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EHR Clinical Forms: Requirements

The caBIG® Clinical Information Suite is a form driven system for data entry by physicians, nursing staff, and ancillary providers. Changes in the health care landscape across the United States over the last several years has led to new requirements for data structure and semantics. These new requirements have led to the need to deal with "meaningful use" semantics in our form structures. One prominent requirement is the need for any EHR system to use the new semantics in order for providers using these systems to be paid for the care they provide to particular patients. Hence lack of adoption of these data standards could lead to diminished availability for cancer patient care if the physician market shrinks through financial attrition.

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To serve these many uses, the context and semantics of data entry must be captured and persisted to a backend data store without loss of meaning. To enable this goal of robust data capture, the forms used to capture the data elements must be semantically structured and linked in context using standards-based information models and explicit terminology with traceability through value set identifiers and coded concept identifiers, allowing aggregation and disambiguation of the captured data.

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The EHR Clinical Forms use case has two primary goals. The first goal involves a form designer and construction of a clinical data entry form for use in the graphical user interface of the caBIG® Clinical Information Suite. This form must be semantically consistent and based on HL7 Reference Information Model (RIM) objects, HL7 structural vocabulary, and Office of the National Coordinator (ONC) required code systems for meaningful use. (caBIG® wishes to adhere to regulations /and rules from the ONC). The second goal involves the data entry person (a physician, nurse or other health care provider) who defines the value set requirements for the form elements, identifies the rules for skip patterns and form element arrangement, and eventually enters and persists clinical data.

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• When a form is loaded in the caBIG® Clinical Information Suite graphical user interface for the first time, the caBIG® Clinical Information Suite system passes the form identifiers to the repository.
• The repository evaluates the identifiers against known templates or HL7 form objects and passes the identifiers to the CTS service to return all identified enumerated value sets.
• The enumerated value sets are returned and bound to the form controls as pick lists and cached by the caBIG® Clinical Information Suite system for future use.
• Subsequent form loading refreshes the cache by value set versions.

Naïve (initial) form submissions from the Enterprise Conformance and Compliance Framework (ECCF) registry perspective are routed to the form design scenario for value set construction invoking the caBIG® Clinical Information Suite Clinical Form Design use case for control binding to terminology.

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A user of the caBIG® Clinical Information Suite uses the 7th Edition of the American Joint Committee on Cancer (AJCC) Cancer Classification system to stage cancer patients. The 8th Edition has now come out and the user would like to upgrade the system to meet the requirements of the state cancer registry. Re-coding the infrastructure for all cancer types in Java is expected to be quite expensive and time consuming. The user queries the ECCF registry for "AJCC Cancer Classification" and finds a plugin reasoner service that implements an OWL version of the AJCC 8th Edition classification system capable of inferring an anatomic stage based on data directly from pathology, imaging, and clinical exam input through a service. The user's system is now able to move with the speed of Cancer Registry requirements rather than the pace of the software vendor.