Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
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Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions

Resource Profile: MfgTestSiteOrganization - Detailed Descriptions

Draft as of 2024-03-04

Definitions for the mfg-test-site-organization resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Organization
2. Organization.meta
4. Organization.meta.profile
Control1..1
Must Supporttrue
6. Organization.identifier
Definition

Manufacturing Site Unique Identifier: A unique identifier assigned to the establishment (facility) which manufactures, prepares, propagates, compounds or processes drugs. [Source: Adapted from FDA Drug Establishment Current Registration Site]

Testing Site Unique Identifier: A unique identifier assigned to the establishment (facility) which performs the testing. [Source: SME Defined]

ShortManufacturing Site Unique Identifier | Testing Site Unique Identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..?
Must Supporttrue
SlicingThis element introduces a set of slices on Organization.identifier. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ system
8. Organization.identifier.type
Definition

A value that identifies the source of the unique identifier. [Source: SME Defined] Examples: Data Universal Number System (DUNS), Facility Establishment Identifiers (FEI), etc.

ShortManufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type
BindingThe codes SHALL be taken from Testing Site and Organization Identifier Type Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology
Must Supporttrue
10. Organization.identifier.system
Control1..?
Must Supporttrue
12. Organization.identifier.value
Control1..?
Must Supporttrue
14. Organization.identifier:DUNSNumber
Slice NameDUNSNumber
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Must Supporttrue
Invariantsorg-length9: Identifier number is 9 digits (system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9)
16. Organization.identifier:DUNSNumber.system
Pattern Valueurn:oid:1.3.6.1.4.1.519.1
18. Organization.identifier:FEINumber
Slice NameFEINumber
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Must Supporttrue
Invariantsorg-length7: 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)
20. Organization.identifier:FEINumber.system
Pattern Valueurn:oid:2.16.840.1.113883.4.82
22. Organization.name
Definition

Manufacturing Site Name: The name of the establishment (facilities) which manufacture, prepare, propagate, compound, process or package drugs that are commercially distributed in the U.S. or offered for import to the U.S[Source: Adapted from FDA Drug Establishment Current Registration Site]

Testing Site Name: The name of the establishment (facility) which tests the raw materials, intermediates, drug substance, drug product, packaging components. [Source: SME Defined]

ShortManufacturing Site Name | Testing Site Name
Control1..?
Must Supporttrue
24. Organization.contact
Control1..1
26. Organization.contact.address
Definition

Manufacturing Site Physical Address: The complete address for the supplier [Source: SME Defined]

Testing Site Address: The complete address for the testing site. [Source: SME defined]

ShortManufacturing Site Physical Address | Testing Site Address
Control1..?
TypeAddress(PqAddress)
Must Supporttrue

Guidance on how to interpret the contents of this table can be found here

0. Organization
Definition

A formally or informally recognized grouping of people or organizations formed for the purpose of achieving some form of collective action. Includes companies, institutions, corporations, departments, community groups, healthcare practice groups, payer/insurer, etc.

ShortA grouping of people or organizations with a common purpose
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
org-1: The organization SHALL at least have a name or an identifier, and possibly more than one ((identifier.count() + name.count()) > 0)
2. Organization.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Organization.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

ShortProfiles this resource claims to conform to
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Control10..1*
Typecanonical(StructureDefinition)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Organization.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Organization.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
10. Organization.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
12. Organization.identifier
Definition

Manufacturing Site Unique Identifier: A unique identifier assigned to the establishment (facility) which manufactures, prepares, propagates, compounds or processes drugs. [Source: Adapted from FDA Drug Establishment Current Registration Site]

Testing Site Unique Identifier: A unique identifier assigned to the establishment (facility) which performs the testing. [Source: SME Defined]


Identifier for the organization that is used to identify the organization across multiple disparate systems.

ShortManufacturing Site Unique Identifier | Testing Site Unique IdentifierIdentifies this organization across multiple systems
NoteThis is a business identifier, not a resource identifier (see discussion)
Control10..*
This element is affected by the following invariants: org-1
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Organizations are known by a variety of ids. Some institutions maintain several, and most collect identifiers for exchange with other organizations concerning the organization.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Organization.identifier. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ system
14. Organization.identifier.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
(required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Organization.identifier.type
Definition

A value that identifies the source of the unique identifier. [Source: SME Defined] Examples: Data Universal Number System (DUNS), Facility Establishment Identifiers (FEI), etc.


A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

ShortManufacturing Site Unique Identifier Type | Testing Site Unique Identifier TypeDescription of identifier
Comments

This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

Control0..1
BindingThe codes SHALL be taken from Unless not suitable, these codes SHALL be taken from Testing Site and Organization Identifier Type Terminologyhttp://hl7.org/fhir/ValueSet/identifier-type
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Organization.identifier.system
Definition

Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control10..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Organization.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Control10..1
This element is affected by the following invariants: ident-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Organization.identifier:DUNSNumber
Slice NameDUNSNumber
Definition

Identifier for the organization that is used to identify the organization across multiple disparate systems.

ShortIdentifies this organization across multiple systems
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1*
This element is affected by the following invariants: org-1
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Organizations are known by a variety of ids. Some institutions maintain several, and most collect identifiers for exchange with other organizations concerning the organization.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
org-length9: Identifier number is 9 digits (system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9)
24. Organization.identifier:DUNSNumber.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
(required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Organization.identifier:DUNSNumber.system
Definition

Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control0..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Pattern Valueurn:oid:1.3.6.1.4.1.519.1
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Organization.identifier:FEINumber
Slice NameFEINumber
Definition

Identifier for the organization that is used to identify the organization across multiple disparate systems.

ShortIdentifies this organization across multiple systems
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1*
This element is affected by the following invariants: org-1
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Organizations are known by a variety of ids. Some institutions maintain several, and most collect identifiers for exchange with other organizations concerning the organization.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
org-length7: 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)
30. Organization.identifier:FEINumber.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
(required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. Organization.identifier:FEINumber.system
Definition

Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control0..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Pattern Valueurn:oid:2.16.840.1.113883.4.82
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. Organization.active
Definition

Whether the organization's record is still in active use.

ShortWhether the organization's record is still in active use
Comments

This active flag is not intended to be used to mark an organization as temporarily closed or under construction. Instead the Location(s) within the Organization should have the suspended status. If further details of the reason for the suspension are required, then an extension on this element should be used.

This element is labeled as a modifier because it may be used to mark that the resource was created in error.

Control0..1
Typeboolean
Is Modifiertrue because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Requirements

Need a flag to indicate a record is no longer to be used and should generally be hidden for the user in the UI.

Meaning if MissingThis resource is generally assumed to be active if no value is provided for the active element
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. Organization.name
Definition

Manufacturing Site Name: The name of the establishment (facilities) which manufacture, prepare, propagate, compound, process or package drugs that are commercially distributed in the U.S. or offered for import to the U.S[Source: Adapted from FDA Drug Establishment Current Registration Site]

Testing Site Name: The name of the establishment (facility) which tests the raw materials, intermediates, drug substance, drug product, packaging components. [Source: SME Defined]


A name associated with the organization.

ShortManufacturing Site Name | Testing Site NameName used for the organization
Comments

If the name of an organization changes, consider putting the old name in the alias column so that it can still be located through searches.

Control10..1
This element is affected by the following invariants: org-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Need to use the name as the label of the organization.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Organization.contact
Definition

The contact details of communication devices available relevant to the specific Organization. This can include addresses, phone numbers, fax numbers, mobile numbers, email addresses and web sites.

ShortOfficial contact details for the Organization
Comments

The address/telecom use code 'home' are not to be used. Note that these contacts are not the contact details of people who provide the service (that would be through PractitionerRole), these are official contacts for the Organization itself for specific purposes. E.g. Mailing Addresses, Billing Addresses, Contact numbers for Booking or Billing Enquiries, general web address, web address for online bookings etc.

Control10..1*
TypeExtendedContactDetail
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Need to keep track of assigned contact points within bigger organization.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
org-3: The telecom of an organization can never be of use 'home' (telecom.where(use = 'home').empty())
org-4: The address of an organization can never be of use 'home' (address.where(use = 'home').empty())
40. Organization.contact.address
Definition

Manufacturing Site Physical Address: The complete address for the supplier [Source: SME Defined]

Testing Site Address: The complete address for the testing site. [Source: SME defined]


Address for the contact.

ShortManufacturing Site Physical Address | Testing Site AddressAddress for the contact
Comments

Note: address is intended to describe postal addresses for administrative purposes, not to describe absolute geographical coordinates. Postal addresses are often used as proxies for physical locations (also see the Location resource).


More than 1 address would be for different purposes, and thus should be entered as a different entry,.

Control10..1
TypeAddress(PqAddress)
Is Modifierfalse
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
addr-state: If the country is USA, then the state and postal code exist (country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists()))
addr-zip: If 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})?$'))

Guidance on how to interpret the contents of this table can be found here

0. Organization
Definition

A formally or informally recognized grouping of people or organizations formed for the purpose of achieving some form of collective action. Includes companies, institutions, corporations, departments, community groups, healthcare practice groups, payer/insurer, etc.

ShortA grouping of people or organizations with a common purpose
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
org-1: The organization SHALL at least have a name or an identifier, and possibly more than one ((identifier.count() + name.count()) > 0)
2. Organization.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

Control0..1
Typeid
Is Modifierfalse
Must Supportfalse
Summarytrue
4. Organization.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Organization.meta.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
8. Organization.meta.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Organization.meta.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
10. Organization.meta.versionId
Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

ShortVersion specific identifier
Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

Control0..1
Typeid
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Organization.meta.lastUpdated
Definition

When the resource last changed - e.g. when the version changed.

ShortWhen the resource version last changed
Comments

This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

Control0..1
Typeinstant
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Organization.meta.source
Definition

A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

ShortIdentifies where the resource comes from
Comments

The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference.

This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

Control0..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Organization.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

ShortProfiles this resource claims to conform to
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Control1..1
Typecanonical(StructureDefinition)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Organization.meta.security
Definition

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

ShortSecurity Labels applied to this resource
Comments

The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

Control0..*
BindingUnless not suitable, these codes SHALL be taken from AllSecurityLabels
(extensible to http://hl7.org/fhir/ValueSet/security-labels
TypeCoding
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Organization.meta.tag
Definition

Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

ShortTags applied to this resource
Comments

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

Control0..*
BindingFor example codes, see CommonTags
(example to http://hl7.org/fhir/ValueSet/common-tags
TypeCoding
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Organization.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Organization.language
Definition

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Control0..1
BindingThe codes SHALL be taken from AllLanguages
(required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Organization.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortText summary of the resource, for human interpretation
Comments

Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control0..1
This element is affected by the following invariants: dom-6
TypeNarrative
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Organization.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
30. Organization.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
32. Organization.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
34. Organization.identifier
Definition

Manufacturing Site Unique Identifier: A unique identifier assigned to the establishment (facility) which manufactures, prepares, propagates, compounds or processes drugs. [Source: Adapted from FDA Drug Establishment Current Registration Site]

Testing Site Unique Identifier: A unique identifier assigned to the establishment (facility) which performs the testing. [Source: SME Defined]

ShortManufacturing Site Unique Identifier | Testing Site Unique Identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..*
This element is affected by the following invariants: org-1
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Organizations are known by a variety of ids. Some institutions maintain several, and most collect identifiers for exchange with other organizations concerning the organization.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Organization.identifier. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ system
36. Organization.identifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
38. Organization.identifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Organization.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
40. Organization.identifier.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse
(required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. Organization.identifier.type
Definition

A value that identifies the source of the unique identifier. [Source: SME Defined] Examples: Data Universal Number System (DUNS), Facility Establishment Identifiers (FEI), etc.

ShortManufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type
Comments

This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

Control0..1
BindingThe codes SHALL be taken from Testing Site and Organization Identifier Type Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. Organization.identifier.system
Definition

Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control1..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. Organization.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Control1..1
This element is affected by the following invariants: ident-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. Organization.identifier.period
Definition

Time period during which identifier is/was valid for use.

ShortTime period when id is/was valid for use
Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. Organization.identifier.assigner
Definition

Organization that issued/manages the identifier.

ShortOrganization that issued id (may be just text)
Comments

The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

Control0..1
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. Organization.identifier:DUNSNumber
Slice NameDUNSNumber
Definition

Identifier for the organization that is used to identify the organization across multiple disparate systems.

ShortIdentifies this organization across multiple systems
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
This element is affected by the following invariants: org-1
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Organizations are known by a variety of ids. Some institutions maintain several, and most collect identifiers for exchange with other organizations concerning the organization.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
org-length9: Identifier number is 9 digits (system = 'urn:oid:1.3.6.1.4.1.519.1' implies value.length() = 9)
54. Organization.identifier:DUNSNumber.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
56. Organization.identifier:DUNSNumber.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Organization.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
58. Organization.identifier:DUNSNumber.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse
(required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. Organization.identifier:DUNSNumber.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

ShortDescription of identifier
Comments

This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
(extensible to http://hl7.org/fhir/ValueSet/identifier-type
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. Organization.identifier:DUNSNumber.system
Definition

Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control0..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Pattern Valueurn:oid:1.3.6.1.4.1.519.1
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. Organization.identifier:DUNSNumber.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Control0..1
This element is affected by the following invariants: ident-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. Organization.identifier:DUNSNumber.period
Definition

Time period during which identifier is/was valid for use.

ShortTime period when id is/was valid for use
Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. Organization.identifier:DUNSNumber.assigner
Definition

Organization that issued/manages the identifier.

ShortOrganization that issued id (may be just text)
Comments

The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

Control0..1
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. Organization.identifier:FEINumber
Slice NameFEINumber
Definition

Identifier for the organization that is used to identify the organization across multiple disparate systems.

ShortIdentifies this organization across multiple systems
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
This element is affected by the following invariants: org-1
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Organizations are known by a variety of ids. Some institutions maintain several, and most collect identifiers for exchange with other organizations concerning the organization.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
org-length7: 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)
72. Organization.identifier:FEINumber.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
74. Organization.identifier:FEINumber.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Organization.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
76. Organization.identifier:FEINumber.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse
(required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. Organization.identifier:FEINumber.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

ShortDescription of identifier
Comments

This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
(extensible to http://hl7.org/fhir/ValueSet/identifier-type
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. Organization.identifier:FEINumber.system
Definition

Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control0..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Pattern Valueurn:oid:2.16.840.1.113883.4.82
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. Organization.identifier:FEINumber.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Control0..1
This element is affected by the following invariants: ident-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. Organization.identifier:FEINumber.period
Definition

Time period during which identifier is/was valid for use.

ShortTime period when id is/was valid for use
Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. Organization.identifier:FEINumber.assigner
Definition

Organization that issued/manages the identifier.

ShortOrganization that issued id (may be just text)
Comments

The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

Control0..1
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. Organization.active
Definition

Whether the organization's record is still in active use.

ShortWhether the organization's record is still in active use
Comments

This active flag is not intended to be used to mark an organization as temporarily closed or under construction. Instead the Location(s) within the Organization should have the suspended status. If further details of the reason for the suspension are required, then an extension on this element should be used.

This element is labeled as a modifier because it may be used to mark that the resource was created in error.

Control0..1
Typeboolean
Is Modifiertrue because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Requirements

Need a flag to indicate a record is no longer to be used and should generally be hidden for the user in the UI.

Meaning if MissingThis resource is generally assumed to be active if no value is provided for the active element
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. Organization.type
Definition

The kind(s) of organization that this is.

ShortKind of organization
Comments

Organizations can be corporations, wards, sections, clinical teams, government departments, etc. Note that code is generally a classifier of the type of organization; in many applications, codes are used to identity a particular organization (say, ward) as opposed to another of the same type - these are identifiers, not codes

When considering if multiple types are appropriate, you should evaluate if child organizations would be a more appropriate use of the concept, as different types likely are in different sub-areas of the organization. This is most likely to be used where type values have orthogonal values, such as a religious, academic and medical center.

We expect that some jurisdictions will profile this optionality to be a single cardinality.

Control0..*
BindingFor example codes, see OrganizationType
(example to http://hl7.org/fhir/ValueSet/organization-type
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Need to be able to track the kind of organization that this is - different organization types have different uses.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. Organization.name
Definition

Manufacturing Site Name: The name of the establishment (facilities) which manufacture, prepare, propagate, compound, process or package drugs that are commercially distributed in the U.S. or offered for import to the U.S[Source: Adapted from FDA Drug Establishment Current Registration Site]

Testing Site Name: The name of the establishment (facility) which tests the raw materials, intermediates, drug substance, drug product, packaging components. [Source: SME Defined]

ShortManufacturing Site Name | Testing Site Name
Comments

If the name of an organization changes, consider putting the old name in the alias column so that it can still be located through searches.

Control1..1
This element is affected by the following invariants: org-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Need to use the name as the label of the organization.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. Organization.alias
Definition

A list of alternate names that the organization is known as, or was known as in the past.

ShortA list of alternate names that the organization is known as, or was known as in the past
Comments

There are no dates associated with the alias/historic names, as this is not intended to track when names were used, but to assist in searching so that older names can still result in identifying the organization.

Control0..*
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Requirements

Over time locations and organizations go through many changes and can be known by different names.

For searching knowing previous names that the organization was known by can be very useful.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
96. Organization.description
Definition

Description of the organization, which helps provide additional general context on the organization to ensure that the correct organization is selected.

ShortAdditional details about the Organization that could be displayed as further information to identify the Organization beyond its name
Control0..1
Typemarkdown
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Requirements

Humans need additional information to verify a correct Organization has been selected.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
98. Organization.contact
Definition

The contact details of communication devices available relevant to the specific Organization. This can include addresses, phone numbers, fax numbers, mobile numbers, email addresses and web sites.

ShortOfficial contact details for the Organization
Comments

The address/telecom use code 'home' are not to be used. Note that these contacts are not the contact details of people who provide the service (that would be through PractitionerRole), these are official contacts for the Organization itself for specific purposes. E.g. Mailing Addresses, Billing Addresses, Contact numbers for Booking or Billing Enquiries, general web address, web address for online bookings etc.

Control1..1
TypeExtendedContactDetail
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Need to keep track of assigned contact points within bigger organization.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
org-3: The telecom of an organization can never be of use 'home' (telecom.where(use = 'home').empty())
org-4: The address of an organization can never be of use 'home' (address.where(use = 'home').empty())
100. Organization.contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
102. Organization.contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Organization.contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
104. Organization.contact.purpose
Definition

The purpose/type of contact.

ShortThe type of contact
Comments

If no purpose is defined, then these contact details may be used for any purpose.

Control0..1
BindingThe codes SHOULD be taken from Contact entity type
(preferred to http://terminology.hl7.org/ValueSet/contactentity-type
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
106. Organization.contact.name
Definition

The name of an individual to contact, some types of contact detail are usually blank.

ShortName of an individual to contact
Comments

If there is no named individual, the telecom/address information is not generally monitored by a specific individual.

Control0..*
TypeHumanName
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
108. Organization.contact.telecom
Definition

The contact details application for the purpose defined.

ShortContact details (e.g.phone/fax/url)
Control0..*
TypeContactPoint
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
110. Organization.contact.address
Definition

Manufacturing Site Physical Address: The complete address for the supplier [Source: SME Defined]

Testing Site Address: The complete address for the testing site. [Source: SME defined]

ShortManufacturing Site Physical Address | Testing Site Address
Comments

Note: address is intended to describe postal addresses for administrative purposes, not to describe absolute geographical coordinates. Postal addresses are often used as proxies for physical locations (also see the Location resource).

Control1..1
TypeAddress(PqAddress)
Is Modifierfalse
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
addr-state: If the country is USA, then the state and postal code exist (country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists()))
addr-zip: If 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})?$'))
112. Organization.contact.organization
Definition

This contact detail is handled/monitored by a specific organization. If the name is provided in the contact, then it is referring to the named individual within this organization.

ShortThis contact detail is handled/monitored by a specific organization
Control0..1
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Requirements

Some specific types of contact information can be an handled by an organization (eg legal council is via a specific firm).

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
114. Organization.contact.period
Definition

Period that this contact was valid for usage.

ShortPeriod that this contact was valid for usage
Comments

If the details have multiple periods, then enter in a new ExtendedContact with the new period.

Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
116. Organization.partOf
Definition

The organization of which this organization forms a part.

ShortThe organization of which this organization forms a part
Control0..1
TypeReference(Organization)
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Need to be able to track the hierarchy of organizations within an organization.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
118. Organization.endpoint
Definition

Technical endpoints providing access to services operated for the organization.

ShortTechnical endpoints providing access to services operated for the organization
Control0..*
TypeReference(Endpoint)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Organizations have multiple systems that provide various services and need to be able to define the technical connection details for how to connect to them, and for what purpose.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
120. Organization.qualification
Definition

The official certifications, accreditations, training, designations and licenses that authorize and/or otherwise endorse the provision of care by the organization.

For example, an approval to provide a type of services issued by a certifying body (such as the US Joint Commission) to an organization.

ShortQualifications, certifications, accreditations, licenses, training, etc. pertaining to the provision of care
Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
122. Organization.qualification.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
124. Organization.qualification.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
126. Organization.qualification.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
128. Organization.qualification.identifier
Definition

An identifier allocated to this qualification for this organization.

ShortAn identifier for this qualification for the organization
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Often, specific identities are assigned for the qualification by the assigning organization.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
130. Organization.qualification.code
Definition

Coded representation of the qualification.

ShortCoded representation of the qualification
Control1..1
Binding

Specific qualification the organization has to provide a service.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
132. Organization.qualification.period
Definition

Period during which the qualification is valid.

ShortPeriod during which the qualification is valid
Control0..1
TypePeriod
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Qualifications are often for a limited period of time, and can be revoked.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
134. Organization.qualification.issuer
Definition

Organization that regulates and issues the qualification.

ShortOrganization that regulates and issues the qualification
Control0..1
TypeReference(Organization)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))