fhir/ValueSet/specimen-collection-method` (preferred) |
| ↳`bodySite` |   | ✅ | 0..1 | `CodeableConcept` | **Specimen Source Site**Anatomical location from which the specimen was collected (if subject is a patient). This is the target site. This element is not used for environmental specimens.**Binding:** `http://hl7.org/fhir/ValueSet/body-site` (extensible) |
| ↳`condition` |   | ✅ | 0..* | `CodeableConcept` | **Specimen condition**A mode or state of being that describes the nature of the specimen.**Binding:** `http://hl7.org/fhir/us/core/ValueSet/us-core-specimen-condition` (extensible) |

```


## USCoreSpecimenProfile — US Core Specimen Profile

The US Core Specimen Profile inherits from the FHIR [Specimen](https://hl7.org/fhir/R4/specimen.html) resource; refer to it for scope and usage definitions. This profile sets minimum expectations for the Specimen resource to record, search, and fetch information about substances associated with a patient being sampled or tested (such as nasopharyngeal swab, whole blood,  or serum). It specifies which core elements, extensions, vocabularies, and value sets **SHALL** be present and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

- **URL:** `http://hl7.org/fhir/us/core/StructureDefinition/us-core-specimen`
- **Version:** 0.1.0
- **Status:** active
- **Kind:** resource
- **Type:** `Specimen`
- **Base Definition:** `http://hl7.org/fhir/StructureDefinition/Specimen`
- **Derivation:** constraint


### Elements (differential)

| Element | Must Support | Add'l USCDI | Cardinality | Type | Description |
|---|:---:|:---:|---|---|---|
| `Specimen` |  |  | 0..* |  | **Sample for analysis**<br/>A sample to be used for analysis. |
| <span style="padding-left: 1.5em;">↳</span> `identifier` | ✅ |  | 0..* | `Identifier` | **Specimen identifier**<br/>Id for specimen. |
| <span style="padding-left: 1.5em;">↳</span> `accessionIdentifier` | ✅ |  | 0..1 | `Identifier` | **Identifier assigned by the lab**<br/>The identifier assigned by the lab when accessioning specimen(s). This is not necessarily the same as the specimen identifier, depending on local lab procedures. |
| <span style="padding-left: 1.5em;">↳</span> `type` | ✅ |  | 1..1 | `CodeableConcept` | **Kind of material that forms the specimen**<br/>The kind of material that forms the specimen.<br/><span style="font-size: 0.85em;">**Binding:** `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54` (extensible)</span> |
| <span style="padding-left: 1.5em;">↳</span> `subject` | ✅ |  | 0..1 | `Reference`<br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/StructureDefinition/Group</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-device</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/StructureDefinition/Substance</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-location</span> | **The patient where the specimen came from.**<br/>Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance or a device. |
| <span style="padding-left: 1.5em;">↳</span> `collection` |  | ✅ | 0..1 | `BackboneElement` | **Collection details**<br/>Details concerning the specimen collection. |
| <span style="padding-left: 3.0em;">↳</span> `method` |  | ✅ | 0..1 | `CodeableConcept` | **Specimen Collection Method**<br/>A coded value specifying the technique that is used to perform the procedure.<br/><span style="font-size: 0.85em;">**Binding:** `http://hl7.org/fhir/ValueSet/specimen-collection-method` (preferred)</span> |
| <span style="padding-left: 3.0em;">↳</span> `bodySite` |  | ✅ | 0..1 | `CodeableConcept` | **Specimen Source Site**<br/>Anatomical location from which the specimen was collected (if subject is a patient). This is the target site.  This element is not used for environmental specimens.<br/><span style="font-size: 0.85em;">**Binding:** `http://hl7.org/fhir/ValueSet/body-site` (extensible)</span> |
| <span style="padding-left: 1.5em;">↳</span> `condition` |  | ✅ | 0..* | `CodeableConcept` | **Specimen condition**<br/>A mode or state of being that describes the nature of the specimen.<br/><span style="font-size: 0.85em;">**Binding:** `http://hl7.org/fhir/us/core/ValueSet/us-core-specimen-condition` (extensible)</span> |





```

**Usages:**

* Refer to this Profile: [US Core Laboratory Result Observation Profile](http://hl7.org/fhir/us/core/2026Jan/StructureDefinition-us-core-observation-lab.html)
* Examples for this Profile: [Specimen/bone-marrow-aspirate](Specimen-bone-marrow-aspirate.md), [Specimen/serum-lipemic-venipuncture](Specimen-serum-lipemic-venipuncture.md), [Specimen/serum-venipuncture](Specimen-serum-venipuncture.md), [Specimen/throat-swab](Specimen-throat-swab.md)... Show 3 more, [Specimen/tissue-biopsy](Specimen-tissue-biopsy.md), [Specimen/urine-catheter](Specimen-urine-catheter.md) and [Specimen/whole-blood-venipuncture](Specimen-whole-blood-venipuncture.md)
* CapabilityStatements using this Profile: [US Core Client CapabilityStatement](http://hl7.org/fhir/us/core/2026Jan/CapabilityStatement-us-core-client.html) and [US Core Server CapabilityStatement](http://hl7.org/fhir/us/core/2026Jan/CapabilityStatement-us-core-server.html)

You can also check for [usages in the FHIR IG Statistics](https://packages2.fhir.org/xig/resource/hl7.fhir.us.healthedata1-sandbox|current/StructureDefinition/StructureDefinition-us-core-specimen.json)

### Formal Views of Profile Content

 [Description of Profiles, Differentials, Snapshots and how the different presentations work](http://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#structure-definitions). 

 

Other representations of profile: [CSV](StructureDefinition-us-core-specimen.csv), [Excel](StructureDefinition-us-core-specimen.xlsx), [Schematron](StructureDefinition-us-core-specimen.sch) 



## Resource Content

```json
{
  "resourceType" : "StructureDefinition",
  "id" : "us-core-specimen",
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 3
  }],
  "url" : "http://hl7.org/fhir/us/core/StructureDefinition/us-core-specimen",
  "identifier" : [{
    "system" : "urn:ietf:rfc:3986",
    "value" : "urn:oid:2.16.840.1.113883.4.642.40.2.42.64"
  }],
  "version" : "0.1.0",
  "name" : "USCoreSpecimenProfile",
  "title" : "US Core Specimen Profile",
  "status" : "active",
  "experimental" : false,
  "date" : "2026-05-19",
  "publisher" : "HL7 International / Cross-Group Projects",
  "contact" : [{
    "name" : "HL7 International / Cross-Group Projects",
    "telecom" : [{
      "system" : "url",
      "value" : "http://www.hl7.org/Special/committees/cgp"
    },
    {
      "system" : "email",
      "value" : "cgp@lists.HL7.org"
    }]
  }],
  "description" : "The US Core Specimen Profile inherits from the FHIR [Specimen](https://hl7.org/fhir/R4/specimen.html) resource; refer to it for scope and usage definitions. This profile sets minimum expectations for the Specimen resource to record, search, and fetch information about substances associated with a patient being sampled or tested (such as nasopharyngeal swab, whole blood,  or serum). It specifies which core elements, extensions, vocabularies, and value sets **SHALL** be present and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.",
  "jurisdiction" : [{
    "coding" : [{
      "system" : "urn:iso:std:iso:3166",
      "code" : "US"
    }]
  }],
  "fhirVersion" : "4.0.1",
  "mapping" : [{
    "identity" : "rim",
    "uri" : "http://hl7.org/v3",
    "name" : "RIM Mapping"
  },
  {
    "identity" : "w5",
    "uri" : "http://hl7.org/fhir/fivews",
    "name" : "FiveWs Pattern Mapping"
  },
  {
    "identity" : "v2",
    "uri" : "http://hl7.org/v2",
    "name" : "HL7 v2 Mapping"
  }],
  "kind" : "resource",
  "abstract" : false,
  "type" : "Specimen",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/Specimen",
  "derivation" : "constraint",
  "differential" : {
    "element" : [{
      "id" : "Specimen",
      "path" : "Specimen",
      "mustSupport" : false
    },
    {
      "id" : "Specimen.identifier",
      "path" : "Specimen.identifier",
      "short" : "Specimen identifier",
      "mustSupport" : true
    },
    {
      "id" : "Specimen.accessionIdentifier",
      "path" : "Specimen.accessionIdentifier",
      "mustSupport" : true
    },
    {
      "id" : "Specimen.type",
      "path" : "Specimen.type",
      "min" : 1,
      "mustSupport" : true,
      "binding" : {
        "strength" : "extensible",
        "valueSet" : "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.54"
      }
    },
    {
      "id" : "Specimen.subject",
      "path" : "Specimen.subject",
      "short" : "The patient where the specimen came from.",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient",
        "http://hl7.org/fhir/StructureDefinition/Group",
        "http://hl7.org/fhir/us/core/StructureDefinition/us-core-device",
        "http://hl7.org/fhir/StructureDefinition/Substance",
        "http://hl7.org/fhir/us/core/StructureDefinition/us-core-location"],
        "_targetProfile" : [{
          "extension" : [{
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-type-must-support",
            "valueBoolean" : true
          }]
        },
        {
          "extension" : [{
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-type-must-support",
            "valueBoolean" : false
          }]
        },
        {
          "extension" : [{
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-type-must-support",
            "valueBoolean" : false
          }]
        },
        {
          "extension" : [{
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-type-must-support",
            "valueBoolean" : false
          }]
        },
        {
          "extension" : [{
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-type-must-support",
            "valueBoolean" : false
          }]
        }]
      }],
      "mustSupport" : true
    },
    {
      "id" : "Specimen.collection",
      "extension" : [{
        "url" : "http://hl7.org/fhir/us/core/StructureDefinition/uscdi-requirement",
        "valueBoolean" : true
      }],
      "path" : "Specimen.collection",
      "short" : "𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Collection details"
    },
    {
      "id" : "Specimen.collection.method",
      "extension" : [{
        "url" : "http://hl7.org/fhir/us/core/StructureDefinition/uscdi-requirement",
        "valueBoolean" : true
      }],
      "path" : "Specimen.collection.method",
      "short" : "𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Specimen Collection Method",
      "binding" : {
        "strength" : "preferred",
        "valueSet" : "http://hl7.org/fhir/ValueSet/specimen-collection-method"
      }
    },
    {
      "id" : "Specimen.collection.bodySite",
      "extension" : [{
        "url" : "http://hl7.org/fhir/us/core/StructureDefinition/uscdi-requirement",
        "valueBoolean" : true
      }],
      "path" : "Specimen.collection.bodySite",
      "short" : "𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Specimen Source Site",
      "comment" : "Body location from where a specimen was obtained. Examples include but are not limited to right internal jugular, left arm, and right eye.",
      "binding" : {
        "strength" : "extensible",
        "valueSet" : "http://hl7.org/fhir/ValueSet/body-site"
      }
    },
    {
      "id" : "Specimen.condition",
      "extension" : [{
        "url" : "http://hl7.org/fhir/us/core/StructureDefinition/uscdi-requirement",
        "valueBoolean" : true
      }],
      "path" : "Specimen.condition",
      "short" : "𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Specimen condition",
      "binding" : {
        "strength" : "extensible",
        "valueSet" : "http://hl7.org/fhir/us/core/ValueSet/us-core-specimen-condition"
      }
    }]
  }
}

```
