Difference between revisions of "Immunization Registry Content"
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− | * Immunization Content - The Immunization Content | + | * 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=== | ===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> |
Revision as of 11:29, 23 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, other public health systems, 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
- 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 IC 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.
- Assuming Care Management (CM) provides a notification option for V2 (VXQ/VXX/VXR), we still don't have a query option for V2. We are asking for public comment on this point.
- 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.
Notes to Author
- 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 "V2" below refers to "V2.3.1". Note V2.5 is also under development.
- Address how to handle updates to referenced V2 Guides.
- POIZ DSTU includes a "subject" tag that is redundant with the "patient" tag in Care Record, and is stated to be "required." We want to omit or ignore it, since it is redundant in the Care Record context.
- POIZ DSTU appears to use different tagnames for "author" and "informant" than PCC defines them in section 6.4.4.1. PCC-2 samples (e.g.:6.4.4.20) and specs (6.4.4.1) show:
<author typeCode='AUT'> <assignedEntity classCode='ASSIGNED'> <id root= extension=/> <addr></addr> <telecom use= value=/> <assignedPerson classCode='PSN'> <name>…</name> </assignedPerson> <representedOrganization> <name>...</name> </representedOrganization> </assignedEntity> </author>
versus POIZ, which appears to me to show in POIZ_HD030050UV and COCT_MT090107UV:
<author typeCode='AUT' contextControlCode='OP'>
<assignedPerson classCode='ASSIGNED'>
<id root= extension=/>
<addr></addr>
<telecom use= value=/>
<person classCode='PSN' determinerCode='INSTANCE'>
<name>...</name>
</person>
<representedOrganization classCode='ORG'
determinerCode='INSTANCE'>
<name>...</name>
</representedOrganization>
</assignedPerson>
</author>
Although the structures are the same (with the addition of a Role code in POIZ), the tagnames are different than those used for author in Care Record. Also, some of the PCC-2 samples show other tagnames for author (e.g.: 6.4.4.6). Is this an issue?
Closed Issues
- 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.
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 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 multiple organizations. By creating common data formats for immunization data that seamlessly integrate with both the existing installed Immunization Information System (IIS) base and with other data needed for the overall care of a patient, exchange among IISs, EMRs, Health Information Exchanges, other public health systems, Personal Health Record (PHR) systems, and other stakeholder systems is facilitated.
The format of data to be queried or sent is a separate topic from whether the data is automatically "pushed" to another system or whether it is queried on demand. By isolating content description from transaction description, the same content can be exchanged both in query and notification (unsolicited update) transaction styles. 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. In the future, it may also be used with document-oriented profiles such as XDS, or with future decision support profiles.
By using composable patterns such as HL7 Version 3 CareRecord, immunization content can be limited to a patient's immunization history only, or can additionally contain other medical summary information that may be required for decision support. 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. At this writing, development of a CDC HL7 Version 2.5 Implementation Guide for IISs is underway; thus an HL7 Version 2.5 option may be added in the future.
The IC Profile is also intended to pave the way for content to be passed to immunization-related decision support services. This however is out of scope for the 2007-2009 IHE cycle and is on the IHE roadmap for the future.
Use Cases
Use Case 1: Immunization Information System Participation
An EMR vendor wishes to facilitate customer requirements to comply with regional mandates to submit immunization histories for its pediatric patients to a regional IIS. The provider IT department configures an HL7 Verion 2.3.1 connection with the IIS. Each time immunizations are recorded for a patient under the age of 18, his or her immunization records are automatically sent to the IIS using a real-time HL7 version 2.3.1 standard format.
This is the historical use case.
Use Case 2: Immunization Yellow Card
A provider wishes to produce an official immunization card. The provider EMR system retrieves demographic information and records of immunization this provider has given from its immunization repository. It then creates a connection with an immunization repository in order to query for records of immunizations for its patients that may have been given by other providers. It assembles the data into a CareRecord format. It passes the formatted immunization content to a module or service that prints the demographic and immunization information in the official Yellow Card format.
Use Case 3: Continuity of Care Document
The EMR system queries repositories for various additional patient information such as allergies, past adverse events, conditions such as pregnancy, past medical history such as disease history, and past immunization history. It assembles the data with previously retrieved immunization information into a CareRecord format. It saves the information as a Continuity of Care Document.
Use Case 4: Vaccine Forecast
A provider wishes to perform a Vaccine Forecast Decision Support Service. 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 HL7 Version 3 format. The provider EMR system retrieves a Continuity of Care Document for the patient that it has previously assembled. It passes the data in a CareRecord format according to the Immunization Content standard format. It passes the formatted immunization content to the Vaccine Forecast Decision Support Service and receives a vaccine forecast care plan in return.
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.
Options
Actor
Option
Section
Immunization Content Options
Content Consumer
Immunization Summary 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)
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.
Content Modules
Content modules describe the content of a payload found in an IHE transaction. Content profiles are transaction neutral. They do not have dependencies upon the transaction that they appear in.
Content Module 1
Process Flow
More text about process flow
Actor Definitions
- Actor
- Definition
Transaction Definitions
- Transaction
- Definition
Volume II
Immunization Registry 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.
- HSSP Retrieve, Locate and Update Service
- Implementation Service Functional Model (SFM), balloted HL7 Draft Standard for Trial Use (DSTU) HL7.
- HSSP Retrieve, Locate and Update Service
- Initial submission to OMG includes a profile that demonstrates immunization data retrieval and update in conformance to SFM
- 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
Data Elements
Other Reference
Care Record Element
Existing Common Care Record Elements Required for Immunization Registry Content
Patient ID
not required for VFM DSS
patient.id
DOB
only required for VFM DSS
patient.birthTime
Gender
only required for VFM DSS
patient.administrativeGender
Data Elements
Other Reference
Care Record Element
Immunization Registry Content Data Elements based on POIZ
Immunization Record ID
instance identifier
immunization.id
Negation Indicator
immunization.negationInd
Description
immunization.text
Immunization Date
immunization.effectiveTime
Confidentiality Code
immunization.confidentialityCode
Uncertainty Code
immunization.uncertaintyCode
Dose Quantity
immunization.doseQuantity.value - units
Route
immunization.routeCode
Approach Site
immunization.approachSiteCode
Vaccine Code
CDC CVX code in US
administerableMaterial.code
Vaccine Name
administerableMaterial.name
Vaccine Lot #
administerableMaterial.lotNumberText
Vaccine Expiration Date
administerableMaterial.expirationTime
Manufacturer ID
CDC MVX code in US
asMedicineManufacturer.manufacturer.id
Manufacturer name
asMedicineManufacturer.manufacturer.name
Vaccine Lot # Recalled Observation
???
Performer ID
performer.assignedPerson.id
Performer Name
performer.assignedPerson.assignedPrincipalChoice List.person.name
Performer Organization ID
performer.assignedPerson.representedOrganization.id
Performer Organization Name
performer.assignedPerson.representedOrganization.name
Author ID
author.assignedPerson.id
Author Role
author.role.code
Author Name
author.person.name
Informant Name
informant.person.name
Informant Mode
written/verbal/electronic
informant.modeCode
Informant Source
patient/relative/provider
informant.informationSourceCode
Vaccine Information Statement Given
observation.code
VIS Version
observation.value
Reason Not Administered
reason.noImmunizationReason.reasonCode
Shot Comments / Notes
annotation.text
Data Elements
Other Reference
Care Record Element
Existing Problem Record Data Elements
ID
problems.id
Problem began
problems.effectiveTime.low
Problem ended
problems.effectiveTime.high
Problem Type
SNOMED CT type of problem
problems.code
Confidentiality Code
problems.confidentialityCode
Uncertainty Code
problems.uncertaintyCode
Problem Code
ICD-9 or SNOMED problem code
problems.value
Severity
problems.severity
Clinical Status
problems.clinicalStatus
Health Status
problems.healthStatus
Comments
problems.comments
Data Elements
Other Reference
Care Record Element
Existing Allergy and Intolerance Data Elements
ID
intolerance.id
Intolerance Type
ObservationIntoleranceType
intolerances.code
Allergy Code
ICD-9 or SNOMED allergy code
intolerances.value
Allergen Substance
substance causing allergy
intolerances.participant.code
Allergic Reaction History
intolerances.reactions
Severity
intolerances.severity
Clinical Status
intolerances.clinicalStatus
Comments
intolerances.comments
Data Elements
Other Reference
Care Record Element
Existing Medications Data Elements
ID
medications.id
Description
medications.text
Date Range
medications.effectiveTime
Drug Code
administeredMaterial.code
Drug Name
administeredMaterial.name
Data Elements
Other Reference
Care Record Element
Existing Simple Observations for Labs
ID
labs.id
Lab Code
labs.code
Description
labs.text
Date
labs.effectiveTime
Result
labs.value
Result Interpretation
labs.interpretationCode
Test Method
labs.methodCode
Author ID
labs.author.id
Author Name
labs.author.name
Data Elements
Other Reference
Care Record Element
Existing Vital Signs Data Elements
Observation Date
vitalSigns.organizer.effectiveTime
Observation by
vitalSigns.organizer.author
ID
vitalSigns.id
Observation Code
LOINC: 8310-5 body temp
vitalSigns.code
Observation Value - Units
vitalSigns.value
Data Elements
Other Reference
Care Record Element
Existing Pregnancy Data Elements
ID
pregnancy.id
Observation Date
pregnancy.effectiveTime
Pregnancy Info Type
LOINC: 11449-6 Pregnancy Status
pregnancy.code
Pregnancy Status
pregnancy.value
Pregnancy Info Type
LOINC: <several codes> Estimated Delivery Date
pregnancy.code
Estimated Due Date
pregnancy.value
Data Elements
Other Reference
Care Record Element
Existing Advanced Directives Data Elements
ID
advanceDirectives.id
Scope (Refusal Reason Code)
<additions to list of SNOMED code(s) to include IZ Refusal Reasons>
advanceDirectives.code
Scope Permitted?
advanceDirectives.value
Description
advanceDirectives.text
Effective From Date
advanceDirectives.effectiveTime.low
Effective Thru Date
advanceDirectives.effectiveTime.high
Comments
advanceDirectives.comments
Data Elements
Other Reference
Care Record Element
Update Entry
Type Code
replace or append
reference.typeCode
Referenced Act ID
ii
reference.externalAct.id
Document Specification
Data Element
Opt
PCC Section
Template ID
Immunization Registry Content Constraints
Original Care Record
R
Patient ID
C
Not Required for VFM DSS
DOB
C
Only Required for VFM DSS
Gender
C
Only Required for VFM DSS
History of Immunizations (POIZ)
R
1.3.6.1.4.1.19376.1.5.3.1.4.??
Immunization Record ID
R
Negation Indicator
R
Description
R
Immunization Date
R
Confidentiality Code
R2
Uncertainty Code
R2
Dose Quantity
R2
Route
R2
Approach Site
R2
Vaccine Code
R
CDC CVX
2.16.840.1.113883.6.59
Vaccine Name
R2
Vaccine Lot #
R2
Vaccine Expiration Date
R2
Manufacturer ID
R2
Performer Person ID
R2
Performer Person Name
O
Performer Organization ID
R2
Performer Organization Name
O
Author
R2
6.4.4.1
Informant
R2
6.4.4.1
Vaccine Information Statement Given
R2
VIS Version
R2
Reason Not Administered
R2
Comments about Shot
R2
6.4.4.6
1.3.6.1.4.1.19376.1.5.3.1.4.2
Authors and Informants
R2
6.4.4.1
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
Update Entry
C
6.4.4.31
1.3.6.1.4.1.19376.1.5.3.1.4.16
Type Code
R
6.4.4.31.3
RPLC or APND
Referenced Act ID
R
6.4.4.31.5
id of section being replaced or appended to
Immunization Registry Content Section
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 Registry Content
Sub-sections
Opt
Description
1.3.6.1.4.1.19376.1.5.3.1.?.?
R
History of Immunizations (POIZ)
(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
<entry>An XML Example</entry>
entry
The parent of this template is CCD 3.11.
SampleMessages
Sample V3 Message
XML sample V3 message
Sample V2 Message
sample V2 message