genetics-genomics/Templates/SOP-Template.md

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]