Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## Resource Profile: Basic Organization

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: CodedOrganization
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.53

A profile for the data elements required to identify the sponsor and/or the supplier of the drug products or substances.

Usages:

- Use this Profile: CMC eCTD 32P10 Document, CMC eCTD 32P32 Document, CMC eCTD 32P55 Document, CMC eCTD 32S10 Document... Show 3 more, CMC eCTD 32S23 Document, CMC eCTD 32S3 Document and CMC eCTD SP4151 Document
- Refer to this Profile: eCTD Product Description and Composition, eCTD Batch Formula, eCTD Product Characterisation of Impurities, eCTD Substance General Information... Show 9 more, eCTD Substance Control of Materials, eCTD Substance Characterisation, eCTD Specification, Component Substance, Drug Substance, Substance General Information, Excipient Drug Substance, Drug Product Batch Formula and Drug Substance Handle

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Organization | C | 0..* | Organization | A grouping of people or organizations with a common purpose Constraints: org-1
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
contained |  | 0..* | Resource | Contained, inline Resources
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
Slices for identifier | S Σ C | 1..* | Identifier | Identifies this organization across multiple systems Slice: Unordered, Open by value:system
identifier:All Slices |  |  |  | Content/Rules for all slices
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system | S Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value | S Σ C | 1..1 | string | The value that is unique Example General: 123456
identifier:DUNSNumber | S Σ C | 0..1 | Identifier | Identifies this organization across multiple systems Constraints: org-length9
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system | S Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:1.3.6.1.4.1.519.1
value | S Σ C | 1..1 | string | The value that is unique Example General: 123456
identifier:FEINumber | S Σ C | 0..1 | Identifier | Identifies this organization across multiple systems Constraints: org-length7
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system | S Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.4.82
value | S Σ C | 1..1 | string | The value that is unique Example General: 123456
active | ?!Σ | 0..1 | boolean | Whether the organization's record is still in active use
name | S Σ C | 1..1 | string | Name used for the organization
contact | S C | 1..* | ExtendedContactDetail | Official contact details for the Organization Constraints: org-3, org-4
address | S Σ | 1..1 | PqAddress | Address for the contact
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Organization.identifier.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|5.0.0` From the FHIR Standard
Organization.identifier.type | extensible | IdentifierTypeCodes `http://hl7.org/fhir/ValueSet/identifier-type` From the FHIR Standard
Organization.identifier:DUNSNumber.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|5.0.0` From the FHIR Standard
Organization.identifier:DUNSNumber.type | extensible | IdentifierTypeCodes `http://hl7.org/fhir/ValueSet/identifier-type` From the FHIR Standard
Organization.identifier:FEINumber.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|5.0.0` From the FHIR Standard
Organization.identifier:FEINumber.type | extensible | IdentifierTypeCodes `http://hl7.org/fhir/ValueSet/identifier-type` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | Organization | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Organization | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | Organization | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | Organization | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Organization | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
org-1 | error | Organization | The organization SHALL at least have a name or an identifier, and possibly more than one : (identifier.count() + name.count()) > 0 |
org-3 | error | Organization.contact | The telecom of an organization can never be of use 'home' : telecom.where(use = 'home').empty() |
org-4 | error | Organization.contact | The address of an organization can never be of use 'home' : address.where(use = 'home').empty() |
org-length7 | error | Organization.identifier:FEINumber | Identifier number is 7 or 10 digits : system = 'urn:oid:2.16.840.1.113883.4.82' implies value.length() = 7 or value.length() = 10 |
org-length9 | error | Organization.identifier:DUNSNumber | Identifier number is 9 digits : system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9 |

This structure is derived from Organization

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Organization |  |  | Organization |
Slices for identifier | S | 1..* | Identifier | Identifies this organization across multiple systems Slice: Unordered, Open by value:system
identifier:All Slices |  |  |  | Content/Rules for all slices
type | S | 0..1 | CodeableConcept | Description of identifier
system | S | 1..1 | uri | The namespace for the identifier value
value | S | 1..1 | string | The value that is unique
identifier:DUNSNumber | S C | 0..1 | Identifier | Identifies this organization across multiple systems Constraints: org-length9
system |  | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:1.3.6.1.4.1.519.1
identifier:FEINumber | S C | 0..1 | Identifier | Identifies this organization across multiple systems Constraints: org-length7
system |  | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.4.82
name | S | 1..1 | string | Name used for the organization
contact | S | 1..* | ExtendedContactDetail | Official contact details for the Organization
address | S | 1..1 | PqAddress | Address for the contact
Documentation for this format

#### Constraints

Id | Grade | Path(s) | Details | Requirements
org-length7 | error | Organization.identifier:FEINumber | Identifier number is 7 or 10 digits : system = 'urn:oid:2.16.840.1.113883.4.82' implies value.length() = 7 or value.length() = 10 |
org-length9 | error | Organization.identifier:DUNSNumber | Identifier number is 9 digits : system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9 |

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Organization | C | 0..* | Organization | A grouping of people or organizations with a common purpose Constraints: org-1
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
CommonLanguages | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
Slices for identifier | S Σ C | 1..* | Identifier | Identifies this organization across multiple systems Slice: Unordered, Open by value:system
identifier:All Slices |  |  |  | Content/Rules for all slices
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system | S Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value | S Σ C | 1..1 | string | The value that is unique Example General: 123456
period | Σ | 0..1 | Period | Time period when id is/was valid for use
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text)
identifier:DUNSNumber | S Σ C | 0..1 | Identifier | Identifies this organization across multiple systems Constraints: org-length9
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system | S Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:1.3.6.1.4.1.519.1
value | S Σ C | 1..1 | string | The value that is unique Example General: 123456
period | Σ | 0..1 | Period | Time period when id is/was valid for use
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text)
identifier:FEINumber | S Σ C | 0..1 | Identifier | Identifies this organization across multiple systems Constraints: org-length7
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system | S Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.4.82
value | S Σ C | 1..1 | string | The value that is unique Example General: 123456
period | Σ | 0..1 | Period | Time period when id is/was valid for use
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text)
active | ?!Σ | 0..1 | boolean | Whether the organization's record is still in active use
type | Σ | 0..* | CodeableConcept | Kind of organization Binding: OrganizationType (example): Used to categorize the organization.
name | S Σ C | 1..1 | string | Name used for the organization
alias |  | 0..* | string | A list of alternate names that the organization is known as, or was known as in the past
description | Σ | 0..1 | markdown | Additional details about the Organization that could be displayed as further information to identify the Organization beyond its name
contact | S C | 1..* | ExtendedContactDetail | Official contact details for the Organization Constraints: org-3, org-4
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
purpose | Σ | 0..1 | CodeableConcept | The type of contact Binding: Contact entity type (preferred): The purpose for which an extended contact detail should be used.
name | Σ | 0..* | HumanName | Name of an individual to contact
telecom | Σ | 0..* | ContactPoint | Contact details (e.g.phone/fax/url)
address | S Σ | 1..1 | PqAddress | Address for the contact
organization | Σ | 0..1 | Reference(Organization) | This contact detail is handled/monitored by a specific organization
period | Σ | 0..1 | Period | Period that this contact was valid for usage
partOf | Σ | 0..1 | Reference(Organization) | The organization of which this organization forms a part
endpoint |  | 0..* | Reference(Endpoint) | Technical endpoints providing access to services operated for the organization
qualification |  | 0..* | BackboneElement | Qualifications, certifications, accreditations, licenses, training, etc. pertaining to the provision of care
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
identifier |  | 0..* | Identifier | An identifier for this qualification for the organization
code |  | 1..1 | CodeableConcept | Coded representation of the qualification Binding Description: (example): Specific qualification the organization has to provide a service.
period |  | 0..1 | Period | Period during which the qualification is valid
issuer |  | 0..1 | Reference(Organization) | Organization that regulates and issues the qualification
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Organization.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
Organization.identifier.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|5.0.0` From the FHIR Standard
Organization.identifier.type | extensible | IdentifierTypeCodes `http://hl7.org/fhir/ValueSet/identifier-type` From the FHIR Standard
Organization.identifier:DUNSNumber.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|5.0.0` From the FHIR Standard
Organization.identifier:DUNSNumber.type | extensible | IdentifierTypeCodes `http://hl7.org/fhir/ValueSet/identifier-type` From the FHIR Standard
Organization.identifier:FEINumber.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|5.0.0` From the FHIR Standard
Organization.identifier:FEINumber.type | extensible | IdentifierTypeCodes `http://hl7.org/fhir/ValueSet/identifier-type` From the FHIR Standard
Organization.type | example | OrganizationType `http://hl7.org/fhir/ValueSet/organization-type` From the FHIR Standard
Organization.contact.purpose | preferred | ContactEntityType `http://terminology.hl7.org/ValueSet/contactentity-type`
Organization.qualification.code | example |

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | Organization | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Organization | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | Organization | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | Organization | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Organization | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
org-1 | error | Organization | The organization SHALL at least have a name or an identifier, and possibly more than one : (identifier.count() + name.count()) > 0 |
org-3 | error | Organization.contact | The telecom of an organization can never be of use 'home' : telecom.where(use = 'home').empty() |
org-4 | error | Organization.contact | The address of an organization can never be of use 'home' : address.where(use = 'home').empty() |
org-length7 | error | Organization.identifier:FEINumber | Identifier number is 7 or 10 digits : system = 'urn:oid:2.16.840.1.113883.4.82' implies value.length() = 7 or value.length() = 10 |
org-length9 | error | Organization.identifier:DUNSNumber | Identifier number is 9 digits : system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9 |

This structure is derived from Organization

Summary

Mandatory: 5 elements(1 nested mandatory element)
Must-Support: 9 elements

Structures

This structure refers to these other structures:

- PqAddress (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-cmc-address)

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of Organization.identifier

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Organization | C | 0..* | Organization | A grouping of people or organizations with a common purpose Constraints: org-1
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
contained |  | 0..* | Resource | Contained, inline Resources
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
Slices for identifier | S Σ C | 1..* | Identifier | Identifies this organization across multiple systems Slice: Unordered, Open by value:system
identifier:All Slices |  |  |  | Content/Rules for all slices
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system | S Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value | S Σ C | 1..1 | string | The value that is unique Example General: 123456
identifier:DUNSNumber | S Σ C | 0..1 | Identifier | Identifies this organization across multiple systems Constraints: org-length9
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system | S Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:1.3.6.1.4.1.519.1
value | S Σ C | 1..1 | string | The value that is unique Example General: 123456
identifier:FEINumber | S Σ C | 0..1 | Identifier | Identifies this organization across multiple systems Constraints: org-length7
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system | S Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.4.82
value | S Σ C | 1..1 | string | The value that is unique Example General: 123456
active | ?!Σ | 0..1 | boolean | Whether the organization's record is still in active use
name | S Σ C | 1..1 | string | Name used for the organization
contact | S C | 1..* | ExtendedContactDetail | Official contact details for the Organization Constraints: org-3, org-4
address | S Σ | 1..1 | PqAddress | Address for the contact
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Organization.identifier.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|5.0.0` From the FHIR Standard
Organization.identifier.type | extensible | IdentifierTypeCodes `http://hl7.org/fhir/ValueSet/identifier-type` From the FHIR Standard
Organization.identifier:DUNSNumber.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|5.0.0` From the FHIR Standard
Organization.identifier:DUNSNumber.type | extensible | IdentifierTypeCodes `http://hl7.org/fhir/ValueSet/identifier-type` From the FHIR Standard
Organization.identifier:FEINumber.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|5.0.0` From the FHIR Standard
Organization.identifier:FEINumber.type | extensible | IdentifierTypeCodes `http://hl7.org/fhir/ValueSet/identifier-type` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | Organization | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Organization | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | Organization | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | Organization | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Organization | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
org-1 | error | Organization | The organization SHALL at least have a name or an identifier, and possibly more than one : (identifier.count() + name.count()) > 0 |
org-3 | error | Organization.contact | The telecom of an organization can never be of use 'home' : telecom.where(use = 'home').empty() |
org-4 | error | Organization.contact | The address of an organization can never be of use 'home' : address.where(use = 'home').empty() |
org-length7 | error | Organization.identifier:FEINumber | Identifier number is 7 or 10 digits : system = 'urn:oid:2.16.840.1.113883.4.82' implies value.length() = 7 or value.length() = 10 |
org-length9 | error | Organization.identifier:DUNSNumber | Identifier number is 9 digits : system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9 |

Differential View

This structure is derived from Organization

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Organization |  |  | Organization |
Slices for identifier | S | 1..* | Identifier | Identifies this organization across multiple systems Slice: Unordered, Open by value:system
identifier:All Slices |  |  |  | Content/Rules for all slices
type | S | 0..1 | CodeableConcept | Description of identifier
system | S | 1..1 | uri | The namespace for the identifier value
value | S | 1..1 | string | The value that is unique
identifier:DUNSNumber | S C | 0..1 | Identifier | Identifies this organization across multiple systems Constraints: org-length9
system |  | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:1.3.6.1.4.1.519.1
identifier:FEINumber | S C | 0..1 | Identifier | Identifies this organization across multiple systems Constraints: org-length7
system |  | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.4.82
name | S | 1..1 | string | Name used for the organization
contact | S | 1..* | ExtendedContactDetail | Official contact details for the Organization
address | S | 1..1 | PqAddress | Address for the contact
Documentation for this format

#### Constraints

Id | Grade | Path(s) | Details | Requirements
org-length7 | error | Organization.identifier:FEINumber | Identifier number is 7 or 10 digits : system = 'urn:oid:2.16.840.1.113883.4.82' implies value.length() = 7 or value.length() = 10 |
org-length9 | error | Organization.identifier:DUNSNumber | Identifier number is 9 digits : system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9 |

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Organization | C | 0..* | Organization | A grouping of people or organizations with a common purpose Constraints: org-1
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
CommonLanguages | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
Slices for identifier | S Σ C | 1..* | Identifier | Identifies this organization across multiple systems Slice: Unordered, Open by value:system
identifier:All Slices |  |  |  | Content/Rules for all slices
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system | S Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value | S Σ C | 1..1 | string | The value that is unique Example General: 123456
period | Σ | 0..1 | Period | Time period when id is/was valid for use
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text)
identifier:DUNSNumber | S Σ C | 0..1 | Identifier | Identifies this organization across multiple systems Constraints: org-length9
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system | S Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:1.3.6.1.4.1.519.1
value | S Σ C | 1..1 | string | The value that is unique Example General: 123456
period | Σ | 0..1 | Period | Time period when id is/was valid for use
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text)
identifier:FEINumber | S Σ C | 0..1 | Identifier | Identifies this organization across multiple systems Constraints: org-length7
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system | S Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.4.82
value | S Σ C | 1..1 | string | The value that is unique Example General: 123456
period | Σ | 0..1 | Period | Time period when id is/was valid for use
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text)
active | ?!Σ | 0..1 | boolean | Whether the organization's record is still in active use
type | Σ | 0..* | CodeableConcept | Kind of organization Binding: OrganizationType (example): Used to categorize the organization.
name | S Σ C | 1..1 | string | Name used for the organization
alias |  | 0..* | string | A list of alternate names that the organization is known as, or was known as in the past
description | Σ | 0..1 | markdown | Additional details about the Organization that could be displayed as further information to identify the Organization beyond its name
contact | S C | 1..* | ExtendedContactDetail | Official contact details for the Organization Constraints: org-3, org-4
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
purpose | Σ | 0..1 | CodeableConcept | The type of contact Binding: Contact entity type (preferred): The purpose for which an extended contact detail should be used.
name | Σ | 0..* | HumanName | Name of an individual to contact
telecom | Σ | 0..* | ContactPoint | Contact details (e.g.phone/fax/url)
address | S Σ | 1..1 | PqAddress | Address for the contact
organization | Σ | 0..1 | Reference(Organization) | This contact detail is handled/monitored by a specific organization
period | Σ | 0..1 | Period | Period that this contact was valid for usage
partOf | Σ | 0..1 | Reference(Organization) | The organization of which this organization forms a part
endpoint |  | 0..* | Reference(Endpoint) | Technical endpoints providing access to services operated for the organization
qualification |  | 0..* | BackboneElement | Qualifications, certifications, accreditations, licenses, training, etc. pertaining to the provision of care
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
identifier |  | 0..* | Identifier | An identifier for this qualification for the organization
code |  | 1..1 | CodeableConcept | Coded representation of the qualification Binding Description: (example): Specific qualification the organization has to provide a service.
period |  | 0..1 | Period | Period during which the qualification is valid
issuer |  | 0..1 | Reference(Organization) | Organization that regulates and issues the qualification
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Organization.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
Organization.identifier.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|5.0.0` From the FHIR Standard
Organization.identifier.type | extensible | IdentifierTypeCodes `http://hl7.org/fhir/ValueSet/identifier-type` From the FHIR Standard
Organization.identifier:DUNSNumber.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|5.0.0` From the FHIR Standard
Organization.identifier:DUNSNumber.type | extensible | IdentifierTypeCodes `http://hl7.org/fhir/ValueSet/identifier-type` From the FHIR Standard
Organization.identifier:FEINumber.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|5.0.0` From the FHIR Standard
Organization.identifier:FEINumber.type | extensible | IdentifierTypeCodes `http://hl7.org/fhir/ValueSet/identifier-type` From the FHIR Standard
Organization.type | example | OrganizationType `http://hl7.org/fhir/ValueSet/organization-type` From the FHIR Standard
Organization.contact.purpose | preferred | ContactEntityType `http://terminology.hl7.org/ValueSet/contactentity-type`
Organization.qualification.code | example |

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | Organization | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Organization | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | Organization | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | Organization | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Organization | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
org-1 | error | Organization | The organization SHALL at least have a name or an identifier, and possibly more than one : (identifier.count() + name.count()) > 0 |
org-3 | error | Organization.contact | The telecom of an organization can never be of use 'home' : telecom.where(use = 'home').empty() |
org-4 | error | Organization.contact | The address of an organization can never be of use 'home' : address.where(use = 'home').empty() |
org-length7 | error | Organization.identifier:FEINumber | Identifier number is 7 or 10 digits : system = 'urn:oid:2.16.840.1.113883.4.82' implies value.length() = 7 or value.length() = 10 |
org-length9 | error | Organization.identifier:DUNSNumber | Identifier number is 9 digits : system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9 |

This structure is derived from Organization

Summary

Mandatory: 5 elements(1 nested mandatory element)
Must-Support: 9 elements

Structures

This structure refers to these other structures:

- PqAddress (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-cmc-address)

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of Organization.identifier

Maturity: 2

Other representations of profile: CSV, Excel, Schematron