98 lines
5.0 KiB
Markdown
98 lines
5.0 KiB
Markdown
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# Quality Policy - Genetics & Genomics Laboratory
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| Document ID | POL-001 |
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| Title | Quality Policy |
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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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---
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## 1. Policy Statement
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[LABORATORY NAME] is committed to providing high-quality clinical genetic and genomic testing services that consistently meet patient care needs, healthcare provider expectations, and applicable regulatory requirements. We strive for continual improvement of our Quality Management System to enhance the accuracy, clinical validity, and clinical utility of our genetic testing services while maintaining the highest standards of patient privacy and data security.
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## 2. Quality Objectives
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Our genetics and genomics laboratory commits to:
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1. **Analytical Accuracy**: Ensuring accurate variant detection, classification, and reporting according to ACMG/AMP guidelines and CAP molecular pathology standards
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2. **Clinical Validity**: Providing clinically meaningful genetic test results that support patient care decisions
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3. **Regulatory Compliance**: Maintaining compliance with CAP, CLIA, FDA, HIPAA, GINA, and other applicable regulations
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4. **Patient Privacy**: Protecting the confidentiality and security of genetic information for patients and family members
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5. **Continuous Improvement**: Continually improving the effectiveness of our QMS through proficiency testing, quality metrics monitoring, and corrective actions
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6. **Scientific Excellence**: Staying current with evolving variant classification guidelines, genomic discoveries, and clinical evidence
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7. **Ethical Practice**: Upholding ethical standards in genetic testing, including appropriate consent, secondary findings management, and family communication
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8. **Staff Competency**: Ensuring all personnel are properly trained and competent in molecular genetics, bioinformatics, and variant interpretation
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## 3. Management Commitment
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Top management demonstrates commitment to the QMS by:
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- Ensuring the quality policy is appropriate to the laboratory's mission of providing clinical genetic testing services
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- Ensuring quality objectives align with patient care needs and clinical utility
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- Ensuring integration of QMS requirements into all testing processes from sample receipt to result reporting
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- Promoting evidence-based variant classification and adherence to professional guidelines (ACMG, AMP, ClinGen)
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- Ensuring resources needed for the QMS are available, including bioinformatics infrastructure and variant databases
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- Communicating the importance of analytical accuracy, clinical validity, and data privacy
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- Ensuring the QMS achieves its intended results of accurate and timely genetic testing
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- Supporting participation in CAP proficiency testing and external quality assessment
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- Fostering collaboration with genetic counselors and clinical genetics professionals
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## 4. Scope
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This policy applies to all employees, contractors, genetic counselors, laboratory directors, bioinformaticians, and processes within the scope of our Clinical Genetics and Genomics Laboratory Quality Management System, including:
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- Germline genetic testing for hereditary conditions
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- Somatic variant testing for cancer genomics
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- Pharmacogenomics testing
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- Next-generation sequencing (NGS) operations
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- Variant interpretation and classification
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- Genetic counseling coordination
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- Biobanking and research specimen management
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- Bioinformatics pipeline operations and validation
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## 5. Compliance Framework
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Our quality policy ensures compliance with:
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- **CAP Molecular Pathology Checklist** (MolPath)
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- **CLIA** regulations for high-complexity testing
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- **ACMG/AMP** variant classification guidelines
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- **ACMG Secondary Findings** recommendations (SF v3.2)
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- **GINA** - Genetic Information Nondiscrimination Act
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- **HIPAA** - Privacy and security of genetic health information
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- **FDA** guidance for NGS-based tests
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- **ISO 15189** - Medical laboratory quality and competence
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- **State regulations** for genetic testing laboratories
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## 6. Communication
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This policy shall be:
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- Communicated and understood within the laboratory organization
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- Made available to clinical staff, genetic counselors, and ordering providers as appropriate
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- Posted in laboratory work areas
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- Reviewed annually for continuing suitability
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- Updated to reflect changes in regulatory requirements or professional guidelines
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## 7. Patient-Centered Care
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We recognize that genetic test results impact not only individual patients but also family members who may share genetic variants. Our quality commitment extends to:
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- Providing accurate and timely genetic testing results
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- Supporting informed decision-making through collaboration with genetic counseling services
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- Respecting patient autonomy in secondary findings preferences
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- Protecting genetic information privacy
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- Facilitating family cascade testing when appropriate
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- Ensuring age-appropriate consent for pediatric genetic testing
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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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