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

10.0.0 Clinical Guideline Development L2 Checklist

Label Item Description Item Status Notes
1. Guideline Content (L1) Complete L1 content and documentation for the guideline    
1.a Permalink Permanent URL for the guideline content, if available    
1.b Citation Appropriately formatted citation for the guideline Required  
1.c Status Current status of the guideline, including last reviewed, endorsing parties, and timeline of pending changes Required  
1.d Contact Contact information for the guideline developer and steward Required  
1.d.i Guideline Developer Direct contact for guideline developer    
1.d.ii Content/Guideline Steward Contact Public contact information for the guideline steward    
2. Legal & Licensing All legal and licensing issues are addressed    
2.a Guideline licensing terms What are the licensing terms for the use of the guideline Required  
2.b Content licensing terms What will the licensing terms for the L2 and L3 artifacts be Required  
2.c Additional licensing terms What additional content licensing is required, if any Required  
3. Scope Clearly determine the overall scope of the project    
3.a Goal(s) What goal(s) is the recommendation trying to achieve?    
3.b Target Recommendations What recommendations are targeted for the project Required  
3.c Per Recommendation For each recommendation, ensure the following   This is a header, not an item to check off
3.c.i GuideLine Implementability Appraisal (GLIA) checklist A GLIA checklist is provided   Although it was designed for end-users who are deciding whether to adopt a (hard-copy) GL, several of the elements in GLIA are worth consideration by all work streams for L2-L4. One sub-element for L4 might be “usability”.  How facile is the end-product to navigate and use?
3.c.ii Triggering How will the recommendation be triggered?    
3.c.ii.1 Terminologies What terminologies are involved?    
3.c.ii.2 Clinical State What clinical states are involved?    
3.c.ii.3 Setting What settings or environments are relevant?    
3.c.ii.4 Periodic How often should the recommendation be triggered/reviewed?    
3.c.iii Condition How will the condition be expressed?    
3.c.iii.1 Terminologies What terminologies are involved?    
3.c.iii.2 Clinical State What clinical states are involved?    
3.c.iv Action How will the action be expressed? Required  
3.c.iv.1 Request/Order What orderables are involved? Required  
3.c.iv.2 Assessment What instruments are involved? Required  
3.c.iv.3 Questionnaire What questionnaires are involved? Required  
3.c.v Monitoring How will the recommendation be assessed/monitored?    
3.c.v.1 Measures What measures are available/appropriate?   Define thresholds related to goal(s)
3.c.v.2 Performance Measures What measures are looking at the aspects related to the clinical condition?    
3.c.v.3 Process Measures What measures are looking at the aspects related to CDS workflow and feasibility   Implementation Team should consider
3.c.v.4 Outcome Measures What measures are looking at the aspects related to the health of the patient    
3.c.v.5 Guideline Evaluation Metrics What measures are looking at how well the recommendation is meeting its goal(s)?    
3.c.vi Use Case A clear description of a use case for the recommendation Required  
3.c.vii Diagram/ workflow diagram A visual depiction of the workflow for the recommendation    
3.c.viii Test Plan A description of the testing plan    
4. Existing Artifacts What existing artifacts are available, either wholesale, or for derivation and reuse?    
4.a Terminologies What value sets are available?    
4.a.i Existing What value sets exist? Can they be reused or do they need modification/augmentation?    
4.a.ii Need to be created What value sets need to be created?    
4.b Assessments What formal instruments are available? Can they be reused?    
4.c Questionnaires What questionnaires are available?    
4.d Profiles What profiles are available?    
4.e PlanDefinition/ActivityDefinition What definitions are already available?    
4.f Libraries What libraries are available?    
4.g Test Data What test data is available? What test data generation facilities are available?    
4.h Decision Aids What aids are available that help patients make decisions or can be used for shared decision-making?    
5. Publication Strategy What publication strategy will be used for the L2/L3 content?    
5.a Target Repository What publication channel will be used? (e.g. FHIR Registry, CDS Connect)    
5.b Project Repository Set up a project repository and collaboration wiki    
5.c Publishing URL Establish a base URL for the content    
5.d Terminology Publication Strategy Where will the terminologies be published? (e.g. FHIR Registry, Simplifier, VSAC, PHINVADS)    
6. Stewarding and Maintenance How will the content be maintained over time?    
6.a Change Management What external dependencies will impact the content? Document change sources and timelines    
6.b L2 Steward Who will maintain the content long term? Required  
6.c Strategy What is the strategy for reacting to changes?    
7. Piloting Who will pilot the content as part of the development process?    
7.a Pilot Site(s) Identify at least one primary pilot site (alpha) and potentially second phase (beta) sites.    
7.b Pilot Team Members Engage pilot site members as part of the development team    
8 System Feedback      
8a. SDO Feedback Are there gaps in the specifications being used that would trigger feedback to an appropriate SDO?    
8b. Policy Are there problems in a policies that would trigger feedback to the policy owner?    
9 Case Reporting 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
9.a. Existing Artifacts     HL7 CDA for initial case report, and CDA for reportability response (currently published); working on case reporting standards - FHIR: knowledge distribution (plan def, trigger codes), eICR, trigger codes