Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Examples
• XML
• JSON

Resource Profile: Manufacturing and/or Test Site Organization ( Abstract )

A profile for the data elements required to identify an organization that manufactures, processes or tests drug products or substances.

Usage:

• Refer to this Resource Profile: Component Substance, Substance General Information, Excipient Drug Substance and Routine Drug Substance
• Examples for this Resource Profile: Manufacturing Site (J. Jones Research), Sams BioPharm, East-West Manufacturing and Vidinaid

Formal Views of Profile Content

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

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

This structure is derived from Organization

Name	Flags	Card.	Type	Description & Constraints
Organization			Organization	This is an abstract profile.
meta
profile	S	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
Slices for identifier	S	1..*	Identifier	Manufacturing Site Unique Identifier | Testing Site Unique Identifier Slice: Unordered, Open by value:system
identifier:All Slices				Content/Rules for all slices
type	S	0..1	CodeableConcept	Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type Binding: Organization-Site Identifier Terminology (required)
system	S	1..1	uri	The namespace for the identifier value
value	S	1..1	string	The value that is unique
identifier:DUNSNumber	SC	0..1	Identifier	Identifies this organization across multiple systems org-length9: Identifier number is 9 digits
system		0..1	uri	The namespace for the identifier value Required Pattern: urn:oid:1.3.6.1.4.1.519.1
identifier:FEINumber	SC	0..1	Identifier	Identifies this organization across multiple systems org-length7: Identifier number is 7 or 10 digits
system		0..1	uri	The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.4.82
name	S	1..1	string	Manufacturing Site Name | Testing Site Name
contact		1..1	ExtendedContactDetail	Official contact details for the Organization
address	S	1..1	PqAddress	Manufacturing Site Physical Address | Testing Site Address
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Organization.identifier.type	required	PqcmcOrgIdentifierTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology from this IG

Constraints

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

Name	Flags	Card.	Type	Description & Constraints
Organization	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
meta	Σ	0..1	Meta	Metadata about the resource
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!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
identifier:All Slices				Content/Rules for all slices
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	SΣ	0..1	CodeableConcept	Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type Binding: Organization-Site Identifier Terminology (required)
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣC	1..1	string	The value that is unique Example General: 123456
identifier:DUNSNumber	SΣC	0..1	Identifier	Identifies this organization across multiple systems org-length9: Identifier number is 9 digits
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: urn:oid:1.3.6.1.4.1.519.1
identifier:FEINumber	SΣC	0..1	Identifier	Identifies this organization across multiple systems org-length7: Identifier number is 7 or 10 digits
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.4.82
active	?!Σ	0..1	boolean	Whether the organization's record is still in active use
name	SΣC	1..1	string	Manufacturing Site Name | Testing Site 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'
address	SC	1..1	PqAddress	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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Organization.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Organization.identifier.type	required	PqcmcOrgIdentifierTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology from this IG
Organization.identifier:DUNSNumber.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Organization.identifier:FEINumber.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard

Constraints

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

Name	Flags	Card.	Type	Description & Constraints
Organization	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
meta	Σ	0..1	Meta	Metadata about the resource
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣC	1..*	Identifier	Manufacturing Site Unique Identifier | Testing Site Unique Identifier Slice: Unordered, Open by value:system
identifier:All Slices				Content/Rules for all slices
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	SΣ	0..1	CodeableConcept	Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type Binding: Organization-Site Identifier Terminology (required)
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣC	1..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:DUNSNumber	SΣC	0..1	Identifier	Identifies this organization across multiple systems org-length9: Identifier number is 9 digits
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: urn:oid:1.3.6.1.4.1.519.1
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:FEINumber	SΣC	0..1	Identifier	Identifies this organization across multiple systems org-length7: Identifier number is 7 or 10 digits
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.4.82
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
active	?!Σ	0..1	boolean	Whether the organization's record is still in active use
type	Σ	0..*	CodeableConcept	Kind of organization Binding: OrganizationType (example): Used to categorize the organization.
name	SΣC	1..1	string	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
description	Σ	0..1	markdown	Additional details about the Organization that could be displayed as further information to identify the Organization beyond its name
contact	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	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
purpose	Σ	0..1	CodeableConcept	The type of contact Binding: Contact entity type (preferred): The purpose for which an extended contact detail should be used.
name	Σ	0..*	HumanName	Name of an individual to contact
telecom	Σ	0..*	ContactPoint	Contact details (e.g.phone/fax/url)
address	SC	1..1	PqAddress	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
partOf	Σ	0..1	Reference(Organization)	The organization of which this organization forms a part
endpoint		0..*	Reference(Endpoint)	Technical endpoints providing access to services operated for the organization
qualification		0..*	BackboneElement	Qualifications, certifications, accreditations, licenses, training, etc. pertaining to the provision of care
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
identifier		0..*	Identifier	An identifier for this qualification for the organization
code		1..1	CodeableConcept	Coded representation of the qualification Binding: (unbound) (example): Specific qualification the organization has to provide a service.
period		0..1	Period	Period during which the qualification is valid
issuer		0..1	Reference(Organization)	Organization that regulates and issues the qualification
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Organization.meta.security	extensible	AllSecurityLabels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
Organization.meta.tag	example	CommonTags http://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard
Organization.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Organization.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Organization.identifier.type	required	PqcmcOrgIdentifierTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology from this IG
Organization.identifier:DUNSNumber.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Organization.identifier:DUNSNumber.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Organization.identifier:FEINumber.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Organization.identifier:FEINumber.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Organization.type	example	OrganizationType http://hl7.org/fhir/ValueSet/organization-type from the FHIR Standard
Organization.contact.purpose	preferred	ContactEntityType http://terminology.hl7.org/ValueSet/contactentity-type
Organization.qualification.code	example

Constraints

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

This structure is derived from Organization

Summary

Mandatory: 6 elements(1 nested mandatory element)
Must-Support: 9 elements

Structures

This structure refers to these other structures:

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

Slices

This structure defines the following Slices:

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

Differential View

This structure is derived from Organization

Name	Flags	Card.	Type	Description & Constraints
Organization			Organization	This is an abstract profile.
meta
profile	S	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
Slices for identifier	S	1..*	Identifier	Manufacturing Site Unique Identifier | Testing Site Unique Identifier Slice: Unordered, Open by value:system
identifier:All Slices				Content/Rules for all slices
type	S	0..1	CodeableConcept	Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type Binding: Organization-Site Identifier Terminology (required)
system	S	1..1	uri	The namespace for the identifier value
value	S	1..1	string	The value that is unique
identifier:DUNSNumber	SC	0..1	Identifier	Identifies this organization across multiple systems org-length9: Identifier number is 9 digits
system		0..1	uri	The namespace for the identifier value Required Pattern: urn:oid:1.3.6.1.4.1.519.1
identifier:FEINumber	SC	0..1	Identifier	Identifies this organization across multiple systems org-length7: Identifier number is 7 or 10 digits
system		0..1	uri	The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.4.82
name	S	1..1	string	Manufacturing Site Name | Testing Site Name
contact		1..1	ExtendedContactDetail	Official contact details for the Organization
address	S	1..1	PqAddress	Manufacturing Site Physical Address | Testing Site Address
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Organization.identifier.type	required	PqcmcOrgIdentifierTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology from this IG

Constraints

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

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Organization	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
meta	Σ	0..1	Meta	Metadata about the resource
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!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
identifier:All Slices				Content/Rules for all slices
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	SΣ	0..1	CodeableConcept	Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type Binding: Organization-Site Identifier Terminology (required)
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣC	1..1	string	The value that is unique Example General: 123456
identifier:DUNSNumber	SΣC	0..1	Identifier	Identifies this organization across multiple systems org-length9: Identifier number is 9 digits
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: urn:oid:1.3.6.1.4.1.519.1
identifier:FEINumber	SΣC	0..1	Identifier	Identifies this organization across multiple systems org-length7: Identifier number is 7 or 10 digits
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.4.82
active	?!Σ	0..1	boolean	Whether the organization's record is still in active use
name	SΣC	1..1	string	Manufacturing Site Name | Testing Site 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'
address	SC	1..1	PqAddress	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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Organization.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Organization.identifier.type	required	PqcmcOrgIdentifierTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology from this IG
Organization.identifier:DUNSNumber.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Organization.identifier:FEINumber.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard

Constraints

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

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Organization	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
meta	Σ	0..1	Meta	Metadata about the resource
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣC	1..*	Identifier	Manufacturing Site Unique Identifier | Testing Site Unique Identifier Slice: Unordered, Open by value:system
identifier:All Slices				Content/Rules for all slices
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	SΣ	0..1	CodeableConcept	Manufacturing Site Unique Identifier Type | Testing Site Unique Identifier Type Binding: Organization-Site Identifier Terminology (required)
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣC	1..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:DUNSNumber	SΣC	0..1	Identifier	Identifies this organization across multiple systems org-length9: Identifier number is 9 digits
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: urn:oid:1.3.6.1.4.1.519.1
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:FEINumber	SΣC	0..1	Identifier	Identifies this organization across multiple systems org-length7: Identifier number is 7 or 10 digits
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: urn:oid:2.16.840.1.113883.4.82
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
active	?!Σ	0..1	boolean	Whether the organization's record is still in active use
type	Σ	0..*	CodeableConcept	Kind of organization Binding: OrganizationType (example): Used to categorize the organization.
name	SΣC	1..1	string	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
description	Σ	0..1	markdown	Additional details about the Organization that could be displayed as further information to identify the Organization beyond its name
contact	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	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
purpose	Σ	0..1	CodeableConcept	The type of contact Binding: Contact entity type (preferred): The purpose for which an extended contact detail should be used.
name	Σ	0..*	HumanName	Name of an individual to contact
telecom	Σ	0..*	ContactPoint	Contact details (e.g.phone/fax/url)
address	SC	1..1	PqAddress	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
partOf	Σ	0..1	Reference(Organization)	The organization of which this organization forms a part
endpoint		0..*	Reference(Endpoint)	Technical endpoints providing access to services operated for the organization
qualification		0..*	BackboneElement	Qualifications, certifications, accreditations, licenses, training, etc. pertaining to the provision of care
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
identifier		0..*	Identifier	An identifier for this qualification for the organization
code		1..1	CodeableConcept	Coded representation of the qualification Binding: (unbound) (example): Specific qualification the organization has to provide a service.
period		0..1	Period	Period during which the qualification is valid
issuer		0..1	Reference(Organization)	Organization that regulates and issues the qualification
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Organization.meta.security	extensible	AllSecurityLabels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
Organization.meta.tag	example	CommonTags http://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard
Organization.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Organization.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Organization.identifier.type	required	PqcmcOrgIdentifierTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-org-identifier-type-terminology from this IG
Organization.identifier:DUNSNumber.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Organization.identifier:DUNSNumber.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Organization.identifier:FEINumber.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Organization.identifier:FEINumber.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Organization.type	example	OrganizationType http://hl7.org/fhir/ValueSet/organization-type from the FHIR Standard
Organization.contact.purpose	preferred	ContactEntityType http://terminology.hl7.org/ValueSet/contactentity-type
Organization.qualification.code	example

Constraints

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

This structure is derived from Organization

Summary

Mandatory: 6 elements(1 nested mandatory element)
Must-Support: 9 elements

Structures

This structure refers to these other structures:

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

Slices

This structure defines the following Slices:

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

Other representations of profile: CSV, Excel, Schematron