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 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

Public comment is solicited on all of the following 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 PCC-2 Immunization Summary template to contain all the fields in POIZ that are also supported in CareRecord. Template for Immunizations needs to be fixed to include Lot #, Manufacturer, and Expiration Date, and a few other items. The updated template is the equivalent of a POIZ template on CareRecord. This update needs to be completed by the appropriate means.
  2. Template for Advanced Directives needs to be fixed to include Immunization Refusal Reasons.
  3. It is expected that ballot comments on the CareRecord DSTU within HL7 will include requests to add elements available in POIZ but not accommodated in CareRecord. Assuming those elements are eventually added, this IC profile will have to be updated to also include them.
  4. Not enough is said about precisely how the HL7 Version 2 messages are to be used. HL7 Version 2 couples content more tightly with message syntax than Verion 3. Care Management (CM) provides the notification-based integration profile, and Query for Existing Data (QED) provides a query-based integration profile for the HL7 V3 portions of this profile. However, it is unclear how CM and QED will handle V2. V2.3.1 messages blend identity resolution, which is outside the scope of this profile, with transmission of clinical data; how will this be handled? Also, if a Version 2 Implementation Guide is referenced, how will updates to that document be handled?
  5. 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 or even three profiles, i.e. , one for HL7 Version 2, and one or two for HL7 Version 3 (depending upon whether the Immunization Summary and Care Record options are combined).
  6. Implementation of this profile within PCC Volumes I and II will involve a two-part exercises: (1) update of the existing PCC-2 Immunization Summary template to reflect missing POIZ fields; and (2) creation of a new profile for the Care Record Option that includes Allergies, Problems, etc. - something that looks more like a discharge summary or a transfer of care summary, etc.
  7. 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?


Closed Issues

  1. 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. The other possibility is to use the POIZ tags, which may be more meaningful to immunization domain experts. However, we felt that the POIZ tag names and definitions within the HL7 POIZ HMD were not significantly more descriptive to warrant "breaking" software that currently parses Care Record messages and may expect Care Record tags.

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 (IC) Care Management (CM) The Content Creator actor of the IC profile must be grouped with the Clinical Data Source Actor of the CM profile The IC profile defines the content sent in the PCC-11 transaction specified in the CM profile
Immunization Content (IC) Care Management (CM) The Content Consumer actor of the IC profile must be grouped with the Care Manager Actor of the CM profile The IC profile defines the content recieved in the PCC-11 transaction specified in the CM profile
Immunization Content (IC) ATNA Actors the IC profile shall implement the Secure Node Actor of the ATNA profile Ensures that transmissions and changes to patient health information are logged in an audit repository, and that communication is secured between nodes.
Immunization Content (IC) ATNA Actors the IC profile shall implement the Time Client Actor of the CT profile Ensures that concistent time is used in all messages.

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.

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
Immunization Content Options
Content Consumer No Options Defined
Content Creator Immunization Summary Option (1)

Immunization Detail Option (1)
V2 Immunization Update Option (1)

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

Immunization Summary Option

The Immunization Summary Option is based upon HL7 Version 3. It includes information about immunization history of a patient.

Immunization Detail Option

The Immunization Detail Option is also based upon HL7 Version 3. It includes all of the requirements of the Immunization Summary Option, plus ancillary information to support decisions about the treatment of a patient related to immunizations. For example, it includes the patient's allergies, which may be relevant in deciding whether or not to give certain vaccines.

V2 Immunization Update Option

The V2 Immunization Update Option is for backwards compatibility with existing HL7 Version 2.3.1 immunization messaging.

Grouping

Care Management (CM)

The Content Creator of this profile must be grouped with the Clinical Data Source of the Care Management profile. The Clinical Data Source actor must implement the V2 Care Management Update Option.

The Content Consumer Actor of this profile must be grouped with the Care Manager actor of the Care Management profile.