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GRBIOMEM2510 - CMLE - Quality Management in Cancer Biomarker Testing
Course Description

Quality Management in Cancer Biomarker Testing 

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.  

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.  

Faculty/Authors

Amanda Hanson, MS 
Director, Precision Medicine 
Spartanburg Regional Healthcare System 
Spartanburg, SC  

Lynnette Pineault, MBA, SCT(ASCP)
Manager of Laboratory Operations and Genetic Counseling Services HealthPartners 
Regions Hospital
St. Paul, MN 

Physician's Competency: Patient Care, Medical Knowledge 

CMLE Credit: 1.5
Estimated Completion Time: 1.5 hour
Format: Online educational activity

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 complete the online activity. CMLE certificates will be provided online. 

Commercial Support 
This activity is supported by a sponsorship from AstraZeneca. 


Instructions

To claim CMLE credit for the exercise, do the following:

  1. Review the Technical Considerations.
  2. Click Go to Content and click the first module of the course.
  3. Complete the Demographic Survey.
  4. Complete the Pre-Test.
  5. Review the Educational Activity.
  6. Complete and submit the Post Exam. You will have a maximum of three attempts to obtain the required score. You will be notified if you have met the credit requirements after each attempt.
  7. Submit the course Evaluation.
  8. Enter the maximum number of credits offered and click Claim CMLE to register credit.

Faculty Disclosures 

Technical Considerations 

Release Dates:10/06/2025        
Review Date:
Expiration Date: 6/10/2028       




Course 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  


 

 

 
Summary
Availability:
On-Demand
Credit Offered:
1.5 CMLE Credits
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