diff --git a/.gitea/workflows/atomicai.yml b/.gitea/workflows/atomicai.yml new file mode 100644 index 0000000..fb3d18f --- /dev/null +++ b/.gitea/workflows/atomicai.yml @@ -0,0 +1,89 @@ +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' diff --git a/Forms/FRM-001-Document-Change-Request.md b/Forms/FRM-001-Document-Change-Request.md new file mode 100644 index 0000000..7d52d9f --- /dev/null +++ b/Forms/FRM-001-Document-Change-Request.md @@ -0,0 +1,66 @@ +# 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* diff --git a/Forms/FRM-003-CAPA-Form.md b/Forms/FRM-003-CAPA-Form.md new file mode 100644 index 0000000..d9de385 --- /dev/null +++ b/Forms/FRM-003-CAPA-Form.md @@ -0,0 +1,110 @@ +# 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* diff --git a/Forms/FRM-004-Training-Record.md b/Forms/FRM-004-Training-Record.md new file mode 100644 index 0000000..3c6a370 --- /dev/null +++ b/Forms/FRM-004-Training-Record.md @@ -0,0 +1,87 @@ +# 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* diff --git a/Forms/FRM-006-Audit-Checklist.md b/Forms/FRM-006-Audit-Checklist.md new file mode 100644 index 0000000..ea15106 --- /dev/null +++ b/Forms/FRM-006-Audit-Checklist.md @@ -0,0 +1,71 @@ +# 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* diff --git a/Forms/Nutrition/.gitkeep b/Forms/Nutrition/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Nutrition/FRM-NUT-001-TPN-Order-Form.md b/Forms/Nutrition/FRM-NUT-001-TPN-Order-Form.md new file mode 100644 index 0000000..93004be --- /dev/null +++ b/Forms/Nutrition/FRM-NUT-001-TPN-Order-Form.md @@ -0,0 +1,143 @@ +# 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. diff --git a/Forms/Patient-Safety/.gitkeep b/Forms/Patient-Safety/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Patient-Safety/FRM-SAF-001-Daily-Safety-Checklist.md b/Forms/Patient-Safety/FRM-SAF-001-Daily-Safety-Checklist.md new file mode 100644 index 0000000..d9915c3 --- /dev/null +++ b/Forms/Patient-Safety/FRM-SAF-001-Daily-Safety-Checklist.md @@ -0,0 +1,138 @@ +# 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* diff --git a/Forms/Sedation-Scoring/.gitkeep b/Forms/Sedation-Scoring/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Sedation-Scoring/FRM-SED-001-COMFORT-Scale.md b/Forms/Sedation-Scoring/FRM-SED-001-COMFORT-Scale.md new file mode 100644 index 0000000..cc8e43c --- /dev/null +++ b/Forms/Sedation-Scoring/FRM-SED-001-COMFORT-Scale.md @@ -0,0 +1,128 @@ +# 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. diff --git a/Forms/Sedation-Scoring/FRM-SED-002-NPASS-Scale.md b/Forms/Sedation-Scoring/FRM-SED-002-NPASS-Scale.md new file mode 100644 index 0000000..7c6e63d --- /dev/null +++ b/Forms/Sedation-Scoring/FRM-SED-002-NPASS-Scale.md @@ -0,0 +1,140 @@ +# 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. diff --git a/Forms/Ventilator-Weaning/.gitkeep b/Forms/Ventilator-Weaning/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Ventilator-Weaning/FRM-VENT-001-Extubation-Readiness-Checklist.md b/Forms/Ventilator-Weaning/FRM-VENT-001-Extubation-Readiness-Checklist.md new file mode 100644 index 0000000..129b779 --- /dev/null +++ b/Forms/Ventilator-Weaning/FRM-VENT-001-Extubation-Readiness-Checklist.md @@ -0,0 +1,156 @@ +# 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* diff --git a/Policies/POL-001-Quality-Policy.md b/Policies/POL-001-Quality-Policy.md new file mode 100644 index 0000000..4f38aee --- /dev/null +++ b/Policies/POL-001-Quality-Policy.md @@ -0,0 +1,97 @@ +# 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] | diff --git a/README.md b/README.md index 29305f6..c40f8ac 100644 --- a/README.md +++ b/README.md @@ -1,3 +1,126 @@ -# 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)**. \ No newline at end of file +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* diff --git a/SOPs/Emergency/.gitkeep b/SOPs/Emergency/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Infection-Control/.gitkeep b/SOPs/Infection-Control/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Nutrition/.gitkeep b/SOPs/Nutrition/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/SOP-001-Document-Control.md b/SOPs/SOP-001-Document-Control.md new file mode 100644 index 0000000..ce774ad --- /dev/null +++ b/SOPs/SOP-001-Document-Control.md @@ -0,0 +1,120 @@ +# 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] | diff --git a/SOPs/SOP-002-CAPA.md b/SOPs/SOP-002-CAPA.md new file mode 100644 index 0000000..0a28e08 --- /dev/null +++ b/SOPs/SOP-002-CAPA.md @@ -0,0 +1,150 @@ +# 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] | diff --git a/SOPs/SOP-003-Training.md b/SOPs/SOP-003-Training.md new file mode 100644 index 0000000..5bd0aa9 --- /dev/null +++ b/SOPs/SOP-003-Training.md @@ -0,0 +1,163 @@ +# 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] | diff --git a/SOPs/SOP-004-Internal-Audit.md b/SOPs/SOP-004-Internal-Audit.md new file mode 100644 index 0000000..3851645 --- /dev/null +++ b/SOPs/SOP-004-Internal-Audit.md @@ -0,0 +1,169 @@ +# 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] | diff --git a/SOPs/SOP-005-Management-Review.md b/SOPs/SOP-005-Management-Review.md new file mode 100644 index 0000000..c9270c6 --- /dev/null +++ b/SOPs/SOP-005-Management-Review.md @@ -0,0 +1,199 @@ +# 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] | diff --git a/SOPs/Sedation/.gitkeep b/SOPs/Sedation/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Transport/.gitkeep b/SOPs/Transport/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Ventilator/.gitkeep b/SOPs/Ventilator/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Templates/SOP-Template.md b/Templates/SOP-Template.md new file mode 100644 index 0000000..16dae24 --- /dev/null +++ b/Templates/SOP-Template.md @@ -0,0 +1,82 @@ +# 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] | diff --git a/Work Instructions/WI-001-Template.md b/Work Instructions/WI-001-Template.md new file mode 100644 index 0000000..b66847a --- /dev/null +++ b/Work Instructions/WI-001-Template.md @@ -0,0 +1,93 @@ +# 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] |