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§170.315(g)(6) Consolidated CDA creation performance

Version 1.0 Updated on 01-20-2016
Revision History
Version # Description of Change Version Date
1.0

Final Test Procedure

01-20-2016
Regulation Text
Regulation Text

§170.315 (g)(6) Consolidated CDA creation performance

The following technical and performance outcomes must be demonstrated related to Consolidated CDA creation. The capabilities required under paragraphs (g)(6)(i) through (iv) of this section can be demonstrated in tandem and do not need to be individually addressed in isolation or sequentially. This certification criterion's scope includes only data expressed within the Common Clinical Data Set definition.

  1. Reference C-CDA match. Create a data file formatted in accordance with the standard adopted in §170.205(a)(4) that matches a gold-standard, reference data file.
  2. Document-template conformance. Create a data file formatted in accordance with the standard adopted in §170.205(a)(4) that demonstrates a valid implementation of each document template applicable to the certification criterion or criteria within the scope of the certificate sought.
  3. Vocabulary conformance. Create a data file formatted in accordance with the standard adopted in §170.205(a)(4) that demonstrates the required vocabulary standards (and value sets) are properly implemented.
  4. Completeness verification. Create a data file for each of the applicable document templates referenced in paragraph (g)(6)(ii) of this section without the omission of any of the data included in the Common Clinical Data Set definition.
Standard(s) Referenced

Applies to entire criterion

§ 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1, August 2015

Please refer to the Data Elements and Vocabularies applicable to the Common Clinical Data Set (CCDS) as outlined in the Common Clinical Data Set Reference Document

Please consult the Final Rule 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 certification criterion with which these testing steps are associated. We also encourage developers to consult the Certification Companion Guide in tandem with the test procedure as they provide clarifications that may be useful for product development and testing.

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.
 

Testing components

No GAP Icon No Documentation Icon Visual Inspection Icon Test Tool Icon ONC Supplied Test Data Icon

The verification of the § 170.315(g)(6) Consolidated CDA Creation Performance criteria for a given criterion is performed in-conjunction with the specific criteria. No additional tests need to be executed to certify for § 170.315(g)(6) Consolidated CDA Creation Performance. The § 170.315(g)(6) Consolidated CDA Creation Performance Test Procedure is provided to illustrate the tests which are performed as part of certifying for § 170.315(g)(6) Consolidated CDA Creation Performance.

 

The following technical and performance outcomes must be demonstrated related to Consolidated CDA creation. The capabilities required under paragraphs (g)(6)(i) through (iv) of this section can be demonstrated in tandem and do not need to be individually addressed in isolation or sequentially. This certification criterion’s scope includes only data expressed within the Common Clinical Data Set definition.

 

Paragraph (g)(6)(i)

System Under Test Test Lab Verification

Data Entry

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

C-CDA Creation

  1. Using the Health IT Module, the user creates a data file formatted in accordance with the standard specified in § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, and includes the appropriate document-templates and content for the certifying criteria being tested in order to match a gold-standard, reference data file for each applicable C-CDA document template.
  2. The C-CDA document created in step 2 is submitted to the tester for verification.
  3. Based upon the health IT setting(s) (i.e. ambulatory and/or inpatient), a user repeats steps 1-3 for each of the instruction documents found in ETT: Message Validators for the criteria being certified.

Data Entry

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

C-CDA Creation

  1. For each file submitted in step 3 of the SUT, the tester uses the ETT: Message Validators – C-CDA Release 2.1 Validator 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.
  2. For each uploaded file in step 2, the tester uses the Validation Report produced by the ETT: Message Validators to verify the validation report indicates the certifying criteria is conformant to the standard specified in § 170.205(a)(4) and includes the required data elements specified by the standard for the certifying criteria in order to match the gold-standard, reference data file.
  3. As required by the criteria instruction document downloaded in step 1 of the SUT, the tester uses the ONC-supplied certifying criteria instructions and the Message Content Report produced by the ETT: Message Validators in step 2 to verify the additional checks for equivalent text for the content of all section level narrative text.

Paragraph (g)(6)(ii)

System Under Test Test Lab Verification

Data Entry

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

C-CDA Creation

  1. The user uses the Health IT Module to create data files formatted in accordance with the standard specified in § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, and includes the appropriate document-templates and content for the certifying criteria being tested 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)(i) 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)(i) step 1.

C-CDA Creation

  1. For each uploaded file in section (g)(6)(i) step 3, the tester verifies that a certifying criteria document can be created for the certifying criteria using the Validation Report to review the document-templates.
  2. For each uploaded file in section (g)(6)(i) step 3, the tester uses the Validation Report produced by the ETT: Message Validators to verify 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 contains the applicable data elements for the certifying criteria. (This validation may have been done as part of the verification done in section (g)(6)(i) step 3)
  3. As required by the criteria instruction document downloaded in section (g)(6)(i) step 1 of the SUT, the tester uses the ONC-supplied summary instructions and the Message Content Report produced by the ETT: Message Validators in section (g)(6)(i) 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)(i) step 4)

Paragraph (g)(6)(iii)

System Under Test Test Lab Verification
  1. If the certifying criteria information was not already entered in sections (g)(6)(i) or (g)(6)(ii), based upon the health IT setting(s) (i.e. ambulatory and/or inpatient), a user enters the appropriate clinical information for the certifying criteria documents into the Health IT Module.
  2. If the certifying criteria documents were not already created in section (g)(6)(ii), the user uses the Health IT Module to create a data file formatted in accordance with the standard specified in § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, and includes the appropriate document-templates, content, vocabularies and value-sets for the certifying criteria being tested in order to demonstrate vocabulary conformance.
  1. The validation of the vocabulary conformance is done as part of the document-template conformance performed in section (g)(6)(ii) step 3 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).

Paragraph (g)(6)(iv)

System Under Test Test Lab Verification

In order to demonstrate the completeness of the created C-CDA document, if the certifying criteria information was not already entered in sections (g)(6)(i) or (g)(6)(ii), a user enters the certifying criteria information for the certifying criteria documents into the Health IT Module. The information entered into the Health IT Module must include all of the required data elements for the certifying criteria (e.g. CCDS summary record or care plan), where applicable.

The validation of the completeness verification is done as part of the document-template conformance performed in section (g)(6)(ii) steps 3 and 4 and verifies that the content of the submitted document is complete and without omission.


Version 1.5 Updated on 09-21-2018
Revision History
Version # Description of Change Version Date
1.0

Initial Publication

10-30-2015
1.1

Revised to note that § 170.315(b)(9) care plan and § 170.315(g)(9) application access – all data request also require C-CDA creation performance demonstration. Revised regulation text per the 2015 Edition final rule correction notice to remove the text that stated the scope of this criterion would not exceed the CCD, Referral Note, and Discharge Summary document templates. Added clarification regarding testing to match a gold standard C-CDA file.

01-05-2016
1.2

Added hyperlinks to the ONC maintained repository for 1) C-CDA’s created to support (g)(6); and 2) “gold standard” C-CDAs.

04-22-2016
1.3

Provides notification of March 2017 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for entire criterion.

09-29-2017
1.4

Provides notification of April 2018 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion. Note: Due to an error in calculation ONC is also updating the dates for compliance with the March 2017 Validator Update of C-CDA 2.1 Corrections that were adopted September 29, 2017.

05-02-2018
1.5

Provides notification of August 2018 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion.

09-21-2018
Regulation Text
Regulation Text

§170.315 (g)(6) Consolidated CDA creation performance

The following technical and performance outcomes must be demonstrated related to Consolidated CDA creation. The capabilities required under paragraphs (g)(6)(i) through (iv) of this section can be demonstrated in tandem and do not need to be individually addressed in isolation or sequentially. This certification criterion's scope includes only data expressed within the Common Clinical Data Set definition.

  1. Reference C-CDA match. Create a data file formatted in accordance with the standard adopted in §170.205(a)(4) that matches a gold-standard, reference data file.
  2. Document-template conformance. Create a data file formatted in accordance with the standard adopted in §170.205(a)(4) that demonstrates a valid implementation of each document template applicable to the certification criterion or criteria within the scope of the certificate sought.
  3. Vocabulary conformance. Create a data file formatted in accordance with the standard adopted in §170.205(a)(4) that demonstrates the required vocabulary standards (and value sets) are properly implemented.
  4. Completeness verification. Create a data file for each of the applicable document templates referenced in paragraph (g)(6)(ii) of this section without the omission of any of the data included in the Common Clinical Data Set definition.
Standard(s) Referenced

Applies to entire criterion

§ 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1, August 2015

Please refer to the Data Elements and Vocabularies applicable to the Common Clinical Data Set (CCDS) as outlined in the Common Clinical Data Set Reference Document

Certification Companion Guide: Consolidated CDA creation performance

This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
 

 

Certification Requirements

This certification criterion was adopted at § 170.315(g)(6), and is required for all developers seeking certification to 2015 Edition certification criteria with C-CDA creation capabilities (i.e., § 170.315(b)(1), (b)(2), (b)(4), (b)(6), (b)(9), (e)(1), and (g)(9)). There are no associated required privacy and security criterion for this criterion at § 170.315(g)(6).

Technical Explanations and Clarifications

 

Applies to entire criterion

Clarifications:

  • The specific requirements in provisions (g)(6)(i)-(iv) can be demonstrated in tandem.
  • This certification criterion focuses on the data expressed in the Common Clinical Data Set definition.
  • If the scope of the certification includes more than one certification criterion with C-CDA creation required, C-CDA creation performance only has to be demonstrated once for each C-CDA document template (e.g., C-CDA creation performance to the CCD template would not have to be demonstrated twice if the Health IT Module presents for certification to both the transitions of care and data export criteria). [see also 80 FR 62674]
  • In order to mitigate potential interoperability errors and inconsistent implementation of the HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, Draft Standard for Trial Use, Release 2.1, ONC assesses, approves, and incorporates corrections as part of required testing and certification to this criterion. [see FAQ #51] Certified health IT adoption and compliance with the following corrections are necessary because they implement updates to vocabularies, update rules for cardinality and conformance statements, and promote proper exchange of C-CDA documents. Consistent with FAQ 51, there is a 90-day delay from the time the CCG has been updated with the ONC-approved corrections to when compliance with the corrections will be required to pass testing (i.e., C-CDA 2.1 Validator). Similarly consistent with FAQ 51, there will be an 18-month delay before a finding of a correction’s absence in certified health IT during surveillance would constitute a non-conformity under the Program.
  • C-CDA files created during testing (using test data) will be retained by NVLAP-Accredited Testing Labs and contributed to an ONC-maintained repository. [see also 80 FR 62675]

Paragraph (g)(6)(i)

Technical outcome – The health IT can create a C-CDA file in accordance with the HL7 C-CDA Release 2.1 Implementation Guide (IG) that matches a gold-standard, reference data file.

Clarifications:

  • Sample gold standard C-CDA documents are available on an ONC-maintained repository. [see also 80 FR 62675]
  • On the gold standard match, the exact match is expected for the coded test data provided to the system under test for creation. In other words, the developer-submitted C-CDA will be matched with a gold standard C-CDA for the test data that is provided to the developer.

Paragraph (g)(6)(ii)

Technical outcome – The health IT can create a C-CDA file in accordance with the HL7 C-CDA Release 2.1 IG for each document template applicable to the certification criteria within the scope of the certification.

Clarifications:

  • No additional clarifications available.

Paragraph (g)(6)(iii)

Technical outcome – The health IT can create a C-CDA file in accordance with the HL7 C-CDA Release 2.1 IG that shows the required vocabulary standards and that value sets are properly implemented.

Clarifications:

  • No additional clarifications available.

Paragraph (g)(6)(iv)

Technical outcome – The health IT can create a C-CDA file in accordance with the HL7 C-CDA Release 2.1 IG that includes all of the data in the Common Clinical Data Set definition.

Clarifications:

  • This provision intends to ensure that the data entered into the health IT system (via whatever workflow and functionality) can be reflected in a C-CDA file created by the system and not be missing data a user otherwise recorded. [see also 80 FR 62675]

Regulation Text
Regulation Text

§170.315 (g)(6) Consolidated CDA creation performance

The following technical and performance outcomes must be demonstrated related to Consolidated CDA creation. The capabilities required under paragraphs (g)(6)(i) through (iv) of this section can be demonstrated in tandem and do not need to be individually addressed in isolation or sequentially. This certification criterion's scope includes only data expressed within the Common Clinical Data Set definition.

  1. Reference C-CDA match. Create a data file formatted in accordance with the standard adopted in §170.205(a)(4) that matches a gold-standard, reference data file.
  2. Document-template conformance. Create a data file formatted in accordance with the standard adopted in §170.205(a)(4) that demonstrates a valid implementation of each document template applicable to the certification criterion or criteria within the scope of the certificate sought.
  3. Vocabulary conformance. Create a data file formatted in accordance with the standard adopted in §170.205(a)(4) that demonstrates the required vocabulary standards (and value sets) are properly implemented.
  4. Completeness verification. Create a data file for each of the applicable document templates referenced in paragraph (g)(6)(ii) of this section without the omission of any of the data included in the Common Clinical Data Set definition.
Testing Tool

Edge Testing Tool (ETT): Message Validators

 

Test Tool Documentation

Test Tool Supplemental Guide

 

Criterion Subparagraph Test Data
(g)(6)(i)

Sample gold standard C-CDA documents are available on an ONC-maintained repository: https://github.com/siteadmin/2015-Certification-C-CDA-Test-Data

The C-CDA Data set to be used corresponds to the criteria for which the Health IT Module is certifying. For example, if the Health IT Module is certifying to 170.315(b)(1) Transitions of care, the following C-CDA validation documents would be used:

Inpatient Setting: 170.315_b1_toc_inp_sample*.pdf (All Samples)

Ambulatory Setting: 170.315_b1_toc_amb_sample*.pdf (All Samples)

Content last reviewed on September 21, 2018
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