This is an elective module of the Biomarker Testing Navigation Certificate program. This online, interactive module explores the core concepts of quality assurance (QA) and quality control (QC), the application of quality metrics specific to cancer biomarker testing, and the pivotal roles of regulatory bodies and accreditation organizations in upholding laboratory standards. The module also emphasizes the importance of effective document control systems and prepares participants for accreditation readiness in pre-analytical, analytical and post- analytical systems. Through these objectives, learners will develop the skills to implement robust quality management practices, ensuring accurate, reliable, and compliant biomarker testing that enhances patient care and meets regulatory requirements.
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Course topics include:
- Quality assurance (QA) and quality control (QC)
- Application of quality metrics specific to cancer biomarker testing
- Roles of regulatory bodies and accreditation organizations in upholding laboratory standards
- Effective document control systems
- Accreditation readiness in pre-analytical, analytical and post-analytical systems
Target Audience
This activity has been designed to meet the educational needs of pathologists and laboratory professionals.
Learning Objectives
Upon completion of this activity, you will be able to:
- Describe the principles of quality assurance (QA) and quality control (QC) in the context of biomarker testing.
- Assess and apply appropriate quality measures for cancer biomarker testing.
- Explain the distinct roles of regulatory bodies and accreditation organizations in ensuring laboratory quality.
- Implement and maintain effective document control systems to uphold laboratory quality standards.
- Ensure accreditation readiness for pre-analytical and analytical systems in biomarker testing.
Faculty
Amanda Hanson, MS
Director, Precision Medicine
Spartanburg Regional Healthcare System
Spartanburg, SC
Lynnette Pineault, MBA, SCT(ASCP)
Manager of Laboatory Operations and Genetic Counseling Services
HealthPartners Regions Hospital
St. Paul, MN
Faculty Disclosures
Amanda Hanson has no financial relationships to disclose.
Credit Designation Statement
ASCP designates this activity for a maximum of 1.5 CMLE credit. This activity meets CMP and state re-licensure requirements for laboratory personnel.
For questions regarding CMLE credit, please contact ASCP Customer Service at 1-800-267-2727, option 2, in the US & Canada or internationally at access code + 3-1-312-541-4890. Monday-Friday, 8am-5pm CT.
Method of Participation
To complete the activity and receive credit, the participant must participate in the online activity. CMLE certificates will be provided online.
Commercial Support
This activity is supported by a sponsorship from AstraZeneca.