Technical outcome – A user can record, change, access, create, and receive care plan information according to the Care Plan document template in the HL7® Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1, including the Health Status Evaluations and Outcomes Section and Interventions Section (V2).
Clarifications:
- In combination with the C-CDA R2.1 standard, developers certifying to the Care Plan criterion must follow the guidance and templates provided in HL7® CDA® R2 IG: C-CDA Templates for Clinical Notes R2 Companion Guide, Release 2 for implementation of the C-CDA Release 2.1 standard for a period up to and including December 31, 2025 or use the templates provided in HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4.1 - US Realm.
- The Care Plan document template supports broader information about the patient, including education, physical therapy/range of motion, and social interventions not commonly found in other parts of the C-CDA standard, and is also distinct from the 'Plan of Treatment Section' in Version 2.1 of the C-CDA. (The Plan of Care Section in C-CDA 1.1 was renamed Plan of Treatment Section in C-CDA 2.1). [see also 80 FR 62648]
- The Care Plan document template is distinct from the “Plan of Care Section” in previous versions of the C-CDA. [see also 80 FR 62648]
- Consistent with ONC policy, health IT must enable a user to record, change, access, create, and receive information for those sections of the C-CDA Care Plan template that are required, including the “Goals” and “Health Concerns” Sections. [see also 80 FR 62648] ONC would expect that these sections could contain patient-expressed information, including patient-expressed goals and health concerns. Because of this, the information contained within the “Goals” and “Health Concerns” Sections of the Care Plan document could differ from the information contained within those same sections in a transition of care/referral summary document.
- Health IT must enable a user to record, change, access, create, and receive information for the “Health Status Evaluations and Outcomes Section” and “Interventions Section (V2)”. Although these sections are deemed optional in the C-CDA standard, they are required for certification. [see also 80 FR 62649]
- Although a system will need to be able to receive a care plan in accordance with C-CDA Release 2.1, the system is not required to enable a user to reconcile the care plan data. [see also 80 FR 62649]
- 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 the ONC Health IT Certification Program Overview]. 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. 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., ETT: Message Validators). Similarly, 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 Certification Program.
- Through the C-CDA Patch Process, the HL7® Structured Documents Work Group (SDWG) approves C-CDA “patches”, which are corrections for issues with the C-CDA implementation guide (C-CDA IG) and companion guides. C-CDA “patches” include corrections for issues such as ambiguous requirements and requirements incompatible with real world deployment. Similar to C-CDA “patches” are C-CDA “additional guidance”. C-CDA “additional guidance” approved by the SDWG indicates guidance included in a newer version of the C-CDA IG or companion guide as being relevant to a previous version of the C-CDA IG or companion guide. A C-CDA “patch” may require a code change to correct errors or ambiguities in the guide, while “additional guidance” is purely clarifying and does not require any code changes. Though C-CDA “patches” and “additional guidance” are not required for certification purposes (unless indicated in the Certification Companion Guide), health IT developers may optionally implement C-CDA “additional guidance” in their Health IT Module and still be conformant with § 170.315(b)(7) criterion requirements.
- More information regarding the C-CDA Patch Process and C-CDA “patches” and “additional guidance” approved by the SDWG is available on the HL7® Confluence pages of C-CDA 'Patch' Process and Approved Patches and Additional Guidance.
