CDA Tutorial. Understanding CDA Templates
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1 CDA Tutorial Understanding CDA Templates Austin Kreisler Consultant CDC Leidos Technical Fellow National Center for Chronic Disease Prevention and Health Promotion Division of Cancer Prevention and Control
2 CDA Overview What is clinical documentation? Characteristics of clinical documents HL7 CDA structure overview CDA s Templates Q/A and Discussion
3 What is Clinical Documentation? Documentation of clinical observations and services Includes but is not limited to documentation appearing in a patients medical record Includes the documentation of any care provided to a patient, regardless of care setting Examples: History and Physical Notes Care Summaries Laboratory Reports Imaging Reports Operative Notes
4 Characteristics of a Clinical Document Persistence A clinical document continues to exist in an unaltered state, for a time period Stewardship A clinical document is maintained by an organization entrusted with its care Potential for authentication - A clinical document is an assemblage of information that is intended to be legally authenticated Context - A clinical document establishes the default context for its contents Wholeness - Authentication of a clinical document applies to the whole Human readability A clinical document is human readable
5 HL7 CDA Structure Overview
6 CDA Structure - Header Metadata about the document Focused on data for document Indexing Document authentication Document context Supports document management
7 Header HL7 CDA Header
8 CDA Structure Body Unstructured Body provides a container for non-xml content Structured Body that provides both structured human readable narrative as well as machine readable content Narrative block that provides the human readable content and represents the authenticated content of the document Entries that optionally provide a discrete, machine readable representation of the document content
9 HL7 CDA Body Body Unstructured Structured Narrative Structured Entries
10 Structured Narrative & Structured Entries Structured Narrative Section text Human readable text that represents the attested content of the document Structured Entries Entries Machine processable discrete data Two kinds of relationships between the Section text and contained Entries Derived (DRIV) The information in Section text is intended to be a faithful and complete rendering of the clinical content of the contained entries Component (COMP) The entries considered as being contained in the source section and no other meaning is implied.
11 CDA & XML XML is Extensible Markup Language ( In XML, structure and format are conveyed by markup which is embedded into the information <markup>text</markup> <section> <title>hospital Course</title> <text> The patient was admitted and started on Lovenox and nitroglycerin paste. The patient had serial cardiac enzymes and was ruled out for myocardial infarction. The patient underwent a dual isotope stress test. There was no evidence of reversible ischemia on the Cardiolite scan. The patient has been ambulated. </text> </section>
12 XML Designed to describe data Tags (the text between the angle brackets <Tag> ) is not predefined Intent is that the tags be self descriptive Use <name> instead of <x> if you are intending to convey the name of something XML doesn t do anything on its own You need some sort of processor to deal with XML
13 XML Example <?xml version="1.0" encoding="utf-8"?> <memo> <to>dick</to> <from>jane</from> <subject>taking a walk</subject> XML declaration at the beginning Closing tag has a leading backslash An XML Element includes matching opening and closing tags Required root element <body>we should take a <b><i>walk</i></b> up the hill</body> </memo> Elements must be properly nested
14 CDA s Dirty Little Secret It s built on the HL7 Version 3.0 RIM HL7 V3 has a reputation for being too complex CDA s has a secret weapon for dealing with V3 Complexity called -
15 TEMPLATES Templates CDA s Secret Weapon In engineering, complex problems can some times be solved by breaking the problem down into smaller parts and finding solutions for the small parts CDA Templates do exactly this CDA Implementation Guides Essentially a collection of templates gathered to together for a particular purpose
16 What is a Template? A template represents a formal definition of a set of constraints on a model A template has two parts: Metadata such as an identifier, version, description, etc. Body that contains the actual constraints Templates can be seen as a "set of instructions" for the proper creation of an instance of data for a specific use
17 CDA Templates - Levels of Constraint The CDA standard describes conformance requirements in terms of three general levels corresponding to three different, incremental types of conformance statements: Level 1 requirements impose constraints upon the CDA Header. The body of a Level 1 document may be XML or an alternate allowed format. If XML, it must be CDA-conformant markup. Level 2 requirements specify constraints at the section level of a CDA XML document: most critically, the section code and the cardinality of the sections themselves, whether optional or required. Level 3 requirements specify constraints at the entry level within a section. A specification is considered Level 3 if it requires any entry-level templates.
18 Types of Templates Document-level templates: These templates constrain fields in the CDA header, and define containment relationships to CDA sections. Section-level templates: These templates constrain fields in the CDA section, and define containment relationships to CDA entries. Entry-level templates: These templates constrain the CDA clinical statement model in accordance with real world observations and acts. Other templates: These templates group a common set of constraints for reuse in CDA documents.
19 HL7 CDA Templates Conformance Statements CDA Templates are expressed as a collection of Conformance Statements Conformance statements constrain some aspect of a CDA class or classes Example: SHALL contain exactly one Observation (CodeSystem: HL7ActClass) STATIC (CONF:7345)
20 Constraint Types Optionality (aka. Appearance): determine whether a particular element must appear in models or messages derived from the base model, and/or whether the element is precluded from appearing therein. Cardinality: define the number of repetitions that may occur for a given element. Type: limit the structure (datatype) of the element in question. Vocabulary: limit the set of concepts that can be taken as valid values in an instance of a coded attribute or field.
21 Optionality Constraints - Conformance Verbs SHALL: an absolute requirement SHALL NOT: an absolute prohibition against inclusion SHOULD/SHOULD NOT: best practice or recommendation. There may be valid reasons to ignore an item, but the full implications must be understood and carefully weighed before choosing a different course MAY/NEED NOT: truly optional; can be included or omitted as the author decides with no implications
22 Cardinality Constraints Number of times a repeating element may appear in a CDA document instance Expressed as a minimum and a maximum values: [0..1] Examples: [0..1] as zero to one present [1..1] as one and only one present [1..*] as one or more present [0..*] as zero to many present [0..0] as zero present
23 Type Constraints All attributes in HL7 V3 models (such as CDA) have an associated data type Data types are essentially a collection attributes that describe the data being conveyed All the V3 data types derive from a data type called ANY The most common data type constrain in templates is for the Observation.value attribute which uses the ANY data type In a CDA Observation template, a specific data type needs to be assigned to the Observation.value Example: SHALL contain exactly one [1..1] value xsi:type is the XML schema language mechanism for overriding an element s base data type
24 Examples: xsi:type <value xsi:type="cd" code="t2 codesystem=" codesystemname="tnm 7. Edition" displayname="tumor > 20 mm but <= to 50 mm in greatest dimension"/> <value xsi:type="pq" value="57" unit="a"/>
25 Vocabulary Constraints Limit the set of concepts that can be taken as valid values in an instance of a coded attribute or field Single code binding Limiting the value to a single coded value Example: SHALL contain exactly one [1..1] code/@code=" " Usual Occupation Hx (CodeSystem: LOINC ) Value Set binding Limiting the set to a value set of allowed codes SHALL contain exactly one [1..1] value to record the occupation of the patient, where SHALL be selected from ValueSet Census Occupation Codes DYNAMIC. Value-set constraints can be STATIC, meaning that they are bound to a specified version of a value set, or DYNAMIC, meaning that they are bound to the most current version of the value set.
26 Vocabulary Constraints Code system constraint narrows the allowed values to a single or multiple code systems where the code SHALL be selected from LOINC (CodeSystem: ) or SNOMED CT (CodeSystem: ) (CONF:7166).
27 OIDs ISO Object Identifier A string of numbers and dots that are used to uniquely identify something (an object) HL7 uses OIDs to identify coding systems and value sets CDA Templates use OIDs to uniquely identify the template SHALL contain exactly one [1..1] templateid such that it a. SHALL contain exactly one
28 Code System vs. Value Set OIDs SHALL contain exactly one [1..1] targetsitecode CD to indicate the anatomic location where the primary tumor originated. a. The targetsitecode SHALL contain exactly one where SHALL be selected from Value Set Body Site (SNOMED CT) DYNAMIC Wrong: <targetsitecode xsi:type="cd" code=" " codesystem=" " codesystemname="snomed CT" displayname="entire breast"> Correct: <targetsitecode xsi:type="cd" code=" " codesystem=" " codesystemname="snomed CT" displayname="entire breast">
29 Representing Null Flavors Null Flavor A mechanism for handling the situation where you have incomplete data The data may be completely or partially missing or it may be present but not valid according to constraints Provides a reason why data is absent Example: <birthtime nullflavor= UNK />
30 Null flavor Coded Values NI - No information - default null flavor. NA - Not applicable - Known to have no proper value UNK Unknown - Proper value is applicable, but is not known ASKU - Asked, but not known - Information was sought, but not found NAV - Temporarily unavailable NASK - Not asked MSK - There is information on this item available but it has not been provided by the sender due to security, privacy, or other reasons OTH Other - actual value is not a member of the set of permitted data values
31 Null Flavors and CDA Templates Templates may require the presence of data even when the document originator has no data Example: SHALL contain at least one [1..*] id <id nullflavor="ni"/> Example: SHALL contain exactly one [1..1] code <code nullflavor="oth"> <originaltext>new Grading system</originaltext> </code>
32 Null Flavor Explicitly Disallowed in a Template 1. SHALL contain exactly one [1..1] effectivetime a. SHALL NOT contain [0..0] nullflavor Note: The above use of SHALL NOT for null flavors isn t actually used in the current IG: Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, Release 1.0, August 2012
33 Unknown Information If the sender doesn t know an attribute of an act, that attribute can be null. <entry> <text>patient was given a medication but I do not know what it was</text> <substanceadministration moodcode="evn" classcode="sbadm"> <consumable> <manufacturedproduct> <manufacturedlabeleddrug> <code nullflavor="ni"/> </manufacturedlabeleddrug> </manufacturedproduct> </consumable> </substanceadministration> </entry>
34 Unknown Information If the sender doesn t know if an act occurred, the nullflavor is on the act (detail could include specific allergy, drug, etc.) <entry> <substanceadministration moodcode="evn" classcode="sbadm" nullflavor="ni"> <text>i do not know whether or not patient received an anticoagulant drug</text> <consumable> <manufacturedproduct> <manufacturedlabeleddrug> <code code=" " displayname="anticoagulant drug«codesystem=" " codesystemname="snomed CT"/> </entry>
35 Unknown Information If the sender wants to state no known, a negationind can be used on the corresponding act (substanceadministration, Procedure, etc.) <entry> <substanceadministration moodcode="evn" classcode="sbadm" negationind= true > <text>no known medications</text> <consumable> <manufacturedproduct> <manufacturedlabeleddrug> <code code=" " displayname="drug or medication codesystem=" codesystemname="snomed CT"/> </manufacturedlabeleddrug> </entry>
36 What s Next Cancer CDA Training Part 2 Hierarchy of validation tools and appropriate order of use Walk-through of CDA document marked up with instructions for how to find relevant data elements Case studies review actual examples from vendor reports to see types of errors and understand their possible causes
37 QUESTIONS For additional questions, please Lindsay Ryan at
38 Austin Kreisler HL7 Subject Matter Expert - Technical Fellow Leidos Health Solutions mobile: duz1@cdc.gov austin.j.kreisler@leidos.com For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA Telephone, CDC-INFO ( )/TTY: cdcinfo@cdc.gov Web: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for Chronic Disease Prevention and Health Promotion Division of Cancer Prevention and Control
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