LRI Validation Suite Meeting
September 20, 2011
Agenda
• Action Item List
• Test data update
– Selection of core message set
– NIST data sets and management of test data
• Review policy proposal for validating receiver processing of
terminology
• Review ELINCS Test Plan and Test Tool
• Update on LIS Test Plan Template
• Update on EHR Test Plan Template
• Juror Document/Spreadsheet Analysis
– Mapping CLIA requirements to HL7 Elements
– Identifying Reportable Conditions to PH Lab Results
• Tooling Update
• Face-to-Face Meeting Plans
• Planning
Selection of Core Test Messages
1.
Common Hematology
–
–
1.
CBC and WBC Differential/Morphology
What lab results should be included in the CBC test message?
Red Blood Cell (RBC) Erythrocyte count (varies with altitude):
•
•
2.
3.
White Blood Cell (WBC) Leukocyte count: 4,500 to 10,000 cells/mcL
Hematocrit (varies with altitude):
•
•
4.
2.
Male: 40.7 to 50.3%
Female: 36.1 to 44.3%
Hemoglobin (varies with altitude):
•
•
5.
6.
7.
8.
–
–
Male: 4.7 to 6.1 million cells/mcL
Female: 4.2 to 5.4 million cells/mcL
Male: 13.8 to 17.2 gm/dL
Female: 12.1 to 15.1 gm/dL
MCV: 80 to 95 femtoliter (Average red blood cell size)
MCH: 27 to 31 pg/cell (amount hemoglobin per red blood cell)
MCHC: 32 to 36 gm/dL (hemoglobin concentration per red blood cell)
Platelet Count 150,000 to 400,000 per microliter (mcL)
Note all seem to be A1 format
What should be included in the WBC Differential/Morphology test message?
Urinalysis
–
Pick A2 format?
Selection of Core Test Messages
3. Comprehensive Metabolic Panel (CMP)
–
–
Calcium; BUN; Creatinine; BUN/Creatinine Ratio (a
calculated value); Total Protein; Albumin; Globulin;
Albumin/Globulin Ratio (a calculated value); Bilirubin,
Total; Glucose; Alkaline Phosphatase; AST; ALT; Sodium;
Potassium; Chloride; CO2.
Should all of these lab results be included in the test
message?
4. Special Chemistry Tests
–
Lipid Panel???, Prostate Test???
5. Microbiology tests, plus antibiotic susceptibility tests
–
A2 data
6. Other Clinical Lab Tests
LOINC-RELMA List for Hemoglobin
LOINC #
11559-2
19949-7
19951-3
19953-9
19955-4
2714-4
2715-1
2716-9
2717-7
30369-3
30370-1
34969-6
Component
Ex. UCUM Units Ex. Units
Order/Obs
Oxyhemoglobin/Hemoglobin.total
%
Observation
1
Oxyhemoglobin/Hemoglobin.total
%
Class
MFr
%
MFr
%
2
Oxyhemoglobin/Hemoglobin.total MFr
%
%
2
Oxyhemoglobin/Hemoglobin.total MFr
%
PULM
2
Oxyhemoglobin/Hemoglobin.total MFr
%
PULM
2
Oxyhemoglobin/Hemoglobin.total MFr
%
%
Observation
1
Oxyhemoglobin/Hemoglobin.total MFr
%
%
Observation
1
Oxyhemoglobin/Hemoglobin.total MFr
%
%
Observation
1
Oxyhemoglobin/Hemoglobin.total MFr
%
%
Observation
1
Oxyhemoglobin/Hemoglobin.total MFr
%
% of tot
Observation
1
Oxyhemoglobin/Hemoglobin.total MFr
%
% of tot
Observation
1
Oxyhemoglobin/Hemoglobin.total MFr
%
% of tot
Observation
1
No Method listed in RELMA for any of these tests
Property Time Aspect System
Scale
Long Common Name
Type
Pt
Bld
Qn
CHEM
Fractional oxyhemoglobin in Blood
8H^max
PULM
BldA
Qn
Fractional oxyhemoglobin in 8 hour maximum Arterial blood
8H^min
PULM
BldA
Qn
Fractional oxyhemoglobin in 8 hour minimum Arterial blood
Pt
Bld.preductal
Qn
Fractional oxyhemoglobin in Blood Preductal
%
Pt
Bld.postductal Qn
Fractional oxyhemoglobin in Blood Postductal
%
Pt
CHEM
BldA
Qn
Fractional oxyhemoglobin in Arterial blood
Pt
CHEM
BldC
Qn
Fractional oxyhemoglobin in Capillary blood
Pt
CHEM
BldV
Qn
Fractional oxyhemoglobin in Venous blood
Pt
CHEM
Plas
Qn
Fractional oxyhemoglobin in Plasma
Pt
CHEM
BldCoV
Qn
Fractional oxyhemoglobin in Venous cord blood
Pt
CHEM
BldCoA
Qn
Fractional oxyhemoglobin in Arterial cord blood
Pt
CHEM
BldMV
Qn
Fractional oxyhemoglobin in Mixed venous blood
Testing Options/Policy
LOINC # Component
Ex. Units
Class
Type
11559-2Oxyhemoglobin/Hemoglobin.total MFr
%
1
19949-7Oxyhemoglobin/Hemoglobin.total MFr
%
2
19951-3Oxyhemoglobin/Hemoglobin.total MFr
%
2
Property Time Aspect System
Long Common Name
Scale
Ex. UCUM Units
Order/Obs
Pt
CHEM
Bld
Fractional oxyhemoglobin in Blood
Qn
%
Observation
8H^max
PULM
BldA
Qn
Fractional oxyhemoglobin in 8 hour maximum Arterial blood
%
8H^min
PULM
BldA
Qn
Fractional oxyhemoglobin in 8 hour minimum Arterial blood
%
OBR|1|111325^EHR^2.16.840.1.113883.19.3.2.3^ISO|1132896^Lab^2.16.840.1.113883.19.3.1.6^ISO|7187^Hemoglobin^LN|||20070701152505|||||||||100^Hippocrates^Harold||||||20070701162505||CH|
F|NA&Not Applicable&LB
OBX|1|NM|11559-2^Hemoglobin.Total^LN||^12.4|g/dL^grams per deciliter^UCUM|12.0 to
16.0||||F|||20070701152505|||||||||Effective Labs,
Inc^^^^^DRSD&2.16.840.1.113883.19.1.11&ISO^XX^^^6543|3434 Test Loop^^Ann Arbor^MI^48103^^B
•
Depending on what the order is, what are possible test results? Are there more than one valid test result base on local
conventions, etc.?
•
Potential Test Case Policy: In the data sheet (test case) we can allow any of these to be selected. This assumes that nothing
else in the message needs to be changed. It would be an easy way to provide the capability to tests all of these LOINC codes
with minimal effort. The Long Common Name is the differentiator.
•
One of the determining factors likely will be whether or not the same result value can be used for all of the various versions
of Oxyhemoglobin/Hemoglobin.total.
Issues/Comments:
•
Other data elements in the HL7 message might also need to be test-specific. For example, if data for the SPM-4: Specimen
Type and SPM-8: Specimen Source are included in the message, then the same message probably could not be used for all
of the versions of Oxyhemoglobin/Hemoglobin.total. OBX-7: Reference Range also might be a limiting factor if venous blood
and arterial blood result values have normal ranges that don’t overlap.
•
The LOINC code is the anchor that discretely and accurately identifies the lab test that was ordered/performed. No matter
what a hospital or physician chooses to call the test, the LOINC code is the one constant that tells everyone which it test
was. For our purposes, we’ll need to be sure that all of the data for the data elements in the HL7 message are appropriate
for the test indicated by the LOINC code.
Note on the use of LOINC
• The list of tests has been organized by order panel or,
for micro related tests, by target organism for easier
readability.
• The LOINC terms included here are considered
examples only – though they may be the more
common LOINC terms, each laboratory needs to be
sure to map their own tests to the most appropriate
LOINC, even if it is NOT on this list.
• This is NOT an exclusive list of LOINC terms – ANY valid
LOINC should be accepted in data exchange projects
based on this specification.
Reporting Format Requirement
1.
Tests and/or components with numeric results, units, and normal ranges
2.
Tests and/or components with a limited set of textual results with or
without normal ranges
1.
2.
3.
4.
positive/negative/indeterminate, resistant/intermediate/susceptibility
cytology / anatomic pathology
mutation type and location
organism name
3.
Tests with defined structure in Observation Result Segment OBX-3
through OBX-8 for the reporting of Culture Results and Antimicrobial
Sensitivities
4.
Semi Structured or Unstructured components or results Tests and/or
components reported in a PDF or data blob
1.
The 4th reporting format may be utilized in the cases where structured data
does not apply (e.g. images).
Processing of Terminology
• Receiver requirements for processing
terminology:
– The receiver shall persist (store) the original
standardized code and the original standardized
code text as received in exact representation.
– The receiver may perform a translation/mapping
to locally defined representations.
Assessment of Terminology
• Proposed procedure for assessing the receiver for incorporation of
terminology:
– Where applicable to meet CLIA requirements the receiver shall display
on the EHR GUI the equivalent representation of the received coded
lab results. The receiver shall display at least one of the following:
• Original standardized code text
• Original standardized code (will the actual code ever be displayed; is it
adequate or good practice to display just the code?)
• Local code text
– The receiver shall be capable of demonstrating the persistent of the
original standardized code and the original standardized code text.
Acceptable methods for attestation:
• Administrative access to database
• Inspector approved method
– If applicable the receiver shall be capable of demonstrating the linkage
of the original standardized code the locally translated/mapped code.
Acceptable methods for attestation:
• Administrative access to database
• Browse capabilities of configuration files
• Inspector approved method
Equivalent Representation
• The exact original code
• The exact original code text
• For translated/mapped local code text an equivalent representation
as determined by clinical terminology expert. The following rules
and guidance are given to promote consistency in assessment:
– Rule: A terminology shall never be made more specific in the
translation/mapping.
– Rule: A terminology shall never be made more specific in the display
of standardized terminology.
– Guidance: A limited number of synonyms are provided to assist the
clinical terminology expert. Note: a predefined definitive set is not
possible—there are too many possible equivalent local
representations.
– Guidance: The inspector must consider the context in which the code
is used as this may impact the translation/mapping.
Questions
• What should be the assessment if a more detailed
terminology term is received that is mapped to a less
specific term?
• This mapping will lead to a loss of information if the original
code is not persisted.
• Is it valid to display a representation that has less
specificity?
• Is it valid to display a representation that has less specificity
as long as the original data is persisted in the system?
• Is it acceptable for a loss of information to occur when data
is rendered as a report or forwarded on to another system
(e.g., public health)? That is we sent a specific code and
then a general code is forwarded on to public health. Is it
acceptable for either the general or specific LOINC code to
be forwarded?
Other Issues
• EHR – Implementation Choices for Terminology
– Use standardize coding internally
– Map to local codes
– Need to account for options in test procedure
• How to we test for complete coverage of recommended
terminology?
– Create all messages for all possible terms (for important code system,
e.g., LOINC)—This is the preferred approach
– Alternative approach: Create a subset and inspect/verify tables for
coverage and accuracy
– Selection of approach may be made on a case-by-case analysis
– It may be necessary to provide coverage for all recommended LOINC
codes. However, for other terminology it may not be priority (e.g.,
state) or may not be feasible (SNOWMED).
• Use of UCUM. Can/should UCUM be mapped locally and displayed
as local representation?
• What terminology can be mapped?
Action Item List I
• Select message to handle core lab results
– Identify 20 or so common lab results
– Obtain/Adapt/Create test messages to cover the core set of lab
results
• Identify/List all pertinent data elements
– 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 value sets
– 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
– 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
– 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
–
–
–
–
–
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
• Determine a process for verifying test cases
• Implement process for verifying test cases
• Research ELINCS Test Tool
– Determine what we can leverage
– Process flow, source code, test messages
Action Item List IV
• Identify all the public health reportable lab results
• Identify the data elements that differ from the public
health IG and the S & I LRI IG
• Determine a policy for validating LRI messages using
EHR PH lab results messages
• Develop spreadsheets for managing test cases/data
– Adapt tooling to process and incorporate data
• Create the HL7 standard message profiles
– 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
Tooling Update
• LRI Implementation Guide is in ballot process
– Open for comments until October 17th, 2011
• We will begin developing the HL7 standard conformance profile
– MWB
– Need to make updates to the conformance profile based on changes
made in version 2.7 and 2.7.1
• Data Management of test cases/data will be with spreadsheet
– Spreadsheet is process to build messages and to create validation
context files
– Validation context files encapsulates test case related assessment
– Leverage/adapt existing NIST Test messages to S&I Framework LRI IG
• Early version of prototype tool developed
– Limited functionality
– Handles message validation based on message profiles and validation
context files
– Message Editing
Validation Methodology
HL7 V2.5.1 Message
Profile (LRI IG
assertions)
Test Case Specific
Assertions (Validation
Context Files)
Vocabulary (Stored in
PHINVADS than
translated to V2.8
Table Library Format)
Validation Engine
and Juror
Document
Generator