LRI Validation Suite Meeting

1. LRI Validation Suite Meeting November 8th, 2011

2. Agenda • Review of LIS Test Plan Template • Follow-up; Questions • Review of EHR Test Plan • EHR Pre-test setup and Test Message Configuration • Data Management Spreadsheet • EHR testing (Juror Document)—Inspection Testing • Juror document discussion continuation • CLIA Testing • Mapping test messages to data spreadsheet • Questions on Test Messages (Start at 1:45) • IG Value Sets Spreadsheet Review (Vocab WG) • Planning

3. Follow-up on Last Week’s Meeting • Since the LRI IG supports multiple profile options which impacts the content of the message, how will these be represented in the test plan? It appears the example included may be supporting the GU - Globally Unique profile since it includes OIDs throughout the message. The NG - Non-Globally Unique profile message will be different. • Yes, we need to account for this. Not sure (probably a test case variation) but the information will be captured in the data management spreadsheet that will be used to produce the test artifacts • See data management spreadsheet • Question is how do we actually test for Globally Unique (beyond an OID format)? • The fields in CLIA may not be sufficient for public safety. The 2nd piece, when you look at oversight of EHR it will mostly be accrediting agencies. Their requirements are more stringent than CLIA. If people only followed CLIA, they will not be compliant with their agency. • Need to separate IG, MU, CLIA, and other requirements • Tool could produce juror document dynamically based on the various requirements wanted for testing (e.g, MU/IG profile/config) • Optional Elements (Should not be part of test case) • Correct • Others?

4. 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

5. Possible EHR Pre-test Configuration • Static Data that may be Required for EHR Vendor Setup

6. Possible EHR/Message Element Configuration

7. CDC E-mail Comments/Questions I • Test report date: HL7 IG (page 123) recommends using OBX-19.  However, this has not been the prior interpretation by all agencies.  During the time of hardcopies, it was the date and time the hardcopy was printed.  However, CMS CLIA has stated the date (and time) of reporting cannot change.  The electronic era has thus interpreted this requirement as the date and time the report becomes available to a healthcare provider, such as the date and time the result is finalized in the LIS with the generally accepted assumption of near real time availability to the provider.  Please advise if OBX-19 was suggested by CMS CLIA?  • Specimen source: SPM-8 is most applicable.  However, additional input is needed on field description and determination if other fields may also apply, e.g. SPM-4, 5, 9, 10. • SPM-8, 5, 9, and 10 are optional (i.e., won’t be tested); SPM-4 is Required (SPM segment is RE) • Patient’s age: No field option for age located in the HL7 IG.  Only DOB appears to be available. • Not sure why this is a problem (calculate); Is Age/DOB a CLIA requirement? • Specimen collection date and time: Appears to have two options in the HL7 IG.  SPM-17 and OBR-7.  SPM-17 description states it should be identical as OBR-7.  Should the validation suite verify the data is present and these two sources are identical? • Yes. The conformance statements need to be cleaned up. For OBR-7 the statement is clear. For SPM-17 (“This value should be the same as OBR-7, unless a new specimen was drawn at the testing laboratory)

8. CDC E-mail Comments/Questions II • Results and interpretation: OBX-5 represents the results; OBX-6 represents the units of measure.  Unclear which element represents the interpretation of the patient result in relation to the reference range (OBX-7), which may be provided in addition, e.g. Hi, Lo, Critical.  (Example.  Patient result: 120 mg/dL; Reference Range: 80-100 mg/dL;  Interpretation of patient result: Hi).  OBX-8 is possible, but is titled “Abnormal Flag”, which is outdated terminology as it may not be considered abnormal.  Also note that OBX-8 describes a microbiology interpretation for ceftazidime of “S” for susceptible as an abnormal flag, which is also a misnomer as it is not “abnormal”.  Result flag/Interpretation would have been a more appropriate field name. • Corrected report identifier: Unclear if the field description addresses this requirement.  This is a guess. • FDA disclaimers: Appear to be included as part of test name at OBX-3.  Concern is for proper and separate display of the name before and the disclaimer after the results (e.g. comment type field). • UCUM: There are references in the HL7 IG to adopting Unified Code for Units of Measure.  Has the laboratory field had input on adopting this reference as the standard?  http://unitsofmeasure.org/ • This is a recommendation; to be in pilots. Should our test message include UCUM? If not, what? • Interpretive reports: Authentication (pathologist signature, date and specialty) is required for interpretive reports by the CMS Conditions of Participation at 42 CFR 482.24(c )(1).

9. 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

10. 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

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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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)

18. Action Item List VI • Identify a strategy for testing systems that supports unique identifiers and those that don’t (Not Started) • So far, will test on for properly formatted OIDs for the GU Profile • Vocabulary (value sets) (In progress) • Need to be reviewed (Vocab WG- C. Johns) • Import into PHINVADS ??