1. S&I Framework Testing HL7 V2 Lab Results Interface and RI Pilot Robert Snelick National Institute of Standards and Technology June 23 rd, 2011 Contact: robert.snelick@nist.gov

2. 2 Agenda S&I Framework Overview –Big picture; MU stage 2; LRI Testing and relationship to MU-2 Testing NIST MU stage 1 –Test Procedures; MU Stage 1 HL7 V2 testing; Role for stage 2 S&I Framework RI and Pilot Testing –Goals, Requirements, and Tooling Needs –Purpose/Scope of tools (for Pilot testing and/or MU certification?) –How and what can NIST contribute Operational Issues –Decide who will do what (and timeline), IP, Ownership, more?? Develop plans for moving forward Plan follow-up actions and meetings

3. 3 LRI Reference Implementation Objectives The primary LRI RI purpose is to demonstrate that an LRI Test Result Message can be generated and consumed using the LRI CIM and the services specified in the LRI Architecture. The first objective of the RI will be to demonstrate the LRI S&I Framework test result message by: Electronically generating an HL7 test result message that –Complies with the LRI Implementation Guide Analysis Workgroup Test Result Guide –Utilizes the vocabulary specified by the LRI CIM/Vocabulary Workgroup Electronically consumes the S&I Framework Test Result Message decomposing the message into the atomic data elements

4. 4 LRI Reference Implementation Objectives The second objective of the RI will be to provide Transformation Services to electronically transform messages that comply with guides other than the S&I Framework Implementation by: –Transforming an LRI S&I Initiative HL7 test result message and the vocabulary to comply with another HL7 test result message Implementation Guide, including: Ambulatory Care Lab Result (ELINCS) R1 HITSP/C36 –Transforming a non LRI S&I Framework Implementation HL7 test result message and the vocabulary to comply with the LRI S&I Initiative HL7 test result message. The non LRI S&I Framework - Implementation HL7 test message may include implementations using the following Implementation Guides: Ambulatory Care Lab Result (ELINCS) R1 HITSP/C36 –Not in NIST scope: No further discussion on this here.

5. 5 LRI Pilot Reference Implementation and Testing Lab Test Tool EHR RI (System under Test) ORU R01 Message 1.The EHR is the system being tested. The EHR system is required to consume and “process” messages that conform to the referenced standards. 2.The LAB system is a test tool. The tool creates and sends conformant LRI (sender profile) messages to the EHR (SUT). The tool needs to support a range of valid and invalid test messages covering typical lab test results and scenarios. 3.The EHR is expected to consume the message (as specified by the LRI receiver profile specification). 4.The EHR will be tested using a combination of automated testing and inspection testing. The tests will validated processing and “use” of the referenced standards. 5.For consideration: How elaborate will the EHR RI be? That is, what will the EHR do with the lab data? LRI Sender LRI Receiver ACK R01 Message

6. 6 MU EHR HL7 V2 Lab Results Scope LAB (or any sending system or tool) EHR (System under Test) Public Health HL7 ELR IG 2010 Direct Data Entry ORU Message ORU Message Elements 1.The EHR is the system being tested (as receiver and sender). 2.NIST developed the test procedure and testing tools for MU stage 1. EHR Lab  PH. Also, developed a tool for validating immunization messages (EHR  PH). 3.The message validation tools and test data can be leveraged since a Lab tool needs to be created that will generate conformant messages. 4.A different methodology is necessary for testing a receiver. Some of level of inspection testing is necessary. 5.Testing the “use” of vocabulary is not straight-forward. NIST is developing plans. ORU Elements Meaningful Use Scope Stage 1 NIST Message Validation Tool Message Captured Meaningful Use Scope Stage 2 S&I Framework LRI

7. 7 LRI Pilot RI Objectives LRI EHR Reference Implementation –Develop a pilot EHR system based on the LRI implementation guide –Demonstrate that LRI implementation guide can be implemented Determine the quality, undercover ambiguities, omissions, errors, etc. –Minimum Functionality Receive, parse, and return acknowledgement (according to the LRI message profiles) Extract message content and map data to an “information model” Provide access to data elements (database access/view; APIs; etc.) –Possible Additional Functionality (will further facilitate testing) Render data as CDA or CCD document Complete end-to-end scenario (building on other EHR MU requirements) –HL7 V2 messages (LAB  EHR  PH for reportable lab results) –Out of scope for LRI, but maybe not for MU Provide HL7 v2 query/retrieve message capabilities (not a requirement for MU) Provide actual EHR display capabilities (browse patient records, etc.)

8. 8 LAB Test Tool Objectives Test EHR systems that implement the LRI receiver message profile –Initial target is the S&I Framework Pilot Reference Implementation –Ultimate target is Meaningful Use Stage 2 Certification Assess LRI ORU R01 sender profile To do list: –Simulate a Lab system capable of creating and sending LRI test messages –Develop test procedure and methodology –Develop test data –Develop data sheets for inspection testing –Develop message validation tools RI and Lab test tool can be created in parallel and can be used to test each other –They will shared common artifacts and software components

9. 9 LAB Test Tool Requirements Create the HL7 V2 XML LRI ORU R01 message profile Generate conformant LRI ORU R01 sender profile messages Validate LRI ORU R01 sender profile messages Send LRI ORU R01 sender profile messages Receive LRI ACK R01 sender profile messages Validate LRI ACK R01 sender profile messages Collect, maintain, and support specified vocabulary Support a range of test messages content –Develop and manage realistic lab test data –Data for various (typical) lab results tests –Support the specified vocabulary –Valid and invalid messages –Messages to test conditional requirements –Message with structural and content variation –Message sequencing (e.g., preliminary, final, corrected results)

10. 10 Proposed Collaboration NIST Lab Test Tool ONC EHR RI (System under Test) ORU R01 Message 1.NIST develop the Lab test tool (suitable for testing RI and MU certification) 2.ONC develop the EHR RI 3.ONC provides expertise on realistic lab data for creating test messages; NIST can manage the test data and has initial test data that needs to be verified (i.e., we have some data) 4.ONC can help validate the test procedure, methodology, and Lab test tool 5.Leverage testing artifacts (e.g., XML message profiles) and software components 6.Timeline TBD 7.Can proceed in stages 8.Timeline for RI is shorter than MU testing 9.Can target Lab tool testing functionality to meet RI pilot test requirements (phase 1) 10.MU Certification testing tool will require much more effort (phase 2) LRI Sender LRI Receiver ACK R01 Message

11. 11 NIST V2 Tools Tool to leverage: HL7 V2 Tool Kit –Focuses on testing –Based on the use of conformance profiles MU Testing (Static Data Instance Validation) Interactive Testing Framework and Tool

12. 12 NIST HL7 Testing Toolkit Message Encoding Profile Validation Message Generation Message Validation HL7 Communication Profile Data SourcesTest Agents Java APIs MU Validation Applications and Services Profile Validation Message Validation Message Maker HL7 Data Repository HL7 Artifacts NIST HL7 Test Data Web Applications IHE PIX/PDQ IHE PCD MU EHR  PH MU Immunization  PH NHIN PIX/PDQ CCHIT Lab Messages Message Generation Message Validation Web Services Message Generation Message Validation 3 rd Party Applications and Testing Environments Java Database Profile Registry APIs and components to support tool development Testing Framework

13. 13 MU Message Validation (Static Message Validation)

14. 14 Isolated System Testing (Interactive) NIST PIX Source Test Agent NIST PIX Source Test Agent ADTA04 – Register patient “ALAN ALPHA” (ID = PIX10501) in domain “HIMSS2005” ACKA04 – Send acknowledgement 1 1a PIX/PDQ Test Tool Vendor PIX Manager Application Vendor PIX Manager Application End User (Vendor) ADTA04 – Register patient “CARL SIMPSON” (ID = ABC10501) in domain “HIMSS2005” ACKA04 – Send acknowledgement 2 2a ADTA04 – Register patient “ALAN ALPHA” (ID = XYZ10501) in domain “XREF2005” ACKA04 – Send acknowledgement 3 3a System Under Test NIST PIX Consumer Test Agent NIST PIX Consumer Test Agent QBPQ23 – Send query message for patient “ALAN ALPHA” in domain “HIMSS2005” seeking the patient ID in domain “XREF2005” 4 4a RSPK23– Send response indicating that the identifier (“XYZ10501”) for patient “ALPHA” was found in domain “XREF2005” QBPQ23 – Send query message for patient “CARL SIMPSON” in domain “HIMSS2005” seeking the patient ID in domain “XREF2005” 5 RSPK23 – Send response message indicating no data was found “NF” 5a Web Application Interface

15. 15 Select Test

16. 16 View Test Steps and Run

17. 17 View Interactive Log

18. 18 Summary Results

19. 19 Discussion and Next Steps Operational Issues –Decide who will do what (and timeline), IP, Ownership, more?? Develop plans for moving forward Plan follow-up actions and meetings