R6 Ballot (1st Draft)

This page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

8.31 Pattern Product - Content

FHIR Infrastructure iconMaturity Level: 1Informative

A pattern to be followed by resources that represent a product used in healthcare, for clinical or operational purposes.

8.31.1 Scope and Usage

This is NOT a resource. It is not part of the FHIR schema and cannot appear directly in FHIR instances. It is a logical model that defines a pattern adhered to by other resources. This pattern serves two purposes:

  • It offers guidance to work groups designing resources and helps ensure consistency of content created by different work groups
  • It provides a standard "view" that might be useful for implementers in processing and manipulating all resources that adhere to the same pattern. (Tooling that supports this may become available in a future release.)

A "Healthcare Product" represents any type of product, manufactured or not, regulated or not, that is used in healthcare, for clinical or operational purposes. The Product pattern provides an abstraction with the common characteristics of Healthcare Products.

Note to Implementers: The Product pattern is being developed. The committee is looking for feedback on this pattern as well as its applicability to the different product resources - Medication, Device, BiologicallyDerivedProduct, Substance, etc.

8.31.2 Boundaries and Relationships

The Product pattern is instantiated in resources like Medication, Device, etc., and it is used in requesting a product (xxxRequest resources), or reporting a delivery or a usage (xxxUsage resources), or in a procedure.

8.31.3 Background and Context

This model represents a pattern. It provides a standard list of data elements with cardinalities, data types, definitions, rationale and usage notes that will ideally be adhered to by resources that fall into the "product" workflow category. However, adherence to this pattern is not mandatory. Not all healthcare domains are the same. Concepts that may be generally applicable (and thus are included in this standard pattern) might still not be relevant everywhere or may be sufficiently uncommon that they are more appropriate to include as extensions than as core properties of the resource. Work groups are encouraged to adjust descriptions, usage notes and rationale to be specific to their resource. As well, design notes in the comments column marked with [square brackets] identifies areas where domain variation is expected and encouraged. Other variation, including differences in names, cardinalities, data types and the decision to omit an element outright are also possible, but should be discussed with the FHIR Infrastructure work group's Workflow project to ensure the rationale for non-alignment is understood, to confirm that the deviation is necessary and to identify whether any adjustments to the pattern are appropriate.

This pattern provides a linkage to the W5 list of standard data elements. Resources that adhere to this pattern should ensure their w5 mappings are consistent, as is their data element ordering.

8.31.4 References to this Pattern

No references for this Pattern.

8.31.5 Pattern Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. Product ILogicalProduct Pattern
... status ?!Σ1..1codeactive | inactive | entered-in-error
Binding: ProductStatus (Required)
... category Σ0..*CodeableConceptA category or class of the product

... code Σ0..1CodeableConceptA code designating a specific type of product
... instance 0..1BackboneElementOne or several physical instances or occurrences of the product
.... quantity 0..1SimpleQuantityThe amount of items
.... identifier 0..*IdentifierThe identifier for the physical instance, typically a serial number

.... lotNumber 0..1stringThe identification of the batch or lot of the product
.... expiry 0..1dateTimeThe expiry date or date and time for the product
.... subject Σ0..1Reference(Patient | Group)Individual the product is associated with, or which has used the product
... note 0..*AnnotationComments made about the product


doco Documentation for this format icon

UML Diagram (Legend)

Product (Base) «Pattern»The current state of the product (this element modifies the meaning of other elements)status : code [1..1] « Codes identifying the lifecycle stage of a product. (Strength=Required)ProductStatus! »A category of the product. For example drug class, or device type. A product can have one or several categories. The categories can be from an official / regulatory source, or internal categorization or classification schemes. Categories are useful in search and retrieval of products, or can be used for determining authorizations, e.g. who can order which kinds of productscategory : CodeableConcept [0..*]The code assigned to the product, for example a catalog number, Device DI, Drug Code or other. Can be an internally assigned or an official product code such as the manufacturer-assigned code. There may be different codes for a product, having different levels of granularity. For example "0123456789" corresponding to "CompuHyper GlobalMed, UltraImplantable 2.25 x 8 mm"code : CodeableConcept [0..1]The organisation (manufacturer, representative or legal authorization holder) that is responsible for the devicemanufacturer : Reference [0..*] « Organization »Comments made about the productnote : Annotation [0..*]InstanceFor products that represent a particular quantity of a substance or type of item, indicates how 'much' of the product (by weight, volume, count, etc.) is represented by this resource instancequantity : Quantity(SimpleQuantity) [0..1]The identifier for the physical instance, typically a serial numberidentifier : Identifier [0..*]The identification of the batch or lot of the productlotNumber : string [0..1]The time after which the product is no longer expected to be in proper condition, or its use is not advised or not allowedexpiry : dateTime [0..1]Individual the product is associated with, or which has used the productsubject : Reference [0..1] « Patient|Group »Conveys instance-level information about this product item. One or several physical, countable instances or occurrences of the productinstance[0..1]

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. Product ILogicalProduct Pattern
... status ?!Σ1..1codeactive | inactive | entered-in-error
Binding: ProductStatus (Required)
... category Σ0..*CodeableConceptA category or class of the product

... code Σ0..1CodeableConceptA code designating a specific type of product
... instance 0..1BackboneElementOne or several physical instances or occurrences of the product
.... quantity 0..1SimpleQuantityThe amount of items
.... identifier 0..*IdentifierThe identifier for the physical instance, typically a serial number

.... lotNumber 0..1stringThe identification of the batch or lot of the product
.... expiry 0..1dateTimeThe expiry date or date and time for the product
.... subject Σ0..1Reference(Patient | Group)Individual the product is associated with, or which has used the product
... note 0..*AnnotationComments made about the product


doco Documentation for this format icon

UML Diagram (Legend)

Product (Base) «Pattern»The current state of the product (this element modifies the meaning of other elements)status : code [1..1] « Codes identifying the lifecycle stage of a product. (Strength=Required)ProductStatus! »A category of the product. For example drug class, or device type. A product can have one or several categories. The categories can be from an official / regulatory source, or internal categorization or classification schemes. Categories are useful in search and retrieval of products, or can be used for determining authorizations, e.g. who can order which kinds of productscategory : CodeableConcept [0..*]The code assigned to the product, for example a catalog number, Device DI, Drug Code or other. Can be an internally assigned or an official product code such as the manufacturer-assigned code. There may be different codes for a product, having different levels of granularity. For example "0123456789" corresponding to "CompuHyper GlobalMed, UltraImplantable 2.25 x 8 mm"code : CodeableConcept [0..1]The organisation (manufacturer, representative or legal authorization holder) that is responsible for the devicemanufacturer : Reference [0..*] « Organization »Comments made about the productnote : Annotation [0..*]InstanceFor products that represent a particular quantity of a substance or type of item, indicates how 'much' of the product (by weight, volume, count, etc.) is represented by this resource instancequantity : Quantity(SimpleQuantity) [0..1]The identifier for the physical instance, typically a serial numberidentifier : Identifier [0..*]The identification of the batch or lot of the productlotNumber : string [0..1]The time after which the product is no longer expected to be in proper condition, or its use is not advised or not allowedexpiry : dateTime [0..1]Individual the product is associated with, or which has used the productsubject : Reference [0..1] « Patient|Group »Conveys instance-level information about this product item. One or several physical, countable instances or occurrences of the productinstance[0..1]

 

Alternate definitions: Master Definition XML + JSON.

8.31.5.1 Terminology Bindings

PathValueSetTypeDocumentation
Product.status ProductStatus Required

Codes identifying the lifecycle stage of a product.

8.31.6 Extensions

Not all resources that follow the 'Product' pattern will necessarily include all of the above elements.

8.31.7 Kind vs Instance

...

8.31.8 Product Defintions and specifications

8.31.8.1 Mappings

status category code manufacturer instance .quantity .identifier .lotNumber .expiry .subject note

Each non-grey cell contains a number, the number of elements and extensions (if > 0) mapped in the resource that are mapped to the pattern element in the column. If there are 0 elements and extensions, the number is not shown. In addition, the cell has a color and some character flags.

Colors:

  • Grey: the resource has no element or extension for the pattern element
  • White: the resource has an element that implements the pattern element with the same name
  • Yellow: the resource has a documented extension that implements the pattern element with the same name
  • Blue: the resource has an element that implements the pattern element with a different name
  • Red: the resource has an element that implements that pattern element, but the type or cardinality does not match

Flags:

  • E: pattern element implemented by an extension
  • N: pattern element implemented by an element with a different name
  • T: pattern element implemented by an element with a different type
  • C: pattern element implemented by an element with a different cardinality