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name: AtomicAI NICU/PICU Assistant
on:
issue_comment:
types: [created]
issues:
types: [opened, assigned]
pull_request:
types: [opened, synchronize, assigned]
pull_request_review_comment:
types: [created]
jobs:
claude-assistant:
runs-on: ubuntu-latest
if: |
github.actor != 'atomicqms-service' &&
(
(github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai')) ||
(github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) ||
(github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) ||
(github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai')) ||
(github.event.action == 'assigned' && github.event.assignee.login == 'atomicai')
)
permissions:
contents: write
issues: write
pull-requests: write
steps:
- uses: actions/checkout@v4
with:
fetch-depth: 0
- name: Run AtomicAI NICU/PICU Assistant
uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main
with:
trigger_phrase: '@atomicai'
assignee_trigger: 'atomicai'
claude_git_name: 'AtomicAI'
claude_git_email: 'atomicai@atomicqms.local'
custom_instructions: |
You are AtomicAI, an AI assistant specialized in Neonatal and Pediatric Intensive Care Quality Management.
## Your Expertise
- Neonatal Resuscitation Program (NRP) protocols
- Pediatric Advanced Life Support (PALS)
- Neonatal and pediatric ventilator management
- Sedation assessment and pain management in critically ill children
- Total Parenteral Nutrition (TPN) protocols
- Family-centered care in ICU settings
- Developmental care for premature and critically ill infants
- High-risk medication protocols (vasopressors, insulin drips, sedatives)
- ECMO (Extracorporeal Membrane Oxygenation) protocols
- Infection prevention and control in NICU/PICU
- Inter-facility transport protocols for critically ill neonates and children
- End-of-life care and palliative care coordination
- Joint Commission standards for special care units
- AAP (American Academy of Pediatrics) guidelines
- NACHRI (National Association of Children's Hospitals and Related Institutions) standards
## Document Creation Guidelines
- Place Ventilator SOPs in SOPs/Ventilator/
- Place Sedation SOPs in SOPs/Sedation/
- Place Nutrition SOPs in SOPs/Nutrition/
- Place Transport SOPs in SOPs/Transport/
- Place Emergency Protocols in SOPs/Emergency/
- Place Infection Control SOPs in SOPs/Infection-Control/
- Place Sedation Scoring Forms in Forms/Sedation-Scoring/
- Place Ventilator Weaning Forms in Forms/Ventilator-Weaning/
- Place Nutrition Forms in Forms/Nutrition/
- Place Patient Safety Forms in Forms/Patient-Safety/
- Place Policies in Policies/
## Numbering Convention
- SOP-VENT-XXX for Ventilator SOPs
- SOP-SED-XXX for Sedation SOPs
- SOP-NUT-XXX for Nutrition SOPs
- SOP-TRN-XXX for Transport SOPs
- SOP-EMR-XXX for Emergency SOPs
- SOP-INF-XXX for Infection Control SOPs
- POL-XXX for Policies
- FRM-XXX for Forms
Always create branches and submit changes as Pull Requests for review.
Prioritize patient safety, family-centered care, and developmental considerations for critically ill neonates and children.
allowed_tools: 'Read,Edit,Grep,Glob,Write'
disallowed_tools: 'Bash,WebSearch'

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# Document Change Request Form
| Form ID | FRM-001 | Revision | 1.0 |
|---------|---------|----------|-----|
---
## Section 1: Request Information
| Field | Entry |
|-------|-------|
| Request Date | |
| Requested By | |
| Department | |
## Section 2: Document Information
| Field | Entry |
|-------|-------|
| Document Number | |
| Document Title | |
| Current Revision | |
## Section 3: Change Description
### Type of Change
- [ ] New Document
- [ ] Revision to Existing Document
- [ ] Document Obsolescence
### Description of Change
*(Describe the proposed change in detail)*
### Reason for Change
*(Explain why this change is needed - e.g., regulatory update, safety concern, process improvement)*
## Section 4: Impact Assessment
### Affected Areas
- [ ] Training Required
- [ ] Other Documents Affected
- [ ] Process Changes Required
- [ ] Equipment or Supply Changes
- [ ] Patient Safety Impact
### List Affected Documents
## Section 5: Approvals
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Requester | | | |
| Document Owner | | | |
| Quality Assurance | | | |
---
*Form FRM-001 Rev 1.0*

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# Corrective and Preventive Action (CAPA) Form
| Form ID | FRM-003 | Revision | 1.0 |
|---------|---------|----------|-----|
---
## Section 1: CAPA Identification
| Field | Entry |
|-------|-------|
| CAPA Number | |
| Date Initiated | |
| Initiated By | |
| CAPA Owner | |
| Target Closure Date | |
## Section 2: Classification
### Type
- [ ] Corrective Action
- [ ] Preventive Action
### Source
- [ ] Patient Safety Event
- [ ] Medication Error
- [ ] Healthcare-Associated Infection
- [ ] Equipment Failure
- [ ] Internal Audit
- [ ] External Audit/Survey
- [ ] Family Complaint
- [ ] Process Deviation
- [ ] Sentinel Event
- [ ] Management Review
- [ ] Other: ____________
### Priority
- [ ] Critical (patient harm occurred or high risk - 5 business days)
- [ ] Major (potential for patient harm - 15 business days)
- [ ] Minor (process deviation, no patient impact - 30 business days)
## Section 3: Problem Description
*(Describe the nonconformity or potential nonconformity - include patient impact if applicable)*
## Section 4: Immediate Containment
*(Actions taken to contain the immediate impact and protect patient safety)*
## Section 5: Root Cause Investigation
### Investigation Method Used
- [ ] Root Cause Analysis (RCA)
- [ ] Failure Mode and Effects Analysis (FMEA)
- [ ] 5 Whys
- [ ] Fishbone Diagram
- [ ] Fault Tree Analysis
- [ ] Other: ____________
### Root Cause Determination
### Contributing Factors
## Section 6: Corrective/Preventive Actions
| Action | Responsible | Due Date | Status |
|--------|-------------|----------|--------|
| | | | |
| | | | |
| | | | |
## Section 7: Staff Communication and Training
| Training/Communication Required | Target Audience | Completion Date |
|--------------------------------|-----------------|-----------------|
| | | |
## Section 8: Effectiveness Verification
| Criteria | Method | Result |
|----------|--------|--------|
| | | |
Verification Date: ____________
Verified By: ____________
## Section 9: Closure
| Role | Name | Signature | Date |
|------|------|-----------|------|
| CAPA Owner | | | |
| Quality Approval | | | |
### Lessons Learned
---
*Form FRM-003 Rev 1.0*

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# Training Record Form
| Form ID | FRM-004 | Revision | 1.0 |
|---------|---------|----------|-----|
---
## Section 1: Employee Information
| Field | Entry |
|-------|-------|
| Employee Name | |
| Employee ID | |
| Department | |
| Job Title | |
## Section 2: Training Information
| Field | Entry |
|-------|-------|
| Training Title | |
| Training Date | |
| Training Duration | |
| Trainer Name | |
| Trainer Qualification | |
### Training Type
- [ ] Initial Training
- [ ] Retraining
- [ ] Annual Competency
- [ ] Procedure Update
- [ ] Equipment Training
- [ ] Certification (NRP, PALS, etc.)
### Delivery Method
- [ ] Classroom
- [ ] On-the-Job
- [ ] Simulation
- [ ] Self-Study
- [ ] Computer-Based
- [ ] Other: ____________
## Section 3: Training Content
*(List topics covered or attach training materials)*
## Section 4: Assessment
### Assessment Method
- [ ] Written Test
- [ ] Practical Demonstration
- [ ] Verbal Assessment
- [ ] Return Demonstration
- [ ] Observation of Clinical Practice
- [ ] Simulation Performance
### Assessment Results
| Metric | Result |
|--------|--------|
| Score (if applicable) | |
| Pass/Fail | |
### Competency Validated
- [ ] Yes - Employee demonstrates competency
- [ ] No - Retraining required
## Section 5: Signatures
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Trainee | | | |
| Trainer | | | |
| Supervisor | | | |
## Section 6: Follow-up (if retraining required)
| Date | Action Taken | Result |
|------|--------------|--------|
| | | |
---
*Form FRM-004 Rev 1.0*

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# Internal Audit Checklist
| Form ID | FRM-006 | Revision | 1.0 |
|---------|---------|----------|-----|
---
## Section 1: Audit Information
| Field | Entry |
|-------|-------|
| Audit Date | |
| Auditor Name | |
| Area/Process Audited | |
| Audit Type | [ ] Process [ ] Document [ ] Compliance [ ] Mock Survey |
## Section 2: Audit Scope
**Standards/Requirements:**
**Documents Reviewed:**
**Personnel Interviewed:**
## Section 3: Audit Checklist
| Item # | Requirement | Compliant | Finding | Evidence |
|--------|-------------|-----------|---------|----------|
| 1 | | [ ] Y [ ] N [ ] NA | | |
| 2 | | [ ] Y [ ] N [ ] NA | | |
| 3 | | [ ] Y [ ] N [ ] NA | | |
| 4 | | [ ] Y [ ] N [ ] NA | | |
| 5 | | [ ] Y [ ] N [ ] NA | | |
| 6 | | [ ] Y [ ] N [ ] NA | | |
| 7 | | [ ] Y [ ] N [ ] NA | | |
| 8 | | [ ] Y [ ] N [ ] NA | | |
| 9 | | [ ] Y [ ] N [ ] NA | | |
| 10 | | [ ] Y [ ] N [ ] NA | | |
## Section 4: Findings Summary
### Critical Findings (Immediate patient safety risk)
### Major Findings (Significant non-compliance)
### Minor Findings (Documentation or procedural deviation)
### Observations (Opportunities for improvement)
## Section 5: Positive Observations
## Section 6: Signatures
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Auditor | | | |
| Auditee | | | |
---
*Form FRM-006 Rev 1.0*

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# Total Parenteral Nutrition (TPN) Order Form
| Form ID | FRM-NUT-001 | Revision | 1.0 |
|---------|-------------|----------|-----|
---
## Patient Information
| Field | Entry |
|-------|-------|
| Patient Name | |
| MRN | |
| Date of Birth | |
| Weight | ______ kg (Date: ______) |
| Gestational Age (if neonate) | ______ weeks |
| Order Date | |
| Start Date/Time | |
## TPN Type
- [ ] Central TPN (peripherally unsafe)
- [ ] Peripheral TPN
- [ ] Transitional (enteral feeds advancing)
## Base Solution
### Dextrose
- Concentration: ______ % (peripherally safe ≤ 12.5%)
- Goal calories from dextrose: ______ kcal/kg/day
### Amino Acids
- [ ] TrophAmine (pediatric)
- [ ] Aminosyn
- Concentration: ______ g/dL
- Goal protein: ______ g/kg/day
### Lipids
- [ ] Intralipid 20%
- [ ] SMOFlipid 20%
- Dose: ______ g/kg/day
- [ ] Infuse over 24 hours
- [ ] Infuse over ______ hours
## Electrolytes (per liter or per day)
| Electrolyte | Amount | Unit |
|-------------|--------|------|
| Sodium Chloride | | mEq/L or mEq/day |
| Sodium Acetate | | mEq/L or mEq/day |
| Potassium Chloride | | mEq/L or mEq/day |
| Potassium Acetate | | mEq/L or mEq/day |
| Potassium Phosphate | | mmol/L or mmol/day |
| Calcium Gluconate | | mEq/L or mEq/day |
| Magnesium Sulfate | | mEq/L or mEq/day |
## Vitamins and Trace Elements
- [ ] MVI Pediatric: ______ mL/day
- [ ] MVI-12 (>11 years): ______ mL/day
- [ ] Trace Elements Pediatric: ______ mL/day
- [ ] Zinc (additional): ______ mcg/kg/day
- [ ] Selenium (additional): ______ mcg/kg/day
## Volume and Rate
**Total Volume:** ______ mL/day
**Infusion Rate:** ______ mL/hour
**Goal Fluid Intake:** ______ mL/kg/day
## Additional Additives
| Medication | Dose | Indication |
|------------|------|------------|
| Heparin | | mL |
| Carnitine | | mg |
| Cysteine | | mg |
| Vitamin K | | mg |
| Other: | | |
## Enteral Nutrition
**Current Enteral Intake:** ______ mL/kg/day
**Enteral Formula/Breast Milk:**
- Type: ______
- Rate: ______ mL/hour or ______ mL q____hours
**Plan:**
- [ ] NPO
- [ ] Advancing enteral feeds
- [ ] Stable enteral feeds
## Laboratory Monitoring
### Required Labs
- [ ] Daily: BMP, ionized calcium, magnesium, phosphorus
- [ ] Twice weekly: CBC, LFTs, triglycerides, albumin
- [ ] Weekly: Zinc, selenium (if on long-term TPN)
### Latest Laboratory Values
| Lab | Value | Date |
|-----|-------|------|
| Glucose | | |
| Sodium | | |
| Potassium | | |
| Chloride | | |
| CO2 | | |
| BUN | | |
| Creatinine | | |
| Calcium (ionized) | | |
| Phosphorus | | |
| Magnesium | | |
| Triglycerides | | |
| AST/ALT | | |
| Bilirubin (total/direct) | | |
## Special Instructions
## Pharmacist Review
**Reviewed by:** ______________________ **Date/Time:** ______________
**Comments/Recommendations:**
## Physician Order
**Ordered by:** ______________________ **Date/Time:** ______________
**Attending Physician Verification:** ______________________ **Date/Time:** ______________
---
*Form FRM-NUT-001 Rev 1.0*
**CRITICAL:** Verify calculations before compounding. Check for incompatibilities. Ensure peripheral safety if no central access.

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# NICU/PICU Daily Safety Checklist
| Form ID | FRM-SAF-001 | Revision | 1.0 |
|---------|-------------|----------|-----|
---
## Patient Information
| Field | Entry |
|-------|-------|
| Patient Name | |
| MRN | |
| Location | |
| Date | |
| Shift | [ ] Day [ ] Night |
## Patient Identification and Communication
- [ ] Patient armband in place and accurate
- [ ] Allergies documented and displayed
- [ ] Code status clearly posted
- [ ] Isolation precautions posted (if applicable)
- [ ] Bedside safety brief completed with team
## Airway and Respiratory
- [ ] ETT secured and position marked/documented
- [ ] ETT depth verified and matches previous
- [ ] Ventilator settings match orders
- [ ] Oxygen delivery device appropriate
- [ ] Suction equipment at bedside and functioning
- [ ] Ambu bag with appropriate mask at bedside
- [ ] Inline suction system functioning (if applicable)
## Vascular Access
- [ ] All IV sites assessed for infiltration/infection
- [ ] Central line dressing clean, dry, intact (date: ______)
- [ ] PICC line secured, dressing intact
- [ ] Umbilical lines secured (if applicable)
- [ ] All IV infusions verified against MAR
- [ ] IV pump alarms functional
- [ ] Flushing protocol followed per policy
## Medications
- [ ] High-alert medications double-checked
- [ ] Infusion pump rates verified
- [ ] Vasopressor/inotrope concentrations verified
- [ ] Sedation/analgesia infusions verified
- [ ] Insulin infusion verified (if applicable)
- [ ] Heparin infusion verified (if applicable)
- [ ] Smart pump drug library enabled
## Monitoring and Alarms
- [ ] Cardiac monitor leads in place
- [ ] Monitor alarm limits set appropriately
- [ ] SpO2 probe positioned correctly
- [ ] Blood pressure cuff size appropriate
- [ ] Temperature monitoring functioning
- [ ] All alarms audible and enabled
## Feeding and Nutrition
- [ ] Feeding tube position verified before use
- [ ] Enteral feeding pump rate matches order
- [ ] Breast milk/formula labeled correctly
- [ ] Feeding advancement per protocol
- [ ] Aspiration precautions in place
- [ ] Head of bed elevated (if not contraindicated)
## Infection Prevention
- [ ] Hand hygiene performed
- [ ] Central line bundle elements met (if applicable)
- [ ] Hand hygiene
- [ ] Chlorhexidine bath (if >2 months)
- [ ] Line necessity assessed
- [ ] Dressing intact
- [ ] VAE prevention bundle (if ventilated)
- [ ] HOB elevated 30 degrees (unless contraindicated)
- [ ] Oral care performed
- [ ] Sedation vacation/assessment
- [ ] Contact isolation for MDRO (if applicable)
## Skin Integrity
- [ ] Skin assessment completed
- [ ] Pressure areas assessed and repositioned
- [ ] Medical device-related pressure injury prevention
- [ ] Diaper area assessed
- [ ] Ostomy sites intact (if applicable)
## Safety Equipment
- [ ] Bed in lowest position when not at bedside
- [ ] Side rails up appropriately
- [ ] Call bell within reach (if age-appropriate)
- [ ] Fall risk assessment completed
- [ ] Restraints (if used) appropriate and documented
## Family-Centered Care
- [ ] Family updated on plan of care
- [ ] Family presence encouraged
- [ ] Parent questions addressed
- [ ] Developmental care practices implemented
- [ ] Quiet time/minimal handling respected
## Documentation
- [ ] I&O documented accurately
- [ ] Weight documented (if scheduled)
- [ ] Vital signs documented per protocol
- [ ] All medications documented in MAR
- [ ] Care plan updated
## Issues Identified
**Issues requiring follow-up:**
**Actions taken:**
## Signature
| Role | Name | Signature | Date/Time |
|------|------|-----------|-----------|
| RN | | | |
---
*Form FRM-SAF-001 Rev 1.0*

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# COMFORT Sedation Assessment Scale
| Form ID | FRM-SED-001 | Revision | 1.0 |
|---------|-------------|----------|-----|
---
## Patient Information
| Field | Entry |
|-------|-------|
| Patient Name | |
| MRN | |
| Date of Birth | |
| Assessment Date | |
| Assessment Time | |
| Assessed By | |
## COMFORT Scale Scoring
### 1. Alertness
- [ ] 1 - Deeply asleep (eyes closed, no response to changes)
- [ ] 2 - Lightly asleep (eyes mostly closed, occasional response)
- [ ] 3 - Drowsy (eyes mostly closed, occasional response to environment)
- [ ] 4 - Fully awake and alert
- [ ] 5 - Hyperalert (exaggerated responses to stimuli)
### 2. Calmness/Agitation
- [ ] 1 - Calm (no agitation, peaceful)
- [ ] 2 - Slightly anxious (slightly anxious but easily reassured)
- [ ] 3 - Anxious (anxious, not easily reassured)
- [ ] 4 - Very anxious (very anxious, resistant to treatment)
- [ ] 5 - Panicky (panicky, fighting/pulling at tubes)
### 3. Respiratory Response (for ventilated patients)
- [ ] 1 - No spontaneous respirations
- [ ] 2 - Spontaneous respirations with little response to ventilator
- [ ] 3 - Occasional cough or resistance to ventilator
- [ ] 4 - Actively breathes against ventilator
- [ ] 5 - Fights ventilator, coughing regularly
### 4. Physical Movement
- [ ] 1 - No movement
- [ ] 2 - Occasional slight movement
- [ ] 3 - Frequent slight movement
- [ ] 4 - Vigorous movement limited to extremities
- [ ] 5 - Vigorous movement including torso and head
### 5. Blood Pressure (MAP) Baseline
**Baseline MAP:** ______ mmHg
- [ ] 1 - MAP below baseline
- [ ] 2 - MAP consistently at baseline
- [ ] 3 - Infrequent elevations ≥15% above baseline
- [ ] 4 - Frequent elevations ≥15% above baseline
- [ ] 5 - Sustained elevation ≥15% above baseline
### 6. Heart Rate Baseline
**Baseline HR:** ______ bpm
- [ ] 1 - HR below baseline
- [ ] 2 - HR consistently at baseline
- [ ] 3 - Infrequent elevations ≥15% above baseline
- [ ] 4 - Frequent elevations ≥15% above baseline
- [ ] 5 - Sustained elevation ≥15% above baseline
### 7. Muscle Tone
- [ ] 1 - Muscles totally relaxed, no muscle tone
- [ ] 2 - Reduced muscle tone
- [ ] 3 - Normal muscle tone
- [ ] 4 - Increased muscle tone and flexion of fingers and toes
- [ ] 5 - Extreme muscle rigidity and flexion of fingers and toes
### 8. Facial Tension
- [ ] 1 - Facial muscles totally relaxed
- [ ] 2 - Facial muscle tone normal, no facial tension
- [ ] 3 - Tension evident in some facial muscles
- [ ] 4 - Tension evident throughout facial muscles
- [ ] 5 - Facial muscles contorted and grimacing
## Total Score
**Total COMFORT Score:** ______ / 40
## Score Interpretation
- **8-16**: Over-sedated
- **17-26**: Optimal sedation range
- **27-40**: Under-sedated
## Clinical Action
### Current Sedation
| Medication | Dose | Rate |
|------------|------|------|
| | | |
| | | |
### Action Taken Based on Score
- [ ] No change needed
- [ ] Increase sedation
- [ ] Decrease sedation
- [ ] Notify physician
- [ ] Other: ____________
### Comments
## Signature
| Role | Name | Signature | Date/Time |
|------|------|-----------|-----------|
| RN/RT | | | |
---
*Form FRM-SED-001 Rev 1.0*
**Reference:** Ambuel B, Hamlett KW, Marx CM, Blumer JL. Assessing distress in pediatric intensive care environments: the COMFORT scale. J Pediatr Psychol. 1992.

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# Neonatal Pain, Agitation & Sedation Scale (N-PASS)
| Form ID | FRM-SED-002 | Revision | 1.0 |
|---------|-------------|----------|-----|
---
## Patient Information
| Field | Entry |
|-------|-------|
| Patient Name | |
| MRN | |
| Gestational Age | |
| Assessment Date | |
| Assessment Time | |
| Assessed By | |
## Assessment Instructions
- Assess infant behavior over 1-2 minutes
- Score sedation criteria first (if sedated), then pain/agitation criteria
- Note: Premature infants may have muted responses
## Sedation/Pain Assessment
### 1. Crying/Irritability
**Sedation**
- [ ] -2: No cry with painful stimuli
- [ ] -1: Moans/cries minimally to painful stimuli
- [ ] 0: Appropriate crying, not irritable
**Pain/Agitation**
- [ ] +1: Irritable at intervals, consolable
- [ ] +2: High-pitched or silent continuous cry, inconsolable
### 2. Behavior/State
**Sedation**
- [ ] -2: No arousal to any stimuli, no spontaneous movement
- [ ] -1: Arouses minimally to stimuli, little spontaneous movement
- [ ] 0: Appropriate for gestational age
**Pain/Agitation**
- [ ] +1: Restless, squirming, awakens frequently
- [ ] +2: Arching, kicking, constantly awake or minimal sleep
### 3. Facial Expression
**Sedation**
- [ ] -2: Mouth lax, no expression
- [ ] -1: Minimal expression with stimuli
- [ ] 0: Relaxed, appropriate facial expression
**Pain/Agitation**
- [ ] +1: Any pain expression intermittent
- [ ] +2: Any pain expression continual
### 4. Extremities/Tone
**Sedation**
- [ ] -2: No grasp reflex, flaccid tone
- [ ] -1: Weak grasp reflex, decreased tone
- [ ] 0: Relaxed hands/feet, normal tone
**Pain/Agitation**
- [ ] +1: Intermittent clenched toes/fisted hands, increased tone
- [ ] +2: Continual clenched toes/fisted hands, body tense
### 5. Vital Signs (HR, RR, BP, SaO2)
**Baseline Values:**
- HR: ______ bpm
- RR: ______ breaths/min
- BP: ______ mmHg
- SaO2: ______ %
**Sedation**
- [ ] -2: No variability with stimuli, hypoventilation or apnea
- [ ] -1: Less than baseline variability, slow or pause in respirations
- [ ] 0: Within baseline, no out-of-sync breathing on vent
**Pain/Agitation**
- [ ] +1: SaO2 76-85% with stimulation, quick return to baseline
- [ ] +2: SaO2 ≤75% with stimulation, slow return to baseline, out-of-sync with vent
## Total Score
**Total N-PASS Score:** ______
(Range: -10 to +10)
## Score Interpretation
- **-10 to -5**: Deep sedation
- **-4 to -2**: Light-moderate sedation
- **-1 to +1**: Normal sedation/pain management
- **+2 to +5**: Mild to moderate pain/agitation
- **+6 to +10**: Severe pain/agitation
## Clinical Action
### Current Sedation/Analgesia
| Medication | Dose | Route | Frequency |
|------------|------|-------|-----------|
| | | | |
| | | | |
### Action Taken Based on Score
- [ ] No change needed
- [ ] Increase sedation/analgesia
- [ ] Decrease sedation/analgesia
- [ ] Notify physician
- [ ] Non-pharmacological comfort measures
- [ ] Other: ____________
### Non-Pharmacological Interventions Used
- [ ] Swaddling
- [ ] Pacifier
- [ ] Positioning
- [ ] Reduced stimulation
- [ ] Skin-to-skin care
- [ ] Other: ____________
### Comments
## Signature
| Role | Name | Signature | Date/Time |
|------|------|-----------|-----------|
| RN | | | |
---
*Form FRM-SED-002 Rev 1.0*
**Reference:** Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008.

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# Extubation Readiness Checklist
| Form ID | FRM-VENT-001 | Revision | 1.0 |
|---------|--------------|----------|-----|
---
## Patient Information
| Field | Entry |
|-------|-------|
| Patient Name | |
| MRN | |
| Age/DOB | |
| Date | |
| Time | |
## Pre-Extubation Assessment
### Clinical Criteria
#### 1. Underlying Condition Resolved/Improved
- [ ] Yes
- [ ] No - Explain: ____________
#### 2. Hemodynamic Stability
- [ ] MAP appropriate for age without significant vasoactive support
- [ ] Heart rate stable
- [ ] No active bleeding
**Current Vasoactive Medications:**
| Medication | Dose |
|------------|------|
| | |
#### 3. Oxygenation
- [ ] FiO2 ≤ 0.40 (or ≤ 0.50 for neonates)
- [ ] PaO2/FiO2 ratio > 200
- [ ] SpO2 > 90% on current settings
**Current Settings:**
- FiO2: ______
- PEEP: ______ cmH2O
- Latest ABG: pH _____ pCO2 _____ pO2 _____ HCO3 _____
#### 4. Ventilation
- [ ] PaCO2 acceptable for patient
- [ ] Peak pressure ≤ 20 cmH2O (or age-appropriate)
- [ ] Spontaneous breathing on minimal support
**Current Settings:**
- Mode: ______
- Rate: ______
- PIP/PS: ______ cmH2O
- Spontaneous rate: ______
#### 5. Spontaneous Breathing Trial (if performed)
- [ ] Performed
- [ ] Not performed
**If performed:**
- Duration: ______ minutes
- Mode: [ ] T-piece [ ] CPAP [ ] PS/CPAP
- Tolerated: [ ] Yes [ ] No
#### 6. Airway Protection
- [ ] Adequate cough reflex
- [ ] Appropriate gag reflex
- [ ] Manageable secretions
- [ ] Alert/appropriate neurological status
**Secretion Description:**
- Amount: [ ] Minimal [ ] Moderate [ ] Copious
- Character: ____________
#### 7. Sedation Status
- [ ] Minimal or weaning sedation
- [ ] Able to follow commands (if age-appropriate)
**Current Sedation:**
| Medication | Dose | Last Given |
|------------|------|------------|
| | | |
#### 8. Metabolic Status
- [ ] Adequate nutrition
- [ ] No significant electrolyte imbalances
- [ ] Normal temperature
**Latest Labs:**
- Na: _____ K: _____ Cl: _____ HCO3: _____
- Ca: _____ Mg: _____ Phos: _____
#### 9. Post-Extubation Plan
- [ ] Non-invasive support planned: ______
- [ ] High-flow nasal cannula available
- [ ] Room air trial planned
- [ ] RT available at bedside for extubation
### Special Considerations
#### For Neonates:
- [ ] Caffeine on board (if applicable)
- [ ] Weight > 500g (or institution-specific threshold)
- [ ] Postmenstrual age considerations addressed
#### For Long-Term Ventilation:
- [ ] Airway evaluation performed (if >7 days intubated)
- [ ] Consider subglottic edema risk
- [ ] Dexamethasone considered (if appropriate)
## Contraindications to Extubation
- [ ] Active seizures
- [ ] Neuromuscular blockade
- [ ] Recent airway surgery
- [ ] Significant facial/airway trauma or edema
- [ ] Other: ____________
## Physician Review
**Attending Physician Notified:** [ ] Yes [ ] No
**Extubation Approved:** [ ] Yes [ ] No
**If No, reason:** ____________
## Extubation Procedure
**Extubation Date/Time:** ____________
**Post-Extubation Support:**
- [ ] Room air
- [ ] Nasal cannula: ______ L/min
- [ ] High-flow nasal cannula: ______ L/min, FiO2: ______
- [ ] CPAP: ______ cmH2O
- [ ] BiPAP: IPAP ______ EPAP ______
**Immediate Post-Extubation Assessment (within 1 hour):**
- SpO2: ______ %
- RR: ______ breaths/min
- HR: ______ bpm
- Work of breathing: [ ] Minimal [ ] Moderate [ ] Severe
- Stridor: [ ] None [ ] Mild [ ] Moderate [ ] Severe
## Signatures
| Role | Name | Signature | Date/Time |
|------|------|-----------|-----------|
| RN | | | |
| RT | | | |
| MD/NP | | | |
---
*Form FRM-VENT-001 Rev 1.0*

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# Quality Policy - NICU/PICU
| Document ID | POL-001 |
|-------------|---------|
| Title | Quality Policy - Neonatal and Pediatric Intensive Care |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
---
## 1. Policy Statement
[ORGANIZATION NAME] is committed to providing the highest quality of critical care to neonates, infants, and children in our intensive care units. We are dedicated to:
- Delivering evidence-based, family-centered care that meets or exceeds national standards
- Maintaining a safe environment for our most vulnerable patients
- Supporting the developmental needs of critically ill neonates and children
- Ensuring all care practices comply with applicable regulatory requirements and professional guidelines
- Continually improving our Quality Management System to enhance patient outcomes and family satisfaction
## 2. Quality Objectives
Our NICU/PICU commits to:
1. **Patient Safety First**: Eliminating preventable harm through proactive safety practices and continuous monitoring
2. **Family-Centered Care**: Engaging families as essential partners in the care of their critically ill child
3. **Evidence-Based Practice**: Implementing the latest evidence-based guidelines for neonatal and pediatric critical care
4. **Developmental Care**: Minimizing stress and supporting neurodevelopmental outcomes for our youngest patients
5. **Regulatory Compliance**: Maintaining compliance with Joint Commission, AAP, CMS, and all applicable standards
6. **Continuous Improvement**: Using data-driven quality improvement initiatives to enhance outcomes
7. **Staff Competency**: Ensuring all staff maintain current competency in neonatal and pediatric resuscitation and critical care
8. **Infection Prevention**: Preventing healthcare-associated infections through rigorous adherence to protocols
## 3. Management Commitment
The NICU/PICU leadership demonstrates commitment to the QMS by:
- Ensuring the quality policy is appropriate for the unique needs of critically ill neonates and children
- Establishing measurable quality objectives aligned with national benchmarks (Vermont Oxford Network, NACHRI)
- Integrating QMS requirements into all clinical processes and protocols
- Promoting evidence-based practice and continuous quality improvement
- Ensuring adequate staffing, equipment, and resources for safe intensive care delivery
- Communicating the importance of quality and safety to all staff, families, and stakeholders
- Supporting family presence and participation in rounds and care decisions
- Engaging interdisciplinary teams in quality improvement initiatives
- Reviewing quality metrics and outcomes regularly
## 4. Scope
This policy applies to:
- All clinical staff working in NICU/PICU (physicians, nurse practitioners, nurses, respiratory therapists, pharmacists)
- Support staff involved in patient care (social work, child life, pastoral care)
- All processes and procedures within the NICU/PICU Quality Management System
- Family members as partners in care
## 5. Quality Metrics
We measure and monitor:
- Mortality rates (risk-adjusted)
- Healthcare-associated infection rates (CLABSI, VAE, CAUTI)
- Medication errors and near-misses
- Unplanned extubations and reintubations
- Skin breakdown and pressure injuries
- Family satisfaction scores
- Length of stay
- Readmission rates within 48 hours
- Breastfeeding/human milk feeding rates (NICU)
- Pain assessment and management compliance
- Code blue response times
- Developmental care practice adherence
## 6. Family-Centered Care Commitment
We recognize families as:
- Essential members of the healthcare team
- The constant in the child's life
- Having the right to participate in all decisions
- Needing support, information, and respect
- Partners in quality improvement efforts
## 7. Communication
This policy shall be:
- Communicated to all NICU/PICU staff during orientation and annually
- Available to families through unit information materials
- Reviewed annually for continuing suitability
- Updated to reflect current best practices and regulatory requirements
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# nicu-picu # NICU/PICU Quality Management System
This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Neonatal Intensive Care Units (NICU)** and **Pediatric Intensive Care Units (PICU)**. This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Neonatal Intensive Care Units (NICU)** and **Pediatric Intensive Care Units (PICU)**.
## Hospital Units Covered
- Neonatal Intensive Care Units (Level II-IV)
- Pediatric Intensive Care Units
- Cardiac Intensive Care Units (pediatric)
- Combined NICU/PICU facilities
- Special Care Nurseries
- Step-down/Intermediate Care Units
## Repository Structure
```
nicu-picu-template/
├── Policies/ # Quality policies and management commitment
├── SOPs/ # Standard Operating Procedures
│ ├── Ventilator/ # Neonatal and pediatric ventilator management
│ ├── Sedation/ # Sedation protocols and pain management
│ ├── Nutrition/ # TPN and enteral nutrition protocols
│ ├── Transport/ # Inter-facility transport procedures
│ ├── Emergency/ # NRP, PALS, code blue protocols
│ └── Infection-Control/ # ICU-specific infection prevention
├── Work Instructions/ # Detailed work instructions
├── Forms/ # Record forms and templates
│ ├── Sedation-Scoring/ # COMFORT, FLACC, NPASS scales
│ ├── Ventilator-Weaning/ # Weaning protocols and assessments
│ ├── Nutrition/ # TPN orders, feeding advancement
│ └── Patient-Safety/ # Safety checklists and assessments
└── Templates/ # Document templates
```
## Document Numbering Convention
- **POL-XXX**: Policies
- **SOP-VENT-XXX**: Ventilator Management SOPs
- **SOP-SED-XXX**: Sedation and Pain Management SOPs
- **SOP-NUT-XXX**: Nutrition SOPs
- **SOP-TRN-XXX**: Transport SOPs
- **SOP-EMR-XXX**: Emergency Protocol SOPs
- **SOP-INF-XXX**: Infection Control SOPs
- **WI-XXX**: Work Instructions
- **FRM-XXX**: Forms and Records
## AI-Powered Document Creation
This template includes **AtomicAI** integration. Simply create an issue and mention `@atomicai` to:
- Generate neonatal resuscitation protocols
- Create ventilator management SOPs
- Draft sedation and pain assessment forms
- Develop family-centered care policies
- Update TPN protocols
- Create transport checklists
## Getting Started
1. Create a new repository using this template
2. Customize documents with your unit's information
3. Create issues with `@atomicai` to generate new documents
4. Review and approve AI-generated content via Pull Requests
## Clinical Focus Areas
### Critical Care Protocols
- Neonatal Resuscitation Program (NRP)
- Pediatric Advanced Life Support (PALS)
- Code blue/rapid response procedures
- ECMO initiation and management
### Respiratory Support
- Conventional mechanical ventilation
- High-frequency ventilation
- Non-invasive respiratory support (CPAP, HFNC)
- Surfactant administration
- Nitric oxide therapy
### Sedation & Pain Management
- Pain assessment tools (NPASS, FLACC, COMFORT)
- Sedation protocols and weaning
- Opioid and benzodiazepine management
- Neuromuscular blockade
- Withdrawal assessment and management
### Nutrition
- Total Parenteral Nutrition (TPN) protocols
- Enteral nutrition advancement
- Human milk handling
- Feeding intolerance management
### Safety & Quality
- Central line-associated bloodstream infection (CLABSI) prevention
- Ventilator-associated events prevention
- Medication safety (high-alert medications)
- Family-centered rounds
- Developmental care practices
### Special Procedures
- Inter-facility transport
- Therapeutic hypothermia
- Exchange transfusion
- Chest tube placement and management
## Regulatory Compliance
These templates support compliance with:
- **Joint Commission** - Critical Care Standards
- **AAP** - American Academy of Pediatrics Guidelines
- **CMS Conditions of Participation** - Special Care Units
- **NACHRI** - Children's Hospital Quality Standards
- **Vermont Oxford Network** - NICU Quality Benchmarks
- **21 CFR Part 11** - Electronic Records
- **HIPAA** - Health Information Privacy
## Developmental Care Considerations
All protocols incorporate:
- Minimal handling protocols
- Noise and light reduction strategies
- Kangaroo care promotion
- Neurodevelopmental follow-up planning
- Family presence and engagement
---
*Powered by AtomicQMS - AI-Enhanced Critical Care Quality Management*

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# Standard Operating Procedure: Document Control
| Document ID | SOP-001 |
|-------------|---------|
| Title | Document Control |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a procedure for the creation, review, approval, distribution, and control of documents within the Quality Management System.
## 2. Scope
This procedure applies to all controlled documents including:
- Policies
- Standard Operating Procedures (SOPs)
- Work Instructions
- Forms and Templates
- Clinical Protocols
- Emergency Procedures
- External documents of external origin
## 3. Responsibilities
### 3.1 Document Owner
- Responsible for document content and accuracy
- Initiates document creation and revision
- Ensures periodic review is performed
### 3.2 Quality Assurance
- Maintains the document control system
- Assigns document numbers
- Manages document distribution
- Archives obsolete documents
### 3.3 Approvers
- Review and approve documents before release
- Ensure documents are adequate for intended purpose
## 4. Procedure
### 4.1 Document Creation
1. Identify the need for a new document
2. Request document number from Quality Assurance
3. Draft document using appropriate template
4. Include all required header information
5. Submit for review and approval
### 4.2 Document Review and Approval
1. Route document to appropriate reviewers
2. Reviewers provide comments within 5 business days
3. Author addresses all comments
4. Final approval by designated approver
5. Quality Assurance releases document
### 4.3 Document Numbering
Documents shall be numbered according to the following convention:
| Type | Prefix | Example |
|------|--------|---------|
| Policy | POL | POL-001 |
| General SOP | SOP | SOP-001 |
| Ventilator SOP | SOP-VENT | SOP-VENT-001 |
| Sedation SOP | SOP-SED | SOP-SED-001 |
| Nutrition SOP | SOP-NUT | SOP-NUT-001 |
| Transport SOP | SOP-TRN | SOP-TRN-001 |
| Emergency SOP | SOP-EMR | SOP-EMR-001 |
| Infection Control SOP | SOP-INF | SOP-INF-001 |
| Work Instruction | WI | WI-001 |
| Form | FRM | FRM-001 |
### 4.4 Revision Control
1. All changes require documented justification
2. Changes follow same review/approval process as new documents
3. Revision number increments with each approved change
4. Revision history maintained in document footer
### 4.5 Document Distribution
1. Current versions available in document control system
2. Obsolete versions marked and archived
3. Training on new/revised documents as needed
### 4.6 Periodic Review
1. Clinical protocols reviewed at least annually
2. Standard SOPs reviewed at least every 2 years
3. Review documented even if no changes made
4. Reviews may result in revision or reaffirmation
## 5. Related Documents
- FRM-001 Document Change Request Form
- FRM-002 Document Review Record
## 6. Definitions
| Term | Definition |
|------|------------|
| Controlled Document | Document managed under document control system |
| Obsolete | Document no longer valid for use |
| Revision | Updated version of a document |
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Corrective and Preventive Action (CAPA)
| Document ID | SOP-002 |
|-------------|---------|
| Title | Corrective and Preventive Action |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities that affect patient care quality and safety in the NICU/PICU.
## 2. Scope
This procedure applies to:
- Patient safety events and near-misses
- Healthcare-associated infections
- Medication errors and adverse drug events
- Equipment failures
- Process deviations
- Audit findings
- Regulatory findings
- Potential nonconformities identified through risk analysis
## 3. Definitions
| Term | Definition |
|------|------------|
| Corrective Action | Action to eliminate the cause of a detected nonconformity |
| Preventive Action | Action to eliminate the cause of a potential nonconformity |
| Root Cause | Fundamental reason for a nonconformity |
| Effectiveness Check | Verification that implemented actions achieved desired results |
| Sentinel Event | Unexpected occurrence involving death or serious physical/psychological injury |
## 4. Responsibilities
### 4.1 CAPA Owner
- Investigates the issue
- Identifies root cause
- Develops and implements corrective/preventive actions
- Verifies effectiveness
### 4.2 Quality Assurance
- Manages CAPA system
- Assigns CAPA numbers
- Tracks CAPA status
- Reviews and approves CAPAs
- Reports CAPA metrics to management
### 4.3 Unit Leadership
- Provides resources for CAPA implementation
- Reviews CAPA trends
- Ensures timely closure
- Communicates serious events to appropriate parties
## 5. Procedure
### 5.1 CAPA Initiation
1. Identify nonconformity or potential nonconformity
2. Document issue on CAPA Form (FRM-003)
3. Classify severity and priority:
- Critical (patient harm or high risk)
- Major (potential for patient harm)
- Minor (process deviation, no patient impact)
4. Assign CAPA owner
5. Notify Risk Management if patient safety event
### 5.2 Investigation
1. Gather relevant data and evidence
2. Interview personnel involved
3. Review related documents and records
4. Review patient chart if applicable
5. Use appropriate investigation tools:
- Root Cause Analysis (RCA)
- Failure Mode and Effects Analysis (FMEA)
- 5 Whys
- Fishbone Diagram
### 5.3 Root Cause Analysis
1. Identify potential root causes
2. Verify root cause through evidence
3. Document root cause determination
4. Consider systemic implications
5. Identify contributing factors
### 5.4 Action Development
1. Develop corrective/preventive actions
2. Assign responsibilities and due dates
3. Assess actions for:
- Appropriateness to problem severity
- Impact on other processes
- Resource requirements
- Sustainability
### 5.5 Implementation
1. Execute approved actions
2. Document implementation evidence
3. Update affected documents/processes
4. Provide staff training as needed
5. Communicate changes to all affected personnel
### 5.6 Effectiveness Verification
1. Define effectiveness criteria (measurable outcomes)
2. Allow sufficient time for actions to take effect
3. Collect and analyze data
4. Document verification results
5. If ineffective, reopen CAPA for further action
### 5.7 Closure
1. Review all CAPA documentation
2. Verify all actions completed
3. Confirm effectiveness verified
4. Obtain approval for closure
5. Share lessons learned with team
## 6. CAPA Metrics
Quality Assurance shall track and report:
- Number of open CAPAs by category
- CAPA aging
- On-time closure rate
- Effectiveness rate
- CAPAs by source (safety event, infection, medication error, etc.)
- Repeat events
## 7. Related Documents
- FRM-003 CAPA Form
- SOP-005 Patient Safety Event Reporting
- Risk Management Policies
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Training and Competence
| Document ID | SOP-003 |
|-------------|---------|
| Title | Training and Competence - NICU/PICU |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Nursing Education / Quality |
---
## 1. Purpose
To ensure personnel caring for critically ill neonates and children are competent based on appropriate education, training, skills, and experience.
## 2. Scope
This procedure applies to:
- All NICU/PICU clinical staff (nurses, physicians, NPs, PAs, RTs)
- Support staff (pharmacists, social workers, child life specialists)
- Contract and temporary personnel
- Students and trainees
## 3. Responsibilities
### 3.1 Unit Leadership/Managers
- Identify training needs for NICU/PICU personnel
- Ensure training is completed before independent practice
- Evaluate competence of personnel
- Maintain department training records
### 3.2 Nursing Education
- Coordinate NICU/PICU orientation programs
- Maintain central training database
- Track training compliance
- Archive training records
### 3.3 Quality Assurance
- Develop QMS-related training
- Approve clinical training curricula
- Audit training compliance
### 3.4 Clinical Staff
- Complete assigned training on time
- Maintain current certifications (NRP, PALS, ACLS)
- Report training needs to supervisor
- Participate in annual competency validation
## 4. Required Certifications
### 4.1 NICU Staff
- Neonatal Resuscitation Program (NRP) - every 2 years
- STABLE Program (post-resuscitation care)
- Electronic Fetal Monitoring (OB/NICU)
### 4.2 PICU Staff
- Pediatric Advanced Life Support (PALS) - every 2 years
- Advanced Cardiovascular Life Support (ACLS) if applicable
### 4.3 All ICU Staff
- Critical care orientation
- High-risk medication administration
- Ventilator management competency
- Central line care
- Sedation assessment
- Pain assessment tools
## 5. Procedure
### 5.1 Training Needs Assessment
1. Identify competence requirements for each role
2. Document requirements in job descriptions
3. Assess current competence of personnel
4. Identify training gaps
5. Consider regulatory and accreditation requirements
### 5.2 New Employee Orientation
All new NICU/PICU staff shall complete:
1. **General Orientation** (1-2 days)
- Hospital policies
- Safety and emergency procedures
- Quality system overview
2. **Unit Orientation** (4-12 weeks depending on role)
- Unit tour and equipment
- Documentation systems
- Communication protocols
- Family-centered care principles
3. **Clinical Competencies** (validated during orientation)
- Patient assessment
- Medication administration
- Respiratory support
- IV access and management
- Emergency response
4. **Required Certifications**
- NRP or PALS (must be current before start)
- Unit-specific competencies
### 5.3 Annual Competency Validation
All staff shall demonstrate competency annually in:
1. Code/emergency response
2. High-alert medication administration
3. Sedation scoring
4. Pain assessment
5. Equipment operation (vents, infusion pumps)
6. Documentation requirements
7. Infection prevention practices
### 5.4 Training Documentation
Training records shall include:
- Employee name and ID
- Training title and date
- Trainer name and qualifications
- Assessment results (minimum 80% passing for written tests)
- Practical demonstration verification
- Signatures
### 5.5 Retraining Requirements
Retraining is required when:
- Significant protocol revisions occur
- Performance deficiencies identified
- Extended absence from unit (>6 months)
- New equipment or technology introduced
- Sentinel event or serious safety concern
### 5.6 Preceptor Qualification
Preceptors must:
- Have minimum 1 year ICU experience
- Complete preceptor training program
- Demonstrate teaching ability
- Maintain current certifications
## 6. Training Records Retention
- Training records maintained for duration of employment
- Records retained 7 years after employee departure
- Records available for Joint Commission and regulatory inspection
## 7. Related Documents
- FRM-004 Training Record Form
- FRM-005 Clinical Competency Checklist
- Job Descriptions
- Preceptor Manual
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Internal Audit
| Document ID | SOP-004 |
|-------------|---------|
| Title | Internal Audit |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a systematic process for conducting internal audits to verify compliance with the Quality Management System and regulatory requirements.
## 2. Scope
This procedure applies to:
- All NICU/PICU processes and procedures
- Clinical documentation
- Equipment maintenance and calibration
- Staff competency and training
- Medication safety practices
- Infection prevention practices
- Patient safety processes
## 3. Responsibilities
### 3.1 Quality Assurance
- Develops annual audit schedule
- Selects and trains auditors
- Ensures audits are conducted
- Tracks audit findings to closure
- Reports audit results to management
### 3.2 Auditors
- Conduct audits per schedule
- Document findings objectively
- Submit audit reports on time
- Follow up on corrective actions
### 3.3 Auditees
- Provide information and access
- Respond to findings
- Implement corrective actions
- Verify effectiveness
## 4. Audit Types
### 4.1 Process Audits
- Review specific processes for compliance
- Conducted quarterly
### 4.2 Document Audits
- Review documentation for completeness and compliance
- Conducted monthly (sampling approach)
### 4.3 Compliance Audits
- Verify compliance with regulatory requirements
- Conducted annually or as needed
### 4.4 Mock Surveys
- Simulate Joint Commission survey
- Conducted annually
## 5. Procedure
### 5.1 Audit Planning
1. Develop annual audit schedule
2. Identify audit scope and criteria
3. Select auditor(s) - must be independent of area audited
4. Review previous audit findings
5. Notify auditee at least 2 weeks in advance
### 5.2 Audit Preparation
1. Review applicable documents and standards
2. Develop audit checklist (FRM-006)
3. Prepare opening meeting agenda
### 5.3 Audit Execution
1. **Opening Meeting**
- Confirm audit scope
- Review audit process
- Identify key personnel
2. **Evidence Gathering**
- Review documents and records
- Observe processes
- Interview personnel
- Take notes and document evidence
3. **Finding Classification**
- **Critical**: Immediate patient safety risk or major non-compliance
- **Major**: Significant deviation from requirements
- **Minor**: Documentation or procedural deviation
- **Observation**: Opportunity for improvement
4. **Closing Meeting**
- Present findings
- Clarify any questions
- Agree on corrective action timeline
### 5.4 Audit Reporting
1. Complete audit report within 5 business days
2. Report includes:
- Executive summary
- Scope and methodology
- List of findings
- Positive observations
- Recommendations
3. Distribute to auditee and management
### 5.5 Corrective Action
1. Auditee develops corrective action plan
2. Submit plan within 10 business days
3. Quality Assurance reviews and approves plan
4. Implement actions per timeline
5. Document completion
### 5.6 Follow-up
1. Verify corrective actions implemented
2. Assess effectiveness
3. Close findings or escalate if inadequate
4. Schedule re-audit if needed
## 6. Auditor Qualification
Auditors must:
- Complete internal auditor training
- Have knowledge of QMS requirements
- Have clinical background (for clinical audits)
- Maintain objectivity and independence
## 7. Audit Metrics
Quality shall track and report:
- Number of audits completed vs. scheduled
- Findings by type and area
- Average time to close findings
- Repeat findings
- Audit effectiveness
## 8. Related Documents
- FRM-006 Audit Checklist
- FRM-007 Audit Report Template
- SOP-002 CAPA
## 9. References
- Joint Commission Standards
- CMS Conditions of Participation
- ISO 9001:2015 (if applicable)
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Management Review
| Document ID | SOP-005 |
|-------------|---------|
| Title | Management Review |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a process for top management to review the NICU/PICU Quality Management System to ensure its continuing suitability, adequacy, and effectiveness.
## 2. Scope
This procedure applies to the periodic review of all aspects of the Quality Management System by NICU/PICU leadership.
## 3. Responsibilities
### 3.1 Unit Medical Director / Nurse Manager
- Chairs management review meetings
- Reviews QMS performance
- Makes decisions on resource allocation
- Ensures actions are implemented
### 3.2 Quality Assurance
- Schedules management review meetings
- Prepares meeting materials and data
- Documents meeting minutes
- Tracks action items to completion
### 3.3 Department Heads
- Provide input on their areas
- Participate in meetings
- Implement assigned actions
## 4. Frequency
Management review meetings shall be conducted:
- At minimum, quarterly
- More frequently if significant issues arise
- In response to sentinel events
## 5. Review Inputs
The management review shall consider:
### 5.1 Quality Metrics
- Mortality rates (observed vs. expected)
- Infection rates (CLABSI, VAE, CAUTI)
- Medication errors and adverse drug events
- Unplanned extubations
- Pressure injuries
- Family satisfaction scores
- Length of stay
- Readmission rates
### 5.2 Performance Against Benchmarks
- Vermont Oxford Network (NICU)
- NACHRI/Children's Hospital Association benchmarks
- State or national databases
### 5.3 Internal Audit Results
- Number and status of audit findings
- Trends in non-conformances
- Areas of concern
### 5.4 External Audit/Survey Results
- Joint Commission survey findings
- State Department of Health findings
- Regulatory agency findings
### 5.5 Patient Safety Events
- Sentinel events
- Serious safety events
- Near-miss reports
- Root cause analysis results
### 5.6 CAPA Status
- Open CAPAs
- Overdue CAPAs
- Effectiveness of corrective actions
- Repeat issues
### 5.7 Training and Competency
- NRP/PALS compliance rates
- Orientation completion
- Competency validation results
- Staffing competency mix
### 5.8 Resource Adequacy
- Staffing levels and ratios
- Equipment functionality
- Budget performance
- Technology needs
### 5.9 Changes Affecting QMS
- New regulations or standards
- New equipment or technology
- Process changes
- Organizational changes
### 5.10 Opportunities for Improvement
- Staff suggestions
- Quality improvement initiatives
- Best practice adoption
## 6. Review Outputs
The management review shall produce:
1. **Decisions on**:
- QMS improvements needed
- Resource allocation
- Quality objectives and targets
- Policy changes
2. **Action Items** with:
- Specific actions to be taken
- Responsible parties
- Target completion dates
3. **Communication Plan**:
- Key messages for staff
- Changes to be implemented
## 7. Procedure
### 7.1 Meeting Preparation
1. Quality Assurance prepares:
- Data summaries and trending reports
- Status updates on previous action items
- Meeting agenda
2. Distribute materials 1 week before meeting
### 7.2 Meeting Conduct
1. Review previous action items
2. Present and discuss each input category
3. Identify trends and systemic issues
4. Discuss resource needs
5. Make decisions and assign actions
6. Set priorities
### 7.3 Documentation
1. Document meeting minutes including:
- Attendees
- Data reviewed
- Decisions made
- Action items with owners and dates
2. Distribute minutes within 1 week
3. Post on quality board
### 7.4 Follow-up
1. Quality Assurance tracks action items
2. Report status at next meeting
3. Escalate overdue items
4. Communicate outcomes to staff
## 8. Meeting Attendees
Required:
- Unit Medical Director
- Nurse Manager
- Quality Coordinator
- Infection Control Representative
As needed:
- Pharmacy Representative
- Respiratory Therapy Manager
- Risk Management
- Social Work/Child Life Leadership
## 9. Related Documents
- Quality Metrics Dashboard
- Audit Reports
- CAPA Log
- FRM-008 Management Review Meeting Minutes Template
## 10. References
- Joint Commission Leadership Standards
- ISO 9001:2015 Clause 9.3 (if applicable)
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: [Title]
| Document ID | SOP-XXX |
|-------------|---------|
| Title | [Title] |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | [DEPARTMENT] |
---
## 1. Purpose
[State the purpose of this procedure]
## 2. Scope
[Define the scope and applicability - specify NICU, PICU, or both]
## 3. Responsibilities
### 3.1 [Role 1]
- [Responsibility]
- [Responsibility]
### 3.2 [Role 2]
- [Responsibility]
- [Responsibility]
### 3.3 [Role 3]
- [Responsibility]
- [Responsibility]
## 4. Definitions
| Term | Definition |
|------|------------|
| | |
| | |
## 5. Procedure
### 5.1 [Section Title]
[Procedure steps]
### 5.2 [Section Title]
[Procedure steps]
### 5.3 [Section Title]
[Procedure steps]
## 6. Safety Considerations
[List any patient safety considerations, high-alert medications, infection control requirements, etc.]
## 7. Documentation Requirements
[Specify what must be documented and where]
## 8. Related Documents
- [List related procedures, forms, protocols]
## 9. References
- [External standards, regulations, clinical guidelines]
- Joint Commission Standards
- AAP Guidelines
- Manufacturer Instructions (if applicable)
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Work Instruction: [Title]
| Document ID | WI-001 |
|-------------|--------|
| Title | [Title] |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | [DEPARTMENT] |
---
## 1. Purpose
[Describe the purpose of this work instruction]
## 2. Scope
[Define what activities this instruction covers - specify NICU, PICU, or both]
## 3. Safety Precautions
- [List any safety requirements]
- [Personal protective equipment needed]
- [Hazards to be aware of]
- [Patient safety considerations]
- [Infection control requirements]
## 4. Equipment/Materials Required
| Item | Specification |
|------|---------------|
| | |
| | |
| | |
## 5. Prerequisites
[Any required competencies, training, or conditions that must be met before performing this procedure]
## 6. Procedure
### Step 1: [Title]
[Detailed instructions]
### Step 2: [Title]
[Detailed instructions]
### Step 3: [Title]
[Detailed instructions]
### Step 4: [Title]
[Detailed instructions]
### Step 5: [Title]
[Detailed instructions]
## 7. Acceptance Criteria
[Define what constitutes successful completion]
## 8. Troubleshooting
| Problem | Possible Cause | Solution |
|---------|----------------|----------|
| | | |
| | | |
## 9. Documentation Requirements
[What must be documented and where]
## 10. Records
| Record | Location | Retention |
|--------|----------|-----------|
| | | |
## 11. References
- [Related SOPs]
- [Protocols]
- [Manufacturer Instructions]
- [Clinical Guidelines]
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |