S&I Framework TestingHL7 V2 Lab Results Interface and RI Pilot

Robert Snelick

National Institute of Standards and TechnologyJune 23rd, 2011Contact: robert.snelick@nist.gov

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

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

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

LRI Pilot Reference Implementation and Testing

LabTest 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

Sen

der

LRI

Rec

eive

r

ACK R01 Message

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

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 ScopeStage 1

NIST Message Validation Tool

Message Captured

Meaningful Use ScopeStage 2

S&I Framework LRI

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 (LABEHRPH 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

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

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

Proposed Collaboration

NIST LabTest 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 RI3. 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 tool5. Leverage testing artifacts (e.g., XML message profiles) and software components6. Timeline TBD7. Can proceed in stages8. Timeline for RI is shorter than MU testing9. 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

Sen

der

LRI

Rec

eive

r

ACK R01 Message

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

NIST HL7 Testing Toolkit

Message

Message Encoding

ProfileValidation

MessageGeneration

MessageValidation

HL7 Communication

Profile

Data Sources Test Agents

Java APIs

MUValidation

Applications and Services

ProfileValidation

MessageValidation

MessageMaker

HL7 DataRepository

HL7Artifacts

NIST HL7Test Data

WebApplications

IHE PIX/PDQIHE PCD

MU EHRPHMU ImmunizationPH

NHIN PIX/PDQCCHIT Lab MessagesMessage GenerationMessage Validation

WebServices

Message GenerationMessage Validation

3rd PartyApplicationsand Testing

EnvironmentsJava

Database

ProfileRegistry

APIs and components to support tool development

Test

ing

Fra

mew

ork

13

MU Message Validation (Static Message Validation)

14

Isolated System Testing (Interactive)

NISTPIX

SourceTest Agent

ADTA04 – Register patient“ALAN ALPHA” (ID = PIX10501) in domain “HIMSS2005”

ACKA04 – Send acknowledgement

1

1a

PIX/PDQ Test Tool

VendorPIX

ManagerApplication

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

NISTPIX

ConsumerTest 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 nodata was found “NF”

5a

Web

App

licat

ion

Inte

rface

15

Select Test

16

View Test Steps and Run

17

View Interactive Log

18

Summary Results

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