Immunization Registry Content
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 Registry Content Profile (IRC)
Glossary
- Immunization Information System (IIS)
- Definition
Issue Log
Open Issues
- If we include POIZ in the Immunization Summary, there are two approaches: (1) make sure all the POIZ elements have counterparts in CareRecord; (2) propose changes to CareRecord that incorporate the syntax of POIZ in CareRecord. Is the latter out of scope to this exercise?
- Can we rename the profile to not include the word "registry" - i.e. Immunization Content or Immunization Information System Content? Immunization registries are trying to get away from that phrase and instead call themselves Immunization Information Systems. Also, the word "registry" implies a Central Data Repository model; this content profile can be used for applications reaching beyond that model.
- Should any mention of V2 content be included here? The plan is not to, but on the other hand, where then will it be included?
- V2.3.1 messages blend identity resolution with transmission of clinical data. How to handle this?
- Note that "V2" below refers to "V2.3.1". Note V2.5 is also under development.
- How to handle updates to referenced V2 Guides.
- Had a discussion about queries (using QED) vs. notifications (updates) (using Care Management), also using templates to describe content, and how this would work in V3 vs. V2. Also whether web services could provide a uniform transport layer interface for passing the different types of content.
- We want to use one WSDL for all v3 use cases, and a second WSDL for the same use cases in v2.
- There are essentially 3 different payloads to pass: Submitted History Update; Query for History; and Submitted History for DSS. We hope to use the same WSDL for all of them, and the same message structure for the Immunization History and Care Record details in all of them.
- 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?
Responses:
- The overarching issue which can be discussed in Phoenix at HL7 is the harmonization of messages and documents. The developer does not want to have to translate one to the other, even if all the elements in the one match the elements in another. A precedent was set for this by CCD. However this may be out of scope to our current exercise.
Closed Issues
- What PCC templates should be used?
- In what order should the specified templates appear?
- How will codesets be specified?
- What happens if two consecutive messages have conflicting content?
- Can we include the HL7 V3 Immunization message (POIZ) in the Immunization Summary so as to harmonize with POIZ?
- If we don't include POIZ in the Immunization Summary, how do we get the important elements that are currently missing from the immunization template included, for example, the person who gave the shot?
Resolution
- Immunizations, Allergies & Intolerances, Vitals, Medications, Past Medical History, Problems
- Order does not matter. This is the precedent from other content profiles.
- IHE may leave codesets to implementation, following HITSP recommendations, etc. Keith: IHE profile should leave it somewhat open, but U.S. realm would use CVX codesets for immunizatons, and ICD9 or SNOMED for problems or allergies. But for realms outside U.S. codesets could and would be different.
- This will be handled in the integration profile.
- It appears that all the POIZ elements are currently included in CareRecord, but this needs to be checked in detail. This has been done by Keith and will be looked at further in Phoenix by authors of POIZ. So far no major show-stoppers have surfaced. Most differences include items that are introduced in POIZ but not necessarily in use in installed bases. Base IZ class includes activity time and uncertainly code, not reflected in CR. POIZ includes more support in the protocol area (which is related to decision support), also a new area. It was noted on the recent HL7 PHER call that POIZ is after all DSTU and if harmonization of labels were agreed upon, the changes could be released in a future ballot.
- CareRecord can include person who administered vaccine in Performer role. That would amount to an update to the current immunization template.
Volume I
Add the following bullet to the list of profiles
- Immunization Registry Content - The Immunization Registry Content profile identifies the data to be sent to Immunization Registries
Dependencies
Add the following row(s) to the list of dependencies
Integration Profile
Dependency
Dependency Type
Purpose
Immunization Registry Content
Profile Name
The Immunization Content Profile (IISC)
The Immunization Content Profile (IISC) provides a template for exchanging immunization data.
Immunization data includes two types of content:
- information about administration of vaccines
- care provision information required in making decisions about administration of vaccines
Thus, IISC draws from two HL7 Version 3 message paradigms: Care Provision and Immunizations. (Something about how CareRecord and POIZ harmonization is resolved.)
It seems there are two cases: one where just the immunization summary is passed and the other where the entire CareRecord is passed.
Should we include: To provide for compatibility with the U.S. installed base of Immunization Information Systems (IISs), or Immunization Registries, HL7 Version 2 content is also included.
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 2007-2008 year and is on the IHE roadmap for the future.
Use Cases
Use Case Name 1
EMR system queries IIS for Immunization Summary only. Elaborate.
Use Case Name 2
EMR system sends entire Care Record to IIS or to Decision Support Service. Elaborate.
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 Registry 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.
Grouping
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
Routte
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
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
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
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.
Entry Template 1
<entry>An XML Example</entry>
entry
Description of the entry element.