CDA Implementation Guide Quality Criteria

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Project Scope Statement (approved by SDWG, pending TSC approval): http://wiki.hl7.org/index.php?title=File:HL7_Project_Scope_Statement_v2012_Quality_Criteria_for_CDA_IGs.06Sept2012.docx

Timeline:

• Draft list by end of Dec 2012;
• Test the use of the list against Jan 2013 ballot;
• Finalize list by end of March 2013;
• Do some good stuff with the list after that.

Implementation Notes:

• These guidelines apply to normative, informative, and STU documents. For comment-only ballots need not conform to all the rules.

Suggested CDA Implementation Guide Quality Criteria

• Title page

http://www.hl7.org/participate/templates.cfm?ref=nav

• • [Jan 14, 2013 Approved for use] Title is specified
    • [Apr 16, 2013 DGL Suggested Revision] Suggest Title is specified and matches the 'official' HL7 name as identified either in the ballot announcement or publication request.
  • [Jan 14, 2013 Approved for use] Version of base standard is specified (e.g. CDA R2)
  • [Jan 14, 2013 Approved for use] Realm(s) is/are specified
  • [Jan 14, 2013 Approved for use] Ballot type (e.g. DSTU, Informative, etc) is specified
    • [Apr 16, 2013 Suggested Revision] Suggest Ballot / publication type (e.g. DSTU, Informative, etc) is specified
  • [Jan 14, 2013 Approved for use] Date of ballot / publication is specified
  • [Jan 14, 2013 Approved for use] HL7 International logo and copyright are present
  • [Jan 14, 2013 Approved for use] HL7-approved title page is used and not changed (i.e. title page is approved by HQ).
    • [Apr 16, 2013 DGL Additional Clarification] Note that the correct title page may change depending upon whether the document in question is up for ballot, being published as a DSTU, being published as an Informative document, or being published as a ANS.
    • [Apr 16, 2013 DGL Additional Title Page Requirements] Note that the Title page SHALL contain the correct HL7 ballot or publication identifier (assigned by HL7 HQ and, for ballot items, available in the ballot announcement)
    • [Apr 16, 2013 DGL Additional Title Page Requirements] Note that the Title page SHALL contain the correct and appropriate HL7 copyright information and IP Compliance statement (noting that on final publications, the IP Compliance statement is placed by itself on page 2.
    • [Apr 16, 2013 DGL Additional Title Page Requirements] Note that for Technical Reports, the title page shall contain the following text: "A Technical Report prepared by Health Level Seven International and registered with ANSI: [technical report ANSI registration date]"
  • [Aug 8,2013 DGL Additional Title Page Requirements] When appropriate, the title page or introductory material will contain the appropriate front matter recognizing LOINC.

• Templates
  • [Jan 14, 2013 Approved for use] Each template has a narrative description
  • [Jan 14, 2013 Approved for use] Each template has a globally unique identifier
    • [Sept 21, 2016 Suggested Revision] The template identifier contains both root and extension, with the extension containing the date of the template in YYYY-MM-DD format.
  • [Jan 14, 2013 Approved for use] Constraints are ordered within a template per the XML ITS ordering rules
  • [Sept 21, 2016 Consider for future use] Requirements should be captured in a publicly accessible (and discoverable) place.
  • [Jan 14, 2013 Consider for future use] Constraints should be traceable to requirements
  • [Mar 21, 2013 Approved for use] Constraint conformance numbers should be present during ballot, but must be present for final publication. Each conformance number must be unique within the guide.
  • [Sept 21, 2016 Consider for future use] Constraints should be testable whenever possible. Consider expressing non-testable constraints as narrative guidance instead.

• Display of template references and inheritance
  • [Feb 7, 2013 SDWG: In the IG Publishing subgroup queue for consideration] Guide specifies both normative and inferred or inherited constraints, but clearly differentiates between them with visual cues
  • or,
  • [Feb 7, 2013 SDWG: In the IG Publishing subgroup queue for consideration] Guide is published both in a concise version for normative purposes, including only constraints unique to the guide, and in a verbose version for developers, making all constraints explicit, whether unique to the guide or inherited

• Value sets
  • Note: Representation of value sets and their metadata is being revamped by vocab. Once that is settled we will need to review the below criteria again (Sept 21, 2016)
  • [Feb 7, 2013 Approved for use] Are linked to coded elements within templates using normative binding syntax
  • [Feb 7, 2013 Approved for use] Each value set is referenced via a value set OID
  • [Feb 7, 2013 Approved for use] Each code in a value set has a specified code system OID
  • [Feb 14, 2013 Consider for future use] SNOMED CT value sets adhere to TermInfo conformance rules (as stated in the "Using SNOMED CT in HL7 Version 3" guide)

• Examples
  • [Feb 14, 2013 Approved for use] At least one stand alone and conformant sample file is present
  • [Sept 21, 2016 Consider for future use] At least one stand alone and conformant sample file is present for each document type in the guide, and each template should be represented at least once across the full set of sample files where possible.
  • [Feb 28, 2013 Approved for use] Inline examples are present for all new (subject to ballot) templates (which can contain ellipses)
  • [Sept 21, 2016 Consider for future use] Encourage the use of technology to reduce the maintenance burden of keeping inline examples in sync with standalone sample files

• Extensions
  • [Feb 28, 2013 Approved for use] A table summarizes all extensions
  • [Feb 28, 2013 Approved for use] Modified Schema including all extensions
  • [Feb 28, 2013 Consider for future use] RIM attribute extensions: Need to appear in the XML where the expected RIM attribute of the same name would have appeared had that attribute not been otherwise constrained from appearing in the CDA XML schema.

• Components of the final publication package
  • [Mar 21, 2013 Approved for use] Implementation Guide
  • [Mar 21, 2013 Approved for use] At least one conformant sample instance
  • [Mar 21, 2013 Approved for use] Extension schema (where applicable)
  • [Mar 21, 2013 Consider for future use] Validation rules (e.g. Schematron, Java code)

• [Mar 21, 2013 Approved for use] Adherence to CDA IG Publishing subgroup decisions as they are created and publically documented

• [May 06, 2014 Approved for use] Validation [suggested addition: Brett Marquard]
  • Provide validation, either on a website or stand alone tool, for templates contained in an IG
  • Optionally, provide the test package used to validate the tool

• Constraints Overview Table [suggested update: Zabrina Gonzaga entered on behalf of Scott Robertson from ASCO ballot comment]
  • On all of the constraints overview tables make the Xpath indent level more obvious.
• Context Specific Constraints [suggested update: Zabrina Gonzaga entered on behalf of Keith Boone from ASCO ballot comment]
  • Create a separate BCTS section sub-type, perhaps we could create context specific constraints for use of templates in certain kinds of documents