Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

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 1.1.6 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: 1.1.6
Active as of 2024-09-22 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 of the drug products or substances, Suppliers.

Usage:

Formal Views of Profile Content

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

This structure is derived from Organization

NameFlagsCard.TypeDescription & Constraintsdoco
.. Organization Organization
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... 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
Binding: Organization-Site Identifier Terminology (required)
..... system S 1..1 uri The namespace for the identifier value
..... value S 1..1 string The value that is unique
.... identifier:DUNSNumber SC 0..1 Identifier Identifies this organization across multiple systems
org-length9: Identifier number is 9 digits
..... system 0..1 uri The namespace for the identifier value
Required Pattern: urn:oid:1.3.6.1.4.1.519.1
.... identifier:FEINumber SC 0..1 Identifier Identifies this organization across multiple systems
org-length7: Identifier number is 7 or 10 digits
..... system 0..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
.... address S 1..1 PqAddress An address expressed using postal conventions (as opposed to GPS or other location definition formats)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Organization.identifier.typerequiredPqcmcOrgIdentifierTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
org-length7errorOrganization.identifier:FEINumberIdentifier 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-length9errorOrganization.identifier:DUNSNumberIdentifier number is 9 digits
: system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9
NameFlagsCard.TypeDescription & Constraintsdoco
.. Organization C 0..* Organization A grouping of people or organizations with a common purpose
org-1: The organization SHALL at least have a name or an identifier, and possibly more than one
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for identifier SΣC 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 SΣ 0..1 CodeableConcept Description of identifier
Binding: Organization-Site Identifier Terminology (required)
..... system SΣ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:DUNSNumber SΣC 0..1 Identifier Identifies this organization across multiple systems
org-length9: Identifier number is 9 digits
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: urn:oid:1.3.6.1.4.1.519.1
.... identifier:FEINumber SΣC 0..1 Identifier Identifies this organization across multiple systems
org-length7: Identifier number is 7 or 10 digits
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: urn:oid:2.16.840.1.113883.4.82
... active ?!Σ 0..1 boolean Whether the organization's record is still in active use
... name SΣC 1..1 string Name used for the organization
... contact SC 1..* ExtendedContactDetail Official contact details for the Organization
org-3: The telecom of an organization can never be of use 'home'
org-4: The address of an organization can never be of use 'home'
.... address SC 1..1 PqAddress An address expressed using postal conventions (as opposed to GPS or other location definition formats)
addr-state: If the country is USA, then the state and postal code exist
addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Organization.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Organization.identifier.typerequiredPqcmcOrgIdentifierTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology
from this IG
Organization.identifier:DUNSNumber.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Organization.identifier:FEINumber.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
addr-stateerrorOrganization.contact.addressIf the country is USA, then the state and postal code exist
: country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-ziperrorOrganization.contact.addressIf the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
: country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
dom-2errorOrganizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorOrganizationIf 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-4errorOrganizationIf 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-5errorOrganizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceOrganizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
org-1errorOrganizationThe organization SHALL at least have a name or an identifier, and possibly more than one
: (identifier.count() + name.count()) > 0
org-3errorOrganization.contactThe telecom of an organization can never be of use 'home'
: telecom.where(use = 'home').empty()
org-4errorOrganization.contactThe address of an organization can never be of use 'home'
: address.where(use = 'home').empty()
org-length7errorOrganization.identifier:FEINumberIdentifier 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-length9errorOrganization.identifier:DUNSNumberIdentifier number is 9 digits
: system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9
NameFlagsCard.TypeDescription & Constraintsdoco
.. Organization C 0..* Organization A grouping of people or organizations with a common purpose
org-1: The organization SHALL at least have a name or an identifier, and possibly more than one
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
... 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 SΣC 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 SΣ 0..1 CodeableConcept Description of identifier
Binding: Organization-Site Identifier Terminology (required)
..... system SΣ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣC 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 SΣC 0..1 Identifier Identifies this organization across multiple systems
org-length9: Identifier number is 9 digits
..... 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 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 Σ 0..1 uri The namespace for the identifier value
Required Pattern: urn:oid:1.3.6.1.4.1.519.1
..... value ΣC 0..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 SΣC 0..1 Identifier Identifies this organization across multiple systems
org-length7: Identifier number is 7 or 10 digits
..... 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 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 Σ 0..1 uri The namespace for the identifier value
Required Pattern: urn:oid:2.16.840.1.113883.4.82
..... value ΣC 0..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 SΣC 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 SC 1..* ExtendedContactDetail Official contact details for the Organization
org-3: The telecom of an organization can never be of use 'home'
org-4: The address of an organization can never be of use 'home'
.... 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 SC 1..1 PqAddress An address expressed using postal conventions (as opposed to GPS or other location definition formats)
addr-state: If the country is USA, then the state and postal code exist
addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
.... 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 (No ValueSet): (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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Organization.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
Organization.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
Organization.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Organization.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Organization.identifier.typerequiredPqcmcOrgIdentifierTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology
from this IG
Organization.identifier:DUNSNumber.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Organization.identifier:DUNSNumber.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Organization.identifier:FEINumber.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Organization.identifier:FEINumber.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Organization.typeexampleOrganizationType
http://hl7.org/fhir/ValueSet/organization-type
from the FHIR Standard
Organization.contact.purposepreferredContactEntityType
http://terminology.hl7.org/ValueSet/contactentity-type
Organization.qualification.codeexample

Constraints

IdGradePath(s)DetailsRequirements
addr-stateerrorOrganization.contact.addressIf the country is USA, then the state and postal code exist
: country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-ziperrorOrganization.contact.addressIf the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
: country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
dom-2errorOrganizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorOrganizationIf 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-4errorOrganizationIf 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-5errorOrganizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceOrganizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
org-1errorOrganizationThe organization SHALL at least have a name or an identifier, and possibly more than one
: (identifier.count() + name.count()) > 0
org-3errorOrganization.contactThe telecom of an organization can never be of use 'home'
: telecom.where(use = 'home').empty()
org-4errorOrganization.contactThe address of an organization can never be of use 'home'
: address.where(use = 'home').empty()
org-length7errorOrganization.identifier:FEINumberIdentifier 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-length9errorOrganization.identifier:DUNSNumberIdentifier 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: 6 elements
Must-Support: 10 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

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

Differential View

This structure is derived from Organization

NameFlagsCard.TypeDescription & Constraintsdoco
.. Organization Organization
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... 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
Binding: Organization-Site Identifier Terminology (required)
..... system S 1..1 uri The namespace for the identifier value
..... value S 1..1 string The value that is unique
.... identifier:DUNSNumber SC 0..1 Identifier Identifies this organization across multiple systems
org-length9: Identifier number is 9 digits
..... system 0..1 uri The namespace for the identifier value
Required Pattern: urn:oid:1.3.6.1.4.1.519.1
.... identifier:FEINumber SC 0..1 Identifier Identifies this organization across multiple systems
org-length7: Identifier number is 7 or 10 digits
..... system 0..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
.... address S 1..1 PqAddress An address expressed using postal conventions (as opposed to GPS or other location definition formats)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Organization.identifier.typerequiredPqcmcOrgIdentifierTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
org-length7errorOrganization.identifier:FEINumberIdentifier 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-length9errorOrganization.identifier:DUNSNumberIdentifier number is 9 digits
: system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Organization C 0..* Organization A grouping of people or organizations with a common purpose
org-1: The organization SHALL at least have a name or an identifier, and possibly more than one
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for identifier SΣC 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 SΣ 0..1 CodeableConcept Description of identifier
Binding: Organization-Site Identifier Terminology (required)
..... system SΣ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:DUNSNumber SΣC 0..1 Identifier Identifies this organization across multiple systems
org-length9: Identifier number is 9 digits
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: urn:oid:1.3.6.1.4.1.519.1
.... identifier:FEINumber SΣC 0..1 Identifier Identifies this organization across multiple systems
org-length7: Identifier number is 7 or 10 digits
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: urn:oid:2.16.840.1.113883.4.82
... active ?!Σ 0..1 boolean Whether the organization's record is still in active use
... name SΣC 1..1 string Name used for the organization
... contact SC 1..* ExtendedContactDetail Official contact details for the Organization
org-3: The telecom of an organization can never be of use 'home'
org-4: The address of an organization can never be of use 'home'
.... address SC 1..1 PqAddress An address expressed using postal conventions (as opposed to GPS or other location definition formats)
addr-state: If the country is USA, then the state and postal code exist
addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Organization.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Organization.identifier.typerequiredPqcmcOrgIdentifierTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology
from this IG
Organization.identifier:DUNSNumber.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Organization.identifier:FEINumber.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
addr-stateerrorOrganization.contact.addressIf the country is USA, then the state and postal code exist
: country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-ziperrorOrganization.contact.addressIf the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
: country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
dom-2errorOrganizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorOrganizationIf 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-4errorOrganizationIf 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-5errorOrganizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceOrganizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
org-1errorOrganizationThe organization SHALL at least have a name or an identifier, and possibly more than one
: (identifier.count() + name.count()) > 0
org-3errorOrganization.contactThe telecom of an organization can never be of use 'home'
: telecom.where(use = 'home').empty()
org-4errorOrganization.contactThe address of an organization can never be of use 'home'
: address.where(use = 'home').empty()
org-length7errorOrganization.identifier:FEINumberIdentifier 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-length9errorOrganization.identifier:DUNSNumberIdentifier number is 9 digits
: system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Organization C 0..* Organization A grouping of people or organizations with a common purpose
org-1: The organization SHALL at least have a name or an identifier, and possibly more than one
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
... 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 SΣC 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 SΣ 0..1 CodeableConcept Description of identifier
Binding: Organization-Site Identifier Terminology (required)
..... system SΣ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣC 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 SΣC 0..1 Identifier Identifies this organization across multiple systems
org-length9: Identifier number is 9 digits
..... 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 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 Σ 0..1 uri The namespace for the identifier value
Required Pattern: urn:oid:1.3.6.1.4.1.519.1
..... value ΣC 0..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 SΣC 0..1 Identifier Identifies this organization across multiple systems
org-length7: Identifier number is 7 or 10 digits
..... 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 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 Σ 0..1 uri The namespace for the identifier value
Required Pattern: urn:oid:2.16.840.1.113883.4.82
..... value ΣC 0..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 SΣC 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 SC 1..* ExtendedContactDetail Official contact details for the Organization
org-3: The telecom of an organization can never be of use 'home'
org-4: The address of an organization can never be of use 'home'
.... 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 SC 1..1 PqAddress An address expressed using postal conventions (as opposed to GPS or other location definition formats)
addr-state: If the country is USA, then the state and postal code exist
addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
.... 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 (No ValueSet): (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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Organization.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
Organization.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
Organization.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Organization.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Organization.identifier.typerequiredPqcmcOrgIdentifierTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology
from this IG
Organization.identifier:DUNSNumber.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Organization.identifier:DUNSNumber.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Organization.identifier:FEINumber.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
Organization.identifier:FEINumber.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Organization.typeexampleOrganizationType
http://hl7.org/fhir/ValueSet/organization-type
from the FHIR Standard
Organization.contact.purposepreferredContactEntityType
http://terminology.hl7.org/ValueSet/contactentity-type
Organization.qualification.codeexample

Constraints

IdGradePath(s)DetailsRequirements
addr-stateerrorOrganization.contact.addressIf the country is USA, then the state and postal code exist
: country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-ziperrorOrganization.contact.addressIf the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
: country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
dom-2errorOrganizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorOrganizationIf 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-4errorOrganizationIf 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-5errorOrganizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceOrganizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
org-1errorOrganizationThe organization SHALL at least have a name or an identifier, and possibly more than one
: (identifier.count() + name.count()) > 0
org-3errorOrganization.contactThe telecom of an organization can never be of use 'home'
: telecom.where(use = 'home').empty()
org-4errorOrganization.contactThe address of an organization can never be of use 'home'
: address.where(use = 'home').empty()
org-length7errorOrganization.identifier:FEINumberIdentifier 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-length9errorOrganization.identifier:DUNSNumberIdentifier 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: 6 elements
Must-Support: 10 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

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

 

Other representations of profile: CSV, Excel, Schematron