ASSOCIATED CERTIFICATION CRITERIA | MEASUREMENT/METRIC | DESCRIPTION | TEST METHOD | JUSTIFICATION | EXPECTED OUTCOME |
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§ 170.315 (b)(1): Transitions of Care | Transition of Care Functionality | Provider identified users are able to create transitions of care, validate and display C-CDA, send and receive summaries from the Health IT module. | Survey, Internal Testing |
This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. |
Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
The Health IT Module must be capable of receiving and sending message via SMTP and transmission should be encrypted by TLS | |||||
Must have the capability to receive one or more attachments such as C-CDA documents and XDM packages. Our EHR must be able to process and recognize XDM mime types | |||||
Must be capable of sending/receiving XDR message with Full (XDS) metadata (IHE XDR Profile for Limited Metadata ) | |||||
Health IT Module must be able to validate the format correctness of C-CDA documents | |||||
Health IT Module must be able to render C-CDA Documents and XDM packages with support for styling via css stylesheets for human readability | |||||
Health IT Module must have the capability to create and send valid C-CDA documents via SMTP Edge Protocol under a TLS connection | |||||
Must ensures that the required Data Elements for different settings are included in generated C-CDA’s | |||||
§ 170.315 (b)(6): Data Export | C-CDA Data Export Functionality | Provider identified users are able to successfully export user-identified client C-CDA files for user-defined date/time ranges from the Health IT module. | Survey, Internal Testing |
This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. |
Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
Provider identified users can create export summaries in real-time; based on a relative date and time or a specific date and time. | |||||
Provider identified users can set configuration options for data elements, date and time ranges, and locations when generating a C-CDA | |||||
Provider identified users can generate a set of C-CDAs for between one client and all clients, without generating each C-CDA individually | |||||
C-CDA generation is limited to those users who have the proper role or system credentials, as determined by the provider | |||||
Provider identified users not having proper system credentials cannot generate C-CDAs. Applies to:
Only authorized users can set the limits of users who can do the above. |
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C-CDAs may be exported to local or network storage, in addition to integrated transmission methods | |||||
§ 170.315 (c)(1): Clinical Quality Measures – Record and Export | Clinical quality measures (CQM) functionality | Provider identified users are able to record and export all of the data that would be necessary to calculate each CQM | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
The Health IT Module must be able to record all of the data that would be necessary to calculate each CQM. | |||||
Must be able to export a data file at any time the user chooses and without subsequent developer assistance to operate:
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§ 170.315 (c)(2): Clinical quality measures import and calculate | Clinical quality measures (CQM) functionality | Provider identified users are able to import a data file and use it to calculate all of the data that would be necessary to each CQM | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
The user must be able to import a data file in accordance with the standard specified in §170.205(h)(2) for one or multiple patients and use such data to perform the capability specified in paragraph (c)(2)(ii) of this section. A user must be able to execute this capability at any time the user chooses and without subsequent developer assistance to operate | |||||
The Health IT Module can calculate each and every clinical quality measure for which it is presented for certification. | |||||
§ 170.315(c)(3) Clinical quality measures report | Clinical quality measures (CQM) functionality | Provider identified users are able to generate CQM data files for transmission based on appropriate QRDA guidelines. | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
The user must be able to electronically create a data file for transmission of clinical quality measurement data:
(i) In accordance with the applicable implementation specifications specified by the CMS implementation guides for Quality Reporting Document Architecture (QRDA), category I, for inpatient measures in § 170.205(h)(3) and CMS implementation guide for QRDA, category III for ambulatory measures in § 170.205 (k)(3); or (ii) In accordance with the standards specified in § 170.205(h)(2) and § 170.205(k)(1) and (2) for the period until December 31, 2022. |
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§ 170.315 (g)(7) Application access – patient selection | Application access functionality | An API must be able to receive a request with sufficient data to uniquely identify a patient and return an ID or other token that can be used by an application to subsequently execute requests for that patient’s data | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
The Health IT Module will uniquely identify a patient and return an ID or other token that can be used by the application to subsequently execute requests for that patient’s data. | |||||
The Health IT Module must be able to respond to requests for patient data (using an ID or other token) for each of the individual categories listed in the Common Clinical Data Set (CCDS) and return the full set of data for that category, according to the required data standards in a computable format. | |||||
The Health IT Module must be able to respond to requests for patient data associated with a specific date as well as requests for patient data with a specific date range. | |||||
§ 170.315 (g)(9) Application access – all data request | Application access functionality | Upon receipt of an ID/Token, the API will return the requested data in a summary format following CCD documentation template guidelines, or provide the CCDS, and address assessment and plan of treatment, goals, health concerns, and unique device identifiers for any implantable devices. | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
The Health IT Module must be able to respond to requests for patient data (using an ID or other token) for all of the data categories specified in the United States Core Data for Interoperability Standard (USCDI) at one time in a summary record formatted according to the Consolidated CDA Release 2.1 Continuity of Care Document (CCD) template. | |||||
The Health IT Module must be able to respond to requests for patient data associated with a specific date as well as with a specific date range. | |||||
§ 170.315 (g)(10) Standardized API for patient and population services | Application access functionality | Provider identified users are able to utilize the standardized API for accessing single and multiple patients. | Survey, Internal Testing |
This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. |
Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
The Health IT Module must be able to respond to requests for patient data (using an ID or other token) for all of the data categories specified in the United States Core Data for Interoperability
Standard (USCDI) at one time in a summary record formatted according to the Consolidated CDA Release 2.1 Continuity of Care Document (CCD) template. |
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The Health IT Module must be able to respond to requests for patient data associated with a specific date as well as with a specific date range. | |||||
§ 170.315 (h)(1) Direct Project | Direct Project functionality | Provider identified users are able to send and receive health information | Survey, Internal Testing | This measure will survey end users to determine real world interoperability and usability of the Health IT module. Internal testing will also be done to ensure expected outcomes are met. | Positive end user feedback will provide a benchmark to determine real-world interoperability and usability of the Health IT Module: |
The Health IT Module can electronically transmit (send and receive) health information to a 3rd party which must be formatted only as a “wrapped” message using the Applicability Statement for Secure Health Transport, Version 1.2. | |||||
The Health IT Module can electronically transmit (send and receive) health information to a 3rd party using Direct in accordance with the Implementation Guide (IG) for Delivery Notification in Direct, Version 1.0. |
ASSOCIATED CERTIFICATION CRITERIA | CARE SETTING | JUSTIFICATION |
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§ 170.315 (b)(1): Transitions of Care | Outpatient behavioral health | Outpatient (ambulatory) behavioral health providers is able to create a C-CDA that also includes the reason for referral, and the referring or transitioning provider’s name and office contact information. |
Residential behavioral health | Residential behavioral health providers is able to create a C-CDA Discharge Summary Document that includes reason for referral; and referring or transitioning provider’s name and office contact information; and discharge instructions. | |
§ 170.315 (b)(6): Data Export | Outpatient behavioral health | Outpatient (ambulatory) behavioral health providers frequently provide C-CDA documentation to outside entities. Outpatient care C-CDA documentation requires reason for referral; and referring or transitioning provider’s name and office contact information. |
Residential behavioral health | Residential behavioral health providers frequently provide C-CDA documentation to outside entities. Residential CCDA documentation requires reason for referral; and referring or transitioning provider’s name and office contact information; and discharge instructions. | |
§ 170.315 (c)(1): Clinical Quality Measures – Record and Export § 170.315 (c)(2): Clinical Quality Measures – Import and Calculate § 170.315 (c)(3): Clinical Quality Measures – Report |
Outpatient behavioral health | QRDA documentation is specific to outpatient behavioral health settings. |
Residential behavioral health | QRDA documentation is specific to inpatient behavioral health settings. | |
§ 170.315 (g)(7) Application access – patient selection § 170.315 (g)(9) Application access – all data request § 170.315 (g)(10) Standardized API for patient and population services |
Outpatient behavioral health | Documentation requirements at the time of discharge are different from Residential Behavioral Health setting requirements. |
Residential behavioral health | Documentation requirements at the time of discharge are different from Outpatient Behavioral Health setting requirements. | |
§ 170.315 (h)(1) Direct Project | Outpatient behavioral health | While technically similar, operational processes differ from residential behavioral health programs. |
Residential behavioral health | While technically similar, operational processes differ from outpatient behavioral health programs. |
Measurement/Metric | Associated Criterion |
Relied Upon Software (if applicable) |
Outcomes |
Challenges Encountered (if applicable) |
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Application access functionality |
§ 170.315 (g)(7) Application access – patient selection § 170.315 (g)(8) Application access – data category request § 170.315 (g)(9) Application access – all data request |
phiQuery HL7 FHIR services |
API is be able to receive a request with sufficient data to uniquely identify a patient and return an ID or other token that can be used by an application to subsequently execute requests for that patient’s data
Practices Queried: 10 |
During our testing, we did not discover any errors or criteria non-conformities. Our results reveal our EHR Module functionality is working as expected. |
Clinical quality measures (CQM) functionality |
§ 170.315 (g)(7) Application access – patient selection § 170.315 (g)(8) Application access – data category request § 170.315 (g)(9) Application access – all data request |
Users are able to record and export and import all of the data that would be necessary to calculate each CQM
Practices Queried: 10 |
During our testing, we did not discover any errors or criteria non-conformities. Our results reveal our EHR Module functionality is working as expected. |
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C-CDA Data Export Functionality | § 170.315 (b)(6): Data Export |
Users are able to successfully export user-identified client C-CDA files for user- defined date/time ranges from the Health IT module.
Practices Queried: 10 |
During our testing, we did not discover any errors or criteria non-conformities. Our results reveal our EHR Module functionality is working as expected. |
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Direct Project Functionality | § 170.315 (h)(1) Direct Project | phiMail Direct Messaging (HISP) service |
Users are able to send and receive health information
Practices Queried: 10 |
During our testing, we did not discover any errors or criteria non-conformities. Our results reveal our EHR Module functionality is working as expected. |
Transition of Care Functionality | § 170.315 (b)(1): Transitions of Care |
Users are able to create transitions of care, validate and display C-CDA, send and receive summaries from the Health IT module.
Practices Queried: 10 |
During our testing, we did not discover any errors or criteria non-conformities. Our results reveal our EHR Module functionality is working as expected. |