§170.315(b)(5) Common Clinical Data Set summary record – receive
§170.315(b)(5)
Updated on 04-06-2018
Revision History
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 |
Final Test Procedure |
01-20-2016
|
| 1.1 |
Clarification of the “rejection” of an invalid C-CDA document in step 4 under the TLV of paragraph (b)(5)(i). |
04-06-2018
|
Regulation Text
Regulation Text
§ 170.315 (b)(5) Common Clinical Data Set summary record – receive—
- Enable a user to receive 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 that includes, at a minimum:
- The Common Clinical Data Set.
- Encounter diagnoses. Formatted according to at least one of the following standards:
- The standard specified in §170.207(i).
- At a minimum, the standard specified in §170.207(a)(4).
- Cognitive status.
- Functional status.
- Ambulatory setting only. The reason for referral; and referring or transitioning provider's name and office contact information.
- Inpatient setting only. Discharge instructions.
- Validate and display. Demonstrate the following functionalities for the document received in accordance with paragraph (b)(5)(i) of this section:
- Validate C-CDA conformance—system performance. Detect valid and invalid transition of care/referral summaries including the ability to:
- Parse each of the document types formatted according to the following document templates: Continuity of Care Document, Referral Note, and (inpatient setting only) Discharge Summary.
- Detect errors in corresponding “document-templates,” “section-templates,” and “entry-templates,” including invalid vocabulary standards and codes not specified in the standards adopted in §170.205(a)(3) and §170.205(a)(4).
- Identify valid document-templates and process the data elements required in the corresponding section-templates and entry-templates from the standards adopted in §170.205(a)(3) and §170.205(a)(4).
- Correctly interpret empty sections and null combinations.
- Record errors encountered and allow a user through at least one of the following ways to:
- Be notified of the errors produced.
- Review the errors produced.
- Display. Display in human readable format the data included in transition of care/referral summaries received and formatted according to the standards specified in §170.205(a)(3) and §170.205(a)(4).
- Display section views. Allow for the individual display of each section (and the accompanying document header information) that is included in a transition of care/referral summary received and formatted in accordance with the standards adopted in §170.205(a)(3) and §170.205(a)(4) in a manner that enables the user to:
- Directly display only the data within a particular section;
- Set a preference for the display order of specific sections; and
- Set the initial quantity of sections to be displayed.
- Validate C-CDA conformance—system performance. Detect valid and invalid transition of care/referral summaries including the ability to:
Standard(s) Referenced
Paragraph (b)(5)(i)
§ 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012
§ 170.207(i) ICD-10-CM
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
Paragraph (b)(5)(ii)
§ 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012. The use of the "unstructured document" document-level template is prohibited.
Additional Resources
- Revision History
-
Version # Description of Change Version Date 1.0 Final Test Procedure
01-20-20161.1 Clarification of the “rejection” of an invalid C-CDA document in step 4 under the TLV of paragraph (b)(5)(i).
04-06-2018 - Regulation Text
-
Regulation Text
§ 170.315 (b)(5) Common Clinical Data Set summary record – receive—
- Enable a user to receive 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 that includes, at a minimum:
- The Common Clinical Data Set.
- Encounter diagnoses. Formatted according to at least one of the following standards:
- The standard specified in §170.207(i).
- At a minimum, the standard specified in §170.207(a)(4).
- Cognitive status.
- Functional status.
- Ambulatory setting only. The reason for referral; and referring or transitioning provider's name and office contact information.
- Inpatient setting only. Discharge instructions.
- Validate and display. Demonstrate the following functionalities for the document received in accordance with paragraph (b)(5)(i) of this section:
- Validate C-CDA conformance—system performance. Detect valid and invalid transition of care/referral summaries including the ability to:
- Parse each of the document types formatted according to the following document templates: Continuity of Care Document, Referral Note, and (inpatient setting only) Discharge Summary.
- Detect errors in corresponding “document-templates,” “section-templates,” and “entry-templates,” including invalid vocabulary standards and codes not specified in the standards adopted in §170.205(a)(3) and §170.205(a)(4).
- Identify valid document-templates and process the data elements required in the corresponding section-templates and entry-templates from the standards adopted in §170.205(a)(3) and §170.205(a)(4).
- Correctly interpret empty sections and null combinations.
- Record errors encountered and allow a user through at least one of the following ways to:
- Be notified of the errors produced.
- Review the errors produced.
- Display. Display in human readable format the data included in transition of care/referral summaries received and formatted according to the standards specified in §170.205(a)(3) and §170.205(a)(4).
- Display section views. Allow for the individual display of each section (and the accompanying document header information) that is included in a transition of care/referral summary received and formatted in accordance with the standards adopted in §170.205(a)(3) and §170.205(a)(4) in a manner that enables the user to:
- Directly display only the data within a particular section;
- Set a preference for the display order of specific sections; and
- Set the initial quantity of sections to be displayed.
- Validate C-CDA conformance—system performance. Detect valid and invalid transition of care/referral summaries including the ability to:
- Enable a user to receive 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 that includes, at a minimum:
- Standard(s) Referenced
-
Paragraph (b)(5)(i)
§ 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012
§ 170.207(i) ICD-10-CM
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
Paragraph (b)(5)(ii)
§ 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012. The use of the "unstructured document" document-level template is prohibited.
Additional Resources
- Testing
-
Testing Tool
Criterion Subparagraph Test Data (b)(5)(i) Inpatient Setting - 170.315_b5_ccds_inp_*_r21_ sample*.xml (all samples)
170.315_b5_ccds_inp_*_r11_ sample*.xml (all samples)
Ambulatory Setting - 170.315_b5_ccds_amb_*_r21_sample*.xml (all samples)
170.315_b5_ccds_amb_*_r11_sample*.xml (all samples)
Negative Tests: NT_*_r21_*.xml
NT_*_r11_*.xml
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
Paragraph (b)(5)(i)
System Under Test
Receive
- Using the ETT: Message Validators – C-CDA R2.1 Validator, the health IT developer downloads the ONC-supplied CCDS xml documents through the receiver download selections of “170.315_b5_CCDS_ Amb” or “170.315_b5_CCDS_Inp” criteria and either a C-CDA R2 R1.1 or C-CDA R2 2.1 xml document and executes the download of the CCDS summary record xml file.
- The user uses the Health IT Module to receive the downloaded CCDS summary record xml files from step 1, which are formatted as a CCD document 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 or formatted with the following C-CDA transition of care/referral summary document types (CCDS summary record) and § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1:
- Continuity of Care Document;
- Referral Note; and
- Inpatient setting only: Discharge Summary.
- Based upon the health IT setting(s) to be certified, a user repeats steps 1-2 for each ambulatory and/or inpatient CCDS summary record (xml) document in the ETT: Message Validators. All of the CCDS summary record documents for a given health IT setting must be received (both C-CDA R2 R1.1 and C-CDA R2 R2.1 formats).
Negative Test - Receive
- Using the ETT: Message Validators – C-CDA R2.1 Validator, the health IT developer downloads each of the negative xml documents by selecting the ONC-supplied care plan xml documents through the receiver download selections of the “Negative Testing CCDS” criteria and one of the invalid C-CDA documents (for either a C-CDA R2 R2.1 and C-CDA R2 R1.1 file) and executes the download of the invalid C-CDA xml file.
- Using the Health IT Module, the user receives the applicable C-CDA document types containing errors in the corresponding “document-templates,” “section-templates,” and “entry-templates,” including invalid vocabulary standards and codes not specified in the standards adopted in § 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 or § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1 and reports the error.
- A user repeats steps 4-5 for each of the negative test samples in ETT: Message Validators “Negative_Testing_CCDS”.
Test Lab Verification
Setup
- The tester creates a human readable version of the downloaded CCDS summary record from step 1 of the SUT to be used for verification for each CCDS summary record document received.
Receive
- The tester uses visual inspection to verify that the Health IT Module can successfully receive the applicable types of transition of care/referral summaries for each CCDS summary record document received by the Health IT Module, either as a:
- C-CDA R2 R1.1 document formatted as a CCD or a C-CDA with no specific document template according to the standard adopted in § 170.205(a)(3); or
- C-CDA R2 R2.1 formatted in accordance with the standard specified in § 170.205(a)(4) as a Continuity of Care, Referral Note, or (inpatient setting only) as a Discharge Summary.
- For each CCDS summary record document received by the SUT, the tester verifies the content specified in (b)(5)(i)(A-F) as applicable, using visual inspection.
Negative Test - Receive
- For each negative test xml received, the tester uses visual inspection to verify that the Health IT Module can successfully notify the user of errors or allow the user to review the errors if the C-CDA documents not specified in accordance with the standards adopted in § 170.205(a)(3) and § 170.205(a)(4) including:
- “document –templates”;
- “section-templates”;
- “entry-templates”;
- invalid vocabulary standards; and
- invalid codes.
| System Under Test | Test Lab Verification |
|---|---|
|
Receive
Negative Test - Receive
|
Setup
Receive
Negative Test - Receive
|
Paragraph (b)(5)(i)(A)
System Under Test
The Common Clinical Data Set
Each of these documents includes, at a minimum, the Common Clinical Data Set as specified in the CCDS Reference Document for C-CDA R2 R1.1 or C-CDA R2 R2.1, as applicable.
Test Lab Verification
The tester verifies the applicable types of transition of care/referral summaries received in (b)(5)(i) include the following data elements, as applicable:
- Common Clinical Data Set in accordance with the CCDS Reference Document for either C-CDA R2 R1.1 or C-CDA R2 R2.1 based upon the document type received.
| System Under Test | Test Lab Verification |
|---|---|
|
The Common Clinical Data Set Each of these documents includes, at a minimum, the Common Clinical Data Set as specified in the CCDS Reference Document for C-CDA R2 R1.1 or C-CDA R2 R2.1, as applicable. |
The tester verifies the applicable types of transition of care/referral summaries received in (b)(5)(i) include the following data elements, as applicable:
|
Paragraph (b)(5)(i)(B)
System Under Test
Encounter Diagnoses
The transition of care/referral summary received in (b)(5)(i) includes at a minimum encounter diagnoses using at least one standard, either
- the standard specified at § 170.207(i) ICD-10-CM for the following conditions:
- Diseases;
- Injuries;
- Impairments;
- Other health problems and their manifestations; and
- Causes of injury, disease, impairment, or other health problems;
- or at a minimum the version of the standard specified at § 170.207(a)(4) SNOMED CT®.
Test Lab Verification
The verification of the applicable types of transition of care/referral summaries received in (b)(5)(i) includes the following data element in accordance to the standard adopted in § 170.205(a)(3) or § 170.205(a)(4):
- Encounter diagnoses, formatted in accordance to one of the following standards:
- The standard specified in § 170.207(i); or
- At a minimum, the standard specified in § 170.207(a)(4).
| System Under Test | Test Lab Verification |
|---|---|
|
Encounter Diagnoses The transition of care/referral summary received in (b)(5)(i) includes at a minimum encounter diagnoses using at least one standard, either
|
The verification of the applicable types of transition of care/referral summaries received in (b)(5)(i) includes the following data element in accordance to the standard adopted in § 170.205(a)(3) or § 170.205(a)(4):
|
Paragraph (b)(5)(i)(C)
System Under Test
Cognitive Status
The transition of care/referral summary received in (b)(5)(i) includes the Cognitive status, when present, in the C-CDA R2 R1.1 or C-CDA R2 R2.1 document.
Test Lab Verification
The verification of the applicable types of transition of care/referral summaries received in (b)(5)(i) includes the Cognitive status, when present, in accordance to the standard adopted in § 170.205(a)(3) or § 170.205(a)(4).
| System Under Test | Test Lab Verification |
|---|---|
|
Cognitive Status The transition of care/referral summary received in (b)(5)(i) includes the Cognitive status, when present, in the C-CDA R2 R1.1 or C-CDA R2 R2.1 document. |
The verification of the applicable types of transition of care/referral summaries received in (b)(5)(i) includes the Cognitive status, when present, in accordance to the standard adopted in § 170.205(a)(3) or § 170.205(a)(4). |
Paragraph (b)(5)(i)(D)
System Under Test
Functional Status
The transition of care/referral summary received in (b)(5)(i) includes the Functional status when present in the C-CDA R2 R1.1 or C-CDA R2 R2.1 document.
Test Lab Verification
The verification of the applicable types of transition of care/referral summaries received in (b)(5)(i) includes the Functional status when present in accordance to the standard adopted in § 170.205(a)(3) or § 170.205(a)(4) as applicable.
| System Under Test | Test Lab Verification |
|---|---|
|
Functional Status The transition of care/referral summary received in (b)(5)(i) includes the Functional status when present in the C-CDA R2 R1.1 or C-CDA R2 R2.1 document. |
The verification of the applicable types of transition of care/referral summaries received in (b)(5)(i) includes the Functional status when present in accordance to the standard adopted in § 170.205(a)(3) or § 170.205(a)(4) as applicable. |
Paragraph (b)(5)(i)(E)
System Under Test
Ambulatory Setting Only
The transition of care/referral summary received in (b)(5)(i) includes, at a minimum:
- reason for referral;
- referring or transitioning provider’s name; and
- office contact information.
Test Lab Verification
For the ambulatory setting only, the verification of the applicable types of transition of care/referral summaries received in(b)(5)(i) includes the following data elements in accordance to the standard adopted in § 170.205(a)(3) or § 170.205(a)(4) as applicable:
- reason for referral;
- referring or transitioning provider’s name; and
- office contact information.
| System Under Test | Test Lab Verification |
|---|---|
|
Ambulatory Setting Only The transition of care/referral summary received in (b)(5)(i) includes, at a minimum:
|
For the ambulatory setting only, the verification of the applicable types of transition of care/referral summaries received in(b)(5)(i) includes the following data elements in accordance to the standard adopted in § 170.205(a)(3) or § 170.205(a)(4) as applicable:
|
Paragraph (b)(5)(i)(F)
System Under Test
Inpatient Setting Only
The transition of care/referral summary received in (b)(5)(i) includes the discharge instructions.
Test Lab Verification
For the inpatient setting only, the verification of the applicable types of transition of care/referral summaries received in (b)(5)(i) includes the discharge instructions in accordance to the standard adopted in § 170.205(a)(3) or § 170.205(a)(4) as applicable.
| System Under Test | Test Lab Verification |
|---|---|
|
Inpatient Setting Only The transition of care/referral summary received in (b)(5)(i) includes the discharge instructions. |
For the inpatient setting only, the verification of the applicable types of transition of care/referral summaries received in (b)(5)(i) includes the discharge instructions in accordance to the standard adopted in § 170.205(a)(3) or § 170.205(a)(4) as applicable. |
Paragraph (b)(5)(ii)(A)
System Under Test
Validate (Parse, Identify, and Interpret)
- Using the Common Clinical Data Set summary records received in (b)(5)(i), the Health IT Module parses the document formatted as a CCD or a C-CDA with no specific document template in accordance with the standards specified in § 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 or as a C-CDA § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, as one of the following document types:
- Continuity of Care;
- Referral Note; and
- Inpatient setting only: Discharge Summary.
- Using the C-CDA documents parsed in step 1, the Health IT Module processes the data elements required in the corresponding section-templates and entry-templates from the standards adopted in § 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 or § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1 as applicable.
- Using the C-CDA documents parsed in step 1, the Health IT Module processes empty sections and null combinations in accordance with document-templates from 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 and interprets them correctly.
Detect Errors
- Using the invalid Common Clinical Data Set summary records received in (b)(5)(i), the Health IT Module detects the C-CDA document types containing errors for the negative test cases referenced from the C-CDA negative testing sample documents corresponding to “document-templates” errors, “section-templates” errors, and “entry-templates” errors including invalid vocabulary standards and codes not specified in 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 and the Health IT Module reports the errors.
Error Handling
- In the Health IT Module, the user is notified and/or can review the recorded errors encountered during the parsing and processing of C-CDA documents.
Test Lab Verification
Validate (Parse, Identify, and Interpret)
- For each document received and parsed by the SUT in step 1, the tester uses visual inspection and the human readable document version created in step 1 of the receive setup, to verify that the Common Clinical Data Set summary records received in (b)(5)(i) are formatted in accordance with either the standard specified in § 170.205(a)(3) as a CCD or C-CDA or § 170.205(a)(4) as a C-CDA with one of the following document types as applicable:
- Continuity of Care;
- Referral Note; and
- Inpatient setting only: Discharge Summary.
- Using visual inspection and the parsed data from step 1 of the SUT, the tester verifies that all of the required data elements from valid C-CDA documents with corresponding section-templates and entry-templates from the standards adopted in § 170.205(a)(3) and § 170.205(a)(4) are successfully processed for each of the appropriate document types.
- Using visual inspection and the processed data from step 2 of the SUT, the tester verifies that valid empty sections and null combinations in valid C-CDA documents with corresponding section-templates and entry-templates from the standards adopted in § 170.205(a)(3) and § 170.205(a)(4) are successfully interpreted for each of the following applicable document types.
Detect Errors
- Using visual inspection and ONC-supplied negative test data, the tester verifies that for each of the negative C-CDA document test files not specified with the standards adopted in § 170.205(a)(3) or § 170.205(a)(4) the Health IT Module correctly identifies errors in the C-CDA document and identifies the C-CDA document as invalid.
Error Handling
- Using visual inspection, the tester verifies that errors encountered during the parsing and processing of the C-CDA documents are recorded, and that a user is either notified of the errors produced OR can review all of the recorded errors using the Health IT Module.
| System Under Test | Test Lab Verification |
|---|---|
|
Validate (Parse, Identify, and Interpret)
Detect Errors
Error Handling
|
Validate (Parse, Identify, and Interpret)
Detect Errors
Error Handling
|
Paragraph (b)(5)(ii)(B)
System Under Test
Display
- Using the Health IT Module and the processed C-CDA documents in (b)(5)(ii)(A), the user displays the transition of care/referral summaries received in human readable format including the data which is formatted in accordance to the standards specified in § 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 or § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, as applicable, and includes, at a minimum, the following content in English (non-coded) representation if they associate with a vocabulary/code set as applicable for the:
- Common Clinical Data Set as specified in (b)(5)(i)(A);
- Encounter diagnoses as specified in (b)(5)(i)(B);
- Cognitive status as specified in (b)(5)(i)(C);
- Functional status as specified in (b)(5)(i)(D);
- Ambulatory setting only: data elements as specified in (b)(5)(i)(E); and
- Inpatient setting only: data elements as specified in (b)(5)(i)(F).
Test Lab Verification
Display
- The tester retrieves the CCDS summary record information in order to validate the display of the CCDS summary records received and validated in (b)(5)(i) and (b)(5)(ii)(A) respectively. This is accomplished by using the human readable versions of the downloaded CCDS summary record created in (b)(5)(i) step 1 of the SUT.
- For each CCDS summary record received in (b)(5)(i), the tester uses the corresponding CCDS summary record information documents and the Health IT Module to verify through visual inspection that the transition of care/referral summaries received in (b)(5)(ii)(B), are displayed accurately and without omission, and that the data is formatted in accordance with the standards specified in § 170.205(a)(3) or § 170.205(a)(4) and includes at a minimum the applicable English (i.e., non-coded) representation if they associate with a vocabulary/code set content from the:
- Common Clinical Data Set;
- Encounter diagnoses;
- Cognitive status;
- Functional status;
- Ambulatory setting only: the reason for referral, referring or transitioning provider’s name, and office contact information; and
- Inpatient setting only: the discharge instructions.
| System Under Test | Test Lab Verification |
|---|---|
|
Display
|
Display
|
Paragraph (b)(5)(ii)(C)
System Under Test
Display Section Views
- Using the Common Clinical Data Set summary record(s) received and processed in (b)(5)(i) and (b)(5)(ii)(A), the user uses the Health IT Module to display each individual section or additional sections (and the accompanying document header information) of the received transition of care/referral summaries displayed, that are formatted according to the standards specified 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 Common Clinical Data Set summary record(s) received and processed in (b)(5)(i), and (b)(5)(ii)(A), the user uses the Health IT module to directly display only the data within a particular section.
Section Order
- The user uses the Health IT Module to set the preference for the display order of specific sections.
Quantity of Sections
- The user uses the Health IT Module to set the initial quantity of sections to be displayed.
Test Lab Verification
Display Section Views
- Using visual inspection, the tester verifies that for transition of care/referral summaries received and processed in (b)(5)(ii)(A)(1), (b)(5)(ii)(A)(3), and (b)(5)(ii)(A)(4) the Health IT Module can display the data from an individual section and its accompanying document header information.
- Using visual inspection, the tester verifies that for the transition of care/referral summaries being displayed in step 1 of the SUT, the user can select data from an additional individual section or sections to be displayed, along with its accompanying document header information.
- Using visual inspection, the tester verifies that data first displayed in step 1 of the SUT is for one particular section of the document for each document type.
- Using visual inspection, the tester verifies that transitions of care/referral summary data displayed in steps 1 and 2 of the SUT are accurate and without omission.
Section Order
- Using visual inspection, the tester verifies the user has the ability to set the order in which the transitions of care/referral summary sections are displayed for each of the supported document-types.
- Using visual inspection, the tester verifies that the sections displayed for transition of care/referral summaries received and processed in (b)(5)(ii)(A)(1), (b)(5)(ii)(A)(3) and (b)(5)(ii)(A)(4) are ordered correctly based upon the section order set in the previous step (step 5 of the TLV). The sections are displayed in the preferred order.
Quantity of Sections
- Using visual inspection, the tester verifies the user has the ability to set the initial quantity of sections for a transitions of care/referral summary to be displayed.
- Using visual inspection, the tester verifies that the number of transition of care/referral summary sections initially displayed in step 1 of the SUT corresponds to the quantity of sections to be displayed in step 7 of the TLV.
| System Under Test | Test Lab Verification |
|---|---|
|
Display Section Views
Section Order
Quantity of Sections
|
Display Section Views
Section Order
Quantity of Sections
|
Updated on 09-21-2018
Revision History
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 |
Initial Publication |
01-05-2016
|
| 1.1 |
Clarification on testing and certification flexibility permitting leveraging test results from § 170.315(b)(1) for (b)(5). |
04-22-2016
|
| 1.2 |
Provides notification of March 2017 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion. |
09-29-2017
|
| 1.3 |
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
|
| 1.4 |
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 (b)(5) Common Clinical Data Set summary record – receive—
- Enable a user to receive 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 that includes, at a minimum:
- The Common Clinical Data Set.
- Encounter diagnoses. Formatted according to at least one of the following standards:
- The standard specified in §170.207(i).
- At a minimum, the standard specified in §170.207(a)(4).
- Cognitive status.
- Functional status.
- Ambulatory setting only. The reason for referral; and referring or transitioning provider's name and office contact information.
- Inpatient setting only. Discharge instructions.
- Validate and display. Demonstrate the following functionalities for the document received in accordance with paragraph (b)(5)(i) of this section:
- Validate C-CDA conformance—system performance. Detect valid and invalid transition of care/referral summaries including the ability to:
- Parse each of the document types formatted according to the following document templates: Continuity of Care Document, Referral Note, and (inpatient setting only) Discharge Summary.
- Detect errors in corresponding “document-templates,” “section-templates,” and “entry-templates,” including invalid vocabulary standards and codes not specified in the standards adopted in §170.205(a)(3) and §170.205(a)(4).
- Identify valid document-templates and process the data elements required in the corresponding section-templates and entry-templates from the standards adopted in §170.205(a)(3) and §170.205(a)(4).
- Correctly interpret empty sections and null combinations.
- Record errors encountered and allow a user through at least one of the following ways to:
- Be notified of the errors produced.
- Review the errors produced.
- Display. Display in human readable format the data included in transition of care/referral summaries received and formatted according to the standards specified in §170.205(a)(3) and §170.205(a)(4).
- Display section views. Allow for the individual display of each section (and the accompanying document header information) that is included in a transition of care/referral summary received and formatted in accordance with the standards adopted in §170.205(a)(3) and §170.205(a)(4) in a manner that enables the user to:
- Directly display only the data within a particular section;
- Set a preference for the display order of specific sections; and
- Set the initial quantity of sections to be displayed.
- Validate C-CDA conformance—system performance. Detect valid and invalid transition of care/referral summaries including the ability to:
Standard(s) Referenced
Paragraph (b)(5)(i)
§ 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012
§ 170.207(i) ICD-10-CM
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
Paragraph (b)(5)(ii)
§ 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012. The use of the "unstructured document" document-level template is prohibited.
Additional Resources
- Revision History
-
Version # Description of Change Version Date 1.0 Initial Publication
01-05-20161.1 Clarification on testing and certification flexibility permitting leveraging test results from § 170.315(b)(1) for (b)(5).
04-22-20161.2 Provides notification of March 2017 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion.
09-29-20171.3 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.
05-02-20181.4 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 (b)(5) Common Clinical Data Set summary record – receive—
- Enable a user to receive 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 that includes, at a minimum:
- The Common Clinical Data Set.
- Encounter diagnoses. Formatted according to at least one of the following standards:
- The standard specified in §170.207(i).
- At a minimum, the standard specified in §170.207(a)(4).
- Cognitive status.
- Functional status.
- Ambulatory setting only. The reason for referral; and referring or transitioning provider's name and office contact information.
- Inpatient setting only. Discharge instructions.
- Validate and display. Demonstrate the following functionalities for the document received in accordance with paragraph (b)(5)(i) of this section:
- Validate C-CDA conformance—system performance. Detect valid and invalid transition of care/referral summaries including the ability to:
- Parse each of the document types formatted according to the following document templates: Continuity of Care Document, Referral Note, and (inpatient setting only) Discharge Summary.
- Detect errors in corresponding “document-templates,” “section-templates,” and “entry-templates,” including invalid vocabulary standards and codes not specified in the standards adopted in §170.205(a)(3) and §170.205(a)(4).
- Identify valid document-templates and process the data elements required in the corresponding section-templates and entry-templates from the standards adopted in §170.205(a)(3) and §170.205(a)(4).
- Correctly interpret empty sections and null combinations.
- Record errors encountered and allow a user through at least one of the following ways to:
- Be notified of the errors produced.
- Review the errors produced.
- Display. Display in human readable format the data included in transition of care/referral summaries received and formatted according to the standards specified in §170.205(a)(3) and §170.205(a)(4).
- Display section views. Allow for the individual display of each section (and the accompanying document header information) that is included in a transition of care/referral summary received and formatted in accordance with the standards adopted in §170.205(a)(3) and §170.205(a)(4) in a manner that enables the user to:
- Directly display only the data within a particular section;
- Set a preference for the display order of specific sections; and
- Set the initial quantity of sections to be displayed.
- Validate C-CDA conformance—system performance. Detect valid and invalid transition of care/referral summaries including the ability to:
- Enable a user to receive 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 that includes, at a minimum:
- Standard(s) Referenced
-
Paragraph (b)(5)(i)
§ 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012
§ 170.207(i) ICD-10-CM
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
Paragraph (b)(5)(ii)
§ 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012. The use of the "unstructured document" document-level template is prohibited.
Additional Resources
- Testing
-
Testing Tool
Criterion Subparagraph Test Data (b)(5)(i) Inpatient Setting - 170.315_b5_ccds_inp_*_r21_ sample*.xml (all samples)
170.315_b5_ccds_inp_*_r11_ sample*.xml (all samples)
Ambulatory Setting - 170.315_b5_ccds_amb_*_r21_sample*.xml (all samples)
170.315_b5_ccds_amb_*_r11_sample*.xml (all samples)
Negative Tests: NT_*_r21_*.xml
NT_*_r11_*.xml
Certification Companion Guide: Common Clinical Data Set summary record – receive
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.
| Base EHR Definition | In Scope for CEHRT Definition |
|---|---|
| Not Included | No |
Certification Requirements
Privacy and Security: This certification criterion was adopted at § 170.315(b)(5). 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.
- The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (b) criterion unless it is the only criterion for which certification is requested.
- As a general rule, a product presented for certification only needs to be tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “VDT” and (e)(2) “secure messaging,” which are explicitly stated.
Table for Privacy and Security
- If choosing Approach 1:
- Authentication, access control, and authorization (§ 170.315(d)(1))
- Auditable events and tamper-resistance (§ 170.315(d)(2))
- Audit reports (§ 170.315(d)(3))
- Automatic access time-out (§ 170.315(d)(5))
- Emergency access (§ 170.315(d)(6))
- End-user device encryption (§ 170.315(d)(7))
- Integrity (§ 170.315(d)(8))
- If choosing Approach 2:
- For each applicable P&S certification criterion not certified for approach 1, the health IT developer may certify for the criterion using system documentation which provides a clear description of how the external services necessary to meet the P&S criteria would be deployed and used. Please see the 2015 Edition final rule correction notice at 80 FR 76870 for additional clarification.
Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
- When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
- When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively the developer must state that no accessibility-centered design was used.
Table for Design and Performance
Certification Requirements
Privacy and Security: This certification criterion was adopted at § 170.315(b)(5). 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.
- The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (b) criterion unless it is the only criterion for which certification is requested.
- As a general rule, a product presented for certification only needs to be tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “VDT” and (e)(2) “secure messaging,” which are explicitly stated.
Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
- When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
- When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively the developer must state that no accessibility-centered design was used.
Table for Privacy and Security
- If choosing Approach 1:
- Authentication, access control, and authorization (§ 170.315(d)(1))
- Auditable events and tamper-resistance (§ 170.315(d)(2))
- Audit reports (§ 170.315(d)(3))
- Automatic access time-out (§ 170.315(d)(5))
- Emergency access (§ 170.315(d)(6))
- End-user device encryption (§ 170.315(d)(7))
- Integrity (§ 170.315(d)(8))
- If choosing Approach 2:
- For each applicable P&S certification criterion not certified for approach 1, the health IT developer may certify for the criterion using system documentation which provides a clear description of how the external services necessary to meet the P&S criteria would be deployed and used. Please see the 2015 Edition final rule correction notice at 80 FR 76870 for additional clarification.
Table for Design and Performance
Technical Explanations and Clarifications
Applies to entire criterion
Clarifications:
- The scope of this criterion is limited to the Consolidated CDA (C-CDA) Continuity of Care Document (CCD), Referral Note, and (inpatient setting only) Discharge Summary document templates. [see also 80 FR 62633]
- We recommend health IT developers and providers follow the guidance provided in the HL7 Implementation Guide: S&I Framework Transitions of Care Companion Guide to Consolidated-CDA for Meaningful Use Stage 2, Release 1 – US Realm. This Companion Guide includes industry best practices guidance for consistent implementation of the C-CDA Release 1.1 standard, including mapping Common MU Data Set elements into the C-CDA standard. [see also 80 FR 62633] We understand that HL7 is developing a Companion Guide for C-CDA Release 2.1 and intend to update this document once it becomes publicly available. In the meantime, we recommend developers follow the guidance provided by the HL7 CDA Example Task Force for implementation of the C-CDA Release 2.1 standard.
- 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.
- March 2017 Validator Update of C-CDA 2.1 Corrections [Effective for testing on December 28, 2017; Surveillance compliance date is March 29, 2019]
- April 2018 Validator Update of C-CDA 2.1 Corrections [Effective for testing on July 31, 2018; Surveillance compliance date is November 2, 2019]
- August 2018 Validator Update of C-CDA 2.1 Corrections [Effective for testing on December 20, 2018; Surveillance compliance date is March 21, 2020]
- At the discretion of the ONC-ATL and ONC-ACB, the requirements of this criterion may be met through testing and certification to § 170.315(b)(1).
Applies to entire criterion
|
Clarifications:
|
Paragraph (b)(5)(i)
Technical outcome – The health IT can receive a C-CDA (formatted to either Release 1.1 or Release 2.1) that includes the Common Clinical Data Set, Encounter diagnoses according to either ICD-10-CM or SNOMED CT® codes, Cognitive status, and Functional status.
- Ambulatory setting only – The user is able to receive a C-CDA (formatted to either Release 1.1 or Release 2.1) that also includes the reason for referral and the referring or transitioning provider’s name and office contact information.
- Inpatient setting only – The user is able to create a C-CDA (formatted to either Release 1.1 or Release 2.1) that also includes the discharge instructions.
Clarifications:
- We are requiring Health IT Modules to be able to receive C-CDAs formatted to both C-CDA Release 1.1 and 2.1. While Release 2.1 largely ensures compatibility between C-CDA Release 1.1 and 2.0, it does not guarantee compatibility without further development effort. [see also 80 FR 62645 and 80 FR 62634]
- In order to facilitate the translation of SNOMED CT® codes to ICD-10-CM in administrative systems, developers are encouraged to reference the publicly available mapping that the National Library of Medicine provides. [see also 77 FR 54220]
- We provide the following OIDs to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards.
- ICD-10 Procedure Coding System OID: 2.16.840.1.113883.6.4
- SNOMED CT® OID: 2.16.840.1.113883.6.96 [see also 80 FR 62612]
- Health IT Modules can present for certification to a more recent version of SNOMED CT®, U.S. Edition than the September 2015 Release per ONC’s policy that permits certification to a more recent version of certain vocabulary standards. [see also 80 FR 62620]
- The C-CDA Cognitive Status Observation template has been deprecated in Release 2.1 and has been replaced with the Mental Status Observation template. Developers should use the Mental Status Observation template for Cognitive status and be aware that the C-CDA Validator will issue an error if the deprecated Cognitive Status Observation is used instead.
Paragraph (b)(5)(i)
|
Technical outcome – The health IT can receive a C-CDA (formatted to either Release 1.1 or Release 2.1) that includes the Common Clinical Data Set, Encounter diagnoses according to either ICD-10-CM or SNOMED CT® codes, Cognitive status, and Functional status.
Clarifications:
|
Paragraph (b)(5)(ii)(A)
Technical outcome – The health IT can detect valid and invalid ToC/referral summaries upon receipt of C-CDA documents formatted to C-CDA Release 1.1 and 2.1.
Clarifications:
- We are requiring Health IT Modules to be able to validate C-CDAs formatted to both C-CDA Release 1.1 and 2.1. While Release 2.1 largely ensures compatibility between C-CDA Release 1.1 and 2.0, it does not guarantee compatibility without further development effort. [see also 80 FR 62645 and 80 FR 62634]
- Testing for the receipt of C-CDA Release 1.1 documents will offer two options – to test either a non-specified C-CDA document or a CCD. Health IT Modules will not be tested for C-CDA Release 1.1 Referral Note and Discharge Summary document templates. Note that Health IT Modules will be tested for receipt of all three document templates (i.e., CCD, Referral Note, and (inpatient setting only) Discharge Summary) for C-CDA Release 2.1.
- Testing for the receipt of C-CDA Release 1.1 documents will offer two options – to test either a non-specified C-CDA document or a CCD. Health IT Modules will not be tested for C-CDA Release 1.1 Referral Note and Discharge Summary document templates. Note that Health IT Modules will be tested for receipt of all three document templates (i.e., CCD, Referral Note, and (inpatient setting only) Discharge Summary) for C-CDA Release 2.1.
- Error notification should be made available to authorized users of the receiving organization who can deal with the errors as appropriate and the error may be resolved by a support analyst or end user. [see also 80 FR 62634]
- There is no requirement that users be interrupted to be notified of errors, only that the user can access and review the errors. [see also 80 FR 62634]
- Receiving systems are not expected to translate codes from a source that has not formatted the data according to the applicable vocabulary standard required by the C-CDA Releases 1.1 and 2.1. [see also 77 FR 54220] However, receiving systems would be expected to identify data not formatted according to the applicable vocabulary standard as an error.
Paragraph (b)(5)(ii)(A)
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Technical outcome – The health IT can detect valid and invalid ToC/referral summaries upon receipt of C-CDA documents formatted to C-CDA Release 1.1 and 2.1. Clarifications:
|
Paragraph (b)(5)(ii)(B)
Technical outcome – The health IT can display, for both C-CDA Releases 1.1 and 2.1, a human-readable C-CDA to a user.
Clarifications:
- No additional clarifications available.
Paragraph (b)(5)(ii)(B)
|
Technical outcome – The health IT can display, for both C-CDA Releases 1.1 and 2.1, a human-readable C-CDA to a user. Clarifications:
|
Paragraph (b)(5)(ii)(C)
Technical outcome – The health IT allows a user to choose to display only the data within a particular C-CDA section, set a preference for the section display order, and set the initial number of sections to be displayed. This applies to both C-CDA Releases 1.1 and 2.1.
Clarifications:
- The use of the C-CDA CDA XSL style sheet will not be sufficient to meet the requirements of this provision. [see also 80 FR 62634]
Paragraph (b)(5)(ii)(C)
|
Technical outcome – The health IT allows a user to choose to display only the data within a particular C-CDA section, set a preference for the section display order, and set the initial number of sections to be displayed. This applies to both C-CDA Releases 1.1 and 2.1. Clarifications:
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