LRI Validation Suite

LRI Validation Suite Meeting Rob Snelick—NISTApril 24th, 2012

Agenda

• Tool status and plans• LRI DSTU Version—demonstration of use

– LIS validation is focus today• LRI DSTU Errata• Schedule -- Tuesdays, 1:00 PM EST

– Next meeting: May 22nd (focus is EHR validation)– Additional meetings to be added if necessary– HL7V2_LRI_Testing Google Group will be used for

notification

Tool Status and Plans• Validation Tool for LRI (Release 1 for trial use)

LRI IG DSTU Version – lri-dstu– http://lri.sipilotdevelopment.org/lri-dstu/Notes:– Addresses LRI IG DSTU version submitted for ballot April 9th,

2012 (Plus Errata)– All technical requirements for LIS validation incorporated– More testing needed and some odds and ends need addressed– Next target is May 22nd—EHR functionality and Test Plan

updated– Start to move into the phase of adding test cases

• However, the framework is in place

– Changes to the tool will still be made; notice of such changes to be announced on the LRI Testing Google Group

Resources• Tool Documentation Tab

– Test plans, messages, profiles, and other testing artifacts

• Wiki Page—Validation Suite Resources– Latest version of test plans, messages, meeting

minutes, etc• Google Group

– Discussion forum for LRI IG, Pilots, Validation Tool, Tool and Resources Updates, Release Notes, etc

– http://groups.google.com/group/hl7v2_lri_testing

Plans• Update EHR Validation

– Test Plan, Juror Documents, Work flow, Communication• Testing the validation tool

– We need community feedback!– Get a head start on MU-2 certification

• More Test Cases (Test Coverage Matrix)– Lab Test Scope (to cover vocabulary recommendations)– Scenario test cases (e.g., P F C)– Technical requirements (e.g., Snapshot processing)– “Negative” testing

• User’s Guide and other documentation• Exploring/Considering LOI and Compendium Validation

– Depending on NIST resources/time

LRI Validation Tool Highlights• Web Application• LIS and EHR Validation• Context-free and context-based testing• Test Plans and Test Cases for LIS and EHR• Example/Test messages• Conformance Profile Browser (on-line requirements)• Vocabulary Browser (Searchable)• Supports IG vocabulary

– HL7, LONIC, UCUM, SNOMED, & external tables• Support IG Profile Variations

– Globally and Non-globally Unique Identifiers Profiles– Order Placer/Filler Number Unique and Order Placer/Number

non-unique Profiles

Phase 1 Core Test Cases/MessagesSupports both NG and GU versions:• Erythrocyte sedimentation rate

– 30341-2 OBR.4 LN code– Valid Minimally Populated Message – Final Results– Valid Typically Populated Message – Final Results– Valid Typically Populated Message – Corrected Results– Valid Maximally Populated Message – Final Results– Valid Specimen Reject Message

• CBC W Auto Differential panel in Blood– 57021-8 OBR.4 LN code– Valid Typically Populated Message – Final Results– 27 Results (OBXs)

• Lipid 1996 panel in Serum or Plasma – 24331-1 OBR.4 LN code– Valid Typically Populated Message – Final Results– 4 Results (OBXs)

• Culture Results Reporting (Relating OBX segments) – Final review needed– 625-4 OBR.4 LN code

• Culture and Susceptibility Results Reporting (Parent/Child Relationships) – Final Review Needed– 625-4 OBR.4 LN code– RU and RN Profile Versions

Tool Demonstration• Big Picture

– Validation Options– Profile Viewer– Vocabulary Browser– Documentation

• LIS Context-free Message Validation– Supported Profiles

• LIS Context-based Validation– Test Plan/Test Cases Overview– Data Sheet– Expected Validation Results

LIS (or Proxy)

LIS Test Tool

Load Cut/paste Send

HL7 V2 Lab Results Message

ValidationReport

Context Free Testing:1. Context free testing will validate a LRI message

created by the LIS2. The context (e.g., the type and results of the

lab test) is unknown to the validation tool3. Therefore not all conformance requirements

of the LRI implementation guide can be assessed

4. However, the validation provides a simple and convenient method for testing message structure and most vocabulary

Process:1. An LRI message is created by the vendor’s LIS2. The message is sent, pasted, or loaded in the

test tool3. A validation is performed

LIS Context-Free Testing1. Test any LRI message created by the LIS2. Select “Message Validation” Tab3. Select profile version (e.g., 4. Enter test messages into validation tool5. Validation results appear

LIS

LIS Test Tool select test case

Test Data Sheet

Manual entry of test data

Load Cut/paste Send

HL7 V2 Lab Results Message

Use Case

Test Case

ValidationReport

EHR transmits Hemoglobin blood test order to the LIS for John Doe along with pertinent demographic and order request data

Lab Results Data SheetJohn DoeDOB: 05/23/1959Gender: MResult: 13.7 g/dL Range 13.2 – 16.2Status: Finaland more…

• A lab test is ordered for a patient• The specimen is collected, and is received and processed in the lab• The lab result is produced and stored in the LIS database• The lab result message is created•The lab result is transmitted to an ambulatory EHR•The lab result is viewed in the ambulatory EHR

Process:1. A technician enters lab results data into LIS

based off the data sheet provided2. The message is sent, pasted, or loaded in the

test tool3. A validation is performed

Context-based Testing:1. Context-based testing will validate a LRI message

created by the LIS2. The context (e.g., the type and results of the lab test)

is known to the validation tool3. Therefore all conformance requirements of the LRI

implementation guide can be assessed4. Supports various scenarios (FC, rejected specimen)

LIS Context-based Testing

EHRLab Message

ACK

Validation

LRI EHR Test HarnessInspection Testing can be performed by:

1. On-site inspection2. Over a webex like technology3. Screen-scraper or screen-capture (include clock)4. Printed Reports

Inspection Testing Techniques1. EHR display screens2. Database access3. Configuration files

Communication

Automated TestingAcknowledgement MessageLimited Utility

LRI Test Message

Validation Report

Test Data

Test Case

Use Case

JurorDocument

ACK

LRI EHR Testing – Test Harness

LRI Validation Suite WG Charter OverviewAmbulatory EHR

ONC S&I Framework Test Data

LIS LRI Validation

Tool

EHR LRITest

Harness

NIST LRI Test Tool

NIST LRI Test Tool1. Suite scope limited to the requirements specified in the LRI IG2. Develop test data

1. provided & verified by the S&I Framework community3. LIS LRI Validation Tool

1. Used to validate vendor LIS systems & Test Harness2. Develop a test plan3. Capture and validate LIS LRI messages

4. EHR LRI Test Harness1. Used to validate EHR systems2. Develop a test plan3. Simulation of an LIS system4. Manage, Send, Receive LRI Messages5. Inherently provides CLIA Testing6. Targets

1. S & I Framework EHR Pilots2. Vendor EHR Products 3. MU Certification

LRI ORU R01

LRI ACK R01

S & I FrameworkEHR Pilots

Vendor EHR Products

Ambulatory EHR Systems1. EHR Pilots

1. Draft standard trial use (implementation)2. Verifies LRI IG can be implemented—provide feedback3. Use LRI test harness to perform conformance testing4. Function of the S&I Framework LRI Pilots WG

2. Vendor Product EHRs1. Can use LRI test harness to perform conformance

testing2. LRI Test Harness expected to be used for MU

certification

Part of validation suite deliverables Anticipated users of validation suite products

LIS

LIS Test Tool select test case

Test Data Sheet

Manual entry of test data

Load Cut/paste Send

HL7 V2 Lab Results Message

Use Case

Test Case

ValidationReport

EHR transmits Hemoglobin blood test order to the LIS for John Doe along with pertinent demographic and order request data

Lab Results Data SheetJohn DoeDOB: 05/23/1959Gender: MResult: 13.7 g/dL Range 13.2 – 16.2Status: Final

• A lab test is ordered for a patient• The specimen is collected, and is received and processed in the lab• The lab result is produced and stored in the LIS database•The lab result is transmitted to an ambulatory EHR•The lab result is viewed in the ambulatory EHR

1. Local code2. No code—text3. LOINC code

No LOINC given for results

• Test tool inspects OBX.3 for a specific LOINC code• Inspect for 718-7 only or inspect for one of 718-7, 20509-6, 30313-1, 30352-9, 30351-1, and 30350-3?

For Discussion:1. No suggested method given (Should we?)2. With no method given we should expect one

from a set of valid LOINC codes for this order (Lab dependent?)

3. If a specific method is given (is this typical/possible?) then should we look for a specific LOINC code in the sent message?

For Discussion:1. Does the LAB expect a local code for the order in

a electronic order request?2. Use Cases to consider: agreement/no agreement

between LIS and EHR for local codes

It is assumed Lab has capabilities for manual entry

Dat

a E

ntry DB

Message

EHRLab Message

ACK

Validation

LRI EHR Test Harness

CommunicationLRI Test

Message

Validation Report

Test Data

Test Case

Use Case

JurorDocument

ACK

718-7 (LN)

718-7 (LN)

718-7 (LN)S Name Value REF Range

F Hemoglobin 13.7 13.2 – 16.2 g/dL

For Discussion:1. What are the requirements on the EHR with regards to LOINC—

given the LRI IG, CLIA, and meaningful use? 2. What are the EHR display (GUI) requirements for the received lab

results?3. What are the EHR storage requirements for the received lab

results?4. Given that the LOINC code is likely to be translated into the EHR

internal representation, what lab test names need to be displayed in exact form and what lab test names can be displayed in an equivalence text (same concept)?

5. What qualifies as “equivalence—same concept”? How is that determined? Can it be? Expert inspector only? Should displaying of the LOINC text (only) be the requirement—i.e., no mapping?

6. What is the impact of sending only the LOINC code (i.e., no local code) on testing?

Translated into internal

representation

Displayed as internal display text representation