Initial commit
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Zhongwei Li
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skills/clinical-reports/assets/case_report_template.md
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skills/clinical-reports/assets/case_report_template.md
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# Clinical Case Report Template
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## Title
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[Insert descriptive title that includes "Case Report" or "Case Study" and indicates the clinical focus]
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Example: Unusual Presentation of Acute Appendicitis in an Elderly Patient: A Case Report
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## Author Information
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[Author names, affiliations, ORCID IDs]
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**Corresponding Author:**
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[Name]
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[Email]
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[Institution]
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## Keywords
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[2-5 keywords, preferably MeSH terms]
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Example: Appendicitis, Atypical presentation, Elderly, Diagnostic imaging
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## Abstract
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### Introduction
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[What is unique about this case? Why is it worth reporting? 1-2 sentences]
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### Patient Concerns
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[Primary symptoms and chief complaint]
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### Diagnosis
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[Final diagnosis, how it was reached]
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### Interventions
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[Key treatments provided]
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### Outcomes
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[Clinical outcome and follow-up status]
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### Lessons
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[Main takeaway messages for clinicians]
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**Word count:** [150-250 words]
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## Introduction
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[Background information - 2-4 paragraphs]
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**Paragraph 1:** Background on the condition
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- Epidemiology of the condition
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- Typical clinical presentation
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- Standard diagnostic approach
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- Current treatment guidelines
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**Paragraph 2:** Why this case is novel
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- What makes this case unusual or important
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- Gap in medical knowledge addressed
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- Literature review showing rarity or uniqueness
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- Clinical significance
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**Paragraph 3:** Objectives
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- Purpose of reporting this case
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- Learning points to be highlighted
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## Patient Information
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**Demographics:**
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- Age: [e.g., "A 72-year-old" or "A woman in her 70s"]
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- Sex: [Male/Female]
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- Ethnicity: [if relevant to case]
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- Occupation: [if relevant]
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**Medical History:**
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- Past medical history: [chronic conditions]
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- Past surgical history: [prior surgeries]
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- Family history: [relevant family history]
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- Social history: [tobacco, alcohol, occupation, living situation]
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**Medications:**
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- Current medications: [list with doses]
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- Allergies: [drug allergies and reactions]
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**Presenting Symptoms:**
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- Chief complaint: ["Patient's words" or clinical presentation]
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- Duration of symptoms
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- Severity and characteristics
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- Associated symptoms
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- Relevant review of systems
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## Clinical Findings
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**Physical Examination:**
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- Vital signs: [T, BP, HR, RR, SpO2]
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- General appearance: [overall state]
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- Systematic examination by organ system:
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- HEENT: [findings]
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- Cardiovascular: [findings]
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- Respiratory: [findings]
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- Abdomen: [findings]
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- Neurological: [findings]
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- Other relevant systems: [findings]
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**Pertinent Negatives:**
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[Important negative findings]
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## Timeline
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| Date/Time | Event |
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|-----------|-------|
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| [Day -X or Date] | [Initial symptom onset] |
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| [Day 0 or Date] | [Presentation to healthcare] |
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| [Day 0 or Date] | [Initial evaluation and tests] |
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| [Day X or Date] | [Diagnosis confirmed] |
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| [Day X or Date] | [Treatment initiated] |
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| [Day X or Date] | [Hospital discharge or follow-up] |
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| [Month X or Date] | [Long-term follow-up] |
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*Note: Use relative days (Day 0, Day 1) or approximate dates (Month 1, Month 3) to protect patient privacy*
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## Diagnostic Assessment
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### Initial Diagnostic Workup
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**Laboratory Tests:**
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| Test | Result | Reference Range | Interpretation |
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|------|--------|----------------|----------------|
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| [Test name] | [Value with units] | [Normal range] | [High/Low/Normal] |
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**Imaging Studies:**
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- [Modality] ([Date]): [Key findings]
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- [Include images if applicable, with labels and arrows pointing to key findings]
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**Other Diagnostic Procedures:**
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- [Procedure name] ([Date]): [Findings]
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### Differential Diagnosis
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**Diagnoses Considered:**
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1. [Primary differential]
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- Supporting evidence:
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- Evidence against:
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2. [Alternative diagnosis]
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- Supporting evidence:
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- Evidence against:
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3. [Additional differentials as appropriate]
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### Diagnostic Challenges
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[Describe any difficulties in reaching the diagnosis]
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- Atypical presentation
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- Misleading initial findings
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- Diagnostic delays
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- Complex decision-making
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### Final Diagnosis
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**Confirmed Diagnosis:** [Final diagnosis with ICD-10 code if applicable]
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**Diagnostic Reasoning:**
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[Explain how diagnosis was reached, key diagnostic features, confirmatory tests]
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## Therapeutic Intervention
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### Treatment Approach
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**Initial Management:**
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- [Immediate interventions]
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- [Supportive care]
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- [Monitoring]
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**Definitive Treatment:**
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1. **Pharmacological Interventions:**
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- [Drug name]: [Dose, route, frequency, duration]
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- Indication: [Why prescribed]
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- Response: [Patient response to treatment]
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2. **Procedural/Surgical Interventions:**
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- [Procedure name] performed on [date/day]
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- Indication: [Why performed]
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- Technique: [Brief description]
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- Findings: [Intraoperative or procedural findings]
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- Complications: [Any complications or none]
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3. **Other Interventions:**
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- [Physical therapy, dietary modifications, etc.]
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**Alternative Treatments Considered:**
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[Other treatment options that were considered and why they were not pursued]
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**Changes to Interventions:**
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[Any modifications to treatment plan]
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- Date of change:
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- Reason for change:
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- New intervention:
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## Follow-up and Outcomes
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**Immediate Outcome:**
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[Outcome during hospitalization or initial treatment period]
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- Clinical response:
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- Laboratory or imaging follow-up:
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- Complications:
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- Length of hospitalization (if applicable):
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**Short-term Follow-up:** ([Timeframe, e.g., 1 month])
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- Clinical status:
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- Follow-up tests:
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- Adherence to treatment:
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- Any issues or concerns:
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**Long-term Follow-up:** ([Timeframe, e.g., 6 months, 1 year])
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- Clinical status:
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- Recovery or resolution:
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- Functional status:
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- Quality of life:
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- Recurrence or complications:
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**Patient-Reported Outcomes:**
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[Symptoms, quality of life, patient satisfaction]
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## Discussion
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**Paragraph 1: Summary and Significance**
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[Briefly summarize the case and state its significance]
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**Paragraph 2: Literature Review**
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[Review similar cases in the literature]
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- Number of similar cases reported
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- Comparison to this case
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- What is novel about this case
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- [Cite relevant references]
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**Paragraph 3: Clinical Implications**
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[What can clinicians learn from this case?]
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- Recognition of atypical presentations
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- Diagnostic pearls
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- Treatment considerations
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- When to consider this diagnosis
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**Paragraph 4: Pathophysiology or Mechanism (if applicable)**
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[Explain underlying mechanism, why this occurred, contributing factors]
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**Paragraph 5: Strengths and Limitations**
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[Acknowledge limitations of case report]
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- Single case report limitations
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- Cannot establish causation
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- Generalizability concerns
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- Strengths of comprehensive evaluation
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**Paragraph 6: Future Directions**
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[Unanswered questions, areas for future research]
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## Learning Points
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- [Point 1: Concise, actionable clinical lesson]
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- [Point 2: Key diagnostic or treatment pearl]
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- [Point 3: When to consider this diagnosis]
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- [Point 4: (optional) Additional takeaway]
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## Patient Perspective
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[Optional but encouraged: Patient's own description of experience, in their own words if possible]
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"[Patient quote describing their experience, symptoms, treatment, or outcome]"
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[Or narrative description of patient's perspective, impact on quality of life, satisfaction with care]
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## Informed Consent
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Written informed consent was obtained from the patient for publication of this case report and any accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal on request.
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[OR if patient deceased/unable to consent:]
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Written informed consent was obtained from the patient's next of kin for publication of this case report, as the patient was deceased [or unable to provide consent due to...] at the time of manuscript preparation.
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## Conflicts of Interest
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The authors declare that they have no conflicts of interest.
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## Funding
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This case report received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
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[OR: This work was supported by [funding source and grant number]]
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## Acknowledgments
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[Acknowledge contributors who do not meet authorship criteria, providers who cared for patient, etc.]
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## References
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[Format according to journal requirements - typically AMA, Vancouver, or APA]
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1. [First reference - Author(s). Title. Journal. Year;Volume(Issue):Pages.]
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2. [Second reference...]
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---
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## CARE Checklist Completion
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Use the CARE checklist to ensure all required elements are included:
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- [ ] Title includes "case report"
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- [ ] Keywords provided (2-5)
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- [ ] Structured/unstructured abstract
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- [ ] Introduction with background and novelty
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- [ ] Patient demographics (de-identified)
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- [ ] Clinical findings
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- [ ] Timeline
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- [ ] Diagnostic assessment
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- [ ] Therapeutic interventions
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- [ ] Follow-up and outcomes
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- [ ] Discussion with literature review
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- [ ] Patient perspective (if possible)
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- [ ] Informed consent statement
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- [ ] All 18 HIPAA identifiers removed
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- [ ] References formatted correctly
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- [ ] Figures/tables labeled and referenced
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- [ ] Word count within journal limits
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---
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## De-identification Checklist
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Verify all HIPAA identifiers removed:
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- [ ] Names (patient, family, providers)
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- [ ] Geographic locations smaller than state
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- [ ] Exact dates (use year only or relative time)
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- [ ] Phone numbers
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- [ ] Email addresses
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- [ ] Medical record numbers
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- [ ] Account numbers
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- [ ] License numbers
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- [ ] Device serial numbers
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- [ ] URLs
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- [ ] IP addresses
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- [ ] Biometric identifiers
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- [ ] Full-face photos (cropped or blurred)
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- [ ] Any other identifying information
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---
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**Notes:**
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- Adapt this template to your specific journal's requirements
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- Check word count limits (typically 1500-3000 words)
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- Follow journal's reference style
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- Include institutional review/ethics exemption if applicable
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- Consider attaching CARE checklist when submitting
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353
skills/clinical-reports/assets/clinical_trial_csr_template.md
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skills/clinical-reports/assets/clinical_trial_csr_template.md
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# Clinical Study Report (CSR) Template
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## ICH-E3 Format
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---
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# TITLE PAGE
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**Study Title:** [Full descriptive title including compound, indication, phase]
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**Protocol Number:** [Sponsor protocol number]
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**Protocol Version:** [Final protocol version and date]
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**Sponsor:** [Company name and address]
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**Compound/Drug Name:** [Generic and proprietary names, compound code]
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**Indication:** [Therapeutic area and specific indication studied]
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**Study Phase:** [I / II / III / IV]
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**Study Type:** [Interventional / Observational]
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**Report Date:** [MM/DD/YYYY]
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**Report Version:** [Version number]
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**Medical Expert:** [Name, MD, Title]
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**Biostatistician:** [Name, PhD, Title]
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|
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**Confidentiality Statement:**
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"This document contains confidential information belonging to [Sponsor]. It may not be reproduced or distributed without permission."
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|
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---
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# SYNOPSIS
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**Title:** [Abbreviated title]
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**Protocol Number:** [Number]
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**Study Phase:** [Phase]
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**Study Period:** [Start date - End date]
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## Study Objectives
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**Primary Objective:**
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[State primary objective clearly and concisely]
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**Secondary Objectives:**
|
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- [Secondary objective 1]
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- [Secondary objective 2]
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|
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## Methodology
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|
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**Study Design:**
|
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[Randomized, double-blind, placebo-controlled, parallel-group, etc.]
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|
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**Study Population:**
|
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- Target population: [Patient population]
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- Key inclusion criteria: [Main criteria]
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- Key exclusion criteria: [Main criteria]
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|
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**Sample Size:**
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- Planned: [N participants]
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- Randomized: [N participants]
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- Completed: [N participants]
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**Treatment:**
|
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- Treatment A: [Drug name, dose, route, frequency]
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- Treatment B: [Comparator/placebo]
|
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- Treatment duration: [Weeks/months]
|
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- Follow-up duration: [Weeks/months]
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|
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**Endpoints:**
|
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|
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Primary:
|
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- [Primary endpoint definition and timepoint]
|
||||
|
||||
Secondary:
|
||||
- [Secondary endpoint 1]
|
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- [Secondary endpoint 2]
|
||||
|
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**Statistical Methods:**
|
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[Brief description of analysis approach, significance level, handling of multiplicity]
|
||||
|
||||
## Results
|
||||
|
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**Participant Disposition:**
|
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- Screened: [N]
|
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- Randomized: [N Treatment A, N Treatment B]
|
||||
- Completed: [N Treatment A, N Treatment B]
|
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- Discontinued: [N overall, % - main reasons]
|
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|
||||
**Demographics and Baseline:**
|
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[Summary of key baseline characteristics, comparability across groups]
|
||||
|
||||
**Efficacy Results:**
|
||||
|
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Primary Endpoint:
|
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- [Result for Treatment A vs B, effect size, 95% CI, p-value]
|
||||
|
||||
Secondary Endpoints:
|
||||
- [Results for each secondary endpoint]
|
||||
|
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**Safety Results:**
|
||||
- Any AE: [% Treatment A vs B]
|
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- Treatment-related AE: [% Treatment A vs B]
|
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- Serious AE: [% Treatment A vs B]
|
||||
- Discontinuations due to AE: [% Treatment A vs B]
|
||||
- Deaths: [N Treatment A vs B]
|
||||
- Common AEs (≥5%): [List with percentages]
|
||||
|
||||
## Conclusions
|
||||
|
||||
[Overall conclusions regarding efficacy and safety, benefit-risk assessment]
|
||||
|
||||
---
|
||||
|
||||
# TABLE OF CONTENTS
|
||||
|
||||
[Detailed table of contents with page numbers]
|
||||
|
||||
---
|
||||
|
||||
# LIST OF ABBREVIATIONS
|
||||
|
||||
| Abbreviation | Definition |
|
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|--------------|------------|
|
||||
| AE | Adverse Event |
|
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| ANCOVA | Analysis of Covariance |
|
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| CI | Confidence Interval |
|
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| CSR | Clinical Study Report |
|
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| FAS | Full Analysis Set |
|
||||
| GCP | Good Clinical Practice |
|
||||
| ICF | Informed Consent Form |
|
||||
| ITT | Intent-to-Treat |
|
||||
| PP | Per-Protocol |
|
||||
| SAE | Serious Adverse Event |
|
||||
| SD | Standard Deviation |
|
||||
| [Add study-specific abbreviations] | |
|
||||
|
||||
---
|
||||
|
||||
# ETHICS (Section 2)
|
||||
|
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## 2.1 Independent Ethics Committee (IEC) or Institutional Review Board (IRB)
|
||||
|
||||
[List of all IECs/IRBs that approved the study]
|
||||
|
||||
| Site Number | Institution | IRB/IEC Name | Approval Date |
|
||||
|-------------|------------|--------------|---------------|
|
||||
| 001 | [Institution] | [IRB name] | [MM/DD/YYYY] |
|
||||
|
||||
## 2.2 Ethical Conduct of the Study
|
||||
|
||||
This study was conducted in accordance with:
|
||||
- ICH Good Clinical Practice (GCP) E6(R2)
|
||||
- Declaration of Helsinki (current version)
|
||||
- Applicable regulatory requirements
|
||||
- Sponsor Standard Operating Procedures
|
||||
|
||||
## 2.3 Patient Information and Consent
|
||||
|
||||
Informed consent was obtained from all participants before any study-specific procedures. The informed consent process included:
|
||||
- Written information about study purpose, procedures, risks, and benefits
|
||||
- Opportunity to ask questions
|
||||
- Voluntary participation with right to withdraw
|
||||
- Signatures of participant and person obtaining consent
|
||||
- Copy provided to participant
|
||||
|
||||
---
|
||||
|
||||
# INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE (Section 3)
|
||||
|
||||
## 3.1 Investigators and Study Centers
|
||||
|
||||
[Table listing all investigators, sites, and enrollment]
|
||||
|
||||
| Site No. | Investigator | Institution | City, Country | Subjects Enrolled |
|
||||
|----------|--------------|-------------|---------------|-------------------|
|
||||
| 001 | [Name, MD] | [Institution] | [City, Country] | [N] |
|
||||
|
||||
**Coordinating Investigator:** [Name, if applicable]
|
||||
|
||||
## 3.2 Study Administrative Structure
|
||||
|
||||
**Sponsor:**
|
||||
- Medical Monitor: [Name, credentials]
|
||||
- Project Manager: [Name]
|
||||
- Biostatistician: [Name, credentials]
|
||||
|
||||
**Contract Research Organization (CRO):** [Name, if applicable]
|
||||
- [Responsibilities]
|
||||
|
||||
## 3.3 Responsibilities of Parties Involved
|
||||
|
||||
[Description of sponsor, investigator, CRO, DSMB responsibilities]
|
||||
|
||||
---
|
||||
|
||||
# INTRODUCTION (Section 4)
|
||||
|
||||
## 4.1 Background
|
||||
|
||||
[Detailed background on disease/condition, unmet medical need, treatment landscape]
|
||||
|
||||
## 4.2 Nonclinical Studies
|
||||
|
||||
[Summary of relevant preclinical pharmacology, toxicology, and safety findings]
|
||||
|
||||
## 4.3 Previous Clinical Studies
|
||||
|
||||
[Summary of prior clinical experience with investigational product]
|
||||
|
||||
## 4.4 Study Rationale and Objectives
|
||||
|
||||
[Justification for conducting this study, specific objectives]
|
||||
|
||||
---
|
||||
|
||||
# STUDY OBJECTIVES AND PLAN (Section 5)
|
||||
|
||||
## 5.1 Objectives and Endpoints
|
||||
|
||||
**Primary Objective:**
|
||||
[Objective statement]
|
||||
|
||||
**Primary Endpoint:**
|
||||
[Detailed endpoint definition, measurement method, timepoint]
|
||||
|
||||
**Secondary Objectives:**
|
||||
1. [Objective]
|
||||
2. [Objective]
|
||||
|
||||
**Secondary Endpoints:**
|
||||
1. [Endpoint definition]
|
||||
2. [Endpoint definition]
|
||||
|
||||
## 5.2 Study Design
|
||||
|
||||
[Detailed description of study design with diagram if helpful]
|
||||
|
||||
**Design Type:** [Parallel, crossover, factorial, etc.]
|
||||
**Blinding:** [Double-blind, open-label, etc.]
|
||||
**Randomization:** [1:1, 2:1, stratified, etc.]
|
||||
**Duration:** [Treatment period, follow-up period]
|
||||
|
||||
**Study Schema:**
|
||||
[Flow diagram showing screening, randomization, treatment periods, follow-up]
|
||||
|
||||
## 5.3 Study Population
|
||||
|
||||
**Key Inclusion Criteria:**
|
||||
1. [Criterion]
|
||||
2. [Criterion]
|
||||
|
||||
**Key Exclusion Criteria:**
|
||||
1. [Criterion]
|
||||
2. [Criterion]
|
||||
|
||||
## 5.4 Treatments
|
||||
|
||||
**Investigational Product:**
|
||||
- Name: [Generic, trade, code]
|
||||
- Formulation: [Tablet, capsule, injection]
|
||||
- Dose: [Dose and regimen]
|
||||
- Route: [PO, IV, SC, etc.]
|
||||
- Packaging and labeling: [Description]
|
||||
|
||||
**Comparator:**
|
||||
[Similar details for comparator or placebo]
|
||||
|
||||
**Concomitant Medications:**
|
||||
[Permitted and prohibited medications]
|
||||
|
||||
## 5.5 Sample Size Determination
|
||||
|
||||
**Target Sample Size:** [N per group, N total]
|
||||
|
||||
**Justification:**
|
||||
- Assumed effect size: [Value]
|
||||
- Variability (SD): [Value]
|
||||
- Type I error (α): [0.05]
|
||||
- Power (1-β): [80% or 90%]
|
||||
- Expected dropout rate: [%]
|
||||
- Two-sided test
|
||||
|
||||
## 5.6 Statistical Analysis Plan
|
||||
|
||||
**Analysis Populations:**
|
||||
- Full Analysis Set (FAS): [Definition]
|
||||
- Per-Protocol Set (PPS): [Definition]
|
||||
- Safety Analysis Set: [Definition]
|
||||
|
||||
**Statistical Methods:**
|
||||
- Primary endpoint: [Method - e.g., ANCOVA with baseline as covariate]
|
||||
- Secondary endpoints: [Methods]
|
||||
- Handling of missing data: [Approach]
|
||||
- Multiplicity adjustment: [Method if applicable]
|
||||
- Interim analyses: [If planned]
|
||||
|
||||
**Significance Level:** α = 0.05 (two-sided)
|
||||
|
||||
---
|
||||
|
||||
# STUDY PATIENTS (Section 6)
|
||||
|
||||
## 6.1 Disposition of Patients
|
||||
|
||||
**Participant Flow (CONSORT Diagram):**
|
||||
|
||||
[Include detailed CONSORT diagram showing screening through analysis]
|
||||
|
||||
**Summary Table:**
|
||||
|
||||
| Category | Treatment A | Treatment B | Total |
|
||||
|----------|-------------|-------------|-------|
|
||||
| Screened | N | N | N |
|
||||
| Screen failures | N (%) | N (%) | N (%) |
|
||||
| Randomized | N | N | N |
|
||||
| Received treatment | N (%) | N (%) | N (%) |
|
||||
| Completed | N (%) | N (%) | N (%) |
|
||||
| Discontinued | N (%) | N (%) | N (%) |
|
||||
| - Adverse event | N (%) | N (%) | N (%) |
|
||||
| - Lack of efficacy | N (%) | N (%) | N (%) |
|
||||
| - Lost to follow-up | N (%) | N (%) | N (%) |
|
||||
| - Withdrawal of consent | N (%) | N (%) | N (%) |
|
||||
| - Other | N (%) | N (%) | N (%) |
|
||||
|
||||
## 6.2 Protocol Deviations
|
||||
|
||||
**Major Protocol Deviations:**
|
||||
[Summary of major deviations, impact on data, subjects affected]
|
||||
|
||||
**Important Protocol Deviations by Category:**
|
||||
|
||||
| Deviation Type | Treatment A | Treatment B | Total |
|
||||
|----------------|-------------|-------------|-------|
|
||||
| Inclusion/exclusion criteria | N (%) | N (%) | N (%) |
|
||||
| Dosing errors | N (%) | N (%) | N (%) |
|
||||
| Prohibited medications | N (%) | N (%) | N (%) |
|
||||
| Missed visits | N (%) | N (%) | N (%) |
|
||||
|
||||
---
|
||||
|
||||
(Continues with sections 7-14 following ICH-E3 structure...)
|
||||
|
||||
---
|
||||
|
||||
**Note:** This is an abbreviated template. A complete CSR following ICH-E3 is typically 50-300 pages with extensive appendices. Key sections to complete:
|
||||
- Section 7: Efficacy Evaluation
|
||||
- Section 8: Safety Evaluation
|
||||
- Section 9: Discussion and Overall Conclusions
|
||||
- Section 10: Tables, Figures, and Graphs
|
||||
- Section 11: References
|
||||
- Section 12-14: Appendices (Protocol, CRFs, Investigator list, etc.)
|
||||
|
||||
|
||||
359
skills/clinical-reports/assets/clinical_trial_sae_template.md
Normal file
359
skills/clinical-reports/assets/clinical_trial_sae_template.md
Normal file
@@ -0,0 +1,359 @@
|
||||
# Serious Adverse Event (SAE) Report Template
|
||||
|
||||
## Report Information
|
||||
|
||||
**Report Type:** [ ] Initial Report [ ] Follow-up Report [ ] Final Report
|
||||
**Report Number:** [SAE-YYYY-####]
|
||||
**Report Date:** [MM/DD/YYYY]
|
||||
**Reporter:** [Name and title]
|
||||
**Reporter Contact:** [Email and phone]
|
||||
|
||||
**Follow-up Number:** [If follow-up: #1, #2, etc.]
|
||||
**Previous Report Date:** [If follow-up]
|
||||
|
||||
---
|
||||
|
||||
## Study Information
|
||||
|
||||
**Protocol Number:** [Protocol ID]
|
||||
**Protocol Title:** [Full study title]
|
||||
**Study Phase:** [ ] Phase I [ ] Phase II [ ] Phase III [ ] Phase IV
|
||||
**Study Sponsor:** [Sponsor name]
|
||||
**IND/IDE Number:** [IND or IDE number if applicable]
|
||||
**ClinicalTrials.gov ID:** [NCT number]
|
||||
|
||||
**Principal Investigator:** [Name]
|
||||
**Site Number:** [Site ID]
|
||||
**Site Name:** [Institution name]
|
||||
|
||||
---
|
||||
|
||||
## Subject Information (De-identified)
|
||||
|
||||
**Subject ID / Randomization Number:** [ID only, no name]
|
||||
**Subject Initials:** [XX] (if permitted by regulatory authority)
|
||||
**Age:** [Years] OR **Date of Birth:** [Year only: YYYY]
|
||||
**Sex:** [ ] Male [ ] Female [ ] Other
|
||||
**Race:** [Category]
|
||||
**Ethnicity:** [Hispanic or Latino / Not Hispanic or Latino]
|
||||
**Weight:** [kg]
|
||||
**Height:** [cm]
|
||||
|
||||
**Study Arm / Treatment Group:** [ ] Treatment A [ ] Treatment B [ ] Placebo [ ] Blinded
|
||||
|
||||
**Date of Informed Consent:** [MM/DD/YYYY]
|
||||
**Date of First Study Drug:** [MM/DD/YYYY]
|
||||
**Date of Last Study Drug:** [MM/DD/YYYY]
|
||||
**Study Drug Status at Time of Event:** [ ] Ongoing [ ] Completed [ ] Discontinued
|
||||
|
||||
---
|
||||
|
||||
## Adverse Event Information
|
||||
|
||||
**Reported Term (Verbatim):** [Exact term reported by investigator/patient]
|
||||
|
||||
**MedDRA Coding:**
|
||||
- **Preferred Term (PT):** [MedDRA PT]
|
||||
- **System Organ Class (SOC):** [MedDRA SOC]
|
||||
- **MedDRA Version:** [e.g., 25.0]
|
||||
|
||||
**Event Description:**
|
||||
[Detailed narrative description of the adverse event]
|
||||
|
||||
**Date of Onset:** [MM/DD/YYYY]
|
||||
**Time of Onset:** [HH:MM] (if known and relevant)
|
||||
**Date of Resolution:** [MM/DD/YYYY] OR [ ] Ongoing
|
||||
**Duration:** [Days/hours if resolved]
|
||||
|
||||
**Event Location:** [ ] Inpatient [ ] Outpatient [ ] Home [ ] Other: ________
|
||||
|
||||
---
|
||||
|
||||
## Seriousness Criteria
|
||||
|
||||
**This event is considered serious because it resulted in or required:**
|
||||
|
||||
- [ ] **Death** - Date of death: [MM/DD/YYYY]
|
||||
- [ ] **Life-threatening** - Immediate risk of death at time of event
|
||||
- [ ] **Hospitalization (initial or prolonged)** - Dates: [MM/DD/YYYY to MM/DD/YYYY]
|
||||
- [ ] **Persistent or significant disability/incapacity**
|
||||
- [ ] **Congenital anomaly/birth defect**
|
||||
- [ ] **Medically important event** - Explanation: _________________
|
||||
|
||||
**Hospitalization Details (if applicable):**
|
||||
- Admission Date: [MM/DD/YYYY]
|
||||
- Discharge Date: [MM/DD/YYYY] OR [ ] Still hospitalized
|
||||
- Hospital Name: [Name and location]
|
||||
- ICU Admission: [ ] Yes [ ] No
|
||||
- If yes, dates: [MM/DD/YYYY to MM/DD/YYYY]
|
||||
|
||||
---
|
||||
|
||||
## Severity Assessment
|
||||
|
||||
**Severity (Intensity):**
|
||||
- [ ] **Mild** - Noticeable but does not interfere with daily activities
|
||||
- [ ] **Moderate** - Interferes with daily activities but manageable
|
||||
- [ ] **Severe** - Prevents usual daily activities, requires intervention
|
||||
|
||||
*Note: Severity is not the same as seriousness*
|
||||
|
||||
---
|
||||
|
||||
## Outcome
|
||||
|
||||
- [ ] **Recovered/Resolved** - Complete resolution, returned to baseline
|
||||
- [ ] **Recovering/Resolving** - Improving but not yet fully resolved
|
||||
- [ ] **Not Recovered/Not Resolved** - Ongoing without improvement
|
||||
- [ ] **Recovered/Resolved with Sequelae** - Persistent effects remain
|
||||
- [ ] **Fatal** - Event resulted in death
|
||||
- [ ] **Unknown** - Unable to determine outcome
|
||||
|
||||
**Date of Final Outcome (if resolved):** [MM/DD/YYYY]
|
||||
|
||||
---
|
||||
|
||||
## Causality Assessment
|
||||
|
||||
**Relationship to Study Drug:**
|
||||
- [ ] **Not Related** - Clearly due to other cause
|
||||
- [ ] **Unlikely Related** - Doubtful connection to study drug
|
||||
- [ ] **Possibly Related** - Could be related, but other causes possible
|
||||
- [ ] **Probably Related** - More likely related to study drug than other causes
|
||||
- [ ] **Definitely Related** - Certain relationship to study drug
|
||||
|
||||
**Relationship to Study Procedures:**
|
||||
- [ ] Not Related [ ] Unlikely [ ] Possibly [ ] Probably [ ] Definitely
|
||||
|
||||
**Relationship to Underlying Disease:**
|
||||
- [ ] Not Related [ ] Unlikely [ ] Possibly [ ] Probably [ ] Definitely
|
||||
|
||||
**Relationship to Concomitant Medications:**
|
||||
- [ ] Not Related [ ] Unlikely [ ] Possibly [ ] Probably [ ] Definitely
|
||||
- Suspected medication(s): _____________________
|
||||
|
||||
**Rationale for Causality Assessment:**
|
||||
[Detailed explanation of causality determination, including temporal relationship, biological plausibility, dechallenge/rechallenge if applicable, alternative explanations]
|
||||
|
||||
---
|
||||
|
||||
## Expectedness
|
||||
|
||||
**Is this event expected based on the Investigator's Brochure or protocol?**
|
||||
- [ ] **Expected** - Listed in IB/protocol with similar characteristics
|
||||
- [ ] **Unexpected** - Not listed OR more severe than documented
|
||||
|
||||
**Reference:** [IB version and section, or protocol section]
|
||||
|
||||
---
|
||||
|
||||
## Action Taken with Study Drug
|
||||
|
||||
- [ ] **No change** - Study drug continued at same dose
|
||||
- [ ] **Dose reduced** - New dose: ______ (from ______)
|
||||
- [ ] **Dose increased** - New dose: ______ (from ______)
|
||||
- [ ] **Drug interrupted** - Dates: [MM/DD to MM/DD]
|
||||
- [ ] Resumed [ ] Not resumed
|
||||
- [ ] **Drug permanently discontinued** - Date: [MM/DD/YYYY]
|
||||
- [ ] **Not applicable** - Event occurred after study drug discontinued
|
||||
|
||||
**Dechallenge:** [ ] Positive (improved after stopping) [ ] Negative [ ] Not done
|
||||
|
||||
**Rechallenge:** [ ] Positive (recurred after restarting) [ ] Negative [ ] Not done
|
||||
|
||||
---
|
||||
|
||||
## Treatment and Interventions
|
||||
|
||||
**Treatments Given for This Event:**
|
||||
|
||||
1. **[Medication/Procedure]**
|
||||
- Dose/Details: _________________
|
||||
- Route: _________________
|
||||
- Start Date: [MM/DD/YYYY]
|
||||
- Stop Date: [MM/DD/YYYY] OR [ ] Ongoing
|
||||
- Response: [ ] Effective [ ] Partially effective [ ] Not effective
|
||||
|
||||
2. **[Additional treatments]**
|
||||
|
||||
**Hospitalization Interventions:**
|
||||
- [ ] IV fluids
|
||||
- [ ] Oxygen therapy
|
||||
- [ ] Mechanical ventilation
|
||||
- [ ] Surgical intervention - Procedure: ______________
|
||||
- [ ] ICU care
|
||||
- [ ] Other: ______________
|
||||
|
||||
---
|
||||
|
||||
## Relevant Medical History
|
||||
|
||||
**Pre-existing Conditions Relevant to This Event:**
|
||||
[List conditions that may be related to the event]
|
||||
|
||||
**Concomitant Medications at Time of Event:**
|
||||
|
||||
| Medication | Indication | Dose/Frequency | Start Date | Stop Date |
|
||||
|------------|-----------|----------------|------------|-----------|
|
||||
| [Name] | [Indication] | [Dose] | [MM/DD/YYYY] | [MM/DD/YYYY or Ongoing] |
|
||||
|
||||
---
|
||||
|
||||
## Laboratory and Diagnostic Tests
|
||||
|
||||
**Relevant Laboratory Values:**
|
||||
|
||||
| Test | Result | Units | Reference Range | Date | Relation to Event |
|
||||
|------|--------|-------|----------------|------|-------------------|
|
||||
| [Test] | [Value] | [Units] | [Range] | [MM/DD] | [Before/During/After] |
|
||||
|
||||
**Imaging/Diagnostic Studies:**
|
||||
- **[Study type] ([Date]):** [Key findings]
|
||||
|
||||
**ECG/Monitoring:**
|
||||
[Results if relevant]
|
||||
|
||||
---
|
||||
|
||||
## Detailed Event Narrative
|
||||
|
||||
[Comprehensive chronological narrative of the event]
|
||||
|
||||
**Minimum elements to include:**
|
||||
- Patient demographics and study participation timeline
|
||||
- Relevant medical history
|
||||
- Chronological description of event development
|
||||
- Symptoms, signs, and clinical course
|
||||
- Diagnostic workup and results
|
||||
- Treatments administered and response
|
||||
- Clinical outcome and current status
|
||||
- Investigator's assessment of causality and reasoning
|
||||
|
||||
**Example Structure:**
|
||||
```
|
||||
A [age]-year-old [sex] with a history of [relevant medical conditions] enrolled in
|
||||
Study [protocol] on [date] and was randomized to [treatment arm]. The patient had
|
||||
been receiving [study drug] at [dose] for [duration] when, on [date], the patient
|
||||
developed [initial symptoms].
|
||||
|
||||
[Describe progression of symptoms, timeline, clinical findings...]
|
||||
|
||||
[Describe diagnostic workup performed and results...]
|
||||
|
||||
[Describe treatments given and patient response...]
|
||||
|
||||
[Describe outcome and current status...]
|
||||
|
||||
The investigator assessed this event as [causality] related to study drug because
|
||||
[reasoning]. Alternative explanations include [list alternative causes considered].
|
||||
```
|
||||
|
||||
---
|
||||
|
||||
## Investigator Assessment
|
||||
|
||||
**Investigator's Comments:**
|
||||
[Additional relevant information, clinical interpretation, conclusions]
|
||||
|
||||
**Does this event meet criteria for expedited reporting to regulatory authorities?**
|
||||
- [ ] Yes - Fatal or life-threatening unexpected SAE
|
||||
- [ ] Yes - Other unexpected SAE
|
||||
- [ ] No - Expected event
|
||||
|
||||
---
|
||||
|
||||
## Follow-up Information Required
|
||||
|
||||
**Information Pending (if initial or follow-up report):**
|
||||
- [ ] Final outcome
|
||||
- [ ] Laboratory results
|
||||
- [ ] Pathology report
|
||||
- [ ] Imaging results
|
||||
- [ ] Autopsy results (if death)
|
||||
- [ ] Consultant reports
|
||||
- [ ] Medical records
|
||||
- [ ] Dechallenge/rechallenge information
|
||||
- [ ] Other: ______________
|
||||
|
||||
**Expected Date for Follow-up Report:** [MM/DD/YYYY]
|
||||
|
||||
---
|
||||
|
||||
## Regulatory Reporting
|
||||
|
||||
**Sponsor Safety Assessment:**
|
||||
[To be completed by sponsor]
|
||||
- Expectedness: [ ] Expected [ ] Unexpected
|
||||
- Relationship: [ ] Related [ ] Not related
|
||||
- Reportable to FDA/EMA: [ ] Yes [ ] No
|
||||
- Timeline: [ ] 7-day [ ] 15-day [ ] Annual
|
||||
|
||||
**IRB Notification:**
|
||||
- Reported to IRB: [ ] Yes [ ] No [ ] Not required
|
||||
- Date reported: [MM/DD/YYYY]
|
||||
- IRB determination: _______________
|
||||
|
||||
---
|
||||
|
||||
## Signatures
|
||||
|
||||
**Investigator Signature:**
|
||||
|
||||
**Name:** [Principal Investigator name]
|
||||
**Title:** [MD, credentials]
|
||||
**Signature:** ____________________
|
||||
**Date:** [MM/DD/YYYY]
|
||||
|
||||
**I certify that this report is accurate and complete to the best of my knowledge.**
|
||||
|
||||
---
|
||||
|
||||
**Sponsor Representative (if applicable):**
|
||||
|
||||
**Name:** [Name]
|
||||
**Title:** [Medical Monitor, Safety Officer]
|
||||
**Signature:** ____________________
|
||||
**Date:** [MM/DD/YYYY]
|
||||
|
||||
---
|
||||
|
||||
## Attachments
|
||||
|
||||
- [ ] Relevant laboratory reports
|
||||
- [ ] Imaging reports
|
||||
- [ ] Pathology reports
|
||||
- [ ] Discharge summary
|
||||
- [ ] Death certificate (if applicable)
|
||||
- [ ] Autopsy report (if applicable)
|
||||
- [ ] Consultant notes
|
||||
- [ ] Other: ______________
|
||||
|
||||
---
|
||||
|
||||
## Distribution List
|
||||
|
||||
- [ ] Study Sponsor
|
||||
- [ ] FDA (if applicable)
|
||||
- [ ] IRB/IEC
|
||||
- [ ] Data Safety Monitoring Board (if applicable)
|
||||
- [ ] Site regulatory files
|
||||
|
||||
---
|
||||
|
||||
## Notes
|
||||
|
||||
**Regulatory Timeline Requirements:**
|
||||
- **Fatal or life-threatening unexpected SAEs:** 7 days for preliminary report, 15 days for complete
|
||||
- **Other serious unexpected events:** 15 days
|
||||
- **IRB notification:** Per institutional policy (typically 5-10 days)
|
||||
|
||||
**Key Points:**
|
||||
- Complete all sections accurately
|
||||
- Provide detailed narrative
|
||||
- Include temporal relationships
|
||||
- Document all sources of information
|
||||
- Follow up until event resolved
|
||||
- Maintain patient confidentiality
|
||||
- Use only de-identified information
|
||||
|
||||
|
||||
305
skills/clinical-reports/assets/consult_note_template.md
Normal file
305
skills/clinical-reports/assets/consult_note_template.md
Normal file
@@ -0,0 +1,305 @@
|
||||
# Consultation Note Template
|
||||
|
||||
**Patient Name:** [Last, First]
|
||||
**Medical Record Number:** [MRN]
|
||||
**Date of Birth:** [MM/DD/YYYY]
|
||||
**Age/Sex:** [years, M/F]
|
||||
|
||||
**Consultation Date:** [MM/DD/YYYY]
|
||||
**Consultation Time:** [HH:MM]
|
||||
**Location:** [Floor, Room number]
|
||||
|
||||
**Requesting Service:** [Primary team]
|
||||
**Requesting Physician:** [Name]
|
||||
**Consulting Service:** [Cardiology, Nephrology, etc.]
|
||||
**Consulting Physician:** [Name and credentials]
|
||||
|
||||
---
|
||||
|
||||
## Reason for Consultation
|
||||
|
||||
[Specific clinical question or reason for consultation]
|
||||
|
||||
Example: "Please evaluate and manage acute kidney injury in setting of heart failure exacerbation."
|
||||
|
||||
---
|
||||
|
||||
## History of Present Illness (Focused on Consultation Question)
|
||||
|
||||
[Relevant history focused on the consultation question]
|
||||
|
||||
[Patient Name] is a [age]-year-old [sex] with a history of [relevant conditions] currently admitted to [service] for [admission diagnosis] who is being consulted for [specific issue].
|
||||
|
||||
[Chronological narrative relevant to consultation question]
|
||||
|
||||
**Timeline of Current Issue:**
|
||||
- [Key events leading to consultation]
|
||||
- [Current status]
|
||||
- [Treatments tried]
|
||||
|
||||
---
|
||||
|
||||
## Relevant Past Medical History
|
||||
|
||||
1. [Condition relevant to consultation]
|
||||
2. [Additional relevant conditions]
|
||||
|
||||
[Only include history pertinent to consultation question]
|
||||
|
||||
---
|
||||
|
||||
## Current Medications
|
||||
|
||||
[List medications relevant to consultation question]
|
||||
|
||||
| Medication | Dose | Route | Frequency | Relevant to: |
|
||||
|------------|------|-------|-----------|--------------|
|
||||
| [Drug] | [mg] | [route] | [freq] | [Why relevant] |
|
||||
|
||||
---
|
||||
|
||||
## Allergies
|
||||
|
||||
| Allergen | Reaction |
|
||||
|----------|----------|
|
||||
| [Drug/substance] | [Reaction] |
|
||||
|
||||
---
|
||||
|
||||
## Relevant Social/Family History
|
||||
|
||||
[Only include if pertinent to consultation]
|
||||
|
||||
---
|
||||
|
||||
## Review of Systems (Focused)
|
||||
|
||||
[Focus on systems relevant to consultation question]
|
||||
|
||||
**[Relevant system]:** [Findings]
|
||||
**[Additional relevant systems]:** [Findings]
|
||||
|
||||
---
|
||||
|
||||
## Physical Examination
|
||||
|
||||
**Vital Signs:**
|
||||
- Temperature: _____ °F
|
||||
- Blood Pressure: _____/_____ mmHg
|
||||
- Heart Rate: _____ bpm
|
||||
- Respiratory Rate: _____ breaths/min
|
||||
- Oxygen Saturation: _____% on [O2 status]
|
||||
- Weight: _____ kg (if relevant)
|
||||
|
||||
**General:**
|
||||
[Overall appearance, distress level]
|
||||
|
||||
**[Focused Examination Relevant to Consultation]:**
|
||||
|
||||
**Example for Cardiology Consult:**
|
||||
- **Cardiovascular:**
|
||||
- JVP: [cm H2O]
|
||||
- PMI: [location]
|
||||
- Heart sounds: [S1, S2, murmurs, gallops, rubs]
|
||||
- Peripheral pulses: [quality]
|
||||
- Edema: [location and severity]
|
||||
|
||||
**Example for Pulmonary Consult:**
|
||||
- **Pulmonary:**
|
||||
- Respiratory effort: [description]
|
||||
- Auscultation: [breath sounds, wheezes, crackles]
|
||||
- Percussion: [findings]
|
||||
|
||||
[Include other relevant systems, may abbreviate or defer non-pertinent systems]
|
||||
|
||||
---
|
||||
|
||||
## Pertinent Laboratory and Imaging Data
|
||||
|
||||
**Labs ([Date]):**
|
||||
|
||||
[Include only labs relevant to consultation]
|
||||
|
||||
| Test | Result | Reference Range | Trend |
|
||||
|------|--------|----------------|-------|
|
||||
| [Relevant lab] | [Value] | [Range] | [↑/↓/→] |
|
||||
|
||||
**Imaging/Diagnostics:**
|
||||
|
||||
**[Study] ([Date]):** [Relevant findings]
|
||||
|
||||
**ECG ([Date]):** [Relevant findings]
|
||||
|
||||
**Other Studies:** [Relevant results]
|
||||
|
||||
---
|
||||
|
||||
## Assessment
|
||||
|
||||
**Consultant's Assessment of [Specific Problem]:**
|
||||
|
||||
[Detailed assessment of the consultation question]
|
||||
|
||||
**Differential Diagnosis:**
|
||||
1. [Most likely diagnosis] - [supporting evidence]
|
||||
2. [Alternative diagnosis] - [evidence for/against]
|
||||
3. [Additional considerations]
|
||||
|
||||
**Severity/Acuity:** [Assessment of severity]
|
||||
|
||||
**Contributing Factors:** [What is contributing to the problem]
|
||||
|
||||
**Prognosis:** [Short-term and long-term outlook]
|
||||
|
||||
---
|
||||
|
||||
## Recommendations
|
||||
|
||||
**[Problem Being Addressed]:**
|
||||
|
||||
**Diagnostic Recommendations:**
|
||||
1. [Specific test] - [Rationale]
|
||||
2. [Additional studies] - [Why needed]
|
||||
|
||||
**Therapeutic Recommendations:**
|
||||
1. **[Intervention/Medication]:**
|
||||
- [Specific dose, route, frequency]
|
||||
- [Duration]
|
||||
- [Rationale]
|
||||
- [Monitoring parameters]
|
||||
|
||||
2. **[Additional treatments]**
|
||||
|
||||
3. **[Procedures if recommended]:**
|
||||
- [Procedure name]
|
||||
- [Indication]
|
||||
- [Timing]
|
||||
|
||||
**Monitoring Recommendations:**
|
||||
- [What to monitor]
|
||||
- [How often]
|
||||
- [Target parameters]
|
||||
|
||||
**Follow-up Recommendations:**
|
||||
- [ ] Will follow along as consultant during hospitalization
|
||||
- [ ] Recommend follow-up in [Specialty] clinic in [timeframe]
|
||||
- [ ] Recommend re-consultation if [specific circumstances]
|
||||
- [ ] No further consultation needed unless [conditions]
|
||||
|
||||
**Additional Recommendations:**
|
||||
- [Lifestyle modifications]
|
||||
- [Patient education points]
|
||||
- [Precautions]
|
||||
|
||||
**Recommendations Summary for Primary Team:**
|
||||
[Concise bulleted list of key recommendations that can be quickly reviewed]
|
||||
1. [Action item 1]
|
||||
2. [Action item 2]
|
||||
3. [Action item 3]
|
||||
|
||||
---
|
||||
|
||||
## Consultantdiscussion with Primary Team
|
||||
|
||||
**Discussed with:** [Name, role]
|
||||
**Date/Time:** [MM/DD/YYYY at HH:MM]
|
||||
**Topics discussed:** [Key points discussed]
|
||||
**Plan agreed upon:** [Agreement or modifications]
|
||||
|
||||
---
|
||||
|
||||
## Follow-up Plan
|
||||
|
||||
**Consultant will:**
|
||||
- [ ] Round daily until [condition met or discharge]
|
||||
- [ ] Re-evaluate in [X] days
|
||||
- [ ] Available for questions or changes in clinical status
|
||||
- [ ] Recommend outpatient follow-up in [timeframe]
|
||||
|
||||
**Primary team to:**
|
||||
- [ ] Implement above recommendations
|
||||
- [ ] Notify consultant if [specific circumstances]
|
||||
- [ ] Monitor [specific parameters]
|
||||
|
||||
---
|
||||
|
||||
## Signature
|
||||
|
||||
**Consultant:** [Name, MD/DO, credentials]
|
||||
**Service:** [Consulting service]
|
||||
**Date/Time:** [MM/DD/YYYY at HH:MM]
|
||||
**Pager/Contact:** [Number]
|
||||
**Signature:** ____________________
|
||||
|
||||
**Co-signature (if fellow or resident):**
|
||||
**Attending:** [Name, credentials]
|
||||
**Date/Time:** [MM/DD/YYYY at HH:MM]
|
||||
**Signature:** ____________________
|
||||
|
||||
---
|
||||
|
||||
## Template Notes
|
||||
|
||||
**Key Principles for Consultation Notes:**
|
||||
|
||||
1. **Answer the question:** Directly address the specific consultation request
|
||||
2. **Be focused:** Include only information relevant to the consultation
|
||||
3. **Be specific:** Provide clear, actionable recommendations
|
||||
4. **Be concise:** Respect primary team's time
|
||||
5. **Be available:** Make follow-up plan clear
|
||||
|
||||
**Common Consultation Types:**
|
||||
|
||||
**Cardiology:**
|
||||
- Pre-operative risk assessment
|
||||
- Arrhythmia management
|
||||
- Heart failure management
|
||||
- Chest pain evaluation
|
||||
|
||||
**Nephrology:**
|
||||
- Acute kidney injury
|
||||
- Chronic kidney disease management
|
||||
- Electrolyte abnormalities
|
||||
- Dialysis initiation/management
|
||||
|
||||
**Infectious Disease:**
|
||||
- Antibiotic selection
|
||||
- Fever of unknown origin
|
||||
- Complex infections
|
||||
- HIV management
|
||||
|
||||
**Endocrinology:**
|
||||
- Diabetes management
|
||||
- Thyroid disorders
|
||||
- Adrenal insufficiency
|
||||
- Calcium disorders
|
||||
|
||||
**Psychiatry:**
|
||||
- Capacity assessment
|
||||
- Depression/anxiety management
|
||||
- Agitation management
|
||||
- Substance withdrawal
|
||||
|
||||
**Pain Management:**
|
||||
- Chronic pain consultation
|
||||
- Post-operative pain control
|
||||
- Cancer pain management
|
||||
|
||||
**Palliative Care:**
|
||||
- Goals of care discussion
|
||||
- Symptom management
|
||||
- End-of-life care planning
|
||||
|
||||
**Tips for Effective Consultations:**
|
||||
|
||||
- Call the referring provider before seeing patient to clarify question
|
||||
- Introduce yourself to patient and explain your role
|
||||
- Review chart thoroughly before examination
|
||||
- Be respectful of primary team's care
|
||||
- Make specific recommendations, not vague suggestions
|
||||
- Document same day as consultation
|
||||
- Communicate recommendations verbally when appropriate
|
||||
- Be available for questions
|
||||
- Follow up consistently if ongoing consultation
|
||||
|
||||
|
||||
453
skills/clinical-reports/assets/discharge_summary_template.md
Normal file
453
skills/clinical-reports/assets/discharge_summary_template.md
Normal file
@@ -0,0 +1,453 @@
|
||||
# Discharge Summary Template
|
||||
|
||||
## Patient Information
|
||||
|
||||
**Patient Name:** [Last, First]
|
||||
**Medical Record Number:** [MRN]
|
||||
**Date of Birth:** [MM/DD/YYYY]
|
||||
**Age:** [years]
|
||||
**Sex:** [M/F]
|
||||
|
||||
**Admission Date:** [MM/DD/YYYY]
|
||||
**Discharge Date:** [MM/DD/YYYY]
|
||||
**Length of Stay:** [X days]
|
||||
|
||||
**Admitting Service:** [Medicine/Surgery/Cardiology/etc.]
|
||||
**Attending Physician:** [Name]
|
||||
**Primary Care Physician:** [Name and contact]
|
||||
**Consulting Services:** [List specialties that saw patient]
|
||||
|
||||
---
|
||||
|
||||
## Admission Diagnosis
|
||||
|
||||
[Primary reason for hospitalization]
|
||||
|
||||
Example: "Acute decompensated heart failure"
|
||||
|
||||
---
|
||||
|
||||
## Discharge Diagnoses
|
||||
|
||||
[Numbered list, prioritized by clinical significance]
|
||||
|
||||
**Primary Diagnosis:**
|
||||
1. [Primary diagnosis with ICD-10 code]
|
||||
|
||||
**Secondary Diagnoses:**
|
||||
2. [Secondary diagnosis with ICD-10 code]
|
||||
3. [Additional diagnosis with ICD-10 code]
|
||||
4. [Comorbidity with ICD-10 code]
|
||||
|
||||
Example:
|
||||
```
|
||||
1. Acute decompensated heart failure (I50.23)
|
||||
2. Acute kidney injury on chronic kidney disease stage 3 (N17.9, N18.3)
|
||||
3. Hypokalemia (E87.6)
|
||||
4. Type 2 diabetes mellitus (E11.9)
|
||||
5. Coronary artery disease (I25.10)
|
||||
```
|
||||
|
||||
---
|
||||
|
||||
## Hospital Course
|
||||
|
||||
[Comprehensive yet concise narrative of hospital stay - can be organized chronologically or by problem]
|
||||
|
||||
### Chronological Format:
|
||||
|
||||
**[Date Range or Hospital Day 1-X]:**
|
||||
|
||||
[Patient Name] was admitted to the [service] service with [chief complaint/presenting problem]. On presentation, patient was [clinical status]. Initial workup revealed [key findings].
|
||||
|
||||
[Description of key events, interventions, and response to treatment organized by day or by problem]
|
||||
|
||||
**Hospital Day 1:** [Events and interventions]
|
||||
|
||||
**Hospital Day 2-3:** [Progression, response to treatment]
|
||||
|
||||
**Hospital Day 4-7:** [Continued treatment, consultations, procedures]
|
||||
|
||||
**Final Hospital Days:** [Stabilization, preparation for discharge]
|
||||
|
||||
### Problem-Based Format (Alternative):
|
||||
|
||||
**1. [Primary Problem]**
|
||||
- Presentation and initial management
|
||||
- Diagnostic workup
|
||||
- Treatment course
|
||||
- Response and outcome
|
||||
- Status at discharge
|
||||
|
||||
**2. [Secondary Problem]**
|
||||
- [Similar structure]
|
||||
|
||||
**3. [Additional Problems]**
|
||||
|
||||
### Key Events and Interventions
|
||||
|
||||
**Consultations Obtained:**
|
||||
- [Specialty] consulted on [date] for [reason]: [Recommendations]
|
||||
|
||||
**Procedures Performed:**
|
||||
- [Procedure name] on [date]: [Indication, findings, complications if any]
|
||||
|
||||
**Significant Diagnostic Studies:**
|
||||
- [Test/imaging] on [date]: [Key findings relevant to discharge care]
|
||||
|
||||
**Complications:**
|
||||
- [Any complications that occurred]: [How managed]
|
||||
|
||||
---
|
||||
|
||||
## Procedures Performed During Hospitalization
|
||||
|
||||
1. [Procedure name] ([Date])
|
||||
- Indication: [Why performed]
|
||||
- Findings: [Key findings]
|
||||
- Complications: [None / specific complications]
|
||||
|
||||
2. [Additional procedures]
|
||||
|
||||
---
|
||||
|
||||
## Hospital Course Summary (Brief Version)
|
||||
|
||||
[One paragraph summary suitable for quick reference]
|
||||
|
||||
Example:
|
||||
```
|
||||
Mr. [Name] was admitted with acute decompensated heart failure in the setting of
|
||||
medication non-adherence. He was diuresed with IV furosemide with net negative
|
||||
5 liters over 3 days, with significant improvement in dyspnea and resolution of
|
||||
lower extremity edema. Echocardiogram showed EF 30%, similar to prior. Kidney
|
||||
function improved to baseline with diuresis. He was transitioned to oral diuretics
|
||||
on hospital day 3 and remained stable. Patient was ambulating without dyspnea on
|
||||
room air by discharge. Comprehensive heart failure education was provided.
|
||||
```
|
||||
|
||||
---
|
||||
|
||||
## Discharge Physical Examination
|
||||
|
||||
**Vital Signs:**
|
||||
- Temperature: \_\_\_\_\_ °F
|
||||
- Blood Pressure: \_\_\_\_\_/\_\_\_\_\_ mmHg
|
||||
- Heart Rate: \_\_\_\_\_ bpm
|
||||
- Respiratory Rate: \_\_\_\_\_ breaths/min
|
||||
- Oxygen Saturation: \_\_\_\_\_% on [room air / O2]
|
||||
- Weight: \_\_\_\_\_ kg (Admission weight: \_\_\_\_\_ kg)
|
||||
|
||||
**General:** [Appearance, distress level]
|
||||
|
||||
**Cardiovascular:** [Heart sounds, edema]
|
||||
|
||||
**Pulmonary:** [Breath sounds, work of breathing]
|
||||
|
||||
**Abdomen:** [Tenderness, bowel sounds, distention]
|
||||
|
||||
**Extremities:** [Edema, pulses]
|
||||
|
||||
**Neurological:** [Mental status, focal deficits]
|
||||
|
||||
**Wounds/Incisions (if applicable):** [Healing status]
|
||||
|
||||
---
|
||||
|
||||
## Pertinent Laboratory and Imaging Results
|
||||
|
||||
### Discharge Labs ([Date])
|
||||
|
||||
| Test | Result | Reference Range |
|
||||
|------|--------|----------------|
|
||||
| WBC | [Value] | [Range] |
|
||||
| Hemoglobin | [Value] | [Range] |
|
||||
| Platelets | [Value] | [Range] |
|
||||
| Sodium | [Value] | [Range] |
|
||||
| Potassium | [Value] | [Range] |
|
||||
| Creatinine | [Value] | [Range] |
|
||||
| [Other relevant labs] | [Value] | [Range] |
|
||||
|
||||
### Imaging/Diagnostic Studies
|
||||
|
||||
**[Study name] ([Date]):** [Key findings relevant to outpatient management]
|
||||
|
||||
---
|
||||
|
||||
## Discharge Medications
|
||||
|
||||
[Complete list with clear indication of changes from admission]
|
||||
|
||||
### New Medications (Started During Hospitalization)
|
||||
|
||||
1. **[Medication name]** [dose] [route] [frequency]
|
||||
- Indication: [Why prescribed]
|
||||
- Duration: [If limited duration]
|
||||
- Special instructions: [With food, time of day, etc.]
|
||||
|
||||
### Changed Medications (Dose or Frequency Modified)
|
||||
|
||||
2. **[Medication name]** [NEW dose] [route] [frequency]
|
||||
- **CHANGED FROM:** [Previous dose and frequency]
|
||||
- Reason for change: [Why modified]
|
||||
|
||||
### Continued Medications (No change from home medications)
|
||||
|
||||
3. **[Medication name]** [dose] [route] [frequency]
|
||||
- **CONTINUED** from home regimen
|
||||
|
||||
### Discontinued Medications (Stopped During Hospitalization)
|
||||
|
||||
4. **[Medication name]** - **DISCONTINUED**
|
||||
- Reason: [Why stopped]
|
||||
|
||||
### Complete Medication List for Patient
|
||||
|
||||
[Consolidated list in simple format for patient]
|
||||
|
||||
```
|
||||
1. Furosemide 40 mg by mouth once daily [NEW - for fluid management]
|
||||
2. Carvedilol 12.5 mg by mouth twice daily [CONTINUED]
|
||||
3. Lisinopril 20 mg by mouth once daily [CONTINUED]
|
||||
4. Metformin 1000 mg by mouth twice daily [CONTINUED]
|
||||
5. Aspirin 81 mg by mouth once daily [CONTINUED]
|
||||
```
|
||||
|
||||
---
|
||||
|
||||
## Discharge Condition
|
||||
|
||||
**Overall Status:** [Stable / Improved / Baseline / Requires continued care]
|
||||
|
||||
**Specific Assessments:**
|
||||
- Hemodynamic status: [Stable]
|
||||
- Respiratory status: [Room air / Oxygen requirement]
|
||||
- Mental status: [Alert and oriented x3 / Other]
|
||||
- Functional status: [Ambulatory / Requires assistance / Bedbound]
|
||||
- Pain control: [Adequate / Inadequate]
|
||||
- Wound healing (if applicable): [Appropriate / Delayed]
|
||||
|
||||
Example:
|
||||
```
|
||||
Patient is hemodynamically stable, ambulatory without assistance, no supplemental
|
||||
oxygen requirement, euvolemic on physical exam, pain well-controlled, and has
|
||||
returned to baseline functional status.
|
||||
```
|
||||
|
||||
---
|
||||
|
||||
## Discharge Disposition
|
||||
|
||||
[Where patient is going after hospital discharge]
|
||||
|
||||
Options:
|
||||
- Home with self-care
|
||||
- Home with home health services
|
||||
- Skilled nursing facility
|
||||
- Acute rehabilitation facility
|
||||
- Long-term acute care hospital
|
||||
- Hospice (home or facility)
|
||||
- Left against medical advice (AMA)
|
||||
- Transferred to another acute care facility
|
||||
|
||||
**Discharge Disposition:** [Selection from above]
|
||||
|
||||
**Services Arranged:**
|
||||
- [ ] Home health nursing
|
||||
- [ ] Physical therapy
|
||||
- [ ] Occupational therapy
|
||||
- [ ] Durable medical equipment: [List items]
|
||||
- [ ] Home oxygen: [Flow rate and delivery method]
|
||||
- [ ] Other: [Specify]
|
||||
|
||||
---
|
||||
|
||||
## Follow-Up Appointments
|
||||
|
||||
1. **[Specialty/PCP]** with Dr. [Name]
|
||||
- Date/Time: [Scheduled date and time] OR [Within X days/weeks]
|
||||
- Location: [Clinic name and address]
|
||||
- Phone: [Contact number]
|
||||
- Purpose: [What needs to be addressed]
|
||||
|
||||
2. **[Additional appointments]**
|
||||
|
||||
### Pending Studies/Labs at Discharge
|
||||
|
||||
- [Test name]: [When due, where to go, reason]
|
||||
- Results will be sent to: [Provider name]
|
||||
|
||||
### Referrals Placed
|
||||
|
||||
- [Specialty]: [Reason for referral, contact information]
|
||||
|
||||
---
|
||||
|
||||
## Patient Instructions
|
||||
|
||||
### Activity
|
||||
|
||||
- [Specific activity restrictions or recommendations]
|
||||
- Example: "Resume normal activities as tolerated. Avoid heavy lifting >10 lbs for 2 weeks."
|
||||
|
||||
### Diet
|
||||
|
||||
- [Dietary restrictions or recommendations]
|
||||
- Example: "Low sodium diet (less than 2 grams per day). Fluid restriction to 2 liters per day."
|
||||
|
||||
### Wound Care (if applicable)
|
||||
|
||||
- [Incision care instructions]
|
||||
- [Dressing change frequency]
|
||||
- [When stitches/staples should be removed]
|
||||
|
||||
### Self-Monitoring
|
||||
|
||||
- [What patient should monitor at home]
|
||||
- Example: "Weigh yourself every morning. Call doctor if weight gain >2 lbs in 1 day or >5 lbs in 1 week."
|
||||
|
||||
### Equipment/Supplies
|
||||
|
||||
- [Equipment provided or prescribed]
|
||||
- [How to use]
|
||||
|
||||
### Medications
|
||||
|
||||
- [General medication instructions]
|
||||
- [Importance of compliance]
|
||||
- [What to do if dose missed]
|
||||
|
||||
---
|
||||
|
||||
## Return Precautions / Warning Signs
|
||||
|
||||
**Call your doctor or return to emergency department if you experience:**
|
||||
|
||||
- [Specific warning signs relevant to condition]
|
||||
- [When to seek immediate care vs. call doctor]
|
||||
|
||||
Example for heart failure:
|
||||
```
|
||||
- Worsening shortness of breath or difficulty breathing
|
||||
- Chest pain or pressure
|
||||
- Severe swelling in legs or abdomen
|
||||
- Weight gain more than 2 lbs in one day or 5 lbs in one week
|
||||
- Dizziness, lightheadedness, or fainting
|
||||
- Fever >101°F
|
||||
- Any other concerning symptoms
|
||||
```
|
||||
|
||||
**Emergency Contact Numbers:**
|
||||
- Primary care physician: [Phone]
|
||||
- Specialty clinic: [Phone]
|
||||
- After-hours nurse line: [Phone]
|
||||
- 911 for emergencies
|
||||
|
||||
---
|
||||
|
||||
## Patient Education Provided
|
||||
|
||||
Topics discussed with patient and/or family:
|
||||
- [ ] Disease process and prognosis
|
||||
- [ ] Medication purpose, dosing, and side effects
|
||||
- [ ] Warning signs and when to seek care
|
||||
- [ ] Activity and dietary restrictions
|
||||
- [ ] Follow-up appointments
|
||||
- [ ] Use of medical equipment
|
||||
- [ ] [Other specific topics]
|
||||
|
||||
**Patient/Family Understanding:**
|
||||
[Patient and family verbalize understanding of discharge instructions / Teach-back method used and patient able to repeat key points / Interpreter used]
|
||||
|
||||
**Written Materials Provided:**
|
||||
- [ ] Discharge instructions
|
||||
- [ ] Medication list
|
||||
- [ ] Disease-specific education materials
|
||||
- [ ] Emergency contact information
|
||||
- [ ] Appointment information
|
||||
|
||||
---
|
||||
|
||||
## Code Status at Discharge
|
||||
|
||||
**Code Status:** [Full code / DNR / DNI / Other limitations]
|
||||
|
||||
[If changed during hospitalization, note when and why]
|
||||
|
||||
---
|
||||
|
||||
## Additional Information
|
||||
|
||||
### Advance Directives
|
||||
|
||||
- [ ] Advance directive on file
|
||||
- [ ] Healthcare proxy designated: [Name and contact]
|
||||
- [ ] Living will present
|
||||
|
||||
### Social Situation
|
||||
|
||||
[Relevant social factors affecting discharge plan]
|
||||
- Living situation: [Lives alone / with family / assisted living]
|
||||
- Caregiver support: [Available / Limited / None]
|
||||
- Transportation: [Adequate / Needs assistance]
|
||||
- Barriers to compliance: [Financial / Cognitive / Language / Other]
|
||||
|
||||
### Pending Issues at Discharge
|
||||
|
||||
[Tests or consultations still pending that require outpatient follow-up]
|
||||
|
||||
---
|
||||
|
||||
## Signature
|
||||
|
||||
**Prepared by:**
|
||||
[Physician name, credentials]
|
||||
[Pager/Contact number]
|
||||
|
||||
**Cosigned by (if resident/fellow):**
|
||||
[Attending physician name]
|
||||
|
||||
**Date and Time:** [MM/DD/YYYY at HH:MM]
|
||||
|
||||
**Electronically signed:** [Yes/No]
|
||||
|
||||
---
|
||||
|
||||
## Template Completion Checklist
|
||||
|
||||
- [ ] All discharge diagnoses listed with ICD-10 codes
|
||||
- [ ] Hospital course summarized clearly
|
||||
- [ ] All procedures documented
|
||||
- [ ] Discharge medications reconciled and clearly marked (new/changed/continued/stopped)
|
||||
- [ ] Follow-up appointments scheduled or timeframe provided
|
||||
- [ ] Patient education documented
|
||||
- [ ] Return precautions specific to patient's conditions
|
||||
- [ ] Pending tests/results documented with follow-up plan
|
||||
- [ ] Code status documented
|
||||
- [ ] Completed within 24-48 hours of discharge (institutional requirement)
|
||||
- [ ] Sent to primary care physician and relevant specialists
|
||||
- [ ] Copy provided to patient
|
||||
|
||||
---
|
||||
|
||||
## Notes
|
||||
|
||||
**Timing Requirements:**
|
||||
- CMS requires completion within 30 days
|
||||
- Many hospitals require 24-48 hours
|
||||
- Should be available for follow-up appointments
|
||||
|
||||
**Distribution:**
|
||||
- Send to primary care physician
|
||||
- Send to referring physician
|
||||
- Send to consulting specialists involved in care
|
||||
- Provide copy to patient
|
||||
- Upload to shared HIE (Health Information Exchange)
|
||||
|
||||
**Quality Measures:**
|
||||
- Medication reconciliation required
|
||||
- Clear communication of changes
|
||||
- Specific follow-up plans
|
||||
- Patient education documented
|
||||
|
||||
|
||||
395
skills/clinical-reports/assets/hipaa_compliance_checklist.md
Normal file
395
skills/clinical-reports/assets/hipaa_compliance_checklist.md
Normal file
@@ -0,0 +1,395 @@
|
||||
# HIPAA Compliance Checklist for Clinical Reports
|
||||
|
||||
## 18 HIPAA Identifiers - De-identification Checklist
|
||||
|
||||
Verify that ALL of the following identifiers have been removed or altered:
|
||||
|
||||
- [ ] **1. Names** - Patient name, family members, healthcare providers (unless necessary and consented)
|
||||
|
||||
- [ ] **2. Geographic subdivisions smaller than state**
|
||||
- No street addresses
|
||||
- No cities (unless >20,000 population and part of ZIP can be kept if >20,000)
|
||||
- No counties
|
||||
- First 3 digits of ZIP code acceptable only if geographic unit >20,000 people
|
||||
- All other portions of ZIP codes removed
|
||||
|
||||
- [ ] **3. Dates** (except year)
|
||||
- No exact dates of birth (year only acceptable; year of birth for those >89 must be aggregated)
|
||||
- No admission dates
|
||||
- No discharge dates
|
||||
- No dates of service
|
||||
- No dates of death
|
||||
- Use relative time periods (e.g., "3 months prior") or years only
|
||||
|
||||
- [ ] **4. Telephone numbers**
|
||||
- No phone numbers of any kind
|
||||
- Including patient, family, provider contact numbers
|
||||
|
||||
- [ ] **5. Fax numbers**
|
||||
- No fax numbers
|
||||
|
||||
- [ ] **6. Email addresses**
|
||||
- No email addresses for patient or related individuals
|
||||
|
||||
- [ ] **7. Social Security numbers**
|
||||
- No SSN or partial SSN
|
||||
|
||||
- [ ] **8. Medical record numbers**
|
||||
- No MRN, hospital ID, or clinic numbers
|
||||
- Use coded study ID or case number if needed
|
||||
|
||||
- [ ] **9. Health plan beneficiary numbers**
|
||||
- No insurance ID numbers
|
||||
- No policy numbers
|
||||
|
||||
- [ ] **10. Account numbers**
|
||||
- No billing account numbers
|
||||
- No financial account information
|
||||
|
||||
- [ ] **11. Certificate/license numbers**
|
||||
- No driver's license numbers
|
||||
- No professional license numbers (unless for author credentials)
|
||||
|
||||
- [ ] **12. Vehicle identifiers and serial numbers**
|
||||
- No license plate numbers
|
||||
- No VIN numbers
|
||||
|
||||
- [ ] **13. Device identifiers and serial numbers**
|
||||
- No pacemaker serial numbers
|
||||
- No implant device serial numbers
|
||||
- Generic device description acceptable (e.g., "implantable cardioverter-defibrillator")
|
||||
|
||||
- [ ] **14. Web URLs**
|
||||
- No personal websites
|
||||
- No URLs identifying individuals
|
||||
|
||||
- [ ] **15. IP addresses**
|
||||
- No IP addresses
|
||||
|
||||
- [ ] **16. Biometric identifiers**
|
||||
- No fingerprints
|
||||
- No voiceprints
|
||||
- No retinal scans
|
||||
- No other biometric data
|
||||
|
||||
- [ ] **17. Full-face photographs and comparable images**
|
||||
- No full-face photographs without consent
|
||||
- Crop or blur faces if showing
|
||||
- Remove identifying features (jewelry, tattoos, birthmarks if not clinically relevant)
|
||||
- Black bars over eyes NOT sufficient
|
||||
- Ensure no reflection or background identification
|
||||
|
||||
- [ ] **18. Any other unique identifying characteristic or code**
|
||||
- No unique characteristics that could identify individual
|
||||
- No rare disease combinations that could identify
|
||||
- Consider if combination of remaining data points could identify individual
|
||||
|
||||
---
|
||||
|
||||
## Additional De-identification Considerations
|
||||
|
||||
### Ages and Dates
|
||||
|
||||
- [ ] Patients aged ≤89: Exact age or age range acceptable
|
||||
- [ ] Patients aged >89: Must be aggregated to "90 or older" or ">89 years"
|
||||
- [ ] Dates: Use only years OR use relative time periods
|
||||
- Example: "3 months prior to presentation" instead of "on January 15, 2023"
|
||||
- Example: "admitted in 2023" instead of "admitted on March 10, 2023"
|
||||
|
||||
### Geographic Information
|
||||
|
||||
- [ ] State or country is acceptable
|
||||
- [ ] Removed specific cities (unless population >20,000 and no other identifying information)
|
||||
- [ ] Removed hospital/clinic names
|
||||
- [ ] Use general descriptors: "a community hospital in the Midwest" or "a tertiary care center"
|
||||
|
||||
### Rare Conditions and Combinations
|
||||
|
||||
- [ ] Consider if very rare disease alone could identify patient
|
||||
- [ ] Consider if combination of:
|
||||
- Age + diagnosis + geographic area + timeframe could identify patient
|
||||
- [ ] May need to be vague about certain unique details
|
||||
- [ ] Balance between providing clinical information and protecting privacy
|
||||
|
||||
### Images and Figures
|
||||
|
||||
- [ ] All patient identifiers removed from image headers/metadata
|
||||
- [ ] DICOM data stripped
|
||||
- [ ] Dates removed from images
|
||||
- [ ] Medical record numbers removed
|
||||
- [ ] Faces cropped, blurred, or obscured
|
||||
- [ ] Identifying marks removed or obscured:
|
||||
- Tattoos
|
||||
- Jewelry
|
||||
- Birthmarks or unique scars (if not clinically relevant)
|
||||
- [ ] Scale bars and annotations do not contain identifying information
|
||||
- [ ] Background environment de-identified (room numbers, nameplates, etc.)
|
||||
|
||||
### Voice and Video
|
||||
|
||||
- [ ] No audio recordings with patient voice (unless consent obtained)
|
||||
- [ ] No video showing identifiable features (unless consent obtained)
|
||||
- [ ] If video necessary, face must be obscured
|
||||
|
||||
---
|
||||
|
||||
## Informed Consent Checklist (for Case Reports/Publications)
|
||||
|
||||
### Consent Requirements
|
||||
|
||||
- [ ] Informed consent obtained BEFORE publication submission
|
||||
- [ ] Consent obtained from patient directly (if capable)
|
||||
- [ ] If patient deceased or incapacitated, consent from legal representative or next of kin
|
||||
- [ ] For pediatric cases, parental/guardian consent obtained
|
||||
|
||||
### Consent Form Elements
|
||||
|
||||
The informed consent form must include:
|
||||
|
||||
- [ ] Purpose of publication (education, medical knowledge)
|
||||
- [ ] What will be published (case details, images, outcomes)
|
||||
- [ ] Journal or publication venue (if known)
|
||||
- [ ] Open access vs. subscription (public availability)
|
||||
- [ ] De-identification efforts explained
|
||||
- [ ] Potential for re-identification acknowledged
|
||||
- [ ] No effect on clinical care
|
||||
- [ ] Right to withdraw consent (timing limitations)
|
||||
- [ ] Contact information for questions
|
||||
- [ ] Patient signature and date
|
||||
- [ ] Witness signature (if required)
|
||||
|
||||
### Consent Documentation
|
||||
|
||||
- [ ] Signed consent form on file
|
||||
- [ ] Copy provided to patient
|
||||
- [ ] Consent available for editor review
|
||||
- [ ] Statement in manuscript confirming consent obtained
|
||||
|
||||
**Example statement for manuscript:**
|
||||
"Written informed consent was obtained from the patient for publication of this case report and any accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal on request."
|
||||
|
||||
---
|
||||
|
||||
## Safe Harbor vs. Expert Determination
|
||||
|
||||
### Safe Harbor Method
|
||||
|
||||
- [ ] All 18 identifiers removed
|
||||
- [ ] No actual knowledge that remaining information could identify individual
|
||||
- [ ] Most straightforward method
|
||||
- [ ] Recommended for most clinical reports
|
||||
|
||||
### Expert Determination Method
|
||||
|
||||
- [ ] Qualified statistician/expert determined very small re-identification risk
|
||||
- [ ] Methodology documented
|
||||
- [ ] Analysis methods specified
|
||||
- [ ] Conclusion documented
|
||||
- [ ] May allow retention of some data elements
|
||||
- [ ] Requires statistical expertise
|
||||
|
||||
**Method used:** [ ] Safe Harbor [ ] Expert Determination
|
||||
|
||||
---
|
||||
|
||||
## Minimum Necessary Standard
|
||||
|
||||
### Use and Disclosure
|
||||
|
||||
- [ ] Only minimum PHI necessary for purpose is used
|
||||
- [ ] Purpose of disclosure clearly defined
|
||||
- [ ] Limited to relevant information only
|
||||
- [ ] Consider de-identified data or limited data set as alternatives
|
||||
|
||||
### Exceptions to Minimum Necessary
|
||||
|
||||
Minimum necessary does NOT apply to:
|
||||
- Treatment purposes (providers may need full information)
|
||||
- Patient-authorized disclosures
|
||||
- Disclosures required by law
|
||||
- Disclosures to HHS for compliance investigation
|
||||
|
||||
---
|
||||
|
||||
## Authorization for Use/Disclosure of PHI
|
||||
|
||||
### When Authorization Required
|
||||
|
||||
Authorization needed for:
|
||||
- [ ] Research (unless IRB waiver granted)
|
||||
- [ ] Marketing purposes
|
||||
- [ ] Sale of PHI
|
||||
- [ ] Psychotherapy notes
|
||||
- [ ] Uses beyond treatment, payment, operations (TPO)
|
||||
|
||||
### Authorization Elements
|
||||
|
||||
If authorization required, it must include:
|
||||
|
||||
- [ ] Specific description of PHI to be used/disclosed
|
||||
- [ ] Person(s) authorized to make disclosure
|
||||
- [ ] Person(s) to receive information
|
||||
- [ ] Purpose of disclosure
|
||||
- [ ] Expiration date or event
|
||||
- [ ] Right to revoke and how
|
||||
- [ ] Right to refuse to sign
|
||||
- [ ] Potential for re-disclosure by recipient
|
||||
- [ ] Patient signature and date
|
||||
|
||||
---
|
||||
|
||||
## Limited Data Set
|
||||
|
||||
### Limited Data Set Option
|
||||
|
||||
A limited data set removes 16 of 18 identifiers but may retain:
|
||||
- [ ] Dates (admission, discharge, service, birth, death)
|
||||
- [ ] Geographic information (city, state, ZIP code)
|
||||
|
||||
### Requirements for Limited Data Set
|
||||
|
||||
- [ ] Data Use Agreement (DUA) required
|
||||
- [ ] DUA specifies permitted uses
|
||||
- [ ] Only for research, public health, or healthcare operations
|
||||
- [ ] Recipient agrees not to re-identify
|
||||
- [ ] Recipient agrees to safeguard data
|
||||
|
||||
---
|
||||
|
||||
## Security Safeguards Checklist
|
||||
|
||||
### Administrative Safeguards
|
||||
|
||||
- [ ] Security management process in place
|
||||
- [ ] Workforce security measures
|
||||
- [ ] Access management (role-based)
|
||||
- [ ] Security training for workforce
|
||||
- [ ] Incident response procedures
|
||||
|
||||
### Physical Safeguards
|
||||
|
||||
- [ ] Facility access controls
|
||||
- [ ] Workstation use policies
|
||||
- [ ] Workstation security measures
|
||||
- [ ] Device and media controls
|
||||
- [ ] Secure disposal procedures
|
||||
|
||||
### Technical Safeguards
|
||||
|
||||
- [ ] Access controls (unique user IDs, passwords)
|
||||
- [ ] Audit controls and logging
|
||||
- [ ] Integrity controls
|
||||
- [ ] Transmission security (encryption)
|
||||
- [ ] Automatic logoff after inactivity
|
||||
|
||||
---
|
||||
|
||||
## Breach Notification Checklist
|
||||
|
||||
### If Unauthorized Disclosure Occurs
|
||||
|
||||
- [ ] Determine if breach occurred (unauthorized access/use/disclosure)
|
||||
- [ ] Assess risk of harm to individual
|
||||
- [ ] If breach affects <500 individuals:
|
||||
- Notify individual within 60 days
|
||||
- Report to HHS annually
|
||||
- [ ] If breach affects ≥500 individuals:
|
||||
- Notify individuals within 60 days
|
||||
- Notify HHS within 60 days
|
||||
- Notify media if affects ≥500 in a state/jurisdiction
|
||||
- [ ] Document breach and response
|
||||
- [ ] Implement corrective action
|
||||
|
||||
### Breach Notification Content
|
||||
|
||||
Notification must include:
|
||||
- [ ] Description of breach
|
||||
- [ ] Types of information involved
|
||||
- [ ] Steps individuals should take
|
||||
- [ ] What organization is doing
|
||||
- [ ] Contact for questions
|
||||
|
||||
---
|
||||
|
||||
## Research-Specific Compliance
|
||||
|
||||
### IRB/Privacy Board Considerations
|
||||
|
||||
- [ ] IRB approval obtained (if research)
|
||||
- [ ] HIPAA authorization obtained OR waiver granted
|
||||
- [ ] Waiver justification documented:
|
||||
- Minimal risk to privacy
|
||||
- Research cannot practically be conducted without waiver
|
||||
- Research cannot practically be conducted without PHI
|
||||
- Plan to protect identifiers
|
||||
- Plan to destroy identifiers when appropriate
|
||||
|
||||
### Clinical Trial Reporting
|
||||
|
||||
- [ ] Subject identified by ID number only
|
||||
- [ ] No names in regulatory submissions
|
||||
- [ ] Initials only if required by regulatory authority
|
||||
- [ ] Dates limited to year or relative time
|
||||
- [ ] Protocol includes privacy protections
|
||||
|
||||
---
|
||||
|
||||
## Special Populations
|
||||
|
||||
### Pediatric Cases
|
||||
|
||||
- [ ] Parent/guardian consent obtained
|
||||
- [ ] Child assent obtained (if age-appropriate)
|
||||
- [ ] Extra care with identifiable photos
|
||||
- [ ] School information removed
|
||||
|
||||
### Deceased Patients
|
||||
|
||||
- [ ] HIPAA protections apply for 50 years post-death
|
||||
- [ ] Next of kin consent for publication
|
||||
- [ ] Autopsy information de-identified
|
||||
|
||||
### Mental Health and Substance Abuse
|
||||
|
||||
- [ ] Extra protections under 42 CFR Part 2
|
||||
- [ ] Explicit consent for disclosure
|
||||
- [ ] Cannot re-disclose without consent
|
||||
|
||||
---
|
||||
|
||||
## Final Compliance Verification
|
||||
|
||||
**Reviewed by:** ____________________
|
||||
**Date:** ____________________
|
||||
**Signature:** ____________________
|
||||
|
||||
**Compliance Status:** [ ] Compliant [ ] Needs revision [ ] Not compliant
|
||||
|
||||
**Issues identified:**
|
||||
1. [Issue]
|
||||
2. [Issue]
|
||||
|
||||
**Corrective actions:**
|
||||
1. [Action]
|
||||
2. [Action]
|
||||
|
||||
**Re-review required:** [ ] Yes [ ] No
|
||||
**Re-review date:** ____________________
|
||||
|
||||
---
|
||||
|
||||
## Documentation to Maintain
|
||||
|
||||
Keep on file:
|
||||
- [ ] Signed patient consent (if applicable)
|
||||
- [ ] IRB approval (if research)
|
||||
- [ ] HIPAA waiver (if applicable)
|
||||
- [ ] De-identification verification
|
||||
- [ ] Data use agreement (if limited data set)
|
||||
- [ ] Authorization forms (if applicable)
|
||||
- [ ] Training records for personnel handling PHI
|
||||
- [ ] Audit logs
|
||||
|
||||
**Retention period:** Minimum 6 years per HIPAA requirement
|
||||
|
||||
|
||||
305
skills/clinical-reports/assets/history_physical_template.md
Normal file
305
skills/clinical-reports/assets/history_physical_template.md
Normal file
@@ -0,0 +1,305 @@
|
||||
# History and Physical Examination (H&P) Template
|
||||
|
||||
**Patient Name:** [Last, First]
|
||||
**Medical Record Number:** [MRN]
|
||||
**Date of Birth:** [MM/DD/YYYY]
|
||||
**Age:** [years]
|
||||
**Sex:** [M/F]
|
||||
|
||||
**Date of Admission/Encounter:** [MM/DD/YYYY]
|
||||
**Time:** [HH:MM]
|
||||
**Location:** [Hospital floor, Clinic, ED]
|
||||
**Admitting Service:** [Medicine, Surgery, etc.]
|
||||
**Attending Physician:** [Name]
|
||||
|
||||
---
|
||||
|
||||
## Chief Complaint (CC)
|
||||
|
||||
"[Patient's stated reason for seeking care, in quotes]"
|
||||
|
||||
---
|
||||
|
||||
## History of Present Illness (HPI)
|
||||
|
||||
[Patient Name] is a [age]-year-old [sex] with a history of [relevant PMHx] who presents with [chief complaint].
|
||||
|
||||
[Use OPQRST format for symptoms, provide chronological narrative]
|
||||
|
||||
**Onset:** [When did symptoms start? Sudden vs gradual onset?]
|
||||
**Location:** [Where? Does it radiate?]
|
||||
**Duration:** [How long?]
|
||||
**Character:** [Quality - sharp, dull, pressure, etc.]
|
||||
**Aggravating factors:** [What makes it worse?]
|
||||
**Relieving factors:** [What makes it better?]
|
||||
**Timing:** [Constant or intermittent? Pattern?]
|
||||
**Severity:** [0-10 scale for pain, functional impact]
|
||||
**Associated symptoms:** [Other symptoms?]
|
||||
|
||||
**Prior evaluations and treatments:**
|
||||
**Why presenting now:**
|
||||
|
||||
---
|
||||
|
||||
## Past Medical History (PMH)
|
||||
|
||||
1. [Condition] - diagnosed [year], [current status]
|
||||
2. [Condition] - diagnosed [year], [treatment]
|
||||
3. [Additional conditions]
|
||||
|
||||
[ ] No known medical problems
|
||||
|
||||
---
|
||||
|
||||
## Past Surgical History (PSH)
|
||||
|
||||
1. [Procedure] ([year]) - [indication, complications if any]
|
||||
2. [Procedure] ([year])
|
||||
|
||||
[ ] No prior surgeries
|
||||
|
||||
---
|
||||
|
||||
## Medications
|
||||
|
||||
| Medication | Dose | Route | Frequency | Indication |
|
||||
|------------|------|-------|-----------|------------|
|
||||
| [Drug name] | [mg] | [PO/IV/etc] | [BID/etc] | [Why prescribed] |
|
||||
|
||||
[ ] No current medications
|
||||
|
||||
---
|
||||
|
||||
## Allergies
|
||||
|
||||
| Allergen | Reaction |
|
||||
|----------|----------|
|
||||
| [Drug/Food/Environmental] | [Type of reaction] |
|
||||
|
||||
[ ] No known drug allergies (NKDA)
|
||||
|
||||
---
|
||||
|
||||
## Family History (FH)
|
||||
|
||||
- **Father:** [Age/deceased at age X], [medical conditions]
|
||||
- **Mother:** [Age/deceased at age X], [medical conditions]
|
||||
- **Siblings:** [Number], [relevant conditions]
|
||||
- **Children:** [Number], [relevant conditions]
|
||||
|
||||
[Note hereditary conditions relevant to patient's presentation]
|
||||
|
||||
[ ] Non-contributory
|
||||
|
||||
---
|
||||
|
||||
## Social History (SH)
|
||||
|
||||
**Tobacco:** [Current/former/never], [pack-years if applicable]
|
||||
**Alcohol:** [Frequency and amount, CAGE questions if indicated]
|
||||
**Illicit drugs:** [Current/former/never, type, route]
|
||||
**Occupation:** [Current or former occupation]
|
||||
**Living situation:** [Lives alone/with family, housing type]
|
||||
**Marital status:** [Single/married/divorced/widowed]
|
||||
**Sexual history:** [If relevant]
|
||||
**Exercise:** [Type and frequency]
|
||||
**Diet:** [General diet description]
|
||||
**Functional status:** [ADL independence, baseline activity level]
|
||||
|
||||
---
|
||||
|
||||
## Review of Systems (ROS)
|
||||
|
||||
[Systematic review - check relevant systems]
|
||||
|
||||
**Constitutional:** [ ] Fever [ ] Chills [ ] Night sweats [ ] Weight loss [ ] Weight gain [ ] Fatigue
|
||||
**Eyes:** [ ] Vision changes [ ] Eye pain [ ] Discharge
|
||||
**ENT:** [ ] Hearing loss [ ] Tinnitus [ ] Sinus problems [ ] Sore throat
|
||||
**Cardiovascular:** [ ] Chest pain [ ] Palpitations [ ] Edema [ ] Orthopnea [ ] PND [ ] Claudication
|
||||
**Respiratory:** [ ] Dyspnea [ ] Cough [ ] Wheezing [ ] Hemoptysis
|
||||
**Gastrointestinal:** [ ] Nausea [ ] Vomiting [ ] Diarrhea [ ] Constipation [ ] Abdominal pain [ ] Melena [ ] Hematochezia
|
||||
**Genitourinary:** [ ] Dysuria [ ] Frequency [ ] Urgency [ ] Hematuria [ ] Incontinence
|
||||
**Musculoskeletal:** [ ] Joint pain [ ] Swelling [ ] Stiffness [ ] Back pain [ ] Weakness
|
||||
**Skin:** [ ] Rash [ ] Lesions [ ] Itching [ ] Changes in moles
|
||||
**Neurological:** [ ] Headache [ ] Dizziness [ ] Syncope [ ] Seizures [ ] Weakness [ ] Numbness [ ] Tingling
|
||||
**Psychiatric:** [ ] Depression [ ] Anxiety [ ] Sleep disturbance
|
||||
**Endocrine:** [ ] Heat/cold intolerance [ ] Polyuria [ ] Polydipsia [ ] Polyphagia
|
||||
**Hematologic/Lymphatic:** [ ] Easy bruising [ ] Bleeding [ ] Lymph node swelling
|
||||
**Allergic/Immunologic:** [ ] Seasonal allergies [ ] Frequent infections
|
||||
|
||||
**All other systems reviewed and negative** [ ]
|
||||
|
||||
---
|
||||
|
||||
## Physical Examination
|
||||
|
||||
**Vital Signs:**
|
||||
- Temperature: _____ °F (oral/axillary/tympanic)
|
||||
- Blood Pressure: _____/_____ mmHg ([right arm, sitting])
|
||||
- Heart Rate: _____ bpm (regular/irregular)
|
||||
- Respiratory Rate: _____ breaths/min
|
||||
- Oxygen Saturation: _____% on [room air / O2 at ___ L/min]
|
||||
- Height: _____ cm / inches
|
||||
- Weight: _____ kg / lbs
|
||||
- BMI: _____ kg/m²
|
||||
- Pain Score: ___/10
|
||||
|
||||
**General:**
|
||||
[Overall appearance, apparent vs stated age, nutritional status, distress level]
|
||||
|
||||
**HEENT:**
|
||||
- Head: [Normocephalic, atraumatic, scalp lesions]
|
||||
- Eyes: [PERRLA, EOMI, conjunctiva, sclera, fundoscopy if done]
|
||||
- Ears: [TMs, canals, hearing]
|
||||
- Nose: [Nares, septum, discharge, sinus tenderness]
|
||||
- Throat: [Oropharynx, tonsils, dentition, mucosa]
|
||||
|
||||
**Neck:**
|
||||
[Supple/stiff, lymphadenopathy, thyroid, JVP, carotid bruits]
|
||||
|
||||
**Cardiovascular:**
|
||||
- Inspection: [PMI, precordial movement]
|
||||
- Palpation: [PMI location, thrills, lifts]
|
||||
- Auscultation: [Rate, rhythm, S1/S2, murmurs/rubs/gallops, location and radiation]
|
||||
- Peripheral pulses: [Radial, femoral, DP, PT - rate quality bilaterally]
|
||||
- Extremities: [Edema, cyanosis, clubbing]
|
||||
|
||||
**Pulmonary:**
|
||||
- Inspection: [Respiratory effort, use of accessory muscles, chest wall deformities]
|
||||
- Palpation: [Tactile fremitus, chest expansion]
|
||||
- Percussion: [Resonance, dullness]
|
||||
- Auscultation: [Breath sounds, adventitious sounds - location and quality]
|
||||
|
||||
**Abdomen:**
|
||||
- Inspection: [Contour, scars, distention, visible peristalsis]
|
||||
- Auscultation: [Bowel sounds - present, hyperactive, hypoactive, absent]
|
||||
- Percussion: [Tympany, dullness, liver span, spleen]
|
||||
- Palpation: [Soft/firm, tenderness, masses, organomegaly, rebound, guarding, Murphy's sign]
|
||||
|
||||
**Musculoskeletal:**
|
||||
- Inspection: [Deformities, swelling, erythema]
|
||||
- Palpation: [Tenderness, warmth]
|
||||
- Range of motion: [Active and passive, limitations]
|
||||
- Strength: [5-point scale by major muscle groups]
|
||||
- Gait: [Normal, antalgic, ataxic, spastic]
|
||||
|
||||
**Skin:**
|
||||
[Color, temperature, moisture, turgor, lesions, rashes, wounds]
|
||||
|
||||
**Neurological:**
|
||||
- Mental Status: [Alert, oriented x3 (person, place, time), speech, memory]
|
||||
- Cranial Nerves: [II-XII - document abnormalities]
|
||||
- Motor: [Strength 5-point scale, tone, bulk, fasciculations]
|
||||
- Sensory: [Light touch, pinprick, proprioception, vibration]
|
||||
- Reflexes: [Deep tendon reflexes 0-4+ scale, Babinski]
|
||||
- Coordination: [Finger-to-nose, heel-to-shin, rapid alternating movements]
|
||||
- Gait: [Already documented above or describe here]
|
||||
|
||||
**Psychiatric:**
|
||||
[Mood, affect, thought process, thought content, judgment, insight]
|
||||
|
||||
**Genitourinary:** (if applicable)
|
||||
[Defer/document findings if examined]
|
||||
|
||||
**Rectal:** (if applicable)
|
||||
[Defer/document findings if examined]
|
||||
|
||||
---
|
||||
|
||||
## Laboratory and Imaging Results
|
||||
|
||||
[Include relevant results available at time of H&P]
|
||||
|
||||
**Labs ([Date]):**
|
||||
|
||||
| Test | Result | Reference Range | Flag |
|
||||
|------|--------|----------------|------|
|
||||
| WBC | [Value] | [Range] | [H/L/-] |
|
||||
| Hemoglobin | [Value] | [Range] | [H/L/-] |
|
||||
| [Additional labs] | | | |
|
||||
|
||||
**Imaging ([Study], [Date]):**
|
||||
[Key findings]
|
||||
|
||||
**ECG ([Date]):**
|
||||
[Rate, rhythm, intervals, axis, ST-T changes, other findings]
|
||||
|
||||
**Other Studies:**
|
||||
|
||||
---
|
||||
|
||||
## Assessment and Plan
|
||||
|
||||
**Assessment:**
|
||||
|
||||
[Patient summary statement in one sentence]
|
||||
|
||||
**Problem List:**
|
||||
|
||||
**1. [Primary Problem/Diagnosis] ([ICD-10 code])**
|
||||
|
||||
**Assessment:** [Brief description of problem, severity, stability]
|
||||
|
||||
**Plan:**
|
||||
- **Diagnostics:** [Labs, imaging, consultations needed]
|
||||
- **Therapeutics:** [Medications, procedures, interventions]
|
||||
- [Medication]: [dose, route, frequency] for [indication]
|
||||
- **Monitoring:** [What to monitor, how often]
|
||||
- **Follow-up:** [When and with whom]
|
||||
- **Disposition:** [Admit to floor/ICU, discharge, observation]
|
||||
|
||||
**2. [Secondary Problem] ([ICD-10 code])**
|
||||
|
||||
**Assessment:** [Description]
|
||||
|
||||
**Plan:**
|
||||
- [Diagnostics]
|
||||
- [Therapeutics]
|
||||
- [Monitoring]
|
||||
|
||||
**3. [Additional Problems]**
|
||||
[Continue for all active problems]
|
||||
|
||||
**Code Status:** [Full code / DNR / DNI / Other]
|
||||
|
||||
**Prophylaxis:**
|
||||
- DVT prophylaxis: [Pharmacologic and/or mechanical]
|
||||
- GI prophylaxis: [If indicated]
|
||||
- Aspiration precautions: [If indicated]
|
||||
|
||||
**Disposition:** [Admit to service, location (floor/ICU), level of care]
|
||||
|
||||
---
|
||||
|
||||
## Signature
|
||||
|
||||
**Physician:** [Name, credentials]
|
||||
**Level:** [Intern, Resident, Attending]
|
||||
**Date/Time:** [MM/DD/YYYY at HH:MM]
|
||||
**Signature:** ____________________
|
||||
|
||||
**Co-signature (if applicable):**
|
||||
**Attending:** [Name, credentials]
|
||||
**Date/Time:** [MM/DD/YYYY at HH:MM]
|
||||
**Signature:** ____________________
|
||||
|
||||
---
|
||||
|
||||
## Template Completion Checklist
|
||||
|
||||
- [ ] Chief complaint documented
|
||||
- [ ] HPI comprehensive (≥4 HPI elements for billing)
|
||||
- [ ] PMH reviewed
|
||||
- [ ] Medications reconciled
|
||||
- [ ] Allergies documented
|
||||
- [ ] ROS performed (≥10 systems for comprehensive)
|
||||
- [ ] Complete physical exam documented (≥8 systems for comprehensive)
|
||||
- [ ] Labs/imaging reviewed
|
||||
- [ ] Assessment and plan for each problem
|
||||
- [ ] Code status documented
|
||||
- [ ] Prophylaxis addressed
|
||||
- [ ] Disposition clear
|
||||
- [ ] Completed within 24 hours of admission (TJC requirement)
|
||||
- [ ] Signed and dated
|
||||
|
||||
|
||||
309
skills/clinical-reports/assets/lab_report_template.md
Normal file
309
skills/clinical-reports/assets/lab_report_template.md
Normal file
@@ -0,0 +1,309 @@
|
||||
# Laboratory Report Template
|
||||
|
||||
## Patient Information
|
||||
|
||||
**Patient Name:** [Last, First]
|
||||
**Medical Record Number:** [MRN]
|
||||
**Date of Birth:** [MM/DD/YYYY]
|
||||
**Age/Sex:** [Age years, M/F]
|
||||
|
||||
**Ordering Physician:** [Name]
|
||||
**Location:** [Inpatient unit / Outpatient clinic]
|
||||
|
||||
---
|
||||
|
||||
## Specimen Information
|
||||
|
||||
**Specimen Type:** [Blood / Serum / Plasma / Urine / CSF / Other]
|
||||
**Collection Date/Time:** [MM/DD/YYYY at HH:MM]
|
||||
**Received Date/Time:** [MM/DD/YYYY at HH:MM]
|
||||
**Reported Date/Time:** [MM/DD/YYYY at HH:MM]
|
||||
|
||||
**Accession Number:** [Lab accession number]
|
||||
**Specimen Condition:** [Acceptable / See comments]
|
||||
**Fasting Status:** [Fasting / Non-fasting / Unknown] (if relevant)
|
||||
|
||||
---
|
||||
|
||||
## Laboratory Results
|
||||
|
||||
| Test Name | Result | Units | Reference Range | Flag |
|
||||
|-----------|--------|-------|----------------|------|
|
||||
| [Test] | [Value] | [Unit] | [Normal range] | [L/H/Critical] |
|
||||
|
||||
### Example: Complete Blood Count (CBC)
|
||||
|
||||
| Test | Result | Units | Reference Range | Flag |
|
||||
|------|--------|-------|----------------|------|
|
||||
| White Blood Cell Count | 12.5 | × 10³/μL | 4.5-11.0 | H |
|
||||
| Hemoglobin | 10.2 | g/dL | 12.0-16.0 (F), 14.0-18.0 (M) | L |
|
||||
| Hematocrit | 31.5 | % | 36.0-48.0 (F), 42.0-52.0 (M) | L |
|
||||
| Platelet Count | 245 | × 10³/μL | 150-400 | - |
|
||||
| MCV | 88.5 | fL | 80.0-100.0 | - |
|
||||
| MCH | 29.5 | pg | 27.0-33.0 | - |
|
||||
| MCHC | 33.2 | g/dL | 32.0-36.0 | - |
|
||||
| RDW | 14.5 | % | 11.5-14.5 | - |
|
||||
|
||||
**Differential:**
|
||||
| Cell Type | Result | Units | Reference Range | Flag |
|
||||
|-----------|--------|-------|----------------|------|
|
||||
| Neutrophils | 75 | % | 40-70 | H |
|
||||
| Lymphocytes | 15 | % | 20-40 | L |
|
||||
| Monocytes | 7 | % | 2-10 | - |
|
||||
| Eosinophils | 2 | % | 1-4 | - |
|
||||
| Basophils | 1 | % | 0-2 | - |
|
||||
|
||||
### Example: Basic Metabolic Panel (BMP)
|
||||
|
||||
| Test | Result | Units | Reference Range | Flag |
|
||||
|------|--------|-------|----------------|------|
|
||||
| Sodium | 138 | mEq/L | 136-145 | - |
|
||||
| Potassium | 3.2 | mEq/L | 3.5-5.0 | L |
|
||||
| Chloride | 102 | mEq/L | 98-107 | - |
|
||||
| CO2 | 24 | mEq/L | 22-30 | - |
|
||||
| Blood Urea Nitrogen | 28 | mg/dL | 7-20 | H |
|
||||
| Creatinine | 1.8 | mg/dL | 0.6-1.2 (F), 0.7-1.3 (M) | H |
|
||||
| Glucose | 145 | mg/dL | 70-100 (fasting) | H |
|
||||
| eGFR | 42 | mL/min/1.73m² | >60 | L |
|
||||
|
||||
---
|
||||
|
||||
## Interpretation / Comments
|
||||
|
||||
[Clinical interpretation when applicable]
|
||||
|
||||
**Example for Anemia:**
|
||||
```
|
||||
Normocytic anemia with elevated WBC. Differential diagnosis includes anemia of chronic
|
||||
disease, recent blood loss, or hemolysis. Consider reticulocyte count, iron studies,
|
||||
and peripheral smear for further evaluation. Clinical correlation recommended.
|
||||
```
|
||||
|
||||
**Example for Electrolyte Abnormality:**
|
||||
```
|
||||
Hypokalemia detected (K+ 3.2 mEq/L). Common causes include diuretic use, GI losses, or
|
||||
inadequate intake. Recommend potassium repletion and follow-up testing. Moderate
|
||||
azotemia present, consistent with acute kidney injury or chronic kidney disease.
|
||||
Clinical correlation with patient history and prior results recommended.
|
||||
```
|
||||
|
||||
---
|
||||
|
||||
## Critical Values
|
||||
|
||||
[If any results meet criteria for critical values]
|
||||
|
||||
**Critical Result:** [Test name] = [Value] [Units]
|
||||
**Reference Range:** [Normal range]
|
||||
**Significance:** [Life-threatening, requires immediate action]
|
||||
|
||||
**Notification:**
|
||||
- **Called to:** [Name and title of person notified]
|
||||
- **Date/Time:** [MM/DD/YYYY at HH:MM]
|
||||
- **Read-back verified:** [Yes]
|
||||
- **Notified by:** [Lab personnel name]
|
||||
|
||||
**Example Critical Values:**
|
||||
- Glucose <40 mg/dL or >500 mg/dL
|
||||
- Potassium <2.5 mEq/L or >6.5 mEq/L
|
||||
- Sodium <120 mEq/L or >160 mEq/L
|
||||
- Hemoglobin <5.0 g/dL
|
||||
- Platelets <20 × 10³/μL
|
||||
- WBC <1.0 × 10³/μL or >50 × 10³/μL
|
||||
- INR >5.0 (on warfarin)
|
||||
- Positive blood culture
|
||||
- Positive CSF Gram stain
|
||||
|
||||
---
|
||||
|
||||
## Quality Control
|
||||
|
||||
**Specimen Quality:** [Acceptable / See note]
|
||||
|
||||
**QC Notes:**
|
||||
- [X] Specimen collected in appropriate tube
|
||||
- [X] Specimen adequately labeled
|
||||
- [X] Specimen volume sufficient
|
||||
- [X] No hemolysis, lipemia, or icterus
|
||||
- [X] Specimen processed within acceptable time
|
||||
|
||||
**Issues (if any):**
|
||||
- [ ] Hemolyzed - may affect [specific tests]
|
||||
- [ ] Clotted - unable to perform coagulation studies
|
||||
- [ ] Insufficient volume - limited testing performed
|
||||
- [ ] Delayed processing - stability concerns for [specific analytes]
|
||||
|
||||
---
|
||||
|
||||
## Methodology
|
||||
|
||||
**Test Method:** [Instrumentation and methodology]
|
||||
|
||||
Examples:
|
||||
- **CBC:** Automated cell counter (Sysmex XN-1000)
|
||||
- **Chemistry:** Spectrophotometry (Beckman AU5800)
|
||||
- **Glucose:** Enzymatic assay, hexokinase method
|
||||
- **HbA1c:** HPLC (high-performance liquid chromatography)
|
||||
- **Troponin:** High-sensitivity immunoassay
|
||||
- **Drug levels:** Liquid chromatography-mass spectrometry (LC-MS/MS)
|
||||
|
||||
---
|
||||
|
||||
## Special Tests Examples
|
||||
|
||||
### Hemoglobin A1c
|
||||
|
||||
| Test | Result | Units | Interpretation |
|
||||
|------|--------|-------|----------------|
|
||||
| HbA1c | 8.5 | % | Consistent with poorly controlled diabetes |
|
||||
| HbA1c | 8.5 | % (69 mmol/mol) | Target <7% for most patients |
|
||||
|
||||
**Reference Ranges:**
|
||||
- Non-diabetic: 4.0-5.6%
|
||||
- Prediabetes: 5.7-6.4%
|
||||
- Diabetes diagnosis: ≥6.5%
|
||||
- Treatment target: <7% (individualized)
|
||||
|
||||
### Lipid Panel
|
||||
|
||||
| Test | Result | Units | Reference Range | Desirable |
|
||||
|------|--------|-------|----------------|-----------|
|
||||
| Total Cholesterol | 245 | mg/dL | - | <200 |
|
||||
| LDL Cholesterol | 160 | mg/dL | - | <100 |
|
||||
| HDL Cholesterol | 38 | mg/dL | - | >40 (M), >50 (F) |
|
||||
| Triglycerides | 235 | mg/dL | - | <150 |
|
||||
| VLDL Cholesterol (calc) | 47 | mg/dL | - | <30 |
|
||||
|
||||
### Coagulation Studies
|
||||
|
||||
| Test | Result | Units | Reference Range | Flag |
|
||||
|------|--------|-------|----------------|------|
|
||||
| PT | 18.5 | seconds | 11.0-13.5 | H |
|
||||
| INR | 2.8 | ratio | 0.8-1.2 | H |
|
||||
| PTT | 42 | seconds | 25-35 | H |
|
||||
|
||||
**Therapeutic Ranges (INR):**
|
||||
- Atrial fibrillation: 2.0-3.0
|
||||
- Mechanical heart valve: 2.5-3.5
|
||||
- DVT/PE treatment: 2.0-3.0
|
||||
|
||||
### Thyroid Function Tests
|
||||
|
||||
| Test | Result | Units | Reference Range | Flag |
|
||||
|------|--------|-------|----------------|------|
|
||||
| TSH | 8.5 | μIU/mL | 0.4-4.0 | H |
|
||||
| Free T4 | 0.7 | ng/dL | 0.8-1.8 | L |
|
||||
| Free T3 | 2.1 | pg/mL | 2.3-4.2 | L |
|
||||
|
||||
**Interpretation:** Findings consistent with primary hypothyroidism
|
||||
|
||||
### Urinalysis
|
||||
|
||||
**Physical Examination:**
|
||||
- Color: [Yellow / Amber / Other]
|
||||
- Clarity: [Clear / Cloudy / Turbid]
|
||||
- Specific Gravity: [1.005-1.030]
|
||||
|
||||
**Chemical Examination:**
|
||||
| Test | Result | Reference |
|
||||
|------|--------|-----------|
|
||||
| pH | 6.0 | 5.0-8.0 |
|
||||
| Protein | Trace | Negative |
|
||||
| Glucose | Negative | Negative |
|
||||
| Ketones | Negative | Negative |
|
||||
| Blood | 2+ | Negative |
|
||||
| Bilirubin | Negative | Negative |
|
||||
| Urobilinogen | Normal | Normal |
|
||||
| Nitrite | Negative | Negative |
|
||||
| Leukocyte Esterase | Positive | Negative |
|
||||
|
||||
**Microscopic Examination (if indicated):**
|
||||
- WBCs: [number] /hpf (normal <5)
|
||||
- RBCs: [number] /hpf (normal <3)
|
||||
- Epithelial cells: [Few/Moderate/Many]
|
||||
- Bacteria: [None/Few/Moderate/Many]
|
||||
- Casts: [Type and number]
|
||||
- Crystals: [Type if present]
|
||||
|
||||
---
|
||||
|
||||
## Microbiology Report Format
|
||||
|
||||
### Culture Results
|
||||
|
||||
**Specimen Source:** [Blood / Urine / Sputum / Wound / Other]
|
||||
**Collection:** [Date and time]
|
||||
|
||||
**Gram Stain:**
|
||||
[Results of Gram stain if performed]
|
||||
Example: "Many Gram-positive cocci in clusters, many WBCs"
|
||||
|
||||
**Culture Results:**
|
||||
|
||||
**Organism:** [Identified organism]
|
||||
**Quantity:** [Light / Moderate / Heavy growth] or [CFU count]
|
||||
|
||||
**Antimicrobial Susceptibility Testing:**
|
||||
|
||||
| Antibiotic | Result | MIC (μg/mL) |
|
||||
|------------|--------|-------------|
|
||||
| [Drug name] | S/I/R | [Value] |
|
||||
|
||||
Example:
|
||||
| Antibiotic | Result | MIC |
|
||||
|------------|--------|-----|
|
||||
| Ampicillin | R | >16 |
|
||||
| Ceftriaxone | S | ≤1 |
|
||||
| Levofloxacin | S | 0.5 |
|
||||
| Vancomycin | S | 1 |
|
||||
|
||||
**Interpretation:** S = Susceptible, I = Intermediate, R = Resistant
|
||||
|
||||
---
|
||||
|
||||
## Molecular/Genetic Testing
|
||||
|
||||
**Test:** [Specific test name]
|
||||
**Method:** [PCR / Sequencing / Array / Other]
|
||||
**Result:** [Detected / Not detected / Variant identified]
|
||||
|
||||
**Interpretation:**
|
||||
[Clinical significance of result]
|
||||
|
||||
---
|
||||
|
||||
## Reference Laboratory Results
|
||||
|
||||
[For send-out tests]
|
||||
|
||||
**Test:** [Name]
|
||||
**Performed by:** [Reference lab name and location]
|
||||
**Result:** [Value]
|
||||
**Reference Range:** [Range]
|
||||
**Method:** [Methodology]
|
||||
**Reported:** [Date]
|
||||
|
||||
---
|
||||
|
||||
## Laboratory Director Signature
|
||||
|
||||
**Medical Director:**
|
||||
[Name, MD]
|
||||
[Board Certifications]
|
||||
[CLIA License Number]
|
||||
|
||||
**Electronically signed:** [Date]
|
||||
|
||||
---
|
||||
|
||||
## LOINC Codes (for interoperability)
|
||||
|
||||
[LOINC codes for each test when applicable for electronic reporting]
|
||||
|
||||
Example:
|
||||
- Hemoglobin: 718-7
|
||||
- Glucose: 2345-7
|
||||
- Creatinine: 2160-0
|
||||
- TSH: 3016-3
|
||||
|
||||
|
||||
249
skills/clinical-reports/assets/pathology_report_template.md
Normal file
249
skills/clinical-reports/assets/pathology_report_template.md
Normal file
@@ -0,0 +1,249 @@
|
||||
# Surgical Pathology Report Template
|
||||
|
||||
## Patient and Specimen Information
|
||||
|
||||
**Patient Name:** [Last, First]
|
||||
**Medical Record Number:** [MRN]
|
||||
**Date of Birth:** [MM/DD/YYYY]
|
||||
**Age:** [years]
|
||||
**Sex:** [M/F]
|
||||
|
||||
**Accession Number:** [PathologyAccessionNumber]
|
||||
**Specimen Received:** [Date and time]
|
||||
**Report Date:** [Date]
|
||||
|
||||
**Ordering Physician:** [Name]
|
||||
**Clinical Service:** [Department]
|
||||
|
||||
---
|
||||
|
||||
## Specimen(s) Submitted
|
||||
|
||||
**Specimen A:** [Description of specimen]
|
||||
Example: "Skin, left forearm, excisional biopsy"
|
||||
|
||||
**Specimen B:** [If multiple specimens]
|
||||
|
||||
---
|
||||
|
||||
## Clinical History / Indication
|
||||
|
||||
[Relevant clinical information provided by clinician]
|
||||
|
||||
Example: "72-year-old woman with enlarging pigmented lesion on left forearm. Clinical concern for melanoma. Previous biopsy showed atypical melanocytic proliferation."
|
||||
|
||||
---
|
||||
|
||||
## Gross Description
|
||||
|
||||
**Specimen A labeled "[Specimen label]":**
|
||||
|
||||
**Description:**
|
||||
- Received [fresh/in formalin]
|
||||
- Consists of [specimen type] measuring [dimensions in cm]
|
||||
- [External surface description]
|
||||
- [Cut surface/sectioning description]
|
||||
- [Lesion description if applicable]
|
||||
- [Orientation markers if present]
|
||||
- [Inking for margins]
|
||||
|
||||
**Sampling:**
|
||||
- [How specimen was sectioned]
|
||||
- [Cassette labeling]
|
||||
- [Percent of tissue submitted]
|
||||
|
||||
**Example:**
|
||||
```
|
||||
Specimen A labeled "Skin, left forearm, excisional biopsy":
|
||||
Received fresh is an oriented ellipse of skin measuring 3.5 x 1.2 x 0.8 cm with a
|
||||
suture indicating superior. The epidermis contains a 1.1 cm diameter irregularly
|
||||
pigmented lesion located 1.5 cm from superior, 1.2 cm from inferior, 0.8 cm from
|
||||
medial, and 1.2 cm from lateral margins. Inking: superior blue, inferior black,
|
||||
medial green, lateral red, deep yellow. Serially sectioned perpendicular to long
|
||||
axis into 10 slices. Entirely submitted in cassettes A1-A4.
|
||||
```
|
||||
|
||||
---
|
||||
|
||||
## Microscopic Description
|
||||
|
||||
[Detailed histological findings]
|
||||
|
||||
**Architecture:**
|
||||
[Structural patterns observed]
|
||||
|
||||
**Cytology:**
|
||||
[Cell type, nuclear features, cytoplasm, pleomorphism]
|
||||
|
||||
**Special Features:**
|
||||
[Necrosis, mitoses, invasion, margins]
|
||||
|
||||
**Stains/Immunohistochemistry Results:**
|
||||
[Results of special stains or immunostains]
|
||||
|
||||
**Example:**
|
||||
```
|
||||
Sections show skin with an asymmetric melanocytic proliferation composed of
|
||||
epithelioid and spindled melanocytes arranged in irregular nests at the
|
||||
dermoepidermal junction with extension into the papillary and reticular dermis.
|
||||
Melanocytes show marked cytologic atypia with nuclear enlargement, hyperchromasia,
|
||||
and prominent nucleoli. Mitotic activity is present with 4 mitoses per mm².
|
||||
No ulceration identified. The lesion extends to a Breslow depth of 1.8 mm
|
||||
(Clark level IV). Margins are free of tumor (closest margin: deep, 0.3 cm).
|
||||
```
|
||||
|
||||
---
|
||||
|
||||
## Diagnosis
|
||||
|
||||
**Specimen A, Skin, left forearm, excisional biopsy:**
|
||||
|
||||
**[DIAGNOSIS IN CAPITAL LETTERS]**
|
||||
|
||||
**Example Format:**
|
||||
```
|
||||
MALIGNANT MELANOMA, SUPERFICIAL SPREADING TYPE
|
||||
|
||||
Pathologic features:
|
||||
- Breslow thickness: 1.8 mm
|
||||
- Clark level: IV
|
||||
- Mitotic rate: 4/mm²
|
||||
- Ulceration: Absent
|
||||
- Margins: Negative for melanoma (closest margin deep, 0.3 cm)
|
||||
- Lymphovascular invasion: Not identified
|
||||
- Perineural invasion: Not identified
|
||||
- Regression: Absent
|
||||
- Tumor-infiltrating lymphocytes: Present, non-brisk
|
||||
- Microsatellites: Absent
|
||||
```
|
||||
|
||||
**For Cancer Specimens - Synoptic Format (CAP Protocol):**
|
||||
|
||||
```
|
||||
SYNOPTIC REPORT FOR [CANCER TYPE]
|
||||
|
||||
Procedure: [Type of resection]
|
||||
Tumor Site: [Specific location]
|
||||
Tumor Size: [Greatest dimension in cm]
|
||||
Histologic Type: [WHO classification]
|
||||
Histologic Grade: [Grading system and result]
|
||||
Depth of Invasion: [Measured in mm if applicable]
|
||||
Lymphovascular Invasion: [Present / Not identified]
|
||||
Perineural Invasion: [Present / Not identified]
|
||||
Margins:
|
||||
- [Margin name]: [Negative/Positive, distance if negative]
|
||||
- [All margins listed]
|
||||
Regional Lymph Nodes:
|
||||
- Number examined: [X]
|
||||
- Number with metastasis: [Y]
|
||||
- Extranodal extension: [Present/Absent]
|
||||
Pathologic Stage (AJCC 8th edition): [pTNM]
|
||||
Additional Findings: [Other relevant findings]
|
||||
```
|
||||
|
||||
---
|
||||
|
||||
## Ancillary Studies
|
||||
|
||||
**Immunohistochemistry:**
|
||||
|
||||
| Antibody | Result | Interpretation |
|
||||
|----------|--------|----------------|
|
||||
| [Marker name] | [Positive/Negative, pattern] | [Clinical significance] |
|
||||
|
||||
**Example:**
|
||||
| Antibody | Result | Interpretation |
|
||||
|----------|--------|----------------|
|
||||
| S100 | Positive, diffuse | Supports melanocytic lineage |
|
||||
| Melan-A | Positive, diffuse | Supports melanocytic lineage |
|
||||
| HMB-45 | Positive, patchy | Supports melanoma |
|
||||
| Ki-67 | 30% | High proliferative index |
|
||||
|
||||
**Molecular/Genetic Testing:**
|
||||
[Results of molecular tests if performed]
|
||||
- BRAF mutation: [Detected/Not detected]
|
||||
- [Other relevant tests]
|
||||
|
||||
---
|
||||
|
||||
## Comment
|
||||
|
||||
[Additional interpretive information, differential diagnosis, recommendations]
|
||||
|
||||
**Example:**
|
||||
```
|
||||
The morphologic and immunohistochemical findings are diagnostic of melanoma. The
|
||||
Breslow thickness of 1.8 mm places this tumor in the T2 category (AJCC 8th edition).
|
||||
Sentinel lymph node biopsy is recommended for staging. BRAF mutation testing may be
|
||||
considered for treatment planning. Close clinical follow-up is recommended.
|
||||
```
|
||||
|
||||
---
|
||||
|
||||
## Signature
|
||||
|
||||
**Pathologist:**
|
||||
[Name, MD]
|
||||
[Board Certification]
|
||||
[License number]
|
||||
|
||||
**Electronically signed:** [Date and time]
|
||||
|
||||
**Gross examination by:** [Name, credentials]
|
||||
**Microscopic examination by:** [Name, MD]
|
||||
|
||||
---
|
||||
|
||||
## Template Notes for Different Specimen Types
|
||||
|
||||
### Breast Biopsy
|
||||
|
||||
**Key Elements:**
|
||||
- Histologic type (invasive ductal, lobular, etc.)
|
||||
- Nottingham grade (tubule formation, nuclear grade, mitotic count)
|
||||
- Size of invasive component
|
||||
- DCIS if present (grade, extent)
|
||||
- ER/PR/HER2 status
|
||||
- Margins for all components
|
||||
- Lymph nodes if present
|
||||
|
||||
### Colon Resection
|
||||
|
||||
**Key Elements:**
|
||||
- Tumor site and size
|
||||
- Histologic type and grade
|
||||
- Depth of invasion (T stage)
|
||||
- Lymph nodes (number positive/total examined)
|
||||
- Margins (proximal, distal, radial/circumferential)
|
||||
- Lymphovascular and perineural invasion
|
||||
- Tumor deposits
|
||||
- MSI/MMR status
|
||||
|
||||
### Prostate Biopsy/Resection
|
||||
|
||||
**Key Elements:**
|
||||
- Gleason score (pattern 1 + pattern 2 = total)
|
||||
- Grade group (1-5)
|
||||
- Percent involvement per core/specimen
|
||||
- Extraprostatic extension (if radical prostatectomy)
|
||||
- Seminal vesicle invasion
|
||||
- Margins
|
||||
- Perineural invasion
|
||||
|
||||
---
|
||||
|
||||
## Frozen Section Report (if applicable)
|
||||
|
||||
**Frozen Section Diagnosis:**
|
||||
|
||||
**Specimen:** [Description]
|
||||
**Clinical Question:** [Reason for frozen]
|
||||
**Frozen Section Diagnosis:** [Diagnosis given intraoperatively]
|
||||
**Time:** [Time reported]
|
||||
**Pathologist:** [Name]
|
||||
|
||||
**Note:** Permanent sections to follow.
|
||||
|
||||
**Final Diagnosis:** [State if concordant or discordant with frozen]
|
||||
|
||||
|
||||
338
skills/clinical-reports/assets/quality_checklist.md
Normal file
338
skills/clinical-reports/assets/quality_checklist.md
Normal file
@@ -0,0 +1,338 @@
|
||||
# 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
|
||||
|
||||
|
||||
318
skills/clinical-reports/assets/radiology_report_template.md
Normal file
318
skills/clinical-reports/assets/radiology_report_template.md
Normal file
@@ -0,0 +1,318 @@
|
||||
# Radiology Report Template
|
||||
|
||||
## Patient Information
|
||||
|
||||
**Patient Name:** [Last, First]
|
||||
**Medical Record Number:** [MRN]
|
||||
**Date of Birth:** [MM/DD/YYYY]
|
||||
**Age:** [years]
|
||||
**Sex:** [M/F]
|
||||
**Exam Date:** [MM/DD/YYYY]
|
||||
**Exam Time:** [HH:MM]
|
||||
**Accession Number:** [Number]
|
||||
|
||||
**Referring Physician:** [Name]
|
||||
**Ordering Service:** [Service/Department]
|
||||
|
||||
---
|
||||
|
||||
## Examination
|
||||
|
||||
**Exam Type:** [CT/MRI/X-Ray/Ultrasound/PET/Nuclear Medicine scan]
|
||||
**Body Part:** [Anatomical region - e.g., Chest, Abdomen and Pelvis, Brain]
|
||||
**Contrast:** [Yes - IV/Oral/Both | No]
|
||||
**Laterality:** [Right/Left/Bilateral if applicable]
|
||||
|
||||
---
|
||||
|
||||
## Clinical Indication
|
||||
|
||||
[Reason for examination, relevant clinical history, specific question to be answered]
|
||||
|
||||
Example: "Rule out pulmonary embolism in patient with acute dyspnea and chest pain. History of recent surgery."
|
||||
|
||||
---
|
||||
|
||||
## Comparison
|
||||
|
||||
**Prior Studies:**
|
||||
[Modality] of [body part] from [date]: [Available/Not available for comparison]
|
||||
|
||||
Example: "CT chest without contrast from 6 months prior (01/15/2023) available for comparison"
|
||||
|
||||
OR: "No prior imaging available for comparison"
|
||||
|
||||
---
|
||||
|
||||
## Technique
|
||||
|
||||
[Detailed description of imaging parameters and protocol]
|
||||
|
||||
**For CT:**
|
||||
```
|
||||
Multidetector CT of the [body region] was performed [without/with] intravenous
|
||||
contrast. [Volume] mL of [iodinated contrast agent name] was administered
|
||||
intravenously. Images were acquired in the [arterial/venous/delayed] phase(s).
|
||||
Multiplanar reconstructions were performed.
|
||||
|
||||
Technical quality: [Adequate / Limited by motion artifact / Limited by patient body habitus]
|
||||
Radiation dose (DLP): [mGy-cm]
|
||||
```
|
||||
|
||||
**For MRI:**
|
||||
```
|
||||
MRI of the [body region] was performed [without/with] intravenous contrast
|
||||
using the following sequences: [list sequences - T1, T2, FLAIR, DWI, etc.]
|
||||
[Volume] mL of [gadolinium-based contrast agent] was administered intravenously.
|
||||
Multiplanar imaging was obtained.
|
||||
|
||||
Technical quality: [Adequate / Limited by motion artifact]
|
||||
```
|
||||
|
||||
**For X-Ray:**
|
||||
```
|
||||
[Number] views of the [body part] were obtained: [AP/PA/Lateral/Oblique]
|
||||
Technical quality: [Adequate penetration and positioning / Limited by...]
|
||||
```
|
||||
|
||||
**For Ultrasound:**
|
||||
```
|
||||
Real-time ultrasound examination of the [body part] was performed using
|
||||
[linear/curved] array transducer.
|
||||
Technical quality: [Adequate / Limited by bowel gas / Limited by body habitus]
|
||||
```
|
||||
|
||||
---
|
||||
|
||||
## Findings
|
||||
|
||||
[Systematic, comprehensive description of findings organized by anatomical region or organ system]
|
||||
|
||||
### [Region/Organ 1]
|
||||
|
||||
[Detailed findings - size, density/intensity, enhancement pattern, abnormalities]
|
||||
|
||||
**Normal statement:** "[Organ] is normal in size, contour, and [attenuation/signal intensity]. No focal lesions."
|
||||
|
||||
**Abnormal statement:** "[Description of abnormality with measurements]"
|
||||
|
||||
Example:
|
||||
```
|
||||
Lungs:
|
||||
- Bilateral ground-glass opacities are present, predominant in the lower lobes.
|
||||
- Right lower lobe consolidation measuring 4.5 x 3.2 cm with air bronchograms.
|
||||
- No pleural effusion or pneumothorax.
|
||||
- Airways are patent bilaterally.
|
||||
```
|
||||
|
||||
### [Region/Organ 2]
|
||||
|
||||
[Findings]
|
||||
|
||||
### [Additional Regions as Applicable]
|
||||
|
||||
**For Chest CT:**
|
||||
- Lungs
|
||||
- Airways
|
||||
- Pleura
|
||||
- Mediastinum and Hila
|
||||
- Heart and Great Vessels
|
||||
- Chest Wall
|
||||
- Upper Abdomen (if included)
|
||||
- Bones
|
||||
|
||||
**For Abdomen/Pelvis CT:**
|
||||
- Liver
|
||||
- Gallbladder
|
||||
- Spleen
|
||||
- Pancreas
|
||||
- Kidneys and Adrenals
|
||||
- Gastrointestinal Tract
|
||||
- Peritoneum and Mesentery
|
||||
- Retroperitoneum
|
||||
- Bladder
|
||||
- Pelvic Organs
|
||||
- Vasculature
|
||||
- Lymph Nodes
|
||||
- Bones
|
||||
- Soft Tissues
|
||||
|
||||
**For Brain MRI:**
|
||||
- Brain Parenchyma
|
||||
- Ventricles and Cisterns
|
||||
- Extra-axial Spaces
|
||||
- Vascular Structures
|
||||
- Orbits (if included)
|
||||
- Skull Base and Calvarium
|
||||
|
||||
### Measurements (if applicable)
|
||||
|
||||
| Structure | Measurement | Normal Range |
|
||||
|-----------|-------------|--------------|
|
||||
| [Lesion/mass] | [Size in cm, 3 dimensions] | - |
|
||||
| [Organ] | [Size] | [Normal size] |
|
||||
|
||||
---
|
||||
|
||||
## Impression
|
||||
|
||||
[Concise summary of key findings with clinical interpretation]
|
||||
|
||||
**Format as numbered list in order of clinical importance:**
|
||||
|
||||
1. **[Most important finding]** - [Diagnosis or differential, clinical significance]
|
||||
- [Additional details, comparison to prior if applicable]
|
||||
- [Recommendation if any]
|
||||
|
||||
2. **[Second finding]** - [Interpretation]
|
||||
|
||||
3. **[Additional findings]**
|
||||
|
||||
**Alternative format for normal study:**
|
||||
```
|
||||
No acute intrathoracic abnormality.
|
||||
Specifically, no evidence of pulmonary embolism.
|
||||
```
|
||||
|
||||
**Recommendations (if applicable):**
|
||||
- [Further imaging, follow-up imaging interval, clinical correlation, biopsy, etc.]
|
||||
- [Timeframe for follow-up]
|
||||
|
||||
Example:
|
||||
```
|
||||
Recommend follow-up CT in 3 months to assess for interval change.
|
||||
Clinical correlation with laboratory values recommended.
|
||||
Consider PET/CT for further characterization if clinically indicated.
|
||||
```
|
||||
|
||||
---
|
||||
|
||||
## Communication of Critical Results
|
||||
|
||||
[If critical/urgent finding]
|
||||
|
||||
**Critical finding:** [Description]
|
||||
|
||||
**Communicated to:** [Name and role of person notified]
|
||||
**Date/Time:** [MM/DD/YYYY at HH:MM]
|
||||
**Method:** [Phone call / Page / In person]
|
||||
**Read back verified:** [Yes]
|
||||
|
||||
---
|
||||
|
||||
## Structured Reporting (if applicable)
|
||||
|
||||
### For Lung Nodules (Lung-RADS):
|
||||
**Category:** [Lung-RADS 0/1/2/3/4A/4B/4X]
|
||||
**Recommendation:** [Per Lung-RADS guidelines]
|
||||
|
||||
### For Breast Imaging (BI-RADS):
|
||||
**Category:** [BI-RADS 0/1/2/3/4/5/6]
|
||||
**Recommendation:** [Per BI-RADS guidelines]
|
||||
|
||||
### For Liver Lesions (LI-RADS):
|
||||
**Category:** [LI-RADS 1/2/3/4/5/M/TIV]
|
||||
**Features:** [Arterial phase hyperenhancement, washout, capsule, size, growth]
|
||||
|
||||
### For Prostate (PI-RADS):
|
||||
**Score:** [PI-RADS 1/2/3/4/5]
|
||||
**Location:** [Peripheral zone / Transition zone]
|
||||
|
||||
---
|
||||
|
||||
## Signature
|
||||
|
||||
**Interpreted by:**
|
||||
[Radiologist name, MD]
|
||||
[Board certification]
|
||||
[NPI number if required]
|
||||
|
||||
**Electronically signed:** [Date and time]
|
||||
|
||||
**Dictated:** [Date and time]
|
||||
**Transcribed:** [Date and time]
|
||||
**Signed:** [Date and time]
|
||||
|
||||
---
|
||||
|
||||
## Template Notes
|
||||
|
||||
### General Principles
|
||||
|
||||
**Be systematic:**
|
||||
- Use consistent order (head to toe, outside to inside)
|
||||
- Don't skip regions even if normal
|
||||
- Include pertinent negatives
|
||||
|
||||
**Be specific:**
|
||||
- Provide measurements (size in 3 dimensions for masses)
|
||||
- Describe location precisely
|
||||
- Use standardized terminology (RadLex)
|
||||
- Quantify when possible
|
||||
|
||||
**Be clear:**
|
||||
- Avoid ambiguous language
|
||||
- Make impression stand-alone
|
||||
- Answer the clinical question directly
|
||||
- State what IS present, not just what isn't
|
||||
|
||||
**Communication:**
|
||||
- Critical findings require immediate verbal notification
|
||||
- Document communication
|
||||
- Provide specific recommendations
|
||||
- Suggest next steps when appropriate
|
||||
|
||||
### Measurement Guidelines
|
||||
|
||||
**Lesions/Masses:**
|
||||
- Three dimensions: [length x width x height in cm]
|
||||
- Use consistent measurement method for follow-up
|
||||
|
||||
**Lymph Nodes:**
|
||||
- Short axis diameter in cm
|
||||
- Note morphology (round vs. oval)
|
||||
|
||||
**Organ Sizes:**
|
||||
- Use established normal ranges
|
||||
- Age and sex appropriate
|
||||
|
||||
### Comparison Statements
|
||||
|
||||
**Improved:**
|
||||
"Interval decrease in size of right upper lobe mass from 3.5 cm to 2.1 cm."
|
||||
|
||||
**Stable:**
|
||||
"Unchanged 8 mm left lower lobe nodule, stable for 2 years."
|
||||
|
||||
**Worsened:**
|
||||
"Interval increase in bilateral pleural effusions, now moderate on the right."
|
||||
|
||||
**New finding:**
|
||||
"New 1.5 cm right adrenal nodule, not present on prior CT."
|
||||
|
||||
### Differential Diagnosis Language
|
||||
|
||||
**Definite:** "Consistent with..."
|
||||
**Probable:** "Most likely represents..." or "Favors..."
|
||||
**Possible:** "Suggestive of..." or "Differential diagnosis includes..."
|
||||
**Uncertain:** "Cannot exclude..." or "Consider..."
|
||||
|
||||
### Recommendations
|
||||
|
||||
**Follow-up imaging:**
|
||||
- Specify modality, timing, and what to assess
|
||||
- "Recommend CT chest in 6-12 months to assess stability"
|
||||
|
||||
**Further characterization:**
|
||||
- "Consider MRI for further characterization"
|
||||
- "Ultrasound correlation recommended"
|
||||
|
||||
**Clinical correlation:**
|
||||
- "Clinical correlation with tumor markers recommended"
|
||||
- "Correlate with patient symptoms and physical examination"
|
||||
|
||||
**Biopsy/Intervention:**
|
||||
- "Consider biopsy for definitive diagnosis"
|
||||
- "Amenable to image-guided biopsy if clinically indicated"
|
||||
|
||||
|
||||
253
skills/clinical-reports/assets/soap_note_template.md
Normal file
253
skills/clinical-reports/assets/soap_note_template.md
Normal file
@@ -0,0 +1,253 @@
|
||||
# SOAP Note Template
|
||||
|
||||
## Patient Information
|
||||
|
||||
**Patient Name:** [Last, First] or [Patient ID for teaching/research contexts]
|
||||
**Date of Birth:** [MM/DD/YYYY]
|
||||
**Medical Record Number:** [MRN]
|
||||
**Date of Visit:** [MM/DD/YYYY]
|
||||
**Time:** [HH:MM]
|
||||
**Location:** [Clinic, Hospital Floor, ED, etc.]
|
||||
**Provider:** [Your name and credentials]
|
||||
|
||||
---
|
||||
|
||||
## S - SUBJECTIVE
|
||||
|
||||
### Chief Complaint (CC)
|
||||
"[Patient's chief complaint in their own words]"
|
||||
|
||||
### History of Present Illness (HPI)
|
||||
|
||||
[Patient Name] is a [age]-year-old [sex] with a history of [relevant PMHx] who presents with [chief complaint].
|
||||
|
||||
**Onset:** [When did symptoms start? Sudden or gradual?]
|
||||
|
||||
**Location:** [Where is the symptom? Does it radiate?]
|
||||
|
||||
**Duration:** [How long has this been going on?]
|
||||
|
||||
**Characterization:** [Describe the quality - sharp, dull, burning, etc.]
|
||||
|
||||
**Aggravating factors:** [What makes it worse?]
|
||||
|
||||
**Relieving factors:** [What makes it better?]
|
||||
|
||||
**Timing:** [Constant or intermittent? Frequency?]
|
||||
|
||||
**Severity:** [How bad is it? 0-10 scale if pain]
|
||||
|
||||
**Associated symptoms:** [Other symptoms occurring with this?]
|
||||
|
||||
**Prior treatment and response:** [What has patient tried? Did it help?]
|
||||
|
||||
**Functional impact:** [How does this affect daily activities?]
|
||||
|
||||
**Review of Systems (pertinent to visit):**
|
||||
- Constitutional: [fever, chills, weight change, fatigue, night sweats]
|
||||
- [Other relevant systems based on chief complaint]
|
||||
- **Pertinent negatives:** [Important symptoms patient denies]
|
||||
|
||||
---
|
||||
|
||||
## O - OBJECTIVE
|
||||
|
||||
### Vital Signs
|
||||
- Temperature: \_\_\_\_\_ °F (oral/axillary/tympanic)
|
||||
- Blood Pressure: \_\_\_\_\_/\_\_\_\_\_ mmHg
|
||||
- Heart Rate: \_\_\_\_\_ bpm
|
||||
- Respiratory Rate: \_\_\_\_\_ breaths/min
|
||||
- Oxygen Saturation: \_\_\_\_\_% on [room air / O2 at \_\_ L/min]
|
||||
- Height: \_\_\_\_\_ cm / inches
|
||||
- Weight: \_\_\_\_\_ kg / lbs
|
||||
- BMI: \_\_\_\_\_ kg/m²
|
||||
- Pain Score: \_\_\_/10
|
||||
|
||||
### Physical Examination
|
||||
|
||||
**General Appearance:**
|
||||
[Well-appearing, no distress / ill-appearing / mild/moderate/severe distress]
|
||||
|
||||
**HEENT:**
|
||||
- Head: [Normocephalic, atraumatic]
|
||||
- Eyes: [PERRLA, EOMI, conjunctiva, sclera]
|
||||
- Ears: [TMs clear bilaterally, canals patent]
|
||||
- Nose: [Nares patent, no discharge]
|
||||
- Throat: [Oropharynx clear, no erythema or exudate, mucosa moist]
|
||||
|
||||
**Neck:**
|
||||
[Supple, no lymphadenopathy, no thyromegaly, no JVD, carotids 2+ without bruits]
|
||||
|
||||
**Cardiovascular:**
|
||||
[RRR, normal S1/S2, no murmurs/rubs/gallops] OR [describe abnormalities]
|
||||
[Peripheral pulses: radial 2+/2+ bilaterally, dorsalis pedis 2+/2+ bilaterally]
|
||||
|
||||
**Pulmonary:**
|
||||
[Lungs clear to auscultation bilaterally, no wheezes/rales/rhonchi, normal work of breathing] OR [describe abnormalities]
|
||||
|
||||
**Abdomen:**
|
||||
[Soft, non-tender, non-distended, normoactive bowel sounds, no masses, no hepatosplenomegaly, no rebound/guarding]
|
||||
|
||||
**Extremities:**
|
||||
[No edema, no cyanosis, no clubbing, full range of motion, no joint swelling or tenderness]
|
||||
|
||||
**Skin:**
|
||||
[Warm and dry, no rashes, no lesions, normal turgor, capillary refill <2 sec]
|
||||
|
||||
**Neurological:**
|
||||
- Mental status: [Alert and oriented to person, place, time]
|
||||
- Cranial nerves: [II-XII intact] OR [specify abnormalities]
|
||||
- Motor: [5/5 strength all extremities, normal tone]
|
||||
- Sensory: [Intact to light touch and pinprick]
|
||||
- Reflexes: [2+ symmetric, downgoing Babinski]
|
||||
- Gait: [Normal / not assessed]
|
||||
- Coordination: [Finger-to-nose intact, rapid alternating movements normal]
|
||||
|
||||
**Psychiatric:**
|
||||
[Normal mood and affect, thought process logical and goal-directed, no SI/HI]
|
||||
|
||||
### Laboratory Results (if applicable)
|
||||
| Test | Result | Reference Range | Flag |
|
||||
|------|--------|----------------|------|
|
||||
| [Test name] | [Value] [unit] | [Range] | [H/L/-] |
|
||||
|
||||
### Imaging Results (if applicable)
|
||||
[Modality] ([Date]): [Key findings]
|
||||
|
||||
### Other Diagnostic Tests
|
||||
[ECG, etc.]: [Results]
|
||||
|
||||
---
|
||||
|
||||
## A - ASSESSMENT
|
||||
|
||||
### Problem List with Assessment
|
||||
|
||||
**1. [Primary Problem/Diagnosis] ([ICD-10 code])**
|
||||
- [Brief assessment: severity, stability, progress toward goals]
|
||||
- [Relevant exam and lab findings supporting diagnosis]
|
||||
- [Differential diagnosis if uncertain]
|
||||
|
||||
**2. [Secondary Problem/Diagnosis] ([ICD-10 code])**
|
||||
- [Assessment]
|
||||
|
||||
**3. [Additional problems as needed]**
|
||||
|
||||
### Overall Assessment
|
||||
[Summary statement about patient's overall status, response to treatment, trajectory]
|
||||
|
||||
---
|
||||
|
||||
## P - PLAN
|
||||
|
||||
### Problem-Based Plan
|
||||
|
||||
**1. [Primary Problem]**
|
||||
|
||||
**Diagnostics:**
|
||||
- [Further tests, labs, imaging, consultations needed]
|
||||
- [Rationale for testing]
|
||||
|
||||
**Therapeutics:**
|
||||
- [Medications:]
|
||||
- [Drug name] [dose] [route] [frequency] x [duration]
|
||||
- Indication: [Why prescribed]
|
||||
- [Procedures or interventions]
|
||||
- [Non-pharmacological interventions]
|
||||
|
||||
**Monitoring:**
|
||||
- [What to monitor, how often]
|
||||
- [Parameters for follow-up labs or imaging]
|
||||
|
||||
**Education:**
|
||||
- [Topics discussed with patient]
|
||||
- [Patient understanding verified]
|
||||
- [Written materials provided]
|
||||
|
||||
**Follow-up:**
|
||||
- [When and where]
|
||||
- [Specific goals for follow-up visit]
|
||||
|
||||
**Return Precautions:**
|
||||
- [When to seek urgent/emergency care]
|
||||
- [Warning signs discussed]
|
||||
|
||||
**2. [Secondary Problem]**
|
||||
|
||||
**Diagnostics:**
|
||||
- [Tests or studies]
|
||||
|
||||
**Therapeutics:**
|
||||
- [Medications or interventions]
|
||||
|
||||
**Monitoring:**
|
||||
- [Parameters to follow]
|
||||
|
||||
**3. [Additional Problems]**
|
||||
[Plan for each problem]
|
||||
|
||||
### Overall Plan Summary
|
||||
- Total new prescriptions: [number]
|
||||
- Referrals placed: [specialty, reason]
|
||||
- Follow-up appointment: [date/timeframe and with whom]
|
||||
- Patient verbalized understanding of plan: [Yes/No, questions answered]
|
||||
- Time spent: [Total time and time spent on counseling/coordination if relevant for billing]
|
||||
|
||||
---
|
||||
|
||||
## Billing Information (if applicable)
|
||||
|
||||
**CPT Code:** [E/M code - 99201-99215 for office visits]
|
||||
|
||||
**Level of Service Justification:**
|
||||
- History: [Problem focused / Expanded / Detailed / Comprehensive]
|
||||
- Exam: [Problem focused / Expanded / Detailed / Comprehensive]
|
||||
- Medical Decision Making: [Straightforward / Low / Moderate / High complexity]
|
||||
- Number of diagnoses/management options: [Minimal / Limited / Multiple / Extensive]
|
||||
- Amount of data to review: [Minimal / Limited / Moderate / Extensive]
|
||||
- Risk: [Minimal / Low / Moderate / High]
|
||||
|
||||
[OR if time-based:]
|
||||
- Total time: [minutes]
|
||||
- Time spent on counseling/coordination: [minutes] (>50% of visit)
|
||||
|
||||
---
|
||||
|
||||
## Signature
|
||||
|
||||
[Provider name, credentials]
|
||||
[Electronic signature or handwritten signature]
|
||||
[Date and time of documentation]
|
||||
|
||||
---
|
||||
|
||||
## Notes for Using This Template
|
||||
|
||||
**Best Practices:**
|
||||
- Document as soon as possible after encounter
|
||||
- Be specific and objective in observations
|
||||
- Avoid copy-forward errors
|
||||
- Review and update problem list
|
||||
- Sign and date all entries
|
||||
- Use standard abbreviations only
|
||||
|
||||
**Billing Considerations:**
|
||||
- Document medical necessity
|
||||
- Match documentation level to billing code
|
||||
- For time-based billing, document total time and counseling time
|
||||
- Include relevant history, exam, and MDM elements
|
||||
|
||||
**Legal Considerations:**
|
||||
- Document facts, not opinions
|
||||
- Quote patient when relevant
|
||||
- Document non-compliance objectively
|
||||
- Never alter records - use addendum for corrections
|
||||
- Ensure legibility
|
||||
|
||||
**Customization:**
|
||||
- Adapt level of detail to setting (quick outpatient visit vs. complex hospital consultation)
|
||||
- Include or exclude sections as relevant
|
||||
- Follow institutional templates if required
|
||||
- Use problem-oriented approach consistently
|
||||
|
||||
|
||||
Reference in New Issue
Block a user