170.314.a.8 clinicaldecisionsupport ps rev 01-aug-2014 releaseset 01-aug-2014

21
7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014 http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 1/21  170.314.a.8 Clinical Decision Support PS Test Criteria: 170.314.a.8 – Clinical Decision Support Testing Result Participant and Product-with- version Setting (Ambulatory or Inpatient) Test Proctor Test Date Results (PASS!AI" DID #$T ATT%&PT) I' !ail describe error Additional So'tware *sed In Demonstration &odi'ications to Product *nder Test Additional Proctor #otes Scope of Proctoring Sheet The $#+ test method associated with this criterion is the only approved test method 'or %,R &eaning'ul *se certi'ication This Proctoring Sheet is not a replacement test method but a test procedure document 'or per'orming the $#+ test method and recording the results Proctoring Sheet describe test data test criteria and epected results It is assumed the .endor or Participant *nder Test is 'amiliar with the associated $#+ test method Test Data Source/ .endor Supplied "oad Time/ +linical decision support rules and associated patient records may be created be'ore the test event begins but clinical decision support rule noti'ication is to be created at the time o' testing at the direction o' Test Proctor Test Tools  #one ersion of !"C Test #etho$ 01 Rev.: 01-Aug-2014 !R "est-08# Page 1 o$ 21 +opyright 2 1304 Drummond 5roup Inc The in'ormation contained in this document is strictly held con'idential and shall not be disclosed in any manner or 'orm directly or indirectly to any person or entity under any circumstances without prior approval

Upload: niazisab

Post on 08-Mar-2016

214 views

Category:

Documents


0 download

DESCRIPTION

8_ClinicalDecisionSupport_PS_Rev_01-Aug-2014_ReleaseSet_01-Aug-

TRANSCRIPT

Page 1: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 1/21

  170.314.a.8 Clinical Decision Support PS

Test Criteria: 170.314.a.8 – Clinical Decision Support

Testing Result

Participant and Product-with-

version

Setting (Ambulatory or Inpatient)

Test Proctor 

Test Date

Results (PASS!AI"

DID #$T ATT%&PT)

I' !ail describe error

Additional So'tware *sed In

Demonstration

&odi'ications to Product *nderTest

Additional Proctor #otes

Scope of Proctoring Sheet

The $#+ test method associated with this criterion is the only approved test method 'or%,R &eaning'ul *se certi'ication This Proctoring Sheet is not a replacement test

method but a test procedure document 'or per'orming the $#+ test method and recording

the results Proctoring Sheet describe test data test criteria and epected results It is

assumed the .endor or Participant *nder Test is 'amiliar with the associated $#+ testmethod

Test Data

Source/ .endor Supplied

"oad Time/ +linical decision support rules and associated patient records may becreated be'ore the test event begins but clinical decision support rule noti'ication

is to be created at the time o' testing at the direction o' Test Proctor 

Test Tools

 #one

ersion of !"C Test #etho$

01

Rev.: 01-Aug-2014

!R "est-08#

Page 1 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 2: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 2/21

  170.314.a.8 Clinical Decision Support PS

Critical Rules for Test %&ent

• Strict time allotment 'or testing

o Supplemental Retest/ 0 hour 

o 0-6 &odules/ 1 hours

o 03-07 &odules/ 8 hours

o 06-18 &odules/ 9 hours

o 1:-41 &odules/ 7 hours

o 44-46 &odules/ 03 hours

o 83; &odules/ 01 hours

• <hen a test error is encountered the module is recorded as 'ailed and the participant

is instructed to move to the net module 'or testing

• I' a module cannot be tested due to the participant 'ailing to pre-load the re=uired pre-

test patient setup data the module is recorded as 'ailed and the participant is

instructed to move to the net module 'or testing• I' time permits the participant will be allowed to retest 'ailed modules a'ter all other

modules have been tested

•  #o code changes or error 'ies are allowed without Proctor permission and until all

registered modules are tested once $nly minor code changes are allowed

• $nly one code change is allowed on speci'ic module 'unctionality during a test event

!or eample a code changemodi'ication is only allowed once on the problem list

'unctionality within a given test day

• >ou must supply patient test data that is 'ictitious and contrived by the participant 'or

test purposes

 #o recording o' audio or video by the participant is allowed during the test event

Ro'ustness an$ Relia'ilit( Re)uire*ent

To satis'y the module criteria it is epected that the Product-*nder-Test is able to

complete the testing re=uirements reliably including repeat testing with the same resultwithout error and with a satis'actory level o' robustness This includes unepected error

messages produced through normal operation multiple unintended restarts o' the

application or any other ?buggy@ 'acets o' the product displayed while testing Theseerrors are record in the Additional Proctor #otes o' the proctor sheet "ac o' reliability

and robustness o' design will result in 'ailure o' the module

Rev.: 01-Aug-2014

!R "est-08#

Page 2 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 3: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 3/21

  170.314.a.8 Clinical Decision Support PS

Test Proctor +nstructions

Prior to administering the test proctor sheet the test proctor will con'irm the currentversion o' the proctor sheet is being used per the controlled document log o' the testing

=uality system

The test proctor instructs and observes the product-under-test per'orming the re=uired test procedure steps 'or each test re=uirement The test proctor shall record pass'ailno

attempt results and observations 'or each test re=uirement section as well as test

veri'ication audit in'ormation in the appropriate sections I' all test re=uirements pass theepected test results per the test procedures steps the entire module test will be mared

as ?PASS@ in the Testing Result section I' one or more test re=uirements are not met the

entire module test is mared as ?!AI"@ $ther test event in'ormation is recorded asdictated in the Testing Results section

I' an error occurs in the product so'tware during the course o' testing the error may be

resolved and module retested once in the course o' the test event i' time permits but onlyunder the supervision o' the test proctor The test proctor records the modi'ication made

to the product either in the &odi'ications to Product *nder Test section or the Test Result

.eri'ication section

The test proctor shall record relevant 'ree 'orm notes regarding the module testing as

necessary in the Additional Proctor #otes section This includes records o' errors or bugsobserved outside the speci'ic scope o' the module test re=uirement such as privacy and

security 'ailures which could be relevant in granting certi'ication or unusual activities o'

the product-under-test revealed in the course o' testing which could impact certi'icationcon'idence

Rev.: 01-Aug-2014

!R "est-08#

Page 3 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 4: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 4/21

  170.314.a.8 Clinical Decision Support PS

Test Re)uire*ent: DTR 170.314.a.8,1: Select-cti&ate ClinicalDecision Support +nter&entions

To Be +ompleted by Test Proctor 

Test Re=uirement R%S*"T (Pass!ail#o Attempt)

*ser RolePermission 'or Selecting +DS

*ser RolePermission not able to Select +DS

+DS Intervention-Problem

+DS Intervention-&ed "ist

+DS Intervention-&ed Allergy "ist

+DS Intervention-Demographics

+DS Intervention-"ab Tests

+DS Intervention-.itals

+DS Intervention-+ombination

Test Procedures0 Proctor will instruct .endor to login as a user without access to selecting or

activating +DS interventions Proctor will instruct .endor to attempt to use

this user to select or activate electronic clinical decision support interventions'or a speci'ic clinical user role and veri'y this cannot be done This user role

will be record in the section above

1 Proctor will instruct .endor to login as a user with access to selecting or

activating +DS interventions Proctor will instruct .endor to use this user toselect or activate electronic clinical decision support interventions 'or a

speci'ic clinical user role This user role will be record in the section above

 #$T% C Any activationdeactivation o' a +DS rule &*ST be loggedappropriately by %,R (can be in audit log or separate +DS log)

4 Proctor will instruct .endor to use this user to select or activate clinical

decision support intervention 'unctionality 'or each o' the 'ollowing elementsand one combination o' data 'rom two or more elements/

Problem list

&edication list

&edication allergy listDemographics

"aboratory test and valuesresults

.ital Signs

The interventions by the .endor and recorded by the Proctor in the sectionabove The .endor will eplain where in the clinical setting or wor'low the

+DS interventions are enacted8 Proctor will con'irm %pected Test Results were achieved

Rev.: 01-Aug-2014

!R "est-08#

Page 4 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 5: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 5/21

  170.314.a.8 Clinical Decision Support PS

: Proctor will audit test results by completing Test Result .eri'ication checlist

&inimum Seven rules

"ogged event to $# or $!! +DS

Test DataTest data is vendor supplied and captured in the Test Result Verification.

%pected Testing Results

• %&'170.314(a)(8) * 1.01+ +linical decision support interventions are activated

 based on data in the Problem list &edication list &edication allergy listDemographics "aboratory tests and valuesresults and .ital signs and based

on at least one combination o' data 'rom two or more o' these data categories

• %&'170.314(a)(8) * 1.02+ %,R logs the status and timing o' the activated

clinical decision support intervention

Test Result .eri'ication

• I#S%RT S+R%%# S,$T C +reation"isting o' clinical decision support

interventions

• I#S%RT S+R%%# S,$T C "ogging the status and timing o' the activated

clinical decision support intervention

Rev.: 01-Aug-2014

!R "est-08#

Page # o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 6: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 6/21

  170.314.a.8 Clinical Decision Support PS

Test Re)uire*ent: DTR 170.314.a.8,/: Trigger Clinical DecisionSupport +nter&entions

To Be +ompleted by Test Proctor 

Test Re=uirement R%S*"T (Pass!ail#o Attempt)

*ser RolePermission 'or Triggering +DS

+linical Decision Support Interventions

Test Procedures0 Proctor will instruct .endor to identi'y or create a test patient(s) containing

.endor-supplied problems medications medication allergies demographicslaboratory tests and valuesresults and vital signs to trigger +DS interventions

con'igured 'or the %,R

1 Proctor will instruct .endor login as a user who receives +DS interventions

and access the test patient Proctor will veri'y the clinical decision supportinterventions recorded in DTR0E3408a7 C 0 section above occur

automatically and electronically when a user is interacting with the %,R

technology 'or the test patient(s)4 Proctor will con'irm %pected Test Results were achieved

8 Proctor will audit test results by completing Test Result .eri'ication checlist

Test DataTest data is vendor supplied and captured in the Test Result Verification.

%pected Testing Results

• %&'170.314(a)(8) * 2.01+ +linical decision support interventions are triggered

'or a user based on based on data in the Problem list &edication list&edication allergy list Demographics "aboratory tests and valuesresultsand .ital signs and based on at least one combination o' data 'rom two or

more o' these data categories

Test Result .eri'ication

• I#S%RT S+R%%# S,$T C Patient Record(s)

• I#S%RT S+R%%# S,$T C Problem "ist +DS Intervention

• I#S%RT S+R%%# S,$T C &ed "ist +DS Intervention

• I#S%RT S+R%%# S,$T C &ed Allergy "ist +DS Intervention

• I#S%RT S+R%%# S,$T C Demographics +DS Intervention

• I#S%RT S+R%%# S,$T C "ab Test +DS Intervention

• I#S%RT S+R%%# S,$T C .itals +DS Intervention

• I#S%RT S+R%%# S,$T C +ombo +DS Intervention

Rev.: 01-Aug-2014

!R "est-08#

Page , o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 7: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 7/21

  170.314.a.8 Clinical Decision Support PS

Test Re)uire*ent: DTR 170.314.a.8,3: +$entif( Diagnostic an$Therapeutic Reference Resources

To Be +ompleted by Test Proctor 

Test Re=uirement R%S*"T (Pass!ail#o Attempt)

*se In'obutton (>%S#$)

Test Procedures0 Proctor will instruct .endor to use %,R 'unction(s) to access diagnostic and

therapeutic re'erence in'ormation using either a general capability or the

In'obutton standard 'or the 'ollowing categories/

• Problem "ist

• &ed "ist

• "ab Tests

• +ombo o' Problem "ist &ed "ist &ed Allergy "ist Demographics

"ab Tests .ital Signs1 Proctor will record i' %,R utiliFes the In'obutton technology 'or +DS

interventions

4 Proctor will con'irm %pected Test Results were achieved

8 Proctor will audit test results by completing Test Result .eri'ication checlist

Test DataTest data is vendor supplied and captured in the Test Result Verification.

%pected Testing Results

• %&'170.314(a)(8) * 3.01+ %,R can identi'y and access diagnostic and

therapeutic re'erence resources o' +DS interventions

Test Result .eri'ication

• I#S%RT S+R%%# S,$T C Accessing diagnostic and therapeutic re'erences

resources

• I#S%RT S+R%%# S,$T C Re'erence sources o' clinical decision support

interventions

Rev.: 01-Aug-2014

!R "est-08#

Page 7 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 8: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 8/21

  170.314.a.8 Clinical Decision Support PS

Test Re)uire*ent: DTR 170.314.a.8,4: Configure Clinical DecisionSupport +nter&entions an$ Diagnostic an$ Therapeutic ReferenceResources

To Be +ompleted by Test Proctor 

Test Re=uirement R%S*"T (Pass!ail#o Attempt)

*ser Role <ho +an +on'igure +DS

*ser Role <ho ,AS +DS Indications

*ser Role <ho Does #$T ,A.% +DS

Indications

*ser Role <ho +an Access Diagnostic and

Therapeutic Re'erence Resources

*ser Role <ho +an #$T Access Diagnostic

and Therapeutic Re'erence Resources

*ser Role <ho +an #$T +on'igure +DS

Interventions or Diagnostic and TherapeuticRe'erence Resources

Test Procedures0 Proctor will instruct .endor to login with a user role who has the ability to

con'igure clinical decision support intervention and record the user role in the

section above

1 Proctor will instruct .endor in this user role to con'igure at least one clinicaldecision support intervention based on a userGs clinical role that is inclusive o' 

one o' the roles !or eample triggered 'or a physician role but not triggered

'or nurse or o''ice sta'' roles Proctor will record these roles in the section

above4 Proctor will instruct .endor to log in to the %,R as a user whose clinical role

has been con'igured to allow 'or indication o' clinical decision support

interventions (eg physician) and then select a patient record identi'ied by the.endor and populated with .endor-supplied test data Proctor will veri'y that

the clinical decision support interventions occur automatically and

electronically when a user is interacting with the %,R technology8 Proctor will instruct .endor to log in to the %,R as a user whose clinical role

does #$T allow 'or indication o' clinical decision support interventions (eg

nurse o''ice sta'') and then select the same patient used in Step 4 Proctor willveri'y that the clinical decision support interventions do not occur

automatically and electronically when a user is interacting with the %,Rtechnology

Rev.: 01-Aug-2014

!R "est-08#

Page 8 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 9: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 9/21

  170.314.a.8 Clinical Decision Support PS

: Proctor will instruct .endor to use the .endor-identi'ied %,R 'unction(s) to

con'igure at least one diagnostic and therapeutic re'erence resource based on a

userGs clinical role9 Proctor will instruct .endor to login in to the %,R as the user whose clinical

role has been con'igured to allow access to diagnostic and therapeuticre'erence resources and shall veri'y that the re'erence resources can beaccessed electronically Proctor will record this user role in the section above

E Proctor will instruct .endor to login in to the %,R as a user whose clinical

role does not have access to diagnostic and therapeutic re'erence resourcesand shall veri'y that the re'erence resources cannot be accessed electronically

Proctor will record this user role in the section above

7 Proctor will instruct .endor to login to %,R as a user who does not have theability to con'igure clinical decision support interventions nor diagnostic and

therapeutic re'erence resources Proctor will veri'y this user role does not have

access to con'igure clinical decision support interventions and diagnostic and

therapeutic re'erence resources Proctor will record this user role in the sectionabove

6 Proctor will con'irm %pected Test Results were achieved

03 Proctor will audit test results by completing Test Result .eri'ication checlist

Test DataTest data is vendor supplied and captured in the Test Result Verification.

%pected Testing Results

• %&'170.314(a)(8) * 4.01+ %,R can con'igure clinical decision support

interventions and the diagnostic and therapeutic re'erence resources based on

a userGs clinical role• &'170.314(a)(8) * 4.02+ %,R can once con'igured automatically produce

clinical decision support interventions based on a userGs clinical role

• &'170.314(a)(8) * 4.03+ %,R can once con'igured allow access to the

diagnostic and therapeutic re'erence resources based on a userGs clinical role

Test Result .eri'ication

• I#S%RT S+R%%# S,$T C *ser role con'iguring +DS support interventions

• I#S%RT S+R%%# S,$T C *ser role with +DS indications receiving +DS

interventions 'or a patient record

• I#S%RT S+R%%# S,$T C *ser role <IT,$*T +DS indications notreceiving +DS interventions 'or same patient record

• I#S%RT S+R%%# S,$T C *ser role accessing to diagnostic and therapeutic

re'erence resourcesRev.: 01-Aug-2014

!R "est-08#

Page o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 10: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 10/21

  170.314.a.8 Clinical Decision Support PS

• I#S%RT S+R%%# S,$T C *ser role not able to access diagnostic and

therapeutic re'erence resources

• I#S%RT S+R%%# S,$T C *ser role who does not have the ability to

con'igure clinical decision support interventions nor diagnostic and

therapeutic re'erence resources

Rev.: 01-Aug-2014

!R "est-08#

Page 10 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 11: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 11/21

  170.314.a.8 Clinical Decision Support PS

Test Re)uire*ent: DTR 170.314.a.8,: Re&ie ttri'utesTo Be +ompleted by Test Proctor 

Test Re=uirement R%S*"T (Pass!ail#o Attempt)

Support o' ,"E In'obutton (>%S#$)

Test Procedures0 Proctor will instruct .endor to login with user role is con'igured to allow 'or

indication o' clinical decision support interventions and shall select a patientrecord identi'ied by the .endor and populated with .endor-supplied test data

1 Proctor will instruct .endor to initiate a point o' care wor'low activity with a

 patient so that the clinical decision support interventions automatically occur4 Proctor will instruct .endor to use the .endor-identi'ied %,R 'unction(s) so

that the Proctor shall display the bibliographic citation o' the intervention

(clinical researchguideline) the developer o' the intervention (translation'rom clinical researchguideline) the 'unding source o' the intervention

development technical implementation and the release (and i' applicable

revision date(s)) o' the intervention

8 Proctor will instruct .endor to use the .endor-identi'ied %,R 'unction(s) sothat the Proctor shall access diagnostic and therapeutic re'erence in'ormation

using either general capability or the ,"E +ontet-Aware Hnowledge

Retrieval (In'obutton) Standard *sing the .endor-identi'ied %,R 'unction(s)the developer o' the intervention and where clinically indicated the

 bibliographic citation o' the intervention Proctor will record support or lac

o' support 'or ,"E In'obutton: Proctor will instruct .endor to enter medication orders via +P$% so that a

drug-drug or drug-allergy contraindication intervention is activated *sing the

.endor-identi'ied %,R 'unction(s) the developer o' the drug-drug or drug-allergy intervention and where clinically indicated the bibliographic citation

o' the intervention shall be displayed

9 Proctor will con'irm %pected Test Results were achieved

E Proctor will audit test results by completing Test Result .eri'ication checlist

Test DataTest data is vendor supplied and captured in the Test Result Verification.

%pected Testing Results

• %&'170.314.a.8-#.01+ !or clinical decision support interventions

 bibliographic citation o' the intervention the developer o' the intervention the'unding source o' the intervention development technical implementation and

Rev.: 01-Aug-2014

!R "est-08#

Page 11 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 12: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 12/21

  170.314.a.8 Clinical Decision Support PS

the release (and i' applicable revision date(s)) o' the intervention are

accessed and viewed

• %&'170.314.a.8-#.02+ !or diagnostic and therapeutic re'erences source

in'ormation are accessed and viewed

• %&'170.314.a.8-#.03+ !or drug-drugdrug-allergy contraindication

interventions developer o' the intervention and bibliographic citation o' the

intervention (where clinical indicated)

Test Result .eri'ication

• I#S%RT S+R%%# S,$T C Bibliographic citation o' the intervention the

developer o' the intervention the 'unding source o' the intervention

development technical implementation and the release (and i' applicable

revision date(s)) o' the intervention

• I#S%RT S+R%%# S,$T C Diagnostic and therapeutic re'erence o'

interventions• I#S%RT S+R%%# S,$T C Attributes 'or drug-drug and drug-allergy

interaction checs

 

Rev.: 01-Aug-2014

!R "est-08#

Page 12 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 13: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 13/21

  170.314.a.8 Clinical Decision Support PS

Test Re)uire*ent: DTR 170.314.a.8,/: Trigger Clinical DecisionSupport +nter&entions – 2or +ncorporate CCD an$ a' Results

To Be +ompleted by Test Proctor 

Test Re=uirement R%S*"T (Pass!ail#o Attempt)

+DS Intervention 'or Problem

+DS Intervention 'or &edication

+DS Intervention 'or &ed Allergy

+DS Intervention 'or "ab Result

Test Procedures0 I' .endor is not testing the incorporation o' summary care record

(0E3408b0) or the Ambulatory incorporation o' lab testresults

(0E3408b:) this test re=uirement is not re=uired and is sipped

1 !or 0E3408b0 Proctor will instruct .endor to incorporate a summary carerecordGs problems medications and medication allergies into a patientGs record

which will activate clinical decision support interventions 'or problems

medications and medication allergies4 !or 0E3408b: Proctor will instruct .endor to incorporate a lab result into a

 patientGs record which will trigger a lab result clinical decision support

interventions8 Proctor will veri'y the clinical decision support interventions automatically

occur and record the interventions in the section above

: Proctor will con'irm %pected Test Results were achieved

9 Proctor will audit test results by completing Test Result .eri'ication checlist

Test DataTest data is vendor supplied and captured in the Test Result Verification.

%pected Testing Results

• %&'170.314.a.8-2.02 &'170.314.a.8-2.04 &'170.314.a.8-2.0,+ *pon

incorporation o' a summary care record clinical decision support

interventions are indicated when medication medication allergies and

 problems are incorporated into the patientGs record

• %&'170.314.a.8-2.03 &'170.314.a.8-2.0# &'170.314.a.8-2.0,+ *pon

incorporation o' a lab result 'or an Ambulatory Setting test clinical decision

support interventions are indicated

Test Result .eri'ication

Rev.: 01-Aug-2014

!R "est-08#

Page 13 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 14: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 14/21

  170.314.a.8 Clinical Decision Support PS

• I#S%RT $R SA.% !I"% C Patient summary care record containing problem

list medication list medication allergy list demographics lab testsresults and

vital signs

• I#S%RT S+R%%# S,$T C Real-time noti'ication o' clinical decision support

interventions 'or incorporation o' summary care record

• I#S%RT $R SA.% !I"% C Patient lab results

• I#S%RT S+R%%# S,$T C Real-time noti'ication o' clinical decision support

interventions 'or incorporation o' lab result

Rev.: 01-Aug-2014

!R "est-08#

Page 14 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 15: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 15/21

  170.314.a.8 Clinical Decision Support PS

ppen$i : Testing 5ui$e

This appendix contains more details and background on the testing requirements,

including explanation on underlying standards, notable issues and best practice

 suggestions.

Rev 13-Dec-1301 Additions

• A +DS intervention is not simply an alert noti'ication or eplicit care suggestion

Rather it should be more broadly interpreted as the user-'acing representation o'evidence-based clinical guidance

• ?Real-time@ means at the point o' clinical decision maing (ie noti'ications must be

 provided when an eligible pro'essional is using +erti'ied %,R Technology and notrun overnight and provided in the morning 'or instance)

Rev.: 01-Aug-2014

!R "est-08#

Page 1# o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 16: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 16/21

  170.314.a.8 Clinical Decision Support PS

ppen$i 6: !"C Criteria an$ Stan$ar$s

This appendix contains copy of the relevant ON criteria and standards for this proctor

 sheet as a reference. !n the event of a discrepancy "ith the ON #inal Rule, the ON

 #inal Rule takes precedence.

/170.314(a)(8) Clinical ecision support

(i) %vidence-based decision support interventions %nable a limited set o'identi'ied users to select (ie activate) one or more electronic clinical decision

support interventions (in addition to drug-drug and drug-allergy

contraindication checing) based on each one and at least one combination o'the 'ollowing data/

A Problem list

B &edication list

+ &edication allergy list

D Demographics% "aboratory tests and valuesresults and

! .ital signs(ii) "ined re'erential clinical decision support

A %,R technology must be able to/

0 %lectronically identi'y 'or a user diagnostic and therapeuticre'erence in'ormation or 

1 %lectronically identi'y 'or a user diagnostic and therapeutic

re'erence in'ormation in accordance with the standard speci'ied

at 0E3138(b) and the implementation speci'ications at 0E3138 (b)(0) or (1)

B !or paragraph (a)(7)(ii)(A) o' this section %,R technology must be ableto electronically identi'y 'or a user diagnostic or therapeutic re'erencein'ormation based on each one and at least one combination o' the

'ollowing data re'erenced in paragraphs (a)(7)(i)(A) through (!) o' this

section/(iii) +linical decision support con'iguration

A %nable interventions and re'erence resources speci'ied in paragraphs (a)(7)

(i) and (ii) o' this section to be con'igured by a limited set o' identi'iedusers (eg system administrator) based on a userGs role

B %,R technology must enable interventions to be electronically triggered/

0 Based on the data re'erenced in paragraphs (a)(7)(i)(A)

through (!) o' this section1 <hen a patientGs medications medication allergies and

 problems are incorporated 'rom a transition o' carere'erral

Rev.: 01-Aug-2014

!R "est-08#

Page 1, o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 17: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 17/21

  170.314.a.8 Clinical Decision Support PS

summary received pursuant to paragraph (b)(0)(iii) o' this

section

4 Ambulatory setting only <hen a patientGs laboratory testsand valuesresults are incorporated pursuant to paragraph (b)(:)

(i)(A)(0) o' this section(iv) Automatically and electronically interact Interventions triggered in

accordance with paragraphs (a)(7)(i) through (iii) o' this section must

automatically and electronically occur when a user is interacting with %,R

technology(v) Source attributes %nable a user to review the attributes as indicated 'or all

clinical decision support resources/

A !or evidence-based decision support interventions under paragraph (a)(7)(i) o' this section/

0 Bibliographic citation o' the intervention (clinical

researchguideline)

1 Developer o' the intervention (translation 'rom clinicalresearchguideline)

4 !unding source o' the intervention development technical

implementation and8 Release and i' applicable revision date(s) o' the

intervention or re'erence source

B !or lined re'erential clinical decision support in paragraph (a)(7)(ii) o'this section and drug-drug drug-allergy interaction checs in paragraph(a)

(1) o' this section the developer o' the intervention and where clinically

indicated the bibliographic citation o' the intervention (clinical

researchguideline)

/170.204() ,"E .ersion 4 Standard/ +ontet-Aware Retrieval Application (In'obutton)0 Implementation speci'ications ,"E .ersion 4 Implementation 5uide/ *R"-

Based Implementations o' the +ontet-Aware In'ormation Retrieval (In'obutton)

Domain1 Implementation speci'ications ,"E .ersion 4 Implementation 5uide/ +ontet-

Aware Hnowledge Retrieval (In'obutton) Service-$riented Architecture

Implementation 5uide

 

Rev.: 01-Aug-2014

!R "est-08#

Page 17 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 18: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 18/21

  170.314.a.8 Clinical Decision Support PS

/170.314()(1) "ransitions o$ care * receive ispla an incorporate transition o$

carere$erral suaries.

iii Incorporate *pon receipt o' a transition o' carere'erral summary 'ormattedaccording to the standard adopted at 0E313:(a)(4) %,R technology must

 be able to/A +orrect patient Demonstrate that the transition o' carere'erral

summary received is or can be properly matched to the correct patient

B Data incorporation %lectronically incorporate the 'ollowing data

epressed according to the speci'ied standard(s)/0 &edications At a minimum the version o' the standard

speci'ied in 0E313E(d)(1)

1 Problems At a minimum the version o' the standardspeci'ied in 0E313E(a)(4)

4 &edication allergies At a minimum the version o' the

standard speci'ied in 0E313E(d)(1)

+ Section views %tract and allow 'or individual display each additionalsection or sections (and the accompanying document header

in'ormation) that were included in a transition o' carere'erral

summary received and 'ormatted in accordance with the standardadopted at 0E313:(a)(4)

/170.20#(a). Content 5c6ange Stanars * Patient Suar Recor

4 Standard/ ,"E Implementation 5uide 'or +DAJ Release 1/

I,% ,ealth Story +onsolidation The use o' the ?unstructured

document@ document-level template is prohibited

/170.207(a). ocaular stanars * Proles(4) I,TSD$ S#$&%D +TJ International Release Kuly 1301 and *S %tension

to S#$&%D +TJ &arch 1301 Release

/170.207(). ocaular stanars * eications

(1) R#orm a standardiFed nomenclature 'or clinical drugs produced by the*nited States #ational "ibrary o' &edicine August 9 1301 Release

/170.314()(#) &ncorporate laorator tests an valuesresults.

i Receive resultsA  Ambulatory setting only

0 %lectronically receive and incorporate clinical laboratory testsand valuesresults in accordance with the standard speci'ied in 0E313:(L) and at a minimum the version o' the standard

speci'ied in 0E313E(c)(1)Rev.: 01-Aug-2014

!R "est-08#

Page 18 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 19: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 19/21

  170.314.a.8 Clinical Decision Support PS

/170.20#(9). Content 5c6ange Stanars * lectronic incorporation an

transission o$ la results.

,"E .ersion 1:0 Implementation 5uide/ SMI !ramewor "ab Results Inter'ace

/170.207(c). ocaular stanars * a Results

(1) "ogical $bservation Identi'iers #ames and +odes ("$I#+J) Database

version 183 a universal code system 'or identi'ying laboratory and clinical

observations produced by the Regenstrie' Institute Inc

Rev.: 01-Aug-2014

!R "est-08#

Page 1 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 20: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 20/21

  170.314.a.8 Clinical Decision Support PS

Change og

Revision +hange Description

30-Aug-1308 Removed a typo error in test procedure step 0 o' DTR 0E3408a7-

4

30-&ay-1308 +lari'ied must record audit entry 'or activation o' +DS rules

30-Dec-1304 Removed re'erence to medications allergies and problems beingincorporated as part o' a lab result 0E3408a7-1 clari'ied

NI#0E3408a7-:31O on viewing source in'ormation o' diagnostic

and therapeutic re'erences

30-Kun-1304 +orrected *ser Role entry under ?To be completed by Test Proctor@

 bo 'or DTR 0E3408a7-1

30-&ay-1304 +orrected typo o' ?Problems@ to correct ?"ab Results@ in Appendi

B/ $#+ +riteria and Standards

30-&ar-1304 Added +hange log and D5I boilerplate

13-Dec-1301 Initial Release

Rev.: 01-Aug-2014

!R "est-08#

Page 20 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval

Page 21: 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

7/21/2019 170.314.a.8 ClinicalDecisionSupport PS Rev 01-Aug-2014 ReleaseSet 01-Aug-2014

http://slidepdf.com/reader/full/170314a8-clinicaldecisionsupport-ps-rev-01-aug-2014-releaseset-01-aug-2014 21/21

  170.314.a.8 Clinical Decision Support PS

'out Dru**on$ 5roup +nc.Drummond 5roup Inc is a global so'tware test and certi'ication lab that serves a wide

range o' vertical industries In healthcare Drummond 5roup tests and certi'ies

+ontrolled Substance $rdering Systems (+S$S) %lectronic Prescription o' +ontrolledSubstances (%P+S) so'tware and processes and %lectronic ,ealth Records (%,Rs) C

designating the trusted test lab as the only third-party certi'ier o' all three initiatives

designed to move the industry toward a digital 'uture !ounded in 0666 and accredited'or the $''ice o' the #ational +oordinator ,IT +erti'ication Program as an AuthoriFed

+erti'ication Body (A+B) and an AuthoriFed Test "ab (AT") Drummond 5roup

continues to build upon its deep eperience and epertise necessary to deliver reliable

and cost-e''ective services !or more in'ormation please visithttp/wwwdrummondgroupcom or email D5Idrummondgroupcom

END OF DOCUMENT

Rev.: 01-Aug-2014

!R "est-08#

Page 21 o$ 21

+opyright 2 1304 Drummond 5roup Inc

The in'ormation contained in this document is strictly held con'idential and shall not be

disclosed in any manner or 'orm directly or indirectly to any person or entity under anycircumstances without prior approval