ITLPEDUC2509 - CME/CMLE - Oversight of LDTs: What We’ve Learned
Course Description
Faculty/Authors

Michelle R. Campbell, MS, MLS(ASCP)CMMBCM,SCCM
Senior Developer
Translational Research, Innovation, and Test Development Office
Mayo Clinic
Rochester, MN 

Eric Q. Konnick, MD, MS
Associate Professor, Department of Laboratory Medicine and Pathology
University of Washington
Seattle, WA 

CME/CMLE Credit: 1.0
Estimated Completion Time: 1 hour
Format: Online Educational Activity

Physician Competencies: Systems-based Practice 

Accreditation Statement:
The American Society for Clinical Pathology (ASCP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education (CME) for physicians. This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME).

Credit Designation Statement 

The ASCP designates this activity for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only credit commensurate with the extent of their participation in the activity.  

ASCP designates this activity for a maximum of 1 CMLE credit.  This activity meets CMP and state re-licensure requirements for laboratory personnel.  

For questions regarding CME 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. 

Instructions

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

  1. Review the Technical Considerations.
  2. Review the Faculty Disclosures.
  3. Click Go to Course to view an overview of the modules in this course.
  4. Click Access to begin the course.
  5. Review the Educational Activity.
  6. Submit the course Evaluation.
  7. Enter the maximum number of credits offered and click Claim CME to register credit.
Faculty Disclosure 1
Faculty Disclosure 2

Technical Considerations

Release Date: 11/19/2025 
Review Date:
Expiration Date: 11/19/2028  

Course Objectives
Following completion of this activity, you will be able to:

  • Describe what LDTs are, how laboratories develop them and why, and how their accuracy and validity are established by the laboratorians developing them; 

  • Conceptualize of appropriate use cases for LDTs 

  • Describe strategies used by lab professional advocacy groups during this round of legislative discussions that had demonstrated success with regulators. 

Summary
Availability:
On-Demand
Credit Offered:
1 CME/CMLE Credit
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