direct immunization pilot project charter 1.5

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. Project Description........................................................................................................ 1 2. Business Objectives ...................................................................................................... 1 3. Stakeholders .................................................................................................................. 1 4. Vision ............................................................................................................................ 2 5. Value Propositions ........................................................................................................ 2 6. 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 Page 1

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 Enabling a structured uniform approach for engaging the public

health and provider communities into the HIT standardization

efforts

Project

Sponsor

ADHS Enables a Direct based interface to ASIIS system which gives an

additional method of receiving the immunization data from the

Arizona provider community

Project

Sponsor

AHCCCS Harmonized standards for public health reporting for the selected

use cases within CMS MU stages.


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.


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

7.1. Use Case

7.1.1 Perspective:

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

SOAP +

HTTPS

ASIIS

Match the patient.

Store the record in the Registry

Registry Publish Web Service

Immunization Registry

SMTP+ S/MIME

HISP

HISP PORTAL

NwHIN Direct Implementation

Physician

EHR

Direct Gateway

Receive

S/MIME Verify w/ Source Cert

S/MIME Decrypt w/ Private Key

Download Document(s)

Encrypted Content

Make Asynch SOAP Requests

SMTP+ S/MIME


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.


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


10. Project Deliverables and Timelines.

Event or Deliverable Target Date

Project Initiation and Analysis Phase Target Date

Project Kick-Off and systems survey initiated 08/04/2011

Systems analysis and scoping complete 09/09/2011

Project scope clarification and charter sign-off 09/23/2011

Phase I Limited test users with no SLA, no standalone environment and no Meaningful Use compliance support

Target Date

Project requirements and design specification walkthrough 09/27/2011

Project plan completed for Phase 1 09/27/2011

Project development started 10/03/2011

Project development completed 12/16/2011

Project QA completed 12/16/2011

Project pilot testing completed 12/23/2011

Phase 1 closed out 12/30/2011

Phase II Limited real users with SLA, standalone environment and Meaningful Use compliance support.

Target Date

Phase II project plan completed 10//14/2011

Project plan approved 10/21/2011

Project team assembled 11/04/2011

Project funding secured and go-nogo decision 11/11/2011

Order software and hardware required for the project 11/15/2011

Project execution initiated 12/05/2011

Project execution completed 03/15/2012

Customer acceptance 03/30/2012

Project closed out 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


Risk Probability 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 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.

Operations / Support to the providers for

the long term

Make HISPs responsible for the

support and make it part of their

business model

Early adapters might have to face the

project teething issues

More testing is done and make sure

the issues are caught during the

quality assurance process.

12. Resources

Resource Description and Source

ASET Provides the project management, technical architecture and the

integration and the Direct enablement for the project

ADHS Project management, ASIIS customizations and STC modifications.


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.


Revision History

Name Date Reason For Changes Version

Sri Koka 09/10/2011 Initial Draft Created 1.0

direct immunization pilot project charter 1.5

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