OO Incubator Implementation Guide, published by HL7 International / Orders and Observations. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/oo-incubator/ and changes regularly. See the Directory of published versions
| Page standards status: Normative | Maturity Level: 1 |
Definitions for the medicalproductofhumanorigin resource profile
Guidance on how to interpret the contents of this table can be foundhere
| 0. BiologicallyDerivedProduct | |
| Definition | This profile is designed for biologically derived products that are derived from a human donor and intended for clinical application in a human recipient. Donor and recipient might, or might not, be the same individual. Products of this nature are referred to as medical products of human origin (MPHO) and have specific traceability requirements to ensure that the bi-directional link between donor and recipient is maintained. The profile specifies the essential identifiers for traceability as required elements. This resource reflects an instance of a biologically derived product. A material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity. |
| Short | Medical Product of Human Origin Profile This resource reflects an instance of a biologically derived product |
| Comments | Substances include, but are not limited to: whole blood, bone marrow, organs, and manipulated blood cells. |
| Control | 0..* |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists()) |
| 2. BiologicallyDerivedProduct.implicitRules | |
| Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. |
| Short | A set of rules under which this content was created |
| Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc. |
| Control | 0..1 |
| Type | uri |
| Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 4. BiologicallyDerivedProduct.contained | |
| Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
| Short | Contained, inline Resources |
| Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an additional resource. |
| Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
| Type | Resource |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Alternate Names | inline resources, anonymous resources, contained resources |
| 6. BiologicallyDerivedProduct.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
| Must Support | false |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 8. BiologicallyDerivedProduct.productCategory | |
| Definition | A category or classification of the product. Products may be assigned multiple categories, for example a human heart valve can be categorized as an 'MPHO' and 'tissue'. |
| Short | A category or classification of the product |
| Control | 10..* |
| Binding | For example codes, see BiologicallyDerivedProductCategoryhttp://hl7.org/fhir/ValueSet/product-category|6.0.0-ballot3 (example to http://hl7.org/fhir/ValueSet/product-category|6.0.0-ballot3)Biologically Derived Product Category. |
| Type | CodeableConcept |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on BiologicallyDerivedProduct.productCategory. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 10. BiologicallyDerivedProduct.productCategory:MPHOCode | |
| Slice Name | MPHOCode |
| Definition | A category or classification of the product. Products may be assigned multiple categories, for example a human heart valve can be categorized as an 'MPHO' and 'tissue'. |
| Short | A category or classification of the product |
| Control | 10..1* |
| Binding | For example codes, see BiologicallyDerivedProductCategoryhttp://hl7.org/fhir/ValueSet/product-category|6.0.0-ballot3 (example to http://hl7.org/fhir/ValueSet/product-category|6.0.0-ballot3)Biologically Derived Product Category. |
| Type | CodeableConcept |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Pattern Value | { |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 12. BiologicallyDerivedProduct.productCode | |
| Definition | A codified value that systematically supports characterization and classification of medical products of human origin inclusive of processing conditions such as additives, volumes and handling conditions. |
| Short | A code that identifies the kind of this biologically derived product |
| Control | 10..1 |
| Binding | For example codes, see BiologicallyDerivedProductCodeshttp://hl7.org/fhir/ValueSet/biologicallyderived-productcodes|6.0.0-ballot3 (example to http://hl7.org/fhir/ValueSet/biologicallyderived-productcodes|6.0.0-ballot3)Biologically-derived Product Codes |
| Type | CodeableConcept |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 14. BiologicallyDerivedProduct.productCode.coding | |
| Definition | A reference to a code defined by a terminology system. |
| Short | Code defined by a terminology system |
| Comments | Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
| Control | 10..* |
| Type | Coding |
| Is Modifier | false |
| Summary | false |
| Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 16. BiologicallyDerivedProduct.productCode.coding.system | |
| Definition | The identification of the code system that defines the meaning of the symbol in the code. |
| Short | Identity of the terminology system |
| Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
| Control | 10..1 |
| Type | uri |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | Need to be unambiguous about the source of the definition of the symbol. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 18. BiologicallyDerivedProduct.productCode.coding.code | |
| Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). |
| Short | Symbol in syntax defined by the system |
| Control | 10..1 This element is affected by the following invariants: cod-1 |
| Type | code |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | Need to refer to a particular code in the system. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 20. BiologicallyDerivedProduct.identifier | |
| Definition | Unique instance identifiers assigned to a biologically derived product. Note: This is a business identifier, not a resource identifier. |
| Short | Under most circumstances an MPHO will be uniquely identified using a single identifier from production to point of use. In some cases, a second identifier may be required (for example, import from another country that uses a different identification coding system). In these cases, both the original and new identifier must be included.Instance identifier |
| Comments | This identifier should uniquely identify the product instance in the business domain. Ideally it should be a globally unique identifier under the control of an ISO/IEC 15459 Issuing Agency. |
| Note | This is a business identifier, not a resource identifier (see discussion) |
| Control | 10..* |
| Type | Identifier |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 22. BiologicallyDerivedProduct.identifier.use | |
| Definition | The purpose of this identifier. |
| Short | usual | official | temp | secondary | old (If known) |
| Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
| Control | 0..1 |
| Binding | The codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|6.0.0-ballot3 (required to http://hl7.org/fhir/ValueSet/identifier-use|6.0.0-ballot3)Identifies the purpose for this identifier, if known . |
| Type | code |
| Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 24. BiologicallyDerivedProduct.identifier.system | |
| Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
| Short | Identity of the Issuing Agency responsible for the allocation of unique identifiersThe namespace for the identifier value |
| Comments | Identifier.system is always case sensitive. The FHIR specification, terminology.hl7.org and HL7 affiliates (for identifiers specific to their jurisdiction) define identifier systems that SHALL be used for certain types of identifiers. Specific rules can be found here. |
| Control | 10..1 |
| Type | uri |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. |
| Example | General: http://www.acme.com/identifiers/patient |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 26. BiologicallyDerivedProduct.identifier.value | |
| Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. |
| Short | Unique identifier of the MPHO itemThe value that is unique |
| Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. |
| Control | 10..1 This element is affected by the following invariants: ident-1 |
| Type | string |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Example | General: 123456 |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 28. BiologicallyDerivedProduct.biologicalSourceEvent | |
| Definition | An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled. |
| Short | An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled |
| Comments | Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier. |
| Control | 10..1 |
| Type | Identifier |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 30. BiologicallyDerivedProduct.biologicalSourceEvent.use | |
| Definition | The purpose of this identifier. |
| Short | usual | official | temp | secondary | old (If known) |
| Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
| Control | 0..1 |
| Binding | The codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|6.0.0-ballot3 (required to http://hl7.org/fhir/ValueSet/identifier-use|6.0.0-ballot3)Identifies the purpose for this identifier, if known . |
| Type | code |
| Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 32. BiologicallyDerivedProduct.biologicalSourceEvent.system | |
| Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
| Short | Identity of the Issuing Agency responsible for the allocation of unique identifiersThe namespace for the identifier value |
| Comments | Identifier.system is always case sensitive. The FHIR specification, terminology.hl7.org and HL7 affiliates (for identifiers specific to their jurisdiction) define identifier systems that SHALL be used for certain types of identifiers. Specific rules can be found here. |
| Control | 10..1 |
| Type | uri |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. |
| Example | General: http://www.acme.com/identifiers/patient |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 34. BiologicallyDerivedProduct.biologicalSourceEvent.value | |
| Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. |
| Short | Unique identifier of the donation, collection or pooling event from which the MPHO item was derivedThe value that is unique |
| Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. |
| Control | 10..1 This element is affected by the following invariants: ident-1 |
| Type | string |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Example | General: 123456 |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be foundhere
| 0. BiologicallyDerivedProduct | |
| Definition | This profile is designed for biologically derived products that are derived from a human donor and intended for clinical application in a human recipient. Donor and recipient might, or might not, be the same individual. Products of this nature are referred to as medical products of human origin (MPHO) and have specific traceability requirements to ensure that the bi-directional link between donor and recipient is maintained. The profile specifies the essential identifiers for traceability as required elements. |
| Short | Medical Product of Human Origin Profile |
| Control | 0..* |
| 2. BiologicallyDerivedProduct.productCategory | |
| Control | 1..? |
| Slicing | This element introduces a set of slices on BiologicallyDerivedProduct.productCategory. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 4. BiologicallyDerivedProduct.productCategory:MPHOCode | |
| Slice Name | MPHOCode |
| Control | 1..1 |
| Pattern Value | { |
| 6. BiologicallyDerivedProduct.productCode | |
| Control | 1..1 |
| 8. BiologicallyDerivedProduct.productCode.coding | |
| Control | 1..? |
| 10. BiologicallyDerivedProduct.productCode.coding.system | |
| Control | 1..1 |
| 12. BiologicallyDerivedProduct.productCode.coding.code | |
| Control | 1..1 |
| 14. BiologicallyDerivedProduct.identifier | |
| Short | Under most circumstances an MPHO will be uniquely identified using a single identifier from production to point of use. In some cases, a second identifier may be required (for example, import from another country that uses a different identification coding system). In these cases, both the original and new identifier must be included. |
| Note | This is a business identifier, not a resource identifier (see discussion) |
| Control | 1..? |
| 16. BiologicallyDerivedProduct.identifier.system | |
| Short | Identity of the Issuing Agency responsible for the allocation of unique identifiers |
| Control | 1..1 |
| 18. BiologicallyDerivedProduct.identifier.value | |
| Short | Unique identifier of the MPHO item |
| Control | 1..1 |
| 20. BiologicallyDerivedProduct.biologicalSourceEvent | |
| Control | 1..1 |
| 22. BiologicallyDerivedProduct.biologicalSourceEvent.system | |
| Short | Identity of the Issuing Agency responsible for the allocation of unique identifiers |
| Control | 1..1 |
| 24. BiologicallyDerivedProduct.biologicalSourceEvent.value | |
| Short | Unique identifier of the donation, collection or pooling event from which the MPHO item was derived |
| Control | 1..1 |
Guidance on how to interpret the contents of this table can be foundhere
| 0. BiologicallyDerivedProduct | |
| Definition | This profile is designed for biologically derived products that are derived from a human donor and intended for clinical application in a human recipient. Donor and recipient might, or might not, be the same individual. Products of this nature are referred to as medical products of human origin (MPHO) and have specific traceability requirements to ensure that the bi-directional link between donor and recipient is maintained. The profile specifies the essential identifiers for traceability as required elements. |
| Short | Medical Product of Human Origin Profile |
| Comments | Substances include, but are not limited to: whole blood, bone marrow, organs, and manipulated blood cells. |
| Control | 0..* |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource ( contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty())dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated ( contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())dom-5: If a resource is contained in another resource, it SHALL NOT have a security label ( contained.meta.security.empty())dom-6: A resource should have narrative for robust management ( text.`div`.exists()) |
| 2. BiologicallyDerivedProduct.id | |
| Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
| Short | Logical id of this artifact |
| Comments | Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case. |
| Control | 0..1 |
| Type | id |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| 4. BiologicallyDerivedProduct.meta | |
| Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. |
| Short | Metadata about the resource |
| Control | 0..1 |
| Type | Meta |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 6. BiologicallyDerivedProduct.implicitRules | |
| Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. |
| Short | A set of rules under which this content was created |
| Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc. |
| Control | 0..1 |
| Type | uri |
| Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 8. BiologicallyDerivedProduct.language | |
| Definition | The base language in which the resource is written. |
| Short | Language of the resource content |
| Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). |
| Control | 0..1 |
| Binding | The codes SHALL be taken from AllLanguages (required to http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot3)IETF language tag for a human language |
| Type | code |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 10. BiologicallyDerivedProduct.text | |
| Definition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. |
| Short | Text summary of the resource, for human interpretation |
| Comments | Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. |
| Control | 0..1 This element is affected by the following invariants: dom-6 |
| Type | Narrative |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Alternate Names | narrative, html, xhtml, display |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 12. BiologicallyDerivedProduct.contained | |
| Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
| Short | Contained, inline Resources |
| Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an additional resource. |
| Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
| Type | Resource |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Alternate Names | inline resources, anonymous resources, contained resources |
| 14. BiologicallyDerivedProduct.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 16. BiologicallyDerivedProduct.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
| Must Support | false |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 18. BiologicallyDerivedProduct.productCategory | |
| Definition | A category or classification of the product. Products may be assigned multiple categories, for example a human heart valve can be categorized as an 'MPHO' and 'tissue'. |
| Short | A category or classification of the product |
| Control | 1..* |
| Binding | For example codes, see BiologicallyDerivedProductCategory (example to http://hl7.org/fhir/ValueSet/product-category|6.0.0-ballot3)Biologically Derived Product Category. |
| Type | CodeableConcept |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on BiologicallyDerivedProduct.productCategory. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 20. BiologicallyDerivedProduct.productCategory:MPHOCode | |
| Slice Name | MPHOCode |
| Definition | A category or classification of the product. Products may be assigned multiple categories, for example a human heart valve can be categorized as an 'MPHO' and 'tissue'. |
| Short | A category or classification of the product |
| Control | 1..1 |
| Binding | For example codes, see BiologicallyDerivedProductCategory (example to http://hl7.org/fhir/ValueSet/product-category|6.0.0-ballot3)Biologically Derived Product Category. |
| Type | CodeableConcept |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Pattern Value | { |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 22. BiologicallyDerivedProduct.productCode | |
| Definition | A codified value that systematically supports characterization and classification of medical products of human origin inclusive of processing conditions such as additives, volumes and handling conditions. |
| Short | A code that identifies the kind of this biologically derived product |
| Control | 1..1 |
| Binding | For example codes, see BiologicallyDerivedProductCodes (example to http://hl7.org/fhir/ValueSet/biologicallyderived-productcodes|6.0.0-ballot3)Biologically-derived Product Codes |
| Type | CodeableConcept |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 24. BiologicallyDerivedProduct.productCode.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 26. BiologicallyDerivedProduct.productCode.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on BiologicallyDerivedProduct.productCode.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 28. BiologicallyDerivedProduct.productCode.coding | |
| Definition | A reference to a code defined by a terminology system. |
| Short | Code defined by a terminology system |
| Comments | Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
| Control | 1..* |
| Type | Coding |
| Is Modifier | false |
| Summary | false |
| Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 30. BiologicallyDerivedProduct.productCode.coding.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 32. BiologicallyDerivedProduct.productCode.coding.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on BiologicallyDerivedProduct.productCode.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 34. BiologicallyDerivedProduct.productCode.coding.system | |
| Definition | The identification of the code system that defines the meaning of the symbol in the code. |
| Short | Identity of the terminology system |
| Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | Need to be unambiguous about the source of the definition of the symbol. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 36. BiologicallyDerivedProduct.productCode.coding.version | |
| Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. |
| Short | Version of the system - if relevant |
| Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. |
| Note | This is a business version Id, not a resource version Id (see discussion) |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 38. BiologicallyDerivedProduct.productCode.coding.code | |
| Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). |
| Short | Symbol in syntax defined by the system |
| Control | 1..1 This element is affected by the following invariants: cod-1 |
| Type | code |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | Need to refer to a particular code in the system. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 40. BiologicallyDerivedProduct.productCode.coding.display | |
| Definition | A representation of the meaning of the code in the system, following the rules of the system. |
| Short | Representation defined by the system |
| Control | 0..1 This element is affected by the following invariants: cod-1 |
| Type | string |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 42. BiologicallyDerivedProduct.productCode.coding.userSelected | |
| Definition | Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). |
| Short | If this coding was chosen directly by the user |
| Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. |
| Control | 0..1 |
| Type | boolean |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 44. BiologicallyDerivedProduct.productCode.text | |
| Definition | A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. |
| Short | Plain text representation of the concept |
| Comments | Very often the text is the same as a displayName of one of the codings. |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 46. BiologicallyDerivedProduct.parent | |
| Definition | Parent product (if any) for this biologically-derived product. |
| Short | The parent biologically-derived product |
| Comments | 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. |
| Control | 0..* |
| Type | Reference(BiologicallyDerivedProduct) |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 48. BiologicallyDerivedProduct.request | |
| Definition | Request to obtain and/or infuse this biologically derived product. |
| Short | Request to obtain and/or infuse this product |
| Control | 0..* |
| Type | Reference(ServiceRequest) |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 50. BiologicallyDerivedProduct.identifier | |
| Definition | Unique instance identifiers assigned to a biologically derived product. Note: This is a business identifier, not a resource identifier. |
| Short | Under most circumstances an MPHO will be uniquely identified using a single identifier from production to point of use. In some cases, a second identifier may be required (for example, import from another country that uses a different identification coding system). In these cases, both the original and new identifier must be included. |
| Comments | This identifier should uniquely identify the product instance in the business domain. Ideally it should be a globally unique identifier under the control of an ISO/IEC 15459 Issuing Agency. |
| Note | This is a business identifier, not a resource identifier (see discussion) |
| Control | 1..* |
| Type | Identifier |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 52. BiologicallyDerivedProduct.identifier.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 54. BiologicallyDerivedProduct.identifier.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on BiologicallyDerivedProduct.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 56. BiologicallyDerivedProduct.identifier.use | |
| Definition | The purpose of this identifier. |
| Short | usual | official | temp | secondary | old (If known) |
| Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
| Control | 0..1 |
| Binding | The codes SHALL be taken from IdentifierUse (required to http://hl7.org/fhir/ValueSet/identifier-use|6.0.0-ballot3)Identifies the purpose for this identifier, if known . |
| Type | code |
| Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 58. BiologicallyDerivedProduct.identifier.type | |
| Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. |
| Short | Description of identifier |
| Comments | This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. |
| Control | 0..1 |
| Binding | Unless not suitable, these codes SHALL be taken from IdentifierTypeCodes (extensible to http://hl7.org/fhir/ValueSet/identifier-type|6.0.0-ballot3)A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| Type | CodeableConcept |
| Is Modifier | false |
| Summary | false |
| Requirements | Allows users to make use of identifiers when the identifier system is not known. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 60. BiologicallyDerivedProduct.identifier.system | |
| Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
| Short | Identity of the Issuing Agency responsible for the allocation of unique identifiers |
| Comments | Identifier.system is always case sensitive. The FHIR specification, terminology.hl7.org and HL7 affiliates (for identifiers specific to their jurisdiction) define identifier systems that SHALL be used for certain types of identifiers. Specific rules can be found here. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. |
| Example | General: http://www.acme.com/identifiers/patient |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 62. BiologicallyDerivedProduct.identifier.value | |
| Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. |
| Short | Unique identifier of the MPHO item |
| Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. |
| Control | 1..1 This element is affected by the following invariants: ident-1 |
| Type | string |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Example | General: 123456 |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 64. BiologicallyDerivedProduct.identifier.period | |
| Definition | Time period during which identifier is/was valid for use. |
| Short | Time period when id is/was valid for use |
| Control | 0..1 |
| Type | Period |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 66. BiologicallyDerivedProduct.identifier.assigner | |
| Definition | Organization that issued/manages the identifier. |
| Short | Organization that issued id (may be just text) |
| Comments | The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. |
| Control | 0..1 |
| Type | Reference(Organization) |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 68. BiologicallyDerivedProduct.biologicalSourceEvent | |
| Definition | An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled. |
| Short | An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled |
| Comments | Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier. |
| Control | 1..1 |
| Type | Identifier |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 70. BiologicallyDerivedProduct.biologicalSourceEvent.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 72. BiologicallyDerivedProduct.biologicalSourceEvent.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on BiologicallyDerivedProduct.biologicalSourceEvent.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 74. BiologicallyDerivedProduct.biologicalSourceEvent.use | |
| Definition | The purpose of this identifier. |
| Short | usual | official | temp | secondary | old (If known) |
| Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
| Control | 0..1 |
| Binding | The codes SHALL be taken from IdentifierUse (required to http://hl7.org/fhir/ValueSet/identifier-use|6.0.0-ballot3)Identifies the purpose for this identifier, if known . |
| Type | code |
| Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 76. BiologicallyDerivedProduct.biologicalSourceEvent.type | |
| Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. |
| Short | Description of identifier |
| Comments | This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. |
| Control | 0..1 |
| Binding | Unless not suitable, these codes SHALL be taken from IdentifierTypeCodes (extensible to http://hl7.org/fhir/ValueSet/identifier-type|6.0.0-ballot3)A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| Type | CodeableConcept |
| Is Modifier | false |
| Summary | false |
| Requirements | Allows users to make use of identifiers when the identifier system is not known. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 78. BiologicallyDerivedProduct.biologicalSourceEvent.system | |
| Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
| Short | Identity of the Issuing Agency responsible for the allocation of unique identifiers |
| Comments | Identifier.system is always case sensitive. The FHIR specification, terminology.hl7.org and HL7 affiliates (for identifiers specific to their jurisdiction) define identifier systems that SHALL be used for certain types of identifiers. Specific rules can be found here. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Requirements | There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. |
| Example | General: http://www.acme.com/identifiers/patient |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 80. BiologicallyDerivedProduct.biologicalSourceEvent.value | |
| Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. |
| Short | Unique identifier of the donation, collection or pooling event from which the MPHO item was derived |
| Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. |
| Control | 1..1 This element is affected by the following invariants: ident-1 |
| Type | string |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Example | General: 123456 |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 82. BiologicallyDerivedProduct.biologicalSourceEvent.period | |
| Definition | Time period during which identifier is/was valid for use. |
| Short | Time period when id is/was valid for use |
| Control | 0..1 |
| Type | Period |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 84. BiologicallyDerivedProduct.biologicalSourceEvent.assigner | |
| Definition | Organization that issued/manages the identifier. |
| Short | Organization that issued id (may be just text) |
| Comments | The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. |
| Control | 0..1 |
| Type | Reference(Organization) |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 86. BiologicallyDerivedProduct.processingFacility | |
| Definition | Processing facilities responsible for the labeling and distribution of this biologically derived product. |
| Short | Processing facilities responsible for the labeling and distribution of this biologically derived product |
| Control | 0..* |
| Type | Reference(Organization) |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 88. BiologicallyDerivedProduct.division | |
| Definition | A unique identifier for an aliquot of a product. Used to distinguish individual aliquots of a product carrying the same biologicalSource and productCode identifiers. |
| Short | A unique identifier for an aliquot of a product |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 90. BiologicallyDerivedProduct.productStatus | |
| Definition | The current status of the product. |
| Short | available | unavailable | processed | applied | discarded |
| Control | 0..1 |
| Binding | For example codes, see BiologicallyDerivedProductStatus (example to http://hl7.org/fhir/ValueSet/biologicallyderived-product-status|6.0.0-ballot3)Biologically Derived Product Status. |
| Type | Coding |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 92. BiologicallyDerivedProduct.expirationDate | |
| Definition | Date, and where relevant time, of expiration. |
| Short | Date, and where relevant time, of expiration |
| Control | 0..1 |
| Type | dateTime |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 94. BiologicallyDerivedProduct.collection | |
| Definition | How this product was collected. |
| Short | How this product was collected |
| Control | 0..1 |
| Type | BackboneElement |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count())) |
| 96. BiologicallyDerivedProduct.collection.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 98. BiologicallyDerivedProduct.collection.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 100. BiologicallyDerivedProduct.collection.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 102. BiologicallyDerivedProduct.collection.collector | |
| Definition | Healthcare professional who is performing the collection. |
| Short | Individual performing collection |
| Control | 0..1 |
| Type | Reference(Practitioner, PractitionerRole) |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 104. BiologicallyDerivedProduct.collection.source | |
| Definition | The patient or entity, such as a hospital or vendor in the case of a processed/manipulated/manufactured product, providing the product. |
| Short | The patient who underwent the medical procedure to collect the product or the organization that facilitated the collection |
| Control | 0..1 |
| Type | Reference(Patient, Organization) |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 106. BiologicallyDerivedProduct.collection.collected[x] | |
| Definition | Time of product collection. |
| Short | Time of product collection |
| Control | 0..1 |
| Type | Choice of: dateTime, Period |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 108. BiologicallyDerivedProduct.collection.procedure | |
| Definition | The procedure performed to collect the biologically derived product. |
| Short | The procedure involved in the collection |
| Control | 0..1 |
| Type | Reference(Procedure) |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 110. BiologicallyDerivedProduct.storageTempRequirements | |
| Definition | The temperature requirements for storage of the biologically-derived product. |
| Short | Product storage temperature requirements |
| Comments | May be extracted from information held in the Product Description Code. |
| Control | 0..1 |
| Type | Range |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 112. BiologicallyDerivedProduct.property | |
| Definition | A property that is specific to this BiologicallyDerviedProduct instance. |
| Short | A property that is specific to this BiologicallyDerviedProduct instance |
| Comments | Property can be used to provide information on a wide range of additional information specific to a particular biologicallyDerivedProduct. |
| Control | 0..* |
| Type | BackboneElement |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count())) |
| 114. BiologicallyDerivedProduct.property.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 116. BiologicallyDerivedProduct.property.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 118. BiologicallyDerivedProduct.property.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 120. BiologicallyDerivedProduct.property.type | |
| Definition | Code that specifies the property. It should reference an established coding system. |
| Short | Code that specifies the property |
| Comments | The element is identified by name and system URI in the type. Some types may have multiple occurrences. |
| Control | 1..1 |
| Binding | For example codes, see BiologicallyDerivedProductPropertyTypeCodes (example to http://hl7.org/fhir/ValueSet/biologicallyderived-product-property-type-codes|6.0.0-ballot3)Biologically Derived Product Property Type Codes |
| Type | CodeableConcept |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 122. BiologicallyDerivedProduct.property.value[x] | |
| Definition | Property values. |
| Short | Property values |
| Comments | The value should be provided as a boolean, integer, CodeableConcept, period, quantity, range, ratio, or attachment. The description can be a string only when these others are not available. The type of value will depend on the property type and is specified in ST-027. |
| Control | 1..1 |
| Type | Choice of: boolean, integer, CodeableConcept, Period, Quantity, Range, Ratio, string, Attachment |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |