102 lines
2.1 KiB
Markdown
102 lines
2.1 KiB
Markdown
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# Standard Operating Procedure: [Title]
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| Document ID | SOP-XXX |
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|-------------|---------|
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| Title | [Title] |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | Genetics & Genomics Laboratory |
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---
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## 1. Purpose
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[State the purpose of this procedure]
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## 2. Scope
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[Define the scope and applicability - e.g., germline testing, somatic testing, specific genes/panels]
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## 3. Responsibilities
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### 3.1 Laboratory Director
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- [Responsibility]
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- [Responsibility]
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### 3.2 Clinical Molecular Geneticist
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- [Responsibility]
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- [Responsibility]
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### 3.3 Genetic Counselor
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- [Responsibility]
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- [Responsibility]
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### 3.4 Bioinformatician
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- [Responsibility]
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- [Responsibility]
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### 3.5 Laboratory Technologist
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- [Responsibility]
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- [Responsibility]
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## 4. Definitions
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| Term | Definition |
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|------|------------|
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| ACMG | American College of Medical Genetics and Genomics |
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| AMP | Association for Molecular Pathology |
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| VAF | Variant Allele Frequency |
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| VUS | Variant of Uncertain Significance |
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| NGS | Next-Generation Sequencing |
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| SNV | Single Nucleotide Variant |
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| CNV | Copy Number Variant |
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| [Term] | [Definition] |
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## 5. Procedure
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### 5.1 [Section Title]
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[Procedure steps]
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### 5.2 [Section Title]
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[Procedure steps]
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## 6. Quality Control
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- [QC checkpoints]
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- [Acceptance criteria]
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- [Monitoring procedures]
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## 7. Related Documents
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- [List related procedures, forms, etc.]
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- Example: SOP-VI-001: ACMG/AMP Variant Classification
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- Example: FRM-VC-001: Variant Classification Worksheet
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## 8. References
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### Regulatory References
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- CAP Molecular Pathology Checklist
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- CLIA regulations for high-complexity testing
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- [Applicable state regulations]
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### Professional Guidelines
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- ACMG/AMP Standards and Guidelines for the Interpretation of Sequence Variants (2015)
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- ACMG Secondary Findings Recommendations (SF v3.2)
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- [Other applicable guidelines]
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### Scientific Literature
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- [Key publications]
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- [Evidence base]
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---
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## Revision History
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| Rev | Date | Description | Author |
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|-----|------|-------------|--------|
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| 1.0 | [DATE] | Initial release | [AUTHOR] |
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