Source: https://www.healthit.gov/test-method/data-export
Timestamp: 2019-04-26 10:41:35+00:00

Document:
General requirements for export summary configuration.
Enable a user to set the configuration options specified in paragraphs (b)(6)(iii) and (iv) of this section when creating an export summary as well as a set of export summaries for patients whose information is stored in the technology. A user must be able to execute these capabilities at any time the user chooses and without subsequent developer assistance to operate.
At a minimum, the version of the standard specified in §170.207(a)(4).
Enable a user to set the date and time period within which data would be used to create the export summaries. This must include the ability to enter in a start and end date and time range.
Create export summaries based on a specific date and time (e.g., on 10/24/2015 at 1:00 a.m.).
Location configuration. Enable a user to set the storage location to which the export summary or export summaries are intended to be saved.
Location Configuration as specified in (b)(6)(iv).
providing this functionality as an administrative function.
Negative Test: The user demonstrates that a user who has not been granted the ability to create export summaries cannot create export summaries.
A user can execute the export summary configuration capability described in (b)(6)(i) steps 1 and 2 any time the user chooses and without subsequent developer assistance to operate.
The tester verifies an authorized user can create export summary documents.
Negative test: The tester verifies that an unauthorized user cannot create export summaries.
Via documentation submitted by the health IT developer, the tester verifies that a user can configure an export summary as specified in (b)(6)(i) any time the user chooses and without subsequent developer assistance to operate.
Using the ETT: Message Validators – C-CDA R2.1 Validator, the Health IT developer downloads the ONC-supplied data instructions through the sender download selections of the “170.315_DE_Amb” or “170.315_DE_Inp” criteria and one of the data export instruction documents, and executes the download.
Using the ONC-supplied data export data instruction document returned in step 1, the user creates patient records in the Health IT Module.
The user submits the data export summary created in step 3 to be verified.
Based on the health IT setting(s) to be certified, a user repeats steps 1-4 for each of the ambulatory and/or inpatient data export instruction document found in the ETT: Message Validators. The data export is required for all of the data export instruction documents for a given health IT setting.
Using the Health IT Developer-supplied data, the user creates records for multiple patients which can be used for data export in the Health IT Module.
An authorized user creates a set of export summaries which includes data from all of the patients in the Health IT Module.
Using the Health IT Developer-supplied selection criteria, an authorized user creates a set of export summaries which includes a sub-set of the patients in the Health IT Module.
Using the ETT: Message Validators – C-CDA R2.1 Validator, the tester uploads the submitted data export summary record (xml file) created by the Health IT module, through the sender upload selection of the “170.315_DE_Amb” or “170.315_DE_Inp” criteria and file name, and executes the uploads of the submitted file to the ETT: Message Validators.
Note: In the case where the data export summary contains multiple xml files, the xml files must be submitted to the ETT: Message Validators one at a time.
For each submitted data export summary document, the tester uses the Validation Report produced by the ETT: Message Validators to verify the Health IT module passes without error to confirm that the data export summary record is a CCD document conformant to the standard adopted in § 170.205(a)(4) and including at a minimum the following applicable data elements defined in the Common Clinical Data Set and (b)(6)(ii)(A)-(F).
As required by the ONC-supplied data export summary record instructions, the tester uses the ONC-supplied data export summary record instructions and ETT: Message Validators Message Content Report to verify the additional checks for equivalent text for the content of all section level narrative text.
Using the Health IT Developer-supplied data from the SUT in step 6 and the data export summaries with all of the patients created from the SUT in step 7, the tester verifies that the number of data export documents is correct.
The tester creates a human readable version of the data export summaries from step 4 and verifies that the all of the patients in the Health It Module are present in the data export summaries.
Using the Health IT Developer-supplied data from the SUT in step 6, and the selection criteria and the data export summaries with a sub-set of the patients created from the SUT in step 8, the tester verifies that the number of data export documents is correct.
The tester creates a human readable version of the data export summaries from step 6 and verifies that the correct patients are present in the set of data export summaries.
CCDS as specified in the 2015 Edition of the CCDS Reference Document, as applicable.
CCDS data elements are in accordance with the CCDS Reference Document for a document specified in accordance with § 170.205(a)(4).
Encounter diagnoses data element is specified in accordance with the constrained standard specified at § 170.207(i) or at a minimum the version of the standard specified at § 170.207(a)(4).
Cognitive Status data element, when present in the Health IT Module.
Functional Status data element, when present in the Health IT Module.
Ambulatory setting only, the following data elements: reason for referral, and referring or transitioning provider's name and office contact information.
Inpatient setting only, the following data elements: the discharge instructions.
Based upon a specific date (e.g., on 10/24/2015 at 1:00am) from the entered start and end dates and times.
export based upon a specific date.
The tester verifies that the data in the export summaries cover the correct time periods and the data contained within the export is complete and without omission.
An authorized user is able to set the location where the export summaries are to be saved.
An authorized user is able to store export summaries to a configured location.
The tester verifies that an authorized user can set the location where the export summaries are to be saved to the local disk or a network disk.
The tester verifies that export summaries can be saved to the configured export location.
Updated to reflect refined language included in corrections notice issued on December 11, 2015.
Clarifications added around date range requirement, and cognitive status observation.
Provides notification of March 2017 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements within paragraph (b)(6)(ii).
Provides notification of April 2018 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements within paragraph (b)(6)(ii). 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.
Provides notification of August 2018 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements within paragraph (b)(6)(ii).
Privacy and Security: This certification criterion was adopted at § 170.315(b)(6). 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.
Technical outcome – A user can set configuration options for data elements, date and time ranges, and locations as specified in paragraphs (b)(6)(ii) through (iv) of this section when creating an export summary as well as a set of export summaries for patients whose information is stored in the technology.
We expect that Health IT must be able to send all required data for a specific date range specified, but we acknowledge that there will be organizational policies / safety best practices that will dictate when records qualify on readiness, and we expect that vendors will employ user-centered design and return information in a way that prioritizes patient preferences and usability.
Technical outcome – A user can configure the technology to create export summaries using the Continuity of Care Document document template (from the Consolidated CDA Release 2.1) that includes the data specified in (ii)(A)-(F), as applicable for the setting.
Substitution of test data codes for valid alternative codes is acceptable provided they are valid, appropriate, and meet the 2015 Edition certification criteria requirements.
Procedures and lab tests are both required to be coded with respective standards. “Lab tests”, if referred to as “future scheduled tests” needed to be coded. The HL7 C-CDA companion guide suggests that future scheduled tests belong in the Plan of Care section and that is how/what the CCDA validator is built to follow. Thus, coded entries for future procedures and lab tests need to be in the Plan of Care section.
CPT codes are acceptable for the test procedure and test data. Please refer to the test procedure for more details.
Technical outcome – A user can set/enter the date and time period within which data would be used to create the export summaries.
The request to enter back dated test data is to simulate previously entered tests so that certain portions of data sit inside a specific period of time.
Create export summaries based on a specific date and time (e.g., on 10/24/2015 at 1:00am).
Technical outcome – A user can set the storage location to which the export summary or export summaries are intended to be saved.

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