Sync template from atomicqms-style deployment
This commit is contained in:
77
.gitea/workflows/atomicai.yml
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77
.gitea/workflows/atomicai.yml
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name: AtomicAI Urgent Care Assistant
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on:
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issue_comment:
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types: [created]
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issues:
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types: [opened, assigned]
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pull_request:
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types: [opened, synchronize, assigned]
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pull_request_review_comment:
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types: [created]
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jobs:
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claude-assistant:
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runs-on: ubuntu-latest
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if: |
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github.actor != 'atomicqms-service' &&
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(
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(github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai')) ||
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(github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) ||
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(github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) ||
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(github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai')) ||
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(github.event.action == 'assigned' && github.event.assignee.login == 'atomicai')
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)
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permissions:
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contents: write
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issues: write
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pull-requests: write
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steps:
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- uses: actions/checkout@v4
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with:
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fetch-depth: 0
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- name: Run AtomicAI Urgent Care Assistant
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uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main
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with:
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trigger_phrase: '@atomicai'
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assignee_trigger: 'atomicai'
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claude_git_name: 'AtomicAI'
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claude_git_email: 'atomicai@atomicqms.local'
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custom_instructions: |
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You are AtomicAI, an AI assistant specialized in Urgent Care Quality Management.
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## Your Expertise
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- Urgent Care Association (UCA) accreditation standards
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- Triage protocols and acuity assessment
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- Point-of-care testing (CLIA waived)
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- Minor procedure protocols (laceration repair, splinting)
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- Occupational medicine and workers comp
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- Infection control and isolation procedures
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- Transfer protocols for higher acuity patients
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- Medication dispensing and prescribing
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- Radiology and diagnostic imaging protocols
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- Patient flow and wait time optimization
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## Document Creation Guidelines
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- Place Clinical SOPs in SOPs/Clinical/
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- Place Triage Protocols in Protocols/Triage/
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- Place Procedure SOPs in SOPs/Procedures/
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- Place Lab SOPs in SOPs/Laboratory/
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- Place Patient Forms in Forms/Patient/
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- Place Policies in Policies/
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## Numbering Convention
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- SOP-UC-XXX for Urgent Care SOPs
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- SOP-TRI-XXX for Triage SOPs
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- SOP-PRO-XXX for Procedure SOPs
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- SOP-LAB-XXX for Laboratory SOPs
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- POL-XXX for Policies
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- FRM-XXX for Forms
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Always create branches and submit changes as Pull Requests for review.
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Focus on efficient, high-quality episodic care.
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allowed_tools: 'Read,Edit,Grep,Glob,Write'
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disallowed_tools: 'Bash,WebSearch'
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0
Forms/Discharge-Instructions/.gitkeep
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0
Forms/Discharge-Instructions/.gitkeep
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64
Forms/FRM-001-Document-Change-Request.md
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64
Forms/FRM-001-Document-Change-Request.md
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# Document Change Request Form
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| Form ID | FRM-001 | Revision | 1.0 |
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|---------|---------|----------|-----|
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---
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## Section 1: Request Information
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| Field | Entry |
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|-------|-------|
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| Request Date | |
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| Requested By | |
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| Department | |
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## Section 2: Document Information
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| Field | Entry |
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|-------|-------|
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| Document Number | |
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| Document Title | |
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| Current Revision | |
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## Section 3: Change Description
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### Type of Change
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- [ ] New Document
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- [ ] Revision to Existing Document
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- [ ] Document Obsolescence
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### Description of Change
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*(Describe the proposed change in detail)*
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### Reason for Change
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*(Explain why this change is needed)*
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## Section 4: Impact Assessment
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### Affected Areas
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- [ ] Training Required
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- [ ] Other Documents Affected
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- [ ] Process Changes Required
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- [ ] Validation Impact
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### List Affected Documents
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## Section 5: Approvals
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| Role | Name | Signature | Date |
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|------|------|-----------|------|
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| Requester | | | |
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| Document Owner | | | |
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| Quality Assurance | | | |
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---
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*Form FRM-001 Rev 1.0*
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91
Forms/FRM-003-CAPA-Form.md
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91
Forms/FRM-003-CAPA-Form.md
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# Corrective and Preventive Action (CAPA) Form
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| Form ID | FRM-003 | Revision | 1.0 |
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|---------|---------|----------|-----|
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---
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## Section 1: CAPA Identification
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| Field | Entry |
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|-------|-------|
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| CAPA Number | |
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| Date Initiated | |
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| Initiated By | |
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| CAPA Owner | |
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| Target Closure Date | |
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## Section 2: Classification
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### Type
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- [ ] Corrective Action
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- [ ] Preventive Action
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### Source
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- [ ] Customer Complaint
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- [ ] Internal Audit
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- [ ] External Audit
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- [ ] Process Deviation
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- [ ] Nonconforming Product
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- [ ] Management Review
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- [ ] Other: ____________
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### Priority
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- [ ] Critical (5 business days)
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- [ ] Major (15 business days)
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- [ ] Minor (30 business days)
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## Section 3: Problem Description
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*(Describe the nonconformity or potential nonconformity)*
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## Section 4: Immediate Containment
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*(Actions taken to contain the immediate impact)*
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## Section 5: Root Cause Investigation
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### Investigation Method Used
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- [ ] 5 Whys
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- [ ] Fishbone Diagram
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- [ ] Fault Tree Analysis
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- [ ] Other: ____________
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### Root Cause Determination
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## Section 6: Corrective/Preventive Actions
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| Action | Responsible | Due Date | Status |
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|--------|-------------|----------|--------|
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| | | | |
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| | | | |
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| | | | |
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## Section 7: Effectiveness Verification
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| Criteria | Method | Result |
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|----------|--------|--------|
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| | | |
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Verification Date: ____________
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Verified By: ____________
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## Section 8: Closure
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| Role | Name | Signature | Date |
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|------|------|-----------|------|
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| CAPA Owner | | | |
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| Quality Approval | | | |
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---
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*Form FRM-003 Rev 1.0*
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56
Forms/FRM-006-Audit-Checklist.md
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56
Forms/FRM-006-Audit-Checklist.md
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# Internal Audit Checklist
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| Form ID | FRM-006 | Revision | 1.0 |
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|---------|---------|----------|-----|
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---
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## Audit Information
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| Field | Entry |
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|-------|-------|
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| Audit Number | |
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| Audit Date | |
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| Area/Process Audited | |
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| Lead Auditor | |
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| Auditee(s) | |
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---
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## Checklist Items
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| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
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|---|---------------------|-----------|---------|----------------|
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| 1 | Are current versions of applicable procedures available? | SOP-001 | | |
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| 2 | Are personnel trained on applicable procedures? | SOP-003 | | |
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| 3 | Are training records current and complete? | SOP-003 | | |
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| 4 | Are records properly maintained and retrievable? | SOP-001 | | |
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| 5 | Are nonconformities being documented and addressed? | SOP-002 | | |
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| 6 | Are CAPAs being completed on time? | SOP-002 | | |
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| 7 | Is equipment calibrated and maintained? | | | |
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| 8 | Are process controls being followed? | | | |
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| 9 | Are quality objectives being monitored? | | | |
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| 10 | | | | |
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**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable
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---
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## Findings Summary
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| Finding # | Type | Description | Clause Reference |
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|-----------|------|-------------|------------------|
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| | | | |
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| | | | |
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---
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## Auditor Signature
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| Auditor | Signature | Date |
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|---------|-----------|------|
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| | | |
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---
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*Form FRM-006 Rev 1.0*
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270
Forms/Intake-Forms/FRM-UC-001-Triage-Assessment.md
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270
Forms/Intake-Forms/FRM-UC-001-Triage-Assessment.md
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# Urgent Care Triage Assessment
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| Form ID | FRM-UC-001 | Revision | 1.0 |
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|---------|-------------|----------|-----|
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---
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## Patient Information
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| Field | Entry |
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|-------|-------|
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| Patient Name | |
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| MRN | |
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| Date of Birth | |
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| Age | |
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| Sex | ☐ Male ☐ Female |
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| Date | |
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| Time of Arrival | |
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| Time of Triage | |
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---
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## Chief Complaint
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*In patient's own words:*
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**Duration of Symptoms:**
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---
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## Vital Signs
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| Parameter | Value | Normal? |
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|-----------|-------|---------|
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| Temperature | °F / °C | ☐ Yes ☐ No |
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| Heart Rate | bpm | ☐ Yes ☐ No |
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| Respiratory Rate | /min | ☐ Yes ☐ No |
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| Blood Pressure | / mmHg | ☐ Yes ☐ No |
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| SpO2 | % on ☐ RA ☐ O2 ___L | ☐ Yes ☐ No |
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| Pain Score | /10 | |
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| Weight | kg / lbs | |
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| Blood Glucose (if indicated) | mg/dL | ☐ N/A |
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---
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## Allergies
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☐ No Known Drug Allergies (NKDA)
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☐ No Known Allergies (NKA)
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| Allergen | Type | Reaction |
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|----------|------|----------|
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| | ☐ Drug ☐ Food ☐ Environmental | |
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| | ☐ Drug ☐ Food ☐ Environmental | |
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| | ☐ Drug ☐ Food ☐ Environmental | |
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---
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## Current Medications
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| Medication | Dose | Frequency |
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|------------|------|-----------|
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| | | |
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| | | |
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| | | |
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| | | |
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---
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## Brief Medical History
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☐ None significant
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| Condition | Yes | Condition | Yes |
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|-----------|-----|-----------|-----|
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| Diabetes | ☐ | Heart Disease | ☐ |
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| Hypertension | ☐ | Lung Disease/Asthma | ☐ |
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| Kidney Disease | ☐ | Liver Disease | ☐ |
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| Blood Clots/DVT | ☐ | Cancer | ☐ |
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| Seizures | ☐ | Immunocompromised | ☐ |
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| Pregnancy | ☐ (LMP: _______) | Other: | ☐ |
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---
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## History of Present Illness
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### OPQRST
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| Element | Response |
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|---------|----------|
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| **O**nset: When did this start? | |
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| **P**rovocation: What makes it better/worse? | |
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| **Q**uality: Describe the symptom | |
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| **R**adiation: Does it travel anywhere? | |
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| **S**everity: How bad is it (0-10)? | |
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| **T**iming: Constant or comes and goes? | |
|
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### Associated Symptoms
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| Symptom | Present | Symptom | Present |
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|---------|---------|---------|---------|
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| Fever/Chills | ☐ | Nausea/Vomiting | ☐ |
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| Headache | ☐ | Diarrhea | ☐ |
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| Shortness of Breath | ☐ | Urinary Symptoms | ☐ |
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| Chest Pain | ☐ | Rash | ☐ |
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| Dizziness | ☐ | Weakness | ☐ |
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| Cough | ☐ | Vision Changes | ☐ |
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| Sore Throat | ☐ | Numbness/Tingling | ☐ |
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|
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---
|
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## Quick Look Assessment
|
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|
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### General Appearance
|
||||
|
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| Observation | Finding |
|
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|-------------|---------|
|
||||
| Alert and oriented | ☐ Yes ☐ No |
|
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| In acute distress | ☐ Yes ☐ No |
|
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| Skin color | ☐ Normal ☐ Pale ☐ Flushed ☐ Cyanotic |
|
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| Respiratory effort | ☐ Normal ☐ Labored |
|
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| Ambulation | ☐ Independent ☐ Assisted ☐ Wheelchair ☐ Stretcher |
|
||||
| Obvious injuries | ☐ None ☐ Present: _______ |
|
||||
|
||||
---
|
||||
|
||||
## Screening Questions
|
||||
|
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### 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*
|
||||
0
Forms/POCT-Records/.gitkeep
Normal file
0
Forms/POCT-Records/.gitkeep
Normal file
0
Forms/Procedure-Consent/.gitkeep
Normal file
0
Forms/Procedure-Consent/.gitkeep
Normal file
72
Forms/Training/FRM-004-Training-Record.md
Normal file
72
Forms/Training/FRM-004-Training-Record.md
Normal file
@@ -0,0 +1,72 @@
|
||||
# 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*
|
||||
0
Forms/Triage-Forms/.gitkeep
Normal file
0
Forms/Triage-Forms/.gitkeep
Normal file
0
Forms/Visit-Documentation/.gitkeep
Normal file
0
Forms/Visit-Documentation/.gitkeep
Normal file
57
Policies/POL-001-Quality-Policy.md
Normal file
57
Policies/POL-001-Quality-Policy.md
Normal file
@@ -0,0 +1,57 @@
|
||||
# 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] |
|
||||
132
README.md
132
README.md
@@ -1,3 +1,133 @@
|
||||
# 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.
|
||||
|
||||
## 🏥 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.*
|
||||
|
||||
0
SOPs/Clinical-Protocols/.gitkeep
Normal file
0
SOPs/Clinical-Protocols/.gitkeep
Normal file
0
SOPs/Diagnostics/.gitkeep
Normal file
0
SOPs/Diagnostics/.gitkeep
Normal file
112
SOPs/General/SOP-001-Document-Control.md
Normal file
112
SOPs/General/SOP-001-Document-Control.md
Normal file
@@ -0,0 +1,112 @@
|
||||
# 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] |
|
||||
134
SOPs/General/SOP-002-CAPA.md
Normal file
134
SOPs/General/SOP-002-CAPA.md
Normal file
@@ -0,0 +1,134 @@
|
||||
# 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] |
|
||||
123
SOPs/General/SOP-003-Training.md
Normal file
123
SOPs/General/SOP-003-Training.md
Normal file
@@ -0,0 +1,123 @@
|
||||
# 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] |
|
||||
136
SOPs/General/SOP-004-Internal-Audit.md
Normal file
136
SOPs/General/SOP-004-Internal-Audit.md
Normal file
@@ -0,0 +1,136 @@
|
||||
# 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] |
|
||||
114
SOPs/General/SOP-005-Management-Review.md
Normal file
114
SOPs/General/SOP-005-Management-Review.md
Normal file
@@ -0,0 +1,114 @@
|
||||
# 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] |
|
||||
265
SOPs/Patient-Care/SOP-UC-001-Triage-Protocol.md
Normal file
265
SOPs/Patient-Care/SOP-UC-001-Triage-Protocol.md
Normal file
@@ -0,0 +1,265 @@
|
||||
# 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] |
|
||||
0
SOPs/Patient-Flow/.gitkeep
Normal file
0
SOPs/Patient-Flow/.gitkeep
Normal file
0
SOPs/Procedures/.gitkeep
Normal file
0
SOPs/Procedures/.gitkeep
Normal file
1
SOPs/Safety/.gitkeep
Normal file
1
SOPs/Safety/.gitkeep
Normal file
@@ -0,0 +1 @@
|
||||
# Placeholder
|
||||
62
Templates/SOP-Template.md
Normal file
62
Templates/SOP-Template.md
Normal file
@@ -0,0 +1,62 @@
|
||||
# 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] |
|
||||
68
Work Instructions/WI-001-Template.md
Normal file
68
Work Instructions/WI-001-Template.md
Normal file
@@ -0,0 +1,68 @@
|
||||
# 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] |
|
||||
Reference in New Lab Ticket
Block a user