HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction
HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction
This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v1.0.1: STU 1 Update) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions 
| Draft as of 2023-08-29 |
XML representation of the icsr-bloodproduct resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="icsr-bloodproduct"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml">Placeholder</div>
</text>
<url
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bloodproduct"/>
<version value="1.0.1"/>
<name value="ICSRBloodProduct"/>
<title value="ICSR Blood Product"/>
<status value="draft"/>
<date value="2023-08-29T21:40:08+00:00"/>
<publisher value="Biomedical Research & Regulation WG"/>
<contact>
<name value="Biomedical Research & Regulation WG"/>
<telecom>
<system value="url"/>
<value value="http://hl7.org/Special/committees/rcrim"/>
</telecom>
</contact>
<contact>
<name value="Jean Duteau"/>
<telecom>
<system value="email"/>
<value value="mailto:jean.duteau@ibm.com"/>
</telecom>
</contact>
<description
value="The common fields needed to represent a blood product used in a transfusion."/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
</coding>
</jurisdiction>
<fhirVersion value="4.0.1"/>
<mapping>
<identity value="rim"/>
<uri value="http://hl7.org/v3"/>
<name value="RIM Mapping"/>
</mapping>
<mapping>
<identity value="w5"/>
<uri value="http://hl7.org/fhir/fivews"/>
<name value="FiveWs Pattern Mapping"/>
</mapping>
<mapping>
<identity value="v2"/>
<uri value="http://hl7.org/v2"/>
<name value="HL7 v2 Mapping"/>
</mapping>
<kind value="resource"/>
<abstract value="false"/>
<type value="BiologicallyDerivedProduct"/>
<baseDefinition
value="http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"/>
<derivation value="constraint"/>
<snapshot>
<element id="BiologicallyDerivedProduct">
<path value="BiologicallyDerivedProduct"/>
<short
value="A material substance originating from a biological entity"/>
<definition
value="A material substance originating from a biological entity intended to be transplanted or infused
into another (possibly the same) biological entity."/>
<comment
value="Substances include, but are not limited to: whole blood, bone marrow, organs, and manipulated blood cells."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BiologicallyDerivedProduct"/>
<min value="0"/>
<max value="*"/>
</base>
<constraint>
<key value="dom-2"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
<expression value="contained.contained.empty()"/>
<xpath value="not(parent::f:contained and f:contained)"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-3"/>
<severity value="error"/>
<human
value="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"/>
<expression
value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
<xpath
value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-4"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
<expression
value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
<xpath
value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-5"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
<expression value="contained.meta.security.empty()"/>
<xpath value="not(exists(f:contained/*/f:meta/f:security))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown
value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
</extension>
<key value="dom-6"/>
<severity value="warning"/>
<human
value="A resource should have narrative for robust management"/>
<expression value="text.`div`.exists()"/>
<xpath value="exists(f:text/h:div)"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="Entity. Role, or Act"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="Material[classCode= Observation[classCode=OBS, moodCode=EVN]"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.id">
<path value="BiologicallyDerivedProduct.id"/>
<short value="Logical id of this artifact"/>
<definition
value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
<comment
value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="id"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="BiologicallyDerivedProduct.meta">
<path value="BiologicallyDerivedProduct.meta"/>
<short value="Metadata about the resource"/>
<definition
value="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."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.meta"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Meta"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="BiologicallyDerivedProduct.implicitRules">
<path value="BiologicallyDerivedProduct.implicitRules"/>
<short value="A set of rules under which this content was created"/>
<definition
value="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."/>
<comment
value="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."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.implicitRules"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/>
<isSummary value="true"/>
</element>
<element id="BiologicallyDerivedProduct.language">
<path value="BiologicallyDerivedProduct.language"/>
<short value="Language of the resource content"/>
<definition
value="The base language in which the resource is written."/>
<comment
value="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)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.language"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
<valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Language"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
<valueBoolean value="true"/>
</extension>
<strength value="preferred"/>
<description value="A human language."/>
<valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
</binding>
</element>
<element id="BiologicallyDerivedProduct.text">
<path value="BiologicallyDerivedProduct.text"/>
<short value="Text summary of the resource, for human interpretation"/>
<definition
value="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."/>
<comment
value="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."/>
<alias value="narrative"/>
<alias value="html"/>
<alias value="xhtml"/>
<alias value="display"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Narrative"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="Act.text?"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.contained">
<path value="BiologicallyDerivedProduct.contained"/>
<short value="Contained, inline Resources"/>
<definition
value="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."/>
<comment
value="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."/>
<alias value="inline resources"/>
<alias value="anonymous resources"/>
<alias value="contained resources"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.contained"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Resource"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.extension">
<path value="BiologicallyDerivedProduct.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="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."/>
<comment
value="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."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.modifierExtension">
<path value="BiologicallyDerivedProduct.modifierExtension"/>
<short value="Extensions that cannot be ignored"/>
<definition
value="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)."/>
<comment
value="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."/>
<requirements
value="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)."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.identifier">
<path value="BiologicallyDerivedProduct.identifier"/>
<short value="External ids for this item"/>
<definition
value="This records identifiers associated with this biologically derived product instance that are defined by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate (e.g. in CDA documents, or in written / printed documentation)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BiologicallyDerivedProduct.identifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Identifier"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="IAM-7"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="id"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.productCategory">
<path value="BiologicallyDerivedProduct.productCategory"/>
<short value="organ | tissue | fluid | cells | biologicalAgent"/>
<definition value="Broad category of this product."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.productCategory"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<fixedCode value="cells"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="BiologicallyDerivedProductCategory"/>
</extension>
<strength value="required"/>
<description value="Biologically Derived Product Category."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/product-category|4.0.1"/>
</binding>
</element>
<element id="BiologicallyDerivedProduct.productCode">
<path value="BiologicallyDerivedProduct.productCode"/>
<short value="What this biologically derived product is"/>
<definition
value="A code that identifies the kind of this biologically derived product (SNOMED Ctcode)."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.productCode"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<strength value="extensible"/>
<valueSet
value="http://hl7.org/fhir/us/icsr-ae-reporting/ValueSet/ISBTBloodProductCodeVS"/>
</binding>
</element>
<element id="BiologicallyDerivedProduct.status">
<path value="BiologicallyDerivedProduct.status"/>
<short value="available | unavailable"/>
<definition value="Whether the product is currently available."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.status"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="BiologicallyDerivedProductStatus"/>
</extension>
<strength value="required"/>
<description value="Biologically Derived Product Status."/>
<valueSet value="http://hl7.org/fhir/ValueSet/product-status|4.0.1"/>
</binding>
</element>
<element id="BiologicallyDerivedProduct.request">
<path value="BiologicallyDerivedProduct.request"/>
<short value="Procedure request"/>
<definition
value="Procedure request to obtain this biologically derived product."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BiologicallyDerivedProduct.request"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ServiceRequest"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.quantity">
<path value="BiologicallyDerivedProduct.quantity"/>
<short value="The amount of this biologically derived product"/>
<definition value="Number of discrete units within this product."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.quantity"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="integer"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.parent">
<path value="BiologicallyDerivedProduct.parent"/>
<short value="BiologicallyDerivedProduct parent"/>
<definition value="Parent product (if any)."/>
<comment
value="For products that have multiple collections. For example Peripheral Blood Stem Cells may be collected over several days from a single donor and the donation split into in multiple containers which must be linked to the parent donation."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BiologicallyDerivedProduct.parent"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.collection">
<path value="BiologicallyDerivedProduct.collection"/>
<short value="How this product was collected"/>
<definition value="How this product was collected."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.collection"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.collection.id">
<path value="BiologicallyDerivedProduct.collection.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.collection.extension">
<path value="BiologicallyDerivedProduct.collection.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<short value="Extension"/>
<definition value="An Extension"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element
id="BiologicallyDerivedProduct.collection.extension:donationIdentificationNumber">
<path value="BiologicallyDerivedProduct.collection.extension"/>
<sliceName value="donationIdentificationNumber"/>
<short value="Extension"/>
<definition value="Indicates the identifier for a donation"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-donationIdentificationNumber"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
</element>
<element id="BiologicallyDerivedProduct.collection.modifierExtension">
<path value="BiologicallyDerivedProduct.collection.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="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 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. 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)."/>
<comment
value="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."/>
<requirements
value="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)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.collection.collector">
<path value="BiologicallyDerivedProduct.collection.collector"/>
<short value="Individual performing collection"/>
<definition
value="Healthcare professional who is performing the collection."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.collection.collector"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.collection.source">
<path value="BiologicallyDerivedProduct.collection.source"/>
<short value="Who is product from"/>
<definition
value="The patient or entity, such as a hospital or vendor in the case of a processed/manipulated/manufactured product, providing the product."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.collection.source"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Patient"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.collection.collected[x]">
<path value="BiologicallyDerivedProduct.collection.collected[x]"/>
<short value="Time of product collection"/>
<definition value="Time of product collection."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.collection.collected[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="dateTime"/>
</type>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.processing">
<path value="BiologicallyDerivedProduct.processing"/>
<short value="Any processing of the product during collection"/>
<definition
value="Any processing of the product during collection that does not change the fundamental nature of the product. For example adding anti-coagulants during the collection of Peripheral Blood Stem Cells."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BiologicallyDerivedProduct.processing"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.processing.id">
<path value="BiologicallyDerivedProduct.processing.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.processing.extension">
<path value="BiologicallyDerivedProduct.processing.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="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."/>
<comment
value="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."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.processing.modifierExtension">
<path value="BiologicallyDerivedProduct.processing.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="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 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. 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)."/>
<comment
value="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."/>
<requirements
value="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)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.processing.description">
<path value="BiologicallyDerivedProduct.processing.description"/>
<short value="Description of of processing"/>
<definition value="Description of of processing."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.processing.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.processing.procedure">
<path value="BiologicallyDerivedProduct.processing.procedure"/>
<short value="Procesing code"/>
<definition value="Procesing code."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.processing.procedure"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="BiologicallyDerivedProductProcedure"/>
</extension>
<strength value="example"/>
<description value="Biologically Derived Product Procedure."/>
<valueSet value="http://hl7.org/fhir/ValueSet/procedure-code"/>
</binding>
</element>
<element id="BiologicallyDerivedProduct.processing.additive">
<path value="BiologicallyDerivedProduct.processing.additive"/>
<short value="Substance added during processing"/>
<definition value="Substance added during processing."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.processing.additive"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Substance"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.processing.time[x]">
<path value="BiologicallyDerivedProduct.processing.time[x]"/>
<short value="Time of processing"/>
<definition value="Time of processing."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.processing.time[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="dateTime"/>
</type>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.manipulation">
<path value="BiologicallyDerivedProduct.manipulation"/>
<short value="Any manipulation of product post-collection"/>
<definition
value="Any manipulation of product post-collection that is intended to alter the product. For example a buffy-coat enrichment or CD8 reduction of Peripheral Blood Stem Cells to make it more suitable for infusion."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.manipulation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.manipulation.id">
<path value="BiologicallyDerivedProduct.manipulation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.manipulation.extension">
<path value="BiologicallyDerivedProduct.manipulation.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="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."/>
<comment
value="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."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.manipulation.modifierExtension">
<path
value="BiologicallyDerivedProduct.manipulation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="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 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. 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)."/>
<comment
value="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."/>
<requirements
value="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)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.manipulation.description">
<path value="BiologicallyDerivedProduct.manipulation.description"/>
<short value="Description of manipulation"/>
<definition value="Description of manipulation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.manipulation.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.manipulation.time[x]">
<path value="BiologicallyDerivedProduct.manipulation.time[x]"/>
<short value="Time of manipulation"/>
<definition value="Time of manipulation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.manipulation.time[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="dateTime"/>
</type>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.storage">
<path value="BiologicallyDerivedProduct.storage"/>
<short value="Product storage"/>
<definition value="Product storage."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BiologicallyDerivedProduct.storage"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.storage.id">
<path value="BiologicallyDerivedProduct.storage.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.storage.extension">
<path value="BiologicallyDerivedProduct.storage.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="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."/>
<comment
value="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."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.storage.modifierExtension">
<path value="BiologicallyDerivedProduct.storage.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="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 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. 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)."/>
<comment
value="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."/>
<requirements
value="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)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="BiologicallyDerivedProduct.storage.description">
<path value="BiologicallyDerivedProduct.storage.description"/>
<short value="Description of storage"/>
<definition value="Description of storage."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.storage.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.storage.temperature">
<path value="BiologicallyDerivedProduct.storage.temperature"/>
<short value="Storage temperature"/>
<definition value="Storage temperature."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.storage.temperature"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="decimal"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="BiologicallyDerivedProduct.storage.scale">
<path value="BiologicallyDerivedProduct.storage.scale"/>
<short value="farenheit | celsius | kelvin"/>
<definition value="Temperature scale used."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.storage.scale"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="BiologicallyDerivedProductStorageScale"/>
</extension>
<strength value="required"/>
<description value="BiologicallyDerived Product Storage Scale."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/product-storage-scale|4.0.1"/>
</binding>
</element>
<element id="BiologicallyDerivedProduct.storage.duration">
<path value="BiologicallyDerivedProduct.storage.duration"/>
<short value="Storage timeperiod"/>
<definition value="Storage timeperiod."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="BiologicallyDerivedProduct.storage.duration"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
</snapshot>
<differential>
<element id="BiologicallyDerivedProduct">
<path value="BiologicallyDerivedProduct"/>
</element>
<element id="BiologicallyDerivedProduct.productCategory">
<path value="BiologicallyDerivedProduct.productCategory"/>
<min value="1"/>
<fixedCode value="cells"/>
<mustSupport value="true"/>
</element>
<element id="BiologicallyDerivedProduct.productCode">
<path value="BiologicallyDerivedProduct.productCode"/>
<min value="1"/>
<mustSupport value="true"/>
<binding>
<strength value="extensible"/>
<valueSet
value="http://hl7.org/fhir/us/icsr-ae-reporting/ValueSet/ISBTBloodProductCodeVS"/>
</binding>
</element>
<element id="BiologicallyDerivedProduct.collection">
<path value="BiologicallyDerivedProduct.collection"/>
<mustSupport value="true"/>
</element>
<element id="BiologicallyDerivedProduct.collection.extension">
<path value="BiologicallyDerivedProduct.collection.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
</element>
<element
id="BiologicallyDerivedProduct.collection.extension:donationIdentificationNumber">
<path value="BiologicallyDerivedProduct.collection.extension"/>
<sliceName value="donationIdentificationNumber"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-donationIdentificationNumber"/>
</type>
<mustSupport value="true"/>
</element>
<element id="BiologicallyDerivedProduct.processing">
<path value="BiologicallyDerivedProduct.processing"/>
<mustSupport value="true"/>
</element>
<element id="BiologicallyDerivedProduct.processing.procedure">
<path value="BiologicallyDerivedProduct.processing.procedure"/>
<mustSupport value="true"/>
</element>
</differential>
</StructureDefinition>
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#1.0.1 based on FHIR 4.0.1. Generated 2023-08-29
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