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SOPs/Emergency-Response/.gitkeep Normal file
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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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# Placeholder