R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

2.44 Resource ItemInstance - Content

Orders and Observations

Work Group

Maturity Level: 0

Trial Use

Compartments: Patient

A physical, countable instance of an item, for example one box or one unit.

2.44.1 Scope and Usage

This resource has not yet undergone proper review by the appropriate Workgroups. At this time, is considered only as a draft resource proposal for potential submission

Different resources have different ways to handle “physical instances”

Lack of clear support and guidance for instance has caused traceability to be a problem in implementations: Standards-guided implementations do not consider “instances” or do so inconsistently.
In border cases (medication containing devices), this can cause issues.
Inconsistency can also require extensions and further divergence. E.g. for adopting the EU Serialization directive, need to add “serial number” to the medication. What and where is that extension?

If the resources that represent physical entities were split into a "kind" resource and an "instance" resource, this resource would represent the instance that would be referenced by the "kind" resource. For example, Device would be split into Device ( representing the kind or type of Device ) + ItemInstance ( representing the instance of a Device ).

Resources impacted:

Substance
Medication
Device

Structure

Name	Flags	Card.	Type	Description & Constraints
ItemInstance	Σ TU		DomainResource	A physical instance of an item Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
count	Σ	1..1	integer	The count of items
location	Σ	0..1	Reference(Location)	The physical location of the item
subject	Σ	0..1	Reference(Patient)	The patient that the item is affixed to
manufactureDate	Σ	0..1	dateTime	The manufacture or preparation date and time
expiryDate	Σ	0..1	dateTime	The expiry or preparation date and time
currentSWVersion	Σ	0..1	string	The Software version associated with the device
lotNumber	Σ	0..1	string	The lot or batch number
serialNumber	Σ	0..1	string	The serial number if available
carrierAIDC	Σ	0..1	string	The machine-readable AIDC string in base64 encoding
carrierHRF	Σ	0..1	string	The human-readable barcode string
Documentation for this format

UML Diagram (Legend)

XML Template

<ItemInstance xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <count value="[integer]"/><!-- 1..1 The count of items -->
 <location><!-- 0..1 Reference(Location) The physical location of the item --></location>
 <subject><!-- 0..1 Reference(Patient) The patient that the item is affixed to --></subject>
 <manufactureDate value="[dateTime]"/><!-- 0..1 The manufacture or preparation date and time -->
 <expiryDate value="[dateTime]"/><!-- 0..1 The expiry or preparation date and time -->
 <currentSWVersion value="[string]"/><!-- 0..1 The Software version associated with the device -->
 <lotNumber value="[string]"/><!-- 0..1 The lot or batch number -->
 <serialNumber value="[string]"/><!-- 0..1 The serial number if available -->
 <carrierAIDC value="[string]"/><!-- 0..1 The machine-readable AIDC string in base64 encoding -->
 <carrierHRF value="[string]"/><!-- 0..1 The human-readable barcode string -->
</ItemInstance>

JSON Template

{
  "resourceType" : "ItemInstance",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "count" : <integer>, // R!  The count of items
  "location" : { Reference(Location) }, // The physical location of the item
  "subject" : { Reference(Patient) }, // The patient that the item is affixed to
  "manufactureDate" : "<dateTime>", // The manufacture or preparation date and time
  "expiryDate" : "<dateTime>", // The expiry or preparation date and time
  "currentSWVersion" : "<string>", // The Software version associated with the device
  "lotNumber" : "<string>", // The lot or batch number
  "serialNumber" : "<string>", // The serial number if available
  "carrierAIDC" : "<string>", // The machine-readable AIDC string in base64 encoding
  "carrierHRF" : "<string>" // The human-readable barcode string
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:ItemInstance;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:ItemInstance.count [ integer ]; # 1..1 The count of items
  fhir:ItemInstance.location [ Reference(Location) ]; # 0..1 The physical location of the item
  fhir:ItemInstance.subject [ Reference(Patient) ]; # 0..1 The patient that the item is affixed to
  fhir:ItemInstance.manufactureDate [ dateTime ]; # 0..1 The manufacture or preparation date and time
  fhir:ItemInstance.expiryDate [ dateTime ]; # 0..1 The expiry or preparation date and time
  fhir:ItemInstance.currentSWVersion [ string ]; # 0..1 The Software version associated with the device
  fhir:ItemInstance.lotNumber [ string ]; # 0..1 The lot or batch number
  fhir:ItemInstance.serialNumber [ string ]; # 0..1 The serial number if available
  fhir:ItemInstance.carrierAIDC [ string ]; # 0..1 The machine-readable AIDC string in base64 encoding
  fhir:ItemInstance.carrierHRF [ string ]; # 0..1 The human-readable barcode string
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = Not Mapped)

Structure

Name	Flags	Card.	Type	Description & Constraints
ItemInstance	Σ TU		DomainResource	A physical instance of an item Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
count	Σ	1..1	integer	The count of items
location	Σ	0..1	Reference(Location)	The physical location of the item
subject	Σ	0..1	Reference(Patient)	The patient that the item is affixed to
manufactureDate	Σ	0..1	dateTime	The manufacture or preparation date and time
expiryDate	Σ	0..1	dateTime	The expiry or preparation date and time
currentSWVersion	Σ	0..1	string	The Software version associated with the device
lotNumber	Σ	0..1	string	The lot or batch number
serialNumber	Σ	0..1	string	The serial number if available
carrierAIDC	Σ	0..1	string	The machine-readable AIDC string in base64 encoding
carrierHRF	Σ	0..1	string	The human-readable barcode string
Documentation for this format

UML Diagram (Legend)

XML Template

<ItemInstance xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <count value="[integer]"/><!-- 1..1 The count of items -->
 <location><!-- 0..1 Reference(Location) The physical location of the item --></location>
 <subject><!-- 0..1 Reference(Patient) The patient that the item is affixed to --></subject>
 <manufactureDate value="[dateTime]"/><!-- 0..1 The manufacture or preparation date and time -->
 <expiryDate value="[dateTime]"/><!-- 0..1 The expiry or preparation date and time -->
 <currentSWVersion value="[string]"/><!-- 0..1 The Software version associated with the device -->
 <lotNumber value="[string]"/><!-- 0..1 The lot or batch number -->
 <serialNumber value="[string]"/><!-- 0..1 The serial number if available -->
 <carrierAIDC value="[string]"/><!-- 0..1 The machine-readable AIDC string in base64 encoding -->
 <carrierHRF value="[string]"/><!-- 0..1 The human-readable barcode string -->
</ItemInstance>

JSON Template

{
  "resourceType" : "ItemInstance",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "count" : <integer>, // R!  The count of items
  "location" : { Reference(Location) }, // The physical location of the item
  "subject" : { Reference(Patient) }, // The patient that the item is affixed to
  "manufactureDate" : "<dateTime>", // The manufacture or preparation date and time
  "expiryDate" : "<dateTime>", // The expiry or preparation date and time
  "currentSWVersion" : "<string>", // The Software version associated with the device
  "lotNumber" : "<string>", // The lot or batch number
  "serialNumber" : "<string>", // The serial number if available
  "carrierAIDC" : "<string>", // The machine-readable AIDC string in base64 encoding
  "carrierHRF" : "<string>" // The human-readable barcode string
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:ItemInstance;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:ItemInstance.count [ integer ]; # 1..1 The count of items
  fhir:ItemInstance.location [ Reference(Location) ]; # 0..1 The physical location of the item
  fhir:ItemInstance.subject [ Reference(Patient) ]; # 0..1 The patient that the item is affixed to
  fhir:ItemInstance.manufactureDate [ dateTime ]; # 0..1 The manufacture or preparation date and time
  fhir:ItemInstance.expiryDate [ dateTime ]; # 0..1 The expiry or preparation date and time
  fhir:ItemInstance.currentSWVersion [ string ]; # 0..1 The Software version associated with the device
  fhir:ItemInstance.lotNumber [ string ]; # 0..1 The lot or batch number
  fhir:ItemInstance.serialNumber [ string ]; # 0..1 The serial number if available
  fhir:ItemInstance.carrierAIDC [ string ]; # 0..1 The machine-readable AIDC string in base64 encoding
  fhir:ItemInstance.carrierHRF [ string ]; # 0..1 The human-readable barcode string
]

Changes since Release 3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = Not Mapped)

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis

2.44.3 Search Parameters

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name	Type	Description	Expression	In Common
subject	reference	The identifier of the patient who has devices assigned to	ItemInstance.subject (Patient)