| Left: | US Core Organization Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-organization) |
| Right: | Manufacturing and/or Test Site Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization) |
| Error | StructureDefinition.url | Values for url differ: 'http://hl7.org/fhir/us/core/StructureDefinition/us-core-organization' vs 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization' |
| Error | StructureDefinition.version | Values for version differ: '7.0.0-ballot' vs '0.1.20' |
| Information | StructureDefinition.name | Values for name differ: 'USCoreOrganizationProfile' vs 'MfgTestSiteOrganization' |
| Information | StructureDefinition.title | Values for title differ: 'US Core Organization Profile' vs 'Manufacturing and/or Test Site Organization' |
| Information | StructureDefinition.status | Values for status differ: 'active' vs 'draft' |
| Information | StructureDefinition.date | Values for date differ: '2022-04-20' vs '2024-03-04T02:24:01+00:00' |
| Information | StructureDefinition.publisher | Values for publisher differ: 'HL7 International / Cross-Group Projects' vs 'HL7 International / Biomedical Research and Regulation' |
| Warning | StructureDefinition.fhirVersion | Values for fhirVersion differ: '4.0.1' vs '5.0.0' |
| Warning | StructureDefinition.abstract | Values for abstract differ: 'false' vs 'true' |
| Information | StructureDefinition.definition | Values for definition differ: '\-' vs '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.' |
| Information | StructureDefinition.comment | Values for comment differ: 'The only time that a resource does not have an id is when it is being submitted to the server using a create operation.' vs '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.' |
| Information | StructureDefinition.comment | Values for comment differ: '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 it's narrative along with other profiles, value sets, etc.' vs '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.' |
| Information | StructureDefinition.comment | Values for comment differ: 'Contained resources do not have 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.' vs '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.' |
| Information | StructureDefinition.definition | Values for definition differ: 'These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.' vs '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.' |
| Information | StructureDefinition.comment | Values for comment differ: '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.' vs '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.' |
| Information | StructureDefinition.definition | Values for definition differ: '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 manageable, 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.' vs '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.' |
| Information | StructureDefinition.definition | Values for definition differ: '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 manageable, 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).' vs '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).' |
| Information | StructureDefinition.requirements | Values for requirements differ: '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](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).' vs '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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).' |
| Information | StructureDefinition.short | Values for short differ: 'Identifies this organization across multiple systems' vs 'Manufacturing Site Unique Identifier | Testing Site Unique Identifier' |
| Information | StructureDefinition.definition | Values for definition differ: 'Identifier for the organization that is used to identify the organization across multiple disparate systems.' vs '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]' |
| Information | Organization.identifier | Element minimum cardinalities differ: '0' vs '1' |
| Information | StructureDefinition.definition | Values for definition differ: '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 manageable, 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.' vs '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.' |
| Error | Organization.identifier.use | Unable to resolve left value set http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 at Organization.identifier.use |
| Information | StructureDefinition.short | Values for short differ: 'Description of identifier' vs 'Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type' |
| Information | StructureDefinition.definition | Values for definition differ: 'A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.' vs 'A value that identifies the source of the unique identifier. [Source: SME Defined] Examples: Data Universal Number System (DUNS), Facility Establishment Identifiers (FEI), etc.' |
| Warning | Organization.identifier.type | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | StructureDefinition.definition | Values for definition differ: 'Establishes the namespace for the value - that is, a URL that describes a set values that are unique.' vs 'Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.' |
| Information | Organization.identifier.system | Element minimum cardinalities differ: '0' vs '1' |
| Information | StructureDefinition.comment | Values for comment differ: '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 [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). 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.' vs '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](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). 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.' |
| Information | Organization.identifier.value | Element minimum cardinalities differ: '0' vs '1' |
| Warning | Organization.active | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | Organization.active | Element minimum cardinalities differ: '1' vs '0' |
| Information | StructureDefinition.short | Values for short differ: 'Name used for the organization' vs 'Manufacturing Site Name | Testing Site Name' |
| Information | StructureDefinition.definition | Values for definition differ: 'A name associated with the organization.' vs '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]' |
| Information | StructureDefinition.short | Values for short differ: 'Contact for the organization for a certain purpose' vs 'Official contact details for the Organization' |
| Information | StructureDefinition.definition | Values for definition differ: 'Contact for the organization for a certain purpose.' vs '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.' |
| Information | StructureDefinition.comment | Values for comment differ: 'Where multiple contacts for the same purpose are provided there is a standard extension that can be used to determine which one is the preferred contact to use.' vs '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.' |
| Information | Organization.contact | Element minimum cardinalities differ: '0' vs '1' |
| Information | Organization.contact | Element maximum cardinalities differ: '2147483647' vs '1' |
| Information | StructureDefinition.definition | Values for definition differ: '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 manageable, 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.' vs '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.' |
| Information | StructureDefinition.definition | Values for definition differ: 'Indicates a purpose for which the contact can be reached.' vs 'The purpose/type of contact.' |
| Information | StructureDefinition.short | Values for short differ: 'A name associated with the contact' vs 'Name of an individual to contact' |
| Information | StructureDefinition.definition | Values for definition differ: 'A name associated with the contact.' vs 'The name of an individual to contact, some types of contact detail are usually blank.' |
| Information | Organization.contact.name | Element maximum cardinalities differ: '1' vs '2147483647' |
| Information | StructureDefinition.short | Values for short differ: 'Contact details (telephone, email, etc.) for a contact' vs 'Contact details (e.g.phone/fax/url)' |
| Information | StructureDefinition.definition | Values for definition differ: 'A contact detail (e.g. a telephone number or an email address) by which the party may be contacted.' vs 'The contact details application for the purpose defined.' |
| Information | StructureDefinition.short | Values for short differ: 'Visiting or postal addresses for the contact' vs 'Manufacturing Site Physical Address | Testing Site Address' |
| Information | StructureDefinition.definition | Values for definition differ: 'Visiting or postal addresses for the contact.' vs '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]' |
| Warning | Organization.contact.address | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | Organization.contact.address | Element minimum cardinalities differ: '0' vs '1' |
| Name | Value | Comments | |
|---|---|---|---|
 abstract | false | true |
|
| baseDefinition | http://hl7.org/fhir/StructureDefinition/Organization | ||
| copyright | Used by permission of HL7 International, all rights reserved Creative Commons License |
| |
| date | 2022-04-20 | 2024-03-04T02:24:01+00:00 |
|
| description | This profile sets minimum expectations for the Organization resource to searching for and fetching an Organization associated with a patient or provider to promote interoperability and adoption through common implementation. It identifies which core elements, extensions, vocabularies, and value sets **SHALL** be present and constrains the way the elements are used and constrains the way the elements are used when using the profile. It provides the floor for standards development for specific use cases. | A profile for the data elements required to identify an organization that manufactures, processes or tests drug products or substances. |
|
| experimental | false |
| |
| fhirVersion | 4.0.1 | 5.0.0 |
|
| jurisdiction | |||
 jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | USCoreOrganizationProfile | MfgTestSiteOrganization |
|
| publisher | HL7 International / Cross-Group Projects | HL7 International / Biomedical Research and Regulation |
|
| purpose | |||
| status | active | draft |
|
| title | US Core Organization Profile | Manufacturing and/or Test Site Organization |
|
| type | Organization | ||
| url | http://hl7.org/fhir/us/core/StructureDefinition/us-core-organization | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization |
|
| version | 7.0.0-ballot | 0.1.20 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | L Type | L Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 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 | C | 0..* | Organization | This is an abstract profile. 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 | Σ | 0..1 | id | Logical id of this artifact | |||||||||
 meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
 id | 0..1 | id | Unique id for inter-element referencing |
| |||||||||||||
 Slices for 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 | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| ||||||||||||
| security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: ?? (extensible): Security Labels from the Healthcare Privacy and Security Classification System. |
| ||||||||||||
| tag | Σ | 0..* | Coding | Tags applied to this resource Binding: ?? (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 | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
| language | 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| |||||||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| Slices for identifier | SΣC | 0..* | Identifier | Identifies this organization across multiple systems Slice: Unordered, Open by pattern:$this | SΣC | 1..* | Identifier | Manufacturing Site Unique Identifier | Testing Site Unique Identifier Slice: Unordered, Open by value:system |
| ||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 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: ?? (required): Identifies the purpose for this identifier, if known . | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known . |
| ||||||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | SΣ | 0..1 | CodeableConcept | Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type Binding: ?? (required) |
| ||||||||
| system | SΣ | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | SΣ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
| ||||||||
| value | SΣ | 0..1 | string | The value that is unique Example General: 123456 | 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 | 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) | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | |||||||||
| active | ?!SΣ | 1..1 | boolean | Whether the organization's record is still in active use | ?!Σ | 0..1 | boolean | Whether the organization's record is still in active use |
| ||||||||
| type | Σ | 0..* | CodeableConcept | Kind of organization Binding: ?? (example): Used to categorize the organization. | Σ | 0..* | CodeableConcept | Kind of organization Binding: ?? (example): Used to categorize the organization. | |||||||||
| name | SΣC | 1..1 | string | Name used for the organization | SΣC | 1..1 | string | Manufacturing Site Name | Testing Site Name | |||||||||
| alias | 0..* | string | A list of alternate names that the organization is known as, or was known as in the past | 0..* | string | A list of alternate names that the organization is known as, or was known as in the past | |||||||||||
| telecom | SC | 0..* | ContactPoint | A contact detail for the organization org-3: The telecom of an organization can never be of use 'home' |
| ||||||||||||
| address | SC | 0..* | Address | An address for the organization org-2: An address of an organization can never be of use 'home' |
| ||||||||||||
| partOf | Σ | 0..1 | Reference(Organization) | The organization of which this organization forms a part | Σ | 0..1 | Reference(Organization) | The organization of which this organization forms a part | |||||||||
| contact | 0..* | BackboneElement | Contact for the organization for a certain purpose | C | 1..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 | string | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ||||||||||||
| purpose | 0..1 | CodeableConcept | The type of contact Binding: ?? (extensible): The purpose for which you would contact a contact party. | Σ | 0..1 | CodeableConcept | The type of contact Binding: ?? (preferred): The purpose for which an extended contact detail should be used. | ||||||||||
| name | 0..1 | HumanName | A name associated with the contact | Σ | 0..* | HumanName | Name of an individual to contact |
| |||||||||
| telecom | 0..* | ContactPoint | Contact details (telephone, email, etc.) for a contact | Σ | 0..* | ContactPoint | Contact details (e.g.phone/fax/url) | ||||||||||
| address | 0..1 | Address | Visiting or postal addresses for the contact | SC | 1..1 | ?? | Manufacturing Site Physical Address | Testing Site Address 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 |
| ||||||||||||
| endpoint | 0..* | Reference(Endpoint) | Technical endpoints providing access to services operated for the organization | 0..* | Reference(Endpoint) | Technical endpoints providing access to services operated for the organization | |||||||||||
| description | Σ | 0..1 | markdown | Additional details about the Organization that could be displayed as further information to identify the Organization beyond its name |
| ||||||||||||
| qualification | 0..* | BackboneElement | Qualifications, certifications, accreditations, licenses, training, etc. pertaining to the provision of care |
| |||||||||||||
| Documentation for this format | |||||||||||||||||