Source: https://www.healthit.gov/test-method/common-clinical-data-set-summary-record-receive
Timestamp: 2019-04-26 09:46:33+00:00

Document:
Clarification of the “rejection” of an invalid C-CDA document in step 4 under the TLV of paragraph (b)(5)(i).
The standard specified in §170.207(i).
At a minimum, the standard specified in §170.207(a)(4).
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).
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).
§ 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.
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.
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).
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”.
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.
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.
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.
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.
At a minimum, the standard specified in § 170.207(a)(4).
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).
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.
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.
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.
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.
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.
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.
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.
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.
Inpatient setting only: data elements as specified in (b)(5)(i)(F).
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.
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.
The user uses the Health IT Module to set the preference for the display order of specific sections.
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 transitions of care/referral summary data displayed in steps 1 and 2 of the SUT are accurate and without omission.
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.
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.
Clarification on testing and certification flexibility permitting leveraging test results from § 170.315(b)(1) for (b)(5).
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.
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).
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.
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.

References: §170
 §170
 §170
 §170
 §170
 §170
 §170
 §170

§ 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170
 § 170