Consolidated CDA creation performance

A Health IT Module currently certified to the § 170.315(g)(6) C-CDA creation performance will attest directly to the ONC-ACB to conformance with the updated § 170.315(g)(6) 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(g)(6) C-CDA creation performance attests conformance to updated § 170.315(g)(6) criteria requirements.

Criteria Data Definition

1. Based upon the criteria for which the health IT developer is certifying (e.g. transition of care, care plan), the appropriate clinical information for the certifying criteria at a minimum must include the following data elements and data classes as applicable:
   • The data classes expressed in the standard in § 170.213, and in accordance with § 170.205(a)(4) HL7^® Implementation Guide for CDA^® Release 2: C-CDA Templates for Clinical Notes, DSTU Release 2.1 (with Errata) and § 170.205(a)(5) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2.
   • The “Assessment and plan of treatment, specified in accordance with the “Assessment and Plan Section (V2)” of the standard specified in § 170.205(a)(4); or in accordance with the “Assessment Section (V2)” and “Plan of Treatment Section (V2)” of the standard specified in § 170.205(a)(4). At a minimum, the Assessment and Plan of Treatment data includes the narrative text.
   • The Goals, specified in accordance with the standard specified in § 170.205(a)(4). At a minimum, the Goals data includes narrative text.
   • The Health Concerns, specified in accordance with the standard specified at § 170.205(a)(4). At a minimum, the Health Concerns data includes narrative text.
   • Unique device identifier(s), specified in accordance with the “Product Instance” in the “Procedure Activity Procedure Section” of the standard specified in § 170.205(a)(4).

Criteria Data Definition

1. Based upon the criteria for which the health IT developer is certifying (e.g. transition of care, care plan), the appropriate clinical information for the certifying criteria at a minimum must include the following data elements and data classes as applicable:
   • The data classes expressed in the standard in § 170.213, and in accordance with § 170.205(a)(4) HL7® Implementation Guide for CDA® Release 2: C-CDA Templates for Clinical Notes, DSTU Release 2.1 (with Errata) and § 170.205(a)(6) HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4.1.
   • The Assessment and Plan of Treatment, specified in accordance with the “Assessment and Plan Section (V2)” of the standard specified in § 170.205(a)(4); or in accordance with the “Assessment Section (V2)” and “Plan of Treatment Section (V2)” of the standard specified in § 170.205(a)(4). At a minimum, the Assessment and Plan of Treatment data includes the narrative text.
   • The Goals, specified in accordance with the standard specified in § 170.205(a)(4). At a minimum, the Goals data includes narrative text.
   • The Health Concerns, specified in accordance with the standard specified at § 170.205(a)(4). At a minimum, the Health Concerns data includes narrative text.
   • Unique device identifier(s), specified in accordance with the “Product Instance” in the “Procedure Activity Procedure Section” of the standard specified in § 170.205(a)(4).

Criteria Data Definition

1. The tester verifies  the clinical summary information for the criteria includes at a minimum the following data definition:
   • All of the United States Core Data for Interoperability (USCDI) data elements as specified in the standard at § 170.213 with the data classes expressed in accordance with the implementation guides at § 170.205(a)(4) and § 170.205(a)(5).
   • The Assessment and Plan or both the Assessment and Plan of Treatment are specified in accordance with the standard specified in § 170.205(a)(4) as narrative text;
   • The Goals are specified in accordance with the standard specified in § 170.205(a)(4) as narrative text; and
   • The Health Concerns are specified in accordance with the standard specified in § 170.205(a)(4) as narrative text.
   • Unique device identifier(s), specified in accordance with the “Product Instance” in the “Procedure Activity Procedure Section” of the standard specified in § 170.205(a)(4).

1. The tester verifies  the clinical summary information for the criteria includes at a minimum the following data definition:
   • All of the United States Core Data for Interoperability (USCDI) data elements as specified in the standard at § 170.213 with the data classes expressed in accordance with the implementation guides at § 170.205(a)(4) and § 170.205(a)(6).
   • The Assessment and Plan or both the Assessment and Plan of Treatment are specified in accordance with the standard specified in § 170.205(a)(4) as narrative text;
   • The Goals are specified in accordance with the standard specified in § 170.205(a)(4) as narrative text; and
   • The Health Concerns are specified in accordance with the standard specified in § 170.205(a)(4) as narrative text.
   • Unique device identifier(s), specified in accordance with the “Product Instance” in the “Procedure Activity Procedure Section” of the standard specified in § 170.205(a)(4).

Data Entry

1. Based upon the criteria for which the Health IT Module is certifying (e.g. transition of care, care plan), the user enters the appropriate clinical information for the certifying criteria into the Health IT Module.

C-CDA Creation

2. Using the Health IT Module, the user creates a data file formatted in accordance with the standard specified in § 170.205(a)(4) and § 170.205(a)(5) and includes the appropriate document templates and content for the certifying criteria, being tested, including at a minimum the data definition in (g)(6)(i)(A), in order to match a gold-standard, reference data file for each applicable C-CDA document-template.
3. The C-CDA document created in step 2, is submitted to the tester for verification.
4. Based upon the health IT settings (i.e. ambulatory and/or inpatient), the user repeats steps 1-3, for each of the instruction documents found in ASTP's Standards Implementation & Testing Environment (SITE): C-CDA Validators - USCDI v1 for the criteria being certified.

Data Entry

1. Based upon the criteria for which the Health IT Module is certifying (e.g. transition of care, care plan), the user enters the appropriate clinical information for the certifying criteria into the Health IT Module.

C-CDA Creation

2. Using the Health IT Module, the user creates a data file formatted in accordance with the standard specified in § 170.205(a)(4) and § 170.205(a)(6) and includes the appropriate document templates and content for the certifying criteria, being tested, including at a minimum the data definition in (g)(6)(i)(B), in order to match a gold-standard, reference data file for each applicable C-CDA document-template.
3. The C-CDA document created in step 2 is submitted to the tester for verification.
4. Based upon the health IT settings (i.e. ambulatory and/or inpatient), the user repeats steps 1-3, for each of the instruction documents found in ASTP's Standards Implementation & Testing Environment (SITE): C-CDA Validators – USCDI v3 for the criteria being certified.

Data Entry

1. Using the criteria instruction document downloaded in step 1, of the System Under Test, the tester verifies the clinical summary information for the criteria entered into the Health IT Module is accurate and without omission using visual inspection.

C-CDA Creation

2. For each file submitted in step 3, of the System Under Test, the tester uses the SITE: C-CDA Validator – USCDI v1 to upload the submitted C-CDA document through the sender upload selection of the criteria being certified along with the file name and executes the upload of the submitted file.
3. For each uploaded file in step 2, the tester uses the Validation Report produced by the SITE: C-CDA Validator- USCDI v1 to verify the validation report indicates the certifying criteria is conformant to the standard specified in § 170.205(a)(4) and § 170.205(a)(5), and includes the required data elements specified by the standard for the certifying criteria, including at a minimum the data definition in (g)(6)(i)(A) in order to match the gold-standard, reference data file.
4. As required by the criteria instruction document downloaded in step 1, of the System Under Test, the tester uses the ASTP/ONC-supplied certifying criteria instructions and the Message Content Report produced by the SITE: C-CDA Validators - USCDI v1 in step 2, to verify the additional checks for equivalent text for the content of all section level narrative text.

Data Entry

1. Using the criteria instruction document downloaded in step 1, of the System Under Test, the tester verifies the clinical summary information for the criteria entered into the Health IT Module is accurate and without omission using visual inspection.

C-CDA Creation

2. For each file submitted in step 3, of the System Under Test, the tester uses the SITE: C-CDA Validator – USCDI v3 to upload the submitted C-CDA document through the sender upload selection of the criteria being certified along with the file name and executes the upload of the submitted file.
3. For each uploaded file in step 2, the tester uses the Validation Report produced by the SITE: C-CDA Validator – USDCI v3 to verify the validation report indicates the certifying criteria is conformant to the standard specified in § 170.205(a)(4) and § 170.205(a)(6), and includes the required data elements specified by the standard for the certifying criteria, including at a minimum the data definition in (g)(6)(i)(B) in order to match the gold-standard, reference data file.
4. As required by the criteria instruction document downloaded in step 1, of the System Under Test, the tester uses the ASTP/ONC-supplied certifying criteria instructions and the Message Content Report produced by the SITE: C-CDA Validator – USCDI v3 in step 2, to verify the additional checks for equivalent text for the content of all section level narrative text.

Data Entry

1. Based upon the criteria for which the Health IT Module is certifying, the user enters the appropriate clinical information into the Health IT Module. (This data was entered in section (g)(6)(ii)(A) step 1).

C-CDA Creation

2. The user uses the Health IT Module to create data files formatted in accordance with the standard specified in § 170.205(a)(4) and § 170.205(a)(5) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2, and includes the appropriate document templates and content for the certifying criteria being tested, including at a minimum the data definition in section (g)(6)(i)(A), for the applicable C-CDA document templates. (These C-CDA documents were created and submitted to the Test Lab for verification in section (g)(6)(ii)(A) step 3).

Data Entry

1. Based upon the criteria for which the Health IT Module is certifying, the user enters the appropriate clinical information into the Health IT Module. (This data was entered in section (g)(6)(ii)(B) step 1).

C-CDA Creation

2. The user uses the Health IT Module to create data files formatted in accordance with the standard specified in § 170.205(a)(4) and § 170.205(a)(6) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1, and includes the appropriate document templates and content for the certifying criteria being tested, including at a minimum the data definition in section (g)(6)(i)(B), for the applicable C-CDA document templates. (These C-CDA documents were created and submitted to the Test Lab for verification in section (g)(6)(ii)(B) step 3).

Data Entry

1. For each file submitted, the tester verifies that the certifying criteria information entered into the Health IT Module is accurate and without omission using visual inspection. This validation may have been done as part of the verification done in section (g)(6)(ii)(A) step 1.

C-CDA Creation

2. For each uploaded file in section (g)(6)(ii)(A) step 3, the tester verifies a certifying criteria document can be created for the certifying criteria using the validation report to review the document-templates and that:
   • The validation report indicates passing without error to confirm that a C-CDA Release 2.1, document can be created, that each document type is conformant to the standard specified in § 170.205(a)(4) and § 170.205(a)(5), and that the document contains the applicable data elements for the certifying criteria, including at a minimum the data definition in section (g)(6)(i)(A). (This validation may have been done as part of the verification done in section (g)(6)(ii)(A) step 3).
   • As required by the criteria instruction document downloaded in section (g)(6)(ii)(A) step 1, of the System Under Test, the tester uses the ASTP/ONC-supplied summary instructions and the Message Content Report produced by the SITE: C-CDA Validator - USCDI v1 in section (g)(6)(ii)(A) step 2, to verify the additional checks for equivalent text for the content of all section-level narrative text. (This validation may have been done as part of the verification done in section (g)(6)(ii)(A) step 4).

Data Entry

1. For each file submitted, the tester verifies the certifying criteria information entered into the Health IT Module is accurate and without omission using visual inspection. This validation may have been done as part of the verification done in section (g)(6)(ii)(B) step 1.

C-CDA Creation

2. For each uploaded file in section (g)(6)(ii)(A) step 3, the tester verifies a certifying criteria document can be created for the certifying criteria using the validation report to review the document-templates and that:

• The validation report indicates passing without error to confirm that a C-CDA Release 2.1, document can be created, that each document type is conformant to the standard specified in § 170.205(a)(4) and § 170.205(a)(6), and that the document contains the applicable data elements for the certifying criteria, including at a minimum the data definition in section (g)(6)(i)(A). (This validation may have been done as part of the verification done in section (g)(6)(ii)(B) step 3).
• As required by the criteria instruction document downloaded in section (g)(6)(ii)(A) step 1, of the System Under Test, the tester uses the ASTP/ONC-supplied summary instructions and the Message Content Report produced by the SITE: C-CDA Validator – USCDI v3 in section (g)(6)(ii)(A) step 2, to verify the additional checks for equivalent text for the content of all section-level narrative text. (This validation may have been done as part of the verification done in section (g)(6)(ii)(A) step 4).

If the certifying criteria information was not already entered in sections (g)(6)(ii)(A) or (g)(6)(iii)(A), based upon the health IT setting(s) (i.e. ambulatory and/or inpatient), the user: enters the appropriate clinical information for the certifying criteria documents into the Health IT Module; creates a data file formatted in accordance with the standard specified in § 170.205(a)(4) and § 170.205(a)(5); and includes the appropriate document templates, content, vocabularies, and value-sets for the certifying criteria being tested, including at a minimum the data definition in section (g)(6)(i)(A), in order to demonstrate vocabulary conformance.

If  the certifying criteria information was not already entered in sections (g)(6)(ii)(B) or (g)(6)(iii)(B), based upon the health IT setting(s) (i.e. ambulatory and/or inpatient), the user: enters the appropriate clinical information for the certifying criteria documents into the Health IT Module; creates a data file formatted in accordance with the standard specified in § 170.205(a)(4) and § 170.205(a)(6); and includes the appropriate document templates, content, vocabularies, and value-sets for the certifying criteria being tested, including at a minimum the data definition in section (g)(6)(i)(B), in order to demonstrate vocabulary conformance.

The validation of the vocabulary conformance is done as part of the document template conformance performed in section (g)(6)(iii)(A) step 2 and verifies the validity of the vocabularies associated with the data elements as well as the data element value being from the required value-set(s).

The validation of the vocabulary conformance is done as part of the document template conformance performed in section (g)(6)(iii)(B) step 2 and verifies the validity of the vocabularies associated with the data elements as well as the data element value being from the required value-set(s).