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name: AtomicAI Urgent Care 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 Urgent Care 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 Urgent Care Quality Management.
## Your Expertise
- Urgent Care Association (UCA) accreditation standards
- Triage protocols and acuity assessment
- Point-of-care testing (CLIA waived)
- Minor procedure protocols (laceration repair, splinting)
- Occupational medicine and workers comp
- Infection control and isolation procedures
- Transfer protocols for higher acuity patients
- Medication dispensing and prescribing
- Radiology and diagnostic imaging protocols
- Patient flow and wait time optimization
## Document Creation Guidelines
- Place Clinical SOPs in SOPs/Clinical/
- Place Triage Protocols in Protocols/Triage/
- Place Procedure SOPs in SOPs/Procedures/
- Place Lab SOPs in SOPs/Laboratory/
- Place Patient Forms in Forms/Patient/
- Place Policies in Policies/
## Numbering Convention
- SOP-UC-XXX for Urgent Care SOPs
- SOP-TRI-XXX for Triage SOPs
- SOP-PRO-XXX for Procedure SOPs
- SOP-LAB-XXX for Laboratory SOPs
- POL-XXX for Policies
- FRM-XXX for Forms
Always create branches and submit changes as Pull Requests for review.
Focus on efficient, high-quality episodic care.
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)*
## Section 4: Impact Assessment
### Affected Areas
- [ ] Training Required
- [ ] Other Documents Affected
- [ ] Process Changes Required
- [ ] Validation 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
- [ ] Customer Complaint
- [ ] Internal Audit
- [ ] External Audit
- [ ] Process Deviation
- [ ] Nonconforming Product
- [ ] Management Review
- [ ] Other: ____________
### Priority
- [ ] Critical (5 business days)
- [ ] Major (15 business days)
- [ ] Minor (30 business days)
## Section 3: Problem Description
*(Describe the nonconformity or potential nonconformity)*
## Section 4: Immediate Containment
*(Actions taken to contain the immediate impact)*
## Section 5: Root Cause Investigation
### Investigation Method Used
- [ ] 5 Whys
- [ ] Fishbone Diagram
- [ ] Fault Tree Analysis
- [ ] Other: ____________
### Root Cause Determination
## Section 6: Corrective/Preventive Actions
| Action | Responsible | Due Date | Status |
|--------|-------------|----------|--------|
| | | | |
| | | | |
| | | | |
## Section 7: Effectiveness Verification
| Criteria | Method | Result |
|----------|--------|--------|
| | | |
Verification Date: ____________
Verified By: ____________
## Section 8: Closure
| Role | Name | Signature | Date |
|------|------|-----------|------|
| CAPA Owner | | | |
| Quality Approval | | | |
---
*Form FRM-003 Rev 1.0*

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# Internal Audit Checklist
| Form ID | FRM-006 | Revision | 1.0 |
|---------|---------|----------|-----|
---
## Audit Information
| Field | Entry |
|-------|-------|
| Audit Number | |
| Audit Date | |
| Area/Process Audited | |
| Lead Auditor | |
| Auditee(s) | |
---
## Checklist Items
| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
|---|---------------------|-----------|---------|----------------|
| 1 | Are current versions of applicable procedures available? | SOP-001 | | |
| 2 | Are personnel trained on applicable procedures? | SOP-003 | | |
| 3 | Are training records current and complete? | SOP-003 | | |
| 4 | Are records properly maintained and retrievable? | SOP-001 | | |
| 5 | Are nonconformities being documented and addressed? | SOP-002 | | |
| 6 | Are CAPAs being completed on time? | SOP-002 | | |
| 7 | Is equipment calibrated and maintained? | | | |
| 8 | Are process controls being followed? | | | |
| 9 | Are quality objectives being monitored? | | | |
| 10 | | | | |
**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable
---
## Findings Summary
| Finding # | Type | Description | Clause Reference |
|-----------|------|-------------|------------------|
| | | | |
| | | | |
---
## Auditor Signature
| Auditor | Signature | Date |
|---------|-----------|------|
| | | |
---
*Form FRM-006 Rev 1.0*

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# Urgent Care Triage Assessment
| Form ID | FRM-UC-001 | Revision | 1.0 |
|---------|-------------|----------|-----|
---
## Patient Information
| Field | Entry |
|-------|-------|
| Patient Name | |
| MRN | |
| Date of Birth | |
| Age | |
| Sex | ☐ Male ☐ Female |
| Date | |
| Time of Arrival | |
| Time of Triage | |
---
## Chief Complaint
*In patient's own words:*
**Duration of Symptoms:**
---
## Vital Signs
| Parameter | Value | Normal? |
|-----------|-------|---------|
| Temperature | °F / °C | ☐ Yes ☐ No |
| Heart Rate | bpm | ☐ Yes ☐ No |
| Respiratory Rate | /min | ☐ Yes ☐ No |
| Blood Pressure | / mmHg | ☐ Yes ☐ No |
| SpO2 | % on ☐ RA ☐ O2 ___L | ☐ Yes ☐ No |
| Pain Score | /10 | |
| Weight | kg / lbs | |
| Blood Glucose (if indicated) | mg/dL | ☐ N/A |
---
## Allergies
☐ No Known Drug Allergies (NKDA)
☐ No Known Allergies (NKA)
| Allergen | Type | Reaction |
|----------|------|----------|
| | ☐ Drug ☐ Food ☐ Environmental | |
| | ☐ Drug ☐ Food ☐ Environmental | |
| | ☐ Drug ☐ Food ☐ Environmental | |
---
## Current Medications
| Medication | Dose | Frequency |
|------------|------|-----------|
| | | |
| | | |
| | | |
| | | |
---
## Brief Medical History
☐ None significant
| Condition | Yes | Condition | Yes |
|-----------|-----|-----------|-----|
| Diabetes | ☐ | Heart Disease | ☐ |
| Hypertension | ☐ | Lung Disease/Asthma | ☐ |
| Kidney Disease | ☐ | Liver Disease | ☐ |
| Blood Clots/DVT | ☐ | Cancer | ☐ |
| Seizures | ☐ | Immunocompromised | ☐ |
| Pregnancy | ☐ (LMP: _______) | Other: | ☐ |
---
## History of Present Illness
### OPQRST
| Element | Response |
|---------|----------|
| **O**nset: When did this start? | |
| **P**rovocation: What makes it better/worse? | |
| **Q**uality: Describe the symptom | |
| **R**adiation: Does it travel anywhere? | |
| **S**everity: How bad is it (0-10)? | |
| **T**iming: Constant or comes and goes? | |
### Associated Symptoms
| Symptom | Present | Symptom | Present |
|---------|---------|---------|---------|
| Fever/Chills | ☐ | Nausea/Vomiting | ☐ |
| Headache | ☐ | Diarrhea | ☐ |
| Shortness of Breath | ☐ | Urinary Symptoms | ☐ |
| Chest Pain | ☐ | Rash | ☐ |
| Dizziness | ☐ | Weakness | ☐ |
| Cough | ☐ | Vision Changes | ☐ |
| Sore Throat | ☐ | Numbness/Tingling | ☐ |
---
## Quick Look Assessment
### General Appearance
| Observation | Finding |
|-------------|---------|
| Alert and oriented | ☐ Yes ☐ No |
| In acute distress | ☐ Yes ☐ No |
| Skin color | ☐ Normal ☐ Pale ☐ Flushed ☐ Cyanotic |
| Respiratory effort | ☐ Normal ☐ Labored |
| Ambulation | ☐ Independent ☐ Assisted ☐ Wheelchair ☐ Stretcher |
| Obvious injuries | ☐ None ☐ Present: _______ |
---
## Screening Questions
### Safety Screens
| Question | Response |
|----------|----------|
| Fall in past 24 hours? | ☐ Yes ☐ No |
| Head injury? | ☐ Yes ☐ No |
| Loss of consciousness? | ☐ Yes ☐ No |
| Recent surgery? | ☐ Yes (When: _______) ☐ No |
| Recent travel? | ☐ Yes (Where: _______) ☐ No |
| Exposure to COVID-19/illness? | ☐ Yes ☐ No |
### For Women of Childbearing Age
| Question | Response |
|----------|----------|
| Could you be pregnant? | ☐ Yes ☐ No ☐ N/A |
| Last menstrual period | |
| Currently breastfeeding? | ☐ Yes ☐ No ☐ N/A |
---
## Red Flag Assessment
**Check if ANY present (requires immediate provider notification):**
| Red Flag | Present |
|----------|---------|
| Chest pain/pressure | ☐ |
| Difficulty breathing at rest | ☐ |
| SpO2 <92% | ☐ |
| Severe headache (worst of life) | ☐ |
| Sudden vision loss | ☐ |
| Sudden weakness/numbness | ☐ |
| Speech difficulty | ☐ |
| Facial droop | ☐ |
| Uncontrolled bleeding | ☐ |
| Altered mental status | ☐ |
| Syncope | ☐ |
| Anaphylaxis symptoms | ☐ |
| Suicidal/homicidal ideation | ☐ |
**If ANY checked → Immediate provider evaluation and consider ED transfer**
---
## Acuity Level Assigned
☐ **Level 1 - Emergent** (ED Transfer Required)
→ Provider/911 notified: Time _______ Name _______
☐ **Level 2 - Urgent** (Provider within 15 min)
→ Provider notified: Time _______
☐ **Level 3 - Semi-Urgent** (Provider within 30 min)
☐ **Level 4 - Non-Urgent** (Provider within 60 min)
☐ **Level 5 - Redirect** (Outside UC scope)
→ Redirected to: _______
---
## Interventions Initiated
| Intervention | Ordered | Completed |
|--------------|---------|-----------|
| Ice pack | ☐ | ☐ |
| Elevation | ☐ | ☐ |
| Wound care | ☐ | ☐ |
| POC glucose | ☐ | ☐ |
| POC UA | ☐ | ☐ |
| POC strep | ☐ | ☐ |
| POC flu/COVID | ☐ | ☐ |
| ECG | ☐ | ☐ |
| Other: | ☐ | ☐ |
---
## Pain Assessment
| Field | Entry |
|-------|-------|
| Location | |
| Quality | ☐ Sharp ☐ Dull ☐ Aching ☐ Burning ☐ Throbbing |
| Intensity (0-10) | /10 |
| Onset | ☐ Sudden ☐ Gradual |
| Duration | |
| What relieves it? | |
| What worsens it? | |
| Previous episodes? | ☐ Yes ☐ No |
---
## Injury Details (if applicable)
| Field | Entry |
|-------|-------|
| Mechanism of Injury | |
| Time of Injury | |
| Location of Injury | |
| Tetanus status | ☐ Up to date ☐ Needs update ☐ Unknown |
| Work-related? | ☐ Yes ☐ No |
---
## Additional Notes
---
## Re-Triage (if waiting time extended)
| Time | Vital Signs | Condition Changed? | New Acuity | Initials |
|------|-------------|-------------------|------------|----------|
| | | ☐ Yes ☐ No | | |
| | | ☐ Yes ☐ No | | |
| | | ☐ Yes ☐ No | | |
---
## Triage Nurse/MA Signature
| Field | Entry |
|-------|-------|
| Name | |
| Credentials | |
| Signature | |
| Date | |
| Time | |
---
## Provider Acknowledgment
| Field | Entry |
|-------|-------|
| Provider notified at | (time) |
| Provider seen at | (time) |
| Provider Signature | |
---
*Form FRM-UC-001 Rev 1.0 - Urgent Care Triage Assessment*

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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
- [ ] Refresher
- [ ] Procedure Update
### Delivery Method
- [ ] Classroom
- [ ] On-the-Job
- [ ] 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
- [ ] Observation
### Assessment Results
| Metric | Result |
|--------|--------|
| Score (if applicable) | |
| Pass/Fail | |
## Section 5: Signatures
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Trainee | | | |
| Trainer | | | |
| Supervisor | | | |
---
*Form FRM-004 Rev 1.0*

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# Quality Policy
| Document ID | POL-001 |
|-------------|---------|
| Title | Quality Policy |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
---
## 1. Policy Statement
[ORGANIZATION NAME] is committed to providing products and services that consistently meet customer requirements and applicable regulatory requirements. We strive for continual improvement of our Quality Management System to enhance customer satisfaction.
## 2. Quality Objectives
Our organization commits to:
1. **Customer Focus**: Understanding and meeting customer needs and expectations
2. **Regulatory Compliance**: Maintaining compliance with all applicable regulations and standards
3. **Continuous Improvement**: Continually improving the effectiveness of our QMS
4. **Employee Engagement**: Ensuring all employees understand their role in quality
5. **Risk-Based Thinking**: Identifying and addressing risks and opportunities
## 3. Management Commitment
Top management demonstrates commitment to the QMS by:
- Ensuring the quality policy is appropriate to the organization's purpose
- Ensuring quality objectives are established and compatible with strategic direction
- Ensuring integration of QMS requirements into business processes
- Promoting the use of the process approach and risk-based thinking
- Ensuring resources needed for the QMS are available
- Communicating the importance of effective quality management
- Ensuring the QMS achieves its intended results
- Engaging, directing, and supporting persons to contribute to QMS effectiveness
## 4. Scope
This policy applies to all employees, contractors, and processes within the scope of our Quality Management System.
## 5. Communication
This policy shall be:
- Communicated and understood within the organization
- Available to relevant interested parties as appropriate
- Reviewed for continuing suitability
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# urgent-care # Urgent Care & Walk-In Clinic Quality Management System
A comprehensive QMS template designed for urgent care centers, walk-in clinics, and immediate care facilities. A comprehensive QMS template designed for urgent care centers, walk-in clinics, and immediate care facilities.
## 🏥 Designed For
- **Urgent Care Centers** - Walk-in acute care facilities
- **Retail Health Clinics** - Pharmacy-based clinics
- **Occupational Health Clinics** - Workers' comp and employer health
- **After-Hours Clinics** - Extended hour primary care
- **Pediatric Urgent Care** - Children's walk-in services
- **Sports Medicine Clinics** - Athletic injury care
- **Freestanding Emergency Departments** - Stand-alone emergency services
## 📋 Regulatory Framework
This template supports compliance with:
- **The Joint Commission** - Ambulatory Care accreditation
- **UCAOA** - Urgent Care Association standards and benchmarks
- **CMS** - Medicare/Medicaid requirements
- **State Medical Board** - Physician practice and supervision
- **OSHA** - Bloodborne pathogens, workplace safety
- **HIPAA** - Patient privacy requirements
- **CLIA** - Point-of-care testing requirements
- **State Facility Licensing** - Urgent care facility regulations
- **EMTALA** - Emergency screening requirements (if applicable)
- **CDC** - Infection control guidelines
## Repository Structure
```
├── SOPs/
│ ├── Patient-Flow/ # Triage, registration, rooming, discharge
│ ├── Clinical-Protocols/ # Chief complaint-based treatment pathways
│ ├── Procedures/ # Suturing, splinting, I&D, injections
│ ├── Diagnostics/ # X-ray, lab, POCT procedures
│ ├── Safety/ # Infection control, emergencies, transfers
│ └── General/ # Document control, training, CAPA
├── Forms/
│ ├── Triage-Forms/ # ESI triage, vital signs, acuity
│ ├── Visit-Documentation/ # History, exam, assessment, plan templates
│ ├── Procedure-Consent/ # Procedure-specific consent forms
│ ├── Discharge-Instructions/# Condition-specific aftercare
│ ├── POCT-Records/ # Point-of-care testing logs
│ └── Training/ # Competency assessments
├── Policies/ # Facility policies
├── Work-Instructions/ # Step-by-step procedures
└── Templates/ # Document templates
```
## Document Numbering Convention
- **POL-XXX**: Policies
- **SOP-PF-XXX**: Patient Flow SOPs
- **SOP-CP-XXX**: Clinical Protocol SOPs
- **SOP-PRC-XXX**: Procedure SOPs
- **SOP-DX-XXX**: Diagnostic SOPs
- **SOP-SAF-XXX**: Safety SOPs
- **WI-XXX**: Work Instructions
- **FRM-XXX**: Forms and Records
## 🤖 AI-Powered Assistance
This repository includes **AtomicAI**, your urgent care QMS assistant. Mention `@atomicai` in any issue or pull request to:
- Draft triage and patient flow procedures
- Create clinical treatment protocols
- Generate procedure SOPs for common urgent care procedures
- Develop discharge instruction templates
- Create emergency transfer protocols
- Review documents for accreditation compliance
### Example Prompts
- "@atomicai create an SOP for ESI triage in urgent care"
- "@atomicai draft a laceration repair protocol with suturing technique"
- "@atomicai write a chest pain evaluation and transfer protocol"
- "@atomicai create discharge instructions for ankle sprain"
- "@atomicai develop a point-of-care strep testing procedure"
- "@atomicai create an occupational injury documentation form"
## Getting Started
1. **Establish Triage Protocols** - Implement acuity-based patient flow
2. **Define Clinical Pathways** - Create chief complaint-based protocols
3. **Set Up Procedure Standards** - Document common urgent care procedures
4. **Implement POCT Program** - Configure point-of-care testing QC
5. **Train Staff** - Use competency assessment forms
## Key Documents to Create First
1. **Triage Protocol** - Acuity assessment and flow decisions
2. **Chest Pain/ACS Protocol** - High-risk complaint management
3. **Laceration Repair SOP** - Wound care and suturing procedure
4. **Fracture/Splinting Protocol** - Immobilization and referral
5. **Transfer to ED Protocol** - Emergency transfer criteria and process
6. **POCT Quality Control SOP** - Point-of-care testing requirements
7. **Discharge Instruction Library** - Condition-specific aftercare
## Special Considerations for Urgent Care
### Patient Flow
- Walk-in vs. scheduled appointments
- Triage and acuity assessment
- Wait time management
- Left without being seen (LWBS) tracking
- Throughput optimization
### Clinical Scope
- Chief complaint-based protocols
- Scope of practice limitations
- Transfer and referral criteria
- High-risk complaint management
- Pediatric-specific considerations
### Procedures
- Wound care and suturing
- Fracture management and splinting
- Abscess I&D
- Foreign body removal
- Injection techniques
### Safety and Compliance
- Emergency equipment and medications
- Infection control (isolation, PPE)
- Controlled substance management
- Medical record documentation
- Quality metrics (door-to-provider, LWBS)
---
*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*

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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
- Specifications
- 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 |
| SOP | SOP | SOP-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. Documents reviewed at least every 2 years
2. Review documented even if no changes made
3. 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.
## 2. Scope
This procedure applies to:
- Product and process nonconformities
- Customer complaints
- Audit findings
- Process deviations
- 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 |
## 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 Management
- Provides resources for CAPA implementation
- Reviews CAPA trends
- Ensures timely closure
## 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
4. Assign CAPA owner
### 5.2 Investigation
1. Gather relevant data and evidence
2. Interview personnel involved
3. Review related documents and records
4. Use appropriate investigation tools:
- 5 Whys
- Fishbone Diagram
- Failure Mode Analysis
### 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
### 5.4 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
### 5.5 Implementation
1. Execute approved actions
2. Document implementation evidence
3. Update affected documents/processes
4. Provide training as needed
### 5.6 Effectiveness Verification
1. Define effectiveness criteria
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
## 6. CAPA Metrics
Quality Assurance shall track and report:
- Number of open CAPAs
- CAPA aging
- On-time closure rate
- Effectiveness rate
- CAPAs by category/source
## 7. Related Documents
- FRM-003 CAPA Form
- SOP-003 Nonconforming Product Control
- SOP-004 Customer Complaints
---
## 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 |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Human Resources / Quality |
---
## 1. Purpose
To ensure personnel performing work affecting product quality are competent based on appropriate education, training, skills, and experience.
## 2. Scope
This procedure applies to:
- All employees performing quality-affecting activities
- Contractors and temporary personnel
- Personnel requiring GxP training
## 3. Responsibilities
### 3.1 Supervisors/Managers
- Identify training needs for their personnel
- Ensure training is completed before performing tasks
- Evaluate competence of personnel
- Maintain department training records
### 3.2 Human Resources
- Coordinate training programs
- Maintain central training database
- Track training compliance
- Archive training records
### 3.3 Quality Assurance
- Develop QMS-related training
- Approve training curricula for GxP activities
- Audit training compliance
### 3.4 Employees
- Complete assigned training on time
- Maintain current qualifications
- Report training needs to supervisor
## 4. Procedure
### 4.1 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
### 4.2 Training Curriculum Development
1. Define learning objectives
2. Develop training materials
3. Identify delivery method:
- Classroom
- On-the-job
- Self-study
- Computer-based
4. Define assessment criteria
5. Obtain approval from Quality (for GxP training)
### 4.3 Training Delivery
1. Schedule training session
2. Document attendance
3. Deliver training per curriculum
4. Assess comprehension through:
- Written test (minimum 80% passing)
- Practical demonstration
- Supervisor observation
### 4.4 Training Documentation
Training records shall include:
- Employee name and ID
- Training title and date
- Trainer name and qualifications
- Assessment results
- Signatures
### 4.5 Retraining Requirements
Retraining is required when:
- Significant document revisions occur
- Performance deficiencies identified
- Extended absence from job function
- Periodic requalification due
### 4.6 New Employee Orientation
All new employees shall complete:
1. Company orientation
2. Quality system overview
3. Job-specific training
4. SOP read and understand for applicable procedures
## 5. Training Records Retention
- Training records maintained for duration of employment
- Records retained 3 years after employee departure
- Records available for regulatory inspection
## 6. Related Documents
- FRM-004 Training Record Form
- FRM-005 Training Assessment Form
- Job Descriptions
---
## 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 approach for conducting internal audits to verify the effectiveness of the Quality Management System.
## 2. Scope
This procedure covers:
- QMS process audits
- Compliance audits
- Product audits
- System audits
## 3. Definitions
| Term | Definition |
|------|------------|
| Audit | Systematic, independent examination to determine conformance |
| Auditor | Person qualified to perform audits |
| Finding | Observation of conformance or nonconformance |
| Observation | Noted item not rising to level of finding |
## 4. Responsibilities
### 4.1 Lead Auditor
- Plans and schedules audits
- Prepares audit checklists
- Conducts audit activities
- Reports audit findings
### 4.2 Quality Manager
- Maintains audit program
- Qualifies auditors
- Reviews audit reports
- Reports to management
### 4.3 Auditee
- Provides access to areas/records
- Responds to findings
- Implements corrective actions
## 5. Procedure
### 5.1 Annual Audit Schedule
1. Develop annual audit schedule considering:
- Previous audit results
- Process criticality
- Regulatory requirements
- Changes to processes
2. Ensure all QMS processes audited at least annually
3. Obtain management approval
4. Communicate schedule to affected areas
### 5.2 Auditor Qualification
Auditors shall:
- Complete auditor training course
- Conduct at least 2 audits under supervision
- Be independent of area being audited
- Maintain competence through ongoing audits
### 5.3 Audit Preparation
1. Review applicable procedures and standards
2. Review previous audit reports
3. Prepare audit checklist
4. Notify auditee of audit scope and schedule
5. Confirm auditor availability
### 5.4 Conducting the Audit
1. Hold opening meeting with auditee
2. Execute audit checklist
3. Gather objective evidence:
- Document review
- Personnel interviews
- Process observation
4. Document findings with evidence
5. Classify findings:
- Major Nonconformance
- Minor Nonconformance
- Observation
6. Hold closing meeting
### 5.5 Audit Reporting
1. Complete audit report within 5 business days
2. Report shall include:
- Audit scope and criteria
- Personnel interviewed
- Findings with evidence
- Recommendations
3. Distribute report to auditee and management
### 5.6 Finding Resolution
1. Auditee responds with corrective action plan within 10 business days
2. Quality reviews and approves plan
3. Auditee implements corrective actions
4. Auditor verifies effectiveness
5. Close finding upon verification
## 6. Audit Records
Maintain for 5 years:
- Audit schedules
- Checklists
- Reports
- Corrective action records
## 7. Related Documents
- FRM-006 Audit Checklist Template
- FRM-007 Audit Report Template
- SOP-002 CAPA
---
## 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 ensure top management reviews the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.
## 2. Scope
This procedure applies to the periodic management review of the QMS, including all processes and quality objectives.
## 3. Frequency
Management reviews shall be conducted:
- At least annually
- More frequently if significant changes occur
- As needed based on quality performance
## 4. Responsibilities
### 4.1 Quality Manager
- Prepares management review agenda and materials
- Facilitates the meeting
- Documents meeting minutes and action items
- Tracks completion of action items
### 4.2 Top Management
- Attends management review meetings
- Reviews QMS performance data
- Makes decisions on QMS improvements
- Allocates resources as needed
### 4.3 Department Managers
- Provides input data for their areas
- Attends management review
- Implements assigned action items
## 5. Management Review Inputs
The following shall be considered:
### 5.1 Actions from Previous Reviews
- Status of action items
- Effectiveness of implemented actions
### 5.2 Changes in Context
- Internal changes (organization, resources)
- External changes (regulations, market)
### 5.3 QMS Performance
- Customer satisfaction and feedback
- Quality objectives achievement
- Process performance metrics
- Nonconformities and corrective actions
- Audit results
- Supplier performance
### 5.4 Resource Adequacy
- Personnel
- Infrastructure
- Work environment
### 5.5 Risk and Opportunities
- Risk assessment results
- Effectiveness of risk controls
- New opportunities identified
### 5.6 Improvement Opportunities
- Process improvements
- Product improvements
- QMS enhancements
## 6. Management Review Outputs
Decisions and actions related to:
- Improvement of QMS and processes
- Product improvement
- Resource needs
- Changes to quality policy or objectives
## 7. Documentation
### 7.1 Meeting Minutes
- Date and attendees
- Items discussed
- Decisions made
- Action items with owners and due dates
### 7.2 Record Retention
- Management review records retained for 5 years
- Available for regulatory inspection
## 8. Related Documents
- FRM-008 Management Review Agenda Template
- FRM-009 Management Review Minutes Template
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Urgent Care Triage Protocol
| Document ID | SOP-UC-001 |
|-------------|-------------|
| Title | Urgent Care Patient Triage and Acuity Assessment |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Urgent Care |
---
## 1. Purpose
To establish standardized procedures for triaging patients presenting to urgent care to ensure appropriate prioritization, timely care, and identification of emergent conditions requiring ED transfer.
## 2. Scope
This procedure applies to all patients presenting to urgent care including:
- Walk-in patients
- Scheduled same-day appointments
- Patients referred from other providers
- Pediatric and adult patients
## 3. Responsibilities
### 3.1 Triage Nurse/Medical Assistant
- Conduct initial patient assessment
- Assign acuity level
- Obtain vital signs
- Identify emergent conditions
- Initiate appropriate protocols
### 3.2 Urgent Care Provider
- Review triage findings
- Evaluate patients per acuity
- Make disposition decisions
- Authorize ED transfers
### 3.3 Front Desk Staff
- Check in patients
- Alert clinical staff to arrivals
- Facilitate registration
## 4. Definitions
| Term | Definition |
|------|------------|
| Triage | Process of prioritizing patients based on clinical urgency |
| Acuity | Severity of patient's condition |
| ESI | Emergency Severity Index (reference scale) |
| ED Transfer | Patient requiring emergency department level care |
| Chief Complaint | Primary reason for visit |
## 5. Triage Levels
### 5.1 Urgent Care Acuity Scale
| Level | Description | Examples | Target Time |
|-------|-------------|----------|-------------|
| 1 - Emergent | Life/limb threatening, requires ED | Chest pain, stroke symptoms, severe dyspnea | IMMEDIATE ED transfer |
| 2 - Urgent | Significant symptoms, needs prompt attention | High fever, moderate dyspnea, severe pain | <15 minutes |
| 3 - Semi-Urgent | Moderate symptoms, stable | Lacerations, minor fractures, UTI symptoms | <30 minutes |
| 4 - Non-Urgent | Minor symptoms, stable | Minor cold symptoms, prescription refills | <60 minutes |
| 5 - Not Appropriate | Outside scope, needs referral | Chronic disease management, specialist care | Redirect to PCP |
## 6. Procedure
### 6.1 Initial Contact
1. **Patient Arrival**
- Acknowledge patient within 5 minutes of arrival
- Brief visual assessment
- Determine if immediate attention needed
2. **Quick Look Assessment**
Rapidly evaluate:
- Level of consciousness
- Respiratory effort
- Skin color
- Obvious distress
- Visible injuries
### 6.2 Triage Assessment
#### 6.2.1 Chief Complaint
Document in patient's own words:
- Primary symptom
- Duration
- Severity (0-10 scale for pain)
#### 6.2.2 Vital Signs
| Parameter | Normal Adult Range | Action if Abnormal |
|-----------|-------------------|-------------------|
| Temperature | 97.0-99.0°F | Assess for fever source |
| Heart Rate | 60-100 bpm | Assess for underlying cause |
| Respiratory Rate | 12-20/min | Oxygen, escalate if distressed |
| Blood Pressure | <140/90 mmHg | Repeat, assess symptoms |
| SpO2 | ≥95% on RA | Oxygen, consider ED transfer |
| Pain Score | 0/10 | Pain management protocol |
#### 6.2.3 Brief History
| Element | Document |
|---------|----------|
| Onset | When did symptoms start? |
| Provocation | What makes it better/worse? |
| Quality | Describe the symptom |
| Radiation | Does pain travel? |
| Severity | Rate 0-10 |
| Time | Constant or intermittent? |
| Medications | Current medications |
| Allergies | Drug and other allergies |
| Last meal | Time of last food/drink |
| Medical history | Relevant conditions |
### 6.3 Level 1 - Emergent (ED Transfer Required)
**Immediate recognition and action for:**
| Condition | Signs/Symptoms | Action |
|-----------|---------------|--------|
| Cardiac emergency | Chest pain, diaphoresis, SOB, arm/jaw pain | Call 911, ECG if available |
| Stroke | Facial droop, arm weakness, speech difficulty | Call 911, note time of onset |
| Respiratory failure | SpO2 <90%, severe distress, cyanosis | Oxygen, call 911 |
| Anaphylaxis | Airway swelling, hypotension, urticaria | Epinephrine, call 911 |
| Severe trauma | Major bleeding, altered consciousness | Stabilize, call 911 |
| Sepsis | Fever, tachycardia, hypotension, AMS | IV access, fluids, call 911 |
| Active seizure | Convulsions, unresponsive | Protect, time seizure, call 911 |
**ED Transfer Protocol:**
1. Call 911 immediately
2. Notify provider
3. Initiate stabilizing measures
4. Document time and interventions
5. Provide EMS with clinical information
6. Send documentation with patient
### 6.4 Level 2 - Urgent
**Requires provider evaluation within 15 minutes:**
| Condition | Characteristics |
|-----------|----------------|
| High fever | >103°F adult, >102°F child <3 months |
| Moderate respiratory distress | SpO2 92-95%, increased work of breathing |
| Severe pain | 8-10/10 |
| Significant bleeding | Controlled but significant |
| Dehydration with vomiting | Unable to keep fluids down |
| Acute abdominal pain | Severe, localized |
| Altered mental status | Confusion, not baseline |
| Syncope | Recent loss of consciousness |
| Diabetic emergency | Hypoglycemia, ketoacidosis symptoms |
### 6.5 Level 3 - Semi-Urgent
**Provider evaluation within 30 minutes:**
| Condition | Characteristics |
|-----------|----------------|
| Lacerations | Requiring sutures, bleeding controlled |
| Possible fractures | Deformity, point tenderness, stable |
| Moderate pain | 5-7/10 |
| UTI symptoms | Dysuria, frequency, no fever |
| Ear pain | Moderate, no fever |
| Minor burns | <5% BSA, superficial |
| Sprains/strains | Ambulating, stable |
| Rash with mild symptoms | No systemic symptoms |
### 6.6 Level 4 - Non-Urgent
**Provider evaluation within 60 minutes:**
- Upper respiratory symptoms (mild)
- Minor sore throat
- Minor skin conditions
- Medication refills
- Minor eye complaints (non-trauma)
- Minor injuries not requiring sutures
### 6.7 Level 5 - Redirect
**Outside urgent care scope:**
- Chronic disease management
- Routine physical exams
- Mental health crisis (redirect to crisis line/ED)
- Dental emergencies (redirect to dentist/ED)
- Specialty care needs
- Workers' compensation (per facility policy)
### 6.8 Pediatric Considerations
#### Age-Specific Concerns
| Age | Automatic Elevation Criteria |
|-----|------------------------------|
| <3 months | Any fever ≥100.4°F → ED |
| <2 years | Fever >103°F, lethargy, poor feeding → Urgent |
| All pediatric | Respiratory distress, dehydration, altered behavior → Urgent |
#### Pediatric Vital Sign Norms
| Age | HR | RR | Systolic BP |
|-----|----|----|-------------|
| Infant | 100-160 | 30-60 | 70-90 |
| 1-3 years | 90-150 | 24-40 | 80-100 |
| 4-6 years | 80-140 | 22-34 | 90-110 |
| 7-12 years | 70-120 | 18-30 | 90-120 |
| >12 years | 60-100 | 12-20 | 100-120 |
### 6.9 Geriatric Considerations
- Lower threshold for escalation
- Atypical presentations common
- Consider polypharmacy
- Falls assessment
- Cognitive baseline consideration
## 7. Documentation
Complete FRM-UC-001 Triage Assessment including:
- Time of arrival and triage
- Chief complaint
- Vital signs
- Allergies and medications
- Brief history
- Assigned acuity level
- Interventions initiated
- Provider notification time
## 8. Re-Triage
Re-assess waiting patients:
- Every 30 minutes for Level 2
- Every 60 minutes for Level 3-4
- Immediately if condition changes
- Document all re-assessments
## 9. Quality Metrics
| Metric | Target |
|--------|--------|
| Time to triage | <10 minutes |
| Appropriate acuity assignment | >95% (audit) |
| ED transfers identified at triage | >99% |
| Patient complaints re: wait time | <5% |
## 10. References
- Emergency Severity Index (ESI) guidelines
- Emergency Nurses Association guidelines
- Pediatric Assessment Triangle
- State nursing practice acts
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Placeholder

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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]
## 3. Responsibilities
### 3.1 [Role 1]
- [Responsibility]
- [Responsibility]
### 3.2 [Role 2]
- [Responsibility]
- [Responsibility]
## 4. Definitions
| Term | Definition |
|------|------------|
| | |
## 5. Procedure
### 5.1 [Section Title]
[Procedure steps]
### 5.2 [Section Title]
[Procedure steps]
## 6. Related Documents
- [List related procedures, forms, etc.]
## 7. References
- [External standards, regulations, etc.]
---
## 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]
## 3. Safety Precautions
- [List any safety requirements]
- [Personal protective equipment needed]
- [Hazards to be aware of]
## 4. Equipment/Materials Required
| Item | Specification |
|------|---------------|
| | |
| | |
## 5. Procedure
### Step 1: [Title]
[Detailed instructions]
### Step 2: [Title]
[Detailed instructions]
### Step 3: [Title]
[Detailed instructions]
## 6. Acceptance Criteria
[Define what constitutes successful completion]
## 7. Records
| Record | Location | Retention |
|--------|----------|-----------|
| | | |
## 8. References
- [Related SOPs]
- [Specifications]
- [Standards]
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |