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+# Clinical Report Quality Assurance Checklist
+
+## General Quality Standards
+
+### Completeness
+- [ ] All required sections present
+- [ ] No blank fields or missing information
+- [ ] All relevant clinical information included
+- [ ] Timeline of events clear and complete
+- [ ] All diagnostic tests and results documented
+- [ ] All treatments and interventions documented
+- [ ] Follow-up plan specified
+
+### Accuracy
+- [ ] Patient demographics correct
+- [ ] Dates and times accurate
+- [ ] Laboratory values with correct units and reference ranges
+- [ ] Medication names, doses, and frequencies correct
+- [ ] Diagnoses coded correctly (ICD-10)
+- [ ] Procedures coded correctly (CPT if applicable)
+- [ ] No contradictory information
+
+### Clarity
+- [ ] Clear, professional language
+- [ ] Medical terminology used appropriately
+- [ ] Abbreviations defined or standard only
+- [ ] Logical organization and flow
+- [ ] Legible (if handwritten)
+- [ ] No ambiguous statements
+- [ ] Clinical reasoning clearly explained
+
+### Timeliness
+- [ ] Documented in real-time or shortly after encounter
+- [ ] Discharge summary completed within 24-48 hours
+- [ ] Critical results communicated immediately
+- [ ] Regulatory reporting deadlines met
+
+---
+
+## Case Report Quality Checklist
+
+### CARE Guidelines Compliance
+- [ ] Title includes "case report"
+- [ ] Keywords provided (2-5 MeSH terms)
+- [ ] Structured abstract with all elements
+- [ ] Introduction explains novelty
+- [ ] Patient information present and de-identified
+- [ ] Clinical findings documented
+- [ ] Timeline provided (table or figure)
+- [ ] Diagnostic assessment detailed
+- [ ] Therapeutic interventions described
+- [ ] Follow-up and outcomes reported
+- [ ] Discussion with literature review
+- [ ] Patient perspective included (if possible)
+- [ ] Informed consent statement present
+
+### Privacy and Ethics
+- [ ] Informed consent obtained and documented
+- [ ] All 18 HIPAA identifiers removed
+- [ ] Dates removed or approximated
+- [ ] Ages reported appropriately (>89 aggregated)
+- [ ] Geographic information limited to state
+- [ ] Images de-identified or consented
+- [ ] IRB approval if applicable
+
+### Scientific Quality
+- [ ] Novelty clearly established
+- [ ] Literature search comprehensive
+- [ ] Differential diagnosis considered
+- [ ] Causality addressed
+- [ ] Limitations acknowledged
+- [ ] Learning points actionable
+- [ ] References current and relevant
+
+---
+
+## Clinical Trial Report Quality Checklist
+
+### SAE Report Checklist
+- [ ] All administrative information complete
+- [ ] Subject de-identified (ID number only)
+- [ ] Event description detailed
+- [ ] MedDRA coding applied
+- [ ] Seriousness criteria documented
+- [ ] Severity assessed
+- [ ] Outcome specified
+- [ ] Causality assessment completed with rationale
+- [ ] Expectedness determined
+- [ ] Action taken with study drug documented
+- [ ] Treatment for event described
+- [ ] Narrative comprehensive and chronological
+- [ ] Critical findings communicated if applicable
+- [ ] Regulatory timelines met (7-day, 15-day)
+
+### Clinical Study Report (CSR) Checklist
+- [ ] ICH-E3 structure followed
+- [ ] Synopsis complete and accurate
+- [ ] All sections numbered correctly
+- [ ] Abbreviations defined
+- [ ] Ethics approvals documented
+- [ ] Investigator list complete
+- [ ] Study design clearly described
+- [ ] Sample size justified
+- [ ] Statistical methods specified
+- [ ] CONSORT diagram included
+- [ ] Baseline demographics table
+- [ ] Primary endpoint results
+- [ ] All secondary endpoints reported
+- [ ] Adverse events summarized
+- [ ] Individual SAE narratives included
+- [ ] Discussion and conclusions present
+- [ ] Appendices complete (protocol, CRFs, etc.)
+
+---
+
+## Diagnostic Report Quality Checklist
+
+### Radiology Report
+- [ ] Patient demographics complete
+- [ ] Clinical indication documented
+- [ ] Comparison studies noted
+- [ ] Technique described
+- [ ] Findings systematic and comprehensive
+- [ ] Measurements provided for abnormalities
+- [ ] Impression summarizes key findings
+- [ ] Answers clinical question
+- [ ] Recommendations specified
+- [ ] Critical results communicated
+- [ ] Structured reporting used if applicable (BI-RADS, Lung-RADS, etc.)
+- [ ] Report signed and dated
+
+### Pathology Report
+- [ ] Specimen labeled correctly
+- [ ] Clinical history provided
+- [ ] Gross description detailed
+- [ ] Microscopic description comprehensive
+- [ ] Diagnosis clear and specific
+- [ ] Cancer staging complete (if applicable)
+- [ ] Margins documented
+- [ ] Lymph nodes quantified
+- [ ] Synoptic reporting used for cancer (CAP protocol)
+- [ ] Immunohistochemistry results included
+- [ ] Molecular results included if applicable
+- [ ] Report signed by pathologist
+
+### Laboratory Report
+- [ ] Specimen type documented
+- [ ] Collection time documented
+- [ ] Results with units
+- [ ] Reference ranges provided
+- [ ] Critical values flagged
+- [ ] Critical values communicated
+- [ ] Specimen quality noted
+- [ ] Methodology specified (if relevant)
+- [ ] Interpretation provided (when applicable)
+- [ ] LOINC codes assigned (for interoperability)
+- [ ] Report signed and dated
+
+---
+
+## Patient Documentation Quality Checklist
+
+### SOAP Note
+- [ ] Chief complaint documented
+- [ ] HPI comprehensive (≥4 elements)
+- [ ] Review of systems performed
+- [ ] Vital signs recorded
+- [ ] Physical exam documented (relevant systems)
+- [ ] Assessment with differential diagnosis
+- [ ] Plan specific and actionable
+- [ ] Return precautions provided
+- [ ] Follow-up arranged
+- [ ] Documentation supports billing level
+- [ ] Signed, dated, and timed
+
+### History and Physical (H&P)
+- [ ] Chief complaint
+- [ ] Detailed HPI
+- [ ] Past medical history
+- [ ] Past surgical history
+- [ ] Medications reconciled
+- [ ] Allergies documented
+- [ ] Family history
+- [ ] Social history
+- [ ] Review of systems (≥10 systems for comprehensive)
+- [ ] Complete physical exam (≥8 systems)
+- [ ] Laboratory and imaging results
+- [ ] Assessment and plan for each problem
+- [ ] Code status documented
+- [ ] Completed within 24 hours of admission
+- [ ] Signed and cosigned (if required)
+
+### Discharge Summary
+- [ ] Admission and discharge dates
+- [ ] Length of stay
+- [ ] Admission diagnosis
+- [ ] Discharge diagnoses (ICD-10 coded)
+- [ ] Hospital course narrative
+- [ ] Procedures performed
+- [ ] Discharge medications reconciled
+- [ ] New/changed/discontinued medications clearly marked
+- [ ] Discharge condition
+- [ ] Discharge disposition
+- [ ] Follow-up appointments
+- [ ] Patient instructions
+- [ ] Return precautions
+- [ ] Pending tests documented
+- [ ] Code status
+- [ ] Completed within 24-48 hours
+- [ ] Sent to outpatient providers
+
+---
+
+## Regulatory Compliance Checklist
+
+### HIPAA Compliance
+- [ ] Only minimum necessary PHI disclosed
+- [ ] PHI secured and protected
+- [ ] Patient authorization obtained (if required)
+- [ ] Business associate agreement (if applicable)
+- [ ] Audit trail maintained (electronic records)
+- [ ] Breach notification procedures followed
+- [ ] De-identification performed correctly
+
+### FDA/ICH-GCP Compliance (Clinical Trials)
+- [ ] GCP principles followed
+- [ ] Informed consent documented
+- [ ] IRB approval current
+- [ ] Protocol adherence documented
+- [ ] Source documentation adequate
+- [ ] ALCOA-CCEA principles met
+- [ ] 21 CFR Part 11 compliance (electronic records)
+- [ ] Safety reporting timelines met
+- [ ] Essential documents maintained
+
+---
+
+## Writing Quality Checklist
+
+### Grammar and Style
+- [ ] Correct spelling
+- [ ] Proper grammar
+- [ ] Appropriate punctuation
+- [ ] Consistent verb tense
+- [ ] Professional tone
+- [ ] Objective language
+- [ ] No personal pronouns in formal reports
+- [ ] Active voice used appropriately
+
+### Format and Presentation
+- [ ] Consistent formatting
+- [ ] Appropriate font and size
+- [ ] Adequate margins
+- [ ] Page numbers (if applicable)
+- [ ] Headers/footers appropriate
+- [ ] Tables properly formatted with labels
+- [ ] Figures high quality with legends
+- [ ] References formatted correctly
+
+### Medical Terminology
+- [ ] Terminology accurate
+- [ ] Abbreviations standard only
+- [ ] Abbreviations defined on first use
+- [ ] Units of measurement correct
+- [ ] Drug names correct (generic preferred)
+- [ ] Anatomical terms correct
+- [ ] Coding accurate (ICD-10, CPT, MedDRA)
+
+---
+
+## Documentation Integrity Checklist
+
+### Legal and Ethical Standards
+- [ ] Facts documented, not opinions
+- [ ] Patient quotes when relevant
+- [ ] Non-compliance documented objectively
+- [ ] No alterations to original record
+- [ ] Addendums used for corrections
+- [ ] Addendums clearly labeled
+- [ ] All entries signed and dated
+- [ ] Authorship clear
+
+### Billing and Coding Support
+- [ ] Medical necessity documented
+- [ ] Complexity of care documented
+- [ ] Time documented (if time-based billing)
+- [ ] ICD-10 codes appropriate and specific
+- [ ] CPT codes match documented services
+- [ ] Modifiers appropriate
+- [ ] Documentation supports level of service billed
+
+---
+
+## Final Review Checklist
+
+Before finalizing any clinical report:
+
+- [ ] Read through entire document
+- [ ] Check for completeness
+- [ ] Verify all data accuracy
+- [ ] Ensure logical flow
+- [ ] Check spelling and grammar
+- [ ] Verify patient identifiers correct (or removed if de-identified)
+- [ ] Ensure compliance with regulations
+- [ ] Confirm all required signatures
+- [ ] Verify proper distribution
+- [ ] Archive copy appropriately
+
+---
+
+## Quality Metrics to Track
+
+- [ ] Report turnaround time
+- [ ] Amendment/addendum rate
+- [ ] Critical value communication time
+- [ ] Completeness score
+- [ ] Accuracy rate (errors per report)
+- [ ] Compliance rate
+- [ ] Patient safety events related to documentation
+- [ ] Peer review feedback
+
+---
+
+**Quality Assurance Reviewer:**
+
+**Name:** ____________________  
+**Date:** ____________________  
+**Signature:** ____________________
+
+**Quality Score:** _____ / 100
+
+**Issues Identified:**
+1. [Issue and recommendation]
+2. [Issue and recommendation]
+
+**Follow-up Required:** [ ] Yes  [ ] No
+
+