Non-Normative Content The Normative content for these specifications may be found on the HL7, IHE, and HITSP web sites.

Conventions Used in This Guide

Conformance Requirements

Conformance statements are grouped and identified by the name of the template, along with the templateId and the context of the template (e.g., ClinicalDocument, section, observation), which specifies the element under constraint. If a template is a specialization of another template, its first constraint indicates the more general template. In all cases where a more specific template conforms to a more general template, asserting the more specific template also implies conformance to the more general template. An example is shown below.

Figure 1. Template name and "conforms to" appearance
Template name

[<type of template>: templateId <XXXX.XX.XXX.XXX>]

Description of the template will be here .....

  1. Conforms to <The template name> Template (templateId: XXXX<XX>XXX>YYY).
  2. SHALL contain [1..1] @classCode = <AAA> <code display name> (CodeSystem: 123.456.789 <XXX> Class) STATIC (CONF:<number>).
  3. .......

The conformance verb keyword at the start of a constraint ( SHALL , SHOULD , MAY, etc.) indicates business conformance, whereas the cardinality indicator (0..1, 1..1, 1..*, etc.) specifies the allowable occurrences within an instance. Thus, " MAY contain 0..1" and " SHOULD contain 0..1" both allow for a document to omit the particular component, but the latter is a stronger recommendation that the component be included if it is known.

The following cardinality indicators may be interpreted as follows:

0..1 as zero to one present
    1..1 as one and only one present
    2..2 as two must be present
    1..* as one or more present
    0..* as zero to many present
    

Value set bindings adhere to HL7 Vocabulary Working Group best practices, and include both a conformance verb ( SHALL , SHOULD , MAY, etc.) and an indication of DYNAMIC vs. STATIC binding. The use of SHALL requires that the component be valued with a member from the cited value set; however, in every case any HL7 "null" value such as other (OTH) or unknown (UNK) may be used.

Each constraint is uniquely identified (e.g., "CONF:605") by an identifier placed at or near the end of the constraint. These identifiers are not sequential as they are based on the order of creation of the constraint.

Figure 2. Template-based conformance statements example
  1. SHALL contain [1..1] component/structuredBody (CONF:4082).
    1. This component/structuredBody SHOULD contain [0..1] component (CONF:4130) such that it
      1. SHALL contain [1..1] Reporting Parameters section (templateId:2.16.840.1.113883.10.20.17.2.1) (CONF:4131).
    2. This component/structuredBody SHALL contain [1..1] component (CONF:4132) such that it
      1. SHALL contain [1..1] Patient data section - NCR (templateId:2.16.840.1.113883.10.20.17.2.5) (CONF:4133).

CCD templates are included within this implementation guide for ease of reference. CCD templates contained within this implementation guide are formatted WITHOUT typical KEYWORD and XML element styles. A WIKI site is available if you would like to make a comment to be considered for the next release of CCD: http://wiki.hl7.org/index.php?title=CCD_Suggested_Enhancements The user name and password are: wiki/wikiwiki. You will need to create an account to edit the page and add your suggestion.

Figure 3. CCD conformance statements example
  1. The value for "Observation / @moodCode" in a problem observation SHALL be "EVN" 2.16.840.1.113883.5.1001 ActMood STATIC. (CONF: 814).
  2. A problem observation SHALL include exactly one Observation / statusCode. (CONF: 815).
  3. The value for "Observation / statusCode" in a problem observation SHALL be "completed" 2.16.840.1.113883.5.14 ActStatus STATIC. (CONF: 816).
  4. A problem observation SHOULD contain exactly one Observation / effectiveTime, to indicate the biological timing of condition (e.g. the time the condition started, the onset of the illness or symptom, the duration of a condition). (CONF: 817).

Keywords

The keywords SHALL, SHALL NOT, SHOULD, SHOULD NOT, MAY, and NEED NOT in this document are to be interpreted as described in the HL7 Version 3 Publishing Facilitator's Guide:

XML Examples

XML samples appear in various figures in this document in a fixed-width font. Portions of the XML content may be omitted from the content for brevity, marked by an ellipsis (…) as shown in the example below.

Figure 4. ClinicalDocument example
<ClinicalDocument xmlns=’urn:h17-org:v3’>
  ...
</ClinicalDocument>

XPath expressions are used in the narrative and conformance requirements to identify elements because they are familiar to many XML implementers.