LRI Validation Suite Meeting

1. LRI Validation Suite Meeting November 1st, 2011

2. Agenda • Review of LIS Test Plan Template • CLIA Testing • EHR testing (Juror Document)—Inspection Testing • Action Item List • Review policy proposal for validating receiver processing of terminology • Planning

3. EHR Test Harness Test Flow—Testing the EHR (Model 1) Use Case Inspection Testing can be performed by: • On-site inspection • Over a webex like technology • Screen-scraper or screen-capture (include clock) • Printed Reports LRI EHR Test Harness Test Case Inspection Testing Techniques • EHR display screens • Database access • Configuration files Test Data Juror Document LRI Test Message Lab Message EHR Communication ACK ACK Automated Testing • Acknowledgement Message • Limited Utility Validation Report Validation

4. CLIA Requirements 42 CFR 493.1291(c) The test report must indicate the following: • For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number • The name and address of the laboratory location where the test was performed • The test report date • The test performed • Specimen source, when appropriate • The test result and, if applicable, the units of measurement or interpretation, or both • Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability

5. CLIA Requirements Mapped to Data Elements 42 CFR 493.1291(c) The test report must indicate the following: • For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number • PID-3 : Unique patient identification number • PID-5 : Patient Name • The name and address of the laboratory location where the test was performed - OBX-23/24/25: Lab Identification Fields • The test report date - OBX-19: Date/Time Analysis • The test performed - OBX-3: LOINC codes for Observation Identifier • Specimen source, when appropriate • SPM-4: Specimen Type • The test result and, if applicable, the units of measurement or interpretation, or both • OBX-5: Observation Value • OBX-6: Units • OBX-7: Reference Range • OBX-8: Abnormal Flag • OBX-11: Observation Result Status • Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability • SPM-21: Specimen Reject Reason • SPM-22: Specimen Quality

6. Required CLIA Report Elements • PID-3 : Unique patient identification number • PID-5 : Patient Name • OBX-3: LOINC codes for Observation Identifier • OBX-5: Observation Value • OBX-6: Units • OBX-7: Reference Range • OBX-8: Abnormal Flag • OBX-11: Observation Result Status • OBX-19: Date/Time Analysis • OBX-23/24/25: Lab Identification Fields • SPM-4: Specimen Type • SPM-21: Specimen Reject Reason • SPM-22: Specimen Quality Are all elements required to be displayed on screen (including the components and subcomponents of these fields)?

7. Format of the EHR Juror Document • Follow the workflow of the EHR • Grouping of Data • Display patient name, id, and lab results • Additional demographics • Performing Labs Information • Demographics • What should be displayed on the EHR and what can be assessed via database access • Also take into account CLIA and MU Requirements

8. Action Item List I • Select message to handle core lab results • Identify 20 or so common lab results (In progress) • Obtain/Adapt/Create test messages to cover the core set of lab results (In progress) • Identify/List all pertinent data elements (In progress) • Create spreadsheet of all data elements with usage of R, RE, and C (rows) • Columns will identify: • Juror Document (How to assess the element) • Identify the elements required for CLIA testing • Identify static, configurable, or indifference data elements • Identify/create/verify value sets (In progress) • Create Spreadsheet; convert to NIST XML tool format • Incorporate the value sets in PHINVADS • Develop download mechanisms and transformation of values to support the NIST tooling format

9. Action Item List II • Review LRI implementation Guide and create a list of all conformance requirements (Not Started) • Create matrix based on data elements • Link all conformance requirements to data elements when possible • Create “higher” level list of conformance requirements • Determine the policy for assessing receiver side terminology (Done: need to write policy statement) • Inspection test requirements and procedure • Automated test requirements and procedure • Complete development of LIS Test Plan Skeleton • Complete development of EHR Test Plan Skeleton

10. Action Item List III • Identify and document the test dimensions (Not Started) • Coverage of Lab Results • Scenarios (e.g., Preliminary, Final, Corrected) • Reporting formats • Negative testing • Minimally and maximally populated • Contact CLIA and CAP inspectors to get their lab inspection process (Need contacts) • Determine a process for verifying test cases (Not Started) • Implement process for verifying test cases (Not Started) • Research ELINCS Test Tool (DONE) • Determine what we can leverage • Process flow, source code, test messages

11. Action Item List IV • Identify all the public health reportable lab results (Done) • Identify the data elements that differ from the public health IG and the S & I LRI IG (Not Started) • Determine a policy for validating LRI messages using EHR PH lab results messages (Not Started) • Develop spreadsheets for managing test cases/data (In progress) • Adapt tooling to process and incorporate data • Phase 1 nearly complete • Phase 2 will include the multiple dimensions (Data, Profile, Juror) • Create the HL7 standard message profiles (Starting soon) • MWB (then produce XML message template) • Need to make updates to the message profile based on changes made in version 2.7 and 2.7.1 • Write XSLT to modify XML message profile

12. Action Item List V • Identify the CLIA conformance requirements and compare to the requirements in the implementation guide (In progress) • Mark in spreadsheet – (DONE) • Make sure conformance requirements and IG match • Write conformance requirements in IG where necessary to match CLIA requirements • Prototype tool (In progress) • Requirements and design (In progress) • Development (In progress) • Incorporate test cases (Not Started) • Testing (Not Started)