FHIR Clinical Guidelines (v1.0.0) (STU1)

This page is part of the Clinical Guidelines (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions

11.0.0 Clinical Guideline Development L3 Checklist

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