Source: https://www.healthit.gov/test-method/clinical-information-reconciliation-and-incorporation
Timestamp: 2019-04-24 12:24:48+00:00

Document:
Updated paragraph (b)(2)(iii)(A) under TLV to remove ordered, prescribed, refilled, dispensed from last medication bullet.
Addition of statement – reconciliation process must be completed in a simultaneous view.
Clarified paragraph (b)(2)(iii)(B) TLV requirements for displaying and reconciling a list for each list type.
General requirements. Paragraphs (b)(2)(ii) and (iii) of this section must be completed based on the receipt of a transition of care/referral summary formatted in accordance with the standards adopted in §170.205(a)(3) and §170.205(a)(4) using the Continuity of Care Document, Referral Note, and (inpatient setting only) Discharge Summary document templates.
Correct patient. Upon receipt of a transition of care/referral summary formatted according to the standards adopted §170.205(a)(3) and §170.205(a)(4), technology must be able to demonstrate that the transition of care/referral summary received can be properly matched to the correct patient.
Simultaneously display (i.e., in a single view) the data from at least two sources in a manner that allows a user to view the data and their attributes, which must include, at a minimum, the source and last modification date.
Enable a user to create a single reconciled list of each of the following: Medications; medication allergies; and problems.
Enable a user to review and validate the accuracy of a final set of data.
System verification. Based on the data reconciled and incorporated, the technology must be able to create a file formatted according to the standard specified in §170.205(a)(4) using the Continuity of Care Document document template.
Paragraphs (b)(2)(ii) and (iii) of this section must be completed based on the receipt of a transition of care/referral summary formatted in accordance with the standards adopted in § 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 and § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1 using the Continuity of Care Document (CCD), Referral Note, and (inpatient setting only) Discharge Summary document templates.
Using the ETT: Message Validators – C-CDA R2.1 Validator, the user selects the receiver “170.315_b2_CIRI_Amb ” or “170.315_b2_CIRI_Inp” criteria, selects one of the C-CDA R2 Release 2.1 xml files, and executes the download of the required Clinical Information Reconciliation document 170.315_b2_ciri_r21_sample*.xml file for C-CDA R2 Release 2.1.
The user repeats step 1, but selects the corresponding CDA R2 Release 1.1 xml file from the File Name and executes the download of the required Clinical Information Reconciliation document 170.315_b2_ciri_r11_sample*.xml file for C-CDA R2 Release 1.1.
Using the xml files downloaded in steps 1 and 2, the user demonstrates that a transition of care summary/referral summary Consolidated-Clinical Document Architecture (C-CDA) document, formatted according to the standard adopted at § 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1, and a transition of care summary/referral summary C-CDA document, formatted according to the standard adopted at § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, can be properly matched to a patient in the Health IT Module. Note that matches can be made automatically or manually.
The user repeats steps 1-3 for each set of C-CDA R2 Release 1.1 and C-CDA R2 Release 2.1 xml files listed in the File Name for each of the health IT settings being certified.
The tester creates a human readable version of the downloaded C-CDA R2 Release 2.1 and C-CDA R2 Release 1.1 files from step 1 of the SUT to be used for verification.
The tester uses visual inspection to verify the Health IT Module can receive the C-CDA document downloaded in step 1 of the SUT as a C-CDA Release 1.1 document formatted according to the standard specified in § 170.205(a)(3) as either a CCD or a C-CDA with no specific document template.
Using the Health IT Module and the human readable xml files from step 1, the tester verifies that the received C-CDA Release 1.1 and Release 2.1 documents can be properly matched to the correct patient record.
Using the ETT: Message Validators – C-CDA R2.1 Validator, the user downloads the Clinical Information Reconciliation documents (xml) by selecting the receiver “170.315_b2_CIRI_Amb” or “170.315_b2_CIRI_Inp” criteria and the required Clinical Information Reconciliation documents xml files for both C-CDA Release 1.1 and Release 2.1 and executes the download.
The Transition of care summary/referral summary C-CDA Release 1.1 and Release 2.1 document, formatted according to the standard adopted at § 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 AND § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1 which includes the reconciliation data 170.315_b2_ciri_r11_ sample*_recon*.xml or 170.315_b2_ciri_r21_ sample*_recon*.xml.
Note that Health IT Module will need to separately demonstrate the ability to reconcile summary of care documents formatted according to § 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 and § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, and they will need to separately demonstrate each of the following document templates: CCD or C-CDA with no specific document template for C-CDA Release 1.1; and CCD, Referral Note, and (inpatient setting only) Discharge Summary document templates for C-CDA Release 2.1 for the health IT setting(s) being certified.
Last date the medication allergy was documented or edited.
Further, the tester must verify that the Health IT Module can display the current patient record and a transition of care summary/referral summary C-CDA Release 1.1 and Release 2.1 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 C-CDA document, formatted according to the standard adopted at § 170.205(a)(4).
The tester must verify that this can be completed for the CCD or C-CDA with no specific document template for C-CDA Release 1.1; and CCD, Referral Note, and (inpatient setting only) Discharge Summary document templates for C-CDA Release 2.1.
The tester verifies that, for each list type: a simultaneous display (i.e. a single view), duplicates can be consolidated into a single representation, list items can be removed, and any other methods the Health IT Module may use to reconcile the list. The entire reconciliation process must occur within a simultaneous view.
The user reviews the details of the reconciled list and validates its accuracy.
The tester verifies that, for each list type, a user is able to review and verify the accuracy of the final list.
The user accepts the reconciled list and the patient record in the Health IT Module is updated.
Problems are expressed according to the standard specified in § 170.207(a)(4) SNOMED CT®.
Using the reconciled CCD document submitted by the SUT, the tester uses the ETT: Message Validators –C-CDA R2.1 Validator to upload the submitted CCD by selecting the sender “170.315_b2_CIRI_Amb” or “170.315_b2_CIRI_Inp” criteria, and the file name corresponding to the reconciliation input samples. The tester executes the upload.
The tester uses the ETT: Message Validators Validation Report created as a result of the upload in step 1 to verify the Health IT Module passes without error to confirm that the Clinical Information Reconciliation CCD document is conformant when it is created after a reconciliation of medications, medication allergies, and/or problems has been performed. Furthermore, the tester verifies that it meets the standard specified in § 170.205(a)(4). This verification is only for C-CDA Release 2.1 CCD documents.
Added the links to the test tool and test tool user guide.
Privacy and Security: This certification criterion was adopted at § 170.315(b)(2). As a result, an ONC-ACB must ensure that a product presented for certification to a § 170.315(b) “paragraph (b)” criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
Technical outcome – The health IT can properly match a received transition of care (ToC)/referral summary (for both Releases 1.1 and 2.1) to the correct patient.
Technical outcome – A user can simultaneously display a patient’s active data and the data attributes from two sources, for each of a patient’s medication list, medication allergy list, and problem list. The data display must include the source and the last modification date.
A vendor must enable a user to electronically and simultaneously display (that is in a single view) the data from at least two list sources. If the two lists cannot be displayed in the tool at the same time this does not constitute a single view and does not meet the requirements for the certification criterion.
Technical outcome – A user can review, validate, and incorporate a patient’s medication list (using RxNorm), medication allergy list (using RxNorm), and problem list (using SNOMED CT®).
Technical outcome – The health IT can create a C-CDA document (using the CCD template in C-CDA Release 2.1) that includes the reconciled and incorporated data.

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