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C-CDA Constraints. FACA - Strategy Discussion June 23, 2014 Mark Roche, MD. Constraints - Agenda. Definitions and Overview Examples Benefits and Drawbacks Constraint Levels Use of Companion Guide Constraints Opportunities and Management Discussion/ QA. Constraints - definition.
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C-CDA Constraints FACA - Strategy Discussion June 23, 2014 Mark Roche, MD
Constraints - Agenda • Definitions and Overview • Examples • Benefits and Drawbacks • Constraint Levels • Use of Companion Guide • Constraints Opportunities and Management • Discussion/ QA
Constraints - definition • Constraints in terms of HL7 structured documents (in simple terms): • Rulesimposed on data that is being collected and/or exchanged • For example: • Data element SHALL (or must) be present • If data element cannot be provided nullFlavormust be provided • Data element values SHALL be drawn from one or more code systems • Sometimes the word Constraintis used synonymously with Optionality • inversely related more constraints = less optionality
Constraints: conformance verbs, nullFlavors and negation Indicators • SHALL: data must be provided; the data is Required • SHOULD: best practice; the data is Optional • MAY: a placeholder to provide data if user wants to; the data is Optional • nullFlavors: a way to satisfy data element requirement when data is unknown (e.g. not available, no information,…) • Any Data Element may use nullFlavor. • Attributes use negation Indicators.
Constraints: pros and cons Pros Cons • Improved consistencyof structured document contents • Improved semantic interoperability • For example, if data element contains the values from onecoding system/value set as opposed to multiple code systems. • Improved predictabilityand reliabilityof information available to the user • Consistent implementationof standards across vendors. • Data element requirements differ based on clinical or administrative intent • Requirement to capture data that may not be relevant to clinical or administrative intent (case) • Systems may be required to extend their databases and GUIsto capture more fields than they do now. • Semantic and structural overload of CCDA templates. • E,g. Smoking Status (MU2) required a new CCDA template (Smoking Status Observation) to satisfy MU2 reqs.
Constraints Levels • Document (CCD, Progress Note, Discharge Summary) • Sections • Entries (free-texted narrative vs coded) • Data Elements (DE) (name, value, code, effectiveTime) • Optionality (SHALL, SHOULD, MAY) • Value (Vocabulary) • Binding (SHALL, SHOULD, MAY) • Type (e.g. just LOINC, vs LOINC OR SNOMED CT) • nullFlavor values • Data Element (DE) Attributes (@code, @codeSystem, @displayName) • Optionality (SHALL, SHOULD, MAY) • Value (Vocabulary) • Binding (SHALL, SHOULD, MAY) • Type (e.g. just LOINC, vs LOINC OR SNOMED CT) • nulFlavors
Constraints Levels - graphic <clinicalDocument> (CCD, Discharge Summary, Progress Note,..) Document Type <header> (document ID, author, patient ID…) Document Sections <section> [Procedures] Entries (free-text vs coded) <entry> (Colonoscopy) procedure Code: 73761001 procedure Date: Jul 1, 2010 procedure Name: Colonoscopy code 73761001 codeSystemSNOMED CT codeSystemOID2.16.840.1.113883.6.96 displayName Data Elements (DE) Data Element (DE): Value Sets/Code System Binding DE Attributes DE attribute: Value Sets/Code System Binding <section> [CurrentMedications] <entry> [ASA] <entry> [Warfarin]
“Companion Guide” (CG) • Provides supplemental guidance an offers practical guidance on how to implement CCDA in light of 2014 Ed. CEHRT requirements • CG is informative and does not impose new constraints beyond those that already exist in C-CDA and in 2014 Ed. CEHRT requirements. • In terms of constraints, CG: • Summarizes existing constraints from CCDA • Ties (maps) CCDA constraints to MU2 requirements. • Provides practical examples for implementers to improve consistency • Recommends adding sections to CCD
Opportunities • Require more data elements (DE) to be collected • (MAY/SHOULD SHALL) • Provide more guidance on where to use nullFlavorsor negation indicators if information is not available. • Reduce the number of code system options for DEs • Narrow code system breadth • Require consistent information for attributes
Example 3: Tighten vocabulary options • Vocabulary options • ICD-9 • Vocabulary breadth (within a code system) • SNOMED CT C-CDA R1.1 C-CDA R2.0
Example 4: Tightening attributes (by declaring and tightening)
Constraints Management - Options • Constraining underlying (CDA) or derivative (C-CDA) standard • Balloting process through HL7 required • 3 times/ year • Time consuming process (July 2012 -> Sep 2014) • Updating base standard often involves other structural improvements to standard in addition to constraints (e.g. new datatypes, new templates, new sections, new entries…etc) • Ballot passing is subjected to approval of all changes to standard (not just tighter constraints) • Constraining “Companion Guide to C-CDA for MU” • Balloting process through HL7 required • Tied to specific version of standard (e.g. CCDA 1.1, CCDA 2.0) • May require updates if underlying standard version changes • Can be more targeted to constraining data elements. • Constraining directly in CFR (specify directly in CFR all DE constraints) • Lengthy and complex. • Not tied to specific version of standard • May require Implementation guide that ties CFR reqs. To standard