Part 1 - Introduction to c - Cda and corresponding 2014 edition ehr certification criteria

Welcome to the recording of Implementing Consolidated Clinical Document Architecture (C-CDA) for Meaningful Use Stage 2, presented for you by the ONC Implementation and Testing Division, April, 17, 2013. This is the first part of a three part self-paced module on Implementing Consolidated Clinical Document Architecture for Meaningful Use Stage 2 and the 2014 Edition EHR Certification Criteria. Let�s start by remembering how health care data was exchanged prior to electronic health records. Previously vast amounts of patient data were collected by clinicians. Medical information such as vitals, orders, prescriptions, lab notes, and discharge summaries were dictated and recorded by hand. All this clinical data was stored as paper records at the point of care. If patient health records needed to be shared between providers, they usually would require manual exchange, or snail mail. Coordination of care between providers was slow, costly, and patient outcomes were inconsistent. On occasion, duplicative health care services (for example, labs and imaging) would occur frequently. So what do the 2014 Edition EHR Certification Criteria, associated with Meaningful Use Stage 2, say about Health Information Exchange? There are two rules associated with Meaningful Use Stage 2 and the 2014 Edition Standards and Certification Criteria. The first is the standards implementation specifications and certification criteria issued by ONC, 2014 Edition, and this specifies the data and standards requirements for certified electronic health record technology needed to achieve meaningful use. On the other side, there�s Medicare and Medicaid�s EHR Incentive Program Stage 2, published by CMS, which outlines incentive payments for early adoption as well as payment adjustments for late adoption or non-compliance. Stage 2 of the meaningful use program can be broken down into seven different categories for objectives which reflect health outcome policy priorities, and those categories are privacy and security, public health, utilization, clinical, clinical quality measures, care coordination, and patient engagement. For the purposes of this session, we�ll be focusing on the areas of care coordination and patient engagement which are the certification categories where the use of the consolidated CDA standard is required. Within the care coordination and patient engagement categories, there are five separate criteria that all require the use of the consolidated CDA. Both of the Transition of Care criteria, the Data Portability criterion, the View, Download and Transmit criterion, as well as the Clinical Summary Criterion. Within each certification criterion associated with the consolidated CDA standard, a summary type is defined. In the case of the Transitions of Care criteria, there�s a transition of care referral summary defined. These summary types merely correspond to the unique set of data requirements that are required within any document pursuing that certification criterion. In many cases, data requirements are a combination of the common MU data set (which is defined in the final rule) as well as criterion-specific data requirements. In many cases, the data requirements additionally have vocabulary requirements stipulated that need to be met when communicating the specific data requirement identified. The goal of identifying a vocabulary requirement is to identify a unique value for a clinical concept. On this slide you�ll see the smoking status vocabulary requirement that�s required by the certification criterion. The goal here is that by standardizing a distinct set of codes for a clinical concept, the Meaningful Use program use of vocabularies promotes the use of common definitions when sharing definitions across diverse clinical environments. So what are the purpose, functionality, usage, and structure of HL7�s Clinical Document Architecture? The Clinical Document Architecture, or CDA, was developed by HL7, which is an international not for profit standards development organization with many members across 500 corporations including over 90% of the IS vendors serving Healthcare. HL7 is dedicated to providing a comprehensive framework for the exchange and management of health information. Now CDA, the Clinical Document Architecture, is a base standard which provides a common architecture, coding, semantic framework, and markup language for the creation of electronic clinical documents. CDA documents are encoded in Extensible Markup Language, or XML. HTML is used to describe the presentation, while XML frames the content. All CDA documents are both human readable and machine interpretable. CDA uses templates, with standardized groupings of information organized according to clinical context, and it�s also object oriented which makes use of classes, associations, and inheritances, and allows tremendous flexibility for re-use. CDA defines building blocks which can be used to contain healthcare data elements that can be captured, stored, accessed, displayed and transmitted electronically for use and reuse in many formats. Sets of these CDA standardized building blocks can then be arranged for whatever needs exist. This approach offers tremendous flexibility; it allows for the creation of a comprehensive variety of clinical documents which share common design patterns but use a single base standard. Arranging (or constraining) the CDA elements in defined ways using Implementation Guides, or IGs, and templates produces clinical documents. For example, a discharge summary and an operative note both draw from the same CDA schema but are scoped for different use cases. The point of CDA, and the functionality of it, is to define a structure of building blocks which can be used to contain a multitude of healthcare data elements that can be captured, stored, accessed, displayed, and transmitted electronically for use and reuse in many formats. Now, CDA does not specify how documents are transported, simply how the critical data elements should be encoded for exchange and interoperability. CDA can also contain both structure and unstructured information. The general structure of the CDA document is consistent between documents that contain structured content. It starts with a header, which sets the context for the document, and then has a body, which may be made up of multiple sections, with each section being made up of zero or more entries. Every CDA document that contains structured content must have at least a header and at least one section. Now XML is used to enable both human and machine readability of CDA documents, and the XML structure for a CDA document nests data in the following way: first there�s a header, and then the body, which contains one or more section, and within each section there is first a narrative block, describing in readable terms the information to be conveyed, and then, in some cases, there are coded entries which contain machine readable versions of the clinical information to be described. The header sets the context for the clinical document as a whole, and it enables clinical document exchange across and within institutions by identifying the context for the document. It facilitates clinical document management, and it facilitates compilation of an individual patient�s clinical documents into a electronic patient record. The body of a document contains the clinical data and in can contain an unstructured blob in the form of a scanned image, a text file, or any other file, or structured content organized into one or more sections. Each section contains at least a narrative block, and also can contain zero or many coded entries. Examples of sections would be allergies, medications, problems, immunizations, and vital signs. The narrative block within each section allows the �human-readability� of a CDA document. Within a document section, the narrative block represents the content to be rendered for viewing. The narrative block has fixed markup, and must be populated by the document originator. Entries allow the �machine-readability� of the data in a CDA document. The goal of entries is to convey the same information that is included in the narrative block, but in a format that a computer program could understand and incorporate into an EHR Technology on the receiving side. So why Consolidated CDA? Before Consolidation, providers trying to implement a specific clinical document (for example, the C32) were faced with a rabbit hole of cross-referenced materials creating an ever growing, complex web of documentation � the Consolidation effort was undertaken to address this issue. Duplicative and conflicting implementation guides published by different standards organizations had been balloted and approved at different times. Implementers were faced with confusing collections of documents containing ambiguous or sometimes conflicting guidance. The Consolidated CDA Implementation Guide included the following clinical documents: the consultation note, discharge summary, imaging integration and DICOM diagnostic imaging reports, history and physical, operative note, progress note, procedure note, and the unstructured document. As disparate standards development organizations developed CDA implementation guides, multiple approaches for documenting template requirements began to diverge, threatening interoperability. The Standards & Interoperability Framework within ONC hosted a collaboration among the standards community in order to address CDA documentation issues which were hampering understanding and consistent implementation in order to examine and analyze CDA Templates across the existing documentation, to identify and address errors, issues of ambiguity, and conflict, and to consolidate prior documentation into a new single Implementation Guide and ballot through HL7. The Consolidation effort harmonized and balloted previous templates into a single Implementation Guide. The goal of the Consolidated CDA Implementation Guide was to provide a single source for CDA templates for common use cases. They included templates for nine document types, which are comprised of 60 different section templates, and across those sections there are 82 distinct entry templates. A modular approach was used, and where possible sections and entries were reused across parent templates. For example, on the right of your screen, you can see that between the Continuity of Care Document, or CCD, and the History & Physical, which sections are highlighted, as those are sections which are reused and the definition of each is identical across the different documents. The Consolidated CDA Implementation Guide has five chapters and an appendix. The first chapter is an introduction defining the scope and goals for the implementation guide, but then it�s broken down by template types. Chapter 2 covers the general header, Chapter 3 covers the various document templates, Chapter 4 the section templates, and Chapter 5 the entry templates. In the appendices you can find non-normative content that�s intended to be present in order to help implementers. So how is the Consolidated CDA Implementation Guide used to achieve applicable Meaningful Use objectives? CDA is the base standard for building electronic documents. Templates provide the building blocks for clinical documents. To help simplify implementation, commonly used templates were harmonized from existing CDA implementation guides and consolidated into a single implementation guide � the Consolidated CDA implementation guide. CDA standardizes the expression of clinical concepts which can be used and re-used. Templates are used to specify the packaging for those clinical concepts. Sets of CDA templates are arranged in a specific format to create a purpose-specific clinical document. Meaningful Use then adds data requirements, which can be layered on top of the Consolidated CDA document templates to achieve Meaningful Use compliance. A key note is that no specific Consolidated CDA document template contains all of the data requirements to sufficiently meet Meaningful Use certification criteria. Consolidated CDA and Meaningful Use guidelines must be implemented together. This concludes the first part of ONC�s three part self-paced module on Implementing Consolidated Clinical Document Architecture for Meaningful Use Stage 2 and the 2014 Edition EHR Certification Criteria. In part 2, we will discuss C-CDA implementation in greater detail. Additional information and helpful resources are available at the links below.