Clinical information reconciliation and incorporation

A Health IT Module currently certified to the § 170.315(b)(2) Clinical information reconciliation and incorporation will attest directly to the ONC-ACB to conformance with the updated § 170.315(b)(2) requirements outlined in the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.

The ONC-ACB verifies the Health IT Module certified to § 170.315(b)(2) Clinical information reconciliation and incorporation attests conformance to § 170.315(b)(2) criterion update requirements.

Setup

1. Using the ASTP Standards Implementation & Testing Environment (SITE): C-CDA Validator – USCDI v1 the user selects the receiver “170.315_b2_CIRI_Amb ” or “170.315_b2_CIRI_Inp” criteria, selects one of the C-CDA 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 R 2.1.
2. The user repeats step 1, but selects the corresponding CDA R1.1, 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 R1.1, or

Correct Patient

3. Using the xml files downloaded in step 1, 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, can be properly matched to a patient in the Health IT Module. Note that matches can be made automatically or manually.
4. Using the xml files downloaded in step 2, the user demonstrates that a transition of care summary/referral summary C-CDA document can be properly matched to a patient in the Health IT Module automatically or manually formatted according to the standards adopted at:
   • § 170.205(a)(4), HL7^® Implementation Guide for CDA^® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, and
   • § 170.205(a)(5), HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2 Companion Guide, Release 2
5. The user repeats steps 1-4, for each set of C-CDA R1.1, and C-CDA R2.1 xml files listed in the File Name for each of the health IT settings being certified.

Setup

1. Using SITE: C-CDA Validator – USCDI v3 the user selects the receiver “170.315_b2_CIRI_Amb ” or “170.315_b2_CIRI_Inp” criteria, selects one of the C-CDA 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 R 2.1.
2. The user repeats step 1, but selects the corresponding CDA R1.1, 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 R1.1.

Correct Patient

3. Using the xml files downloaded in step 1, 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, can be properly matched to a patient in the Health IT Module. Note that matches can be made automatically or manually.
4. Using the xml files downloaded in step 2, the user demonstrates that a transition of care summary/referral summary C-CDA document can be properly matched to a patient in the Health IT Module automatically or manually formatted according to the standards adopted at:

• § 170.205(a)(4), HL7^® Implementation Guide for CDA^® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, and
• § 170.205(a)(6), HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2 Companion Guide, Release 4.1

5. The user repeats steps 1-4, for each set of C-CDA R1.1, and C-CDA R2.1 xml files listed in the File Name for each of the health IT settings being certified.

Setup

1. The tester creates a version in human readable format of the downloaded C-CDA R2 Release 2.1, in accordance with § 170.213 from step 1, of the System Under Test to be used for verification.
2. The tester creates a human readable version of the downloaded C-CDA R2 Release 1.1, files from step 2, of the System Under Test to be used for verification.

Correct Patient

3. The tester uses visual inspection to verify the Health IT Module can receive the C-CDA document downloaded in step 1, of the System Under Test 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.
4. The tester uses visual inspection to verify the Health IT Module can receive the C-CDA document downloaded in step 2, of the System Under Test as a C-CDA Release 2.1, document formatted according to the standard specified in § 170.205(a)(4) using one of the following document templates:
   • CCD;
   • Referral Note; and
   • Inpatient setting only: Discharge Summary.
5. Using the Health IT Module and the human readable xml files from steps 1 and 2, the tester verifies that each of the received C-CDA Release 1.1 and Release 2.1, documents can be properly matched to the correct patient record.

Setup

1. The tester creates a version in human readable format of the downloaded C-CDA R2.1, in accordance with § 170.213 from step 1 of the System Under Test to be used for verification.
2. The tester creates a human readable version of the downloaded C-CDA R 1.1 files from step 2 of the System Under Test to be used for verification.

Correct Patient

3. The tester uses visual inspection to verify the Health IT Module can receive the C-CDA document downloaded in step 1 of the System Under Test as a C-CDA R1.1 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.
4. The tester uses visual inspection to verify the Health IT Module can receive the C-CDA document downloaded in step 2 of the System Under Test as a C-CDA R2.1 document formatted according to the standard specified in § 170.205(a)(4) using one of the following document templates:

• CCD;
• Referral Note; and
• Inpatient setting only: Discharge Summary.

5. Using the Health IT Module and the human readable xml files from steps 1 and 2, the tester verifies that each of the received C-CDA R1.1 and R2.1 documents can be properly matched to the correct patient record.

Simultaneous Display

1. Using SITE: C-CDA Validator – USCDI v1 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 R1.1 and R2.1 and executes the download.
2. The user simultaneously views data (including active medications, allergies and intolerances, and problems) along with the source and last modification date attributes from at least two sources:

• The current patient record which includes the base input received in section (b)(2)(ii); and
• The Transition of Care Summary/Referral Summary C-CDA R1.1 and R2.1 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, and
  • § 170.205(a)(5) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2 Companion Guide, Release 2, 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), § 170.205(a)(4), and  will need to separately demonstrate each of the following document templates: CCD or C-CDA with no specific document template for C-CDA R1.1, and CCD, Referral Note, and (inpatient setting only) Discharge Summary document templates for C-CDA R2.1 in accordance with the standard specified at § 170.213 for the health IT setting(s) being certified.

Simultaneous Display (Approved SVAP Version)

• Complete steps above using SITE C-CDA Validator for USCDI v4 and;
• Reference United States Core Data for Interoperability (USCDI), Version 4, October 2023 Errata, and;
• Use HL7® CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes Edition 3.0 - US Realm, May 2024 for § 170.205(a)(4), (a)(5) or (a)(6).

1. Using SITE: C-CDA Validator USCDI v3, 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 R1.1 and R2.1 and executes the download.
2. The user simultaneously views data (including active medications, allergies and intolerances, and problems) along with the source and last modification date attributes from at least two sources:

• The current patient record which includes the base input received in section (b)(2)(ii); and
• The Transition of Care Summary/Referral Summary C-CDA R1.1 and R2.1 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, and
  • § 170.205(a)(6) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2 Companion Guide, Release 4.1, 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), § 170.205(a)(4), and  will need to separately demonstrate each of the following document templates: CCD or C-CDA with no specific document template for C-CDA R1.1, and CCD, Referral Note, and (inpatient setting only) Discharge Summary document templates for C-CDA R2.1 in accordance with the standard specified at § 170.213 for the health IT setting(s) being certified.

Simultaneous Display (Approved SVAP Version)

• Complete steps above using SITE C-CDA Validator for USCDI v4 and;
• Reference United States Core Data for Interoperability (USCDI), Version 4, October 2023 Errata, and;
• Use HL7® CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes Edition 3.0 - US Realm, May 2024 for § 170.205(a)(4), (a)(5) or (a)(6).

Simultaneous Display

1. The tester verifies data from multiple sources can be simultaneously displayed in a single view for medications, allergies and intolerances, 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 or edited;
   • Last date the problem was documented or edited; and
   • Last date the allergies and intolerances were documented or edited.
2. Further, the tester must verify the Health IT Module can display the current patient record and a Transition of Care Summary/Referral Summary C-CDA R1.1 and R2.1, 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) and § 170.205(a)(5).

Note: The tester must verify this can be completed for the CCD or C-CDA with no specific document template for C-CDA R1.1; and CCD, Referral Note, and (inpatient setting only) Discharge Summary document templates for C-CDA R2.1.

Simultaneous Display

1. The tester verifies data from multiple sources can be simultaneously displayed in a single view for medications, allergies and intolerances, 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 or edited;
   • Last date the problem was documented or edited; and
   • Last date the allergies and intolerances were documented or edited.
2. Further, the tester must verify the Health IT Module can display the current patient record and a Transition of Care Summary/Referral Summary C-CDA R1.1 and R2.1, 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) and § 170.205(a)(6).

Note: The tester must verify this can be completed for the CCD or C-CDA with no specific document template for C-CDA R1.1; and CCD, Referral Note, and (inpatient setting only) Discharge Summary document templates for C-CDA R2.1.

1. For each reconciliation in section (b)(2)(iii), the user creates a CCD that includes the reconciled and incorporated data, in accordance with the standard adopted at § 170.205(a)(4) and § 170.205(a)(5), for each of the following:
   • Medications;
   • Allergies and Intolerances; and
   • Problems.

1. For each reconciliation in section (b)(2)(iii), the user creates a CCD that includes the reconciled and incorporated data, in accordance with the standard adopted at § 170.205(a)(4) and § 170.205(a)(6), for each of the following:
   • Medications;
   • Allergies and Intolerances; and
   • Problems.

Using the reconciled CCD document submitted by the System Under Test, the tester uses SITE: C-CDA 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 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, allergies and intolerances, and/or problems has been performed. Furthermore, the tester verifies that the Health IT Module meets the standard specified in § 170.205(a)(4) and § 170.205(a)(5).

This verification is only for C-CDA R2.1 CCD documents.

Using the reconciled CCD document submitted by the System Under Test, the tester uses the SITE: C-CDA 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 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, allergies and intolerances, and/or problems has been performed. Furthermore, the tester verifies that the Health IT Module meets the standard specified in § 170.205(a)(4) and § 170.205(a)(6).

This verification is only for C-CDA R2.1 CCD documents.