LRI+Architecture+IR

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Purpose

 * Create Lab Reporting deployment models to evaluate how the Lab Reporting Interface specification would work when implemented.
 * Identify the policies, services, regulatory requirements, and other dependencies that are needed to ensure that a Lab Reporting Interface specification is implementable.

=LRI Objectives= There are two distinct S&I Framework LRI Architecture objectives:
 * Enable the demonstration of the LRI User Story for electronic test results delivery using the S&I Framework Implementation Guide and Vocabulary using **S&I Initiative LRI** **Pilot Demonstration** artifacts. The Pilot Demonstration artifacts will only address ambulatory message exchange.
 * ‍‍‍‍‍‍And provide **S&I Initiative LRI Validation Services** artifacts which the community can use to validate the messages created to comply with the S&I Initiative LRI artifacts. The Validation Services artifacts will address ambulatory and public health exchange.

=LRI Projects=

S&I Initiative LRI Pilot Demonstrations
The LRI Use Case describes the sample user story to transmit Laboratory Test Results from an LIS to an EHR. In addition, the Use Case also identifies the content that needs to be exchanged for the Laboratory Test Results to be delivered electronically. See Section 9.0 of the Final LRI Use Case. The LRI Abstract Model identifies the systems actors and interactions and defines some of the terms and definitions relevant to the LRI Implementation. ‍‍‍LRI Pilot Demonstration architectural artifacts will help define the operating environment of the IT Systems.‍‍‍ The LRI Deployment Models and LRI Sequence Diagrams/Activity Diagrams further define the expected environment within the IT System is expected to function, while the LRI Policy and Service Identification define the expected behavior of the IT Systems.

The S&I Initiative LRI Pilot Demonstration provides implementers with the basis from which participants can implement systems defined in the LRI Abstract Model and which are capable of supporting the HL7 Laboratory Test Result messages specified by the LRI S&I Framework Implementation Guide which is being developed by the LRI IGs Analysis WG, as well as support the Vocabulary constraints being developed by the LRI Vocabulary WG. The LRI Vocabulary WG has also defined the list of Laboratory Test Results which will be tested as part of the Pilot Demonstration.**‍**

LRI Pilot Demonstration Assumptions
The LRI Initiative itself is focused on the exchange of the LRI Test Results Messages.As such, there are a number of assumptions which have been made by the Use Case which may need to taken into account when developing a system for the LRI Pilot Demonstration.


 * T**he definition of the Transport, Security, Privacy, Addressing, Audit, and Patient Identification** are out of scope for the LRI Pilot. These are all essential components from an overall system perspective and will likely be provided by the LIS and EHR systems selected for pilot. Other projects (Direct Project, Nationwide Health Information Network Exchange and CONNECT, etc.) have already produced open source reference implementations for transport, encryption, and other infrastructure. Some of the code from these other projects may be used in the LRI Pilot Demonstrations for access control, audit log, authentication, integrity, encryption of data in rest and in transit. These projects have already been specified by ONC in its Final Rule for EHR Standards and Certification. Other ONC S&I Framework Initiatives, such as Provider Directory and Certificate Interoperability, will address gaps in standards and implementation guidance that have not been previously specified in regulations and/or standards.
 * **The LRI Initiative acknowledges the variations in requirements for reporting across local, state, tribal, and territorial boundaries as well as voluntary versus mandatory requirements**; however, the handling of these requirements is out of scope for the purpose of the LRI Pilot.
 * **Organizations are assumed to have patient consent policies** in place as appropriate and these existing mechanisms will be used by the LIS and EHR before LRI information is exchanged between the IT Systems..
 * **Additional assumptions and preconditions** can be found in the LRI Final Use Case (Sections 2.1 and 2.2 as well as Sections 6.0 and 7.0).

**LRI Pilot Demonstrations Works in Progress**

 * < **Artifact Name** ||< **Description/Purpose** ||< **Status** ||< **Owners/Editors** ||
 * Sequence Diagrams/Activity Diagrams || Re-use Sequence / Activity diagrams showing the interaction between the various systems involved in the LRI use case, and expand scope and detail. || Closed || Rob Allen ||
 * Deployment Models || Describes the various deployment models and configuration of services required to implement the LRI use case. || Closed || Bob Lutolf/Rob Allen ||
 * LRI Policy and Service Identification || Document and model linkages to the policies and services to ensure LRI specification is implementable. || Closed || Rob Allen ||
 * LRI Architecture Consensus || This consensus page references the main LRI Architecture wiki page; Sequence Diagrams/Activity Diagrams; Deployment Models; and LRI Policy and Service Identification. || Closed ||  ||

S&I Initiative LRI Validation Services
‍‍‍The primary purpose of the S&I Initiative LRI Validation Services is to provide validation tools to verify the LRI messaging between the LIS and EHR IT Systems, and furthermore to enable Users to visualize the data required for CLIA compliance prior to LIS/EHR Certification. In order to accomplish this the following validation tools will be required:
 * LIS Validation Test Tool to create LRI Test Results Messages
 * EHR Validation Test Tool to consume LRI Test Results Messages
 * Visualization Test to Tool to display the Laboratory Test Results specified by CLIA

The LRI Validation Services will incorporate the LRI messaging requirements and vocabulary being defined by the LRI IGs Analysis WG and LRI Vocabulary WG, using validation test data for the Laboratory Test Results specified by the LRI Vocabulary WG. THE LRI Validation Services will show that test result messages can be generated by senders and consumed by receivers as described in the LRI Abstract Model.‍‍‍



Reference Materials/Artifacts

 * **Date** || **Description** || **Relevant Project** ||
 * 05/08/2011 || [|HITSP/SC115 HL7 Messaging Service Collaboration v 1.1 (2010)] || For Background Only ||
 * 05/08/2011 || [|HITSP/TN900 Security and Privacy Technical Note v 1.3 (2009)] || For Background Only ||
 * 05/08/2011 || [|HITSP/TP14 Send Lab Result Message v 2.1 (2007)] || For Background Only ||
 * 05/08/2011 || [[file:siframework/HL7_AmbulatoryCareLabResultSpecification-R1_v2.5.1.pdf|HL7 v 2.5.1 Ambulatory Care Lab Result (ELINCS) R1 (2008)]] || For Background Only ||
 * 05/08/2011 || [[file:siframework/InteroperabilitySpecificationLabResultMessage_v2.5.1.pdf|HL7 v 2.5.1 Interoperability Specification Lab Result Message (2007)]] || For Background Only ||
 * 05/25/2011 || Abstract Model - consensus achieved on 5/23/2011 || Pilot Demonstration ||
 * 07/06/2011 || [[file:siframework/LRI RI Preliminary.pdf|NIST LRI RI Preliminary (PDF)]] || Validation Services ||
 * 07/06/2011 || [[file:siframework/LabMU-S2-Testing.pptx|NIST Lab Meaningful Use Stage 2 Testing (PowerPoint)]] || Validation Services ||
 * 07/11/2011 || [[file:siframework/LRI_RI_NIST_07112011 Arch WG.pptx|LRI Validation Suite and Pilots: Vision, Charter, NIST Collaboration (PowerPoint)]] || Validation Services ||

Meeting Minutes

 * **Meeting Date** || **Presentation** || **Minutes** ||
 * April 5, 2011 || [[file:siframework/LRI Implementation Requirements SWG - Kickoff.pdf|04/05 Agenda]] || 04/05 Meeting Minutes ||
 * April 6, 2011 || [[file:siframework/LRI Architecture SWG - Kickoff.pdf|04/06 Agenda]] || 04/06 Meeting Minutes ||
 * April 18, 2011 || [[file:siframework/20110418 LRI Arch_Implementation RQ Agenda.pdf|04/18 Agenda]] || 04/18 Meeting Minutes ||
 * May 2, 2011 || 05/02 Agenda || 05/02 Meeting Minutes ||
 * May 9, 2011 || 05/09 Agenda || 05/09 Meeting Minutes ||
 * May 23, 2011 || 05/23 Agenda || 05/23 Meeting Minutes ||
 * June 2, 2011 || 06/02 Agenda || 06/02 Meeting Minutes ||
 * June 6, 2011 || 06/06 Agenda || 06/06 Meeting Minutes ||
 * June 20, 2011 || 06/20 Agenda || 06/20 Meeting Minutes ||
 * June 27, 2011 || 06/27 Agenda || 06/27 Meeting Minutes ||
 * July 6, 2011 || None || 07/06 Meeting Minutes ||
 * July 11, 2011 || 07/11 Agenda || 07/11 Meeting Minutes ||

Workgroup Members

 * WG Chairs:** Bob Lutolf, Gensa Corporation and Rob Allen, Gensa Corporation
 * ONC Representative:** Jitin Asnaani
 * **Name** || **Organization** || **Contact Info** || **Role** ||
 * Jitin Asnaani || ONC || jitin.asnaani@hhs.gov || ONC Representative ||
 * Erik Pupo || ONC Contractor (Deloitte) || erpupo@deloitte.com || Support Lead ||
 * Ken McCaslin || Quest Diagnostics || Kenneth.h.mccaslin@questdiagnostics.com || Committed Member ||
 * Robert Snelick || NIST || robert.snelick@nist.gov || Committed Member ||
 * Rob Allen || Gensa Corporation || allenr@gensa.com || Co-Lead ||
 * Krishna Murali Brahmandam || Proheamon, Inc. || krishna@proheamon.com || Committed Member ||
 * Lalith Vaka || HealthNow NY Inc || lalith.vaka@healthnow.org || Committed Member ||
 * Nagesh Bashyam || ONC Contractor (Harris) || nbashy01@harris.com || Architecture Support ||
 * Cindy Levy || ONC Contractor (Pomegranate) || clevy@pomegranate-econsulting.com || Architecture Support ||
 * Andrew Splitz || S&P Consultants || asplitz@spconinc.com || Committed Member ||
 * David Cheng || IBM || dcheng@us.ibm.com || Committed Member ||
 * Lester Keepper || SHAPE HITECH || lkeepper@shapehithech.com || Committed Member ||
 * Ernest Grove || SHAPE HITECH || egrove@shapehitech.com || Committed Member ||
 * Freida Hall || Quest Diagnostics || Freida.X.Hall@QuestDiagnostics.com || Committed Member ||
 * Chris Doucette || Deloitte || cdoucette@deloitte.com || Committed Member ||
 * Andriy Selivonenko || ONC Contractor (Lockheed Martin) || Andriy.Selivonenko@lmco.com || Contractor ||
 * Anjali Gupte || ONC Contractor (Lockheed Martin) || anjali.gupte@lmco.com || Contractor ||
 * Tom Boal || ONC Contractor (Lockheed Martin) || thomas.boal@lmco.com || Contractor ||
 * Nikolay Lipskiy || CDC, OSELS || dgz1@cdc.gov || Committed Member ||
 * Bob Yencha || ONC Contractor (Lantana) || Bob.Yencha@lantanagroup.com || Contractor ||
 * Ed Larson || ONC Contractor (Accenture) || e.larsen@ix.netcom.com || Contractor ||
 * Jeff Tunkel || ONC Contractor (Lockheed Martin) || jeffrey.w.tunkel@lmco.com || Contractor ||
 * John Ritter || College of American Pathologists || jritter@cap.org || Committed Member ||
 * John Roberts || TN Dept of Health || john.a.roberts@tn.gov || Committed Member ||
 * Jonathan Tadese || ONC Contractor (Deloitte) || jtadese@deloitte.com || Contractor ||
 * Rich Kernan || ONC Contractor (Deloitte) || rkernan@deloitte.com || Support Lead/Contractor ||
 * Rita Altamore || State of WA - DOH || Rita.Altamore@doh.wa.gov || Committed Member ||
 * Tim Reardon || A+ Government Solutions || treardon@aplusgov.com || Committed Member ||
 * Neelima Chennamaraja || ONC Contractor (Harris) || nchennam@harris.com || Contractor ||
 * Kosta Makrodimitris || USFDA,FHIMS || kosta.makrodimitris@fda.hhs.gov || Committed Member ||
 * Bob Lutolf || Gensa Corporation || lutolfr@gensa.com || Co-Lead ||
 * David Burgess || Labcorp || burgesd@labcorp.com || Committed Member ||

**LRI Pilot Architecture ‍‍‍‍‍‍‍‍Assumptions‍‍‍‍‍‍‍‍ ** **In-Scope ** **Out-of-Scope ** **Transport, Security, Privacy, Addressing, Audit, and Patient Identification are out of scope for the LRI Pilot. ** These are all essential components from an overall system perspective and will likely be provided by the LIS and EHR systems selected for pilot. However, this LRI initiative is about message structure and content, not about transport or other infrastructure. The pilot should not require code to transport, encrypt, or otherwise "secure" the payloads from a sender to a receiver. Other projects (Direct Project, Nationwide Health Information Network Exchange and CONNECT, etc.) have already produced open source reference implementations for transport, encryption, and other infrastructure. Some of the code from these other projects may be used in the LRI Pilot Demonstrations for access control, audit log, authentication, integrity, encryption of data in rest and in transit. These projects have already been specified by ONC in its Final Rule for EHR Standards and Certification. Other ONC S&I Framework Initiatives, such as Provider Directory and Certificate Interoperability, will address gaps in standards and implementation guidance that have not been previously specified in regulations and/or standards.

The LRI Initiative acknowledges the variations in requirements for reporting across local, state, tribal, and territorial boundaries as well as voluntary versus mandatory requirements; however, the handling of these requirements is out of scope. **Patient Consent ** Organizations are assumed to have patient consent policies in place as appropriate and these existing mechanisms will be used by the senders and receivers before LRI information is exchanged between the senders and the receivers. **Additional Assumptions ** <span style="display: block; height: 1px; left: -10000px; overflow: hidden; position: absolute; top: 440px; width: 1px;">Additional assumptions and preconditions can be found in the LRI Final Use Case (Sections 6.0 and 7.0). <span style="color: #025aa3; display: block; font-family: century; font-size: 36pt; height: 1px; left: -10000px; overflow: hidden; position: absolute; top: 2090px; width: 1px;">Vision, Charter, NIST Collaboration

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