LRI Validation Suite Meeting
September 06, 2011
Agenda
• Test data update
– Selection of core message set
• Update
• Review validation discussion page
– Mapping lab results and LOINC
•
•
•
•
•
•
Review of EHR Test Plan Template
Update on LIS Test Plan Template
Face-to-Face Questionnaire
NIST/LMCO meeting
Tooling
Juror Document/Spreadsheet Analysis
– Identify other MU requirements we can leverage (e.g., usability)
– Mapping CLIA requirements to HL7 Elements
– Identifying Reportable Conditions to PH Lab Results
• Planning
Categorization of Tests
• The 144 individual tests in the final version of the
list can be clinically organized into six clinical lab
test categories. These are:
1)Common Hematology tests (16),
2)Urinalysis test (1),
3)Common Chemistry tests (34),
4)Special Chemistry tests (27),
5)Microbiology tests (50), plus antibiotic
susceptibility tests (7), and
6)Other Clinical Lab tests (9).
20 Common Tests
1. CBC and WBC Differential/Morphology,
2. Urinalysis, and
3. Comprehensive Metabolic Panel (CMP)
–
–
Quest Diagnostics Directory of Services and Specimen
Collection Guide of May, 2008 the CMP included 17
items:
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.
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.
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).
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.
Action List: Initial Set of Test Data
• Select at least one test from first 5 clinical test categories
– Category 6 is “others”
•
Include:
–
–
–
•
Include test to cover the 4 (3 ??) reporting formats
–
•
Results (1 to many LOINC codes—how do we handle,
document?)
Get sample messages
–
–
–
•
However, the second format is not in the test list
Create coverage mapping table of tests/LOINC codes
–
•
CBC and WBC Differential/Morphology, (2 results)
Urinalysis, and (1 result)
Comprehensive Metabolic Panel (CMP) (17 Results)
Example from IG
NIST Related set of test data
Messages to be verified
Finish test case for one simple message
Examples From IG
•
•
•
•
•
•
LEAD LABORATORY RESULT MESSAGE
CAMPYLOBACTER JEJUNI
ANIMAL RABIES
HEPATITIS C VIRUS
Example: Minimal Message
Culture Results
– stool culture
– Three pathogens: Campylobacter jejuni, Salmonella
and Shigella.
• Examples of Culture and Susceptibility Results
• LINKING PARENT AND CHILD RESULTS
LEAD LABORATORY RESULT MESSAGE
MSH|^~\&|Lab1^1234^CLIA|^1234^CLIA|ELR^2.16.840.1.113883.19.3.2^ISO|SPH^2.16.840.1.113883.19.3.2^ISO|20080818183002.10700||ORU^R01^ORU_R01|1234567890|P^T|2.5.1|||NE|NE|USA||||USELR1.0^^2.16.840.1.114222.4.10.3^ISO
SFT|1|Level Seven Healthcare Software, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1.2|An Lab System|56734||20080817
PID|1||36363636^^^MPI&2.16.840.1.113883.19.3.2.1&ISO^MR^A&2.16.840.1.113883.19.3.2.1&ISO~444333333^^^&2.16.840.1.113883.4.
1^ISO^SS||Everyman^Adam^A^^^^L^^^^^^^BS|Mum^Martha^M^^^^M|20050602|M||21063^White^CDCREC^^^^04/24/2007|2222 Home Street^^Ann
Arbor^MI^99999^USA^H||^PRN^PH^^1^555^5552004|^WPN^PH^^1^955^5551009|eng^English^ISO6392^^^^3/29/2007|M^Marrie
d^HL70002^^^^2.5.1||||||N^Not Hispanic or Latino^HL70189^^^^2.5.1||||||||N|||2008081510000700|Reliable^2.16.840.1.113883.19.3.1^ISO
NK1|1|Mum^Martha^M^^^^L|MTH^Mother^HL70063^^^^2.5.1| 444 Home Street^Apt B^Ann
Arbor^MI^99999^USA^H|^PRN^PH^^1^555^5552006
PV1|1|O|4E^234^A^Good Health Hospital&2.16.840.1.113883.19.3.2.3&ISO^N^N^Building 1^4^Nursing unit 4
East^1234&&2.16.840.1.113883.19.3.2.3&ISO^&2.16.840.1.113883.19.3.2.3&ISO|R||||||||||||||||||||||||||||||||||||||||2008
08151000-0700|200808151200-0700
PV2|||1^Sick^99AdmitReason|||||||||||||N||||||||Level Seven Healthcare,
Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|||20010603|||19990603ORC|RE|23456^EHR^2.16.840.1.113883.19.3.2.3^IS
O|9700123^Lab^2.16.840.1.113883.19.3.1.6^ISO|||||||||1234^Admit^Alan^A^III^Dr^^^&2.16.840.1.113883.19.4.6^ISO^L^^^EI^&2.
16.840.1.113883.19.4.6^ISO^^^^^^^^MD||^WPN^PH^^1^555^5551005|||||||Level Seven Healthcare,
Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1005 Healthcare Drive^^Ann
Arbor^MI^99999^USA^B|^WPN^PH^^1^555^5553001|4444 Healthcare Drive^Suite 123^Ann Arbor^MI^99999^USA^B
OBR|1|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2.16.840.1.113883.19.3.1.6^ISO|10368-9^Lead BldCmCnc^LN^3456543^Blood lead test^99USI^2.24|||2008081510300700||||||diarrhea|||1234^Admit^Alan^A^III^Dr^^^&2.16.840.1.113883.19.4.6^ISO^L^^^EI^&2.16.840.1.113883.19.4.6^ISO^^^^^^
^^MD|^WPN^PH^^1^555^5551005|||||2008081830-0700|||F||||||787.91^
DIARRHEA^I9CDX^^^^07/09/2008|1235&Slide&Stan&S&&Dr&MD&&DOC&2.16.840.1.113883.19.4.6&ISO
OBX|1|NM|10368-9^Lead BldC-mCnc^LN^^^^2.24|1|50|ug/dL^micro-gram per deci-liter^UCUM^^^^1.6|<10
ug/dL|H|||F|||200808151030-0700|||||200808181800-0700||||Lab^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434
Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16.840.1.113883.19.4.6&ISO^L^^^NPI
SPM|1|23456&EHR&2.16.840.1.113883.19.3.2.3&ISO^9700122&Lab&2.16.840.1.113883.19.3.1.6&ISO||122554006^Capillary blood
specimen^SCT^BLDC^Blood capillary^HL70070^20080131^2.5.1||HEPA^Ammonium heparin^HL70371^^^^2.5.1|CAP^Capillary
Specimen^HL70488^^^^2.5.1|181395001^Venous structure of
digit^SCT^^^^20080731|||P^Patient^HL60369^^^^2.5.1|50^uL&MicroLiter&UCUM&&&&1.6|||||2008081510300700|200808151100-0700
OBX|2|NM|35659-2^Age at specimen collection^LN^^^^2.24||3|a^year^UCUM^^^^1.6|||||F|||2008081510300700|||||200808151030-0700||||Lab^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann
Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16.840.1.113883.19.4.6&ISO^L^^^NPI
CAMPYLOBACTER JEJUNI
MSH|^~\&|Lab1^1234^CLIA|^1234^CLIA|ELR^2.16.840.1.113883.19.3.2^ISO|SPH^2.16.840.1.113883.19.3.2^ISO|20080818183002.10700||ORU^R01^ORU_R01|1234567890|P^T|2.5.1|||NE|NE|USA||||USELR1.0^^2.16.840.1.114222.4.10.3^ISO
SFT|1|Level Seven Healthcare Software, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1.2|An Lab System|56734||20080817
PID|1||36363636^^^MPI&2.16.840.1.113883.19.3.2.1&ISO^MR^A&2.16.840.1.113883.19.3.2.1&ISO~444333333^^^&2.16.840.1.113883.4.
1^ISO^SS||Everyman^Adam^A^^^^L^^^^^^^BS|Mum^Martha^M^^^^M|19800602|M||21063^White^CDCREC^^^^04/24/2007|2222 Home Street^^Ann
Arbor^MI^99999^USA^H||^PRN^PH^^1^555^5552004|^WPN^PH^^1^955^5551009|eng^English^ISO6392^^^^3/29/2007|M^Marrie
d^HL70002^^^^2.5.1||||||N^Not Hispanic or Latino^HL70189^^^^2.5.1||||||||N|||200808151000-0700|
Reliable^2.16.840.1.113883.19.3.1^ISO
PV1|1|O|4E^234^A^Good Health Hospital&2.16.840.1.113883.19.3.2.3&ISO^N^N^Building 1^4^Nursing unit 4
East^1234&&2.16.840.1.113883.19.3.2.3&ISO^&2.16.840.1.113883.19.3.2.3&ISO|R||||||||||||||||||||||||||||||||||||||||2008
08151000-0700|200808151200-0700
PV2|||1^Sick^99AdmitReason|||||||||||||N||||||||Level Seven Healthcare,
Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|||20010603|||19990603
ORC|RE|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2.16.840.1.113883.19.3.1.6^ISO|||||||||1234^Admit^Alan^A^III^Dr^
^^&2.16.840.1.113883.19.4.6^ISO^L^^^EI^&2.16.840.1.113883.19.4.6^ISO^^^^^^^^MD||^WPN^PH^^1^555^5551005|||||||Level
Seven Healthcare, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1005 Healthcare Drive^^Ann
Arbor^MI^99999^USA^B|^WPN^PH^^1^555^5553001|4444 Healthcare Drive^Suite 123^Ann Arbor^MI^99999^USA^B
OBR|1|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2.16.840.1.113883.19.3.1.6^ISO|625-4^Bacteria
identified^LN^3456543^ CULTURE, STOOL^99USI^2.26|||2008081510300700||||||diarrhea|||1234^Admit^Alan^A^III^Dr^^^&2.16.840.1.113883.19.4.6^ISO^L^^^EI^&2.16.840.1.113883.19.4.6^ISO^^^^^^
^^MD|^WPN^PH^^1^555^5551005|||||2008081830-0700|||F||||||787.91^
DIARRHEA^I9CDX^^^^07/09/2008|1235&Slide&Stan&S&&Dr&MD&&DOC&2.16.840.1.113883.19.4.6&ISO
OBX|1|CWE|625-4^Bacteria identified:Prid:Pt:Stool:Nom:Culture^LN^^^^2.26|1|66543000^Campylobacter jejuni^SCT^^^^January
2007||||||P|||200906041458|||0086^Bacterial identification^OBSMETHOD^^^^501-20080815||200906051700||||GHH
Lab^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann
Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16.840.1.113883.19.4.6&ISO^L^^^NPI
SPM|1|23456&EHR&2.16.840.1.113883.19.3.2.3&ISO^9700122&Lab&2.16.840.1.113883.19.3.1.6&ISO||119339001^Stool
specimen^SCT^^^^20080131|||||||P^Patient^HL60369^^^^2.5.1|10^g&gram&UCUM&&&&1.6|||||2008081510300700|200808151100-0700
Example: Minimal Message
MSH|^~\&|Lab1^1234^CLIA|^1234^CLIA|ELR^2.16.840.1.113883.19.3.2^ISO|SPH^2.16.840.1.113883.19.3.2^ISO|20080818183002.10700||ORU^R01^ORU_R01|1234567890|P^T|2.5.1|||NE|NE|USA||||USELR1.0^^2.16.840.1.114222.4.10.3^ISO
SFT|1|Level Seven Healthcare Software, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1.2|An Lab System|56734||20080817
PID|1||36363636^^^MPI&2.16.840.1.113883.19.3.2.1&ISO^MR^A&2.16.840.1.113883.19.3.2.1&ISO~444333333^^^&2.16.840.1.113883.4.
1^ISO^SS||Everyman^Adam^A^^^^L^^^^^^^BS|Mum^Martha^M^^^^M|20050602|M||21063^White^CDCREC^^^^04/24/2007|2222 Home Street^^Ann
Arbor^MI^99999^USA^H||^PRN^PH^^1^555^5552004|^WPN^PH^^1^955^5551009|eng^English^ISO6392^^^^3/29/2007|M^Marrie
d^HL70002^^^^2.5.1||||||N^Not Hispanic or Latino^HL70189^^^^2.5.1||||||||N|||200808151000-0700|
Reliable^2.16.840.1.113883.19.3.1^ISO
ORC|RE|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2.16.840.1.113883.19.3.1.6^ISO|||||||||1234^Admit^Alan^A^III^Dr^
^^&2.16.840.1.113883.19.4.6^ISO^L^^^EI^&2.16.840.1.113883.19.4.6^ISO^^^^^^^^MD||^WPN^PH^^1^555^5551005|||||||Level
Seven Healthcare, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1005 Healthcare Drive^^Ann
Arbor^MI^99999^USA^B|^WPN^PH^^1^555^5553001|4444 Healthcare Drive^Suite 123^Ann Arbor^MI^99999^USA^B
OBR|1|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2.16.840.1.113883.19.3.1.6^ISO|10368-9^Lead BldCmCnc^LN^3456543^Blood lead test^99USI^2.24|||2008081510300700||||||diarrhea|||1234^Admit^Alan^A^III^Dr^^^&2.16.840.1.113883.19.4.6^ISO^L^^^EI^&2.16.840.1.113883.19.4.6^ISO^^^^^^
^^MD|^WPN^PH^^1^555^5551005|||||20080818300700|||F||||||787.91^DIARRHEA^I9CDX^^^^07/09/2008|1235&Slide&Stan&S&&Dr&MD&&DOC&2.16.840.1.113883.19.4.6&ISO
OBX|1|NM|10368-9^Lead BldC-mCnc^LN^^^^2.24||50|ug/dL^micro-gram per deci-liter^UCUM^^^^1.6|<10
ug/dL|H|||F|||200808151030-0700|||||200808181800-0700||||Lab^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434
Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16.840.1.113883.19.4.6&ISO^L^^^NPI
SPM|1|23456&EHR&2.16.840.1.113883.19.3.2.3&ISO^9700122&Lab&2.16.840.1.113883.19.3.1.6&ISO||122554006^Capillary blood
specimen^SCT^BLDC^Blood capillary^HL70070^20080131^2.5.1||HEPA^Ammonium heparin^HL70371^^^^2.5.1|CAP^Capillary
Specimen^HL70488^^^^2.5.1|181395001^Venous structure of
digit^SCT^^^^20080731|||P^Patient^HL60369^^^^2.5.1|50^uL&MicroLiter&UCUM&&&&1.6|||||2008081510300700|200808151100-0700