Immunization Registry Content

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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

  1. 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?
  2. 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.
  3. How will V2 content be handled here? If not here, where then will it be included?

This text needs to be fixed-->>register IZ Implementation Guide with HL7 Message Profile Registry<<--

  1. V2.3.1 messages blend identity resolution with transmission of clinical data. How to handle this?
  2. Note that "V2" below refers to "V2.3.1". Note V2.5 is also under development.
  3. How to handle updates to referenced V2 Guides.
  4. 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.

This text needs to be fixed-->>Care mgt defining WSDL, we supply template<<--

  1. We want to use one WSDL for all v3 use cases, and a second WSDL for the same use cases in v2.

This text needs to be fixed-->>V2 uses MLLP/MLLP under TLS might belong in Care Management batch vs. realtime belongs here?<<--

  1. 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.
  2. 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.
  3. 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:

  1. 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

  1. What PCC templates should be used?
  2. In what order should the specified templates appear?
  3. How will codesets be specified?
  4. What happens if two consecutive messages have conflicting content?
  5. Can we include the HL7 V3 Immunization message (POIZ) in the Immunization Summary so as to harmonize with POIZ?
  6. 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

  1. Immunizations, Allergies & Intolerances, Vitals, Medications, Past Medical History, Problems
  2. Order does not matter. This is the precedent from other content profiles.
  3. 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.
  4. This will be handled in the integration profile.
  5. 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.
  6. 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:

  1. information about administration of vaccines
  2. 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.

Immunization Registry Content Actor Diagram

Options

Actor Option Section
Immunization Registry 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.

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
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
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.


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