Difference between revisions of "Immunization Registry Content"

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===Open Issues===
 
===Open Issues===
 
Public comment is solicited on all of the following issues:
 
Public comment is solicited on all of the following issues:
# In preparation for the development of this profile, the compatibility of HL7 Version 3 POIZ and CareRecord were analyzed.  The standards were found to be highly compatible.  A few differences were identified and referred back to the HL7 Public Health and Emergency Response (PHER) Work Group for resolution through comments on both Draft Standards for Trial Use (DSTU).  The approach taken in the Immunization Content (IC) Profile is to update the current PCC-2 Immunization Summary template to contain all the fields in POIZ that are also supported in CareRecord.  The updated template is the equivalent of a POIZ template on CareRecord.  This update needs to be completed by the appropriate means.
+
# In preparation for the development of this profile, the compatibility of HL7 Version 3 POIZ and CareRecord were analyzed.  The standards were found to be highly compatible.  A few differences were identified and referred back to the HL7 Public Health and Emergency Response (PHER) Work Group for resolution through comments on both Draft Standards for Trial Use (DSTU).  The approach taken in the Immunization Content (IC) Profile is to update the current PCC-2 Immunization Summary template to contain all the fields in POIZ that are also supported in CareRecord.  Template for Immunizations needs to be fixed to include Lot #, Manufacturer, and Expiration Date, and a few other items.  The updated template is the equivalent of a POIZ template on CareRecord.  This update needs to be completed by the appropriate means.
 +
# Template for Advanced Directives needs to be fixed to include Immunization Refusal Reasons.
 
# It is expected that ballot comments on the CareRecord DSTU within HL7 will include requests to add elements available in POIZ but not accommodated in CareRecord.  Assuming those elements are eventually added, this IC profile will have to be updated to also include them.
 
# It is expected that ballot comments on the CareRecord DSTU within HL7 will include requests to add elements available in POIZ but not accommodated in CareRecord.  Assuming those elements are eventually added, this IC profile will have to be updated to also include them.
# Not enough is said about precisely how the HL7 Version 2 messages are to be used.  HL7 Version 2 couples content more tightly with message syntax than Verion 3.  Care Management (CM) provides the notification-based integration profile, and Query for Existing Data (QED) provides a query-based integration profile for the HL7 V3 portions of this profile.  However, it is unclear how CM and QED will handle V2.   
+
# Not enough is said about precisely how the HL7 Version 2 messages are to be used.  HL7 Version 2 couples content more tightly with message syntax than Verion 3.  Care Management (CM) provides the notification-based integration profile, and Query for Existing Data (QED) provides a query-based integration profile for the HL7 V3 portions of this profile.  However, it is unclear how CM and QED will handle V2.   V2.3.1 messages blend identity resolution, which is outside the scope of this profile, with transmission of clinical data; how will this be handled? Also, if a Version 2 Implementation Guide is referenced, how will updates to that document be handled?
 
# This IC profile contains three options for each actor.  This has been thought to be problematic because two systems implementing different options may not be able to communicate.  Another approach would be to break this profile into two or even three profiles, i.e. , one for HL7 Version 2, and one or two for HL7 Version 3 (depending upon whether the Immunization Summary and Care Record options are combined).
 
# This IC profile contains three options for each actor.  This has been thought to be problematic because two systems implementing different options may not be able to communicate.  Another approach would be to break this profile into two or even three profiles, i.e. , one for HL7 Version 2, and one or two for HL7 Version 3 (depending upon whether the Immunization Summary and Care Record options are combined).
 
# Implementation of this profile within PCC Volumes I and II will involve a two-part exercises:  (1) update of the existing PCC-2 Immunization Summary template to reflect missing POIZ fields; and (2) creation of a new profile for the Care Record Option that includes Allergies, Problems, etc. - something that looks more like a discharge summary or a transfer of care summary, etc.
 
# Implementation of this profile within PCC Volumes I and II will involve a two-part exercises:  (1) update of the existing PCC-2 Immunization Summary template to reflect missing POIZ fields; and (2) creation of a new profile for the Care Record Option that includes Allergies, Problems, etc. - something that looks more like a discharge summary or a transfer of care summary, etc.
 
# We assume we can use the Simple Observation template of Care Record to record Vaccine Information Statement Given (VIS Given) and VIS Version fields.  Is this the best approach?
 
# We assume we can use the Simple Observation template of Care Record to record Vaccine Information Statement Given (VIS Given) and VIS Version fields.  Is this the best approach?
  
===Notes to Author/Editor (do not include in final drafts)===
+
 
# V2.3.1 messages blend identity resolution with transmission of clinical data.  Profiles such as QED and CM do not handle identity management; this is the purview of PIX and PDQ.  How then is this aspect of HL7 Version 2.3.1 to be handled?
+
# Note that HL7 "V2" below refers to "V2.3.1".  Note that an implementation guide for HL7 V2.5 is also under development in the U.S. Centers for Disease Control (CDC).
+
# Address how to handle updates to referenced V2 Guides.
+
# Template for Advanced Directives needs to be fixed to include Immunization Refusal Reasons.
+
# Template for Immunizations needs to be fixed to include Lot #, Manufacturer, and Expiration Date.
+
  
 
===Closed Issues===  
 
===Closed Issues===  
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===Dependencies===
 
===Dependencies===
 
<pre>Add the following row(s) to the list of dependencies</pre>
 
<pre>Add the following row(s) to the list of dependencies</pre>
{|style='background-color:#7f7f7f;' align='center' border='1' cellspacing='0'
+
{{T|Integration Profile|Dependency|Dependency Type|Purpose|Rows=
!Integration Profile
+
{{R|Immunization Content (IC)|Care Management (CM)|The Content Creator actor of the IC profile must be grouped with the Clinical Data Source Actor of the CM profile|The IC profile defines the content sent in the PCC-11 transaction specified in the CM profile}}
!Dependency
+
{{R|Immunization Content (IC)|Care Management (CM)|The Content Consumer actor of the IC profile must be grouped with the Care Manager Actor of the CM profile|The IC profile defines the content recieved in the PCC-11 transaction specified in the CM profile}}
!Dependency Type
+
{{R|Immunization Content (IC)|ATNA|Actors the IC profile shall implement the Secure Node Actor of the ATNA profile|Ensures that transmissions and changes to patient health information are logged in an audit repository, and that communication is secured between nodes.}}
!Purpose
+
{{R|Immunization Content (IC)|ATNA|Actors the IC profile shall implement the Time Client Actor of the CT profile|Ensures that concistent time is used in all messages.}}
|- style='background-color:#ffffff;' align='center'
+
}}
|Immunization Content
+
|ATNA
+
 
+
CT
+
|
+
|
+
|-
+
|}
+
  
 
==The Immunization Content Profile (IC)==
 
==The Immunization Content Profile (IC)==
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The following progression of use cases is illustrated in the drawing below.
 
The following progression of use cases is illustrated in the drawing below.
  
{{Fixme|insert Drawing for Public Comment here}}
 
 
====Use Case 1:  Immunization Information System Participation====
 
====Use Case 1:  Immunization Information System Participation====
 
Various provider organizations - airport flu shot clinics, storefront vaccine clinics, and hospital vaccine clinics - wish to submit immunization histories for patients to a regional Immunization Information System (IIS) with appropriate patient consent.  The provider IT departments configure HL7 Verion 2.3.1 connections with the IIS.  Each time immunizations are recorded, records of the administered vaccines are automatically sent to the IIS using an HL7 version 2.3.1 standard format.
 
Various provider organizations - airport flu shot clinics, storefront vaccine clinics, and hospital vaccine clinics - wish to submit immunization histories for patients to a regional Immunization Information System (IIS) with appropriate patient consent.  The provider IT departments configure HL7 Verion 2.3.1 connections with the IIS.  Each time immunizations are recorded, records of the administered vaccines are automatically sent to the IIS using an HL7 version 2.3.1 standard format.
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!Actor
 
!Actor
 
!Option
 
!Option
!Section
 
 
|+Immunization Content Options
 
|+Immunization Content Options
 
|- style='background-color:#ffffff;' align='center'
 
|- style='background-color:#ffffff;' align='center'
 
|Content Consumer
 
|Content Consumer
|Immunization Summary Option [[#note1|(1)]]<br/>
+
|No Options Defined
Care Record Option [[#note1|(1)]]<br/>
+
HL7 V2 Option [[#note1|(1)]]<br/>
+
|PCC TF-1: X.X.X<br/>
+
PCC TF-1: X.X.X<br/>
+
PCC TF-1: X.X.X
+
 
|- style='background-color:#ffffff;' align='center'
 
|- style='background-color:#ffffff;' align='center'
 
|Content Creator  
 
|Content Creator  
 
|Immunization Summary Option [[#note1|(1)]]<br/>
 
|Immunization Summary Option [[#note1|(1)]]<br/>
Care Record Option [[#note1|(1)]]<br/>
+
Immunization Detail Option [[#note1|(1)]]<br/>
HL7 V2 Option [[#note1|(1)]]<br/>
+
V2 Immunization Update Option [[#note1|(1)]]<br/>
|PCC TF-1: X.X.X<br/>
+
PCC TF-1: X.X.X<br/>
+
PCC TF-1: X.X.X
+
 
|}
 
|}
  
Line 115: Line 93:
 
==== Immunization Summary Option ====
 
==== Immunization Summary Option ====
 
The Immunization Summary Option is based upon HL7 Version 3.  It includes information about immunization history of a patient.
 
The Immunization Summary Option is based upon HL7 Version 3.  It includes information about immunization history of a patient.
==== Care Record Option ====
+
==== Immunization Detail Option ====
The Care Record is also based upon HL7 Version 3.  It includes all of the requirements of the Immunization Summary Option, plus ancillary information to support decisions about the treatment of a patient related to immunizations.  For example, it includes the patient's allergies, which may be relevant in deciding whether or not to give certain vaccines.
+
The Immunization Detail Option is also based upon HL7 Version 3.  It includes all of the requirements of the Immunization Summary Option, plus ancillary information to support decisions about the treatment of a patient related to immunizations.  For example, it includes the patient's allergies, which may be relevant in deciding whether or not to give certain vaccines.
==== Hl7 V2 Option ====
+
==== V2 Immunization Update Option ====
The HL7 V2 Option is for backwards compatibility with existing HL7 Version 2 immunization messaging.
+
The V2 Immunization Update Option is for backwards compatibility with existing HL7 Version 2.3.1 immunization messaging.
 
+
Note that HL7 "V2" refers to "V2.3.1".  Note that at this writing, an implementation guide for HL7 V2.5 is also under development in the U.S. Centers for Disease Control (CDC).
+
 
+
=Volume II=
+
==Immunization Content==
+
Immunization Content (IC) draws from two HL7 Version 3 message standards - Immunizations and Care Provision - and from one HL7 Version 2 standard.
+
 
+
Immunizations contains a message information model which handles detailed immunization information only. It includes history of administered vaccines with such details as lot number, who administered the shot, and so forth. The Immunization Summary Option of IC is based upon the PCC-2 Immunization Summary template, with additions to harmonize it with the HL7 Version 3 Immunizations standard (POIZ). 
+
 
+
Care Provision contains a message information model (Care Record) which handles immunizations as well as other information related to the patient's care. For example, it includes medical history, medications, allergies, vital signs, and so forth.  The PCC-2 Immunization Summary is contained within Care Record.  The Care Record Option of IC is based upon a new template which includes existing PCC-2 Care Record templates, plus the enhanced PCC-2 Immunization Summary template of the Immunization Summary Option. 
+
 
+
To provide for compatibility with the U.S. installed base of Immunization Information Systems (IISs), an HL7 Version 2.3.1 content option is also included.  The HL7 V2 Option is entirely based upon the Implementation Guide for Immunization Data Transactions Using V 2.3.1 of the Health Level Seven (HL7) Standard Protocol, referenced in Standards below.  All document specification, data elements specification, and sample messages for HL7 V2 Option are as described in that Implementation Guide.
+
=== Standards ===
+
 
+
; [http://www.hl7.org/v3ballot/html/welcome/environment/index.htm HL7 V3 Immunizations (Click on Universal Domains, Immunizations) ] : HL7 Version 3 Standard: Immunization, Release 1 DSTU Ballot 3 - May 2008
+
; [http://www.hl7.org/v3ballot/html/welcome/environment/index.htm HL7 V3 Care Provision (Click on Universal Domains, Care Provision)] : HL7 Version 3 Standard: Care Provision, Release 1  Last Ballot: DSTU Ballot 3 - September 2007
+
; [http://www.cdc.gov/vaccines/programs/iis/stds/downloads/hl7guide.pdf Implementation Guide for Immunization Data Transactions Using V 2.3.1 of the Health Level Seven (HL7) Standard Protocol] : Implementation Guide for Immunization Data Transactions Using V 2.3.1 of the Health Level Seven (HL7) Standard Protocol.
+
 
+
=== Data Element Index ===
+
====Immunization Summary Option====
+
The table below gives the data elements to be used in the Immunization Summary Option.  It shows the mapping between HL7 Version 3 Care Provision (CareRecord) and HL7 Version 3 Immunizations (POIZ) messages.  The table shows where one standard has elements that are unavailable in the other. 
+
 
+
In this profile, CareRecord tags are used in the message definition.  The mapping here is given to show that most elements in POIZ are also included.  In the future, if and when missing POIZ elements are added to CareRecord, this profile may be also updated to include them.
+
 
+
{| cellspacing=0 border=1 align='center'
+
!style='background-color:#cfcfcf' |Data Elements
+
!style='background-color:#cfcfcf' |Element from Care Record Root
+
!style='background-color:#cfcfcf' |Element from POIZ Root
+
!style='background-color:#cfcfcf' |Other Reference
+
|-
+
| '''Patient Elements for Immunization Content'''|| || ||
+
|-
+
|Patient ID ||patient.id||subject.id||not required for Vaccine Decision Support
+
|-
+
|DOB ||patient.birthTime||subject.birthTime ||only required for Vaccine Decision Support
+
|-
+
|Gender ||patient.administrativeGender||subject.administrativeGender||only required for Vaccine Decision Support
+
|-
+
| || || ||
+
|-
+
|'''History of Immunizations'''|| || ||
+
|-
+
|Immunization Record ID ||id  ||id || instance identifier
+
|-
+
|Negation Indicator ||negationInd ||negationInd  ||
+
|-
+
|Description ||text ||text  ||
+
|-
+
|Immunization Date ||effectiveTime ||effectiveTime  ||
+
|-
+
|Confidentiality Code || ||confidentialityCode  || not defined in Care Record
+
|-
+
|Uncertainty Code ||||uncertaintyCode  || not defined in Care Record
+
|-
+
|Dose Quantity ||doseQuantity.value - units||doseQuantity.value - units ||
+
|-
+
|Route ||routeCode ||routeCode  ||
+
|-
+
|Approach Site ||approachSiteCode ||approachSiteCode  ||
+
|-
+
|Vaccine Code ||consumable. administerableMaterial. administerableMaterial. code||consumable. administerableMedication. administerableMedicine. code || CDC CVX code in US
+
|-
+
|Vaccine Name ||consumable. administerableMaterial. administerableMaterial. name ||consumable. administerableMedication. administerableMedicine. name||
+
|-
+
|Vaccine Lot # ||consumable. administerableMaterial. administerableMaterial. lotNumberText||consumable. administerableMedication. administerableMedicine. lotNumberText || 
+
|-
+
|Vaccine Expiration Date ||consumable. administerableMaterial. administerableMaterial. expirationTime ||consumable. administerableMedication. administerableMedicine. expirationTime  ||
+
|-
+
|Manufacturer ID ||consumable. administerableMaterial. administerableMaterial. asMedicineManufacturer. manufacturer.id ||consumable. administerableMedication. administerableMedicine. asMedicineManufacturer. manufacturer.id  || CDC MVX code in US 
+
|-
+
|Manufacturer name ||consumable. administerableMaterial. administerableMaterial. asMedicineManufacturer. manufacturer. name ||consumable. administerableMedication. administerableMedicine. asMedicineManufacturer. manufacturer. name  || 
+
|-
+
|Vaccine Lot # Recalled Effective Date ||consumable. administerableMaterial. administerableMaterial. asMedicineManufacturer. entryRelationship. observation. effectiveTime||consumable. administerableMedication. administerableMedicine. asMedicineManufacturer. entryRelationship. observation. effectiveTime  || Date Recall was effective
+
|-
+
|Vaccine Lot # Recalled Code ||consumable. administerableMaterial. administerableMaterial. asMedicineManufacturer. entryRelationship. observation. code||consumable. administerableMedication. administerableMedicine. asMedicineManufacturer. entryRelationship. observation. code||SNOMED code for vaccine recalled
+
|-
+
|Vaccine Lot # Recalled Noted Time ||consumable. administerableMaterial. administerableMaterial. asMedicineManufacturer. entryRelationship. observation. value||consumable. administerableMedication. administerableMedicine. asMedicineManufacturer. entryRelationship. observation. value||Date Recall was noted
+
|-
+
|Adverse Event ||entryRelationship. observation. code ||entryRelationship. observation. code || 6.4.4.15.8 - Observation w/SNOMED code
+
|-
+
|Adverse Event Time ||entryRelationship. observation. effectiveTime||entryRelationship. observation. effectiveTime|| 6.4.4.15.8
+
|-
+
|Adverse Event Severity||entryRelationship. observation. entryRelationship. observation. code||entryRelationship. observation. entryRelationship. observation. code|| 6.4.4.15.8
+
|-
+
|Performer ID ||performer. assignedEntity. id ||performer. assignedEntity. id ||
+
|-
+
|Performer Name ||performer. assignedEntity. assignedPerson. name ||performer. assignedEntity. assignedPerson. name ||
+
|-
+
|Performer Organization ID ||performer. assignedPerson. representedOrganization. id ||performer. assignedPerson. representedOrganization. id ||
+
|-
+
|Performer Organization Name ||performer. assignedPerson. representedOrganization. name ||performer. assignedPerson. representedOrganization. name ||
+
|-
+
|Author ID ||author. assignedEntity. id ||author. assignedEntity. id ||
+
|-
+
|Author Name ||author. assignedEntity. assignedPerson. name ||author. assignedEntity. assignedPerson. name ||
+
|-
+
|Informant Name ||informant. assignedEntity. assignedPerson. name ||informant. assignedEntity. assignedPerson. name ||
+
|-
+
|Informant Mode ||||informant. modeCode || written/verbal/electronic
+
|-
+
|Informant Source ||||informant. informationSource. code || patient/relative/provider
+
|-
+
|Informant Name||informant. relatedEntity. assignedPerson. name|| || Care Record also defines options for informant by electronic data transfer
+
|-
+
|Reason Not Administered || ||reason. noImmunizationReason. reasonCode ||
+
|-
+
|Vaccine Information Statement Given ||observation. code ||observation. code ||
+
|-
+
|VIS Version ||observation. value ||observation. value ||
+
|-
+
|Shot Comments / Notes ||annotation. text ||annotation. text ||
+
|}
+
<br>
+
====Care Record Option====
+
The Care Record Option includes additional data elements from existing PCC-2 templates.  This table shows the additional existing templates that are included, along with the Immunization Summary data elements, in the Care Record Option.
+
{| cellspacing=0 border=1 align='center'
+
!style='background-color:#cfcfcf' |Data Elements
+
!style='background-color:#cfcfcf' |Other Reference
+
!style='background-color:#cfcfcf' |Care Record Element
+
|-
+
| || ||
+
|-
+
| '''Existing Problem Record Data Elements''' || use as-is||templateId=1.3.6.1.4.1.19376.1.5.3.1.4.5
+
|-
+
| || || 
+
|-
+
|'''Existing Allergy and Intolerance Data Elements'''|| use as-is||templateId= 1.3.6.1.4.1.19376.1.5.3.1.4.6
+
|-
+
|Allergen Substance || substance causing allergy (allergy to eggs must be noted) ||intolerances.participant.code 
+
|-
+
|Allergic Reaction History || ||intolerances.reactions
+
|-
+
|Severity || ||intolerances.severity
+
|-
+
|Clinical Status || ||intolerances.clinicalStatus
+
|-
+
|Comments || ||intolerances.comments
+
|-
+
| || || 
+
|-
+
|'''Existing Medications Data Elements'''|| use as-is||templateId= 1.3.6.1.4.1.19376.1.5.3.1.4.7
+
|-
+
| || || 
+
|-
+
|'''Existing Simple Observations for Labs'''|| use as-is||templateId= 1.3.6.1.4.1.19376.1.5.3.1.4.13
+
|-
+
| || || 
+
|-
+
|'''Existing Vital Signs Data Elements'''|| use as-is||templateId= 1.3.6.1.4.1.19376.1.5.3.1.4.13.1 templateId= 1.3.6.1.4.1.19376.1.5.3.1.4.13.2
+
|-
+
|Observation Code || LOINC: 8310-5 body temp (must be noted if reason for not immunizing) ||vitalSigns.code 
+
|-
+
|Observation Value - Units || ||vitalSigns.value
+
|-
+
| || || 
+
|-
+
|'''Existing Pregnancy Data Elements'''|| use as-is||templateId= 1.3.6.1.4.1.19376.1.5.3.1.4.13.5
+
|-
+
| || || 
+
|-
+
|'''Existing Advanced Directives Data Elements'''|| use as-is||templateId= 1.3.6.1.4.1.19376.1.5.3.1.4.13.7
+
|-
+
|Scope (Refusal Reason Code) || <additions to list of SNOMED code(s) to include IZ Refusal Reasons> ||advanceDirectives.code
+
|}
+
 
+
<br>
+
 
+
=== Document Specification ===
+
====Immunization Summary Option====
+
The following table shows the data elements used from the existing PCC-2 Immunization Summary Template, plus modifications required for use in this IC profile.
+
{| cellspacing=0 border=1 align='center'
+
! style='background-color:#cfcfcf'|Data Element
+
! style='background-color:#cfcfcf'|Opt
+
!  style='background-color:#cfcfcf'|PCC-2 Section
+
! style='background-color:#cfcfcf' |Template ID
+
|+ Immunization Summary Option - Updated Constraints
+
|-
+
| || || ||
+
|-
+
|'''History of Immunizations''' ||R|| ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Immunization Record ID ||R||6.4.4.17.4 || 1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Negation Indicator ||R||6.4.4.17.2 ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Description ||R||6.4.4.17.6 ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Immunization Date ||R||6.4.4.17.8 || 1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Dose Quantity ||R2||6.4.4.17.11 ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Route ||R2||6.4.4.17.9 ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Approach Site ||R2||6.4.4.17.10 ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Vaccine Code ||R||6.4.4.17.12 / 6.4.4.19.3 ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Vaccine Name ||R2||6.4.4.17.12 / 6.4.4.19.3 ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Vaccine Lot # ||R2||needs to be added ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Vaccine Expiration Date ||R2||needs to be added ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Manufacturer ID ||R2||needs to be added || 1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Manufacturer Name ||O||needs to be added || 1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Vaccine Lot # Recalled Effective Date ||R2||6.4.4.20 ||1.3.6.1.4.1.19376.1.5.3.1.4.13
+
|-
+
|Vaccine Lot # Recalled Code ||R2||6.4.4.20 ||1.3.6.1.4.1.19376.1.5.3.1.4.13
+
|-
+
|Vaccine Lot # Recalled Noted Time ||O||6.4.4.20 ||1.3.6.1.4.1.19376.1.5.3.1.4.13
+
|-
+
|Adverse Event Code ||R2||6.4.4.15.5 ||1.3.6.1.4.1.19376.1.5.3.1.4.5
+
|-
+
|Adverse Event Time||R2||6.4.4.15.2 ||1.3.6.1.4.1.19376.1.5.3.1.4.5
+
|-
+
|Adverse Event Severity||R2||6.4.4.15.11 ||1.3.6.1.4.1.19376.1.5.3.1.4.1
+
|-
+
|Performer Person ID ||R2||needs to be added  ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Performer Person Name ||O||needs to be added  ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Performer Organization ID ||R2||needs to be added  ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Performer Organization Name ||O||needs to be added  ||1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|-
+
|Author||R2||6.4.4.1|| no template -- see below
+
|-
+
|Informant||R2||6.4.4.1|| no template -- see below
+
|-
+
|Vaccine Information Statement Given||R2||6.4.4.20 ||1.3.6.1.4.1.19376.1.5.3.1.4.13
+
|-
+
|VIS Version||R2||6.4.4.20 ||1.3.6.1.4.1.19376.1.5.3.1.4.13
+
|-
+
|Comments about Shot||R2||6.4.4.6||1.3.6.1.4.1.19376.1.5.3.1.4.2
+
|}
+
<br>
+
====Care Record Option====
+
The following table describes the Care Record Option.  It includes the Immunization Summary Option just described in its entirety.  It also makes use of other existing PCC-2 templates as indicated.  These templates are used unmodified from their present form, except that optionality of fields is specified in the table below.
+
{| cellspacing=0 border=1 align='center'
+
! style='background-color:#cfcfcf'|Data Element
+
! style='background-color:#cfcfcf'|Opt
+
!  style='background-color:#cfcfcf'|PCC-2 Section
+
! style='background-color:#cfcfcf' |Template ID
+
|+ Care Record Option - Updated Constraints
+
|-
+
| || || ||
+
|-
+
|'''Immunization Care Event''' ||R||need new template ID ||1.3.6.1.4.1.19376.1.5.3.1.?.?
+
|-
+
|Patient ID ||C|| ||Not Required for Vaccine Decision Support
+
|-
+
|DOB ||C|| ||'''Only''' Required for Vaccine Decision Support
+
|-
+
|Gender||C|| ||'''Only''' Required for Vaccine Decision Support
+
|-
+
| || || ||
+
|-
+
|'''History of Immunizations''' ||R||6.4.4.17 ||1.3.6.1.4.1.19376.1.5.3.1.4.12 (updated - see above)
+
|-
+
| || || ||
+
|-
+
|'''Authors and Informants''' ||R2||6.4.4.1||<use as defined in PCC-2>
+
|-
+
|ID ||R|| ||
+
|-
+
|Address ||R|| ||
+
|-
+
|Telecom ||R|| ||
+
|-
+
|Role Code ||R2|| ||
+
|-
+
|Name ||O|| ||
+
|-
+
|Informant Mode ||R2|| ||
+
|-
+
|Informant Source ||R2|| ||
+
|-
+
| || || ||
+
|-
+
|'''Problem Entry''' ||R2||6.4.4.14||1.3.6.1.4.1.19376.1.5.3.1.4.5
+
|-
+
|ID||R|| ||
+
|-
+
|Problem began ||R2|| ||
+
|-
+
|Problem ended ||R2|| ||
+
|-
+
|Problem Type ||R2|| ||
+
|-
+
|Confidentiality Code ||R2|| ||
+
|-
+
|Uncertainty Code ||R2|| ||
+
|-
+
|Problem Code ||R|| ||
+
|-
+
|Severity ||R2||6.4.4.3||1.3.6.1.4.1.19376.1.5.3.1.4.1
+
|-
+
|Clinical Status ||O||6.4.4.4||1.3.6.1.4.1.19376.1.5.3.1.4.1.1
+
|-
+
|Health Status ||O||6.4.4.5||1.3.6.1.4.1.19376.1.5.3.1.4.1.2
+
|-
+
|Comments ||O||6.4.4.6||1.3.6.1.4.1.19376.1.5.3.1.4.2
+
|-
+
| || || ||
+
|-
+
|'''Allergies and Intolerances''' ||R2||6.4.4.15||1.3.6.1.4.1.19376.1.5.3.1.4.6
+
|-
+
|ID||R|| ||
+
|-
+
|Intolerance Type ||R|| ||
+
|-
+
|Allergy Code ||R|| ||
+
|-
+
|Allergen Substance ||R2|| ||
+
|-
+
|Allergic Reaction History ||R2|| ||
+
|-
+
|Severity ||R2||6.4.4.3||1.3.6.1.4.1.19376.1.5.3.1.4.1
+
|-
+
|Clinical Status ||O||6.4.4.4||1.3.6.1.4.1.19376.1.5.3.1.4.1.1
+
|-
+
|Comments ||O||6.4.4.6||1.3.6.1.4.1.19376.1.5.3.1.4.2
+
|-
+
| || || ||
+
|-
+
|'''Medications''' ||R2||6.4.4.16||1.3.6.1.4.1.19376.1.5.3.1.4.7
+
|-
+
|ID||R|| ||
+
|-
+
|Description ||R2|| ||
+
|-
+
|Date Range ||R|| ||
+
|-
+
|Drug Code ||R2|| ||
+
|-
+
|Drug Name ||R2|| ||
+
|-
+
| || || ||
+
|-
+
|'''Lab Results''' ||R2||6.4.4.16||1.3.6.1.4.1.19376.1.5.3.1.4.13
+
|-
+
|ID||R|| ||
+
|-
+
|Lab Code||R|| ||
+
|-
+
|Description ||R2|| ||
+
|-
+
|Date ||R|| ||
+
|-
+
|Result ||R2|| ||
+
|-
+
|Result Interpretation ||R2|| ||
+
|-
+
|Test Method||R2|| ||
+
|-
+
|Author||R2||6.4.4.1||
+
|-
+
| || || ||
+
|-
+
|'''Vital Signs Organizer''' ||R2||6.4.4.21||1.3.6.1.4.1.19376.1.5.3.1.4.13.1
+
|-
+
|Observation Date ||R|| ||
+
|-
+
|Observation by ||R2|| ||
+
|-
+
| || || ||
+
|-
+
|'''Vital Signs Observation'''||R2||6.4.4.22||1.3.6.1.4.1.19376.1.5.3.1.4.13.2
+
|-
+
|ID||R|| ||
+
|-
+
|Observation Code ||R||LOINC: 8310-5 body temp ||vitalSigns.code 
+
|-
+
|Observation Value - Units||R|| ||
+
|-
+
| || || ||
+
|-
+
|'''Pregnancy Observation''' ||R2||6.4.4.26||1.3.6.1.4.1.19376.1.5.3.1.4.13.5
+
|-
+
|ID||R|| ||
+
|-
+
|Observation Date||R|| ||
+
|-
+
|Pregnancy Info Type ||R2|| ||
+
|-
+
|Pregnancy Status ||R2|| ||
+
|-
+
|Pregnancy Info Type ||R2|| ||
+
|-
+
|Estimated Due Date ||R2|| ||
+
|-
+
| || || ||
+
|-
+
|'''Advance Directive Observation''' ||R2||6.4.4.28||1.3.6.1.4.1.19376.1.5.3.1.4.13.7
+
|-
+
|ID||R|| ||
+
|-
+
|Refusal Reason Code ||R||6.4.4.28.4|| <need to expand SNOMED list to include vaccines, refusal reasons, etc.>
+
|-
+
|Reason Code Permits Immunization? ||R2|| ||
+
|-
+
|Effective From Date ||R2|| ||
+
|-
+
|Effective Thru Date ||R2|| ||
+
|-
+
|Comments ||O||6.4.4.6||1.3.6.1.4.1.19376.1.5.3.1.4.2
+
|}
+
 
+
===Summary of Document Specification===
+
====Immunization Summary Option====
+
The table below summarizes the templates needed for the Immunization Summary Option.  This already appears in PCC-2, in Section 6.4.3.3.5, but is repeated here for convenience.
+
{| border=1 cellspacing=0
+
|-
+
!style='background-color:#cfcfcf;'|TemplateID
+
| colspan=2|1.3.6.1.4.1.19376.1.5.3.1.3.23
+
|-
+
!style='background-color:#cfcfcf;'|Parent Template
+
| colspan=2|CCD 3.11(2.16.840.1.113883.10.20.1.6)
+
|-
+
!style='background-color:#cfcfcf;'|General Description
+
|colspan=2|This section shall contain a full description of the immunizations administered to the patient in the past.  It shall include entries for medication administration as described in the Entry Content Module.  It shall also contain all known medical information which is relevant to past and future immunization decisions for the patient.
+
|- style='background-color:#cfcfcf;'
+
!LOINC Code
+
!Opt
+
!Description
+
|-
+
|11369-6
+
|align='center'|R
+
|HISTORY OF IMMUNIZATIONS
+
|- style='background-color:#cfcfcf;'
+
!Entries
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|align='center'|R
+
|Immunizations
+
|}
+
 
+
====Care Record Option====
+
The table below summarizes the templates needed for the Care Record Option.  Note that it includes the Immunizations template discussed above in its entirety.
+
{| border=1 cellspacing=0
+
|-
+
!style='background-color:#cfcfcf;'|TemplateID
+
| colspan=2|1.3.6.1.4.1.19376.1.5.3.1.?.?
+
|-
+
!style='background-color:#cfcfcf;'|Parent Template
+
| colspan=2|CCD 3.11(2.16.840.1.113883.10.20.1.6)
+
|-
+
!style='background-color:#cfcfcf;'|General Description
+
|colspan=2|This section shall contain a full description of the immunizations administered to the patient in the past.  It shall include entries for medication administration as described in the Entry Content Module.  It shall also contain all known medical information which is relevant to past and future immunization decisions for the patient.
+
|- style='background-color:#cfcfcf;'
+
!LOINC Code
+
!Opt
+
!Description
+
|-
+
|11369-6
+
|align='center'|R
+
|HISTORY OF IMMUNIZATIONS
+
|- style='background-color:#cfcfcf;'
+
!Entries
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.?.?
+
|align='center'|R
+
|Immunization Content
+
|- style='background-color:#cfcfcf;'
+
!Sub-sections
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.4.12
+
|align='center'|R
+
|Immunizations <br> (if no immunizations have been given, that fact must be stated with negationInd = true, and NoImmunizationReason supplied)
+
|- style='background-color:#cfcfcf;'
+
!Sub-sections
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.4.5
+
|align='center'|R2
+
|Problems and Conditions
+
|- style='background-color:#cfcfcf;'
+
!Sub-sections
+
!Opt
+
!Description
+
|-
+
|11.3.6.1.4.1.19376.1.5.3.1.4.6
+
|align='center'|R
+
|Allergies and Intolerances <br> (allergy to eggs must be specified, whether positive, negative, or unknown) <br> (any known reactions to vaccine events must be specified, and linked to the particular immunization event, if known)
+
|- style='background-color:#cfcfcf;'
+
!Sub-sections
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.4.7
+
|align='center'|R2
+
|Medications
+
|- style='background-color:#cfcfcf;'
+
!Sub-sections
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.4.13.1
+
|align='center'|R2
+
|Vital Signs Organizer
+
|- style='background-color:#cfcfcf;'
+
!Sub-sections
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.4.13.2
+
|align='center'|R2
+
|Vital Signs Observation
+
|- style='background-color:#cfcfcf;'
+
!Sub-sections
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.4.13.5
+
|align='center'|C
+
|Pregnancy Observation
+
|- style='background-color:#cfcfcf;'
+
!Sub-sections
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.4.13.7
+
|align='center'|R2
+
|Advance Directives and Consent Observation
+
|- style='background-color:#cfcfcf;'
+
!Sub-sub-sections
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.4.1
+
|align='center'|R2
+
|Severity <br> (used in Problems and Allergies)
+
|- style='background-color:#cfcfcf;'
+
!Sub-sub-sections
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.4.1.1
+
|align='center'|R2
+
|Clinical Status <br> (used in Problems and Allergies)
+
|- style='background-color:#cfcfcf;'
+
!Sub-sub-sections
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.4.1.2
+
|align='center'|R2
+
|Health Status <br> (used in Problems)
+
|- style='background-color:#cfcfcf;'
+
!Sub-sub-sections
+
!Opt
+
!Description
+
|-
+
|1.3.6.1.4.1.19376.1.5.3.1.4.2
+
|align='center'|R2
+
|Comments <br> (used in POIZ, Problems, Allergies and Advance Directives)
+
|}
+
 
+
===Parent Template===
+
{{Fixme|do we need this?}}
+
 
+
The parent of this template is CCD 3.11.
+
 
+
===SampleMessages===
+
====Sample V3 Message for Immunization Summary Option====
+
 
+
<controlActProcess moodCode="EVN">
+
    <subject>
+
        <registrationEvent>
+
            <id root='903e67b1-3169-481e-b9e8-3fdfe84ceb8c'/>
+
            <statusCode code="active"/>
+
            <custodian>
+
                <assignedEntity>
+
                    <id root="1.3.6.1.4.1.21367.2008.1.2.190"/>
+
                    <addr>
+
                        <streetAddressLine>987 Maple St.</streetAddressLine>
+
                        <streetAddressLine>Building 44-B</streetAddressLine>
+
                        <city>Sometown</city>
+
                        <state>CA</state>
+
                        <postalCode>12345</postalCode>
+
                        <country>USA</country>
+
                    </addr>
+
                    <telecom use="WP" value="123-456-7890"/>
+
                    <assignedOrganization>
+
                        <name>Connectathon</name>
+
                    </assignedOrganization>
+
                </assignedEntity>
+
            </custodian>
+
            <subject2>
+
                <careProvisionEvent>
+
                    <recordTarget>
+
                        <patient>
+
                            <id extension="NA5050" root="1.3.6.1.4.1.21367.2005.3.7"/>
+
                            <addr>
+
                                <state>CA</state>
+
                                <country>USA</country>
+
                            </addr>
+
                            <telecom use="HP" value=""/>
+
                            <statusCode code="normal"/>
+
                            <patientPerson>
+
                                <name use="L">
+
                                    <given>ONE</given>
+
                                    <family>QED</family>
+
                                </name>
+
                                <administrativeGenderCode code="F" displayName="Female" codeSystem='2.16.840.1.113883.5.1'
+
                                    codeSystemName='AdministrativeGender'/>
+
                                <birthTime value="19300102"/>
+
                            </patientPerson>
+
                        </patient>
+
                    </recordTarget>
+
                   
+
                    <!-- zero or many representations of a substance administration -->
+
                    <substanceAdministration moodCode="EVN" negationInd="false" classCode="SBADM">
+
                        <templateId root="2.16.840.1.113883.10.20.1.24"/>
+
                        <templateId root="1.3.6.1.4.1.19376.1.5.3.1.4.12"/>
+
                        <id extension="63" root="1.3.6.1.4.1.21367.2008.1.2.190.2"/>
+
                        <code code="IMMUNIZ" codeSystem="2.16.840.1.113883.5.4" codeSystemName="ActCode"/>
+
                        <text>cvxCode</text>
+
                        <statusCode code="completed"/>
+
                        <effectiveTime value="20070911"/>
+
                        <routeCode nullFlavor="UNK"/>
+
                        <approachSiteCode nullFlavor="UNK"/>
+
                        <doseQuantity value="1"/>
+
                        <consumable typeCode="CSM">
+
                            <administerableMaterial classCode='ADMM' determinerCode='INSTANCE'>
+
                                <!-- zero or one representation of the instance information of the administerableMaterial  -->
+
                                <administerableMaterial classCode='MMAT' determinerCode='INSTANCE'>
+
                                    <templateId root="1.3.6.1.4.1.19376.1.5.3.1.4.7.2" />
+
                                    <templateId root="2.16.840.1.113883.10.20.1.53" />
+
                                    <code code="88" codeSystem="2.16.840.1.113883.6.59" displayName="FLU VAX"/>
+
                                    <lotNumberText>ABC12345M</lotNumberText>
+
                                    <expirationTime value='20080305'/>
+
                                    <!-- Manufacturer of Vaccine -->
+
                                    <asMedicineManufacturer classCode='MANU'>
+
                                        <manufacturer classCode='ORG'>
+
                                            <id root='2.16.840.1.113883.6.60' extension='SKB'/>
+
                                            <name>Glaxo Smith Kline Beacham</name>
+
                                        </manufacturer>
+
                                    </asMedicineManufacturer>
+
                                </administerableMaterial>
+
                            </administerableMaterial>
+
                            <desc>influenza immunization has been administered</desc>
+
                        </consumable>
+
                       
+
                        <!-- zero or more representations of adverse events caused 6.4.4.15.8 -->
+
                        <entryRelationship inversionInd='false' typeCode='CAUS'>
+
                            <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.6.1'/>
+
                            <observation typeCode='OBS' moodCode='EVN'>
+
                                <templateId root='2.16.840.1.113883.10.20.1.54'/>
+
                                <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/>
+
                                <id root='' extension=''/>
+
                                <code code=' 12345678' displayName="edema with fever" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/>
+
                                <statusCode code="completed"/>
+
                                <effectiveTime><low value="20070911"></low><high value="20070916"></high></effectiveTime>
+
                                <value type="CD" code="xxx" displayName="Edema with fever" codeSystem="2.16.840.1.113883.6.103" codeSystemName="ICD-9CM"></value>
+
                                <!-- zero or more representations of the severity of the above adverse event -->
+
                                <entryRelationship typeCode="SUBJ" inversionInd="true">
+
                                    <observation classCode="OBS" moodCode="EVN">
+
                                        <templateId root="2.16.840.1.113883.10.20.1.55"/>
+
                                        <templateId root="1.3.6.1.4.1.19376.1.5.3.1.4.1"/>
+
                                        <code code="SEV" displayName="Severity" codeSystem="2.16.840.1.113883.5.4" codeSystemName="ActCode"/>
+
                                        <text>moderately severe edema with moderate fever</text>
+
                                        <statusCode code="completed"/>
+
                                        <value type="CD" code="M" codeSystem="2.16.840.1.113883.5.1063" codeSystemName="ObservationValue"></value>
+
                                    </observation>
+
                                </entryRelationship>
+
                            </observation>
+
                        </entryRelationship>   
+
                       
+
                        <!-- zero or one representation of the person who administered the vaccine  -->
+
                        <performer typeCode='PRF'>
+
                            <assignedEntity typeCode="ASSIGNED">
+
                                <id root='1.2.3' extension="MUNB23"/>
+
                                <addr></addr>
+
                                <telecom use='' value=''/>
+
                                <assignedPerson>
+
                                    <name><given>Bill</given><family>Munroe</family></name>
+
                                </assignedPerson>
+
                                <representedOrganization>
+
                                    <name>ABC Healthcare</name>
+
                                </representedOrganization>
+
                            </assignedEntity>
+
                        </performer>
+
                       
+
                        <!-- exactly one Author of the Substance Administration -->
+
                        <author typeCode='AUT'>
+
                            <assignedEntity typeCode='ASSIGNED'>
+
                                <id root=' 1.2.3' extension=' SMIM01'/>
+
                                <assignedPerson classCode='PSN' determinerCode='' root=''>
+
                                    <name><given>Mary</given><family>Smith</family></name>
+
                                </assignedPerson>
+
                            </assignedEntity>
+
                        </author>
+
                       
+
                        <!-- zero or more representations of the source of information about the substanceAdministration -->
+
                        <!--<informant typeCode='INF'>
+
                            <relatedEntity classCode=' '>
+
                            <id root=' ' extension=' '/>
+
                            <assignedPerson classCode='PSN'>
+
                            <determinerCode root=''/>
+
                            <name>…</name>
+
                            </assignedPerson>
+
                            </relatedEntity>
+
                            </informant>-->
+
                        <!--or the following-->
+
                        <!--<observation typeCode='OBS' moodCode='EVN'>
+
                            <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/>
+
                            <id root='' extension=''/>
+
                            <code code='' displayName='' codeSystem='' codeSystemName=''/>
+
                            <text>foo bar text</text>
+
                            <statusCode code='completed'/>
+
                            <effectiveTime value=''/>
+
                            <repeatNumber value=''/>
+
                            <value type=''/>
+
                            <interpretationCode code='' codeSystem='' codeSystemName=''/>
+
                            <methodCode code='' codeSystem='' codeSystemName=''/>
+
                            <targetSiteCode code='' codeSystem='' codeSystemName=''/>
+
                            <author typeCode='AUT'>
+
                            <assignedEntity typeCode='ASSIGNED'>
+
                            <Person classCode='PSN'>
+
                            <determinerCode root=''/>
+
                            <name>…</name>
+
                            </Person>
+
                            </assignedEntity>
+
                            </author>
+
                            </observation>-->
+
                        <informant typeCode='INF'>
+
                            <time  value=''/>
+
                            <!-- verbal paper electronicData etc. -->
+
                            <modeCode code="VERBAL|WRITTEN|ELECTRONIC" codeSystem="2.16.840.1.113883.5.1064" codeSystemName="Participation Mode"/>
+
                            <informationSource classCode="PRS | LIC | PAT" codeSystem="2.16.840.1.113883.5.110" codeSystemName="RoleClass">
+
                                <!-- someone with a personal relationship, such as mother -->
+
                                <code> role </code>
+
                                <!-- licensed entity, such as another provider -->
+
                                <code> role </code>
+
                                <!-- patient, no further information needed -->
+
                            </informationSource>
+
                        </informant>
+
                       
+
                        <!-- zero to many representations of Comments about this IZ Instance -->
+
                        <entryRelationship typeCode="SUBJ" inversionInd="true">
+
                            <observation classCode='COND' moodCode='EVN' negationInd=' false|true '>
+
                                <templateId root='2.16.840.1.113883.10.20.1.40'/>
+
                                <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.2'/>
+
                                <id root=' ' extension=' '/>
+
                                <code code=' 48767-8' displayName=' Annotation Comment'
+
                                    codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
+
                                <statusCode code='completed'/>
+
                                <effectiveTime value='20070911'/>
+
                                <text>
+
                                    this child has extreme panic attacks at the sight of a needle.
+
                                </text>
+
                            </observation>
+
                        </entryRelationship>
+
                       
+
                    </substanceAdministration>
+
                </careProvisionEvent>
+
               
+
            </subject2>
+
        </registrationEvent>
+
    </subject>
+
</controlActProcess>
+
 
+
====Sample V3 Message for Care Record Option====
+
 
+
<controlActProcess moodCode="EVN">
+
    <subject>
+
        <registrationEvent>
+
            <id root='903e67b1-3169-481e-b9e8-3fdfe84ceb8c'/>
+
            <statusCode code="active"/>
+
            <custodian>
+
                <assignedEntity>
+
                    <id root="1.3.6.1.4.1.21367.2008.1.2.190"/>
+
                    <addr>
+
                        <streetAddressLine>987 Maple St.</streetAddressLine>
+
                        <streetAddressLine>Building 44-B</streetAddressLine>
+
                        <city>Sometown</city>
+
                        <state>CA</state>
+
                        <postalCode>12345</postalCode>
+
                        <country>USA</country>
+
                    </addr>
+
                    <telecom use="WP" value="123-456-7890"/>
+
                    <assignedOrganization>
+
                        <name>Connectathon</name>
+
                    </assignedOrganization>
+
                </assignedEntity>
+
            </custodian>
+
            <subject2>
+
                <careProvisionEvent>
+
                    <recordTarget>
+
                        <patient>
+
                            <id extension="NA5050" root="1.3.6.1.4.1.21367.2005.3.7"/>
+
                            <patientPerson>
+
                                <administrativeGenderCode code="F" displayName="Female" codeSystem='2.16.840.1.113883.5.1'
+
                                    codeSystemName='AdministrativeGender'/>
+
                                <birthTime value="19300102"/>
+
                            </patientPerson>
+
                        </patient>
+
                    </recordTarget>
+
                   
+
                    <!-- zero or many representations of a substance administration -->
+
                    <substanceAdministration moodCode="EVN" negationInd="false" classCode="SBADM">
+
                        <templateId root="2.16.840.1.113883.10.20.1.24"/>
+
                        <templateId root="1.3.6.1.4.1.19376.1.5.3.1.4.12"/>
+
                        <id extension="63" root="1.3.6.1.4.1.21367.2008.1.2.190.2"/>
+
                        <code code="IMMUNIZ" codeSystem="2.16.840.1.113883.5.4" codeSystemName="ActCode"/>
+
                        <text>cvxCode</text>
+
                        <statusCode code="completed"/>
+
                        <effectiveTime value="20070911"/>
+
                        <routeCode nullFlavor="UNK"/>
+
                        <approachSiteCode nullFlavor="UNK"/>
+
                        <doseQuantity value="1"/>
+
                        <consumable typeCode="CSM">
+
                            <administerableMaterial classCode='ADMM' determinerCode='INSTANCE'>
+
                                <!-- zero or one representation of the instance information of the administerableMaterial  -->
+
                                <administerableMaterial classCode='MMAT' determinerCode='INSTANCE'>
+
                                    <templateId root="1.3.6.1.4.1.19376.1.5.3.1.4.7.2" />
+
                                    <templateId root="2.16.840.1.113883.10.20.1.53" />
+
                                    <code code="88" codeSystem="2.16.840.1.113883.6.59" displayName="FLU VAX"/>
+
                                    <lotNumberText>ABC12345M</lotNumberText>
+
                                    <expirationTime value='20080305'/>
+
                                    <!-- Manufacturer of Vaccine -->
+
                                    <asMedicineManufacturer classCode='MANU'>
+
                                        <manufacturer classCode='ORG'>
+
                                            <id root='2.16.840.1.113883.6.60' extension='SKB'/>
+
                                            <name>Glaxo Smith Kline Beacham</name>
+
                                        </manufacturer>
+
                                    </asMedicineManufacturer>
+
                                </administerableMaterial>
+
                            </administerableMaterial>
+
                            <desc>influenza immunization has been administered</desc>
+
                        </consumable>
+
                       
+
                        <!-- zero or more representations of adverse events caused 6.4.4.15.8 -->
+
                        <entryRelationship inversionInd='false' typeCode='CAUS'>
+
                            <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.6.1'/>
+
                            <observation typeCode='OBS' moodCode='EVN'>
+
                                <templateId root='2.16.840.1.113883.10.20.1.54'/>
+
                                <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/>
+
                                <id root='' extension=''/>
+
                                <code code=' 12345678' displayName="edema with fever" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/>
+
                                <statusCode code="completed"/>
+
                                <effectiveTime><low value="20070911"></low><high value="20070916"></high></effectiveTime>
+
                                <value type="CD" code="xxx" displayName="Edema with fever" codeSystem="2.16.840.1.113883.6.103" codeSystemName="ICD-9CM"></value>
+
                                <!-- zero or more representations of the severity of the above adverse event -->
+
                                <entryRelationship typeCode="SUBJ" inversionInd="true">
+
                                    <observation classCode="OBS" moodCode="EVN">
+
                                        <templateId root="2.16.840.1.113883.10.20.1.55"/>
+
                                        <templateId root="1.3.6.1.4.1.19376.1.5.3.1.4.1"/>
+
                                        <code code="SEV" displayName="Severity" codeSystem="2.16.840.1.113883.5.4" codeSystemName="ActCode"/>
+
                                        <text>moderately severe edema with moderate fever</text>
+
                                        <statusCode code="completed"/>
+
                                        <value type="CD" code="M" codeSystem="2.16.840.1.113883.5.1063" codeSystemName="ObservationValue"></value>
+
                                    </observation>
+
                                </entryRelationship>
+
                            </observation>
+
                        </entryRelationship>   
+
                       
+
                        <!-- zero or one representation of the person who administered the vaccine  -->
+
                        <performer typeCode='PRF'>
+
                            <assignedEntity typeCode="ASSIGNED">
+
                                <id root='1.2.3' extension="MUNB23"/>
+
                                <addr></addr>
+
                                <telecom use='' value=''/>
+
                                <assignedPerson>
+
                                    <name><given>Bill</given><family>Munroe</family></name>
+
                                </assignedPerson>
+
                                <representedOrganization>
+
                                    <name>ABC Healthcare</name>
+
                                </representedOrganization>
+
                            </assignedEntity>
+
                        </performer>
+
                       
+
                        <!-- exactly one Author of the Substance Administration -->
+
                        <author typeCode='AUT'>
+
                            <assignedEntity typeCode='ASSIGNED'>
+
                                <id root=' 1.2.3' extension=' SMIM01'/>
+
                                <assignedPerson classCode='PSN' determinerCode='' root=''>
+
                                    <name><given>Mary</given><family>Smith</family></name>
+
                                </assignedPerson>
+
                            </assignedEntity>
+
                        </author>
+
                       
+
                        <!-- zero or more representations of the source of information about the substanceAdministration -->
+
                        <!--<informant typeCode='INF'>
+
                            <relatedEntity classCode=' '>
+
                            <id root=' ' extension=' '/>
+
                            <assignedPerson classCode='PSN'>
+
                            <determinerCode root=''/>
+
                            <name>…</name>
+
                            </assignedPerson>
+
                            </relatedEntity>
+
                            </informant>-->
+
                        <!--or the following-->
+
                        <!--<observation typeCode='OBS' moodCode='EVN'>
+
                            <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/>
+
                            <id root='' extension=''/>
+
                            <code code='' displayName='' codeSystem='' codeSystemName=''/>
+
                            <text>foo bar text</text>
+
                            <statusCode code='completed'/>
+
                            <effectiveTime value=''/>
+
                            <repeatNumber value=''/>
+
                            <value type=''/>
+
                            <interpretationCode code='' codeSystem='' codeSystemName=''/>
+
                            <methodCode code='' codeSystem='' codeSystemName=''/>
+
                            <targetSiteCode code='' codeSystem='' codeSystemName=''/>
+
                            <author typeCode='AUT'>
+
                            <assignedEntity typeCode='ASSIGNED'>
+
                            <Person classCode='PSN'>
+
                            <determinerCode root=''/>
+
                            <name>…</name>
+
                            </Person>
+
                            </assignedEntity>
+
                            </author>
+
                            </observation>-->
+
                        <informant typeCode='INF'>
+
                            <time  value=''/>
+
                            <!-- verbal paper electronicData etc. -->
+
                            <modeCode code="VERBAL|WRITTEN|ELECTRONIC" codeSystem="2.16.840.1.113883.5.1064" codeSystemName="Participation Mode"/>
+
                            <informationSource classCode="PRS | LIC | PAT" codeSystem="2.16.840.1.113883.5.110" codeSystemName="RoleClass">
+
                                <!-- someone with a personal relationship, such as mother -->
+
                                <code> role </code>
+
                                <!-- licensed entity, such as another provider -->
+
                                <code> role </code>
+
                                <!-- patient, no further information needed -->
+
                            </informationSource>
+
                        </informant>
+
                       
+
                        <!-- zero to many representations of Comments about this IZ Instance -->
+
                        <entryRelationship typeCode="SUBJ" inversionInd="true">
+
                            <observation classCode='COND' moodCode='EVN' negationInd=' false|true '>
+
                                <templateId root='2.16.840.1.113883.10.20.1.40'/>
+
                                <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.2'/>
+
                                <id root=' ' extension=' '/>
+
                                <code code=' 48767-8' displayName=' Annotation Comment'
+
                                    codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
+
                                <statusCode code='completed'/>
+
                                <effectiveTime value='20070911'/>
+
                                <text>
+
                                    this child has extreme panic attacks at the sight of a needle.
+
                                </text>
+
                            </observation>
+
                        </entryRelationship>
+
                       
+
                    </substanceAdministration>
+
                   
+
                    <!-- zero to many representations of Problems -->
+
                    <observation classCode='OBS' moodCode='EVN' negationInd=' false|true '>
+
                        <templateId root='2.16.840.1.113883.10.20.1.28'/>
+
                        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/>
+
                        <id root=' ' extension=' '/>
+
                        <code code=' ' displayName=' '
+
                            codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'/>
+
                        <statusCode code='completed'/>
+
                        <effectiveTime><low value=' '/><high value=' '/></effectiveTime>
+
                        <value type='CD' code=' ' codeSystem=' ' displayName=' ' codeSystemName=' '>
+
                            <originalText><reference value=' '/></originalText>
+
                        </value>
+
                        <!-- zero or one <subjectOf typeCode='SUBJ' inversionInd='true'> elements containing severity  -->
+
                        <!-- zero or one <subjectOf typeCode='REFR' inversionInd='false'> elements identifying the health status of concern -->
+
                        <!-- zero or one <subjectOf typeCode='REFR' inversionInd='false'> elements containing clinical status -->
+
                        <!-- zero to many <subjectOf typeCode='SUBJ' inversionInd='true'> elements containing comments -->
+
                        <subjectOf typeCode='SUBJ' inversionInd='true'>
+
                            <observation classCode='COND' moodCode='EVN' negationInd=' false|true '>
+
                                <templateId root='2.16.840.1.113883.10.20.1.40'/>
+
                                <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.2'/>
+
                                <id root=' ' extension=' '/>
+
                                <code code=' 48767-8' displayName=' Annotation Comment'
+
                                    codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
+
                                <statusCode code='completed'/>
+
                                <effectiveTime value='20070911'/>
+
                                <text>
+
                                    this child has extreme panic attacks at the sight of a needle.
+
                                </text>
+
                            </observation>
+
                        </subjectOf>
+
                       
+
                    </observation>
+
                   
+
                    <!-- zero to many representations of Allergies and Intolerances -->
+
                    <observation classCode='OBS' moodCode='EVN' negationInd='false'>
+
                        <templateId root='2.16.840.1.113883.10.20.1.18'/>
+
                        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.6'/>
+
                        <id root=' ' extension=' '/>
+
                        <code
+
                            code='ALG|OINT|DALG|EALG|FALG|DINT|EINT|FINT|DNAINT|ENAINT|FNAINT'
+
                            codeSystem='2.16.840.1.113883.5.4'
+
                            codeSystemName='ObservationIntoleranceType'/>
+
                        <statusCode code='completed'/>
+
                        <effectiveTime>
+
                            <low value=' '/>
+
                            <high value=' '/>
+
                        </effectiveTime>
+
                        <value type='CD' code=' ' codeSystem=' ' displayName=' ' codeSystemName=' '/>
+
                        <participant typeCode='CSM'>
+
                            <participantRole classCode='MANU'>
+
                                <playingEntity classCode='MMAT'>
+
                                    <code code=' ' codeSystem=' '>
+
                                        <originalText><reference value='#substance'/></originalText>
+
                                    </code>
+
                                    <name></name>
+
                                </playingEntity>
+
                            </participantRole>
+
                        </participant>
+
                        <!-- zero to many <entryRelationship> elements containing reactions (Adverse Events),
+
                            for example:
+
                            <entryRelationship typeCode='MFST'>
+
                            <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.6.1'/>
+
                            <observation classCode='OBS' moodCode='EVN'>
+
                            <templateId root='2.16.840.1.113883.10.20.1.54'/>
+
                            <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/>
+
                            :
+
                            </observation>
+
                            </entryRelationship>
+
                        -->
+
                        <!-- zero or one <subjectOf typeCode='SUBJ' inversionInd='true'> elements containing severity -->
+
                        <!-- zero or one <subjectOf typeCode='REFR' inversionInd='false'> elements containing clinical status -->
+
                        <!-- zero to many <subjectOf typeCode='SUBJ' inversionInd='true'> elements containing comments -->
+
                        <subjectOf typeCode='SUBJ' inversionInd='true'>
+
                            <observation classCode='COND' moodCode='EVN' negationInd=' false|true '>
+
                                <templateId root='2.16.840.1.113883.10.20.1.40'/>
+
                                <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.2'/>
+
                                <id root=' ' extension=' '/>
+
                                <code code=' 48767-8' displayName=' Annotation Comment'
+
                                    codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
+
                                <statusCode code='completed'/>
+
                                <effectiveTime value='20070911'/>
+
                                <text>
+
                                    this child has extreme panic attacks at the sight of a needle.
+
                                </text>
+
                            </observation>
+
                        </subjectOf>
+
                    </observation>
+
                   
+
                    <!-- zero or many representations of a substance administration for medication -->
+
                    <substanceAdministration moodCode="EVN" negationInd="false" classCode="SBADM">
+
                        <templateId root="2.16.840.1.113883.10.20.1.24"/>
+
                        <templateId root="1.3.6.1.4.1.19376.1.5.3.1.4.7"/>
+
                        <id extension="63" root="1.3.6.1.4.1.21367.2008.1.2.190.2"/>
+
                        <code code="MEDICAT" codeSystem="2.16.840.1.113883.5.4" codeSystemName="ActCode"/>
+
                        <text>cvxCode</text>
+
                        <statusCode code="completed"/>
+
                        <effectiveTime value="20070911"/>
+
                        <consumable typeCode="CSM">
+
                            <administerableMaterial>
+
                                <templateId root="1.3.6.1.4.1.19376.1.5.3.1.4.7.2"/>
+
                                <templateId root="2.16.840.1.113883.10.20.1.53"/>
+
                                <administerableMaterial>
+
                                    <code code="12345" codeSystem="2.16.840.1.113883.6.?.?" displayName="Penicillin">
+
                                        <originalText>Penicillin</originalText>
+
                                    </code>
+
                                </administerableMaterial>
+
                                <desc>patient given Penicillin</desc>
+
                            </administerableMaterial>
+
                        </consumable>
+
                    </substanceAdministration>
+
                   
+
                    <!-- zero to many representations of Lab Results -->
+
                    <observation classCode='OBS' moodCode='EVN' negationInd=' false'>
+
                        <templateId root='2.16.840.1.113883.10.20.1.28'/>
+
                        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/>
+
                        <id root=' ' extension=' '/>
+
                        <code code=' ' displayName=' '
+
                            codeSystem='2.16.840.1.113883.?.?' codeSystemName='SNOMED CT'/>
+
                        <statusCode code='completed'/>
+
                        <effectiveTime><low value=' '/><high value=' '/></effectiveTime>
+
                        <value type='CD' code=' ' codeSystem=' ' displayName=' ' codeSystemName=' '>
+
                            <originalText><reference value=' '/></originalText>
+
                        </value>
+
                        <interpretationCode></interpretationCode>
+
                        <methodCode></methodCode>
+
                        <author></author>
+
                    </observation>
+
                   
+
                    <!-- zero to many representations of Vital Signs observed -->
+
                    <organizer classCode='CLUSTER' moodCode='EVN'>
+
                        <templateId root='2.16.840.1.113883.10.20.1.32'/>
+
                        <templateId root='2.16.840.1.113883.10.20.1.35'/>
+
                        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.1'/>
+
                        <id root='' extension=''/>
+
                        <code code='46680005' displayName='Vital signs'
+
                            codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'/>
+
                        <statusCode code='completed'/>
+
                        <effectiveTime value=''/>
+
                        <author classCode='AUT'>
+
                            <assignedAuthor typeCode='ASSIGNED'>
+
                            </assignedAuthor>
+
                        </author>
+
                        <component typeCode='COMP'>
+
                            <observation classCode='OBS' moodCode='EVN'>
+
                                <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/>
+
                                <templateId root='2.16.840.1.113883.10.20.1.31'/>
+
                                <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.2'/>
+
                                <id root=' ' extension=' '/>
+
                                <code code=' ' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
+
                                <text><reference value='#xxx'/></text>
+
                                <statusCode code='completed'/>
+
                                <effectiveTime value=' '/>
+
                                <repeatNumber value=' '/>
+
                                <value type='PQ' value='' unit=''/>
+
                                <interpretationCode code=' ' codeSystem=' ' codeSystemName=' '/>
+
                                <methodCode code=' ' codeSystem=' ' codeSystemName=' '/>
+
                                <targetSiteCode code=' ' codeSystem=' ' codeSystemName=' '/>
+
                            </observation>
+
                        </component>
+
                    </organizer>
+
                   
+
                    <!-- zero to many representations of Pregnancy Observations -->
+
                    <observation classCode='OBS' moodCode='EVN' negationInd=' false'>
+
                        <templateId root='2.16.840.1.113883.10.20.1.28'/>
+
                        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.5'/>
+
                        <id root=' ' extension=' '/>
+
                        <code code=' ' displayName=' '
+
                            codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
+
                        <statusCode code='completed'/>
+
                        <effectiveTime><low value=' '/><high value=' '/></effectiveTime>
+
                        <value type=' ' code=' ' codeSystem=' ' displayName=' ' codeSystemName=' '>
+
                            <originalText><reference value=' '/></originalText>
+
                        </value>
+
                        <author></author>
+
                    </observation>
+
                   
+
                    <!-- zero to many representations of Advanced Directives -->
+
                    <observation classCode='OBS' moodCode='EVN' negationInd=' false'>
+
                        <templateId root='2.16.840.1.113883.10.20.1.28'/>
+
                        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7'/>
+
                        <id root=' ' extension=' '/>
+
                        <code code=' ' displayName=' '
+
                            codeSystem='2.16.840.1.113883.?.?' codeSystemName='SNOMED CT'/>
+
                        <statusCode code='completed'/>
+
                        <effectiveTime><low value=' '/><high value=' '/></effectiveTime>
+
                        <value type='BL' value='true|false'/>
+
                        <author></author>
+
                        <!-- zero to many <subjectOf typeCode='SUBJ' inversionInd='true'> elements containing comments -->
+
                        <subjectOf typeCode='SUBJ' inversionInd='true'>
+
                            <observation classCode='COND' moodCode='EVN' negationInd=' false|true '>
+
                                <templateId root='2.16.840.1.113883.10.20.1.40'/>
+
                                <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.2'/>
+
                                <id root=' ' extension=' '/>
+
                                <code code=' 48767-8' displayName=' Annotation Comment'
+
                                    codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
+
                                <statusCode code='completed'/>
+
                                <effectiveTime value='20070911'/>
+
                                <text>
+
                                    This person is a strict vegetarian, and does not want any vaccines made from animals or animal substances.
+
                                </text>
+
                            </observation>
+
                        </subjectOf>
+
                    </observation>
+
                   
+
                </careProvisionEvent>
+
               
+
            </subject2>
+
        </registrationEvent>
+
    </subject>
+
</controlActProcess>
+
  
===Sample V2 Message===
+
=== Grouping ===
 +
==== Care Management (CM) ====
 +
The [[Content Creator]] of this profile must be grouped with the [[Clinical Data Source]] of the Care Management profile.  The Clinical Data Source actor must implement the V2 Care Management Update Option.
  
See ''Implementation Guide for Immunization Data Transactions Using V 2.3.1 of the Health Level Seven (HL7) Standard Protocol'', referenced in Standards above.
+
The [[Content Consumer]] Actor of this profile must be grouped with the [[Care Manager]] actor of the Care Management profile.

Latest revision as of 12:37, 2 June 2008

Introduction

This is a draft of the Immunization Registry Content Profile (IRC) supplement to the PCC Technical Framework. This draft is a work in progress, not the official supplement or profile.

Profile Abstract

The Immunization Content Profile (IC)

The Immunization Content Profile defines standard immunization data content for Immunization Information Systems (IISs), other public health systems, electronic medical records (EMR) systems, Health Information Exchanges, and others wishing to exchange immunization data electronically in a standard format.

Glossary

Immunization Information System (IIS) 
Preferred term of the American Immunization Registry Association for "Immunization Registry"

Issue Log

Open Issues

Public comment is solicited on all of the following issues:

  1. In preparation for the development of this profile, the compatibility of HL7 Version 3 POIZ and CareRecord were analyzed. The standards were found to be highly compatible. A few differences were identified and referred back to the HL7 Public Health and Emergency Response (PHER) Work Group for resolution through comments on both Draft Standards for Trial Use (DSTU). The approach taken in the Immunization Content (IC) Profile is to update the current PCC-2 Immunization Summary template to contain all the fields in POIZ that are also supported in CareRecord. Template for Immunizations needs to be fixed to include Lot #, Manufacturer, and Expiration Date, and a few other items. The updated template is the equivalent of a POIZ template on CareRecord. This update needs to be completed by the appropriate means.
  2. Template for Advanced Directives needs to be fixed to include Immunization Refusal Reasons.
  3. It is expected that ballot comments on the CareRecord DSTU within HL7 will include requests to add elements available in POIZ but not accommodated in CareRecord. Assuming those elements are eventually added, this IC profile will have to be updated to also include them.
  4. Not enough is said about precisely how the HL7 Version 2 messages are to be used. HL7 Version 2 couples content more tightly with message syntax than Verion 3. Care Management (CM) provides the notification-based integration profile, and Query for Existing Data (QED) provides a query-based integration profile for the HL7 V3 portions of this profile. However, it is unclear how CM and QED will handle V2. V2.3.1 messages blend identity resolution, which is outside the scope of this profile, with transmission of clinical data; how will this be handled? Also, if a Version 2 Implementation Guide is referenced, how will updates to that document be handled?
  5. This IC profile contains three options for each actor. This has been thought to be problematic because two systems implementing different options may not be able to communicate. Another approach would be to break this profile into two or even three profiles, i.e. , one for HL7 Version 2, and one or two for HL7 Version 3 (depending upon whether the Immunization Summary and Care Record options are combined).
  6. Implementation of this profile within PCC Volumes I and II will involve a two-part exercises: (1) update of the existing PCC-2 Immunization Summary template to reflect missing POIZ fields; and (2) creation of a new profile for the Care Record Option that includes Allergies, Problems, etc. - something that looks more like a discharge summary or a transfer of care summary, etc.
  7. We assume we can use the Simple Observation template of Care Record to record Vaccine Information Statement Given (VIS Given) and VIS Version fields. Is this the best approach?


Closed Issues

  1. Where CareRecord and POIZ have different tags for the same elements, we have chosen to use the CareRecord tags in the templates and sample messages. The other possibility is to use the POIZ tags, which may be more meaningful to immunization domain experts. However, we felt that the POIZ tag names and definitions within the HL7 POIZ HMD were not significantly more descriptive to warrant "breaking" software that currently parses Care Record messages and may expect Care Record tags.

Volume I

Add the following bullet to the list of profiles
  • Immunization Content - The Immunization Content Profile defines standard immunization data content for Immunization Information Systems, other public health systems, EMR systems, Health Information Exchanges, and others wishing to exchange immunization data electronically in a standard format.

Dependencies

Add the following row(s) to the list of dependencies
Integration Profile Dependency Dependency Type Purpose
Immunization Content (IC) Care Management (CM) The Content Creator actor of the IC profile must be grouped with the Clinical Data Source Actor of the CM profile The IC profile defines the content sent in the PCC-11 transaction specified in the CM profile
Immunization Content (IC) Care Management (CM) The Content Consumer actor of the IC profile must be grouped with the Care Manager Actor of the CM profile The IC profile defines the content recieved in the PCC-11 transaction specified in the CM profile
Immunization Content (IC) ATNA Actors the IC profile shall implement the Secure Node Actor of the ATNA profile Ensures that transmissions and changes to patient health information are logged in an audit repository, and that communication is secured between nodes.
Immunization Content (IC) ATNA Actors the IC profile shall implement the Time Client Actor of the CT profile Ensures that concistent time is used in all messages.

The Immunization Content Profile (IC)

The Immunization Content Profile (IC) provides a standard message, document and web service formats for exchanging immunization data. It is intended to facilitate the exchange of immunization data among multiple systems belonging to a single or to multiple organizations. Data exchange with and among the installed base of U.S. Immunization Information System (IIS) base was a critical consideration in formulating this profile. However, its intention is to go beyond data exchange among IISs, and facilitate immunization data exchange on a healthcare information network that includes electronic medical record (EMR) systems, Health Information Exchanges, other public health systems, Personal Health Record (PHR) systems, and other stakeholder systems. Thus, the profile specifies common data formats for exchanging immunization data only, or for exchanging immunization data along with medical summary data needed for the overall care of a patient related to immunizations.

To accomplish this, IC draws from two HL7 Version 3 message standards: Immunizations and Care Provision. Immunizations contains a message information model which handles detailed immunization information only. It includes history of administered vaccines with such details as lot number, who administered the shot, and so forth. Care Provision contains a message information model which handles immunization as well as other information related to the patient's care. For example, it includes medical history, medications, allergies, vital signs, and so forth. To provide for compatibility with the U.S. installed base of Immunization Information Systems (IISs), an HL7 Version 2.3.1 content option is also included.

The format of data is treated here as a separate topic from whether the data communicated in message, service, or document format, or whether an enclosing message is query-based or notification-based. By isolating content description from transaction description, the same content can be exchanged both in query and notification (unsolicited update) transaction styles, or in a service. IC is intended to be used in conjunction with integration profiles such as Query for Existing Data (QED) and Care Management (CM) to create architectures for immunization information exchange. It is also hoped that in the future, IC can be used in document-oriented profiles such as XDS. Finally, the IC Profile is also intended to pave the way for content to be passed to immunization-related decision support services. Decision support, however, is out of scope for the 2007-2009 IHE cycle and is on the IHE roadmap for the future.


Use Cases

The following progression of use cases is illustrated in the drawing below.

Use Case 1: Immunization Information System Participation

Various provider organizations - airport flu shot clinics, storefront vaccine clinics, and hospital vaccine clinics - wish to submit immunization histories for patients to a regional Immunization Information System (IIS) with appropriate patient consent. The provider IT departments configure HL7 Verion 2.3.1 connections with the IIS. Each time immunizations are recorded, records of the administered vaccines are automatically sent to the IIS using an HL7 version 2.3.1 standard format.

This is representative of the present-state use case in the U.S.

Use Case 2: Immunization Yellow Card

A pediatrician's office produces official immunization records (sometimes called "Yellow Card") for patients. The provider electronic medical record (EMR) system retrieves demographic information and records of immunization its immunization repository. To supplement its records with immunizations that the patient may have received from other providers, it queries the regional Immunization Information System (IIS). It passes the immunization content to a software module or service that prints the information in the official Yellow Card format.

Use Case 3: Personal Health Record

The provider wishes to make the assembled immunization information available in the patient's Personal Health Record (PHR). The pediatrician's office EMR system includes the retrieved immunization information in its complete care provision information about the patient. The standard Care Provision information contains current conditions, allergies and past adverse events, medications, vital signs, past medical history such as disease history, and so forth, in addition to immunizations. Knowing that the patient also has visited providers in a neighboring state, the EMR system queries the neighboring state's Health Information Exchange (HIE) to retrieve additional care provision information in a standard format. Since the neighboring state IIS is also part of the HIE, the retrieved information also includes immunizations. The pediatrician's office EMR system combines the retrieved and local information and sends it to the provider's PHR system in a standard format.

Use Case 4: Vaccine Forecast

The pediatrician's office wishes to run an automated Vaccine Forecast Decision Support Service to calculate which vaccines due on the next visit, and to assist with reminder/recall. The service may be integrated within the EMR or may be accessed externally using a web service interface. The service accepts a standard XML-based payload in Immunization Content format. The pediatrician's EMR system submits the patients Care Provision data that it has previously assembled to the Vaccine Forecast Decision Support Service and receives a vaccine forecast care plan in return. It records the care plan and uses it in reminder/recall.

Actors/Transaction

There are two actors in this profile, the Content Creator and the Content Consumer. Content is created by a Content Creator and is to be consumed by a Content Consumer. The sharing or transmission of content from one actor to the other is addressed by the appropriate use of IHE profiles described below, and is out of scope of this profile.

Immunization Registry Content Actor Diagram

Options

Actor Option
Immunization Content Options
Content Consumer No Options Defined
Content Creator Immunization Summary Option (1)

Immunization Detail Option (1)
V2 Immunization Update Option (1)

Note (1): The Actor shall support at least one of these options.

Immunization Summary Option

The Immunization Summary Option is based upon HL7 Version 3. It includes information about immunization history of a patient.

Immunization Detail Option

The Immunization Detail Option is also based upon HL7 Version 3. It includes all of the requirements of the Immunization Summary Option, plus ancillary information to support decisions about the treatment of a patient related to immunizations. For example, it includes the patient's allergies, which may be relevant in deciding whether or not to give certain vaccines.

V2 Immunization Update Option

The V2 Immunization Update Option is for backwards compatibility with existing HL7 Version 2.3.1 immunization messaging.

Grouping

Care Management (CM)

The Content Creator of this profile must be grouped with the Clinical Data Source of the Care Management profile. The Clinical Data Source actor must implement the V2 Care Management Update Option.

The Content Consumer Actor of this profile must be grouped with the Care Manager actor of the Care Management profile.