This page is part of the Clinical Guidelines (v2.0.0-ballot: STU2 Ballot 1) based on FHIR (HL7® FHIR® Standard) R4. The current version which supersedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions
Label | Item | Description | Item Status | Notes |
---|---|---|---|---|
1. | Publishing Information | Publishing metadata for the L2 and L3 content | Platform Specific vs Independent | |
1.a | Publisher | Who is the publisher? (Name and public contact information) | Required | |
1.b | Steward | Who is the steward? (Name and public contact information) | Required | |
1.c | License | What are the licensing terms for the content? | Required | |
1.c.i | License Page | The IG includes a license page | ||
1.c.ii | External Content Licenses | Any referenced/included content contains appropriate licensing statements | ||
2. | Documentation | Overall documentation for the IG | ||
2.a | Overview | Clear description of the project, purpose, and content | Required | |
2.b | Scope | Clear delineation of what is included and excluded | Required | |
2.c | Roadmap | Clear description of maintenance dependencies and known plans for future work | ||
2.d | References | Permalinks and appropriate citations for the guideline and all relevant/referenced documentation | Required | |
2.e | Content Index | Easily accessible index for all content | ||
2.f | Recommendation Documentation | For each recommendation, the IG includes the following | ||
2.f.i | Recommendation statement | Recommendation statement from the guideline | Required | |
2.f.ii | Qualify of Evidence | Quality of evidence, expressed using GRADE | ||
2.f.iii | Strength of Recommendation | Strength of recommendation, expressed using GRADE | ||
2.f.iv | Narrative Description | Narrative description of the recommendation and any additional documentation as appropriate | ||
2.f.v | Workflow Diagram | Visual depiction of the workflow for the recommendation | ||
2.f.vi | Use Case | Description of the use case for the recommendation | ||
2.f.vii | Decision Points | Documentation of any decision points that impacted the L3 content | ||
2.f.viii | Referenced Artifacts | References to the implementation guide artifacts that formally describe the recommendation | ||
2.f.ix | Test Cases | Description of test cases for the recommendation and any associated test data | ||
3.a | Artifacts | For each artifact, ensure the following information is present (ValueSet/CodeSystem/Profile/Library/ActivityDefinition/PlanDefinition/Measure/Questionnaire) | ||
3.a.i | id | Unique within the IG, somewhat friendly | ||
3.a.ii | url | Globally unique, somewhat friendly, canonical identifier for the artifact | ||
3.a.iii | identifier | Other identifiers (such as a VSAC or HL7 OID) | Required | |
3.a.iv | version | Version of the artifact | Required | |
3.a.v | name | Machine-friendly name of the artifact | ||
3.a.vi | title | Human-readable name of the artifact | ||
3.a.vii | status | Status of the artifact | ||
3.a.viii | experimental | Whether the artifact is experimental | Required | |
3.a.ix | date | Publication date | Required | Consider adding date of last update |
3.a.x | publisher | Name of publishing organization or individual | ||
3.a.xi | contact | Contact information for the publisher | ||
3.a.xii | description | Clear description of the artifact | Required | |
3.a.xiii | useContext | Coded contexts of use for the artifact (include at least clinical focus, setting, and any relevant demographics) | ||
3.a.xiv | jurisdiction | Appropriate jurisdiction for the artifact | ||
3.a.xv | purpose | Purpose of the artifact | ||
3.a.xvi | usage | Additional usage documentation for the artifact | ||
3.a.xvii | approvalDate | Date the artifact was approved | ||
3.a.xviii | lastReviewDate | Date the artifact was last reviewed | Consider use of ‘reviewed’ or ‘updated’ (i.e., changed) | |
3.a.xix | effectivePeriod | Effective period for the artifact | ||
3.a.xx | topic | Coded topics for the artifact | ||
3.a.xxi | contributor | Contributors to the artifact content (author, reviewer, endorser) | ||
3.a.xxii | copyright | Legal copyright for the artifact | ||
3.a.xxiii | relatedArtifact | Any related artifact references | ||
3.b | ValueSet | In addition to the elements for all artifacts, for each value set, include the following | ||
3.b.i | compose | The definition of the value set | ||
3.b.ii | shareableValueSet profile | Declare conformance with the shareableValueSet profile | ||
3.b.iii | knowledgeArtifactValueSet profile | Declare conformance with the knowledgeArtifactValueSet profile | ||
3.b.iv | expression extension | Provide expression extensions that define the value set content in terminology languages, if available | ||
3.c | Profile | In addition to the elements for all artifacts, for each Profile, include the following | ||
3.c.i | keyword | Coded keywords for the profile | ||
3.c.ii | example instance | An example instance conforming to the profile | ||
3.d | Library | In addition to the elements for all artifacts, for each Library, include the following | ||
3.d.i | dataRequirement | Data requirements for the library content | ||
3.d.ii | content | Base64 encoded content for CQL and ELM | ||
3.d.iii | CQL source | Include a reference to the source CQL in the IG | Required | |
3.d.iv | ELM content | Include a reference to the ELM content in the IG | ||
3.e | PlanDefinition | In addition to the elements for all artifacts, for each PlanDefinition, include the following | ||
3.e.i | triggerDefinition | When the artifact is triggered | ||
3.e.ii | condition | The condition for performing the action(s) | ||
3.e.iii | action | The action(s) to be performed | ||
3.e.iv | qualityOfEvidence | The qualityOfEvidence for the recommendation | ||
3.e.v | strengthOfRecommendation | The strengthOfRecommendation for the recommendation | ||
4. | Testing | Ensure adequate testing of the IG content | ||
4.i | Build | The IG builds successfully | ||
4.ii | Resources Load | All resources load without issues into a Clinical Reasoning knowledge repository | ||
4.iii | Test Cases Pass | All test cases pass without issues in a Clinical Reasoning reference implementation | ||
5. | Review | Content is reviewed and approved by | ||
5.i | Guideline developer | The initial guideline developer | ||
5.ii | Terminologist | A clinical terminologist | ||
5.iii | Clinician | A clinician, preferably with expertise in the area of focus of the IG | ||
5.iv | Informaticist | An informaticist with expertise in the relevant specification standards | ||
5.v | Engineer | An engineer from the alpha pilot site, ideally from multiple beta sites as well | ||
6. | Publish | Publish the content in the target content repository (FHIR Registry, Simplifier, CDS Connect) | ||
7. | Case Reporting (may belong in 3.e.) | Is there a potential need for monitoring disease trends or outbreak management? | Required by law for clinicians to report certain conditions to the appropriate public health agency/jurisdiction | |
7.a | Sending case to public health | |||
7.b | Triggering | |||
7.b.i | Data | |||
7.b.ii | Workflow | |||
7.b.iii | Timing | |||
7.c | Reporting Rules | |||
7.d | Feedback to providers/reporters in clinical care |