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name: AtomicAI Clinical Inpatient 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 Clinical Inpatient 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 Clinical Inpatient Quality Management.
## Your Expertise
- Hospital accreditation standards (Joint Commission, DNV)
- Inpatient care protocols and clinical pathways
- Patient safety and fall prevention
- Infection control and hospital-acquired conditions
- Medication administration and reconciliation
- Code Blue and rapid response procedures
- Discharge planning and transitions of care
- Nursing documentation standards
- CMS Conditions of Participation
## Document Creation Guidelines
- Place Clinical SOPs in SOPs/Clinical/
- Place Nursing SOPs in SOPs/Nursing/
- Place Safety SOPs in SOPs/Safety/
- Place Emergency Protocols in Protocols/Emergency/
- Place Patient Forms in Forms/Patient/
- Place Policies in Policies/
## Numbering Convention
- SOP-IP-XXX for Inpatient SOPs
- SOP-NUR-XXX for Nursing SOPs
- SOP-SAF-XXX for Safety SOPs
- PRO-EMR-XXX for Emergency Protocols
- POL-XXX for Policies
- FRM-XXX for Forms
Always create branches and submit changes as Pull Requests for review.
Prioritize patient safety and regulatory compliance.
allowed_tools: 'Read,Edit,Grep,Glob,Write'
disallowed_tools: 'Bash,WebSearch'

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# Nursing Admission Assessment
| Form ID | FRM-INP-001 | Revision | 1.0 |
|---------|-------------|----------|-----|
---
## Patient Information
| Field | Entry |
|-------|-------|
| Patient Name | |
| MRN | |
| Date of Birth | |
| Admission Date | |
| Admission Time | |
| Admitting Physician | |
| Unit/Room | |
| Admitting Diagnosis | |
| Source of Admission | ☐ Home ☐ ED ☐ Transfer ☐ Other: _______ |
| Mode of Arrival | ☐ Ambulatory ☐ Wheelchair ☐ Stretcher |
---
## Vital Signs
| Parameter | Value | Time |
|-----------|-------|------|
| Temperature | °F / °C | |
| Heart Rate | bpm | |
| Respiratory Rate | breaths/min | |
| Blood Pressure | / mmHg | |
| SpO2 | % on ☐ RA ☐ O2 ___L/min | |
| Pain Level | /10 | |
| Height | | |
| Weight | | |
---
## Allergies
☐ No Known Allergies (NKA)
☐ No Known Drug Allergies (NKDA)
| Allergen | Type | Reaction |
|----------|------|----------|
| | ☐ Drug ☐ Food ☐ Environmental ☐ Other | |
| | ☐ Drug ☐ Food ☐ Environmental ☐ Other | |
| | ☐ Drug ☐ Food ☐ Environmental ☐ Other | |
**Allergy band applied?** ☐ Yes ☐ N/A
---
## Current Medications
| Medication | Dose | Frequency | Last Taken | Continue? |
|------------|------|-----------|------------|-----------|
| | | | | ☐ Yes ☐ No |
| | | | | ☐ Yes ☐ No |
| | | | | ☐ Yes ☐ No |
| | | | | ☐ Yes ☐ No |
| | | | | ☐ Yes ☐ No |
| | | | | ☐ Yes ☐ No |
| | | | | ☐ Yes ☐ No |
| | | | | ☐ Yes ☐ No |
**Medication source:** ☐ Patient/Family ☐ Pharmacy Records ☐ PCP Records ☐ Other: _______
**Medications brought to hospital?** ☐ Yes (inventory attached) ☐ No
---
## Medical History
### Past Medical History
☐ None significant
| Condition | Notes |
|-----------|-------|
| ☐ Hypertension | |
| ☐ Diabetes | Type: ☐ 1 ☐ 2 |
| ☐ Heart Disease | |
| ☐ COPD/Asthma | |
| ☐ Stroke/TIA | |
| ☐ Cancer | Type: |
| ☐ Kidney Disease | |
| ☐ Liver Disease | |
| ☐ Seizures | |
| ☐ Psychiatric | |
| ☐ Other: | |
### Past Surgical History
☐ None
| Surgery/Procedure | Year |
|-------------------|------|
| | |
| | |
| | |
---
## Review of Systems
### General
- ☐ Fatigue/Weakness
- ☐ Fever/Chills
- ☐ Weight Change
- ☐ Night Sweats
### Cardiovascular
- ☐ Chest Pain
- ☐ Palpitations
- ☐ Edema
- ☐ Shortness of Breath with Activity
### Respiratory
- ☐ Cough
- ☐ Shortness of Breath at Rest
- ☐ Oxygen Use at Home
- ☐ CPAP/BiPAP Use
### Gastrointestinal
- ☐ Nausea/Vomiting
- ☐ Abdominal Pain
- ☐ Diarrhea
- ☐ Constipation
- ☐ Blood in Stool
### Genitourinary
- ☐ Incontinence
- ☐ Dysuria
- ☐ Urgency/Frequency
- ☐ Foley Catheter
### Neurological
- ☐ Numbness/Tingling
- ☐ Weakness
- ☐ Confusion
- ☐ Dizziness/Vertigo
### Skin
- ☐ Rash
- ☐ Open Wounds
- ☐ Bruising
---
## Pain Assessment
| Field | Entry |
|-------|-------|
| Pain Present? | ☐ Yes ☐ No |
| Location | |
| Character | ☐ Sharp ☐ Dull ☐ Aching ☐ Burning ☐ Stabbing |
| Intensity (0-10) | |
| Duration | ☐ Constant ☐ Intermittent |
| Aggravating Factors | |
| Relieving Factors | |
| Current Pain Management | |
---
## Fall Risk Assessment
**Morse Fall Scale** (or institutional tool)
| Risk Factor | Score |
|-------------|-------|
| History of falling | ☐ No (0) ☐ Yes (25) |
| Secondary diagnosis | ☐ No (0) ☐ Yes (15) |
| Ambulatory aid | ☐ None/Bed rest/Nurse assist (0) ☐ Crutches/Cane/Walker (15) ☐ Furniture (30) |
| IV/Heparin Lock | ☐ No (0) ☐ Yes (20) |
| Gait | ☐ Normal/Bed rest/Immobile (0) ☐ Weak (10) ☐ Impaired (20) |
| Mental Status | ☐ Oriented to own ability (0) ☐ Overestimates/forgets limitations (15) |
| **Total Score** | |
**Risk Level:**
- ☐ Low Risk (0-24)
- ☐ Moderate Risk (25-44)
- ☐ High Risk (≥45)
**Fall precautions initiated?** ☐ Yes ☐ N/A
---
## Pressure Ulcer Risk Assessment
**Braden Scale**
| Category | Score (1-4) |
|----------|-------------|
| Sensory Perception | |
| Moisture | |
| Activity | |
| Mobility | |
| Nutrition | |
| Friction/Shear | |
| **Total Score** | |
**Risk Level:**
- ☐ Mild Risk (15-18)
- ☐ Moderate Risk (13-14)
- ☐ High Risk (10-12)
- ☐ Very High Risk (≤9)
**Skin interventions initiated?** ☐ Yes ☐ N/A
---
## Skin Assessment
☐ Skin intact, no abnormalities noted
**Abnormalities (document location and description):**
| Location | Description | Size | Stage/Type |
|----------|-------------|------|------------|
| | | | |
| | | | |
---
## Nutritional Screen
| Field | Entry |
|-------|-------|
| Diet at Home | |
| Recent Weight Loss? | ☐ Yes (____lbs in ____weeks) ☐ No |
| Difficulty Swallowing? | ☐ Yes ☐ No |
| Dentures? | ☐ Yes ☐ No |
| Food Allergies/Intolerances | |
| Special Diet Needs | |
**Dietitian Referral Needed?** ☐ Yes ☐ No
---
## Functional Assessment
### Mobility
- ☐ Independent
- ☐ Assistive Device: _______
- ☐ Requires Assistance
- ☐ Bed Bound
### Activities of Daily Living
| Activity | Independent | Needs Assistance | Dependent |
|----------|-------------|------------------|-----------|
| Bathing | ☐ | ☐ | ☐ |
| Dressing | ☐ | ☐ | ☐ |
| Toileting | ☐ | ☐ | ☐ |
| Feeding | ☐ | ☐ | ☐ |
| Transfers | ☐ | ☐ | ☐ |
---
## Psychosocial Assessment
| Field | Entry |
|-------|-------|
| Living Situation | ☐ Alone ☐ With Family/Spouse ☐ Assisted Living ☐ SNF ☐ Other: _______ |
| Primary Caregiver | |
| Emergency Contact | |
| Contact Phone | |
| Relationship | |
| Barriers to Care | ☐ None ☐ Language ☐ Transportation ☐ Financial ☐ Other: _______ |
| Interpreter Needed? | ☐ Yes (Language: _______) ☐ No |
---
## Advance Directives
| Field | Entry |
|-------|-------|
| Advance Directive on File? | ☐ Yes ☐ No ☐ Unknown |
| Healthcare Proxy/POA? | ☐ Yes (Name: _______) ☐ No |
| Copy Obtained? | ☐ Yes ☐ No ☐ N/A |
| Code Status | ☐ Full Code ☐ DNR ☐ DNR/DNI ☐ Comfort Care Only |
| Physician Order for Code Status? | ☐ Yes ☐ Pending |
---
## Discharge Planning Screen
| Field | Entry |
|-------|-------|
| Anticipated Discharge Disposition | ☐ Home ☐ Home with Services ☐ Rehab ☐ SNF ☐ Unknown |
| DME Needs Anticipated? | ☐ Yes ☐ No ☐ Unknown |
| Home Health Needs? | ☐ Yes ☐ No ☐ Unknown |
| Case Management Referral? | ☐ Yes ☐ No |
| Social Work Referral? | ☐ Yes ☐ No |
---
## Safety Measures Initiated
- [ ] Fall precautions per risk level
- [ ] Skin precautions per risk level
- [ ] Call light within reach
- [ ] Bed in low position
- [ ] Side rails per policy
- [ ] Patient education on safety
---
## Orientation Provided
- [ ] Room orientation (call light, bathroom, bed controls)
- [ ] Visiting hours
- [ ] Unit phone number
- [ ] Patient rights information
- [ ] Advance directive information
- [ ] Valuables policy
---
## Assessment Completion
| Field | Entry |
|-------|-------|
| Assessment Completed By | |
| Credentials | |
| Date | |
| Time | |
| Signature | |
---
*Form FRM-INP-001 Rev 1.0 - Nursing Admission Assessment*

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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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# 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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# clinical-inpatient # Clinical Inpatient Services Quality Management System
A comprehensive QMS template designed for hospital inpatient units, nursing services, and acute care facilities. A comprehensive QMS template designed for hospital inpatient units, nursing services, and acute care facilities.
## 🏥 Designed For
- **Medical-Surgical Units** - General inpatient nursing care
- **Intensive Care Units** - ICU, CCU, SICU, MICU
- **Step-Down Units** - Progressive and intermediate care
- **Specialty Units** - Oncology, transplant, cardiac, neuro
- **Rehabilitation Units** - Acute inpatient rehabilitation
- **Observation Units** - Short-stay and clinical decision units
- **Long-Term Acute Care** - LTACH facilities
## 📋 Regulatory Framework
This template supports compliance with:
- **The Joint Commission** - Hospital accreditation standards
- **CMS Conditions of Participation** - Medicare/Medicaid requirements
- **State Hospital Licensing** - State-specific regulations
- **ANA Standards** - American Nurses Association practice standards
- **AACN Standards** - Critical care nursing standards
- **NPSG** - National Patient Safety Goals
- **OSHA** - Occupational safety requirements
- **HIPAA** - Patient privacy requirements
- **CDC/NHSN** - Healthcare-associated infection surveillance
- **Nurse Practice Act** - State-specific nursing regulations
## Repository Structure
```
├── SOPs/
│ ├── Patient-Care/ # Assessment, interventions, documentation
│ ├── Medication-Admin/ # High-alert meds, IV therapy, controlled substances
│ ├── Safety/ # Fall prevention, skin integrity, restraints
│ ├── Infection-Control/ # HAI prevention, isolation, hand hygiene
│ ├── Emergency-Response/ # Code blue, rapid response, emergency protocols
│ └── General/ # Document control, training, CAPA
├── Forms/
│ ├── Assessment-Tools/ # Admission, pain, fall risk, skin assessments
│ ├── Care-Plans/ # Interdisciplinary care plan templates
│ ├── Medication-Records/ # MAR, IV therapy, controlled substance logs
│ ├── Safety-Checklists/ # Hourly rounding, shift handoff, safety huddles
│ ├── Incident-Reports/ # Event reporting, near-miss documentation
│ └── Training/ # Competency assessments
├── Policies/ # Institutional nursing policies
├── Work-Instructions/ # Step-by-step procedures
└── Templates/ # Document templates
```
## Document Numbering Convention
- **POL-XXX**: Policies
- **SOP-PC-XXX**: Patient Care SOPs
- **SOP-MED-XXX**: Medication Administration SOPs
- **SOP-SAF-XXX**: Safety SOPs
- **SOP-IC-XXX**: Infection Control SOPs
- **SOP-ER-XXX**: Emergency Response SOPs
- **WI-XXX**: Work Instructions
- **FRM-XXX**: Forms and Records
## 🤖 AI-Powered Assistance
This repository includes **AtomicAI**, your inpatient QMS assistant. Mention `@atomicai` in any issue or pull request to:
- Draft patient care and assessment SOPs
- Create medication administration procedures
- Generate fall prevention and safety protocols
- Develop infection control procedures
- Create emergency response workflows
- Review documents for Joint Commission compliance
### Example Prompts
- "@atomicai create an SOP for central line insertion and maintenance"
- "@atomicai draft a high-alert medication double-check procedure"
- "@atomicai write a fall prevention bundle protocol"
- "@atomicai create a CLABSI prevention checklist"
- "@atomicai develop a rapid response team activation procedure"
- "@atomicai create a restraint assessment and monitoring protocol"
## Getting Started
1. **Align with Hospital Policies** - Ensure consistency with institutional requirements
2. **Customize Assessment Tools** - Adapt forms for your patient population
3. **Set Up Safety Protocols** - Implement fall prevention and skin care bundles
4. **Establish Medication Safety** - Configure high-alert medication procedures
5. **Train Staff** - Use competency assessment forms
## Key Documents to Create First
1. **Admission Assessment SOP** - Standardized patient intake process
2. **Medication Administration Policy** - Five rights, high-alert drugs
3. **Fall Prevention Protocol** - Risk assessment and interventions
4. **Pressure Injury Prevention** - Braden scale, turning schedules
5. **Shift Handoff Communication** - SBAR or standardized handoff tool
6. **Rapid Response Activation** - Criteria and escalation procedures
7. **Central Line Care Bundle** - CLABSI prevention protocol
## Special Considerations for Inpatient Care
### Patient Assessment
- Comprehensive admission assessment
- Ongoing reassessment frequency
- Pain assessment and management
- Fall risk stratification (Morse, Hendrich)
- Skin integrity (Braden scale)
### Medication Safety
- High-alert medication protocols
- Look-alike/sound-alike medications
- Independent double-check requirements
- Controlled substance management
- IV compatibility and administration
### Patient Safety
- Two-patient-identifier verification
- Hourly rounding programs
- Bed alarm and fall precautions
- Restraint use and monitoring
- Suicide risk assessment
### Infection Prevention
- Hand hygiene compliance
- Isolation precautions by type
- Central line bundle (CLABSI)
- Catheter care (CAUTI prevention)
- Surgical site infection prevention
---
*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: Patient Admission and Discharge
| Document ID | SOP-INP-001 |
|-------------|-------------|
| Title | Inpatient Admission and Discharge Process |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Patient Care Services |
---
## 1. Purpose
To establish standardized procedures for the admission and discharge of inpatients to ensure safe, efficient transitions of care and compliance with regulatory requirements.
## 2. Scope
This procedure applies to all inpatient admissions and discharges including:
- Elective admissions
- Emergency admissions
- Transfers from other facilities
- Same-day discharges
- Transfer to other levels of care
## 3. Responsibilities
### 3.1 Admitting Staff
- Complete registration and insurance verification
- Assign appropriate bed based on admission type
- Communicate with receiving unit
### 3.2 Nursing Staff
- Conduct admission assessment
- Implement physician orders
- Complete discharge education
- Ensure safe handoff
### 3.3 Attending Physician
- Complete admission orders
- Document admission H&P
- Authorize discharge
- Complete discharge summary
### 3.4 Case Management/Social Work
- Assess discharge needs
- Coordinate post-acute care
- Arrange equipment and services
## 4. Definitions
| Term | Definition |
|------|------------|
| Admission | Formal entry into inpatient status with expectation of overnight stay |
| Observation | Outpatient status with close monitoring (not admission) |
| Discharge | Formal release from inpatient care |
| Readmission | Return to inpatient status within 30 days of prior discharge |
## 5. Procedure
### 5.1 Admission Process
#### 5.1.1 Pre-Admission (Elective)
1. **Scheduling**
- Confirm surgery/procedure date
- Verify insurance authorization
- Complete pre-admission testing as ordered
2. **Pre-Admission Call**
- Review arrival instructions
- Confirm medication list
- Review NPO requirements
- Verify transportation plans
#### 5.1.2 Emergency Admission
1. **ED Assessment Complete**
- Stabilization and workup completed
- Admission decision made by physician
- Bed request placed
2. **Bed Assignment**
- Match patient needs to unit capabilities
- Consider isolation requirements
- Prioritize by acuity
#### 5.1.3 Registration and Consent
1. **Patient Registration**
- Verify demographic information
- Confirm insurance/payer
- Issue identification band
- Provide patient rights information
2. **Consent**
- General consent for treatment
- HIPAA acknowledgment
- Advance directive inquiry
- Specific procedure consents as applicable
#### 5.1.4 Nursing Admission Assessment
| Assessment Component | Documentation |
|---------------------|---------------|
| Vital signs | T, HR, RR, BP, SpO2, Pain |
| Allergies | Drug, food, environmental, reactions |
| Current medications | Name, dose, frequency, last taken |
| Medical/surgical history | Complete review |
| Chief complaint | Current presentation |
| Fall risk | Validated tool score |
| Pressure ulcer risk | Braden or similar scale |
| Nutritional screen | Weight, recent changes, intake |
| Pain assessment | Intensity, quality, location |
| Functional status | ADLs, mobility, cognition |
| Psychosocial | Social support, barriers |
3. **Safety Checks**
- [ ] Fall risk interventions implemented
- [ ] Allergies documented and visible
- [ ] Appropriate ID band (allergy band if indicated)
- [ ] Code status verified and documented
- [ ] Valuables secured
#### 5.1.5 Physician Admission Orders
Required elements:
- [ ] Diagnosis/reason for admission
- [ ] Level of care
- [ ] Diet orders
- [ ] Activity orders
- [ ] Vital sign frequency
- [ ] Medication orders (reconciled)
- [ ] IV fluids (if applicable)
- [ ] Labs and tests
- [ ] Consults
- [ ] VTE prophylaxis
- [ ] Nursing orders
### 5.2 Discharge Process
#### 5.2.1 Discharge Planning
**Initiate at Admission:**
- Anticipated length of stay
- Likely discharge disposition
- Early identification of barriers
- Case management referral if complex needs
**Ongoing Assessment:**
- Daily review of discharge readiness
- Multidisciplinary rounds participation
- Family/caregiver engagement
#### 5.2.2 Discharge Criteria
Patient must meet all applicable criteria:
- [ ] Medical condition stable or appropriately managed
- [ ] Discharge orders written by physician
- [ ] Patient/caregiver education completed
- [ ] Medications available/filled
- [ ] Follow-up appointments scheduled
- [ ] Post-acute care arranged (if needed)
- [ ] Transportation arranged
- [ ] Patient/caregiver verbalize understanding
#### 5.2.3 Medication Reconciliation
1. **Compare Lists**
- Pre-admission medications
- Inpatient medications
- Discharge medications
2. **Reconciliation Actions**
- Continued unchanged
- Dose changed
- New medication
- Discontinued (with reason)
3. **Patient Education**
- New medications explained
- Changes to existing medications explained
- Written medication list provided
- Teach-back confirmed
#### 5.2.4 Discharge Education
**Required Topics:**
| Topic | Completed | Patient Verbalized Understanding |
|-------|-----------|----------------------------------|
| Diagnosis/condition | ☐ | ☐ |
| Medications | ☐ | ☐ |
| Activity restrictions | ☐ | ☐ |
| Diet restrictions | ☐ | ☐ |
| Wound/device care | ☐ | ☐ |
| Warning signs to watch for | ☐ | ☐ |
| When to call doctor | ☐ | ☐ |
| When to seek emergency care | ☐ | ☐ |
| Follow-up appointments | ☐ | ☐ |
#### 5.2.5 Discharge Documentation
**Discharge Summary** (by physician):
- Admission diagnosis and reason
- Hospital course summary
- Significant findings
- Procedures performed
- Discharge diagnosis
- Discharge condition
- Discharge plan and instructions
- Follow-up care
**Nursing Discharge Note:**
- Discharge date and time
- Mode of transport
- Condition at discharge
- Patient/family understanding confirmed
- Discharge supplies/equipment provided
- Prescriptions given
- Follow-up appointments confirmed
### 5.3 Special Situations
#### 5.3.1 Against Medical Advice (AMA)
1. Physician discusses risks with patient
2. Document patient capacity to make decision
3. Attempt to address patient concerns
4. Complete AMA form if patient insists
5. Provide discharge instructions despite AMA status
6. Offer follow-up options
#### 5.3.2 Transfer to Another Facility
1. Accepting facility and physician confirmed
2. Complete transfer summary
3. Send copies of relevant records
4. Ensure safe transport
5. Call report to receiving unit
## 6. Documentation
- FRM-INP-001 Admission Assessment
- FRM-INP-002 Discharge Checklist
- Medication Reconciliation Form
- AMA Discharge Form (if applicable)
- Transfer Summary (if applicable)
## 7. Quality Metrics
| Metric | Target |
|--------|--------|
| Admission assessment completed within 8 hours | >95% |
| Discharge instructions documented | 100% |
| Medication reconciliation completed | 100% |
| 30-day readmission rate | Per benchmark |
| Patient satisfaction with discharge | Per benchmark |
## 8. References
- CMS Conditions of Participation
- The Joint Commission Standards
- State licensing regulations
- Institutional policies
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: [Title]
| Document ID | SOP-XXX |
|-------------|---------|
| Title | [Title] |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | [DEPARTMENT] |
---
## 1. Purpose
[State the purpose of this procedure]
## 2. Scope
[Define the scope and applicability]
## 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] |