NIST Normative Test Process Document: e-prescribing (erx) Test Tool

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NIST Normative Test Process Document: e-prescribing (erx) Test Tool Test Tool and Test Descriptions to Conduct ONC 2015 Edition Certification Version 1.7 Date: December 3, 2015 Developed by the National Institute of Standards and Technology (NIST) in collaboration with the National Council for Prescription Drug Programs (NCPDP) and the Office of the National Coordinator (ONC) for Health IT

Explanation of Terms List of Contents A table containing a key of equivalents for names and terms used frequently in this document Informative Test Description Key background information for conducting the certification testing; includes information about Definition of Tester for this document Care settings and profiles that are in-scope for the testing Capabilities the Health IT Module must be able to demonstrate during the certification testing Normative Test Description Detailed description of the testing process, including Derived Test Requirement(s), Testing Workflow Diagram(s), Required Vendor Information, Required Testing Actions, and Inspection Test Guide Test Data Detailed description of the purpose and use of the provided test data, including allowed exceptions Navigating a Test Case Detailed description of the information and instructions available in the NIST Test Tool related to the Test Cases How to Interpret the Message Content Data Sheet Detailed description of the purpose of and information available in the Message Content Data Sheet, including the meaning of the NIST Test Data Categories and Qualifiers Conformance Test Tools Links to the web-based NIST Test Tool and Support sites, as well as information to assist the Tester in interpreting the Validation Reports generated by the Tool Document History Listing of Version Numbers and Publication Dates for the final published versions of the NIST Normative Testing Process document 2

NIST Normative Test Process Document for 170.315(b)(3) Electronic Prescribing This document explains the testing process for which a National Institute of Standards and Technology (NIST) validation test tool is used in evaluating conformance of a health information technology module (Health IT Module) to the certification criterion 170.315(b)(3) Electronic Prescribing defined in 45 CFR Part 170 of the Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services (HHS) 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications Final Rule. For the ONC Approved 170.315(b)(3) Electronic Prescribing test procedure visit http://confluence.oncprojectracking.org/pages/viewpage.action?pageid=8389456 For detailed certification criterion verbiage, please consult ONC s 2015 Edition Certification Companion Guide for Electronic Prescribing https://www.healthit.gov/sites/default/files/2015ed_ccg_b3-eprescribing.pdf EXPLANATION OF TERMS Key for Names and Terms Used Frequently in this Document Referenced Names and Terms NCPDP SCRIPT Standard, Implementation Guide, Version 10.6 RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, September 8, 2015 Release International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT ) Health IT Module Context-based capability of the NIST eprescribing Test Tool Equivalent Used in Document SCRIPT Implementation Guide Named RxNorm Standard or RxNorm ICD-10-CM or ICD-10 SNOMED CT or SNOMED HIT Module or Module Tool 3

INFORMATIVE TEST DESCRIPTION This section provides key background information for conducting the certification testing. This document has been developed to be used by the ONC-Accredited Testing Laboratories (ATLs) in certification of Health IT Modules for the ONC. The term Tester, when used in this document, refers to a person (such as an ATL employee) acting on behalf of an ATL for certification testing of a Vendor s HIT Module. In addition, a Vendor may use this document to test their own HIT Modules in preparation for certification testing by an ATL. The test evaluates the capability for a Health IT Module to Support prescription-related electronic transactions that o Are conformant to the NCPDP SCRIPT Standard, Implementation Guide, Version 10.6; and use, at minimum, the RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, September 8, 2015 Release, including a) Creating messages for new prescriptions and receiving/processing new prescription status messages b) Receiving/processing request messages for changing a prescription and creating messages for change prescription responses c) Creating messages for cancel prescription requests and receiving/processing response messages for cancelling prescriptions d) Receiving/processing request messages for refilling a prescription and creating messages for refill prescription responses e) Receiving/processing fill status notification messages f) Creating request messages for medication history information and receiving/processing medication history information response messages Receive/process and transmit the reason for each of the prescription-related electronic transactions named in a) f) above, using ICD-10-CM coded data in the diagnosis elements in DRU Segment Limit prescription-related electronic transaction to use of only metric standard units of ml (i.e., not cc) for all oral liquid medications Enforce insertion of leading zeroes before the decimal point for [dosage] amounts less than one (1) Enforce never allowing use of trailing zeroes after a decimal point for [dosage amounts in] prescription-related electronic transactions Optionally. Receive/process and transmit each of the prescription-related electronic transactions named in a) f) above (except for the Cancel Prescription Response and Medication History Request), with the SNOMED CT coded reason for the prescription in the indication elements and ICD-10 codes for diagnosis elements in the SIG Segment The ONC 2015 Edition Final Rule specifies the NCPDP SCRIPT Standard, Implementation Guide, Version 10.6, as the messaging standard. This standard defines 12 Profiles; the Profiles shown in Table 1 are in-scope for the certification testing process. 4

Transaction Change Prescription (RXCHG, CHGRES) Cancel Prescription (CANRX, CANRES) Refill Prescription (REFREQ, REFRES) Fill Status (RXFILL) Medication History (RXHREQ, RXHRES) STATUS ERROR VERIFY Table 1 In-Scope eprescribing Profiles and Description Description Allows a pharmacist to request a change of a new prescription or a fillable prescription. Allows a prescriber to respond to pharmacy requests to change a prescription. Notifies the pharmacist that a previously sent prescription should be canceled and not filled. Sends the prescriber the results of a prescription cancellation request. Allows the pharmacist to request approval for additional refills of a prescription beyond those originally prescribed. Allows the prescriber to grant the pharmacist permission to provide a patient with additional refills or decline to do so. Allows the pharmacist to notify the prescriber about the status of a prescription in three cases: 1) to notify the prescriber of a dispensed prescription, 2) to notify the prescriber of a partially dispensed prescription, and 3) to notify a prescriber of a prescription not dispensed. Allows a requesting entity to generate a patient-specific medication history request. The responding entity can respond, as information is available, with a patient s medication history, including source, fill number, follow-up contact, date range. Is used to relay acceptance of a transaction back to the sender. A STATUS in response to REFREQ, REFRES, NEWRX, VERIFY, RXCHG, CHGRES, CANRX, CANRES, or RXFILL indicates acceptance and responsibility for a request. This indicates an error has occurred indicating the request was terminated. (An ERROR can be generated when there is a communication problem or when the transaction actually had an error.) If the sender asked for verification that the recipient did in fact receive the message, this is the message type that is sent back to the sender. The National Council for Prescription Drug Programs (NCPDP) supports a task group, the Meaningful Use and NIST Test Methods for eprescribing Task Group, which, in collaboration with NIST, provided the Test Cases and Test Data for this testing process. The testing process also follows the implementation recommendations of NCPDP in the NCPSP SCRIPT Implementation Recommendations, Version 1.29. 1 Listed in the Test Data section of this document are the Test Scenarios that have been developed for the NIST testing process. Test Data PDF Documents, which are accessible from the NIST eprescribing Test Tool identified in the Conformance Test Tools section of this testing process document, contain the test data that are specific to each Test Scenario. Instructions for use of the provided test data are listed in the Normative Test Description and Test Data sections of this testing process document. The testing process entails four groups of Scenarios that cover the prescription-related electronic transactions required in the certification criterion. Diagrams 1 5 illustrate the key transactions that comprise the Test Steps in the Scenarios. (The numbers in these diagrams indicate transaction flow within each diagram and do not correlate with the numbers of the Derived Test Requirements listed in the Normative Test Description section.) 1 http://www.ncpdp.org/ncpdp/media/pdf/scriptimplementationrecommendationsv1-29.pdf 5

Each of the Scenario groups includes several Test Scenarios consisting of multiple Test Steps; the Test Steps are provided for both edi and xml. For ONC certification testing, the Tester shall select all of the Test Scenarios and all of the Test Steps (either edi or xml) and shall use the Test Steps together in the sequence in which they are listed in the Test Tool (see Table 2 in the Test Data section of this document for a detailed list of the Scenarios and their Test Steps). Diagram 1 Overview of erx Use Cases and Test Steps Included in Testing Process 6

Diagram 2 erx Use Case and Test Steps: Change Prescription Scenarios Diagram 3 erx Use Case and Test Steps: Cancel Prescription Scenarios 7

Diagram 4 erx Use Case and Test Steps: Refill Prescription Scenarios Diagram 5 erx Use Case and Test Steps: Medication History Scenarios 8

NORMATIVE TEST DESCRIPTION Derived Test Requirements The following four Scenario groups cover the prescription-related electronic transactions identified in the ONC erx criterion. Each Scenario group is composed of two or more Test Steps (which equate to Derived Test Requirements (DTR)) that are to be tested together in the indicated sequence. Each DTR listed below corresponds to a Test Step found in the Test Scenarios provided in the ONC Certification Test Plan of the eprescribing Test Tool. Change Prescription and Receive Fill Status Notifications Scenario Test Steps (NEWRX, RXCHG, CHGRES, RXFILL) erx_dtr - 1: Create Electronic Transaction for New Prescription erx_dtr - 2: Receive and Process Electronic Status Transaction for New Prescription erx_dtr - 3: Receive and Process Electronic Transaction for Change Prescription Request erx_dtr - 4: Create Electronic Status Transaction for Change Prescription Request erx_dtr - 5: Create Electronic Change Response Transaction for Change Prescription Request erx_dtr - 6: Receive and Process Electronic Status Transaction for Change Prescription Response erx_dtr - 7: Receive and Process Electronic Transaction for Fill Status Notification erx_dtr - 8: Create Electronic Status Transaction for Fill Status Notification Cancel Prescription Scenario Test Steps (NEWRX, CANRX, CANRES) erx_dtr - 9: Create Electronic Transaction for New Prescription erx_dtr - 10: Receive and Process Electronic Status Transaction for New Prescription erx_dtr - 11: Create Electronic Transaction for Cancel Prescription Request erx_dtr - 12: Receive and Process Electronic Status Transaction for Cancel Prescription Request erx_dtr - 13: Receive and Process Electronic Transaction for Cancel Prescription Response erx_dtr - 14: Create Electronic Status Transaction for Cancel Prescription Response Refill Prescription Scenario Test Steps (NEWRX, REFREQ, REFRES). erx_dtr - 15: Create Electronic Transaction for New Prescription erx_dtr - 16: Receive and Process Electronic Status Transaction for New Prescription erx_dtr - 17: Receive and Process Electronic Transaction for Refill for Prescription Request erx_dtr - 18: Create Electronic Status Transaction for Refill for Prescription Request erx_dtr - 19: Create Electronic Refill Response Transaction for Refill for Prescription Request erx_dtr - 20: Receive and Process Electronic Status Transaction for Refill Response Transaction Medication History Request Scenario Test Steps (RXHREQ, RXHRES) erx_dtr - 21: Create Electronic Transaction for Medication History Information Request erx_dtr - 22: Receive and Process Electronic Transaction for Medication History Response 9

Change Prescription and Receive Fill Status Notifications Scenario Test Steps (NEWRX, RXCHG, CHGRES, RXFILL) erx_dtr - 1: Create Electronic Transaction for New Prescription Figure 1 Create New Prescription Message The instructions in the testing process listed below reference the numbered test steps in Figure 1. Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) create patient records in the Module and input the test data for the test patients, 2) create prescription-related electronic transaction messages using the test data according to the Referenced Standards, and 3) import 2 the prescription-related electronic transaction messages into the Tool 2. Vendor shall provide the mechanism necessary to import the prescription-related electronic transaction messages into the Tool 2 During certification testing, the mechanism by which the eprescibing test message is imported (sent) from or to the Health IT Module being tested is not specified. The ATL may have their own utility, they may allow the Module vendor to use a utility created by that vendor, or the message can be cut from the Module and pasted into the NIST Test Tool or cut from the NIST Test Tool and pasted into the Module. For certification testing, the key requirement is for the Module to demonstrate real time/dynamic import. 10

Required Testing Actions 1. Using the Context-based capability provided in the Tool identified in the Conformance Test Tools section of this testing process document, the Tester shall access the ONC Certification Test Plan and the Change Prescription Tests, and shall a) Select a Change Scenario and either edi or xml [Figure 1, Step 1] b) Select a Create New Prescription Test Step [Figure 1, Step 2] 2. Using the capabilities in the Health IT Module, the Tester shall a) Input the provided new prescription test data using the Test Data Specification in the Tool for the Test Step (input can be performed using a manual or automated process) [Figure 1, Step 3] i. For Change Prescription Tests/Scenario 3, using the capabilities of the HIT Module the Tester shall attempt to enter the test data for the New Prescription for an oral liquid medication first using a unit of measure other than ml (e.g., cc or teaspoon ) for the dosage in the medication order, and the Tester shall inspect the HIT Module to verify its ability to prevent use of any unit of measure other than ml b) Cause the Module to generate the indicated new prescription message [Figure 1, Step 4] 3. In the Tool, the Tester shall load the selected Create New Prescription Test Step and import the new prescription message generated by the HIT Module [Figure 1, Steps 5 & 6] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module created the new prescription message correctly and that the message includes the specified information Inspection Test Guide 1. Using the Validation Report produced by the Tool, the Tester shall analyze the Report and verify that the message created by the Health IT Module meets the conformance requirements in the Referenced Standards [Figure 1, Step 7, 8, & 9], and that a) The HIT Module limits prescription-related electronic transaction to use of only metric standard units of ml (i.e., not cc) for all oral liquid medications b) The HIT Module enforces insertion of leading zeroes before the decimal point for [dosage] amounts less than one (1) c) The HIT Module enforces never allowing use of trailing zeroes after a decimal point for [dosage amounts in] prescription-related electronic transactions 2. ICD-10 codes in the messages are acceptable with or without decimals 3. If the Tester determines that the ICD-10 code in a message created by the Module is a valid code for a data item (e.g., diagnosis) even though it is different from the ICD-10 code provided for that data item in the test data for that message, the Tester shall allow an exception 4. Once during the certification testing for this criterion, the Tester shall inspect the HIT Module to verify its ability to support the ICD-10 and SNOMED CT coding systems as specified in the SCRIPT Implementation Guide and in the Preamble of the ONC 2015 Final Rule regarding the erx criterion a) Using the functions of the HIT Module and the Tool, the Vendor shall demonstrate to the Tester that their Module supports o The ICD-10 coding system for the diagnosis elements in the DRU Segment 11

o o Optionally, the SNOMED CT coding system for the reason for prescription in the indication elements in the SIG Segment Optionally, the ICD-10 coding system for the diagnosis element in the SIG Segment. erx_dtr - 2: Receive and Process Electronic Status Transaction for New Prescription Figure 2 Receive New Prescription Status Message The instructions in the testing process listed below reference the numbered test steps in Figure 2. Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) import the Status messages into the Module, and 2) verify that the Status messages are processed according to the Referenced Standards 2. Vendor shall provide the mechanism necessary to import the Status messages into the Module Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 1: Create Electronic Transaction for New Prescription [Figure 2, Step 1] and shall a) Select the New Prescription Status Test Step [Figure 2, Step 2] b) Load the test message [Figure 2, Step 3] 2. Using the capabilities in the Health IT Module, the Tester shall import the Status message into the Module, and the Module will consume the message [Figure 2, Steps 3 & 4] 12

3. In the Tool, the Tester shall retrieve the test step-specific Juror Document for the selected New Prescription Status Test Step [Figure 2, Step 5] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module processed the Status message correctly Inspection Test Guide 1. Using the test step-specific Juror Document retrieved from the Tool, the Tester shall inspect the Health IT Module and verify that the Module processed the Status message according to the conformance requirements in the Referenced Standards [Figure 2, Step 6] a) No notification need be made visible in the Health IT Module unless the Module is unable to process the Status message b) If the Module is unable to process the Status message, the processing issue(s) must be made visible to the user in some manner in the Module erx_dtr - 3: Receive and Process Electronic Transaction for Change Prescription Request Figure 3 Receive Change Prescription Request Message The instructions in the testing process listed below reference the numbered test steps in Figure 3. 13

Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) import the prescription-related electronic transaction messages into the Tool, and 2) verify that the Change Prescription Request messages are processed according to the Referenced Standards 2. Vendor shall provide the mechanism necessary to import the prescription-related electronic transaction messages into the Tool Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 1: Create Electronic Transaction for New Prescription [Figure 3, Step 1] and shall a) Select the Receive Change Prescription Request Test Step [Figure 3, Step 2] b) Load the test message [Figure 3, Step 3] 2. Using the capabilities in the Health IT Module, the Tester shall import the Change Prescription Request message into the Module, and the Module will consume the message [Figure 3, Steps 3 & 4] 3. In the Tool, the Tester shall retrieve the test step-specific Juror Document for the selected Receive Change Prescription Request Test Step [Figure 3, Step 5] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module processed the change prescription request message correctly Inspection Test Guide 1. Using the test step-specific Juror Document retrieved from the Tool, the Tester shall inspect the Health IT Module and verify that the Module processed the Change Prescription Request message according to the conformance requirements in the Referenced Standards [Figure 3, Step 6] 14

erx_dtr - 4: Create Electronic Status Transaction for Change Prescription Request Figure 4 Create Change Prescription Request Status Message The instructions in the testing process listed below reference the numbered test steps in Figure 4. Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) input the test data for the test patients, 2) create prescription-related electronic transaction status messages using the test data according to the Referenced Standards, 3) and import the prescription-related electronic transaction status messages into the Tool 2. Vendor shall provide the mechanism necessary to import the prescription-related electronic transaction status messages into the Tool Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 1: Create Electronic Transaction for New Prescription [Figure 4, Step 1] and shall select the Create Change Prescription Request Status Test Step [Figure 4, Step 2] 2. Using the capabilities in the Health IT Module, the Tester shall a) Input the provided change prescription request status test data using the Test Data Specification in the Tool for the Test Step (input can be performed using a manual or automated process) [Figure 4, Step 3] 15

b) Cause the Module to generate the indicated change prescription request status message [Figure 4, Step 4] 3. In the Tool, the Tester shall load the selected Create Change Prescription Request Status Test Step and import the change prescription request status message generated by the HIT Module [Figure 4, Steps 5 & 6] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module created the change prescription request status message correctly and that the message includes the specified information Inspection Test Guide 1. Using the Validation Report produced by the Tool, the Tester shall analyze the Report and verify that the message created by the Health IT Module meets the conformance requirements in the Referenced Standards [Figure 4, Step 7, 8, & 9] 16

erx_dtr - 5: Create Electronic Response Transaction for Change Prescription Request Figure 5 Create Change Prescription Response Message The instructions in the testing process listed below reference the numbered test steps in Figure 5. Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) input the test data for the test patients, 2) create prescription-related electronic transaction messages using the test data according to the Referenced Standards, 3) and import the prescription-related electronic transaction messages into the Tool 2. Vendor shall provide the mechanism necessary to import the prescription-related electronic transaction messages into the Tool Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 1: Create Electronic Transaction for New Prescription [Figure 5, Step 1] and shall select the Create Change Prescription Response Test Step [Figure 5, Step 2] 2. Using the capabilities in the Health IT Module, the Tester shall 17

a) Input the provided change prescription response test data using the Test Data Specification in the Tool for the Test Step (input can be performed using a manual or automated process) [Figure 5, Step 3] b) Cause the Module to generate the indicated change prescription response message [Figure 5, Step 4] 3. In the Tool, the Tester shall load the selected Create Change Prescription Response Test Step and import the change prescription response message generated by the HIT Module [Figure 5, Steps 5 & 6] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module created the change prescription response message correctly and that the message includes the specified information Inspection Test Guide 1. Using the Validation Report produced by the Tool, the Tester shall analyze the Report and verify that the message created by the Health IT Module meets the conformance requirements in the Referenced Standards [Figure 5, Step 7, 8, & 9] erx_dtr - 6: Receive and Process Electronic Status Transaction for Change Prescription Response Figure 6 Receive Change Prescription Response Status Message The instructions in the testing process listed below reference the numbered test steps in Figure 6. 18

Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) import the Change Prescription Response Status messages into the Module, and 2) verify that the Change Prescription Response Status messages are processed according to the Referenced Standards 2. Vendor shall provide the mechanism necessary to import the Change Prescription Response Status messages into the Module Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 1: Create Electronic Transaction for New Prescription [Figure 6, Step 1] and shall a) Select the Receive Change Prescription Response Status Test Step [Figure 6, Step 2] b) Load the test message [Figure 6, Step 3] 2. Using the capabilities in the Health IT Module, the Tester shall import the Change Prescription Response Status message into the Module, and the Module will consume the message [Figure 6, Steps 3 & 4] 3. In the Tool, the Tester shall retrieve the test step-specific Juror Document for the selected Receive Change Prescription Response Status Test Step [Figure 6, Step 5] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module processed the Change Prescription Response Status message correctly Inspection Test Guide 1. Using the test step-specific Juror Document retrieved from the Tool, the Tester shall inspect the Health IT Module and verify that the Module processed the Change Prescription Response Status message according to the conformance requirements in the Referenced Standards [Figure 6, Step 6] 19

erx_dtr - 7: Receive and Process Electronic Transaction for Fill Status Notification Figure 7 Receive Fill Status Notification The instructions in the testing process listed below reference the numbered test steps in Figure 7. Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) import the Fill Status Notification messages into the Module, and 2) verify that the Fill Status Notification messages are processed according to the Referenced Standards 2. Vendor shall provide the mechanism necessary to import the Fill Status Notification messages into the Module Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 1: Create Electronic Transaction for New Prescription [Figure 7, Step 1] and shall a) Select the Receive Fill Status Notification Test Step [Figure 7, Step 2] b) Load the test message [Figure 7, Step 3] 2. Using the capabilities in the Health IT Module, the Tester shall import the Fill Status Notification message into the Module, and the Module will consume the message [Figure 7, Steps 3 & 4] 3. In the Tool, the Tester shall retrieve the test step-specific Juror Document for the selected Fill Status Notification Test Step [Figure 7, Step 5] 20

4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module processed the Fill Status Notification message correctly Inspection Test Guide 1. Using the test step-specific Juror Document retrieved from the Tool, the Tester shall inspect the Health IT Module and verify that the Module processed the Fill Status Notification message according to the conformance requirements in the Referenced Standards [Figure 7, Step 6] erx_dtr - 8: Create Electronic Status Transaction for Fill Status Notification Figure 8 Create Fill Status Notification Status Message The instructions in the testing process listed below reference the numbered test steps in Figure 8. Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) input the test data for the test patients, 2) create prescription-related electronic transaction status messages using the test data according to the Referenced Standards, 3) and import the prescription-related electronic transaction status messages into the Tool 21

2. Vendor shall provide the mechanism necessary to import the prescription-related electronic transaction status messages into the Tool Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 1: Create Electronic Transaction for New Prescription [Figure 8, Step 1] and shall select the Create Fill Status Notification Status Test Step [Figure 8, Step 2] 2. Using the capabilities in the Health IT Module, the Tester shall a) Input the provided fill status notification status test data using the Test Data Specification in the Tool for the Test Step (input can be performed using a manual or automated process) [Figure 8, Step 3] b) Cause the Module to generate the indicated fill status notification status message [Figure 8, Step 4] 3. In the Tool, the Tester shall load the selected Create Fill Status Notification Status Test Step and import the fill status notification status message generated by the HIT Module [Figure 8, Steps 5 & 6] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module created the fill status notification status message correctly and that the message includes the specified information Inspection Test Guide 1. Using the Validation Report produced by the Tool, the Tester shall analyze the Report and verify that the message created by the Health IT Module meets the conformance requirements in the Referenced Standards [Figure 8, Step 7, 8, & 9] 22

Cancel Prescription Scenario Test Steps (NEWRX, CANRX, CANRES) erx_dtr - 9: Create Electronic Transaction for New Prescription Figure 9 Create New Prescription Message The instructions in the testing process listed below reference the numbered test steps in Figure 9. Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) create patient records in the Module and input the test data for the test patients, 2) create prescription-related electronic transaction messages using the test data according to the Referenced Standards, 3) import the prescription-related electronic transaction messages into the Tool, and 4) demonstrate support for the named standard coding systems 2. Vendor shall provide the mechanism necessary to import the prescription-related electronic transaction messages into the Tool 23

Required Testing Actions 1. In the Tool, the Tester shall access the ONC Certification Test Plan and the Cancel Prescription Tests, and shall a) Select a Cancel Scenario and either edi or xml [Figure 9, Step 1] b) Select a Create New Prescription Test Step [Figure 9, Step 2] 2. Using the capabilities in the Health IT Module, the Tester shall a) Input the provided new prescription test data using the Test Data Specification in the Tool for the Test Step (input can be performed using a manual or automated process) [Figure 9, Step 3] b) Cause the Module to generate the indicated new prescription message [Figure 9, Step 4] 3. In the Tool, the Tester shall load the selected Create New Prescription Test Step and import the new prescription message generated by the HIT Module [Figure 9, Steps 5 & 6] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module created the new prescription message correctly and that the message includes the specified information Inspection Test Guide 1. Using the Validation Report produced by the Tool, the Tester shall analyze the Report and verify that the message created by the Health IT Module meets the conformance requirements in the Referenced Standards [Figure 9, Step 7, 8, & 9] 2. ICD-10 codes in the messages are acceptable with or without decimals 3. If the Tester determines that the ICD-10 code in a message created by the Module is a valid code for a data item (e.g., diagnosis) even though it is different from the ICD-10 code provided for that data item in the test data for that message, the Tester shall allow an exception; 24

erx_dtr - 10: Receive and Process Electronic Status Transaction for New Prescription Figure 10 Receive and Process New Prescription Status Message The instructions in the testing process listed below reference the numbered test steps in Figure 10. Required Vendor Information Same as for erx_dtr 2 Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 9: Create Electronic Transaction for New Prescription [Figure 10, Step 1] and shall a) Select the New Prescription Status Test Step [Figure 10, Step 2] b) Load the test message [Figure 10, Step 3] 2. Using the capabilities in the Health IT Module, the Tester shall import the Status message into the Module, and the Module will consume the message [Figure 10, Steps 3 & 4] 3. In the Tool, the Tester shall retrieve the test step-specific Juror Document for the selected New Prescription Status Test Step [Figure 10, Step 5] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module consumed the Status message correctly 25

Inspection Test Guide 1. Using the test step-specific Juror Document retrieved from the Tool, the Tester shall inspect the Health IT Module and verify that the Module processed the Status message according to the conformance requirements in the Referenced Standards [Figure 10, Step 6] a) All Status messages provided in the Test Tool are positive acknowledgements, and no notification need be made visible in the Health IT Module unless the Module is unable to process the message b) If the Module is unable to process the Status message, the processing issue(s) must be made visible to the user in some manner in the Module erx_dtr - 11: Create Electronic Transaction for Cancel Prescription Request Figure 11 Create Cancel Prescription Request Message The instructions in the testing process listed below reference the numbered test steps in Figure 11. 26

Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) create patient records in the Module and input the test data for the test patients, 2) create prescription-related electronic transaction messages using the test data according to the Referenced Standards, 3) and import the prescription-related electronic transaction messages into the Tool 2. Vendor shall provide the mechanism necessary to import the prescription-related electronic transaction messages into the Tool Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 9: Create Electronic Transaction for New Prescription [Figure 11, Step 1] and shall select the Create Cancel Prescription Request Test Step [Figure 11, Step 2] 2. Using the capabilities in the Health IT Module, the Tester shall a) Input the provided cancel prescription test data using the Test Data Specification in the Tool for the Test Step (input can be performed using a manual or automated process) [Figure 11, Step 3] b) Cause the Module to generate the indicated cancel prescription request message [Figure 11, Step 4] 3. In the Tool, the Tester shall load the selected Create Cancel Prescription Request Test Step and import the cancel prescription request message generated by the HIT Module [Figure 11, Steps 5 & 6] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module created the cancel prescription request message correctly and that the message includes the specified information Inspection Test Guide 1. Using the Validation Report produced by the Tool, the Tester shall analyze the Report and verify that the message created by the Health IT Module meets the conformance requirements in the Referenced Standards [Figure 11, Step 7, 8, & 9] 27

erx_dtr - 12: Receive and Process Electronic Status Transaction for Cancel Prescription Request Figure 12 Receive and Process Cancel Prescription Request Status Message The instructions in the testing process listed below reference the numbered test steps in Figure 12. Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) import the Cancel Prescription Request Status messages into the Module, and 2) verify that the Cancel Prescription Request Status messages are processed according to the Referenced Standards 2. Vendor shall provide the mechanism necessary to import the Cancel Prescription Request Status messages into the Module Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 9: Create Electronic Transaction for New Prescription [Figure 12, Step 1] and shall a) Select the Receive Cancel Prescription Request Status Test Step [Figure 12, Step 2] b) Load the test message [Figure 12, Step 3] 2. Using the capabilities in the Health IT Module, the Tester shall import the Cancel Prescription Request Status message into the Module, and the Module will consume the message [Figure 12, Steps 3 & 4] 28

3. In the Tool, the Tester shall retrieve the test step-specific Juror Document for the selected Receive Cancel Prescription Request Status Test Step [Figure 12, Step 5] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module processed the Cancel Prescription Request Status message correctly Inspection Test Guide 1. Using the test step-specific Juror Document retrieved from the Tool, the Tester shall inspect the Health IT Module and verify that the Module processed the Cancel Prescription Request Status message according to the conformance requirements in the Referenced Standards [Figure 12, Step 6] erx_dtr - 13: Receive and Process Electronic Transaction for Cancel Prescription Response Figure 13 Receive Cancel Prescription Response Message The instructions in the testing process listed below reference the numbered test steps in Figure 13. Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) import the prescription-related electronic transaction messages into the Tool, and 2) verify that the Cancel Prescription Response messages are processed according to the Referenced Standards 2. Vendor shall provide the mechanism necessary to import the prescription-related electronic transaction messages into the Tool 29

Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 9: Create Electronic Transaction for New Prescription [Figure 13, Step 1] and shall a) Select the Receive Cancel Prescription Response Test Step [Figure 13, Step 2] b) Load the test message [Figure 13, Step 3] 2. Using the capabilities in the Health IT Module, the Tester shall import the Cancel Prescription Response message into the Module, and the Module will consume the message [Figure 13, Steps 3 & 4] 3. In the Tool, the Tester shall retrieve the test step-specific Juror Document for the selected Receive Cancel Prescription Response Test Step [Figure 13, Step 5] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module processed the cancel prescription response message correctly and that the message includes the specified information Inspection Test Guide 1. Using the test step-specific Juror Document retrieved from the Tool, the Tester shall inspect the Health IT Module and verify that the Module processed the Cancel Prescription Response message according to the conformance requirements in the Referenced Standards [Figure 13, Step 6] 30

erx_dtr - 14: Create Electronic Status Transaction for Cancel Prescription Response Figure 14 Create Cancel Prescription Response Status Message The instructions in the testing process listed below reference the numbered test steps in Figure 14. Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) input the test data for the test patients, 2) create prescription-related electronic transaction messages using the test data according to the Referenced Standards, 3) and import the prescription-related electronic transaction messages into the Tool 2. Vendor shall provide the mechanism necessary to import the prescription-related electronic transaction messages into the Tool Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 9: Create Electronic Transaction for New Prescription [Figure 14, Step 1] and shall select the Create Cancel Prescription Response Status Test Step [Figure 14, Step 2] 2. Using the capabilities in the Health IT Module, the Tester shall a) Input the provided cancel prescription response status test data using the Test Data Specification in the Tool for the Test Step (input can be performed using a manual or automated process) [Figure 14, Step 3] 31

b) Cause the Module to generate the indicated cancel prescription response status message [Figure 14, Step 4] 3. In the Tool, the Tester shall load the selected Create Cancel Prescription Response Status Test Step and import the cancel prescription response status message generated by the HIT Module [Figure 14, Steps 5 & 6] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module created the cancel prescription response status message correctly and that the message includes the specified information Inspection Test Guide 1. Using the Validation Report produced by the Tool, the Tester shall analyze the Report and verify that the message created by the Health IT Module meets the conformance requirements in the Referenced Standards [Figure 14, Step 7, 8, & 9] 32

Refill Prescription Scenario Test Steps (NEWRX, REFREQ, REFRES). erx_dtr - 15: Create Electronic Transaction for New Prescription Figure 15 Create New Prescription Message The instructions in the testing process listed below reference the numbered test steps in Figure 15. Required Vendor Information Same as for erx_dtr 1 Required Testing Actions 1. In the Tool, the Tester shall access the ONC Certification Test Plan and the Refill Prescription Tests, and shall a) Select a Refill Scenario and either edi or xml [Figure 15, Step 1] b) Select a Create New Prescription Test Step [Figure 15, Step 2] 2. Using the capabilities in the Health IT Module, the Tester shall 33

a) Input the provided new prescription test data using the Test Data Specification in the Tool for the Test Step (input can be performed using a manual or automated process) [Figure 15, Step 3] b) Cause the Module to generate the indicated new prescription message [Figure 15, Step 4] 3. In the Tool, the Tester shall load the selected Create New Prescription Test Step and import the new prescription message generated by the HIT Module [Figure 15, Steps 5 & 6] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module created the new prescription message correctly and that the message includes the specified information Inspection Test Guide 1. Using the Validation Report produced by the Tool, the Tester shall analyze the Report and verify that the message created by the Health IT Module meets the conformance requirements in the Referenced Standards [Figure 15, Step 7, 8, & 9] 2. ICD-10 codes in the messages are acceptable with or without decimals 3. If the Tester determines that the ICD-10 code in a message created by the Module is a valid code for a data item (e.g., diagnosis) even though it is different from the ICD-10 code provided for that data item in the test data for that message, the Tester shall allow an exception erx_dtr - 16: Receive and Process Electronic Status Transaction for New Prescription Figure 16 Receive New Prescription Status Message The instructions in the testing process listed below reference the numbered test steps in Figure 16. 34

Required Vendor Information Same as for erx_dtr 2 Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 15: Create Electronic Transaction for New Prescription [Figure 16, Step 1] and shall a) Select the New Prescription Status Test Step [Figure 16, Step 2] b) Load the test message [Figure 16, Step 3] 2. Using the capabilities in the Health IT Module, the Tester shall import the Status message into the Module, and the Module will consume the message [Figure 16, Steps 3 & 4] 3. In the Tool, the Tester shall retrieve the test step-specific Juror Document for the selected New Prescription Status Test Step [Figure 16, Step 5] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module processed the Status message correctly Inspection Test Guide 1. Using the test step-specific Juror Document retrieved from the Tool, the Tester shall inspect the Health IT Module and verify that the Module processed the Status message according to the conformance requirements in the Referenced Standards [Figure 16, Step 6] a) No notification need be made visible in the Health IT Module unless the Module is unable to process the Status message b) If the Module is unable to process the Status message, the processing issue(s) must be made visible to the user in some manner in the Module 35

erx_dtr - 17: Receive and Process Electronic Transaction for Refills for Prescription Request Figure 17 Receive Prescription Refills Request Message The instructions in the testing process listed below reference the numbered test steps in Figure 17. Required Vendor Information Same as for erx_dtr 3 Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 15: Create Electronic Transaction for New Prescription [Figure 17, Step 1] and shall a) Select the Receive Refill Prescription Request Test Step [Figure 17, Step 2] b) Load the test message [Figure 17, Step 3] 2. Using the capabilities in the Health IT Module, the Tester shall import the Refill Prescription Request message into the Module, and the Module will consume the message [Figure 17, Steps 3 & 4] 3. In the Tool, the Tester shall retrieve the test step-specific Juror Document for the selected Receive Refill Prescription Request Test Step [Figure 17, Step 5] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module processed the Refill Prescription Request message correctly 36

Inspection Test Guide 1. Using the test step-specific Juror Document retrieved from the Tool, the Tester shall inspect the Health IT Module and verify that the Module processed the Refill Prescription Request message according to the conformance requirements in the Referenced Standards [Figure 17, Step 6] erx_dtr - 18: Create Electronic Status Transaction for Refills for Prescription Request Figure 18 Create Refills for Prescription Request Status Message The instructions in the testing process listed below reference the numbered test steps in Figure 18. Required Vendor Information Same as for erx_dtr 4 Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 15: Create Electronic Transaction for New Prescription [Figure 18, Step 1] and shall select the Create Refill Prescription Request Status Test Step [Figure 18, Step 2] 2. Using the capabilities in the Health IT Module, the Tester shall 37

a) Input the provided refill prescription request status test data using the Test Data Specification in the Tool for the Test Step (input can be performed using a manual or automated process) [Figure 18, Step 3] b) Cause the Module to generate the indicated refill prescription request status message [Figure 18, Step 4] 3. In the Tool, the Tester shall load the selected Create Refill Prescription Request Status Test Step and import the refill prescription request status message generated by the HIT Module [Figure 18, Steps 5 & 6] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module created the refill prescription request status message correctly and that the message includes the specified information Inspection Test Guide 1. Using the Validation Report produced by the Tool, the Tester shall analyze the Report and verify that the message created by the Health IT Module meets the conformance requirements in the Referenced Standards [Figure 18, Step 7, 8, & 9] 38

erx_dtr - 19: Create Electronic Response Transaction for Refill for Prescription Request Figure 19 Create Response for Prescription Refills Request Message The instructions in the testing process listed below reference the numbered test steps in Figure 19. Required Vendor Information Same as for erx_dtr 5 Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 15: Create Electronic Transaction for New Prescription [Figure 19, Step 1] and shall select the Create Refill Prescription Response Test Step [Figure 19, Step 2] 2. Using the capabilities in the Health IT Module, the Tester shall a) Input the provided refill prescription response test data using the Test Data Specification in the Tool for the Test Step (input can be performed using a manual or automated process) [Figure 19, Step 3] b) Cause the Module to generate the indicated refill prescription response message [Figure 19, Step 4] 39

3. In the Tool, the Tester shall load the selected Create Refill Prescription Response Test Step and import the refill prescription response message generated by the HIT Module [Figure 19, Steps 5 & 6] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module created the refill prescription response message correctly and that the message includes the specified information Inspection Test Guide 1. Using the Validation Report produced by the Tool, the Tester shall analyze the Report and verify that the message created by the Health IT Module meets the conformance requirements in the Referenced Standards [Figure 19, Step 7, 8, & 9] erx_dtr - 20: Receive and Process Electronic Status Transaction for Refills for Prescription Response Figure 20 Receive Refills for Prescription Response Status Message The instructions in the testing process listed below reference the numbered test steps in Figure 20. Required Vendor Information Same as for erx_dtr 6 Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 15: Create Electronic Transaction for New Prescription [Figure 20, Step 1] and shall a) Select the Receive Refill Prescription Response Status Test Step [Figure 20, Step 2] 40

b) Load the test message [Figure 20, Step 3] 2. Using the capabilities in the Health IT Module, the Tester shall import the Refill Prescription Response Status message into the Module, and the Module will consume the message [Figure 20, Steps 3 & 4] 3. In the Tool, the Tester shall retrieve the test step-specific Juror Document for the selected Receive Refill Prescription Response Status Test Step [Figure 20, Step 5] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module processed the Refill Prescription Response Status message correctly Inspection Test Guide 1. Using the test step-specific Juror Document retrieved from the Tool, the Tester shall inspect the Health IT Module and verify that the Module processed the Refill Prescription Response Status message according to the conformance requirements in the Referenced Standards [Figure 20, Step 6] Medication History Request Scenario Test Steps (RXHREQ, RXHRES) erx_dtr - 21: Create Electronic Transaction for Medication History Request Figure 21 Create Medication History Request The instructions in the testing process listed below reference the numbered test steps in Figure 21. 41

Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) create patient records in the Module and input the test data for the test patients, 2) create prescription-related electronic transaction messages using the test data according to the Referenced Standards, 3) and import the prescription-related electronic transaction messages into the Tool 2. Vendor shall provide the mechanism necessary to import the prescription-related electronic transaction messages into the Tool Required Testing Actions 1. In the Tool, Tester shall access the ONC Certification Test Plan and the Medication History Tests [Figure 21, Step 1] and shall select the Create Medication History Request Test Step [Figure 21, Step 2] 2. Using the capabilities in the Health IT Module, the Tester shall a) Input the provided request medication history test data using the Test Data Specification in the Tool for the Test Step (input can be performed using a manual or automated process) [Figure 21, Step 3] b) Cause the Module to generate the indicated medication history request message [Figure 21, Step 4] 3. In the Tool, the Tester shall load the selected Create Medication History Request Test Step and import the medication history request message generated by the HIT Module [Figure 21, Steps 5 & 6] 4. Using the Inspection Test Guide, the Tester shall verify that the HIT Module created the medication history request message correctly and that the message includes the specified information Inspection Test Guide 1. Using the Validation Report produced by the Tool, the Tester shall analyze the Report and verify that the message created by the Health IT Module meets the conformance requirements in the Referenced Standards [Figure 21, Step 7, 8, & 9] 42

erx_dtr - 22: Receive and Process Electronic Transaction for Medication History Response Figure 22 Receive Medication History The instructions in the testing process listed below reference the numbered test steps in Figure 22. Required Vendor Information 1. Vendor shall identify the Health IT Module function(s) that are available to 1) import the prescription-related electronic transaction messages into the Tool, and 2) verify that the Response messages are processed according to the Referenced Standards 2. Vendor shall provide the mechanism necessary to import the prescription-related electronic transaction messages into the Tool Required Testing Actions 1. In the Tool, Tester shall select the same Test Scenario (and edi or xml) selected for erx-dtr - 21: Create Electronic Transaction for Medication History Request [Figure 22, Step 1] and shall a) Select the Receive Medication History Response Test Step [Figure 22, Step 2] b) Load the test message [Figure 22, Step 3] 2. Using the capabilities in the Health IT Module, the Tester shall import the Medication History Response message into the Module, and the Module will consume the message [Figure 22, Steps 3 & 4] 43