2014 Editin Test Prcedure fr 170.314(a)(1) Cmputerized prvider rder entry Apprved Test Prcedure Versin 1.3, December 19, 2014 Test Prcedure fr 170.314(a)(1) Cmputerized prvider rder entry This dcument describes the test prcedure fr evaluating cnfrmance f electrnic health recrd (EHR) technlgy t the certificatin criteria defined in 45 CFR Part 170 Subpart C f the Health Infrmatin Technlgy: Standards, Implementatin Specificatins, and Certificatin Criteria fr Electrnic Health Recrd Technlgy, 2014 Editin; Revisins t the Permanent Certificatin Prgram fr Health Infrmatin Technlgy, Final Rule and 45 CFR Part 170 Electrnic Health Recrd (EHR) Certificatin Criteria and the ONC HIT Certificatin Prgram; Regulatry Flexibilities, Imprvements, and Enhanced Health Infrmatin Exchange, 2014 Editin, Release 2, Final Rule. The test prcedures may be updated t reflect n-ging feedback received during the certificatin activities. Questins r cncerns regarding the ONC HIT Certificatin Prgram shuld be sent t: ONC.Certificatin@hhs.gv CERTIFICATION CRITERIA This certificatin criterin is frm the Health Infrmatin Technlgy: Standards, Implementatin Specificatins, and Certificatin Criteria fr Electrnic Health Recrd Technlgy, 2014 Editin; Revisins t the Permanent Certificatin Prgram fr Health Infrmatin Technlgy, Final Rule issued by the Department f Health and Human Services (HHS) n September 4, 2012. This certificatin criterin is included in the definitin f a Base EHR. 170.314(a)(1) Cmputerized prvider rder entry. Enable a user t electrnically recrd, change, and access the fllwing rder types, at a minimum: (i) Medicatins; (ii) Labratry; and (iii) Radilgy/imaging. Diagnstic imaging 2014 EDITION RELEASE 2 PREAMBLE LANGUAGE Per Sectin III.A.2 f the preamble f the 2014 Editin Release 2 Electrnic Health Recrd (EHR) Certificatin Criteria and the ONC HIT Certificatin Prgram; Regulatry Flexibilities, Imprvements, and Enhanced Health Infrmatin Exchange Final Rule (September 11, 2014), the at a minimum language in these certificatin criteria has nt been included and the relevant regulatin text f this certificatin criterin has been changed frm radilgy and imaging rders t diagnstic imaging rders. 2014 EDITION PREAMBLE LANGUAGE Per Sectin III.A f the preamble f the Health Infrmatin Technlgy: Standards, Implementatin Specificatins, and Certificatin Criteria fr Electrnic Health Recrd Technlgy, 2014 Editin; Revisins t the Permanent Certificatin Prgram fr Health Infrmatin Technlgy, Final Rule (September 4, 2012) where the cmputerized prvider rder entry certificatin criterin is discussed: 1
2014 Editin Test Prcedure fr 170.314(a)(1) Cmputerized prvider rder entry Apprved Test Prcedure Versin 1.3, December 19, 2014...we d clarify that the change in the CPOE denminatr affects the autmated measure calculatin certificatin criterin ( 170.314(g)(2)), which is a revised certificatin criterin fr the 2014 Editin EHR certificatin criteria. This certificatin criterin fcuses n enabling a user t electrnically recrd, change, and access, at a minimum, medicatin, labratry and radilgy/imaging rders. It des nt fcus n transmissin f thse rders. 2011 PREAMBLE LANGUAGE Per Sectin III.D f the preamble f the Health Infrmatin Technlgy: Initial Set f Standards, Implementatin Specificatins, and Certificatin Criteria fr Electrnic Health Recrd Technlgy, Final Rule (July 28, 2010) where the cmputerized prvider rder entry certificatin criterin is discussed: We clarify that the adpted certificatin criteria related t CPOE pertain nly t the rdering, and nt t the delivery f results (reprts r images). CHANGES FROM 2011 TO 2014 EDITION Per Sectin III.A f the preamble f the Health Infrmatin Technlgy: Standards, Implementatin Specificatins, and Certificatin Criteria fr Electrnic Health Recrd Technlgy, 2014 Editin; Revisins t the Permanent Certificatin Prgram fr Health Infrmatin Technlgy, Final Rule (September 4, 2014) where the cmputerized prvider rder entry certificatin criterin is discussed: We prpsed a CPOE certificatin criterin that merged the separate ambulatry and inpatient CPOE certificatin criteria in the 2011 Editin EHR certificatin criteria int ne criterin because they thse [sic] certificatin criteria are identical. We prpsed t replace the terms mdify and retrieve with change and access, respectively. We als prpsed t remve the term stre frm the criterin because it is redundant with ur interpretatin f the term recrd....we prpsed t mve the phrase at a minimum in the certificatin criterin t eliminate any pssible ambiguity as t what the phrase mdifies. As prpsed, the certificatin criterin made clear that the phrase mdifies the rder types and nt the terms recrd, change, and access. INFORMATIVE TEST DESCRIPTION This sectin prvides an infrmative descriptin f hw the test prcedure is rganized and cnducted. It is nt intended t prvide nrmative statements f the certificatin requirements. This test evaluates the capability fr EHR technlgy t enable a user t electrnically recrd, change, and access the fllwing rder types: (i) Medicatins; (ii) Labratry; and (iii) Diagnstic imaging. 2
2014 Editin Test Prcedure fr 170.314(a)(1) Cmputerized prvider rder entry Apprved Test Prcedure Versin 1.3, December 19, 2014 The test prcedure is nt prescriptive abut the methd used t change an rder. Fr example, changing an rder des nt require changing an existing instance f an rder. Change may be accmplished thrugh discntinuing/canceling an existing rder and entering a new rder. ONC supplies part f the test data and the Vendr supplies part f the test data fr this test prcedure. This test prcedure is rganized int three sectins: Recrd evaluates the capability t electrnically enter rders fr medicatins, labratry, and diagnstic imaging within the EHR system The Tester enters the ONC-supplied test data rders fr medicatins, labratry, and diagnstic imaging The Tester verifies that the rders are recrded in the EHR Change evaluates the capability fr a user t electrnically change entered rders fr medicatins, labratry, and diagnstic imaging in the EHR The Tester displays the entered rders fr medicatins, labratry, and diagnstic imaging Tester changes the medicatins, labratry, and diagnstic imaging rders The Tester verifies that the changed rders are accurate and cmplete Access evaluates the capability t access and display the rders that have been previusly entered int the EHR The Tester displays the rders fr medicatins, labratry, and diagnstic imaging entered during the test The Tester verifies that the displayed rder data are accurate and cmplete Fr EHR technlgy targeted t the ambulatry setting, the fllwing derived test requirements apply: DTR170.314(a)(1) 1: Electrnically Recrd Orders in an Ambulatry Setting DTR170.314(a)(1) 2: Electrnically Change Orders in an Ambulatry Setting DTR170.314(a)(1) 3: Electrnically Access Orders in an Ambulatry Setting Fr EHR technlgy targeted t the inpatient setting, the fllwing derived test requirements apply: DTR170.314(a)(1) 4: Electrnically Recrd Orders in an Inpatient Setting DTR170.314(a)(1) 5: Electrnically Change Orders in an Inpatient Setting DTR170.314(a)(1) 6: Electrnically Access Orders in an Inpatient Setting REFERENCED STANDARDS Nne NORMATIVE TEST PROCEDURES AMBULATORY SETTING Derived Test Requirements DTR170.314(a)(1) 1: Electrnically Recrd Orders in an Ambulatry Setting DTR170.314(a)(1) 2: Electrnically Change Orders in an Ambulatry Setting DTR170.314(a)(1) 3: Electrnically Access Orders in an Ambulatry Setting DTR170.314(a)(1) 1: Electrnically Recrd Orders in an Ambulatry Setting Required Vendr Infrmatin 3
2014 Editin Test Prcedure fr 170.314(a)(1) Cmputerized prvider rder entry Apprved Test Prcedure Versin 1.3, December 19, 2014 VE170.314(a)(1) 1.01:Vendr shall identify a patient with an existing recrd in the EHR t be used fr this test VE170.314(a)(1) 1.02:Vendr shall identify the EHR functin(s) that are available t: 1) select the patient, 2) enter rders fr medicatins, labratry, and diagnstic imaging, 3) change rders fr medicatins, labratry, and diagnstic imaging, and 4) access rders fr medicatins, labratry, and diagnstic imaging in an ambulatry setting Required Test Prcedure TE170.314(a)(1) 1.01: Tester shall select rder test data frm ne ONC-supplied test data set in TD170.314(a)(1) 1 TE170.314(a)(1) 1.02: Using the EHR functin(s) identified by the Vendr, the Tester shall select the patient s existing recrd and enter rders frm the selected test data set in TD170.314(a)(1) 1 fr Medicatin Labratry Diagnstic imaging TE170.314(a)(1) 1.03: Using the Inspectin Test Guide (belw), the Tester shall verify that the rders have been entered crrectly and withut missin Inspectin Test Guide IN170.314(a)(1) 1.01: Using the data in the selected ONC-supplied test data set in TD170.314(a)(1) 1, Tester shall verify that the rder test data are entered crrectly and withut missin IN170.314(a)(1) 1.02: Tester shall verify that the rder data are recrded in the patient s recrd fr data elements listed in TE170.314(a)(1) 1.02 DTR170.314(a)(1) 2: Electrnically Change Orders in an Ambulatry Setting Required Vendr Infrmatin As defined in DTR170.314(a)(1) 1, n additinal infrmatin is required Required Test Prcedure TE170.314(a)(1) 2.01: Tester shall select rder test data frm ne ONC-supplied test data set in TD170.314(a)(1) 2 that crrespnds t the data set selected fr DTR170.314(a)(1) 1: Electrnically Recrd Orders in an Ambulatry Setting TE170.314(a)(1) 2.02: Using the EHR functin(s) identified by the Vendr, the Tester shall select the patient s existing recrd, shall display the rder data entered during the DTR170.314(a)(1) 1: Electrnically Recrd Orders in an Ambulatry Setting test, and shall change the previusly entered rders fr the data elements listed in TE170.314(a)(1) 1.02 TE170.314(a)(1) 2.03: Using the Inspectin Test Guide (belw), the Tester shall verify that the rders that were entered in TE170.314(a)(1) 2.02 have been entered crrectly and withut missin Inspectin Test Guide IN170.314(a)(1) 2.01: Using the data in the selected ONC-supplied 4
2014 Editin Test Prcedure fr 170.314(a)(1) Cmputerized prvider rder entry Apprved Test Prcedure Versin 1.3, December 19, 2014 test data set in TD170.314(a)(1) 2, Tester shall verify that the medicatin, labratry, and diagnstic imaging rder data entered during the DTR170.314(a)(1) 1: Electrnically Recrd Orders in an Ambulatry Setting test are accessed and changed crrectly and withut missin IN170.314(a)(1) 2.02: Tester shall verify that the changed rders are recrded in the patient recrd crrectly, including the data elements listed in TE170.314(a)(1) 1.02 DTR170.314(a)(1) 3: Electrnically Access Orders in an Ambulatry Setting Required Vendr Infrmatin As defined in DTR170.314(a)(1) 1, n additinal infrmatin is required Required Test Prcedure TE170.314(a)(1) 3.01: Using the EHR functin(s) identified by the Vendr, the Tester shall select the patient s existing recrd and display the rders the Tester entered during the DTR170.314(a)(1) 1: Electrnically Recrd Orders in an Ambulatry Setting test and changed during the DTR170.314(a)(1) 2: Electrnically Change Orders in an Ambulatry Setting test fr the data elements listed in TE170.314(a)(1) 1.02 TE170.314(a)(1) 3.02: Using the Inspectin Test Guide (belw), the Tester shall verify that the rder data display crrectly and withut missin Inspectin Test Guide IN170.314(a)(1) 3.01: Using the data in the ONC-supplied test data set in TD170.314(a)(1) 3 that crrespnds t the data set selected fr DTR170.314(a)(1) 1: Electrnically Recrd Orders in an Ambulatry Setting, Tester shall verify that the rder data entered during the DTR170.314(a)(1) 1: Electrnically Recrd Orders in an Ambulatry Setting test and changed during the DTR170.314(a)(1) 2: Electrnically Change Orders in an Ambulatry Setting test display crrectly and withut missin, including the data elements listed in TE170.314(a)(1) 1.02 NORMATIVE TEST PROCEDURES INPATIENT SETTING Derived Test Requirements DTR170.314(a)(1) 4: Electrnically Recrd Orders in an Inpatient Setting DTR170.314(a)(1) 5: Electrnically Change Orders in an Inpatient Setting DTR170.314(a)(1) 6: Electrnically Access Orders in an Inpatient Setting DTR170.314(a)(1) 4: Electrnically Recrd Orders in an Inpatient Setting Required Vendr Infrmatin VE170.314(a)(1) 4.01:Vendr shall identify a patient with an existing recrd in the EHR t be 5
2014 Editin Test Prcedure fr 170.314(a)(1) Cmputerized prvider rder entry Apprved Test Prcedure Versin 1.3, December 19, 2014 used fr this test VE170.314(a)(1) 4.02:Vendr shall identify the EHR functin(s) that are available t: 1) select the patient, 2) enter rders fr medicatins, labratry, and diagnstic imaging, 3) change rders fr medicatins, labratry, and diagnstic imaging, and 4) access rders fr medicatins, labratry, and diagnstic imaging in an inpatient setting Required Test Prcedure TE170.314(a)(1) 4.01: Tester shall select rder test data frm ne ONC-supplied test data set in TD170.314(a)(1) 4 TE170.314(a)(1) 4.02: Using the EHR functin(s) identified by the Vendr, the Tester shall select the patient s existing recrd and enter rders frm the selected test data set in TD170.314(a)(1) 4 fr Medicatins Labratry Diagnstic imaging TE170.314(a)(1) 4.03: Using the Inspectin Test Guide (belw), the Tester shall verify that the rders have been entered crrectly and withut missin Inspectin Test Guide IN170.314(a)(1) 4.01: Using the data in the selected ONC-supplied test data set in TD170.314(a)(1) 4, Tester shall verify that the rder test data are entered crrectly and withut missin IN170.314(a)(1) 4.02: Tester shall verify that the rder data are recrded in the patient s recrd fr the data elements listed in TE170.314(a)(1) 4.02 DTR170.314(a)(1) 5: Electrnically Change Orders in an Inpatient Setting Required Vendr Infrmatin As defined in DTR170.314(a)(1) 4, n additinal infrmatin is required Required Test Prcedure TE170.314(a)(1) 5.01: Tester shall select rder test data frm ne ONC-supplied test data set in TD170.314(a)(1) 5 that crrespnds t the data set selected fr DTR170.314(a)(1) 4: Electrnically Recrd Orders in an Inpatient Setting TE170.314(a)(1) 5.02: Using the EHR functin(s) identified by the Vendr, the Tester shall select the patient s existing recrd, shall display the rder data entered during the DTR170.314(a)(1) 4: Electrnically Recrd Orders in an Inpatient Setting test, and shall change the previusly entered rders fr the data elements listed in TE170.314(a)(1) 4.02 TE170.314(a)(1) 5.03: Using the Inspectin Test Guide (belw), the Tester shall verify that the rders that were entered in TE170.314(a)(1) 5.02 have been entered crrectly and withut missin Inspectin Test Guide IN170.314(a)(1) 5.01: Using the data in the selected ONC-supplied test data set in TD170.314(a)(1) 5, Tester shall verify that the medicatin, labratry, 6
2014 Editin Test Prcedure fr 170.314(a)(1) Cmputerized prvider rder entry Apprved Test Prcedure Versin 1.3, December 19, 2014 and diagnstic imaging rder data entered during the DTR170.314(a)(1) 4: Electrnically Recrd Orders in an Inpatient Setting test are accessed and changed crrectly and withut missin IN170.314(a)(1) 5.02: Tester shall verify that the changed rders are recrded in the patient recrd crrectly, including the data elements listed in TE170.314(a)(1) 4.02 DTR170.314(a)(1) 6: Electrnically Access Orders in an Inpatient Setting Required Vendr Infrmatin As defined in DTR170.314(a)(1) 4, n additinal infrmatin is required Required Test Prcedure TE170.314(a)(1) 6.01: Using the EHR functin(s) identified by the Vendr, the Tester shall select the patient s existing recrd and display the rders the Tester entered during the DTR170.314(a)(1) 4: Electrnically Recrd Orders in an Inpatient Setting test and changed during the DTR170.314(a)(1) 5: Electrnically Change Orders in an Inpatient Setting test fr the data elements listed in TE170.314(a)(1) 4.02 TE170.314(a)(1) 6.02: Using the Inspectin Test Guide (belw), the Tester shall verify that the rder data display crrectly and withut missin Inspectin Test Guide IN170.314(a)(1) 6.01: Using the data in the ONC-supplied test data set in TD170.314(a)(1) 6 that crrespnds t the data set selected fr DTR170.314(a)(1) 4: Electrnically Recrd Orders in an Inpatient Setting, Tester shall verify that the rder data entered during the DTR170.314(a)(1) 4: Electrnically Recrd Orders in an Inpatient Setting test and changed during the DTR170.314(a)(1) 5: Electrnically Change Orders in an Inpatient Setting test display crrectly and withut missin, including the data elements listed in TE170.314(a)(1) 4.02 TEST DATA ONC- and Vendr-supplied test data are prvided with the test prcedure t ensure that the applicable requirements identified in the criteria can be adequately evaluated fr cnfrmance, as well as t prvide cnsistency in the testing prcess acrss multiple Natinal Vluntary Labratry Accreditatin Prgram (NVLAP)-Accredited Testing Labs (ATLs). The prvided test data fcus n evaluating the basic capabilities f required EHR technlgy, rather than exercising the full breadth/depth f capability that installed EHR technlgy might be expected t supprt. The test data are frmatted fr readability f use within the testing prcess. The frmat is nt prescribing a particular end-user view r rendering. N additinal requirements shuld be drawn frm the frmat. The Tester shall use and apply the prvided test data during the test, withut exceptin, unless ne f the fllwing cnditins exists: The test prcedure requires r permits the use f vendr-supplied test data. 7
2014 Editin Test Prcedure fr 170.314(a)(1) Cmputerized prvider rder entry Apprved Test Prcedure Versin 1.3, December 19, 2014 The Tester determines that the Vendr prduct is sufficiently specialized that the prvided test data needs t be mdified in rder t cnduct an adequate test. Having made the determinatin that sme mdificatin t the prvided test data is necessary, the Tester shall recrd the mdificatins made as part f the test dcumentatin. The Tester determines that changes t the test data will imprve the efficiency f the testing prcess; primarily thrugh using cnsistent demgraphic data thrughut the testing wrkflw. The Tester shall ensure that the applicable requirements identified in the criterin can be adequately evaluated fr cnfrmance and that the test data prvides a cmparable level f rbustness. Having made the determinatin that sme mdificatin t the prvided test data is necessary, the Tester shall recrd the mdificatins made as part f the test dcumentatin. Any departure frm the prvided test data shall strictly fcus n meeting the basic capabilities required f EHR technlgy relative t the certificatin criterin rather than exercising the full breadth/depth f capability that installed EHR technlgy might be expected t supprt. The test prcedures require that the Tester enter the applicable test data int the EHR technlgy being evaluated fr cnfrmance. The intent is that the Tester fully cntrls the prcess f entering the test data in rder t ensure that the data are crrectly entered as specified in the test prcedure. If a situatin arises where it is impractical fr a Tester t directly enter the test data, the Tester, at the Tester s discretin, may instruct the Vendr t enter the test data, s lng as the Tester remains in full cntrl f the testing prcess, directly bserves the test data being entered by the Vendr, and validates that the test data are entered crrectly as specified in the test prcedure. Fr Vendr-supplied test data, the Tester shall address the fllwing: Vendr-supplied test data shall ensure that the requirements identified in the criterin can be adequately evaluated fr cnfrmance. Vendr-supplied test data shall strictly fcus n meeting the basic capabilities required f an EHR relative t the certificatin criterin rather than exercising the full breadth/depth f capability that an installed EHR might be expected t supprt. Tester shall recrd as part f the test dcumentatin the specific Vendr-supplied test data that was utilized fr testing. Fr additinal infrmatin regarding the prvided test data fr use in this test prcedure: Test Data fr 170.314(a)(1) Cmputerized prvider rder entry available at http://www.healthit.gv/certificatin (navigatin: 2014 Editin Test Methd) CONFORMANCE TEST TOOLS Nne 8
2014 Editin Test Prcedure fr 170.314(a)(1) Cmputerized prvider rder entry Apprved Test Prcedure Versin 1.3, December 19, 2014 Dcument Histry Versin Number Descriptin f Change Date 1.0 Released fr public cmment September 7, 2012 1.1 Delivered fr Natinal Crdinatr Apprval December 4, 2012 1.2 Psted Apprved Test Prcedure December 14, 2012 1.3 Remval f fllwing sectins: Fr EHR technlgy targeted t bth settings, the fllwing derived test requirements Additin f the fllwing sectin: 2014 Editin Release 2 Preamble Language The Test Prcedure has been update t reflect the 2014 Editin Release 2 rule and remves the at a minimum language. The text f this certificatin criterin has been changed frm radilgy and imaging rders t diagnstic imaging rders. The test steps have been changed t reflect diagnstic imaging instead f radilgy/imaging December 19, 2014 9