Sync template from atomicqms-style deployment

SOPs/General/SOP-001-Document-Control.md

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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] |

SOPs/General/SOP-002-CAPA.md

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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] |

SOPs/General/SOP-003-Training.md

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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] |

SOPs/General/SOP-004-Internal-Audit.md

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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] |

SOPs/General/SOP-005-Management-Review.md

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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] |

SOPs/Safety/.gitkeep

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+# Placeholder

SOPs/Specimen-Handling/SOP-PATH-001-Specimen-Accessioning.md

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+# Standard Operating Procedure: Pathology Specimen Accessioning
+
+| Document ID | SOP-PATH-001 |
+|-------------|-------------|
+| Title | Pathology Specimen Accessioning and Processing |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Anatomic Pathology |
+
+---
+
+## 1. Purpose
+
+To establish standardized procedures for the receipt, accessioning, and initial processing of pathology specimens to ensure proper identification, optimal preservation, and regulatory compliance.
+
+## 2. Scope
+
+This procedure applies to all anatomic pathology specimens including:
+- Surgical pathology specimens
+- Cytology specimens
+- Skin biopsies
+- Bone marrow biopsies
+- Autopsy specimens
+
+## 3. Responsibilities
+
+### 3.1 Accessioning Staff
+- Receive and log specimens
+- Verify specimen-requisition match
+- Assign case numbers
+- Distribute to appropriate areas
+
+### 3.2 Histology Technician
+- Process tissue specimens
+- Embed and section specimens
+- Prepare slides for pathologist review
+
+### 3.3 Pathologist
+- Perform gross examination
+- Dictate gross description
+- Review slides and render diagnosis
+
+### 3.4 Laboratory Director
+- Ensure quality standards
+- Review policies and procedures
+- Oversee accreditation compliance
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Accession | Process of receiving and logging specimens |
+| Fixation | Chemical preservation of tissue |
+| Grossing | Macroscopic examination and description |
+| Cassette | Container for tissue during processing |
+| Block | Paraffin-embedded tissue section |
+
+## 5. Equipment and Materials
+
+- Specimen containers (various sizes)
+- 10% neutral buffered formalin (NBF)
+- Requisition forms
+- Barcoded labels
+- Cassettes
+- Tissue processor
+- Embedding station
+- Microtome
+- Slides and coverslips
+
+## 6. Procedure
+
+### 6.1 Specimen Receipt
+
+#### 6.1.1 Verification at Receipt
+Upon receiving each specimen:
+- [ ] Container properly labeled with patient identifiers
+- [ ] Requisition form accompanies specimen
+- [ ] Container intact without leakage
+- [ ] Specimen in appropriate fixative (if applicable)
+- [ ] Time of collection documented
+
+#### 6.1.2 Label Verification
+
+**Minimum required on container:**
+| Element | Present |
+|---------|---------|
+| Patient name | ☐ |
+| Second identifier (MRN, DOB) | ☐ |
+| Specimen type/site | ☐ |
+| Date of collection | ☐ |
+| Collector identification | ☐ |
+
+**Requisition must include:**
+| Element | Present |
+|---------|---------|
+| Patient name and identifiers | ☐ |
+| Ordering physician | ☐ |
+| Specimen source/site | ☐ |
+| Clinical history | ☐ |
+| Date/time of collection | ☐ |
+| Date/time of receipt in lab | ☐ |
+
+#### 6.1.3 Discrepancy Handling
+
+If discrepancies exist:
+1. Do NOT accessioned until resolved
+2. Contact ordering physician/collector
+3. Document resolution in LIS
+4. Complete discrepancy log
+
+| Discrepancy Type | Required Action |
+|------------------|-----------------|
+| Name mismatch | Contact collector, do not process |
+| Missing information | Request completion before accessioning |
+| Damaged container | Document, assess specimen integrity |
+| No requisition | Hold specimen, request requisition |
+| Unlabeled specimen | Do not process until properly labeled |
+
+### 6.2 Accessioning
+
+#### 6.2.1 Case Number Assignment
+1. Log specimen into Laboratory Information System (LIS)
+2. System assigns unique accession number
+3. Format: [Year]-S[Sequential#] (e.g., 2024-S12345)
+4. Generate specimen labels
+
+#### 6.2.2 Labeling
+1. Apply barcoded labels to:
+   - Specimen container
+   - Cassettes
+   - All associated paperwork
+2. Verify label matches requisition
+3. Apply orientation labels if applicable
+
+#### 6.2.3 Specimen Categorization
+
+| Category | Description | Priority |
+|----------|-------------|----------|
+| Routine | Standard turnaround | 2-3 days |
+| Rush | Expedited processing | 24-48 hours |
+| STAT | Emergency | Same day |
+| Intraoperative | Frozen section | Immediate |
+
+### 6.3 Fixation Assessment
+
+#### 6.3.1 Optimal Fixation Times
+
+| Specimen Type | Minimum | Optimal | Maximum |
+|---------------|---------|---------|---------|
+| Small biopsy (≤5mm) | 6 hours | 6-12 hours | 24 hours |
+| Medium tissue (5-15mm) | 12 hours | 12-24 hours | 48 hours |
+| Large specimen (>15mm) | 24 hours | 24-48 hours | 72 hours |
+
+#### 6.3.2 Fixative Requirements
+- Standard: 10% neutral buffered formalin (10:1 ratio)
+- Breast tissue for biomarkers: Cold ischemia <1 hour, fixed within 1 hour
+- Special fixatives per protocol (e.g., Bouin's, B5)
+
+Document:
+- Time of collection (if available)
+- Time of receipt in fixative
+- Time placed in processor
+
+### 6.4 Gross Examination (Grossing)
+
+#### 6.4.1 Pre-Grossing Preparation
+1. Verify specimen identity
+2. Review clinical history and prior pathology
+3. Gather appropriate supplies
+4. Photograph specimen (if indicated)
+
+#### 6.4.2 Gross Description Components
+
+**Standard elements:**
+- [ ] Specimen type and site
+- [ ] How received (container, fixative)
+- [ ] Dimensions (3 measurements)
+- [ ] Weight (if applicable)
+- [ ] External appearance
+- [ ] Cut surface appearance
+- [ ] Lesion description (size, location, margins)
+- [ ] Sections submitted summary
+
+**For resection specimens:**
+- [ ] Orientation (sutures, clips, inks)
+- [ ] Margin assessment
+- [ ] Lymph node identification
+- [ ] Relationship of lesion to margins
+
+#### 6.4.3 Inking Protocol
+
+| Color | Common Usage |
+|-------|--------------|
+| Black | Anterior/superficial |
+| Blue | Posterior/deep |
+| Green | Superior |
+| Orange | Inferior |
+| Red | Medial |
+| Yellow | Lateral |
+
+Document inking scheme in gross description.
+
+#### 6.4.4 Section Submission
+
+| Specimen Type | Standard Sections |
+|---------------|-------------------|
+| Small biopsy | Entire specimen |
+| Skin ellipse | 3mm cross-sections, all margins |
+| Breast lumpectomy | Lesion, margins (6 directions), representative |
+| Colon resection | Tumor (4 sections), margins, nodes, mucosa |
+
+### 6.5 Tissue Processing
+
+#### 6.5.1 Processing Steps
+1. Dehydration (graded alcohols)
+2. Clearing (xylene)
+3. Infiltration (paraffin)
+4. Total processing time: 8-14 hours
+
+#### 6.5.2 Processing Schedules
+
+| Schedule | Duration | Specimen Types |
+|----------|----------|----------------|
+| Routine overnight | 12-14 hours | Standard specimens |
+| Extended | 16-20 hours | Fatty tissue, large specimens |
+| Rapid | 2-4 hours | Urgent specimens |
+| Rush microwave | 1-2 hours | STAT specimens |
+
+### 6.6 Embedding
+
+1. Orient tissue in cassette per protocol
+2. Embed in paraffin at 60°C
+3. Cool on cold plate
+4. Verify block identity
+
+### 6.7 Microtomy
+
+1. Face block until full tissue visible
+2. Cut at specified thickness (typically 4-5 µm)
+3. Float sections on warm water bath
+4. Pick up on labeled slide
+5. Dry slides before staining
+
+### 6.8 Slide Preparation
+
+1. H&E staining (routine)
+2. Special stains per request/protocol
+3. Immunohistochemistry as ordered
+4. Coverslip slides
+5. Verify slide-block-patient match
+
+## 7. Quality Control
+
+### 7.1 Daily QC
+- [ ] Reagent checks
+- [ ] Processor function verification
+- [ ] Temperature monitoring
+- [ ] Staining controls
+
+### 7.2 Specimen Quality Metrics
+
+| Metric | Target |
+|--------|--------|
+| Specimen rejection rate | <2% |
+| Accessioning errors | <0.5% |
+| Lost specimens | 0 |
+| Turnaround time (routine) | ≤48 hours |
+| Block/slide discrepancies | <0.1% |
+
+## 8. Documentation
+
+- FRM-PATH-001 Specimen Receipt Log
+- FRM-PATH-002 Gross Description Template
+- FRM-PATH-003 Processing Log
+- Discrepancy reports
+- QC logs
+
+## 9. References
+
+- CAP Laboratory Accreditation Checklist
+- ASCO/CAP Guidelines for Biomarker Testing
+- CLIA regulations
+- Institutional policies
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |