LRI Validation Suite Meeting
November 1st, 2011
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
EHR Test Harness Test Flow—Testing the EHR
(Model 1)
Use Case
1.
2.
3.
4.
LRI EHR Test Harness
Test Case
Test Data
Inspection Testing can be performed by:
On-site inspection
Over a webex like technology
Screen-scraper or screen-capture (include clock)
Printed Reports
Inspection Testing Techniques
1. EHR display screens
2. Database access
3. Configuration files
Juror
Document
Lab Message
LRI Test
Message
EHR
Communication
ACK
ACK
Validation
Validation
Report
Automated Testing
Acknowledgement Message
Limited Utility
CLIA Requirements
42 CFR 493.1291(c) The test report must indicate the following:
1.
2.
3.
4.
5.
6.
7.
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
CLIA Requirements Mapped to Data Elements
42 CFR 493.1291(c) The test report must indicate the following:
1.
For positive patient identification, either the patient's name and identification number, or a
unique patient identifier and identification number
–
–
2.
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
3.
The test report date
- OBX-19: Date/Time Analysis
4.
The test performed
- OBX-3: LOINC codes for Observation Identifier
5.
Specimen source, when appropriate
–
SPM-4: Specimen Type
6.
The test result and, if applicable, the units of measurement or interpretation, or both
–
–
–
–
–
7.
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
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)?
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
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
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
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
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
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)