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ELINCSHL7Release1

EHRImplementationTestScriptDocument
Version1.0

Sujansky&Associates,LLC
March30,2009

ELINCS HL7-R1 EHR IMPLEMENTATION TEST SCRIPTS ........................................... 1
INTRODUCTION ................................................................................................................... 1
SETUP REQUIRED PRIOR TO TESTING .................................................................................. 1
TEST PATIENT INFORMATION ............................................................................................... 1
TEST PROVIDER INFORMATION ............................................................................................ 2
COPY-TO PROVIDER INFORMATION ..................................................................................... 2
LABORATORY FACILITY INFORMATION .................................................................................. 2
SYSTEM TEST IDENTIFICATION SCHEME ............................................................................... 3
TEST SCRIPTS .................................................................................................................... 5
TEST 1: SPECIMEN RECEIVED ............................................................................................. 6
TEST 2: TEST CANCELLED ................................................................................................... 8
TEST 3: FINAL RESULT ...................................................................................................... 10
TEST 4: FINAL RESULT (ADVANCED) .................................................................................. 14
TEST 5: FINAL RESULT (ERRORS) ...................................................................................... 21
TEST 6: PRELIMINARY +FINAL RESULT .............................................................................. 24
TEST 7: FINAL RESULT +REFLEX ...................................................................................... 27
TEST 8: FINAL RESULT +ADD ON ...................................................................................... 29
TEST 9: FINAL RESULT +CORRECTION .............................................................................. 31
TEST 10: FINAL RESULT +DELETION ................................................................................. 34
TEST 11: FINAL RESULT (COPY TO) ................................................................................... 37
TEST 12: FINAL RESULT (UNSOLICITED COPY) ................................................................... 40
ELINCS HL7-R1 TEST SCRIPT VALIDATION SUMMARY ..................................................... 43
APPENDICES ................................................................................................................. 44
ENTERING COMMON ORDER INFORMATION IN ELINCS EDGE ........................................... 44
MESSAGE TYPE AND MESSAGE SCENARIO ......................................................................... 44
REQUISITION ID ................................................................................................................ 45
PATIENT INFORMATION ...................................................................................................... 45
PROVIDER INFORMATION ................................................................................................... 45
TEST IDENTIFIER INFORMATION ......................................................................................... 46
REFLEX AND ADD-ON TESTS ............................................................................................. 47
OTHER TEST OPTIONS ...................................................................................................... 47
EVALUATING MT-ACK-1 ACKNOWLEDGEMENT MESSAGES ............................................... 48
ELINCS HL7 Release 1
EHR Implementation Test Script Document v1.0
1
ELINCS HL7-R1 EHR Implementation Test Scripts
Introduction
ThepurposeofthisdocumentistoassistanyEHRvendorthatisimplementingan
ELINCSHL7Release1labdatainterfacetoconfirmthatitsinterfacefullysupportsthe
ELINCSHL7R1implementationguide.Specifically,thisdocumentcontains(1)
instructionsforusingtheELINCSEDGEtooltogenerateacompletesetofELINCS
complianttestmessagesand(2)testvalidationscriptscorrespondingtoeachtest
messagethatassistanEHRvendortodeterminewhetheritsEHRproductfullymeetthe
requirementsoftheELINCSimplementationguide.

ThedocumentalsoincludestestsetupinstructionstoconfiguretheELINCSEDGEtool
andyourEHRsystemtosimulate,ascloselyaspossible,alabsystemthatsendsELINCS
compliantlabresultmessages.Forexample,specificdemographicinformationfor
PatientsandOrderingProvidersissuggestedforyourconvenience(althoughyoumay
substituteyourowndemographicinformationeasily).

Lastly,theappendixtothisdocumentcontainsinstructionsonhowtoconfigureallof
thelaborderinformationthatwillappearinresultmessagesgeneratedbytheEDGE
toolandhowtovalidatetheAcknowledgementmessagesthatyourEHRsystemwill
generateinresponsetoELINCSresultmessages.
Setup Required Prior to Testing
PriortotestingyourELINCSInterfacewiththetestscriptsprovidedinthisdocument,
youmustspecifyanumberofrecords/accountsinyourEHRandappropriatelyconfigure
theELINCSEDGEtool.
Test Patient Information
Allinstructionsandexamplesinthistestscriptdocumentrefertothesametestpatient
(EllieElincs).Ifyouchoosetousethispatientforyouractualtesting,createanew
patientrecordinyoursystemwiththedemographicinformationprovidedbelow
(recordtheidentifierassignedbyyourEHRtothispatientintheblankspaceprovided).
Ifyouprefertouseatestpatientrecordthatalreadyexistsinyoursystem,youmaydo
so.Inthiscase,substituteyourowntestpatientinformationforthatofEllieElincsin
thetestscriptsinthisdocument.

Prefix:Mrs.
FirstName:Ellie
MiddleInitial:E
LastName:Elincs
DateofBirth:April1,1944
Gender:Female
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PatientIdentifier:_________________________________________________________
Test Provider Information
Allinstructionsandexamplesinthistestscriptdocumentusethesametestprovider
(HenryL.Seven).Ifyouchoosetousethisphysicianforyourinterfacetesting,create
anewphysicianrecordinyoursystemwiththeinformationprovidedbelow.Ifyou
prefertouseaphysicianaccountalreadyinyoursystem,youmaydoso.Inthiscase,
substituteyourownorderingphysicianinformationforthatofHenryL.Seveninthetest
scriptsinthisdocument.

NPI#:1234567897
Prefix:Dr.
FirstName:Henry
MiddleInitial:L
LastName:Seven
Copy-To Provider Information
Forteststhatincludecopytoinformation,thefollowingproviderinformationwillbe
usedintheinstructionsandexamplesinthistestscriptdocument.Ifyouprefertousea
differentphysicianaccountalreadyinyoursystem,youmaydoso.Inthiscase,
substituteyourowncopytophysicianinformationforthatofthecopytoprovider
indicatedinthetestscripts.Notealsothatyoumayspecifymultiplecopytoprovidersif
youwish.

NPI#:2345678904
Prefix:Dr.
FirstName:Carla
MiddleInitial:C
LastName:Copyto
Laboratory Facility Information
ThissectiondescribeshowyoucanconfiguretheELINCSEDGETooltousetheactual
CLIAidentifierofthelaboratoryfacilitywithwhichyouwillbeperforminglivetesting
later(ifyouhavethisinformation).Ifyoudonothavethatinformationavailableatthe
timeyouperformthesetests,youmayusethesampleCLIAIDprovidedwiththistest
scriptdocument.
1. StarttheELINCSEDGEToolinEHRMode
2. Fromtheapplicationmenu,selectEditPreferencesTheapplicationwill
displaythePreferencesdialog.
3. IntheMessageHeaderValuessection,findtheSendingFacilityfields.Inthe
UniversalIDcolumn,entertheCLIAIDofthelabyouwillbetestingwith.Ifyou
donotknowtheCLIAID,youcanusethevalue05D0101010

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TheMessageHeaderssectionofthedialogboxshouldnowlooklikethis:

YoumayenterSendingApplication,ReceivingApplication,andReceivingFacility
informationasfitsyourrequirements(notethatthesefieldsareoptional).Ifyouspecify
thisinformation,besuretochecktheIncludeboxtoensurethatitisincludedinthe
resultmessage.
System Test Identification Scheme
SomeEHRsgenerateasingleidentifierfortheentirerequisition,regardlessofthe
numberoftests/panelsordered(apracticereferredtoasRequisitionOnly
IdentificationorRO).OtherEHRsgenerateuniqueidsforeachtestorderedona
laboratoryrequisitioninadditiontoanidentifierfortheentirerequisition(apractice
referredtoasTestSpecificIdentificationorTS).ThemannerinwhichtheEHR
generatestestidentifiers(i.e.,ROvs.TS),incombinationwithalaboratoryssupportof
aparticularidentificationscheme,determineshowcertainfieldsinanELINCSresult
messagewillbepopulated(Forfurtherexplanationandexamples,seetheELINCSHL7
Release1ImplementationGuide,section5.5).

TheELINCSEDGEToolallowsyoutospecifywhichwayyourEHRsystemgenerates
identifiersfortestorders(TSorRO):.
1. StarttheELINCSEDGEToolinEHRMode
2. Fromtheapplicationmenu,selectEditPreferencesTheapplicationwill
displaythePreferencesdialog.
3. IntheEHRTestIdSchemearea,indicatewhichschemeyourEHRsystem
supports.

OR

YoumustalsoindicateifthelaboratoryfromwhichyouwillbelaterreceivingELINCS
messagessupportsTestSpecificorRequisitionOnlyidentificationschemes.Thisshould
beindicatedintheLISTestIdSchemearea(Seenotebelow).


OR
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NOTE:ForfullELINCScompliance,yoursystemmustbeabletoreceiveELINCSdata
fromalaboratoryregardlessoftheLISTestIdSchemesupportedbythelabs
informationsystem.Hence,alltestsinthistestscriptdocumentshouldberun
twice,oncewiththeLISTestIdSchemesettoRequisitionOnlyandoncewiththe
LISTestIdSchemesettoTestSpecific.Inbothcases,theEHRTestIDScheme
shouldbesettotheschemethatyourEHRsupports.
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Test Scripts
ThissectionincludesalltestscriptsnecessarytovalidatethatyourEHRsystemsupports
theELINCSHL7Release1specification.EachtestincludesaTestSetupsectionanda
TestValidationsection.TheTestSetupsectionincludesstepbystepinstructionson
settinguptheorderandgeneratingthetestmessage(s).Ifyouplantousethe
suggestedtestpatientandorderingproviderinformation,youcansavetimebyloading
intotheEDGEtooltheorderfilelistedineachtestsetupsection(theseorderfilesare
providedwiththisdocument).Eachpredefinedorderfileincludesthepatient
information,providerinformation,andthetestidentifiersindicatedinthetestsetup
section.Youmuststillmanuallyenterthetesttype/scenario,labrequisitionidentifier,
patientidentifier,andtestserviceidentifier(ifapplicable)foreachtest,asthisisspecific
totheorderinformationgeneratedbyyourEHRandcannotbepredefinedintheorder
fileswehaveprovided.
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Test 1: Specimen Received
Amessagefromthelabindicatingthattheserumspecimenwasreceivedforthe
orderedHgbA1cquantificationtest(Note:NotalllabswillsendaSpecimenReceived
message,butanELINCScompliantEHRshouldbepreparedtoprocesssuchmessages).
Test 1 Setup Script
1. CreateanorderbyDr.H.L.SevenforaHemoglobinA1cforEllieElincsinyour
EHRsystem.
2. UsingtheEDGETool,loadtheorderfileandentertheorderinformationas
specifiedbelow:

OrderFileName: test01specimenreceived.ord
ScenarioType: SingleMessage
MessageScenario: SpecimenReceived
IncludeTQ1Segment: Unchecked
IncludeNTESegment: Unchecked
IncludeSetIDs: Checked
Test: HgbA1cQuant
SampleCollectionDate: January1,2009

3. Entertherequisitionidentifier,patientidentifier(s),andtestserviceidentifier(if
required)fromtheEHRordergeneratedbyyoursystemintotheorder
informationformoftheEDGETOol.
4. GeneratetheSpecimenReceivedmessagebyclickingtheGenerateMessages
Button.
5. SavethegeneratedSpecimenReceivedmessageastest01specimenreceived
byclickingtheSavebuttonandenteringthenewfilename.
6. Importthetest01specimenreceived.orumessageintoyourinterfaceengineor
EHRsysteminwhatevermannerHL7labresultmessagesareusuallyreceived.
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Test 1 Validation Criteria
# EHR System Action
Pass/Fail
RO TS
Specimen Received Message
1.1
The system receives the MT-ORU-1 Specimen Received message and safely
stores the message data.
1.2
The system parses and validates the MT-ORU-1 Specimen Received
message to ensure that all required fields are present.
1.3
The system acknowledges receipt of the MT-ORU-1 Specimen Received
message by generating an MT-ACK-1 Acknowledgement message. This
message passes validation in the ELINCS EDGE Tool (see the section
Evaluating MT-ACK-1 Acknowledgement Messages below).
1.4
The system automatically associates the MT-ORU-1 Specimen Received
message with the correct patient record.
1.5
[CLIA Requirement] The system displays the patient id [PID-3] from the MT-
ORU-1 Specimen Received message when displayed to the ordering provider
on the lab report display screen (or makes this data otherwise available to
view).
1.6
[CLIA Requirement] The system displays the patient's name [PID-5] to the
ordering provider on the lab report display screen (or makes this data
otherwise available to view).
1.7
[CLIA Requirement] The system displays the ordered test/panel name and
identifier [OBR-4] to the ordering provider on the lab report display screen (or
makes this data otherwise available to view). Note that the EHR need not
display the full value of OBR-4 to the user, but the full value should be stored
and available for review.



1.8
[CLIA Requirement] The MT-ORU-1 Specimen Received message is only
released to authorized persons and the individual responsible for using the
test results (determined by the ordering provider information [OBR-16])
1.9
[CLIA Requirement] The system displays the date/time that the status was
changed [OBR-22] to the ordering provider on the lab report display screen (or
makes this data otherwise available to view).
1.10
[CLIA Requirement] If the lab result includes the specimen type [SPM-4], the
system displays this information to the ordering provider on the lab report
display screen (or makes this data otherwise available to view).



1.11
The EHR system should update the status of the lab order to indicate that the
order and specimen were Received by Lab or an equivalent status.

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Test 2: Test Cancelled
Amessagethatindicatesanorderedtesthasbeencancelledbythelaboratorybecause
ofahemolyzedserumsample.
Test 2 Setup Script
1. CreateanorderbyDr.H.L.SevenforaHepaticFunctionPanelforEllieElincsin
yourEHRsystem.
2. UsingtheEDGETool,loadtheorderfileandentertheorderinformationas
specifiedbelow:

OrderFileName: test02testcancelled.ord
ScenarioType: SingleMessage
MessageScenario: TestCancelled
IncludeTQ1Segment: Unchecked
IncludeNTESegment: Unchecked
IncludeSetIDs: Checked
Test: HepaticFunctionPanel
SampleCollectionDate: January1,2009

3. Entertherequisitionidentifier,patientidentifier(s),andtestserviceidentifier(if
required)fromtheEHRorderintotheorderinformationform.
4. GeneratetheTestCancelledmessagebyclickingtheGenerateMessages
Button.
5. AddaspecimenrejectedcommenttotheOBRsegment:
a. IntheMessagespanel,opentheTestCancelledmessageuntiltheOBR
segmentisvisible.
b. RightclickontheOBRsegmentrowandselectAddNTEfromthemenu
orchooseEditAddNTESegmentfromtheapplicationmenu.

or

c. DoubleclickontheNTE3Commentfieldofthenewsegmentandadd
thetextSpecimenrejectedSamplehemolyzedintothedialogfield.
ClickOKtoacceptthecomment.
6. SavetheTestCancelledmessageastest02testcancelledbyclickingthe
Savebuttonandenteringthenewfilename.
7. Importthetest02testcancelled.orumessageintotheEHRsystem.
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Test 2 Validation Criteria
# EHR System Action
Pass/Fail
RO TS
Test Cancelled Message
2.1
The system receives the MT-ORU-1 Test Cancelled message and safely stores
the message data.
2.2
The system parses and validates the MT-ORU-1 Test Cancelled message to
ensure that all required fields are present.
2.3
The system acknowledges receipt of the MT-ORU-1 Test Cancelled message by
generating an MT-ACK-1 Acknowledgement message. This message passes
validation in the ELINCS EDGE Tool (see the Evaluating MT-ACK-1
Acknowledgement Messages section below).
2.4
The MT-ORU-1 Test Cancelled message is automatically associated with the
correct patient record.
2.5
[CLIA Requirement] The system displays the patient id [PID-3] from the MT-
ORU-1 Test Cancelled message when displayed to the ordering provider on the
lab report display screen (or makes this data otherwise available to view).
2.6
[CLIA Requirement] The system displays the patient's name [PID-5] to the
ordering provider on the lab report display screen (or makes this data otherwise
available to view).
2.7
[CLIA Requirement] The system displays the ordered test/panel name and
identifier [OBR-4] to the ordering provider on the lab report display screen (or
makes this data otherwise available to view).



2.8
[CLIA Requirement] The MT-ORU-1 Test Cancelled message is only released
to authorized persons and the individual responsible for using the test results
(determined by the ordering provider information [OBR-16])
2.9
[CLIA Requirement] The system displays the date/time that the status was
changed [OBR-22] to the ordering provider on the lab report display screen (or
makes this data otherwise available to view).
2.10
[CLIA Requirement] The system clearly indicates that the entire test was
cancelled, based on the value of the Result Status [OBX-25]
2.11
[CLIA Requirement] The system displays the specimen type [SPM-4] to the
ordering provider on the lab report display screen (or makes this data otherwise
available to view).



2.12
The EHR system should update the status of the order to indicate that the test
was cancelled by the laboratory and possibly alert the ordering provider.

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Test 3: Final Result
Thisisasimplelipidpanelfinalresultmessage.
Test 3 Setup Script
1. CreateanorderbyDr.H.L.SevenforaLipidPanelforEllieElincsinyourEHR
system.
2. UsingtheEDGETool,loadtheorderfileandentertheorderinformationas
specifiedbelow:

OrderFileName: test03finalresult.ord
ScenarioType: SingleMessage
MessageScenario: FinalResult
IncludeTQ1Segment: Unchecked
IncludeNTESegment: Unchecked
IncludeSetIDs: Checked
Test: LipidPanel
SampleCollectionDate: January1,2009

3. Entertherequisitionidentifier,patientidentifier(s),andtestserviceidentifier(if
required)fromtheEHRorderintotheorderinformationform.
4. GeneratetheFinalResultmessagebyclickingtheGenerateMessages
Button.
5. SavetheFinalResultmessageastest03finalresultbyclickingtheSave
buttonandenteringthenewfilename.
6. Importthetest03finalresult.orumessageintotheEHRsystem.
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Test 3 Validation Criteria
# EHR System Action
Pass/Fail
RO TS
Final Result Message
3.1
The system receives the MT-ORU-2 Final Result message and safely stores
the result data.
3.2
The system acknowledges receipt of the MT-ORU-2 Final Result message by
sending an MT-ACK-1 Acknowledgement message to the originating
laboratory. This message passes validation in the ELINCS EDGE Tool (see
the Evaluating MT-ACK-1 Acknowledgement Messages section below).
3.3
The MT-ORU-2 Final Result message is automatically associated with the
correct patient record.
3.4
[CLIA Requirement] The system displays the patient id [PID-3] from the MT-
ORU-2 result message when results are displayed to the ordering provider on
the lab report display screen (or makes this data otherwise available to view).
3.5
[CLIA Requirement] The system displays the patient's name [PID-5] to the
provider on the lab report display screen (or makes this data otherwise
available to view).
3.6
[CLIA Requirement] The system displays the ordered test/panel name and
identifier [OBR-4] to the provider on the lab report display screen (or makes
this data otherwise available to view).



3.7
[CLIA Requirement] The MT-ORU-2 result message is only released to
authorized persons and the individual responsible for using the test results
(determined by the ordering provider information [OBR-16])
3.8
CLIA Requirement] The system displays the date/time that the result was
reported [OBR-22] to the ordering provider on the lab report display screen (or
makes this data otherwise available to view).
3.9
[CLIA Requirement] The system displays the name and identifier of every
analyte [OBX-3] present in the MT-ORU-2 result message to the ordering
provider on the lab report display screen.



3.10
[CLIA Requirement] The system displays the result value of every analyte
[OBX-5] present in the MT-ORU-2 result message to the ordering provider on
the lab report display screen.



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# EHR System Action
Pass/Fail
RO TS
3.11
[CLIA Requirement] The system displays the result value units of every
analyte [OBX-6] present in the MT-ORU-2 result message to the ordering
provider on the lab report display screen.



3.12
[CLIA Requirement] The system displays the result references range of
every analyte [OBX-7] present in the MT-ORU-2 result message to the
ordering provider on the lab report display screen (or makes this data
otherwise available to view).



3.13
[CLIA Requirement] The system displays the result abnormal flags of
analytes that contain abnormal information [OBX-8] present in the MT-ORU-2
result to the ordering provider on the lab report display screen.



3.14
[CLIA Requirement] The system displays the name of the lab that produced
the test results [OBX-23] to the ordering provider on the lab report display
screen (or makes this data otherwise available to view).



3.15
[CLIA Requirement] The system displays the address of the lab that
produced the test results [OBX-24] to the ordering provider on the lab report
display screen (or makes this data otherwise available to view).



3.16
[CLIA Requirement] If present in the MT-ORU-2 result message, the system
displays the name of the medical director for the lab that produced the test
results [OBX-24] to the ordering provider on the lab report display screen (or
makes this data otherwise available to view).



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# EHR System Action
Pass/Fail
RO TS
3.17
[CLIA Requirement] The system displays the specimen type [SPM-4] to the
ordering provider on the lab report display screen (or makes this data
otherwise available to view).


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Test 4: Final Result (Advanced)
Thisisamorecomplexfinalresultmessagethatincludesresultsfortwoorderedtests
performedattwodifferentlocations.Thetestisreportedanonymously(i.e.,nopatient
nameisincluded).Oneofthetestshasacancelledanalyte(duetoinsufficientspecimen
quantity)andananalytethatwasnotperformedbecausethetestwasnotmedically
necessary.Finally,thetestincludesaTQ1segmentindicatingthatthetestwasordered
tobeperformedpriortoadesignateddate.
Test 4 Setup Script
1. CreateanorderbyDr.H.L.SevenforanHgbA1candBasicMetabolicPanelfor
EllieElincsinyourEHRsystem.
2. UsingtheEDGETool,loadtheorderfileandentertheorderinformationas
specifiedbelow:

OrderFileName: test04finalresult_advanced.ord
ScenarioType: SingleMessage
MessageScenario: FinalResult
IncludeTQ1Segment: Checked
IncludeNTESegment: Unchecked
IncludeSetIDs: Checked
Tests: HGBA1cQuant
BasicMetabolicPanel(BMP)
SampleCollectionDate: <empty>

3. Entertherequisitionidentifier,patientidentifier(s),andtestserviceidentifier(if
required)fromtheEHRorderintotheorderinformationform.
4. GeneratetheFinalResultmessagebyclickingtheGenerateMessages
Button.
5. Deletethepatientsnamefromtheresult.
a. OpenthegeneratedmessagetothePIDsegment.
b. DoubleclickonthePatientName[PID5]field.
c. ClicktheClearAllbuttonintheEditingValuesdialog.
d. ClicktheAddRepetitionbuttonontheEditingValuesdialog.
e. EnterthevalueSintotheNameTypeCodecomponentofrepetition2.
f. ClicktheOKbutton.

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6. AddaFastingcommenttobothOBRsegments:
a. OpenthemessagetreeupsothatbothOBRsegmentsarevisible.
b. RightclicktheOBRsegmentrowandselectAddNTEfrommenuor
chooseselecttheOBRandclickEditAddNTEfromtheapplication
menu.
c. DoubleclickontheNTE3Commentfieldofthenewsegmentandadd
thetextFasting.ClickOKtoacceptthecomment.
d. RepeatstepsacforthesecondOBRsegment.
7. AddanInsufficientSampleQuantitycommenttothecancelledanalyte:
a. Fromtheapplicationmenu,selectEditFind(CtrlF).
b. Enterthevalue29512intothesearchfieldandclicktheFindbutton.
TheapplicationopensthemessagetothecancelledSODIUManalyteOBX
segment.
c. RightclicktheOBXsegmentrowandselectAddNTEfrommenuor
selecttheOBRandclickEditAddNTEfromtheapplicationmenu.
d. DoubleclickontheNTE3Commentfieldofthenewsegmentandadd
thetextSamplequantityinsufficienttoperformtest.ClickOKto
acceptthecomment.
8. ChangetheProducerInformationfortheHgbA1cresult:
a. Fromtheapplicationmenu,selectEditFind(CtrlF).
b. Enterthevalue45484intothesearchfieldandclicktheFindbutton.
TheapplicationopensthemessagetotheHEMOGLOBINA1CanalyteOBX
segment.
c. DoubleclickthePerformingOrganizationName[OBX23]field.Change
theOrganizationnameinformationto:
i. OrganizationName:FastLab
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ii. NamespaceID:CLIA
iii. OrganizationIdentifier:05D111111
d. DoubleclickthePerformingOrganizationAddress[OBX24]field.Change
theOrganizationaddressinformationto:
i. StreetorMailingAddress:123TestDr.
ii. City:Anytown
iii. State:CA
iv. ZiporPostalCode:94123
e. DoubleclickthePerformingOrganizationMedicalDirector[OBX25]field.
ChangetheOrganizationmedicaldirectorinformationto:
i. Surname:Smith
ii. GivenName:Janet
9. SavetheFinalResultmessageastest04finalresult_advancedbyclickingthe
Savebuttonandenteringthenewfilename.
10. Importthetest04finalresult_advanced.orumessageintotheEHRsystem.
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Test 4 Validation Criteria
# EHR System Action
Pass/Fail
RO TS
Final Result Message
4.1
The system receives the MT-ORU-2 Final Result message and safely stores
the result data.
4.2
The system acknowledges receipt of the MT-ORU-2 Final Result message by
sending an MT-ACK-1 Acknowledgement message to the originating
laboratory. This message passes validation in the ELINCS EDGE Tool (see
the Evaluating MT-ACK-1 Acknowledgement Messages section below).
4.3
The MT-ORU-2 Final Result message is automatically associated with the
correct patient record.
4.4
[CLIA Requirement] The system displays the patient id [PID-3] from the MT-
ORU-2 result message when results are displayed to the ordering provider on
the lab report display screen (or makes this data otherwise available to view).
4.5
[CLIA Requirement] The system displays the filler order number [OBR-3]
(i.e., accession number to the provider on the lab report display screen (or
makes this data otherwise available to view), in lieu of the patients name.
4.6
[CLIA Requirement] The system displays the ordered test/panel names and
identifiers [OBR-4] to the provider on the lab report display screen (or makes
this data otherwise available to view) for both ordered tests.




4.7
[CLIA Requirement] The MT-ORU-2 result message is only released to
authorized persons and the individual responsible for using the test results
(determined by the ordering provider information [OBR-16])
4.8
CLIA Requirement] The system displays the date/time that the result was
reported [OBR-22] to the ordering provider on the lab report display screen (or
makes this data otherwise available to view).
4.9
[CLIA Requirement] The system displays the name and identifier of every
analyte [OBX-3] present in the MT-ORU-2 result message to the ordering
provider on the lab report display screen.





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# EHR System Action
Pass/Fail
RO TS

4.10
[CLIA Requirement] The system displays the result value of every analyte
[OBX-5] present in the MT-ORU-2 result message to the ordering provider on
the lab report display screen.




4.11
[CLIA Requirement] The system displays the result value units of every
analyte [OBX-6] present in the MT-ORU-2 result message to the ordering
provider on the lab report display screen.




4.12
[CLIA Requirement] The system displays the references ranges of every
analyte [OBX-7] present in the MT-ORU-2 result message to the ordering
provider on the lab report display screen (or makes this data otherwise
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# EHR System Action
Pass/Fail
RO TS
available to view).



4.13
[CLIA Requirement] The system displays the abnormal flags of analytes that
contain abnormal information [OBX-8] present in the MT-ORU-2 result to the
ordering provider on the lab report display screen.




4.14
[CLIA Requirement] The system clearly indicates to the ordering provider on
the lab report display screen those tests that have been cancelled by the
laboratory (e.g., the Observation Result Status [OBX-11] value is X or N).



4.15
The system displays the Comment [NTE-3] text for the cancelled UREA
NITROGEN test.



4.16
[CLIA Requirement] The system displays the name of each lab that produced
the test results [OBX-23] to the ordering provider on the lab report display
screen (or makes this data otherwise available to view).




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# EHR System Action
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4.17
[CLIA Requirement] The system displays the address of each lab that
produced the test results [OBX-24] to the ordering provider on the lab report
display screen (or makes this data otherwise available to view).




4.18
[CLIA Requirement] If present in the MT-ORU-2 result message, the system
displays the name of the medical director for the lab that produced the test
results [OBX-24] to the ordering provider on the lab report display screen (or
makes this data otherwise available to view).




4.19
[CLIA Requirement] The system displays the specimen type [SPM-4] to the
ordering provider on the lab report display screen (or makes this data
otherwise available to view).


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Test 5: Final Result (Errors)
Thisisalipidpanelfinalresultmessagewithanumberoferrors.TheEHRshould
indicatethattheresultisunmatchedtoapatientrecordandhandletheresult
accordingly.ThistestwillhelpyoudeterminehowyoursystemhandlesinvalidELINCS
messageswithinvalidormissinginformationcriticaltomatchingtotheexistingorderor
thepatientsrecord.
Test 5 Setup Script
1. CreateanorderbyDr.H.L.SevenforaLipidPanelforEllieElincsinyourEHR
system.
2. UsingtheEDGETool,loadtheorderfileandentertheorderinformationas
specifiedbelow.Forthistest,itisimportanttousetheorderfileprovidedinthe
testscriptpackagetopopulatetheorderformasspecialvaluesareusedwhen
generatingtheresultmessage.

OrderFileName: test05finalresult_error.ord
ScenarioType: SingleMessage
MessageScenario: FinalResult
IncludeTQ1Segment: Unchecked
IncludeNTESegment: Unchecked
IncludeSetIDs: Unchecked
Test: LipidPanel
SampleCollectionDate: <empty>

3. GeneratetheFinalResultmessagebyclickingtheGenerateMessages
Button.
4. SavetheFinalResultmessageastest05finalresult_nomatchbyclickingthe
Savebuttonandenteringthenewfilename.
5. ClickontheGenerateTestMessage(s)tab.
6. Withoutchanginganysettings,clickontheGenerateMessage(s)buttonagain.A
newversionofthemessagewillbecreatedwithanewMSH10MessageControl
ID.
7. Deletethepatientidentifier(s):
a. IntheMessagespanel,openupthemessageuntilthePIDsegmentis
visible.
b. DoubleclickthePatientIdentifierList[PID3]field.Theapplicationopens
theeditordialogforPID3.
c. ClicktheClearAllbutton.Theformisfullycleared.
d. Ifanyotheridentifiershavebeenprovidedintheorder,deleteall
additionalidentifiersbyselectingtheeachrepetitionintheRepetitions
panelandclicktheRemoveRepetitionbuttonforeach.
e. ClicktheOKbutton.
8. DeletethePatientName
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a. IntheMessagespanel,openthemessageuntilthePIDsegmentisvisible.
b. DoubleclickthePatientName[PID5]field.Theapplicationopensthe
editordialogforPID5.
c. ClicktheClearAllbutton.Theformisfullycleared.
d. ClicktheOKbutton.
9. Deletetheplacerordernumbers:
a. IntheMessagespanel,openthemessageuntiltheORCsegmentis
visible.
b. DoubleclickthePlacerGroupNumber[ORC4]field.Theapplication
openstheeditordialogforORC4.
c. ClicktheClearAllbuttonandthenclickOK.
d. IntheMessagespanel,openthemessageuntiltheOBRsegmentis
visible.
e. DoubleclickthePlacerOrderNumber[OBR2]field.Theapplication
openstheeditordialogforOBR2]
f. ClicktheClearAllbuttonandthenclickOK.
10. Deletetheorderingproviderinformation:
a. IntheMessagespanel,openthemessageuntiltheOBRsegmentis
visible.
b. DoubleclicktheOrderingProvider[OBR16]field.Theapplicationopens
theeditordialogforOBR16.
c. ClicktheClearAllbuttonandthenclickOK.
11. SavetheFinalResultmessageastest05finalresult_errorsbyclickingthe
Savebuttonandenteringthenewfilename.
12. Importthetest05finalresult_nomatch.oruandtest05finalresult_errors.oru
messagesintotheEHRsystem.
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Test 5 Validation Criteria
# EHR System Action
Pass/Fail
RO TS
Final Result Message No Match
5.1
The system receives the MT-ORU-2 Final Result message and safely stores
the result data.
5.2
The system sends an MT-ACK-1 Acknowledgement message to the originating
laboratory. The Acknowledgement Code [MSA-1] should have the value CE
indicating that the EHR is reporting an error or failure. This message passes
validation in the ELINCS EDGE Tool (see the Evaluating MT-ACK-1
Acknowledgement Messages section below).

Inclusion of ERR segments in the MT-ACK-1 Acknowledgement message is
optional.
5.3
The system should be unable to match the results to the correct patient
automatically. The system should add the message to a queue to be manually
matched to the correct patient record.
5.4
[CLIA Requirement] Once matched to the correct patient, the system captures
and displays all data elements that are required to be reported by laboratories
per the CLIA laboratory regulations (See Test 3 Validation Criteria). The
system shall make the CLIA required data elements available for review by
appropriate end-users.
Final Result Message Errors
5.5
The system receives the MT-ORU-2 Final Result message and safely stores
the result data.
5.6
The system determines that the following required fields are missing: PID-3,
PID-5, ORC-4, OBR-2, and OBR-16.
5.7
The system sends an MT-ACK-1 Acknowledgement message to the originating
laboratory. The Acknowledgement Code [MSA-1] should have the value CE
indicating that the EHR is reporting an error or failure. This message passes
validation in the ELINCS EDGE Tool (see the Evaluating MT-ACK-1
Acknowledgement Messages section below).

Inclusion of ERR segments in the MT-ACK-1 Acknowledgement message is
optional.
5.8
The system may discard the message because of the missing required field
data or add it to a messaging queue to be resolved manually. In this situation,
the laboratory should send a new message with the required values present.
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Test 6: Preliminary + Final Result
Thistestgeneratestworesultmessagesrepresentingapreliminaryurinecultureresult
thatislaterfollowedbyafinalurineculture.ThistestwillhelpdeterminehowtheEHR
systemhandlestheupdateofalabresultasitmovesfromapreliminarytoafinal
status.
Test 6 Setup Script
1. CreateanorderbyDr.H.L.SevenforaUrineCultureforEllieElincsinyourEHR
system.
2. UsingtheEDGETool,loadtheorderfileandentertheorderinformationas
specifiedbelow

OrderFileName: test06preliminary+finalresult.ord
ScenarioType: MultipleMessages
MessageScenario: Preliminary/FinalCultureResult
IncludeTQ1Segment: Unchecked
IncludeNTESegment: Unchecked
IncludeSetIDs: Checked
Test: UrineCulture
SampleCollectionDate: January1,2009

3. Entertherequisitionidentifier,patientidentifier(s),andtestserviceidentifier(if
required)fromtheEHRorderintotheorderinformationform.
4. GeneratethePreliminaryResultandFinalResultmessagesbyclickingthe
GenerateMessagesButton.
5. SavethePreliminaryResultmessageastest06preliminary(topfilename
field)andtheFinalResultmessageastest06finalresult(bottomfilename
field)byclickingtheSaveAllbuttonandenteringthenewfilenames.
6. Importthetest06preliminary.orumessageintotheEHRsystemandreview
thevalidationcriteriaforthepreliminarymessage.
7. Importthetest06finalresult.orumessageintotheEHRsystemandreviewthe
validationcriteriaforthefinalmessage.
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Test 6 Validation Criteria
# EHR System Action
Pass/Fail
RO TS
Preliminary Result Message
6.1
The system receives the MT-ORU-2 Preliminary Result message and safely
stores the result data.
6.2
The system acknowledges receipt of the MT-ORU-2 Preliminary Result
message by sending an MT-ACK-1 Acknowledgement message to the
originating laboratory. This message passes validation in the ELINCS EDGE
Tool (see the Evaluating MT-ACK-1 Acknowledgement Messages section
below).
6.3
The MT-ORU-2 Preliminary Result message is automatically associated with
the correct patient record.
6.4
[CLIA Requirement] The system captures and displays all data elements that
are required to be reported by laboratories per the CLIA laboratory regulations
(See Test 3 Validation Criteria). The system shall make the CLIA required
data elements available for review by appropriate end-users.
6.5
[CLIA Requirement] The system includes a suitable representation of the
Result Status [OBR-25] on lab report display screen to clearly indicate to the
end-user that the message contains preliminary results.



6.6
[CLIA Requirement] The system includes a suitable representation of the
Observation Result Status [OBX-11] for each preliminary analyte reported on
lab report display screen to clearly indicate to the end-user that the result is
preliminary.



Final Result Message
6.7
The system receives the MT-ORU-2 Final Result message and safely stores
the result data.
6.8
The system acknowledges receipt of the MT-ORU-2 Final Result message by
sending an MT-ACK-1 Acknowledgement message to the originating
laboratory. This message passes validation in the ELINCS EDGE Tool (see
the Evaluating MT-ACK-1 Acknowledgement Messages section below).
6.9
The MT-ORU-2 Final Result message is automatically associated with the
correct patient record.
6.10
[CLIA Requirement] The system captures and displays all data elements that
are required to be reported by laboratories per the CLIA laboratory regulations
(See Test 3 Validation Criteria). The system shall make the CLIA required
data elements available for review by appropriate end-users.
6.11
The EHR system updates the values of the preliminary result message to
display the updated final values to the ordering provider on the report display
screen.

Preliminary Values:
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Final Values:

6.12
The EHR should update the preliminary result to the final result such that a
duplicate view or second copy of the record is not created in the system from
the perspective of an end-user viewing the results. Original data may be
maintained in the database for legal and regulatory archival purposes.

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Test 7: Final Result + Reflex
Thistestsimulatesthereportingofafinalcultureresultandthelaterreportingofa
reflexantimicrobialsensitivitytestinitiatedbythelaboratory.Thistestwillhelp
determinehowyoursystemhandlesELINCSreflextests.Thisexamplemakesuseofthe
specialruleswithinELINCSforreportingcultureresultsandmicrobialsensitivities.
However,fromthepointofviewoftheEHR,itisexactlythesameasarunofthemill
reflextest,andcanbehandledjustthesame.
Test 7 Setup Script
1. CreateanorderbyDr.H.L.SevenforaRespiratoryCultureforEllieElincsinyour
EHRsystem.
2. UsingtheEDGETool,loadtheorderfileandentertheorderinformationas
specifiedbelow:

OrderFileName: test07final+reflex.ord
ScenarioType: MultipleMessages
MessageScenario: FinalCulture/SensitivityReflex
IncludeTQ1Segment: Unchecked
IncludeNTESegment: Unchecked
IncludeSetIDs: Checked
Test: RespiratoryCulture
ReflexTest: BacterialSusceptibilityPanel
SampleCollectionDate: January1,2009

3. Entertherequisitionidentifier,patientidentifier(s),andtestserviceidentifier(if
required)fromtheEHRorderintotheorderinformationform.
4. GeneratetheFinalCultureResultandSensitivityReflexTestmessagesby
clickingtheGenerateMessagesButton.
5. SavetheFinalCultureResultmessageastest07finalresultandtheFinal
Resultmessageastest07reflexbyclickingtheSaveAllbuttonandentering
thenewfilenames.
6. Importthetest07finalresult.orumessageintotheEHRsystemandreviewthe
validationcriteriafortheculturemessage.
7. Importthetest07reflex.orumessageintotheEHRsystemandreviewthe
validationcriteriaforthefinalmessage.

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Test 7 Validation Criteria
# EHR System Action
Pass/Fail
RO TS
Final Result Message
7.1
The system receives the MT-ORU-2 Final Result message and safely stores
the result data.
7.2
The system acknowledges receipt of the MT-ORU-2 Final Result message by
sending an MT-ACK-1 Acknowledgement message to the originating
laboratory. This message passes validation in the ELINCS EDGE Tool (see the
Evaluating MT-ACK-1 Acknowledgement Messages section below).
7.3
The MT-ORU-2 Final Result message is automatically associated with the
correct patient record.
7.4
[CLIA Requirement] The system captures and displays all data elements that
are required to be reported by laboratories per the CLIA laboratory regulations
(See Test 3 Validation Criteria). The system shall make the CLIA required
data elements available for review by appropriate end-users.
Reflex Message
7.5
The system receives the MT-ORU-2 Reflex message and safely stores the
result data.
7.6
The system acknowledges receipt of the MT-ORU-2 Reflex message by
sending an MT-ACK-1 Acknowledgement message to the originating
laboratory. This message passes validation in the ELINCS EDGE Tool (see the
Evaluating MT-ACK-1 Acknowledgement Messages section below).
7.7
The MT-ORU-2 Reflex message is automatically associated with the correct
patient record.
7.8
[CLIA Requirement] The system captures and displays all data elements that
are required to be reported by laboratories per the CLIA laboratory regulations
(See Test 3 Validation Criteria). The system shall make the CLIA required
data elements available for review by appropriate end-users.
7.9
The EHR should link the reflex results to the test and result from the originally
reported MT-ORU-2 Final Result Message that spawned the reflex test,
identified by the OBR fields Parent Result [OBR-26], Parent [OBR-29] and
Parent Universal Service Identifier [OBR-50]. The system should display this
linkage to the end-user in a very clear manner. The system should make it
easy for the end-user to view the reflex results and the result that spawned the
reflex test concurrently.

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Test 8: Final Result + Add On
Thistestscriptsimulatesthesituationwhereaurinalysisisoriginallyorderedfora
patient.Later,theorderingprovidercallstoaddaurineMicroalbumintesttothe
originallyorderedurinalysis.NoseparateorderfortheurineMicroalbuminisentered
intotheEHR,meaningthattheaddontestisunsolicitedfromtheperspectiveofthe
EHRsystem.However,pertheELINCSspecification,theaddontestwillhavethesame
requisitionidentifierastheoriginallyorderedurinalysis.
Test 8 Setup Script
1. CreateanorderbyDr.H.L.SevenforaUrinalysisPanelforEllieElincsinyourEHR
system.
2. UsingtheEDGETool,loadtheorderfileandentertheorderinformationas
specifiedbelow

OrderFileName: test08final+addon.ord
ScenarioType: MultipleMessages
MessageScenario: FinalResult/AddonTest
IncludeTQ1Segment: Unchecked
IncludeNTESegment: Unchecked
IncludeSetIDs: Checked
Test: Urinalysis
AddonTest: UrineMicroalbumin
SampleCollectionDate: January1,2009

3. Entertherequisitionidentifier,patientidentifier(s),andtestserviceidentifier(if
required)fromtheEHRorderintotheorderinformationform.
4. GeneratetheFinalResultandAddonTestmessagesbyclickingthe
GenerateMessagesButton.
5. SavetheFinalResultmessageastest08finalresultandtheAddonTest
messageastest08addonbyclickingtheSaveAllbuttonandenteringthe
newfilenames.
6. Importthetest08finalresult.oruandtest08addon.orumessagesintothe
EHRsystem.
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Test 8 Validation Criteria
# EHR System Action
Pass/Fail
RO TS
Final Result Message
8.1
The system receives the MT-ORU-2 Final Result message and safely stores
the result data.
8.2
The system acknowledges receipt of the MT-ORU-2 Final Result message by
sending an MT-ACK-1 Acknowledgement message to the originating
laboratory. This message passes validation in the ELINCS EDGE Tool (see the
Evaluating MT-ACK-1 Acknowledgement Messages section below).
8.3
The MT-ORU-2 Final Result message is automatically associated with the
correct patient record.
8.4
[CLIA Requirement] The system captures and displays all data elements that
are required to be reported by laboratories per the CLIA laboratory regulations
(See Test 3 Validation Criteria). The system shall make the CLIA required
data elements available for review by appropriate end-users.
Add-on Message
8.5
The system receives the MT-ORU-2 Add-on message and safely stores the
result data.
8.6
The system acknowledges receipt of the MT-ORU-2 Add-on message by
sending an MT-ACK-1 Acknowledgement message to the originating
laboratory. This message passes validation in the ELINCS EDGE Tool (see the
Evaluating MT-ACK-1 Acknowledgement Messages section below).
8.7
The MT-ORU-2 Add-on message is automatically associated with the correct
patient record.
8.8
[CLIA Requirement] The system captures and displays all data elements that
are required to be reported by laboratories per the CLIA laboratory regulations
(See Test 3 Validation Criteria). The system shall make the CLIA required
data elements available for review by appropriate end-users.
8.9
The EHR should link the add-on results to the originally reported MT-ORU-2
Final Result Message. One option is to add the results of the add-on test to
those of the originally ordered result and display all results from both messages
when the end-user reviews results for the requisition. Another option is to
create a linkage between the two results so that the end-user can quickly switch
between the originally ordered test and the add-on test.

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Test 9: Final Result + Correction
Thisgeneratestwomessages,thefirstistheoriginalfinalresultmessagethatreports
theresultsofaHepaticFunctionPanelandthesecondisafollowupcorrectionmessage
thatcorrectstwooftheanalytevalues.ThistestwillhelpdeterminehowtheEHR
systemhandlesthecorrectionofanexistinglabresultvalue.
Test 9 Setup Script
1. CreateanorderbyDr.H.L.SevenforaHepaticFunctionPanelforEllieElincsin
yourEHRsystem.
2. UsingtheEDGETool,loadtheorderfileandentertheorderinformationas
specifiedbelow

OrderFileName: test09final+correction.ord
ScenarioType: MultipleMessages
MessageScenario: FinalResult/Correction
IncludeTQ1Segment: Unchecked
IncludeNTESegment: Unchecked
IncludeSetIDs: Checked
Test: HepaticFunctionPanel
SampleCollectionDate: January1,2009

3. Entertherequisitionidentifier,patientidentifier(s),andtestserviceidentifier(if
required)fromtheEHRorderintotheorderinformationform.
4. GeneratetheFinalResultandCorrectionmessagesbyclickingtheGenerate
MessagesButton.
5. SavetheFinalResultmessageastest09finalresultandtheCorrection
messageastest09correctionbyclickingtheSaveAllbuttonandenteringthe
newfilenames.
6. Importthetest09finalresult.orumessageintotheEHRsystemandreviewthe
validationcriteriafortheFinalResultmessage.
7. Importthetest09correction.orumessageintotheEHRsystemandreviewthe
validationcriteriafortheCorrectionmessage.

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Test 9 Validation Criteria
# EHR System Action
Pass/Fail
RO TS
Final Result Message
9.1
The system receives the MT-ORU-2 Final Result message and safely stores
the result data.
9.2
The system acknowledges receipt of the MT-ORU-2 Final Result message by
sending an MT-ACK-1 Acknowledgement message to the originating
laboratory. This message passes validation in the ELINCS EDGE Tool (see
the Evaluating MT-ACK-1 Acknowledgement Messages section below).
9.3
The MT-ORU-2 Final Result message is automatically associated with the
correct patient record.
9.4
[CLIA Requirement] The system captures and displays all data elements that
are required to be reported by laboratories per the CLIA laboratory regulations
(See Test 3 Validation Criteria). The system shall make the CLIA required
data elements available for review by appropriate end-users.
Correction Message
9.5
The system receives the MT-ORU-2 Correction message and safely stores the
result data.
9.6
The system acknowledges receipt of the MT-ORU-2 Correction message by
sending an MT-ACK-1 Acknowledgement message to the originating
laboratory. This message passes validation in the ELINCS EDGE Tool (see
the Evaluating MT-ACK-1 Acknowledgement Messages section below).
9.7
The MT-ORU-2 Correction message is automatically associated with the
correct patient record.
9.8
[CLIA Requirement] The system captures and displays all data elements that
are required to be reported by laboratories per the CLIA laboratory regulations
(See Test 3 Validation Criteria). The system shall make the CLIA required
data elements available for review by appropriate end-users.
9.9
[CLIA Requirement] The system includes a suitable representation of the
Result Status [OBR-25] on lab report display screen to clearly indicate that the
results have been corrected.



9.10
[CLIA Requirement] The system includes a suitable representation of the
Observation Result Status [OBX-11] on lab report display screen to clearly
identify the analytes that have been corrected.




9.11
The EHR system updates the values of the final result message to display the
corrected values to the ordering provider on the report display screen.

Original Values:



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Corrected Values:


9.12
The EHR should update the original result such that a duplicate view or
second copy of the record is not created in the system from the perspective of
an end-user viewing the results. Original data may be maintained in the
database for legal and regulatory archival purposes.

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Test 10: Final Result + Deletion
Thisgeneratestwomessages,thefirstistheoriginalfinalresultmessagethatreports
theresultsofaBasicMetabolicPanelandthesecondisafollowupdeletionmessage
thatmarksoneofthepreviouslyreportedanalytesasdeletedandremovesthevalue.
ThistestwillhelpdeterminehowtheEHRsystemhandlesthedeletionofanexistinglab
resultvalue.
Test 10 Setup Script
1. CreateanorderbyDr.H.L.SevenforaBasicMetabolicPanelforEllieElincsin
yourEHRsystem.
2. UsingtheEDGETool,loadtheorderfileandentertheorderinformationas
specifiedbelow

OrderFileName: test10final+deletion.ord
ScenarioType: MultipleMessages
MessageScenario: FinalResult/Deletion
IncludeTQ1Segment: Unchecked
IncludeNTESegment: Unchecked
IncludeSetIDs: Checked
Test: BasicMetabolicPanel
SampleCollectionDate: January1,2009

3. Entertherequisitionidentifier,patientidentifier(s),andtestserviceidentifier(if
required)fromtheEHRorderintotheorderinformationform.
4. GeneratetheFinalResultandDeletionmessagesbyclickingtheGenerate
MessagesButton.
5. SavetheFinalResultmessageastest10finalresultandtheDeletion
messageastest10deletionbyclickingtheSaveAllbuttonandenteringthe
newfilenames.
6. Importthetest10finalresult.orumessageintotheEHRsystemandreviewthe
validationcriteriafortheFinalResultmessage.
7. Importthetest10deletion.orumessageintotheEHRsystemandreviewthe
validationcriteriafortheDeletionmessage.
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Test 10 Validation Criteria
# EHR System Action
Pass/Fail
RO TS
Final Result Message
10.1
The system receives the MT-ORU-2 Final Result message and safely stores
the result data.
10.2
The system acknowledges receipt of the MT-ORU-2 Final Result message
by sending an MT-ACK-1 Acknowledgement message to the originating
laboratory. This message passes validation in the ELINCS EDGE Tool (see
the Evaluating MT-ACK-1 Acknowledgement Messages section below).
10.3
The MT-ORU-2 Final Result message is automatically associated with the
correct patient record.
10.4
[CLIA Requirement] The system captures and displays all data elements
that are required to be reported by laboratories per the CLIA laboratory
regulations (See Test 3 Validation Criteria). The system shall make the
CLIA required data elements available for review by appropriate end-users.
Correction Message
10.5
The system receives the MT-ORU-2 Deletion message and safely stores the
result data.
10.6
The system acknowledges receipt of the MT-ORU-2 Deletion message by
sending an MT-ACK-1 Acknowledgement message to the originating
laboratory. This message passes validation in the ELINCS EDGE Tool (see
the Evaluating MT-ACK-1 Acknowledgement Messages section below).
10.7
The MT-ORU-2 Deletion message is automatically associated with the
correct patient record.
10.8
[CLIA Requirement] The system captures and displays all data elements
that are required to be reported by laboratories per the CLIA laboratory
regulations (See Test 3 Validation Criteria). The system shall make the
CLIA required data elements available for review by appropriate end-users.
10.9
[CLIA Requirement] The system includes a suitable representation of the
Result Status [OBR-25] on lab report display screen to clearly indicate that
the results have been corrected.



10.10
[CLIA Requirement] The system includes a suitable representation of the
Observation Result Status [OBX-11] on lab report display screen to clearly
identify the analytes that have been corrected.




10.11
The EHR system updates the values of the final result message to display
the deleted analytes to the ordering provider on the report display screen.

Original Values:



Deleted Values:


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10.12
The EHR should update the original result such that a duplicate view or
second copy of the record is not created in the system from the perspective
of an end-user viewing the results. Original data may be maintained in the
database for legal and regulatory archival purposes.
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Test 11: Final Result (Copy To)
Thisisafinalresultmessageforasimplelipidpanel,withtheexceptionthatthe
orderingproviderindicatedthatacopyoftheresultbesenttoanothercovering
provider.Thefollowingscriptprovidesguidelinesfortherecommendedhandlingbyan
EHRsystemof(1)resultmessagesthatacknowledgethatarequestwasmadetocopy
anotherproviderontheresult[ResultCopiesRequested]and(2)resultmessagesthatare
copiesoftestresultsthatwerereportedtoanotherprovider[ResultCopiesEnclosed]
withinthesameorganization(i.e.,bothprovidersareregisteredasphysiciansinthe
sameEHRsystem).

Test 11 Setup Script


1. CreateanorderbyDr.H.L.SevenforaLipidPanelforEllieElincsinyourEHR
system.
2. UsingtheEDGETool,loadtheorderfileandentertheorderinformationas
specifiedbelow

OrderFileName: Test11finalresult_copyto.ord
ScenarioType: SingleMessage
MessageScenario: FinalResult
IncludeTQ1Segment: Unchecked
IncludeNTESegment: Unchecked
IncludeSetIDs: Checked
Test: LipidPanel
SampleCollectionDate: January1,2009

3. UsetheprovidedorderfileorenterdifferentCopyToinformationas
describedintheProviderInformationsection.
4. GeneratetheFinalResultmessageandcopybyclickingtheGenerate
MessagesButton.TwomessageswillbecreatedanddisplayedintheMessages
Paneloftheapplication.ThefirstFinalResultmessageistheoriginalmessage
fortheorderingprovider(OBR21=ResultCopiesRequested).Thesecond
messageisthecopyandisforthecopytoprovider(OBR21=
ResultCopiesEnclosed).
5. ClicktheSaveAllAsbutton.Inthesavedialog,enterthefilenametest05
finalresult_originalinthetopfieldandtest11finalresult_copyinthebottom
field.ClickOk.
NOTE:Evenifamessageisreceivedthatindicatescopieswererequestedtobesent
toanotherprovider(i.e.,[ResultCopiesRequested]),thatdoesnotguaranteethat
thecopywassentbythelabtothatprovider.PerELINCS,thelabmustonlyindicate
thatcopieswererequested,notnecessarilysent.
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6. Importthetest11finalresult(original)lipidpanel.oruandtest05
finalresult(original)lipidpanel.orumessagesintotheEHRsystem.

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Test 11 Validation Criteria
# EHR System Action
Pass/Fail
RO TS
Final Result Message - ORIGINAL
11.1
The system receives the MT-ORU-2 Final Result ORIGINAL message and
safely stores the result data.
11.2
The system acknowledges receipt of the MT-ORU-2 Final Result
ORIGINAL message by sending an MT-ACK-1 Acknowledgement message
to the originating laboratory. This message passes validation in the ELINCS
EDGE Tool (see the Evaluating MT-ACK-1 Acknowledgement Messages
section below).
11.3
The MT-ORU-2 Final Result ORIGINAL message is automatically
associated with the correct patient record.
11.4
[CLIA Requirement] The MT-ORU-2 result message is only released to the
ordering provider [OBR-16] and any other authorized personnel.
11.5
All criteria listed in Test3ValidationCriteria have been met for the
display of result data for the Final Result ORIGINAL message.
11.6
The system should indicate that copies of the current MT-ORU-2 Final Result
message were requested to be sent to other providers [OBR-21] on the lab
report display screen (or make it otherwise available to view).
11.7
The system should display the provider information of the provider the MT-
ORU-2 Final Result message was requested to be copied to [OBR-28] to the
ordering provider on the lab report display screen (or make it otherwise
available to view).
Final Result Message - COPY
11.8
The system receives the MT-ORU-2 Final Result COPY message and
safely stores the result data.
11.9
The system acknowledges receipt of the MT-ORU-2 Final Result COPY
message by sending an MT-ACK-1 Acknowledgement message to the
originating laboratory. This message passes validation in the ELINCS EDGE
Tool (see the Evaluating MT-ACK-1 Acknowledgement Messages section
below).
11.10
The MT-ORU-2 Final Result COPY message is automatically associated
with the correct patient record.
11.11
The MT-ORU-2 result message is only released to the ordering provider
[OBR-16], the copy to provider [OBR-28], and any other authorized
personnel.
11.12
All criteria listed in Test3ValidationCriteria have been met for the
display of result data for the Final Result ORIGINAL message.
11.13
The system should indicate that this is a copy of the original MT-ORU-2 Final
Result message [OBR-21] on the lab report display screen (or make it
otherwise available to view)
11.14
The system should display the ordering provider information [OBR-16] to the
copy to provider on the lab report display screen (or make it otherwise
available to view).
11.15
Receipt of a message copy on a system where the original already exists
should be handled so as not to create a duplicate view of the lab result
record when the ordering provider or copy to provider view the patients lab
data.

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Test 12: Final Result (Unsolicited Copy)
ThisoptionaltestdetermineshowyourEHRsystemhandlesthereceiptofanunsolicited
FinalResultmessagecopyfromanexternalsystem.ThistestisdifferentfromTest11:
FinalResult(CopyTo)intwoways.First,therewillbenopreexistingorderintheEHR
forthereturnedresults.Second,theorderingprovideridentifiedinOBR16willnot
existinyoursystem(buttheResultsCopyToinformationwillmatchaproviderinyour
system).ThepatientrecordwillexistinyourEHRsystem.
Test 12 Setup Script
1. DonotcreateanorderforthepatientintheEHRsystem.
2. UsingtheEDGETool,loadtheorderfileandentertheorderinformationas
specifiedbelow
OrderFileName: test12finalresult_unsolicitedcopy.ord
ScenarioType: SingleMessage
MessageScenario: FinalResult
IncludeTQ1Segment: Unchecked
IncludeNTESegment: Unchecked
IncludeSetIDs: Checked
Test: LipidPanel
SampleCollectionDate: January1,2009
3. Whenpopulatingtherequisitionandtestserviceidentifierinformation,enter
anyvalueyouchooseforthesefields,butmakesurethattheseidentifiersdonot
matchanyexistingrequisitionidentifiersortestidentifiersinyourapplication.
4. EntertheOrderingProviderinformationsothatitdoesnotmatchthatofany
physicianinyoursystem.Suggestedvaluesare:
a. IDNumber:9876543217
b. GivenName:Silvia
c. MiddleInitial:S
d. FamilyName:Six
5. LeavetheCopyToproviderinformationexactlyasitwasintheTest11Setup
Script.
6. GeneratethemessagesbyclickingtheGenerateMessagesbutton
7. SelectthesecondFinalResultMessageintheSourceFilestableandclickthe
Savebutton.
8. Enterthefilenametest12finalresult_unsolicitedcopyintothesavedialogand
clickOK.

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9. Importthetest12finalresult_unsolicitedcopymessageintotheEHRsystem.
Youmaydiscardtheunsavedoriginalmessageforthepurposesofthistest.
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Test 12 Validation Criteria (Advanced)
# EHR System Action
Pass/Fail
RO TS
Final Result Message UNSOLICITED COPY
12.1
The system receives the MT-ORU-2 Final Result COPY message and safely
stores the result data.
12.2
The system acknowledges receipt of the MT-ORU-2 Final Result COPY
message by sending an MT-ACK-1 Acknowledgement message to the
originating laboratory. This message passes validation in the ELINCS EDGE
Tool (see the Evaluating MT-ACK-1 Acknowledgement Messages section
below).
12.3
The MT-ORU-2 Final Result message is associated with the correct patient
record. Manual steps may be required in the absence of requisition identifiers,
or ordering provider identifiers.
12.4
The MT-ORU-2 result message is only released to the identified copy to
provider [OBR-28], and any other authorized personnel.
12.5
All criteria listed in Test 3 Validation Criteria have been met for the display of
result data for the Final Result ORIGINAL message.
12.6
The system should indicate that this is a copy of the original MT-ORU-2 Final
Result message [OBR-21] on the lab report display screen (or make it
otherwise available to view)
12.7
The system should display the ordering provider information [OBR-16] to the
copy to provider on the lab report display screen (or make it otherwise
available to view).

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ELINCS HL7-R1 Test Script Validation Summary
Test Name
Pass/Fail
RO TS
Test 1: Specimen Received
Test 2: Test Cancelled
Test 3: Final Result
Test 4: Final Result (Advanced)
Test 5: Final Result (Errors)
Test 6: Preliminary +Final Result
Test 7: Final Result +Reflex
Test 8: Final Result +Add On
Test 9: Final Result +Correction
Test 10: Final Result +Deletion
Test 11: Final Result (Copy To)
Test 12: Final Result (Unsolicited Copy)

_______________________________________ ______________________________
ProductName Version/Build

_______________________________________ ______________________________
Tester TestDate
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Appendices
Entering Common Order Information in ELINCS EDGE
Thissectiondescribeshowtotransferinformationfromordersgeneratedbyyour
systemintotheEnterOrderInformationsectionoftheELINCSEDGEToolGenerate
TestMessagestab.Thisisgeneralinformationthatwillbetrueforalltestsinthistest
document.FordetailsabouttheOrderInformationarea,seetheELINCSEDGETool
UsersGuide.

Ifyoudecidetousethetestpatientandproviderdemographicinformation,youmay
savetimebyusingtheorderfilesincludedinthetestscriptpackagetopopulatethe
orderfieldsforeachtest(e.g.,test01specimenreceived.ord).Toloadtheorder
information:
1. ClicktheLoadOrderbuttonontheEnterOrderInformationform.
2. BrowsetotheorderfileindicatedbythecurrenttestscriptandclickOpen.
Message Type and Message Scenario
Eachtesthasaspecificscenariothatisbeingusedtosimulaterealliferesultssituations.
Thescenariotypeandmessagescenariothataretobeusedforeachscriptarespecified
inthescriptsetupinstructions.TheEDGEToolsupportstwogeneralscenariotypes,
SingleMessageandMultipleMessages.Thescenarioslistedaredependentonthe
typeselected.Belowarethesupportedscenariosforeachscenariotype.


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Requisition ID
PlacetherequisitionlevelidintheEntityIdentifierfield.Youmayoptionallypopulate
eithertheNamespaceIDortheUniversalID/IDTypefieldsifyoudesire.Ifyoupopulate
theNamespaceIDfield,youmaynotpopulatetheUniversalID/IDTypefields,andvice
versa,pertheHL7rulesforthistypeofdata.

Patient Information
ThePatientInformationareaallowsyoutoprovidealistofpatientidentifiersandthe
patientsdemographicinformation.ThisinformationwillbereportedinthePID
segmentoftheresultmessage.Multiplepatientidsmaybesubmittedforeachpatient.
IDandIdentifierTypeCodesarerequired.Atleastoneidentifier,theprimarypatient
identifier,musthavetheIdentifierTypeCodePT.TheGivenName,FamilyNameand
DateofBirthfieldsarerequired.

Provider Information
TheProviderInformationareaallowsyoutoprovideidentifyinginformationforthe
orderingproviderandanyprovider(s)towhomtheresultsshouldbecopied.TheID
Number,IdentifierTypeCode,GivenNameandFamilyNamefieldsarerequired.

TospecifyCopyToproviders:
1. DoubleclickontheCopyTofield.Aneditordialogwillbedisplayed.
2. Populatethefieldswiththeproviderinformationforthephysicianwhoisto
receivethecopiedresult.

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3. Toaddadditionalcopytoproviders,clicktheAddRepetitionbuttonand
populatethefieldsofthenewform.Thesameinformationthatisrequiredfor
theorderingproviderisalsorequiredfortheCopyToprovider.
4. Whendone,clicktheOKbutton.
Test Identifier Information
TheTestIdentifier(s)sectioncontainsatablethatallowsanynumberofteststobe
indicated.ThecellsoftheTestcolumnhaveaselectboxthatallowsyoutoselectoneof
thesupportedtesttypes.SelectingatestfromtheTestcolumnwillautomatically
populatetheTestCode,Text,andCodingSystemColumns.Youmaychangethevalues
ofthesecellsasdesired.Toaddtests,clicktheAddTestbuttonatthebottomofthe
table.

IfyouhaveselectedaTestSpecificEHRtestidscheme,thentheTestServiceIdentifier
celloftheTestIdentifiersmustalsobepopulated.Populatethisfieldwiththeunique
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orderidentifierforthetest.Topopulatethefielddoubleclickthecell.Adialogwillbe
displayedtoenterthetestspecificidentifierdata.
Reflex and Add-on Tests
Sometestscriptsrequirethecreationofreflexoraddontestsaspartofthetestsetup.
ReflexandAddontestscanonlybespecifiedwhenanappropriatetestscenariohas
beenselected(e.g.,FinalResult/ReflexTest).Selectthetestnamefromthedrop
downmenuthatcorrespondstotheReflexorAddontestindicatedinthescript.Note
thatthecontentsofthelistmaybedifferentdependingonthescenarioselected.

Note:Addontestsarenotsavedaspartofasavedorderfile.Ifusingthedesignated
orderfileforthetestscript,besuretoselecttheindicatedreflex/addontestmanually
eachtimeyouusetheorderfile.
Other Test Options
Additionaloptionsmaybeidentifiedforthetestslistedinthisdocument.Theoptions
controltheinclusionofNTEsegments,aTQ1segment,segmentsetids(anoptional
sequentialidentifierthatispresentinmanyHL7segments),andthepresenceoftest
cancelledortestnotnecessaryOBXresults.Thesettingsforeachoftheseoptions
areindicatedinthesetupsectionofeachscript.Someoptionsmaybedisabled,
dependingonthescenarioselected.

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Evaluating MT-ACK-1 Acknowledgement Messages
ThissectiondescribeshowtoevaluatetheMTACK1Acknowledgementmessagesthat
yourEHRsystemshouldbegeneratingforeachofthetestmessagesusedinvalidation
testing.Toevaluateanacknowledgementmessage,theELINCSEDGEtoolmustbeable
tocomparetheMTACK1AcknowledgementmessagetotheELINCSmessagethat
spawnedit.ToevaluateyourAcknowledgementmessages:
1. WhenyoursystemgeneratesanAcknowledgementmessageforatestscript
resultmessage,savetheresultingacknowledgementasafile.
2. StarttheELINCSEDGEToolinEHRMode.
3. ClickontheEvaluateAcknowledgementMessagetabatthetopofthe
applicationscreen.
4. ClicktheSelectAcknowledgementFilebuttonorchooseFileOpenACK
Message.Theapplicationdisplaystheacknowledgmentfilebrowserdialog.
5. BrowsetofindtheAcknowledgementmessageandtheoriginalORUmessage.
ClicktheOKbutton.

6. ThesystemdisplaystheloadedfilesintheSourceFilestable.

7. ClicktheEvaluateAcknowledgementbutton.Theapplicationevaluatesthe
MTACK1message.
8. Reviewthemessageevaluationresults.Fieldsthatcontainerrorswillbe
highlightedwithredboldtext.ClicktheEvaluationOutputtabtoviewafull
reportofthemessageevaluation.

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