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.
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 |
---|---|---|
Content Consumer | Immunization Summary Option (1) |
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 |
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 | CDA Element |
---|---|---|
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 | CDA Element |
---|---|---|
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 | CDA Element |
---|---|---|
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 | CDA Element |
---|---|---|
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 | CDA Element |
---|---|---|
Current Medications | medications | |
Description | medications.text | |
Date Range | medications.effectiveTime | |
Drug Code | administeredMaterial.code | |
Drug Name | administeredMaterial.name |
Data Elements | Other Reference | CDA Element |
---|---|---|
Observation Date | vitalSigns.organizer.effectiveTime | |
Observation by | vitalSigns.organizer.author | |
Observation Code | LOINC: 8310-5 body temp | vitalSigns.code |
Observation Value - Units | vitalSigns.value |
Data Elements | Other Reference | CDA Element |
---|---|---|
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 | CDA Element |
---|---|---|
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 |
---|---|---|---|
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 | ||
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 |
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 |
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 |
Description | R2 | ||
Date Range | R | ||
Drug Code | R2 | ||
Drug Name | R2 | ||
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 |
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 |
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 |
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) |
Sub-sections | Opt | Description |
1.3.6.1.4.1.19376.1.5.3.1.4.5 | R | Problems and Conditions |
Sub-sections | Opt | Description |
1.3.6.1.4.1.19376.1.5.3.1.4.1 | R | Severity |
Sub-sections | Opt | Description |
1.3.6.1.4.1.19376.1.5.3.1.4.1.1 | R | Clinical Status |
Sub-sections | Opt | Description |
1.3.6.1.4.1.19376.1.5.3.1.4.1.2 | R | Health Status |
Sub-sections | Opt | Description |
1.3.6.1.4.1.19376.1.5.3.1.4.2 | R | Comments |
Sub-sections | Opt | Description |
11.3.6.1.4.1.19376.1.5.3.1.4.6 | R | Allergies and Intolerances |
Sub-sections | Opt | Description |
1.3.6.1.4.1.19376.1.5.3.1.4.7 | R | Medications |
Sub-sections | Opt | Description |
1.3.6.1.4.1.19376.1.5.3.1.4.13.1 | R | Vital Signs Organizer |
Sub-sections | Opt | Description |
1.3.6.1.4.1.19376.1.5.3.1.4.13.2 | R | Vital Signs Observation |
Sub-sections | Opt | Description |
1.3.6.1.4.1.19376.1.5.3.1.4.13.5 | R | Pregnancy Observation |
Sub-sections | Opt | Description |
1.3.6.1.4.1.19376.1.5.3.1.4.13.7 | R | Advance Directives and Consent Observation |
Header Template 1
<entry>An XML Example</entry>
entry
Description of the entry element.
Entry Template 1
<entry>An XML Example</entry>
entry
Description of the entry element.