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