Project Charter

Direct Immunization Pilot Project

An Eligible Provider/ Eligible Hospital to Submit
Immunization Records to Public Health
Immunization Registry
Version 1.5

Prepared by:

Sri Koka

09/12/2011

Project Charter for Direct Pilot: Immunization Registry

Page ii

Table of Contents
1.
2.
3.
4.
5.
6.

Project Description........................................................................................................ 1
Business Objectives ...................................................................................................... 1
Stakeholders .................................................................................................................. 1
Vision ............................................................................................................................ 2
Value Propositions ........................................................................................................ 2
Project Scope ................................................................................................................ 2
6.1. In Scope ................................................................................................................. 2
6.2. Out of Scope .......................................................................................................... 2
7. User Story ..................................................................................................................... 3
7.1. Use Case ................................................................................................................ 3
7.1.1 Perspective: ..................................................................................................... 3
7.1.2 Context: ........................................................................................................... 4
7.1.3 Story: ............................................................................................................... 4
8. Success Criteria ............................................................................................................. 4
9. Assumptions and Dependencies ................................................................................... 4
10. Project Deliverables and Timelines. ............................................................................. 6
Notes: .................................................................................................................................. 6
11. Business Risks .............................................................................................................. 6
12. Resources ...................................................................................................................... 7
Approvals ............................................................................................................................ 8
Revision History ................................................................................................................. 9

Project Charter for Direct Pilot: Immunization Registry

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1. Project Description
The Direct Project developed specifications and reference implementations for a secure, scalable,
standards-based way to establish universal health addressing and transport for participants
(including providers, laboratories, hospitals, pharmacies and patients) to send encrypted health
information directly to known, trusted recipients over the internet.
This projects intent is to build a Direct based interface to the Arizona State Immunization
Information System (ASIIS) as an additional way for a provider or his/her staff to be able to
submit immunizations to Arizona Department of Health Services (ADHS). This project is
implemented in two phases.
Phase 1 is a limited pilot to submit test immunization data interfacing with the existing ADHS
test environment. This focus of this phase is primarily to test the interoperability between the
Direct HISP and the ASIIS environments. The testing for this will be done by the test users in a
controlled environment. This test environment will have a very low or no SLAs.
Phase 2 of this pilot is to extend this to the real providers. The pilot software will be hosted in a
standalone pilot environment with higher SLAs. Since this involves more resources and systems
additional funding efforts will have to be made. This phase efforts will be in parallel to phase 1
efforts so that this phase will be a gradual progress from phase 1.

2. Business Objectives
Capability to submit electronic immunization data to Arizona State Immunization Information
System using the Direct push based exchange. Providers in the white space areas will be able to
securely submit immunization data to the public health department in one of the following
methods.

Using their Email Client

Using the HISP portal

3. Stakeholders
Stakeholder

Major Benefits

Project
Sponsor

ASET

Project
Sponsor

ADHS

Project
Sponsor

AHCCCS

Enabling a structured uniform approach for engaging the public

health and provider communities into the HIT standardization
efforts
Enables a Direct based interface to ASIIS system which gives an
additional method of receiving the immunization data from the
Arizona provider community
Harmonized standards for public health reporting for the selected
use cases within CMS MU stages.

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4. Vision
To help the Arizona physicians to submit immunization records electronically to the Arizona
Department of Health Services and claim Meaningful Use compliance.

5. Value Propositions

Currently ADHS has a secure web URL for the Arizona provider to submit the
immunization data and achieve MU compliance

The project will give head start into Stage 2 Meaningful Use mandatory requirement

Implementing Direct will give an additional way for an Arizona provider to achieve MU
compliance through Email (SMTP) or a Web Portal as the transport and in the future
when the EHR/EMR market is ready to adapt Direct.

Provides Transitional support for achieving MU.

Offers an immediate workflow efficiency gain by avoiding the double entries into their
EHRs and ASIIS portal.

Less expensive option for eligible providers and ADHS.

6. Project Scope and Constraints

ADHS will provide HISP services by hosting a Direct based gateway system in their data center
to receive immunization data from the providers and hospitals.

6.1. In Scope
The following are in scope through this pilot:
1. Submission of individual immunization records to ADHS.
2. Submission of individual demographics to ADHS.
3. Batch submission of immunization records. (There might be limitation of the attachment
size)
4. CDC compliant HL7 2.3.1 VXU payload is used for the scope of this Charter.
5. Handling ACKs(HL7 Acknowledgements) and NACKs (HL7 Errors) (Phase 2 only)

6.2. Out of Scope

The following are out of scope
1. Submission of Adult (18 years and above) Immunizations.

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2. Responding to immunization history requests.

3. Responding to demographic queries.

6.3. Constraints
1. Adult immunizations are scoped out of this pilot. So this pilot might be constrained for
only the pediatric facilities.
2. Phase 2 needs additional funding requirements which needs to be addressed and can
become constraint for Phase 2.

7. User Story
HISP

Physician

Direct
Gateway

HISP
PORTAL

NwHIN Direct
Implementation

SMTP+
S/MIME

Make Asynch
SOAP Requests

Download
Document(s)

EHR

SMTP+
S/MIME

S/MIME Verify
w/ Source Cert
S/MIME Decrypt
w/ Private Key

Encrypted
Content
Receive

7.1. Use Case

7.1.1 Perspective:
A Provider has a patient immunization event to report to public health.

SOAP
+
HTTPS

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7.1.2 Context:
The provider has made the determination that it is clinically and legally appropriate to
send the immunization message, and the immunization service recognizes the provider's
address.
7.1.3 Story:
A child presents for a routine appointment at a provider office. The provider office staff
searches the EHR for the patient's record. The provider office staff notes that an
immunization is due. (Note, standard protocol in the Provider office may require a
separate query/response transaction to an external immunization registry to confirm exact
immunization status of the patient, but such a query is a background detail that is out of
scope for this user story.) The provider, noting that there are no contraindications for the
immunization, authorizes the immunization.
After the vaccine is administered, the patient record in the Provider EHR is updated with
the vaccine administered, the lot number of the vaccine, the dose of the vaccine, the route
of administration, the body site of the injection (if an injection), and the time of the
vaccine administration. When the vaccine record is saved, the EHR creates a file with
VXU message in the folder.
Provider staff will use the HISP portal or an enterprise email client like Microsoft
Outlook and enters the ADHS Direct email address and clicks the send button. The
message along with the attachment is S/MIME encrypted and sent to the Direct gateway
hosted at ADHS.
The gateway receives the encrypted content, validates the senders certificate and
decrypts the content and calls the ASIIS web service and publishes the record to ASIIS.

8. Success Criteria

Provider successfully submit immunization data to ASIIS

ADHS will be the Direct enabled.
Submit 10 to 100 immunization messages and then audit Immunization registry to
confirm the correct receipt of messages.

9. Assumptions and Dependencies

AS-1: The HISP or the Direct Gateway (DG) is fully trusted and responsible for content
packaging, addressing, security and delivery.
AS-2: Providers EHR is able to create the HL7/VXU messages.
AS-3: Transactions are asynchronous and HISPs or Provider Gateways can request for
acknowledgements.
AS-4: The test environment is available from M F from 7:00 AM 6:00 PM for compliance
testing. (Phase II only)
AS-5: HL7 2.3.1 messages are used for the scope of this Charter.

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DE-1: The system performance and availability depends on the backend ASIIS system and STC
Modules.

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10. Project Deliverables and Timelines.

Event or Deliverable
Project Initiation and Analysis Phase
Project Kick-Off and systems survey initiated
Systems analysis and scoping complete
Project scope clarification and charter sign-off
Phase I Limited test users with no SLA, no standalone environment and no
Meaningful Use compliance support
Project requirements and design specification walkthrough
Project plan completed for Phase 1
Project development started
Project development completed
Project QA completed
Project pilot testing completed
Phase 1 closed out
Phase II Limited real users with SLA, standalone environment and
Meaningful Use compliance support.
Phase II project plan completed
Project plan approved
Project team assembled
Project funding secured and go-nogo decision
Order software and hardware required for the project
Project execution initiated
Project execution completed
Customer acceptance
Project closed out

Target Date
Target Date
08/04/2011
09/09/2011
09/23/2011
Target Date
09/27/2011
09/27/2011
10/03/2011
12/16/2011
12/16/2011
12/23/2011
12/30/2011
Target Date
10//14/2011
10/21/2011
11/04/2011
11/11/2011
11/15/2011
12/05/2011
03/15/2012
03/30/2012
03/30/2012

Phase 2 timelines listed in this document are not firm at the time of writing this Charter. The
detailed timelines will be published after a detail requirement analysis which is planned to be
done at the commencement of Phase 2.

Notes:
1. Phase I is interoperability testing only and will be executed in the test environment. Test data will
be used for testing.
2. Phase I is already agreed upon by ADHS and ASET.
3. Phase I users are the test users only, not meant for the real providers.
4. Phase I is already in progress and currently being the requirements and the design phase.
5. Intent to do the Phase II needs to agreed upon.
6. Phase II needs additional resources, new environment and funding.

11. Business Risks

Project Charter for Direct Pilot: Immunization Registry

Risk

Probability

Page 7

Impact

Mitigation

Not able to secure resources and funding

for doing Phase II as a permanent
environment for the white space
providers to submit immunizations
Provider adaption could be low

Operations / Support to the providers for

the long term
Early adapters might have to face the
project teething issues

More training and show and tell

sessions about this availability.
Include the Direct based
Immunization publishing as a part of
the ADHS training to the providers.
Make HISPs responsible for the
support and make it part of their
business model
More testing is done and make sure
the issues are caught during the
quality assurance process.

12. Resources
Resource
ASET
ADHS

Description and Source

Provides the project management, technical architecture and the
integration and the Direct enablement for the project
Project management, ASIIS customizations and STC modifications.

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Approvals
Agency

Name and Signature

Date

ASET Project Sponsor /

Stakeholder

ADHS Project Sponsor /

Stakeholder

AHCCCS Project Sponsor /

Stakeholder

1. Phase 2 timelines are for planning purposes only. These dates will be
more concrete in November timeframe based on the detailed analysis.

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Revision History
Name

Sri Koka

Date

09/10/2011

Reason For Changes

Initial Draft Created

Version

1.0