Difference between revisions of "Immunization Registry Content"

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==Immunization Content Section==
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===Summary of Document Specification===
===Immunization Summary Option===
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====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.
 
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.
 
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===Care Record Option===
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====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.
 
The table below summarizes the templates needed for the Care Record Option.  Note that it includes the Immunizations template discussed above in its entirety.
 
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Revision as of 20:21, 29 May 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

  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 Immunization Summary template provided in QED to contain all the fields in POIZ and to use POIZ tags (in order to best reflect terminology created by immunization and public health domain experts). The updated template is the equivalent of a POIZ template on CareRecord.
  2. Care Management (CM) provides the notification-based integration profile for HL7 V2 immunization messages (VXQ/VXX/VXR). Query for Existing Data (QED) provides a query-based integration profile for the HL7 V3 portions of this profile, but doesn't include an option for HL7 V2. Thus, we still don't have a query option for V2. We are asking for public comment on this point.
  3. 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, one for HL7 Version 2, and one for HL7 Version 3 (combining the Immunization Summary and Care Record options into one). Public comment on this issue is sought.
  4. We see this as a two-part exercise: (1) update of the existing IHE Immunization Summary template to reflect missing POIZ fields; and (2) creation of a new profile that includes Allergies, Problems, etc. - something that looks more like a discharge summary or a transfer of care summary, etc.
  5. 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)

  1. 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?
  2. 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).
  3. Address how to handle updates to referenced V2 Guides.
  4. Template for Advanced Directives needs to be fixed to include Immunization Refusal Reasons.
  5. Template for Immunizations needs to be fixed to include Lot #, Manufacturer, and Expiration Date.

Closed Issues

  1. Important elements are currently missing from the PCC QED immunization template, for example, the person who gave the shot. CareRecord can include person who administered vaccine in Performer role. This will be resolved by updating the current immunization template.
  2. 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.

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 ATNA

CT

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.

This text needs to be fixed-->>insert Drawing for Public Comment here<<--

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 Section
Immunization Content Options
Content Consumer Immunization Summary Option (1)

Care Record Option (1)
HL7 V2 Option (1)

PCC TF-1: X.X.X

PCC TF-1: X.X.X
PCC TF-1: X.X.X

Content Creator Immunization Summary Option (1)

Care Record Option (1)
HL7 V2 Option (1)

PCC TF-1: X.X.X

PCC TF-1: X.X.X
PCC TF-1: X.X.X

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





Volume II

Immunization Content

Standards

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.
HL7 V3 Immunizations (Click on Universal Domains, Immunizations)  
HL7 Version 3 Standard: Immunization, Release 1 DSTU Ballot 3 - May 2008
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

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.

Data Elements Element from Care Record Root Element from POIZ Root 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


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.

Data Elements Other Reference 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


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.

Data Element Opt PCC-2 Section 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


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.

Data Element Opt PCC-2 Section 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.

TemplateID 1.3.6.1.4.1.19376.1.5.3.1.3.23
Parent Template CCD 3.11(2.16.840.1.113883.10.20.1.6)
General Description 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.
LOINC Code Opt Description
11369-6 R HISTORY OF IMMUNIZATIONS
Entries Opt Description
1.3.6.1.4.1.19376.1.5.3.1.4.12 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.

TemplateID 1.3.6.1.4.1.19376.1.5.3.1.?.?
Parent Template CCD 3.11(2.16.840.1.113883.10.20.1.6)
General Description 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.
LOINC Code Opt Description
11369-6 R HISTORY OF IMMUNIZATIONS
Entries Opt Description
1.3.6.1.4.1.19376.1.5.3.1.?.? R Immunization Content
Sub-sections Opt Description
1.3.6.1.4.1.19376.1.5.3.1.4.12 R Immunizations
(if no immunizations have been given, that fact must be stated with negationInd = true, and NoImmunizationReason supplied)
Sub-sections Opt Description
1.3.6.1.4.1.19376.1.5.3.1.4.5 R2 Problems and Conditions
Sub-sections Opt Description
11.3.6.1.4.1.19376.1.5.3.1.4.6 R Allergies and Intolerances
(allergy to eggs must be specified, whether positive, negative, or unknown)
(any known reactions to vaccine events must be specified, and linked to the particular immunization event, if known)
Sub-sections Opt Description
1.3.6.1.4.1.19376.1.5.3.1.4.7 R2 Medications
Sub-sections Opt Description
1.3.6.1.4.1.19376.1.5.3.1.4.13.1 R2 Vital Signs Organizer
Sub-sections Opt Description
1.3.6.1.4.1.19376.1.5.3.1.4.13.2 R2 Vital Signs Observation
Sub-sections Opt Description
1.3.6.1.4.1.19376.1.5.3.1.4.13.5 C Pregnancy Observation
Sub-sections Opt Description
1.3.6.1.4.1.19376.1.5.3.1.4.13.7 R2 Advance Directives and Consent Observation
Sub-sub-sections Opt Description
1.3.6.1.4.1.19376.1.5.3.1.4.1 R2 Severity
(used in Problems and Allergies)
Sub-sub-sections Opt Description
1.3.6.1.4.1.19376.1.5.3.1.4.1.1 R2 Clinical Status
(used in Problems and Allergies)
Sub-sub-sections Opt Description
1.3.6.1.4.1.19376.1.5.3.1.4.1.2 R2 Health Status
(used in Problems)
Sub-sub-sections Opt Description
1.3.6.1.4.1.19376.1.5.3.1.4.2 R2 Comments
(used in POIZ, Problems, Allergies and Advance Directives)

Parent Template

This text needs to be fixed-->>do we need this?<<--

<entry>An XML Example</entry>

entry

The parent of this template is CCD 3.11.

SampleMessages

Sample V3 Message for Immunization Summary Option Only

<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>
                   
                   <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'>
                               <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'/>
                                   <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>
                       
                       <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>
                               <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>     
                       
                       <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>
                       
                       <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>
                       
                       <informant typeCode='INF'>
                           <time  value=/>
                           <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">
                                role  
                                role 
                           </informationSource>
                       </informant>
                       
                       <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 Full Immunization Care Record

<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>
                   
                   <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'>
                               <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'/>
                                   <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>
                       
                       <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>
                               <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>     
                       
                       <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>
                       
                       <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>
                       
                       <informant typeCode='INF'>
                           <time  value=/>
                           <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">
                                role  
                                role 
                           </informationSource>
                       </informant>
                       
                       <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>
                   
                   <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>
                       <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>
                   
                   <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'>
                                   
                                       <originalText><reference value='#substance'/></originalText>
                                   
                                   <name></name>
                               </playingEntity>
                           </participantRole>
                       </participant>
                       <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>
                   
                   <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>
                                   
                                       <originalText>Penicillin</originalText>
                                   
                               </administerableMaterial>
                               <desc>patient given Penicillin</desc>
                           </administerableMaterial>
                       </consumable>
                   </substanceAdministration>
                   
                   <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>
                   
                   <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>
                   
                   <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>
                   
                   <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>
                       <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

See Implementation Guide for Immunization Data Transactions Using V 2.3.1 of the Health Level Seven (HL7) Standard Protocol, referenced in Standards above.