Guidelines for Domain Analysis Model Development in Clinical Interoperability

1. Domain Analysis Model Development Guidelines Clinical Interoperability Council Working Group

2. Acknowledgment • Anita WaldenPrepared the initial presentation, allowed the use of material from earlier presentations. • Abdul-MalikShakirProvided definition and discussion of DAM components based on work for NCI.

3. Healthcare Data Systems Data Uses Patient care Quality Improvement Research Reimbursement Post Marketing Safety Decision Support Administration & Mgt. Public Health Reporting … Clinician Patient Purpose of a DAM: Multiple Uses Single Source

4. Construction Procedures • Standardize at source  healthcare • Data element as atomic unit of exchange • Specificity sufficient for semantic interoperability • Include all Stakeholders Examples • Public Health Representation  CDC • Quality Imp.  Professional Societies • Research representation  CDISC,NIH,FDA

5. Goals for the Guide • Provide CIC DAM project groups with a guide on developing Clinical DAMs • Promote reuse of DAM components in subsequent DAM projects • Provide DAMs with similar designs: increase consistency for smoother harmonization, for integration with other DAMs and HL7 artifacts • Improve the quality of the specifications used to develop HL7 products: messages, EHR profiles, CDAs

7. What is a DAM? • An analysis model developed to improve communication between stakeholders from different organizations. This requirements document is used to formally define and structure data and/or process information to develop specifications within HL7 (e.g., Messaging, EHR functional models, DCMs).

8. HL7 Educational Resources Tutorials relating to working on DAMs: • Introduction to the HDF • Domain Analysis Modeling • Introduction to UML • Introduction to Project Insight • Introduction to V3

9. DAM and the HL7 Process • First comes the project statement • Determine who is involved • Collaborate with the relevant working groups • Include international communities & affiliates • Follow the HDF/SAEF process • Ballot as an informative document

10. DAM Components • An HL7 Domain Analysis Model (DAM) is not simply an information model. • The DAM may include multiple diagram types. This section discusses the components of a DAM, and their relationships.

11. ECCF (Enterprise Conformance and Compliance Framework) Components in a picture

12. Story Board/Scenario • Rationale: Provide a story of some relevant occurrence – sequence of events. • Example: Wallace Wackyford, a Fun Store employee, submitted an adverse event report to the FDA to report an incident after being contacted by the principal of the Central Z Middle School. A black color face paint (item# 5), produced by Coverings Corporation, as listed on the label, was applied to the students as part of a special theme day. Approximately 300 students received an application of face paint with different brushes. The following day, approximately 70 - 80 students reported having a rash on their face. Later the number of rashes had accumulated to approximately 173. A dozen or so students sought medical treatment. Medical information was not included in the report from Mr. Wackyford. The report was sent electronically using a web-based form. The web-based form translates the information into an HL7 ICSR and routes the report to the appropriate FDA safety evaluator for analysis.

13. Use Cases • Rationale: Provide a more formal treatment of requirements than the storyboard. • Describes a sequence of actions that provide a measurable value to an actor. • The formality includes: • Identifying use case actors, • showing how actors participate in use cases, • defining the associations between use cases • Example: See over

15. Data Elements • Rationale: Represent the data in a way that is more intuitive to clinicians (non modelers) than a class mode (or use case diagram, or activity diagram) • Allows easy pulling from forms or existing lists • Easy to consider as the unit of data exchange Example:

16. Example Part Two Data Element Name: History of peripheral vascular disease Clinical Definition: Indicate if the patient has a history of peripheral vascular disease. This can include:1. Claudication either with exertion or at rest.2. Amputation for arterial vascular insufficiency.3. Aorto-iliac occlusive disease reconstruction, peripheral vascular bypass surgery, angioplasty or stent; or percutaneous intervention to the extremities.4. Documented abdominal aortic aneurysm (AAA) repair or stent.5. Positive non-invasive/invasive test.This does not include procedures such as vein stripping, carotid disease, or procedures originating above the diaphragm. Valid Values: Yes, No

17. Class & Attribute Component • Rationale: represent the information needs of the domain with more formality than the data element list • Show how data elements clump into classes • Define relationships between classes. • Supports downstream migration: • Ease the creation of HL7 RIM based specifications. • Create an entry point for CaDSR migration. • Example: See over

18. TB Class Component

20. Class Model & Data Elements • Both represent the information content of the DAM • Can often be reviewed separately: • Clinicians reading the list of elements • Modelers & HL7ists examining the class diagram, class descriptions, attribute descriptions. • Keeping these synchronized can be difficult. It always involves work.

21. Activity Component • Rationale: Express workflow within the domain • Identify specific activities, • Show the sequence and conditionality of activities, • Use “swim lanes” to provide hints on where data exchanges take place. • Example: See over

22. Cardio-vascular DAM Activity Component

24. State Machine Component • Rationale: Show the behavior of an individual class within the class diagram. When used for critical classes, it exposes the need for a service or message specification. • Example: So far, we don’t have a DAM that has built one.

25. Working with a Data Repository Class Components are deposited in CaDSR and therefore the requirements should follow their submission criteria

26. Next Steps • Complete Modeling Guides for each Model Component • Work with development teams to use and improve the modeling guide • Support fuller implementation of DAM building into the HL7 process

27. Are there any questions?