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

12.0.0 Clinical Guideline Development L4 Checklist

Label Item Description Item Status Notes
1. Publishing Information Publishing metadata for the content    
1.a Publisher Who is the publisher? (Name and public contact information)    
1.b Steward Who is the steward? (Name and public contact information)    
2. Local Prioritization and Selection      
2.a Charter Project Charter, including high-level approach to evaluation and measurement    
2.b Gap Analysis Care gap analysis    
2.c Local Feasibility Local feasibility assessment (harmonization guidelines)    
2.d Guideline Selection Make decision which guidelines/CDS to implement; assess implementability    
2.d.i Local Applicability Assess local organizational need/applicability (including GUIDES checklist Domain 1: The CDS context)    
2.d.ii Implementability Assess intrinsic implementability of guideline (e.g. GLIA v2.0; GUIDES checklist Domain 2: The CDS content)    
2.e Communication Communicate and market decision to implement    
2.f Incentives Decide whether to incentivize (and how)    
3. Evaluate Local Context Evaluate Local Workflow and Context    
3.a Burden Assess burden    
3.b Workflow Localize workflows (include “5 rights” of CDS)    
3.c Entry Points Identify points of entry    
3.d Apply Workflow Template Apply workflow template to point of entry    
3.e Stakeholder Engagement Engage stakeholders    
4. Feasibility Assessment (Technical) Feasibility Assessment (Technical)    
4.a EHR Technical Feasibility EHR technical feasibility requirements    
4.b Technical Design Strategy Design technical strategy for local setting (EHR capabilities, interfaces, etc.)    
4.c Measurement Strategy Design Design measurement strategy (e.g. process measures, outcome measures)    
4.d Update Charter Update charter with additional details of technical approach and measures    
5. Local Design Local Design (Localization of new workflow and L3 “tweaks”)    
5.a Convene End Users Convene end users    
5.b “To-be” Workflow Map “to-be” workflow    
5.c System Architecture Evaluate and design system architecture    
5.d Design I.T. artifacts/features Detailed design of localized I.T. artifacts/features    
5.e Localize Measure Capture Localize measure capture (e.g., what demographic group or other conditions are included in the denominator)    
5.f Start to develop training (localize) Start to develop training (localize) – make them aware of workflow, etc.    
5.g Consider Multiple EMRs Consider multiple EMRs; repeat localization design per EMR as needed    
6. Build L4 Artifacts/Features Build L4 Artifacts/Features: a) in EMR, or b) as web service or app    
6.a Build L4 Artifacts/Features Build the L4 artifacts/features, e.g., value sets, logic records, rules, alerts    
6.b Build Review Conduct a build review    
6.c Demonstration Demo to end users    
6.d Repeat if heterogenous EMRs Repeat if heterogenous EMR environment (e.g., if there is more than one EMR)    
7. Test and Refine Test and Refine    
7.a Unit Test Unit test code/artifacts    
7.b Integrated Test Scripts Write localized test scripts for integrated testing    
7.c Integrated System Test Integrated system test, e.g., call out to a Web; systems working together    
7.d Create Test Milieu Create test milieu (test patients)    
7.e UAT (user acceptance testing) UAT (user acceptance testing); does the thing it’s needed to do downstream    
7.f Usability Testing Usability testing e.g., practical issues such as #clicks to get to recs.    
7.g Refine Revise at all steps    
8. Educate and Train Educate and Train    
8.a Localize Education/Training Update education with local EHR design, e.g., screenshots; finish localization of training and who to train; how to best deliver training.    
8.b Tailor Training Strategy Finish localization of training and who to train; how best to deliver training including tailoring to usual training channels (multiple pathways)    
8.c Training Policy and Procedures Develop training policy & procedures    
8.d Train End Users Train end users on CDS, policy, & procedures    
8.e Update Training Update and reinforce training based on initial training rounds    
9. Deploy Deploy    
9.a Migrate Artifacts Migrate artifacts from Dev to Test to Production    
9.b Go-live Staffing Plan go-live staffing    
9.c Test Silently Test with real patients, but behind screen (silently)    
9.d Test in Production Test in Production by small number of clinicians (e.g.: ~2)    
9.e Readiness Perform readiness assessment    
9.f Pilot and Provide Feedback Pilot (e.g. in 2-3 pilot clinics or depts., if multi-clinic organization) and provide feedback    
10. Use Clinically Use Clinically    
10.a Use System Use system as designed    
10.b Observation Observe end users    
10.c Feedback Provide feedback to users    
11. Measure, Evaluate, and Refine Measure, Evaluate, and Refine    
11.a Extract Data Pull data & create reports    
11.b Analyze Data Analyze and assess per measurement strategy    
11.c Focus groups Focus groups    
11.d Satisfaction Surveys Satisfaction surveys built into artifact    
11.e Report Findings Report findings to leadership and Quality    
11.f Optimize Iteratively optimize clinical decision artifacts and/or workflows