| Left: | Manufacturing and/or Test Site Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization) |
| Right: | Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization) |
| Error | StructureDefinition.url | Values for url differ: 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization' vs 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization' |
| Error | StructureDefinition.version | Values for version differ: '1.0.0-ballot' vs '1.0.0' |
| Information | StructureDefinition.name | Values for name differ: 'MfgTestSiteOrganization' vs 'CodedOrganization' |
| Information | StructureDefinition.title | Values for title differ: 'Manufacturing and/or Test Site Organization' vs 'Basic Organization' |
| Information | StructureDefinition.date | Values for date differ: '2024-04-08T17:51:06+00:00' vs '2024-12-11T14:20:21+00:00' |
| Warning | StructureDefinition.abstract | Values for abstract differ: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Manufacturing Site Unique Identifier | Testing Site Unique Identifier' vs 'Identifies this organization across multiple systems' |
| Information | StructureDefinition.definition | Values for definition differ: '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]' vs 'Identifier for the organization that is used to identify the organization across multiple disparate systems.' |
| Information | StructureDefinition.short | Values for short differ: 'Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type' vs 'Description of identifier' |
| Information | StructureDefinition.definition | Values for definition differ: 'A value that identifies the source of the unique identifier. [Source: SME Defined] Examples: Data Universal Number System (DUNS), Facility Establishment Identifiers (FEI), etc.' vs 'A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.' |
| Information | StructureDefinition.short | Values for short differ: 'Manufacturing Site Name | Testing Site Name' vs 'Name used for the organization' |
| Information | StructureDefinition.definition | Values for definition differ: '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]' vs 'A name associated with the organization.' |
| Warning | Organization.contact | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | Organization.contact | Element maximum cardinalities differ: '1' vs '2147483647' |
| Information | StructureDefinition.short | Values for short differ: 'Manufacturing Site Physical Address | Testing Site Address' vs 'An address expressed using postal conventions (as opposed to GPS or other location definition formats)' |
| Information | StructureDefinition.definition | Values for definition differ: '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]' vs 'An address expressed using postal conventions (as opposed to GPS or other location definition formats). This data type may be used to convey addresses for use in delivering mail as well as for visiting locations which might not be valid for mail delivery. There are a variety of postal address formats defined around the world. The ISO21090-codedString may be used to provide a coded representation of the contents of strings in an Address.' |
| Information | StructureDefinition.comment | Values for comment differ: '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](location.html#) resource).' vs '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](http://hl7.org/fhir/R5/location.html#) resource).' |
| Name | Value | Comments | |
|---|---|---|---|
 abstract | true | false |
|
| baseDefinition | http://hl7.org/fhir/StructureDefinition/Organization | ||
| copyright | |||
| date | 2024-04-08T17:51:06+00:00 | 2024-12-11T14:20:21+00:00 |
|
| description | A profile for the data elements required to identify an organization that manufactures, processes or tests drug products or substances. | A profile for the data elements required to identify the sponsor of the drug products or substances, Suppliers. |
|
| experimental | |||
| fhirVersion | 5.0.0 | ||
| jurisdiction | |||
 jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | MfgTestSiteOrganization | CodedOrganization |
|
| publisher | HL7 International / Biomedical Research and Regulation | ||
| purpose | |||
| status | active | ||
| title | Manufacturing and/or Test Site Organization | Basic Organization |
|
| type | Organization | ||
| url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization |
|
| version | 1.0.0-ballot | 1.0.0 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 Organization | C | 0..* | Organization | This is an abstractprofile. 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 | 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: ?? (required): IETF language tag for 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 | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| Slices for identifier | SΣC | 1..* | Identifier | Manufacturing Site Unique Identifier | Testing Site Unique Identifier Slice: Unordered, Open by value:system | SΣC | 1..* | Identifier | Identifies this organization across multiple systems Slice: Unordered, Open by value:system | |||||||||
| id | 0..1 | id | 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 | SΣ | 0..1 | CodeableConcept | Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type Binding: ?? (required) | SΣ | 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. | |||||||||
| system | SΣ | 1..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 | SΣC | 1..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 | ?!Σ | 0..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 | Manufacturing Site Name | Testing Site Name | SΣC | 1..1 | string | Name used for the organization | |||||||||
| alias | 0..* | string | A list of alternate names that the organization is known as, or was known as in the past | 0..* | string | A list of alternate names that the organization is known as, or was known as in the past | |||||||||||
| description | Σ | 0..1 | markdown | Additional details about the Organization that could be displayed as further information to identify the Organization beyond its name | Σ | 0..1 | markdown | Additional details about the Organization that could be displayed as further information to identify the Organization beyond its name | |||||||||
| contact | 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' | SC | 1..* | ExtendedContactDetail | Official contact details for the Organization org-3: The telecom of an organization can never be of use 'home' org-4: The address of an organization can never be of use 'home' |
| ||||||||
| id | 0..1 | id | Unique id for inter-element referencing | 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 | |||||||||||
| purpose | Σ | 0..1 | CodeableConcept | The type of contact Binding: ?? (preferred): The purpose for which an extended contact detail should be used. | Σ | 0..1 | CodeableConcept | The type of contact Binding: ?? (preferred): The purpose for which an extended contact detail should be used. | |||||||||
| name | Σ | 0..* | HumanName | Name of an individual to contact | Σ | 0..* | HumanName | Name of an individual to contact | |||||||||
| telecom | Σ | 0..* | ContactPoint | Contact details (e.g.phone/fax/url) | Σ | 0..* | ContactPoint | Contact details (e.g.phone/fax/url) | |||||||||
| address | 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 | SC | 1..1 | ?? | An address expressed using postal conventions (as opposed to GPS or other location definition formats) addr-state: If the country is USA, then the state and postal code exist addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers | |||||||||
| organization | Σ | 0..1 | Reference(Organization) | This contact detail is handled/monitored by a specific organization | 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 | Σ | 0..1 | Period | Period that this contact was valid for usage | |||||||||
| partOf | Σ | 0..1 | Reference(Organization) | The organization of which this organization forms a part | Σ | 0..1 | Reference(Organization) | The organization of which this organization forms a part | |||||||||
| endpoint | 0..* | Reference(Endpoint) | Technical endpoints providing access to services operated for the organization | 0..* | Reference(Endpoint) | Technical endpoints providing access to services operated for the organization | |||||||||||
 qualification | 0..* | BackboneElement | Qualifications, certifications, accreditations, licenses, training, etc. pertaining to the provision of care | 0..* | BackboneElement | Qualifications, certifications, accreditations, licenses, training, etc. pertaining to the provision of care | |||||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| identifier | 0..* | Identifier | An identifier for this qualification for the organization | 0..* | Identifier | An identifier for this qualification for the organization | |||||||||||
| code | 1..1 | CodeableConcept | Coded representation of the qualification Binding Description (No ValueSet): (example): Specific qualification the organization has to provide a service. | 1..1 | CodeableConcept | Coded representation of the qualification Binding Description (No ValueSet): (example): Specific qualification the organization has to provide a service. | |||||||||||
| period | 0..1 | Period | Period during which the qualification is valid | 0..1 | Period | Period during which the qualification is valid | |||||||||||
| issuer | 0..1 | Reference(Organization) | Organization that regulates and issues the qualification | 0..1 | Reference(Organization) | Organization that regulates and issues the qualification | |||||||||||
| Documentation for this format | |||||||||||||||||