Please consult the Notice of Proposed Rulemaking (NPRM) entitled: 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications for a detailed description of the proposed certification criterion with which these testing steps are associated. 1. Required Tests Note: The order in which the test steps are listed reflects the sequence of the certification criterion and does not necessarily prescribe the order in which the test should take place. Note that the Health IT Module must demonstrate their capabilities as it relates to transition of care/referral summaries formatted in accordance with standards adopted at §170.205(a)(3) and §170.205(a)(4). 1.1 Correct Patient Evaluate the Health IT Module’s ability to properly match C-CDA documents (specifically the Continuity of Care (CCD), Discharge Summary, and Referral Summary document templates) received from third parties to correct patients with existing records in the Health IT Module. Item # 1 Technical Outcome Test Lab Verification Test Approach A transition of care summary/referral summary C-CDA document, formatted according to the standard adopted at §170.205(a)(3) or §170.205(a)(4), is correctly matched to a patient in the Health IT Module. The tester verifies that the received C-CDA documents (including a CCD, Discharge Summary, and Referral summary) are matched to the correct patient record. Visual inspection of test data (C-CDA documents formatted in both the §170.205(a)(3) and §170.205(a)(4) standards). 1.2 Reconciliation Evaluate the Health IT Module’s ability to enable a user to electronically reconcile the data that represents a patient’s active medication list, medications allergy list or problem list through the simultaneous display of the multiple sources, creation of a single reconciled list, the review and validation of the reconciled list, and update of the patient record in the Health IT Module. 1 Item # 1 Technical Outcome Test Lab Verification Test Approach A user simultaneously views data (including active medications, medication allergies, and problems) that includes the source and last modification data from at least two sources: • The current patient record AND • Transition of care summary/referral summary C-CDA document, formatted according to the standard adopted at §170.205(a)(3) OR §170.205(a)(4). The tester verifies that data from multiple sources can be displayed for medications, medication allergies, and problems, including both the source and last modification date. The last modification date is defined for each list as: • Last date medication was documented, ordered, prescribed, refilled, dispensed or edited; • Last date the problem was documented or edited; and • Last date the medication allergy was documented, edited, or updated. Visual inspection of test data. Note that Health IT Modules will need to separately demonstrate the ability to reconcile summary of care documents formatted according to §170.205(a)(3) and §170.205(a)(4). 2 A user creates a single, reconciled medications, problems, or medication allergies list using the viewed data from the multiple medications, problems or medication allergies list sources. Further, the tester must verify that the Health IT Module can display the current patient record and a transition of care summary/referral summary CCDA document, formatted according to the standard adopted at §170.205(a)(3) and separately the current patient record and a transition of care summary/referral summary CCDA document, formatted according to the standard adopted at §170.205(a)(4). The tester must also verify that this can be completed for the Continuity of Care (CCD), Discharge Summary, and Referral Summary document templates. The tester verifies that for each list type, the lists can be merged, duplicates can be consolidated into a single representation, that list items can be removed, and any other means the Health IT Module may use to reconcile the list. Visual inspection of test data. 2 Item # 3 Technical Outcome Test Lab Verification Test Approach A user reviews the details of the reconciled list and validates its accuracy. The tester verifies that for each list type, a reconciled list is accurate and without omission including: Visual inspection. • • • 4 A user accepts the reconciled list and the patient record in the Health IT Module is updated. the inclusion of the minimum CCDS data elements for each list type, according to the definition adopted at §170.102; where applicable the use of medication vocabularies according to the standard adopted at §170.207(d)(3); and where applicable the use of problem vocabularies according to the standard adopted at §170.207(a)(4). The tester verifies that reconciled medications, medication allergies, and problems data are accurately incorporated into the patient record without omission, and that at a minimum • • • Visual inspection. medications are expressed according to the standard specified in §170.207(d)(3); medication allergies are expressed according to the standard specified in §170.207(d)(3); and problems are expressed according to the standard specified in §170.207(a)(4). 1.3 System Verification Evaluate the capability for a Health IT Module to create a valid transition of care summary/referral summary C-CDA document for a patient after patient data reconciliation of medication, medication allergies, and problems has occurred. Item # 1 Technical Outcome Test Lab Verification Test Approach A user creates a CCD that includes the reconciled and incorporated data, in accordance with the standard adopted at §170.205(a)(4). The tester verifies that the C-CDA documents (CCD only) created after a reconciliation of medications, medication allergies and/or problems reconciliation has been performed, meet the standard specified in § 170.207(a)(4). C-CDA Validator Tool and visual inspection. 2. Document History Version Number Description of Change Date 3 1.0 Released for Public Comment March 31, 2015 3. Dependencies For the related and required criteria, please refer to the Master Table of Related and Required Criteria. 4
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